ACL TOP Family Operator's Manual

Help ♦ Version 5.2 ♦ P/N 00027503450 R00 ♦ 2014

Manufacturer EU Authorized Representative

Instrumentation Laboratory Instrumentation Laboratory SpA
180 Hartwell Road Viale Monza 338
Bedford, MA 01730-2443 20128 Milan
USA Italy
Phone: 781-861-0710 Phone: +39-02-25-22-1
Fax: 781-861-1908 Fax: +39-02-25-75-250
www.ilus.com Email: [email protected]
www.il-italia.it

®ACL TOP is a registered trademark of Instrumentation Laboratory Co.

 ACL TOP Family Operator's Manual

© Copyright 2014 Instrumentation Laboratory

All Rights Reserved
This publication and any and all materials (including software) related to the products of IL are of a
proprietary nature and are communicated on a strictly confidential basis; they may not be reproduced,
recorded, stored in a retrieval system, transmitted or disclosed in any way or by any means whatsoever,
whether electronic, mechanical through photocopying or otherwise, without IL’s prior written consent.
Information contained herein is believed by IL to be accurate; in any event, no responsibility, whether
expressed or implied, is assumed hereby by IL for or in connection with the use thereof, or for infringement
of any third party rights that might arise therefrom, or from any representation or omissions contained therein.

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Table of Contents

Table of Contents iii

CHAPTER 1 About This Manual 1
Welcome to Help 1
Important Symbols 7
Hazards 8
CHAPTER 2 General Information 10
General Information Overview 10
Intended Use 11
Symbols 11
Measured Parameters 13
Operating Principles 13
Instrument Description 15
Modules 15
ACL TOP 300 Model 15
ACL TOP 500 CTS Model 16
ACL TOP 700/ TOP 700 CTS Models 17
ACL TOP 700 LAS Model 18
Instrument Safety Covers 19
Power Connector 19
Emergency Stop Button 20
Keypad 21
Laboratory Automation System (LAS) 22
LAS Arm and Probe 23
LAS Probe Aspirating from Sample on the LAS Track 24
Cuvette Loading Area 25
Bar Code Reader 27
Sample Area 28
Diluent Area 30
Reagent Area 31
Probe 33
Incubators 34
Optical Reading Unit 34
System Fluids – Rinse and Clean 35
Fluid Waste 38
Monitor and Volume Control 42
Calibrating the All-in-One CM Monitor Touch Screen 42
All In One Monitor Diagrams 43
Configuring Volume Control on the ELO Touchsystems Entuitive Monitor 45
Manufacturer 46

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Certification 47
CE Certification 47
CSA Certification 47
Other Certification 48
System Specifications 49
ACL TOP 300 CTS Specifications 50
ACL TOP 500 CTS Specifications 52
ACL TOP 700 and 700 CTS Specifications 54
ACL TOP 700 LAS Specifications 57
Test Performance 60
Typical Precision Performance 60
Interference 66
Analytical Limitations 67
Installing the ACL TOP Instrument 68
Site Requirements 68
Limited Warranty 68
Spatial Requirements 69
Electrical Requirements 71
Actions Upon Delivery 74
Bringing Into Operation 74
Training Requirements 75
Warranty 76
Limitations and Disclaimers 77
CHAPTER 3 User Interfaces 79
User Interfaces 79
Input Devices 79
Touch Screen 79
Mouse 80
Keyboard 80
Bar Code Reader 80
Two-Dimensional Bar Code Reader 80
Push Buttons 80
LIS 80
CD-ROM Drive 80
Output Devices 81
Getting Started 82
Terminology 83
Calibration/NPP 83
Cuvettes 83
Incubators 87
LAS Terminology 87
Material 90

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Optical Reading Unit (ORU) 91

Visual Styles 92
Layout 92
Main Screen 93
ACL TOP Family Software Main Screen 93
Menu Bar 94
Toolbar 99
General Toolbar 99
Operations Toolbar 100
Navigation Toolbar 101
Other Commonly Used Toolbar Icons 102
Icon Tooltips 102
Moving the Toolbars 103
Toolbar Icon Drop-down Menu 103
Working Area 104
Navigation Toolbar 104
Analysis Menu 104
Scrolling 104
Unique Identifiers 104
Status Bar 106
General Log Icon 106
Analyzer Status 106
LIS Status 107
Auto Run Status 107
LAS Status 107
Alarm Buttons 108
Information Panel 109
Time To Completion 109
User ID 109
Security Level 109
Number of Entries 109
Current Date and Current Time 109
Common Functions Overview 110
Logging In 111
Placing Focus 112
Placing Focus on an Item 112
Combinations of Select and Focus 113
Selecting Objects 114
Selecting All the Objects in a List 114
Adding an Item 115
Viewing an Item 115
Deleting an Item 116
Sorting Lists 116

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Filtering Data 117

Find and Auto-Search 118
Save 119
Restore 119
Previous Screen 119
Print 120
Printing an Entire List 120
Printing Selected Data 120
Print Screen 121
Run / Auto Run 122
Overview 122
After Initiating a Test 123
Running Tests on Manually Loaded Samples 123
Enabling and Resuming Auto Run 124
Exporting Data 125
Exporting an Entire List 125
Exporting Selected Data 125
Cancel / Stop / Progress Bar 127
Exit 127
CHAPTER 4 Setup 128
Material List 128
Accessing the Material List 128
Filtering the Material List 128
Material List Toolbar 129
Material List Actions Menu 130
Material List Table 132
Material Definition 135
Viewing and Adding Material Definitions 135
Configuring Reporting of INR Results 136
Material Definition Actions Menu 137
Material Definition – Toolbar 138
Assigned Values 155
Overview 155
Viewing, Editing, Printing, Exporting Assigned Values 155
Assigned Values for Calibration 156
Assigned Values for QC 157
Test List 158
Accessing the Test List 158
Filtering the Test List 158
Viewing a Test Definition 158
Printing and Exporting a Test Definition Report – Single Test 159
Printing and Exporting a Test Definition Report – Multiple Tests 159
Adding/Creating a User-Defined Test 160

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Copying a Test 160

Deleting a Test Definition 161
Enabling or Disabling a Test 162
Finding a Test 162
Test List Toolbar 163
Test List Actions Menu 163
Test List Screen 164
Test Definition 166
Viewing a Test Definition 166
Printing and Exporting a Test Definition Report – Single Test 166
Printing and Exporting a Test Definition Report – Multiple Tests 166
Creating a User-Defined Test 167
Test Definition Operations Toolbar 167
General Information Screen 169
Accessing the General Information screen 169
General Information Actions Menu 170
General Information 171
Assay 172
Manual validation required 172
Enable as Shadow Test 173
Enable as Paired Test 174
Consistency Check 175
Analytical Cycle Definition 176
Overview 176
Adding a Material Load Cycle Definition – for user-defined tests 176
Deleting a Material Load Cycle Definition – for user-defined tests 177
Analytical Cycle Definition Screen Toolbar 178
Analytical Cycle Definition Screen 179
Material/Sample Load Cycle Definition Screen 183
Sample Pre-Dilution 190
Overview 190
Accessing the Sample Pre-Dilution Screen 190
Sample Pre-dilution Screen 190
General Tab 191
Sample/Mixture Tab 193
Diluent tab 197
Alternative Pre-Dilution 201
Overview 201
Accessing the Alternative Pre-dilution Screen 201
Alternative Pre-dilution Screen 201
General Tab 203
Data Reduction Parameters 212
Configuring Data Reduction Parameters for the Primary Wavelength 212
Primary Wavelength 212
Wavelength Definition 214

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Overview 214
Accessing the Wavelength definition screen 214
Wavelength Definition screen 215
Raw Data Checks 218
Overview 218
Accessing the Raw Data Checks screen 218
Raw Data Checks screen 219
Normalized Data Checks 225
Overview 225
Accessing the Normalized Data Checks Screen 225
Normalized Data Checks Screen 226
Baseline Check Tab 228
Endpoint Check tab 229
Multiple Threshold Check Tab 230
Primary Algorithm 232
Accessing Primary Algorithm Parameters 232
Primary Algorithm Screen 232
Enable Primary Algorithm 233
Endpoint Algorithm 233
Linear Kinetic Algorithm 234
Linear Kinetic Algorithm Screen 235
Threshold Algorithm 240
First and Second Derivative Algorithms 243
Delta Algorithm 254
Delta Second Derivative Tab 255
Final Minus Initial Algorithm 256
Statistics Algorithm 259
Secondary Algorithm 261
Result Unit Definition 262
Accessing the Result Unit Definition screen 262
Viewing and Editing Measured Units 262
Deleting a Result Unit 263
Result Unit Definition 264
Result Unit Definition Screen 266
Calibration Setup 272
Accessing the Calibration Definition screen 272
Accessing the Pre-diluted Calibrators screen 273
Calibration Definition Screen 274
Enable calibration 274
General tab 275
Frequency Tab 278
DR Parameters Tab 279
Math Model tab (or Math Model High) 280
Math Model Low Tab 283
Automatic Dilution Screen 284
General Tab 285

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Calibrator Tab 292

Diluent Tab 296
Pre-diluted Calibrators Screen 299
Column Headings 299
Configuring Factor Parallelism 301
Overview 301
Factor Parallelism Testing Options 302
Factor Parallelism Criteria 306
IL Tests Default Criteria 307
Determining Factor Activity Using Factor Parallelism (multiple sample dilutions) 308
Examples of Factor Parallelism results 310
Parallelism Setup 312
Overview 312
Viewing and Editing the Parallelism Definition Screen 312
Parallelism Definition Screen 313
Analytical Cycle tab 314
Data Reduction Tab 315
Normal Pool Plasma Setup 320
Test Definition – Normal Pool Plasma Screen 321
General Tab 322
Frequency Tab 324
Rerun Rules Setup 325
Overview 325
Consistency Check 332
Performing a Consistency Check 332
Consistency Check Window 332
QC List 333
Accessing the QC List 333
QC List Toolbar 333
QC List screen 334
QC Setup Definition 335
Accessing the QC Setup Definition screen 335
QC Setup Definition screen 336
Test Profiles List 342
Accessing the Test Profiles List 342
Configuring the Standard Test Profile 344
Test Profiles List Toolbar 344
Test Profiles List Screen 345
QC Profiles List 346
Accessing the QC Profiles List 346
QC Profiles List Toolbar 346
QC Profiles List Column Descriptions 347
Defining QC Profiles 348
Creating a QC Profile 348

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Viewing a QC Profile 349

Editing a QC Profile 349
Deleting a QC Profile 349
Reflex Rules 351
Creating a Reflex Rule 351
Viewing or Editing a Reflex Rule 351
Reflex List Operations Toolbar 352
Reflex List 352
Auto-Validation Setup 355
Configuring Auto-Validation 355
Revision History Report 359
Importing and Exporting Definitions 360
Overview 360
Exporting Definitions 361
Importing Definitions 363
Field Descriptions 365
Global Definitions Setup 366
Setting Up Global Definitions 366
Global Definitions Setup Screen 366
Bar Code Definitions Setup 373
Configuring Bar Code Reading 373
Bar Code Definitions screen 374
Bar Code Label Placement 376
LIS Configuration 377
Overview 377
Configuring Communication with an LIS 377
Performing a Manual LIS Query 377
Host Communications Configuration Tab 378
ASTM-1394 Configuration Tab 380
Communications Configuration Tab 381
Sender List 382
Accessing the Sender List 382
Sender List 382
LAS Overview 383
Definition 383
Sample Workflow 384
Prioritization of Samples 385
Communication 385
Hazards and Warnings 386
LAS Terminology 386
LAS Configuration 387
Accessing the LAS Configuration screen 387
LAS Configuration tab 388
LAS Interface Module Configuration tab 391

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LAS Tube Types tab 391

System Security 392
User Security List 392
Accessing the User Security List 392
User Security List screen 393
Adding and Editing Users 394
Adding a New User 394
Unlocking a User 395
Editing a User 395
User Security Screen 397
Software Access Screen 399
Accessing the Software Access Screen 399
Formatting Reports 400
Configuring Reports 400
Laboratory Header Tab 401
Demographic Tab 402
Footer Tab 402
AutoPrint Setup Tab 403
Display Overview 404
Sample List Display Settings 405
Test Programming Window 406
Configuring the Test/Profiles Programming Window 406
Material Programming Window 407
Configuring the Material Programming Window 407
Setup Language 408
CHAPTER 5 Preparing the System 409
Additional Preparation 409
Material Identification 410
Manually Identifying Offline Rack Material 410
Manually Identifying Inserted Rack Material 411
Automatic Material Identification – Using the Bar Code Reader 412
Manual Material Identification – Using the Offline Rack 413
Bar Code Reader 414
TOP 300 CTS Bar Code Reader 415
TOP 500 CTS Bar Code Reader 415
TOP 700 Bar Code Reader 416
2D Bar Code Scanner 417
Overview 417
Setup 417
Using the 2D Bar Code Scanner 418
Verified Barcode Material Data dialog box 419
Reaction Cuvettes 422

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Rinse Fluid 423

Overview 423
Changing the Rinse Fluid 424
Clean Fluid 425
Overview 425
Changing the Clean Fluid 426
Fluid Waste 427
Reagents 430
Calibrators and NPP 431
Quality Controls 431
Samples 432
Sample Containers and Adapters 433
Sample Adapters for Open and Closed Tubes 433
Sarstedt Closed Tube Sample (CTS) Racks 435
Old Style Sarstedt Closed Tube Sample (CTS) Rack and Adapters 437
Validated Uncapped Sample Containers 439
Validated Uncapped Sample Containers for LAS – Track Only 441
Validated Capped Sample Containers for CTS – Piercing Mode Enabled 442
Validated Capped Sample Containers for CTS – Low-Fill Tubes 444
Sample Containers Not Recommended for CTS 445
Diluents 447
Restriction Map 448
Overview 448
Accessing the Restriction Map 448
TOP 500 CTS Restriction Map 450
TOP 700 Restriction Map 451
TOP 700 LAS Restriction Map 452
Closed Tube Sampling 453
Overview 453
Enabling/Disabling CTS Mode 454
Closed Tube Sampling (CTS) Probe 455
Sarstedt Closed Tube Sample (CTS) Rack and Adapters 457
Sample Area 458
Reagent Area 458
Accessing the Reagent Area and Rack Details 458
Programming Non-Bar Coded Reagents Using the Offline Rack 459
Viewing On-board Materials 460
Reagent Area Operations Toolbar 461
Reagent Rack Details Operations Toolbar 462
Reagent Area Screen 464
Reagent Rack Details Screen 468
Offline or Virtual Rack 471
Diluent Area 472
Accessing the Diluent Area 472

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Diluent Area 473

Viewing On-board Materials 476
Diluent Rack Details 476
Reagent/Diluent Area 477
Overview 477
Accessing the Reagent/Diluent Area and Rack Details 477
Programming Non-Bar Coded Reagents Using the Offline Rack 478
Viewing On-board Materials 478
Reagent/Diluent Area Operations Toolbar 479
Reagent Rack Details Operations Toolbar 480
Reagent/Diluent Area Screen 481
Reagent Rack Details Screen 486
Offline Racks 489
Diluent Rack Details Screen 490
Test Feasibility 492
Accessing The Test Feasibility List 492
Test Feasibility List window 492
Test Feasibility List Tab 493
QC Feasibility List Tab 497
Refresh/Close 498
CHAPTER 6 Starting and Stopping the Instrument 499
Starting and Stopping Overview 499
Starting the Instrument 499
Shutting Down the Instrument 501
Emergency Stop 502
Controlled Stop 503
Resume Auto Run 504
Recovery 505
Performing a Recovery Operation 505
Performing a Forced Recovery 506
CHAPTER 7 Calibration 507
Calibration Details 507
Overview 507
Reviewing and Validating Calibration Test Results 508
Viewing Calibration Curves 509
Deleting a Calibration Point Value 510
Printing and Exporting a Calibration Report 511
Calibration Details Screen 513
Calibration Curve Tab 513
Calibration Status List 520
Performing a Calibration 522
CHAPTER 8 Normal Pool Plasma 525
NPP Status Details 525

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Overview 525
Reviewing NPP Results 525
Recalculating NPP Test Results 526
Printing an NPP List Report 526
Printing an NPP Results Report 527
Exporting a Report 527
NPP Status List Screen 528
Performing a Normal Pool Plasma Measurement 531
Programming an NPP in the NPP Details screen 531
Programming an NPP from the Sample Rack Details screen 532
Automatic NPP 532
CHAPTER 9 Quality Control 533
QC Overview 533
QC Performed on Alternate Lots 533
Activating an Alternate Lot 533
QC Results List 534
Accessing the QC Results List 534
QC Results List 535
QC Test Status List 537
Accessing the QC Test Status List 537
QC Test Status List screen 537
Performing a Quality Control Test 538
Programming QC in the QC Test Status List 538
Programming QC in the Sample Rack Details screen 542
Enabling Automatic QC 543
Programming a QC Profile 543
Reviewing QC Results 545
Viewing and Filtering the QC Results 545
Viewing QC Statistics in Chart and Grid View 546
Adding or Viewing Comments 547
Tracking QC Information 547
Viewing Reaction Curves 547
Omitting Points 548
Restoring Points 548
Purging Data 549
Setting Statistics as Target 550
Activating an Alternate Lot 550
Uploading results to the LIS 550
Filtering Results for Printing Reports 550
Printing QC Test Status Reports 555
Exporting Reports 555
QC Statistics Screen 556
Active Lot Tab 557
Chart View 558
Grid View 562

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Grid Plus Chart View 564

Multi-Chart View 565
CHAPTER 10 Sample Analysis 566
Sample Collection and Storage 566
Plasma Collection 566
Plasma Separation 566
Sample Area 567
Accessing the Sample Area 567
Viewing On-board Materials 568
Sample Area Operations Toolbar 569
Sample List Toolbar 570
Sample Area Screen 571
Restriction Map 575
Racks 580
Track Control Panel 583
Bar Code Reader Indicator 583
LAS Cuvette Holding Area 585
LAS Cuvette Holding Area Operations Toolbar 586
Sample Rack Details 590
Accessing Sample Rack Details 590
Deselecting Tests 591
Sample Area Toolbar 591
Sample Rack Details Operations Toolbar 592
Sample Rack Details screen 594
Tests and Profiles Window 596
Rack Summary Information 597
Programming Bar Coded Samples 598
Programming Bar Coded Samples Using an LIS (Host) 598
Programming Bar Coded Samples After Loading the Rack, Without an LIS 599
Programming Non-Bar Coded Samples 600
Programming Non-Bar Coded Samples Using the Offline Rack and an LIS (Host) with Automatic
Downloading Enabled 600
Programming Non-Bar Coded Samples After Inserting the Rack, Using an LIS with Host Query
Enabled 601
Programming Non-Bar Coded Samples After Inserting the Rack, Without Using an LIS 602
Programming Non-Bar Coded Samples Using the Offline Rack, Without Using an LIS 603
Reviewing Sample Status 604
Reviewing Test Results 605
Recalculating Test Results 605
Validating a Single Completed Test Result 606
Validating All Completed Test Results for a Sample 606
Uploading a Single Completed Test Result to the LIS 607
Uploading All Completed Test Results for a Sample to the LIS 608
Deleting Results 608
Printing Sample Results Reports 609

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Printing Sample Results Detailed Reports 610

Printing Patient Reports 611
Exporting Reports 612
Sample List 613
Viewing Sample Details 613
Selecting and Placing Focus on Samples 613
Adding and Removing Tests Associated with a Sample 615
Validating a Single Completed Test Result 615
Validating All Completed Test Results for a Sample 615
Uploading a Single Completed Test Result to the LIS 616
Uploading All Completed Test Results for a Sample to the LIS 617
Finding a Sample ID 617
Filtering Selected Samples by Test Code 618
Changing the Sample List Display Settings 619
Configuring Sample List Display Settings 620
Actions Menu 622
Sample List Toolbar 625
Sample List Screen 626
Sample List Columns 628
Test Information Columns 631
Time to Completion 633
Sample Details 634
Viewing Sample Details 634
Viewing Parallelism Details 634
Test Information Tab 635
Patient Demographics Tab 636
Test Details 637
Viewing Test Details 637
Printing and Exporting a Parallelism Report 638
Printing the Clot Curve 639
Test Details Screen 640
Parallelism Test Details Screen 642
Clot Curve Analysis 643
Overview 643
Configuring, Viewing and Analyzing Derivative Curves 644
Clot Curve Analysis 648
Conclusion 650
Results Statistics 651
Viewing Results Statistics 651
Results Statistics Window 653
Test Counters Statistics 654
Accessing the Test Counters Statistics Windows 654
Simple Test Counter Statistics 655
Detailed Test Counter Statistics 656
Sample List Filter 658

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Sample Filters 1 Tab 659

Set of Filters 2 Tab 661
Set of Filters 3 Tab 662
Test Filters 1 Tab 663
All Samples 664
CHAPTER 11 Analyzer Status 665
Analyzer Status Indicators 665
CHAPTER 12 Alarms and Troubleshooting 666
Alarm Messages 666
Accessing Alarm Messages 666
Material Alarms 668
Job Frequency Alarms 683
QC Alarms 684
Maintenance Alarms 685
Analyzer Alarms 687
External Communications Alarms 739
Setup Alarms 747
Other Alarms 751
Popup Alarms 754
Alarm Buttons 768
Warning Alarms 768
Error Alarms 768
No New Alarms 768
Alarm Buttons in the Status Bar 769
Troubleshooting Other Problems 770
Data Flags 772
Data Flag Groups 773
Data Flags List 774
Accessing Data Flags 792
Sample List 792
Sample Details Screen 792
Test Details Screen 793
Calibration Details Screen 793
QC Statistics Screen 794
NPP Details Screen 794
CHAPTER 13 System 795
Maintenance Schedule 795
Daily Maintenance 795
Weekly Maintenance 796
Monthly and Quarterly Maintenance 796
Annual and Semi-Annual Maintenance 796
As Needed Maintenance 797
By Number of Piercings Maintenance 797

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Good Laboratory Practice 797

Maintenance List 799
Accessing Maintenance Activities 799
Maintenance Actions Menu 801
Operations Toolbar 804
Maintenance Activity Table 805
Viewing and Configuring a Maintenance Activity 807
Viewing and Editing a Maintenance Activity 807
Adding a Manual Maintenance Activity 807
Configuring a Warning Threshold 808
Maintenance Activity Configuration dialog box 809
Adding a New Maintenance Activity 812
Adding a Manual Maintenance Activity 812
Maintenance Activity Configuration dialog box 813
Deleting a Maintenance Activity 813
Maintenance Definitions 815
Automatic Fluidic Line Priming Cycle 815
Automatic Routine Clean for All Probes 816
Clean Cuvette Waste Drawer 816
Clean Deep Wash and Clean Cup Area 817
Clean Rack Areas 817
CTS Foot Cleaning 817
Cuvette Evacuation Cycle 818
Empty Cuvette Waste – Daily (Manual Activity) 818
Empty Waste Fluid – Weekly (Manual Activity) 818
Enhanced Clean for All Probes 819
Enhanced Clean for LAS Probe 820
Enhanced Clean for Reagent 1 and Reagent 2 Probes 821
Enhanced Clean for Reagent 1 Probe 822
Enhanced Clean for Reagent 2 Probe 823
Enhanced Clean for Reagent Probe 824
Enhanced Clean for Sample Probe 825
Foot and Probe Inspection 825
Replace CTS Filter and clean Clean Cup Area 826
Replace CTS Piercer 826
Replace LAS Syringe 826
Replace LAS Syringe Tip 827
Replace Reagent 1 and Reagent 2 Syringe Tips 827
Replace Reagent 1 Syringe 827
Replace Reagent 1 Syringe Tip 827
Replace Reagent 2 Syringe 828
Replace Reagent 2 Syringe Tip 828
Replace Reagent Syringe 828
Replace Reagent Syringe Tip 828
Replace Sample Syringe 829
Replace Sample Syringe Tip 829

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Rinse/Clean Priming Cycle for All Probes 829

Rinse/Clean Priming Cycle for LAS Probe 830
Rinse/Clean Priming Cycle for Reagent 1 Probe 830
Rinse/Clean Priming Cycle for Reagent 2 Probe 831
Rinse/Clean Priming Cycle for Reagent Probe 831
Rinse/Clean Priming Cycle for Sample Probe 832
Routine Clean for All Probes 832
Wipe Down All Probes 833
Wipe Down LAS Probe 833
Wipe Down Reagent Probes 833
Wipe Down Sample Probe 834
Performing Maintenance Activities 835
Maintenance Activities (listed alphabetically) 835
Automatic Fluidic Line Priming Cycle 835
Automatic Routine Clean for all Probes 836
Clean Deep Wash and Clean Cup Area – Weekly (Manual Activity) 837
Clean Rack Areas – As Needed (Manual Activity) 838
CTS Foot Cleaning – As Needed (Manual Activity) – CTS Models Only 839
Cuvette Evacuation Cycle – As Needed (Semi-automatic Activity) 840
Empty Cuvette Waste – Daily (Manual Activity) – 300 CTS Models Only 840
Empty Waste Fluid– Weekly (Manual Activity) – 300 CTS Models Only 841
Enhanced Clean for All Probes – Daily for all probes together (Semi-automatic Activity) 842
Enhanced Clean for LAS Probe – As Needed (Semi-automatic Activity) – LAS Models Only 844
Enhanced Clean for Reagent 1 and Reagent 2 Probes – As Needed (Semi-automatic Activity) –
TOP 700 Models Only 845
Enhanced Clean for Reagent 1 Probe – As Needed (Semi-automatic Activity) 846
Enhanced Clean for Reagent 2 Probe – As Needed (Semi-automatic Activity) – TOP 700 Models
Only 847
Enhanced Clean for Reagent Probe – As Needed (Semi-automatic Activity) – 300/500 CTS Models
Only 848
Enhanced Clean for Sample Probe – Daily (Semi-automatic Activity) 849
Foot and Probe Inspection – As Needed (Manual Activity) – CTS Models Only 850
Replace CTS Filter and clean Clean Cup Area – 5000 Piercings (Manual Activity) – CTS Models
Only 852
Replace CTS Piercer – Every 120,000 piercings (Manual Activity) – CTS Models Only 853
Replace LAS Syringe – As Needed (Semi-automatic Activity) 853
Replace LAS Syringe Tip – Every 6 months (Semi-automatic Activity) 853
Replace Reagent 1 and Reagent 2 Syringe Tips – Every 6 months (Semi-automatic Activity) 853
Replace Reagent 1 Syringe – As Needed (Semi-automatic Activity) 853
Replace Reagent 1 Syringe Tip – Every 6 months (Semi-automatic Activity) 854
Replace Reagent 2 Syringe – As Needed (Semi-automatic Activity) 854
Replace Reagent 2 Syringe Tip – Every 6 months (Semi-automatic Activity) 854
Replace Reagent Syringe – As Needed (Semi-automatic Activity) 854
Replace Reagent Syringe Tip – Every 6 months (Semi-automatic Activity) 854
Replace Sample Syringe – As Needed (Semi-automatic Activity) 854
Replace Sample Syringe Tip – Every 6 months (Semi-automatic Activity) 854
Rinse/Clean Priming Cycle for All Probes – As Needed (Semi-automatic Activity) 855
Rinse/Clean Priming Cycle for LAS Probe – As Needed (Semi-automatic Activity) 855

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Rinse/Clean Priming Cycle for Reagent 2 Probe – As Needed (Semi-automatic Activity) 856
Rinse/Clean Priming Cycle for Reagent Probe – As Needed (Semi-automatic Activity) 856
Rinse/Clean Priming Cycle for Sample Probe – As Needed (Semi-automatic Activity) 857
Routine Clean for All Probes – As Needed (Semi-automatic Activity) 857
Wipe Down All Probes – As Needed (Manual Activity) – Non-CTS Models Only 858
Wipe Down LAS Probe – Weekly (Manual Activity) 859
Wipe Down Reagent Probes – As Needed (Manual Activity) 860
Wipe Down Sample Probe – Weekly (Manual Activity) – Non-CTS instruments Only 861
Replacing the Syringe and Syringe Tip 862
Hamilton Syringe Procedures 862
CTS Piercer/Probe Replacement Procedure Overview 868
CTS Piercer/Probe Replacement Procedures 868
Probe and Seal Assembly Removal Procedure 869
Probe and Seal Assembly Installation Procedure 873
Piercer Probe Removal Procedure 875
Piercer Probe Installation Procedure 877
Warning Thresholds 880
System Decontamination 882
Cleaning the Monitor 884
Cleaning the Reagent Cooling Filter 885
Diagnostics Overview 886
Cuvettes 887
Viewing the Cuvettes Screen 887
Cuvettes Tab 887
Optical Reading Unit 888
ORU Cleaning Procedure 888
ORU Blanking Procedure 888
ORU Tab 890
ORU Linearity Test 892
Viewing the ORU Linearity Test Screen 892
ORU Linearity Test Tab 892
Controllers, Covers and Racks 893
Viewing the Controllers, Covers and Racks Screen 893
Controllers, Covers and Racks Tab 893
Fluids 894
Viewing the Fluids Screen 894
Fluids Tab 894
Probes Coordinates Adjustment 895
Accessing the Probes tab 895
Preparing for Adjusting Probe Coordinates 895
Adjusting Probe Coordinates 898
Setting the LAS Aspiration Point Manually 898

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Setting the LAS Aspiration Point Semi-Automatically 899

Probes Tab 900
Voltages 902
Viewing the Voltages Screen 902
Voltages Tab 902
Universal Arm 903
Viewing the Universal Arm Screen 903
Universal Arm Tab 903
Fluid Precision Test 904
Viewing the Fluid Precision Test screen 904
Fluid Precision Test Tab 904
Instrument Status 905
Viewing Instrument Status 906
Configuring the Alarms Grid and Alarms Chart tabs 906
Filtering the Alarms Grid and Alarms Chart tabs 907
Viewing Status Statistics 907
Instrument Status Operations Toolbar 907
Versions tab 908
Alarms Chart Tab 911
Alarms Display Settings Dialog Box 912
Alarms Filter Dialog Box 915
Status Statistics Screen 917
Instrument Temperatures 919
Viewing Instrument Temperatures 919
Instrument Temperatures Window 919
Analytical Versions 920
General Log List 921
Accessing the General Log List 921
Printing a Report 921
Exporting a Report 922
Clearing the Log List 922
General Log List Toolbar Icons 923
General Log Entry Creation window 925
CHAPTER 14 Backup and Restore 926
Backup and Restore 926
Overview 926
Full Backup of Database 927
Full Restore of Database 929
Burn Backup of Database to CD or DVD using Nero Express Essentials 930
Backup and Restore screen 931
CHAPTER 15 Parts and Consumables 932
Parts and Consumables List 932
Most Frequently Ordered Items 933
Less Frequently Ordered Items 934

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Contents

Reagent Racks, Diluent Racks and Bottle Adapters 935

CHAPTER 16 Reference 939
Reference Section Overview 939
Toolbar Icons 940
Grid Icons 947
Graph Icons 950
Sample Status Color Codes 952
Reagent Status Color Codes 954
Reagent Placement 954
Reagent Remaining Stability 954
Reagent On-board Volume 955
LED Status Color Codes 956
Measured Units 957
Measured Units 957
Calculated Units 957
Parallelism Units 957
Calibrated Units 958
Calibration Units 958
Statistical Units 958
Derivative Units 958
Paired Results Units 959
CHAPTER 17 IL Locations 960
Instrumentation Laboratory Worldwide Locations 960
Instrumentation Laboratory Headquarters 960
Werfen Group Corporate Headquarters 960
US, Canada, Latin America, and South America 961
Pacific Region 963
Europe, Middle East, Africa 965
Glossary 969
Index 973

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CHAPTER 1
ABOUT THIS MANUAL

Welcome to Help
This manual describes the some of the features of the ACL TOP Family Operator's Manual. The primary
manual is an online help system that is readily available while using the instrument.

NOTE:

l This manual is for use with all ACL TOP Family models.
l The screens displayed in this manual may vary slightly from what appears on the instrument. This is
due to slight differences on those screens between various ACL TOP models.
The online help uses drop-down text extensively to make it easier for you to locate areas of interest. Click
the following drop-down text to view other descriptions of functionality deployed in the online help:

Accessing the Help Manual

To access the manual, perform one of the following procedures:
l Press the <F1> key.

l Select the Help icon in the toolbar.

l Select Help in the menu bar.
See Parts and Consumables List to order a CD containing this manual in PDF format.

Locating Topics in the Table of Contents

The TOC tab in the Navigation pane is dynamic. It always expands to and highlights the topic that is
currently open. If the TOC tab is not displayed, simply open it to view where the open topic exists in the
TOC structure.

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Managing Favorite Topics and Searches

Favorite Topics
To add a topic to Favorites:
1. Open a topic that you want to add to Favorites.

2. Select the Add topic to favorites icon in the toolbar.

3. Open the Favorites tab in the navigation pane to view the topic title under Favorite Topics.
4. To open a Favorite topic, select a topic title under Favorite Topics.
5. To remove the topic from Favorites, select the check box next to the topic title, then select the Delete
selected favorite topics icon above the check boxes.

Favorite Searches
1. Open the Search tab in the navigation pane and perform a search. The search results appear in the
Search pane.

2. Select the Add search string to favorites icon next to the Search button in the Search pane.
3. Open the Favorites tab in the navigation pane to view the search string under Favorite Searches.
4. To perform a Favorite search, select a search string under Favorite Searches.
5. To remove the topic from Favorites, select the check box next to the search string, and select the
Delete selected favorite searches above the check boxes.

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Online Help Toolbar

– Show/Hide navigation – Toggle the Navigation pane in and out of view.

– Expand all - Expand all the drop-down text in the open topic.

– Collapse all - Collapse all the drop-down text in the open topic.

– Print topic – Print all or part of the open topic.

Quick search – Search the current topic for the text entered in the Quick search text box to the
–
left of the button. Single words only. Not case-sensitive.
Remove search highlighting – After a search, remove the highlighting from the search text
–
found in the open topic.

– Back – Open the previous topic.

Forward – After using the Back button to view previously opened topics, click the Forward
–
button to retrace the sequence forward.

– Refresh – Refresh the current screen.

– Home – Open the Title page of the ACL TOP Operator's Manual.

– Search – Open the Search tab in the Navigation pane.

– Index – Open the Index tab in the Navigation pane.

Favorites – Open the Favorites tab in the Navigation pane. See Managing Favorite Topics and
–
Searches.
TOC – Open the Table of Contents tab in the Navigation pane. See Locating Topics in the
–
Table of Contents.

Links
Links are provided throughout this manual to allow you to quickly move to other topics that are related to
the topic that is open. Links are blue and underlined. Click a link to jump to its target.

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Image Thumbnail Links

Large pictures in the online help appear as expandable thumbnail images. To print a thumbnail image in full
size, right-click the expanded image and select Print.
Click the following thumbnail to expand the image.

Expanding Text
Click here This is expending text. to view the expending text.

Also, click the colored text to view toolbar icons. For example, the Run icon.

Printing Help Topics

l When printing topics that contain drop-down or expanding text, you must display all hidden text
before printing. Content in text drop-downs does not print in the collapsed state.
l Large pictures in the online help appear as expandable thumbnail images. To print a thumbnail image
in full size, right-click the expanded image and select Print.

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Commonly Used Terms

The following terminology appears throughout this manual:
l Analytical Module – Part of the instrument where sample processing and testing are performed. Also
referred to as the AM and the Analyzer.
l Control Module – A Microsoft® Windows™ PC running the ACL TOP software developed by IL.
Also referred to as the CM, it provides the User Interface and Data Management functionality. The
CM connects to the Analytical Module and provides the high level controls. The CM includes the
monitor, keyboard, and mouse.
l System/Instrument – Analytical Module + Control Module
See Terminology and the Glossary for more terms.

NOTE: The terms jobs and tests are used interchangeably both on the instrument and in this help
manual. This is also true for bottles and vials.

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Tooltips Display Material and Test Information

The instrument displays useful material and test information in tooltips when you hover the cursor over the
various rack positions displayed in the Working Area. Some examples follow.

Material Information Tooltip

Hovering over a material in a reagent or diluent rack displays the Material Type, Expiration Date, Lot ID and
Volume of material on-board.

Test Information Tooltip

Hovering over a position in a sample rack displays the Sample ID and the test status. In this case the tooltip
displays the time remaining to complete the tests ordered on the sample.

User-editable Fields
Many screens contain fields that you can edit, especially those screens having to do with user-defined tests
and materials. Other fields for IL-locked tests and materials, for example, are editable only by IL Test
Developers and these are grayed out. Access to fields varies depending on login level and security setting.

See Also
l Terminology
l General Information Overview

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Important Symbols
Only trained operators following the procedures described in this manual should use the ACL TOP Family of
instruments. IL declines any responsibility otherwise.
Good laboratory practices dictate that biohazard precautions be taken while operating the ACL TOP and
when handling patient samples, controls, calibrators, or similar materials.
Throughout this manual, you should pay particular attention to paragraphs marked WARNING, CAUTION,
NOTE, and BIOHAZARD. These paragraphs are labeled with the following symbols and contain important
information:

WARNING: Warning statements provide information about electrical hazards

CAUTION: Caution statements provide information about personal injury hazards and product
damage hazards.

NOTE: Note statements contain important user information.

BIOHAZARD: Biohazard statements alert you to potentially biohazardous conditions.

See Also
l Hazards
l Symbols

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Hazards

WARNING:

On most ACL TOP instruments, the computer, monitor, keyboard and mouse are located on the
left side of the instrument. On the ACL TOP 700 LAS model, these components are located on
the right side of the instrument to facilitate the LAS Track operation.
Use extreme caution when handling any liquid, liquid waste, cuvette waste, or bulk rinse or
clean fluid on the instrument. Care must be taken to avoid spilling anything that can cause
electrical shorts or other malfunctions related to spills or causing a biohazardous condition
when using the keyboard, mouse, monitor or computer.
Do not connect the analyzer to power before verifying correct voltage setting. The analyzer
can be used with a power (main) voltage of 100-127 VAC or 135-264 VAC (50/60 Hz). Verify
the voltage of the local power (main) to be used. Check the voltage select label located on the
backplate of the analyzer. Listed are the nominal ranges of 115 (for 100-127 VAC input) and
240 (for 135-264 VAC input). Be sure the analyzer is correctly set for the power (main) being
applied. Always plug the analyzer into a grounded outlet.
Allow at least 6 inches (15.24 cm) of clearance on the sides, back, and top of the analyzer to
ensure proper cooling.
This equipment has been tested and found to comply with national and international EMC and
RFI requirements. These requirements are designed to provide reasonable protection against
harmful interference when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency. If not installed and used in
accordance with the manufacturer’s instructions, this equipment may cause harmful interference
to radio communications. Operation of this equipment in a residential area may cause harmful
interference. In this case you will be required to correct the interference at your own expense.

WARNING:

Operating technicians and maintenance personnel are urged to follow sound electrical safety
practices at all times. Although all exposed metal parts of the analyzer are at ground potential
(zero volts), never touch them with one hand while also touching a plumbing fixture, radiator,
AC-operated device, or other grounded object with the other hand.

Before opening the analyzer, remove the power cable from the power outlet. Do not replace
components or attempt any repair with the analyzer switched on. Do not operate the analyzer
in an atmosphere containing explosive gases; components of the analyzer could possibly
generate sparks.

CAUTION:

Avoid spilling fluid on or into the analyzer at any time. Spills should be cleaned up promptly.

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WARNING Piercing Hazard:

Do not reach hands inside covers while instrument is on. Piercing probe can cause injury if
probe arms are in motion.

BIOHAZARD:

When working with human blood products, all accessible parts of the analyzer must be
considered biohazardous. The analyzer surface, racks, track area, and probes should be
routinely disinfected.

CAUTION Biohazard:

While it is unlikely that spills or leaks will travel to the underside of the instrument or the
table it is on, care should be taken to inspect both the underside of the system and table for
possible leaks. Clean and disinfect any spills discovered. Report leaks to Service personnel for
repair.
System fluid waste is biohazardous. Use precautions when changing or emptying the fluid
waste container. Always follow local regulations when disposing of liquid waste.

See Also
l Important Symbols

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CHAPTER 2
GENERAL INFORMATION

General Information Overview

General information about the ACL TOP Family includes the following:
l Intended Use
l Symbols
l Measured Parameters
l Operating Principles
l Instrument Description
l Monitor and Volume Control
l Manufacturer
l Certification
l System Specifications
l Instrument Specifications
l Test Performance
l Analytical Limitations
l Hazards
l Installing the ACL TOP
l Site Requirements
l Actions Upon Delivery
l Bringing into Operation
l User Training Requirements
l Warranty
l Limitations and Disclaimers

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Intended Use
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro
diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the
assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.

NOTE: Installation and use of any additional software on the ACL TOP control module is not
allowed as it could affect instrument performance. Addition of any software other than validated programs
from the manufacturer would be considered a device modification as defined in the warranty section of this
manual. See Warranty.

See Also
l Instrument Description
l Warranty
l Limitations and Disclaimers

Symbols
The following symbols appear on the labels of ACL TOP Family components.

Symbol Description
CE Mark

CSA Mark

Temperature Limitation

Use by

Manufacturer

Batch Code

Biological Risk

Caution: Risk of Danger { IEC 61010.1 }

Consult Accompanying Documents

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Symbol Description
Caution: Risk of Electric Shock

Note: Important User Information

Attention: Consult Instructions for Use

Catalog Number

Serial Number

In Vitro Diagnostic Device

Authorized Representative

Contains sufficient for <n> tests

Protective Conductor Terminal - Earth

Earth Ground

Off (supply)

On (supply)

Bar Code Reader Hazard

Stop Action – Instrument stops all moving parts immediately

See Also
l Reference Section Overview
l Important Symbols
l Hazards

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Measured Parameters
The ACL TOP instrument performs the following types of tests:
l Coagulometric (Turbidimetric) Tests
l Chromogenic (Absorbance) Tests
l Immunological Tests

See Also
l General Information Overview
l Measurement Units

Operating Principles
Coagulometric (Turbidimetric) Measurements
The principle of coagulometric (turbidimetric) clot detection is used in the system to measure and record the
amount of time required for a plasma specimen to clot. This technique assesses coagulation endpoint by
measuring change in optical density.
Clot detection is based on the principle that light passing through a medium in which fibrinogen is
converted to fibrin is absorbed by the fibrin strands. Light (671 nm) is transmitted through a sample onto a
photodetector, which is positioned 180° to the source.
Light absorption increases as fibrin clot formation progresses. Consequently, light transmittance through the
sample continuously decreases and is measured by the photodetector.
The corresponding electrical signal output from the photodetector changes according to the detected light.
The signal output is processed via software through a series of algorithms to determine the clot point.

Chromogenic (Absorbance) Measurements

Chromogenic tests can be either direct or indirect.
l Direct test – Test where the analyte of interest (e.g. protein C, plasminogen) acts directly on a
specified synthetic substrate.
l Indirect test – Test where the analyte of interest (antithrombin, plasmin inhibitor) reacts with a fixed
quantity of enzyme to form inactive complexes. Under optimized test conditions, residual enzyme
activity is then measured using a specific synthetic substrate.
In most cases, the reaction is monitored at 405 nm by the continuous release of paranitroaniline (pNA) from
the synthetic substrate.
The chromogenic channels use the colorimetric principle of measuring absorbance in the cuvette. An optical
sensor reads light (405 nm) that passes through the cuvette. The light is absorbed by the fluid in the cuvette
in direct proportion to the concentration of pNA. The amount of light reaching the photodetector is
converted into an electrical signal that is proportional to the enzyme activity.

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Immunological Measurements
The principle of immunological measurement is used on the system to directly measure and record the
amount of an analyte. This technique assesses the physical concentration of the analyte (and not its activity)
by measuring change in optical density.
Although similar to the turbidimetric method, the immunological method relies on the formation of antigen-
antibody complexes to affect light transmission.
Immunological testing of the ACL TOP uses the 405 nm or the 671 nm channels depending on the test and
the reagent formulation.
Both the 405 nm and the 671 nm channels use the principle of measuring absorbance in the cuvette. An
optical sensor reads the light (at 405 nm or 671 nm) that passes through the cuvette. The light is absorbed by
the fluid in the cuvette in direct proportion to the concentration of antigen-antibody complexes. The amount
of light reaching the photodetector is converted into an electrical signal that is proportional or inversely
proportional to the analyte concentration.

See Also
l Instrument Description

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Instrument Description

Modules
The ACL TOP instrument is composed of two modules:

C ontrol Module (C M)
The CM provides a user interface and operation control. It consists of a personal computer running
Windows™ software, keyboard, touch screen display monitor, mouse, and communications interfaces to the
AM and external devices/systems. The CM provides the major functionality associated with the user interface
(UI) including data management, data reduction, LIS (Laboratory Information System) communications,
sample identification, test materials management, fluid management, reporting, test tracking and QC
management, and monitoring.

A nalytical Module (A M)
The AM consists primarily of sample and reagent handling hardware. It processes reagents and auxiliary
materials. It can perform coagulometric (turbidimetric), chromogenic (absorbance), and immunological
measurements.

ACL TOP 300 Model

The ACL TOP 300 is a low to medium volume (40 sample capacity) bench-top, fully automatic, random-
access analyzer that is intended for analysis using both open and closed (capped) sample tubes and having
cap piercing capability.

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ACL TOP 500 CTS Model

The ACL TOP 500 CTS is a mid to large volume (80 sample capacity) bench-top, fully automatic, random-
access analyzer that is intended for analysis using both open and closed (capped) sample tubes and having
cap piercing capability.

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ACL TOP 700/ TOP 700 CTS Models

The ACL TOP 700 (includes ACL TOP Base) instrument is a large volume analyzer (120 sample capacity)
intended for open sample tube analysis.
The ACL TOP 700 CTS (includes ACL TOP CTS) instrument is the same as the ACL TOP 700 (includes
ACL TOP Base) but is intended for analysis using both open and closed (capped) sample tubes. Closed tube
analysis is enabled using a cap-piercing capability.
The major parts of the TOP 700 (includes TOP Base) are:
l Control Module (CM) – User interface and operation control
l Analytical Module (AM) – Primarily sample and reagent handling hardware including
o AM Computer
o Cuvette Handling
o Sample Area
o Diluent Area
o Reagent Area
o Bulk Fluids
o Waste Handling
o Sample Handling
o Reagent Handling
o Reaction and Detection
o Interconnect and Power Supply
o Access-restricting Cover with Safety Interlocks
o Instrument-supporting Structure-chassis
o Safety Interlock for Cuvette Waste Drawer

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CAUTION: Care must be taken to avoid spilling any liquids and possibly causing electrical shorts
or other malfunctions related to spills.

ACL TOP 700 LAS Model

The system is similar to the instruments described above, having the Control Module (CM) and the
Analytical Module (AM), and also including communications interfaces on the CM with the external
devices/systems of the laboratory automation system.
The ACL TOP 700 LAS Laboratory Automation System (LAS) is a fully automated random access analyzer
designed specifically for in-vitro diagnostic clinical use in the track-automated hemostasis laboratory.
Intended for coagulation and fibrinolysis testing and in the assessment of thrombosis and hemostasis, the
instrument provides results for both direct hemostasis measurements and calculated results.
This instrument interfaces with LAS track in accordance with the CLSI guideline for point-of reference
sampling. Primary sample tubes can be introduced to the analyzer via the laboratory automation track or by
loading pre-spun open tubes or sample cups directly onto the instrument.
The computer, monitor, keyboard and mouse are located on the right side of the instrument.

NOTE: Capped, unspun samples must be spun and uncapped by the LAS system before moving them
to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
accept capped tubes.

NOTE: Placing items on the cover could cause damage to the cover or LAS arm and probe. Do not
place any items on the LAS arm cover.

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Instrument Safety Covers

The covers enhance operator safety and reduce the effect of the external environment on the instrument when
operating at environmental extremes and minimize the evaporation from samples and reagents. They help to
maintain temperature control and reduce the effect of stray light on sample data acquisition. The instrument
will not operate with any of the access covers open.
The LAS area, sample and reagent access covers are designed to provide increased operating safety. The LAS
arm cover is on the far left, the sample area cover is the large cover in the middle, and the reagent area cover
is the large cover on the right. These must remain closed during system operation.

NOTE: Unlocking the instrument cover may take a few seconds.

Power Connector
The AM1 power switch is located on the right side of the analytical module, adjacent to the power cord
connection. This switch is for the main power supply and controls all power to the AM.

WARNING: This switch must be turned off and the power cord disconnected before performing
service on the instrument. Leave sufficient room to quickly disconnect the power cord, if necessary.

NOTE:

l The power supply carries UL/CSA approvals.

l Maximum power requirements for the AM do not exceed 1100 watts.
l The power supplies in both the AM and CM incorporate a power factor correction to prevent
harmonic distortions in the power lines and to satisfy requirements for EMC/EMI Standard
EN61326.1.
l The AM incorporates a standard AC input IEC 1010.1-92 connector. Leave sufficient room to
quickly disconnect the power cord, if necessary.

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Emergency Stop Button

The emergency stop button is located on the front of the AM. Use this button to immediately stop the
instrument, when necessary. Tests that were in progress will need to be restarted.

TOP 300 CTS Emergency Stop Button

TOP 500 CTS Emergency Stop Button

TOP 700 Emergency Stop Button

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Keypad
The physical keypad on the front of each instrument varies by model. It contains some or all of the following
buttons and indicators:

Status LEDs
These instrument LEDs in some cases correspond to LEDs on the status bar.
l System – Refers to the analyzer status.
l Loader – Status of the cuvette loader.
l Rinse – Status of the rinse solution.
l Clean – Status of the clean solution.

Sample Rack Buttons and LEDs

Press a button to move the bar code reader to the corresponding sample rack position.
The LEDs indicate the status of the sample rack positions.
l Green – Rack position contains a sample rack, and is available to unload. It is NOT an indication
that all samples in that rack have finished testing.
l Amber – Rack position is unavailable, in use and locked.
l No color – Rack position is available to load sample racks, or rack has been rejected.

Diluent Rack Buttons and LEDs

Press a button to move the bar code reader to the corresponding diluent rack position.
The LEDs indicate the status of the diluent rack positions.
l Green – Rack position contains a diluent rack, and is available to unload.
l Amber – Rack position is unavailable, in use and locked.
l No color – Rack position is available to load diluent racks, or the rack has been rejected.

Reagent Rack Buttons and LEDs

Press a button to move the bar code reader to the corresponding reagent rack position.
The LEDs indicate the status of the reagent rack positions.
l Green – Rack position contains a reagent rack, and is available to unload.
l Amber – Rack position is unavailable, in use and locked.
l No color – Rack position is available to load reagent racks, or the rack has been rejected.

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Bar Code Reader Home Button

The Bar Code Reader Home button appears on TOP 300 CTS and TOP 500 CTS models. It bypasses the bar
code reader 30 second timeout before it returns to the home position. The bar code reader must be in the
home position to perform reagent liquid level detecting, or to begin sampling. Pressing this button decreases

the time for sample processing. The Home icon in the toolbar performs this same function.

TOP 300 CTS Keypad

TOP 500 CTS Keypad

TOP 700 CTS Keypad

Laboratory Automation System (LAS)

The LAS consists of two modules, the LAS manager and an LAS track.
The LAS Manager software determines which samples require testing by the ACL TOP 700 LAS instrument
and routes those samples to it on the LAS track.
The LAS track transports sample tubes to the LAS instrument for processing and consists of the main track
and the sample tube queue.
The instrument has an arm with an unheated probe and syringe, an aspiration area, a holding area, an
enhanced clean area, and a cover with an access door for the placement and removal of the enhanced clean
material, all on the exterior of the left side of the instrument. This module is positioned adjacent to the LAS
track.
Communication between the ACL TOP 700 LAS instrument and the LAS track uses an embedded interface
module (IM). LAS configuration and communication is achieved by means of the LAS Configuration screen.

CAUTION: To avoid contamination, Instrumentation Laboratory strongly recommends against using

the ACL TOP instrument to perform analysis on Hepabsorb samples.

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LAS Arm and Probe

When the LAS Manager detects that a sample requires testing, the sample is moved via the LAS track to the
sample tube queue. The LAS arm dispenses the sample material into cuvette cells in the holding area (cuvette
slots 1-3 of the 14 slot holding area). The cuvettes are then moved to slots 6 - 12 in the holding area. The
sample is processed the same way as in other ACL TOP instruments. The LAS Manager ensures the sample
tube queue does not become backlogged.

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LAS Probe Aspirating from Sample on the LAS Track

NOTE: LAS sample priority is lower than stat1 samples but higher than any front-loaded, normal
priority samples. Stat samples on-board the LAS are treated as LAS priority.
See Laboratory Automation System (LAS) for additional information.

NOTE: Capped, unspun samples must be spun and uncapped by the LAS system before moving them
to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
accept capped tubes.

CAUTION: The computer, monitor, keyboard and mouse are located the right side of the instrument.
Use extreme caution when handling any liquid, liquid waste, cuvette waste, or bulk rinse or clean fluid on
the ACL TOP 700 LAS instrument. Care must be taken to avoid spilling any liquids and possibly causing
electrical shorts or other malfunctions related to spills or causing a biohazardous condition when using the
keyboard, mouse, monitor or computer.

1In medical terminology, immediate; with no delay. Stat samples have highest priority.

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Cuvette Loading Area

The cuvette loading area is on the left side of the AM. A conveyor belt moves the cuvette strips to the
cuvette shuttle, which places them in position to be used by the AM for sample handling.

Cuvette Loader

The cuvette loader can be filled with up to 20 clips of 10 cuvette strips each, for a maximum of 200 cuvette
strips (800 cuvette cells).
l A conveyor belt transports the cuvette clips to the front of the loading area.
l Electrical sensors detect when additional cuvette clips need to be loaded onto the system, and inform
the operator by means of an indicator on the front right of the instrument. An amber LED for Cuvette
Loader indicates the loader contains 3 or fewer clips. A red LED indicates the loader is empty.
l The indexer1 pushes the cuvette clip to the right to position it so one strip can be picked up by the
cuvette shuttle.
l As the cuvette strips are used, new cuvette clips are brought forward and positioned for pickup. You
can add more to the loading area while the analyzer is running.

1The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism.

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NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used
cuvettes on ACL TOP instruments. See Limitations and Disclaimers.

Cuvette Shuttle
The cuvette shuttle picks up a single cuvette strip from the cuvette clip and transports it from one position or
slot to another.

Cuvette Strip being picked up by Cuvette Shuttle

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Bar Code Reader

The bar code reader moves to each track position to allow for insertion of the sample, diluent or reagent
racks. Bar coded information on sample tubes or diluent or reagent bottles is scanned into the instrument as
the racks are inserted.
Move the bar code reader to the desired track using the track buttons on the front of the AM or by clicking
the virtual track buttons displayed on the reagent area screen on the CM. With the bar code reader positioned
in front of the track position, insert the rack. A track guides the insertion of the rack into its correct position.
After the bar code reader has been at a track position for 30 seconds, it moves to its home position. This also

occurs when you select the Run icon in the toolbar.

You can use the Home button on the touch screen when the Sample, Reagent, or Diluent screen is displayed
to immediately move the bar code reader to its home position.

NOTE:

l When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling
a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.
l Care should be taken when the bar code reader is moving so that your fingers do not get pinched.
l When you use the Home button, the Bar Code Reader warning light (located on the BCR cover)
blinks three times to warn you to clear the path. A rack incompletely placed in a track causes the
homing function to fail, and displays the BCR movement failure error.

Bar Code Reader

This example is the TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS
models.

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Sample Area
To the right of the cuvette loader is the sample area where manually placed patient samples are placed on the
AM. The sample tubes or cups are placed on racks that are inserted through a bar code reader.
The sample area is at ambient temperature and can hold 4-12 racks, depending on the model, each capable of
holding 10 samples for a total of 40-120 samples.
When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track
position. When the rack is no longer in use the LED changes to green and the rack is released.
The sample rack holds both capped and uncapped sample tubes and open sample cups. Sample racks
identified as CTS are designed to hold capped sample tubes, while those without the CTS designation are for
open sample tubes and cups.

NOTE: When using sample cups they must be IL 2.0 mL sample cups. The use of non-IL sample
cups may lead to improper sampling and incorrect results. See Parts and Consumables List.
The wash station for the sample probe is located behind the sample rack area.

See Also
l Sample Area
l Reagent Area
l Parts and Consumables List

Sample Area with Both LAS Arm (left) and Sample Arm (right)

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Sample Rack – non CTS

Sample Rack – CTS

NOTE: For cleaning racks and adapters, IL recommends that you use any of the following:

l 10% bleach
l 0.1 N HCl
l Mild soap
After decontamination with bleach you should always rinse with tap water to remove excess bleach residue
on the inner walls of the container.
DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels.

Sample Arm
The sample arm consists of a probe and syringe used for aspirating and dispensing samples.

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Diluent Area
Depending on the ACL TOP model, the diluent area can accommodate 1-3 diluent racks. Each diluent rack
can hold up to eight vials of QC materials, calibration and NPP1 plasmas, sample diluents and clean
materials. For more information, see Diluent Area.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Reagent Area
The Reagent Area is on the right side of the AM1. There are 3-6 tracks each with six reagent positions, that
hold 18-36 reagents. As with sample racks, reagent racks are inserted into reagent tracks by means of the bar
code reader.
This area is cooled to 15° C ± 3° C. Positions 1 and 2 on each rack allow for the use of magnetic stir bars.
See Test Feasibility for proper placement of all reagents.

Reagent Area Showing Intermediate (left) and Start (right) Reagent Arms

Reagent Arms
There are up to two reagent arms, depending on the model. The left reagent arm when present, is used for
aspirating/dispensing materials placed in D3, and intermediate and start reagents in reagent racks placed in
R1-R4. (An intermediate reagent is one that, when mixed with sample, activates certain constituents of the
sample but is not enough to bring the reaction to completion.)
On models with multiple reagent arms, the right reagent arm is used for aspirating/dispensing start reagents
from tracks R3-R6 of the Reagent Area. (A start reagent is one that, when mixed with the sample or sample
mixture, begins the reaction of interest. It must be the final reagent added to the cuvette cell.)
On TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS models, both
reagent arms can access positions in tracks R3-R4 in the Reagent Area.
On TOP 300/500 CTS models, the reagent arm may access all reagent racks.
See Test Feasibility for proper placement of all reagents.

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid
damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible.

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.
The wash station for the left reagent probe is located in the back left side of the reagent area; the wash
station for the right reagent arm is located in the back right side of the reagent area.

See Also
l Reagent Area

Reagent Rack

NOTE: For cleaning racks and adapters, IL recommends that you use any of the following:

l 10% bleach
l 0.1 N HCl
l Mild soap
After decontamination with bleach you should always rinse with tap water to remove excess bleach residue
on the inner walls of the container.
DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels.

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Probe
The probe is the part of the instrument that makes contact with liquid material.
Each probe has a sensor that recognizes the presence of liquids and stops at the optimized liquid level. A
Teflon tube connects the sample or reagent probe to a syringe that is capable of delivering 4 to 250 µL. The
LAS probe has a maximum volume of 1000 µL.
The reagent probes are heated and heat liquids being pipetted to 37° C ± 1° C.
If a probe appears to be damaged, bent, shows visible corrosion, or if you are experiencing frequent liquid
level detection failures, the probe may need to be replaced. Contact Service.
Whenever a probe is replaced, the arm coordinates must be adjusted.

Probe (in foreground) and Syringe

Probe Syringes
There is a syringe pump for each probe to enable the separate movement of rinse, clean, sample or reagent
through the probe.

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Incubators
Behind the rack areas are two incubators that are used for the sample and/or reagent incubation phase(s) of
the test.
The sample incubator can hold up to 8 cuvette strips (4 for TOP 300 CTS). The reagent incubator can hold
up to 8 cuvette strips (4 for TOP 300 CTS). The incubator temperature is maintained at 37.0° C ± 0.5° C.
In the sample incubator, sample material is pipetted into the cuvette cells. The cuvette strips are then moved
into the reagent incubator where intermediate reagents are dispensed.

Right Sample Probe and Incubator Slots

Optical Reading Unit

There are 2-4 optical reading units (ORUs), each with four reading stations, located to the right of the reagent
incubator where start reagents are dispensed into the cuvette cells to start a reaction. Readings are taken of
the reaction using wavelengths of 671 nm for coagulometric, 405 nm for chromogenic, and either 671 or 405
nm for immunologic measurements.

Instrument Model # ORUs # Reading Channels

TOP 300 CTS 2 8

TOP 500 CTS 3 12

TOP 700 (includes TOP Base) 4 16

TOP 700 CTS (includes TOP CTS) 4 16

TOP 700 LAS 4 16

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System Fluids – Rinse and Clean

The rinse fluid system and the clean fluid system remove contaminants from the system to reduce the risk of
carryover1 affecting test results.
These fluids clean not only the internal surfaces of the probe and the related tubing, but also the external
surface of each probe tip, removing contaminants that may have contacted the probe during fluid aspiration.

Rinse Fluid System

The rinse fluid is used to rinse the probes after the aspiration and dispensation of a test fluid. Typically, the
probe is rinsed after each syringe pump cycle. However, in instances where a common reagent is being
dispensed into consecutive cells, the rinse pump may not be operated until after the final dispense. The
amount of rinse fluid used is not test-dependent.
The rinse fluid system is composed of the system rinse fluid bottle, the rinse fluid tubing, two rinse pumps,
the rinse pump tubing, the rinse/clean stations in the sample and reagent areas, and the waste fluid.
Each probe is connected to a dedicated rinse pump and has a dedicated rinse/clean station at which it is
positioned during the operation of the rinse cycle. The probe is positioned above the rinse cup and rinse is
dispensed through the probe into the rinse cup. Rinse dispensed from the probe enters the rinse cup,
displacing any rinse that is in the rinse cup. Any excess fluid that overflows from the rinse cup drains into
the accumulator through an opening in the bottom of the rinse/clean station.
The rinse fluid is placed on the ACL TOP instrument in a 4L rinse bottle. A rinse fluid sensor located on the
front of the AM2 monitors the level of rinse fluid. It displays an amber warning light (except for TOP 300
CTS) when the level drops below 1000 mL, and displays a red error light when the level drops below 600
mL. If the rinse fluid sensor changes to red during the BUSY state, the instrument performs a controlled stop
to finish running the active tests. The remaining tests do not run until the operator replaces the rinse, and
presses Start again. If the rinse fluid drops below 100 mL the system performs an emergency stop.

CAUTION: Do not replace the rinse fluid when the instrument is Busy or in a Controlled Stop.

l When replacing the rinse fluid, ensure the computer, monitor and keyboard are moved far enough out
of the way to prevent any rinse spilling on them.
l The 4 liter rinse bottle is not designed to be refilled during instrument operation. We recommend
periodic changing of the rinse bottles to prevent accumulation of particulates and other contaminants.
l Do not top off. Refilling (topping off) the 4 liter rinse bottle during operation of the instrument may
cause the introduction of air bubbles into the tubing. This can happen if the bottle is almost empty or
if the end of the tubing is raised above the liquid level. Bubbles created in the rinse fluid can enter
the rinse tubing and cause improper rinsing of the probes. Extra care should be taken to ensure any
manipulation of the contents of the rinse bottle doesn't create bubbles.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.
2The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Clean Fluid system

The clean fluid system is composed of the system clean fluid bottle, the clean fluid tubing, a pump, a
manifold, three valves, clean cup tubing, the rinse/clean stations and fluid waste. A pump is used to transport
clean fluid from the clean fluid bottle to the clean stations. Each rinse/clean station contains a clean cup that
serves as a reservoir for the clean fluid. The clean cups are filled from the bottom.
The probe enters the clean fluid and aspirates fluid from the clean cup, the pump is operated and the valve
dedicated to the clean cup is opened. Clean fluid is pumped into the clean cup. The volume of clean fluid
pumped into the clean cup is sufficient to not only fill the clean cup, but to also flush any contaminants from
the clean cup. Any excess fluid that overflows from the clean cup drains into the accumulator through an
opening in the bottom of the rinse/clean station.
A cleaning cycle is used to clean the probe at specific times during the operation of the instrument. It cleans
the probe more completely than the rinse system. The probe aspirates clean fluid from the clean cup in the
rinse/clean station or from a bottle of clean material placed on a rack and dispenses the clean fluid into the
rinse/clean station.
A clean fluid sensor located on the front of the AM (except for TOP 300 CTS) monitors the level of clean
fluid and displays an amber warning light when the level drops to 75 mL. It displays a red error light when
the level drops to 25 mL. If the clean fluid sensor changes to red while the instrument is Busy, the instrument
performs a controlled stop after running the active tests. Wait until the system comes to a complete stop,
replace the bottle with a new one, then restart the testing.
For the LAS probe only:
If the instrument detects an insufficient volume of clean material during testing, an emergency stop is
performed to prevent possible contamination.

CAUTION: Do not replace the clean fluid during busy or controlled stop. When replacing the clean
fluid ensure the computer, monitor and keyboard are moved far enough out of the way to prevent any clean
fluid spilling on them.
See Rinse Fluid and Clean Fluid.

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Rinse (left) and Clean Bottles with Fluid Waste Container Underneath

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Fluid Waste
A fluid waste pump (except for TOP 300 CTS) removes fluid from the internal waste reservoirs located under
the Clean and Rinse stations in the Sample and Reagent Areas. Sensors in each reservoir detect when the
accumulator is full, and turn on the pump for a configured span of time to empty the waste into the waste
container.

NOTE:

l The TOP 300 CTS uses gravity to empty waste fluid from the reservoirs.
l The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table or bench that
holds the instrument. It must maintain a negative slope across the entire length of the tubing to
minimize the backup of waste fluids. There must be no crimping in the tubing.
l For all instruments except the TOP 300, a sensor indicates when fluids fail to empty. If fluids back up,
the system performs an emergency stop.

Waste Container
A 10 liter waste container holds the fluid waste pumped from the accumulators. A waste fluid sensor (except
for TOP 300 CTS) on the front of the AM1 warns the operator when the waste container is nearly full by
turning amber (warning), and turning red (error) when the waste container is full. When the sensor turns red,
the instrument performs a controlled stop. If the waste container is not replaced with an empty one, the
instrument eventually performs an emergency stop. You must empty or change the waste container before
running more tests.
See Empty Waste Fluid.

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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CAUTION Biohazard:

l System fluid waste is biohazardous. Use precautions when changing or emptying the fluid waste
container. Always follow local regulations when disposing of liquid waste.
l The TOP 300 CTS model does not have a waste fluid sensor. You must empty the waste container
frequently. See Fluid Waste.

See Also
l Fluid Waste
l Controlled Stop
l Emergency Stop

Cuvette Waste Container

The cuvette waste container is located on the lower right side of the instrument behind the cuvette waste
door (the TOP 300 CTS does not have a door).
The cuvette waste module includes an accumulator that allows the cuvette waste drawer to empty without
shutting down the instrument (the TOP 300 CTS does not have a cuvette waste accumulator). Six used
cuvette strips are moved onto the accumulator as readings are finished, then deposited into the cuvette waste
drawer. The cuvette waste liner has a capacity of 100-250 (+/- 10) used cuvettes, depending on the model.
Cuvette waste liners are used in the cuvette waste drawer to contain used cuvette strips, keep the waste
drawer clean and free of contaminants, and facilitate disposal of the waste cuvettes.

CAUTION Biohazard:

l Cuvette waste is biohazardous. Use precautions when emptying the cuvette waste drawer. Refer to
local and state regulations for disposal of potentially hazardous materials.
l The TOP 300 CTS model does not have a cuvette waste sensor. You must empty the cuvette waste
container frequently. See Empty Cuvette Waste.

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Cuvette Waste Door Open

Cuvette Waste Container – TOP 300 CTS

When the waste drawer is removed, the analyzer performs a controlled stop, and completes only the tests that
are running, providing the cuvette accumulator is not full. If the drawer is re-inserted before the running tests
are finished, the AM1 cancels the controlled stop and finishes running the tests on all the samples. If the
active tests are completed before the drawer is reinserted, the AM enters the READY state. You must restart
the remaining tests. If the cuvette waste drawer is not reinserted, the instrument does not restart.
The following two status indicators appear on the front of the AM for the cuvette waste:

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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l Door open indicator – Turns green when the waste door is open.
l Cuvette waste indicator – Turns amber (warning) when the drawer is nearly full. Turns red (error)
when the waste drawer is full or removed.

Cuvette Waste Drawer

See Also
l Operating Principles
l Intended Use
l LED Status Color Codes

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Monitor and Volume Control Chapter 2 – General Information

Monitor and Volume Control

NOTE: Instrumentation Laboratory recommends the monitor volume be turned up to maximum

volume. Consult the monitor manufacturer's user guide.

Calibrating the All-in-One CM Monitor Touch Screen

To calibrate the All-in-One monitor touch screen supplied with the ACL TOP 300 model.
1. Select the Microsoft® Windows™ Start button.
2. Select Programs > PenMount Universal Driver > PenMount Control Panel.
3. Select the PenMount icon, and select Configure.

4. Select Standard Calibration.

5. Follow the screen prompts to complete touch screen calibration.

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All In One Monitor Diagrams

The diagrams in this section apply to the All In One Monitor and CM1 supplied with the ACL TOP 300
model.

Function/Control

NOTE: Auto Adjust aligns the screen when it becomes misaligned.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Connectors

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Configuring Volume Control on the ELO Touchsystems Entuitive

Monitor
The ELO Touchsystems Entuitive monitor is configured with speakers. The volume of these speakers can be
changed to accommodate laboratories with varying ambient noise. The Touchmonitor factory sound is
configured to be very low. Use the following procedure to increase the sound of the speakers:
1. On the right side of the monitor are five push buttons. They are, from top to bottom, MENU, UP
arrow, DOWN arrow, SELECT and POWER.
2. Select the menu button to display a menu window on the Touchmonitor. Using the up or down arrow
buttons, navigate to the volume setting (symbol). Press the select button to choose the volume setting.

3. Using the up or down arrow buttons, configure the volume of the speakers. Press the select button to
store the volume setting.
4. Select the menu button to exit the menu functionality.

See Also
l General Information Overview
l System Specifications

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Manufacturer
The ACL TOP Family of instruments is manufactured by:
Headquarters
Instrumentation Laboratory
180 Hartwell Road
Bedford, MA 01730-2443
USA
Phone: 781-861-0710
Fax: 781-861-1908
www.ilus.com

See Also
l Worldwide Locations

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Certification Chapter 2 – General Information

Certification

CE Certification
The CE label on the back of the instrument indicates that the ACL TOP instrument conforms to the European
Directives as stated in IL's Declaration of Conformity.

EU Directive:
l IVD - 98/79/EC (27/10/1998) – Annex I and III

Applicable standards:
l CEI/IEC 61326-1: 1998 (Class A)
l CEI/IEC 61010-2-04

CSA Certification
The CSA label on the back of the instrument indicates that the Canadian Standards Association (CSA) has
certified the ACL TOP instrument to the applicable standards.

Applicable standards:
l CAN/CSA C22.2 No. 1010.1-92
l UL Std. No. 61010-1, 2nd Edition

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Other Certification
The ACL TOP instrument meets CEI/IEC 61010-1, 2001 Mod, Second Edition, for the following:
l External surface temperature
l Flame resistance
l Fluid resistance
l Internal air flow and temperature
l Audible noise
l Product labeling
The ACL TOP instrument shipping crate complies with the International Safe Transit Packaging Testing
Procedure 1B (June, 1999), ASTM 999.

European Union Directive 2002/96/EC on Waste Electrical and Electrical

Equipment (WEEE)

Instrumentation Laboratory is committed to meeting or exceeding the conditions of the WEEE Directive and
being a good environmental partner. In compliance with the WEEE Directive, beginning with product
shipped after August 13, 2005, all instruments are labeled with the symbol shown above.
Disposing of this product correctly helps prevent potential negative consequences for the environment and
for human health. Recycling conserves natural resources.
Penalties may be applicable for incorrect disposal of this waste, in accordance with national (European)
legislation.
Please call your local Instrumentation Laboratory distributor for information regarding the disposal of any
end-of-life instruments.

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System Specifications
l ACL TOP 300 CTS Specifications
l ACL TOP 500 CTS Specifications
l ACL TOP 700 and 700 CTS Specifications
l ACL TOP 700 LAS Specifications

See Also
l Test Performance
l Analytical Limitations
l Hazards

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ACL TOP 300 CTS Specifications Chapter 2 – General Information

ACL TOP 300 CTS Specifications

The TOP 300 CTS is a bench top, fully automated, random access coagulation instrument characterized by its
ability to analyze a medium volume of samples with excellent throughput and a extended walkaway time.
The TOP 300 CTS model meets the needs of medium size routine and specialty laboratories. Most important
for users are features that provide consistency of test results across ACL TOP family members, minimize the
need for user interaction, and increase the efficiency and safety of laboratory procedures.

TOP 300 CTS Specifications

Test Menu Clotting tests (671 YES (standard)
nm)
Chromogenic tests YES (standard)
(405 nm)
Immunological YES (standard)
tests (671 or 405
nm)
System ACL TOP 300 Compact design with coagulometric, chromogenic and immunologic
Configurations CTS tests; and open tube sampling and closed tube sampling with cap
piercing.
Throughput PT tests/hour Up to 110
APTT tests/hour Up to 110
PT & APTT Up to 110
tests/hour
Random access YES
Continuous sample loading YES
Continuous reagent loading YES
Continuous cuvettes loading YES
Sample transport system Racks
Samples on-board 40 (10 samples/rack)
Sample containers Primary tubes and cups
Sample bar code reader YES (integrated)
Sample pipetting arms/probes Configurable CTS
Sample liquid level detecting YES (capacitance probe)
Sample area protection cover YES (with lock and sensor)
Reagent transport system Racks
Reagents on-board (refrigerated) 26 (18 positions in reagent racks + 8 positions in a diluent rack)
Reagent containers Original bottles
Reagent bar code reader YES (integrated)
Bar coded reagents YES (bar code includes lot, exp. date and bottle size)
Hand-held 2D bar code reader YES (optional)
Reagent pipetting arms/probes 1 reagent probe is integrated on common arm
Reagent liquid level detecting YES (capacitance probes)

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TOP 300 CTS Specifications

Reagent area protection cover YES (with lock and sensor)
Cuvettes on-board 800
Cuvettes type Plastic disposable (4 cuvettes/strip)
Applications on-board 500
User programmable applications 250
Tests per sample 30
Walkaway capability 400 tests (100 cuvette strip capacity of cuvette waste container)
Sample pre-dilution YES
Calibration curve pre dilution YES
Factor parallelism YES
STAT capability YES (at any time in any position)
STAT time Time to PT result when the system is idle: ~ 3 minutes
Rerun testing YES (configurable)
Reflex testing YES (configurable)
Reaction curves display YES
Quality Control program YES (with configurable multi-rules)
Results auto validation YES
Patient samples results database 2,000 - 20,000 samples (configurable)
QC results database 2,000 - 20,000 samples (configurable)
Security system YES (configurable)
Events log system YES
Bi-directional interface YES
Host Query function YES
Integrated PC and monitor Intel processor. 17 inch color LCD touch screen (external). Portwell
(Control Module) Model #286229-04. Ratings: 100-240 VAC, 2.5 A, 50/60 Hz.
Operating System Windows XP
Keyboard YES (external)
Mouse YES (external)
User Interface Windows based
Dimensions Width 81 cm (32 inches)
(analyzer)
Depth 84 cm (33 inches)
Height 73 cm (29 inches)
Weight 91 kg (200 pounds)

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ACL TOP 500 CTS Specifications

The TOP 500 CTS is a bench top, fully automated, random access coagulation instrument characterized by its
ability to analyze a medium-to-large volume of samples with high throughput and a long walkaway time.
The ACL TOP 500 CTS meets the needs of medium to large size routine and specialty laboratories. Most
important for users are features that provide consistency of test results across ACL TOP family members,
minimize the need for user interaction, and increase the efficiency and safety of laboratory procedures.

ACL TOP 500 CTS Specifications

Test Menu Clotting tests (671 YES (standard)
nm)
Chromogenic tests YES (standard)
(405 nm)
Immunological YES (standard)
tests (671 or 405
nm)
System ACL TOP 500 Compact design with coagulometric, chromogenic and immunologic
Configurations CTS tests; and open tube sampling and closed tube sampling with cap
piercing.
Throughput PT tests/hour Up to 240
APTT tests/hour Up to 180
PT & APTT Up to 180
tests/hour
Random access YES
Continuous sample loading YES
Continuous reagent loading YES
Continuous cuvettes loading YES
Sample transport system Racks
Samples on-board 80 (10 samples/rack)
Sample containers Primary tubes and cups
Sample bar code reader YES (integrated)
Sample pipetting arms/probes Configurable CTS
Sample liquid level detecting YES (capacitance probe)
Sample area protection cover YES (with lock and sensor)
Reagent transport system Racks
Reagents on-board 40 (24 positions in reagent racks + 16 positions in diluent racks)
Reagents on-board storage 40 refrigerated (24 refrigerated positions in 4 reagent racks, 16
temperature refrigerated positions in 2 diluent racks)
Reagent containers Original bottles
Reagent bar code reader YES (integrated)
Bar coded reagents YES (bar code includes lot, exp. date and bottle size)
Hand-held 2D bar code reader YES

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ACL TOP 500 CTS Specifications

Reagent pipetting arms/probes 1
Reagent liquid level detecting YES (capacitance probes)
Reagent area protection cover YES (with lock and sensor)
Cuvettes on-board 800
Cuvettes type Plastic disposable (4 cuvettes/strip)
Applications on-board 500
User programmable applications 250
Tests per sample 30
Walkaway capability 2400 tests (max. 80 samples on-board X max. 30 tests per sample)
Sample pre-dilution YES
Calibration curve pre dilution YES
Factor parallelism YES
STAT capability YES (at any time in any position)
STAT time Time to PT result when the system is idle: ~ 3 minutes
Rerun testing YES (configurable)
Reflex testing YES (configurable)
Reaction curves display YES
Quality Control program YES (with configurable multi-rules)
Results auto validation YES
Patient samples results database 2,000 - 20,000 samples (configurable)
QC results database 2,000 - 20,000 samples (configurable)
Security system YES (configurable)
Events log system YES
Bi-directional interface YES
Host Query function YES
PC (Control Module) External (Intel processor). Continental Resources Model #286229-06.
Ratings: 100-120/200-240 VAC, 4/2 A, 50/60 Hz, Watts 230.
Monitor 17 inch color LCD touch screen (external). Elo TouchSystems Model
#ET1715L, Rating: 100-240 V, 1 A, 50-60 HZ
Operating System Windows XP
Keyboard YES (external)
Mouse YES (external)
User Interface Windows based
Dimensions Width 110 cm (43 inches)
(analyzer)
Depth 82 cm (32 inches)
Height 73 cm (29 inches)
Weight 142 kg (312 pounds)

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ACL TOP 700 and 700 CTS Specifications

This topic describes specifications for the ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700 CTS
(includes ACL TOP CTS) instruments:
These instruments are bench top, fully automated, random access coagulation instruments characterized by
their ability to analyze a high volume of samples with high throughput and a long walkaway time.
These instruments meet the needs of the large routine and specialty laboratories. Most important for users are
features that provide consistency of test results across ACL TOP family members, minimize the need for user
interaction, and increase the efficiency and safety of laboratory procedures.

ACL TOP 700 and 700 CTS Specifications

Test Menu Clotting tests (671 YES (standard)
nm)
Chromogenic tests YES (standard)
(405 nm)
Immunological YES (standard)
tests (671 or 405
nm)
System Configurations Base Coagulometric, chromogenic and immunologic tests; open tube
sampling
CTS Base configuration + Closed Tube Sampling (cap piercing)
Throughput (base PT tests/hour Up to 360
model)
APTT tests/hour Up to 320
PT&APTT Up to 330 (165 samples of each test/hour)
tests/hour
Throughput (CTS PT tests/hour Up to 270
model)
APTT tests/hour Up to 270
PT & APTT Up to 260 (130 samples of each test/hour)
tests/hour
Random access YES
Continuous sample loading YES
Continuous reagent loading YES
Continuous cuvettes loading YES
Sample transport system Racks
Samples on-board 120 (10 samples/rack)
Sample containers Primary tubes and cups
Sample bar code reader YES (integrated)
Hand held 2D sample bar code reader YES
Sample pipetting arms/probes 1 (standard) + 1 (optional cap-piercing)
Sample liquid level detecting YES (capacitance probe)
Sample area protection cover YES (with lock and sensor)

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ACL TOP 700 and 700 CTS Specifications

Reagent transport system Racks
Reagents on-board 60 (36 positions in reagent racks + 24 positions in diluent
racks)
Reagents on-board storage temperature 44 refrigerated + 16 room temperature (36 refrigerated positions
in 6 reagent racks, 8 refrigerated positions in 1 diluent rack, 16
room temperature positions in 2 diluent racks)
Reagent containers Original bottles
Reagent bar code reader YES (integrated)
Bar coded reagents YES (bar code includes lot, exp. date and bottle size)
Reagent pipetting arms/probes 2
Reagent liquid level detecting YES (capacitance probes)
Reagent area protection cover YES (with lock and sensor)
Cuvettes on-board 800
Cuvettes type Plastic disposable (4 cuvettes/strip)
Applications on-board 500
User programmable applications 250
Tests per sample 30
Walkaway capability 120 samples
Sample pre dilution YES
Calibration curve pre dilution YES
Factor parallelism YES
STAT capability YES (at any time in any position)
STAT time Time to PT result when the system is idle: ~ 3 minutes
Rerun testing YES (configurable)
Reflex testing YES (configurable)
Analytical Reference YES
Reaction curves display YES
Quality Control program YES (with configurable multi-rules)
Results auto validation YES
Patient samples results database 2,000 - 20,000 samples (configurable)
QC results database 2,000 - 20,000 samples (configurable)
Security system YES (configurable)
Events log system YES
Bi-directional interface YES
Host Query function YES
PC (Control Module) External (Pentium IV). Continental Resources Model #286229-
06. Ratings: 100-120/200-240 VAC, 4/2 A, 50/60 Hz, Watts
230.
Monitor 17 inch color LCD touch screen (external). Elo TouchSystems
Model #ET1715L, Rating: 100-240 V, 1 A, 50-60 HZ

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ACL TOP 700 and 700 CTS Specifications Chapter 2 – General Information

ACL TOP 700 and 700 CTS Specifications

Operating System Windows XP Service Pack 2
Keyboard YES (external)
Mouse YES (external)
User Interface Windows based
Dimensions (analyzer) Width 151 cm (59 inches)
Depth 76 cm (30 inches)
Height 73 cm (29 inches)
Weight (Base TOP analyzer) 162 kg (356 pounds)
Weight (CTS TOP analyzer) 166 kg (367 pounds)

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ACL TOP 700 LAS Specifications Chapter 2 – General Information

ACL TOP 700 LAS Specifications

The ACL TOP model is a fully automated random access analyzer designed specifically for in-vitro
diagnostic clinical use in the track-automated hemostasis laboratory. Intended for coagulation and fibrinolysis
testing and in the assessment of thrombosis and hemostasis, the LAS provides results for both direct
hemostasis measurements and calculated results.
The TOP 700 LAS model is designed to interface with laboratory automation track systems in accordance
with the CLSI guideline for point-of-reference sampling. Primary sample tubes can be introduced to the
analyzer via the laboratory automation track or by loading pre-spun open tubes or sample cups directly onto
the instrument. The LAS instrument is mounted to a table.
The TOP 700 LAS model meets the needs of large routine and specialty laboratories. Most important for
users are features that provide consistency of test results across ACL TOP family members, minimize the need
for user interaction, and increase the efficiency and safety of laboratory procedures.

ACL TOP 700 LAS Specifications

Test Menu Clotting tests YES (standard)
(671 nm)
Chromogenic YES (standard)
tests (405 nm)
Immunological YES (standard)
tests (671 or
405 nm)
System LAS Coagulometric, chromogenic and immunologic tests; open tube
Configurations sampling + Laboratory Automation System compatibility

Random access YES

Continuous sample loading YES
Continuous reagent loading YES
Continuous cuvettes loading YES
Sample transport system Racks
Samples on-board 90 (10 samples/rack)
Sample containers Primary tubes and cups
Sample bar code reader YES (integrated)
Hand held 2D sample bar code YES
reader
Sample pipetting arms/probes 1 (standard) + 1 (off-board)
Sample liquid level detecting YES (capacitance probe)
(for volume tracking)
Sample area protection cover YES (with lock and sensor)
LAS area protection cover YES (with sensor)
Reagent transport system Racks
Reagents on-board 60 (36 positions in reagent racks + 24 positions in diluent racks)
Reagents on-board storage 44 refrigerated + 16 room temperature (36 refrigerated positions in 6
temperature reagent racks, 8 refrigerated positions in 1 diluent rack, 16 room

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ACL TOP 700 LAS Specifications

temperature positions in 2 diluent racks)
Reagent containers Original bottles
Reagent bar code reader YES (integrated)
Bar coded reagents YES (bar code includes lot, exp. date and bottle size)
Reagent pipetting arms/probes 2
Reagent liquid level detecting YES (capacitance probes)
Reagent area protection cover YES (with lock and sensor)
Cuvettes on-board 800
Cuvettes type Plastic disposable (4 cuvettes/strip)
Applications on-board 500
User programmable 250
applications
Tests per sample 30
Sample pre dilution YES
Calibration curve pre dilution YES
Factor parallelism YES
Stat capability YES (for manually loaded samples at the front of the instrument, at
any time in any position)
Stat time Time to PT result when the system is idle: ~ 3 minutes
Rerun testing YES (configurable)
Reflex testing YES (configurable)
Reaction curves display YES
Quality Control program YES (with configurable multi-rules)
Results auto validation YES
Patient samples results 2,000 - 20,000 samples (configurable)
database
QC results database 2,000 - 20,000 samples (configurable)
Security system YES (configurable)
Events log system YES
Bi-directional interface YES
Host query function YES
PC (Control Module) External (Pentium IV). Continental Resources Model #286229-06.
Ratings: 100-120/200-240 VAC, 4/2 A, 50/60 Hz, Watts 230.
Monitor 17 inch color LCD touch screen (external). Elo TouchSystems Model
#ET1715L, Rating: 100-240 V, 1 A, 50-60 HZ
Operating system Windows XP
Keyboard YES (external)
Mouse YES (external)
User Interface Windows based
Dimensions Width 188 cm (74 inches)

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ACL TOP 700 LAS Specifications

(analyzer)
Depth 87 cm (34 inches)
Height 162 cm (64 inches), includes integrated table.
Weight (total) 319 kg (703 pounds)
Analyzer 184 kg (406 pounds)
Table 135 kg (297 pounds)

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Test Performance Chapter 2 – General Information

Test Performance
The data presented in this section is representative of all instruments in the ACL TOP Family.

Typical Precision Performance

The following are typical performance characteristics provided only as examples. Refer to product insert
sheets to obtain specific information.

Typical Precision
Typical precision was performed using normal and abnormal controls. Precision is calculated following CLSI
Document EP5-A.
Within run and total precision assessed over multiple runs (n=80) using multiple levels of control plasma
gave the following results:

Reagent Type Control Level Mean Within Run Total

(Result Unit) %CV %CV
Antithrombin Normal 108.5 5.7 5.8
(%) Low Abnormal 53.5 5.6 6.8
High Abnormal 32.0 6.8 9.1
APTT Normal 30.3 1.2 1.6
(seconds) Low Abnormal 49.3 0.9 2.1
High Abnormal 59.0 0.9 1.4
D-Dimer Low Control 340 4.6 7.7
(ng/mL) High Control 729 2.5 4.5
Factor II Normal 110.7 4.2 5.2
(%) Low Abnormal 64.5 4.1 5.3
High Abnormal 37.5 3.8 5.6
Factor V Normal 124.7 4.0 4.7
(%) Low Abnormal 79.9 3.0 4.7
High Abnormal 43.4 3.6 4.8
Factor VII Normal 106.2 3.6 3.9
(%) Low Abnormal 61.3 2.1 3.7
High Abnormal 33.0 2.9 4.4
Factor X Normal 114.6 1.8 2.8
(%) Low Abnormal 64.6 2.2 3.4
High Abnormal 38.3 1.9 3.6
Fibrinogen-C (mg/dL) Normal 364.7 7.9 8.8
Low Fibrinogen 92.9 7.7 8.4
Protein C Normal 120.4 2.6 3.3
(%) Low Abnormal 30.9 3.0 4.3
High Abnormal 18.4 3.7 4.7
Prothrombin (PT) Normal 11.9 1.3 1.4

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Reagent Type Control Level Mean Within Run Total

(Result Unit) %CV %CV
(seconds) Low Abnormal 25.7 1.5 2.7
High Abnormal 37.3 1.8 3.0
PT-Based Fibrinogen Normal 302.6 3.7 4.1
(mg/dL) Low Fibrinogen 128.2 7.7 7.8

Typical Method Comparison

Typical method comparison was performed using normal and abnormal patient samples. Method comparison
is calculated following CLSI Document EP9-T.
In method comparison studies evaluating citrated plasma samples, the ACL TOP Family member and the
ACL Advance (predicate device) were shown to be statistically similar as shown below.

Reagent Type n Slope Intercept r Sample Range

(Result Unit)
Antithrombin 123 1.03 -1.418 0.9660 25.0 to 121.7
(%)
APTT 205 1.076 -0.380 0.9943 24.2 to 236.7
(seconds)
D-Dimer 120 1.12 -16.0 0.993 84 to 19809
(ng/mL)
Factor II 101 0.95 -0.551 0.9753 6.0 to 128.2
(%)
Factor V 93 0.81 4.742 0.9822 2.1 to 149.3
(%)
Factor VII 96 0.882 3.153 0.9922 6.3 to 147.4
(%)
Factor X 109 0.97 2.995 0.9954 5.0 to 142.3
(%)
Fibrinogen-C 98 1.00 -8.740 0.9759 121.6 to 695.0
(mg/dL)
Protein C 123 1.15 -0.323 0.9902 9.4 to 129.7
(%)
Prothrombin (PT) 150 0.990 1.46 0.9987 9.8 to 107.4
(seconds)
PT-Based Fibrinogen 93 1.084 -9.93 0.9587 121.6 to 695.0
(mg/dL)

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A ntithrombin

A PTT

D -D imer

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Factor II

Factor V

Factor VII

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Factor X

Fibrinogen-C (C lauss Method)

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Protein C (%)

Prothrombin Time (PT)

PT-B ased Fibrinogen

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Typical Linearity
Linearity studies were performed using multiple sample levels with each level tested in replicates of four on
an ACL TOP Family member. Results are shown in the table below.

Reagent Type
(Result Unit) No. of Levels Test Range Slope r2
Antithrombin 9 Levels 0 to 152.7 0.9039 0.9991
(%)
D-Dimer 9 Levels 143.7 to 1086.7 1.0000 0.9984
(ng/mL)
Factor II 9 Levels 0.86 to 154.13 0.9946 0.9997
(%)
Factor V 9 Levels 1.04 to 187.34 0.9540 0.9986
(%)
Factor VII 9 Levels 0.92 to 165.33 0.9411 0.9981
(%)
Factor X 8 Levels 0.95 to 143.03 0.9322 0.9975
(%)
Fibrinogen-C 9 Levels 72.2 to 721.6 0.9164 0.9866
(mg/dL)
Protein C 7 Levels 5.6 to 166.8 0.9237 0.9948
(%)
Prothrombin Time (PT) 9 Levels 12.3 to 160.3 1.0222 0.9992
(%)
PT-based Fibrinogen 10 Levels 58.3 to 777.8 0.9015 0.9978
(mg/dL)

Interference
Refer to the product insert sheets.

See Also
l System Specifications
l Analytical Limitations

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Analytical Limitations Chapter 2 – General Information

Analytical Limitations
On the ACL TOP instrument, sample carryover1 is negligible. In most situations inaccuracy attributed to
carryover is within the normal imprecision of the method, and therefore not statistically or clinically
significant.

NOTE: Refer to the reagent label for test-specific interference and limitation information.

See Also
l Test Performance
l System Specifications

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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Installing the ACL TOP Instrument Chapter 2 – General Information

Installing the ACL TOP Instrument

Review the following regarding the installation of your system:
l Site Requirements
l Actions Upon Delivery
l Bringing Into Operation

Site Requirements
IL personnel or other person(s) duly authorized by IL must install the ACL TOP instrument.

NOTE:

l The control module (CM) is dedicated to a specific ACL TOP instrument. Any attempt to swap the
CM with one from another ACL TOP Family instrument results in the following warning: CM is in
use from a different ACL TOP model. Use of this CM will require Service intervention.
l The CM for the ACL TOP instrument is a dedicated computer. Do not install any other software
application on it as this would qualify as a modification. Modifications to the programming or the
instrument may affect instrument performance and may void IL's warranty. Do not use thumb drives
(USB flash drives) that contain third-party software on the instrument. Do not plug or unplug any
cables or drives without Service guidance.
l The ACL TOP instrument complies with all local, state and national regulations and requirements in
the US for installation and site requirements.

CAUTION: The ACL TOP instrument weighs from 200-365 pounds (91-166 kg) depending on the
model. Use extreme care when moving the instrument. A total of four people should be used. Two people
should lift using the two molded handles in the rear of the unit. The third and fourth persons should each
take a front corner.

Limited Warranty
Instrumentation Laboratory is responsible for the safety and electrical performance of this equipment under
the following mandatory conditions:
l Persons authorized by IL carry out assembly operations, extensions, adjustments, modifications or
repairs.
l The electrical installation of the room complies with the local, state, or national requirements
(including power supply circuit with independent grounding).
l The equipment is used in accordance with these instructions.
l IL brand products are used. Non-IL brands are not covered.

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Spatial Requirements
Maximum Dimensions for Analytical Module (AM)
All measurements are in centimeters/inches and kilograms/pounds.

Model Weight Height Depth Width

TOP 300 91 kg 73 cm 84 cm 81 cm
CTS 200 lbs 29 in 33 in 32 in

TOP 500 141 kg 73 cm 81 cm 110 cm

CTS 312 lbs 29 in 32 in 43 in

TOP 700 162 kg 73 cm 76 cm 151 cm

356 lbs 29 in 30 in 59 in

TOP 700 166 kg 73 cm 76 cm 151 cm

CTS 367 lbs 29 in 30 in 59 in

TOP 184 kg 73 cm 76 cm 188 cm

700 LAS 406 lbs 29 in 30 in 74 in
With integrated
table
319 kg
703 lbs

NOTE: In the LAS configuration the instrument is bolted to the table.

The instrument must be positioned so that a waste tube can be connected to the right side of the unit without
any kinks or bends that could cause an obstruction.
The instrument must be positioned so that there is at least 15.2 cm (6 inches) clearance on all sides, back and
top for proper air circulation.

Maximum Dimensions for Stand-alone Control Module (CM)

For all models except TOP 300 CTS.

Weight Height Depth Width

17 kg 45 cm 49 cm 19 cm
37 lbs 17.5 in 19 in 7.5 in

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Maximum Dimensions for the Touch Screen Monitor

For all models except TOP 300 CTS.

Height Depth Width

37 cm 8 cm 43 cm
14.5 in 3 in 17 in

Maximum Dimensions for Integrated CM and Touch Screen Monitor

For TOP 300 CTS model.

Height Depth Width

36 cm 9 cm 43 cm
14 in 3.5 in 17 in

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Site Requirements Chapter 2 – General Information

Electrical Requirements
The instrument is designed to operate correctly with electrical variations to ±10% in an ambient temperature
of 15° C to 32° C (59° F to 89° F) with a relative humidity of 5%-85% (non-condensing). The instrument
should be placed in an area free from dust, fumes, vibrations and excessive variations of temperature. The
instrument should not be used at an altitude greater than 2000 meters.
The ACL TOP instrument is single phase, has current leakage of less than 500 µAmps, and produces 2,049
BTUs per hour.
In accordance with safety standard IEC 1010, paragraph 1.4, there is no safety hazard in the temperature
range 5-40° C.
The instrument is designed to operate correctly with electrical variations of up to ±10% on the nominal
supply and with supply frequencies between 47 and 63 Hz.

WARNING: Ensure the supply voltage in the laboratory is compatible with the label on the rear of
the AM1 as shown in the following table:

Value of supply voltage Current Value as shown

for normal function (A) on the label

240V AC ±10% 5A 100-240 VAC

115V AC ±10% 10 A 100-240 VAC

100V AC ±10% 10 A 100-240 VAC

The CM2 requires an input voltage between 100-240V and an amperage of 3.5A.
The monitor requires an input voltage between 100-240V and an amperage of 1.8-0.9A.
The power cord provided with the instrument is a certified cord with a three-prong, double insulated,
grounded (NEMA) receptacle and plug.

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.
2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Instrument Volt-Amps Specifications

ACL TOP Analytical Module
Volts AC Amps Volts/Amp Watts Frequency

100 VAC 10A 1000 VA 600 W 50/60Hz

115VAC 10A 1150 VA 600 W 50/60Hz

240VAC 5A 1200 VA 300 W 50/60 Hz

ACL TOP Control Module

Volts AC Amps Volts/Amp Watts Frequency

100 VAC 6A 600 VA 600 W 50/60Hz

115VAC 6A 690 VA 600 W 50/60Hz

240VAC 3A 720 VA 300 W 50/60 Hz

Monitor
Volts AC Amps Volts/Amp Watts Frequency

12 VDC 4.16A 50 VA * 50 W 50/60Hz

* DC voltage has no phase difference. Therefore VA = Watts.

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Environmental Conditions
The instrument functions correctly in an ambient temperature of 15° C to 32° C (59° F to 89° F) with a
relative humidity of 5% to 85% (non-condensing).
In accordance with the IEC regulations, no instrument failures occur in the presence of short-term ambient
temperatures as low as 5° C or as high as 40° C.
The instrument has been tested to IEC 60068-2-40 to 2000 meters. The instrument should not be used at an
altitude greater than 2000 meters.
The instrument should be placed in an area free from dust, fumes, vibrations and excessive variations of
temperature.
The heat generated by the instrument during normal operation is exhausted from the bottom, the front-right
and the left side of the unit.
Sufficient space (at least 6 inches) must be provided around the instrument to permit circulation of air for
cooling. The instrument must be positioned so that a waste tube can be easily connected on its right side.
Leave sufficient room to quickly disconnect the power cord, if necessary.
The audible noise emission is a maximum of 55 dBA, which passes IEC/CEI 61010-1 :2001 Second Edition.

Storage Conditions
Store the instrument and startup kit at 10°C to 30°C, and 5% to 85% relative humidity, non-condensing.

Shipping Conditions
Ship the instrument and startup kit at -30°C to 60°C, and 5% to 85% relative humidity, non-condensing.

Reagent Specifications
Reagent specifications for the ACL TOP instrument are published separately and distributed in the reagent
packaging.

Non-IL Reagents
The use of non-IL brand reagents or supplies for testing may cause a clinically significant degradation of
performance and results. IL does not assume any obligation or warranty engagement concerning precision
and/or accuracy of the measurements, nor for any damage to the instrument directly or indirectly resulting
from the use of reagents, consumables and/or expendable supplies other than those produced by IL.

See Also
l Warranty
l Limitations and Disclaimers

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Actions Upon Delivery Chapter 2 – General Information

Actions Upon Delivery

Only an IL-certified representative may perform the following actions upon delivery:
l Uncrate the ACL TOP instrument.
l Make sure that the shipping list is complete.
l Make sure all materials are in proper condition.
l Install the ACL TOP instrument.
IL is not responsible for damages resulting from attempts by an employee or representative of your company
to perform any of the above actions.

Bringing Into Operation

The entire ACL TOP instrument installation process is the responsibility of an IL-certified representative.

CAUTION: The ACL TOP instrument weighs from 200-365 pounds (91-166 kg) depending on the
model. Use extreme care when moving the instrument. A total of four people should be used. Two people
should lift using the two molded handles in the rear of the unit. The third and fourth persons should each
take a front corner.
IL is not responsible for damages resulting from any attempt by any employee or representative of your
company to install the ACL TOP instrument.

See Also
l Warranty
l Limitations and Disclaimers
l User Training Requirements
l Site Requirements

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Training Requirements Chapter 2 – General Information

Training Requirements
The user will operate the instrument in accordance with instructions for use in this manual. Using the
instrument improperly may result in impairment or injury.
The operator will follow normal laboratory practices for handling biohazardous substances, including the use
of lab coats, gloves, and shield, where required.
Users who operate the ACL TOP instrument must be properly trained by Instrumentation Laboratory, or an IL
representative.
Contact your local IL representative for information about training programs and the training certification
policy.
IL is not responsible for damages caused by using, or attempting to use, the ACL TOP instrument by
employees, or representatives of your company or laboratory.

See Also
l Warranty
l Limitations and Disclaimers
l Actions Upon Delivery
l Bringing Into Operation
l Site Requirements

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Warranty Chapter 2 – General Information

Warranty
IL warrants to Customer that the Products will be free from defects in material or workmanship for one year
from date of delivery, in the case of instruments and ninety (90) days from date of delivery for other products
(unless a different period is specified), or IL will repair or replace the product or provide credit, at its sole
option, upon prompt notification and compliance with its instructions. IL makes no warranty and shall have
no obligation with respect to expendable or consumable parts and supplies nor with respect to damage
caused by or resulting from accident; misuse; neglect; use of parts, materials or products not furnished by IL;
or unauthorized installation, alterations or repairs to the Products. IL EXPRESSLY DISCLAIMS ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTY OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR OR AN INTENDED PURPOSE.
IL's sole responsibility and the Customer's exclusive remedy for any claims arising out of the purchase of the
Products is the repair, replacement, or credit as described above where applicable. In no event:
1. shall the cost of the exclusive remedy exceed the purchase price;
2. shall IL be liable for any claims, losses or damages of any third party or for lost profits or any special,
indirect, incidental, consequential, or exemplary damages, irrespective of whether attributable to
contract, warranty, negligence, strict liability, or otherwise, even if IL has been advised of the
possibility of such damages.

See Also
l Limitations and Disclaimers
l Actions Upon Delivery
l Bringing Into Operation
l User Training Requirements
l Site Requirements

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Limitations and Disclaimers

Warranty Claims
Customer must inform IL of any defects found within 8 days from receipt or from discovery, in case of defects
which may not be identified in the normal inspection or which may appear at a later time.

Neglect and Misuse

The warranty does not apply to those defective instruments or materials showing defects or damage from such
as:
l Insufficient or negligent care by the customer.
l Use of the instrument by a user who has not been properly trained by IL or its representative.
l Failure of customer to follow to the instructions contained in the Manuals prepared by IL for this
purpose.
l Tampering with or altering the instrument.
l Repairs made by any person not duly authorized by IL.
l Misuse due to carelessness, negligence or inexperience.
l Employment of materials under heavier conditions than those for which they had been designed and
manufactured and use of the same in combination with incompatible or dangerous products.
l Failure to observe regulations relative to installation, power supply and operation of the instruments
(with particular regard to the regulations for accident prevention).
It is also understood that, following the purchase and delivery of the instrument, the customer shall be
deemed liable for any losses, damages or complaints concerning persons or things incurred by the use or
misuse of the instrument on behalf of the customer, his employees, co-operators or others.

Damage during Transportation

Damages caused by or connected to transport are excluded. Customer shall bear all risk and cost for
transporting products to and from IL’s factory.

Third Party Products

Those instruments or accessories that are supplied by IL but are not of IL manufacture will only benefit from
the warranty conditions offered by the manufacturer of such products.

Safety
Instrumentation Laboratory (IL) is responsible for the safety and electrical performance of this equipment if
and only if:
l Assembly operations, extensions, adjustments, modifications or repairs are carried out by persons
authorized by IL,
l The electrical installation of the room complies with the local, state or national requirements
(including a power supply circuit with independent grounding),
l The equipment is used in accordance with these instructions for use.

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“Washed” Cuvettes
The IL ACL TOP instrument cuvette was designed and manufactured as a single use product. Instrumentation
Laboratory and its authorized dealers shall not be responsible for instrument malfunction, invalid test values
or damages of any kind resulting from use of washed cuvettes.

Non-IL Brand Product

IL does not test other manufacturer reagents to ascertain their suitability for the ACL's methodology or their
level of performance on the IL ACL instruments.
The use of non-IL brand reagents or supplies for testing may cause a clinically significant degradation of
performance and results. IL does not assume any obligation or warranty engagement concerning precision
and/or accuracy of the measurements, nor for any damage to the instrument directly or indirectly resulting
from the use of reagents, consumables and/or expendable supplies other than those produced by IL.
IL brand reagents, consumables and expendable supplies (including, for example, cuvettes) were developed
specifically for the ACL TOP instrument’s detection systems. IL ACL TOP instrument products are tested to
ensure proper performance when using plasma samples in accordance with the protocol. Each lot of IL brand
ACL TOP instrument reagents is tested against these criteria. Verification of other brands of reagent or
supplies to ascertain their suitability for the ACL TOP instrument methodology or their level of performance
on the IL ACL TOP instruments is not performed. The use of non-IL brand reagents or supplies for testing
that is not done in accordance with IL protocols may cause a clinically significant degradation of
performance and results.
IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the
measurements or for any damage to the instrument directly or indirectly resulting from the use of reagents
and/or consumables other than those produced by IL.

User-Defined Tests
A user with the appropriate security level can create a new test or copy an existing test. All responsibility
for parameter development and validation of new or copied tests belongs to the user alone.
NO AGENT OR EMPLOYEE OF IL IS AUTHORIZED TO EXTEND ANY OTHER WARRANTY
OR TO ASSUME FOR IL ANY LIABILITY EXCEPT AS ABOVE SET FORTH.

See Also
l Warranty
l Actions Upon Delivery
l Bringing Into Operation
l User Training Requirements
l Site Requirements

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CHAPTER 3
USER INTERFACES

User Interfaces
Click one of the following links to view the corresponding ACL TOP User Interface (UI) feature:
l Input Devices
l Output Devices
l Software – Getting Started

See Also
l LIS Configuration
l Global Definitions Setup
l Visual Styles

Input Devices
Input devices include the following:
l Touch Screen
l Mouse
l Keyboard
l Bar Code reader
l 2-dimensional bar code reader
l Push Buttons
l LIS
l CD Read/Write Drive

Touch Screen
The screen is touch-sensitive. Pressing an icon or field selects it similar to selecting it with a mouse.

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Mouse
The ACL TOP instrument uses a standard two-button mouse and follows the standard Microsoft®
conventions for its use.

Keyboard
The ACL TOP instrument uses a standard 105 key Windows keyboard and follows the standard Microsoft®
conventions for its use.

Bar Code Reader

If the sample tubes and/or the reagent bottles have bar code labels, the system scans the labels as the racks
are inserted into the AM. After the bar code reader moves away from the track where you inserted the rack,
the scanned information displays.

Two-Dimensional Bar Code Reader

See 2D Bar Code Scanner.

Push Buttons
The AM1 has push buttons on the front that move the bar code reader to the sample and reagent rack areas.
There is also a push button in the center front of the AM that initiates an Emergency Stop as soon as it is
pressed.

LIS
The interface to the Laboratory Information System provides a means of downloading test requests remotely.
See LIS Configuration.

CD-ROM Drive
The CD-ROM drive on the CM may be used for input. Typically it is used for software and parameters
upgrades.

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Output Devices
Output devices include the following:
l Monitor – Primary output device to display test results.
l Diskette drive – Where present, use to export configuration or data files.
l CD read/write drive – Use to export configuration or data files.
l Printer (optional) – Uses a standard interface for printing reports.
l LIS – Use to output sample results.

See Also
l Input Devices
l Software – Getting Started
l LIS Configuration

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Getting Started
To use the ACL TOP software effectively, review the following topics:
l Terminology
l Layout
l Common Functions

See Also
l Input Devices
l Output Devices
l Global Definitions Setup

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Terminology
See the Glossary for more terms.

Calibration/NPP
An analytical material with a defined concentration or activity used to calibrate a test. A calibrator1 may be
calibration plasma or NPP. An NPP, or Normal Pool Plasma, is made by combining plasma from a large
number of people so that the pool acts as a representation of typical plasma. It is free of biases due to race,
sex, age, etc.

Cuvettes
Cuvette
A vessel, cell, chamber, or well in which sample and reagents are deposited, mixed, incubated and analyzed.
The cuvette cell is also called the cuvette well. Each cuvette cell has an optical path of 0.67 cm and is
designed to hold a minimum of 150 µL to a maximum of 600 µL of reaction mixture.

NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used
cuvettes on ACL TOP instruments. See Limitations and Disclaimers.

Cuvette Accumulator
A holding area for used cuvettes. It collects cuvettes after they leave the shuttle, but before they are dumped
into the cuvette waste drawer.

Cuvette Box
A cuvette box is a group of 10 cuvette clips packaged together for easy loading on the system (10 cuvette
clips = 100 cuvette strips = 400 cuvette cells). Cuvettes are loaded by the box.

1A type of sample with an assigned value used to calibrate a test.

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Cuvette Clip
A group of 10 cuvette strips joined together by features incorporated in the cuvette strips themselves.

Cuvette Loader
The cuvette loader is the left-most part of the instrument and is a defined area for cuvette loading that
includes the pivot arm and the indexer. The cuvette loader can hold up to 20 cuvette clips of ten strips per
clip for a total of 800 cuvette cells. The transport is a conveyor belt that transports the clips along the loader
and onto the pivot arm, which, with the help of the indexer1, positions the cuvette strips for pickup by the
cuvette shuttle.

While the analysis is proceeding, the space on the indexer left by the cuvette clips that have been moved to
the incubation/analysis areas is filled with new cuvette clips. A sensor detects when more cuvette clips need
to be placed onto the loader and an LED on the front of the instrument displays yellow when there are 3 or
fewer cuvette strips remaining, and red when the loader is empty. A message is also displayed in the Material
Alarms screen.

Cuvette Shuttle
The cuvette shuttle includes the carriage, gripper and jaw. It can position a cuvette at any slot and move it to
any other slot. To the right of the cuvette loader are slots for the cuvette strips. It is here that sample pre-
dilutions and calibration dilutions are performed at ambient temperature.

C arriage
The part of the shuttle that moves the cuvette strip from the loader to the various slots.

Gripper
Moves the cuvette strip into and out of the slots. The gripper includes the jaw.

Jaw
The part of the gripper that locks on to the cuvette strip.

1The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism.

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Cuvette Slot
Any valid drop-off and/or pick-up point for the cuvette strip. Examples of cuvette slots are incubator slots
and ORU slots.

Cuvette Strip
Four cells molded together in a disposable plastic piece form the cuvette strip. A cuvette strip is used for the
analysis. Each cuvette strip incorporates features to clip strips together to form cuvette clips and features to
enhance handling capabilities.

Cuvette Waste Container – TOP 300 CTS only

This container holds the waste cuvette strips. Used cuvette strips are moved to the right side of the AM1
where they are deposited into a cuvette waste container.

CAUTION Biohazard: Refer to local and state regulations for disposal of potentially
hazardous materials.
The cuvette waste container must be properly seated in the waste container area such that the cuvettes fall
directly into the waste container. The waste container must sit securely against the inner wall of the waste
area.
Improper seating of the cuvette waste container may result in cuvettes falling onto the bench or floor. The
cuvette waste area contains no sensor. It should be emptied once per day, when cuvettes reach the Max level
printed on the container, or as needed to prevent overflow.
Disposable gloves should be worn when handling waste cuvettes to avoid contact with potentially infectious
material.

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Cuvette Waste Drawer – Excludes TOP 300 CTS

A leak-proof five-sided container designed to be used with a disposable liner. This container holds the waste
cuvette strips. Used cuvette strips are moved to the right side of the AM and onto a cuvette accumulator
which holds 6 used strips. When the sixth strip moves to the accumulator, it drops down and causes the strips
to fall into the waste drawer.

CAUTION Biohazard: Refer to local and state regulations for disposal of potentially
hazardous materials.
The cuvette waste drawer must be properly seated such that the cuvette exit path from the analyzer is open
and waste cuvettes can fall freely. Improper seating of the cuvette waste drawer or use of improper waste
containers may result in cuvettes jamming.
Cuvette waste liners may be cleaned in an autoclave. However, sharp edges may result which could cause
injury. Place the cuvette waste liner in an autoclave bag before putting it into an autoclave.
Disposable gloves should be worn when handling waste cuvettes to avoid contact with potentially infectious
material.

Waste Cuvette
A cuvette that contains a completed coagulation or chemical reaction, and is ready to discard.

NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used
cuvettes on ACL TOP instruments. See Limitations and Disclaimers.

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Incubators
Sample Incubator
A heated area to the right of the dilution area contains slots for cuvette strips. Sample material is pipetted
into the cuvette cells here. The temperature is maintained at 37.0° C ± 0.5° C.

Reagent Incubator
A heated area to the right of the sample incubator contains slots for cuvette strips. Intermediate reagents are
pipetted into the cuvette cells here. The temperature is maintained at 37.0° C ± 0.5° C.

LAS Terminology
Adjustment Volume
Percentage of extra liquid added to every LAS probe sample aspiration to account for volume loss due to
LAS probe inaccuracy. The IL default is 2%.

Aliquoting Area
The cuvette slots where the LAS arm aliquots the LAS samples.

Aliquoting Area Expiration Time

Time used to determine whether a sample is moved to the LAS Cuvette Holding Area. If the time exceeds the
configured setting, it is not moved.

Aspiration Point
Position on the sample tube queue where the LAS probe can access a sample tube.

Interface Module (IM)

Interface Module Embedded System. Communication between the LAS instrument and the LAS track is
through an embedded interface module (IM) that is configured in the LAS Configuration screen.

LAS
Laboratory Automation System

LAS Arm
The LAS arm aspirates external samples and aliquots them into the system.

LAS Cuvette Holding Area

Cuvette slots where the LAS samples are placed in the system after the LAS arm has aspirated the samples
from the LAS track. It is the same as the Base TOP holding area except for the slots that belong to the LAS
aliquoting area.

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LAS Manager
Software or application that coordinates all the modules (track, decapper, analyzer, etc.) integrated in an LAS.

LAS Sample
Sample provided by a Laboratory Automation System.

Sample aspiration time

A time out, specified in the Sample Aspiration Unit, used to determine whether to aspirate an accepted tube
or release it to another instrument. Countdown starts when the tube is accepted. The default is 15 minutes.

Sample expiration time

The time used to determine whether or not the LAS sample is moved to the waste station.

LAS Status
Status of the LAS track and communications with the instrument. The statuses are as follows:

R EA D Y
LAS is ready and functioning.

U N A VA ILA B LE
LAS track is not able to provide samples automatically.

D ISA B LED
The LAS arm cannot be used and there is no communication with the LAS track.

U N K N OW N (blank)
LAS track is down or there is a communications error between the IM and the LAS track or the IM is not
responding.

R ESET QU EU E
The instrument is resetting the track queue. During this time the instrument does not interact with the LAS
track and Diagnostics is disabled.

N OT C ON N EC TED
The instrument is not an LAS instrument or there is a communication error between the CM and the IM or
the IM is down.

STOPPED
Auto Run is temporarily deactivated or a controlled stop has been requested or interaction with the LAS
track has stopped. The stopped state ends when you select Run Tests (the icon or the Actions menu item)
from any screen.

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LAS Track
The LAS Track transports LAS samples to the ACL TOP 700 LAS instrument. It includes the sample tube
queue and the aspiration point.

Preparation cuvettes
The number of cuvette strips to use for preparing dilutions and predilutions.

Query Point
Position at the entrance to the sample tube queue.

Sample Tube Queue

A dedicated branch of the LAS track where LAS samples that are to be processed by the instrument are
diverted from the main LAS track.

Virtual Sample Tube Queue

A software list that represents the LAS samples located at the sample tube queue. The list is maintained by
the ACL TOP 700 LAS.

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Material
Cleaning material
A liquid used to reduce or remove unwanted substances from the probe surfaces. The material is typically
acid or bleach-based.

Clean B diluted
A dilute cleaning solution used in many tests. To make: dilute 1 mL of Clean B with 7 mL of CLSI (formerly
NCCLS) CLRW Type water or equivalent. This solution must be made up fresh each day.

Deficient plasma
A plasma-based material that is lacking certain factors necessary to complete the coagulation cascade.

Diluent
A liquid used to reduce the concentration of a sample or a reagent. See sample diluent, reagent diluent,
below.

Empty material
Material that is present on the AM but the liquid level has been detected to be below the volume error
threshold.

Intermediate reagent
Material that is added to the sample material to activate certain constituents of the sample but does not bring
the reaction to completion. These materials are placed in diluent tracks and reagent tracks on-board the ACL
TOP instrument.

Known Material
Material that is defined and used in at least one test, calibration or QC definition.

Placed Material
Material that is known and located in a defined position on the AM. You cannot change the material
definition of any materials that are placed.

QC Material
A sample-like material typically having known amounts of analyte that is used to detect changes from stable
system operation and eliminate reporting of results affected by system instability.

Reagent
A liquid material used as part of a test, that, when mixed with sample, provides the necessary constituents to
either initiate or complete the desired biochemical reaction.

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Reagent Diluent
A liquid material used to reduce the concentration of reagent materials or to reconstitute a lyophilized
reagent.

Sample
Any material used for the sample component of a test. Typically, a sample is plasma-based material, either
patient sample or control/calibrator.

Sample Diluent
A liquid material used to reduce the concentration of sample materials.

Sample Type
Refers to the different kinds of materials that can generate data (patient, QC or calibrator).

Start Reagent
Material added to the cuvette in the ORU that acts as a trigger to start acquisition. These materials are placed
in reagent tracks R3 to R6.

Unidentified Material
Material that is defined but is not used in any test, calibration, or QC definition.

Optical Reading Unit (ORU)

ORU 1, 2, 3, 4
Slots with the optical reading units where start reagents such as APTT CaCl2 are pipetted into the cuvette
cells. It is also here that the readings are taken of the reactions occurring in the cuvette cells. Each ORU has
four reading stations.

See Also
l Welcome to Help
l Glossary

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Visual Styles
To configure the ACL TOP user interface style:
1. Select Setup > Visual Style in the menu bar.
2. Select a color in the submenu.

See Also
l User Interfaces
l Getting Started
l Layout

Layout
Each screen contains the following areas:
l Main Screen
l Menu Bar
l Toolbar
l Working Area
l Status Bar
l Information Panel

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Main Screen

ACL TOP Family Software Main Screen

The ACL TOP Family user interface contains the following functional areas:
l Title Bar – Displays the instrument name and the screen name.
l Menu Bar
l Toolbar
l Working Area
l Status Bar
l Information Panel

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Menu Bar
The ACL TOP instrument main menu bar contains the following menu options:

Instrument Menu
l Controlled Stop
l Recovery
l Resume Auto Run
l Log Out
l Exit

NOTE: The choices on the Actions menu differ depending upon what is displayed in the working
area.

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Sample List Actions Menu

Configuration
l Filter
Results
l Recalculate
l Validate
l Upload
l Delete
l Find Sample
l Previous
l Next
l Select All
l Unselect All
l Filter Selection by Test Code
l Download Tests Order
l Add/Remove Tests
l Run Tests
Print Preview
l Sample Results Report
l Patient Report
Print
l Sample Results Report
l Patient Report
Export
l Sample Results Report
l Patient Report
l Sample Results (EXCEL)
Raw Data Report
Patient Demographics
l Save
l Restore
Print Screen
Review

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l Previous Screen
l Sample Details
l Test Details
l Results Statistics
l Simple Test Counters Statistics
l Detailed Test Counters Statistics

Analysis Menu
l Sample Area
l Reagent Area
l Diluent Area
l Sample List

QC Menu
l Results List
l Test Status List

Calibration Menu
l Status List

NPP Menu
l Status List

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Setup Menu
l Vial Lists
l Material List
l Test List
l QC List
l Test Profiles List
l QC Profiles List
l Reflex List
l Auto Validation
l Revision History Report
l Import/Export
l Global Definitions
l Bar Code Definitions
l LIS
l Communications
l Sender List
l LAS Configuration ( ACL TOP 700 LAS only)
l Security
l User Security List
l Software Access Screen
l Reports
l Display
l Sample List Display Settings
l Test Programming Window
l Material Programming Window
l Languages

System Menu
l Maintenance
l Diagnostics
l Instrument Status
l Status Statistics
l General Log List

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Help Menu
l Help Topics
l About ACL TOP

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

See Also
l Layout

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Toolbar
The toolbar that appears over the ACL TOP instrument Working Area is divided into three sections: General,
Operations, and Navigation toolbars. The content of the toolbar is dynamic, depending on the context of the
Working Area. In this topic, TOP 700 LAS Sample List toolbar is used as an example:

General Toolbar

Online help is accessible in all ACL TOP instrument screens.

Help – Launches the online help.

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Operations Toolbar

The Sample List operations toolbar is used to perform operations on samples and the tests associated with
them. It contains the following icons:

Sample List Display Settings

Validate

Upload

Filter

Filter in Use

Find

Add/Remove Tests

Print

Sample Details

Test Details

Save

Restore

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Navigation Toolbar

The Sample List navigation toolbar is used to navigate among the Sample, Reagent, and Diluent areas, as
well as the QC Results List and Calibration Status List areas. It contains the following icons:

Previous Screen

QC Results List

Calibration Status List

LAS Cuvette Holding Area

Sample Area

Reagent Area

Diluent Area

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Other Commonly Used Toolbar Icons

The following commonly used toolbar icons appear dynamically depending on the context in the Working
Area. Toolbar icons remain disabled until the configuration in the Working Area is correct for the respective
task. See Toolbar Icons.

Add

Add/Remove Material

Scan (Bar code)

Copy Test

Delete Item/Delete Material

Test Feasibility List

Perform a Maintenance Activity

Run Programmed Tests

Restriction Map

Save

View Item/View Material

Warning Thresholds

Icon Tooltips
When you hover the cursor over a toolbar icon, a tooltip displays the task it performs.

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Moving the Toolbars

At the left side of the operations and navigation sub-toolbars are vertical bars. When you select one of these
bars, the position of the toolbar moves vertically to another position in the <screen> toolbar.

Toolbar Icon Drop-down Menu

Some toolbar icons have a small arrow on their right side.

When you select the arrow, a drop down menu appears. This drop-down menu is typically configurable, and
may also appear on the touch screen.

See Also
l Graph Icons
l Grid Icons
l Toolbar Icons
l Layout

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Working Area
The Working Area is below the toolbar. It typically contains a data table or a form. There are a number of
different data tables and forms that appear in the working area. By default, the Sample List is shown at
startup. Other lists (tables) may be viewed by selecting an icon in the navigation toolbar.

Navigation Toolbar
The navigation toolbar is dynamic. Its contents depend on the context in the Working Area.

TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and TOP 300 CTS
700 LAS TOP 500 CTS

Analysis Menu
You can select a data area from Analysis menu, as shown here (TOP 700 (includes ACL TOP Base), 700
CTS (includes ACL TOP CTS) and 700 LAS example):

These are the most commonly used data areas. There are others not listed on this menu.

Scrolling
The working area often has arrow icons on its right side and below the table that let you scroll up and down
or left and right through the table data. There are also arrow icons that go to the topmost or bottommost row
or leftmost or rightmost column of data.

Unique Identifiers
Most tables that appear in the Working Area contain a unique identifier column (for example, test code).
When you select a row, the cell in the unique identifier column appears with blue cell borders, indicating
that object has focus. See Placing Focus.

See Also
l Layout
l Sample Area

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l Reagent Area
l Diluent Area
l Reagent/Diluent Area
l Sample List
l Information Panel

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Status Bar
The status bar is located below the working area.

General Log Icon

The General Log icon opens a General Log List that displays the events that have occurred.

Analyzer Status
The Analyzer1 Status displays a short description and a color indicator of the current state of the analyzer, as
follows:

Description Color of Indicator

Power-up Blue
Initializing Blinking Blue
Warming Up Blinking Blue
Ready Green
Busy Blue
Controlled Stop Blue

Error Amber
Emergency Stop Amber

Diagnostics Blinking Amber

Maintenance Blinking Amber
Connecting No indicator
Not Connected No indicator

The Connecting status indicator is used during startup. The status changes to Not Connected when the
system times out without connecting to the Analytical Module.
It typically takes up to 30 minutes for the analyzer to complete the power-up process and go to the Ready
state. However, it can take up to 60 minutes at temperature extremes.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analytical Module.

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LIS Status
The LIS Status displays the following states:
l Amber – Rejected
l Gray – Not connected
l Green – Connected

Auto Run Status

The Auto Run Status displays the following states:
l Amber – Stopped
l Gray – Disabled
l Green – Enabled
l Red – Error
To view a short error message, hover the cursor over the red LED. A tooltip displays the cause of the error. If
the Auto Run status is both Stopped and Error, the Stopped status displays. If Auto Run leaves the Stopped
state but remains in the Error state, the status displays Failed.

LAS Status
The LAS Status displays the following states:
l Amber – Unavailable or Stopped
l Gray – Disabled
l Green – Ready

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Alarm Buttons
The following icons in the status area open a window with a table that lists alarm warnings and error
messages. These are disabled until there is something to report. See Alarm Buttons.

Material Alarms

Job Frequency
Alarms

QC Alarms

Maintenance
Alarms

Analyzer Alarms

External
Communications
Alarms (LIS and LAS
alarms)

See Also
l Layout
l Alarm Messages
l LED Status Color Codes

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Information Panel
The lowest area of the screen contains an information panel with the following:

Time To Completion
The Time To Completion area is located under the analyzer status LED. It displays the estimated time to
complete all currently running tests. Not all tests are scheduled at once. As tests are added to the schedule,
the time to completion updates. The blue progress bar visually represents the time to completion.

User ID
See Adding and Editing Users.

Security Level
See System Security.

Number of Entries
Number of entries on the open screen. For example, if the Material List is open, a Number of Entries value of
131 indicates there are 131 materials in the Material List.

Current Date and Current Time

Do not change the date and time in the Control Panel. Changing them may affect material stability and
patient data. The instrument has an internal clock that resets the date and time when necessary.

See Also
l Layout
l LED Status Color Codes

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Common Functions Overview

The following functions are generally available in all areas of the instrument:
l Log in
l Focus
l Select
l Add Item
l View Item
l Delete Item
l Sort
l Filtering Data
l Find and Auto-Search
l Save
l Restore
l Previous Screen
l Print
l Print Screen
l Run/Auto Run
l Exporting Data
l Cancel/Stop/Progress Bar
l Log Out
l Exit

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Logging In
To start the ACL TOP instrument software you must log in with your user name and password.
1. Enter your user name and password.
2. Select OK to continue logging in or select the Shutdown button to shut down the ACL TOP
instrument software.
If your password has a defined duration and it goes into the warning period, you are alerted on-screen and
you have the option of changing it.
l If the password is not changed you can log on for the remainder of the valid period only.
l When the password expires you are given the option to change it. If No is selected you are no longer
allowed to log on.
l If you select Yes, the change password screen displays, and you enter the new password, which is
then valid for the period defined in the User security screen.

If your password does not have a defined duration it will not expire.

See Also
l Log Out
l Adding and Editing Users
l Common Functions Overview

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Placing Focus

Placing Focus on an Item

To place focus on a list item:
1. Open the list in table format (for example, Material List, Test List, Sample List, QC List, Reflex List,
etc.).
2. Click a cell in the column that contains the unique identifier. For example:

l Material Name column

l Test Code column
l Sample ID column

3. A blue cell border indicates the row has focus. Only one row at a time can have focus.

4. You can perform an operation on the item that has focus.

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Combinations of Select and Focus

NOTE: Do not edit the sample ID after an analytical session has started, unless you remove the rack
first.

N ot Selected / N o Focus

Focus

When a sample has focus you can obtain detailed information about the sample and its tests. Only one
sample at a time may have focus.

Selected

Multi-selection is allowed. You can print, validate or upload the sample information for all selected samples.

Selected with Focus

Select and place focus to obtain detailed information about a sample and its tests. You can validate and
upload in this configuration.

U nderlined – H idden D ata

An underlined sample ID indicates there are test results that are not displayed in the Sample List. See Sample
List Display Settings to display hidden columns.

See Also
l Selecting Objects
l Selecting and Placing Focus on Samples

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Selecting Objects Chapter 3 – User Interface

Selecting Objects
You can perform actions such as add, delete, edit, print, validate or upload on items displayed on a screen by
selecting the objects, then performing the action.

Selecting an Object
To select an item:

1. Click in the left-most Select column in the row on which to perform an action.
2. A red check mark indicates the row is selected.
3. The unique identifier in the row also has focus1, indicated by a blue cell border around it.
4. You can now perform intended actions on the selected item.

Selecting All the Objects in a List

To select all the items in a list:

1. Click the Select icon in the column heading to place a red check mark in every row in the list.
2. You can now perform intended actions on all the items in the list.

See Also
l Placing Focus
l Selecting and Placing Focus on Samples
l Sorting Lists
l Filtering Data
l Find and Auto-Search

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Adding an Item Chapter 3 – User Interface

Adding an Item
To add an item:

1. Select the Add icon in the toolbar (when it is active).

2. The task that runs depends on the context in the Working Area. A new row is added to the table in
the Working Area.

See Also
l Adding a New Maintenance Activity
l Adding a New Material
l Adding a Test Definition

Viewing an Item

The action triggered when you select the View icon in the toolbar depends on the context in the
Working Area. It typically displays detailed information on the object1 that has focus2.

See Also
l Material Definition
l Test Definition

1A data item in the Working Area of the ACL TOP application. For example, the unique identifier in a table,
a maintenance activity, or function, etc.
2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Deleting an Item Chapter 3 – User Interface

Deleting an Item
To delete an item:
1. Select1 one or more items in a list to delete.

2. Select the Delete icon in the toolbar.

3. Confirm the deletion when prompted.
See Test Deletion Rules.

NOTE: You may not delete IL-locked materials.

Sorting Lists
To sort a list:
1. Select a column heading. A small arrow appears in the column heading to indicate the column is
sorted in ascending or descending order.
2. Select the same column heading again to resort in reverse order.
3. Select a second column heading to sort the list by that criteria. The first column you sorted now
becomes the secondary sorting criteria.
The sorting condition is retained when you exit and re-enter the screen.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Filtering Data Chapter 3 – User Interface

Filtering Data
To filter data in the Working Area:

1. Select the Filter icon in the toolbar, or select Actions > Configuration > Filter in the menu
bar.

2. If the current view has been filtered, the icon displays in the toolbar.
3. <Optional> Select the Filter icon in the toolbar and change or remove the currently applied filter
criteria.
Filters are available for the following screens:
l Material List
l Test List
l QC List
l Sample List
l Maintenance List
l General Log List

See Also
l Sample List Filter
l Find and Auto-Search
l Sorting Lists
l Placing Focus
l Selecting Objects

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Find and Auto-Search

Find
To find an item in the Working Area:
1. Open the screen that contains the table you want to search.

2. Select the Find icon in the toolbar, or select Actions > Results > Find in the menu bar.
3. Enter all or part of the search text in the Quick Search dialog box.
4. Select the Next or Previous button to locate items with similar names in the Working Area.

Auto-Search
Auto-Search is programmed for most tables in the ACL TOP interface. This means that you do not have to
select Find in the menu bar or toolbar to begin the search.
To find an object capable of having focus1 in a table:
1. Open the screen that contains the table you want to search.
2. <Optional> Sort the column you want to search in.
3. Start typing the text you want to search for. For example: SA1174
4. The focus automatically moves to the first object in the column that corresponds to the characters you
have typed.

See Also
l Filtering Data
l Sorting Lists
l Placing Focus
l Selecting Objects

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Save Chapter 3 – User Interface

Save

Select the Save icon in the toolbar, or select Actions >Save in the menu bar to save the following
types of information:
l Auto validation information
l Bar code definitions
l Calibration data
l LIS communications configuration
l LAS configuration
l Interface Module configuration
l Material definitions
l Patient identification data
l Profile data
l QC data
l Reflex definition
l System configuration information
l Test definitions
l User security

Restore
Restore returns the system configuration to its previous saved state. Any changes made since that time are
discarded.
To restore the system to its previous configuration:

l Select the Restore icon in the toolbar, or select Actions > Restore in the menu bar.

Previous Screen
To view the previously displayed screen (when available):

l Select the Previous Screen icon in the toolbar, or select Actions > Previous Screen in the
menu bar.

See Also
l Toolbar
l Toolbar Icons

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Print Chapter 3 – User Interface

Print

Printing an Entire List

To print an entire list:
1. Open the list to print (Material List, Test List, etc.).
2. Select Actions > Print > <submenu> in the menu bar. For example, select Print Material List or
Print Test List.
3. In the Print dialog box, select OK.

Printing Selected Data

To print selected data:
1. Open a list (Material List, Test List, etc.).
2. Select1 one or more rows in the list that is open in the Working Area.
3. Select Actions > Print > <submenu> in the menu bar.
4. In the Print dialog box and select OK.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

See Also
l Formatting Reports
l Exporting Data
l Print Screen

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Print Screen Chapter 3 – User Interface

Print Screen
To print the screen that is currently displayed:
1. Open the appropriate screen in the Working Area.
2. Select Actions > Print Screen in the menu bar.

NOTE: Except for alarm screens, Print Screen is not available when a window or dialog box is open
on top of the screen.

See Also
l Formatting Reports
l Exporting Data
l Print

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Run / Auto Run Chapter 3 – User Interface

Run / Auto Run

Overview
When Auto Run is enabled, samples run automatically when PLACED. You do not have to select Run in the
toolbar or the menu bar.Auto Run is enabled in the Global Definitions Setup screen. Auto Run cannot be
disabled for LAS.
The run starts automatically when all the following conditions are met:
l The AM status is READY.
l Sample status is PLACED.
l Enhanced clean is not required.
l Temperatures are in range.
l At least one ORU is enabled.
The instrument monitors these conditions at one-minute intervals. If the required conditions are not met, the
instrument retries Auto Run after each monitoring interval.
After Auto Run starts, the instrument status remains BUSY until testing is complete.
A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become
feasible, or until the sample expiration time elapses.
LAS alarms appear in the General Log as well as in External Communications Alarms area in the Status Bar.
Auto Run has its own status line at the bottom of the screen. The LED statuses include the following:
l Amber – Stopped
l Gray – Disabled
l Green – Ready
l Red – Not Available
See LED Status Color Codes.
To determine why Auto Run is not available, hover your mouse over the red LED to display a tooltip stating
cause of the error. If the Auto Run status is both STOPPED and NOT AVAILABLE, the STOPPED status
displays. If Auto Run leaves the STOPPED state but remains in the ERROR state, the status displays NOT
AVAILABLE.

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After Initiating a Test

When you confirm the run, a progress bar appears while the system is processing the run command. It
disappears when processing is finished.
After the run starts, other jobs can be added and executed within the same analytical session. You are not
forced to press the Run icon again after new tests are programmed within existing or new racks.
The time to completion is displayed in the status bar during test execution. See Information Panel.
The testing finishes when all feasible jobs programmed in the last started analytical session are completed.
NOT FEASIBLE tests generate alarms for each missing material.
If the job is not feasible because QC failed or there is no validated calibration, an alarm message appears. See
Calibration Setup and QC Setup Definition to see how to set this feasibility check.
When the analytical session finishes, NOT FEASIBLE tests are canceled and their status changes to
PLACED.
If, between the programming and the run, one or more tests become inconsistent or disabled, associated tests
are canceled and their status changed from PLACED to TO DO when the run begins. An alarm is also
generated.
When the analytical cycle completes, the system performs a clean cycle for all probes and activates the waste
accumulator peristaltic pump to empty the contents of both the sample and reagent waste accumulators. See
Fluid Waste.

Running Tests on Manually Loaded Samples

You can only run tests when the analyzer status is READY. You can run tests programmed in one or more
sample racks.
To run tests on manually loaded samples:

l Select the Run icon in the toolbar, or select Run in the Actions menu.

NOTE: After selecting the run command, the following apply:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running
the test. You must perform the enhanced clean before running the test. See Enhanced Clean in
Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run command or cancel
and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput
changes. Confirm or cancel the run.

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Enabling and Resuming Auto Run

To enable Auto Run:
1. Make sure the instrument is in the READY state.
2. Select Setup > Global Definitions in the menu bar.
3. Select Auto Run in the Run area of the Global Definitions screen.

4. Select the Save icon in the toolbar to save your changes.

5. With Auto Run enabled, testing begins as soon you load the required materials onto the instrument.

You do not have to select Run in the toolbar or the menu bar to start a test.
6. If any of the following conditions occur, the instrument disables Auto Run:

l The AM status is not READY.

l Sample status is not PLACED.
l Enhanced clean is required.
l Temperatures are out of range.
l All ORUs are enabled.

7. If the instrument disables Auto Run, hover the cursor over the red LED on the screen to display a
tooltip stating cause of the error. Correct the error. Then select Instrument > Resume Auto Run in the
menu bar to resume Auto Run.

See Also
l LED Status Color Codes
l Reference Section Overview
l Resume Auto Run

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Exporting Data Chapter 3 – User Interface

Exporting Data

Exporting an Entire List

To export an entire list to an external file:
1. Open a list to export (Material List, Test List, Sample List).
2. Select Actions > Export > <submenu> in the menu bar. For example, select Export Material List or
Export Test List.
3. In the Export dialog box, select a file format and destination, then select OK.

Exporting Selected Data

To export selected to an external file:
1. Open a list to export (Material List, Test List, Sample List).
2. Select1 one or more rows in the list that is open in the Working Area.
3. Select Actions > Export > <submenu> in the menu bar.
4. In the Export dialog box, select a file format and destination, then select OK.

Export File Formats

l Acrobat
l Crystal Reports
l HTML 3.2
l HTML 4.0
l MS Excel 97-2000
l MS Excel 97-2000 (Data only)
l MS Word
l ODBC
l Record Style (columns no spaces)
l Record Style (columns with spaces)
l Report Definition
l Rich Text Format
l Separated Value (CSV)
l Tab-separated Text
l Text
l XML

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

See Also
l Importing and Exporting Definitions
l Print

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Cancel / Stop / Progress Bar Chapter 3 – User Interface

Cancel / Stop / Progress Bar

The Cancel button cancels the operation currently in progress, and rolls back the changes that have occurred
up to that point.
The Stop button cancels the operation that is currently in progress.
The Progress Bar graphically represents the execution of an operation that requires time to run, and can be
canceled.

See Also
l Common Functions Overview

Logging Out
Use the Log Out command if you leave the system unattended and want to prevent access to it with your log
on name. You can log out while the system is operating.
1. Select Instrument > Log Out.
2. Select OK in the confirmation dialog box.

See Also
l Login
l Common Functions Overview

Exit
To close out of the ACL TOP software:
l Select Instrument > Exit in the menu bar, or select the close box in the upper right corner of the
screen.

See Also
l Starting the Instrument
l Shutting Down the Instrument
l Emergency Stop
l Controlled Stop
l Recovery

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CHAPTER 4
SETUP

Material List
The Material List contains all the available defined materials used on the system. Before a material can be
used it must be defined. The system contains a library of definitions for materials manufactured by IL for use
on the instrument.

Accessing the Material List

To open the Material List screen:
l Select Setup > Material List in the menu bar.

Filtering the Material List

To filter the Material List:

1. Select the down arrow to the right of the Filter icon in the toolbar.
2. Select one or more of the following options on the filter drop-down menu:

l Show All
l Cal1/NPP2 and QC
l Diluents
l Reagents
l Clean
l Enabled materials
l Disabled materials

1Calibrator. A type of sample with an assigned value used to calibrate a test.

2Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Material List Toolbar

The operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Add a New Material

View Material Definition

Delete a Material

Filter

Material Restriction Map

Scan (2D bar code)

Print the Material List

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Material List Actions Menu

C onfiguration
Select Configuration > Filter to open a submenu of filters used to filter the materials displayed in the
Material List Table.

Material
Select Material > Add to add a material definition.
Select Material > Delete to delete a non-IL material definition. To delete, you must first place a check mark
in the left column in the Material List Table next to the material name. A material used in a test definition
cannot be deleted before the test definition is deleted. Either remove it from the test definition, or delete the
test definition, then delete the material.
Select Material > Scan to scan a 2D bar code to update lot information and other values. (for example, ISI
value for reagents, or assigned value for calibrators).

NOTE: You may not delete IL-locked materials.

R esults
Select Results > Find Material to open the Quick Search window. Enter the material name and select OK.

Print Preview
Select Print Preview > Print Preview Material List to preview a report containing the entire Material List
before printing.

Print
Select Print > Print Material List to print a report containing the entire Material List.
Select Print > Print Material Definitions to print a report containing the selected material definitions.

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Export
Select Export > Export Material List to export the Material List report. Specify the format and the
destination in the popup Export dialog box. See: Exporting Data.
Select Export > Export Material Definitions to export the selected1 material definitions.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

Print Screen
Select Print Screen to print the screen currently displayed.

R eview
Select Review >Previous Screen to return to the last screen displayed.
Select Review > Material Definition to display the Material Definition screen for the material that has the
focus.
Select Review > Restriction Map to display the Restriction Map showing the types of material to place onto
each track. It also shows the types of racks that may be placed and their corresponding track positions.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Material List Table

The Material List displays what is defined for each material.

Column Heading Descriptions

Select
Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the
Select icon in the column heading to select or deselect all the rows in the table.

When you select one or more rows, the Delete toolbar icon is enabled (for non-IL materials only).

N ame
The name of the material.

Type
A material can be one of the following types:
l Intermediate reagent
l Start reagent
l Sample Diluent
l Quality Control
l Calibrator/NPP
l Clean
l Deficient Plasma

Start R eagent
A check mark indicates the material is a start reagent. A start reagent is a material that, when mixed with a
sample or a sample mixture (for example, a sample + diluent) begins the reaction.
See Test Feasibility for proper placement of all reagents.

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Material R eferenced
A check mark indicates the material is used in at least one test definition. A material is also referenced if it is
configured in the Material Programming Window. Referenced materials cannot be deleted. A material
becomes non-referenced when it is no longer in the Material Programming window in a test definition, or
when the test definition is deleted.

Material On-board
A check mark indicates the material is currently placed on the system. Placed materials cannot be deleted or
edited.

Material Manufactured by IL
A check mark indicates the material was manufactured and approved by Instrumentation Laboratory. IL-
defined materials cannot be deleted.

Lot ID
An alphanumeric code that identifies where and when the material was manufactured.

Exp. D ate
The date when the material no longer meets the manufacturer’s specifications.

R efrigeration
A check mark indicates the material requires refrigeration.

Stirring
A check mark indicates the material requires stirring. Stirring is available only in rack positions 1 and 2 on
all reagent racks.

Index
The following values indicate:
l 1-500 – Material manufactured by Instrumentation Laboratory.
l 501-999 – User-defined material. Unique for each material.

A lternate Lot
A check mark indicates the material has an alternate lot defined. An alternate lot can be used to evaluate a
new material lot before the current lot expires.

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Enabled Material
A check mark indicates the material is referenced by an enabled test. An unchecked box indicates the
material is included in a test definition for a test that has been disabled. See Test List .

See Also
l Material Definition
l Reagents
l Restriction Map
l Test Feasibility
l Reagent Area

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Material Definition Chapter 4 – Setup

Material Definition

Viewing and Adding Material Definitions

To view material definition information:
1. Select Setup > Material List in the menu bar.

2. Select the View icon in the toolbar, or double-click a material on the Material List to display
the Material Definition screen.
3. View settings on the following tabs:

l General Information tab

l Stir, Rinse & Clean Information tab
l Lot Specific Information tab

4. Select the Add icon in the toolbar to define a new material.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Material List.

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Configuring Reporting of INR Results

To report INR1, you must enable NPP2 and define a valid NPP value in the test definition. The NPP default
value is 0.0.
Enter the ISI3 value into the Material definition for the PT reagents as follows:
1. Select Setup > Material List in the menu bar.

2. Place focus4 on the PT reagent, and select the View icon in the toolbar.
3. On the Lot Specific Information tab select Enable lot management.
4. Select the ISI Value option and enter the ISI value from the PT reagent package insert.

5. Select the Save icon in the toolbar to save your changes.

6. Select Setup > Test List in the menu bar.

7. In the Test List, place focus on the PT test code and select the View icon in the toolbar.
8. In the Test Definition screen, select Normal Pool Plasma in the navigational tree.
9. In the Normal Pool Plasma screen, select the Enable NPP option (if not selected) and edit the NPP
information as appropriate for your laboratory.

10. Select the Save icon in the toolbar to save your changes.
11. The ACL TOP instrument is now properly set up to report INRs.
See ISI Value.

NOTE:

l If the product lot number changes, the new ISI value from the package insert must be entered.
l If the measured result is 0, the Ratio and INR results fail.

1International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time (PT)
worldwide.
2Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.
3International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and used to
calculate the International Normalized Ratio (INR).
4To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Material Definition Actions Menu

Material
Select Material > Save to save the changes to the material definition.
Select Material >Restore to restore the screen to its previous values.
Select Material >Activate Lot to activate the alternate lot.

Print Preview
Select Print Preview to display a preview of the Material Definition Report before printing.

Print
Select Print to print the Material Definition Report. The report displays the same information as the Material
Definition screen, with the fields labeled as Enabled or Disabled.

Export
Select Export to export the Material Definition Report. See Exporting Data.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

Print Screen
Select Print Screen to print the screen that is currently displayed.

Review
l Select Review > Previous Screen to view the previous screen.
l Select Review > Assigned Values to view the Assigned Values window. See Assigned Values.

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Material Definition – Toolbar

The operations toolbar for this screen includes the following:

Select the following icons to perform the associated tasks:

Assigned Values (only for a material defined as a calibrator1).

Save – Saves the Material Definition.

Restore.

Activate Lot.

Print – Prints Material Definition Report.

1A type of sample with an assigned value used to calibrate a test.

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Material Definition – General Information Tab

Material Index
Unique number for each material. The analyzer uses the material index value internally, as follows:
l 1-500 – IL materials
l 501-999 – User-defined materials

Material Name
Enter a name for a new material, or edit an existing name. Accepts a maximum of 20 alphanumeric characters.

NOTE: Changing the name of a material, invalidates its calibration. If you change the material name,
you must recalibrate the tests that use the material.

Manufacturer
Defaults to IL, but may be edited if the material is from another manufacturer. Accepts a maximum of 15
alphanumeric characters.

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Category Type / Material Type

These fields define the material type. They cannot be changed for an existing material. For a new material,
select options from the category drop down list. Then select the material type from the drop down list.

C al/N PP and QC
l Calibrator/NPP1
l Quality Control

C lean
l Clean

D iluents
l Sample Diluent
l Reagent Diluent

R eagents
l Deficient Plasma
l Intermediate Reagent – A material that, when mixed with sample, activates certain components of
the sample, but is not enough to bring the reaction to the desired completion. These reagents are
always be followed by a start reagent. See Test Feasibility for proper placement of all reagents.
l Start Reagent – A start reagent is a material that, when mixed with a sample or a sample mixture (for
example, a sample + diluent) begins the reaction.
See Assigned Values.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Bottle Type
Use to specify the bottle size. The system calculates the actual volume of material available in the bottle
when the probe senses the presence of the liquid. For IL materials, the bottle volume is obtained from the bar
code on the bottle. When a new material is defined, the correct volume must be selected from a drop down
list.

NOTE: When materials are loaded and identified via the bar code, the system recognizes the bottle
type, and automatically updates the material definition. When manually identifying a material, make sure the
bottle size matches the defined bottle type. Mismatch of bottle size and bottle type may result in erroneous
volume tracking and handling.
The following graphic depicts the bottles and shows their volumes and maximum fill lines.

Smallest Volume/D ead Volume

The ACL TOP instrument indicates when a bottle of material can no longer be used. The liquid remaining in
the bottle when the bottle is no longer valid is defined as the throwaway material. The throwaway material
depends on both 1) the smallest volume for a material; and 2) the dead volume of a material bottle.
l Smallest Volume – For each enabled material definition in the system that is referenced by an
enabled test definition, the system automatically computes the smallest volume defined for it. The
smallest volume equals the smallest pipetting volume for a single pipetting step in any test where the
material is used. This volume is used by the system to compute the zero bottle volume. The system

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considers as EMPTY all bottles that contain less than the smallest volume for that bottle. For example,
if the volume of liquid in a bottle is too low to perform a test: 1) the status of that material is changed
to EMPTY; 2) the on-board volume changes to 0; and 3) the bottle status changes to a red color
(status = PLACED, ERROR).

The smallest volume may be modified: 1) each time any related test definition is changed; and 2)
when you change system parameters that could affect test definition volumes (for example, dilution
parameters).

Important: Material smallest volume affects only the display of the material status (the on-board
volume and the material bottle status [color]).
l Dead Volume – The unusable volume that triggers the <Material name> insufficient volume alarm.
For example: 1) there are no more bottles of the same material available on the instrument; 2) it is the
last available bottle; or 3) there is not enough material to execute the test.

The dead volume depends on the material bottle. Dead volume is based on the physical geometry of
the bottle, mechanical tolerances, etc. Aspirating from a bottle beyond its dead volume creates a risk
of performing partial aspirations, which may affect analytical results, or risk the probe striking the
bottom of the bottle.

Dead volumes have been optimized for reagent bottles located in stirred positions.

The following table lists dead volumes, including volume measurement accuracies that depend on
instrument-to-instrument variability.

NOTE: Values shown here represent estimates. Since material properties differ, actual values may
vary due to inherent differences in the physical properties of the sample or reagent within them.

Bottle Size Max. Dead Volume Non- Max. Dead Volume Volume Measurement
Stirred Stirred Accuracy
2 mL sample cup 0.15 mL N/A N/A
4 mL 0.4 mL N/A ± 0.2 mL
7.5 mL 0.8 mL N/A ± 0.3 mL
10 mL 0.8 mL 2.0 mL ± 0.3 mL
15 mL 1.3 mL 2.8 mL ± 0.5 mL
20 mL 1.3 mL 2.8 mL ± 0.5 mL
30 mL 3.5 mL N/A ± 0.7 mL
Aliquot tube N/A* N/A
(Fisherbrand)
Aliquot tube N/A* N/A
(Corning)
Cuvette 65 μL N/A

* Dead volumes for aliquot tubes cannot be determined due to variability of tube geometry, tolerance,
sample characteristics, and tube material.

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l Throwaway Material – This depends on both the material smallest volume and the bottle dead
volume.
l Usable Volume – The total volume of liquid in a specific material bottle minus the dead (unusable)
volume of that bottle.

Volume Tracking
The system uses the fill volume to track the available volume of material in real-time, and generates a
warning when the volume reaches the defined warning threshold.

Enable Volume Threshold

Specifies the volume of material remaining that triggers low volume. The minimum allowed value is 0.3 mL
(to eliminate the possibility of having insufficient material to complete a run. The low volume warning
threshold should be established for every material based on the laboratory workload and workflow to allow
enough time to replace the material.

Enable Expiration Tracking

Option to generate a warning when the material approaches its expiration date. The expiration date is defined
in the Lot Specific Information tab. This option also is available when Lot Management is disabled. For IL
materials, the expiration date is read from the bar code on the bottle.

NOTE: Expiration tracking is linked to the data contained in the bar code on the reagent vial. When
Lot Management is disabled, expiration tracking for the reagent vial remains enabled. Expired material
generates a material expiration warning. To enable extended expiration time, select the Enable lot
management and Enable extended expiration date options on the Lot Specific Informationtab.

Enable W arning Threshold

Specifies the number of days before the material expiration date to generate a warning. The Expiration
Tracking warning threshold should be established for every material, based on laboratory needs.

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On-board stability

Enable On-board Stability Tracking

Option to automatically track the stability of a material placed in the reagent area.

On-board Stability
Specifies the number of minutes, hours or days that the material remains stable while it is on the Analyzer1 in
the Diluent or Reagent area. The system generates an error and stops using that material when the defined on-
board stability time elapses. This field is available only for user-defined materials.

Enable warning threshold

Specifies the number of minutes, hours or days before reaching the on-board stability limit to issue a warning.
The low on-board stability warning threshold should be established for every material, based on laboratory
needs.

NOTE: Do not change the date and time on the host computer. This can affect material stability and
patient data. The instrument has an internal clock that resets the date/time when necessary.

Test not feasible when stability is expired

When this option is selected, the following events occur when the reagent material exceeds the on-board
stability:
l Tests in the TO DO state will not run.
l Tests that are PLACED but not scheduled will not run.
l Tests that are PLACED and scheduled, but NOT FEASIBLE (required materials are not on-board) will
not run.
l Tests that are PLACED and ACTIVE (required materials are on-board) will run, and the results are
flagged.
l Tests that are NOT FEASIBLE (required materials are not on-board) will not run. Exception: If an on-
board material expires while a test is ACTIVE, the test will run but the results will be flagged.
l Tests that are COMPLETE remain complete.

NOTE: Rerun and Reflex tests are created and executed (if feasible) during the run session, so they
have PLACED status, and run based on the above rules.

Comments
Enter notes about the material, if desired.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analytical Module.

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Location Information
Location information is provided only when the material is on-board. This consists of a table with the
following data columns:
l Track identifier – ID for a track
l Rack identifier – ID for a rack
l Rack position identifier – ID for a rack position
l Lot identifier – ID for a lot number
l Stirring indicator – Check mark means position has stirring
l Refrigeration indicator – Check mark means position has cooling

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Material Definition – Stir, Rinse & Clean Information Tab

On this tab, define: 1) how the instrument performs rinse and clean after a material has been pipetted; and 2)
whether stirring is necessary. Select Rinse or Clean and Rinse for reagent, diluent and sample materials.

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Rinse
Option to perform probe rinse operations.
This option is disabled if you select the Clean & Rinse option.

Frequency
Specifies when to perform probe rinsing. Options are:
l Between changes in material only – Default option. Rinsing is not performed between multiple,
successive dispensations of this material, but is performed between changes of material.
l After each dispensation of same material – Rinsing is performed between each dispensation of the
same material.

R inse time
Time allocated for the probe rinsing operation.
l Minimum: 1 sec.
l Maximum: 5 sec.
l Default: 1 sec.
See Analytical Cycle Definition Screen.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.

Stirring required
Option to stir the material. You must place a magnetic stir bar (IL Part Number 09746610) in the bottle with
the fluid. The bottle must be placed in reagent rack positions R1 or R2. If the bottle is placed into a rack
position that does not support stirring, the instrument issues a warning.

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Clean & Rinse

Option to perform probe clean and rinse operations.
This option is disabled if you select the Rinse option.

N umber of clean & rinse cycles

Configure the number of clean and rinse cycles to perform.

Clean Cycle

C lean material
Select a system clean material in the drop down list.

NOTE:

l IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B
diluted bottle becomes empty, the instrument performs an emergency stop, and all work in progress is
lost. To avoid loss of work, place multiple bottles of Clean B diluted on-board the instrument. See
Test Feasibility for proper placement of all reagents.
l The absence of the selected clean material from on-board the instrument makes the test that uses the
material for which the clean is defined NOT FEASIBLE.

N umber of aspiration cycles

Configure the number of times to run the clean and rinse cycle.

C lean airgap
Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean
material and ensures accurate volume delivery.
l Minimum: 0 µL
l Maximum: 250 µL
l Default: 15 µL

C lean volume
Volume of clean material in microliters that the probe aspirates during the clean and rinse cycle.
l Minimum: 0 µL
l Maximum: 190 µL
l Default: 130 µL

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C lean transport airgap

Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and
ensures accurate volume delivery. This is not selectable for system clean.
l Minimum: 0 µL
l Maximum: 250 µL
l Default: 0 µL (Zero indicates not used.)

C lean total volume

Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume must not exceed
the maximum probe volume, or 250 µL.

H old time
Period of time the clean material is held in the probe before it is agitated or dispensed to waste.
l Minimum: 0 sec.
l Maximum: 60 sec.
l Default: 0 sec.

Enable agitation
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.

C lean material volume for all cycles

Volume of clean material required for the configured number of aspiration cycles.

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Rinse cycle

Frequency
Specifies when to perform probe rinsing. Options are:
l Between changes in material only (default) – Rinsing is not performed between multiple, successive
dispensations of this material, but is performed between changes of material.
l After each dispensation of same material – Rinsing is performed between each dispensation of the
same material.

R inse after clean time

Time allocated for the probe rinsing operation.
l Minimum: 1 sec.
l Maximum: 5 sec.
l Default: 1 sec.
See Analytical Cycle Definition Screen.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.

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Material Definition – Lot Specific Information Tab

Enable Lot Management

Check this option to enable the fields on this tab.
You can define two different lots of a material: an active lot and an alternate lot. If lot management is
enabled, the material is identified by both name and lot number. This option must be enabled if an ISI value
is used with a reagent. When this option is not selected, the material is identified by name only, and either
lot may be placed on the system. Both lots are considered the same, and can be used for either an active lot
study or an alternate lot study. Lot specific data located in this screen can be viewed and edited only when
lot management is enabled. The system tracks the materials used with their corresponding lot tracking
information for every test performed on the system, including calibration, QC, and patient sample tests. See
Enable Alternate Lot.

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Active Lot
Lot ID
A Lot ID is mandatory if lot management is enabled. The material identification appears on the bar code
label. When using bar coded materials, if the lot ID on the bar code label does not match the lot number
specified in this field, the system does not use the bar code information, and the bottle position on the CM
displays a question mark to indicate MATERIAL PLACED BUT UNIDENTIFIED.

Expiration D ate
The expiration date of a material is printed on its label. When using bar coded materials, if the expiration
date on the bar code does not match the expiration date specified in this field, the system will not use the bar
coded information, and the bottle position on the CM will display a question mark to indicate MATERIAL
PLACED BUT UNIDENTIFIED.

Enable Extended Expiration D ate

If IL extends a material expiration date, select this option and enter the new expiration date. If the extended
expiration date is earlier than the original expiration date, the system issues an error, and the new date is not
saved.

ISI Value
Available only if the material type is reagent. If you select this option, enter the manufacturer's ISI value
from the reagent insert sheet to calculate the INR value. By default, this field is blank.
ISI Value
ISI (International Sensitivity Index) specific to the lot of thromboplastin reagent used by Prothrombin Time
(PT) tests. The ISI value compares the behavior of a specific lot of PT reagent with the International
Reference Thromboplastin. The ISI value must be entered in the material definition of the PT reagent in order
to obtain correct INR (International Normalized Ratio) values. Failure to edit the ISI default value causes
incorrect INR results. A warning is generated when the ISI value is missing. If the corresponding lot number
is changed, this value becomes blank, and you must enter the ISI value for the new lot number found in the
new package insert.
INR Formula
l INR = (PT Patient / PT Normal)ISI value
l PT PATIENT = Patient’s PT in seconds
l PT Normal = PT Normal Pool Plasma value, dependent on user-specified NPP mode
l ISI Value = International Sensitivity Index from the current lot number of the PT reagent used

CAUTION: Important Warning

l If the INR calculation is not properly set up, erroneous patient results may be reported.
l If the product lot number changes, insert the new ISI value from the package.

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See Configuring Reporting of INR Results.

Lot Specific C omment

Enter a comment for this lot.

Last Modification D ate/Time

Date and time the lot information was last changed.

Enable Alternate Lot

An alternate lot is used to perform parallel studies. The results of an alternate lot study are not used by the
system. You cannot validate patient results generated by the alternate lot.
Select this option to use another lot of the same material. The fields for alternate lot are the same as for active
lot. The lot ID must be different than the active lot ID. If the last 4 digits of the ID are the same for both lots,
the expiration dates must be different or an error is issued.
Tests that require a calibration allow an active lot calibration and an alternate lot calibration to be valid at
the same time. This allows the results from the new lot of material to be compared to its own calibration
curve.
You can automatically activate the alternate lot if the material is not on-board and if both the active and
alternate lots have been enabled and defined for the material.
When the alternate lot has been automatically activated, the lot information is copied from the alternate lot
to the active lot, the existing active lot data is archived, the alternate lot fields are set to their default values

and the alternate lot is disabled. Use the Actions menu or the Activate Lot icon to activate the
alternate lot.
If the material that is being activated is a calibrator, the calibrations obtained with an active lot of calibrator
always remain active and can always be validated (even when that lot does not exist any more). Calibrations
obtained with an alternate lot of calibrator become active when the alternate lot becomes active. All other
existing active and validated tests that were run with the previous active lot of calibrator, but were not run
with the alternate lot of that calibrator, are not affected. They remain active and validated, although obtained
with an active lot that is no longer active.

NOTE:

l Only active calibrations can have a calibration lot that is no longer in the system. Validated
alternative lot calibrations become unvalidated when any of the lots of the calibrator or reagents used
for them are removed from the system.
l The recalculation function is not available for calibrations performed using an old calibrator lot or an
old reagent lot.
l To manually switch from alternate lot to active lot, you must first disable the alternate lot.
l The active and alternate lots cannot have the same lot number.
l When you manually disable the alternate lot of QC material, all QC data associated with that lot is
lost.

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Test not feasible when lot is expired

Option to cancel tests that use this material after the lot expires.

See Also
l Review and Validation
l Reviewing QC Results
l Reviewing Test Results

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Assigned Values Chapter 4 – Setup

Assigned Values

Overview
The Assigned Values window for a material is accessible only when the following conditions are met:
l Calibration – The material is used in a test definition for calibration/NPP1. The assigned value field
for a calibration material is also available in Test Definition – Calibration.
l QC – The material is used in a Quality Control definition in the QC List. The assigned value for a
quality control material is also available in QC Definition.

Viewing, Editing, Printing, Exporting Assigned Values

To view assigned values:
1. Select Setup > Material List in the menu bar.
2. In the Material List, double-click a material of type Quality Control or Calibrator/NPP to open the
Material Definition screen.

3. Select the Assigned Values icon in the toolbar to open the Assigned Values dialog box for
the selected material.

NOTE: If you enable lot management, you must enter and save the lot number and expiration

date on the Lot Specific Information tab. Failure to do this disables the Assigned Values
icon.
4. To edit assigned values, double-click a cell in the appropriate column, edit the value, and select the
OK button.
5. To print assigned values, select the Print button and follow the prompts.
6. To preview assigned values before printing, select the Preview button.
7. To export assigned values, select the Export button and follow the prompts.

NOTE: NOTE: After you print or export a report or a list, you may not be able to perform
certain operations, such as shutting down the instrument. The system may seem to lock up. When you print
or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a
menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL
TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP
application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also
press ALT+Tab to display the Print or Export dialog box.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Assigned Values for Calibration

Assigned values for the active lot of a calibrator1 are edited in the Active Lot column.
Assigned values for the alternate lot of a calibrator are edited in the Alternate Lot column.

1A type of sample with an assigned value used to calibrate a test.

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Assigned Values for QC

Target mean values for the active lot of control are edited in the Active Lot – Mean column. The SD values
are edited in the corresponding Active Lot – SD column.
Target mean values for the alternate lot of control are edited in the Alternate Lot – Mean column. The SD
values are edited in the corresponding Alternate Lot – SD column.

See Also
l Material Definition
l QC Setup Definition

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Test List Chapter 4 – Setup

Test List
This screen contains a list of tests that are performed on the ACL TOP instrument. The information displayed
in the Test List table is imported from the Test Definition screens.

Accessing the Test List

To open the Test List:
l Select Setup > Test List in the menu bar.

Filtering the Test List

To filter the Test List:
1. Select Setup > Test List in the menu bar.
2. Do one of the following:

l Select Actions > Configuration > Filter > Enabled Tests and/or Disabled Tests in the
menu bar to toggle those filters on and off.

l Select the arrow on the Filter icon in the toolbar, and select Enabled Tests
and/or Disabled Tests to toggle those filters on and off.

3. The filter configuration persists.

Viewing a Test Definition

To view a test definition:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. Select an item in the Test Definition navigation tree to view the test settings in the respective screen.

4. Select the Previous Screen icon in the toolbar to return to the Test List.

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Printing and Exporting a Test Definition Report – Single Test

A test definition report contains all the test settings defined in the test definition.
To print or export a test definition report for a single test:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.

3. In the ACL TOP menu bar, select Actions > Print or Actions > Export...Or select the Print or

Export icon in the toolbar.

4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save.

Printing and Exporting a Test Definition Report – Multiple Tests

A test definition report contains all the test settings defined in the test definition.
To print or export a test definition report for multiple tests:
1. Select Setup > Test List in the menu bar.
2. In the Test List, select1 the tests to print or export.
3. In the ACL TOP menu bar, select Actions > Print > Print Tests Definition or Actions > Export >
Export Tests Definition.
4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save.

NOTE: Test definitions can be from several to forty pages long. Printing or exporting multiple test
definitions may result in a long processing time. These operations perform in the background.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Adding/Creating a User-Defined Test

To create a new user-defined test:
1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper
security level to perform the required actions.
2. Select Setup > Test List in the menu bar.

3. In the Test List, select the Add icon in the toolbar, or select Actions > Test > Add in the menu
bar.
4. Enter a unique Test code and Test name in the Non-IL Test Definition – General Information screen.
5. Select the required test definition items in the navigation tree and configure the required fields in the
respective screens.

6. Select the Save icon in the toolbar to save your changes.

7. Select the Previous Screen icon in the toolbar to return to the Test List. The new test appears
in the list.

NOTE: A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user alone.

Copying a Test
To copy a test:
1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper
security level to perform the required actions.
2. Select Setup > Test List in the menu bar.
3. Select1 a test in the Test List.

4. Select the Copy icon in the toolbar, or select Actions > Test > Copy in the menu bar.
5. The copied test opens in the Test Definition screen. All test definition information except the Test
Code, Test Name and LIS number is copied to the new test definition.

NOTE: A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user alone.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Deleting a Test Definition

To delete a test:
1. Select Setup > Test List in the menu bar.
2. Select1 a user-defined test in the Test List.

3. Select the Delete icon in the toolbar, or select Actions > Test > Delete in the menu bar.
4. Confirm the deletion in the Deleting Test Definition dialog box. This dialog box lists all the
references associated with that test that will also be deleted.
5. See Test Deletion Rules.

NOTE: A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user alone.

About Deleting Test Definitions

Tests referenced elsewhere in the system cannot be deleted unless the references are also deleted (for example,
parent/shadow, paired test, imported test, reflex rules, QC, test profile, Test Programming window, and
Sample List). You may manually delete references to tests, or allow the instrument to delete them
automatically. If tests are referenced in other locations, the system displays a message listing the references to
delete.

Test Deletion Rules

The rules for deleting a test from the system are as follows:
l IL-locked tests cannot be deleted in the Test List.
l A parent test cannot be deleted until all of its shadow tests are deleted.
l A test whose calibration results are imported by another test cannot be deleted until all tests that
import the test are deleted.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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l The master test in a paired test definition cannot be deleted until the paired test partner is deleted.
l A test referenced in one or more QC definitions cannot be deleted until the QC definitions
referencing the test are deleted.
l A test referenced in one or more test profile definitions cannot be deleted until the references or
profiles are deleted.
l A test referenced in one or more reflex rules cannot be deleted until the references or rules are
deleted.
l A test referenced in the Test/Profiles Programming window cannot be deleted until it is removed from
the programming window.
l A test referenced in the Sample List Display Settings cannot be deleted until it is removed from the
display settings.

Enabling or Disabling a Test

To enable or disable a test:
1. Select Setup > Test List in the menu bar.
2. <Optional> Filter the Test List by Enabled Tests or Disabled Tests, or both
3. Select one or more tests in the Test List.

4. Select the Enable/Disable Test icon in the toolbar, or select Actions > Test > Enable/Disable
in the menu bar.
5. If a test is enabled, it becomes disabled. If disabled, it becomes enabled. A check mark in the Test
Status column in the Test List indicates the test is enabled.

NOTE:

l A test referenced elsewhere cannot be enabled/disabled until the references are disabled/enabled (for
example: parent/shadow, paired test, imported test, reflex rules, test profile, Profiles Programming
screen, or Sample List Display Settings). References must be manually enabled or disabled.
l The Promote function on the Actions > Test menu is available only to IL test developers.

Finding a Test
To find a test in the Test List:
1. Select Setup > Test List in the menu bar.
2. Select Actions > Results > Find Test in the menu bar.
3. Enter all or part of the test code in the Quick Search window.
4. Select Next or Previous to find and place focus1 on the test code in the Test List.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Test List Toolbar

The operations toolbar for the test list screen includes the following:

Select the following icons to perform the associated tasks:

Add a new test

View a test definition

Delete a test

Copy a test

Enable/Disable test

Filter the Test List

Print the Test List

Test List Actions Menu

The Actions menu for the test list is as follows:

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Test List Screen

Select
Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the
Select icon in the column heading to select or deselect all the rows in the table.

Selecting one row enables the Copy, Delete and Enable/Disable Test toolbar icons.

C ode
Unique identifier for the test. The maximum length is 8 characters.

N ame
Full name of the test. The maximum length is 20 characters.

IL Test
A checkmark indicates a test developed by Instrumentation Laboratory.

LIS
Laboratory Information System test identifier used to communicate between a host computer and the ACL
TOP instrument.
Tests with an extended acquisition mode enabled have a unique LIS number for the test run in this mode.
Tests with parallelism enabled have a unique LIS number for the test run in the parallelism mode.
The maximum number of LIS numbers per test definition is four: 1) standard acquisition mode; 2) extended
acquisition mode; 3) parallelism mode; and 4) alternative pre-dilution.

A cq. Time
Standard Acquisition Time = The number of seconds the instrument spends acquiring data during a test.

N o. R eps
Number of replicates the test performs on patient and/or QC samples. The default value is 1.

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U nit
Primary unit for the measured result in the test.

N ormal R ange
Range of values the user has defined as the normal range of test results for patients in their population. The
default range is -999999.9 to 999999.9.

C onsistency
A check mark indicates the test definition is consistent. Inconsistencies must be corrected before a test can
run.

Test Enabled/D isabled

A check mark indicates the test is enabled to run on the instrument.
A test referenced elsewhere cannot be enabled/disabled until the references are disabled/enabled (for
example: parent/shadow, paired test, imported test, reflex rules, test profile, Profiles Programming screen, or
Sample List Display Settings). References must be manually enabled or disabled.

See Also
l Test Definition

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Test Definition

Viewing a Test Definition

To view a test definition:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. Select an item in the Test Definition navigation tree to view the test settings in the respective screen.

4. Select the Previous Screen icon in the toolbar to return to the Test List.

Printing and Exporting a Test Definition Report – Single Test

A test definition report contains all the test settings defined in the test definition.
To print or export a test definition report for a single test:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.

3. In the ACL TOP menu bar, select Actions > Print or Actions > Export...Or select the Print or

Export icon in the toolbar.

4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save.

Printing and Exporting a Test Definition Report – Multiple Tests

A test definition report contains all the test settings defined in the test definition.
To print or export a test definition report for multiple tests:
1. Select Setup > Test List in the menu bar.
2. In the Test List, select1 the tests to print or export.
3. In the ACL TOP menu bar, select Actions > Print > Print Tests Definition or Actions > Export >
Export Tests Definition.
4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save.

NOTE: Test definitions can be from several to forty pages long. Printing or exporting multiple test
definitions may result in a long processing time. These operations perform in the background.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Creating a User-Defined Test

To create a new user-defined test:
1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper
security level to perform the required actions.
2. Select Setup > Test List in the menu bar.

3. In the Test List, select the Add icon in the toolbar, or select Actions > Test > Add in the menu
bar.
4. Enter a unique Test code and Test name in the Non-IL Test Definition – General Information screen.
5. Select the required test definition items in the navigation tree and configure the required fields in the
respective screens.

6. Select the Save icon in the toolbar to save your changes.

7. Select the Previous Screen icon in the toolbar to return to the Test List. The new test appears
in the list.

NOTE: A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user alone.

Test Definition Operations Toolbar

The Test Definition toolbar consist of, but is not limited to, the following:

Select the following icons to perform the associated tasks:

Apply Consistency Checks to determine whether the current test definition information is
consistent.

Save the test definition.

Restore the previously saved information.

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NOTE:

l If you change the parameters of a user-defined test such that the analytical performance of that test is
affected, you must recalibrate that test. See User-Defined Tests disclaimer.
l You cannot edit the test definition of a test with a status of PLACED.

See Also
l Test List
l General Information
l Analytical Cycle Definition
l Data Reduction Parameters
l Result Unit Definition
l Calibration
l Parallelism
l Normal Pool Plasma
l Rerun Rules

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General Information Screen

Accessing the General Information screen

To open the General Information screen for a test:
1. Select Setup > Test List in the menu bar.
2. Do one of the following in the Test List to open the Test Definition screen for a test:

l Double-click a test.

l Place focus1 on a test code, and select the Test Definition icon in the toolbar.
l Select2 a test, and select Actions > Review > Test Definition in the menu bar.

3. Select General Information in the navigation tree to view the General Information screen.
4. <Optional> Edit the General Information screen.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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General Information Actions Menu

Test
l Select Test > Apply Checks to apply consistency checks to the test definition.
l Select Test > Save to save the test definition.
l Select Test > Restore to restore the test definition to the previously saved version.

Print Preview
Previews the Test Definition report containing the data displayed on the General Information screen before
printing.

Print
Prints a Test Definition report containing the data displayed on the General Information screen.

Export
Exports the test definition data displayed on the General Information screen.

Print Screen
Prints the General Information screen.

R eview
Select Actions > Review > Previous Screen in the ACL TOP menu bar to return to the Test List.

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General Information
Test code
Unique mnemonic for the test. The maximum length is 8 alphanumeric characters.

Test name
Complete name of the test. The maximum length is 20 alphanumeric characters. The test name is printed on
the Patient report.

LIS number
Laboratory Information System identifier (used in host communication) for a test when using the standard
acquisition time. The following extensions are appended to the test code for the LIS number:
l 1 – Standard tests
l 2 – Extended tests
l 3 – Parallelism tests
l 4 – Alternative Pre-dilution
For example, PT-RP has a test number of 13, a standard test LIS Number of 131, an extended test LIS number
of 132, a parallelism test LIS number of 133, and a Diluted LIS number of 134.

NOTE: The LIS code must be programmed before analyzing samples that require test results to be
uploaded to the host. Samples run before programming the LIS codes are not uploaded.

Test number
Unique numeric identifier for the test. Consistency requires all user-defined and IL locked tests to have a
value in this field. Values are as follows:
l 1-250 – IL locked tests
l 251-500 – User-defined tests
l 501-750 – IL locked tests for investigation only.
When creating a new test or copying an existing test, the next available test number is automatically
assigned to the test.

IL test
Read-only. If checked, the test is an IL-defined and locked.

For investigation only

Read-only. If checked, the test is for investigational use only.

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Assay
A ssay release number
Indicates whether the assay has been modified from the last parameter release. The maximum length is 50
alphanumeric characters.

Test modification number

Automatically increments by a value is one each time this test definition is saved.

U ser revision comment

Comment stating the reason a change was made to the test definition. The maximum length is 50
alphanumeric characters.

IL revision comment
For IL use only. Comment stating the reason a change was made to the test definition. The maximum length
is 50 alphanumeric characters.

Manual validation required

Option to force manual validation of test results before results can upload to the LIS.

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Enable as Shadow Test

Shadow tests are used when multiple test results are derived using the same raw data.
Example
Prothrombin Time (PT – the Parent Test) and Fibrinogen (FIB – the Shadow Test) where the same
coagulation curve can be used to give two different results: 1) the clotting time; and 2) the amount of
fibrinogen in the sample.

Parent test
Test that generates the raw data from which multiple results are obtained (using different algorithms to
compute the results). When enabled, the Parent test drop down list becomes active.

Inherit LIS numbers from parent test

A checkmark indicates the LIS number from this test is identical to the parent test.
Shadow Test Rules
l A shadow test must have a parent test assigned to it.
l A parent test may have more than one shadow test associated with it. The maximum number of
shadow tests is 5.
l A parent test definition cannot be deleted until after all of its shadow test definitions are disassociated
from the parent test (Disable the Enable as shadow test option and deselect the parent test. Or delete
the shadow test).

NOTE: If you enable a test as a shadow test, you can configure a delay time for the shadow test. See
Analytical Cycle Screen.

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Enable as Paired Test

Paired tests are used when a meaningful result can be generated only by comparing the results of two
different tests, such as an activated form of a test against a non-activated form.
Example
Activated Protein C Resistance (aPCR) ratio result that compares the activated aPCR measured result against
the non-activated aPCR measured result.

Master paired test

Option to select a test whose results are required to generate the reported result. A paired test uses the
measured results from two tests and their corresponding NPP1 values to compute the result. When enabled,
the Master Paired Test drop down list becomes active.

Enable Paired Test D ependency

When this option is enabled both tests of the pair run simultaneously, and both results are used to generate
the reported result. The second test of the pair must start while the first test is active.
When this option is disabled the paired test results are computed only when the master test runs and there is
a result for the partner test on the patient sample.
Example
Lupus anticoagulant Screen (LAC-S) and Lupus anticoagulant Confirm (LAC-C) paired test. These tests do
not need to be ordered together. LAC-C may only be required if there is a questionable LAC-S result. You
could request LAC-C later and the result is used with the previously run LAC-S to calculate a ratio.
Paired Test Rules
The master test of a paired test definition:
l Must be enabled in order for the paired test partner to be enabled.
l Cannot be disabled until the paired test partner is disabled, regardless of whether it is an independent
or dependent paired test.
l Can be enabled regardless of whether the paired test partner is enabled.
l Can be deleted while the paired test partner remains present, regardless of whether it is an
independent or dependent paired test.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Consistency Check

Indicates whether the test definition is consistent, meaning the test can run as defined. If a test is not
consistent, the inconsistency must be corrected before the test can run. See Consistency Check.

NOTE: If you change the parameters for your user-defined tests so the analytical performance of that
test is affected, you must recalibrate that test. See User-Defined Tests disclaimer.

See Also
l Analytical Cycle Definition
l Data Reduction Parameters
l Result Unit Definition
l Calibration
l Parallelism
l Normal Pool Plasma
l Rerun Rules

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Analytical Cycle Definition

Overview
The Analytical Cycle Definition screen allows the test developer to do the following:
l Select the primary wavelength that produces measured results.
l Select the acquisition time used to acquire data.
l Set up the loading cycles required to obtain a reaction curve.
l Enable the extended mode.
l Select the number of replicates.

Adding a Material Load Cycle Definition – for user-defined tests

To add a material in a user-defined test:
1. Select Setup > Test List in the menu bar.
2. Do one of the following in the Test List to open the Test Definition screen for a test:

l Double-click a user-defined test.

l Place focus1 on a user-defined test code, and select the Test Definition icon in
the toolbar.
l Select2 a user-defined test, and select Actions > Review > Test Definition in the menu
bar.

NOTE: A user with the appropriate security level can create a new test or copy an existing
test. All responsibility for parameter development and validation of new or copied tests belongs to
the user alone.
3. In the Test Definition screen, select Analytical cycle definition in the navigation tree.

4. Select the Add icon in the toolbar. The Material/Sample Load Cycle Definition window opens.
5. Select materials in the Material list in the same order they are to be used.

6. Select the Save icon in the toolbar to save your changes.

7. Select the Previous Screen icon in the toolbar to return to the Test List.

See Creating a user-defined test.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Deleting a Material Load Cycle Definition – for user-defined tests

To delete a material from the analytical cycle:
1. Select Setup > Test List in the menu bar.
2. Double-click a user-defined test in the Test List.
3. In the Test Definition screen, select Analytical cycle definition in the navigation tree.
4. In the Load cycle table, select1 the material to delete.

5. Select the Delete icon in the toolbar.

6. Select the Save icon in the toolbar to save your changes.

7. Select the Previous Screen icon in the toolbar to return to the Test List.

NOTE: A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user alone.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Analytical Cycle Definition Screen Toolbar

The operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Apply Consistency Checks to determine whether the current test definition information is
consistent.

Save the test definition.

Restore the previously saved information.

Add a material to a user-defined test. Opens the Material/Sample Load Cycle Definition
window. See User-Defined Tests disclaimer.
View the Material/Sample Load Cycle Definition window for the material with focus1 in the
Test List. Applies to the load cycle.

Delete a material from the load cycle. See Deleting a Material Load Cycle Definition.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Analytical Cycle Definition Screen

Acquisition – wavelength

Primary wavelength
The primary wavelength determines the optical wavelength that is used to monitor the reaction and to
produce a result. The options are:
l 405 nm – Typically used for chromogenic tests.
l 671 nm – Typically used for coagulometric tests.
The default option when creating a test is 671 nm.

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Acquisition – time

Standard time
Acquisition time during which enough data points are collected to determine the clotting point or reaction
rate for the majority of samples. The acquisition time is expressed in seconds. The raw data may store a
maximum of 6000 data points, which corresponds to 600 seconds of data read every 1/10th of a second. For
acquisition times greater than 600 seconds, the sample rate (the amount of time between each data point) will
increase.
l Minimum: 20 seconds
l Maximum: 1800 seconds
l Default: 30 seconds

NOTE: For user-defined tests, if a test imports the raw calibration data from another test, you can
configure the standard time for the test that is importing the calibration, with the restriction that the standard
time must be less than or equal to either the standard time or the extended time, if enabled, of the test whose
calibration is being imported. See User-Defined Tests disclaimer.

D elay time
The delay time specifies the interval of data to be ignored by data reduction when calculating the result. The
delay time is part of the acquisition time.
l Minimum: 0 seconds
l Maximum: 750 seconds
l Default: 3 seconds

NOTE: For user-defined tests:

l If you enable a test as a shadow test, you can configure the delay time for the shadow test
independently of the parent test.
l If a test imports the raw calibration data from another test, you can configure the delay time for the
test that is importing the calibration.
l Delay time is not displayed in reaction graphs.
l A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user
alone.

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Enable extended test mode

Option to collect data for a longer time period.

Extended time
When configured for extended acquisition, data is collected for a longer period of time compared to the
standard acquisition, to be able to determine the clotting point for samples that have prolonged clotting
times. If the extended test mode is enabled, the extended time must be greater than the standard time. The
default is 30 seconds
The extended test mode must be enabled for a calibration to run using extended acquisition time.
The extended test mode must be enabled for parallelism to run using extended acquisition time.

NOTE: For user-defined tests, if a test imports the raw calibration data from another test, you can
configure the extended time for the test that is importing the calibration, with the restriction that the
extended time cannot be greater than the extended time, if enabled, of the test whose calibration is being
imported. See User-Defined Tests disclaimer.

LIS number
This field displays the extended mode LIS number of the test. The LIS number for an extended test must be
unique.

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Test code
This field displays the extended mode test code of the test. The extended test code is the test code appended
by the character defined in the test mode extension area of the Global Definitions screen.

Load cycle

N umber of replicates
This allows for selection of the number of times the test is to be repeated on a sample. The default value is 1;
the maximum value is 2.
Load Cycle Table

The Load Cycle table contains read-only information populated from the Material/Sample Load Cycle
Definition screen. (See Adding a Material Load Cycle Definition.) The display order is the order materials are
added to the reaction cuvette. Double-click the material name to access detailed material information, or

click select1 the material and select the View icon in the toolbar, which opens the Material/Sample
Load Cycle Definition window.

NOTE: If you enable a test as a shadow test, you can view the Analytical cycle fields for the shadow
test but you cannot edit them.

Total cuvette volume

Total Cuvette Volume indicates the total volume of reaction mix as defined in the Load Cycle table. The
minimum volume required is 150 μL. The maximum volume is 600 μL.
l The total of all liquid volumes cannot be less than 150 μL, the volume of liquid required to fill the
optical window on the cuvette cell.
l If you change the parameters for a user-defined test, so that the analytical performance of that test is
affected, you must recalibrate that test. See User-Defined Tests disclaimer.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Material/Sample Load Cycle Definition Screen

Material
List of materials that have been defined for use on the system. Select materials from the drop-down list.

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NOTE:

l The intermediate and start reagents of a test that imports the raw calibration data from another test
must be the same as the intermediate and start reagents of the test that is imported.
l When defining the first load cycle, the material must be either sample or a sample diluent. When
defining the last load cycle, the material must be a start reagent.
l IMPORTANT – Many IL-defined tests use Clean B diluted as the clean material. If the Clean B
diluted bottle becomes empty, the instrument performs an emergency stop, with the consequent loss of
all work that was in progress. Hint: To avoid loss of work, place multiple bottles of Clean B diluted
on-board the instrument. See Test Feasibility for proper placement of all reagents.

Aspiration information
This area defines the arrangement of volumes in the probe is as follows:

H ead volume
Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This
volume is not delivered to the cuvette.

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l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL

NOTE: When creating a user-defined test, the head volume for the sample defined in
Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic
Dilution section of the Test Definition. See User-Defined Tests disclaimer.

A irgap
Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination
and ensure accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.

Material/Sample volume
Volume of material or sample in microliters (0 – 250 µL) that is delivered to the cuvette.

Transport airgap
Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

Total volume
Sum of the volumes and airgaps for the specified material. This field is read-only and is computed by the
system based on the total of the load volumes.

Dispensation information

Enhanced dispense
Option to improve reagent mixing in the reaction cuvette when a material is added. This dispense option is
key to the optimal development of test parameters where a fast mix is required.

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Enable mix
Option to mix the contents of the cuvette cell. Mixing is done by re-aspirating and dispensing a quantity of
material in the same cell.
Mix
The mix volume percentage is used to calculate the volume of material that is aspirated from the cuvette cell
and redispensed into the same cuvette cell to facilitate a mix. The mix volume is calculated as:
l Mix volume = (total cuvette volume – cuvette dead volume) mix %
l Minimum: 25%
l Maximum: 100%
l Default: 50%
Rinse time after mix
Amount of time to rinse the probe after mixing is completed.
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec
Number of cycles
This is the number of mix/rinse cycles to be performed.
l Minimum: 1 cycle
l Maximum: 3 cycles
l Default: 1 cycle

NOTE: To perform a mix, a minimum of 100 μL of liquid must be in the cuvette cell.

Enable incubation time

Select to enable incubation of the material. Incubation may be required for warming the cuvette contents or
to allow sufficient time for a reaction to occur.

Incubation range
The incubation range is the minimum and maximum amount of time in seconds (20-1800) the material should
remain in the cuvette before another material is added. The instrument automatically applies a 20-90 second
incubation range to sample or reagent loading steps that do not have incubation enabled.

Rinse

Time
Length of time to rinse the probe after material delivery when the Enable mix option is disabled.

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l Minimum: 1 second
l Maximum: 5 seconds
l Default: 1 second

Enable agitation
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec

Before Aspiration Rinse / Clean & Rinse

Enable rinse / clean & rinse before aspiration

Option to enable rinse and clean operations before the probe aspirates sample.

R inse
Select this option to perform rinse cycles.
l Rinse cycles – Configure the number of rinse cycles to perform.
l Time – Configure the number of seconds for each rinse cycle to run.
o Minimum: 1 sec
o Maximum: 5 sec
o Default: 1 sec
l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the
rinse material up and down inside the probe. Configure the number of times to agitate in the field
provided.

C lean & rinse

Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a user-
defined field when the default for that test has Rinse enabled (sample load cycle only). This option allows
you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform.
l Aspiration cycles – Configure the number of times to run the clean and rinse cycle.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents
contaminating the clean material and ensures accurate volume delivery.
l Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle.

NOTE:
o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the
Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To
avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test
Feasibility for proper placement of all reagents.
o The clean total volume must not exceed the maximum probe volume, or 250 µL.
o When using a clean material other than system clean, the clean material must be placed
in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a
sample, the clean material must be placed in a diluent rack in the Sample Area. If it is
enabled for a reagent, you must place the clean material in a diluent rack in the
Reagent Area.

l Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss
during probe movement, and ensures accurate volume delivery. This is not selectable for system clean.
l Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean
total volume cannot exceed the maximum probe volume, or 250 μL.
l Clean volume (all cycles) – Volume of clean material required for the configured number of
aspiration cycles.
l Clean material – Select a system clean material in the drop down list.
l Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to
waste.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.
l Rinse time – Time allocated for the probe rinsing operation.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.

After Dispensation Rinse / Clean & Rinse

The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above.

See Also
l General Information
l Data Reduction Parameters
l Result Unit Definition
l Calibration

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l Parallelism
l Normal Pool Plasma
l Rerun Rules

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Sample Pre-Dilution

Overview
There are two pre-dilution options:
l Sample pre-dilution – Dilution typically used to run a test
l Alternative pre-dilution – Atypical dilution used to eliminate certain effects

Accessing the Sample Pre-Dilution Screen

To access the Sample pre-dilution screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigational tree, expand Analytical cycle definition and select Sample pre-
dilution.
4. <Optional> Edit the Sample pre-dilution screen.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

Sample Pre-dilution Screen

Enable sample pre-dilution
Option to activate pre-dilution parameters. Enables the fields on the General, Sample/Mixture and Diluent
tabs.

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General Tab

Dilution definition

N umber of parts sample

Specifies the number of parts of sample to use in sample dilutions.
Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts
of diluent are added for every one part of sample. This dilution ratio is 1:10.

N umber of parts diluent

Specifies the number of parts of diluent to use in diluent dilutions.
Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts
of diluent are added for every one part of sample. This dilution ratio is 1:10.

Minimum aspiratable volume

Minimum volume of material used in dilutions. By default, the instrument attempts to use the smallest
possible volume (4 µL) when performing calculations. The value in this field overrides the default volume
and forces the system to use the volume of material specified in this field when preparing dilutions.
l Minimum: 4 μL
l Maximum: 50 μL
l Default: 4 μL

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Pre-dilution Table
This read-only table lists the volumes that are used to dilute the sample.

Enable Mix
Option to activate the mix parameters. Enables the fields in this section.

Mix Volume
Percentage of material in the cuvette cell that is aspirated from the cuvette cell and redispensed into the same
cuvette cell to mix the material. The mix volume is calculated as:
l Mix volume = (total cuvette volume - cuvette dead volume) * mix %
o Minimum: 25 μL
o Maximum: 250 μL
l Cuvette dead volume is 65 μL. Cuvette maximum volume is 600 μL.

N umber of C ycles
Number of mix cycles to perform.
l Minimum: 1 cycle
l Maximum: 3 cycles
l Default: 1 cycle

R inse after Mix

Number of seconds to rinse the probe after a mix is performed.
l Maximum: 1 sec
l Maximum: 5 sec
l Default: 1 sec

NOTE: To perform a mix, the cuvette cell must contain a minimum of 100 μL of liquid.

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Sample/Mixture Tab

Use this tab to define sample and mixture1 loading parameters.

Volumes

NOTE: The sum of all volumes cannot exceed 250 μL.

H ead volume
Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This
volume is not delivered to the cuvette.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL

NOTE: When creating a user-defined test, the head volume for the sample defined in
Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic
Dilution section of the Test Definition. See User-Defined Tests disclaimer.

1A dilution that requires a two-step dilution process to achieve the required dilution ratio.

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A irgap
Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination
and ensure accurate volume delivery.
The airgap prevents rinse contamination and ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

Transport airgap
Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.

Before Aspiration Rinse / Clean & Rinse

Enable rinse / clean & rinse before aspiration

Option to enable rinse and clean operations before the probe aspirates sample.

R inse
Select this option to perform rinse cycles.
l Rinse cycles – Configure the number of rinse cycles to perform.
l Time – Configure the number of seconds for each rinse cycle to run.
o Minimum: 1 sec
o Maximum: 5 sec
o Default: 1 sec
l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the
rinse material up and down inside the probe. Configure the number of times to agitate in the field
provided.

C lean & rinse

Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a user-
defined field when the default for that test has Rinse enabled (sample load cycle only). This option allows

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you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform.
l Aspiration cycles – Configure the number of times to run the clean and rinse cycle.
l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents
contaminating the clean material and ensures accurate volume delivery.
l Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle.

NOTE:
o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the
Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To
avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test
Feasibility for proper placement of all reagents.
o The clean total volume must not exceed the maximum probe volume, or 250 µL.
o When using a clean material other than system clean, the clean material must be placed
in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a
sample, the clean material must be placed in a diluent rack in the Sample Area. If it is
enabled for a reagent, you must place the clean material in a diluent rack in the
Reagent Area.

l Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss
during probe movement, and ensures accurate volume delivery. This is not selectable for system clean.
l Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean
total volume cannot exceed the maximum probe volume, or 250 μL.
l Clean volume (all cycles) – Volume of clean material required for the configured number of
aspiration cycles.
l Clean material – Select a system clean material in the drop down list.
l Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to
waste.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.
l Rinse time – Time allocated for the probe rinsing operation.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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After Dispensation Rinse / Clean & Rinse

The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above.

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Diluent tab

Use this tab to define the loading parameters for diluent material. The Head volume, Airgap, Transport
airgap and Head volume airgap fields on the Diluent tab are identical to those on the Sample/Mixture tab.

Volumes

NOTE: The sum of all volumes cannot exceed 250 μL.

Material
Select a sample diluent material in the list. The material must be defined as a Diluent type in the Material
Definition.

H ead volume
The diluent volume aspirated to wet the probe before aspirating the diluent volume required to run the test.
This volume is not delivered to the cuvette.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL

NOTE: When creating a user-defined test, the head volume for the sample defined in
Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic
Dilution section of the Test Definition. See User-Defined Tests disclaimer.

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A irgap
Volume of air to aspirate immediately before aspirating the diluent, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the diluent and head volume. The airgap prevents rinse
contamination and ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

Transport airgap
Volume of air to aspirate after the diluent volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.

Before Aspiration Rinse / Clean & Rinse

Enable rinse / clean & rinse before aspiration

Option to enable rinse and clean operations before the probe aspirates sample.

R inse
Select this option to perform rinse cycles.
l Rinse cycles – Configure the number of rinse cycles to perform.
l Time – Configure the number of seconds for each rinse cycle to run.
o Minimum: 1 sec
o Maximum: 5 sec
o Default: 1 sec
l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the
rinse material up and down inside the probe. Configure the number of times to agitate in the field
provided.

C lean & rinse

Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a user-
defined field when the default for that test has Rinse enabled (sample load cycle only). This option allows

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you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform.
l Aspiration cycles – Configure the number of times to run the clean and rinse cycle.
l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents
contaminating the clean material and ensures accurate volume delivery.
l Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle.

NOTE:
o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the
Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To
avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test
Feasibility for proper placement of all reagents.
o The clean total volume must not exceed the maximum probe volume, or 250 µL.
o When using a clean material other than system clean, the clean material must be placed
in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a
sample, the clean material must be placed in a diluent rack in the Sample Area. If it is
enabled for a reagent, you must place the clean material in a diluent rack in the
Reagent Area.

l Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss
during probe movement, and ensures accurate volume delivery. This is not selectable for system clean.
l Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean
total volume cannot exceed the maximum probe volume, or 250 μL.
l Clean volume (all cycles) – Volume of clean material required for the configured number of
aspiration cycles.
l Clean material – Select a system clean material in the drop down list.
l Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to
waste.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.
l Rinse time – Time allocated for the probe rinsing operation.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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After Dispensation Rinse / Clean & Rinse

The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above.

See Also
l Test Definition
l Analytical Cycle Definition
l Material Definition

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Alternative Pre-Dilution Chapter 4 – Setup

Alternative Pre-Dilution

Overview
Alternative pre-dilution means using a different sample dilution. For example, a D-Dimer HS test may require
a higher dilution ratio to eliminate prozone effects.
An alternative pre-dilution may be ordered for samples where concentration effects may be a known issue.
An alternative pre-dilution may be triggered via a rerun test if the test is so configured. Alternative pre-
dilution must be enabled and defined before it can be used in test reruns. See Rerun Rule Setup.

Accessing the Alternative Pre-dilution Screen

To open the Alternative Pre-dilution screen:
1. Select Setup > Test List in the menu bar.

2. Double-click a test in the Test List. Or if you are creating a new user-defined test, select the Add
icon in the toolbar.

NOTE: A user with the appropriate security level can create a new test or copy an existing
test. All responsibility for parameter development and validation of new or copied tests belongs to
the user alone.
3. In the Test Definition navigation tree, expand Analytical cycle definition, and select Alternative pre-
dilution.
4. Edit the Alternative pre-dilution screen.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List..

Alternative Pre-dilution Screen

Enable alternative pre-dilution
Option to enable an alternative pre-dilution for a test.
Some IL locked tests have alternative pre-dilution enabled and defined.
For user-defined tests, this option allows you to define an additional pre-dilution. When this option is
enabled, you can run the pre-diluted test as a separate test. See User-Defined Tests disclaimer.
When a diluted test is ordered either directly or as a rerun, the dilutions settings defined here are used.

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Use extended acquisition time

Option to use an extended acquisition time1 (for acquiring data).
Select this option when the alternative pre-dilution requires a more diluted sample than is defined in the
standard reaction or sample pre-dilution parameters.

Diluted LIS number

The diluted LIS test ID number may be the same as the parent test or it may be unique. When it is the same
as the parent test, validated results are transmitted to the LIS using the parent LIS test ID number and test
name.
When the diluted LIS number is unique, the diluted format of the test may be ordered from the LIS directly,
and runs using the alternative pre-dilution settings. Diluted tests with validated results and unique LIS
numbers are transmitted to the LIS using the diluted LIS number.
When the LIS number is unique, the LIS can directly order a diluted version of the test. Diluted versions can
also be ordered manually, or as a result of reflex or rerun settings.

Test code
Unique test code for the alternative pre-dilution test. The alternative pre-dilution test code is the test code
plus an automatically added one character extension. You can define the one character extension in Global
Definitions.

1The amount of time that optical data is collected by the system. Acquisition Time can be either Standard or
Extended. Standard Acquisition Time is the time spent collecting the required number of data points to
determine the clotting point or reaction rate for the majority of samples. With Extended Acquisition Time,
data is collected for a longer period of time to determine the clotting point for samples which have prolonged
clotting times.

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General Tab

Dilution definition

N umber of parts sample

Specifies the number of parts of sample to use in sample dilutions.
Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts
of diluent are added for every one part of sample. This dilution ratio is 1:10.

N umber of parts diluent

Specifies the number of parts of diluent to use in diluent dilutions.
Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts
of diluent are added for every one part of sample. This dilution ratio is 1:10.

Minimum aspiratable volume

Minimum volume of material used in dilutions. By default, the instrument attempts to use the smallest
possible volume (4 µL) when performing calculations. The value in this field overrides the default volume
and forces the system to use the volume of material specified in this field when preparing dilutions.
l Minimum: 4 μL
l Maximum: 50 μL
l Default: 4 μL

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Pre-dilution Table
This read-only table lists the volumes that are used to dilute the sample.

Enable Mix
Option to activate the mix parameters. Enables the fields in this section.

Mix Volume
Percentage of material in the cuvette cell that is aspirated from the cuvette cell and redispensed into the same
cuvette cell to mix the material. The mix volume is calculated as:
l Mix volume = (total cuvette volume - cuvette dead volume) * mix %
o Minimum: 25 μL
o Maximum: 250 μL
l Cuvette dead volume is 65 μL. Cuvette maximum volume is 600 μL.

N umber of C ycles
Number of mix cycles to perform.
l Minimum: 1 cycle
l Maximum: 3 cycles
l Default: 1 cycle

R inse after Mix

Number of seconds to rinse the probe after a mix is performed.
l Maximum: 1 sec
l Maximum: 5 sec
l Default: 1 sec

NOTE: To perform a mix, the cuvette cell must contain a minimum of 100 μL of liquid.

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Sample/Mixture Tab

Volumes

NOTE: The sum of all volumes cannot exceed 250 μL.

H ead volume
Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This
volume is not delivered to the cuvette.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL

NOTE: When creating a user-defined test, the head volume for the sample defined in
Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic
Dilution section of the Test Definition. See User-Defined Tests disclaimer.

A irgap
Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination
and ensure accurate volume delivery.

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The airgap prevents rinse contamination and ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

Transport airgap
Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.

Before Aspiration Rinse / Clean & Rinse

Enable rinse / clean & rinse before aspiration

Option to enable rinse and clean operations before the probe aspirates sample.

R inse
Select this option to perform rinse cycles.
l Rinse cycles – Configure the number of rinse cycles to perform.
l Time – Configure the number of seconds for each rinse cycle to run.
o Minimum: 1 sec
o Maximum: 5 sec
o Default: 1 sec
l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the
rinse material up and down inside the probe. Configure the number of times to agitate in the field
provided.

C lean & rinse

Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a user-
defined field when the default for that test has Rinse enabled (sample load cycle only). This option allows
you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform.
l Aspiration cycles – Configure the number of times to run the clean and rinse cycle.
l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents
contaminating the clean material and ensures accurate volume delivery.
l Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle.

NOTE:
o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the
Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To
avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test
Feasibility for proper placement of all reagents.
o The clean total volume must not exceed the maximum probe volume, or 250 µL.
o When using a clean material other than system clean, the clean material must be placed
in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a
sample, the clean material must be placed in a diluent rack in the Sample Area. If it is
enabled for a reagent, you must place the clean material in a diluent rack in the
Reagent Area.

l Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss
during probe movement, and ensures accurate volume delivery. This is not selectable for system clean.
l Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean
total volume cannot exceed the maximum probe volume, or 250 μL.
l Clean volume (all cycles) – Volume of clean material required for the configured number of
aspiration cycles.
l Clean material – Select a system clean material in the drop down list.
l Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to
waste.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.
l Rinse time – Time allocated for the probe rinsing operation.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.

After Dispensation Rinse / Clean & Rinse

The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above.

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Diluent Tab

Volumes

NOTE: The sum of all volumes cannot exceed 250 μL.

Material
Select a sample diluent material in the list. The material must be defined as a Diluent type in the Material
Definition.

H ead volume
The diluent volume aspirated to wet the probe before aspirating the diluent volume required to run the test.
This volume is not delivered to the cuvette.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL

NOTE: When creating a user-defined test, the head volume for the sample defined in
Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic
Dilution section of the Test Definition. See User-Defined Tests disclaimer.

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A irgap
Volume of air to aspirate immediately before aspirating the diluent, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the diluent and head volume. The airgap prevents rinse
contamination and ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

Transport airgap
Volume of air to aspirate after the diluent volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.

Before Aspiration Rinse / Clean & Rinse

Enable rinse / clean & rinse before aspiration

Option to enable rinse and clean operations before the probe aspirates sample.

R inse
Select this option to perform rinse cycles.
l Rinse cycles – Configure the number of rinse cycles to perform.
l Time – Configure the number of seconds for each rinse cycle to run.
o Minimum: 1 sec
o Maximum: 5 sec
o Default: 1 sec
l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the
rinse material up and down inside the probe. Configure the number of times to agitate in the field
provided.

C lean & rinse

Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a user-
defined field when the default for that test has Rinse enabled (sample load cycle only). This option allows

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you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform.
l Aspiration cycles – Configure the number of times to run the clean and rinse cycle.
l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents
contaminating the clean material and ensures accurate volume delivery.
l Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle.

NOTE:
o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the
Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To
avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test
Feasibility for proper placement of all reagents.
o The clean total volume must not exceed the maximum probe volume, or 250 µL.
o When using a clean material other than system clean, the clean material must be placed
in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a
sample, the clean material must be placed in a diluent rack in the Sample Area. If it is
enabled for a reagent, you must place the clean material in a diluent rack in the
Reagent Area.

l Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss
during probe movement, and ensures accurate volume delivery. This is not selectable for system clean.
l Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean
total volume cannot exceed the maximum probe volume, or 250 μL.
l Clean volume (all cycles) – Volume of clean material required for the configured number of
aspiration cycles.
l Clean material – Select a system clean material in the drop down list.
l Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to
waste.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.
l Rinse time – Time allocated for the probe rinsing operation.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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After Dispensation Rinse / Clean & Rinse

The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above.

See Also
l Test Definition
l Analytical Cycle Definition
l Sample Pre-Dilution

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Data Reduction Parameters Chapter 4 – Setup

Data Reduction Parameters

Data reduction parameters are configurable for the Primary Wavelength of user-defined tests. See User-
Defined Tests disclaimer.

Configuring Data Reduction Parameters for the Primary Wavelength

To configure the data reduction parameters for the Primary Wavelength:
1. Select Setup > Test List in the menu bar.

2. In the Test List, double-click a user-defined test, or select the Add icon in the toolbar to create a
new user-defined test.

NOTE: A user with the appropriate security level can create a new test or copy an existing
test. All responsibility for parameter development and validation of new or copied tests belongs to
the user alone.
3. In the Test Definition navigation pane, expand DR Parameters, Primary wavelength.
4. Select an item under Primary wavelength to open the respective screen.
5. Configure parameters on each screen.

6. Select the Save icon in the toolbar to save your changes.

7. Select the Previous Screen icon in the toolbar to return to the Test List.

Primary Wavelength
The selections under Primary Wavelength in the navigational tree allow you to configure the following
primary wavelength settings:
l Wavelength Definition
l Raw Data Checks
l Normalized Data Checks
l Primary Algorithm
l Secondary Algorithm

NOTE: If you change the data reduction parameters for your user-defined tests such that the
analytical performance of that test is affected, recalculate the calibrations and samples. See Reviewing Test
Results for information on recalculation. See User-Defined Tests disclaimer.

See Also
l General Information
l Analytical Cycle Definition

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l Result Unit Definition

l Calibration
l Parallelism
l Normal Pool Plasma
l Rerun Rules

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Wavelength Definition Chapter 4 – Setup

Wavelength Definition

Overview
The Wavelength Definition screen is used to setup the Reference and Normalization methods used in Data
Reduction as well as in error and warning reporting.
All data acquired by the Analyzer1 is reported in terms of its initial value multiplied by 1,000,000. To
convert the data back to its original value, each raw data point is divided by 1,000,000.
l Raw data value = raw data value from analytical module/1,000,000
All raw data points are adjusted by their corresponding ORU blanking value. The ORU blanking value is
determined through Diagnostics and each ORU unit. Each position in the ORU and each wavelength has its
own value. See Optical Reading Unit.
l Raw data value = <raw data value>/<ORU blank value>

NOTE: If the ORU blank value is less than the raw data value, the resulting raw data value will be
greater than 1.0. This results in negative values if the data is normalized by absorbance.

Accessing the Wavelength definition screen

To access the Wavelength definition screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigational tree, expand DR Parameters > Primary wavelength, and select
Wavelength definition.
4. <Optional> Edit the parameters on the Primary wavelength screen.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analytical Module.

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Wavelength Definition screen

Primary Wavelength
Read-only value extracted from the Analytical Cycle screen. Data generated at this wavelength is used to
calculate results.

Enable Warnings and Enable Errors

Options to issue warning and error messages. Error reporting is enabled by default.

Enable Reference Method

Option to enable curve referencing, which shifts the normalized data curve towards a baseline value of zero
(or near zero). Data curves are referenced so the curves of a particular test have the same starting point
(reference point) across all samples. This feature is useful with algorithms such as the Threshold algorithm
(when searching for an absolute value) and the Endpoint algorithm.

N umber of Seconds
Time interval used to compute the average of the raw data points. This average is subtracted from each raw
data point in the curve, shifting the entire curve closer to zero.

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Enable Normalization Method

Option to enable the normalization method, which converts the data values from the optical reading unit into
Intensity or Absorbance values, as selected here. The resulting data is used to generate the normalized curve.
The default method is Absorbance.

A bsorbance
To normalize using absorbance, each data point in the raw data is converted to mAbs using the following
formula:
l Value = -log (data) * 1000

Intensity
To normalize using intensity, each data point in the raw data is converted to %Transmittance using the
following formula:
l Value = data * 1000

Smoothing
The process of modifying the normalized data curve to reduce the noise and give it a smoother appearance.
This helps identify the true clot point. The normalized curve may be smoothed up to three times using a
moving average method. For each smooth, the limits are 1-20 data points.
Smoothing uses a moving average algorithm where the number of points specified (the degree) on either side
of each point are averaged. The averaged value replaces the specific point. This process continues for all
points in the data curve.

NOTE: When averaging the data points, the original (not the replaced value) is used. The original
data points are the input. The averaged data point is the output.

Example
In the following example, the normalized data is smoothed three times. Each smoothing operation uses 9
points.

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In the transition from normalized to Smooth 1, 9 points on either side of a particular point are averaged to
produce the new point value, as represented in Smooth 1.
In the transition from Smooth 1 to Smooth 2, smoothing of the beginning of the data is demonstrated. The
first point is always an exact copy. The second smoothed point is the average of the first three points (one
point on either side of the second point). The third smoothed point is the average of the first five points (two
points on either side of the third point), and so on, until there are enough points to average the specified
number of points. The end of the data curve is processed the same way, as demonstrated in the transition from
Smooth 2 to Smooth 3.
The number of points used for smoothing determines the coarseness of the smoothing action. The greater the
number of points specified, the greater the number of points averaged and the smoother the curve.

NOTE: For sensitive reactions, a large smoothing degree may erase much of the signal change of the
reaction, and may greatly reduce the ability of the data reduction to locate the clot point. Conversely, a
smoothing degree that is too small may not smooth the curve sufficiently so that the clot point can be
distinguished from the noise.

See Also
l Optical Reading Unit
l Data Reduction Parameters

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Raw Data Checks Chapter 4 – Setup

Raw Data Checks

Overview
Use the Raw Data Checks screen to configure the checks to perform on the raw data collected by the
Analytical Module1. The data checks you configure are performed before the data is processed (normalized,
smoothed or referenced) by the instrument.
The settings on the Raw Data Checks screen are locked for all tests defined by Instrumentation Laboratory.
These fields are editable only for user-defined tests. See User-Defined Tests disclaimer.

Raw data – Values and Delta

Raw data values typically range from 0 to 1.2. Some data points acquired by the analyzer may be marked
with ORU flags (noise, calculation errors, etc.). These points, and other erroneous data points (those
significantly different than their surrounding points) may be omitted from the data through the Signal Check.
Data checks identify raw data curves with patterns that do not match expected (or classical) data curves.

NOTE: Many raw data checks use the delta of the curve (signal change across the curve). The delta
of the raw data curve is not always computed as the signal difference between the last point in the curve and
the first point in the curve (as for classic curves). The delta of the data curve is computed as the difference
between the minima and the maxima of the data curve, where the minima and maxima follow a particular
curve sequence. For example, if a data curve starts at a high value, then drops to a smaller value, then goes
back up to a high value, the delta is computed as the difference between the lowest value and the highest
value.

Accessing the Raw Data Checks screen

To access the Raw Data Checks screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigation tree, expand DR Parameters, Primary wavelength and select Raw
data checks.
4. <User-defined test> Configure the data check parameters in the Raw Data Checks screen. See User-
Defined Tests disclaimer.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analyzer.

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Raw Data Checks screen

The fields on the Raw Data Checks screen are editable only for user-defined tests. They are not editable for
IL-defined tests. See User-Defined Tests disclaimer.

Enable Raw Data Checks

Option to configure one or more data checks to run on the raw data collected by the Analytical Module1.
The data checks are performed on the data before it is processed by the instrument.

Enable First Point Check

Option to perform the first data point check on the first point after the end of the delay period in the raw
data. Compares the value of the first point in the data curve against some percentage of the delta of the data
curve.
The result is flagged or fails when an unacceptable amount of noise is detected at the beginning of the cycle.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analyzer.

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Error and W arning thresholds

Maximum percentage of the delta of the data curve allowed before a warning or error is issued.
Example – CE 5050 (Data) Start point out of range

Enable Last Point Check

Option to compare the value of the last point in the data curve against some percentage of the delta of the
data curve.
The result is flagged or fails when the curve drifts at the end of the reaction.

Error and W arning thresholds

Maximum percentage of the delta of the data curve allowed before a warning or error is issued.
Example –CE 5058 (Data) Endpoint range

Enable Signal Check

Option to perform a signal check on all data points in the raw data curve. The signal check performs both of
the following tasks:
l Checks the value of each data point.
l Marks bad data points with ORU flags.

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Signal minimum an d Signal maximum

Set the acceptable signal range in these fields. If a data point occurs outside the specified range or is marked
with an ORU flag, it may be replaced with a calculated data point that is within the range and is not marked
with an ORU.
Configure an acceptable number of bad data points for substitution in the Maximum illegal values field.

Maximum illegal values

Maximum number of bad data points to allow for substitution, expressed as a percentage of the total number
of points in the data curve. Configure the percentage in this field. If the number of bad points found in the
data curve exceeds this value (%), the result fails.

Enable Substitution Method

Data point substitution methods to use with signal check, allowing data processing to continue. Options
include:
l Replace with previous value – The preceding data point replaces the one that is outside the expected
range or marked with an ORU flag.
l Extrapolate – A bad data point is replaced with one extrapolated by computing the average value of
the preceding data point and the next valid data point in the raw data curve.

Enable Curve Sequence Check

Option to perform a curve sequence check on all data points in the raw data curve. Determines the sequence
of data points in terms of value, from smaller to larger, or from larger to smaller. Most tests have an
expected curve. This check ensures the data set follows expected behavior. Results that do not follow
expected behavior fail. Options are:
l Min follows max – Data values decrease in value over time.
l Max follows min – Data values increase in value over time.
Example –CE 5057 (Data) Curve min. and max. not in correct sequence

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Example –CE 5057 (Data) Curve min. and max. not in correct sequence

Enable Spike Removal

Option to remove data spikes in the raw data curve. Compares the difference between two consecutive data
points to a value computed as a percentage of the delta of the raw data curve specified in the Max. % of
curve delta field. If the difference between the two data points exceeds the maximum difference allowed, the
second point may be replaced with a point within the allowable range.
Configure an acceptable number of bad data points for substitution in the Max. % of illegal points field.

Max. % of curve delta

Maximum allowable percentage of the delta of the raw data curve between consecutive data points.
Configure the percentage in this field. If the difference between two consecutive data points exceeds this
percentage, the second point may be replaced with a point within the allowable range.

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Max. % of illegal points

Maximum number of bad data points to allow for substitution, expressed as a percentage of the total number
of points in the data curve. Configure the percentage in this field. If the number of bad points found in the
data curve exceeds this value (%), the result fails.

Enable Substitution Method

Data point substitution methods used with spike removal, allowing data processing to continue. Options
include:
l Replace with previous value – The preceding data point replaces the one that is outside the expected
range.
l Extrapolate – A bad data point is replaced with one extrapolated by computing the average value of
the preceding data point and the next valid data point in the raw data curve.
Maximum number of bad data points to allow for substitution, expressed as a percentage of the total number
of points in the data curve. Configure the percentage in this field. If the number of bad points found in the
data curve exceeds this value (%), the result fails.

Enable Baseline by Moving SD

Option to truncate noisy data in the baseline area of a reaction curve. A stable baseline of the raw data curve
is established by locating the section of the data curve with the smallest standard deviation (SD) followed by
truncation of all data points that occur before the point in time where the smallest SD was found. This
bypasses noise at the beginning of a data curve (for example, noise caused by mixing reagents or the
presence of a bubble).

Enable percentage of time

Option to use the specified percentage of the reaction curve time to locate the smallest SD calculated as
follows:
l (Total acquisition time – delay) * percentage

Specify the percentage in the Percentage field. The SD calculation begins at the end of the delay time and
continues for the time corresponding to the percentage of time specified.

Enable absolute time

Option to use an absolute amount of time in the reaction curve, specified in the Time field, over which to
locate the smallest SD. The SD calculation begins at the end of the delay time and continues for the specified
time. This option should be selected if Enable baseline by moving SD is selected and the test uses an
extended acquisition mode.
l Minimum: 0.100 seconds
l Maximum: 1800.00 seconds

Siz e of window
Indicates the data points to use (over the specified period of time) to compute the SD. For faster reactions, the
size of the window should be fairly small.

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See Also
l Data Reduction Parameters
l Data Flags
l Alarm Messages

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Normalized Data Checks Chapter 4 – Setup

Normalized Data Checks

Overview
The Normalized data checks screen allows you to select which normalized data checks you want to perform
and the limits to apply to each of those checks. The normalized data is the data that has been acquired from
the analyzer and is subsequently normalized, then smoothed and finally referenced, providing these data
checks have been enabled.
For many of the normalized data checks, the delta (signal change across the curve) of the normalized data
curve is used. It is important to note that the delta of the normalized data curve is not necessarily computed
as the signal difference between the last point in the curve and the first point in the curve (although for
classic curves, this is the case). The delta of the data curve is computed as the difference between the minima
and the maxima of the data curve, where the minima and maxima follow a particular curve sequence. So, for
example, if a data curve starts at a high value, then drops to a lower value, then goes back up to a high
value, the delta is computed as the difference between the lowest value and the highest value.

Accessing the Normalized Data Checks Screen

To access the Normalized Data Checks screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigational tree, expand DR Parameters, Primary wavelength and select
Normalized data checks.
4. <User-defined tests> Configure the Normalized data checks screen. See User-Defined Tests
disclaimer.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

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Normalized Data Checks Screen

Enable Normalized Data Checks

Check to enable any or all normalized data checks. The normalized data checks are checks that are performed
on the normalized and smoothed data curve.

N ormalized Signal C heck

Aids in choosing the correct derivative peak for algorithms based on derivative methods (first derivative,
second derivative, and delta). When enabled, derivative peaks found in an area of the normalized curve
where the signal is trending in a negative direction are not considered valid and are ignored.

Enable N ormaliz ed C urve D elta U pper Limit

Determines if the magnitude of the reaction curve is too high. Computes the delta of the normalized data
curve and compares the actual delta value against the allowed delta value. Results obtained from curves
where the delta is greater than the maximum delta expected fail.
When enabled, the following fields are also enabled:
l Error limit (Upper)
l Warning limit (Upper)

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Enable N ormaliz ed C urve D elta Lower Limit

Determines if the magnitude of the reaction curve is too low. Computes the delta of the normalized data
curve and compare the actual delta value against the allowed delta value. Results obtained from curves where
the delta is less than the minimum delta expected fail.
If this field is enabled, the following fields are also enabled:
l Error limit (Lower)
l Warning limit (Lower)
Example – CE 5060 (Data) Minima delta not found

Enable C alibrated R esult D elta C heck

Compares the normalized curve delta of a sample to that of the lowest calibrator1 dilution. If the normalized
curve delta of the sample is not within the tolerance range of the lowest calibrator dilution normalized curve
delta, the result is either failed or flagged. This check is only applicable to tests that have a validated
calibration.
Max Tolerance
Defines the allowable variation (%) around the lowest calibrator dilution delta. If this range is violated, the
result is failed.
Max Tolerance warning
Defines the allowable variation (%) around the lowest calibrator dilution delta. If this range is violated, the
result is flagged.

1A type of sample with an assigned value used to calibrate a test.

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Baseline Check Tab

Enable Baseline Check
Verifies that the baseline (beginning) of the reaction is stable. If the data curve has been referenced, you can
establish an expected mean and tolerance for the baseline of the curve. Regardless of whether the data curve
has been referenced or not, you can establish an expected maximum standard deviation (SD). Not all data
curves have a signature that allows for a stable baseline.

N umber of Seconds
Number of seconds over which the baseline average of the normalized data is computed.

Enable Mean C heck

Verifies that the mean computed for the baseline is within the expected range.

Enable SD C heck
Ensures the beginning of the data curve is stable. Results obtained from curves that do not meet the SD
check error criterion fail.
Example – CE 5052 (Data) Baseline SD out of range

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Endpoint Check tab

Enable Endpoint Check

Verifies that the end of the reaction curve is stable and is not drifting. If the data curve has been referenced
and the test has predictable curves, you can establish an expected mean and tolerance for the endpoint of the
curve. Regardless of whether the data curve has been referenced or not, you can establish an expected
maximum standard deviation. Not all data curves have a signature that allows for a stable endpoint.

N umber of Seconds
Number of seconds over which the endpoint average of the normalized data is computed.

Enable Mean C heck

Verifies that the mean computed for the endpoint is within the expected range.

Enable SD C heck
Fails samples that exceed the variation determined during test method development. Ensures the end of the
data curve is stable. Curves that do not meet the SD check error criterion fail.

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Multiple Threshold Check Tab

Enable Multiple Threshold Check

Searches the normalized data, starting at the beginning of the data, for multiple occurrences of a defined
threshold value. Only considers data that is moving in a positive direction. The threshold value is defined as
either an absolute value or a percentage of the normalized curve delta.

Method
If the method is Absolute value of referenced curve, the curve must be referenced.
If the method is Percentage of curve, the threshold limit value is calculated as follows:

Threshold Limit Value (Error or Warning) = Curve Minimum + (Curve Delta * Limit
Value/100)

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The Multiple Threshold Check can fail or flag samples that present with this type of abnormal curve
characteristic.

Error Limit
The Error Limit is calculated using the Threshold Limit Value calculation above where the limit value is the
value defined in the Error Limit field. If the Threshold Limit Error Value is found two times and the time
between each occurrence of the located threshold value is greater than the defined time span, the result fails
with the error, CE 5092 Normalized data contains multiple thresholds.

W arning Limit
The Warning Limit is calculated using the Threshold Limit Value calculation above where the limit value is
the value defined in the Warning Limit field. If the Threshold Limit Warning Value is found twice and the
time between each occurrence of the located threshold value is greater than the defined time span, the result
is reported with the warning: CW 5232 “Normalized data contains multiple thresholds.

NOTE: If the warning limit is set to the same value as the error limit, only the error is generated.

Time Span
Distinguishes between true reaction curve anomalies and baseline noise and is the time between two
occurrences of the threshold limit value. To produce an error or warning, the time between two occurrences
of the threshold limit value must be greater than the limit defined in the Time Span field; otherwise the two
values are considered noise.

See Also
l Data Reduction Parameters

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Primary Algorithm Chapter 4 – Setup

Primary Algorithm
The primary algorithm used to determine the end point of a reaction.
The settings on the Primary Algorithm screen are locked for all tests defined by Instrumentation Laboratory.
These fields are editable only for user-defined tests. See User-Defined Tests disclaimer.

Accessing Primary Algorithm Parameters

To view the primary algorithm for a test:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigation pane, expand DR Parameters, Primary wavelength and select
Primary algorithm.
4. <User-defined tests> Configure the primary algorithm parameters in the Primary algorithm screen.
Note: A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user
alone.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

Primary Algorithm Screen

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Enable Primary Algorithm

Option to enable the fields on the Primary Algorithm screen.

Endpoint Algorithm
The average of a specified number of data points at the end of the curve is calculated to produce a result in
terms of milliabsorbance or % transmittance.

l indicates region defined by endpoint time (2 sec)

l The red dot indicates average of data points defined by endpoint time

Endpoint time
Time span at the end of the curve over which to compute the average of the normalized data points.

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Linear Kinetic Algorithm

The change in optical signal over a given amount of time is calculated. Valid results are
%Transmittance/min, Transmittance/min, or Milliabsorbance/min.

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Linear Kinetic Algorithm Screen

Slope of curve
Option to compute the change in optical signal as the slope of the normalized data curve beginning at the
start time and continuing for the total time indicated by Time. The slope calculation is a simple linear
regression calculation. At the end of the calculation, the computed slope is adjusted for the length of time of
the calculation and for the rate at which the data was acquired.

Start time
Point in time in the reaction data where computing the slope begins.

Time
Total amount of time used to calculate the slope.

Delta of curve
The difference between the reaction signal at the specified starting time and that at the specified end time is
calculated. At the conclusion of the calculation, the computed delta is adjusted for the length of time of the
calculation and for the rate at which the data was acquired.

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Method
Select the method used to calculate the change in optical signal over a given amount of time. Options are:
l Baseline/Endpoint averages – The instrument calculates the averages of the data over the specified
baseline and endpoint times, then calculates the difference.
l Exact start/end Time – The system calculates the difference between the data values of a point at the
specified start time and end time.

Start time
Enabled only when the method is Exact start/end time. The start time is the point in time in the reaction data
to begin computing the slope of the normalized data.

End time
Editable only when the method is Exact start/end time. Time is the total amount of time over which to
calculate the slope.

B aseline time
Editable only when the method is Baseline/Endpoint averages. Baseline time is the amount of time at the
beginning of the curve over which to compute the average of the normalized data points.

Endpoint time
Editable only when the method is Baseline/Endpoint averages. Endpoint time is the amount of time at the
end of the curve over which to compute the average of the normalized data points.

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Example – 5060 CE (Data) Minima delta not found:

Enable linear regression SD error check

Verifies whether the standard deviation of the calculated slope is less than the specified error limit. If greater
than the error limit, the result fails.

SD error limit
Maximum standard deviation allowed before the data is considered to be in error.

Enable linear regression SD warning check

Verifies whether the standard deviation of the slope is less than the specified warning limit. If greater than
the warning limit, the result returns with a warning flag.

SD warning limit
Maximum standard deviation allowed before a warning flag is associated with the result.

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Example – 5066 CE (Reaction) Linear Regression SD out of range:

Enable negative calculation

When selected, difference calculations within the slope or delta methods are not computed using the absolute
value. As a result, negative measured values may be produced. If enabled, the initial slope check is also
calculated without considering absolute values. If disabled, the absolute value is used for difference
calculations within the slope or delta methods as well as in the initial slope check computation.

Enable initial slope check

When enabled, the slope of the normalized data is calculated starting at the beginning of the data curve, after
the end of any delay period and for the total time as indicated by the parameter Time. The initial slope
calculation is a simple linear regression. At the conclusion of the calculation, the computed slope is adjusted
for the length of time of the calculation and for the rate at which the data was acquired.

Time
Amount of time used to calculate the initial slope. The valid range is 0 seconds to the standard acquisition
time.

Maximum Error Limit

If the computed initial slope is greater than the maximum error limit, all processing ceases and the result fails.
The valid range is 0.0 to the maximum displayable value.

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Maximum W arning Limit

If the computed initial slope is less than the maximum error limit but greater than the warning limit,
processing continues, but the result is flagged. Valid range is 0.0 to the maximum displayable value.

Example – 5076 CE (Reaction) Initial slope error:

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Threshold Algorithm
Determines the measured result by locating a threshold limit value within the data curve. The limit value
may be determined as a percentage of the delta of the normalized data curve, or it may be an absolute value
within the data curve. If the limit value to search for is an absolute value, the data curve must first be
referenced.
When locating values in the data curve as a percentage of the data curve, the threshold limit value (and
check value, if enabled) is always be located (because the computed value is guaranteed to be within the
delta of the data curve).

Method
The following methods can be used to compute (or assign) the value located in the data curve.
l Percentage of curve – The system calculates the threshold search value using the following
relationship:
o Threshold value = Normalized curve baseline + ((Normalized curve
maximum – Normalized curve baseline) * Limit value)
l Absolute value of referenced curve – The system tries to locate the point with the value closest to
this value. Reference must be enabled if searching for absolute values. See Enable reference method.

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Search Direction
The following search directions can be used to move through the curve when locating the threshold value.
l Forward – Starts searching at the beginning of the reaction curve when trying to locate the threshold
value. Stops searching at the last instance of the sought-after value.
l Backward – Starts searching at the end of the reaction curve when trying to locate the threshold
value. Stops searching at the first instance of the sought-after value.

Limit Value
Value to search in the data curve. The value depends upon the method.
l If method is Percentage of curve, enter a value in terms of percent ranging from 0-100%.
l If method is Absolute value of referenced curve, enter an absolute value ranging from 0 to the
maximum displayable value.

Enable Threshold Check

Option for the threshold algorithm to search the data curve for an additional value. Ensures the data curve
has enough magnitude (if using absolute values); or ensures the reaction has occurred in an expected amount
of time for the test.

C heck Value
Additional value to locate in the data curve.
l If method is Percentage of curve, enter a value in terms of percent ranging from 0-100%.
l If method is Absolute value of referenced curve, enter an absolute value ranging from 0 to the
maximum displayable value.

Enable Threshold C heck Error

Option to flag the data with an error when the threshold check value is not found in the data curve. It is
impossible to get this error if the threshold method is Percentage of the curve.

Enable Time Span C heck

Option to calculate the difference in time between the location of the threshold value and the threshold
check value and generate a warning or an error if the difference is outside the specified range.

Method
l Greater than – An error is generated when the time at which the limit and check values are located is
greater than the specified error limit.
l Less than – An error is generated when the time between the time at which the limit and check
values are located is less than the specified error limit.

Error Limit
Difference in time between thresholds used to generate an error.

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W arning Limit
Difference in time between thresholds used to generate a warning.
Example
In the example below, the data curve has not been referenced. The red line indicates the time when the
threshold limit value was located. The green line indicates the time when the threshold check value was
located. The time span is the time (8 seconds) between when the limit value was found (31 seconds) and the
check value was found (39 seconds).
The measured result is the time when the limit value was found in the data curve.

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First and Second Derivative Algorithms

First Derivative
The first derivative algorithm locates the clotting time by finding the point of maximum inflection in the
normalized curve.

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Second Derivative
The second derivative algorithm locates the clotting time by finding the point of maximum inflection in the
second derivative curve.

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Method
l Slope – Uses slope to plot the clot curve.
l Least squares – Uses the least squares method to plot the clot curve.
l Points – Number of data points to the left and right of each data point to use in the slope and least
squares methods of calculating the clot curve.

Peak Search Method (1st and 2nd D erivative)

l Greatest maxima peak – (1st and 2nd Derivative) Searches the derivative curve for the peak with the
greatest positive value. The peak maxima must be greater than the value established by the Maxima
Peak Check, if enabled. If not enabled, the value must be greater than zero to be recognized as a peak.
A maximum of one peak is located.
l Last maxima peak – (1st and 2nd Derivative) Searches the derivative curve for all peaks that satisfy
the maxima peak criteria. The peak maxima must be greater than the value established by the Maxima
Peak Check, if enabled. If not enabled, the value must be greater than zero to be recognized as a peak.
The first point in the data curve cannot be considered a maxima peak, nor can the time of a maxima
peak be after what is considered the end of the curve (maximum value of absorbance-normalized
curve). A maximum of 100 peaks are located. The last maxima peak found is used for calculating
results, if it passes all peak check criteria. If the last max peak fails the peak check criteria, the next to
last peak is used, and so on, until a result is determined, or until the list of peaks is exhausted.
l Greatest Max/Min Couplet – (2nd Derivative) A minima peak (<0) must immediately follow the
maxima peak. For this reason, this check can only be used with second derivative curves. The peak
maxima must be greater than the value established by the Maxima Peak Check value and the absolute
value of the peak minima must be greater than the Minima Peak Check value, if enabled. The first
point in the data curve cannot be considered a maxima peak, nor can the time of a maxima or minima
peak be after what is considered the end of the curve (maximum value of absorbance-normalized
curve). A maximum of 100 couplets are located. The couplet with the greatest signal difference
between the minima and the maxima is considered first. If this couplet fails the peak check criteria,
the couplet with the next greatest difference between minima and maxima is used, and so on, until a
valid couplet is found or the list of peaks is exhausted.
l Last Max/Min Couplet – (2nd Derivative) A minima peak (<0) must immediately follow the maxima
peak. For this reason, this check can only be used with second derivative curves. The peak maxima
must be greater than the value established by the Maxima Peak Check value and the absolute value of
the peak minima must be greater than the Minima Peak Check value, if enabled. The first point in the
data curve cannot be considered a maxima peak, nor can the time of a maxima or minima peak be
after what is considered the end of the curve (maximum value of absorbance-normalized curve). A
maximum of 100 couplets are located. The last couplet located is considered first. If this couplet fails
the peak check criteria, the couplet with the next greatest difference between minima and maxima is
used, and so on, until a valid couplet is found or the list of peaks is exhausted.
l Greatest Max/Min to Zero Couplet – (2nd Derivative) This search method is identical to the
Greatest Max/Min Couplet with the following exception:
o After the couplet is located, the search continues through the 2nd derivative minima to find
the first point greater than zero.
l Last Max/Min to Zero Couplet – (2nd Derivative) This search method is identical to the Last
Max/Min Couplet with the following exception:

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o After the couplet is located, the search continues through the 2nd derivative minima to find
the first point greater than zero.

Smoothing (1st and 2nd D erivative)

Process of adjusting data points to remove noise artifacts. Select the best option. Up to three smooths can be
applied to each derivative function.

Delta Checks

Max. Peak D elta C heck (1st and 2nd D erivative)

l Calculates the delta of the normalized data at the location within the normalized data for each
maxima peak found in the derivative data. This is computed by taking the difference of the value of
the point in the normalized data at the time indicated by the maxima peak value and the point in the
normalized data at the time that is considered the baseline of the curve.
l Verifies the calculated delta is greater than the user-specified absolute value.

Max. Peak D elta % C heck (1st and 2nd D erivative)

l Calculates the delta of the normalized data at the location within the normalized data for each
maxima peak found in the derivative data. This is computed by taking the difference of the value of
the point in the normalized data at the time indicated by the maxima peak maximum value and the
point in the normalized data at the time that is considered the baseline of the curve.
l Verifies the calculated delta is greater than the user-specified percentage of the delta of the normalized
curve.

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D erivative Max. Type (1st derivative)

Enable one of the following:
l Max to the normalized endpoint – The first derivative maximum is computed by calculating the
difference between the first derivative signal maxima and the first derivative signal corresponding to
the time of the normalized curve endpoint.
l Max to the normalized baseline – The first derivative maximum is computed by calculating the
difference between the first derivative signal maxima and the first derivative signal corresponding to
the time of the normalized curve baseline.

Peak D elta C heck (2nd D erivative)

l Calculates the delta of the normalized data at the location within the normalized data for each
maxima/minima peak found in the derivative data. This is computed by taking the difference between
the value of the point in the normalized data at the time indicated by the maxima peak value and the
minima peak value.
l Verifies the calculated delta is greater than the user-specified absolute value.

Peak D elta % C heck (2nd D erivative)

l Calculates the delta of the normalized data at the location within the normalized data for each
maxima peak found in the derivative data. This is computed by taking the difference between the
value of the point in the normalized data at the time indicated by the maxima peak maximum value
and the minima peak minimum value.
l Verifies that the calculated delta is greater than the user-specified percentage of the delta of the
normalized curve.

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For the data shown above, assume the following warning and error limits are set:
l Peak Delta Check Warning: 8 mAbs
l Peak Delta Check Error: 4 mAbs
l Peak Delta % Check Warning: 40%
l Peak Delta % Check Error: 20%

NOTE: In this example:

l The Total Curve Δ is 21.8 mAbs.

l ΔMax2 - Min 2 = 11.6 mAbs (indicated by Xs on normalized curve) or 53.2% of curve
l ΔMax 1 - Min 1 = 1 mAbs (indicated by an X with a vertical line through it on normalized curve) or
4.5% of curve
In the example above, all search methods would use the peak checks as follows:
l ΔMax 1- Min 1 is less than the Peak Delta Warning and Error
l ΔMax 2- Min 2 is greater than the Peak Delta Warning
l ΔMax 1- Min 1 is less than the Peak Delta % Warning and Error
l ΔMax 2- Min 2 is greater than the Peak Delta % Warning
Depending on the search method, Max 2 or couplet 2 would be used to calculate the result.

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Peak Checks

Peak checks are used to help identify the correct peaks. If a peak or couplet passes the peak check criteria
(warning and error) a result returns. If a peak or couplet exceeds the warning limit but not the error limit, a
result returns with a warning. If a peak or couplet exceeds the error limit, the result returns as failed.
Peak checks may be useful in removing 2nd derivative maxima and minima which are the result of rises in
the baseline or bumps in the clot curve after the clotting has slowed.

Max. Peak C heck (1st and 2nd D erivative)

Verifies the maxima peak occurs earlier than the last valid point in the derivative curve.
Verifies the value of the maxima peak is greater than the user-specified warning/error limits established for
the maxima peak.

Min. Peak C heck (2nd D erivative only)

Verifies the minima peak occurs earlier than the last valid point in the derivative curve.
Verifies the absolute value of the minima peak is greater than the user-specified warning/error limits
established for the minima peak.

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Enable 1st D erivative B ound C heck (2nd D erivative only)

Ensures the second derivative maxima peak selected occurs before the first derivative maxima peak. If the
peak search method used is a couplet method, it ensures the minima peak selected occurs after the first
derivative maxima peak.
For example:

If the Peak Search Method is:

Greatest Max Peak
l Max1 is less than Max Peak Check warning limit, but is considered.
l Max2 is greater than Max Peak Check warning limit and is considered.
l Max3 is greater than Max Peak Check warning limit and is considered.
l Max2 is chosen to calculate result as Max2 is greater than Max3.
If Max1 was the only Max to be found, the system would return a result using this peak with a warning
(Maxima of 2nd derivative is low).

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Greatest Max/Min Couplet

l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered.
l Max/Min2 meets all Peak Check criteria and is considered.
l Max/Min3 meets all Peak Check criteria and is considered.
l Max/Min2 is used to calculate result as this couplet has the largest difference between the max and
min of all the couplets that were considered.
l If Min1 and Max1 were the only min/max pair to be found, the system would return an error
(min/max peak criteria not met).
l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered.
l Max/Min2 meets all Peak Check criteria and is considered.
l Max/Min3 meets all Peak Check criteria and is considered.
l Max/Min2 is used to calculate result as this couplet has the largest difference between the max and
min of all the couplets that were considered.
l If Min1 and Max1 were the only min/max pair to be found, the system would return an error
(min/max peak criteria not met).
Last Max Peak
l Max1 does not meet Max Peak warning limit, but is considered.
l Max2 meets Max Peak Check criteria and is considered.
l Max3 meets Max Peak Check criteria and is considered.
l Max3 is the last max found which meets criteria and is used to calculate result.
l If Max1 were the only max to be found, the system would return a warning (Maxima of 2nd
derivative is low).
Last Max/Min Couplet
l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered.
l Max/Min2 meets all Peak Check criteria and is considered.
l Max/Min3 meets all Peak Check criteria and is considered.
l Max/Min3 is used to calculate result as it is the last couplet found which passes all criteria.
l If Min1 and Max1 were the only couplet to be found, the system would return an error (Min/Max
peak criteria not met).

Peak C ount C heck (1st and 2nd derivatives)

This check counts the number of maxima peaks (either as a maxima alone or as part of a peak couplet) within
the specified window size. Starting at the first maxima peak, the window size is determined by adding the
time corresponding to the maxima peak to the window size value. The number of maxima peaks are counted,
and if the number exceeds the number allowed (error or warning limits), the result is flagged (warning) or
failed (error) with an error ERR MAX PEAK COUNT EXCEEDED.

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First Peak B oundary (1st and 2nd D erivative)

Check used to distinguish a true peak from noise at the beginning of the data curve. The ascent value is the
increase in intensity of the peak after the first data point. If the curve does not ascend to the defined limit
(calculated as Percent Limit x Max Peak Delta) the peak is not considered a valid peak.

D efinition B oundary (1st and 2nd D erivative)

When the Definition Boundary (percent) check is enabled, data reduction uses the maximum value of all the
data within this peak as the peak maxima. You can choose the following three options to determine which of
the local maxima peaks are selected:
l First peak
l Greatest peak
l Last peak

Post Processing Checks (Second Derivative)

Time Span
Compares the difference in time between the minima and maxima peak when a couplet peak search method is
used. Depending on the chosen method, if the difference in time is less than or greater than the error limit,
the result is FAILED. Depending on the chosen method, if the difference in time is less than or greater than
the warning limit, a numeric result with a warning is generated. See: Data Flags, CE 5064.

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Delta Algorithm
Uses the 2nd derivative algorithm. The 2nd derivative minima and maxima are located. The time when these
points occur is referenced back to the normalized curve. The difference between the values of the normalized
curve at these times is computed to obtain the delta value.
The chart below shows how the delta is computed when the peak search method is either Greatest Max/Min
to Zero Couplet or Last Max/Min to Zero Couplet. The location of the first point in the 2nd derivative curve
that is greater than zero (after it has gone through the minima) is used.

If the Greatest Max/Min Couplet or Last Max/Min Couplet method is used, the minimum of the 2nd
derivative references back to the normalized curve.

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Delta Second Derivative Tab

The Delta algorithm setup is similar to the Second Derivative algorithm setup with the following exception:
l Because the Delta Algorithm must use a couplet peak search method, the Last Maxima Peak and
Greatest Maxima Peak methods are not available as peak search options.

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Final Minus Initial Algorithm

The Final Minus Initial Algorithm calculates a measured result using one of the following methods:
l Computes the difference between two points (Exact start/end time).
l Computes the difference of the averages of several points obtained at the beginning and end of the
curve (Baseline/Endpoint averages).

Method
Select one of the following options in the drop-down list:
l Baseline/Endpoint averages – The system calculates the averages of the data over the specified
baseline and endpoint times, and calculates the difference.
l Baseline Time – Length of time over which to compute the average of the normalized data,
starting from the beginning of the curve. Editable only if the method is Baseline/Endpoint
averages.
l Endpoint Time – Length of time at the end of the curve over which to compute the average.
Editable only if the method is Baseline/Endpoint averages.

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indicates region defined by Baseline/Endpoint time

Red dots indicate average of data points defined by Baseline/Endpoint time.

l Exact Start/End Time – If selected, the system calculates the difference between the data values
corresponding to the exact points specified in Start time and End time.
l Start Time – This is only editable if the method is Exact Start/End time. This is the point in
time in the reaction to begin computing the slope of the normalized data.
l End Time – This is only editable if the method is Exact Start/End time. This is the total
amount of time used to calculate the slope of the normalized data.

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Enable Linear Regression SD Error Check

Option to verify that the standard deviation of the slope is less than the specified error limit. A value greater
than the warning limit returns a FAILED result.
l SD Error Limit – Maximum standard deviation allowed before the data is considered in error.

Enable Linear Regression SD Warning Check

Option to verify that the standard deviation of the slope is less than the specified warning limit. A value
greater than the error limit returns a result with a warning flag.
l SD Warning Limit – Maximum standard deviation allowed before results are flagged with a warning.

Enable Negative Calculation

With the negative calculation option enabled, the Final minus initial algorithm is no longer computed using
the absolute value of the difference. As a result, negative measured values may be produced. If it is enabled,
the Initial slope check is also calculated without considering absolute values. If disabled, the absolute value
is used for the difference calculation within the final minus initial algorithm, as well as in the initial slope
check computation.

Enable Initial Slope Check

The slope of the normalized data is calculated starting at the beginning of the data curve (after the end of any
delay period) and for the total time indicated by the Time parameter. The initial slope calculation is a simple
linear regression. After the slope is calculated, it is adjusted for the length of time of the calculation and for
the rate at which the data was acquired.

Time
Total amount of time used to calculate the initial slope. The valid range is 0 seconds to the standard
acquisition time.

Maximum Error Limit

If the computed initial slope is greater than the maximum error limit, all processing ceases, and the result
fails. The valid range is 0 to the maximum displayable value.

Maximum W arning Limit

If the computed initial slope is less than the maximum error limit but greater than the warning limit,
processing continues, but the result is flagged. The valid range is 0 to the maximum displayable value.

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Statistics Algorithm

The Statistics algorithm performs a linear regression calculation on the range of data between the statistics
start time and statistics time values. It calculates the mean of the linear regression data.

Statistics

Statistics Start Time

Time in the data to begin performing calculations.

Statistics Time
Total amount of time over which to perform calculations.

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Enable Optical Interference Check

Option to apply error and warning checks to the data.

Error Limit an d Tolerance

Parameters used to define the range of acceptable mean values. An error message is generated when the limit
is exceeded.

ER ange
Range of acceptable mean values computed using the error limit and tolerance values.

W arning Limit an d Tolerance

Parameters used to define the range of acceptable mean values. A warning flag associated with the sample
when the limit is exceeded.

W R ange
Range of acceptable mean values computed using the warning limit and tolerance values.

See Also
l Data Reduction Parameters
l Clot Curve Analysis

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Secondary Algorithm
The system uses the secondary algorithm if the primary algorithm fails any of its curve checks.

NOTE:

l The secondary algorithm must be enabled by clicking the Enable range for secondary algorithm
option in Calibration Setup.
l The secondary algorithm must use the same measured result unit (for example, seconds) as the primary
algorithm.
If any of the raw data checks or normalized data checks fail, neither the primary algorithm nor the secondary
algorithm is used, and an error results.
The secondary algorithm options are similar to those of the primary algorithm.

See Also
l Data Reduction Parameters

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Result Unit Definition

Use the Result Unit Definition screen to define sample result units and select them for sample result display.

Accessing the Result Unit Definition screen

To open the Result Unit Definition screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigation tree, select Result units.

Viewing and Editing Measured Units

To view or edit a measured unit:
1. Open the Result Unit Definition screen.
2. Place focus1 on a unit of measurement in the Unit column.

3. Select the View icon in the toolbar.

4. Configure editable fields in the Result Unit Definition dialog box.
5. Select OK to close the window.

6. Select the Save icon in the toolbar to save your changes.

7. Select the Previous Screen icon in the toolbar to return to the Test List.

NOTE:

l A test must always have a measured unit defined. The default measured unit is seconds.
l The measured result unit and ranges of the test that imports results calibration data from another test
must be the same as the measured result unit and ranges of the imported test.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Adding Result Units

To add a result unit:
1. Open the Result Unit Definition screen.

2. Select the Add icon in the toolbar to open the Non-IL Result Unit Definition window.
3. Configure the new result unit in the Non-IL Result Unit Definition window.
4. Select OK to close the window.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

NOTE: If the measured result is 0, the Ratio and INR results fail.

Deleting a Result Unit

To delete a result unit:
1. Open the Result Unit Definition screen.
2. Select1 the result unit in the table to delete.

3. Select the Delete icon and confirm.

4. Select the Save icon in the toolbar to save your changes.

5. Select the Previous Screen icon in the toolbar to return to the Test List.

NOTE: Measured result units cannot be deleted.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Result Unit Definition

From this screen you can do the following:

l Add a result unit.
l View result unit details.
l Delete a result unit.

Result Unit Definition Columns

Selection C olumn
Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the
Select icon in the column heading to select or deselect all the rows in the table.

U nit
The unit that is measured in the test.

U nit Type
The type of unit measured in the test. Available unit types are Measured, Calibrated, Calculated, Paired,
Statistical and Derivative.

Label
Abbreviated form of the unit. Indicates how the unit appears in the sample list.

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A check mark indicates the material is an IL-defined material.

dec.
Number of decimal places the reported result contains.

NOTE: - Numeric values are calculated using precise values. However, when displayed, these values
are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen
may appear to be within the defined range limit when it is actually out of range. Such values are flagged to
indicate that they are out of the range.

N ormal, Therapeutic, Linear a n d Test R ange

Normal, Therapeutic, Linear and Test Range columns display the established minimum and maximum values
for each of these ranges.

Patient Result Selection

Select up to four predefined result unit types per sample to display in the Sample List.

Primary Unit Configuration

Primary U nit
Select the predefined result unit used to check the maximum difference between replicate results.

NOTE: You should define only one primary calibrated unit.

Enable Max D ifference

If this option is enabled, and the number of replicates is 2, the maximum difference between each of the
replicates is computed. If the percent difference between either of the results and the mean of the results is
greater than the maximum difference allowed, the mean of the result is flagged with a warning.

Max D ifference
Specifies the maximum difference between an individual result and the mean result as a percentage that
cannot be exceeded or the mean result is flagged as an error or warning.

Measured Result Curve Display Settings

Use these fields to configure the graphical display settings for the measured result curve.

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Result Unit Definition Screen

Unit selection

U nit type
Select one of the following result unit types:
l Calculated – Some tests require more than one result or the use of a conversion factor to compute a
result. An example of such a test is the Prothrombin Time test, where an ISI value is required to
compute the INR result. The following options are available for calculated units:
o Ratio
o INR
If the measured result is 0, the Ratio and INR results fail.
l Calibrated – If a test requires calibration, it must always have a calibrated unit defined to report a
calibrated result.

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NOTE: You should define one primary calibrated unit (one unit with no conversion).

The following options are available for calibrated units:

o %
o IU/mL
o User-Defined
o mg/dL
o μg/L
o mg/L
o μg/mL
o mU/mL
o μmol/L
o ng/mL
o AU/mL
o nmol/L
o g/L
o U/mL
o IU/dL
l Derivative – The following options are available for derivative units:
o 1st der = Maximum peak height of first derivative curve
o 2nd der - = Maximum negative peak height of second derivative curve
o 2nd der + = Maximum positive peak height of second derivative curve
l Paired – Tests that are configured as paired tests require the use of a paired unit. An example of such
a test is the APCR test, where results from both the activated and non-activated forms of the test are
required to compute a Ratio result. The following options are available for paired units:
o % Correction = ((Measured Result 1 - Measured Result 2) / (Measured Result 1 - NPP1)) *
100
o PiCi% = ((ThP-B - ThP-A) / ThP-B )*100=PiCi%
o Rosner Index = (Measured Result 1 - NPP2) / Measured Result 2) * 100
o Test Delta = (S1 - S2)
o Test Delta % = ((S1 - S2) / S1) * 100
o Test Delta-N = ((S1 - S2) / (NPP1 - NPP2))
o Test Delta-N% = ((S1/S2) / (NPP1/NPP2)) * 100
o Test Ratio = (S1/S2)
o Test Ratio-N = ((S1/S2) / (NPP1/NPP2))
o Test Ratio-N% = ((S1 - S2) / (NPP1 - NPP2)) * 100
l Statistical – A statistical unit is required when the statistic algorithm is chosen as the primary
algorithm. The options available for statistical units are:
o %CV
o SD
o Slope

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U nit
Select the unit specific to the unit type.

U ser-defined label
The user-defined label allows you to input the user-defined calibration unit. It is used when you want to
define your own calibrated unit. You can create one user-defined unit per test.

D ecimals
Select the number of decimal places to be reported for the result.

NOTE: - Numeric values are calculated using precise values. However, when displayed, these values
are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen
may appear to be within the defined range limit when it is actually out of range. Such values are flagged to
indicate that they are out of the range.

Calibrated unit data

This is editable only if the selected unit type is calibrated.

Enable conversion
Option to enable conversion. Select an option in the Conversion unit list.

C onversion factor
Linear multiplication factor applied to the result unit for converting results (e.g. from g/L to mg/dL).

Paired result data

This is editable only if the selected unit type is paired.

Paired unit
Tests that are configured as paired tests require the use of a paired unit. An example of such a test is the
APCR test, where results from both the activated and non-activated form of the test are required to compute a
ratio result.

INR unit data

Read-only information extracted from the material definition. It displays material to which the ISI value is
specific, as well as the ISI value itself, provided that the unit type is calculated and the unit is INR.

Minimum limits

A llow negative results (QC jobs excluded)

Option to enter a limit for acceptable negative values. If a negative result is obtained and the value is less
than zero but more positive than the negative value limit, the value is reported as a true negative value. If a
negative result is obtained that is less than zero and more negative than the negative value limit, the value

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fails. For Linear Kinetic and Final minus initial algorithms, negative values for measured results are only
reported if negative calculation is enabled from within the Primary algorithm setup for these algorithms and
Allow negative results is enabled for the measured result unit.
This option applies to all unit types.

Enable negative limit

Option to allow negative results.

N egative value limit

The negative limit below which the result fails.

Enable transform negative results to z ero

This option is available only for calibrated units.
Option to define a limit for acceptable negative calibrated values. If a negative calibrated result is obtained
with a value that is less than zero but more positive than the negative value limit, the result is reported as
zero. If a negative calibrated result is obtained with a value that is less than zero and more negative than the
negative value limit, the result fails.

NOTE: Calibration results are automatically reported as 0 in the following situations:

l When measured result values (any sample type) are less than the mean of the measured result of the
0% calibration dilution for assays employing a 0% dilution that have a positive calibration slope; or
l When measured result values (any sample type) are greater than the mean of the measured result of the
0% calibration dilution for assays employing a 0% dilution that have a negative calibration slope.

Transform to
Field where you configure a number to convert a negative result.

Enable result correlation

When this option is enabled and the result is found to be within the specified correlation range, a correlation
factor and offset are applied to the result to obtain better agreement with results obtained by another method.
The result correlation default is disabled.
Result Correlation Formula
y = a*x + b
Where:
y = Calculated new result
x = Original result
a = Factor
b = Offset

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NOTE: In a linear regression, results from the ACL TOP are the x set of values.

Correlation Range

C orrelation range Minimum a n d Maximum

Range in which the result must fall in order to apply correlation factor and offset.

Method
Specifies the use of the linear method when applying factor and offset.

Factor
Value to multiply by each result to shift the slope of the curve. The default value is 1.000.

Offset
Value to add to each result to shift the curve on the y-axis. The offset value is applied before the factor value
is applied. The default value is 0.000.

Ranges

Enable normal range

Option to flag results that fall outside the established limits.
l Minimum/Maximum – Enter minimum and maximum values to define the normal range for the test.

NOTE: For calibrated results employing a conversion factor, the normal range minimum and
maximum values are automatically calculated from the range of the primary calibrated unit and the
conversion factor.

Enable therapeutic range

Option to flag results that fall outside the established limits.
l Minimum/Maximum – Enter minimum and maximum values to define the therapeutic range for the
test.

Enable linear range

Option to flag results that fall outside the established limits.
l Minimum/Maximum – Enter minimum and maximum values to define the linear range for the test.
l Extended Time Minimum and Maximum – Enter minimum and maximum values to define the linear
range for the result unit when extended acquisition analysis is performed.
l Alternative Pre-dilution Minimum and Maximum – Enter minimum and maximum values to define
the linear range for the result unit when alternative pre-dilution is performed.

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NOTE: For calibrated results employing a conversion factor, all linear range minimum and
maximum values are automatically calculated from the range of the primary calibrated unit and the
conversion factor.

Enable test range

Option to flag results that fall outside the established limits.
l Minimum/Maximum – Enter minimum and maximum values to define the test range for the result
unit.
l Extended time/alternative pre-dilution – Enter minimum and maximum values to define the test
range for the result unit when extended acquisition analysis is performed.

NOTE: For calibrated results employing a conversion factor, all test range minimum and
maximum values are automatically calculated from the range of the primary calibrated unit and the
conversion factor.

See Also
l General Information
l Analytical Cycle Definition
l Data Reduction Parameters
l Calibration
l Parallelism
l Normal Pool Plasma
l Rerun Rules

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Calibration Setup
Overview
You can define the following calibration items:
l Calibration method, dilution volumes and pipetting parameters for calibrator1 and diluent materials
used to prepare automatic dilutions
l Calibrator materials used in manual calibrations
l Calibration frequency tests
l Data reduction parameters for the calibration math model and related checks.
Calibration can be defined using automatic dilution or pre-diluted calibrators.

NOTE: A calibration will become an alternate lot if any of the material lots (other than the
calibrator) used to generate the active calibration are no longer on-board the system. When a calibration
changes from active to alternate, the calibration status changes from validated to unvalidated.

Accessing the Calibration Definition screen

To access the Calibration Definition screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. Select Calibration in the Test Definition navigational tree.
4. Click the General, Frequency and DR Parameters tabs to access the respective calibration fields.
5. <Optional> Perform edits in the calibration fields.

6. Select the Save icon in the toolbar to save your changes.

7. Select the Previous Screen icon in the toolbar to return to the Test List.

1A type of sample with an assigned value used to calibrate a test.

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Accessing the Automatic Dilution screen

To access the Automatic Dilution screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigation tree, expand Calibration and select Automatic Dilution.
4. <Optional> Perform edits in the General, Calibrator and Diluent tabs.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

Accessing the Pre-diluted Calibrators screen

To access the Pre-diluted Calibrators screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigation tree, expand Calibration and select Pre-diluted calibrators.
4. <Optional> Edit the calibration points.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

See Pre-diluted Calibrators Screen.

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Calibration Definition Screen

Enable calibration
Option to activate calibration parameters for editing.

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General tab
General

N umber of R eplicates
Number of repeat measurements to perform on each dilution.
l Minimum: 1
l Maximum: 6
l Default: 3

C alibration U nit
Select the unit from the drop down list. Only a primary calibration unit may be selected. A primary
calibration unit is a calibrated unit that does not employ a conversion factor.

C alibration Mode
You can enable Automatic dilutions process or Prediluted calibrators. These are not selectable if import
calibration is enabled.
When the Prediluted calibrators option is enabled, the following columns in the Prediluted Calibrators table
become user-definable:
l Calibrator Material – A type of sample with an assigned value used to calibrate a test.
l Target Value – The value that has been defined for the calibrator by its manufacturer. It represents
the expected value at 100% dilution. If a calibrator material has not been selected or the assigned
value defined, the Target Value column displays 0.00 for each concentration. The target value is
automatically updated after the missing information is entered and saved.
l Min. Replic. – The minimum number of valid replicates per calibration point to validate a calibration
result.
l %CV Max – Maximum %CV for each calibrator concentration that is allowed. If the %CV is greater
than the maximum specified here, that calibration point fails.

Enable Import Calibration

Option to import calibration data from another test to calculate calibrated results. If Imported type field is set
to Results Data, the Imported unit field will match the calibration unit from the imported test.
If Imported type is set to Raw Data, the Imported unit field is blank.
Calibration data reduction fields from the imported test are automatically copied into the calibration data
reduction fields of the test that is importing the calibration.
If a test uses an imported calibration, the validated imported calibration must use the same validated
calibration as the master test. If it does not, the calibrated results of the test using the imported calibration are
flagged. If the master calibration is not validated or no longer exists, calibration results of the test using the
imported calibration are flagged.

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A llow define parallelism / clean & rinse

Option to force an additional clean and rinse cycle before aspiration begins on parallelism jobs.

Imported Test
From this list, select a test from which to import calibration data.

Imported Type
Select one of the following:
l Raw Data – Data as it is acquired from the analyzer.
l Results Data – Values such as the slope, intercept and r2 values calculated for the calibration that is
being imported. When you import results data, the calibration is automatically validated. However, if
you import an unvalidated master calibration, the calibration in the importing test is unvalidated.
Selecting this option enables the Correction Factor field.

C orrection Factor
Multiplier applied to an imported calibration when the Enable Import Calibration option is enabled and the
Imported Type is set to Results Data. This option is only available for copied (open) tests.
This field is disabled for IL tests.

Imported U nit
This displays the calibration unit to import from the calibration.

NOTE:

l If a test imports the raw calibration data from another test, you can configure the delay time for the
importing test.
l The intermediate and start reagents of a test that imports the raw calibration data from another test
must be the same as the intermediate and start reagents of the test that is imported.
l When you import calibration results data into a test, the results correlation setup (including the
measured result unit and result unit ranges) of the test are overwritten by the imported data.

Import Validation Status

Option to import the calibration from a master test. When the calibration to import is validated, the imported
calibration is automatically validated.

Test Feasibility

Test not feasible when no validated calibration

Option to make a test not feasible when there is no validated calibration for that test and the on-board lot of
reagent it uses. This condition is reflected in the Test Feasibility screen and applies to patient tests and
associated QC tests.

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NOTE: When creating an open test that uses a calibration that is imported from another test, the
calibration for the imported test must be performed after the new test definition has been created in order to
obtain calibrated results. The same applies if an existing open test definition is modified to use an imported
calibration.

Calibration Execution

Force mode with reduced clean

Option to force a selected test to calibrate without running any other jobs. When this option is selected, the
only operation you can perform is to calibrate the selected test.
This option decreases calibration time for assays that require extra rinsing between dispensing reagents.
When a calibration test has the this option enabled and the dilution process is configured to run in batch
mode, the calibration must be programmed in the Calibration Details screen on a calibrator placed in a
diluent rack. Extra rinsing is not required because multiple reagents are not dispensed.
This feature is locked for all IL tests.

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Frequency Tab

Use this screen to define the calibration frequency.

Enable Frequency
Option to define the frequency parameters and to display a warning when calibration is due.

Frequency
Option (in number of tests or hours or days) between calibrations.

NOTE: Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration
points, and NPP points are excluded.

Enable W arning Threshold

Option to configure a warning to issue when calibration is due.
Warning Threshold
Establishes the time to notify you that a calibration is due. If the frequency is set to tests, the warning
threshold must be in terms of tests. Likewise, if the frequency is set to hours, the warning threshold must be
in terms of hours. If the frequency is in terms of days, select the warning threshold in terms of hours or days.

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DR Parameters Tab

Enable Extrapolation
Option to specify to what extent extrapolation of the calibration curve is allowed. The result unit for these
limits is the same as that specified for the calibration unit on the General tab. Calibration results outside
these limits fail, but the measured result is reported. (The error codes are 5508 for Out of calibration range
high, and 5509 for Out of calibration range low.)

NOTE: The out of calibration range high and low checks are done before the result is multiplied by
the pre-dilution factor.

Enable range for secondary algorithm

Check to set a range for the secondary algorithm so that, if the secondary algorithm is used, a result value
that falls below the minimum limit allowed or exceeds the maximum limit allowed fails.

Enable %C V C heck
If this field is enabled, the %CV between the replicates for each dilution point is calculated. If the %CV of
the replicates exceeds the corresponding value shown in the %CV Max. column in the Calibration Points
table for any dilution point, the calibration curve is flagged and fails. This check can only be enabled if the
number of replicates is two or more. (See Pre-diluted Calibrators for a screen shot displaying the Calibration
Point table.)

Enable Outlier R emoval

If checked and there are at least three good replicate results for a concentration, the replicate with the value
furthest from the mean is discarded. After the outlier is removed, the mean of the replicates is recalculated.

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Enable 0% D ilution Target Value

Check to override the automatic target value concentration for a 0% calibration dilution with a manually
entered non-zero value, provided the new value is less than the target value of the next dilution. This ensures
calibrations with transformations for which zero is illegal produce failed results for the 0% dilution. The
ability to configure this value on a test-by-test basis preserves the true zero value for those tests for which
there is no transformation conflict, such as D-Dimer HS.

Measured R esult on X A xis

If checked, calibration measured results are plotted on the X axis.

Enable Math Model Low

Some factor tests require multiple math models applied to different areas of the calibration curve to obtain the
best fit. If checked, you can define an additional math model in the Math Model Low tab.

NOTE: If both math model high and math model low are used, the first math model must include the
highest concentration but not the lowest; the second math model must include the lowest concentration but
not the highest.

Math Model tab (or Math Model High)

Math Model
Select a linear curve fit, spline curve fit, or Polynomial order 2 through Polynomial order 6 for
the math model. This field is locked for IL tests.

NOTE: If both math model high and math model low are used, the first math model
must include the highest concentration but not the lowest; the second math model must
include the lowest concentration but not the highest.

Spline
Enables a Monotonic check to ensure within a given range of values there is only one result
possible. Spline curves that move both up and down, and hence could have more than one
calibrated result for a single measured value, are failed.

Linear R egression
Enables the lower part of the screen to allow selection of Enable slope check and Enable Y-
intercept check.
l Enable Slope Check – Verifies the slope of the calibration curve is within the specified
tolerance of the expected slope.
o Expected Slope – Target slope value for the test. The default is 1.000.
o Tolerance – Acceptable deviation around the expected slope in percent. The
default is 10.

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o Range – Acceptable range for slope automatically calculated from the expected
slope and tolerance values.
l Enable Y-intercept Check – Verifies that the y-intercept of the calibration curve is
within the expected tolerance.
o Expected Y-Intercept – Target y-intercept value for the test. The default is
0.000.
o Tolerance – Acceptable deviation around the expected y-intercept in percent.
The default is 10.
o Range – Acceptable range for y-intercept automatically calculated from the
Expected Y-Intercept and Tolerance values.

Polynomial Order 2-6

These math models are available to improve curve fit. If a polynomial fit is selected, you can
enable the Monotonic check to ensure within a given range of values there is only one result
possible. Curves that move both up and down, and hence could have more than one calibrated
result for a single measured value, are failed.

Transformations
Read-only fields for IL locked tests that display the mathematical transformations applied to
the measured results and the calibration dilution target values, to aid in making the calibration
curve more linear. For user-defined tests, transformations can be enabled for any of the math
models. See User-Defined Tests disclaimer.

X-A xis transformation

Converts the X data into a value that produces a linear curve fit. The available transformations
are:

l No transformation l 10x
l x2 l 1/x
l x1/2 l x =x/x(0)
l Log10(x) l x2.5
l Log10(Log10(x)) l 1/x1/2
l Ln(x) l (Ln(x))2
l ex

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Y-A xis transformation

Converts the Y data in order to obtain a linear curve fit. The available transformations are:

l No transformation l 10y
l y2 l 1/y
l y1/2 l y = y/y(0)
l Log10(y) l y2.5
l Log10(Log10(y)) l (Ln(y))2
l Ln(y) l 1/y1/2
l ey

Enable Trend Check

Verifies that all of the measured results generated for the calibration curve follow a trend in
measured result signal. This means that all data points increase in value as the concentrations
decrease, or all data points decrease in value as the concentrations increase. (Calibration curves
with data that do not follow a trend are failed.) See Data Flags, CA 5566.

Enable Monotonic Check

Checks each segment (interval) of the curve (a segment is between two calibration points) to
ensure there are no local maxima or minima within that segment. Curves that move up and
down within calibration points are failed. See Data Flags, CA 5567. This check is disabled for
the linear regression math model.

Enable R2 Check
Verifies that the coefficient of determination (R2 ) is greater than or equal to the specified
value. The minimum R2 is the minimum acceptable value for R2 . The default is 0.985.

NOTE: - The R2 value is calculated using precise values. However, when displayed
they are rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-
screen as within the defined range limit. Such values are flagged to indicate that they are out
of the range.

First Concentration
Defines the first point to use for this calibration segment.

Last Concentration
Defines the last point to use for this calibration segment.

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Enable Reverse Slope Check

Option to perform a reverse slope check when the Math Model High selected is Polynomial
order 2-6. This option generates an error when all of the following conditions are met:
l The measured values are decreasing for lower concentrations; and
l The measured value is higher or lower than the measured mean for highest calibration
concentration; and
l The corresponding target value is lower than the target value for the highest
concentration.
The following curve shows the failed results.

Math Model Low Tab

Some factor tests require the use of two different math models at different calibration dilutions
to provide the best fit in the specific dilution ranges. Two curve segments, high and low, are
used, with each segment having a different math model. The setup of the low math model is
identical to that described for the high math model, with the exception that a cutoff point can
be defined.

Cut-off
Defines which calibration segment to use for calculating calibrated results from measured
results.

Value
Measured results that are less than the specified value are converted to calibrated results using
the high math model segment. Measured results greater than the specified value are converted
to calibrated results using the low math model segment.

B y concentration
Measured results less than the value corresponding to the selected calibration dilution are
converted to calibrated results using the high math model segment. Measured results greater
than the value corresponding to the selected calibration dilution are converted to calibrated
results using the low math model segment.

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The curve is displayed in the Calibration Status List screen. See Reviewing and Validating
Calibration Test Results.

Automatic Dilution Screen

Use the Automatic Dilution screen to obtain the calibration points from one calibrator material.

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General Tab
Dilution Points

D efine Points by % D ilution

If selected, for each dilution point the concentration field is enabled for editing and defines a calibration
point. The calibration point target value field is disabled for editing and is calculated from the calibrator
assigned value and the corresponding calibration dilution concentration.

D efine Points by Target C oncentration

For user-defined tests, if selected, for each dilution point the calibration point target value field is enabled for
editing and defines a calibration point. The calibration dilution concentration field is disabled for editing and
is calculated from the calibrator assigned value and the corresponding calibration point target value. The
resulting calibration curves have concentration points (X-axis) that are always the same regardless of the
calibrator lot. Define points by target concentration can only be used if sample pre-dilution is enabled for the
test. If sample predilution is not enabled and the target value entered is greater than the calibrator target
value, the screen displays blank volumes. If you save, an inconsistency message is displayed: Calibration:
Dilution point definition mode by target is only available with Sample Pre-dilution enabled. See User-
Defined Tests disclaimer.
The Define points by target concentration option is used when the calibration is based on the assigned
value, which may change from lot to lot. (Refer to the calibrator insert sheet. )
Example
If you use this option to calibrate a factor test with a calibrator having a value of 80% activity, the dilutions
are adjusted so that the 100%, 50%, 20%, 10% and 5% target concentrations are maintained. This could also
work for an insert sheet value of 120% activity where the calibrator dilutions would be adjusted so that the
100%, 50%, 20%, 10% and 5% activities are maintained. In this instance, no matter what the calibrator
assignment value is, the calibration target values for the particular test would always be 100%, 50%, 20%,
10% and 5% activities.

C alibrator Target Value a n d U n it

Calibrator assigned value for the active lot of the calibrator. The calibration unit is the unit used when
defining the assigned value.

Dilution Process

D irect
Calibrator level is prepared directly from the calibrator vial instead of from the previous serial dilution,
reducing the number of material transfer steps and minimizing unwanted dilution.

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Serial
With serial dilution, neat calibrator1 is first transferred to an aliquot cuvette before being transferred to the
reaction cuvette. Each successive dilution is prepared from the dilution preceding it.
The transfer of calibrator to cuvette during calibration introduces a slight dilution of the calibrator, which is
intrinsic to any syringe-driven fluidic system. This dilution is the reason for a slight discrepancy in measured
results between the calibrator run as part of the calibration cycle and the same calibrator run as a sample.

1Undiluted calibration plasma (100% strength).

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Single D ilution
If you select Single dilution, the dilution sequence (calibration plus sample pre-dilution) for a particular
calibrator level is prepared and sent to a reaction cuvette before preparing the next dilution level.

NOTE:

l All replicates of a particular dilution are processed in the same cuvette strip.
l Preparation of the next dilution does not begin until all the dilution steps of the previous dilution are
complete.

B atch
If you select Batch, all dilutions (calibration plus sample predilution) for all dilution levels are prepared
before the reaction processing starts. Replicates of different dilutions can be mixed in a cuvette strip.

Calibration Definition Table

Calibration Points Definition

For each dilution point the following fields are defined:

C oncentration
To enter a concentration:
1. Double-click the first cell in the column.
2. Enter the concentration in terms of percent (i.e., enter 100 for 100%).
The system accepts concentrations up to 200%.

NOTE: For concentrations greater than 100%, sample pre-dilution must be enabled and defined.

Because the system automatically calculates the volumes required to make the calibration dilutions, you must
enter concentrations in the order highest to lowest. At least three (3) concentrations are required in order to
perform a calibration and up to eight (8) concentrations are allowed.

Target Value
After you select the calibrator material and define the assigned value, each concentration target value is
automatically calculated. If a calibrator material has not been selected or the assigned value defined, the

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Target Value column displays 0.00 for each concentration.

The target value is automatically updated after the missing information is entered and saved.

NOTE: The following volumes are not computed until you define the Test Definition Load Cycle,
and, if using concentrations greater than 100%, until Sample Predilution has been enabled and defined.

Min. R eplicates
The minimum number of valid replicates per calibration point to validate a calibration result.

% C V Max.
Maximum %CV for each calibrator concentration that is allowed. If the %CV is greater than the maximum
specified here, that calibration point fails.

% Max. mean an d % Min. mean

The mean check within a dilution verifies that the measured mean is inside a tolerance range compared with
the 100% dilution.
The tolerance range for a concentration using the 100% concentration measured mean is calculated as
follows:

Min = (mean100 * (<Minimum mean value %>/100.0))

Max = (mean100 * (<Maximum mean value %>/100.0))

The concentration is flagged when the concentration measured mean is outside tolerance range.
This check is not available for 100% and 0% dilutions.
If the check fails and the autovalidation is configured with DR warnings on measured results, the
autovalidation fails.

C alibrator Volume
Read-only display of the total amount of calibrator, in μL, that is required to prepare the dilution.

NOTE: All replicates (max of 6) of every dilution (max of 8) that are run for calibration of a test
must use calibrator from the same bottle placed on-board. (6 replicates X 8 dilutions = 48 tests.) Factor tests
require more calibrator than is available in a 1 mL bottle. You must pool 2 bottles and place it on-board
before starting the calibration tests.

Mixture Volume
Read-only display of the total amount of the previous concentration, in μL, that is required to prepare the
dilution.

D iluent Volume
Read-only display of the total amount of diluent, in μL, that is required to prepare the dilution.

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Calibration Data Point Checks

Select the View icon to display the DR Checks Configuration window for the concentration having
focus.

Use this window to apply some, all, or none of the data checks to specific concentrations. To select a data
check to apply to a specific dilution, the data check must be enabled and defined for the test within the test
setup. DR check is only available for Automatic dilution. It is not available for pre-diluted calibrators.

Enable Mix
Activates the mix parameters for editing.

Mix
Uses the mix volume percentage to calculate the volume of material that is aspirated from the cuvette cell
and re-dispensed into the same cuvette cell to facilitate a mix. The mix volume is calculated as follows:
l Mix Volume = (Total cuvette volume – Cuvette dead volume) * Mix %

N umber of C ycles
Number of mix cycles to be performed.
l Minimum: 1
l Maximum: 3
l Default: 1

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R inse A fter Mix

Amount of time, in seconds, to rinse the probe after a mix has been performed.
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec

Minimum A spiratable Volume

Specifies the minimum volume of calibrator to use when making a dilution. Because the system
automatically performs dilution calculations, it tries to use the smallest possible volume (4µL) when
performing calculations. By entering a value greater than 4µL, the system is forced to use volumes no less
than the entered volume when making dilutions.
l Minimum: 4 μL
l Maximum: 50 μL
l Default: 4 μL

Pre-Dilution volumes
When sample pre-dilution is enabled, the system computes the number of steps needed to generate enough
volume of diluted calibrator for each calibration dilution point. The chart shows the calibration point pre-
dilution sample volume, mixture volume, and diluent volume for the indicated dilution point. See Sample
Pre-dilution.

D ilution Point
To prepare concentrations greater than 100%, the system alters the sample predilution parameters to use a
larger volume of calibrator and a smaller volume of diluent. When entering a concentration greater than
100% in the Calibrator Volumes table, the only volume displayed is the total calibrator volume required to
prepare all replicates.
In the Calibration Definition table, the 150% dilution point is selected and its corresponding altered sample
predilution volumes are displayed in the Predilution volumes area. Note that volumes in cells with a blue
background are delivered directly to the reaction cuvette, or if predilution is enabled for the test, to the
predilution cuvette.

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Calibrator Tab

Volumes
The calibrator liquid volume is the same as the one defined for the sample material in the load cycle.

Material
Name of the material to use as calibrator. The calibration material may be adjusted on copied (open) tests
only. Material must be defined as a Calibrator/NPP type. You can access available materials using the drop
down list.

NOTE: The sum of all volumes cannot exceed 250 μL.

H ead volume
Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This
volume is not delivered to the cuvette.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL

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NOTE: When creating a user-defined test, the head volume for the sample defined in
Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic
Dilution section of the Test Definition. See User-Defined Tests disclaimer.

A irgap
Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination
and ensure accurate volume delivery.
The airgap prevents rinse contamination and ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

Transport airgap
Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.

Before Aspiration Rinse / Clean & Rinse

Enable rinse / clean & rinse before aspiration

Option to enable rinse and clean operations before the probe aspirates sample.

R inse
Select this option to perform rinse cycles.
l Rinse cycles – Configure the number of rinse cycles to perform.
l Time – Configure the number of seconds for each rinse cycle to run.
o Minimum: 1 sec
o Maximum: 5 sec
o Default: 1 sec

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l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the
rinse material up and down inside the probe. Configure the number of times to agitate in the field
provided.

C lean & rinse

Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a user-
defined field when the default for that test has Rinse enabled (sample load cycle only). This option allows
you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform.
l Aspiration cycles – Configure the number of times to run the clean and rinse cycle.
l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents
contaminating the clean material and ensures accurate volume delivery.
l Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle.

NOTE:
o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the
Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To
avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test
Feasibility for proper placement of all reagents.
o The clean total volume must not exceed the maximum probe volume, or 250 µL.
o When using a clean material other than system clean, the clean material must be placed
in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a
sample, the clean material must be placed in a diluent rack in the Sample Area. If it is
enabled for a reagent, you must place the clean material in a diluent rack in the
Reagent Area.

l Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss
during probe movement, and ensures accurate volume delivery. This is not selectable for system clean.
l Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean
total volume cannot exceed the maximum probe volume, or 250 μL.
l Clean volume (all cycles) – Volume of clean material required for the configured number of
aspiration cycles.
l Clean material – Select a system clean material in the drop down list.
l Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to
waste.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.
l Rinse time – Time allocated for the probe rinsing operation.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.

After Dispensation Rinse / Clean & Rinse

The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above.

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Diluent Tab

Volumes

NOTE: The sum of all volumes cannot exceed 250 μL.

Material
Select a sample diluent material in the list. The material must be defined as a Diluent type in the Material
Definition.

H ead volume
The diluent volume aspirated to wet the probe before aspirating the diluent volume required to run the test.
This volume is not delivered to the cuvette.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL

NOTE: When creating a user-defined test, the head volume for the sample defined in
Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic
Dilution section of the Test Definition. See User-Defined Tests disclaimer.

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A irgap
Volume of air to aspirate immediately before aspirating the diluent, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the diluent and head volume. The airgap prevents rinse
contamination and ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

Transport airgap
Volume of air to aspirate after the diluent volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL

H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.

Before Aspiration Rinse / Clean & Rinse

Enable rinse / clean & rinse before aspiration

Option to enable rinse and clean operations before the probe aspirates sample.

R inse
Select this option to perform rinse cycles.
l Rinse cycles – Configure the number of rinse cycles to perform.
l Time – Configure the number of seconds for each rinse cycle to run.
o Minimum: 1 sec
o Maximum: 5 sec
o Default: 1 sec
l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the
rinse material up and down inside the probe. Configure the number of times to agitate in the field
provided.

C lean & rinse

Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a user-
defined field when the default for that test has Rinse enabled (sample load cycle only). This option allows

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you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use.
Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down
inside the probe. Configure the number of times to agitate in the field provided.
l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform.
l Aspiration cycles – Configure the number of times to run the clean and rinse cycle.
l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents
contaminating the clean material and ensures accurate volume delivery.
l Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle.

NOTE:
o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the
Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To
avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test
Feasibility for proper placement of all reagents.
o The clean total volume must not exceed the maximum probe volume, or 250 µL.
o When using a clean material other than system clean, the clean material must be placed
in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a
sample, the clean material must be placed in a diluent rack in the Sample Area. If it is
enabled for a reagent, you must place the clean material in a diluent rack in the
Reagent Area.

l Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss
during probe movement, and ensures accurate volume delivery. This is not selectable for system clean.
l Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean
total volume cannot exceed the maximum probe volume, or 250 μL.
l Clean volume (all cycles) – Volume of clean material required for the configured number of
aspiration cycles.
l Clean material – Select a system clean material in the drop down list.
l Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to
waste.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.
l Rinse time – Time allocated for the probe rinsing operation.
o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by
moving the rinse material up and down inside the probe. Configure the number of times to
agitate in the field provided.

1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

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After Dispensation Rinse / Clean & Rinse

The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above.

Pre-diluted Calibrators Screen

If the calibration mode is set to Prediluted calibrators, you can use the Pre-diluted Calibrators screen to set
up the list of calibrators to define the pre-diluted calibration points. See Accessing the Pre-diluted Calibrators
screen.

Column Headings
C alibrator Material
For each dilution point, click the Calibrator Material table cell, then select the calibrator material from a
drop down list.

NOTE:

l Calibrators must be previously defined in the Material List before you can select them from the
Calibrator Material drop down list.
l Each pre-diluted calibrator material can only be selected once in the same list of pre-diluted
calibrators.
l All pre-diluted calibrators must have the same lot management configuration as defined in lot
management and alternate lot in material definitions.

Target Value
The target value is the known concentration of the calibrator.
The advantage of entering target values instead of dilution percentages is that calibration dilutions have the
same value regardless of the assigned value of the calibrator.

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Min. R eplicates
The minimum number of valid replicates per calibration point required to produce a valid calibration.
Minimum = 1. Maximum = 6.

%C V Max
The maximum %CV for each calibration dilution that is allowed. If the %CV is greater than this value, that
calibration point fails.
Min. Replicates and % CV Max. are calculated by the instrument, and the fields are automatically
populated after you select the calibrator material. If Enable %CV check is enabled on the Calibration – DR
Parameters tab, both of these settings are user-definable.

See Also
l Calibration Details
l Calibration Status List
l Performing a Calibration
l General Information
l Global Definitions Setup
l Analytical Cycle Definition
l Data Reduction Parameters
l Result Unit Definition
l Parallelism
l Normal Pool Plasma
l Rerun Rules

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Configuring Factor Parallelism

This topic describes how to set up parallelism testing on the Parallelism screens.

Overview
Factor parallelism increases the quality of test results and identifies causes of interference that may affect
those results.
Regulatory bodies recommend a minimum of 2-3 different dilutions of plasma for factor tests. A reportable
dilution should fall within the working range of the test. Ideally, dilutions of test plasma should be the same
as those of the calibrator1. The test results of the various plasma dilutions should parallel the calibration
curve.
The criteria to define ”parallelism” are based on statistical or mathematical analysis that might employ, for
example, a comparison of the slopes of the curve obtained with the test plasma dilutions versus the slope of
the calibration curve, a check of the r2 of the parallelism curve or a check of the variance between the
recalculated results of the first sample dilution (100%) and the subsequent dilutions.
The ACL TOP instrument offers a wide range of mathematical data-checks which, if enabled by the operator,
allow the determination of parallelism. The system also displays default-criteria for each data-check that can
be customized. Since there are no official guidelines that establish these criteria, they can be defined
according to the discretion and needs of the individual laboratory.
As mentioned above, the factor parallelism feature allows the detection of interference to the test. In
particular, the presence of heparin, lupus anticoagulants or specific factor inhibitors may affect the results of
the single factor tests; therefore, performing the testing with different dilutions of the test plasma may assist
in a diagnosis.
Lupus anticoagulants may prolong APTT and PT clotting times, depending on the sensitivity of the reagent
used. In these cases, plasma test dilutions could have the effect of increasing the calculated % activity of the
increasingly diluted replicates.
Unfractionated heparin usually prolongs the APTT clotting times. Therefore, when testing a single
heparinized sample for factor activity in the standard test, the presence of heparin may interfere and cause
falsely low factor activity. When tested in the parallelism mode, the multiple sample dilutions can serve to
dilute the heparin effect with each increasing dilution, and as a consequence result in higher % factor
activities with subsequent dilution.
Factor inhibitors, on the other hand, may or may not be detected with the parallelism function.
The ACL TOP instrument provides a unique competitive advantage for testing of factors. Although most of
the major competitors offer the ability to test multiple factor dilutions, only the ACL TOP instrument
provides a sophisticated and comprehensive array of options to automatically assess the results.

1A type of sample with an assigned value used to calibrate a test.

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Factor Parallelism Testing Options

For each factor test the ACL TOP instrument provides two testing modes:
l Standard Factor (single dilution) – The sample is measured at a pre-defined dilution ratio. Results are
provided in seconds and % activity.
l Factor Parallelism (up to four dilutions) – The sample is measured at different dilution levels
(typically three, up to four).
The system can also detect whether the sample dilutions curve is parallel to the calibration curve. Non-
parallelism can indicate interference in the patient sample, possibly due to heparin, lupus anticoagulants or
factor inhibitors.

Testing Options
The following sections and examples describe the factor parallelism testing options available on the ACL
TOP instrument:
l Factor Parallelism Reporting Units
l Factor Parallelism Criteria
l IL Tests Default Criteria
l Definition and Use of Factor Parallelism
l Examples of Factor Parallelism Results

Factor Parallelism Reporting Units

When defining a factor parallelism test, you may select up to four units to display on the screen and include
in the results printout.
The following test definition screen shows where the selection of the units is made (drop-down options from
unit 1 to 4):

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All selected units are always displayed in the parallelism result details screen.
The following parallelism units are available for selection:

Mean of 100%
The system calculates the % activity of the 100% dilution. If more than one replicate is defined (up to three),
the mean is provided.
While all the available units are specifically intended to aid in the determination of the parallelism, this
particular unit provides information only about the 100% dilution.

Mean of Corrected Results (CR)

The system calculates the % activity of each sample plasma dilution (excluding the 100% dilution) and
corrects each corresponding % activity result to compensate for the dilution factor (Corrected Results). It then
calculates the mean of these corrected results.
Example

Dilution (%) % Activity CR %

100 96 96

50 47 94

25 23 92

The Mean of Corrected Results (CR) in this example is 93% (mean of 94% and 92%).

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%CV of Corrected Results (CR)

The system calculates the % activity of each sample plasma dilution (excluding the 100% dilution) and
corrects each corresponding % activity result to compensate for the dilution factor (Corrected Results). It then
calculates the %CV of these CR results.
Example

Dilution (%) % Activity CR %

100 96 96

50 47 94

25 23 92

The %CV of Corrected Results (CR) in this example is 1.5% (CV % of 94% and 92%).

Mean of Corrected Results (CR) 100%

This is the same as the Mean of Corrected Results but this calculation includes the 100% dilution result in
the mean calculation.
Example

Dilution (%) % Activity CR %

100 96 96

50 47 94

25 23 92

The Mean of Corrected Results (CR) 100% in this example is 94% (mean of 96%, 94% and 92%).

%CV of Corrected Results (CR) 100%

This is the same as % CV of Corrected Results but this calculation includes the 100% dilution in the CV
calculation.
Example

Dilution (%) % Activity CR %

100 96 96

50 47 94

25 23 92

The %CV of Corrected Results (CR) 100% in this example is 2.1% (CV % of 96%, 94% and 92%).

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Slope
The system computes the slope of the sample dilution results which make up the parallelism curve. The slope
is calculated using the math model defined in the parallelism Transformation fields.
Example

NOTE: The following examples are not test-specific and are given for information only.

FVIII Calibration [X = sec; Y = ln(% FVIII)]

Dilution% Target % FVIII ln(% FVIII) sec

130 140.4 4.94 45.3
100 108 4.68 48.1
40 43.2 3.77 57.4
5 5.4 1.69 81.3
1 1.1 0.10 95.4

Slope -10.508
Intercept 97.39
r2 0.998

Parallelism dilutions [X = sec; Y = ln(% Dilution)]

dilution% ln(% FVIII)) sec % CR%

100 4.61 45.8 135.8 135.8
50 3.91 52.8 69.6 139.2
25 3.22 59.2 37.8 151.2

Slope -9.666
Intercept 90.414
r2 0.999

The reported parallelism slope in this example is -9.666.

r2
The system computes the r2 of the parallelism curve. The r2 is calculated using the math model defined in the
parallelism Transformations fields. See example in slope unit: the reported parallelism r2 is 0.999.

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NOTE: - The R2 value is calculated using precise values. However, when displayed they are
rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the
defined range limit. Such values are flagged to indicate that they are out of the range.

y-Intercept
The system computes the y-intercept of the parallelism curve. The y-intercept is calculated using the math
model defined in the parallelism Transformations fields. See example in slope unit: the reported y-intercept in
this example is 90.414.

Factor Parallelism Criteria

The system provides a number of criteria to evaluate the factor parallelism data.
These criteria are enabled and configured in the same screen where the parallelism units are defined. For your
convenience the screen is included again below:

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IL Tests Default Criteria

The following criteria are available:

Slope Check
If this check is enabled, the system compares the slope of the parallelism curve to the slope of the calibration
curve. The acceptable slope range is definable by means of acceptable % deviation around the calibration
slope (tolerance). After the tolerance is defined, the system displays the acceptable range. If the parallelism
slope falls outside the acceptable range, the following flag is generated:

Code Flag Message W/E

5254 RW Slope out of range W

r2 Check
If this check is enabled, the system verifies that the r2 of the parallelism curve is greater than or equal to the
specified value (Min r2 ). If not, the following flag is generated:

Code Flag Message W/E

5255 RW Parallelism r2 out of range W

NOTE: - The R2 value is calculated using precise values. However, when displayed they are
rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the
defined range limit. Such values are flagged to indicate that they are out of the range.

Variance Check
If this check is enabled, the system computes the percent difference between the average corrected result at
each concentration and the average result at 100%. If any of the dilutions have a percent difference that
exceeds the Max. Variance, the following flag is generated:

Code Flag Message W/E

5253 RW Max. variance of parallelism dilution out of range W

%CV of Corrected Result (CR)

If this check is enabled, the system calculates the %CV of the corrected primary results excluding the 100%
dilution, and compares it against the maximum %CV defined (Max %CV). If the maximum %CV is
exceeded, the following flag is generated:

Code Flag Message W/E

5259 RW %CV of the CR is greater than the maximum %CV allowed W

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%CV of Corrected Result (CR) and 100%

If this check is enabled, the system calculates the %CV of the corrected primary results, including the 100%
dilution, and compares it against the maximum %CV defined (“Max %CV”). If the maximum %CV is
exceeded, the following flag is generated:

Code Flag Message W/E

5260 RW %CV of the CR and the 100% dilution is greater than the maximum %CV W
allowed.

Determining Factor Activity Using Factor Parallelism (multiple sample

dilutions)
Factor parallelism is configured in the Parallelism screen.

Number of dilutions
For user-defined tests, up to four dilutions can be defined, with the 100% dilution point being mandatory. IL
tests that use factor parallelism have three dilutions defined. See User-Defined Tests disclaimer.

Primary U nit
The primary unit is the calibrations unit used to display the parallelism results. Default options for IL locked
tests are % and U/mL.
Units from 1 to 4 are user selectable for results display and printing. See: Factor Parallelism Reporting Units,
above.

U nit 1
Select Mean of 100%. This provides the average % activity obtained at the different dilution levels (usually
three dilutions are selected).

U nit 2
Mean Corrected Results 100%.

U nit 3
%CV of Corrected Results 100%.

U nit 4
Can be left blank.

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Selecting the Criteria

Enable the Variance check option to flag those results with significant discrepancies among different sample
dilutions. The sample should undergo further analysis before factor activity results are reported. In addition to
variance check, other parallelism criteria may be enabled.
The following checks can be enabled:

Slope Check
This check is used to establish a proper tolerance value between the slope of the parallelism curve compared
to the slope of the calibration curve. Measurement of some known samples (with and without factor
inhibitor) starting with a tolerance value of 15% can help define the desired tolerance to discriminate
between normal samples and abnormal samples. Observe the flagging and eventually modify this threshold as
needed (sample results re-calculation can be used to test the effect of the changes without having to re-run
the samples).

r2 Check
This is the same as for the check above; start testing with a min r2 value of 0.980.

NOTE: - The R2 value is calculated using precise values. However, when displayed they are
rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the
defined range limit. Such values are flagged to indicate that they are out of the range.

Variance Check
This is the same as for the check above; start testing with a max variance value of 20%.

%CV of CR
This is the same as for the check above; start testing with a max %CV value of 15%.

%CV of CR and 100%

This criterion is very similar to the %CV of CR; if it is used in the definition of the max CV%, consider that
the inclusion of the 100% usually leads to lower CV%.

Reporting Factor Activity Results

If an inhibitory pattern is not found, then report the first dilution whose uncorrected % activity result falls
within the linearity of the test.
If an inhibitory pattern is determined to be present, more dilutions may be required to determine accurate
factor level.

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Examples of Factor Parallelism results

Normal Sample

Sample with inhibitors

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NOTE:

l The College of American Pathologists (CAP) guidelines require at least 2 dilutions be tested before a
factor test is reported. This requirement was instituted as a tool for identification of inhibitors and/or
activators. In conjunction with these guidelines, IL suggests making three (3) dilutions per sample to
be tested for factors. The dilutions should be chosen according to an individual facility's protocol.
Additional dilutions are not made to guarantee precision of recovery
l After the dilutions are tested, the results should be reviewed. Two consecutive values with laboratory-
defined maximum variance (for example, less than or equal to ± 20%) indicate acceptable results. Be
certain to use only values within the calibrated range for this assessment. Average the two (2)
acceptable results and report.

Example Calibration Plasma Test Factor VIII 100%

Laboratory Maximum Variance ± 20%
Dilutions: 1:10 1:20 1:40
Values: 98% 92% 106%

The 98% and 92% pair meets the criteria for within the calibrated
range and within ± 20% of each other.

The 92% and 106% pair does not meet the criteria. Report 95%, the
average of 98% and 92%.

See Also
l Parallelism

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Parallelism Setup

Overview
Use the Parallelism Definition screen to:
l Enable or disable parallelism for the current test.
l Configure the analytical cycle and data reduction parameters used when performing factor parallelism
studies.
You cannot enable parallelism if any of the following conditions apply:
l The test is a paired test.
l The test is a shadow test.
l Calibration is not enabled.

Viewing and Editing the Parallelism Definition Screen

To open and edit the Parallelism Definition screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition screen, select Parallelism in the navigational tree.
4. <Optional> Edit the parallelism fields on the Analytical Cycle and Data Reduction tabs.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List..

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Parallelism Definition Screen

Enable parallelism
Option to run parallelism tests. Enables the fields on the Parallelism screen.

Parallelism LIS number

Unique parallelism mode test ID number for the Laboratory Information System (LIS).

Test code
Unique parallelism test identifier appended by the character defined in the Parallelism mode extension option
in Global Definitions.

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Analytical Cycle tab

Number of Replicates
Number of repeat measurements to perform on a parallelism dilution.
l Minimum: 1
l Maximum: 3
l Default: 1

Diluent Material
Diluent material name extracted from the Calibration Definition – Diluent tab. Read-only for IL locked tests.

Dilution Process
Dilution process used for this test. It is read-only for IL locked tests.

D irect
Option to make all parallelism dilutions directly from the sample cup.

Serial
Option to transfer the sample to an aliquot cuvette before transferring it to the reaction cuvette. Successive
dilutions are made from the previous dilution mixture.

Single dilution
Option to prepare the dilution sequence (parallelism plus sample pre-dilution) for a particular parallelism
level and transfer it to a reaction cuvette before starting the preparation of the next dilution level.

NOTE:

l All replicates of a particular dilution are processed in the same cuvette strip.
l Preparation of the next dilution does not begin until all dilution steps of the previous dilution are
complete.

B atch
Option to prepare all dilutions (parallelism plus sample pre-dilution) for all dilution levels before the reaction
processing starts. Replicates of different dilutions may be mixed in a cuvette strip.

Dilutions Table
This table lists the dilutions. For user-defined tests, up to four dilutions can be defined, with the 100%
dilution point being mandatory. IL Tests that use factor parallelism have three dilutions defined. See User-
Defined Tests disclaimer.

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Data Reduction Tab

Parallelism Point Units

Primary U nit
Calibrated unit used to display parallelism results. You can select any defined calibration unit. Options for IL
locked tests are % and U/mL. If the unit is changed from the default value, parallelism results must be
recalculated to update the patient information with the new unit and its respective values. The parallelism
graph is still displayed using the unit defined for the calibration.

NOTE:

l You must have a validated calibration for the test before running the parallelism test.
l Statistical results based on the corrected results (mean CR, %CV of CR, etc.) displayed in both the
Parallelism Detail screen and the Sample List screen are in terms of the primary calibrated unit.

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Units
Select up to four result units for parallelism from the following list for results display and printing:
l Mean of 100%
l Mean CR
l Mean CR 100%
l Slope
l r2
l y-intercept
l %CV of CR
l %CV of CR 100%.
See Determining Factor Activity for an example of configuring this setting.

Enable Slope Check

Option to generate an error message when the slope of the parallelism curve falls outside the expected range.
See Determining Factor Activity for an example of configuring this setting.

Target Slope
Read-only value of the slope of the validated calibration curve calculated using linear regression and the
parallelism transformations.

Tolerance
Acceptable deviation from the target slope in percent.
l Minimum: 0
l Maximum: 100
l Default: 10

R ange
Acceptable range for the slope, calculated automatically from the target slope and tolerance values.

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Transformations
Read-only values for IL locked tests. They display the transformations, if any, that are used for the current
test. For user-defined tests, transformations can be enabled for any of the math models. See User-Defined
Tests disclaimer.

X A xis Transformation
Selections are:

l No transformation l Log10(Log10(X))
l 1/X l 10X
l X2 l eX
l X1/2 l X=X/X(0)
l 1/X1/2 l X2.5
l In(X) l (1n(x))2
l Log10(X)

Y A xis Transformation
Selections are:

l No transformation l Log10(Log10(Y))
l 1/Y l 10Y
l Y2 l eY
l Y1/2 l Y=Y/Y(0)
l 1/Y1/2 l Y2.5
l In(Y) l (1n(Y))2
l Log10(Y)

NOTE: For user-defined tests:

l If parallelism is defined after a calibration for that test has been validated, the calibration must be
recalculated to apply the correct parallelism transformation to the calibration to use in the parallelism
display. See Review and Validation for information on recalculation.
l If parallelism transformations are modified after parallelism results are obtained, both the calibration
and parallelism sample for that test must be recalculated to update the parallelism display.
l Failure to perform either of the above actions triggers a results warning 5568: Calibration and
parallelism transformations do not match.
l A user with the appropriate security level can create a new test or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to the user
alone.

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Enable r2 Check
Option to system-verify whether the coefficient of determination (r2 ) is greater than or equal to the specified
value. If not, an error is generated. See Determining Factor Activity for an example of configuring this
setting.

NOTE: - The R2 value is calculated using precise values. However, when displayed they are
rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the
defined range limit. Such values are flagged to indicate that they are out of the range.

Min r 2
Minimum acceptable value for parallelism r2. The default value is 0.980.

Variance Check
When selected, the system calculates the difference between the corrected primary result at 100% and each of
the means of corrected results at the other concentrations, and verifies that the computed % difference of the
concentration is less than the maximum % difference allowed. If the maximum variance is exceeded, an error
is generated. See Determining Factor Activity for an example of configuring this setting.

Max. Variance
This is the maximum acceptable percent difference allowed. The default is 15.

%CV of CR (corrected result)

When selected, the system calculates the %CV of the corrected primary results (excluding the 100% and 0%
dilutions) and compares it against the maximum %CV allowed. If the maximum %CV is exceeded, an error is
generated. See Determining Factor Activity for an example of configuring this setting.

Max. %C V
Maximum acceptable %CV allowed. The default is 15.

%CV of CR (corrected result) and 100%

When selected, the system calculates the %CV of the corrected primary results (excluding 0% dilutions) and
compares it against the maximum %CV allowed. If the maximum %CV is exceeded, an error is generated. See
Determining Factor Activity for an example of configuring this setting.

Max. %C V
Maximum acceptable %CV allowed. The default is 15.

See Also
l Configuring Factor Parallelism
l General Information
l Analytical Cycle Definition

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l Data Reduction Parameters

l Result Unit Definition
l Calibration
l Normal Pool Plasma
l Rerun Rules

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Normal Pool Plasma Setup Chapter 4 – Setup

Normal Pool Plasma Setup

The NPP1 test definition screen allows you to define the NPP mode, material and frequency for a test.

Viewing and Editing the Normal Pool Plasma screen

To view and edit the Normal Pool Plasma screen:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigation tree, select Normal Pool Plasma.
4. <Optional> Edit the fields on the NPP General and Frequency tabs.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

NOTE: Before using a new NPP definition to recalculate patient test results, the calibration must be
recalculated, saved and validated. Perform the following steps in sequence:
1. Change the NPP definition as desired and save the changes.
2. Select the desired calibration, recalculate, save the changes and validate. See Calibration Details.
3. Recalculate the patient results. See Recalculating Test Results.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Test Definition – Normal Pool Plasma Screen

Enable NPP
Option to configure the Normal Pool Plasma parameters. Enables the fields on the General and Frequency
tabs.

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General Tab
NPP Mode
Select a mode in the NPP mode drop-down list.

D erived from C alibration

Enables the following options on the Method drop-down list:
l Mean of calibration point replicates – Uses the Mean of a specified calibration point to obtain the
NPP value. Enables the Calibration point list:
o Calibration point – List of calibration standards whose mean is used as the NPP value.
After you select the standard option in this list, the concentration and target value for
the standard displays to the right of the Calibration point list.

l Compute value from calibration curve equation – The NPP value used to calculate results is
computed from the calibration curve at the concentration/activity level you specify. Enables theNPP
value list.
o NPP value – Allows you to input the concentration/activity level used to compute the
NPP value.

Midpoint of N ormal R ange

Uses the midpoint of the normal range defined in result units to obtain the NPP value.

R un as Sample
An NPP material placed on board runs each time an NPP is ordered. Enables the NPP material list.
l NPP material – List of materials to use as NPP. The material must be defined as type Calibrator/NPP.

U ser Input N PP Value

Option to manually enter an NPP value. Enables the NPP field.
l NPP – Allows input of measured result values to use for calculations involving NPP.

Enable Adjust Calibration to NPP

Available for NPP values only when the calibrated result unit is percentage (%). Intended primarily for PT
tests. It can be used only for calibrations that use a linear regression math model. When enabled, the
Calibration Details screen shows the original calibration curve (green) as well as the adjusted calibration
curve (purple).

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NPP Calibration Curve Screen

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Frequency Tab

Enable Frequency
This option must be selected to edit frequency parameters and automatically run NPP calibration or to prompt
when calibration is due. This is only enabled if the NPP mode is Run as Sample.

Frequency
Enter the frequency to prompt for NPP calibration or run NPP calibration in terms of number of tests, hours or
days. Next, select the appropriate interval (tests, hours or days) from the drop down list.

NOTE: Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration
points, and NPP points are excluded.

Enable Warning Threshold

Option to generate a warning when an NPP is due.

W arning Threshold
This establishes when to notify you that an NPP is due. If the frequency is set to Tests, the warning threshold
must also be in terms of Tests. Likewise, if the frequency is set to Hours, the warning threshold must also be
in terms of Hours. If the frequency is in terms of days, select the warning threshold in terms of either hours or
days.

Enable Automatic Execution

Option to automatically execute NPP when the frequency threshold is reached. Automatic execution can be
performed only if all the necessary materials are available on-board with sufficient volumes, adequate
stability, and valid expiration dates.

See Also
l General Information l Calibration
l Analytical Cycle Definition l Parallelism
l Data Reduction Parameters l Rerun Rules
l Result Unit Definition

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Rerun Rules Setup Chapter 4 – Setup

Rerun Rules Setup

Overview
You can configure the ACL TOP instrument to automatically rerun a test based on result range violations or
data reduction conditions. If Rerun is enabled, and a defined test result is obtained, the test runs again on that
sample. You can configure rerun to do the following:
l Run same test.
l Run the same test using an extended acquisition time.
l Run the same test using an alternative pre-dilution on the sample.

NOTE: Parallelism, QC, and calibration cannot trigger a rerun.

Configuring Rerun Rules

To configure the rerun rules:
1. Select Setup > Test List in the menu bar.
2. Double-click a test in the Test List.
3. In the Test Definition navigation tree, select Rerun - Rules.
4. Configure the rerun rules on the Result Ranges and DR Errors tabs.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test List.

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Rerun Rules Screen

This screen contains two tabs – Result Ranges and DR Errors.

Enable Rerun
Option to rerun tests based on the rules configures in the Rerun Rules screen. Activates the rerun parameters
for editing.

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Result Ranges Tab

Result Unit to Test
Select a result unit in the list to configure in the rerun rules.

Table columns

R ule
The available range result rules include:
l Above Normal Range
l Below Normal Range
l Above Therapeutic Range
l Below Therapeutic Range
l Above Linear Range
l Below Linear Range
l Above Test Range
l Below Test Range
l Above Extrapolation Range
l Below Extrapolation Range
l Above Secondary Algorithm Range
l Below Secondary Algorithm Range
l (Range) Above Measured Result Test Range
l (Range) Below Measured Result Test Range.

Same Test / Extended Test / A lternative pre-dilution

To select a rerun rule, select Same Test, Extended Test, or Alternative Pre-Dilution.

NOTE:

l To use a range rule, the test result ranges must have been pre-configured in the Result Unit Definition
screen.
l To use extended test, Extended Test Mode must be enabled and defined in the Analytical Cycle
screen.
l To use alternative pre-dilution, it must be enabled and defined in Alternative Pre-Dilution.
For example:
l If a sample returns a result with an Above Linear Range flag, and the rerun action is set to Alternative
pre-dilution, the sample is diluted according to the alternative pre-dilution setup, and the same test is
repeated.

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l If the sample returns a result with an Above Test Range flag, and the rerun action is set to Extended
Test, that sample reruns using the Extended acquisition time.
l If a sample returns a result with an Above Normal Range flag, and the rerun action is set to Same Test,
the same test is run again.
l If you have enabled Extended Acquisition Time configured in the Alternative Pre-dilution, and
Extended acquisition has been enabled in the Analytical cycle definition for that test, an alternative
pre-dilution rerun occurs using the extended acquisition mode. See Alternative Pre-Dilution.

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DR Errors Tab

Generic failure on measured result

Options to select all the rerun rules in the corresponding column (only one column) for the test selected in
the Test List.

Table columns

R ule
This allows you to select some of the available DR Rules without having to select them all. They include:
l (Data) First point out of range
l (Data) Last point out of range
l (Data) Curve min. and max. not in correct sequence
l (Data) Curve sequence unknown
l (Data) Incorrect number of raw data points
l (Data) Too many invalid raw data points
l (Data) Number of spikes exceeds error limit
l (Data) Insufficient points remaining for calculation
l (Data) Normalized curve delta too high
l (Data) Normalized curve delta too low

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l (Data) Normalized curve delta less than lowest calibrator1 delta

l (Data) Baseline average high
l (Data) Baseline average low
l (Data) Baseline SD exceeds error limit
l (Data) Endpoint average high
l (Data) Endpoint average low
l (Data) Endpoint SD exceeds error limit
l (Coag) First derivative peak not found
l (Coag) First derivative negative check failed
l (Coag) Second derivative peak not found
l (Coag) Too many first derivative peaks
l (Coag) Too many second derivative peaks
l (Coag) First threshold limit not found
l (Coag) Second threshold limit not found
l (Coag) Max (min) time span violation
l (Reaction) Initial slope exceeds error limit
l (Reaction) Linear regression SD exceeds error limit
l (Data) Result exceeds negative value limit
l (Data) Result check failed
l (Data) Calculation error
l (Data) Interference error
l (Prep) Aspiration baseline error
l (Prep) Unexpected LLD error
l %Max difference of replicates exceeded
l (Data) Normalized data contains multiple thresholds

Same Test / Extended Test / A lternative pre-dilution

To create a rerun rule, select Same Test, Extended Test, or Alternative Pre-Dilution run. You must enable
and define extended test mode (Analytical Cycle Definition) and alternative pre-dilution (Alternative Pre-
Dilution) to use those rerun rules.

R erun Priority
If multiple rules are configured with different rerun responses, and multiple rules trigger a test rerun, only one
rerun occurs, according to the following priority:

1A type of sample with an assigned value used to calibrate a test.

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l First priority: Alternative pre-dilution – Rules configured to rerun Alternative pre-dilution tests
override the Extended Test and Same Test reruns.
l Second priority: Extended Test – Rules configured to rerun Extended Tests override Same Test reruns.
l Third priority: Same Test – Rules configured to rerun the Same Test activate only when there are no
rule violations configured for Alternative pre-dilution or Extended Test reruns.

See Also
l General Information
l Analytical Cycle Definition
l Data Reduction Parameters
l Result Unit Definition
l Calibration
l Parallelism
l Normal Pool Plasma

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Consistency Check Chapter 4 – Setup

Consistency Check
All parameter information for the test definition is verified for consistency and relationships between different
areas by means of a consistency check. After the consistency check is performed, the area of the Test
Definition screen located at the bottom of the screen provides information to help identify problems within
the test definition. On the navigational tree inconsistent areas are highlighted in red, starting with the first
inconsistent area, to facilitate correcting the inconsistency. As each area becomes consistent, the next
inconsistent area is highlighted in red.

Performing a Consistency Check

To perform a consistency check:
1. Select Setup > Test List in the menu bar.

2. Place focus1 on a test in the Test List, and select the Apply Checks icon in the toolbar, or
select Actions > Test > Apply Checks in the menu bar.
3. Locate and select the inconsistency in the navigational tree (red text) to open the respective screen.
4. Correct the inconsistent settings.

5. Select the Save icon in the toolbar to save your changes.

Consistency Check Window

Double-click an inconsistency message to open the screen with the inconsistent configuration. The
inconsistent screen is identified in red text in the navigational tree.

See Also
l Test Definition

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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QC List
The read only QC List displays information from the QC Definition for QC materials and test pairings.

Accessing the QC List

To access the QC List:
1. Select Setup > QC List in the menu bar.

2. To filter the QC list, select the down arrow beside the Filter icon in the toolbar, then select
Enabled QC Definitions or Disabled QC Definitions in the submenu.
3. To view or edit a QC setup definition, double-click a test in the list, or place focus on a test code and

select the QC Definition icon in the toolbar.

4. To add a new QC definition, click the Add icon in the toolbar.

5. After creating or editing a definition in the QC Setup Definition screen, do one of the following:

l Select the Save icon in the toolbar to save your changes.

l Select the Restore icon in the toolbar to restore the original configuration.

6. Select the Previous Screen icon in the toolbar to return to the QC List.

QC List Toolbar
The operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Add a new QC definition. Opens the QC Setup Definition screen.

View QC Definition details. Opens the QC Setup Definition screen for the test in focus.

Delete a QC Test. Deletes the selected test from the QC List screen. A test that is referenced
in one or more QC definitions cannot be deleted until these QC definitions are deleted.
Filter. Select Enabled QC Definitions, Disabled QC Definitions, or both from a drop down
list.

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QC List screen

Selection C olumn
Click one or more rows to place check marks in this column, indicating selection of one or more tests.

Test C ode
Unique name of the test that is paired with the QC material in the Material Name column.

Material N ame
Name of the control material, a sample-like material typically having known amounts of analyte, which is
used to detect changes from stable system operation.

U nit
Result unit for the test using the selected QC material.

Target Mean
Expected mean for the test using the selected QC material.

Target SD
Expected standard deviation for the test using the selected QC material.

Test Enabled/D isabled

Indicates whether a test is enabled for use on the instrument.

See Also
l Quality Controls l QC Setup Definition
l QC Overview l QC Test Status List
l QC Profiles List l Reviewing QC Results
l QC Results List

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QC Setup Definition Chapter 4 – Setup

QC Setup Definition

Accessing the QC Setup Definition screen

To access the QC Setup Definition screen:
1. Select Setup > QC List in the menu bar.

2. To filter the QC list, select the down arrow beside the Filter icon in the toolbar, then select
Enabled QC Definitions or Disabled QC Definitions in the submenu.
3. To view or edit a QC setup definition, double-click a test in the list, or place focus on a test code and

select the QC Definition icon in the toolbar.

4. To add a new QC definition, click the Add icon in the toolbar.

5. After creating or editing a definition in the QC Setup Definition screen, do one of the following:

l Select the Save icon in the toolbar to save your changes.

l Select the Restore icon in the toolbar to restore the original configuration.

6. Select the Previous Screen icon in the toolbar to return to the QC List.

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QC Setup Definition screen

Material Name
Drop down list where you select the control material for the QC being defined. Material must be defined as a
QC type. An alternate lot of a material is used for QC studies whose information does not affect the QC
system status and whose results are not able to flag patient samples. After you save the definition, the
material name cannot be changed.

Comments
Read-only field containing user-defined text imported from the Comments field in the Material Definition.

Test Code
In the drop down list, select the test code for which QC is being defined. After you save the definition for
this material, you cannot change the test code. You can select the same test code for a maximum of 20
different quality control materials. Thereafter the test code is no longer available for selection.

Unit
This field is enabled after the test code has been selected. Use the drop down list to select a result unit
defined for that test.
If you define a QC test with a calibrated result unit, the QC test is not feasible if there is no validated
calibration.

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Target (Active Lot)

Mean
Enter the expected mean for the test using the selected QC material.

SD
Enter the expected standard deviation for the test using the selected QC material.

Enable Rules

Option to apply rules to check QC results. Select a rule to apply in the Selection column. The following
Rules are available:
l 1-2S
l 1-2.5S
l 1-3S
l 1-3.5S
l 2-2S
l 2 of 3-2S
l R-4S
l 3-1S
l 4-1S
l 7x
l 7T
l 10x
l % Rule

Patient Flags

QC failed
Option to flag all patient results for this test when QC fails.

QC Expired
Option to flag all patient results for this test when QC becomes overdue.

Test Feasibility

Test not feasible when QC failed.

Option to make a test Not Feasible when the QC status changes from Passed to Failed. If this transition
occurs while the system is busy, active tests complete and the results are flagged. All other tests (pending,
not feasible) are not performed. When QC changes from Failed to Passed, these other tests become Feasible.

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User Defined Deviation Rule

The allowed percent deviation from the mean, which enables compliance with RiLiBÄK standards.

NOTE: When the % Rule is selected in the Enabled Rules table in this screen, the User Defined
Deviation Rule/Allowed Variance field is enabled for editing. When this rule is selected, the Allowed
Variance field must contain a numeric value.

NOTE: - Numeric values are calculated using precise values. However, when displayed, these values
are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen
may appear to be within the defined range limit when it is actually out of range. Such values are flagged to
indicate that they are out of the range.

RiLiBÄK Conformance

Enable R iLiB Ä K root of means square calculation

Option to use RiLiBÄK rules for calculating the root of means square when defining the acceptable percent
variation from the root of means square for a defined interval of points identified in the interval state setting
(for example, a date range or number of points) in the QC Results List filter.

A llowed variance
Defines the value for acceptable percent variation as described in the previous paragraph.

Frequency
In this section, configure the instrument to run QC or to generate a warning message based on the number of
tests, number of hours, absolute time of day and at a reagent vial change. QC is performed automatically
when all of the following conditions are met:
l Automatic execution is enabled.
l The configured thresholds or events are reached.
l The QC is feasible (materials on-board with sufficient volume and not expired).
l You have ordered a specific test related to the QC.
If any of the above conditions are not met, the system generates a warning and sets the QC status to Overdue.

NOTE: When Auto Run is configured in Global Definitions Setup, it only auto-executes a QC job
when By Absolute Time is configured.

B y tests
Option to configure the instrument to: 1) run QC (automatically, if enabled); or 2) generate a warning after
the specified number of tests have been performed (specify the frequency in the Number of tests field.

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l Enable warning threshold – Option to generate a message to run QC when the warning threshold is
reached. Enter the number of hours/tests in the field beside this option.
l Automatic execution – Option to run QC automatically when the threshold number of Tests/Hours is
reached. Automatic execution can be performed only if all the necessary materials are on-board in
sufficient volumes, adequate stability, and valid expiration dates.

NOTE:

l After a QC job has finished running, the frequency timer for Tests/Hours resets to the starting point.
This is true whether the QC job is manually or automatically generated.
l A manually executed QC job that runs at the same time as a frequency-initiated QC job, does not
cause a duplicate QC test to run.
l The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By
Absolute Time.
l The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By
Absolute Time.
l Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration points,
and NPP points are excluded.

NOTE: Automatic execution of a QC job By tests or By hours occurs when all the following
conditions are met:
o Automatic execution is enabled.
o All the required materials for the QC test are on board.
o The QC test is feasible.
o An order has been created to run the test related to the QC. For example, to run a QC
job for Routine Control X for the test APTT, an APTT test must be ordered.
If Automatic execution is enabled By tests or By hours in the QC Setup Definition, and the
above conditions are not met when the frequency is due, the system generates an alarm
indicating that QC is not feasible, or QC is overdue.

B y hours
Option to configure the instrument to: 1) run QC (automatically, if enabled); or 2) generate a warning after
the specified number of hours have passed (specify the frequency in the Number of hours field.
l Enable warning threshold – Option to generate a message to run QC when the warning threshold is
reached. Enter the number of hours/tests in the field beside this option.
l Automatic execution – Option to run QC automatically when the threshold number of Tests/Hours is
reached. Automatic execution can be performed only if all the necessary materials are on-board in
sufficient volumes, adequate stability, and valid expiration dates.

NOTE:

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l After a QC job has finished running, the frequency timer for Tests/Hours resets to the starting point.
This is true whether the QC job is manually or automatically generated.
l A manually executed QC job that runs at the same time as a frequency-initiated QC job, does not
cause a duplicate QC test to run.
l The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By
Absolute Time.
l The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By
Absolute Time.

NOTE: Automatic execution of a QC job By tests or By hours occurs when all the following
conditions are met:
o Automatic execution is enabled.
o All the required materials for the QC test are on board.
o The QC test is feasible.
o An order has been created to run the test related to the QC. For example, to run a QC
job for Routine Control X for the test APTT, an APTT test must be ordered.
If Automatic execution is enabled By tests or By hours in the QC Setup Definition, and the
above conditions are not met when the frequency is due, the system generates an alarm
indicating that QC is not feasible, or QC is overdue.

B y A bsolute Time
Option to configure the instrument to run QC at a specified time of day or generate a warning. Select one or
more of the following options and enter a time of day. This option sets the starting time for the By Hours
option if selected in this screen.
l First time – Check option and configure the time in the adjacent field.
l Second time – Check option and configure the time in the adjacent field.
l Third time – Check option and configure the time in the adjacent field.
l Fourth time – Check option and configure the time in the adjacent field.
Example
If First time is configured as 07:00, and Number of hours configured as 8, the instrument runs QC or
generates a warning message at local times: 15:00, 23:00, and 07:00.
Automatic execution
Option to run QC automatically at the times specified in this parameter. Automatic execution can be
performed only when all the following conditions are met:
l All required materials are on-board in sufficient volumes
l The on-board stability parameters in Material Definition have not been exceeded.
l If you have enabled Auto Run in Global Definitions Setup, or have manually ordered a test associated
with the QC.

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NOTE:

l A QC job triggered by a By Absolute Time setting resets the frequency timer for By Test and/or By
Hours.
l The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By
Absolute Time.

NOTE: If Automatic execution of a QC job By Absolute Time is selected in the QC

Setup Definition, and Auto Run is selected in Global Definitions Setup, QC automatically
executes the QCs at the defined times if the following conditions are met:
o All the required materials for the QC test are on board.
o The QC test is feasible.

B efore vial use

Option to run automatic QC if any of the vials used for the specific assay (start or intermediate reagents) have
changed. This is not recommended if you are using more than one reagent, because a vial change of an
intermediate or start reagent forces a QC, even if one has just been performed.

NOTE:

l This frequency option is independent (and in addition to) the By Tests, By Hours and By Absolute
Time frequency options.
l When this frequency option is selected, automatic QC executes (in addition to other frequency-
initiated QC jobs).
l If a QC job is triggered by the Before vial use option, the By tests and By hours frequency timer resets
to the starting point.

See Also
l Quality Controls
l QC Overview
l QC List
l QC Profiles List
l QC Results List
l QC Test Status List
l Reviewing QC Results

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Test Profiles List Chapter 4 – Setup

Test Profiles List

The Test Profiles List contains a list of all test profiles1 currently defined on the system. The ACL TOP
instrument can store up to 100 test profiles, each containing up to 15 individual tests.

Accessing the Test Profiles List

To access the Test Profiles List:
1. Select Setup > Test Profiles List in the menu bar.

2. To view a test profile, place focus2 on a profile in the Test Profiles List, and select the Profile
icon in the toolbar. View the test profile in the Profile Definition screen.
3. To delete a test profile, select3 one or more profiles in the Test Profiles List and select the Delete

icon in the toolbar. Confirm the deletion.

1A test profile is a grouping of tests. When you associate the test profile with a sample, all the tests in the
profile run on sample.
2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
3Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Defining a New Test Profile

To define a new test profile:
1. Select Setup > Test Profiles List in the menu bar to open the Test Profiles List.

2. Select the Add icon in the toolbar.

3. In the Profile Definition screen, enter a name and description for the new test profile.

4. Use the arrow buttons to move selected test codes from the Available tests window to the Selected
tests window.

NOTE:

l The Available tests window contains only enabled test definitions. The Selected tests
window contains the test definitions to add to the test profile.
l You cannot duplicate tests within a single profile.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the Test Profiles List.

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Configuring the Standard Test Profile

To configure the Standard Profile:
1. Select Setup > Test Profiles List in the menu bar to open the Test Profiles List.
2. Select1 a profile in the Test Profiles List.

3. Select the Toggle Standard Profile icon in the toolbar. A check mark appears in the Standard
column in the Test Profiles List.
Tests contained in the standard profile are automatically programmed on every sample that has a sample ID
but does not have a test programmed through the LIS. There can be only one standard test profile on the
system.

Test Profiles List Toolbar

The Test Profiles List operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Add – Opens the Profile Definition screen where you can define a new test profile.

View – Opens the Profile Definition screen for the profile having focus2.

Delete – Deletes the selected profiles.

Toggle Standard Profile. Enables/disables the standard profile.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Test Profiles List Screen

Selection C olumn
Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the
Select icon in the column heading to select or deselect all the rows in the table.

N ame
Unique test profile name. Maximum 10 characters.

D escription
User-created description of the test profile. Maximum 50 characters

Standard
A check mark indicates the standard profile. Tests contained in the standard profile are automatically
programmed on every sample that has a sample ID but does not have a test programmed through the LIS.
There can be only one standard test profile on the system. If the LIS orders a test that is contained in the
standard profile, the system does not run a duplicate test.
See Configuring the standard profile.

NOTE:

l The Available tests window contains only enabled test definitions.

l You cannot duplicate tests within a single profile.
l You cannot delete a test definition that is referenced in any test profile.
l You cannot disable a test definition that is referenced in any test profile.

See Also
l Test Definition

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QC Profiles List Chapter 4 – Setup

QC Profiles List
The QC Profiles List contains all QC profiles currently defined on the system.

Accessing the QC Profiles List

To access the QC Profiles List:
1. Select Setup > QC Profiles List in the menu bar.
2. To view a QC profile, double-click a profile in the table.

3. To add a new QC profile, click the Add icon in the toolbar.

4. Select the Save icon in the toolbar to save your changes.

5. Select the Previous Screen icon in the toolbar to return to the QC Profiles List.

QC Profiles List Toolbar

The operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Add a new QC profile. Opens the Profile Definition screen.

View Profile Definition details. Opens the Profile Definition screen for the profile in focus.

Delete a Profile. Deletes the selected profiles.

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QC Profiles List Column Descriptions

Selection C olumn
Click one or more rows to place check marks in this column, indicating selection of one or more QC profiles.
Maximum 10 characters.

N ame
Name of the QC profile.

D escription
User-created description of the QC profile. Maximum 50 characters.
The following requirements apply:
l Duplicate profile names are not allowed.
l The Available QCs List contains only enabled QC definitions. See QC List.
l The selected QCs list contains only QC definitions you selected from the available QCs list.
l You cannot duplicate QCs within a single profile.
l You cannot delete a QC definition that is referenced in any QC profile.
l You cannot disable a QC definition that is referenced in any QC Profile.

See Also
l Quality Controls
l QC Overview
l QC List
l QC Results List
l QC Setup Definition
l QC Test Status List
l Reviewing QC Results

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Defining QC Profiles Chapter 4 – Setup

Defining QC Profiles
A QC Profile is a group of QC tests under one heading or name that you can select to run without needing to
individually select each of the QC tests. The ACL TOP instrument is capable of storing up to 100 QC
profiles, each containing up to 15 individual tests.

Creating a QC Profile
To create a QC Profile:
1. Select Setup > QC Profiles List in the menu bar.

2. Select the Add icon in the toolbar, or select Actions > QC Profile > Add in the menu bar. The
QC Profile Definition screen appears. A maximum of 100 QC profiles may be defined.

3. Enter a unique name (maximum of 10 characters) and a description (maximum of 50 characters) in the
appropriate fields.
4. Select the tests in the Available QCs field to included in the new QC profile, and select the right
arrow to move them into the Selected QCs field.

5. Select the Save icon in the toolbar to save your changes.

6. Select the Previous Screen icon in the toolbar to return to the QC Profiles List.

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Viewing a QC Profile
To view a QC profile:
1. Select Setup > QC Profiles List in the menu bar.
2. In the QC Profiles List, do one of the following to open the QC Profile Definition screen:

l Double-click a profile.

l Select a profile and select the View icon in the toolbar.

l Select a profile and select Actions > Review > QC Profile Definition in the menu bar.

3. In the QC Profile Definition screen, the tests listed in the Selected QCs field are the tests in the QC
profile that has focus1 in the QC Profiles List.

4. Select the Previous Screen icon in the toolbar to return to the QC Profiles List.

Editing a QC Profile
To edit a QC profile:
1. Open a QC profile in the QC Profile Definition screen. See Viewing a QC profile.
2. Select tests in the Available QCs and Selected QCs fields, and use the arrow buttons to move them to
and from the Selected QCs field. The tests in the Selected QCs field are the tests that are included in
the QC profile after you save.

3. Select the Save icon in the toolbar to save your changes.

4. Select the Previous Screen icon in the toolbar to return to the QC Profiles List.

Deleting a QC Profile
To delete a QC profile:
1. Select Setup > QC Profiles List in the menu bar.

2. Select one or more QC profiles in the QC Profiles List and select the Delete icon in the
toolbar.
3. Click OK in the confirmation dialog box.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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See Also
l Quality Controls
l QC Overview
l QC List
l QC Profiles List
l QC Results List
l QC Setup Definition
l QC Test Status List
l Reviewing QC Results

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Reflex Rules Chapter 4 – Setup

Reflex Rules
Reflex rules allow you to program and automatically execute a test generated by a condition of another test's
results. The ACL TOP instrument can store up to 100 reflex rules, each containing up to 10 conditions.

Creating a Reflex Rule

To create a reflex rule:
1. Select Setup > Reflex List in the menu bar.

2. Select the Add icon in the toolbar.

3. In the Reflex Definition screen, enter a unique name for the reflex rule in the Rule name field. The
name can be 1-10 characters.
4. Enter a description of the rule in the Description field. The description can be 1-80 characters.
5. Click in the Test Code column, then select a test code in the drop down list.
6. Click in the Result Unit column, then select the result unit in the drop down list.
7. Click in the Rule column, then select a rule in the drop down list.
8. If the rule contains an operator (<, >, =), enter a numeric value for the rule in the Value column.
9. If multiple rules are used in the reflex test, select either the AND or OR operator from the Op.
(operator) drop down list. This is available only if two or more rules are selected.
10. Use the arrow buttons to move one or more tests to execute in response to the reflex rule violation
from the Available window to the Selected window. You cannot select the same test code you
selected in the earlier step.

11. Select the Save icon in the toolbar to save your changes.

Viewing or Editing a Reflex Rule

To view or edit an existing reflex rule:
1. Select Setup > Reflex List in the menu bar.
2. Double-click a rule in the Reflex List to view the rule settings in the Reflex Definition screen.
3. Follow the steps in the Creating a Reflex Rule procedure to edit the rule.

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Reflex List Operations Toolbar

Select the following icons to perform the associated tasks:

Add Reflex Rule – Opens the Reflex Definition screen.

View Reflex Rule – Opens the Reflex Definition screen for the Reflex Rule having focus.

Delete Reflex Rule – Deletes the selected Reflex Rule.

Reflex List

The Reflex List screen contains a list of all reflex rules currently defined on the instrument.

Selection C olumn
Click in the column to select. Select one or more reflex rules to delete.

N ame
Name of the reflex rule. Must be a unique name with a maximum of ten characters.

IL Locked C olumn
A check mark indicates a locked reflex rule, which cannot be edited or deleted.

D escription
Description of the reflex rule. Cannot exceed 80 characters.

NOTE: After a reflex triggers, the reflex test does not execute if it has already been performed on a
sample. For example, the FXIII Ag test is run and a reflex rule causes the FXIII High test to run. Later, FXIII
Ag is requested for the same sample again and again meets the criteria to reflex. The reflex test does not
execute because it has already been performed.

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Reflex Definition Screen

Rule name
Name of the reflex rule. Enter a unique name with a maximum of 10 characters.

IL Locked
A check mark indicates a locked reflex rule, which cannot be edited or deleted.

Description
Description of the reflex rule. Enter a description with a maximum of 80 characters.

Conditions

Test C ode
Unique identifier of a test in the reflex rule. Click in the table cell, then select a test code in the drop down
list.

R esult U nit
Test result unit for a test in the reflex rule. Click in the table cell, then select a result unit in the drop down
list.

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R ule
List of rules to apply to the reflex rule. Click in the table cell, then select a rule in the drop down list.

Value
Numeric value to apply to the reflex rule. If the rule contains an operator (<, >, =), enter a numeric value in
this table cell.

NOTE: - Numeric values are calculated using precise values. However, when displayed, these values
are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen
may appear to be within the defined range limit when it is actually out of range. Such values are flagged to
indicate that they are out of the range.

Op.
Operator to use if multiple rules are used in the reflex test. Click in the table cell, then select the AND or OR
operator in the drop down list. This is available only if two or more rules are selected.

Tests to be executed
Use the arrow buttons to move the selected tests to execute in the reflex rule from the Available window to
the Selected window.

A vailable
List of available tests.

Selected
List of tests to run if the reflex rules trigger an event.

See Also
l Alternative Pre-Dilution

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Auto-Validation Setup Chapter 4 – Setup

Auto-Validation Setup
Use the Auto-Validation Setup screen to configure the instrument to automatically validate test results based
on the criteria you select.

Configuring Auto-Validation
To configure auto-validation:
1. Select Setup > Auto Validation in the menu bar.
2. In the Auto Validation screen, select the Enable auto-validation option.
3. Select the Patient result, Parallelism result and/or Calibration result options to enable selection of
the auto-validation exception criteria in the Patient, Parallelism and Calibration columns. If you do
not select any of these options, auto-validation is performed for every test result.
4. Select the Auto-Validation Exception criteria in the Patient, Parallelism and/or Calibration columns.
Auto-validation of test results does not occur for the criteria you select.

5. Select the Save icon in the toolbar to save your changes.

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Auto-Validation Setup screen

Enable auto-validation
Option to auto-validate test results. Enables the controls on this screen. Data reduction tests each mean result
against the established result range flags.

Patient result
Option to auto-validate patient test results. Enables the selection of exception criteria in the Patient column.

Parallelism result
Option to auto-validate parallelism test results. Enables the selection of exception criteria in the Parallelism
column.

C alibration result
Option to auto-validate calibration test results. Enables the selection of exception criteria in the Calibration
column.

Auto-Validation Exceptions
Auto-validation exceptions are organized by the following criteria:

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Failures
Test failed – Option to block auto-validation when a test fails.

Errors
l DR error on measured results – Option to block auto-validation when a data reduction error occurs
on a measured result.
l Max. difference on primary test result – Option to block auto-validation when the Max. difference
value for a test result exceeds the value defined in the respective test definition. See Result Unit
Definition.
l Parallelism error – Option to block auto-validation when any of the parallelism data reduction
parameters have been exceeded. (See Parallelism Setup - Data Reduction Tab.) Parallelism must be
enabled.
l QC errors – Option to block auto-validation when any QC rule has been violated, as defined in the
respective QC setup definition.
l Temperature error – Option to block auto-validation when the analyzer temperature drifts from
nominal during a test.
l Errors on test results – Option to block auto-validation when any error occurs on test results.

W arnings
l DR warning on measured results – Option to block auto-validation when a data reduction error
occurs on a measured result (as defined, and if enabled) in a test definition under Raw Data Checks,
Normalized Data Checks, or Primary/Secondary Algorithm. (See Data Reduction Parameters.)
l Parallelism warning – Option to block auto-validation when a parallelism error occurs on a
parallelism result.

R esults outside range

These four options are automatically selected when the DR error on measured results option in the Errors
criteria group is selected. They can also can be selected independently.
l Results outside test range – Option to block auto-validation when test results are outside the test
range.
l Results outside therapeutic range – Option to block auto-validation when test results are outside the
therapeutic range.
l Results outside linear range – Option to block auto-validation when test results are outside the linear
range.
l Results outside normal range – Option to block auto-validation when test results are outside the
normal range.

Expirations
l LAS Sample expired during processing – Option to block auto-validation when the LAS sample
expiration time has been exceeded before the Sample results are obtained.

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l Material expiration – Option to block auto-validation when a material used for a specific test has
expired before the Sample results are obtained. The Enable lot management option must be selected.
See Material Definition – Lot Specific Information Tab.
l Material stability expired – Option to block auto-validation when a material used for a specific test
has exceeded the on-board stability value, as defined in the Material Definition before the Sample
results are obtained. The On-board stability tracking option must be selected. See Material Definition
– General Information Tab.

Overdues
l Calibration overdue – Option to block auto-validation when a calibration related to an ordered test
becomes overdue before the test results are final.
l Maintenance overdue – Option to block auto-validation when any maintenance operation becomes
overdue.
l NPP overdue – Option to block auto-validation when an NPP1 related to an ordered test becomes
overdue before the test results are final.
l QC overdue – Option to block auto-validation when a QC related to an ordered test becomes
overdue before the test results are final.

See Also
l Data Reduction Parameters

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Revision History Report Chapter 4 – Setup

Revision History Report

Available only to IL personnel.

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Importing and Exporting Definitions Chapter 4 – Setup

Importing and Exporting Definitions

Overview
The Import/Export feature allows you to transfer a copy of any or all of the following data:
l Materials
l Tests
l QCs
l Vials
l Profiles
o Test
o QC

l Reflex
l Sample display settings
l Programming window
o Tests
o Materials

l Maintenance activities
l Bar code definitions
l LIS definitions
l Global definitions
l Security definitions
l LAS definitions
l Report configuration
l Validation rules
Use the import/export function to transfer test and material definitions from one instrument to another. Data
transfer can occur between all ACL TOP Family instruments.
For example:
l From one ACL TOP 700 instrument to another ACL TOP 700 instrument
l From an ACL TOP 500 CTS instrument to an ACL TOP 700 instrument

NOTE: All ACL TOP models contain some unique Test, Material and QC definitions that are not
compatible with other ACL TOP models, and therefore cannot be imported/exported between instrument
models.

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Exporting Definitions

To export data from the Import/Export screen:

1. Select Setup > Import/Export to open the Import/Export screen.
2. Select the Export tab.
3. In the Destination file field enter a file name with extension .XML after the displayed path. Use the

Browse button to change the file path. The Export icon is enabled only for XML files, as
in the following example:

4. Select the tab that corresponds to type of data to export.

5. In the Available window, select one or more items to export. Use the Shift/CTRL keys to multi-select.
6. Select the upper right arrow to move selected items to the Selected definitions to Export window.
The system automatically moves other related definitions.

For example: If you select the PT-RP test on the Tests tab, all materials associated with the PT-RP test
are automatically moved to the Selected definitions to Export window on the Materials tab.
7. <Optional> Check the Select All option to move everything in the Available window to the Selected
definitions to Export window.
8. <Optional> Place a check mark in the box to the left of an item in the Selected definitions to Export
window to force that definition to be imported during a subsequent import process. A check mark

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here prevents deselection of that definition when performing the subsequent import. All dependent
definitions are also be imported.

For example: If you select the PT-RP assay for forced subsequent import during the creation of the
export file, all materials required to perform the test (Factor Diluent, HemosIL Cal Plasma, PT
RecombiPlastin, Clean B Diluted) are also imported. Materials that are not required to run the test
(QC materials) are not imported. Enable the selection of dependencies on the Others tab. By default,
the system forces import of everything used in the exported definition.
9. To delete definitions, use the lower right arrow to move them to the Selected (definitions) to delete
window. The system does not automatically move related definitions. You must move related
definitions manually. To force the deletion of a definition on import, check the item in the Selected to
Delete window.

10. Select the Export icon in the toolbar to move a copy of the definitions to the selected file
location.

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Importing Definitions

NOTE: An import operation cannot be performed while the system status is BUSY or in a
CONTROLLED STOP.
To import data:
1. Select Setup > Import/Export to open the Import/Export screen.
2. Select the Import tab.

3. In the Source Data area use the Browse button to locate the source file to import. Files for
import must have an .XML extension. After selecting the file, the definitions contained in the file
appear in the Available and Available Definitions Marked to be deleted windows in each tab of the
Import screen. Definitions selected for mandatory import or deletion are displayed in the Selected
definitions to add/import and Selected definitions to delete windows, respectively.
4. Select the tab for the type of data you are importing.
5. Select one or more definitions in the Available window, and select the upper right arrow to move
them to the Selected definitions to add/import window. Use the Shift/CTRL keys to multi-select.
Select the Select All option to move everything to the Selected definitions to add/import window.
6. By default, all available definitions are selected for import. To deselect a definition for import, use the
left arrow to move it from the Selected definitions to add/import window to the Available window.
Select the Select All option to move everything from the Selected definitions to add/import window
to the Available window.

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NOTE:

l Importing data overwrites all IL-Locked fields. It does not overwrite most user-defined
fields. An exception is user-defined fields in the QC definition. To avoid overwriting
QC definitions, move QC definitions from the Selected definitions to add/import
window to the Available window before import.
l Importing items with check boxes is mandatory. Importing items without check boxes
is not mandatory. To avoid importing unchecked items, move them to the Available
window. To import non-mandatory items, move them to the Selected definitions to
add/import window.

7. Select the Import user defined fields option to import user-defined fields.
8. To delete definitions, use the lower right arrow to move them to the Selected (definitions) to delete
window. The system does not automatically move related definitions. You must move related
definitions manually.

9. Select the Import icon to transfer the definitions to the instrument.

CAUTION:

l When you import results data from a calibration, the Result Correlation setup in Result Units is not
protected from editing. Changing the correlation factor or the offset for IL locked tests can
compromise calibration results.
l After importing a test over an existing test in the database, you must recalibrate the imported test
before running any type of sample.

NOTE:

l A definition with a broken underline indicates the definition exists on the system, and will be
overwritten during the import.
l If two materials or tests have different ID numbers but the same name, the system imports all the
parameters except the one with the duplicate name code. A message displays information about the
definition with the duplicate name code.
l When importing a maintenance activity, the Frequency field is overwritten if the imported activity is
more frequent than the one set by the system. Frequency is not overwritten if the imported activity is
less frequent than the one set by the system.

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Field Descriptions
Major Version
Number assigned to the major version of the test parameters.

Minor Version
Two fields indicating the minor version of the test parameters.

Others Tab
Select the dependencies to force the instrument to import for each definition being imported. By default, the
instrument imports everything used in the definition. Dependencies imported include the following:
l Maintenance activities
l Barcode definitions
l LIS definitions
l Global definitions
l Security definitions
l LAS definitions
l Report configuration
l Validation rules
The settings in this tab are exportable to assist in the transfer of user-defined settings from one instrument to
another of the same model.

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Global Definitions Setup Chapter 4 – Setup

Global Definitions Setup

Global Definitions is the area of configuration that allows you to select options that define default values
used by the system when configuring other areas of the system.

Setting Up Global Definitions

To set up global definitions:
1. Make sure the instrument is in the READY state.
2. Select Setup > Global Definitions in the menu bar.
3. In the Global Definitions screen, configure the global parameters.

4. Select the Save icon in the toolbar to save your changes.

Global Definitions Setup Screen

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Run
Patient Priority
Option to pipette all test requests for one patient sample before starting the next patient sample. For example,
if PT and APTT tests were ordered for four samples, the processing order would be:

Sample 1: PT
Sample 1: APTT
Sample 2: PT
Sample 2: APTT
Sample 3: PT
Sample 3: APTT
Sample 4: PT
Sample 4: APTT

Throughput
Option to schedule the test to run starting with the 8 tests that complete the quickest. Then the scheduler
processes the next 8 quickest tests, and so on. In the example used above the processing order would be:

Sample 1: PT
Sample 2: PT
Sample 3: PT
Sample 4: PT
Sample 1: APTT
Sample 2: APTT
Sample 3: APTT
Sample 4: APTT

A uto R un
Option to run tests automatically after a sample is PLACED.
The run starts automatically when all the following conditions are met:
l A sample is placed (sample status is PLACED).
l An enhanced clean is not currently required.
l Temperatures are not out of range.
l All ORUs are enabled.

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The instrument monitors these conditions at 1 minute intervals. If the above conditions are not met, the
instrument retries Auto Run after each monitoring interval.
After Auto Run starts, the instrument status remains BUSY until testing completes.
A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become
feasible, or until the sample expiration time elapses.

Test Definition Features

D isplay D erivative C urves

Option to enable/disable displaying the first and second derivative curves in the reaction graph on the Test
Details screen. In the Test Details screen you can toggle derivative curves on and off. This option defines the
default global setting.

Enable Global R erun

Option to enable/disable all rerun rules for all tests that have Rerun parameters defined and enabled.

Enable Global R eflex

Option to enable/disable all reflex rules for all tests that have Reflex parameters defined and enabled.

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Sample Life
Sample life specifies a time frame, in days or hours, that is used to determine whether new test requests,
coming from the LIS or programmed by you, are assigned to a sample ID that is already in the system. In
other words, if a sample/test request is received by the ACL TOP within the time specified in the sample life
field, and the same sample/test request (with identical patient demographics) is already in the system, the new
test request is appended to the sample already in the system.
For example, if the sample life field is set to 24 hours and a sample ID 123 with test APTT (having blank
patient demographics) is received by the TOP at 10:00 a.m. Oct 1, then another sample ID 123 with test
APTT (having blank patient demographics) is received by the system at 8:00 a.m. Oct. 2, the second APTT
test is appended to the first sample ID 123. In this example, the results for the two tests are displayed as
follows:

Sample ID Test

APTT
123
APTT

If a sample ID 123 with test APTT (having blank patient demographics) is received by the TOP at 10:00 a.m.
Oct 1, then another sample ID 123 with test APTT (having blank patient demographics) is received by the
system at 11:00 a.m. Oct. 2, the second sample ID/APTT test is run as a completely separate test from the first
sample ID. In this example, the results for the two tests are displayed as follows:

Sample ID Test

123 APTT
.

Sample ID Test

123 APTT

If sample life is disabled, sample IDs are reused. The range is 1-99, the unit is hours or days. The default is 24
hours.

Default File Path

Location where data logs are stored, if enabled. The system must be configured by an IL representative to
save data reduction reports. To change the default file path, select the browse button and enter a new
location.

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Test Mode Extensions

Extended A cquisition Mode Extension

Extension added to the test code for tests run in extended acquisition mode. Any keyboard character may be
used. The default value is E.

Parallelism Mode Extension

Extension added to the test code for parallelism tests. Any keyboard character may be used. The default value
is P.

D iluted Mode Extension

Extension added to the test code for diluted tests. Any keyboard character may be used. The default value is
D.

Editing Options

Enable K eypad
Option for a numeric keypad to popup anytime you click in a field that contains a numeric value. Disabled
by default.

Enable K eypad for Sample ID

Option for a numeric keypad to popup anytime you click in a sample ID field that contains a numeric value.
Disabled by default.

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Sample/Reagent Probe Dilution Parameters

Max. Syringe Volume

Maximum volume of fluid able to be aspirated or dispensed. Limited by the physical characteristics of the
syringe pump. The default value is 250 μL.

Min. Syringe Volume

Minimum volume of fluid able to be aspirated or dispensed accurately. Limited by the performance
characteristics of the syringe pump. The default value is 4 μL.

Max. C onsecutive D ispensations

Number of dispenses of the same material that can be injected into the same cuvette well without rinsing
when preparing dilutions. The default value is 3.

Cuvette Dilution Parameters

C uvette Overflow Volume

Maximum volume capacity of a cuvette well. The default value is 600 μL.

C uvette B lind Volume

Volume of fluid, in microliters, that cannot be removed from the cuvette well by a probe aspiration. The
default value is 65 μL.

Min. C uvette Volume for Mix

Minimum volume of fluid, in microliters, required to be present in a cuvette well in order to mix the cuvette
well contents. The default value is 100 μL.

Min. C uvette Volume for Test

Minimum volume of fluid, in microliters, required to be present in a cuvette well before it can be sent to the
optical reading unit (ORU). The default value is 150 μL.

Max. C uvettes per D ilution

Maximum number of cuvettes to use when making dilutions. Select a number between 1 and 8.

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Global Definitions Setup Chapter 4 – Setup

CTS Parameters

Enable Piercing Mode

Option to enable cap piercing on the ACL TOP CTS instrument. Cap piercing is required when running tests
on closed tube samples. This option enables the Low-Fill Tubes Handling option.

Low-Fill Tubes H andling

Select the Enable Lower z-depth option to enable the ACL TOP CTS instrument to run tests on low fill
closed tube samples.
This option addresses sample tube types where a small fill volume (e.g. 1.8 mL) is paired with a tube inner
diameter typical of tubes designed to accommodate larger fill volumes (e.g. 2.7 mL). In these tubes, the
plasma fill line sits very low (near the bottom of the tube, and far from the tube cap), at a distance that is
barely reachable by the sample probe. Contact Service to enable this option.

Enable deep wash when rinsing before aspirating

Enables the deep wash cycle that is generally used when CTS mode is enabled. For IL test development use
only.

System Identification

Serial N o.
AM serial number identifier.

Model
Type of configuration that defines the instrument. For example:
l ACL TOP 300
l ACL TOP 500 CTS
l ACL TOP 700 (includes ACL TOP Base)
l ACL TOP 700 CTS (includes ACL TOP CTS)
l TOP 700 LAS

System Capacities

Patient Samples
You can configure up to 20,000. You are prompted to confirm if the change causes a large amount of data to
be deleted.

QC Jobs
You can configure up to 20,000. You are prompted to confirm if the change causes a large amount of data to
be deleted.

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Bar Code Definitions Setup Chapter 4 – Setup

Bar Code Definitions Setup

Configuring Bar Code Reading

To configure the bar code reading in the Sample and Reagent Areas:
1. Select Setup > Bar Code Definitions in the menu bar.
2. Configure the bar code settings in the Bar Code Definitions screen.

3. Select the Save icon in the toolbar to save your changes.

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Bar Code Definitions screen

Enable Reagent Area Bar Code Reading

Option to enable the reading of bar code labels on the reagent bottles placed on racks in the Reagent Area.
When this option is disabled, the instrument does not read the bar code labels on the bottles it detects in the
reagent racks.

NOTE: When this option is disabled, the materials on the rack must be manually defined. Each
instance of an unknown reagent in a rack position triggers an alarm code 3004 error when reagent racks are
inserted into the instrument.
l Alarm 3004
Non-identified Material in rack <rack ID> position <rack position #>, track # <rack track #>.

Enable Sample Area Bar Code Reading

Option to enable the reading of bar code labels on the sample cups and tubes placed on racks in the Sample
Area. When this option is disabled, the instrument does not read the bar code labels on the sample cups and
tubes it detects in the sample racks.

Available Bar Code Formats

The bar code formats in this area of the screen are available for selection.

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Bar Code Definitions Setup Chapter 4 – Setup

Enable code 128

This option is always enabled. Code 128 format is used for 1) all reagent bar codes; and 2) sample and
reagent rack information bar codes.

Enable interleaved 2 of 5
Option to use the Interleaved 2 of 5 barcode format.

NOTE:

l This value must be set to 6, 8, 10, 12, 14 or 16 characters (minimum 6 characters, maximum 16, even
number of digits).
l When an odd number of barcode digits is configured, the system appends a zero to the beginning
when the label is scanned to convert the number of digits to an even number.
l The Checksum option adds a character to the barcode value. When using the Checksum option, set
the Max. Number of digits value to 14 or fewer.
l For safety reasons set both the minimum number of digits and the maximum number of digits to your
commonly used size. For example, if you commonly use a 12 digit bar code, set both the Min. and
Max. Number of digits fields to 12.

Enable C ode 39
Option to use the Code 39 barcode format.
The following options are available:
l Enable Checksum – Option to use a checksum. Select the checksum type from the drop down list.
Disabled by default.
l Enable Large Intercharacter Gap – Option to use a Large Intercharacter Gap. Enables the scanner to
read symbols with gaps between the bar code characters that exceed three times the narrow element
width. This is useful for reading symbols that are printed out of specification.

Enable C odabar N W (7) Japan

Option to use the Codabar NW(7) barcode format.
The following options are available:
l Enable Checksum – Option to use a checksum. Select the checksum type from the drop down list.
Disabled by default.
l Enable Large Intercharacter Gap – Option to use a Large Intercharacter Gap. Enables the scanner to
read symbols with gaps between the bar code characters that exceed three times the narrow element
width. This is useful for reading symbols that are printed out of specification.

NOTE: An alarm is triggered when the bar code reader encounters a label longer than 16 characters.

See Also
l Material Identification

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Bar Code Label Placement Chapter 4 – Setup

Bar Code Label Placement

To ensure accurate bar code scanning, do not place the label too low or too high on the tube. Use the
following diagram to determine correct placement of the label.

NOTE: Place the label inside the Symbol Placement Zone.

See Also
l Material Identification
l Bar Code Definitions Setup
l Bar Code Reader

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LIS Configuration Chapter 4 – Setup

LIS Configuration

Overview
The ACL TOP instrument can interface to an LIS (Laboratory Information System). There are two types of
communication between the ACL TOP instrument and the LIS (host). The communication from the LIS to the
ACL TOP instrument is known as Host downloads and the communication from the ACL TOP instrument to
the LIS is known as Host uploads.
In a host downloading process, the information that travels from the LIS to the ACL TOP instrument is a set
of test orders. A test order can be described as a test request to be performed on a sample. In a host uploading
process, the information that travels from the ACL TOP instrument to the LIS is a set of test results. A test
result can be briefly described as the numeric analytical values (measured or calculated) and/or associated
error status, flags, and warnings, produced by the execution of the test.

NOTE: The ACL TOP instrument does not run duplicate tests, whether ordered through the LIS or
ordered manually. Only one test is performed per test code, per sample. To run duplicate tests on a sample,
you must either 1) configure the test definition to run a replicate; or 2) wait until a test has generated test
results.
You configure the method of communication with the LIS on the LIS setup screen.

Configuring Communication with an LIS

NOTE: An LIS Administrator should supervise LIS configuration.

To configure communication with an LIS:

1. Select Setup > LIS > Communications in the menu bar.
2. In the LIS Setup screen, complete the information on the Host Communications Configuration,
ASTM-1394 Configuration, and Communications Configuration tabs according to your LIS
requirements.

Performing a Manual LIS Query

To manually request test orders from the LIS:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, select Actions > Results > Download Tests Order in the menu bar.
Alternatively, see Programming Non-Bar Coded Samples After Inserting the Rack, Using an LIS without Host
Query Enabled.

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Host Communications Configuration Tab

Use this tab to enable the ACL TOP instrument to work with an LIS and configure the following modes and
identifiers.

Enable Host Communication

Option to enable the ACL TOP instrument to work with an LIS system.

Host Configuration

Instrument ID
ID of the ACL TOP instrument to send and receive messages.

H ost ID
ID of the LIS host to send and receive messages.

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LIS Configuration Chapter 4 – Setup

Futura C ompatible Protocol

Option to set the ACL TOP instrument communications protocol to be compatible with LIS drivers
developed for communications with the ACL Futura or the ACL Advance. This protocol is not fully ASTM-
1394 compatible and has modifications that make it unique. If you select this protocol, the full ASTM-1394
Compatible Mode is automatically deselected.
If you select the Futura Compatible Protocol, only Upload Quality Controls and Trace communications
protocols can be selected.

Full A STM-1394 C ompatible Mode (aka TOP-C ompatible mode)

Option to set the ACL TOP instrument communications protocol to be compatible with the LIS drivers
developed for ACL TOP instrument communications that are fully ASTM-1394 compatible. If you select this
protocol, the Futura Compatible Protocol is automatically deselected.
If you select Full ASTM-1394 Compatible Mode, the following four LIS options can be selected:
l Use internal instrument sample ID – Option to provide the LIS with the sample ID assigned by the
system.
l Upload quality controls – Option to upload quality control results to the LIS.
l Report errors to host – Option to report any LIS communications errors it encounters to the LIS.
l Trace communications protocols – Option to add trace information to the Operating System Event
Log.

Automatic Host Operation

H ost D ownloading
The following modes are configurable.
l Automatic Downloading – Option to perform an automatic download request each minute.
l Host Query – Option to query the LIS for test requests after a sample is placed on the instrument.

H ost U ploading
Selecting the Enable automatic uploading option enables you to select one of the following Automatic
patient uploading modes:
l Upload results per test – Option to upload each test result individually as the result is available.
l Upload results per sample – Option to upload all results for a specific sample ID.

Storage
When the laboratory LIS communication status is Disconnected, and ACL TOP LIS communications are
enabled, the instrument stores up to a maximum of 7200 messages.

R eset button
Resets the contents of storage so that messages pending to be uploaded are not sent when connections are
reestablished.

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ASTM-1394 Configuration Tab

Use this tab to configure LIS protocol delimiters. The delimiters cannot be used more than once. Duplicate
delimiters are not ASTM compatible.

Field D elimiter
List of characters to use to delimit (or separate) consecutive fields. Select one from the list.

R epeat D elimiter
List of characters to use to separate several occurrences of a given field. Select one from the list.

C omponent D elimiter
List of characters to use to differentiate several parts within a given field. Select one from the list.

Escape D elimiter
List of characters to use to signal special uses of several characters. Select one from the list.

C ode pages
Select the appropriate code page set (for character encoding) from the list.

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Communications Configuration Tab

Use this tab to configure either Serial Port LIS communications or Network LIS communications protocol.

Serial

Port C onfiguration
Only the COM port can be set. The selections are from a drop down list that contains COM1, COM2, COM3
or COM4.

NOTE: All the other RS232 configuration parameters, such as baud rate, parity, stop bits, etc., can be
configured through the Windows control panel and are not part of the ACL TOP instrument application.
Select the appropriate COM port from the drop down list.

Network
If you select Network configuration, the setting of the Network TCP/IP configuration can be performed.

TC P/IP C onfiguration
If the connection mode is Server, the IP address is not editable. It is the responsibility of the Host to know
the IP address of the instrument.
If the connection mode is Client, enter the IP address and Port for the LIS host.

See Also
l Reviewing Test Results l Sender List
l Reviewing QC Results

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Sender List Chapter 4 – Setup

Sender List
The Sender represents the location from which a sample has been received. The Sender List displays a
summary of currently defined senders.

Accessing the Sender List

To access the Sender List:
1. Select Setup > LIS > Sender List.

2. To add a sender to the list, select the Add icon in the toolbar.
3. Fill out the form fields.

4. Select the Save icon in the toolbar to save your changes.

5. To delete a sender in the list, select1 the sender in the Sender List and select the Delete icon in
the toolbar. Confirm the deletion.

Sender List
Each sender is identified by the following information:
l Code – Unique identifier for sender
l Name
l Department
l Street
l City
l State/Country
l Contact
l Phone

See Also
l LIS Configuration

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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LAS Overview Chapter 4 – Setup

LAS Overview

Definition
Laboratory automation systems are large automated laboratories that use a track to route primary sample tubes
requiring analysis through pre-analytical, analytical and post-analytical stations positioned throughout the
track. See Sample Containers and Adapters for a list of approved primary sample containers for use on the
LAS track.
The ACL TOP 700 LAS is a laboratory track automation-compatible hemostasis analyzer with the same
features and functionality as the ACL TOP. It is designed for point-of-reference sampling following standards
referenced in the following CLSI documents:
l AUTO1: Specimen Container/Specimen Carrier
l AUTO2: Bar Codes for Specimen Container Identification
l AUTO3: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and
Information Systems
l AUTO4: Systems Operational Requirements, Characteristics, and Information Elements
l AUTO5: Electromechanical Interfaces (from the automated track positioned adjacent to the
instrument, or sampling from samples manually loaded at the front of the analyzer)

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Sample Workflow
Sampling from the LAS track is performed by the LAS sampling module located on the left side of the
instrument. The LAS module consists of an LAS sampling arm with dedicated sample probe syringe, vial
position and LAS cuvette holding area.
The LAS area includes an enhanced clean station with an access door. The LAS arm accesses a bottle of
clean material in the clean station to perform daily enhanced cleans. The access door allows you to place and
remove clean material. See Enhanced Clean for LAS Probe.

NOTE:

l Do not place any items on the LAS arm cover.

l If the door on the LAS sampling module is opened when it is unsafe, the instrument performs an
emergency stop. If the door is opened during power-up, the system stays in Power Up status until the
door is closed.
l Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the
analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
accept capped tubes.
When the LAS automation track is enabled in the LAS Configuration screen and the LAS automation track is
functioning, primary sample tubes are scanned at the LAS query point before entering the LAS sample tube
queue. If the LAS Manager software determines that the sample requires testing by the TOP LAS analyzer,
the LAS track diverts primary sample tube from the main track to the sample tube queue. Primary sample
tubes that do not require testing bypass the TOP LAS and remain on the main LAS automation track.
Sample aliquots are drawn from the primary sample tube and placed on-board in a cuvette cell. The maximum
volume for an aliquot from the LAS track is 600 μL. The maximum sample volume that can be removed from
the sample tube is 1200 μL.
The aspirated sample remains accessible in the LAS holding area for rerun and reflex tests until the sample
expiration time has elapsed.

Auto Run
When the LAS Track option is enabled, Auto Run is automatically enabled and cannot be disabled.
Exception: LAS Controlled Stop.
The instrument begins processing tests automatically after all of the following conditions are met:
l A sample is placed (sample status is PLACED).
l No enhanced clean is currently required.
l Temperatures are not out of range.
l All ORUs are enabled.
l Test is feasible (reagents on-board).
The instrument monitors these conditions at one minute intervals. If a condition is not met, it tries to initiate
Auto Run after each monitoring interval.

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After Autorun starts, the instrument status remain Busy until testing is complete.
A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become
feasible, or until the sample expiration time elapses.

Prioritization of Samples
You can place samples in the front of the instrument at any time using the sample racks in the sample tracks.
Sample tracks S1-S3 are blocked and cannot accept sample racks.

Run priority is based on sample status and position placed on the instrument according to the following:
l Highest Priority – STAT samples front-loaded in sample racks
l Middle Priority – Samples aspirated from the LAS track
l Lowest Priority – Non-priority samples front-loaded in sample racks

NOTE:

l Samples aspirated from the LAS track do not receive priority status. The fastest way to process a test
is to assign priority status (STAT) and front load the sample on a sample rack.
l Test orders for samples provided by the LAS track are received from the LIS. Manually entered test
requests can only run on samples that are manually loaded in the sample area.

Communication
The LAS Manager runs on an external computer and manages the primary sample tubes traveling on an LAS
automation track.
Communication between the LAS instrument and the LAS track is through an embedded interface module
(IM) that is configured in the LAS Configuration screen.

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Hazards and Warnings

CAUTION Biohazard: Check the underside of the instrument and table on that it sits for
leaks. Clean and disinfect any spills discovered. Report leaks to Service personnel for repair.

NOTE: LAS alarms are displayed in the General Log as well as in External Communications Alarms
in the Status Bar at the bottom of the screen. See External Communications Alarms.

CAUTION: To avoid contamination, Instrumentation Laboratory strongly recommends against using

the ACL TOP instrument to perform analysis on Hepabsorb samples.

LAS Terminology
See Terminology.

See Also
l LAS Configuration
l LAS Cuvette Holding Area
l ACL TOP 700 LAS Specifications

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LAS Configuration Chapter 4 – Setup

LAS Configuration
The LAS Configuration screen is used to configure the ACL TOP instrument for operation and network
communication. Most of the fields on the three tabs contain read-only values defined by IL and the system
installer. You can enable or disable the Laboratory Automation System (LAS) on the LAS Configuration tab.
When LAS is enabled, communications with the LAS track are initiated.

Accessing the LAS Configuration screen

To access the LAS Configuration screen:
l Select Setup > LAS Configuration in the menu bar.

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LAS Configuration tab

The parameters defined in the LAS Configuration tab do not affect the following configurations defined
elsewhere:
l Sample and reagent dilution parameters defined in Global Definitions.
l Load cycle parameters defined in Test Definitions.

Enable LAS Track

Option to enable the Laboratory Automation System (LAS).
If unchecked, the connection to the LAS track is disabled and the LAS arm moves to the rinse station. When
disabled the LAS track remains available for Diagnostics and Maintenance.

NOTE:

l Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the
analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
accept capped tubes.
l If the instrument detects insufficient volume of clean material for the LAS probe to perform a required
clean cycle during testing, it performs an emergency stop to prevent contamination.

C onnection
The connection settings are read-only, configured at initial set up, and should not be altered.

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LAS Parameters
Most of the fields on this tab are for test developers only.

# Slots for dilution preparation

Number of slots reserved for calibrations and sample pre-dilutions. You can select values from 2-8. The
default value is 2 which ensures maximum throughput. Increasing the number of preparation cuvettes in this
field lowers the number of slots available for cuvette strips on-board, and lowers system throughput. See LAS
Cuvette Holding Area.

NOTE:

l The system status must be Ready to adjust this setting.

l When the LAS arm is disabled, the TOP instrument ignores the value in this field and operates by
front loading with 8 slots for predilutions.
l When the LAS arm is re-enabled (in this screen or in Diagnostics), this field is enabled and the
instrument sets the number of predilutions to the value in this field.
Adjustments for Calibration
You may need to adjust this setting during calibration. If the current setting is insufficient to run calibration,
an error message states: Number of preparation cuvette slots is insufficient to execute a calibration or
parallelism job.
When performing multiple calibrations, IL recommends setting this value to 8 for maximum efficiency.
When performing a single calibration, you may run normal samples, but throughput is reduced. For this
reason, IL recommends running calibrations independently of sample processing. When calibrating a single
test, the required setting is 3-8 slots.

When calibration is complete reset this value to 2 for maximum throughput. If the value is not reset to 2,
throughput is reduced, and a back up of primary sample tubes may occur in the LAS track sample queue.

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Sample aspiration time

Maximum time a sample tube sits in the LAS Sample queue on the LAS track before the system removes it
from the aspiration position. The default value is 15 minutes.
The cause for delay may include the following:
l The LAS system performs a controlled stop.
l Maintenance is performed.
l The instrument is processing a large number of samples.

NOTE:

l You can adjust the sample aspiration time to avoid sample tubes getting stuck for a long time. The
aspiration time starts when the instrument accepts a tube from the LAS track. When the aspiration
time expires, the tube is released without aspiration. The acceptable range for this value is 5-99
minutes or 1-99 hours.
l If it becomes necessary to adjust this setting, take optimization measures to meet your turnaround
requirements. Consider load balancing adjustments using existing TOP 700 LAS units connected to
the LAS track, or connect additional TOP 700 LAS units.

A liquoting area expiration time

Amount of time after which the LAS instrument discards the aliquotted sample. The default time is five
minutes. The System Administrator may change this setting in minimum increments of one minute.

Sample expiration time

This value cannot be modified.
Time used to determine when a sample that has been aliquotted from the LAS track to a cuvette in the
holding area moves to waste. The LAS sample expiration time starts when the LAS sample is fully aliquotted
into the first cuvette cell in the aliquotting area. If the time expires while a test is in the active state, the test
executes and is flagged.
Tests (including reflex and reruns) become not feasible when the LAS Sample expiration time has elapsed. If
a test has not entered the active state when the Sample expiration time elapses, the test does not execute,
and the sample must be reinserted into the instrument.

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LAS Configuration Chapter 4 – Setup

LAS Interface Module Configuration tab

Enable Interface Module

This option is set by the system installer and cannot be modified. The TCP/IP configuration settings apply to
the interface module computer.

LAS Tube Types tab

This tab is a read only reference for the system installer.

See Also
l LAS Overview
l LAS Cuvette Holding Area
l ACL TOP 700 LAS Specifications

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System Security Chapter 4 – Setup

System Security
The ACL TOP instrument user interface has four security levels. These are listed below from highest to
lowest access level for: 1) IL locked tests and materials; and 2) non-IL tests and materials:
l Administrator
l Supervisor
l Senior operator
l Operator
Setting up your system security is a three-step process. You need to:
1. Decide the tasks that you want each security level to be able to perform.
2. Configure the Software Access screen accordingly.
3. Define the users.

NOTE:

l Instrumentation Laboratory recommends that certain critical operations (for example, ISI value,
calibrator values, etc.) be reserved for lab supervisor or lab administrator roles.
l Only the lab administrator should have access to Diagnostics.
l You cannot modify or delete IL pre-defined users/levels.

See Also
l Software Access screen
l Adding and Editing Users
l User Security List

User Security List

The User Security List screen lists the users configured on the system.

Accessing the User Security List

To access the User Security List:
1. Select Setup > Security > User Security List in the menu bar to open the User Security List.
2. See Adding and Editing Users.

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User Security List screen

Depending on your security level, you can add a new user, delete a user, or edit an existing user by clicking
the appropriate icons in the toolbar.

Selection C olumn
Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the
Select icon in the column heading to select or deselect all the rows in the table.

Locked Status C olumn

A check mark indicates the user ID is locked, and cannot log into the ACL TOP application. A user ID
becomes locked when any of the following occurs:
l The account expires.
l After three unsuccessful login attempts.
l A system administrator selects the User Locked option for a user in the User Security screen.
Only a system administrator can unlock an account.

See Also
l Adding and Editing Users
l Software Access Screen
l System Security

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Adding and Editing Users Chapter 4 – Setup

Adding and Editing Users

Only users with Supervisor or Administrator access rights can add, delete or modify users (user names). You
can define up to a maximum of 100 users.
The Supervisor and Administrator level can delete all users except the last Administrator.
The current user cannot delete his/her own entry in the User Security List, and cannot delete users with a
higher level of access than his/her own.

Adding a New User

To add a new user:
1. Select Setup > Security > User Security List in the menu bar to open the User Security List.

2. Select the Add icon in the toolbar.

3. In the User security screen, enter a unique user name in the Log on name field.
4. Enter the new user’s first name and last name in the appropriate fields.
5. Select a user security level in the Security level drop down list.
6. <Optional> Enter a comment in the Comments field.
7. Enter the login password in the Password field.
8. Reenter the password in the Confirm Password field.
9. <Optional> Select the Allow expiration option and configure the Valid period and Warning period
as necessary.
10. <Optional> Select the User Locked option lock a user out of the system.

11. Select the Save icon in the toolbar to save your changes.

12. Select the Previous Screen icon in the toolbar to return to the User Security List.
13. The new user appears in the User Security List.

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Unlocking a User
To unlock a user:
1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper
security level to perform the required actions.
2. Select Setup > Security > User Security List in the menu bar to open the User Security List.
3. Select1 the user in the User Security List.

4. Select the User Definition icon in the toolbar.

5. In the User security screen, remove the check mark in the User Locked setting.

6. Select the Save icon in the toolbar to save your changes.

Editing a User
To edit a user:
1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper
security level to perform the required actions.
2. Select Setup > Security > User Security List in the menu bar to open the User Security List.
3. Select2 the user in the User Security List.

4. Select the User Definition icon in the toolbar.

5. In the User security screen, make the necessary edits.

6. Select the Save icon in the toolbar to save your changes.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Deleting a User
To delete a user:
1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper
security level to perform the required actions.
2. Select Setup > Security > User Security List in the menu bar to open the User Security List.
3. Select1 one or more users in the User Security List.

4. Select the Delete icon in the toolbar.

5. Confirm the deletion.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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User Security Screen

User

Log on name
Unique user name. Used to log onto the ACL TOP instrument. Must be 1-20 case-sensitive characters.

First name
User’s first name (maximum 20 characters).

Last name
User’s last name (maximum 20 characters).

Security level
List of user security levels. Options are Administrator, Supervisor, Senior operator, and Operator.

C omment
Enter a comment with a maximum 80 characters.

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Adding and Editing Users Chapter 4 – Setup

Password

Password an d C onfirm password

User's login password (maximum 14 case-sensitive characters).

A llow expiration
Option to allow the password to expire after a configured number of days. If this option is not selected, the
password never expires. If selected, the following fields are enabled:
l Valid period – The period a password remains valid, after which the password becomes invalid.
Options are 1-365 days.
l Warning period – The period of time before password expiration when a system generated warning is
issued to the user. Options are 1-30 days.

Last modification
Date and time the user configuration was last changed.

U ser Locked
Option to lock a user out of the system. A check mark indicates the user is locked out of the system. A user
becomes locked when any of the following occurs:
l The account expires.
l After three unsuccessful login attempts.
l A system administrator selects this option.
See Unlocking a user.

See Also
l User Security List
l Software Access Screen
l System Security

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Software Access Screen Chapter 4 – Setup

Software Access Screen

The Software Access screen contains a table of operations that can be performed on the ACL TOP instrument,
and the user access level required to perform them. Any user can view the Software Access screen.

Accessing the Software Access Screen

To open the Software Access screen:
1. Select Setup > Security > Software Access Screen in the menu bar.
2. Click the expand/collapse icon in the left column to show and hide additional rows for a screen.
3. To update user access levels, click an entry in the Access Level column and select a new access level
in the drop down list.

4. Select the Save icon in the toolbar to save your changes.

NOTE: You can edit the Software Access screen only if you are logged on with the appropriate
access rights. The lab administrator is always allowed to edit this screen.

See Also
l User Security List
l Adding and Editing Users

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Formatting Reports Chapter 4 – Setup

Formatting Reports

Configuring Reports
To configure reports:
1. Select Setup > Reports in the menu bar.
2. Configure settings in the Report Configuration dialog box in the following tabs. Click a link for
details:

l Laboratory Header
l Demographic
l Footer
l AutoPrint Setup

3. To edit a table cell on the Laboratory Header and Footer tabs, double-click the cell and begin
typing.
4. Select OK.

NOTE: Patient results and calibration results must be validated before printing. See Reviewing Test
Results and Calibration Details.

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Laboratory Header Tab

This section is used to identify the laboratory that performed the analysis.

Alignment
Select one of the following options:
l Left – Left justifies the entire header at the top of the report.
l Middle – Centers the entire header at the top of the report.
l Right – Right justifies the entire header at the top of the report.

Column Headings

Field N ame
User-defined text field. The value entered identifies the data type to display in the report header. For
example: Laboratory. Maximum 15 characters. The actual text in this column does not appear in the report
header.

Field Value
Enter the text to display in the report header. This text corresponds to the Field Name cell to the left. For
example: Hemostasis Lab

NOTE:

l Defining a report header is optional.

l If you define a field name, the Field Value cell to the right of it must have an entry. For example, to
display the name of your laboratory, double-click the first empty cell in the Field Name column and
type Laboratory. Then double-click the Field Value cell to its right and type in your laboratory
name. The text in the Field Value column appears in the header of each report.

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Formatting Reports Chapter 4 – Setup

l If you leave a Field Name/Field Value pair empty, a blank line appears at that location in the header.
l The maximum number of lines in a report header is 20, including blank lines. Unused Field
Name/Field Value pairs beneath the last pair that you define are ignored. They do not produce blank
lines.
l Click a column heading to sort up or down.

Demographic Tab

Check or uncheck the data to appear on the Patient Report and Sample Results Report.

Footer Tab

This data appears on the report footer. Configuring this tab is similar to configuring the Laboratory Header
tab.

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Formatting Reports Chapter 4 – Setup

AutoPrint Setup Tab

You can autoprint patient samples by sample, test or rack. Printing starts when one of the following occurs:
l As soon as the configured number of samples or tests completes.
l When the rack, if selected, is completed.
l When the configured number of minutes has elapsed.
Printing does not occur while the AM1 is Busy or in a Controlled Stop.
If you select autoprint By sample, all unprinted tests for a specific sample are printed. If all tests for a given
sample have already printed, auto print is not initiated for that sample.
If you select autoprint By test, completed tests that have not yet printed will autoprint.
If you select auto print By rack, all programmed tests of the selected test types are printed when the sample
track status for that rack changes from In use to Present or Empty.

NOTE: If autoprint is enabled for patient samples, a page is used for each individual sample or test
(depending on the mode enabled).

See Also
l Reviewing Test Results
l Reviewing QC Results
l Sample List Area

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Display Overview Chapter 4 – Setup

Display Overview
You can configure the display settings for the Sample List, the Test Programming window, and the Material
Programming window:
To configure display settings:
1. Select Setup > Display in the menu bar.
2. In the Display submenu, select one options:

l Sample List Display Settings

l Test Programming Window
l Material Programming Window

See Also
l Sample List Area
l Test Programming Window
l Material Programming Window

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Sample List Display Settings Chapter 4 – Setup

Sample List Display Settings

See Configuring Sample List Display Settings in Sample List.

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Test Programming Window Chapter 4 – Setup

Test Programming Window

Use the Test Programming window to do the following:
l Make various tests and profiles accessible for programming in the Sample Details screen.
l Add and remove test orders to and from a sample rack position on the Rack Details screen in the
sample area.

Configuring the Test/Profiles Programming Window

To configure the Test/Profiles Programming Window:
1. Select Setup > Display > Test Programming Window in the menu bar. The Program Tests and
Profiles Placement Window first opens with blank programmable buttons.

2. To create a new tab, select the Add Tab button. In the Program tab name dialog box, enter a unique
tab name with a maximum 16 characters, and select OK. The new tab is added to the right of the
currently selected tab. Each tab contains twelve test or profile buttons. You can create up to 30 tabs.
3. To sort tabs, drag and drop tabs one at a time.
4. To remove a tab, select the tab and click the Remove Tab button. Confirm the deletion.
5. To program a button, drag a test or profile from the Available tests or Available profiles list to a
blank button on the tab. The test or profile name appears on the button, and the material is removed
from the respective list (for that tab only).
6. To remove a test or profile, drag the test or profile name from the button to the respective list. The
test or profile name is removed from the button and added to the respective list.
7. Select OK to save the configuration.

NOTE: Test and profile names can be added to only one button per tab, but can be added to
multiple tabs.

See Also
l Sample Rack Details l Sample Details
l Sample List Area

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Material Programming Window Chapter 4 – Setup

Material Programming Window

Use the Material Programming Window to do the following:
l Add or remove materials used for testing samples, QC, calibration, etc.
l Add or remove materials to or from a reagent or diluent rack position on the Rack Details screen in
the Reagent and Diluent Areas.

Configuring the Material Programming Window

To configure program materials:
1. Select Setup > Display > Material Programming Window in the menu bar. The Program Materials
Placement Window first opens with blank programmable buttons.

2. If the programming controls do not appear in the Program Materials Placement Window, select the

Show Programming Controls button to display them. Select the Hide Programming

Controls button to toggle these controls out of view.

3. To create a new tab, select the Add Tab button. In the Program tab name dialog box, enter a unique
tab name with a maximum 16 characters, and select OK. The new tab is added to the right of the
currently selected tab. Each tab contains twelve material buttons. You can create up to 30 tabs.
4. To sort tabs, drag and drop tabs one at a time.
5. To remove a tab, select the tab and click the Remove Tab button. Confirm the deletion.
6. To program a button, drag a material from the Available materials list to a blank button on the tab.
The material name appears on the button, and the material is removed from the Available materials
list (for that tab only).
7. To remove a material, drag the material name from the button to the Available materials list. The
material name is removed from the button and added to the Available materials list.
8. Select OK to save the configuration.

NOTE: Material names can be added to only one button per tab, but can be added to multiple tabs.

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Setup Language Chapter 4 – Setup

See Also
l Reagent Area
l Material List

Setup Language
To select the language to use on the ACL TOP instrument:
1. Select Setup > Language to open the list of available languages.
2. Select a language to use on the instrument.

NOTE: You must install the language files for this option to be available. Contact Service.

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CHAPTER 5
PREPARING THE SYSTEM

Additional Preparation
The system can stay on 24 hours a day. Automatic maintenance procedures such as fluidic priming cycles
and routine cleaning of the probes ensure the system is ready for analysis at any time. If the system stays on,
there is no need to perform any startup procedure before operating the system.
If the system is turned off, follow the Starting the Instrument instructions to start the system.
In addition, the following may require some preparation:
l Material Identification
l Bar Code Reader
l 2D Bar Code Scanner
l Reaction Cuvettes
l Rinse Fluid
l Clean Fluid
l Fluid Waste
l Reagents
l Calibrators and NPP
l Quality Controls
l Sample Containers and Adapters
l Diluents
l Restriction Map
l Sample Area
l Reagent Area
l Diluent Area
l Test Feasibility

See Also
l Managing Materials

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Material Identification Chapter 5 – Preparing the System

Material Identification
To ensure automatic material identification, make sure the bottle bar code labels are properly aligned in the
rack before placing them on the instrument. See Bar Code Label Placement.
An active material is defined as one that is placed and required to complete an ACTIVE test.

Manually Identifying Offline Rack Material

To manually identify offline rack material:
1. Select the menu option Analysis > <material area> (Diluent or Reagent Area).
2. Double-click a position on the offline rack (located on the left hand side of the screen) to display the
Rack Details screen.
3. Select the position where the material is located.

4. Select the Add/Remove Material icon in the toolbar, or select the ellipsis next to the
Material name field.
5. Select the material from the Materials window.

6. Select the Insert Rack icon from the toolbar.

7. Insert the rack.

NOTE:

l If you manually identify a material placed on the offline rack (sample, diluent, or reagent) and a tube
or bottle with a bar code label is on the same rack, the system attempts to match the information
manually entered with the bar code label. If it does not match, the system displays an error message.
l If you manually identify the presence of a material (tube, bottle, or sample cup) placed on the offline
rack (sample, diluent or reagent rack) and upon insertion, the bar code reader does not detect the
presence of that material, an error message displays for that position.
l If you fail to manually identify the presence of a material (tube, bottle or sample cup) placed on the
offline rack (sample, diluent, or reagent rack) and upon insertion, the bar code reader detects the
presence of a material, an error message displays for each detected position the system was not
expecting.
l When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling
a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

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Manually Identifying Inserted Rack Material

To manually identify inserted rack material:
1. Insert the rack with the material to identify manually (non-bar coded material). The system generates
an alarm.
2. In the Diluent or Reagent Area screen, double-click the rack containing the unidentified material
(displayed with a question mark) to access the Rack Details screen.
3. Select the position to identify.

4. Select the Add/Remove Material icon in the toolbar.

5. Select the material from the Materials window.

NOTE:

l When the material is in use, manual identification is disabled until the rack is removed.
l When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling
a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.
There are two ways to identify a material on board the ACL TOP instrument:
l Automatic Material Identification
l Manual Material Identification

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Automatic Material Identification – Using the Bar Code Reader

The ACL TOP instrument performs automatic material identification using a 1D bar code reader.

1D B ar C ode R eader
The 1D bar code reader is built into the ACL TOP instrument and is configured in Setup/Bar code
Definitions Setup.

1D B ar C odes
A material rack containing 1D bar coded material is inserted into the instrument. The the built-in bar code
reader reads the bar coded label looking for a match in the Materials database. If found, the information
(material name, type, lot number, expiration date, stability, etc) is displayed.
Inserting a rack or scanning material disables manual identification for bar coded materials. If the bar code
label is not readable, does not match the material definition information, or is otherwise unusable, manual
identification may be used to identify the material.

Update of Material Information

2D B ar C ode R eader
(Sold as an option for some models.)
The 2D bar code reader is external to the ACL TOP instrument and is hand held. See 2D Bar Code Scanner.
Bi-dimensional (2D) bar codes have been added to the boxes of those products with value assignment (PT
reagents, calibrators and controls) to provide a means of importing lot specific information and assigned
values into the system. In a single operation, the bi-dimensional bar code scanner provides a way for you to
scan the 2D bar codes to update lot information and related values such as ISI values for reagents, and
assigned values for calibrators and QC controls.

2D B ar C odes
An external hand held 2D bar code reader is used to scan 2D bar coded materials looking for a match in its
Materials database. If a match is found, the information for lot number, ISI values for reagents, and assigned
values for calibrators and QCs is updated.
If the matching information is not found, you must manually define it before it can be used. See Material
Definition.

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Manual Material Identification – Using the Offline Rack

Use the offline (virtual) rack to program a rack that has not been inserted into the instrument. The
programmed information is preserved while the rack is not placed. (Do not exit the application.) The
information moves with the rack as it is inserted into the instrument. The information is removed from the
offline rack when either of the following occurs:
l The information read by the bar code reader matches what you have manually identified on the rack
l If the bar code reader is disabled.
If the bar code reader is enabled but the scanned information does not match your offline rack information,
the offline rack information is not used.

See Also
l Bar Code Definitions Setup
l Bar Code Label Placement
l Reagents
l Reagent/Diluent Area
l Sample Area

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Bar Code Reader Chapter 5 – Preparing the System

Bar Code Reader

The bar code reader moves to each track position to allow for insertion of sample, diluent or reagent racks.
Bar coded information on sample tubes or diluent or reagent bottles is scanned into the instrument as the
racks are inserted.
Move the bar code reader to the desired track using the track buttons on the front of the AM or by clicking
the virtual track buttons displayed on the Reagent area screen on the CM. With the bar code reader
positioned in front of the track position, insert the rack. A track guides the insertion of the rack into its
correct position.

After the bar code reader has been at a track position for 30 seconds, or if the Run icon is selected, the
bar code reader moves back to its home position.

You can select the Home button displayed on the touch screen when the sample or reagent screen is
displayed to move the bar code reader (BCR) to its home position without having to wait for the BCR
timeout.
If the bar code reader is disabled, it will still scan the rack to detect vial presence. The material status
becomes Unknown.

CAUTION:

l Care should be taken when the bar code reader is moving so that your fingers do not get pinched.
l When you use the Home button, the Bar Code Reader warning light (located on the BCR cover)
blinks three times to warn you to clear the path. A rack incompletely placed in a track causes the
homing function to fail, and displays the BCR movement failure error.
l When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling
a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

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Bar Code Reader Chapter 5 – Preparing the System

TOP 300 CTS Bar Code Reader

TOP 500 CTS Bar Code Reader

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Bar Code Reader Chapter 5 – Preparing the System

TOP 700 Bar Code Reader

Includes the TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS
instruments.

See Also
l Bar Code Definitions Setup
l Bar Code Label Placement
l Instrument Description

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2D Bar Code Scanner Chapter 5 – Preparing the System

2D Bar Code Scanner

(Sold as an option on some ACL TOP models.)

Overview
Bi-dimensional (2D) bar codes
2D bar code labels appear on boxes of products with value assignment (PT reagents, calibrators and controls).
This allows you to scan, import and update the following types of material information on the system:
l Material lot information
l Assigned values for calibrators and QC controls
l Related values (such as ISI values for PT reagents)

Setup
Refer to the Plug and Play Program Guide that accompanies the 2D bar code scanner for setup information.

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Using the 2D Bar Code Scanner

To use the 2D bar code scanner:
1. Select Setup > Material List on the menu bar.

2. In the Material List, select the Scan icon in the toolbar.

3. Pull the trigger on the scanner to activate it. If communication with the device is successful, you are
prompted to scan the bar code. If communication is unsuccessful the Material List screen displays.

4. Scan the bar code label.

5. The bar coded information displays in the Verified barcode material data dialog box.
6. The system considers the newly scanned material as the alternate lot. Select the Toggle Lot button to
use the alternate lot (newly scanned material) on the system instead of the current active lot.

NOTE: Activating the alternative lot may necessitate calibration and validation. Refer to your
own laboratory procedures to determine the appropriate action.
7. To rescan the material, select the Retry button to clear the imported data, and scan the bar code label
again.
8. Select the Save button to update the Material List with the new scanned values for each material.
9. The new values do not replace the active lots when the scanned values are saved.

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Verified Barcode Material Data dialog box

A status message appears below the table.

Generally, all scanned information is displayed for each material. A blank field indicates unknown,
unmatched or not applicable information.

Material Information

N ame
Name of the scanned material.

Index
Material identifier. Values are as follows:
l 1-500 – Material manufactured by Instrumentation Laboratory.
l 501-999 – User-defined material. Unique for each material.

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Type
A material can be one of the following types:
l Intermediate reagent
l Start reagent
l Sample Diluent
l Quality Control
l Calibrator/NPP
l Clean
l Deficient Plasma

Import data
The scanned data area displays in the following two columns for comparison:
l New scanned data – Values of the newly scanned material. The system considers this the alternate
lot. (See Toggle Lot button.)
l Current Data (Active Lot) – Values of the same material that currently exists on the system.
The scanned values for each material are compared with the active lot information for the corresponding
material definition in the system.

Lot ID
An alphanumeric code that identifies where and when the material was manufactured.

Expiration date
The date when the material no longer meets the manufacturer’s specifications.

ISI value yes/no

Defines whether an ISI1 value is defined for the material.

ISI value
ISI value for the material.

B ottle type
Type of bottle that contains the material.

1International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and used to
calculate the International Normalized Ratio (INR).

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Column Descriptions

Errors
A check mark in this column indicates that additional information is available. Click a check mark to access
this information. An error does not necessarily mean a problem exists. In the example above, the error
indicates that the source of the assigned value available for import has units that are not defined for that test
on this instrument. This is a notification rather than a problem.

Buttons

Toggle Lot
Changes from active lot to alternate lot.

R etry
After a valid bar code is scanned and the results displayed, you can ignore them and scan again. Select the
Retry button to clear the screen data and re-enable the scan operation.

Save
A status message displays for each material shown. If all the scanned material definitions are available for
import, the Save button is enabled.
Select the Save button to update the Material List with the new scanned values for each material. The new
values do not replace the active lots when the scanned values are saved. You must still do calibrations,
validations, etc.

C ancel
Cancels the scan operation. You may cancel at any point during the scan procedure.

See Also
l Material Identification
l Bar Code Definitions Setup
l Bar Code Label Placement
l Bar Code Reader

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Reaction Cuvettes Chapter 5 – Preparing the System

Reaction Cuvettes
Cuvettes are packaged in boxes that contain 400 cuvettes. Each box contains 10 clips, each clip consisting of
10 strips of 4 cuvette cells. The instructions for opening the box and loading the cuvettes are printed on the
top of the box. The cuvette loader can hold up to 20 clips – a total of 800 cuvettes. Cuvettes may be loaded
at any time, regardless of the state of the ACL TOP instrument.

Cuvette Warning
The ACL TOP instrument generates a warning when the number of cuvettes falls below 3 clips (120 cells).
When the warning is generated, the cuvette loader LED in the auxiliary material status area of the Reagent or
Diluent Area screen becomes amber. In addition, the status light on the front of the AM1 turns amber, and a
yellow exclamation point appears on the Material Alarms button on the CM2.

Cuvette Error
When there are no cuvette strips in the cuvette loader, an error is generated. The Analytical Module stops
processing new samples and performs a controlled stop. The cuvette loader LED changes to red, and the AM
status light changes to red. A red exclamation point appears on the Material Alarms button on the Control
Module, and a message informs you that there are no more cuvettes available.

If you add more cuvette strips to the cuvette loader before the instrument performs a controlled stop, the
instrument continues performing whatever tests remain.

CAUTION Biohazard: Cuvette waste is biohazardous. Use precautions when emptying the
cuvette waste drawer. Refer to local and state regulations for disposal of potentially hazardous materials.

NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used
cuvettes on ACL TOP instruments. See Limitations and Disclaimers.

See Also
l Additional Preparation

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.
2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Rinse Fluid Chapter 5 – Preparing the System

Rinse Fluid
Rinse fluid is used to rinse the probes during analysis.

Overview
Rinse fluid is packaged in a 4-liter bottle that is placed on the right side of the analyzer. A tube connecting
the bottle to the system allows the rinse to be drawn into the analyzer.
The ACL TOP instrument has a sensor that automatically detects the presence and volume of rinse fluid. All
models except the ACL TOP 300 generate a warning when the volume is below 1000 mL, and an error
when the volume is less than 600 mL. The warning sensor is not included on the ACL TOP 300.

Material Alarm Warning

When the warning is generated, the Rinse fluid LED on the Auxiliary Material Status area of the Reagent
Area and Diluent Area screens turns amber, and a yellow exclamation point appears on the Material Alarm

Warning button on the CM1. The Rinse status light on the front of the analyzer turns amber.

Error Alarm Warning

When an error is generated, the analyzer stops processing new samples and performs a controlled stop. The

Rinse fluid LED changes to red, and a red exclamation point appears on the Material Alarm Error
button on the CM. In addition, the Rinse status light on the front of the AM2 turns red. When the level of the
rinse fluid drops below 100 mL, the instrument performs an emergency stop.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.
2The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Changing the Rinse Fluid

To change the rinse fluid:
1. Remove and discard the cap and foil from the new bottle.
2. Remove the cap with the tubing from the old bottle and discard the bottle.
3. Screw the old cap onto the new bottle.
4. Place the new bottle into its receptacle.
5. Check the tubing for large air bubbles, blockages, or kinks and remove if necessary.
The instrument detects when a new bottle of rinse is placed and performs an automatic priming cycle to
remove air bubbles from the rinse lines.

NOTE: In step 3, the old cap has a siphon and tubing attached. Steps 3 and 4 can be reversed, but
doing them in order minimizes the amount of time the siphon is in the air, and minimizes the risk of air
entering the tubing. If the cap assembly is damaged, remove the assembly. Unclip the tubing from the side of
the AM, remove the cap from the bottle and discard it. Replace it with a new assembly.

CAUTION:

l When replacing the rinse fluid, move computer, monitor and keyboard out of the way to prevent rinse
from spilling on them.
l The rinse bottle must be replaced when the instrument is not busy or in a controlled stop. Removing
the rinse bottle while the instrument is running causes an emergency stop.
l The 4 liter rinse bottle is not designed to refill during instrument operation. IL recommends periodic
changing of the rinse bottles to prevent accumulation of particulates and other contaminants.
l Do not top off. Refilling (topping off) the 4 liter rinse bottle during operation may cause air bubbles
in the tubing. This can happen when the bottle is close to empty, or if the end of the tubing is raised
above the liquid level. Bubbles in the rinse fluid can enter the rinse tubing and cause improper rinsing
of the probes. Take extra care to prevent bubbles when manipulating the contents of the rinse bottle.
l Allow the rinse sensor to turn to red before replacing the bottle. This ensures the system performs an
autoprime when the new bottle of rinse is detected and the sensor turns off.

See Also
l Parts and Consumables List
l LED Status Color Codes

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Clean Fluid Chapter 5 – Preparing the System

Clean Fluid
Clean fluid is used to clean the probes during analysis. This occurs when specified in a test parameter, or
through a maintenance activity.

Overview
The clean fluid is packaged in a 500 mL bottle that is placed on the right side of the analyzer. A tube
connecting the bottle to the system allows the cleaning solution to be drawn into the analyzer.
The ACL TOP instrument has a sensor that automatically detects the presence and volume of the clean fluid.
The warning sensor is not included on the ACL TOP 300. It generates a warning when the volume is below
75 mL and an error when the volume is less than 25 mL.
When the warning is generated, the Clean fluid LED on the Auxiliary Material Status area on the Reagent
Area and Diluent Area screens turns amber and a yellow exclamation point appears on the Material Alarm

Warning button on the CM1. In addition, the Clean status light on the front of the AM turns amber.

When the error is generated, the analyzer stops processing new samples and performs a controlled stop. The

Clean fluid LED changes to red, a red exclamation point appears on the Material Alarm Error button
and a message informs you that there is no more clean fluid available. In addition, the Clean status light on
the front of the AM turns red. If no clean fluid is detected in the clean well the instrument performs an
emergency stop.

CAUTION:

l Clean fluid contains hydrochloric acid and must be handled carefully. DO NOT ALLOW CLEAN
FLUID TO COME IN CONTACT WITH SKIN OR EYES. When handling or changing clean
solution bottles, wear protective eyewear, protective gloves and protective garments.
l When replacing the clean fluid, move the computer, monitor and keyboard to prevent clean fluid from
spilling on them.

NOTE:

l The clean bottle must be replaced when the instrument is not in the BUSY or CONTROLLED STOP
state.
l If the system detects a lack of clean fluid in the clean well (for example, caused by an air bubble in
the tubing reaching the clean well) an alarm is generated and the instrument performs an emergency
stop.
l A Rinse/Clean Priming Cycle for each probe can be performed in Maintenance to remove air bubbles
from the clean line.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Changing the Clean Fluid

To change the clean fluid:
1. Remove the cap from the new bottle and discard it.
2. Remove the cap from the old bottle.
3. Screw the old cap onto the new bottle.
4. Place the new bottle into its receptacle.
5. Check the tubing for large air bubbles, blockages, or kinks and remove if necessary.

NOTE:

l In step 3, the old cap has a siphon and tubing attached. Steps 3 and 4 can be reversed, but doing them
in order minimizes the amount of time the siphon is in the air, and minimizes the risk of air entering
the tubing. If the cap assembly is damaged, remove the assembly. Unclip the tubing from the side of
the AM, remove the cap from the bottle and discard it. Replace it with a new assembly.
l The instrument detects when a new bottle of clean fluid is placed, and performs a priming cycle to
remove air bubbles from the clean lines.

See Also
l Parts and Consumables List
l Performing Maintenance Activities
l LED Status Color Codes

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Fluid Waste Chapter 5 – Preparing the System

Fluid Waste
System fluid waste consists of the clean and rinse fluids used by the instrument during analysis and
maintenance operations.

Overview
Waste Pump
System fluid waste is discharged at the waste position located in the rinse/clean station for each probe.
Internal waste reservoirs located under the rinse/clean stations hold the waste fluid until enough fluid builds
up to trip the waste accumulator sensor which in turn starts the waste pump.

NOTE:

l The TOP 300 CTS uses gravity to empty waste fluid from the reservoirs.
l The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table or bench that
holds the instrument. It must maintain a negative slope across the entire length of the tubing to
minimize the backup of waste fluids. There must be no crimping in the tubing.
l For all instruments except the TOP 300, a sensor indicates when fluids fail to empty. If fluids back up,
the system performs an emergency stop.

Waste Container – Excludes the TOP 300 CTS

The waste pump empties the internal waste reservoirs through tubing into a waste container that is located
below the AM1. This container has its own sensor that detects when the container is nearly full. This causes a
warning message to display in Material Alarms, and the Fluid Waste LED on the front of the analyzer

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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changes to amber. If the nearly full waste container is not replaced with an empty one, the system generates
an error message after a predefined interval.
The TOP 300 CTS does not have a waste sensor. You must visually inspect the level of the liquid waste
container on a regular basis and empty it as necessary.

Material Alarm Warning

When an error is generated, the AM stops processing new samples and performs a controlled stop. The Fluid
Waste LED changes to red, a red exclamation point appears on the Material Alarms button, and a message
states that the waste container is full. At the conclusion of the controlled stop, an error displays on the CM1
instrument status.

Material Alarm Error

If the waste container continues to fill, an emergency stop is performed and an error message is generated in
the Materials Alarm window that states: Unable to empty the internal waste reservoir.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Changing the Fluid Waste Container

NOTE: The fluid waste container is not disposable. It is reusable. Changing the waste container is
not a common occurrence. For the common maintenance activity, see Empty Waste Fluid.
To change the fluid waste container:
1. Remove the cap from the new container and discard it.
2. Remove the cap from the old container.
3. Screw the old cap onto the new container.
4. Place the new container into its receptacle.
5. Check the tubing for large air bubbles, blockages, or kinks and remove if necessary.

NOTE:

l In Step 2 the old cap has tubing attached to it. Steps 3 and 4 can be reversed, but doing them in order
minimizes the amount of time the tubing is in the air and the risk of fluid waste dripping outside the
waste container. If the cap assembly is damaged, remove the assembly. Unclip the tubing from the
side of the AM, remove the cap from the container, and discard it. Replace it with a new assembly.
l If bleach is used, rinse the waste bottle with distilled water.
l Do not fill the bottle with bleach after you empty it.
l Make sure the lollipop sensor is secure against the side of the waste bottle. (The ACL TOP 300 does
not contain the lollipop sensor.)

CAUTION Biohazard: System fluid waste is biohazardous. Use precautions when

changing or emptying the fluid waste container. Always follow local regulations when disposing of liquid
waste.

See Also
l Performing Maintenance Activities
l Controlled Stop
l Emergency Stop
l Parts and Consumables List
l LED Status Color Codes
l System Decontamination

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Reagents Chapter 5 – Preparing the System

Reagents
The term reagents includes both chemical reagents and deficient plasmas. Reagents are classified as
intermediate reagents and start reagents. Depending on the instrument model, the reagent type may require a
specific placement location on the instrument. The instrument prompts with the proper placement.

Start Reagent
A start reagent is a reagent that, when mixed with sample or a sample mixture1, activates the reaction in the
optical reading unit (ORU). It is the last material added to the cuvette.

Intermediate Reagent
An intermediate reagent is a reagent that, when mixed with sample, activates certain ingredients of the
sample but is not enough to bring the reaction to the desired completion.
The reagent rack positions hold the 15 mL and 20 mL bottles. In addition, 4 mL and 10 mL bottles can be
used with the proper adapters (see Material Definition). There is an adapter for each of these bottles that
allows these smaller bottles to be seated correctly in the rack position while allowing the bar code label on
the bottle to be read.

Bottle Adapters

Reagents are placed in reagent racks inserted into reagent tracks, but can also be placed in a diluent rack.
Placing a reagent in the wrong position in the Reagent Area results in a warning message. See Test
Feasibility for proper placement of all reagents.
A warning message appears if the volume of a reagent falls below the limit defined as the warning threshold.
An error message appears when the bottle is empty. When multiple bottles of the same reagent are placed on-
board the instrument, after the volume in the bottle with a priority of 1 changes to 0, the probe moves to the
bottle with the priority of 2, then 3, etc. No further aspirations occur on bottles with a volume of 0.

See Also
l Managing Materials
l Test Feasibility

1A dilution that requires a two-step dilution process to achieve the required dilution ratio.

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Calibrators and NPP

Calibrator (Cal)
Calibrator is a type of sample with an assigned value used to calibrate a test.

Normal Pool Plasma (NPP)

Normal Pool Plasma is a type of sample used as a standard of comparison. It is used in the calculation of the
INR1 and in the calculation of test results that use the normalized ratio.

Quality Controls
Quality control (QC) materials can be placed in the ACL TOP instrument as follows:
l On diluent racks accessible by the sample arm.
l On sample racks in the Sample Area.
See Test Feasibility for proper placement of all reagents.
When you use sample cups in the sample racks, you cannot use bar codes, and therefore ACL TOP material
tracking features such as volume warning, on-board stability tracking, and expiration date tracking cannot
be used.

See Also
l QC Overview
l QC List
l QC Profiles List
l QC Results List
l QC Setup Definition
l QC Test Status List
l Reviewing QC Results

1International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time (PT)
worldwide.

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Samples Chapter 5 – Preparing the System

Samples
A sample is an aliquot1 of patient plasma from a primary sample tube or aliquot cuvette. Sample can also
refer to the material on which the test is being performed, including calibrators, controls, and NPP2
materials.
Samples are placed on sample racks that are inserted into tracks in the Sample Area of the ACL TOP
instrument. See Restriction Map. You may use either primary tubes or sample cups.

NOTE:

l If sample cups are used, they must be IL 2.0 mL sample cups. Using non-IL sample cups may lead to
improper sampling and incorrect results. See Parts and Consumables List.
l The amount of plasma in a sample tube must be sufficient to complete the tests and also avoid the
probe syringe tip entering the red blood cell level, which would contaminate the probe and
compromise patient results.
Bar coded sample tubes provide the ACL TOP instrument with the required sample ID information. If the
sample tubes are not bar coded, you must provide the sample ID.

NOTE: You cannot change a sample ID if the test status for that sample is ACTIVE.

1A known fraction of a whole, constituting a sample.

2Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Sample Containers and Adapters

Sample Adapters for Open and Closed Tubes

CAUTION: Fill sample tubes with enough plasma to complete the tests and to avoid entering the
red blood cell level, which would contaminate the probe and compromise patient results.
Open sample racks are designed to work with a variety of sample tubes and associated adapters to ensure the
tubes are held firmly in place during aspiration and the maximum amount of plasma is available for use.
CTS sample racks are designed to accommodate a variety of different tubes. The use of specially designed
adapters is needed to ensure the tubes are held firmly in place during the piercing and aspiration routines,
and to ensure the maximum amount of plasma is available for use.
If the surface of the liquid is below the bottom level of the sample cup (which represents the maximum depth
the sample probe can reach) the sample cannot be aspirated. The following types of adapters are available to
address this risk:
l Aliquot sample tube adapter – Raises the bottom of the aliquot tube to the same height as the
bottom of the sample cup. Aliquot tube adapters are black.
l Pediatric sample tube adapter – Similar to the aliquot sample tube adapter, but with a smaller
diameter to hold these thin tubes centered in the sample position. It has been validated to work with
1.8 mL and 2.7 mL tubes. Pediatric tube adapters are blue.
l Microtube adapter– Use exclusively with the Sarstedt 1.3 mL Microtube. Microtube adapters are
green.
l CTS adapter – Red adapter used with the standard CTS sample rack—one adapter per rack position.
l CTS rack adapter – Blue adapter that fits on top of all ten sample rack positions in the standard CTS
rack—one adapter per ten rack positions.
l Sarstedt CTS adapter – Red adapter used with the red Sarstedt CTS rack.
To avoid aspiration errors, probe errors, and probe contamination, use the correct adapter with the correct
tube type.

CAUTION: You must use only closed tubes on CTS sample racks. Use regular, uncapped, sample
tubes and sample cups on open tube sample racks. Failure to use the proper rack (standard rack for open
tubes; closed rack for closed tubes) may result in probe damage.

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Sample Tube Adapter

Adapter in Sample Rack

CTS Rack Adapter on Standard CTS Rack

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Sarstedt Closed Tube Sample (CTS) Racks

10 position Sarstedt CTS Racks

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These racks increase the cap piercing reliability of the closed Sarstedt primary sample tubes on ACL TOP
CTS instruments. The following two rack styles are designed to accommodate different sized Sarstedt tubes:
l One type securely holds Sarstedt tubes with cap diameters of 16.3 mm (for example, Sarstedt part
number 04.1902.100, 2.9 mL fill volume).
l The other type accepts and securely holds Sarstedt tubes with cap diameters of 14.0 mm (for example
Sarstedt part number 05.1165.100 or 05.1071.100 with 3.0 mL or 5 mL fill).

CAUTION: Monovette tubes with NEW Sarstedt racks and Adapters

When using the Sarstedt Monovette tubes on a ACL TOP CTS instrument, you must use the Sarstedt
CTS rack. In addition, you must do one of the following:
l Leave the sample track to the right of the Sarstedt rack empty; or
l Insert only a Sarstedt CTS rack in the track to the right of a Sarstedt rack.
This requirement prevents the protrusion on the left side of the CTS foot from contacting a Sarstedt CTS
rack when the piercer probe accesses non-Sarstedt tubes in a track to the right of a Sarstedt rack.

Cleaning

NOTE: For cleaning racks and adapters, IL recommends that you use any of the following:

l 10% bleach
l 0.1 N HCl
l Mild soap
After decontamination with bleach you should always rinse with tap water to remove excess bleach residue
on the inner walls of the container.
DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels.

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Old Style Sarstedt Closed Tube Sample (CTS) Rack and Adapters

10 position Sarstedt CTS Rack

These racks and adapters increase the cap piercing reliability of the closed Sarstedt primary sample tubes on
ACL TOP CTS instruments.

2-sided Sarstedt Tube Adapter

Sarstedt Tube Adapter

This tube adapter accepts all sizes of Sarstedt coagulation tubes by changing the orientation of the adapter in
the Sarstedt CTS rack. One side of the adapters have an opening that accepts larger diameter caps. Proper
orientation is essential for reliable cap piercing of Sarstedt tubes.

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Adapter Orientation 1 – Indicator (hole) up

With the indicator side up, the adapter accepts and securely holds Sarstedt tubes with cap diameters of 16.3
mm. (for example, Sarstedt part number 04.1902.100, 2.9 mL fill volume).

Adapter Orientation 2 – Indicator (hole) down

With the indicator side down, the adapter accepts and securely holds Sarstedt tubes with cap diameters of
14.0 mm (for example Sarstedt part number 05.1165.100 or 05.1071.100 with 3.0 mL or 5 mL fill).

CAUTION: Monovette tubes with OLD-STYLE Sarstedt racks and

Adapters
When using Sarstedt 5 mL Monovette tubes on a CTS instrument, always leave the sample tracks to the
right of these tall tubes empty unless the rack to the right also contains Sarstedt 5 mL Monovette tubes.
Do not place shorter tubes with these 5 mL tall tubes on the same rack. With the exception of the 5 mL
tubes, all other tubes can be mixed and matched in the same rack, and do not require empty rack
positions on the right side. This requirement ensures the foot does not hit the tall Sarstedt tube while it
is trying to reach the shorter (i.e., 1.8 mL Pedi) tube.

Cleaning

NOTE: For cleaning racks and adapters, IL recommends that you use any of the following:

l 10% bleach
l 0.1 N HCl
l Mild soap
After decontamination with bleach you should always rinse with tap water to remove excess bleach residue
on the inner walls of the container.
DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels.

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Validated Uncapped Sample Containers

The containers in the following table are valid for all ACL TOP models with uncapped tubes loaded in open
tube sample racks.
For a list of validated uncapped primary sample tubes that can be directly sampled from an LAS track, see
Validated Uncapped Sample Containers – LAS Track.

CAUTION: Use extra caution when using glass tubes which are prone to breakage.

Validated Uncapped Sample Containers

Sample Container Source/Available Adapter Needed Why Adapter
Type Part No. Needed
2.0 mL Cup IL P/N 55751-00 N/A
1.8 mL Pediatric Becton Dickinson Pedi (IL P/N 285246-00) Small OD, Low
Vacutainer® 366392 (IL P/N 285335-00) set of 10 fill volume
1.8 mL Plastic Becton Dickinson N/A
Vacutainer® 363080
1.8 mL Vacutainer® Becton Dickinson N/A
368273
2.7 mL Pediatric Becton Dickinson Pedi (IL P/N 285246-00) Small OD, Low
Vacutainer® 366393 (IL P/N 285335-00) set of 10 fill volume
2.7 mL Plastic Becton Dickinson N/A
Vacutainer® 363083
4.5 mL Vacutainer® Becton Dickinson N/A
369714
4.5 mL Vacutainer® Becton Dickinson N/A
366415
4.5 mL Vacutainer® Becton Dickinson N/A
367714
1.8 mL Greiner Bio-One Greiner Bio-One Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
Vacuette® * 454321 285334-00) set of 10
3.15 mL Greiner Bio- Greiner Bio-One N/A
One Vacuette® 454327
5.0 mL Vacuette Greiner Bio-One N/A
454330
5.0 mL Vacuette Greiner Bio-One CTS Adapter
456323
1.8 mL Greiner Bio-One Greiner Bio-One Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
Vacuette® 454322 285334-00) set of 10
3.15 mL Greiner Bio- Greiner Bio-One N/A
One Vacuette® 454332
2.7 mL Greiner Bio-One Greiner Bio-One N/A
Vacuette® 454334

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Validated Uncapped Sample Containers

Sample Container Source/Available Adapter Needed Why Adapter
Type Part No. Needed
1.3 mL Micro Tube * Sarstedt Micro (IL P/N 285296-00) Small OD, Low
41.1506.005 (IL P/N 285337-00) set of 10 fill volume
2.9 mL S-Monovette® Sarstedt N/A
04.1902.100
3 mL S-Monovette® Sarstedt N/A
05.1165.100
5 mL S-Monovette® Sarstedt N/A
05.1071.100
1.8 mL Venosafe® Terumo VF- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
052SBCS07 285334-00) set of 10
2.7 mL Venosafe® Terumo VF- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
053SBCS07 285334-00) set of 10
3.6 mL Venosafe® Terumo VF- N/A
054SBCS07
1.8 mL Venoject II® Terumo VP- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
C052K 285334-00) set of 10
2.7 mL Venoject II® Terumo VP- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
CW053K 285334-00) set of 10
4.5 mL Venoject II® Terumo VP- N/A
CW050K
1.8 mL Nipro sample Nipro NP-CD0185 Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
tube NP-CS0185 285334-00) set of 10
2.7 mL Nipro sample Nipro NP-CD0275 Aliquot (IL P/N 285245-00) (IL P/N Hold tube in rack
tube NP-CS0275 285334-00) set of 10
3.6 mL Nipro sample Nipro NP-CD0365 N/A
tube NP-CS0365
1.8 mL Sekisui sample Sekisui SPM- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
tube K0502S 285334-00) set of 10
1.8 mL Sekisui sample Sekisui ST-518SC Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
tube 285334-00) set of 10
Aliquot Tube Fisherbrand P/N Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
14-956 3D 285334-00) set of 10
Aliquot Tube Corning® P/N Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
430662 285334-00) set of 10

* Tubes are usable when filled to nominal levels. However, the amount of usable plasma will be lower than
500uL.

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Validated Uncapped Sample Containers for LAS – Track Only

Only the following tubes may be used on the LAS track.

Validated Uncapped Sample Containers for LAS - Track Only

Sample Container Type Source/Available Part No.
1.8 mL Plastic Vacutainer® Becton Dickinson 363080
2.7 mL Plastic Vacutainer® Becton Dickinson 363083
4.5 mL Vacutainer® Becton Dickinson 369714
4.5 mL Vacutainer® Becton Dickinson 366415
1.8 mL Greiner Bio-One Vacuette® Greiner Bio-One 454321
3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One 454327
1.8 mL Greiner Bio-One Vacuette® Greiner Bio-One 454322
3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One 454332
2.7 mL Greiner Bio-One Vacuette® Greiner Bio-One 454334
2.9 mL S-Monovette® Sarstedt 04.1902.100
3 mL S-Monovette® Sarstedt 05.1165.100
5 mL S-Monovette® Sarstedt 05.1071.100
1.8 mL Venosafe® Terumo VF-052SBCS07
2.7 mL Venosafe® Terumo VF-053SBCS07
3.6 mL Venosafe® Terumo VF-054SBCS07
1.8 mL Venoject II® Terumo VP-C052K
2.7 mL Venoject II® Terumo VP-CW053K
4.5 mL Venoject II® Terumo VP-CW050K
1.8 mL Nipro sample tube Nipro NP-CD0185, NP-CS0185
2.7 mL Nipro sample tube Nipro NP-CD0275, NP-CS0275
3.6 mL Nipro sample tube Nipro NP-CD0365, NP-CS0365
1.8 mL Sekisui sample tube Sekisui SPM-K0502S
1.8 mL Sekisui sample tube Sekisui ST-518SC

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Validated Capped Sample Containers for CTS – Piercing Mode

Enabled
These containers are valid for use on all ACL TOP CTS models. Piercing mode must be enabled.

Validated Capped Sample Containers for CTS –

Piercing Mode Enabled
Sample Container Type Source/Available Adapter needed Rack needed
Part No.
1.8 mL Pediatric Vacutainer® Becton Dickinson Pedi (IL P/N CTS sample
366392 285246-00) rack (IL P/N
(IL P/N 285335- 294008)
00) set of 10
1.8 mL Plastic Vacutainer® Becton Dickinson N/A CTS sample
363080 rack (IL P/N
294008)
2.7 mL Pediatric Vacutainer® Becton Dickinson Pedi (IL P/N CTS sample
366393 285246-00) rack (IL P/N
(IL P/N 285335- 294008)
00) set of 10
2.7 mL Plastic Vacutainer® Becton Dickinson N/A CTS sample
363083 rack (IL P/N
294008)
4.5 mL Vacutainer® Becton Dickinson N/A CTS sample
369714 rack (IL P/N
294008)
4.5 mL Vacutainer® Becton Dickinson CTS (IL P/N CTS sample
366415 285288-00) rack (IL P/N
(IL P/N 285336- 294008)
00) set of 10
3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One N/A CTS sample
454327 rack (IL P/N
294008)
1.8 mL Greiner Bio-One Vacuette® Greiner Bio-One Aliquot (IL P/N Low fill volume
454322 285245-00) (IL
P/N 285334-00)
set of 10
3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One N/A
454332
2.7 mL Greiner Bio-One Vacuette® Greiner Bio-One N/A
454334
2.9 mL S-Monovette®*° Sarstedt Sarstedt (IL P/N Sarstedt sample
04.1902.100 285821-00) rack (IL P/N
(IL P/N 294127- 285831)
00 set of 10)

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Validated Capped Sample Containers for CTS –

Piercing Mode Enabled
Sample Container Type Source/Available Adapter needed Rack needed
Part No.
3 mL S-Monovette®*° Sarstedt Sarstedt (IL P/N Sarstedt sample
05.1165.100 285821-00) rack (IL P/N
(IL P/N 294127- 285831)
00 set of 10)
5 mL S-Monovette®*° Sarstedt Sarstedt (IL P/N Sarstedt sample
05.1071.100 285821-00) rack (IL P/N
(IL P/N 294127- 285831)
00 set of 10)
2.7 mL Venosafe® Terumo VF- Aliquot (IL P/N CTS sample
053SBCS07 285245-00) (IL rack (IL P/N
P/N 285334-00) 294008)
set of 10
2.7 mL Venoject II® Terumo VP- Aliquot (IL P/N CTS sample
CW053K 285245-00) (IL rack (IL P/N
P/N 285334-00) 294008)
set of 10
1.8 mL Vacutainer® Becton Dickinson N/A
368273
4.5 mL Vacutainer® Becton Dickinson N/A
367714
5.0 mL Vacuette Greiner Bio-One CTS Adapter
456323

° Sarstedt sample rack (IL P/N 285831) is needed to run in closed tube mode. See Sarstedt Sample Rack.
* See old style Sarstedt CTS rack and adapter note.

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Validated Capped Sample Containers for CTS – Low-Fill Tubes

Use the following tubes when the Low-Fill Tubes Handling CTS option is enabled.

Validated Capped Sample Containers for CTS – Lower Z Piercing Mode

Enabled
Sample Container Source/Available Adapter Needed Why Adapter Needed
Type Part No.
1.8 mL Sekisui sample ST-518SC-J2 (IL P/N 285334-00) set CTS sample rack (IL P/N
tube * of 10 294008)

* Validated for use in CTS mode without Lower Z piercing mode enabled. However the usable volume1 will
be 200 uL or less.

1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.

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Sample Containers Not Recommended for CTS

These containers are not recommended for use on ACL TOP when capped.

Sample Containers Not Recommended for CTS

Sample Source/Available Why NOT RECOMMENDED for CTS
Container Part No. (Piercing mode enabled)
Type
2.0 mL Cup IL P/N 55751-00 Uncapped sample containers are not to be used with CTS sample racks.
Sampling from open tube when CTS is in pierce mode (sample may not
be collected correctly).
Aliquot Fisherbrand P/N Uncapped sample containers are not to be used with CTS sample racks.
Tube 14-956 3D Sampling from open tube when CTS is in pierce mode (sample may not
be collected correctly).
Aliquot Corning® P/N Uncapped sample containers are not to be used with CTS sample racks.
Tube 430662 Sampling from open tube when CTS is in pierce mode (sample may not
be collected correctly).
1.3 mL Sarstedt Push cap material cannot be pierced. Use in OPEN mode only Remove
MicroTube 41.1506.005 flip cap. Maximum usable volume1 is 200 uL. Contains an anticoagulant
(capped) in the tube and a flip top—it is not a vacutainer tube nor is it an aliquot
tube. Draw blood with a syringe, then fill the tube and mix the blood
with the anticoagulant.
1.8 mL Sekisui SPM- Cap of SPM-U0502S has indented core (diameter close to that of piercing
Sekisui K0502S (change probe). May be problematic for CTS. The piercer may not be able to
sample tube in cap material) center on the indented core correctly and pierce.
(capped) *
1.8 mL Sekisui SPM- This tube does not meet the requirement that a sample tube (excludes
Sekisui K0502S aliquot tubes) must have a minimum usable volume2 of 500 uL (10 PT
sample tube assays) to be used on the system. Currently, an average of only 250 uL
(capped) can be aspirated from this tube. This is because the distance from the cap
to the fill line is 52.50 mm and the CTS probe can only travel 54 mm
from the top of the cap into the tube. If the tube is not filled to the fill
line, a test cannot be performed.
4.5 mL Terumo VP- This tube has a high fill volume; there is not enough clearance between
Venoject CW050K the top of the plasma and the bottom of the cap during sample probe
II® (capped) aspiration. Using this capped sample tube in a CTS sample rack results in
the probe diving into the fluid during aspiration and possibly
contaminating the probe or resulting in fluidic imprecision.
3.6 mL Terumo VF- This tube has a high fill volume; there is not enough clearance between
Venosafe® 054SBCS07 the top of the plasma and the bottom of the cap during sample probe
(capped) aspiration. Using this capped sample tube in a CTS sample rack results
in the probe diving into the fluid during aspiration and possibly

1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.
2The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.

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Sample Containers Not Recommended for CTS

Sample Source/Available Why NOT RECOMMENDED for CTS
Container Part No. (Piercing mode enabled)
Type
contaminating the probe or resulting in fluidic imprecision.
1.8 mL Nipro NP- Tests revealed that the caps appear to be more elastic then other
Nipro CD0185, NP- manufactures and that this cap produces larger pieces of coring compared
sample tube CS0185 to other brands. The analytical precision of these tubes, does not meet
(capped) acceptance criteria for precision. This tube functions well only in
NONCTS mode.
2.7 mL Nipro NP- Tests revealed that the caps appear to be more elastic then other
Nipro CD0275, NP- manufactures and that this cap produces larger pieces of coring compared
sample tube CS0275 to other brands. The analytical precision of these tubes, does not meet
(capped) acceptance criteria for precision. This tube functions well only in
NONCTS mode.
3.6 mL Nipro NP- Tests revealed that the caps appear to be more elastic then other
Nipro CD0365, NP- manufactures and that this cap produces larger pieces of coring compared
sample tube CS0365 to other brands. The analytical precision of these tubes, does not meet
(capped) acceptance criteria for precision. This tube functions well only in
NONCTS mode.
SARSTEDT Sarstedt Carrier with tube above ZMax1. Needs adapter to fit on sample racks. Can
06.1668.001 only aspirate 80 uL without an adapter.
Monovette®
1.4 mL
sample
tubes
Greiner Greiner P/N This tube cannot be pierced. Also because the inside of this tube is
pediatric 450413 tapered there is a possibility of coming out of liquid for some test on our
tube 1 mL list.

See Also
l Parts and Consumables List

1Maximum travel distance of a probe in the Z (vertical) direction, measured at the lowest possible aspiration
point of the probe.

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Diluents
A diluent is a liquid used to reduce the concentration of another liquid. A sample diluent reduces the
concentration of sample material; a reagent diluent reduces the concentration of reagent material.
Sample diluents must be placed in a diluent rack. Placing a sample diluent in the wrong position causes a
warning message. See Test Feasibility for proper placement of all reagents.
The first two positions on the diluent rack hold 30 mL bottles, but can be used for 4 mL, 10 mL, and 20 mL
bottles providing the correct adapter is inserted into the position on the rack. There is an adapter for each of
these smaller bottles that allows them to be seated correctly in the rack position while allowing the bar code
label on the bottle to be read. These adapters are red to distinguish them from the reagent rack adapters.

Bottle Adapters

A warning message is displayed if the volume of a diluent falls below the limit defined as the warning
threshold. See Material Definition. An error message is displayed when the bottle is determined to be empty.

See Also
l Restriction Map
l Test Feasibility
l Material Definition
l Reagent/Diluent Area

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Restriction Map

NOTE: See Test Feasibility for proper placement of all reagents.

Overview
The Restriction Map shows which types of materials may be placed onto which tracks. It also the shows the
types of racks that may be placed and their corresponding track positions.

Important Considerations
l Place sample tubes and reagent/diluent bottles on the rack carefully to avoid damaging the bar code
labels. Make sure the labels can be read by the bar code reader.
l Use the tracks to guide the racks into the correct position. Improper seating of the rack can cause
spillage.

Accessing the Restriction Map

To open the Restriction Map:
1. Select one of the following icons in the toolbar to open the corresponding area:

Sample Area

Reagent Area

Diluent Area

LAS Cuvette Holding Area

2. Select the Restriction Map icon in the toolbar, or select Actions > Review > Restriction Map
in the menu bar.

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TOP 300 CTS Restriction Map

A bottle in a cell means that the material can be placed in the corresponding track position. For example:
l A patient sample may be placed in any track from S1 to S4.
l A calibrator1 sample may be placed in Sample tracks S1 - S4 plus diluent track D1.
l Sample diluents are restricted to tracks D1, reagent diluents to tracks D1 and R1-R3.

NOTE:

l If you define a sample clean material and select the Clean and Rinse option requiring a non-system
clean material such as Clean B diluted, that clean material must be placed in track D1.
l Non-system clean materials used by the reagent probes must be placed in tracks D1, or R1-R3.

1A type of sample with an assigned value used to calibrate a test.

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TOP 500 CTS Restriction Map

A bottle in a cell means that the material can be placed in the corresponding track position. For example:
l A Patient sample may be placed in any track from S1 to S8.
l A Calibrator sample may be placed in Sample tracks S1 - S8 plus diluent track D1.
l Sample diluents are restricted to tracks D1, reagent diluents to tracks D2 and R1 - R4.

NOTE:

l If you define a sample clean material and select the Clean and Rinse option requiring a non-system
clean material such as Clean B diluted, that clean material must be placed in track D1.
l Non-system clean materials used by the reagent probes must be placed in tracks D2, or R1-R4.

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TOP 700 Restriction Map

The following is the restriction map on ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700 CTS
(includes ACL TOP CTS) instruments:

A bottle in a cell means that the material can be placed in the corresponding track position. For example:
l A Patient sample may be placed in any track from S1 to S12.
l A Calibrator sample may be placed in Sample tracks S1 - S12 plus diluent tracks D1 and D2.
l Sample diluents are restricted to tracks D1 and D2, reagent diluents to tracks D3 and R1 - R4.

NOTE:

l If you define a sample clean material and select the Clean and Rinse option requiring a non-system
clean material such as Clean B diluted, that clean material must be placed in track D1 or D2.
l Non-system clean materials used by the reagent probes must be placed in tracks D3, R1, R2, R5,
and/or R6. Do not place non-system clean materials in tracks R3 or R4.

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TOP 700 LAS Restriction Map

A bottle in a cell means that the material can be placed in the corresponding track position. For example:
l A Patient sample may be placed in any track from S4 to S12.
l A Calibrator sample may be placed in Sample tracks S4 - S12 plus diluent tracks D1 and D2.
l Sample diluents are restricted to tracks D1 and D2, reagent diluents to tracks D3, and R1 - R4.

NOTE:

l Tracks S1 - S3 are unavailable on the LAS.

l If you define a sample clean material and select the Clean and Rinse option requiring a non-system
clean material such as Clean B diluted, that clean material must be placed in track D1 or D2.
l Non-system clean materials used by the reagent probes must be placed in tracks D3, R1, R2, R5,
and/or R6. Do not place non-system clean materials in tracks R3 or R4.

See Also
l Test Feasibility
l Reagent Area
l Diluent Area
l Reagent/Diluent Area

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Closed Tube Sampling Chapter 5 – Preparing the System

Closed Tube Sampling

WARNING Piercing Hazard: Do not put hand inside instrument while sample arm is in motion.

CAUTION Biohazard: In the unlikely event that the CTS piercer probe gets stuck or
jammed in the cap of a primary sample tube, do not attempt to remove the cap. Call Service for assistance.
The CTS piercer probe assembly is delicate, very sharp, and biohazardous. The removal of a stuck cap from
the piercer probe could cause personal injury or damage to the instrument.

Overview
In Closed Tube Sampling (CTS) mode, the instrument accepts both CTS sample racks and open tube sample
racks.

CAUTION: You must use only closed tubes on CTS sample racks. Use regular, uncapped, sample
tubes and sample cups on open tube sample racks. Failure to use the proper rack (standard rack for open
tubes; closed rack for closed tubes) may result in probe damage.
Sample tube adapters used with the CTS sample racks are listed in CTS Capped and Uncapped Sample
Containers and Adapters.
With CTS mode disabled, the instrument does not accept CTS sample racks. If a CTS sample rack is inserted
an error message displays: CTS rack rejected. When CTS is disabled, the instrument runs only uncapped
tubes and sample cups on open tube sample racks.
If you try to disable the CTS mode while CTS racks are on the instrument, a message displays: Unable to
disable CTS mode. CTS racks currently in use.
The following diagram shows the piercer/probe in the piercing mode (on left) and in the sample probe mode
(on right).

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Enabling/Disabling CTS Mode

To enable/disable CTS mode:
1. Make sure the instrument is in the READY state.
2. Select Setup > Global Definitions in the menu bar.
3. In the Global Definitions screen, select or clear the Enable piercing mode option in the CTS
parameters section.

4. Select the Save icon in the toolbar to save your changes.

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Closed Tube Sampling (CTS) Probe

The piercer probe assembly consists of both a piercer and a sample probe located in a piercer assembly. This
assembly is designed for sampling from capped primary sample tubes. The CTS piercer probe assembly has a
foot to hold the sample tube in place, allowing the piercer to cut through the cap. After the piercer cuts
through, the foot remains on the cap long enough to allow the probe to move down into the tube to aspirate
material. The debris from piercing the cap is collected by the piercer and deposited into a filter at the sample
arm rinse station.

Sample Arm CTS Probe

Sample Tube Cap Piercing

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After aspirating the sample, the CTS/Sample arm moves to the wash station and performs a deep wash.
Pressurized air is released through the piercer/probe to blow out any material that might remain following a
wash or rinse.
Special CTS racks are used for cap piercing. These racks are labeled CTS on the front of the rack.

CAUTION: If a cap is not detected on a sample tube placed in a CTS rack, an alarm displays. In this
case, remove the tube from the CTS rack and load it onto an open-tube sample rack. Use only capped sample
tubes on CTS racks. Use sample cups and uncapped sample containers on open-tube sample racks.

CTS Sample Rack

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NOTE: For cleaning racks and adapters, IL recommends that you use any of the following:

l 10% bleach
l 0.1 N HCl
l Mild soap
After decontamination with bleach you should always rinse with tap water to remove excess bleach residue
on the inner walls of the container.
DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels.

Sarstedt Closed Tube Sample (CTS) Rack and Adapters

See Sample Containers and Adapters.

See Also
l CTS Capped and Uncapped Sample Containers and Adapters

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Sample Area Chapter 5 – Preparing the System

Sample Area
See Sample Area under Sample Analysis.

Reagent Area
This topic applies to the following models:
l TOP 700 (includes TOP Base)
l TOP 700 CTS (includes TOP CTS)
l TOP 700 LAS
For TOP 500 CTS and TOP 300 CTS models, see Reagent/Diluent Area.

Overview
Each reagent rack in the reagent area holds up to six 20 mL or 15 mL bottles, but can also be used for the 4
mL and 10 mL bottles providing the correct adapter is inserted into the position on the rack. (See Reagents
and Restriction Map.) When placed on-board the analyzer, the first two positions (#1 and #2) in each reagent
rack provide stirring capability if a stir bar has been placed in the reagent bottle.
When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track
position. When the rack is no longer in use the LED changes to green and the rack is released.

Accessing the Reagent Area and Rack Details

To access the Reagent Area and Rack Details:

1. Select the Reagent Area icon in the toolbar, or select Analysis > Reagent Area in the menu
bar to open the Reagent Area.
2. Double-click a position on the offline rack (located on the left side of the screen) to open the Reagent
Rack Details screen.

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Programming Non-Bar Coded Reagents Using the Offline Rack

1. Select the Reagent Area icon, or select Analysis > Reagent Area in the menu bar.
2. Double-click a rack to open the Rack Details screen.

3. Select a position in the rack, then select the Add/Remove Material icon to open the Materials
window with that rack position in focus.
4. Select a reagent button to place that reagent in the reagent rack position. (See Material Programming
Window for configuring this window with reagents to select.)
5. To program additional reagents on the rack, select a position and repeat the previous step.

6. When you have programmed all the materials on the rack, select the Insert Rack icon in the
toolbar.
7. Insert the rack into the instrument.

NOTE: If for any reason a sample, diluent or reagent material that you manually program on an
offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is
issued. This includes failing to program a material the instrument detects.

CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before
loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Viewing On-board Materials

The Reagent & Diluent Map displays on-board materials in table format.
To view on-board materials:

1. Select the Sample Area , Diluent Area or Reagent Area icon in the toolbar to
open the Sample, Diluent or Reagent Area.
2. Select Actions > Review > Reagent & Diluent Map in the menu bar.
3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials by
position in each rack.
4. Select the Reagent Area tab to view the on-board reagents by position in each rack.
5. Select the right and left arrows below the table to display more racks.

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Reagent Area Operations Toolbar

Select the following icons to perform the associated tasks:

Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status.
Same as Actions > Map > Run Tests in the menu bar.

Test Feasibility List – Opens the Test Feasibility List which indicates the following:
l Whether the test is feasible. A red X indicates the test is not feasible.
l Whether the materials have been correctly placed.
l Number of tests that can run based on the volume of materials on-board.
You can add and run tests while the analyzer is running.

Restriction Map – Opens the Restriction Map. Also select Actions > Review > Restriction
Map in the menu bar.

Rack Details – Opens the Rack Details screen for the rack that has focus in the Reagent
Area screen.

Bar Code Home Position – Moves the bar code reader to its home position.

Print – Prints a report that contains the following:

l State of all inserted racks with material placed on-board.
l State of on-board materials.
This report is useful when a maintenance activity is performed requiring removal of material
racks.

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Reagent Rack Details Operations Toolbar

Select the following icons to perform the associated tasks:

Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status. Same as
Actions > Map > Run Tests in the menu bar.

Add/Remove Materials – Opens the Materials window where you select a reagent to add to the
reagent rack position in focus.

Clear rack information – Clears all reagents from the rack in focus.

Bar Code and Comments – Opens the Bar Code Edition dialog box where you can review
comments about the selected reagent (comments entered in the Material Definition – General
Information tab).

Insert Rack – Inserts the rack into the instrument.

Test Feasibility List – Opens the Test Feasibility List which indicates the following:
l Whether the test is feasible. A red X indicates the test is not feasible.
l Whether the materials have been correctly placed.
l Number of tests that can run based on the volume of materials on-board.
You can add and run tests while the analyzer is running.

Bar Code Home Position – Moves the bar code reader to its home position.

Print – Prints the rack details report for the rack displayed.

NOTE: After selecting Run:

l The instrument issues a warning if an enhanced clean is required. You must perform the enhanced
clean before running any other operations. See Enhanced Clean in Performing Maintenance
Activities.
l The instrument issues a warning if temperatures are out of range. You can confirm to run the current
operation, or cancel and wait until the temperatures are in range.

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l The instrument issues a message with the list of the disabled ORUs, if applicable, to warn of any
throughput changes. You can confirm to run the current operation, or cancel it.

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Reagent Area Screen

The reagent area includes the tracks on the right side of the AM. It is cooled to 15° C ± 3°. This screen is
functionally similar to the Sample Area screen.

Rack Representation
The reagent rack representation on the screen is:

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NOTE:

l You may notice a slight resistance when inserting or removing racks. This is normal.
l Material #1 is at the top. Material #6 is at the bottom.

Reagent & Diluent Map

Displays the materials that are on-board. Columns in the screen represent the tracks where racks are inserted
on the instrument. Rows in the screen represent the positions in the rack.

R eagent A rea tab

Display on-board reagents.

D iluent A rea tab

Display on-board diluent materials.

A rrow buttons
Select the right and left arrows below the map to display more racks.

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Rack Warnings and Errors

The Reagent Area of the Control Module1 has a boxed area to the right that contains rack warning and error
messages and status indicators.

D escription field
Displays the errors and warnings issued for the materials placed on-board.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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A uxiliary material status

Green – Cuvette waste door is open

Gray – Waste fluid status is OK

– Clean fluid status is OK
– Rinse fluid status is OK
– Cuvette waste status is OK
– Cuvette waste door is closed

Yellow – Waste fluid status is warning

– Clean fluid status is warning
– Rinse fluid status is warning
– Cuvette waste status is warning
– Cuvette loader status is warning

Red – Waste fluid status is full

– Clean fluid status is empty
– Rinse fluid status is empty
– Cuvette waste status is full or removed
– Cuvette loader status is empty

NOTE:

l IL recommends daily visual monitoring of the rinse and clean solutions.

l For all models except the ACL TOP 300, when rinse or clean solutions reach a low level, a warning is
issued.
l When the ACL TOP 300 rinse or clean bottle become empty, the instrument performs a controlled
stop, issues a warning, and the LED on the front of the instrument turns red.
l The ACL TOP 300 model does not have a status indicator for the waste fluid, cuvette door or cuvette
waste.

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Reagent Rack Details Screen

This screen contains information for each placed bottle of reagent. Double-click the reagent rack to open the
Rack Details screen.

Material N ame

Select browse ellipsis next to this field, or select the Add/Remove Material icon in the toolbar
to open the Materials window.

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The first tab of the Materials window opens with the reagents that have been configured for selection. (See
Material Programming Window for configuring this window with reagents to select.) Additional tabs contain
additional material names from which you can select. Select one material name per rack position. A reagent
definition can be changed when the reagent is not placed.

Lot ID
Material lot ID. By default, the active lot ID is selected. If defined, you may select the alternate lot ID
instead.

Priority
The default priority is zero. Priorities are automatically assigned by the system. Typically, first bottle placed
is assigned priority 1, the second bottle placed priority 2, and so on. An exception is made for QC reagents
(see QC Reagents).
You may also assign a numeric priority value. Material positions with the highest priority are used first (for
example, priority 1). You cannot change priority when a warning or error condition is displayed.

NOTE: If you remove a reagent or diluent rack, you may lose priority settings upon reentry of the
rack into the instrument. See Working Information.
QC Reagents
When new vials of QC reagent are added to a rack that contains existing vials of the same QC reagent, and
the rack is reinserted within one hour, the instrument uses all the reagent in the older vials before using the
QC reagent in new vial.
Separate Priority with Same Material Placed On Two Sides of the Analyzer
Vial priority is set based on the ability of the reagent to be transported. For example, if four vials of Material
A are placed on the system (two on the Sample side, and two on the Reagent side) the two vials on the
Sample side are assigned priority 1 and 2, and the two vials on the Reagent side are also assigned priority 1
and 2.

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For TOP 300 CTS, the diluent rack is accessible by the sample probe and reagent probe. However, priority
for reagents in the diluent rack is assigned to the sample probe. Reagents for the sample probe in the diluent
rack receive separate priority as identical reagents in reagent racks. When reagents in the reagent racks are
used up or expired, the reagent probe accesses the reagent in the diluent rack regardless of priority.

Expiration date
The reagent lot’s expiration date as established by the manufacturer.

W arnings and errors

List of warning and error message issued against the reagent in that rack position. Double-click this field to
display a window with the complete text of the message. Some possible messages are:
l Low material volume
l Empty material
l Lot not defined
l Material placement error
l Inconsistent bottle size
l Stability expired
l Material expiration
l Material not stirred

R emaining stability
The number of days, hours and minutes the reagent remains stable on-board the analyzer.

On-board volume
The current volume of reagent (in mL) on-board the analyzer.

R eagent color codes

On the far left of each reagent position is a colored circle that conveys additional information concerning the
reagent in that position, as follows:

Not placed Gray

Placed, not identified Green with a question mark
Placed, identified Green
Placed, warning Amber
Placed, error Red
In use Green surrounded by a heavy black circle
In use, warning Amber surrounded by a heavy black circle
In use, error Red surrounded by a heavy black circle

See Reagent Color Codes and LED Status Color Codes.

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W orking information
The working information refers to the attributes of a bar coded reagent vial on-board. It is used by the system
to determine test feasibility and reagent on-board stability.
The vial bar code contains the material name, expiration date, lot number, and vial size.
If the reagent or diluent rack is removed from the instrument and replaced, the bar code scan determines
whether the reagent vial is the same as the vial that was removed. The working information of a vial (on-
board stability) is retained under the following conditions:
l The vial must be reinserted into the same position from which it was removed.
l The vial must be reinserted within one hour after removal.
l The volume of fluid in the reagent vial cannot change by more than 30%.

Offline or Virtual Rack

The rack to the far left in the Reagent Area represents an offline rack on your workbench. It is used to pre-
program reagents for a rack before inserting it into the analyzer. You can also program a rack after it has been
inserted, but it is often preferable to do it beforehand.

CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before
loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

NOTE: If for any reason a sample, diluent or reagent material that you manually program on an
offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is
issued. This includes failing to program a material the instrument detects.

See Also
l Material Programming Window
l Reagent Color Codes
l Test Feasibility
l Restriction Maps
l LED Status Color Codes

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Diluent Area

Accessing the Diluent Area

To access the Diluent Area:

l Select the Diluent Area icon in the toolbar, or select Analysis > Diluent Area in the menu
bar.

l <300/500 CTS> Select the Reagent Area icon in the toolbar, or select Analysis > Diluent
Area in the menu bar.

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Diluent Area
TOP 300 CTS Diluent Area
The diluent area in the TOP 300 CTS model includes the one diluent rack position located in the reagent
area. This diluent rack holds up to 8 calibration plasmas, QC materials, and dilution materials in original
bottles placed on diluent racks.

500 CTS Diluent Area

The diluent area in the 500 CTS model includes the two diluent rack positions in the reagent area. These
diluent racks hold up to 16 calibration plasmas, QC materials, and dilution materials in original bottles
placed on diluent racks.

TOP 700 Diluent Area

The diluent area in the TOP 700 models includes the three diluent rack positions. Two in the sample area
and one in the reagent area. These diluent racks hold up to 24 calibration plasmas, QC materials, and dilution
materials in original bottles placed on diluent racks.
When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track
position. When the rack is no longer in use the LED changes to green and the rack is released.
See Test Feasibility for proper placement of all reagents.
The sample arm aspirates and dispenses materials from diluent racks placed in the sample area. The reagent
arm aspirates and dispenses materials from the diluent rack placed in the reagent area.
The Diluent Area screen is functionally similar to the Reagent Area screen. The diluent area can
accommodate three diluent racks (two tracks in the sample area and one in the reagent area). Each diluent
rack can hold two large bottles and six smaller bottles. The first two positions of the diluent rack can also be
used for 4 mL, 10 mL, and 20 mL bottles, providing the correct adapter is inserted into the position on the
rack. (See Diluents.) The diluent rack representation on the screen is:

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Diluent Area with Sample Probe

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Diluent Rack

NOTE:

l Material #1 is at the top; material #8 is at the bottom.

l You may notice a slight resistance when you are inserting or removing racks. This is normal.

NOTE: For cleaning racks and adapters, IL recommends that you use any of the following:

l 10% bleach
l 0.1 N HCl
l Mild soap
After decontamination with bleach you should always rinse with tap water to remove excess bleach residue
on the inner walls of the container.
DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels.

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Viewing On-board Materials

The Reagent & Diluent Map displays on-board materials in table format.
To view on-board materials:

1. Select the Sample Area , Diluent Area or Reagent Area icon in the toolbar to
open the Sample, Diluent or Reagent Area.
2. Select Actions > Review > Reagent & Diluent Map in the menu bar.
3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials by
position in each rack.
4. Select the Reagent Area tab to view the on-board reagents by position in each rack.
5. Select the right and left arrows below the table to display more racks.

Diluent Rack Details

This screen is identical to the Reagent Details screen. It contains information for each placed bottle of
material. Double-click the diluent rack in the Diluent Area screen that has focus to open the Rack Details
screen.

See Also
l Reagent Area l Test Feasibility
l Sample Status Color Codes l Restriction Map
l Reagent Color Codes

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Reagent/Diluent Area
This topic applies to TOP 500 CTS and TOP 300 CTS models. For TOP 700 (includes TOP Base), TOP 700
CTS (includes TOP CTS) and TOP 700 LAS models, see Reagent Area.

Overview
The Reagent/Diluent Area has diluent (D) tracks and reagent (R) tracks. The screen also displays an offline
rack for diluents on the left side, and an offline rack for reagents on the right side.
The Reagent/Diluent Area is cooled to 15° C ± 3°. Each reagent rack holds up to six 20 mL or 15 mL
bottles. You can also use 4 mL and 10 mL bottles with adapters. (See Sample Area and Reagents.) Positions
#1 and #2 in each reagent rack provide stirring if you place a stir bar in the reagent1 bottle.
See Test Feasibility for proper placement of all reagents.See Restriction Map for general placement of samples
and reagents.
A clear cover placed over the area helps to reduce condensation.

Accessing the Reagent/Diluent Area and Rack Details

To access the Reagent/Diluent Area and Rack Details:

1. Select the Reagent Area icon in the toolbar, or select Analysis > Reagent Area in the menu
bar to open the Reagent/Diluent Area.
2. Double-click a position on the offline rack (located on the left side of the screen) to open the Reagent
Rack Details screen.

1A liquid material used as part of a test. When mixed with sample, a reagent provides the necessary
constituents to initiate or complete the desired biochemical reaction. For example: test reagents, diluents,
QC/NPP materials, calibrator materials, clean materials, etc.

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Programming Non-Bar Coded Reagents Using the Offline Rack

1. Select the Reagent Area icon, or select Analysis > Reagent Area in the menu bar.
2. Double-click a rack to open the Rack Details screen.

3. Select a position in the rack, then select the Add/Remove Material icon to open the Materials
window with that rack position in focus.
4. Select a reagent button to place that reagent in the reagent rack position. (See Material Programming
Window for configuring this window with reagents to select.)
5. To program additional reagents on the rack, select a position and repeat the previous step.

6. When you have programmed all the materials on the rack, select the Insert Rack icon in the
toolbar.
7. Insert the rack into the instrument.

NOTE: If for any reason a sample, diluent or reagent material that you manually program on an
offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is
issued. This includes failing to program a material the instrument detects.

CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before
loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

Viewing On-board Materials

To view on-board materials:

1. Select the Sample Area or the Reagent/Diluent Area icon in the toolbar to open the
Sample or Reagent/Diluent Area.
2. Select Actions >Review > Reagent & Diluent Map in the menu bar.
3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials.
4. Select the Reagent Area tab to view the on-board reagents.
5. Select the right and left arrows below the map to display more racks.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Reagent/Diluent Area Operations Toolbar

Select the following icons to perform the associated tasks:

Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status.
Same as Actions > Map > Run Tests in the menu bar.

Test Feasibility List – Opens the Test Feasibility List which indicates the following:
l Whether the test is feasible. A red X indicates the test is not feasible.
l Whether the materials have been correctly placed.
l Number of tests that can run based on the volume of materials on-board.
You can add and run tests while the analyzer is running.

Restriction Map – Opens the Restriction Map. Also select Actions > Review > Restriction
Map in the menu bar.

Rack Details – Opens the Rack Details screen for the rack that has focus in the Reagent
Area screen.

Bar Code Home Position – Moves the bar code reader to its home position.

Print – Prints a report that contains the following:

l State of all inserted racks with material placed on-board.
l State of on-board materials.
This report is useful when a maintenance activity is performed requiring removal of material
racks.

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Reagent Rack Details Operations Toolbar

Select the following icons to perform the associated tasks:

Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status. Same as
Actions > Map > Run Tests in the menu bar.

Add/Remove Materials – Opens the Materials window where you select a reagent to add to the
reagent rack position in focus.

Clear rack information – Clears all reagents from the rack in focus.

Bar Code and Comments – Opens the Bar Code Edition dialog box where you can review
comments about the selected reagent (comments entered in the Material Definition – General
Information tab).

Insert Rack – Inserts the rack into the instrument.

Test Feasibility List – Opens the Test Feasibility List which indicates the following:
l Whether the test is feasible. A red X indicates the test is not feasible.
l Whether the materials have been correctly placed.
l Number of tests that can run based on the volume of materials on-board.
You can add and run tests while the analyzer is running.

Bar Code Home Position – Moves the bar code reader to its home position.

Print – Prints the rack details report for the rack displayed.

NOTE: After executing an operation:

l The instrument prompts you to abort and install a CTS filter if one is not detected. See Replace CTS
Filter and clean Clean Cup Area.
l The instrument issues a warning if an enhanced clean is required. You must perform the enhanced
clean before running any other operations. See Enhanced Clean in Performing Maintenance
Activities.

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l The instrument issues a warning if temperatures are out of range. You can confirm to run the current
operation, or cancel and wait until the temperatures are in range.
l The instrument issues a message with the list of the disabled ORUs, if applicable, to warn of any
throughput changes. You can confirm to run the current operation, or cancel it.

Reagent/Diluent Area Screen

TOP 300 CTS

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ACL TOP 500 CTS

When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track
position. When the rack is no longer in use the LED changes to green and the rack is released.

Rack Representation
The reagent rack representation on the screen is:

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NOTE:

l You may notice a slight resistance when inserting or removing racks. This is normal.
l Material #1 is at the top. Material #6 is at the bottom.

Reagent & Diluent Map

Displays the materials that are on-board. Columns in the screen represent the tracks where racks are inserted
on the instrument. Rows in the screen represent the positions in the rack.

R eagent A rea tab

Display on-board reagents.

D iluent A rea tab

Display on-board diluent materials.

A rrow buttons
Select the right and left arrows below the map to display more racks.

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Rack Warnings and Errors

The Reagent/Diluent Area has a boxed area to the right that contains rack warning and error messages and
status indicators:

D escription field
Displays the errors and warnings issued for the materials placed on-board.

A uxiliary material status

Green - Waste fluid status is OK

- Clean fluid status is OK
- Rinse fluid status is OK
- Cuvette waste status is OK

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- Cuvette waste door is open

Yellow - Waste fluid status is warning

- Clean fluid status is warning
- Rinse fluid status is warning
- Cuvette waste status is warning
- Cuvette loader status is warning

Red - Waste fluid status is full

- Clean fluid status is empty
- Rinse fluid status is empty
- Cuvette waste status is full or removed
- Cuvette loader status is empty

Status Indicator on Physical Instrument

NOTE:

l IL recommends daily visual monitoring of the rinse and clean solutions.

l For all models except the ACL TOP 300, when rinse or clean solutions reach a low level, a warning is
issued.
l When the ACL TOP 300 rinse or clean bottle become empty, the instrument performs a controlled
stop, issues a warning, and the LED on the front of the instrument turns red.
l The ACL TOP 300 model does not have a status indicator for the waste fluid, cuvette door or cuvette
waste.

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Reagent Rack Details Screen

This screen contains information for each placed bottle of reagent. Double-click the reagent rack to open the
Rack Details screen.

Material N ame

Select browse ellipsis next to this field, or select the Add/Remove Material icon in the toolbar
to open the Materials window.

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The first tab of the Materials window opens with the reagents that have been configured for selection. (See
Material Programming Window for configuring this window with reagents to select.) Additional tabs contain
additional material names from which you can select. Select one material name per rack position. A reagent
definition can be changed when the reagent is not placed.

Lot ID
Material lot ID. By default, the active lot ID is selected. If defined, you may select the alternate lot ID
instead.

Priority
The default priority is zero. Priorities are automatically assigned by the system. Typically, first bottle placed
is assigned priority 1, the second bottle placed priority 2, and so on. An exception is made for QC reagents
(see QC Reagents).
You may also assign a numeric priority value. Material positions with the highest priority are used first (for
example, priority 1). You cannot change priority when a warning or error condition is displayed.

NOTE: If you remove a reagent or diluent rack, you may lose priority settings upon reentry of the
rack into the instrument. See Working Information.
QC Reagents
When new vials of QC reagent are added to a rack that contains existing vials of the same QC reagent, and
the rack is reinserted within one hour, the instrument uses all the reagent in the older vials before using the
QC reagent in new vial.
Separate Priority with Same Material Placed On Two Sides of the Analyzer
Vial priority is set based on the ability of the reagent to be transported. For example, if four vials of Material
A are placed on the system (two on the Sample side, and two on the Reagent side) the two vials on the
Sample side are assigned priority 1 and 2, and the two vials on the Reagent side are also assigned priority 1
and 2.

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For TOP 300 CTS, the diluent rack is accessible by the sample probe and reagent probe. However, priority
for reagents in the diluent rack is assigned to the sample probe. Reagents for the sample probe in the diluent
rack receive separate priority as identical reagents in reagent racks. When reagents in the reagent racks are
used up or expired, the reagent probe accesses the reagent in the diluent rack regardless of priority.

Expiration date
The reagent lot’s expiration date as established by the manufacturer.

W arnings and errors

List of warning and error message issued against the reagent in that rack position. Double-click this field to
display a window with the complete text of the message. Some possible messages are:
l Low material volume
l Empty material
l Lot not defined
l Material placement error
l Inconsistent bottle size
l Stability expired
l Material expiration
l Material not stirred

R emaining stability
The number of days, hours and minutes the reagent remains stable on-board the analyzer.

On-board volume
The current volume of reagent (in mL) on-board the analyzer.

R eagent color codes

On the far left of each reagent position is a colored circle that conveys additional information concerning the
reagent in that position, as follows:

Not placed Gray

Placed, not identified Green with a question mark
Placed, identified Green
Placed, warning Amber
Placed, error Red
In use Green surrounded by a heavy black circle
In use, warning Amber surrounded by a heavy black circle
In use, error Red surrounded by a heavy black circle

See Reagent Color Codes and LED Status Color Codes.

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W orking information
The working information refers to the attributes of a bar coded reagent vial on-board. It is used by the system
to determine test feasibility and reagent on-board stability.
The vial bar code contains the material name, expiration date, lot number, and vial size.
If the reagent or diluent rack is removed from the instrument and replaced, the bar code scan determines
whether the reagent vial is the same as the vial that was removed. The working information of a vial (on-
board stability) is retained under the following conditions:
l The vial must be reinserted into the same position from which it was removed.
l The vial must be reinserted within one hour after removal.
l The volume of fluid in the reagent vial cannot change by more than 30%.

Offline Racks
The racks to the far left and far right represent offline racks on your workbench. You can pre-program the
diluents on the left offline rack, or the reagents on the right offline rack before inserting them into the
analyzer. You can also program a rack after it has been inserted, but it is often preferable to do it beforehand.
See Material Identification.

NOTE: If for any reason a sample, diluent or reagent material that you manually program on an
offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is
issued. This includes failing to program a material the instrument detects.

NOTE: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading.
Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Diluent Rack Details Screen

This screen is functionally similar to the reagent Rack Details screen described in this topic.
The Diluent Area includes the 1-3 tracks, depending on the model. The diluent rack holds up to 8
calibration/NPP plasmas, QC materials, and sample dilution materials in original bottles placed on the
racks, or up to 8 intermediate reagents, deficient plasmas, reagent dilution materials. See Test Feasibility for
proper placement of all reagents.
Each diluent rack can hold two large bottles and six small bottles. The first two positions of the diluent rack
can be used for 4 mL, 10 mL, and 20 mL bottles when the correct adapter is inserted into the position on the
rack. (See Diluents.)

Rack Representation
The diluent rack representation on the screen is:

NOTE:

l Material #1 is at the top; material #8 is at the bottom.

l You may notice a slight resistance when you are inserting or removing racks. This is normal.

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LED
When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track
position. When the rack is no longer in use the LED changes to green and the rack is released.

See Also
l Material Programming Window
l Reagent Color Codes
l Test Feasibility
l Restriction Maps
l LED Status Color Codes

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Test Feasibility
Test Feasibility checks whether all the materials a selected test needs are available and usable. It answers the
question: Why won't my test run?
The Test Feasibility window identifies the reagents required to run the test, and where to place them on the
instrument (rack and position).

NOTE: See Restriction Map for general placement of samples and reagents.

Accessing The Test Feasibility List

To access the Test Feasibility List:

1. Select the Sample Area , Diluent Area or Reagent Area icon in the toolbar to
open the Sample, Diluent or Reagent Area.
2. Select Actions > Review > Test Feasibility List in the menu bar, or select the Test Feasibility List

icon in the toolbar.

3. The Test Feasibility List window opens, where you can view information on the Test Feasibility List
and QC Feasibility List tabs.

Test Feasibility List window

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Test Feasibility List Tab

Test C ode
Tests defined on the system.

General C onsistency
If checked, the test is set up correctly and can run.

General Feasibility
Feasibility status of normal and extended tests. The following values can appear in this column:
l X – One or more materials are not placed on-board, or are placed in the wrong position, or are placed
with insufficient volume.
l Black number – The test is feasible, and the materials are correctly placed. The value indicates the
approximate number of tests that can run based on the usable volume1 of materials on-board.
l Black zero – An insufficient volume of material is placed on-board.
l Yellow number – The test is feasible, but there is no valid calibration for the on-board lot.
Clicking a cell in this column displays a window with the following information:
l List of the materials required to run the test.
l Material types.
l Positions where the materials should be placed on-board.
l Number of tests that can run with the volumes of material on-board.
l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The
materials may not be in the correct rack position. The following message appears in the Status bar:
Job not feasible: Needed materials not placed, incorrect placement or empty volume.

NOTE: The numbers displaying how many tests are feasible are approximate, and should be used
only as a guide.

1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.

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Required materials may include some or all of the following, depending on what has been defined:
l Load cycle reagents
l Load cycle sample diluents
l Load cycle reagent diluents
l Clean materials for load cycle materials
l Predilution diluent
l Predilution diluent clean
l Rerun predilution diluent
l Rerun predilution diluent clean.

Parallelism Feasibility
All tests for which parallelism has been defined have either a red X or a number. The following values can
appear in this column:
l X – One or more materials are not placed on-board, or are placed in the wrong position, or are placed
with insufficient volume.
l Black number – The test is feasible, and the materials are correctly placed. The value indicates the
approximate number of tests that can run based on the usable volume1 of materials on-board.
l Black zero – An insufficient volume of material is placed on-board.
l Yellow number – The test is feasible, but there is no valid calibration for the on-board lot.
Clicking a cell in this column displays a window with the following information:
l List of the materials required to run the test.
l Material types.
l Positions where the materials should be placed on-board.

1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.

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l Number of tests that can run with the volumes of material on-board.
l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The
materials may not be in the correct rack position. The following message appears in the Status bar:
Job not feasible: Needed materials not placed, incorrect placement or empty volume.

C alibration Feasibility
All tests for which calibration has been defined and do not use an imported calibration have either a red X or
a number. The following values can appear in this column:
l X – The required materials are not placed in the correct positions, or there is no validated calibration
for the on-board lot.
l Black number – The test is feasible and the materials have been correctly placed. The number
indicates the approximate number of tests that can run with the usable volume1 of materials on-board.
l Black zero – An insufficient volume of material is placed on-board.
Clicking a cell in this column displays a window with the following information:
l List of the materials required to run the test.
l Material types.
l Positions where the materials should be placed on-board.
l Number of tests that can run with the volumes of material on-board.
l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The
materials may not be in the correct rack position. The following message appears in the Status bar:
Job not feasible: Needed materials not placed, incorrect placement or empty volume.

QC Feasibility
See QC Feasibility List tab.
The following values can appear in this column:
l Black Check Mark – QC for the test is feasible. All materials (reagents and controls) are correctly
placed and have sufficient volume.
l Gray Check Mark – Some of the materials do not have sufficient volume to run the test. QC can run
using the controls that are present in sufficient volume. See Grid Icons.
l X – QC is not feasible.

1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.

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N PP Feasibility
All tests for which NPP1 has been defined have either a red X or a number. The following values can appear
in this column:
l X – One or more materials are not placed on-board, or are placed in the wrong position, or are placed
with insufficient volume.
l Black number – The test is feasible, and the materials are correctly placed. The value indicates the
approximate number of tests that can run based on the usable volume2 of materials on-board.
l Black zero – An insufficient volume of material is placed on-board.
l Yellow number – The test is feasible, but there is no valid calibration for the on-board lot.
Clicking a cell in this column displays a window with the following information:
l List of the materials required to run the test.
l Material types.
l Positions where the materials should be placed on-board.
l Number of tests that can run with the volumes of material on-board.
l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The
materials may not be in the correct rack position. The following message appears in the Status bar:
Job not feasible: Needed materials not placed, incorrect placement or empty volume.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.
2The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.

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QC Feasibility List Tab

Test C ode
Lists all tests for which QC has been defined.

Material name
Lists all the QC controls defined for the test.

QC Feasibility
Number of QC tests that can run with the usable volume1 on-board.
Clicking a cell in this column displays a window with the following information:
l List of the materials required to run the test.
l Material types.
l Positions where the materials should be placed on-board.
l Number of tests that can run with the volumes of material on-board.

1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle.

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l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The
materials may not be in the correct rack position. The following message appears in the Status bar:
Job not feasible: Needed materials not placed, incorrect placement or empty volume.

Refresh/Close
Select Refresh to refresh the contents of the window. Select Close to close the window.

LAS Test Feasibility

A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become
feasible, or until the sample expiration time elapses.

See Also
l Material Definition – Smallest Volume

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CHAPTER 6
STARTING AND STOPPING THE INSTRUMENT

Starting and Stopping Overview

To start or stop the instrument, select one of the following:
l Starting the Instrument
l Shutting Down the Instrument
l Emergency Stop
l Controlled Stop
l Recovery
l Resume Auto Run

Starting the Instrument

To start the instrument:
1. Make sure the access cover is closed.
2. Power on the CM1.
3. Power on the AM2 using the On/Off switch on the right side of the analyzer.

4. Double-click the ACL TOP icon on the desktop.

5. Log onto the ACL TOP instrument.
See Recovery for starting the instrument after an emergency stop.
The analyzer mechanical initialization process takes about three minutes. After initialization, the AM enters
the Adjusting Thermal state to regulate all thermally controlled devices.
The time for the AM to reach specified temperature (Power-Up to Ready) with empty sample and reagent
modules takes approximately 30 minutes at a nominal operating temperature of 25° C. At the extreme

1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.
2The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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operating temperatures of 15° C and 32° C, it takes approximately 60 minutes with empty sample and reagent
modules.

NOTE:

l A rinse flow verification test is performed automatically by the instrument at the end of mechanical
initialization. However, it does not start if the cuvette loader is Empty or if there is a Rinse Bottle
Empty error or Low warning. If a probe fails this test (each probe can retry one additional time), a
Rinse Flow Test Failure message appears.
l If any probe coordinates files are missing, the instrument status changes from Initializing to Error, and
you must select System > Diagnostics > Probes and perform the coordinates adjustment for the
affected arm(s) before the instrument can complete initialization. When you exit Diagnostics,
mechanical initialization is performed automatically by the instrument. See Probes/Coordinates
Adjustment.
The time required to stabilize depends on the ambient temperature and initial conditions of the system.
The system is ready to use when the status LED is green and the CM displays Ready.

Normally, the instrument is kept running continuously. Automatic maintenance procedures such as periodic
fluidic priming cycles ensure the system is Ready for analysis at all times.

See Also
l Starting and Stopping Overview

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Shutting Down the Instrument Chapter 6 – Starting and Stopping the Instrument

Shutting Down the Instrument

To shut down the instrument:
1. Make sure the AM1 in the Ready state.
2. Select Instrument > Exit in the menu bar.
3. Select OK in the confirmation dialog box. The AM begins an abbreviated mechanical initialization to
place the analyzer into a known safe state.
4. At the conclusion of the mechanical initialization, turn off the AM. The switch is located on the right
side of the analyzer.
5. Shut down the CM2 according to standard Windows procedures.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

See Also
l Starting the Instrument
l Starting and Stopping Overview
l Emergency Stop
l Controlled Stop
l Recovery

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.
2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Emergency Stop
An emergency stop immediately terminates all operations and motion on the Analyzer1. An emergency stop
can be performed when the instrument is in any state except Not Connected, even when no user is logged on.
To perform an emergency stop
l Press the red emergency stop button on the front of the Analyzer.

See Also
l Starting the Instrument
l Starting and Stopping Overview
l Emergency Stop
l Controlled Stop
l Recovery

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analytical Module.

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Controlled Stop Chapter 6 – Starting and Stopping the Instrument

Controlled Stop
The Instrument > Controlled Stop menu command stops the ACL TOP instrument from processing new
samples. This is a user-initiated controlled stop as opposed to the instrument-initiated controlled stop. These
two operations are the same. They complete samples that have started testing, then return the Analytical
Module1 to the READY state. Tests that had not started when the controlled stop initiated return to the
PLACED state.

Performing a Controlled Stop

To perform a controlled stop:
1. Select Instrument > Controlled Stop in the menu bar.
2. Select OK on the confirmation dialog box.

NOTE: If you select Cancel or close the confirmation dialog box without selecting OK, the
controlled stop request is canceled.

TOP 700 LAS Controlled Stop

Since the ACL TOP 700 LAS system has Auto Run always enabled, you need the ability to stop processing
samples at any time. The LAS Controlled Stop choice on the Instrument menu stops processing new samples.
This is a user-initiated controlled stop. If selected while the instrument is in the BUSY state, it allows the
tests that have already started to complete. Tests that had not started when the LAS Controlled Stop was
initiated return to the PLACED state.
When the ACL TOP 700 LAS status is Stopped the following applies:
l New tubes from the LAS track are rejected.
l No new aspirations are performed.
l The sample tube currently in use is held at the track aspiration point.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analyzer.

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Resume Auto Run Chapter 6 – Starting and Stopping the Instrument

Performing a Controlled Stop on an ACL TOP 700 LAS Instrument

To perform an LAS Controlled Stop:
1. Select Instrument > LAS Controlled Stop in the menu bar.
2. Select OK on the confirmation dialog box.

NOTE: If you select Cancel or close the confirmation dialog box without selecting OK, the
controlled stop request is canceled.
3. After the LAS controlled stop completes, do one of the following to start a new analytical session.
The instrument status changes from Stopped to Ready.

l Select Instrument > Resume Auto Run in the menu bar.

l Select the Run icon in the toolbar.

l Select Actions > Map > Run Tests in the menu bar.

See Also
l Starting and Stopping Overview
l Resume Auto Run

Resume Auto Run

If any of the following conditions occur, the instrument disables Auto Run:
l The AM status is not READY.
l Sample status is not PLACED.
l Enhanced clean is required.
l Temperatures are out of range.
l All ORUs are disabled.
To re-start Auto Run:
1. Hover the cursor over the red LED on the screen to display a tooltip stating cause of the error.
2. Correct the error.
3. Select Instrument > Resume Auto Run in the menu bar.
4. The Auto Run status changes to Ready and the Auto Run function starts again.

See Also
l Run / Auto Run

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Recovery Chapter 6 – Starting and Stopping the Instrument

Recovery
Recovery initializes the system and returns the instrument to the Ready state after an emergency stop.

Overview
After an emergency stop occurs and recovery is performed, the sample and reagent rack information is
retained when both of the following conditions are met:
l The bar code reader is not moved.
l The covers are not opened during the emergency stop.

After recovery, select the Run icon in the toolbar to run tests on samples in the TO DO state.

LA S
On the TOP 700 LAS model, after an emergency stop has occurred and recovery is initiated, the Analytical
Module1 notifies the Control Module2 of all cuvettes detected in the LAS aspiration area, the LAS holding
area, and in the shuttle. Only cuvettes with successfully aspirated sample and tests programmed are restored.
Cuvettes that are empty or have partially aspirated samples are not restored and are eventually moved to the
cuvette waste.

Performing a Recovery Operation

To perform recovery:
1. <Optional> To retain sample and reagent rack information, do not move the bar code reader or open
the instrument covers while the instrument is in the emergency stop.
2. Select Instrument > Recovery in the menu bar.
3. If the bar code reader was moved or the covers opened during the emergency stop, remove the racks
and reinsert them into the instrument to restore sample and reagent rack information that was lost
during recovery.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analyzer.
2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

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Performing a Forced Recovery

Use this procedure if the instrument stalls.
To perform a forced recovery:
1. <Optional> To retain sample and reagent rack information, do not move the bar code reader or open
the instrument covers while the instrument is in the emergency stop.
2. Press the emergency stop button on the front of the instrument.
3. Select Instrument > Recovery in the menu bar.
4. If the bar code reader was moved or the covers opened during the emergency stop, remove the racks
and reinsert them into the instrument to restore sample and reagent rack information that was lost
during recovery.

See Also
l Starting and Stopping Overview

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CHAPTER 7
CALIBRATION

Calibration Details

Overview
Calibration allows for the conversion of a measured value (raw data) to a value expressing units of
concentration or activity of the analyte. The analyzer makes dilutions, adds reagents, and takes readings, then
generates a calibration curve.
After a calibration is complete, you can review the calibration results and manually validate them so they can
be used to calculate sample results. When you validate a calibration, you confirm that the calibration results
are valid for a particular lot of calibrator1 and reagent. You can also autovalidate the calibration results. See
Auto Validation Setup
The ACL TOP instrument can store the ten most recent calibrations, but only one calibration can be
validated at any time. After the 11th calibration runs, the oldest calibration is removed from the Calibration
Details screen. The validated calibration is never removed.

NOTE: If you change the parameters of a user-defined test so the analytical performance of that test
is affected, you must recalibrate that test. See User-Defined Tests disclaimer.

NOTE: A calibration will become an alternate lot if any of the material lots (other than the
calibrator) used to generate the active calibration are no longer on-board the system. When a calibration
changes from active to alternate, the calibration status changes from validated to unvalidated.

1A type of sample with an assigned value used to calibrate a test.

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Reviewing and Validating Calibration Test Results

To review and validate calibration test results:
1. Select Calibration > Status List in the menu bar.
2. In the Calibration Status List, double-click a test code, or select a test code and select the

Calibration Details icon to open the Coagulation Calibration Details screen.

By default, the Calibration Details screen opens displaying the validated calibration. If a test has no
validated calibration, the Calibration Details screen displays Calibration 1.
3. Select the Calibration Curve tab to view the calibration curve and results for the various dilutions.
4. Select the Calibration Information tab to view calibration status information.
5. Select the Reactions Information tab to view the reaction curves for each point on the calibration
curve as well as errors and warnings for specific data points.
6. Select the Tracking Information tab to view lot specific information for the materials used and a log of
all comments related to the calibration.

7. To add or edit a comment in the Tracking Information tab, select the Comments icon in the
toolbar. The system also prompts you for comments after you make any edits in the Coagulation
Calibration Details screen.
8. To validate a calibration, select the tab with the calibration to validate (e.g., Calibration 1, 2, etc.),
and select the Validate icon in the toolbar. The calibration data is stored in the system and is
used to calculate calibrated results for future tests. Validation is not possible if any calibration check
fails.

9. To recalculate a calibration, select the Recalculate Calibration icon. This replots the
calibration curve according to the current test and material definitions. When recalculating calibration
results, the system uses the calibrator lot number used during execution. If the lot number does not
exist or the proper assigned values are not accessible, the recalculation fails. See Reviewing Test
Results.

10. Select the Save icon in the toolbar to save your changes.

11. Select the Previous Screen icon in the toolbar to return to the Calibration Status List.

NOTE:

l If the calibration result has a warning and you validate the result despite the warning, that warning is
not posted to the sample results. You are responsible for acknowledging the warning and ignoring it.
l Failed calibrations may not be validated.

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l A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to
generate the active calibration are no longer on-board the system. When a calibration changes from
active to alternate, the calibration status changes from validated to unvalidated.

Viewing Calibration Curves

To view a curve in the Calibration Curve tab:
1. Open a test in the Coagulation Calibration Details screen.
2. Select the Calibration Curve tab.
3. Double-click the curve to enlarge the window.
4. Select Actions > Configuration > Multiple Math Model View in the menu bar to display a
calibration curve that is a combination of two curve segments. A solid vertical line shows the point in
the curve at which the math model segments meet.
5. To view each segment individually, select Actions > Configuration > Math Model High View or
Math Model Low View in the menu bar.

6. Select the Previous Screen icon in the toolbar to return to the Calibration Status List.

HINT: If the scale makes the curve unreadable, clear the Enable Display Transformed Axes option
and reselect it to display the points properly.
The Multiple Math Model View is the default view. The selected view is named in the title bar.

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Deleting a Calibration Point Value

To delete a calibration point value:
1. Open a test in the Coagulation Calibration Details screen.
2. Select the Calibration Curve tab.
3. In the table of data point values, double-click the point value to delete in the Replicate column.
4. Select the point value in the table again to highlight it.
5. Press the Delete key on the keyboard.
6. Click elsewhere on the tab screen to see the curve with the deleted value. A deleted point value
appears in the table as parentheses, and in the calibration curve as an X.
7. To restore the deleted point value before saving, select Actions > Calibration > Restore in the menu
bar.

8. Select the Save icon in the toolbar to save your changes.

9. To restore the deleted point value after saving, select the Recalculate Calibration icon. This
replots the calibration curve according to the current test and material definitions. When recalculating
calibration results, the system uses the calibrator lot number used during execution. If the lot number
does not exist or the proper assigned values are not accessible, the recalculation fails. See Reviewing
Test Results.

10. Select the Previous Screen icon in the toolbar to return to the Calibration Status List.

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Printing and Exporting a Calibration Report

To print or export a calibration report for a completed test:
1. Open a test in the Coagulation Calibration Details screen.

2. Select the Print icon in the toolbar, or select Actions > Print in the menu bar.
3. To export the calibration report, select Actions > Export in the menu bar. See Exporting Data.

C alibration R eport
A calibration report includes the following information:
l Test code
l Calibration unit
l Date and time performed
l Date and time validated
l Calibrator materials (up to eight are listed)
l In case of manually diluted calibrations, all calibrator materials are listed including:
o Diluent name
o Validation status
o Calibration status
o Master calibration test code
l Result information including:
o Regression type
o X-Axis transformation
o Y-Axis transformation
l Calibration factors including:
o Y Intercept
o Slope
o r2
o Errors and warnings
l For each concentration the following is printed:
o Concentration if automatic pre-dilution is used
o Calibrator material if manual pre-dilution is used
o Concentration – assigned value
o Concentration – CV%
o Concentration – mean value

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o Replicate value (printed once for each replicate up to a maximum of 6) – If a replicate value is
a detected value, it is displayed in brackets [ ]. If it is an edited value, it appears on the report
in bold characters. If it is an omitted value it is displayed in braces { }.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

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Calibration Details Screen

Calibration Curve Tab

This tab contains important information to help you decide which calibration to validate.

NOTE: The X-axis is calibrated from the smallest measured value, not from zero.

Calibration Statistics

Slope
If the Slope Check option is enabled for the test, this value is checked to verify that the curve falls within the
acceptable slope range.

R 2 Value
If the R2 Check is enabled for the test, this value is checked to verify that the curve falls within the
acceptable R2 range.

Y-Intercept
If the Y-Intercept Check has been enabled for the test, this value is checked to verify that it falls within the
acceptable y-intercept range.

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A djusted Y
Part of the calibration slope calculation for the linear regression math model only. If the slope cannot be
calculated, the Y-Intercept field is blank.

N PP
If NPP mode is enabled and the mode is Derived from Calibration, the NPP measured result is displayed
(mean value of replicates of the selected calibration dilution).

N PP Value
If NPP mode is enabled, and the mode is Derived from Calibration, the NPP1 calibrated result is displayed
(target value of the selected calibration dilution).

Enable Display Transformed Axes

Option to enable toggling between the current calibration graph display mode (no axis transformation, x =
time and y = measured unit) and the transformed axes mode. See Viewing Calibration Curves.

HINT: If the scale makes the curve unreadable, clear the Enable Display Transformed Axes option
and reselect it to display the points properly.

Point Value Table Column Headings

C alc. Value
Calculated value for the mean of each calibration dilution.

%C V
CV calculated for the replicates of a dilution. If the Enable %CV Check option is enabled, this value is
checked to verify that it is less than the maximum %CV allowed. %CVs greater than the maximum allowed
CV are displayed in red text. This value is not reported if the level has less than 3 replicate values.

Mean Value
Mean of the replicates for a dilution.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Multiple Math Model

For factor tests having multiple math models using polynomial equations defined for the calibration, the
Calibration Curve tab screen shows the polynomial coefficients as exponents. See Viewing Calibration
Curves.

C alibration R esult with Math Model H igh

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Calibration Information Tab

Displays important status information about the calibration, including the following:
l Test execution date/time
l Validation status
l Validation date/time
l Errors and warnings – QC overdue or failed, Maintenance overdue or failed, Results recalculated
l Other general information.

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Reactions Information Tab

Displays the following:

l Reaction curves for each point in the calibration curve
l Errors and warnings specific to that data point. (Temperature errors and warnings are flagged only on
replicates, not on the test as a whole.)
To view the reaction curve for a particular dilution replicate:
1. Double-click the value in the Replicate column.
2. Double-click the reaction curve to enlarge the window.
No reaction curve is displayed for points that are manually edited.

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Tracking Information Tab

Displays the following for the active or alternate lot material used for the test selected in the Calibration
Status List:
l Material name
l Lot number
l Expiration date
l Comments log for the calibration

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Comments
You can view and enter comments in the Comments field. Comments contain Time, Date, and User ID. See
Viewing Calibration Curves.

See Also
l Calibration Status List
l Calibration Setup
l Performing a Calibration
l Reviewing Test Results
l Auto Validation Setup

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Calibration Status List

Accessing the Calibration Status List
To view the Calibration Status List:
1. Select Calibration > Status List in the menu bar.

2. To print a Calibration Status List, select the Print icon in the toolbar.
3. To export the Calibration Status List Report, select Actions > Export in the menu bar.

4. See Calibration Details.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

NOTE: A calibration will become an alternate lot if any of the material lots (other than the
calibrator) used to generate the active calibration are no longer on-board the system. When a calibration
changes from active to alternate, the calibration status changes from validated to unvalidated.

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Calibration Status List screen

This screen contains the following status information for tests with calibration enabled and defined:
l Test Code
l Calibrator
l Job Status
l Unit
l Frequency Status
l Overdue Date and Time
l Last Validated
l Frequency
l Last Completed

See Also
l Calibration Details
l Calibration Setup
l Performing a Calibration

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Performing a Calibration Chapter 7 – Calibration

Performing a Calibration
Before Programming a Calibration
The following conditions must be met before programming a calibration.
1. Define the calibration materials. See Calibration Setup.
2. In the Test Definition screen, define the calibration units. See Result Unit Definition.
3. Place all reagents, diluents and calibrators in the appropriate positions on the instrument. See Test
Feasibility for proper placement of all reagents.

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Programming a Calibration in the Calibration Details screen

Use this procedure when working with calibrator1 material placed in the original bottle on a diluent rack
inserted into a diluent track.

NOTE: When a calibration is programmed in the Calibration Details screen and the test is not
feasible because the calibration plasma has expired, the instrument uses calibration plasma from other placed
bottles, taking first from an active lot placed in track D1, then from an alternate lot placed in track D1.
1. Make sure the required conditions are met.
2. Select Calibration > Status List in the menu bar.

3. In the Calibration Status List double-click a test, or select a text and select the View icon in
the toolbar.
By default, the Calibration Details screen opens displaying the validated calibration. If a test has no
validated calibration, the Calibration Details screen displays Calibration 1.

4. Select the Program icon in the toolbar, or select Action > Calibration > Program in the
menu bar.

NOTE: After selecting the run command, the following apply:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running
the test. You must perform the enhanced clean before running the test. See Enhanced Clean in
Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run command or cancel
and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput
changes. Confirm or cancel the run.
l A new calibration test cannot be programmed if it is running or scheduled to run.
l A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to
generate the active calibration are no longer on-board the system. When a calibration changes from
active to alternate, the calibration status changes from validated to unvalidated.

1A type of sample with an assigned value used to calibrate a test.

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Programming a Calibration in the Sample Rack Details screen

Use this procedure when working with calibrator material placed in a sample container on a sample rack.

1. Select the Sample Area icon in the toolbar, or select Analysis > Sample Area in the menu
bar.

2. Select the Rack Details icon in the toolbar to open the Rack Details screen for the appropriate
rack.
3. Select Cal/NPP in the Sample Type drop down list.
4. Select a material in the Sample ID drop down list.
5. Select the Cal1 option beside the Sample ID list.
6. If lot management is enabled, select the Active Lot or Alternate Lot button.

7. Select the Add/Remove Tests icon to open the Tests and Profiles dialog box.
8. Double-click one or more test cells on the right side of the screen and select tests in the Test
Programming Window to add to the Rack Details screen.

9. Select the Run icon in the toolbar.

NOTE: After selecting the run command, the following apply:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running
the test. You must perform the enhanced clean before running the test. See Enhanced Clean in
Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run command or cancel
and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput
changes. Confirm or cancel the run.
l A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to
generate the active calibration are no longer on-board the system. When a calibration changes from
active to alternate, the calibration status changes from validated to unvalidated.
You can now Review and Validate calibration results.

See Also
l Calibration Details
l Calibration Status List
l Calibration Setup

1Calibrator. A type of sample with an assigned value used to calibrate a test.

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CHAPTER 8
NORMAL POOL PLASMA

NPP Status Details

Overview
Normal Pool Plasma (NPP) is a type of sample used to generate a standard value that is used to calculate ratio
and INR1 results. The ACL TOP instruments use calibration data, normal range data, or NPP sample data to
generate an NPP value.

NOTE: If the measured result is 0, the Ratio and INR results fail.

The ACL TOP instrument stores the five most recent NPP results per test. After the sixth NPP sample is run,
the oldest NPP data is removed from the NPP Details screen.

Reviewing NPP Results

To review status and NPP test results:
1. Select NPP > Status List in the menu bar.
2. <Optional> Click a column to sort the NPP Status List by ascending or descending order.
3. Do one of the following to open the NPP Details screen.

l Double-click a test in the list.

l Place focus on the test code and select the NPP Details icon.
l Select Actions > Review > NPP Details in the menu bar.

4. Select the General Information tab to view important status information about the NPP.
5. Select the Reaction Information tab to view the reaction curves, result values, and errors and
warnings for each NPP replicate.
6. Select the Tracking Information tab to view lot information for the NPP material and the comments
log.

1International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time (PT)
worldwide.

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Recalculating NPP Test Results

To recalculate the results of the NPP test displayed in the active tab:
1. Make sure the NPP test has completed.
2. Open the test in the NPP Details screen.

3. Select the Recalculate Results icon, or select Actions > NPP > Recalculate in the menu bar.
The NPP test results update after the operation completes. This operation uses the current validated
calibration with the same lot number.

NOTE: When recalculating results, the system uses the ISI value from the lot that matches the
material used during the test. If the lot used during test execution is no longer in the system, or the current
material with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results
for information on recalculation.

Printing an NPP List Report

To print an NPP List report:
1. Select NPP > Status List.

2. Select Actions > Print in the menu bar, or select the Print icon.

An NPP List report includes the following information:

l Test code
l NPP material
l NPP unit
l Frequency status
l Overdue date and time
l Frequency, including:
o Automatic execution enabled
o Last executed date and time

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Printing an NPP Results Report

To print an NPP Results report:
1. Select NPP > Status List.
2. Double-click a test in the NPP Status List, or select Actions > Review > NPP Details in the menu bar
to open the NPP Details screen.

3. Select Actions > Print Screen in the menu bar, or select the Print icon.

An NPP Results report includes the following information:

l Test code
l NPP material
l Frequency status
l Rack ID
l Position
l Date and time performed
l Errors and warnings
l For each replicate the following information is included:
o Measured value + Measured unit
o Calibrated value + Calibrated unit
o Replicate errors
o Reaction curve

l Test tracking information

Exporting a Report
To export a report:
1. Select NPP > Status List in the menu bar.
2. Double-click a test in the NPP Status List to open the NPP Details screen.
3. Select Export to export the NPP List report or the NPP Results report.
4. In the Export dialog box, select the format and destination in the respective fields.
5. Click OK.
See Exporting Data.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before

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you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

NPP Status List Screen

The NPP Status List contains current status information for tests that are NPP-enabled and defined
exclusively as NPP Run as Sample. The table contains the following columns:
l Test Code
l Material
l Job Status
l Unit
l Frequency Status
l Overdue Date and Time
l Frequency

l Auto Execution Mode

l Last Completed

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NPP Details Screen

General Information Tab

Displays the following NPP status information:

l Test execution date/time
l Validation status
l Validation date/time
l Errors and warnings
l Other general information

Reaction Information Tab

Displays the reaction curves, result values, and errors and warnings for each NPP replicate.

Tracking Information Tab

Displays the following NPP material information:
l Material name
l Lot number
l Expiration date
l Comments log

See Also
l Normal Pool Plasma Setup
l Performing a Normal Pool Plasma Measurement

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l Accessing Data Flags

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Performing a Normal Pool Plasma Measurement

An NPP test can run as follows:
l In the Sample Rack Details screen
l In the NPP Details screen
l Automatically by the system if the NPP mode is set to Run as sample.

Before You Begin NPP

1. Define the NPP materials for the test. See Normal Pool Plasma Setup.
2. In the test definition, set the NPP mode to Run as Sample. See Normal Pool Plasma Setup.
3. Place the NPP materials in the appropriate positions on the analyzer. See Test Feasibility for proper
placement of all reagents.

Programming an NPP in the NPP Details screen

Use the NPP method when working with NPP material placed in its original bottle on a diluent rack inserted
into a diluent track.

NOTE: If the NPP material has expired, and the NPP is run from the NPP Details screen, the
instrument uses NPP material from other placed bottles, taking first from an active lot placed in track D1 or
D2, then from an alternate lot placed in track D1 or D2.
1. Make sure the required conditions are met.
2. Select NPP > Status List in the menu bar.
3. Double-click a test.

4. Select the Program icon.

NOTE: After selecting the run command, the following apply:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running
the test. You must perform the enhanced clean before running the test. See Enhanced Clean in
Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run command or cancel
and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput
changes. Confirm or cancel the run.
l A new NPP test cannot be programmed if it is running or scheduled to run.

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Programming an NPP from the Sample Rack Details screen

Use the NPP method when working with NPP material placed in a sample container on a sample rack.

1. Select the Sample Area icon in the toolbar, or select Analysis > Sample Area in the menu
bar.

2. Select the Rack Details icon in the toolbar to open the Rack Details screen for the appropriate
rack.
3. Select Cal/NPP in the Sample Type drop down list.
4. Select a material in the Sample ID drop down list.
5. Select the NPP1 button beside the Sample ID list.
6. If lot management is enabled, select the Active Lot or Alternate Lot button.

7. Select the Add/Remove Tests icon in the toolbar to open the Tests and Profiles dialog box.
8. Double-click one or more test cells on the right side of the screen and select tests in the Test
Programming Window to add to the Rack Details screen.

9. Select the Run icon in the toolbar.

NOTE: After selecting the run command, the following apply:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running
the test. You must perform the enhanced clean before running the test. See Enhanced Clean in
Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run command or cancel
and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput
changes. Confirm or cancel the run.

Automatic NPP
If Automatic NPP is enabled for the test, the system automatically performs an NPP measurement when the
user-defined frequency interval expires. To enable Automatic NPP, see Normal Pool Plasma Setup.

NOTE: Automatic NPP can only be performed using NPP material placed on a diluent rack inserted
into a diluent track.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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CHAPTER 9
QUALITY CONTROL

QC Overview
The ACL TOP instrument provides a quality control (QC) program that allows you to monitor performance
characteristics of an analytical system for precision and accuracy as well as alert you to sources of
unacceptable analytical performance.
QC definitions must be set up before performing QC. See QC Setup Definition.

QC Performed on Alternate Lots

QC may be performed on alternate lots of QC materials to establish a new control range while the original
material is processed. After a sufficient number of control determinations has been performed, the alternate lot
can be activated. Alternate lot results are not used to flag patient sample results. The result data points may
be displayed on the Levey-Jennings chart in a different color than the active lot result data points. See
Reviewing QC Results.
When the alternate lot has been automatically activated the following occurs:
l The lot information is copied from the alternate lot to the active lot.
l The existing active lot data is archived.
l The alternate lot fields are set to their default values.
l The alternate lot is disabled.

Activating an Alternate Lot

To activate an alternate lot:
1. Select QC > Results List in the menu bar.
2. Double-click a material name or test code in the results list.

3. Select the Activate Lot icon in the toolbar, or select Actions > QC > Activate Lot in the menu
bar.

See Also
l Quality Controls
l QC List

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l QC Profiles List
l QC Results List
l QC Setup Definition
l QC Test Status List
l Reviewing QC Results

QC Results List
The QC Results List screen displays the results obtained from the most recent QC measurement.

Accessing the QC Results List

To access the QC Results List:
1. Select QC > Results List in the menu bar.
2. Double-click a test code in the QC Results List to view the associated QC statistics.
3. See Reviewing QC Results.

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QC Results List
The QC Results List displays the results obtained from the most recent QC measurement. It contains the
following information for tests that have QC enabled and defined:
l Test Code – Unique test code for the test.
l Material Name – Name of material as defined in the Material Definition.
l Last QC Results – Numeric result of the last QC run.
l Unit – Unit for the last QC run.
l Last QC Job Status – Status of the last QC job run for that point. Status can be PASSED, FAILED or
OMITTED.
l Target Mean – Expected mean as defined in the Material Definition. See Assigned Values.
l Target SD – Expected standard deviation as defined in the Material Definition. See Assigned Values.
l Cumulative Statistic Mean – Mean value of all QC points for the active lot.
l Cumulative Statistic SD – Standard deviation for the active lot.
l Cumulative Statistic N – Number of points used to determine the mean and standard deviation of the
active lot.

NOTE: To change the cumulative statistics for the QC results list, change the active lot or
perform a QC purge.
l Frequency Status – Frequency status of the QC test as defined in the QC Setup Definition. Status can
be OVERDUE, DUE or no status. If frequency is not configured, this field is blank. This column is
different from the Frequency Status column in the QC Test Status List screen. It is used to display the
last QC status for this test.
l Time to Overdue – The time when a QC is expected to become overdue, as defined in the QC Setup
Definition.
l Tests to Overdue – The number of tests at which a QC is expected to become overdue, as defined in
the QC Setup Definition. You must have frequency By tests enabled to have a value in this column.

l Auto Execution Mode – A check mark indicates automatic execution is enabled in the QC Setup
Definition.

NOTE: Automatic execution of a QC job By tests or By hours occurs when all the following
conditions are met:
o Automatic execution is enabled.
o All the required materials for the QC test are on board.
o The QC test is feasible.
o An order has been created to run the test related to the QC. For example, to run a QC
job for Routine Control X for the test APTT, an APTT test must be ordered.

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If Automatic execution is enabled By tests or By hours in the QC Setup Definition, and the
above conditions are not met when the frequency is due, the system generates an alarm
indicating that QC is not feasible, or QC is overdue.

NOTE: If Automatic execution of a QC job By Absolute Time is selected in the QC

Setup Definition, and Auto Run is selected in Global Definitions Setup, QC automatically
executes the QCs at the defined times if the following conditions are met:
o All the required materials for the QC test are on board.
o The QC test is feasible.

l Active Lot/Lot ID – Lot ID of the active lot.

l Active Lot/Expiration Date – Expiration Date of the active lot.

l Enabled Alternate Lot – A check mark indicates the alternate lot is enabled in the Material
Definition.

NOTE:
o Running a QC on an alternate lot does not reset the frequency status.
o Running a QC on an alternate lot results in a blank QC status. Results are not
evaluated for alternate lots.

See Also
l Quality Controls
l QC Overview
l QC List
l QC Profiles List
l QC Setup Definition
l QC Test Status List
l Reviewing QC Results

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QC Test Status List

Accessing the QC Test Status List

To access the QC Test Status List.
1. Select QC > Test Status List in the menu bar.
2. See Reviewing QC Results.

QC Test Status List screen

The QC Test Status List screen contains the following status information for tests that have QC enabled and
defined.
Test Code – Unique test code for the test.
Active QC Lot Status – Overall status of the active QC lot.
Frequency Status – Frequency status of the QC test as defined in the QC Setup Definition. Status can be
OVERDUE, DUE or no status. If frequency is not configured, this field is blank. Applies to an active QC lot
only. Does not apply to alternate QC lots.

NOTE: The frequency status in the QC Test Status List screen is different from the QC
Results List screen frequency status as follows:
o If all defined QCs are OK, the test frequency status is OK.
o If any QC test has an overdue status, the test frequency status is Overdue.
o If no QC test is overdue and there is at least one QC test that is due, the test frequency
status is Due.

Time to Overdue – The time when a QC is expected to become overdue, as defined in the QC Setup
Definition.
Tests to Overdue – The number of tests at which a QC is expected to become overdue, as defined in the QC
Setup Definition. You must have frequency By tests enabled to have a value in this column.
Last QC Material – Lot number of the last QC material result for the test code.
Last Completed QC – Date and time stamp at completion of the last QC result for the test code.

See Also
l Performing a Quality Control Test l QC List
l Reviewing QC Results l QC Profiles List
l Quality Controls l QC Results List
l QC Overview l QC Setup Definition

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Performing a Quality Control Test

Before You Begin A Quality Control Task
1. Define and enable the quality control materials for the test. See QC Setup Definition.
2. Place the QC materials correctly on the instrument. See Test Feasibility for proper placement of all
reagents.

Programming QC in the QC Test Status List

Use this procedure when working with QC materials placed in the original bottles on a diluent rack inserted
into a diluent track.

NOTE: When QC is programmed in the QC Statistics screen and the test is not feasible because the
QC material has expired, the instrument uses QC material from other placed bottles.
To program QC in the QC Test Status List:
1. Make sure the required conditions are met, as described in Before You Begin A QC Task (in this
topic).
2. Select QC > Test Status List in the menu bar.

3. In the QC Test Status List, double-click a test, or select1 a test and select the QC Statistics
icon in the toolbar. The QC Statistics screen opens.

4. Select the Material/Test View icon in the toolbar to toggle the view in the Material/Tests
Definition Tree between Tests > Material and Material > Tests mode.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Material/Tests Definition Tree

5. Select the Material/Test View icon in the toolbar to toggle the tree view to the desired
configuration.

l If the tree is organized by Material > Tests, when you check a material, all the QC
tests related to that material are added to the Program QC list. Click the check box

again to deselect it, or select the Clear QC Selection icon to deselect

everything.
l If the tree is organized by Tests > Material, when you check a test, all the QC
materials related to that test are added to the Program QC list. Click the check box

again to deselect it, or select the Clear QC Selection icon to deselect

everything.

6. <Paired Tests> Make sure both tests (master and paired) are feasible.

l If the master test is not feasible, and the paired test is feasible, the master test does not
run and the paired test fails.

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l If the master test is feasible, and the paired test is not feasible, the master test runs and
produces results, but the paired test does not run.

7. Select one or more tests or materials in the Tests/Material Definition tree.

8. To select one or more QC profiles to run, select the Select QC Profiles icon in the toolbar.
Then select the QC profiles in the Select multiple QC profiles dialog box, and click OK. The tests in
those profiles appear selected in the tree.

9. Select the Program icon in the toolbar to run the QC tests . See Reviewing QC Results.

NOTE: After selecting the run command, the following apply:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to
abort running the test. You must perform the enhanced clean before running the test.
See Enhanced Clean in Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run
command or cancel and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning
about throughput changes. Confirm or cancel the run.
l A new QC test cannot be programmed if it is running or scheduled to run.
l If QC is not feasible, a message prompts you to view feasibility detailed information.
See Test Feasibility.

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10. When the QC tests are complete, the QC Statistics screen for each material/test combination updates
with the result information. See Reviewing QC Results.

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Programming QC in the Sample Rack Details screen

Use this procedure when working with a QC material placed in a sample container in a Sample Rack.

NOTE: This method does not use bar codes. Therefore, volume warning, on-board stability tracking,
and expiration date tracking cannot be used.
To program QC in the Sample Rack Details screen:

1. Select the Sample Area icon in the toolbar, or select Analysis > Sample Area in the menu
bar.
2. Place the QC controls into sample cups on a sample rack.
3. Insert the sample rack onto the analyzer.

4. Place focus on the rack with the QC controls and select the Rack Details icon in the toolbar to
open the Rack Details screen.
5. Select the rack position.
6. In the Sample Type drop down list, select Quality Control.
7. In the Sample ID drop down list, select the material.
8. If lot management is enabled, select the Active lot or Alternate lot button.

9. Select the Add/Remove Tests icon in the toolbar to open the Tests and Profiles dialog box.
10. Click the appropriate tests to populate the Rack Detail screen.

11. Select the Run icon in the toolbar.

NOTE: After selecting the program command:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to
abort running the test. You must perform the enhanced clean before running the test.
See Enhanced Clean in Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run
command or cancel and wait until temperatures are in range..
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning
about throughput changes. Confirm or cancel the run.
l You can place active and alternative lots of QC materials on-board the instrument at
the same time.

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CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the
way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or
sample cups may result in misidentification of rack contents.

Enabling Automatic QC
If Automatic QC is enabled for a test, the system automatically performs QC when the user-defined frequency
expires.
To enable automatic QC:
l See QC Setup Definition.

NOTE: Automatic QC can only be performed using QC materials placed on a diluent rack inserted
into a diluent track.

Programming a QC Profile
To program a QC profile:
1. Define one or more QC profiles before programming a QC profile. See Defining QC Profiles.
2. Make sure the required conditions are met, as described in Before You Begin A QC Task (in this
topic).
3. Select QC > Test Status List in the menu bar.
4. In the QC Test Status List, double-click a test to open the QC Statistics screen.

5. <Optional> Select the Material/Test View icon in the toolbar to toggle the navigation tree to
the appropriate view.

6. <Optional> Select the Clear QC Selection icon in the toolbar to remove all selections in the
navigation tree.

7. Click the Select QC Profiles icon in the toolbar.

8. In the Select Multiple QC Profiles dialog box, select one or more QC profiles.
9. Select OK.

See Also
l QC Setup Definition
l Restriction Map
l Reviewing QC Results
l Performing Maintenance Activities

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l Test Feasibility
l Defining QC Profiles

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Reviewing QC Results
The QC Results List provides a statistical summary of QC results for all material/test combinations. The
instrument typically uses rounded values1 when displaying results.

Viewing and Filtering the QC Results

To view the QC Results List:
1. Select QC > Results List in the menu bar.
2. Select a column heading in the QC Results List to sort the results data by that criteria.

3. To filter the QC Results List, select the Filter icon in the toolbar, or select Actions >
Configuration > Filter in the menu bar.
4. Select filter options in the QC Result List Filter dialog box. Select All QCs to display all the result
data.
5. Click OK.

1Values are calculated using full precision values. However, when displayed, these values are rounded to a
specified number (n) of decimal places. When rounding of an out-of-range value results in a false in-range
displayed value, the displayed value is flagged to indicate that it is out-of-range.

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Viewing QC Statistics for a Specific Result

To view statistics for a specific QC result:
1. Open the QC Results List.
2. Do one of the following:

l Double-click a material name or test code in the results list.

l Select a material name or test code and select the QC Statistics icon.

3. In the QC Statistics screen, select the Filter icon in the toolbar, or select Actions >
Configuration > Filter in the menu bar.
4. Select filter options in the QC Statistics – Date Interval dialog box. Select Apply to all the QCs to
display all the statistics.
5. Click OK.

Viewing QC Statistics in Chart and Grid View

To view QC information in Chart or Grid View:
1. Open a QC result in the QC Statistics screen.
2. Do one of the following:

l In the toolbar, select the Switch View icon, which appears dynamically as the Grid

View icon, the Switch View icon or the Chart View icon in
sequence.
l In the menu bar, select a view option on the Actions > Configuration > Switch View
submenu.

3. <Chart View> To view both the active and alternate lot points on the same chart, in either the Active
Lot or Alternate Lot tab, select the Display active/alternate lot option.

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Using Multi-Chart View

To use Multi-Chart View:

1. In the QC Statistics screen, select the Material/Test View icon to toggle the Material/Test
Definitions tree to one of the following views:

l Test > Materials – Graphically displays the different QC materials used for a specific
test.
l Material > Tests – Graphically displays the same QC material used for different tests.

2. Select Actions > Configuration > Multi-Chart View in the menu bar.
See Multi-Chart View.

Adding or Viewing Comments

To view or add comments:
1. Open a QC result in Grid or Chart View.
2. <Grid View> Place a check mark in the left column next to the QC result.
3. <Chart View> Place the focus on the result (data point).

4. Select the Comments icon in the toolbar, or select Actions > Review > Comment in the menu
bar.
5. Add comments and select OK.

Tracking QC Information
To track QC information:
1. Open a QC result in the QC Statistics screen.
2. In the Active Lot or Alternate Lot tab, click to place a check mark next to a test.
3. Select Actions > Review > Tracking information in the menu bar.
The window displays the material name, lot number, and expiration date of the materials used for this test.

Viewing Reaction Curves

To view a reaction curve:
1. Open a QC result in the QC Statistics screen.

2. Select the Reaction Curve icon in the toolbar, or select Actions > Review > Reaction Curve in
the menu bar.

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Omitting Points
You can omit selected points from QC statistics. Omitted points appear on the graph as an X.
To omit points:
1. Open QC results in a Chart View.
2. In the chart, click the result (chart point) to omit.

3. Select the Omit Point icon, or select Actions > Results > Omit Point in the menu bar.
4. Select OK to confirm the omission. A Comments dialog box opens.
5. Enter a comment and select Save.
See Recalculating Interval Statistics.

Restoring Points
To restore omitted data points:
1. Open QC results in a Chart View.
2. In the chart, click the result (chart point) to omit.
3. Select Actions > Results > Restore Point in the menu bar.
4. Select OK to confirm the restoration. A Comments dialog box opens.
5. Enter a comment and select Save.

NOTE: Only a result arrived at after the last QC event (such as QC definition change) can be
omitted or restored.
See Recalculating Interval Statistics.

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Recalculating Interval Statistics

To recalculate interval statistics:
1. Place a check mark next to the test you want to recalculate interval statistics for.
2. Select Actions > Results > Recalculate in the menu bar.
3. The QC recalculation follows the same rules as a patient result recalculation and omit/restore points.
4. After recalculation, the results are saved and statistics are recalculated. If the recalculation cannot be
performed or there is an event after the QC result execution date and time, the operation fails and an
error message appears.

NOTE: When recalculating results, the system uses the ISI value from the lot that matches the
material used during the test. If the lot used during test execution is no longer in the system, or the current
material with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results
for information on recalculation.

Purging Data
Results from a test up to a certain date can be purged. The purge function can be used with 1) all results; 2)
active lot results only; or 3) alternate lot results only. This operation is intended to remove obsolete data
points. It recalculates the cumulative statistics with the remaining points. Data cannot be recovered after it
has been purged.

NOTE: Purge data is not available if the instrument is running tests.

To purge data:
1. Open a QC result in the QC Statistics screen.
2. Select Actions > QC > QCPurge in the menu bar. The Purge Data dialog box opens with the
following choices:
l Purge All
l Purge Active Lot
l Purge Alternate Lot
3. Select a date in the Purge Data dialog box and select OK.
4. The data up to this date is removed from the chart.

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Setting Statistics as Target

The target mean and SD can be replaced with the statistics mean and SD values.
To set statistic as target:
1. Open a result in the QC Statistics screen.

2. Select the Set Statistics Target icon in the toolbar, or select Actions > QC > Set Statistic as
Target in the menu bar.
3. Select OK to confirm your choice. The statistics values for the active lot are copied to the active
target values and the statistics values for the alternate lot are copied to the alternate target values.

Activating an Alternate Lot

An alternate lot can be activated at any time.
To activate the alternate lot:
1. Open a result in the QC Statistics screen.

2. Select the Activate Lot icon in the toolbar, or select Actions > QC > Activate lot in the menu
bar.

Uploading results to the LIS

To upload a result to the LIS:
1. Make sure the LIS is enabled.
2. Open a QC result in Grid View.
3. Place a check mark next to the result to be uploaded.
4. Select Actions > Results > Upload in the menu bar.

Filtering Results for Printing Reports

To filter results for printing reports:

1. Select the Filter icon in the toolbar, or select Actions > Configuration > Filter in the menu
bar.
2. Select filter options in the QC Result List Filter.
3. Select OK. Only displayed results are included in reports.

Printing QC Statistics Reports

To print a QC Statistics Report:

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1. Open the QC Statistics screen.

2. <Optional> Filter the results data.
3. Select Actions > Print > Print Compact Report or Print Comprehensive Report in the menu bar.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

C ompact R eport

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C omprehensive R eport

A QC Statistics Report includes the following information:

l Date and time report generated
l Name of hospital or laboratory
l ACL TOP Instrument
l ACL TOP Instrument Serial Number
l Test code
l QC Material
l Data Interval

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l Target
o Mean
o SD
l Statistic
o Mean
o SD
o CV
o N
o Omitted
o Total Data
l Levey-Jennings chart
l Tracking Information
o Material Name
o Lot Number
o Expiration Date
o User Name
l Sample Result Information
o Point No.
o Result
o SD Value
o Unit
o Omitted
o Errors
o Comment
o Date/Time (data interval)
o Target Mean (for the control material when test was completed)
o Target SD (for the control material when test was completed)
o Delta
o CV
o QC Status
o Freq. Status
o Lot ID (for this lot)
o Exp. Date (for this lot)
o Manufacturer (of the control material)

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Printing QC Results Status List Reports

To print a QC Results Status List Report:
1. Open the QC Results List screen.

2. Select Actions > Print in the menu bar, or select the Print icon in the toolbar.

QC R esults Status List R eport

A QC Results Status List Report includes the following information:
l Test Code
l Material Name
l Result Unit
l Frequency Status
l QC Test Status
l Lot Number (for the active lot)
l Expiration Date (for the active lot)
l Alternate Lot - enabled check
l Target Mean
l Target SD
l Cumulative Mean
l Cumulative SD
l Number of Results (for the active lot)
l For each QC test the following is displayed for each QC data point of the current day and the active
lot:
o Point Index
o Completion Date
o Result Value
o Result Unit
o SD Value
o DR Flags
o QC Status (after this result was added)
o Frequency Status
o Omitted
o Lot Number
o Expiration Date (for this lot)

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o Manufacturer (of the control material)

o Target Mean (for the control material when test was completed)
o Target SD (for the control material when test was completed)
o Delta
o CV
o Comment

Printing QC Test Status Reports

To print a QC Test Status Report:
1. Open the QC Tests Status List.

2. Select Actions > Print in the menu bar, or select the Print icon in the toolbar.

A QC Tests Status Report contains the same information displayed on the QC Tests Status screen.

Exporting Reports
To export a report:
1. Select Export.
2. In the window that opens specify the format and select the destination.
See Exporting Data.

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QC Statistics Screen
The QC Statistics screen contains information for both the active and alternate material lots located on the
Active Lot and Alternative Lot tabs.

NOTE: Only active lots are used to monitor quality control. The alternate lot tab provides
information about QC materials before they are used as an active lot.
The QC Statistics screen can display QC data points in a Grid View, Chart View or Grid Plus Chart View.

NOTE: Failed or omitted results are not provided in QC statistics.

Material/Test Definitions Tree

The Material/Test Definitions tree on the left side of the QC Statistics screen is used to perform the following
tasks:
l Select QCs to run.
l Select material/tests to display in Multi-Chart view.

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Active Lot Tab

The Active Lot tab contains the results for a particular material/test combination over a certain data interval.
The Data Interval is user-configurable by means of the QC Statistics filter and can be set in terms of the
following:
l Last days – The period between the current date and the defined number of days before the current
date. Valid range is 1 to 365.
l From/To – The period between the specified dates.
l Last Points – The last defined number of results received for this test and this control. Valid range is
1 to 999,999.
Select the following icons to perform the associated tasks:

Select QC Profiles

Clear Tree Selection

Program QC – Starts one or all QCs defined for the selected test. You can also select
Actions > QC > Program QC in the menu bar.

Material/Test View – Toggles sorting the Material/Test Definitions tree between Test view
and Material view. Select the relevant tree view before displaying data in Multi-Chart View.
Also use this icon to sort QC tests before Performing a quality control test.

Switch View – Toggles the current view to Grid View. Appears dynamically in the toolbar,

in sequence with the Chart View icon and the Switch View icon.
See Viewing QC Statistics in Chart and Grid View.
Switch View – Toggles current view to Chart View. Appears dynamically in the toolbar, in

sequence with the Switch View icon and the Grid View icon.
See Viewing QC Statistics in Chart and Grid View.
Switch View – Toggles the current view to Grid Plus Chart View. Appears dynamically in

the toolbar, in sequence with the Grid View icon and the Chart View icon.
See Viewing QC Statistics in Chart and Grid View.

Omit Point

Set Statistic as Target

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Activate Alternate lot

Comment

Test Feasibility List – Checks whether all the materials a selected QC test needs are
available for use. You can also select Actions > Review > Test Feasibility List in the menu
bar. See Test Feasibility for complete information.

QC Statistics Filter

Print

Chart View
In the QC Statistics screen, the Switch View icon appears in the toolbar dynamically, and in sequence, as the

Grid View icon, the Chart View icon, and the Switch View icon.

The chart view includes a Levey-Jennings chart. The chart shows the variability of the result, in terms of
standard deviations from the mean, over the defined data interval.

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Double-click the chart to expand to full screen view.

A legend pops up when you hover the cursor over a chart. For example:

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The vertical colored lines on the chart indicate that certain events have taken place. Click the vertical line for
a description and date and time of the event.

Red Active Lot Changed – The active lot for the related QC material changed due to:
l Enable or disable lot management
l Active lot definition change.
Yellow Target Values Updated – Target values were updated due to:
l Active lot assigned values change in QC definition
l Active lot assigned values change in related QC material
l Alternate lot assigned values change in QC material.
Green QC Definition Changed – The QC definition changed due to:
l Rules change in QC definition
l Unit change in QC definition
l Frequency configuration change in QC definition
l Patient flags change in QC definition
l Alternate lot definition change for related QC material
l Enable or disable of test definition.
Blue Related Reagent Lot Changed – The QC test related reagent lot changed due to:
l Enable or disable of lot management
l Active lot definition change
l Alternate lot definition change.

NOTE: You cannot omit a QC point from QC statistics after one of the above events has occurred.

Chart View Display Settings

l Scale +/- – To change the Y-axis display scale, enter a value in the Scale +/- field.
l Display Alternate Lot – To view the Alternate Lot QC data, select this field.

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l Statistic Mean – If selected, a red horizontal line is added to the chart to indicate the Statistic Mean
value.
l Trend Line – If selected, a green linear regression line is added to the chart to indicate the trending of
the data.

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Grid View
In the QC Statistics screen, the Switch View icon appears in the toolbar dynamically, and in sequence, as the

Grid View icon, the Chart View icon, and the Switch View icon.

Column Headings
l Select – Click one or more cells in this column to place check marks, selecting rows to perform
actions on. Click the Select icon in the column heading to select or deselect all the rows in the
table.
l No. – QC point number from the defined interval. See Filtering the Results List.
l Completed D&T – Completion date and time for the QC result.
l Result – Numerical value of the QC test result.
l Unit – QC result unit as defined in the QC Setup Definition.
l SD Value – A calculated number that tells how many standard deviations a control result is from its
mean value and is the Z-Score value for Levey-Jennings chart. Calculated as: (Result Value - Target
Mean)/Target SD.

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l Check box – A check mark indicates an error or warning is associated with the QC test result.
Click the check mark to view details.
l QC Status – Indicates whether the individual QC result has PASSED, FAILED or been OMITTED.
When QC fails, click this field to open a window that displays which rules failed. When the status is
OMITTED, the point is not included in the QC statistics.
l Frequency Status – If QC Frequency is enabled, indicates the status of the test – either Overdue, Due
or OK, and represents the status at the time QC was executed.

l Omitted Point – If checked, indicates that a QC result has been removed from the statistical
calculations.

l Upload Status – If checked, indicates that the QC test has been uploaded to the Host.
l Lot ID – The lot ID for the control material.
l Exp. Date – The expiration date for the control material lot.
l Manufacturer – Manufacturer of the control material.
l Target Mean – Expected mean value for the control material as defined in the product insert, or as
defined by the user. See Assigned Values.
l Target SD – Expected standard deviation for the control material as defined in the product insert, or
as defined by the user. See Assigned Values.
l Delta – The difference between the target and the measured result
l CV – CV of the QC point as compared to the initial target mean defined for an active lot. See
Assigned Values. If the target mean changes, this CV value represents the CV compared to target
mean before any changes.

l Comment – If checked, indicates that a user has entered a comment for this result.
l Ordered by – User ID of the person logged on when the QC test was performed.

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Grid Plus Chart View

In the QC Statistics screen, the Switch View icon appears in the toolbar dynamically, and in sequence, as the

Grid View icon, the Chart View icon, and the Switch View icon.

The Grid Plus Chart View combines both the Grid and Chart Views, including functionality, into one view.

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Multi-Chart View
Use Multi-Chart View to graphically compare QC results for:
l Different tests using the same QC material; or
l Different QC materials within the same test.
This view shows all the available chart information for 1) the test; and 2) the materials for the test selected in
the tree. The maximum number of graphs displayed per tab is four. The maximum number of tabs is six. Only
graphs that contain values for at least one not-failed test are displayed.

In Multi-Chart view, you can drag and drop charts within or between tabs.
See Using Multi-Chart View.

See Also
l Quality Controls
l QC List
l QC Overview
l QC Profiles List
l QC Results List
l QC Setup Definition
l QC Test Status List

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CHAPTER 10
SAMPLE ANALYSIS

Sample Collection and Storage

A detailed procedure for collection, transport, and preparation of plasma for coagulation testing is necessary
since important diagnostic and therapeutic decisions are based on the results of these tests. Many variables
are important because they affect the analytical results (for example: type of anticoagulant, storage of the
sample, and the collection container for the blood sample. The following procedures are considered standard
for any coagulation test.

Plasma Collection
Perform the following procedures when collecting plasma:
1. Draw blood with minimum stasis using a plastic syringe.
2. Transfer the drawn blood into a graduated polystyrene (or similar plastic material) test tube to avoid
activation of the contact phase of coagulation. Alternatively, use an evacuated siliconized glass tube
or an evacuated glass in plastic.
3. Immediately after drawing blood, anti-coagulate the plasma with one volume 3.2% trisodium citrate
mixed with nine volumes of freshly drawn venous blood. Mix thoroughly.
The correct concentration of the anticoagulant is fundamentally important to the precision of the results.
References to the CLSI (formerly NCCLS) guideline may be followed when adjustments to the citrate
concentration are required due to sample hematocrit variations.

Plasma Separation
Avoid hemolysis during collection and centrifugation of the sample. The breakage of red cells whose
phospholipid surfaces have thromboplastin activity causes a change in coagulation times. Therefore,
centrifuge samples as soon as possible according to the latest CLSI guideline.

See Also
l Sample Containers and Adapters

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Sample Area
The left side of the Analytical Module1 is the Sample Area where patient samples are manually loaded onto
the AM. Place sample material on racks and insert the racks through the bar code reader.
The Sample Area screen shows the status of all the racks in the sample area. Use the Sample Area screen to
program tests for each sample.

Accessing the Sample Area

To access the Sample area:

1. Select the Sample Area icon in the toolbar, or select Analysis > Sample Area in the menu
bar.
2. Use the Sample Area screen to program tests for each sample.

1The part of the instrument where sample processing and testing are performed. Also called the AM or the
Analyzer.

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Viewing On-board Materials

The Reagent & Diluent Map displays on-board materials in table format.
To view on-board materials:

1. Select the Sample Area , Diluent Area or Reagent Area icon in the toolbar to
open the Sample, Diluent or Reagent Area.
2. Select Actions > Review > Reagent & Diluent Map in the menu bar.
3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials by
position in each rack.
4. Select the Reagent Area tab to view the on-board reagents by position in each rack.
5. Select the right and left arrows below the table to display more racks.

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Sample Area Operations Toolbar

The Sample Area operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Run Tests – Starts an analytical session. Disabled if the analyzer is running or is in any
status other than Ready. You can also select Actions > Map > Run Tests in the menu bar.
Also available on the Sample Rack Details screen.

Test Feasibility List – Opens the Test Feasibility and QC Feasibility Lists. See Test
Feasibility.

Restriction Map – Opens the Restriction Map.

Rack Details – Opens the Sample Rack Details screen for the rack that has focus1 in the
Sample Area screen.

Bar Code Home Position – Moves the bar code reader to its home position.

Print – Prints a report showing the status of all inserted racks that have at least one
material placed on-board, and the status of these materials. Useful when a maintenance
activity is performed that requires the removal of material racks.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Sample List Toolbar

The following icons can appear in the Sample List toolbar depending on the instrument model:

Use the following icons to navigate in the Sample List, Reagent Area and Diluent Area.

Returns to the Previous screen.

Displays the QC Results List.

Displays the Calibration Status List.

Display the LAS Cuvette Holding Area for TOP 700 LAS.

Displays the Reagent Area (Reagent/Diluent Area for TOP 300 CTS and 500
CTS ).

Displays the Diluent Area.

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Sample Area Screen

The Sample Area is at ambient temperature and holds up to 12 racks, depending on the instrument model.
Each rack can hold 10 samples.
When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track
position. When the rack is no longer in use the LED changes to green and the rack is released. When a rack
is inserted with samples, and one or more sample tests are PLACED, NOT FEASIBLE, or ACTIVE, that rack
displays in the Sample Area screen as light blue. See Racks.
The non-CTS sample rack holds both open sample tubes and sample cups.
The CTS sample rack holds closed sample tubes. See Closed Tube Sampling and Global Definitions.

TOP 300 CTS Sample Area Screen

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TOP 500 CTS Sample Area Screen

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TOP 700 Sample Area Screen

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TOP 700 LAS Sample Area Screen

TOP 700 LAS Cuvette Holding Area

See LAS Cuvette Holding Area.

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Restriction Map
The Restriction Map shows which tracks you can insert various types of materials. See Restriction Map.

CAUTION:

l IMPORTANT – Many IL-defined tests use Clean B diluted as the clean material. If the Clean B
diluted bottle becomes empty, the instrument performs an emergency stop, with the consequent loss of
all work that was in progress. Hint: To avoid loss of work, place multiple bottles of Clean B diluted
on-board the instrument. See Test Feasibility for proper placement of all reagents.
l When loading sample, diluent or reagent racks, the racks must be pulled all the way out before
loading. Pulling out racks partially while loading or changing bottles, tubes, or sample cups may
result in incorrect identification of the rack contents.
l TOP 300 CTS – Clean materials used by the sample probe must be placed in track D1. Those used by
the reagent probe must be placed in track R1 - R3.
l TOP 500 CTS – Clean materials used by the sample probe must be placed in track D1. Those used by
the reagent probe must be placed in track D2 - R4.
l TOP 500 CTS – If you define a sample diluent material and select the Rinse and Clean option
requiring a non-system clean material such as Clean B, that clean material must be placed in track D1.
l TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS – If you define
a sample diluent material and select the Rinse and Clean option requiring a non-system clean
material such as Clean B, that clean material must be placed in track D1 or D2.
l TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS – Clean
materials used by the reagent probes must be placed in tracks D3 - R2, R5 - R6.

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Restriction Map – TOP 300 CTS

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Restriction Map – TOP 700

For ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700 CTS (includes ACL TOP CTS) instruments.

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Restriction Map – TOP 700 LAS

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Racks
A non-CTS sample rack is represented on the left, a CTS sample rack is in the middle, and Sample rack
present with test PLACED, NOT FEASIBLE or ACTIVE is on the right.

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NOTE:

l The CTS sample rack is identified with CTS on-screen.

l Sample #1 is at the top of the rack. Sample #10 is at the bottom.
l A sample rack may hold cups of calibrator1, controls, and patient samples as well as tubes of patient
samples.
l The color-coded circles in the rack representation correspond to the 10 sample positions in the sample
rack.
l When you hover the mouse pointer over a colored sample, its sample ID appears in a tooltip.
l When you single-click a sample, you get information about the sample such as the sample ID, the
tests to be performed on the sample, and time to completion for a test in progress. For example:

l When a rack is inserted with samples, and one or more sample tests are PLACED, NOT FEASIBLE, or
ACTIVE, that rack displays in the Sample Area screen as light blue.

Offline Racks
The rack to the far left in the Sample Area screen represents an offline rack that is on your workbench and
not inside the analyzer. You can pre-program the samples for that rack before inserting it into the analyzer.
You can program the rack after it has been inserted, but it is often preferable to do it beforehand. See
Material Identification.

1A type of sample with an assigned value used to calibrate a test.

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On-board Racks
You can access a rack by pressing the buttons in the instrument or touching or clicking the on-screen buttons
on the track control panel. The bar code indicator on the CM and the bar code reader on the AM both move.
As the selected rack is placed on the instrument it is also displayed on the screen.

NOTE:

l An ambulance on the sample rack circle indicates a priority (stat) sample.

l A red cross symbol indicates a stat1 sample.

A question mark indicates an unidentified sample. This happens when the sample does not have a bar code
label and it has been inserted without having been manually programmed. For a full listing of the color
codes, see Sample Status Color Codes.

1In medical terminology, immediate; with no delay. Stat samples have highest priority.

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Track Control Panel

Below the rack area on the screen is the Track Control Panel. Each track is identified by the abbreviations S
<sample>, D <diluent> and R <reagent>.

TOP 300 CTS Track Control Panel

TOP 500 CTS Track Control Panel

TOP 700 Track Control Panel

TOP 700 LAS Track Control Panel

Each track access button can be used to insert and remove a rack from the analyzer. It is functionally
identical to the physical buttons on the analyzer. Pressing the physical buttons or touching or clicking the
on-screen buttons all move the bar code reader to that track position to allow the rack to be inserted.
Each track position button has an LED indicator below it.
l Gray – No rack is on-board.
l Green – Rack is not in use, is accessible.
l Orange – Rack is in use, not accessible.
l Button grayed out (S1-S3) – Rack is not available – for use by LAS only.

Bar Code Reader Indicator

Just above the Track Control Panel is an indicator for the location of the bar code reader:

Bar code reader movements are simulated on the computer screen. When you press a track access button, the
bar code reader indicator appears above the button after the bar code reader reaches this position.

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See Also
l Sample List
l Sample Details
l Sample List Filter
l Sample Rack Details

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LAS Cuvette Holding Area

The LAS Cuvette Holding Area screen is a graphical representation of samples that have begun aliquotting
from the LAS track and are scheduled for testing, or are in the process of testing. You can delete tests from
samples in the holding area, but you cannot add tests.

Accessing the LAS Cuvette Holding Area

To open the LAS Cuvette Holding Area screen:
l Select Analysis > LAS Cuvette Holding Area in the menu bar.
Or

1. Select the Sample Area icon in the toolbar.

2. Select the LAS Cuvette Holding Area icon in the toolbar.

Deleting a Test
To delete a test from a cuvette in the LAS Cuvette Holding Area:
1. Open the LAS Cuvette Holding Area.
2. Click a Test cell to place focus1 on the test to delete.

3. Select the Delete Test icon in the toolbar.

4. In the Test and Profiles dialog box, deselect one or more tests to delete.

NOTE:

l You cannot add a test to a cuvette in the LAS Cuvette Holding Area.
l If the test has started, you cannot delete it.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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LAS Cuvette Holding Area Operations Toolbar

The LAS Cuvette Holding Area operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Run Tests – Starts an analytical session. Disabled if the analyzer is already running or is
in any status other than Ready. You can also select Actions > Map > Run Tests in the
menu bar. Also available on the Sample Rack Details screen. See Sample Rack Details.

Test Feasibility List – Runs Test Feasibility.

Delete Tests – Deletes the test selected in the cuvette cell. A cuvette cell must have
focus1 in the LAS Cuvette Holding Area screen.

Restriction Map – See Restriction Map.

Sample Details – Displays the Sample Details screen.

Patient Demographics – Displays patient information, such as name, gender, DOB,

patient ID, etc.

Bar Code Home Position – Allows you to move the bar code reader to its home position
without having to wait.

Print – Prints a report showing the state of all inserted racks that have at least one
material placed on-board, and the state of these materials. Useful when a maintenance
activity is performed that requires the removal of material racks.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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LAS Cuvette Holding Area Screen

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C uvette Strip

Graphical representation of a cuvette strip1 containing four cuvette wells. Each cell contains a separate
aliquot2 taken from a sample on the LAS track.
When displayed, it indicates the presence of a cuvette strip in the LAS Cuvette Holding Area. Click here for
color indicators descriptions.
Hover the cursor over a cuvette well to display a tooltip with the status of the sample.
When the cuvette strip is in focus, the Sample ID and Test cells populate with the values associated with that
sample.

LA S C uvette H olding A rea A vailability Indicator

Represents an available position for sample analysis. A maximum of 7 indicators can display. The number of
available positions is inversely related to the # Slots for dilution preparation value configured in the LAS
Configuration screen. When the # Slots for dilution preparation value is 2, seven indicators are present. Use
this configuration for maximum throughput when testing samples. You can adjust the configuration to
optimize sample or calibration throughput. See Adjustments for Calibration.

Sample ID
Obtained through communication with the LAS track. You may not manually enter a value into this field.

1Four cells molded together in a disposable plastic piece. Used for testing samples. Multiple cuvette strips
clip together to form cuvette clips.
2A known fraction of a whole, constituting a sample.

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Test C ells
To the right of each row are Test cells in two rows and several columns for each sample. More columns are

available as needed – up to 30 tests for each sample. When you select a test cell an ellipsis displays to
the right of the cell.

See Also
l LAS Overview
l LAS Configuration
l ACL TOP 700 LAS Specifications

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Sample Rack Details

The Rack Details screen contains information for each sample placed on a rack.

Accessing Sample Rack Details

To access sample rack details:

1. Select the Sample Area icon in the toolbar, or select Analysis > Sample Area in the menu
bar.
2. In the Sample Area screen, do one of the following:

l Double-click a sample rack representation or a sample position on the rack.

l Select Actions > Review > Rack Details in the menu bar.

l Select the Rack Details icon in the toolbar.

Programming Sample Tests

To select one or more tests to run on a sample:
1. Open the Rack Details screen.
2. Select the sample type in the Sample type list. Select Patient for medical tests.
3. Select the sample ID in the Sample ID list. If you selected a Cal/NPP or Quality Control sample
type, this field becomes a drop down list of available materials to use for calibration, NPP1, or quality
control.
4. Select the Stat option if the test is high priority.
5. <Optional> If the sample type is Quality Control or Cal/NPP, and lot management is enabled for the
sample, select to use the active or alternate lot.
6. Click a test cell on the right side of the Rack Details screen.

7. Select the dynamic ellipsis that appears on the right side of the test cell, or select the

Add/Remove Tests icon in the toolbar to open the Tests and Profiles window.
8. Select a test or profile in the Tests and Profiles window, and select OK.
9. Repeat these steps for each test to run on the sample.
10. IMPORTANT – See Tests and Profiles window for important information about tests.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Deselecting Tests
When you click a named cell in the Tests and Profiles window, that test name is copied to the test list on the
Rack Details screen and the test button on the Tests and Profiles window is depressed. Clicking a button a
second time removes the test name from the Rack Details screen and deletes the test order. You can also
deselect a test that has been ordered in the Sample List screen if the test has a TO DO status. After an ordered
test has become active, it cannot be deselected.
To remove a test with TO DO status from a sample:

1. Select the Sample List icon in the toolbar, or select Analysis > Sample List in the menu bar.
2. In the Sample List, select the sample ID with a test with TO DO status.

3. Select the Sample Details icon in the toolbar to open the Sample Details screen.
4. On the Test Information tab, place focus1 on the TO DO test and press the <Delete> on the keyboard
before the test executes.

Sample Area Toolbar

The Sample Area toolbar includes the following:

Select the following icons to perform the associated tasks:

Run tests.

Display Test Feasibility List.

Display the Restriction Map.

Display Rack Details.

Move Bar Code Reader to home position.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Sample Rack Details Operations Toolbar

The Sample Rack Details screen toolbar includes the following:

Select the following icons to perform the associated tasks:

Run Tests – Starts an analytical session. Disabled if the analyzer is running or not Ready.
You can also select Actions > Map > Run Tests in the menu bar.

Auto List – Automatically programs a set of patient tests (for those in the TO DO state) that
exist on the system. Applies only to patient tests and is only available for the off-line rack in
the sample area (also see Reagent Area). The sample programming information is
automatically loaded and displayed based on the priority of each sample. See Programming
Non-Bar Coded Samples (Using an LIS).

Add/Remove Tests and Profiles.

Clear Rack – Clears all the material information. Available only for the off-line rack and
disabled for all other racks.

Insert Rack – Inserts a rack carrying the information and materials you defined on the off-
line rack. Disabled for all other racks.

Test Feasibility List – Opens the Test Feasibility List.

Display Patient Demographics.

Open Sample Details to view detailed rack information.

Bar Code Home Position – Moves the bar code reader to its home position.

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NOTE: After selecting the run command, the following apply:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running
the test. You must perform the enhanced clean before running the test. See Enhanced Clean in
Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run command or cancel
and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput
changes. Confirm or cancel the run.
l When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling
a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.
See Run and Auto Run.

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Sample Rack Details screen

The picture below shows 2 rows of the test list displayed in the Rack Details screen. All the rows are similar,
with one row for each sample.

Select a row to configure by clicking the sample position at the left side of the screen. The selected sample
has a ring around it to indicate it has focus.

When you hover the cursor over a test, a tooltip displays the result for that test.
Click the following icons on the right side of the toolbar to display the sample Rack Details screen for the
rack to the left or right of the currently displayed rack.

and

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Sample Type
The default sample type is Patient. The following sample types appear in the list:
l Patient – A sample being analyzed for medical purposes.
l Cal/NPP – A grouping that allows a single material to be used for multiple sample types.
o Cal (Calibrator) – A sample with an assigned value used to calibrate a test.
o NPP (Normal Pool Plasma) – A sample used as a standard of comparison for calculating: 1)
INR; and 2) test results that use the normalized ratio.
l Quality Control – A sample having known amounts of analyte that is used to monitor system
performance.

Sample ID
Unique identifier of the sample. This value is normally obtained by scanning a bar code label on a sample
tube. You can also manually enter a value into this field. It must be an alphanumeric value with fewer than
16 characters. You cannot change the sample ID while the sample is in use. This field can be edited only
when the sample type is Patient.
For Cal/NPP and Quality Control samples, this field becomes a drop down list of available materials to use
for calibration, NPP1, or quality control.

Stat
The Stat option specifies a high-priority patient sample. The priority codes for samples and tests are:
l Normal – Regular priority
l LAS – Higher priority (for all samples from the LAS track)
l Stat – Highest priority (available for front-loaded samples only)
l Partial – One or more, but not all tests for the sample are stat

CAUTION: Continuously adding stat2 samples delays testing on non-stat samples, possibly
indefinitely.

Lot Selection
If the sample type is Quality Control or Cal/NPP and lot management is enabled for the material, a pair of
buttons is displayed to the right of the stat indicator. These buttons allow you to select either the active lot
or the alternate lot.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.
2In medical terminology, immediate; with no delay. Stat samples have highest priority.

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Test Selection
To the right of each row are Test cells in two rows and several columns for each sample. More columns are

available as needed – up to 30 tests for each sample. When you select a test cell an ellipsis displays to
the right of the cell.

After you click the ellipsis, the Test and Profiles window opens, allowing you to select from the available

tests and profiles. You can also double-click the test list cell or use the Add/Remove Tests icon in
the toolbar to open the Tests and Profiles window.
The Tests and Profiles window is also available from the Sample List screen menu item Actions > Results >
Add/Remove Tests when a sample is selected (has a check mark in the Select column).

Tests and Profiles Window

Use the Tests and Profiles window to program tests to run on samples.
Programming the Tests and Profiles window is similar to programming the Material Programming Window.

NOTE:

l A profile is a set of tests. Up to 15 tests may be in a profile. Profiles are underlined to distinguish
them from individual tests. When a profile is selected, all the buttons for the tests in that profile are
depressed on the Tests and Profiles window.
l You cannot type a test name into the cell. Tests must be selected through the Tests and Profiles
window.
l You cannot select tests for a sample that does not have a sample ID.
l When you click a named cell in the Tests and Profiles window, that test name is copied to the test
list on the Rack Detail screen, and the test button on the Tests and Profiles window is depressed. You
may select more than one test.

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l Tests in a profile must be deselected individually. Pressing a profile button a second time does not
deselect the tests in that profile.
l The ACL TOP instrument does not run duplicate tests, whether ordered through the LIS or ordered
manually. Only one test is performed per test code, per sample. To run duplicate tests on a sample,
you must either 1) configure the test definition to run a replicate; or 2) wait until a test has generated
test results.
l If you select the Apply to each Sample ID option at the bottom of the Test and Profiles window
before selecting a test, each test you select is assigned to all sample IDs in the rack.
l If you assign more than 10 tests to the sample, you can use the scroll arrows at the right side of the
test list to view the cells containing the test names.

Rack Summary Information

After you request a test, a summary information table appears below and to the left of the test table with the
following information:
l Track ID value – Identifies the track number where the rack is placed.
l Rack ID – Displays the rack ID that is read on the rack bar code label.
l Number of samples
l Number of tests

See Also
l Sample Status Color Codes
l Sample List

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Programming Bar Coded Samples

NOTE:

l To perform these procedures, the Enable Bar Codes option must be pre-configured in the Bar Code
Definitions setup screen.
l Feasible tests programmed for samples placed on-board while the instrument is performing analysis are
immediately scheduled when you perform the operations in this topic. It is not necessary to re-select

the Run icon for these tests when the instrument is already running.

Programming Bar Coded Samples Using an LIS (Host)

1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar.
2. Select an available track position from the track control panel.
3. Insert a rack containing bar coded samples into the ACL TOP instrument. See Restriction Map for
general placement of samples and reagents. The system reads the bar codes and programs the Sample
IDs automatically into the Rack Detail screen. The programming of the tests is obtained from the LIS,
according to the LIS communication configuration (host query or batch downloading).

4. Select the Run icon to start the analysis.

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Programming Bar Coded Samples After Loading the Rack, Without an

LIS

1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar.
2. Select an available track position from the track control panel.
3. Insert a rack containing bar coded samples into the ACL TOP instrument. See Restriction Map for
general placement of samples and reagents. The system reads the bar codes and programs the Sample
IDs automatically into the Rack Detail screen.

4. Select the Rack Details icon to open the Rack Detail screen.
5. Select the Stat option if the sample requires immediate action.

NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly
indefinitely.

6. Select the Add/Remove Tests icon to open the Tests and Profiles window. Program the
appropriate tests by selecting the test and/or profile buttons (profiles are underscored).

7. Select the Run icon to start the analysis.

See Also
l Laboratory Information Systems
l Bar Code Definition
l Manually Programming Non-Bar Coded Samples

1In medical terminology, immediate; with no delay. Stat samples have highest priority.

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Programming Non-Bar Coded Samples

Programming Non-Bar Coded Samples Using the Offline Rack and an

LIS (Host) with Automatic Downloading Enabled
You can use this method if your laboratory is connected to an LIS after the information regarding the samples
to be programmed has been downloaded from the LIS to the analyzer.

1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar.
2. Double-click a sample on the offline rack (located on the left side of the screen) to open the Rack
Details screen.

3. Select the Auto List icon. The LIS orders populate the screen.
4. Load the rack in the sample ID order shown on the screen.

5. Select the Insert Rack icon.

6. Insert the rack into the ACL TOP instrument.

7. Select the Run icon to start the analysis.

NOTE:

l If you manually identify a material placed on the off line rack (sample, diluent, or reagent) and a tube
or bottle containing a bar code is on the rack, the system attempts to match the information manually
entered with the information on the bar code in that position. If the bar coded information fails to
match the manually entered information, the system generates an error message.
l If you manually identify the presence of a material (tube, bottle, or sample cup) placed on the off line
rack (sample, diluent, or reagent) and, upon insertion, the bar code reader does not detect the presence
of that material, an error message displays for that position that the system was expecting to detect the
material's presence.
l If you fail to manually identify the presence of a material (tube, bottle, or sample cup) placed on the
off line rack (sample, diluent, or reagent) and, upon insertion, the bar code reader does detect the
presence of a material, an error message displays for each detected position that the system was not
expecting to detect.

CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before
loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

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Programming Non-Bar Coded Samples After Inserting the Rack, Using

an LIS with Host Query Enabled

1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar.
2. Select an available track position from the track control panel.
3. Insert the rack into the ACL TOP instrument. See Restriction Map for general placement of samples
and reagents. The samples positions are displayed with question marks, indicating the system detects
their presence but has no sample ID information (unknown samples). If Host Query is enabled, the
instrument automatically queries the LIS when a rack is inserted.

4. Select the Rack Details icon to open the Rack Details screen.
5. Enter the sample ID in the Sample ID field.
6. Select the Stat option if the sample requires immediate action.

NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly
indefinitely.
7. The LIS is queried for test requests and if it finds any for the sample ID, enters them in the test list
field to the right of the sample ID.

8. Select the Run icon to start the analysis.

1In medical terminology, immediate; with no delay. Stat samples have highest priority.

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Programming Non-Bar Coded Samples After Inserting the Rack,

Without Using an LIS

1. Select the Sample Area or select Analysis > Sample Area in the menu bar.
2. Select an available track position from the track control panel.
3. Insert the rack into the ACL TOP instrument. See Restriction Map for general placement of samples
and reagents. Notice the samples positions are displayed with a question mark, indicating that the
system identified their presence but had no Sample ID information (unknown samples).

NOTE: When a rack is inserted, the instrument automatically queries the LIS only when Host
Query is enabled.

4. Select the Rack Details icon to open the Rack Details screen.
5. Enter the sample ID in the Sample ID field.

NOTE: You cannot change a sample ID if the test status for that sample is ACTIVE.

6. Select the Stat option if the sample requires immediate action.

NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly
indefinitely.

7. Select the Add/Remove Tests icon to open the Tests and Profiles window. Program the
appropriate tests by pressing Test and/or Profile buttons (profiles are underscored).

8. Select the Run icon to start the analysis.

CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before
loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

1In medical terminology, immediate; with no delay. Stat samples have highest priority.

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Programming Non-Bar Coded Samples Using the Offline Rack,

Without Using an LIS

1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar.
2. Double-click a sample on the off line rack (located on the left side of the screen) to open the Rack
Details screen.
3. Enter the sample ID in the Sample ID field.

NOTE: You cannot change a sample ID if the test status for that sample is ACTIVE.

4. Select the Stat option if the sample requires immediate action.

NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly
indefinitely.

5. Select the Add/Remove Tests icon to open the Tests and Profiles window.
6. Program the appropriate tests by pressing Test and/or Profile buttons (profiles are underscored).

7. Select the Insert Rack icon.

8. Insert rack into the ACL TOP instrument.

9. Select the Run icon to start the analysis.

NOTE: Feasible tests that are programmed for samples placed on-board while the instrument is

performing analysis are immediately scheduled. Pressing the Run icon again is not required when the
instrument is running.

See Also
l Laboratory Information Systems
l Bar Code Definition
l Programming Bar Coded Samples

1In medical terminology, immediate; with no delay. Stat samples have highest priority.

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Reviewing Sample Status

To review the status of an on-board sample:
1. Select Analysis > Sample List in the menu bar.
2. View the test fields at the right side of the Sample List for the results of individual tests performed on
the sample. See Sample Details.

See Also
l Sample Details
l Sample List
l Test Details
l Sample Status Color Codes

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Reviewing Test Results

Test result values are shown in a data table at the right side of the Sample List.

Recalculating Test Results

To recalculate test results:
1. Select Analysis > Sample List in the menu bar.
2. Select1 one or more samples in the Sample List.
3. Select Actions > Results > Recalculate in the menu bar.
4. <Optional> Select Stop in the window with a progress bar to interrupt the recalculation if it takes too
long. Results recalculated remain recalculated, and additional recalculations do not process.

This causes the values to recalculate after you have made a change to any of the following:
l Delay time – You cannot change the delay time to be shorter than that used in the original analysis.
l Acquisition time – You cannot change the acquisition time to be longer than that used in the original.
l Test definition data reduction fields
l Calibration
l Parallelism data reduction fields

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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NOTE:

l When recalculating results, the system uses the ISI value from the lot that matches the material used
during the test. If the lot used during test execution is no longer in the system, or the current material
with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results
for information on recalculation.
l You can recalculate results only for tests having editable fields.
l You can recalculate results for all tests, or for only the tests that are filtered to display in the list. See
Sample List.

Validating a Single Completed Test Result

To validate1 a single completed test result:
1. Select Analysis > Sample List in the menu bar.
2. Place focus2 on the sample ID.

3. Select the Sample Details icon in the toolbar to open the Sample Details screen.
4. In the Sample Details screen, select3 the test to validate.

5. Select the Validate icon in the toolbar.

Validating All Completed Test Results for a Sample

To validate4 all the completed test results for a sample ID:
1. Select Analysis > Sample List in the menu bar.
2. Select5 one or more sample IDs in the Sample List.

3. Select the Validate icon in the toolbar, or select Actions > Results > Validate in the menu bar.
4. When the operation completes a black check mark appears in the Validation Status column. See
Sample List Display Settings to display hidden columns.

1The acceptance of test results by the user.

2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
3Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
4The acceptance of test results by the user.
5Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Uploading a Single Completed Test Result to the LIS

You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must
be enabled before uploading can occur. See Laboratory Information Systems (LIS).
To upload a single completed test result:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, place focus2 on a sample ID with test results to upload.

3. Select the Sample Details icon in the toolbar to open the Sample Details screen.
4. In the Sample Details screen, select3 the test with results to upload.

5. Click the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.

See Upload Status.

Test U pload
A test upload sends the following information to the host:
l Test ID
l Test Status
l Test Order Date
l Test Results

1Test results accepted by the user.

2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
3Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Uploading All Completed Test Results for a Sample to the LIS

You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must
be enabled before uploading can occur. See Laboratory Information Systems (LIS).
To upload all the completed test results for a sample:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, place focus2 on a sample ID with test results to upload.

3. Select the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.
4. When the operation is complete, a black check mark appears in the Upload Status column. See
Sample List Display Settings to display hidden columns.
See Upload Status.

Sample U pload
A sample upload sends the following information to the host:
l Print Status
l Priority
l Sample Status
l Upload Status
l Validation Status

Deleting Results
To delete results or tests:
1. Select Analysis > Sample List in the menu bar.
2. Select a result or test.
3. Select Actions > Results > Delete in the menu bar.

1Test results accepted by the user.

2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Printing Sample Results Reports

To print a Sample Results Report:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List select1 one or more sample IDs.

3. Select the Print icon in the toolbar, or select Actions > Print > Sample Results Report in the
menu bar.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

Sample R esults R eport

If the test triggered a rerun test, an * appears in the first result cell in the report. The & sign appears for a
result with a rerun test. See Rerun Rules Setup.
A Sample Results report includes the following information:
l Report Date and Time
l Report Header (user configurable) with
o Hospital
o Laboratory
o System (instrument name; for example ACL TOP 700)
o Serial Number (of the instrument)

l Sample ID
l Sample Type
l First Name (user configurable)
l Last Name (user configurable)
l Rack ID
l Position ID

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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l Test Code
l Results (including the unit) or status of test if not successfully completed including:
o UNDEFINED
o COMPLETE
o FAILED
o PENDING
o ACTIVE
o TO DO

l Flag
l Performed Date and Time
l Validated

Printing Sample Results Detailed Reports

To generate and print a Sample Results Detailed Report:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, place focus1 a on sample ID.

3. Select the Test Details icon in the toolbar to open the Test Details screen.
4. Select Actions > Sample Results Detailed Report > Print in the menu bar.
See Formatting Reports.

Sample R esults D etailed R eport

This report is available only if the test has completed.
The Sample Results Detailed Report contains the same information as the Sample Results Report with the
following additions:
l Result for each replicate
l Replicate errors
l Reaction curve graph
l Tracking information

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Printing Patient Reports

NOTE: Patient Result Reports are only available for validated results.

To print a Patient Report:

1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, select1 one or more sample IDs.
3. Select Actions > Print > Patient Report.

Patient R eport
If the test triggers a rerun test, an * appears in the first result cell.
If the test triggered a diluted rerun, an & appears in the first result cell.
A Patient report includes the following information:
l Report Date and Time
l Report Header (user configurable) with the following information:
o Hospital or Laboratory Name
o Serial Number (of the instrument)
o System ID number

l Sample ID
l Sample Type
l First Name
l Last Name
l Rack ID
l Position ID
l Test Code
l Results (including the unit) or the status of the test if not successfully completed, including:
o UNDEFINED
o COMPLETE
o FAILED
o PENDING
o ACTIVE

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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o TO DO

l Flag
l Performed Date and Time
l Validated

Exporting Reports
To export a Sample Results report:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, select1 one or more sample IDs.
3. Select Actions > Export in the menu bar.
4. Specify the format and select the destination on the Export window.
See Exporting Data.

See Also
l Sample List
l Sample Details
l Test Details

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Sample List
The Sample List contains information on samples. Only patient samples appear in the Sample List, including
parallelism, extended and diluted tests. Sample information appears on the left side of the Sample List, and
test information appears on the right.
All tests associated with a sample ID appear in the Sample Details screen which, when open, appears under
the Sample List.
See Sample List Display Settings.

Viewing Sample Details

To view sample details:
1. Select Analysis > Sample List in the menu bar.

2. In the Sample List, place focus1 on a sample ID and select the Sample Details icon in the
toolbar to open the Sample Details screen below the Sample List.
3. Select the Test Information tab in the Sample Details screen to view the tests associated with the
sample in focus in the Sample List.
4. Select the Patient Demographics tab to view Sample and Patient information for the sample in focus
in the Sample List.

Selecting and Placing Focus on Samples

To select and place focus on samples:
1. Select Analysis > Sample List in the menu bar.

2. To select one or more samples, click to place a check mark in the Select column of those
samples.
3. To place focus on a sample ID, perform one of the following actions. You can place focus on only
one sample ID. As you move focus to a different sample in the Sample List, the information in the
Sample Details screen changes.

l Press the Up and Down arrow keys on the keyboard to move the blue focus rectangle
up and down the list of sample IDs.
l Select a row in the Sample List to place focus on the sample ID in that row.
l Touch the sample ID cell on the screen.
l Use the Find tool to locate a sample ID in the Sample List.

4. Perform an action on the selected samples. Actions may be performed on multi-selected samples. For
example, you can validate or upload the multi-selected samples, or filter the selected samples by test
code. Multi-selected sample IDs do not have to be in focus.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Combinations of Select and Focus

NOTE: Do not edit the sample ID after an analytical session has started, unless you remove the rack
first.

N ot Selected / N o Focus

Focus

When a sample has focus you can obtain detailed information about the sample and its tests. Only one
sample at a time may have focus.

Selected

Multi-selection is allowed. You can print, validate or upload the sample information for all selected samples.

Selected with Focus

Select and place focus to obtain detailed information about a sample and its tests. You can validate and
upload in this configuration.

U nderlined – H idden D ata

An underlined sample ID indicates there are test results that are not displayed in the Sample List. See Sample
List Display Settings to display hidden columns.

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Adding and Removing Tests Associated with a Sample

To add or remove tests associated with a sample:
1. Select Analysis > Sample List in the menu bar.
2. Select1 one or more samples in the Sample List.

3. Select the Add/Remove Tests icon in the toolbar.

4. In the Test and Profiles dialog box, select or deselect the tests to add or remove from the selected
samples. Select the Apply to all samples option to perform this action on all samples. See Test
Programming Window for configuring this dialog box.

Validating a Single Completed Test Result

To validate2 a single completed test result:
1. Select Analysis > Sample List in the menu bar.
2. Place focus3 on the sample ID.

3. Select the Sample Details icon in the toolbar to open the Sample Details screen.
4. In the Sample Details screen, select4 the test to validate.

5. Select the Validate icon in the toolbar.

Validating All Completed Test Results for a Sample

To validate5 all the completed test results for a sample ID:
1. Select Analysis > Sample List in the menu bar.
2. Select6 one or more sample IDs in the Sample List.

3. Select the Validate icon in the toolbar, or select Actions > Results > Validate in the menu bar.
4. When the operation completes a black check mark appears in the Validation Status column. See
Sample List Display Settings to display hidden columns.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2The acceptance of test results by the user.
3To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
4Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
5The acceptance of test results by the user.
6Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Uploading a Single Completed Test Result to the LIS

You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must
be enabled before uploading can occur. See Laboratory Information Systems (LIS).
To upload a single completed test result:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, place focus2 on a sample ID with test results to upload.

3. Select the Sample Details icon in the toolbar to open the Sample Details screen.
4. In the Sample Details screen, select3 the test with results to upload.

5. Click the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.

See Upload Status.

Test U pload
A test upload sends the following information to the host:
l Test ID
l Test Status
l Test Order Date
l Test Results

1Test results accepted by the user.

2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
3Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Uploading All Completed Test Results for a Sample to the LIS

You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must
be enabled before uploading can occur. See Laboratory Information Systems (LIS).
To upload all the completed test results for a sample:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, place focus2 on a sample ID with test results to upload.

3. Select the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.
4. When the operation is complete, a black check mark appears in the Upload Status column. See
Sample List Display Settings to display hidden columns.
See Upload Status.

Sample U pload
A sample upload sends the following information to the host:
l Print Status
l Priority
l Sample Status
l Upload Status
l Validation Status

Finding a Sample ID
To find a sample ID:
1. Select Analysis > Sample List in the menu bar.

2. Select the Find icon in the toolbar, or select Actions > Results > Find Sample in the menu bar
to open the Quick Search window.
3. Enter all or the first part of the sample ID and select Previous to search up, or Next to search down in
the Sample List.

You can also filter the Sample List to find a sample ID.

1Test results accepted by the user.

2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Filtering Selected Samples by Test Code

To select sample IDs associated with a test code:
1. Select Analysis > Sample List in the menu bar.
2. Select1 one or more sample IDs in the Sample List.

3. <Optional> Click the Select column icon in the column heading to select all sample IDs in the
Sample List.
4. Select Actions > Results > Filter Selection by Test Code in the menu bar to open the Test Code
Selection Filter.

5. Select2 one or more test codes in the Available column and click the right arrow to move them to the
Selected column.
6. <Optional> Select one or more test codes in the Selected column and click the left arrow to move
them to the Available column.
7. Select OK to filter the Sample List selection by the test codes in the Selected column.
8. The sample IDs associated with the filtered test codes now appear selected in the Sample List.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Changing the Sample List Display Settings

To change the Sample List to another saved configuration:
1. Select Analysis > Sample List in the menu bar.
2. Do one of the following:

l Select the Sample List Display Settings icon in the toolbar to display the
default setting.

l Select the down arrow to the right of the Sample List Display Settings icon,
and select a setting from the in menu.
l Select Setup > Display > Sample List Settings in the menu bar, and select a defined
setting in the submenu.

3. See Sample List Display Settings to display hidden columns.

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Configuring Sample List Display Settings

Use this procedure to create and save up to eight configurations of fixed and scrollable columns in the
Sample List table. Also use this procedure to edit an existing configuration.
To configure a new Sample List display setting:
1. Select Analysis > Sample List in the menu bar.
2. Select Setup > Display > Sample List Settings > View in the menu bar.
3. In the Sample List Display Settings dialog box, select a Setting tab to configure with new display
settings.

4. In the Configuration name field, enter a name for the new configuration to appear on this tab and the
submenu.
5. <Optional> Select the Default option to make this configuration the default display.
6. Select the Non Scrollable Columns tab. Use the Left and Right arrows to populate the Selected
columns list with the fixed columns to appear on the left side of the Sample List.
7. Select the Scrollable Columns tab. Use the upper Left and Right arrows to populate the Selected
columns list with the test names to appear in the large scrollable header column to right of the fixed
columns in the Sample List.

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8. Use the lower Left and Right arrows on the Scrollable Columns tab to populate the Selected test unit
columns list with the test units to appear in the scrollable columns under the test name heading
column to right of the fixed columns in the Sample List.
9. Select OK to save the configuration.

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Actions Menu

C onfiguration
Opens the Sample List Filter submenu.

R esults
Opens a submenu with the following options:
l Recalculate
l Validate
l Upload
l Delete
l Find Sample
l Select All
l Unselect All
l Filter Selection by Test Code
l Download Tests Order
l Add/Remove Tests – Opens the Tests and Profiles window where you can manually add or delete a
test for a sample selected in the Sample List.
See Reviewing Test Results.

Print Preview
Opens a submenu with the following options:
l Sample Results Report
l Patient Report
Pre-select one or more sample IDs or test codes to preview before printing.

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Print
Opens a submenu with the following options:
l Sample Results Report
l Patient Report
Pre-select one or more sample IDs or test codes to print.

Export
Opens a submenu with the following options:
l Sample Results Report
l Patient Report
l Sample Results (EXCEL) – Exports the filtered list created with Filter Selection by Test Code.
Pre-select one or more sample IDs or test codes to export.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

R aw D ata R eport
Includes measured results and results stored within the test (results that were not recalculated). Pre-select one
or more samples or tests for a sample. Only completed tests can generate a report. The report is a text file
placed into the folder specified in Global Definitions/Default File Path.

Patient D emographics
Opens a submenu with the following options:
l Save
l Restore

Print Screen
Prints the open screen.

R eview
Opens a submenu with the following options:
l Previous screen
l Sample details

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l Test details
l Results statistics – All results within a time interval, or results inside the normal range within that
time interval, display for each Test Code/Unit. Results include Mean, Number of results, SD, Min and
Max. See Results Statistics.
l Test Counters Statistics – Displays a table with the number of tests (active and alternate) executed for
a test definition since the last reset of this screen. See Test Counters Statistics.

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Sample List Toolbar

Select the following icons to perform the associated tasks:

Sample List Display Settings – Changes the view settings. See Sample List Display
Settings to display hidden columns.

Validate – Use to validate1 selected test results.

Upload – Upload selected test results to the LIS.

Filter – Filters the Sample List. See Sample List Filter.

Find – Search for a sample ID.

Add/Delete Tests.

Sample Details – Opens the Sample Details screen under the Sample List. Displays test
information for the sample in focus2.

Test Details – Opens the Test Details screen for the sample test in focus3.

NOTE: Only patient samples are displayed in the Sample List.

See Sample Area, Sample Details and Test Details.

1The acceptance of test results by the user.

2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
3To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Sample List Screen

Sample List Screen Displaying the Data Area
Each row in the Sample List corresponds to a sample that has been programmed.

Sample List
To sort the Sample List:
1. Click a column heading.
2. Click the same column heading again to sort in reverse order.
3. Click a 2nd column to resort the list. This column becomes the primary sorting criterion, and the first
column sorted becomes the secondary sorting criterion.

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Sample List with Tests and Profiles Window

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Sample List Columns

See Sample List Display Settings to display hidden columns.

Selection C olumn
Click in this column to place a check mark there. This selects a sample. You can multi-select samples in this
column.

Sample ID
Sample unique identifier. Click a row place focus1 on the sample ID in that row. Only one sample ID can
have focus. When the sample has focus, the tests associated with it appear in the Sample Details screen.

Sample Status
Displays the color-coded status of each sample. See Sample Status Color Codes.

Print Status
Status of print jobs associated with the sample. AutoPrint must be enabled to activate this column. A black
check mark indicates all actions are complete for all of the tests in the sample. A gray check mark indicates
one or more actions are incomplete.

Priority Status
A check mark indicates the sample is a stat, which processes with the highest priority.

CAUTION: Continuously adding stat2 samples delays testing on non-stat samples, possibly
indefinitely.

Validation Status
Validation status of the sample. A black check mark indicates all actions are complete for all of the tests in
the sample. A gray check mark indicates one or more actions are incomplete.

Sample H ighest Error

Code for the highest priority error associated with the sample. If the cell is empty, no error or warning exists
for the sample. If a code is underlined, additional errors or warnings exist for this sample. See Sample List
Display Settings to display hidden columns. See Data Flags for error descriptions.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
2In medical terminology, immediate; with no delay. Stat samples have highest priority.

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D ate & Time

Date and time the sample was entered into the system.

R ack ID
Track where the sample rack containing the sample is placed. An LAS value indicates the sample came from
the LAS track. A sample aliquotted from the LAS track is assigned a rack ID of 999. This value is not
displayed but is transmitted to the LIS.

Position
Position of the sample on the sample rack. An LAS value indicates the sample came from the LAS track. A
sample aliquotted from the LAS track is assigned a rack position of 99. This value is not displayed but is
transmitted to the LIS.

U pload Status
Upload status of sample results to the LIS. A black check mark indicates all actions are complete for all of
the tests in the sample. A gray check mark indicates one or more actions are incomplete.
A sample upload sends the following information to the host:
l Print Status
l Priority
l Sample Status
l Upload Status
l Validation Status
A test upload sends the following information to the host:
l Test ID
l Test Status
l Test Order Date
l Test Results

On B oard Status
A black check mark indicates the sample is on board.

A dditional C olumn H eadings

See Sample List Display Settings to display the following additional columns:
l First Name of patient
l Last Name of patient
l Patient ID
l Birth date

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l Gender
l Status of sample
l Ordered date & time – Date/time of the first test order
l Last test completed date & time – Blank if no test has been completed for the sample.
l First test completed date & time – Blank if no test has been completed for the sample.
l Sender ID

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Test Information Columns

<test> Columns
On the right side of the Sample List are the Test Results columns. There is one large test results column (with
sub-columns) for each test performed on a sample. The large <test> column contains the test name in the
column heading. Under the <test> are sub-columns that contain the units used for the results and two
columns with icon headings to identify the job type and rerun mode.

The cells in the Test Results column can contain the following information for the sample:
l If the test is complete, the Test Result numeric value is displayed. (FAILED is displayed if the result
failed.)
l If the test is not complete the status appears in the first result column for each test. Status can be: TO
DO, PLACED, NOT FEASIBLE and ACTIVE.

Job Type
Displays a letter to indicate the type or mode of the test performed. The letter for each test type is defined in
Global Definitions in Test Mode Extensions. The most commonly used letters are: E – Extended mode, P –
Parallelism mode, and D – Dilution mode, although you can use any letter you choose for each of these
modes.

R erun Mode
This column displays the following:

o – Rerun test triggered by a previous test.

o – This test triggered a rerun.

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R esult U nit C olumns

l If the test completed successfully, the mean result for each unit displays.
l If the test completed but the results failed, the word FAILED displays.
l If the test is incomplete, its status displays in the first result column.
l If the result is underlined – There are more results for this test that cannot display. See Sample List
Display Settings to change the display.
l If the result is italicized – There is at least one warning against it. The only exception to this is the
Second Algorithm used flag.
l If the result is purple and bold – The result is out of test range.
l If the result is red and bold– The result is out of linear range but within test range.
l If the result is orange and bold – The result is out of therapeutic range.
l If the result is blue and not bold – The result is out of normal range but within linear range.
l If the result is black and not bold – The result is within normal range.

l An exclamation point displays on the sample status circle to indicate failed results. It appears
based on the last result for each test run, or for a given sample.

Example
If a PT result fails, an exclamation point appears:
l If the test repeats and the result is good (for example: PT=80 seconds) the exclamation point
disappears.
l If the test repeats in the extended mode and the result of the PT-E test is good (for example: PT-
E=105 seconds) the exclamation point still appears for the PT result, but not for the PT-E result
because these are two different tests.
In parallelism, if any of the parallelism indices fail (for example, slope, CV) an exclamation point appears.

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Time to Completion
At the bottom of the screen, below the instrument status field, the time required to complete running tests
displays dynamically, along with the number of tests completed and ordered.

See Also
l Exporting Data
l Sample Details
l Test Details
l Sample Area
l Sample List Filter
l Reviewing Test Results
l Results Statistics
l Test Counters Statistics
l Clot Curve Analysis

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Sample Details

Viewing Sample Details

To view sample details:
1. Select Analysis > Sample List in the menu bar.

2. In the Sample List, place focus1 on a sample ID and select the Sample Details icon in the
toolbar to open the Sample Details screen below the Sample List.
3. Select the Test Information tab in the Sample Details screen to view the tests associated with the
sample in focus in the Sample List.
4. Select the Patient Demographics tab to view Sample and Patient information for the sample in focus
in the Sample List.

Viewing Parallelism Details

To open the Parallelism Detail screen:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, place focus2 on a sample ID with a parallelism test.

3. Select the Sample Details icon in the toolbar.

4. Select the parallelism test in the Sample Details screen.

5. Select the Test Details icon, or select Actions > Review > Test Details in the menu bar to
open the Test Details screen.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.
2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Test Information Tab

Column Headings

Job Type
Displays a letter to indicate the type or mode of the test performed. The letter for each test type is defined in
Global Definitions in Test Mode Extensions. The most commonly used letters are: E – Extended mode, P –
Parallelism mode, and D – Dilution mode, although you can use any letter you choose for each of these
modes.

R erun Mode
This column displays the following:

o – Rerun test triggered by a previous test.

o – This test triggered a rerun.

R esult U nit C olumns

l If the test completed successfully, the mean result for each unit displays.
l If the test completed but the results failed, the word FAILED displays.
l If the test is incomplete, its status displays in the first result column.
l If the result is underlined – There are more results for this test that cannot display. See Sample List
Display Settings to change the display.
l If the result is italicized – There is at least one warning against it. The only exception to this is the
Second Algorithm used flag.
l If the result is purple and bold – The result is out of test range.
l If the result is red and bold– The result is out of linear range but within test range.
l If the result is orange and bold – The result is out of therapeutic range.
l If the result is blue and not bold – The result is out of normal range but within linear range.
l If the result is black and not bold – The result is within normal range.

l An exclamation point displays on the sample status circle to indicate failed results. It appears
based on the last result for each test run, or for a given sample.

Example
If a PT result fails, an exclamation point appears:
l If the test repeats and the result is good (for example: PT=80 seconds) the exclamation point
disappears.
l If the test repeats in the extended mode and the result of the PT-E test is good (for example: PT-
E=105 seconds) the exclamation point still appears for the PT result, but not for the PT-E result
because these are two different tests.

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In parallelism, if any of the parallelism indices fail (for example, slope, CV) an exclamation point appears.

Patient Demographics Tab

Displays information such as Patient ID, Name and Date of birth for the patient from whom the sample was
obtained.

See Also
l Test Details
l Sample Area
l Sample List
l Sample List Filter

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Test Details

Viewing Test Details

To view test details:
1. Select Analysis > Sample List in the menu bar.

2. In the Sample List, place focus1 on a sample ID and select the Sample Details icon in the
toolbar to open the Sample Details screen below the Sample List.
3. In the Sample Details screen select the Test Information tab.

4. In the Test Information tab place focus on a test and select the Test Details icon in the toolbar
to view the Test details screen.

5. Select the Previous Job and Next Job icons in the toolbar to scroll through the test
results for the sample ID in focus in the Sample List.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Printing and Exporting a Parallelism Report

To print or export a Parallelism Report for a completed test:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, select one or more patient sample IDs with parallelism results.
3. To print a Parallelism Report, select Actions > Print > Print Parallelism Report in the menu bar.
4. To export a Parallelism Report, select Actions > Export > Export Parallelism Report in the menu
bar.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

Parallelism Result report

A Parallelism Result report includes the following information:
l Test code
l Sample ID
l Sample type
l Rack ID
l Sample rack position ID
l Execution date & time
l Validation status
l Validation date & time
l Primary unit at 100%
l Parallelism curve slope
l Calibration curve slope
l Parallelism Y-intercept
l %CV-CR
l Parallelism r2
l Average of correction result
l Parallelism curve
l Parallelism errors

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l Concentration
l Mean primary value
l Corrected result
l Result
l Replicates
l For each concentration the following is printed:
o Concentration
o Mean (mean value + measured unit)
o Primary (primary value + primary unit)
o Corrected result
o Replicate value (printed once for each replicate up to a maximum of 3)
o Replicate errors and warnings

l Test tracking information

Printing the Clot Curve

To print the clot curve:
1. Display the test details.

2. Select the Print icon in the toolbar.

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Test Details Screen

Use the Test Details screen to access detailed information on each test for a sample ID.

Test Information
l Test code– Test code as defined in Test Definition.
l Test type – Type of test. For example: Patient, Calibrator, QC, NPP1, Patient parallel, Extended, etc.
Defined in Test Definition.
l Sample ID– Unique sample identifier as defined on the sample bar code or as manually entered in the
Sample Rack Details.
l Rack ID – Rack identifier of the rack used to run the sample.
l Status – Status of the result.
l Upload status – Status of the result. Uploaded indicates the results were uploaded to the LIS.
l Validation status – The sample validation status.
l Sample position – Position on the rack where the sample was loaded when run.
l Ordered date/time – Date and time the test was ordered (manually or through the LIS). This does not
represent the time the test executed.
l Completed date/time – Date and time the test completed execution.

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Check Boxes
The check boxes on the left side of the Test Information section indicate the status of the sample ID when
tests were performed.
l CTS – Closed tube sample
l Reflex – A test that orders one or more secondary tests based on preset criteria applied to the initial
test results.
l Rerun – A test that runs again based on preset criteria applied to the initial test results.

Errors and warnings

Table listing the Group, Code and Description of the errors and warnings generated when the sample was
tested. See Data Flags.

Measured
Measured results for replicates. If applicable, additional reported results are also listed in the Unit 1-4 fields.

Reaction graphs
Graphical representation of the reaction curve. Select the Display derivative curves option to display the
derivative curves. The default for this option is configured in Global Definitions.

Tracking Information Tab

Displays the Material name, Lot number, and Expiration date of the materials used in the test.

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Parallelism Test Details Screen

The following screen displays parallelism results:

Tabs exist for General Information, Tracking Information and one for each dilution (for example, Dilution
100.00%, Dilution 50.00%, etc.)

Enable Display Transformed Axes

On the General Information tab you can select how to display the curve – with or without the transformed
axes – whether X and/or Y axis transformation is enabled in Parallelism Setup. In the screen above, the curve
is displayed with transformed axes.

See Also
l Configuring Factor Parallelism
l Parallelism Setup
l Sample Details
l Sample Rack Details
l Exporting Data
l Global Definitions
l Data Flags
l Test Definition
l Clot Curve Analysis

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Clot Curve Analysis

The PT and APTT tests are used as examples in this topic.

Overview
The ACL TOP instrument provides high quality results from both an accuracy and precision perspective. The
instrument incorporates optical-based reading systems with the means to precisely monitor clotting,
chromogenic, and immuno-turbidimetric reactions in the cuvette during the data acquisition cycle. The
optical data is processed by means of sophisticated algorithms as well as data checks designed to ensure
minimum acceptance criteria are met, and also ensuring that results are not reported from significantly
abnormal reaction curves.
In the case of clotting reactions, significantly abnormal conditions may be found, for example, in samples
from patients with liver function impairments. These pathologic conditions are known to cause coagulation
factor deficiencies as well as low fibrinogen levels.Samples from patients with these conditions can be
difficult to analyze. They may result in non-optimal readings especially from mechanical based clotting
analyzers which do not allow the clot to form undisturbed. Samples of this nature should be flagged on all
systems and the reaction visually evaluated. This evaluation can be performed on the ACL TOP systems to
establish a clot time.

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Configuring, Viewing and Analyzing Derivative Curves

The PT and APTT tests are used as examples in this procedure and analyses.
To configure, view and analyze derivative curves:
1. Select Setup > Global Definitions in the menu bar.
2. In the Global Definitions screen, under Test definition features, select the Display derivative curves
option to enable the display of clot curves on the Test Details screen.
3. Select Analysis > Sample List in the menu bar.

4. In the Sample List, place focus1 on a sample ID and select the Sample Details icon in the
toolbar to open the Sample Details screen below the Sample List.
5. In the Sample Details screen select the Test Information tab.
6. In the Test Information tab place focus on a PT or APTT test (the examples in this

procedure/analysis) and select the Test Details icon in the toolbar to view the Test details
screen.
7. On a Replicate tab, select Display derivative curves to view the clot curves for the test in focus.
8. Review the following sections for viewing PT and APTT clot curve examples.
The First Derivative is plotted as a pink line. The Second Derivative is plotted in light blue. The dark blue
line is the standard sample reaction plotted.
For the PT reaction, the clot time is noted at the peak of the First Derivative. For the APTT, the clot time is
noted at the peak of the Second Derivative. These selections correspond to the settings found in the test
definition for these test examples.
To view the settings for the test:
1. Select Setup > Test List in the menu bar.
2. Double-click the test in the Test List.
3. In the Test Details navigation tree, expand DR Parameters, Primary wavelength and select Primary
algorithm.
When a sample does not meet the criteria defined within the test definition, no result value are displayed. For
these samples the clot curve, with the derivatives curves enabled, can be a useful tool to establish a clot time
for the sample visually.
The display of a clotting reaction is a dynamic display. You can utilize the mouse cursor to view the time
by placing the cursor anywhere along the entire acquisition interval for the standard curve, First Derivative
(pink line), or Second Derivative (light blue line). Positioning the cursor at the peak of the respective curve

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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(i.e. Second Derivative for APTT) would provide the clot time for that sample, had it met all of the data
check criteria.
The APTT sample below is an example of how to read the curve value.

Example 1 – Low Fibrinogen APTT Sample

This reaction resulted in a Failed result with the error 5071 (Coag) First derivative peak not found.

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Double click the reaction graph on the ACL TOP interface to enlarge it.

This is a reaction for an APTT processed using HemosILSynthASil. This assay uses the Second Derivative to
establish a clotting time. This reaction shows a standard-looking clot curve with the characteristic S shape.
The S shape indicates the reaction has a baseline, acceleration, and plateau phase. You can also notice a
distinct peak for the Second Derivative (light blue) plot. The Y axis for the graph however has a limited
scale. The readings range from 89 to 106 (curve delta of 17) which is much smaller than what you would
normally obtain processing a sample with a normal fibrinogen value.
For a sample such as this, if you place the cursor at the peak of the Second Derivative you get a reading of
107.7 seconds. This would correspond to the reading obtained if all data check criteria had passed.
The clot curve can be a useful tool to establish what a clot time would be for a sample if the quality data
checks were not enabled in the test definition.

NOTE: Things to keep in mind when using this tool:

l The standard clot curve (dark blue line) should have the characteristic S shape
l A distinct peak for the First Derivative (pink line) should be present for assays using this algorithm.
l A distinct peak for both the First Derivative (pink line) and Second Derivative (light blue line) should
be present for assays using the Second Derivative algorithm.

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Example 2 – Extended APTT Sample – Failed Result

This reaction resulted in a Failed result with the error 5071 (Coag) First derivative peak not found.
Double click the reaction graph on the ACL TOP interface to enlarge it.

For this example, the standard clot curve (dark blue line) does not present the classic S shape. The curve has
a baseline and acceleration phase but lacks the plateau phase. In addition there is no distinct peak for the
Second Derivative (light blue line). This particular clot curve cannot be used to manually establish a clotting
time.
This example presents a sample with an extremely long clotting time. This type of sample would need to be
analyzed on a test/system that does not limit the data acquisition phase in order to establish the APTT clot
time.

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Clot Curve Analysis

On ACL TOP instrument, the monitored clotting reaction is plotted as a clot curve. A clot curve is generated
for all processed samples. Samples with low fibrinogen often produce a normal looking clotting reaction.
However, if the reaction does not meet the minimum delta specification, the system does not provide a result.
On the ACL TOP systems the clot curve display may be reviewed the following ways:
l Clot Curve reaction solely (no curves)
l Clot Curve reaction plus derivative curves.
An example of each of these is shown below for a PT and APTT reaction:

PT Curve without Derivative Curves

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PT Curve with Derivative Curves

APTT Curve without Derivative Curves

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APTT Curve with Derivative Curves

The PT and APTT appear different due to the algorithm used to identify the clot point of the sample:
l The PT using HemosIL™ RecombiPlasTin 2G reagent is resulted using the First Derivative algorithm;
therefore a single derivative curve is overlaid on the clot curve.
l The APTT using HemosIL SynthASil or APTT SP is resulted using a Second Derivative algorithm;
therefore two Derivative curves are overlaid on the APTT clot curve.

Conclusion
You can use the clot curve evaluate results from compromised samples. In many situations, samples that
present a Failed value (for example, due to very low fibrinogen content [fragile clot]) can be assessed via the
clot curve and a visual result obtained. It is always important to first ensure a clot has formed by reviewing
the clot curve for a baseline, acceleration and plateau phase before reading the result off the appropriate
derivative curve for the particular assay.

See Also
l Global Definitions Setup
l Primary Algorithm

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Results Statistics Chapter 10 – Sample Analysis

Results Statistics
The Results Statistics window displays test result information grouped by test code and unit.

Viewing Results Statistics

To view results statistics:
1. Select Analysis > Sample List in the menu bar.
2. With the Sample List open, select Actions >Review > Result Statistics in the menu bar.
3. In the Results Statistics Filter window, configure the date constraints and the results to display.
4. Select OK to display the test results in the Results Statistics window.
5. To print a Results Statistics report, select the Print button on the Results Statistics window. All the
information displayed in the window appears in the report.
6. Select the Preview or Export button on the Results Statistics window to preview or export a Results
Statistics report. See Exporting Data.

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NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

Results Statistics Filter

Filters the results to display in the Results Statistics window.

Enable filter by date/time interval

Option to filter by a date range. Enables the From and To fields.

From and To
Select the date range parameters for results to view in these fields.

Results

R esults Inside N ormal R ange

Displays all non-failed results without the DR flags Normal Range Low or Normal Range High.

A ll R esults
Displays all non-failed results.

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R esults from Selected Jobs

Displays non-failed results from jobs you have selected in the Sample List. See: Data Flags.)

Results Statistics Window

The title bar displays the filtering options you chose.

The following columns are displayed:
l Test & Unit – Displays the name of the test and the result unit.
Each of the following are calculated using results that match the test code/test result unit:
l Mean
l Number of Results
l SD
l Min
l Max
l %CV

See Also
l Sample List Area

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Test Counters Statistics Chapter 10 – Sample Analysis

Test Counters Statistics

There are two Test Counters Statistics windows:
l Simple Test Counters Statistics – Displays only the test code and the total number of determinations
for each test.
l Detailed Test Counters Statistics – Displays more details for each test.
By default, these are only available to Test Specialist/Service level (non-customer) users. However, service
can change the access level for either to a customer level.

Accessing the Test Counters Statistics Windows

To open a Test Counters Statistics window:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, select Actions > Review > Simple Test Counters Statistics or Detailed Test
Counters Statistics in the menu bar.
3. The title bar displays the date of the last reset of the counters.
4. To sort the data in the table, select a column. See Sorting Lists.
5. To reset the counters, select the Reset Counters button in the window and confirm when prompted.
All counters reset to 0 and the current date displays in the title bar.
6. To print a Test Counters List or Detailed Test Counters List report, select the Print button in the
window. All the information displayed in the window prints in the report.
7. To preview a report, select the Preview button in the window.
8. Select OK to exit the window.

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Simple Test Counter Statistics

Displays the Test Code and the total number of Determinations for all test types.

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Detailed Test Counter Statistics

Displays a table containing the number of tests executed for a test definition since the last reset of this
screen.
The number of Standard, Rerun and Reflex tests run for both number of tests and number of determinations is
displayed.

Columns Descriptions
Icon Test Code

Normal Jobs Counter

Extended Jobs Counter

Parallel Jobs Counter

Alternative Predilution Jobs Counter

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Icon Test Code

Calibration Jobs Counter – Number of calibrations (not tests) included in the calibration. The
total values are displayed in bold text. Calibration points are counted as individual determinations.

NPP Jobs Counter – Value is displayed in bold.

QC Jobs Counter – Value is displayed in bold.

# Total – The total number of jobs equals the sum of the patient calibration, NPP, and QC tests.
This value displays in bold text. The totals displayed in bold are used to calculate the total number
of tests. Values that display in plain text represent subtotals.

For calibration, NPP1 and QC tests, rerun and reflex do not apply. Those cells are blank.
For parallelism, rerun does not apply. Those cells are blank.
If a test is canceled before its completion, the counters are not updated.

See Also
l Test Details
l Sample List
l Reviewing Test Results
l Results Statistics

1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

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Sample List Filter Chapter 10 – Sample Analysis

Sample List Filter

By default, all known samples are displayed in the Sample List. Use the up to three filter options to reduce
the selection in the Sample List.

Filtering the Sample List

To filter the Sample List:
1. Select Analysis > Sample List in the menu bar.

2. Select the Filter icon in the toolbar, or select Actions > Configuration > Filter in the menu
bar.
3. In the Sample List Filter dialog box, select a maximum of three filters on the Sample Filters and Test
Filters tabs.
4. Configure the filter criteria for the filters enabled in the previous step. See the descriptions of Sample
List Filters and Test Filters tabs in this topic.
5. Select OK. The filtered results appear in the Sample List.
6. See Sample List to view sample and test details.

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Sample Filters 1 Tab

Enable filter by sample ID

Option to filter the Sample List by a range of sample IDs. To use this filter, select this option and configure
the sample ID range in the From and To fields. When the same sample ID is entered in both fields, one
sample ID displays.

Enable filter by sample priority

Option to filter the Sample List by sample priority. To use this filter, select this option and choose one of the
following in the Sample priority drop-down list:
l Normal – Displays normal priority samples.
l LAS – Displays samples on the LAS1 track.
l Stat – Displays the highest priority samples.

Enable filter by sample upload status

Option to filter the Sample List by sample upload status. To use this filter, select this option and choose one
of the following in the Upload status drop-down list:
l Not uploaded – Displays sample IDs with test results that have not been uploaded to the LIS.
l Uploaded – Displays sample IDs that have had all test results uploaded to the LIS.
l Partial – Displays sample IDs that have uploaded some, but not all, test results to the LIS.

Enable filter by ordered date/time

Option to filter the Sample List by tests ordered within a date range or by the current date. To use this filter,
select this option, then do one of the following:

1Laboratory Automation System

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l Select the Filter by current date option.

l Configure the date range in the From and To fields.

Enable filter by sample validation status

Option to filter the Sample List by sample validation status. To use this filter, select this option and choose
one of the following in the Validation status drop-down list:
l Not validated – Displays sample IDs with results that have not been validated.
l Validated – Displays sample IDs that have had all results validated.
l Partial – Displays sample IDs that have had some, but not all results validated.
l Not validated or partial – Displays 1) sample IDs with results that have not been validated; and 2)
sample IDs that have had some, but not all results validated.

Enable filter by sample print status

Option to filter the Sample List by sample print status. To use this filter, select this option and choose one of
the following in the Print status drop-down list:
l Not printed – Displays sample IDs that have test results that have not printed.
l Printed – Displays sample IDs that have test results that have all printed.
l Partial – Displays sample IDs that have printed some, but not all test results.

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Set of Filters 2 Tab

Enable filter by patient ID

Option to filter the Sample List by a range of patient IDs. To use this filter, select this option and configure
the patient ID range in the From and To fields. When the same patient ID is entered in both fields, one
patient ID displays.

Enable filter by sample highest error

Option to filter the Sample List by sample highest error. To use this filter, select this option and choose a
sample error code in the Sample error drop-down list. Only samples having the selected error are displayed
in the Sample List. Selecting Any group displays sample IDs the highest error among all the errors or
warnings.
Underlined samples in the Sample List have multiple errors. See Alarms and Troubleshooting/Data Flags for a
list of the error codes.

Enable filter by failed jobs

Option to filter the Sample List by failed jobs. To use this filter, select this option and choose one of the
following in the Failed Jobs drop-down list:
l Samples with failed jobs – Displays only samples with failed jobs .
l Samples with no failed jobs – Displays only samples with no failed jobs .

Enable filter by patient last name

Option to filter the Sample List by a range of patient last names. To use this filter, select this option and
configure the alphabetical range in the From and To fields (For example, enter A-Z or spell out full or partial
last names).

Enable filter by sample status

Option to filter the Sample List by sample status. To use this filter, select this option and choose one of the
following in the Sample status drop-down list:

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l TO DO – Displays samples with TO DO status.

l PLACED – Displays samples with PLACED status.
l IN USE – Displays samples with IN USE status.
l COMPLETED – Displays samples with COMPLETED status.
l PENDING – Displays samples with PENDING status.
l NOT FEASIBLE – Displays samples with NOT FEASIBLE status.

Enable filter by sample on board

Option to filter the Sample List by sample on board. To use this filter, select this option and choose one of
the following in the Sample status drop-down list:
l Not on board – Displays samples that are on board.
l On board – Displays only samples that are not on board.

Set of Filters 3 Tab

Enable filter by first test completed date/time

Option to filter the Sample List by first test completed within a date range or by the current date. To use
this filter, select this option, then select the Filter by current date option, or configure the date range in the
From and To fields.

Enable filter by last test completed date/time

Option to filter the Sample List by last test completed within a date range or by the current date. To use this
filter, select this option, then select the Filter by current date option, or configure the date range in the
From and To fields.

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Test Filters 1 Tab

Enable filter by test code

Option to filter the Sample List by test code. To use this filter, select this option and select a Test code in the
Test code drop-down list.

Test code
List of enabled tests, including parallel and extended tests. Type one or two letters of the test code, then
expand the list to jump to that text string in the list. You can select a test code in the list, or enter the first
letters of the test code in this field. The filter displays all the sample IDs with tests that exactly or partially
match the text string in this field.

R erun
Option to filter the Sample List by rerun. To filter by rerun only, select the Rerun option and leave the Test
code field empty. This configuration displays all sample IDs with a test that triggered a rerun.

Filter by both Test C ode and R erun

To filter by both Test Code and Rerun, enter the test code and select the Rerun option. This configuration
displays sample IDs that ran the selected test and triggered a rerun.

Enable filter by job type

Option to filter the Sample List by job type. To use this filter, select this option and choose one of the
following in the Sample status drop-down list:
l Patient – Displays patient jobs in the Sample List.
l Alt. Predilution – Displays alternative predilution jobs in the Sample List.
l Parallelism – Displays parallelism jobs in the Sample List.
l Extended – Displays extended jobs in the Sample List.

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Enable filter by job error

Option to filter the Sample List by job error. To use this filter, select this option and choose an error code in
the Job error drop-down list. Samples having the selected error display. Selecting Any group displays jobs
with any error or warning.
Underlined samples in the Sample List have multiple errors. See Data Flags for a list of the error codes.

All Samples
The All Samples option applies to all tabs. It cancels all filter criteria and displays all sample IDs in the
Sample List.

See Also
l Sample List
l Sample Details
l Sample Area
l Data Flags
l Alarm Messages

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CHAPTER 11
ANALYZER STATUS

Analyzer Status Indicators

To the right of the General Log on the Status Bar is a color-coded indicator of the current status of
the analyzer.

The LED indicates the status of the instrument as follows:

Power-up Blue
Startup initialization Blinking blue
Shutdown initialization Blinking blue
Adjusting thermal Blinking blue
Ready Green
Busy Blue
Controlled stop Blue
Error Amber
Emergency Stop Amber
Maintenance Blinking amber
Diagnostics Blinking amber
Connecting No LED
Not connected No LED

It typically takes up to 30 minutes for the analyzer to complete the power-up process from a cold start. It can
take up to 60 minutes at extreme temperatures.

See Also
l Starting and Stopping Overview

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CHAPTER 12
ALARMS AND TROUBLESHOOTING

Alarm Messages
You are notified of alarm messages through the alarm buttons on the instrument status bar. Alarm warning1
and error2 popup messages communicate important information as needed, such as when operator intervention
is required.

NOTE: Data flags do not appear in the General Log List or as popup alarms. For more information,
see Accessing Data Flags.

Accessing Alarm Messages

To view an alarm message do one of the following:
l Select the specific alarm button at the bottom of the screen to open that alarm window.
l Select System > General Log in the menu bar to view a list of all archived alarm messages.

l Select the General Log button on the left side of the status bar.

See Alarm Buttons for a complete description of all alarm buttons.

1A warning message indicates that some user action may be required. Warnings do not affect the operation of
the instrument. However, an error condition may eventually occur if the operator does not perform the
required action.
2An error message indicates that a condition has been detected that requires immediate action. Failure to act
may result in the instrument performing an emergency stop.

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New alarm messages are displayed in bold text. When you close this window, the message text returns to
normal font. The window can contain up to 200 messages. All messages that occur can be found in the
General Log.

Warning and Error Messages

Select a link to view alarms by category:
l Material Alarms
l Job Frequency Alarms
l QC Alarms
l Maintenance Alarms
l Analyzer Alarms
l External Communications Alarms
l Setup Alarms
l Other Alarms
l Popup Alarms

See Also
l Data Flags
l Alarm Buttons
l General Log List
l Troubleshooting Other Problems

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Material Alarms Chapter 12 – Alarms and Troubleshooting

Material Alarms
Back to Alarm Messages.

The alarms in this section are sorted by code number.

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid
damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible.
Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.

Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

1210 Cuvette waste level Cuvette Waste Level The system performed a controlled stop: the
sensor failure. Sensor Not run has to be re-started. If the problem persists,
Responding. call Service.

1215 Unable to empty Waste Accumulator Verify that the waste container is not full, and
internal waste reservoir. Full Sensor remains in that the indicator is not red. If the problem
ON state. persists, call Service.
Notes:
l TOP
500/700/700
CTS/700 LAS:
After 90
seconds
running the
Waste Pump.
TOP 300: After
five seconds.

1220 Reagent stirring failure. A check on the power Call Service.

required for stirring
returned an error

1239 Cuvette Loader failure. Failure during cuvette The system performed a controlled stop: the
indexing detected. run has to be re-started. If the problem persists,
call Service.

1240 Cleaning solution low Validate LLD height Perform a Clean prime cycle (Maintenance). If
in clean well. in Clean well. If too the problem persists call Service.
low, short sipping may
occur.

1241 <Probe> Clean priming Clean priming failure. Inspect tubing for kinks and/or leaks.

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

failure.
Check clean solution bottle.

If the problem persists, call Service.

1282 Probe <Probe> Rinse Rinse flow verification Inspect probe tip for blockage and clear if
Flow Test Failure procedure failure blocked.

Inspect tubing for kinks and/or leaks.

Check rinse solution bottle.

Call Service.

1285 Probe <Probe> Liquid LLD error occurred Check probe conditions. If the problem
Level Detection error in during pipetting persists, call Service.
rack position <X>, track operation.
<YY>.

1286 Probe <Probe> missing Missing post dispense Check probe conditions. If the problem
post dispense error/clean rinse/clean detected persists, call Service.
detected.

1292 Probe <Probe> Liquid LLD error in LAS Check probe conditions. If the problem
Level Detection error in Track persists, call Service.
LAS Track.

1293 Probe <Probe> Liquid LLD error in cuvette Check probe conditions. If the problem
Level Detection error in persists, call Service.
cuvette position <X>,
slot <YY>.

1294 Probe <Probe> Liquid LLD error in well Check probe conditions. If the problem
Level Detection error in persists, call Service.
well position <well
pos>.

1336 Probe <Arm> Liquid LLD error in LAS Arm Check probe conditions. If the problem
Level Detection error in cover aspiration point. persists, call Service.
LAS Arm cover
aspiration point.

1419 Probe <Probe> The probe detects Check probe conditions. If the problem
unexpected liquid level liquid but the persists, call Service.
in rack position <X>, measured position of
track <YY>. the liquid is
unexpected.

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

1420 Probe <Probe> The probe detects Check probe conditions. If the problem
unexpected liquid level liquid but the persists, call Service.
in cuvette position <X>, measured position of
slot <YY>. the liquid is
unexpected.

1421 Probe <Probe> The probe detects Check probe conditions. If the problem
unexpected liquid level liquid but the persists, call Service.
in well position <well measured position of
pos>. the liquid is
unexpected.

1422 Probe <Probe> Pre Invalid liquid Check probe conditions. If the problem
Aspiration Baseline detection: difference persists, call Service.
Check Failure in rack in baseline values read
position <X>, track before and after liquid
<YY>. detection is too low.

1423 Probe <Probe> Pre Invalid liquid Check probe conditions. If the problem
Aspiration Baseline detection: difference persists, call Service.
Check Failure in cuvette in baseline values read
position <X>, slot before and after liquid
<YY>. detection is too low.

1424 Probe <Probe> Pre Invalid liquid Check probe conditions. If the problem
Aspiration Baseline detection: difference persists, call Service.
Check Failure in well in baseline values read
position <well pos>. before and after liquid
detection is too low.

1425 Probe <Probe> Invalid liquid Check probe conditions. If the problem
aspiration baseline detection: difference persists, call Service.
check failure in rack in baseline values read
position <X>, track before and after
<YY>. aspiration is too high.

1426 Probe <Probe> Invalid liquid Check probe conditions. If the problem
aspiration baseline detection: difference persists, call Service.
check failure in cuvette in baseline values read
position <X>, slot before and after
<YY>. aspiration is too high.

1427 Probe <Probe> Invalid liquid Check probe conditions. If the problem
aspiration baseline detection: difference persists, call Service.
check failure in well in baseline values read
position <well pos>. before and after
aspiration is too high.

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

1428 Probe <Probe> Post Invalid liquid Check probe conditions. If the problem
Aspiration Baseline aspiration. LLD persists, call Service.
Check Failure in rack Baseline read after
position <X>, track liquid level detection
<YY>. and after liquid
aspiration is too high:
the probe did not stay
submerged.

1429 Probe <Probe> Post Invalid liquid Check probe conditions. If the problem
Aspiration Baseline aspiration. LLD persists, call Service.
Check Failure in cuvette Baseline read after
position <X>, slot liquid level detection
<YY>. and after liquid
aspiration is too high:
the probe did not stay
submerged.

1430 Probe <Probe> Post Invalid liquid Check probe conditions. If the problem
Aspiration Baseline aspiration. LLD persists, call Service.
Check Failure in well Baseline read after
position <well pos>. liquid level detection
and after liquid
aspiration is too high:
the probe did not stay
submerged.

1431 Probe <Probe> The probe detects Check probe conditions. If the problem
unexpected liquid level liquid but the persists, call Service.
in LAS Track. measured position of
the liquid is
unexpected.

1432 Probe <Probe> Pre The probe detects Check probe conditions. If the problem
Aspiration Baseline liquid but the persists, call Service.
Check Failure in LAS measured position of
Track. the liquid is
unexpected.

1433 Probe <Probe> Invalid liquid Check probe conditions. If the problem
aspiration baseline detection: difference persists, call Service.
check failure in LAS in baseline values read
Track. before and after
aspiration is too high.

1434 Probe <Probe> Post Invalid liquid Check probe conditions. If the problem

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

Aspiration Baseline aspiration. LLD persists, call Service.

Check Failure in LAS Baseline read after
Track. liquid level detection
and after liquid
aspiration is too high:
the probe did not stay
submerged.

1435 Probe <Probe> Unexpected liquid Check probe conditions. If the problem
unexpected liquid level level in LAS arm persists, call Service.
in LAS arm cover cover aspiration point.
aspiration point.

1436 Probe <Arm> Pre Invalid liquid Check probe conditions. If the problem
Aspiration Baseline detection: difference persists, call Service.
Check Failure in LAS in baseline values read
Arm cover aspiration before and after liquid
point. detection is too low.

1437 Probe <Arm> aspiration Invalid liquid Check probe conditions. If the problem
baseline check failure in detection: difference persists, call Service.
LAS Arm cover in baseline values read
aspiration point. before and after
aspiration is too high.

1438 Probe <Arm> Post Invalid liquid Check probe conditions. If the problem
Aspiration Baseline aspiration. LLD persists, call Service.
Check Failure in LAS Baseline read after
Arm cover aspiration liquid level detection
point. and after liquid
aspiration is too high:
the probe did not stay
submerged.

1440 Probe <Probe> The probe detects Check probe conditions. If the problem
unexpected clean level clean but the measured persists, call Service.
in rack position <X>, position of the liquid
track <YY>. is unexpected.

1449 Clean aspiration error There was an error Perform an enhanced clean maintenance
for probe <Probe>. during the aspiration activity.
of a clean liquid.

2000 Rinse solution bottle Rinse fluid system Replace the current Rinse bottle with a new
empty. liquid EMPTY sensor one. DO NOT TOP OFF the Rinse bottle. It
detected. must be replaced when the instrument is not

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

running. The system will automatically detect

the presence of a new bottle. A prime cycle
will be automatically performed. If the rinse
fluid level drops below 600 mL during a run,
the system will perform a controlled stop. In
this case, wait until the analysis completes
and the system comes to a complete stop, then
replace the Rinse bottle. If the rinse fluid level
drops below 100 mL, the system will perform
an emergency stop.

2005 Waste tank full. Waste Fluid Container Empty and replace the waste tank.
FULL sensor detected.
Note: The TOP 300 CTS liquid waste line
cannot rest in a horizontal position across the
table or bench that holds the instrument. It
must maintain a negative slope across the
entire length of the tubing to minimize the
backup of waste fluids. There must be no
crimping in the tubing.

2006 Unable to empty Cannot Empty Waste Replace the waste tank.
internal waste reservoir. into Container

2015 Clean solution bottle Clean fluid system Replace the current Clean bottle with a new
empty. liquid EMPTY sensor one. The Clean bottle must be replaced when
detected. the instrument is not running. If the Clean
bottle emptied during a run, the system
performs a controlled stop: wait until the
system comes to a complete stop, replace the
bottle with a new one, then restart the
analysis.

2020 Cuvette load area No cuvette strips Load cuvettes. The system performed a
empty. detected at EMPTY controlled stop and two situations can occur
sensor in load area. when loading new cuvettes:

- The cuvettes are loaded while the system is

in controlled stop. In this case the run is
automatically recovered (if there are tests
pending to be performed).

- The cuvettes are loaded when the system

already completed the analysis and went from
controlled stop to error. In this case the run
has to be restarted (if there are tests pending

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

to be performed).

2025 Cuvettes waste drawer Cuvette waste drawer Insert cuvette waste drawer or make sure that
missing. sensor defines waste it is properly inserted.
drawer not present
If the drawer is removed while the system is
running, a controlled stop is performed and
two situations can occur when re-inserting the
drawer:

- The drawer is re-inserted when the system is

in controlled stop. In this case the run is
automatically recovered (if there are tests
pending to be performed).

- The drawer is re-inserted when the system

already completed the analysis and went from
controlled stop to error. In this case the run
has to be restarted (if there are tests pending
to be performed).

If the system needs to dispose used cuvettes

when the drawer is missing, an Emergency
Stop is performed. In this case perform a
Recovery after the cuvette drawer is re-
inserted.

2030 Cuvette waste full. Cuvette waste drawer Empty cuvette waste drawer. The system
FULL sensor detected. performed a controlled stop and two situations
can occur when re-inserting the drawer: 1.-
The drawer is re-inserted when the system is
in controlled stop. In this case the run is
automatically recovered (if there are tests
pending to be performed). 2.- The drawer is re-
inserted when the system already completed
the analysis and went from controlled stop to
error. In this case the run has to be restarted (if
there are tests pending to be performed). If the
system needs to dispose used cuvettes when
the drawer is missing, an Emergency Stop is
performed. In this case perform a Recovery
after the cuvette drawer is re-inserted.

2035 Cuvettes strip dropoff Unable to Drop Off The system performed an Emergency stop.
failure in position Cuvette in the Perform a Recovery. If the problem persists,
<Cuvette Slot ID>. requested position. call Service.

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

2040 Cuvettes strip The requested Cuvette The system performed an Emergency stop.
positioning failure. move is not allowed Perform a Recovery. If the problem persists,
call Service.

2045 Cuvettes strip pickup Unable to Pickup The system performed an Emergency stop.
failure in position Cuvette in the Perform a Recovery. If the problem persists,
<Cuvette Slot ID>. requested position. call Service.

2046 Insufficient Clean Clean volume in vial Load additional clean material.
volume in track #<Track detected to be at error
ID>, position #<rack threshold.
position>.

2055 Insufficient volume in Insufficient liquid for Make sure that there is enough material for
track #<Track ID>, the aspirate (sample or the analysis and that it is presented in an
position #<rack reagent) appropriate container.
position>.

2074 Insufficient volume for Insufficient liquid for Check probe conditions. Make sure that there
sample <SampleID> at the sample aspiration is enough sample for the analysis.
Aspiration Point. (LAS Track)

2075 Insufficient liquid in Insufficient Liquid Call Service.

cuvette <Cuvette Slot detected when mixing
ID> well <well is performed in a
position>. cuvette.

2076 Probe <Probe>: Insufficient liquid for Perform a Clean prime cycle (Maintenance). If
Insufficient volume in the aspirate (sample or the problem persists call Service.
clean cup. reagent)

2077 Insufficient volume in Insufficient liquid for Make sure that there is a vial at the aspiration
LAS Arm cover the aspirate (LAS Arm point containing the appropriate volume of
aspiration point. Cover) material.

2083 <Material Name> Volume for last vial Load additional material.
insufficient material to detected to be at error
run additional threshold. The volume
calibration / test. of liquid on-board for
a specific material is
not enough to run a
single job, so a new
vial should be placed.

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

3001 <Material Name> Volume for last vial Load additional material before the currently
volume low. detected to be at used vial gets empty.
warning threshold.

3002 <Material Name> on- Remaining stability Load fresh material before the stability elapses
board stability low. for last vial detected for the currently used vial.
to be at warning
threshold.

3003 <Material Name> close Remaining expiration Load a new lot of material with later
to expiration. time for last vial/lot expiration date before the currently used lot
detected to be at expires.
warning threshold.

3004 Non-identified Material A material has been Manually define the material or remove rack,
in rack <rack ID> inserted without a re-position the vial barcode and re-insert the
position <rack position BarCodeID Label. rack.
#>, track # <rack track
#>.

3005 Unknown material in A material has been Remove the material and verify. Define
rack <rack ID> position inserted with a material prior to use in the system. Non-IL
<rack position #>, track BarCodeID label material should be used without barcodes.
# <rack track #>. whose Material Index
does not correspond to
any material definition
in the material list. In
this case the <Lot not
defined> alarm shall
not be triggered.
Follow Link to Data
Dictionary for further
information about
Barcode ID contents.

If the bottle type

contained in the Bar
Code is not defined or
is disabled, this alarms
will be also displayed.

3006 New Bottle Type The Bottle Type The vial size has been automatically updated.
(<Material Name> in contained in the Bar Make sure that the fill volume defined in
rack <rack ID> position Code is different than Material Definition is consistent with the new
<rack position #>, track the Bottle Type vial size. Also the on-board stability

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

# <rack track #>). defined in the material definition may change.

definition.

3007 Unknown lot (<Material A material has been Remove material from the system. Verify that
Name> in rack <rack loaded on-board the material is a defined lot in the system
ID> position <rack whose lot is not prior to loading.
position #>, track # defined in the system.
<rack track #>). In this case the
Material ID contained
in the Barcode Label
is known but the Lot
Id is not. Therefore the
alarm <Non-
Referenced Material>
shall not be generated.
Follow link to Data
Dictionary for further
information about the
contents of the
Barcode ID.

3009 Placement error A material has been Remove the CAL/NPP and load it in a
(<Material Name> in placed in a wrong rack suitable position. See Test Feasibility for
rack <rack ID>, position position. proper placement of all reagents.
<rack position #>, track
#<rack track#>).

3010 Placement error A material has been Remove the QC and load it in a suitable
(<Material Name> in placed in a wrong rack position. See Test Feasibility for proper
rack <rack ID>, position position. placement of all reagents.
<rack position #>, track
#<rack track#>).

3011 Placement error A material has been Remove the Sample Diluent and load it in a
(<Material Name> in placed in a wrong rack suitable position. See Test Feasibility for
rack <rack ID>, position position. proper placement of all reagents.
<rack position #>, track
#<rack track#>).

3012 Placement error A material has been Remove the Reagent Diluent and load it in a
(<Material Name> in placed in a wrong rack suitable position. See Test Feasibility for
rack <rack ID>, position position. proper placement of all reagents.
<rack position #>, track
#<rack track#>).

3013 Placement error A material has been Remove the Intermediate Reagent and load it

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

(<Material Name> in placed in a wrong rack in a suitable position. See Test Feasibility for
rack <rack ID>, position position. proper placement of all reagents.
<rack position #>, track
#<rack track#>).

3014 Placement error A material has been Remove the Start Reagent and load it in a
(<Material Name> in placed in a wrong rack suitable position. See Test Feasibility for
rack <rack ID>, position position. proper placement of all reagents.
<rack position #>, track
#<rack track#>).

3015 Placement error A material has been Remove the Deficient Plasma and load it in a
(<Material Name> in placed in a wrong rack suitable position. See Test Feasibility for
rack <rack ID>, position position. proper placement of all reagents.
<rack position #>, track
#<rack track#>).

3016 Placement error A material has been Remove the Clean Material and load it in a
(<Material Name> in placed in a wrong rack suitable position. See Test Feasibility for
rack <rack ID>, position position. proper placement of all reagents.
<rack position #>, track
#<rack track#>).

3017 Placement error A material has been Remove the rack and load it in a suitable
(<Material Name> in placed in a wrong rack position. Start Reagents are always placed to
rack <rack ID>, position position. the right of Intermediate Reagents and
<rack position #>, track Deficient Plasma. See Test Feasibility for
#<rack track#>). proper placement of all reagents.

3018 Placement error A material has been Remove the rack and load it in a suitable
(<Material Name> in placed in a wrong rack position. Intermediate Reagents and Deficient
rack <rack ID>, position position. Plasma are always placed to the left of Start
<rack position #>, track Reagents. See Test Feasibility for proper
#<rack track#>). placement of all reagents.

3019 Placement error A material has been Remove the Start Reagent and load it on
(<Material Name> in placed in a wrong rack another rack. Do not mix on the same rack
rack <rack ID>, position position. Start Reagents with Intermediate Reagents or
<rack position #>, track the Deficient Plasma. See Test Feasibility for
#<rack track#>). proper placement of all reagents.

3020 Placement error A material has been Remove the Intermediate Reagent or Deficient
(<Material Name> in placed in a wrong rack Plasma and load it on another rack. Do not
rack <rack ID>, position position. mix on the same rack Start Reagents with
<rack position #>, track Intermediate Reagents or Deficient Plasma.
#<rack track#>). See Test Feasibility for proper placement of
all reagents.

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

3021 Placement error Two lots of the same Remove the lot that you do not want to use.
(<Material Name> in material have been See Test Feasibility for proper placement of
rack <rack ID>, position placed on-board at the all reagents.
<rack position #>, track same time.
#<rack track#>).

3024 <TestCode> <JobType> A job has been sent to Check the materials required for the assay or
job not feasible. AM and there is no place more reagents.
Waiting for <material enough volume for
name>. some of the reagents
or a reagent is not
placed. Clean
Materials are not
included in this alarm.

3025 <TestCode> Automatic An automatic job Check the materials required for the assay or
<JobType> job not created by the AM not place more reagents.
feasible. Waiting for have enough volume
<material name>. for some of the
reagents or a reagent is
not placed. Clean
Materials are not
included in this alarm.

3055 Placement error Material with vial Review bottle type for possible bar code
(<Material Name> in profile different than label/bottle type inconsistency. Use another
rack <rack ID>, position 4mL placed in a position for bottle placement.
<rack position #>, track Diluent rack Pos 3 to
#<rack track#>). 8.

Material with vial

profile equal to 30mL
placed in a non
Diluent rack or in Pos
3 to 8 of a diluent
rack.

3084 <Material Name> on- Remaining stability Load fresh material.

board stability expired for last vial expired.
for last available vial.

3085 <Material Name> The present date is Define a new active lot of material.
expired. greater than the
expiration date of the Depending on the material, calibration, QC

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

last available vial/lot. or NPP measurements may be required prior to

running patient samples.

3086 <Material Name> A material requiring Remove material and load it in a stirring-
requires stirring (rack stirring is placed in a enabled position (reagent rack positions 1 or
<rack ID> position position not having 2, inserted in track with stirring enabled).
<rack position #>, track stirring capability
# <rack track #>)

3096 <Test Code> is There was a Check for test consistency, whether the test is
inconsistent/disable/lock programmed test enabled, or if it is locked for manual ordering.
manual ordering. inconsistent/disabled
or locked for manual
ordering and the test
was removed.

3097 <TestCode> <JobType> Number of predilution Increase the number of predilution cuvette
job cannot be executed cuvette slots is slots defined in the LAS Configuration
and was removed from insufficient to execute Screen. Please refer to the Operator's Manual
sample/material a calibration or a for more guidance.
<Sample ID/Material parallelism job.
Name>. Number of
predilution cuvette slots
is insufficient.

3182 <Test Code> is There was a Check for test consistency and check if it is
inconsistent/disabled. programmed test for an enabled.
LAS sample. The test
definition is
inconsistent/disabled
and the test was
removed.

3183 Sample volume for The LAS sample Retrieve the LAS sample and introduce the
<Test Code> volume required to sample to the instrument via a sample rack.
<JobType> job exceeds complete a single test
the limit of a cuvette cannot exceed 535 uL
cell.

3184 <TestCode> <JobType> A job cannot start Load fresh sample.

job not feasible. Sample because the LAS
<SampleID> has sample expired
expired.

3185 <TestCode> <JobType> A job has been sent to Load fresh sample.
job not feasible. AM and there is not
Waiting for sample enough sample

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

<SampleId>. volume.

3187 <TestCode> <JobType> A job has been sent to Check the clean material volume periodically
Required Clean Material AM and there is not and replenish as needed.
shortage has been enough volume for a
estimated. Monitor required clean material
<material name> or the clean is not
availability. placed.

3088 Volume check not Volume check not Perform an enhanced clean for the required
performed (<Material performed because probes.
Name> in rack <rack enhanced clean is
ID>, position <rack required
position #>, track
#<rack track #>).

3215 LAS sample expiration The time that an LAS Load more sample.
time exceeded for <Data sample can remain on
Dictionary - SampleID>. board has been
exceeded.

4025 Clean solution level Clean fluid system Replace Clean solution bottle before it
low. liquid WARN sensor empties. The Clean bottle must be replaced
detected. when the instrument is not running.
Removing the Clean bottle while the
instrument is running will cause an
Emergency Stop.

4030 Rinse solution level Rinse fluid system Replace rinse solution bottle before it empties.
low. liquid WARN sensor The Rinse bottle must be replaced when the
detected. instrument is not running. Removing the
Rinse bottle while the instrument is running
will cause an Emergency Stop.

4035 Cuvettes low in the load No cuvette strips Load new cuvettes.
area. detected at WARN
sensor in load area.

4040 Cuvette waste almost The level of cuvettes Empty cuvette waste drawer before it gets full.
full. in the waste drawer is
close to maximum
height

4050 Waste tank almost full. Waste fluid container Empty waste tank before it gets full.
WARN sensor
Note: The TOP 300 CTS liquid waste line
detected
cannot rest in a horizontal position across the

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Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

table or bench that holds the instrument. It

must maintain a negative slope across the
entire length of the tubing to minimize the
backup of waste fluids. There must be no
crimping in the tubing.

4056 Waste tank not present. Waste tank is not Replace waste container.
present.

Back to Alarm Messages.

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 ACL TOP Family Operator's Manual
Job Frequency Alarms Chapter 12 – Alarms and Troubleshooting

Job Frequency Alarms

Back to Alarm Messages.

The alarms in this section are sorted by code number.

Job Frequency Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

3053 Calibration due for Calibration frequency in the warning Perform a calibration
<TestCode>. threshold. before it becomes
overdue.

3054 Normal Pool Plasma due for NPP frequency in the warning Run a Normal Pool
<TestCode>. threshold. Plasma before it
becomes overdue.

3056 Calibration of <Test Code> A calibration has been executed and Review and validate
completed: please review and requires validation from the user. calibration if required.
validate.

3057 Calibration of <Test Code> A calibration has been recalculated or

recalculated. edited.

3058 Calibration of <Test Code> A calibration has been manually

validated. validated.

3059 Calibration of <Test Code> A calibration has been completed and

completed and autovalidated. autovalidated.

3090 Calibration Overdue for Frequency expired for the active Perform a calibration
<TestCode>. validated calibration. job using active lots
and validate it.

3091 Normal Pool Plasma Overdue The NPP frequency has expired. Perform a Normal Pool
for <TestCode>. Plasma job.

3094 Calibration for <Test Code> A Calibration was active and it was Recalibrate (even if
interrupted. manually or automatically interrupted. frequency is OK).

3095 Autovalidation of completed A calibration has been completed and Review and validate
calibration for <Test Code> the autovalidation failed. calibration if required.
failed.

3098 <TestCode> <JobType> job A patient job has been sent to AM and Validate a calibration
not feasible. Calibration not there is no validated calibration for the for the on-board lots.
available. on board lots.

3099 <TestCode> <JobType> job A patient job has been sent to AM and Run QC jobs.
not feasible. QC Failed for there is a QC failed for that test.
<material name>.

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QC Alarms Chapter 12 – Alarms and Troubleshooting

QC Alarms
Back to Alarm Messages.

The alarms in this section are sorted by code number.

QC Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

3026 QC Due : <TestCode>- The expiration time to Run QC before it becomes overdue.
<MaterialName> perform a QC job has entered
in its threshold period.

3027 QC Frequency OK : Transition from QC

<TestCode>- frequency Overdue/Due to
<MaterialName> OK

3028 QC Omitted point: QC result omitted

<TestCode>-
<MaterialName>

3029 QC Point An omitted QC result has

restored:<TestCode>- been re-enabled.
<MaterialName>

3030 QC Results purged until QC results have been purged.

<limitDate> : <TestCode>-
<MaterialName>.

3087 QC Overdue: <TestCode>- The expiration date for a QC Perform QC.

<MaterialName> has been reached.

3088 QC Failed: <TestCode>- QC rules have failed. It is a Review QC results, statistics and
<MaterialName> hint to detect problems in the graphs. Based on the situation, take
measurement. proper corrective actions.

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Maintenance Alarms Chapter 12 – Alarms and Troubleshooting

Maintenance Alarms
Back to Alarm Messages.

The alarms in this section are sorted by code number.

Maintenance Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

2086 Maintenance activity A semi-Automatic or automatic The activity has not

interrupted: <Maintenance Maintenance Activity's Execution has been completed. Remove
Activity> been interrupted due to an error. the cause of the error
and re-select the activity.

3047 Maintenance activity due: An indicated maintenance activity shall Perform maintenance
be executed by the user. The expiration activity before it
<Maintenance Activity>. time to perform the activity has entered becomes overdue.
in its threshold period.

3048 Manual maintenance A new manual maintenance activity has

activity <Maintenance been defined and added by the user.
Activity Name> has been
added.

3049 Manual maintenance A manual maintenance Activity has been

activity <Maintenance deleted by the user.
Activity Name> has been
deleted.

3050 Maintenance activity A maintenance activity has been

<Maintenance Activity reconfigured. Their values might be
Name> has been changed.
configured.

3051 Frequency status for The frequency status of a maintenance

manual maintenance activity has changed to OK.
activity <Maintenance
Activity Name> has
changed to OK.

3052 Manual maintenance A maintenance activity has been

activity <Maintenance executed either manually by the user or
Activity Name> has been automatically by the system.
executed.

3089 Maintenance activity An indicated Maintenance Activity Perform the maintenance

overdue: should already have been executed by activity.
the user. The expiration date for a

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Maintenance Alarms – Warnings and Errors

Code Message Alarm Description Operator Action

<Maintenance Activity>. Maintenance Activity has been reached.

3216 Semiautomatic A maintenance activity has been

maintenance activity executed either manually by the user or
<Maintenance Activity automatically by the system.
Name> has been executed.

3217 Automatic maintenance A maintenance activity has been

activity <Maintenance executed either manually by the user or
Activity Name> has been automatically by the system.
executed.

Back to Alarm Messages.

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 ACL TOP Family Operator's Manual
Analyzer Alarms Chapter 12 – Alarms and Troubleshooting

Analyzer Alarms
Back to Alarm Messages.

The alarms in this section are sorted by code number.

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid
damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible.
Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.

Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

0000 Analyzer / A non-recoverable Communication cable Check communication

Control Module error occurred in the disconnection. Software or cable.
loss of CM/AM electronic failure.
communication. Communications Power off and restart
Manager (e.g. loss of the instrument.
connection).
If the problem persists,
If the instrument is call Service.
in Emergency Stop
this alarm is not
reported.

0005 Master controller Failure of LRC or Master controller board Power off and restart
failure. CRC check. malfunction. the instrument.

If the problem persists,

call Service.

0007 <Arm> Arm One of the AM Arm controller board did not Power off and restart
controller processors failed to pass initialization tests. the instrument.
initialization initialize, due to an
failure. Invalid Controller ID. If the problem persists,
call Service.

0010 Rack-Cuvette One of the AM Rack-Cuvette controller Power off and restart
controller processors failed to board did not pass the instrument.
initialization initialize, due to an initialization tests.
failure. Invalid Controller ID. If the problem persists,
call Service.

0011 Cuvettes One of the AM Cuvettes controller board did Power off and restart
controller processors failed to not pass initialization tests. the instrument.
initialization initialize, due to an
failure. Invalid Controller ID. If the problem persists,

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

call Service.

0012 Racks controller One of the AM Racks controller board did Power off and restart
initialization processors failed to not pass initialization tests. the instrument.
failure. initialize, due to an
Invalid Controller ID. If the problem persists,
call Service.

0013 Optical Reading One of the AM Optical Reading Units Power off and restart
Units controller processors failed to controller board did not pass the instrument.
initialization initialize, due to an initialization tests.
failure. Invalid Controller ID. If the problem persists,
call Service.

0014 <Arm> Arm Invalid parameter Built-in checks in the Power off and restart
Controller provided in a software detected an the instrument.
software error. function call, unrecoverable error.
message queue or If the problem persists,
inter-task call Service.
communication
mechanism.

0015 Master Controller Invalid parameter Built-in checks in the Power off and restart
software error. provided in a software detected an the instrument.
function call, unrecoverable error.
message queue or If the problem persists,
inter-task call Service.
communication
mechanism.

0016 Cuvettes Invalid parameter Built-in checks in the Power off and restart
Controller provided in a software detected an the instrument.
software error. function call, unrecoverable error.
message queue or If the problem persists,
inter-task call Service.
communication
mechanism.

0017 Racks Controller Invalid parameter Built-in checks in the Power off and restart
software error. provided in a software detected an the instrument.
function call, unrecoverable error.
message queue or If the problem persists,
inter-task call Service.
communication
mechanism.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

0018 Optical Reading Invalid parameter Built-in checks in the Power off and restart
Units Controller provided in a software detected an the instrument.
software error. function call, unrecoverable error.
message queue or If the problem persists,
inter-task call Service.
communication
mechanism.

0019 Rack-Cuvette Invalid parameter Built-in checks in the Power off and restart
Controller provided in a software detected an the instrument.
software error. function call, unrecoverable error.
message queue or If the problem persists,
inter-task call Service.
communication
mechanism.

0020 Analyzer internal A non-recoverable Built-in checks in the Power off and restart
communication error occurred in the software detected an the instrument.
error. Controller unrecoverable error.
Communications If the problem persists,
Manager or the low call Service.
level CAN bus driver
(master or controller
side.

0025 Master Controller Memory allocation Built-in checks in the Power off and restart
software error. failed or stack usage software detected an the instrument.
exceeds limit. unrecoverable error.
If the problem persists,
call Service.

0030 Master Controller Error detected when Built-in checks in the Power off and restart
software error. calling kernel software detected an the instrument.
facilities. unrecoverable error.
If the problem persists,
call Service.

0031 Cuvettes Error detected when Built-in checks in the Power off and restart
Controller calling kernel software detected an the instrument.
software error. facilities. unrecoverable error.
If the problem persists,
call Service.

0032 Racks Controller Error detected when Built-in checks in the Power off and restart
software error. calling kernel software detected an the instrument.
facilities. unrecoverable error.

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Code Message Alarm Description Cause Operator Action

If the problem persists,

call Service.

0033 Optical Reading Error detected when Built-in checks in the Power off and restart
Units Controller calling kernel software detected an the instrument.
software error. facilities. unrecoverable error.
If the problem persists,
call Service.

0034 Rack-Cuvette Error detected when Built-in checks in the Power off and restart
Controller calling kernel software detected an the instrument.
software error. facilities. unrecoverable error.
If the problem persists,
call Service.

0035 Master Controller Software logic error Built-in checks in the Power off and restart
software error. such as an invalid software detected an the instrument.
path in a switch unrecoverable error.
statement or if.else If the problem persists,
branch. call Service.

0036 Cuvettes Software logic error Built-in checks in the Power off and restart
Controller such as an invalid software detected an the instrument.
software error. path in a switch unrecoverable error.
statement or if.else If the problem persists,
branch. call Service.

0037 Racks Controller Software logic error Built-in checks in the Power off and restart
software error. such as an invalid software detected an the instrument.
path in a switch unrecoverable error.
statement or if.else If the problem persists,
branch. call Service.

0038 Optical Reading Software logic error Built-in checks in the Power off and restart
Units Controller such as an invalid software detected an the instrument.
software error. path in a switch unrecoverable error.
statement or if.else If the problem persists,
branch. call Service.

0039 Rack-Cuvette Software logic error Built-in checks in the Power off and restart
Controller such as an invalid software detected an the instrument.
software error. path in a switch unrecoverable error.
statement or if.else If the problem persists,
branch. call Service.

0040 Master Controller Invalid state for an Built-in checks in the Power off and restart
software error. event, function call, software detected an the instrument.

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message, etc unrecoverable error.

If the problem persists,
call Service.

0041 Cuvettes Invalid state for an Built-in checks in the Power off and restart
Controller event, function call, software detected an the instrument.
software error. message, etc unrecoverable error.
If the problem persists,
call Service.

0042 Racks Controller Invalid state for an Built-in checks in the Power off and restart
software error. event, function call, software detected an the instrument.
message, etc unrecoverable error.
If the problem persists,
call Service.

0043 Optical Reading Invalid state for an Built-in checks in the Power off and restart
Units Controller event, function call, software detected an the instrument.
software error. message, etc unrecoverable error.
If the problem persists,
call Service.

0044 Rack-Cuvette Invalid state for an Built-in checks in the Power off and restart
Controller event, function call, software detected an the instrument.
software error. message, etc unrecoverable error.
If the problem persists,
call Service.

0045 Master Controller It was detected that Built-in checks in the Power off and restart
software error. there is a potential software detected an the instrument.
for a stack problem. unrecoverable error.
If the problem persists,
call Service.

0046 Cuvettes It was detected that Built-in checks in the Power off and restart
Controller there is a potential software detected an the instrument.
software error. for a stack problem. unrecoverable error.
If the problem persists,
call Service.

0047 Racks Controller It was detected that Built-in checks in the Power off and restart
software error. there is a potential software detected an the instrument.
for a stack problem. unrecoverable error.
If the problem persists,
call Service.

0048 Optical Reading It was detected that Built-in checks in the Power off and restart

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Code Message Alarm Description Cause Operator Action

Units Controller there is a potential software detected an the instrument.

software error. for a stack problem. unrecoverable error.
If the problem persists,
call Service.

0049 Rack-Cuvette It was detected that Built-in checks in the Power off and restart
Controller there is a potential software detected an the instrument.
software error. for a stack problem. unrecoverable error.
If the problem persists,
call Service.

0050 Master Controller The command Built-in checks in the Power off and restart
software error. received is not software detected an the instrument.
supported. unrecoverable error.
If the problem persists,
call Service.

0051 Cuvettes The command Built-in checks in the Power off and restart
Controller received is not software detected an the instrument.
software error. supported. unrecoverable error.
If the problem persists,
call Service.

0052 Racks Controller The command Built-in checks in the Power off and restart
software error. received is not software detected an the instrument.
supported. unrecoverable error.
If the problem persists,
call Service.

0053 Optical Reading The command Built-in checks in the Power off and restart
Units Controller received is not software detected an the instrument.
software error. supported. unrecoverable error.
If the problem persists,
call Service.

0054 Rack-Cuvette The command Built-in checks in the Power off and restart
Controller received is not software detected an the instrument.
software error. supported. unrecoverable error.
If the problem persists,
call Service.

0056 Interrupted The CM has lost the Communication cable Check communication
communication connection with the disconnected. Analyzer cable connection.
between the AM module. powered off. Other Verify that the
Analyzer and the hardware/software Analyzer is powered
Control Module. communication problems. on. Restart the system
(both Analyzer and

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Code Message Alarm Description Cause Operator Action

Control Module); if
the problem persist
call Service.

0057 Optical Reading One of the Built-in checks in the Power off and restart
Units Controller wavelengths not used software detected an the instrument.
software error. in ORU acquisitions. unrecoverable error.
If the problem persists,
call Service.

0058 Controller Controller Upgrade Controller Upgrade has Call Service.

<Controller has failed since failed.
Name> upgrade downloaded SW
failure. version does not
match SW version
actually used. The
AM reported an
exception during the
upgrade process.

The AM not
responding during
controllers upgrade.
There is a 1 min
timeout.

AM/CM loss of
communications
during upgrade
process.

0061 <Arm> Arm Error detected when Built-in checks in the Power off and restart
Controller calling kernel software detected an the instrument.
software error. facilities. unrecoverable error.
If the problem persists,
call Service.

0065 <Arm> Arm Software logic error Built-in checks in the Power off and restart
Controller such as an invalid software detected an the instrument.
software error. path in a switch unrecoverable error.
statement or if.else If the problem persists,
branch. call Service.

0070 <Arm> Arm Invalid state for an Built-in checks in the Power off and restart
Controller event, function call, software detected an the instrument.
software error. message, etc unrecoverable error.

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Code Message Alarm Description Cause Operator Action

If the problem persists,

call Service.

0075 <Arm> Arm It was detected that Built-in checks in the Power off and restart
Controller there is a potential software detected an the instrument.
software error. for a stack problem. unrecoverable error.
If the problem persists,
call Service.

0080 <Arm> Arm The command Built-in checks in the Power off and restart
Controller received is not software detected an the instrument.
software error. supported. unrecoverable error.
If the problem persists,
call Service.

0084 Incompatible AM Incompatible AM Master version is Call Service.

Master software interface version incompatible with current
version. Detected between AM/CM CM software.
interface version
<Interface
Version> and
expected
<Interface
Version>.

0085 Incompatible Incompatible A controller version is Call Service.

<Controller interface version incompatible with current
Name> controller between a controller AM Master software.
version. and the AM Master
software

0086 Material SW detected a There was a software If the problem persists,

<Material Name> material that was not scheduling conflict. call Service.
not dispensed. dispensed

1001 <Arm> Arm The arm is Software or mechanical The system performed
failure. inoperable. error. Initialization error. an Emergency stop.
Perform a Recovery.
If the problem persists,
call Service.

1002 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Invalid Command. Perform a Recovery.
If the problem persists,

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Code Message Alarm Description Cause Operator Action

call Service.

1003 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Invalid Operand. Perform a Recovery.
If the problem persists,
call Service.

1004 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Invalid command sequence. Perform a Recovery.
If the problem persists,
call Service.

1005 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Device not implemented. Perform a Recovery.
If the problem persists,
call Service.

1006 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Timeout error. Perform a Recovery.
If the problem persists,
call Service.

1007 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Device not initialized. Perform a Recovery.
If the problem persists,
call Service.

1008 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Command overflow. Perform a Recovery.
If the problem persists,
call Service.

1009 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
No liquid detected with ZX Perform a
command. Recovery. The system
performed an
Emergency stop.
Perform a Recovery.
If the problem persists,
call Service.

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Code Message Alarm Description Cause Operator Action

1010 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Entered move for Z-axis out Perform a Recovery.
of range. If the problem persists,
call Service.

1011 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Not enough liquid detected Perform a Recovery.
with ZX command. If the problem persists,
call Service.

1012 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
No liquid detected with ZZ Perform a Recovery.
command. If the problem persists,
call Service.

1013 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Not enough liquid detected Perform a Recovery.
with ZZ command. If the problem persists,
call Service.

1017 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Arm collision avoided. Perform a Recovery.
If the problem persists,
call Service.

1020 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Step loss on X axis. Perform a Recovery.
If the problem persists,
call Service.

1021 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Step loss on Y axis. Perform a Recovery.
If the problem persists,
call Service.

1022 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Step loss on Z axis. Perform a Recovery.
If the problem persists,
call Service.

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Code Message Alarm Description Cause Operator Action

1023 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Step loss detected on X-axis Perform a Recovery.
of opposing arm. If the problem persists,
call Service.

1024 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
ALDIUM pulse time out. Perform a Recovery.
If the problem persists,
call Service.

1025 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Tip not fetched. Perform a Recovery.
If the problem persists,
call Service.

1026 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Tip crash. Perform a Recovery.
If the problem persists,
call Service.

1027 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Tip not clean. Perform a Recovery.
If the problem persists,
call Service.

1028 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Undefined error code Perform a Recovery.
reported. If the problem persists,
call Service.

1029 <Arm> Arm The arm is Software or mechanical error. The system performed
failure. inoperable. an Emergency stop.
Communication timeout. Perform a Recovery.
If the problem persists,
call Service.

1031 <Syringe> The pump used to Software or mechanical The system performed
Syringe failure. aspirate/dispense error. Initialization error. an Emergency stop.
fluids is inoperable. Perform a Recovery.
If the problem persists,
call Service.

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Code Message Alarm Description Cause Operator Action

1032 <Syringe> The pump used to Software or mechanical error. The system performed
Syringe failure. aspirate/dispense Invalid command. an Emergency stop.
fluids is inoperable. Perform a Recovery.
If the problem persists,
call Service.

1033 <Syringe> The pump used to Software or mechanical error. The system performed
Syringe failure. aspirate/dispense Invalid operand. an Emergency stop.
fluids is inoperable. Perform a Recovery.
If the problem persists,
call Service.

1034 <Syringe> The pump used to Software or mechanical error. The system performed
Syringe failure. aspirate/dispense Invalid command sequence. an Emergency stop.
fluids is inoperable. Perform a Recovery.
If the problem persists,
call Service.

1035 <Syringe> Fluid Detection Error. The sensor board detects The system performed
Syringe failure. This error occurs fluid, which is caused by an Emergency stop.
when the sensor leaking out the back of the Perform a Recovery.
board detects fluid, valve. If the problem persists,
which is caused by call Service.
leaking out the back
of the valve.

1036 <Syringe> EEPROM Failure. EEPROM is faulty. The system performed

Syringe failure. This error occurs an Emergency stop.
when the EEPROM Perform a Recovery.
is faulty. If the problem persists,
call Service.

1037 <Syringe> The pump used to Software or mechanical error. The system performed
Syringe failure. aspirate/dispense Device not initialized. an Emergency stop.
fluids is inoperable. Perform a Recovery.
If the problem persists,
call Service.

1038 <Syringe> The pump used to Software or mechanical error. The system performed
Syringe failure. aspirate/dispense Command overflow. an Emergency stop.
fluids is inoperable. Perform a Recovery.
If the problem persists,
call Service.

1039 <Syringe> Syringe Pump and Asynchronous dispensation The system performed
Asynchronous ORU controller in ORU failure. an Emergency stop.
dispensation in communications Perform a Recovery.

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Code Message Alarm Description Cause Operator Action

ORU. failure. If the problem persists,

call Service.

1040 <Syringe> The pump used to Software or mechanical error. The system performed
Syringe failure. aspirate/dispense Communication timeout. an Emergency stop.
fluids is inoperable. Perform a Recovery.
If the problem persists,
call Service.

1041 The Optical The ORU Head has The ORU has been disabled.
Reading Unit been disabled. User request.
<ORU ID> has
been disabled.

1042 The Optical The ORU Head has The ORU has been disabled. Call Service.
Reading Unit been disabled due to Air reading out of range
<ORU ID> has low air limit. (low).
been disabled.

1043 The Optical The ORU Head has The ORU has been disabled. Call Service.
Reading Unit been disabled due to Air reading out of range
<ORU ID> has due to a high air (high).
been disabled. limit.

1044 The Optical The ORU Head has The ORU has been disabled. Call Service.
Reading Unit been disabled due to Air reading drift (low)
<ORU ID> has air drift low limit. detected.
been disabled.

1045 The Optical The ORU Head has The ORU has been disabled. Call Service.
Reading Unit been disabled due to Air reading drift (high)
<ORU ID> has air drift high limit. detected.
been disabled.

1046 The Optical The ORU Head has The ORU has been disabled. Call Service.
Reading Unit been disabled due to Detector voltage error
<ORU ID> has an ORU voltage detected.
been disabled. problem.

1047 <Syringe> Plunger Overload. Movement of the syringe The system performed
Syringe failure. This error occurs plunger was blocked by an Emergency stop.
when movement of excessive pressure. Perform a Recovery.
the syringe plunger is If the problem persists,
blocked by excessive call Service.
pressure.

1048 <Syringe> Valve Overload. This Valve drive loses steps by The system performed

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

Syringe failure. error occurs when the blockage or excess back an Emergency stop.
valve drive loses pressure. Perform a Recovery.
steps by blockage or If the problem persists,
excess back pressure. call Service.
Continual valve
overload errors are an
indication the valve
should be replaced.

1049 <Syringe> Plunger Move Not Plunger Move Not Allowed. The system performed
Syringe failure. Allowed. When the When the valve is in bypass an Emergency stop.
valve is in bypass or or throughput position Perform a Recovery.
throughput position plunger movement If the problem persists,
plunger movement commands are not allowed. call Service.
commands are not
allowed.

1050 <Syringe> Command Overflow. Command Overflow. This The system performed
Syringe failure. This error occurs error occurs when the an Emergency stop.
when the command command buffer contains too Perform a Recovery.
buffer contains too many characters. If the problem persists,
many characters. call Service.

1100 Optical reading Voltage out-of-range Voltage out of range in Call Service.
units voltage fault detected. optical reading units.
control failure.

1105 Arm RS232 Software or Hardware failure. Call Service.

communication communications error
error. with arms

1110 Cuvettes Incubator temperature Temperature out of range in Call Service.

incubator No. 1 defined to be out of cuvette incubator.
temperature range for a period
control failure. exceeding the fatal
error limits.

1111 Cuvettes Incubator temperature Temperature out of range in Call Service.

incubator No. 2 defined to be out of cuvette incubator.
temperature range for a period
control failure. exceeding the fatal
error limits.

1115 Optical reading ORU temperature Temperature out of range in Call Service.
unit No. 1 defined to be out of optical reading unit.
temperature range for a period
control failure. exceeding the fatal

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Code Message Alarm Description Cause Operator Action

error limits.

1116 Optical reading ORU temperature Temperature out of range in Call Service.
unit No. 2 defined to be out of optical reading unit.
temperature range for a period
control failure. exceeding the fatal
error limits.

1117 Optical reading ORU temperature Temperature out of range in Call Service.
unit No. 3 defined to be out of optical reading unit.
temperature range for a period
control failure. exceeding the fatal
error limits.

1118 Optical reading ORU temperature Temperature out of range in Call Service.
unit No. 4 defined to be out of optical reading unit.
temperature range for a period
control failure. exceeding the fatal
error limits.

1120 Cuvette shuttle Cuvette Shuttle Cuvette shuttle temperature The system performed
temperature temperature defined out of range. a controlled stop: the
control failure. to be out of range for run has to be re-
a period exceeding started. If the problem
the fatal error limits. persists, call Service.

1125 Reagent area Reagent Area Reagent area temperature out The system performed
temperature temperature defined of range. a controlled stop: the
control failure. to be out of range for run has to be re-
a period exceeding started. If the problem
the fatal error limits. persists, call Service.

1130 Optical reading Detector interface Built-in checks detected an Call Service.
units data fault, e.g. conversion error.
acquisition did not complete,
control failure. emitter light source
not correct.

1131 <Arm> Arm CRC Error detected Arm controller board Call Service.
controller failure. in writing to or malfunction.
reading from a
permanent storage
device (e.g.
EEPROM)

1135 Cuvettes CRC Error detected Cuvettes controller board Call Service.
controller failure. in writing to or malfunction.

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Code Message Alarm Description Cause Operator Action

reading from a
permanent storage
device (e.g.
EEPROM)

1136 Racks controller CRC Error detected Racks controller board Call Service.
failure. in writing to or malfunction.
reading from a
permanent storage
device (e.g.
EEPROM)

1137 Optical Reading CRC Error detected Optical Reading Units Call Service.
Units controller in writing to or controller board malfunction.
failure. reading from a
permanent storage
device (e.g.
EEPROM)

1138 Rack-Cuvette CRC Error detected Rack-Cuvette controller Call Service.

controller failure. in writing to or board malfunction.
reading from a
permanent storage
device (e.g.
EEPROM)

1139 Rack-Cuvette Error detected in Rack-Cuvette controller Call Service.

controller failure. updating data on a board malfunction.
permanent storage
device (e.g.
EEPROM)

1140 Cuvettes Error detected in Cuvettes controller board Call Service.

controller failure. updating data on a malfunction.
permanent storage
device (e.g.
EEPROM)

1141 Racks controller Error detected in Racks controller board Call Service.
failure. updating data on a malfunction.
permanent storage
device (e.g.
EEPROM)

1142 Optical Reading Error detected in Optical Reading Units Call Service.
Units controller updating data on a controller board malfunction.
failure. permanent storage

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Code Message Alarm Description Cause Operator Action

device (e.g.
EEPROM)

1143 <Arm> Arm Error detected in Arm controller board Call Service.
controller failure. updating data on a malfunction.
permanent storage
device (e.g.
EEPROM)

1151 <Arm> Arm Voltage out-of-range Arm controller board Call Service.
controller voltage fault detected on a malfunction.
out of range. controller.

NOTE: MicroTOP
shall have one arm
controller only.
Therefore, the term
'Instrument Arm' shall
be used.

1155 Cuvettes Voltage out-of-range Cuvettes controller board Call Service.

controller voltage fault detected on a malfunction.
out of range. controller.

1156 Racks controller Voltage out-of-range Racks controller board Call Service.
voltage out of fault detected on a malfunction.
range. controller.

1157 Optical Reading Voltage out-of-range Optical Reading Units Call Service.
Units controller fault detected on a controller board malfunction.
voltage out of controller.
range.

1158 Rack-Cuvette Voltage out-of-range Rack-Cuvette controller Call Service.

controller voltage fault detected on a board malfunction.
out of range. controller.

1160 Probe <Probe> Automatic Probe coordinates mismatch. The probe cannot
coordinates error. coordinates check initialize. Perform a
failure probe alignment. If
the problem persists,
call Service.

1161 Wash station Wash station Conductivity failure between Wipe down probe tip
coordinates error. coordinates error. probe and wash station and clean station.
bracket.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

1165 Probe <Probe> AM coordinates have Coordinate adjustment Service or Lab

coordinate adjust never been adjusted procedure not executed or Administrator to run
required. using the "Coordinate failed. the Coordinate Adjust
adjustment" procedure.
procedure.

1166 Missing Until the user defines The coordinates of the Service or Lab
coordinates of the coordinates of the aspiration point on the LAS Administrator to run
aspiration point aspiration point on track are not defined. the Coordinate Adjust
in track. the LAS track, the procedure for LAS
instrument is unable track position.
to move the LAS
probe there.

1170 Invalid system Invalid emitter, System detected a hardware Check system
configuration. detection, or configuration that cannot configuration settings.
incubator module support the current system
configuration configuration settings: Power off and restart
detected, or reference missing or inactive optical the instrument.
channel not on reading unit(s), cuvettes
installed detection incubator or CTS module. If the problem persists,
module. call Service.

1175 <Probe> probe Probe Pre-Heater Probe pre-heating system The system performed
pre-heater temperature defined malfunction. a controlled stop. Call
temperature to be out of range for Service.
control failure. a period exceeding
the fatal error limits.

1180 <Probe> probe Probe temperature Probe heating system The system performed
temperature defined to be out of malfunction. a controlled stop. Call
control failure. range for a period Service.
exceeding the fatal
error limits.

1185 <Arm> arm clean Valve commanded Clean fluid valve not The system performed
fluid valve ON(OFF) but sensor responding. an Emergency stop.
failure. did not indicate ON Perform a Recovery.
(OFF) state. If the problem persists,
call Service.
NOTE: MiniTOP
and MicroTOP have
no valves.

1190 Sample Clean Pump commanded Clean pump not responding. The system performed
pump failure. ON(OFF) but sensor an Emergency stop.

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Code Message Alarm Description Cause Operator Action

did not indicate ON Perform a Recovery.

(OFF) state. If the problem persists,
call Service.
NOTE:

BaseTOP, CTS, LAS,

MiniTOP and
MicroTOP have:

Sample Clean Pump

Reagent Clean Pump

1191 Reagent clean Pump commanded Clean pump not responding. The system performed
pump failure. ON(OFF) but sensor an Emergency stop.
did not indicate ON Perform a Recovery.
(OFF) state. If the problem persists,
call Service.

1200 <Arm> arm rinse Pump commanded Rinse pump not responding. The system performed
pump failure. ON(OFF) but sensor an Emergency stop.
did not indicate ON Perform a Recovery.
(OFF) state. If the problem persists,
call Service.

NOTE: For Micro

there is only 1 pump.
<Arm> will be
empty. Terminology
for MicroTOP shall
be 'Instrument Arm'

1205 Waste pump Pump commanded Waste pump not responding. The system performed
failure. ON(OFF) but sensor an Emergency stop.
did not indicate ON Perform a Recovery.
(OFF) state. If the problem persists,
call Service.

1206 Coordinate File Failure saving Invalid FTP server Call Service.
Saving Failure. coordinates file on configuration, AM/CM
the FTP server connection network not
working.

1207 ORU Stored Failure saving ORU Invalid FTP server Call Service.

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Code Message Alarm Description Cause Operator Action

Reading File stored reading file on configuration, AM/CM

Saving Failure. the FTP server connection network not
working.

1208 CTS sample arm Pump commanded Air pump not responding. The system performed
air pump failure. ON(OFF) but sensor an Emergency stop.
did not indicate ON Perform a Recovery.
(OFF) state. If the problem persists,
call Service.

1209 CTS Failed to The foot hit the wash The foot hit the wash station The system performed
Enter Deep Wash. station edge when edge when the CTS probe an Emergency stop.
the CTS probe was was inserted inside the wash Perform a Recovery.
inserted inside the station. If the problem persists,
wash station. This call Service.
would have caused a
probe mode switch
failure at the end of
the wash cycle.

1236 Cuvette Pivot Failure on pivot arm Pivot Arm malfunction. The system performed
Arm failure. movement. Either the motor, pivot arm a controlled stop: the
up sensor, or pivot arm down run has to be re-
sensor is not functioning. started. If the problem
persists, call Service.

1237 Cuvette indexer Failure of the indexer Cuvette indexer motor The system performed
motor failure. motor detected. failure. a controlled stop: the
run has to be re-
started. If the problem
persists, call Service.

1238 Cuvette Loader Failure moving Cuvette loader malfunction. The system performed
Failure. cuvette loader belts Some cuvettes strips may not a controlled stop: the
detected. have been placed properly in run has to be re-
the loader, belts motor or started. If the problem
cuvette loader sensors persists, call Service.
malfunction.

1243 Cuvettes shuttle The motor did not Cuvette was not detected in The system performed
movement failure. complete the the shuttle after a cuvette an Emergency stop.
requested move. pickup operation completed. Perform a Recovery.
OR Cuvette was not If the problem persists,
detected in the cuvette call Service.
shuttle prior to a cuvette
drop off.

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Code Message Alarm Description Cause Operator Action

1244 Cuvettes shuttle The motor did not Unexpected cuvette present. The system performed
movement failure. complete the an Emergency stop.
requested move. Perform a Recovery.
If the problem persists,
call Service.

1245 Cuvettes shuttle The motor did not The motor moved to the left The system performed
movement failure. complete the limit then to the home an Emergency stop.
requested move. position at the loader and the Perform a Recovery.
home position was not If the problem persists,
found. call Service.

1246 Cuvettes shuttle The motor did not Incorrect # slots found. The system performed
movement failure. complete the an Emergency stop.
requested move. Perform a Recovery.
If the problem persists,
call Service.

1247 Cuvettes shuttle The motor did not Home Required. A cuvette The system performed
movement failure. complete the shuttle operation was an Emergency stop.
requested move. requested before the shuttle Perform a Recovery.
was initialized into a known If the problem persists,
state. call Service.

1248 Cuvettes shuttle The motor did not Cuvettes shuttle movement The system performed
movement failure. complete the timeout. Move Timeout. This an Emergency stop.
requested move. occurs if the software does Perform a Recovery.
not complete the move If the problem persists,
profile. call Service.

1249 Cuvettes shuttle The motor did not Cuvettes shuttle movement The system performed
movement failure. complete the stalled. an Emergency stop.
requested move. Perform a Recovery.
If the problem persists,
call Service.

1250 Cuvettes shuttle The motor did not Cuvettes shuttle movement The system performed
movement failure. complete the hit unexpected travel limit. an Emergency stop.
requested move. Perform a Recovery.
If the problem persists,
call Service.

1251 Cuvettes shuttle The motor did not Cuvettes shuttle movement The system performed
movement failure. complete the timeout. Gripper back sensor an Emergency stop.
requested move. failure. Perform a Recovery.
If the problem persists,
call Service.

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Code Message Alarm Description Cause Operator Action

1252 Cuvettes shuttle The motor did not Cuvettes shuttle movement The system performed
movement failure. complete the timeout. Gripper forward an Emergency stop.
requested move. sensor failure. Perform a Recovery.
If the problem persists,
call Service.

1253 Cuvettes shuttle The motor did not Cuvettes shuttle movement The system performed
movement failure. complete the timeout. Gripper move an Emergency stop.
requested move. failure. Perform a Recovery.
If the problem persists,
call Service.

1254 Cuvette waste Accumulator is full Cuvette waste drawer Please check that the
accumulator and unable to dump missing. cuvette waste drawer
unable to empty. is present.

1255 Barcode reader The motor did not Barcode reader movement Clear obstruction and
movement failure. complete the timeout. Home Not Found. wait for barcode
requested move prior reader timeout to
to a motor move time occur (homing of
out (bar code). barcode). If problem
persists call Service.

1256 Barcode reader The motor did not Barcode reader movement Clear obstruction and
movement failure. complete the timeout. Incorrect Slots wait for barcode
requested move prior Found. reader timeout to
to a motor move time occur (homing of
out (bar code). barcode). If problem
persists call Service.

1257 Barcode reader The motor did not Barcode reader movement Clear obstruction and
movement failure. complete the timeout. Home Required. wait for barcode
requested move prior reader timeout to
to a motor move time occur (homing of
out (bar code). barcode). If problem
persists call Service.

1258 Barcode reader The motor did not Barcode reader movement Clear obstruction and
movement failure. complete the timeout. wait for barcode
requested move prior reader timeout to
to a motor move time Move Timeout. occur (homing of
out (bar code). barcode). If problem
persists call Service.

1259 Barcode reader The motor did not Barcode reader movement Clear obstruction and
movement failure. complete the timeout. wait for barcode
requested move prior reader timeout to

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Code Message Alarm Description Cause Operator Action

to a motor move time Stalled. occur (homing of

out (bar code). barcode). If problem
persists call Service.

1260 Barcode reader The motor did not Barcode reader movement Clear obstruction and
movement failure. complete the timeout. wait for barcode
requested move prior reader timeout to
to a motor move time Unexpected Travel Limit. occur (homing of
out (bar code). barcode). If problem
persists call Service.

1261 All the Optical All the ORU have All the ORUs have been If the ORUs have
Reading Units are been disabled, either disabled, either automatically been automatically
disabled. manually or or manually. disabled, call Service.
Analysis cannot automatically.
be performed. - Automatically: ORU real- When all the ORUs
The instrument time check failed are disabled the
cannot perform any system cannot perform
tests. - Manually: operator analysis.
disabled ORU through
Diagnostics If this occurs during a
run, the system
performs an
Emergency Stop.

1263 Cuvettes The accumulator does Cuvettes accumulator The system performed
accumulator not return to the up movement timeout. an Emergency stop.
failure. position within 2 Perform a Recovery.
seconds of being If the problem persists,
emptied. call Service.

1264 Optical reading Temperature out of Temperature out of range in Call Service.
unit No. 1 range in a reading optical reading unit.
temperature unit
control failure.

1265 Optical reading Temperature out of Temperature out of range in Call Service.
unit No. 2 range in a reading optical reading unit.
temperature unit
control failure.

1266 Optical reading Temperature out of Temperature out of range in Call Service.
unit No. 3 range in a reading optical reading unit.
temperature unit
control failure.

1267 Optical reading Temperature out of Temperature out of range in Call Service.

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Code Message Alarm Description Cause Operator Action

unit No. 4 range in a reading optical reading unit.

temperature unit
control failure.

1268 Cuvettes Temperature out of Temperature out of range in Call Service.

incubator No. 1 range in an incubator cuvettes incubator.
temperature
control failure.

1269 Cuvettes Temperature out of Temperature out of range in Call Service.

incubator No. 2 range in an incubator cuvettes incubator.
temperature
control failure.

1270 <Probe> probe Probe temperature or Probe heating system Call Service.
temperature or dispense temperature malfunction.
dispense defined to be out of
temperature out warning range but
of range. within failure range.

1273 <Probe> probe Probe Pre-Heater Probe pre-heating system Call Service.
pre-heater temperature defined malfunction.
temperature out to be out of warning
of range. range but within
failure range

1276 Reagent area Reagent area Reagent cooling system Call Service.
temperature out temperature defined malfunction.
of range. to be out of warning
range but within
failure range.

1277 Cuvette shuttle Cuvette shuttle Cuvette shuttle heating Call Service.
temperature out temperature defined system malfunction.
of range. to be out of warning
range but within
failure range.

1278 Optical reading Optical Reference LED or electronic failure. Call Service.
units reference readings not within
readings out of expected range,
range for ORU possibly due to LED
<ORU ID>. aging or failure.

1279 Optical reading ORU dark readings Stray light interference or Call Service.
unit <ORU ID> are too high, possibly electronic failure.
dark readings too indicating excessive

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Code Message Alarm Description Cause Operator Action

high. stray light.

1280 Optical reading Optical readings too LED or electronic failure. Call Service.
units readings too noisy, possibly due
noisy for ORU to LED aging or
<ORU ID>. failure.

1281 Optical reading ORU amplifier and/or ORU LED or electronic Call Service.
unit <ORU ID> A/D converter failure. Amplifier and/or
readings out of saturated A/D converter saturated.
range.

1283 Optical reading Math exception error If the problem persists,

unit raw data (e.g. attempt to call Service.
calculation error. divide by zero,
overflow, result not
reasonable).

1284 Air read drift Current air read for ORU air reading drift Go to diagnostics,
detected for this wavelength, read detected. clean the ORU
ORU# <ORU head and read channels, enable the
ID> Channel# channel is outside of ORU in question and
<CHAN ID> the stored air read repeat the blanking
Wavelength# plus tolerance procedures (AIR and
<WAVE ID> Factor Diluent).
Drift percentage
<DRIFT
PERCENTAGE>

1295 Air read out of Current air read for ORU air reading out of Call Service.
range for ORU# this wavelength, read range.
<ORU ID> head and read
Channel# channel is out of
<CHAN ID> range
Wavelength#
<WAVE ID>
Reading: <ORU
READING>

1313 Failed to load When attempting to Either motor could have The system performed
cuvette clip at the move the cuvette stalled, sensor was not an Emergency stop.
indexer. indexer to pick up a reached, or sensor is not Perform a Recovery.
new cuvette clip, the functional. If the problem persists,
indexer was not call Service.
detected to be fully
to the left to allow

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Code Message Alarm Description Cause Operator Action

the clip to fall.

Move is attempted
for five seconds in
order to search for the
proper position.

1314 Failed to place When the cuvette Either the motor could have The system performed
cuvette clip in indexer is attempting stalled, the sensor was not an Emergency stop.
position for to load the cuvette reached, or the sensor is not Perform a Recovery.
pickup. clip into the position functional. If the problem persists,
for the cuvette shuttle call Service.
to pick it up, the clip
was not detected.
Move is attempted
for five seconds in
order to search for the
proper position.

1315 Pivot arm did not The move of the Either the motor was stalled The system performed
move to the up pivot arm to the up or the up sensor is not an Emergency stop.
position. position was not functioning properly. Perform a Recovery.
detected as If the problem persists,
completed. The call Service.
motor moves for 10
seconds and the
expected sensor to
stop the motor was
not found.

1316 Pivot arm did not The move of the Either the motor was stalled The system performed
move to the pivot arm to the or the up sensor is not an Emergency stop.
down position. down position was functioning properly. Perform a Recovery.
not detected as If the problem persists,
completed. The call Service.
motor moves for 10
seconds and the
expected sensor to
stop the motor was
not found.

1317 Cuvette strip not After all devices have Either the presence sensor is The system performed
in shuttle after successfully not functioning properly (ex. an Emergency stop.
pick up performed their dirty) or a cable has come Perform a Recovery.
operation. individual operations unplugged. If the problem persists,
to pick up a cuvette, call Service.
but a cuvette was not

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detected in the
shuttle.

1318 No cuvette strip A request was made Either a cuvette is really not The system performed
in shuttle to drop to drop off a cuvette, present, the presence sensor an Emergency stop.
off. but no cuvette is is not functioning properly Perform a Recovery.
detected in the (ex. dirty), or a cable has If the problem persists,
shuttle. come unplugged. call Service.

1319 Missing cuvette The shuttle is ready Either the operator did not The system performed
strip in slot for to pick up a cuvette, place a cuvette using an Emergency stop.
pick up. but there is no diagnostics, the Cuvette in Perform a Recovery.
cuvette in the slot. slot sensor is not If the problem persists,
functioning, or the scheduler call Service.
timing is not coordinated.

1320 Cuvette shuttle is The shuttle cannot Either the presence sensor is The system performed
full. perform a cuvette not functioning properly (ex. an Emergency stop.
pick up operation dirty), a cable has come Perform a Recovery.
because a cuvette is unplugged, an operator is If the problem persists,
already detected in attempting an invalid call Service.
the shuttle. operation in diagnostics, or
the scheduler timing is not
correct.

1321 Cuvette not After all devices have Either the presence sensor is The system performed
released into slot. successfully not functioning properly (ex. an Emergency stop.
performed their dirty), the gripper did not let Perform a Recovery.
individual operations go, the slot indexer did not If the problem persists,
to drop off a cuvette, engage the cuvette strip, a call Service.
but a cuvette was cable has come unplugged,
still detected in the or the gripper did not release
shuttle. the cuvette.

1323 Cuvette not The source position Either a scheduler error or The system performed
present to pickup. for picking up a operator error in diagnostics. an Emergency stop.
cuvette is empty. Perform a Recovery.
If the problem persists,
call Service.

1324 Cuvette The destination Either a scheduler error or The system performed
destination position for placing a operator error in diagnostics. an Emergency stop.
position full. cuvette is occupied. Perform a Recovery.
If the problem persists,
call Service.

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Code Message Alarm Description Cause Operator Action

1325 Cannot pickup The requested cuvette Software logic error. The system performed
from waste. pick up position is an Emergency stop.
the waste position Perform a Recovery.
which is not possible. If the problem persists,
call Service.

1326 Cannot drop off The requested drop Software logic error. The system performed
at loader. off position is the an Emergency stop.
loader position which Perform a Recovery.
is not possible. If the problem persists,
call Service.

1327 Cuvette load Second cuvette move Clip load time is too slow. The system performed
operation too operation attempted Operation did not complete an Emergency stop.
slow. prior to the prior to next request. Perform a Recovery.
loader/indexer If the problem persists,
preparing a new call Service.
cuvette strip.

1328 Invalid number of The number of The cuvette shuttle sensors The system performed
cuvette slots. cuvette slots detected are dirty or the configuration an Emergency stop.
is not a valid dip switch is set incorrectly. Perform a Recovery.
configuration (Base If the problem persists,
vs. Aurora vs. Mini). call Service.

1329 Cuvette slot The number of Either there are too many The system performed
found too early. required slots was mechanical slots or the an Emergency stop.
detected too early in sensor has picked up noise. Perform a Recovery.
move distance. If the problem persists,
call Service.

1330 Gripper back During initialization Either a sensor failure, The system performed
sensor still active. (home), the gripper cabling failure, or motor an Emergency stop.
attempts to move off stall. Perform a Recovery.
the back sensor, but If the problem persists,
the sensor is still call Service.
detected. OR
Extend gripper
operation performed,
but the back sensor is
still detected.

1331 Gripper back During initialization Either a sensor failure, The system performed
sensor not found. (home), the gripper cabling failure, or motor an Emergency stop.
moves off the back stall. Perform a Recovery.
sensor. Once If the problem persists,

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Code Message Alarm Description Cause Operator Action

detected to be off the call Service.

sensor, the motor
moves towards the
sensor to make sure it
can be detected. If
the back sensor is not
detected during this
search then the alarm
is generated.

1332 Gripper forward After the gripper has Either a sensor failure, The system performed
sensor still active. completed a retract cabling failure, or motor an Emergency stop.
move the forward stall. Perform a Recovery.
sensor is still If the problem persists,
detected. call Service.

1333 Gripper forward Extend gripper Either a sensor failure, The system performed
sensor not found. operation did not cabling failure, or motor an Emergency stop.
detect the front stall. Perform a Recovery.
sensor. If the problem persists,
call Service.

1334 Cuvette waste The accumulator is Tray mechanically stuck or The system performed
tray did not energized to be in the solenoid malfunction. an Emergency stop.
dump. down position to Perform a Recovery.
drop the cuvettes on If the problem persists,
the tray, but the tray call Service.
is still detected in the
up position.
Allowed 250 ms to
move.

1335 Cuvette waste The accumulator is Tray mechanically stuck or The system performed
tray not ready to deenergized to go to solenoid malfunction. an Emergency stop.
receive cuvettes. the up position to get Perform a Recovery.
more cuvettes onto If the problem persists,
the tray, but the tray call Service.
is still detected in the
down position.
Allowed 250 ms to
move.

1341 X Axis - Invalid X Axis - Invalid The universal arm controller The system performed
Profile Parameter Profile Parameter reporting the alarm was sent an Emergency stop.
a velocity profile parameter Perform a Recovery.
(s) for the X axis motor that If the problem persists,

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Code Message Alarm Description Cause Operator Action

exceeded call Service.

maximum/minimum criteria
or was incompatible with
other profile parameters.

1342 Y Axis - Invalid Y Axis - Invalid The universal arm controller The system performed
Profile Parameter Profile Parameter reporting the alarm was sent an Emergency stop.
a velocity profile parameter Perform a Recovery.
(s) for the Y axis motor that If the problem persists,
exceeded call Service.
maximum/minimum criteria
or was incompatible with
other profile parameters.

1343 Z Axis - Invalid Z Axis - Invalid The universal arm controller The system performed
Profile Parameter Profile Parameter reporting the alarm was sent an Emergency stop.
a velocity profile parameter Perform a Recovery.
(s) for the Z axis motor that If the problem persists,
exceeded call Service.
maximum/minimum criteria
or was incompatible with
other profile parameters.

1344 X Axis - Speed X Axis - Speed The universal arm controller The system performed
Exceeds Profile Exceeds Profile reporting the alarm was sent an Emergency stop.
Maximum Maximum a command to move in the X Perform a Recovery.
axis at a speed that would If the problem persists,
exceed the maximum stored call Service.
in the velocity profile.

1345 Y Axis - Speed Y Axis - Speed The universal arm controller The system performed
Exceeds Profile Exceeds Profile reporting the alarm was sent an Emergency stop.
Maximum Maximum a command to move in the Y Perform a Recovery.
axis at a speed that would If the problem persists,
exceed the maximum stored call Service.
in the velocity profile.

1346 Z Axis - Speed Z Axis - Speed The universal arm controller The system performed
Exceeds Profile Exceeds Profile reporting the alarm was sent an Emergency stop.
Maximum Maximum a command to move in the Z Perform a Recovery.
axis at a speed that would If the problem persists,
exceed the maximum stored call Service.
in the velocity profile.

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Code Message Alarm Description Cause Operator Action

1347 X Axis - Cannot X Axis - Cannot The universal arm controller The system performed
Process Steps Process Steps reporting the alarm was sent an Emergency stop.
Required Required a command to set the Perform a Recovery.
velocity profile for the X If the problem persists,
axis but the parameters will call Service.
generate a profile that will
exceed allocated memory.

1348 Y Axis - Cannot Y Axis - Cannot The universal arm controller The system performed
Process Steps Process Steps reporting the alarm was sent an Emergency stop.
Required Required a command to set the Perform a Recovery.
velocity profile for the Y If the problem persists,
axis but the parameters will call Service.
generate a profile that will
exceed allocated memory.

1349 Z Axis - Cannot Z Axis - Cannot The universal arm controller The system performed
Process Steps Process Steps reporting the alarm was sent an Emergency stop.
Required Required a command to set the Perform a Recovery.
velocity profile for the Z axis If the problem persists,
but the parameters will call Service.
generate a profile that will
exceed allocated memory.

1350 X Axis - Selected X Axis - Selected The universal arm controller The system performed
Profile Is Invalid Profile Is Invalid reporting the alarm was sent an Emergency stop.
a command to select a Perform a Recovery.
particular profile for the X If the problem persists,
axis motor but the profile call Service.
does not exist.

1351 Y Axis - Selected Y Axis - Selected The universal arm controller The system performed
Profile Is Invalid Profile Is Invalid reporting the alarm was sent an Emergency stop.
a command to select a Perform a Recovery.
particular profile for the Y If the problem persists,
axis motor but the profile call Service.
does not exist.

1352 Z Axis - Selected Z Axis - Selected The universal arm controller The system performed
Profile Is Invalid Profile Is Invalid reporting the alarm was sent an Emergency stop.

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Code Message Alarm Description Cause Operator Action

a command to select a Perform a Recovery.

particular profile for the Z If the problem persists,
axis motor but the profile call Service.
does not exist.

1353 X Axis - Move X Axis - Move Took The universal arm controller The system performed
Took Too Long Too Long To reporting the alarm has an Emergency stop.
To Complete Complete detected that the an X axis Perform a Recovery.
move is taking longer than If the problem persists,
expected to complete. call Service.

Possible causes:

1. The universal arm

controller receives a
verification pulse from the X
axis motor circuitry for each
step pulse. The controller
assumes that an X axis move
is complete when the number
of verification pulses
received is equal to the step
pulses sent. Therefore a
malfunction in the step
clock/step verification
circuitry will cause this
alarm.

2. Software defect especially

TPU loading complications.

1354 Y Axis - Move Y Axis - Move Took The universal arm controller The system performed
Took Too Long To Long To reporting the alarm has an Emergency stop.
To Complete Complete detected that the an Y axis Perform a Recovery.
move is taking longer than If the problem persists,
expected to complete. call Service.

Possible causes:

1. The universal arm

controller receives a
verification pulse from the Y
axis motor circuitry for each
step pulse. The controller
assumes that an Y axis move

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Code Message Alarm Description Cause Operator Action

is complete when the number

of verification pulses
received is equal to the step
pulses sent. Therefore a
malfunction in the step
clock/step verification
circuitry will cause this
alarm.

2. Software defect especially

TPU loading complications.

1355 Z Axis - Move Z Axis - Move Took The universal arm controller The system performed
Took Too Long Too Long To reporting the alarm has an Emergency stop.
To Complete Complete detected that a Z axis move Perform a Recovery.
is taking longer than If the problem persists,
expected to complete. call Service.

Possible causes:

1. The universal arm

controller receives a
verification pulse from the Z
axis motor circuitry for each
step pulse. The controller
assumes that a Z axis move
is complete when the number
of verification pulses
received is equal to the step
pulses sent. Therefore a
malfunction in the step
clock/step verification
circuitry will cause this
alarm.

2. Software defect especially

TPU loading complications.

1356 X Axis - X Axis - Movement The universal arm controller The system performed
Movement Generates Too Many reporting the alarm was sent an Emergency stop.
Generates Too Steps a command to move the X Perform a Recovery.
Many Steps axis motor to a position If the problem persists,
which would require call Service.
exceeding the number of
steps that can be processed.

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Code Message Alarm Description Cause Operator Action

1357 Y Axis - Y Axis - Movement The universal arm controller The system performed
Movement Generates Too Many reporting the alarm was sent an Emergency stop.
Generates Too Steps a command to move the Y Perform a Recovery.
Many Steps axis motor to a position If the problem persists,
which would require call Service.
exceeding the number of
steps that can be processed.

1358 Z Axis - Z Axis - Movement The universal arm controller The system performed
Movement Generates Too Many reporting the alarm was sent an Emergency stop.
Generates Too Steps a command to move the Z Perform a Recovery.
Many Steps axis motor to a position If the problem persists,
which would require call Service.
exceeding the number of
steps that can be processed.

1359 X Axis - Invalid X Axis - Invalid The universal arm control The system performed
Limit State While Limit State While reporting the alarm was an Emergency stop.
Homing Homing attempting to initialize the X Perform a Recovery.
axis motor but encountered a If the problem persists,
limit sensor that did not call Service.
change state as expected.

Could be caused by
slippage in the X axis,
software defect, or
malfunctioning or misplaced
limit sensor(s).

1360 Y Axis - Invalid Y Axis - Invalid The universal arm control The system performed
Limit State While Limit State While reporting the alarm was an Emergency stop.
Homing Homing attempting to initialize the Y Perform a Recovery.
axis motor but encountered a If the problem persists,
limit sensor that did not call Service.
change state as expected.

Could be caused by
slippage in the Y axis,
software defect, or
malfunctioning or misplaced
limit sensor(s).

1361 Z Axis - Invalid Z Axis - Invalid The universal arm control The system performed
Limit State While Limit State While reporting the alarm was an Emergency stop.
Homing Homing attempting to initialize the Z Perform a Recovery.
If the problem persists,

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Code Message Alarm Description Cause Operator Action

axis motor but encountered a call Service.

limit sensor that did not
change state as expected.

Could be caused by
slippage in the Z axis,
software defect, or
malfunctioning or misplaced
limit sensor(s).

1362 X Axis - Limit X Axis - Limit The universal arm control The system performed
Detected During Detected During reporting the alarm has an Emergency stop.
Move Move detected that the X axis Perform a Recovery.
motor tripped a travel limit If the problem persists,
sensor during a move. call Service.

Could be caused by:

1. slippage in the X axis.

2. software defect

3. malfunctioning or
misplaced limit sensor(s)

4. X axis Encoder
malfunction.

1363 Y Axis - Limit Y Axis - Limit The universal arm control The system performed
Detected During Detected During reporting the alarm has an Emergency stop.
Move Move detected that the Y axis Perform a Recovery.
motor tripped a travel limit If the problem persists,
sensor during a move. call Service.

Could be caused by:

1. slippage in the Y axis.

2. software defect

3. malfunctioning or
misplaced limit sensor(s)

4. Y axis Encoder
malfunction.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

1364 Z Axis - Limit Z Axis - Limit The universal arm control The system performed
Detected During Detected During reporting the alarm has an Emergency stop.
Move Move detected that the Z axis Perform a Recovery.
motor tripped a travel limit If the problem persists,
sensor during a move. call Service.

Could be caused by:

1. slippage in the Z axis.

2. software defect

3. malfunctioning or
misplaced limit sensor(s)

4. Z axis Encoder
malfunction.

1365 X Axis - Slippage X Axis - Slippage The universal arm control The system performed
Detected Detected reporting the alarm has an Emergency stop.
detected that the X axis Perform a Recovery.
motor did not reach the If the problem persists,
expected position at the call Service.
completion of a move.

Could be caused by:

1. Blockage or restricted
movement in the X axis.

2. Faulty X axis position

encoder.

3. X axis velocity profile

parameters are incompatible
with current system.

1366 Y Axis - Slippage Y Axis - Slippage The universal arm control The system performed
Detected Detected reporting the alarm has an Emergency stop.
detected that the Y axis Perform a Recovery.
motor did not reach the If the problem persists,
expected position at the call Service.
completion of a move.

Could be caused by:

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

1. Blockage or restricted
movement in the Y axis.

2. Faulty Y axis position

encoder.

3. Y axis velocity profile

parameters are incompatible
with current system.

1367 Z Axis - Slippage Z Axis - Slippage The universal arm control The system performed
Detected Detected reporting the alarm has an Emergency stop.
detected that the Z axis Perform a Recovery.
motor did not reach the If the problem persists,
expected position at the call Service.
completion of a move.

Could be caused by:

1. Blockage or restricted
movement in the Z axis.

2. Faulty Z axis position

encoder.

3. Z axis velocity profile

parameters are incompatible
with current system.

1368 X Axis - Cannot X Axis - Cannot The universal arm controller The system performed
Store More Store More Ramps reporting the alarm ran out of an Emergency stop.
Ramps memory allocated for storage Perform a Recovery.
of ramps for the X axis If the problem persists,
motor. call Service.

1369 Y Axis - Cannot Y Axis - Cannot The universal arm controller The system performed
Store More Store More Ramps reporting the alarm ran out of an Emergency stop.
Ramps memory allocated for storage Perform a Recovery.
of ramps for the Y axis If the problem persists,
motor. call Service.

1370 Z Axis - Cannot Z Axis - Cannot The universal arm controller The system performed
Store More Store More Ramps reporting the alarm ran out of an Emergency stop.
Ramps memory allocated for storage Perform a Recovery.
of ramps for the Z axis If the problem persists,

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

motor. call Service.

1371 X Axis - Motor X Axis - Motor The universal arm controller The system performed
Stalled Stalled reporting the alarm is an Emergency stop.
reporting that periodic Perform a Recovery.
readings of the X axis motor If the problem persists,
position encoder indicate call Service.
that the current move is
being restricted or blocked.

Could be caused by:

1. Blockage or restricted
movement in the X axis.

2. Faulty X axis position

encoder.

3. X axis velocity profile

parameters are incompatible
with current system.

1372 Y Axis - Motor Y Axis - Motor The universal arm controller The system performed
Stalled Stalled reporting the alarm is an Emergency stop.
reporting that periodic Perform a Recovery.
readings of the Y axis motor If the problem persists,
position encoder indicate call Service.
that the current move is
being restricted or blocked.

Could be caused by:

1. Blockage or restricted
movement in the Y axis.

2. Faulty Y axis position

encoder.

3. Y axis velocity profile

parameters are incompatible
with current system.

1373 Z Axis - Motor Z Axis - Motor The universal arm controller The system performed
Stalled Stalled reporting the alarm is an Emergency stop.
reporting that periodic Perform a Recovery.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

readings of the Z axis motor If the problem persists,

position encoder indicate call Service.
that the current move is
being restricted or blocked.

Could be caused by:

1. Blockage or restricted
movement in the Z axis.

2. Faulty Z axis position

encoder.

3. Z axis velocity profile

parameters are incompatible
with current system.

1374 X Axis - X Axis - Operation The universal arm controller The system performed
Operation Timeout reporting the alarm has an Emergency stop.
Timeout detected that the X axis Perform a Recovery.
motor is taking too long to If the problem persists,
complete a move. call Service.

Possible causes:

1. The universal arm

controller receives a
verification pulse from the X
axis motor circuitry for each
step pulse. The controller
assumes that an X axis move
is complete when the number
of verification pulses
received is equal to the step
pulses sent. Therefore a
malfunction in the step
clock/step verification
circuitry will cause this
alarm.

2. Software defect especially

TPU loading complications.

1375 Y Axis - Y Axis - Operation The universal arm controller The system performed
Operation Timeout an Emergency stop.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

Timeout reporting the alarm has Perform a Recovery.

detected that the Y axis If the problem persists,
motor is taking too long to call Service.
complete a move.

Possible causes:

1. The universal arm

controller receives a
verification pulse from the Y
axis motor circuitry for each
step pulse. The controller
assumes that an Y axis move
is complete when the number
of verification pulses
received is equal to the step
pulses sent. Therefore a
malfunction in the step
clock/step verification
circuitry will cause this
alarm.

2. Software defect especially

TPU loading complications.

1376 Z Axis - Z Axis - Operation The universal arm controller The system performed
Operation Timeout reporting the alarm has an Emergency stop.
Timeout detected that the Z axis Perform a Recovery.
motor is taking too long to If the problem persists,
complete a move. call Service.

Possible causes:

1. The universal arm

controller receives a
verification pulse from the Z
axis motor circuitry for each
step pulse. The controller
assumes that a Z axis move
is complete when the number
of verification pulses
received is equal to the step
pulses sent. Therefore a
malfunction in the step
clock/step verification

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

circuitry will cause this

alarm.

2. Software defect especially

TPU loading complications.

1377 X Axis - X Axis - Operation This is an internal software The system performed
Operation Failed Failed error. an Emergency stop.
Perform a Recovery.
Cause is always software If the problem persists,
defect. call Service.

Incorrect message was

placed on a queue.

1378 Y Axis - Y Axis - Operation This is an internal software The system performed
Operation Failed Failed error. an Emergency stop.
Perform a Recovery.
Cause is always software If the problem persists,
defect. call Service.

Incorrect message was

placed on a queue.

1379 Z Axis - Z Axis - Operation This is an internal software The system performed
Operation Failed Failed error. an Emergency stop.
Perform a Recovery.
Cause is always software If the problem persists,
defect. call Service.

Incorrect message was

placed on a queue.

1380 Tube Release Tube Release The universal arm controller The system performed
Procedure Failed Procedure Failed reporting the alarm has an Emergency stop.
detected during initialization Perform a Recovery.
the tube release operation If the problem persists,
failed. call Service.

The tube release operation is

fairly complicated, but in
general it attempts to extract
the piercer from a capped
tube during initialization by

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

locking the foot and moving

the piercer up until the cap
detect is no longer active.

This is only applicable to

CTS instruments.

The failure can have many

causes:

1. Faulty cap, limit, piercer

position, or piercer latch
sensors.

2. restricted or blocked
movement in the Z axis.

3. Piercer latch solenoid.

4. Excessive friction
between piercer latch and
probe.

5. Excessive force required

to extract the piercer from
the cap.

6. Software defect.

1381 Sensor Or Motor Sensor Or Motor The universal arm controller The system performed
Failure Caused Failure Caused Latch reporting the alarm has an Emergency stop.
Latch Offset Offset Measurement detected that the latch offset Perform a Recovery.
Measurement To To Fail measurement operation If the problem persists,
Fail failed. call Service.

This is only applicable to

CTS instruments.

The failure can have many

causes:

1. Faulty cap, limit, piercer

position, or piercer latch
sensors.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

2. Restricted or blocked
movement in the Z axis.

3. Piercer latch solenoid.

4. Excessive friction
between piercer latch and
probe.

5. Software defect.

1382 LLD Hardware LLD Hardware The universal arm controller The system performed
Failure Failure reporting the arm has an Emergency stop.
detected that the LLD Perform a Recovery.
circuitry is not interrupting If the problem persists,
the processor at the required call Service.
rate.

1383 Piercer Was Not Piercer Was Not In The universal arm controller The system performed
In The Expected The Expected State reporting the alarm was sent an Emergency stop.
State a command to verify that the Perform a Recovery.
piercer was in a particular If the problem persists,
state (CTS or Sample). The call Service.
verification failed.

i.e. There is a mismatch

between the state that the
Master SW expects the
Piercer to be in and the state
that the universal arm
controller thinks the piercer
is in.

1384 Z Axis - Power Z Axis - Power DAC The universal arm controller The system performed
DAC failed failed reporting the alarm has an Emergency stop.
detected that DAC Perform a Recovery.
controlling the amount of If the problem persists,
power to the Z axis motor is call Service.
not performing within
tolerances.

1385 Syringe Is Syringe Is Always The universal arm controller The system performed
Always Busy Busy reporting the alarm is an Emergency stop.
waiting for the syringe to Perform a Recovery.
complete an operation but it If the problem persists,

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

is taking too long. call Service.

1387 Syringe Took Syringe Took Too The universal arm controller The system performed
Too Long To Long To Respond reporting the alarm is an Emergency stop.
Respond waiting for the syringe to Perform a Recovery.
respond to a previous If the problem persists,
command but it took too call Service.
long.

1388 Syringe Could Syringe Could Not The universal arm controller The system performed
Not Be Initialized Be Initialized reporting the alarm could not an Emergency stop.
initialize the arms syringe Perform a Recovery.
pump. If the problem persists,
call Service.

1389 Syringe Does Not Syringe Does Not The universal arm controller The system performed
Understand The Understand The reporting the alarm received an Emergency stop.
Command Command an error message from the Perform a Recovery.
arms syringe indicating that If the problem persists,
the syringe did not call Service.
understand the last command
sent to it.

1390 Syringe Syringe Command The universal arm controller The system performed
Command Parameter Is Invalid reporting the alarm received an Emergency stop.
Parameter Is an error message from the Perform a Recovery.
Invalid arms syringe indicating that If the problem persists,
the last command sent to it call Service.
contained an invalid
parameter.

1391 Syringe Must Be Syringe Must Be The universal arm controller The system performed
Initialized Initialized reporting the alarm received an Emergency stop.
an error message from the Perform a Recovery.
arms syringe indicating that If the problem persists,
it must be initialized before call Service.
any further commands can be
performed.

1392 Syringe Plunger Syringe Plunger Is The universal arm controller The system performed
Is Overloaded Overloaded reporting the alarm received an Emergency stop.
an error message from the Perform a Recovery.
arms syringe indicating that If the problem persists,
the plunger is overloaded. call Service.

1393 Syringe Valve Is Syringe Valve Is The universal arm controller The system performed
Overloaded Overloaded reporting the alarm received an Emergency stop.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

an error message from the Perform a Recovery.

arms syringe indicating that If the problem persists,
the valve is overloaded. call Service.

1394 Syringe Move Is Syringe Move Is Not The universal arm controller The system performed
Not Permitted Permitted reporting the alarm received an Emergency stop.
an error message from the Perform a Recovery.
arms syringe indicating that If the problem persists,
a plunger move is not call Service.
permitted. When the valve is
in bypass or throughput
position plunger movement
commands are not allowed.

1395 Syringe Error Syringe Error With The universal arm controller The system performed
With Unknown Unknown Source reporting the alarm received an Emergency stop.
Source an error message from the Perform a Recovery.
syringe but it is not a If the problem persists,
recognized published error. call Service.

1396 Error Error Communicating The universal arm controller The system performed
Communicating With The Syringe reporting the alarm is an Emergency stop.
With The Syringe indicating that either Perform a Recovery.
If the problem persists,
1. The buffer used for call Service.
receiving serial data from the
syringe has overflowed.

2. The control signals used

for coordinating serial data
transmission to the syringe
are not in the correct state.

1397 Syringe Hardware Syringe Hardware Not used. The system performed
Malfunction Malfunction an Emergency stop.
Perform a Recovery.
If the problem persists,
call Service.

1414 CTS piercer lock CTS piercer lock not The AM has detected that The system performed
not locked locked the piercer latch is not in one an Emergency stop.
of it's detent positions. Perform a Recovery.
If the problem persists,
call Service.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

1415 CTS probe mode CTS probe mode The AM attempted to set the The system performed
switch failure switch failure CTS mode (sample or CTS) an Emergency stop.
but after verifying Perform a Recovery.
determined that the piercer If the problem persists,
was not in the expected call Service.
mode.

Possible causes:

1. CTS spring tension too

light.

2. Faulty CTS position,

or latch sensor

3. Faulty latch solenoid or

circuitry.

1416 Cannot switch The CTS hardware The sensor was not seen after Perform a recovery. If
CTS between used to change the performing the CTS mode the problem persists,
piercing and probe between switch operation. Failure call service.
sample mode. piercing mode and could be sensor, spring,
sample mode failed solenoid, or software.
to switch.

1417 Location Vial Location Invalid arm homing position Perform Coordinates
unreachable by Unreachable or coordinate adjustment Adjustment. If the
Probe <Probe>: failure. problem persists, call
track # service.
<Rack>,position
<Position>.

1418 Location Cuvette Location Invalid arm homing position Perform Coordinates
unreachable by Unreachable or coordinate adjustment Adjustment. If the
Probe <Probe>: failure. problem persists, call
cuvette <Cuvette service.
Slot ID>, well
<well position>.

1439 <Probe> probe Cannot communicate Cannot communicate with The system performed
communications with the probe. the probe. Either an Emergency stop.
failure. communications cable is not Perform a Recovery.
in place or probe computer If the problem persists,
board has malfunctioned. call Service.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

2010 <Cover ID> Safety cover detected The cover was left open. Close the cover. The
open. open not in system performed an
diagnostics. Emergency stop: once
the cover is closed,
perform a Recovery.

2080 Unrecoverable The actual execution Internal scheduling conflict. The system performed
scheduling time did not meet a an Emergency stop.
violation. critical scheduling Perform a Recovery.
time. The job failed
and it is not possible If the problem persists,
to recover call Service.

2081 Rack in <Track A rack already Rack accidentally dislodged. Perform Recovery
ID> slot inserted becomes operation.
unplugged. unplugged with the
reader not in front of
the rack.

2082 ORU Air Air Calibration data The Optical Reading Unit air Go to Diagnostics and
Calibration data for the specified calibration procedure has run the Air
not available for ORU are not never been executed for this Calibration procedure.
ORU <ORU ID>. available. ORU.

The instrument is
not able to perform
air reading drift
checks.

2084 An invalid An invalid ORU The user has accepted an out Go to Diagnostics and
blanking value blanking value has of range blanking value. run ORU Blanking
has been accepted been accepted by the procedure again.
for ORU <ORU user. The ORU will
ID> (Value = be automatically
<VALUE>). The disabled.
ORU will be
automatically
disabled.

2085 ORU Factor Factor Diluent The Optical Reading Unit Go to Diagnostics and
Diluent Calibration data for Factor Diluent Calibration run the Stored Factor
Calibration data the specified ORU procedure has never been Diluent Calibration
not available for are not available. executed for this ORU. procedure.
ORU <ORU ID>.
The instrument is
not able to calculate

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

absolute absorbance.

2087 Maximum There is not more There is not enough memory The tests exceeding
number of tests memory in the AM for processing more tests. the maximum number
allowed per run for processing more per run are not
exceeded. tests. performed. Run
canceled tests within
another analytical
session.

2091 CTS Filter CTS Filter missing Foot could not reach the Please install a clean
missing. expected position of the CTS CTS filter.
Filter.

2092 Air pressure Air pressure sensor The air pressure sensor is not Call Service.
sensor not not operating responding. Air is not being
operating correctly. discharged to CTS piercer
correctly. correctly due to obstructed,
damaged or disconnected air
pressure Valves.

2093 Not enough free System detected not The system detected less Shutdown the CM
disk space. enough free disk than 100 megabytes of free application and free
space to run the space in the disk where the some disk space. If
application ACL TOP application is this problem persists,
installed. contact your System
Administrator.

2094 The default file If the default file path Wrong file path specification Verify the file path
path for the log does not exist, the or insufficient rights to write specification: if it is
files does not system tries to to the drive or HW/SW wrong, correct it and
exist and cannot automatically create failure of the drive. retry. If this is not the
be created. it. The operation case, verify he has the
could fail for appropriate write
different causes: permissions or call
service to repair the
- wrong file path drive.
specification

- insufficient rights
to write to the drive

- HW/SW failure of
the drive

3023 Duplicated Rack Two different Racks Two racks with the same ID Remove one of the

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

ID, Rack ID have been identified have been loaded on-board. two racks with the
<Rack ID>. with the same Rack duplicated ID.
ID.

3046 Analyzer Status AM status changed

changed from
<AM Status> to
<AM Status>.

3211 Auto Run failed. Auto Run could not Possible causes are: The system looks for
be started and the an opportunity to auto
instrument is Ready. - CTS Filter was not start every 1 minute.
detected (for CTS Certain conditions
configuration only). might change without
operator's
- Enhanced clean required. intervention.

- Temperatures are out of Identify the cause

range. among the following
and resolve if
necessary:

- CTS Filter missing:

install a new filter
(Maintenance
activity).

- Enhanced Clean
required: perform
Enhanced Clean for
all probes
(Maintenance
activity).

- Temperatures are
out of range: wait
until the temperatures
stabilize (depending
from the system and
ambient conditions,
this might take more
than 30 minutes); if
they do not stabilize,
call Service.

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

3212 <Controller Controller upgraded

Name> controller successfully.
has been
upgraded to
version <Version
Name>.

3213 The system Software version is CM, AM Master software or Call Service.
detected a for experimental use controller software is not a
software version only. A controller, system release version.
designed for master, IM or CM is
experimental use. compiled in debug or
the version name is
experimental. CM is
a Demo installation.

3214 Interface Module IM has been

has been upgraded.
upgraded to
version <Version
Name>.

4004 Invalid barcode Barcode size bigger Barcode label bigger that 16 Use valid barcode
size. than the maximum characters. labels.
size of sample Id (16
characters)

4005 Rack rejected. The bar code label Rack barcode reading error, Reinsert the rack. If
read is invalid. missing barcode labels or the problem persists,
rack entered too quickly. use another rack.

4006 CTS rack CTS rack rejected. CTS Rack inserted when cap Enable cap piercing
rejected. piercing is not enabled or and reinsert the rack
CTS arm not installed. or use a non-CTS
rack.

4007 Cap not detected Cap not detected by The CTS probe descended If a sample cup is
for sample in rack the piercer down to the maximum cap loaded in that
<Rack ID>, search depth but could not position, remove it
position detect the presence of a cap from the CTS rack and
<position #>, for the sample in the load it on a open-tube
track <Track ID>. specified position. Possible sample rack. Only
cause is the presence of a capped sample tubes
sample cup or a similar low- should be loaded on
height sample container. CTS racks. Sample
cups and uncapped

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

sample containers
should be loaded on
open-tube sample
racks.

4015 Rack button The rack button Rack position keypad Call Service.
identification pressed is not a valid malfunction.
failure. code.

4020 Barcode reader Cannot communicate Cable disconnected. Barcode Call Service.
communication with the bar code reader malfunction.
failure. reader.
Rack controller or Reader
Traveling board malfunction.

4051 A new set of A new set of ORU The ORU air blanking
ORU air blanking air blanking values procedure has been
values has been has been saved. successfully performed and a
saved. new set of ORU air blanking
values has been saved.

4052 A new set of A new set of ORU The ORU factor diluent
ORU factor factor diluent blanking procedure has been
diluent blanking blanking values has successfully performed and a
values has been been saved. new set of ORU factor
saved. diluent blanking values has
been saved.

4053 Probe <Probe>: Probe Coordinates The coordinates adjustment

Coordinates adjustment procedure for the specified probe has
adjustment completed. been successfully completed
procedure and the coordinates file has
completed. been successfully updated.

4054 The analyzer is The analyzer is The analyzer is able to Remove the CTS rack.
unable to process unable to process the process the request only if Define the piercing
the request to request to change the instrument status is mode when the
change CTS CTS mode or change POWER UP, READY or instrument is in the
piercing probe Lower z-depth DIAGNOSTICS and the proper status.
mode. piercing probe mode. sample probe is not
performing any diagnostics
activity and there is no CTS
rack inserted.

4055 The analyzer is The analyzer is The analyzer is able to Disable again the
piercing mode when

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Analyzer Alarms – Warnings and Errors

Code Message Alarm Description Cause Operator Action

unable to process unable to process the process the request only if the instrument is the
the request to request to disable the instrument status is proper status.
disable CTS CTS or disable Lower POWER UP, READY or
piercing probe z-depth piercing DIAGNOSTICS and the
mode. probe mode. sample probe is not
performing any diagnostics
activity.

4057 CM in use is from The system detected A database has been restored The use of this CM
a different ACL the instrument model from a different model or the will require service
TOP model. is different than application is connected to a intervention. Please
during last different instrument model. call service.
connection. This will
happened between
MicroTOP, MiniTop
and TOP models
(base TOP, CTS,
LAS).

4058 Unable to create Unable to create a Unable to create raw data Please verify that
raw data report raw data report file. report file. there is enough disk
<path&filename>. space on the system.
Please verify that the
raw data report path is
legitimate and you
have write privileges
in the log folder.

Back to Alarm Messages.

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External Communications Alarms

Back to Alarm Messages.

The alarms in this section are sorted by code number.

External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

0059 Interface Module IM Upgrade Failed The application must be LAS

upgrade failed. re-started in order to
execute the IM upgrade
process again. If the
problem persist, call
Service.

0060 Incompatible IM Incompatible IM software version. Call Service LAS

software version.

3022 The LIS host has The LIS host has requested a test LIS
requested a test with invalid demographic data like
with invalid a birthdate greater than current date.
demographic data.

3031 Incorrect The ACL-TOP instrument has Check the Instrument ID LIS
Instrument ID received a message from the LIS in Host communications
(<Instrument ID>) host with an Instrument ID and/or configuration, and
message received Host ID, which do not match the modify its value if
from LIS host. configured ones. required. Otherwise,
check LIS host operation.

3032 Message received The ACL-TOP instrument has Check the Host ID in LIS
with incorrect received a message from the LIS Host communications
Host ID (<Host host with an Instrument ID and/or configuration, and
ID>). Host ID, which do not match the modify its value if
configured ones. required. Otherwise,
check LIS host operation.

3033 Invalid Test Code The LIS host has requested an Check tests currently LIS
received from host unknown test. available or contact the
host administrator.
(LIS # <LIS #>).

3034 Test orders The user requests a manual job Report the error to the LIS
downloading from orders download that the ACL-TOP host administrator.
host not instrument cannot accomplish. In
performed. the same way, the ACL-TOP

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External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

instrument tries to perform an

automatic job orders downloading,
and the result is the same.

3035 Test results The user requests a manual test Report the error to the LIS
uploading to LIS results upload that the ACL-TOP host administrator.
host not instrument cannot accomplish. In
performed. the same way, the ACL-TOP
instrument tries to perform an
automatic test results uploading, and
the result is the same.

3036 Invalid Test The LIS host has requested a test Update test definition LIS
Request received that is either disabled, inconsistent and/or enable it. Check
from host (LIS # or a locked manually ordered test. whether the test can be
<LIS #>). manually programmed.

3037 Duplicated Test The LIS host has requested a test LIS
Order for that is already present in the
<SampleId> instrument.
received from host
(LIS # <LIS #>).

3038 Invalid Instrument The LIS host has requested a test for Report the error to the LIS
Sample ID sample whose Instrument Sample ID host administrator.
<Instrument is unknown.
Sample ID>
received from host.

3039 LIS request not LIS host sent a request that is not Report the error to the LIS
allowed. implemented for TOP. host administrator.

3040 Invalid message The format of the message or fields Report the error to the LIS
format received contained in it are not compliant host administrator.
from LIS host. with the TOP specifications.

3041 Host Query not The ACL-TOP instrument tries to Report the error to the LIS
performed. perform an automatic host query host administrator.
without succeeding.

3042 Communications Communications between the Report the error to the LIS
between the instrument and the LIS have been host administrator.
instrument and the lost.
LIS have been lost.

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External Communications Alarms Chapter 12 – Alarms and Troubleshooting

External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

3043 Test Order The ACL-TOP could not process a Report the error to the LIS
cancellation not test order cancellation coming from host administrator.
performed (LIS # the LIS host.
<LIS #>).

3044 Creation of the LIS The ACL-TOP could not create a Report the error to the LIS
communication channel for communicating with the host administrator.
channel failed. LIS Host.

3045 Current LIS The current channel configuration Report the error to the LIS
channel defined through the control panel is host administrator.
configuration is not supported.
not supported.

3200 Storage of The UDC storage is almost full of Check communication LIS
messages sent to messages waiting to be sent to LIS. status in both ends. If
LIS <%> full. communication cannot
be restored, disable them
and call service.

3201 Storage of The UDC storage is almost full of Check communication LIS
messages sent to messages waiting to be sent to LIS. status in both ends. If
LIS overloaded. No more messages are accepted. communication cannot
New uploaded be restored, disable them
messages will be and call service.
rejected.

3202 Upload message UDC Rejected Uploaded Message Check communication LIS
was rejected and status in both ends. If
therefore not sent communication cannot
to LIS. be restored, disable them
and call service.

4059 LAS Interface LAS Interface Manager (IM) Check LAS Interface LAS
Manager (IM) communications error. Manager (IM)
communications connection, if the
error. problem persists call
Service. During IM
Upgrade process, ignore
this alarm.

10000 LAS Track LAS Track communications error. Check LAS Track/IM LAS
communications connection. If the
error. problem persists, call
Service.

10002 LAS Track LAS Track Unavailable. Check LAS Track. If the LAS

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 ACL TOP Family Operator's Manual
External Communications Alarms Chapter 12 – Alarms and Troubleshooting

External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

Unavailable. problem persists call

Service of Track Vendor.

10003 LAS Sample LAS Track has provided sample LAS

<Sample ID> data with inconsistencies.
rejected.

10004 LAS Sample Capped Tube provided by the LAS LAS

<Sample ID> Track.
rejected.

10005 Reset Queue LAS Track has requested to reset the Check Analyzer. LAS
Request denied. queue but the instrument does not
Allow to clear the let it do that. Check LAS probe to
physical queue is ensure the LAS probe is
unsafe. not inside the sample
tube. If problem persists,
call Service.

10007 LAS Sample LAS Sample was intended to be LAS

<Sample ID> provided while a Reset Queue was
rejected. in progress.

10006 LAS Sample The instrument rejects the LAS If problem persists, call LAS
<Sample ID> Sample because it is not ready for Service.
cannot be sampling.
processed at this
time.

10008 LAS Sample Sample not expected at Aspiration LAS

<Sample ID> not Point.
expected at
Aspiration Point.
This sample shall
not be processed.

10009 LAS Sample Sample not expected at Aspiration LAS

<Sample ID> order Point.
different than the
expected at
Aspiration Point.
This sample shall
be processed.

10010 LAS Sample Sample Not processed due to the LAS

<Sample ID> not jobs are not available.
processed.

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External Communications Alarms Chapter 12 – Alarms and Troubleshooting

External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

10011 LAS Sample Sample Not processed due to the LAS

<Sample ID> not Sample Tube Queue is empty
processed.

10012 LAS Sample Sample Not processed due to a not LAS

<Sample ID> not fluid detected.
processed.

10013 LAS Sample Sample Not processed due to an LAS

<Sample ID> not Insufficient Volume.
processed.

10014 LAS Sample Sample Not Processed due to a LAS LAS

<Sample ID> not Arm Failure.
processed.

10015 LAS Sample Sample ID mismatching when LAS

<Sample ID> not releasing the Sample Tube.
processed. ID
before aspiration:
<Sample ID>. ID
after aspiration:
<Sample ID>.

10016 LAS Track request LAS Track sent a request that is not Report the error to the LAS
not supported. implemented/supported for TOP. administrator. If problem
persists, call Service.

10017 Invalid Format The format of the message or fields Report the error to the LAS
Message. contained in it are not compliant administrator.
with the TOP specifications.
The Operating System
Event Log can be
reviewed for further
information about the
field that was not
properly formatted.

10018 Creation of the The ACL-TOP could not create a Report the error to the LAS
LAS Track channel for communicating with the administrator.
communication LAS Track.
channel failed.

10019 Creation of the The current channel configuration Report the error to the LAS
LAS Track defined through the control panel is administrator
communication not supported.
channel failed.

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External Communications Alarms Chapter 12 – Alarms and Troubleshooting

External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

10020 Storage of The Synapse storage is almost full Check communication LAS
messages sent to of messages waiting to be sent to status in both ends. If
the LAS Track the LAS Track. communication cannot
<%> full. be restored, disable them
and call service.

10021 Storage of The Synapse storage is almost full Check communication LAS
messages sent to of messages waiting to be sent to status in both ends. If
the LAS Track the LAS Track. No more messages communication cannot
overloaded. New are accepted. be restored, disable them
uploaded messages and call service.
will be rejected.

10022 LAS Track Message not delivered to the LAS Check communication LAS
communications Track. status in both ends. If
error. communication cannot
be restored, disable them
and call service.

10023 LAS Sample Tube Type provided by the LAS LAS

<Sample ID> Track not supported.
rejected.

10024 LAS Sample Sample Not Processed due to an LAS

<Sample ID> not Instrument Hardware Error.
processed.

10026 IM software error. IM Software internal exception. Report the error to the LAS
administrator.

10027 LAS Track Message not responded by the LAS Check communication LAS
communications Track. status in both ends. If
error. communication cannot
be restored, disable them
and call service.

10028 LAS Sample Sample ID not supported. LAS

<Sample ID> not
supported. This
tube shall be
released.

10029 LAS Sample Sample Not Processed due to LAS Resend the tube to the LAS
<Sample ID> not Sample Aspiration timeout. track in case the tube
processed. needs to be processed.

10030 LAS Manager LAS Manager communications error. Check LAS Manager/IM LAS

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External Communications Alarms Chapter 12 – Alarms and Troubleshooting

External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

communications connection. If the

error. problem persists call
Service.

10031 LAS Manager LAS Manager communications error. Check LAS Manager/IM LAS
communications connection. If the
error. problem persists call
Service.

10032 LAS Manager LAS Manager communications error. Check LAS Manager/IM LAS
communications connection. If the
error. problem persists call
Service.

10033 LAS Manager Capped Tube provided by the LAS Report the error to the LAS
communications Track. administrator. If problem
error. persists, call Service.

10034 Reset Queue Invalid Message value. Report the error to the LAS
Request denied. administrator. The
Allow to clear the Operating System Event
physical queue is Log can be reviewed for
unsafe. further information about
the field that was not
properly formatted.

10035 Creation of the The ACL-TOP could not create a LAS

LAS Manager channel for communicating with the
communication LAS Manager.
channel failed.

10036 Creation of the The current channel configuration Report the error to the LAS
LAS Manager defined through the control panel is administrator.
communication not supported.
channel failed.

10037 Storage of The Synapse storage is almost full Check communication LAS
messages sent to of messages waiting to be sent to status in both ends. If
the LAS Manager the LAS Manager. communications cannot
%1 full. be restored disable them
and call service.

10038 Storage of The Synapse storage is almost full LAS

messages sent to of messages waiting to be sent to
the LAS Manager the LAS Manager. No more
overloaded. New messages are accepted.
uploaded messages

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External Communications Alarms Chapter 12 – Alarms and Troubleshooting

External Communications Alarms – Warnings and Errors

Code Message Alarm Description Operator Action Category

will be rejected.

10039 LAS Manager LAS

requested to stop
LAS Tubes from
the LAS Track.

10040 LAS Manager LAS

requested to start
LAS Tubes from
the LAS Track.

Back to Alarm Messages.

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 ACL TOP Family Operator's Manual
Setup Alarms Chapter 12 – Alarms and Troubleshooting

Setup Alarms
Back to Alarm Messages.

The alarms in this section are sorted by code number.

Setup Alarms – Warnings and Errors

Code Message Alarm Description

The test cannot be saved. Some of the Test Units Test Definitions: Result Unit referenced in a
that have been removed are referenced in one or QC Definition cannot be removed.
more of the QC Definitions.

The test cannot be saved. Some of the Test Units Test Definitions: Result Unit referenced in a
that have been removed are referenced in one or Reflex Rule cannot be removed.
more of the Reflex Rules.

The test cannot be saved. Some of the Test Units Test Definitions: Result Unit referenced in
that have been removed are referenced in Sample Sample List cannot be removed.
List.

3060 Test Definition <test name> has been added. A new Test Definition has been added.

3061 Test Definition <test name> has been modified. An existing Test Definition has been
modified.

3062 Test Definition <test name> has been deleted. A Test Definition has been deleted.

3063 Material Definition <material name> has been A new Material Definition has been added.
added.

3064 Material Definition <material name> has been A Material Definition has been deleted.
deleted.

3065 Material Definition <material name> modified: ISI The Active Lot - ISI value of a Material
value (active Lot). Definition has been changed.

3066 Material Definition <material name> modified: on- The stability configuration of a Material
board stability. Definition has been changed.

3067 Material Definition <material name> modified: The active Lot - assigned value of a
assigned value for Test <test name> (active Lot). Material Definition & Test Definition has
been changed.

3068 Material Definition <material name> modified: The active Lot - expiration date cfg. of a
expiration date (active Lot). Material Definition has been changed.

3069 Material Definition <material name> modified: Lot The Lot management cfg. of a Material
management. Definition has been changed.

3070 Material Definition <material name> modified: Lot The active Lot - Lot Number of a Material

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Setup Alarms Chapter 12 – Alarms and Troubleshooting

Setup Alarms – Warnings and Errors

Code Message Alarm Description

Number (active Lot). Definition has been changed.

3071 Material Definition <material name> modified: The alternative Lot cfg. of a Material
Alternative Lot cfg. Definition has been changed.

3072 Material Definition <material name> generic An existing Material Definition has been
change. modified.

3073 System Definitions: generic change. Global change in System Definitions.

3074 System Definitions: Barcode parameters modified. System Definitions, Barcode parameters
changed.

3075 System Definitions: LIS parameters modified. System Definitions, LIS parameters changed.

3076 QC Definition <Test name> - <Material name> has A new QC Definition has been added.
been added.

3077 QC Definition <Test name> - <Material name> has A QC Definition has been deleted.
been deleted.

3078 QC Definition <Test name> - <Material name> The Target Mean of a QC Definition has
modified: Target Mean. been changed.

3079 QC Definition <Test name> - <Material name> The Target SD of a QC Definition has been
modified: Target SD. changed.

3080 QC Definition <Test name> - <Material name> The Patient Flags of a QC Definition have
modified: Patient Flags. been changed.

3081 QC Definition <Test name> - <Material name> The Rules cfg. of a QC Definition have
modified: Rules cfg. been changed.

3082 QC Definition <Test name> - <Material name> The Frequency cfg. of a QC Definition has
modified: Frequency cfg. been changed.

3083 QC Definition <Test name> - <Material name> The Unit of a QC Definition has been
modified: QC Unit. changed.

3100 Software access permissions have been modified. The user changed some access levels in the
Software access screen.

3101 User Definition <User Name> has been added. A new User Definition has been added

3102 User Definition <User Name> has been deleted. An existing User Definition has been
deleted.

3103 User Definition <User Name> has been modified. An existing User Definition has been
modified.

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Setup Alarms Chapter 12 – Alarms and Troubleshooting

Setup Alarms – Warnings and Errors

Code Message Alarm Description

3104 User Definition <User Name> modified: Security The security Level of an existing User
Level. Definition has been changed.

3105 User Definition <User Name> locked by the The user intended to log in with erroneous
system. password 3 consecutive times, so the system
has locked this user.

3110 Reflex Rule <Reflex Rule Name> has been added. A new Reflex Rule has been added.

3111 Reflex Rule <Reflex Rule Name> has been deleted. An existing Reflex Rule has been deleted.

3112 Reflex Rule <Reflex Rule Name> has been Reflex Rule has been modified.
modified.

3120 Auto-Validation Rules have been modified. Auto-Validation Rules have been modified.

3130 Sender Definition <Sender Code> has been added. A new Sender Definition has been added.

3131 Sender Definition <Sender Code> has been deleted. An existing Sender Definition has been
deleted.

3132 Sender Definition <Sender Code> has been An existing Sender Definition has been
modified. modified.

3140 Test Profile <Test Profile Name> has been added. A new Test Profile Definition has been
added.

3141 Test Profile <Test Profile Name> has been deleted. A Test Profile Definition has been deleted.

3142 Test Profile <Test Profile Name> has been A Test Profile Definition has been modified.
modified.

3145 QC Profile <QC Profile Name> has been added. A new QC Profile Definition has been
added.

3146 QC Profile <QC Profile Name> has been deleted. A QC Profile Definition has been deleted.

3147 QC Profile <QC Profile Name> has been modified. A QC Definition has been modified.

3161 Test Definition <source test Name> has been A Test Definition has been promoted.
promoted to <target test Name>.

3164 Vial Properties <Vial Type Name> <Vial AVial Properties has been added by the
Properties Revision> has been added. user.

3165 Vial Properties <Vial Type Name> <Vial AVial Properties has been deleted by the
Properties Revision> has been updated. user.

3166 Vial Properties <Vial Type Name> <Vial AVial Properties has been deleted by the

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Setup Alarms Chapter 12 – Alarms and Troubleshooting

Setup Alarms – Warnings and Errors

Code Message Alarm Description

Properties Revision> has been deleted. user.

3167 Vial Set <Vial Set Name> has been added. AVial Set has been added by the user.

3168 Vial Set <Vial Set Name> has been updated. AVial Set has been deleted by the user.

3169 Vial Set <Vial Set Name> has been deleted. AVial Set has been deleted by the user.

3180 LAS parameters modified. LAS Definitions parameters changed.

3181 IM parameters modified. IM parameters changed.

3186 Imported Params Report files deleted. Analytical Files to generate Imported Params report
Version in files is different than current one. have been deleted.

4060 Test counter statistics have been reset. User reset the test counter statistics

4061 A new software version has been created with A new system software version has been
following label: <Data Dictionary-SW Version>. detected.

4062 A new hardware event has been created with A new Hardware event has been added by
following label: <Data Dictionary-HW Event>. the user.

Back to Alarm Messages.

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 ACL TOP Family Operator's Manual
Other Alarms Chapter 12 – Alarms and Troubleshooting

Other Alarms
Back to Alarm Messages.

The alarms in this section are sorted by code number.

Other Alarms
Code Message Alarm Description Operator Action Category

Incorrect username or Username or password mismatch. SW

password.

New password must be The given new password is equal SW

different from the to the old password.
current password.

The user <User Name> User has exceeded the maximum SW

is currently locked. consecutive number of allowed
Please contact your attempts to log in with an
administrator. incorrect password.

Temperatures out of Temperatures are out of range. SW

Range. Do you want
to initiate the Run?

The following Optical One or more ORUs have been SW

Reading Units have disabled, either manually, through
been disabled: Diagnostics, or automatically. The
instrument can continue, but with
l ORU No
decrease throughput.
<Head #>
l TOP 700, 700 CTS and
l ORU No
700 LAS instruments have
<Head #>
four ORUs available.
l ORU No
l TOP 500 instrument has
<Head #>
three ORUs available.
l ORU No
l TOP 300 has two ORUs
<Head #>
available.
Do you want to
initiate the Run?

Enhanced Clean must Enhanced Clean was not SW

be performed. Enter performed due an LLD or an
maintenance to Emergency Stop and it is required
perform the appropriate before a new run begins.
clean operation for:
<Probe>
<Probe>

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 ACL TOP Family Operator's Manual
Other Alarms Chapter 12 – Alarms and Troubleshooting

Other Alarms
Code Message Alarm Description Operator Action Category

<Probe>

Replace CTS Filter. CTS Filter was not detected during SW

Enter maintenance to mechanical initialization.
perform the appropriate
activity.

Processing Run The System is accessing to the Wait. SW

Command... database for retrieving the test
definition data required for
processing the jobs.

Startup of database The startup of the database failed. Not applicable. SW

failed, DB could not DB could not connect to MS Data
connect to MS data Engine.
engine.

Startup of database The startup of the database failed. SW

failed. the DB The DB subsystem version does
subsystem version does not match TOP database version.
not match TOP
database version.

An unrecoverable data The database service is down and Start SQL service. SW
base exception has it is not accessible. Start CM app.
occurred.

3106 Successful log in by User was recognized and could Other

user: <User>. log into the system.

3107 Unsuccessful log in by User could not be recognized and Other

user: <User>. could not log into the system.

3108 Logout by user: User logged out from the system. Other
<User>.

3109 The user modified The user modified patient Other

patient demographics demographic information.
for sample <Sample
Id>.

4063 Description: User entered a manual alarm. Other

<Description>

Functional Area:
<Functional Area>

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Other Alarms Chapter 12 – Alarms and Troubleshooting

Other Alarms
Code Message Alarm Description Operator Action Category

5090 (Prep) Material AM reported a material dispense SW

dispense error error. An unexpected material
dispense error was detected by the
AM software. Not expected
behavior.

5100 Measured result failed The result unit is the measured SW

result and DR has been unable to
compute it

5568 Calibration and Calibration transformations do not Calibration X or Y SW

parallelism match parallelism transformations. transformations do
transformations do not not match.
match Calibration may
require
recalculation.

XXXXX <Restricted> This message displays instead of Other

patient information when a non-
authorized user is logged on.

Back to Alarm Messages.

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 ACL TOP Family Operator's Manual
Popup Alarms Chapter 12 – Alarms and Troubleshooting

Popup Alarms
Back to Alarm Messages.

Some warnings and errors are displayed in windows to warn the operator or to prompt for action. For the LIS,
warnings and errors may also be displayed on the LIS host.

Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

%s directory does not exist. Do Before saving Global Definition,

you want to create it? the system checks if the selected
folder for Logs exists, if it does
not, then it asks the user if s/he
wants to create it.

A software upgrade is in process. An AM software components

Please do not shut down the CM being upgraded.
or AM.

AC Load Cycle: AC Load Cycle: Test Definitions - Analytical

Before aspiration clean volume Cycle: Inconsistent Before
must be less than or equal to Aspiration Clean Volume.
<Data Dictionary - Clean Cup
Capacity> uL.

AC Load Cycle: After Test Definition: After

dispensation clean total volume dispensation clean total volume
exceeds the maximum allowed by exceeds the maximum allowed by
the syringe. the syringe.

AC Load Cycle: After Test Definitions - Analytical

dispensation sample clean volume Cycle: Inconsistent After
must be less than or equal to Dispensation Sample Clean
<Data Dictionary - Clean Cup Volume..
Capacity> uL.

AC Load Cycle: At least one of Test Definition: At least one of

the after dispensation clean the after dispensation clean
volumes is less than the minimum volumes is less than the minimum
syringe volume. syringe volume.

AC Load Cycle: At least one of Test Definition: At least one of

the before aspiration clean the before aspiration clean
volumes is less than the minimum volumes is less than the minimum
syringe volume. syringe volume.

AC Load Cycle: At least one of Test Definition: for a single

the material transport volumes is dispensing, any of the material
less than the minimum syringe

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Popup Alarms Chapter 12 – Alarms and Troubleshooting

Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

volume. volumes defined (including head

volume and air gaps) cannot be
less than the minimum syringe
volume.

AC Load Cycle: Before aspiration Test Definition: Before aspiration

clean total volume exceeds the clean total volume exceeds the
maximum allowed by the syringe. maximum allowed by the syringe.

AC Load Cycle: The material Test Definition: the after

after dispensation clean pipetting dispensation total clean volume
volumes are out of the Syringe exceeds syringe max. or any
volume limits. See associated individual clean volume is less
Material Definition. than the syringe min.

Alternative Predilution: At least Test Definition: At least one of

one of the before aspiration the before aspiration clean
diluent clean volumes is less than volumes for alternative pre-
the minimum syringe volume. dilution diluent is less than the
minimum syringe volume.

Alternative Predilution: At least Test Definition: At least one of

one of the before aspiration the before aspiration clean
sample/mixture clean volumes is volumes for alternative pre-
less than the minimum syringe dilution sample/ mixture is less
volume. than the minimum syringe
volume.

Alternative Predilution: Before Test Definitions - Alternative

aspiration diluent clean volume Sample Predilution: Inconsistent
must be less than or equal to Alternative Pre-dilution diluent
<Data Dictionary - Clean Cup before aspiration Clean Volume.
Capacity> uL.

Alternative Predilution: Before Test Definitions - Sample

aspiration sample/mixture clean Alternative Predilution:
volume must be less than or equal Inconsistent Pre-dilution
to <Data Dictionary - Clean Cup sample/mixture before aspiration
Capacity> uL. Clean Volume.

Alternative Predilution: Diluent Test Definition: for a single

after dispensation clean volume dispensing the material volume
exceeds the limits allowed by the (including air gaps) must be
Syringe. See associated Material within the syringe volume.
Definition.

Alternative Predilution: Diluent Test Definition: Alternative pre-

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Popup Alarms Chapter 12 – Alarms and Troubleshooting

Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

before aspiration clean total dilution diluent before aspiration

volume exceeds the maximum clean total volume exceeds the
allowed by the syringe. maximum allowed by the syringe.

Alternative Predilution: Test Definition: Alternative pre-

Sample/mixture before aspiration dilution sample/mixture before
clean total volume exceeds the aspiration clean total volume
maximum allowed by the syringe. exceeds the maximum allowed by
the syringe.

Automatic Dilutions Calibration: Test Definition: At least one of

At least one of the before the before aspiration clean
aspiration calibrator clean volumes for calibrator material is
volumes is less than the minimum less than the minimum syringe
syringe volume. volume.

Automatic Dilutions Calibration: Test Definition: At least one of

At least one of the before the before aspiration clean
aspiration diluent clean volumes volumes for calibration diluent is
is less than the minimum syringe less than the minimum syringe
volume. volume.

Automatic Dilutions Calibration: Test Definitions - Automatic

Before aspiration calibrator clean Dilutions Calibration:
volume must be less than or equal Inconsistent calibrator material
to <Data Dictionary - Clean Cup before aspiration Clean Volume.
Capacity> uL.

Automatic Dilutions Calibration: Test Definitions - Automatic

Before aspiration diluent clean Dilutions Calibration:
volume must be less than or equal Inconsistent calibration diluent
to <Data Dictionary - Clean Cup before aspiration Clean Volume.
Capacity> uL.

Automatic Dilutions Calibration: Test Definition: Calibrator

Calibrator before aspiration clean material before aspiration clean
total volume exceeds the total volume exceeds the
maximum allowed by the syringe. maximum allowed by the syringe.

Automatic Dilutions Calibration: Test Definitions - Calibration

Diluent after dispensation clean Diluent after dispensation Clean
volume exceeds the limits transport volumes exceed syringe
allowed by the Syringe Volume. volume limits.
See associated Material
Definition.

Automatic Dilutions Calibration: Test Definition: Calibration

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Popup Alarms Chapter 12 – Alarms and Troubleshooting

Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

Diluent before aspiration clean diluent before aspiration clean

total volume exceeds the total volume exceeds the
maximum allowed by the syringe. maximum allowed by the syringe.

Autorun not available due to: This message shall be displayed

Missing CTS filter. as a tooltip when autorun status is
in error if the instrument has a
CTS probe and a CTS filter was
not detected.

Autorun not available due to: This message shall be displayed

Need to run enhanced clean on as a tooltip when autorun status is
Reagent 1 Probe. in error if an enhanced clean is
required on Reagent 1 probe.

Autorun not available due to: This message shall be displayed

Need to run enhanced clean on as a tooltip when autorun status is
Reagent 2 Probe. in error if an enhanced clean is
required on Reagent 2 probe.

Autorun not available due to: This message shall be displayed

Need to run enhanced clean on as a tooltip when autorun status is
Sample Probe. in error if an enhanced clean is
required on Sample probe.

Autorun not available due to: No This message shall be displayed

ORU is enabled. as a tooltip when autorun status is
in error if there is no enabled
ORU.

Autorun not available due to: This message shall be displayed

Temperatures out of range. as a tooltip when autorun status is
in error if temperatures are out of
range.

Backup or restore could not be The backup or restore failed due

performed. to an unknown error.

Calibration DR: If selected math Calibration DR: If selected math

model is Polynomial and is not model is Polynomial and is not
measured on X results, then measured on X results, then
extrapolation range is required. extrapolation range is required.

Calibration is failed. Failed calibrations cannot be

validated.

Calibration unit changed. The calibration unit in the

calibration job does not match the

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Popup Alarms Chapter 12 – Alarms and Troubleshooting

Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

current calibration unit in the test

definition.

Clean volume settings cannot be Clean volume for <Data

less than the minimum syringe Dictionary - Clean Airgap>,
volume. <Data Dictionary - Clean
Volume> and <Data Dictionary -
Clean Transport Airgap> is less
than the minimum syringe
volume.

Concentration value changed. A concentration value has

changed in the test definition
since the execution of the
calibration or dilution mode is
different.

Coordinates are: Diagnostics "Defining the LAS

Measured X = <measured X> mm aspiration point - Manual
Measured Y = <measured Y> mm procedure" activity: message to
Measured Z start LLD = display the measured coordinates.
<measured z-start> mm
Measured Z end LLD =
<measured z-max> mm
Press OK to save or Cancel to
Abort

Data base fragmentation. It's DB Indexes are fragmented.

suggested to shutdown the Defragmentation is recommended.
application.

Database backup or restore failed The backup or restore failed

because the database engine is because the database engine was
down. The operation cannot be down.
performed. Exit application.
Restart PC to automatically restart
database engine.

Database installation failed The installation of a new database

failed due to an unknown error.

Database installation failed due The installation of a new database

to disk full. Increase free space failed because there is not enough
and start again. free space on the disk selected for
installation.

Database installation failed due The installation of a new database

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

to installation scripts are not failed due to were not found the
available in installation scripts installation scripts in scripts
directory. Please exit the directory.
application and reinstall the ACL
TOP application.

Database installation failed. The installation of a new database

Database engine is not failed due to the database engine
functioning. Please exit the was down.
application and restart the CM to
automatically restart database
engine.

Database installation failed. The installation of a new database

There is another application using failed due to existed open
the TOP database. Please close connections to TOP databases.
all open applications.

Database upgrade failed The upgrade of the database failed

due to an unknown error.

Database upgrade failed because The upgrade of the database failed

the database engine is down. The because the database engine was
operation cannot be performed. down.
Exit application.
Restart PC to automatically restart
database engine.

Database upgrade failed because The upgrade of the database failed

there are no upgrades available. because there are no available
Exit application. upgrades.

Database upgrade failed because The upgrade of the database failed

upgrade script is invalid. Exit because the upgrade script was
application. Reinstall ACL TOP. invalid.

Database upgrade failed due to The upgrade to a new database

disk full. Increase free space and failed because there is not enough
start again. free space on the disk selected for
upgrade.

Database upgrade failed due to The upgrade of the database failed

existing open connections to TOP due to existing open connections
database. Please close all open to TOP databases.
data base connections first.

Deleting sample %1 of %2. Deleting sample %1 of %2.

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

During adjusting thermal, Warning message (static label) to

temperatures may appear within let the user know that during
range, but the system is still adjusting thermal, temperatures
stabilizing. may appear within range, but the
system is still stabilizing.

Error writing disk due to disk The backup or restore failed

capacity exceeded or invalid because there is not enough free
network access. Increase free space on installation location or a
space and start again. Check network error was detected.
network connections if a network
unit was used.

First you must select a clean Enhanced Clean: error message to

material in this activity's detail notify the user that the clean
dialog. material is not configured.

Fluid may flow out of the probe Diagnostics "Set Valve" Test:
when the valve position is Message to let the user know that
changed. changing the syringe valve
position some liquid could flow
out of the probe

Global Definition incorrect The field Cuvette Blind Volume

syringe settings: cuvette blind has a value greater than LAS Min.
volume must be less than the Dispense Volume in LAS
LAS minimum dispense volume. Configuration.

High data base fragmentation. It's DB Indexes are fragmented.

highly recommended to shutdown Defragmentation is highly
the application. recommended.

High data base fragmentation. DB Indexes are fragmented.

The application will Defragmentation is mandatory.
automatically shutdown.

Impossible to create the selected The user agreed to create the Logs
Default path for Logs. Do you folder, but the system cannot
want to continue saving? create neither current, not
controlled users.

LAS Definition incorrect syringe The field Min. Dispense Volume

settings. Min. Dispense volume has a value greater than Max.
greater than Max. probe volume. probe volume when saving LAS
configuration.

LAS Definition incorrect syringe The field Airgap greater than Save LAS configuration (Setup -

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

settings: Airgap greater than Max. Max. probe volume LAS Configuration)
probe volume.

LAS Definition incorrect syringe The field Aliquoting area

settings: Aliquoting area expiration time has a value greater
expiration time greater than LAS than LAS sample expiration time.
sample expiration time.

LAS Definition incorrect syringe The field Head volume greater Save LAS configuration (Setup -
settings: Head volume greater than Max. probe volume LAS Configuration)
than Max. probe volume.

LAS Definition incorrect syringe The field Cuvette Blind Volume

settings: LAS minimum dispense has a value greater than LAS Min.
volume must be greater than the Dispense Volume in LAS
cuvette blind volume. Configuration.

LAS Definition incorrect syringe The field Max. sample volume is

settings: Max. sample volume too too small when saving LAS
small. configuration.

LAS Definition incorrect syringe The field Min. syringe volume Save LAS configuration (Setup -
settings: Min. syringe volume greater than Airgap. LAS Configuration)
greater than Airgap.

LAS Definition incorrect syringe The field Min. syringe volume has Save LAS configuration (Setup -
settings: Min. syringe volume a value greater than Clean airgap. LAS Configuration)
greater than Clean airgap.

LAS Definition incorrect syringe The field Min. syringe volume has Save LAS configuration (Setup -
settings: Min. syringe volume a value greater than Clean LAS Configuration)
greater than Clean volume. volume.

LAS Definition incorrect syringe The field Min. syringe volume Save LAS configuration (Setup -
settings: Min. syringe volume greater than Head volume airgap. LAS Configuration)
greater than Head volume airgap.

LAS Definition incorrect syringe The field Min. syringe volume Save LAS configuration (Setup -
settings: Min. syringe volume greater than Head volume. LAS Configuration)
greater than Head volume.

LAS Definition incorrect syringe The field Min syringe Volume has
settings: Min. syringe volume a value greater than Max Probe
greater than Max. probe volume. Volume when saving LAS
configuration.

LAS Definition incorrect syringe The field Min. syringe volume has
settings: Min. syringe volume a value greater than Min. dispense

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

greater than Min. dispense volume.

volume.

LAS Definition incorrect syringe The field Min. syringe volume Save LAS configuration (Setup -
settings: Min. syringe volume greater than Transport airgap after LAS Configuration)
greater than Transport airgap after dispense.
dispense.

LAS Definition incorrect syringe The field Min. syringe volume Save LAS configuration (Setup -
settings: Min. syringe volume greater than Transport airgap. LAS Configuration)
greater than Transport airgap.

LAS Definition incorrect syringe The field Transport airgap greater Save LAS configuration (Setup -
settings: Transport airgap greater than Max. probe volume LAS Configuration)
than Max. probe volume.

Lower the LAS probe to the Diagnostics "Defining the LAS

maximum reachable position in aspiration point - Manual
the sample tube. procedure" activity: message to
ask the user to move the probe to
zMax position.

Manually raise the LAS probe to Diagnostics "Defining the LAS

the liquid level detection start aspiration point - Manual
position. procedure" activity: message to
ask the user to move the probe to
the LLD start position.

Material lot changed – different Material <Data Dictionary -

lots. Material Name> used with lot
<Data Dictionary - Lot Number>
and current lot is <Data
Dictionary - Lot Number>.

Material lot changed – lot Material <Data Dictionary -

disabled. Material Name>' used with lot
<Data Dictionary - Lot Number>
and current lot is disabled.

Material lot changed – lot Material <Data Dictionary -

enabled. Material Name> used with lot
disabled and current lot is
enabled.

Material position warning Material position warning

Materials changed. Materials used to run the job

differ from current materials

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

defined for the test.

One or more of the QCs could One or more QCs could not be
not be processed probably processed due to a lack of
because not all materials are on- materials or a test definition
board or the test definition is not inconsistency.
consistent.

Place a 20 mL vial containing Maintenance "Enhanced Clean "

Clean B in the LAS Cover activity: message to ask the user
aspiration point. to place the vial containing the
clean material in the LAS cover
aspiration point.

Place cylinder under the probe Diagnostics Flow Rate Test:

and press the button to start the Directions to the user about where
Rinse Pump to place the graduate cylinder and
For Sample Probe - Rack S4 how to proceed. Only for TOP,
Position 5 CTS & MiniTOP instruments.
For Reagent Probe - Rack R3
Position 3

Place cylinder under the probe Diagnostics Flow Rate Test:

and press the button to start the Directions to the user about where
Rinse Pump to place the graduate cylinder and
For Sample Probe (use graduated how to proceed. Only for
cylinder) - Rack S4 Position 5 MicroTOP instruments.
For Reagent Probe (use graduated
cylinder)- Rack R3 Position 3

Place empty container under the Diagnostics Flow Rate Test:

probe and press the button to start Directions to the user about where
the Rinse Pump to place the graduate cylinder or
For LAS Probe (use empty 20 ml empty 20 ml vial and how to
vial) - LAS Arm Cover Aspiration proceed. Only for LAS
Point instrument.
For Sample Probe (use graduated
cylinder) - Rack S4 Position 5
For Reagent Probes (use
graduated cylinder)- Rack R3
Position 3

Place the Aspiration Point Diagnostics "Defining the LAS

Alignment Tool at the LAS aspiration point - Semi-Automatic
Aspiration Point to proceed procedure" activity: message to
ask the user to place the
alignment tool on the LAS track

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

aspiration point.

Please place a 20mL vial Enhanced Clean for LAS probe:

containing Clean B in the LAS message to ask the user to place
cover aspiration point. the clean material
Press OK to proceed or Cancel to
abort.

Please remove the alignment tool Diagnostics Defining the LAS

from the LAS track aspiration aspiration point - Semi-Automatic
point. procedure: Message to remind the
user to remove the alignment tool
from the LAS track

Please remove the Clean B vial Enhanced Clean for LAS probe:
from the LAS cover aspiration message to ask the user to remove
point and press OK to proceed. the clean material

Please remove the following racks Diagnostics Travel To Target

and press Okay to proceed: Test: Request to remove racks if Z
Racks D2, R1-R4 limit position is selected

Please remove the following racks Diagnostics Travel To Target

and press Okay to proceed: Test: Request to remove racks if Z
Racks D3, R1-R6 limit position is selected

Please remove the following racks Diagnostics Travel To Target

and press Okay to proceed: Test: Request to remove racks if Z
Racks S1-S4, D1, R1-R3 limit position is selected

Please remove the following racks Diagnostics Travel To Target

and press Okay to proceed: Test: Request to remove racks if Z
Racks S1-S8, D1 limit position is selected

Please remove the following racks Diagnostics Travel To Target

and press Okay to proceed: Test: Request to remove racks if Z
Racks S1-S12, D1-D2 limit position is selected

Probe warning The probe is going to move.

QC Profile Error: Duplicated QC Profile name is already used

Name. by another QC profile.

Required Clean Material not Enhanced Clean: error message to

placed or there is not enough notify the user that the clean is
volume to perform this activity. not placed or there is not enough
volume

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

Sample Predilution: At least one Test Definition: At least one of

of the before aspiration diluent the before aspiration clean
clean volumes is less than the volumes for pre-dilution diluent is
minimum syringe volume. less than the minimum syringe
volume.

Sample Predilution: At least one Test Definition: At least one of

of the before aspiration the before aspiration clean
sample/mixture clean volumes is volumes for pre-dilution sample/
less than the minimum syringe mixture is less than the minimum
volume. syringe volume.

Sample Predilution: Before Test Definitions - Sample

aspiration diluent clean volume Predilution: Inconsistent Pre-
must be less than or equal to dilution diluent before aspiration
<Data Dictionary - Clean Cup Clean Volume.
Capacity> uL.

Sample Predilution: Before Test Definitions - Sample

aspiration sample/mixture clean Predilution: Inconsistent Pre-
volume must be less than or equal dilution sample/mixture before
to <Data Dictionary - Clean Cup aspiration Clean Volume.
Capacity> uL.

Sample Predilution: Diluent after Test Definition: for a single

dispensation clean volumes dispensing the material volume
exceed the limits allowed by the (including air gaps) must be
Syringe. See associated Material within the syringe volume limits.
Definition.

Sample Predilution: Diluent Test Definition: Pre-dilution

before aspiration clean total diluent before aspiration clean
volume exceeds the maximum total volume exceeds the
allowed by the syringe. maximum allowed by the syringe.

Sample Predilution: Test Definition: Pre-dilution

Sample/mixture before aspiration sample/mixture before aspiration
clean total volume exceeds the clean total volume exceeds the
maximum allowed by the syringe. maximum allowed by the syringe.

Select import parameters file. The user shall select an import Choose a file or cancel the import
parameters file if the ACL-TOP parameters operation.
executing in a unattended
parameters mode without an
specified file.

The <material description> vial Diagnostics Fluid Precision Test:

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

for fluid precision test is empty. One of the vials used to perform
Place a new vial and then press the fluid precision test didn't have
OK to continue. enough liquid to complete the
Press Cancel to abort the execution of the test.
procedure.
Note: <material description> is
"optical control" or "factor
diluent"

The arm is going to move back Diagnostics "Defining the LAS

into the instrument. aspiration point - Manual
procedure" activity: Warning
message to notify the user that the
arm is going to be moved back
inside the instrument.

The database restore failed The restore failed because the

because the ACL TOP upgrade after the restore failed.
application installation is invalid.
Exit the DB Backup/Restore
application.
Reinstall the ACL TOP
application. Restart the database
restore operation.

The descriptor file is not a valid The restore failed due to an

xml-file. Perform another backup. invalid backup descriptor.

The modification of these Changing any Sample/Reagent

parameters might alter the Probe Dilution or Cuvette
consistency of the Test Dilution Parameter will trigger a
Definitions in the system. Please, full Consistency checking for all
confirm changes. defined Tests (a lengthy
operation), because these
parameters affect directly to the
feasibility of the Analytical
Cycle, automatic and prediluted
Dilution algorithms and may
result in some Test being non-
Feasible.

The operation cannot be The backup or restore failed due

performed. Please close all open to existing open connections to
data base connections first. TOP databases.

The restore operation from a CD The backup or restore from a CD

failed because the CD was

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Popup Alarms – Warnings and Errors

Message Alarm Description Operator Action

failed. Check that provided CD corrupted.

has valid format and content. Use
another backup.

The value of # Slots for dilution When the user tries to save the
preparation has changed. Saving LAS configuration and s/he has
this configuration will perform a changed the # of slots for dilution
Cuvette Evacuation Cycle preparation, the system will show
maintenance activity. this message to warn the user this
This operation could take some may be a lengthy operation
time. Do you want to save the (because it may trigger a Cuvette
LAS configuration anyway? Evacuation Cycle) and let him/her
abort the saving operation.

There is no available information The "Monthly Report" will

to print. display this message if no data is
available after applying the filter

Unable to modify CTS mode. Enable CTS Mode cannot be

CTS rack in use or invalid changed when a CTS rack is
instrument status. onboard or Instrument Status is
different than Not Connected,
Power up or , Ready.

You don't have enough write If the user has not write rights for
rights in the Default path for the log path the alarms is risen
Logs. Do you want to continue
saving?

Back to Alarm Messages.

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Alarm Buttons Chapter 12 – Alarms and Troubleshooting

Alarm Buttons
Alarm buttons appear in the status bar at the bottom of all ACL TOP instrument screens. The system notifies
you of new alarm messages in the following ways:
l A blinking red or yellow exclamation point appears on the alarm button in the status bar.
l The system provides an audible beep.
The ACL TOP instrument produces two types of alarm messages: Errors and Warnings.

Warning Alarms
A warning message indicates that some user action may be required. Warnings do not affect the operation of
the instrument. However, an error condition may eventually occur if the operator does not perform the
required action.
Warnings are indicated by a yellow exclamation point on the alarm button in the status bar.

Error Alarms
An error message indicates that a condition has been detected that requires immediate action. Failure to act
may result in the instrument performing an emergency stop.
Errors display a red exclamation point on the alarm button in the status bar.

No New Alarms
When an alarm button in the status bar is enabled but without an exclamation point, there are no new alarms.

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Alarm Buttons in the Status Bar

The following alarm buttons appear in the status bar.

Alarm Button Alarm Name Description

Material Alarms related to the availability of materials on

board the AM1.

Job Frequency Alarms related to the ability of the analyzer to

complete a test.

Quality Control Alarms related to the Quality Control functionality.

Maintenance Alarms that indicate a maintenance operation must be

performed.

Analyzer Alarms related to the AM functionality.

External Communications Alarms related to the host connection or to LAS.

Alarms

See Also
l Status Bar
l Alarm Messages
l Data Flags

1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or
the Analytical Module.

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Troubleshooting Other Problems Chapter 12 – Alarms and Troubleshooting

Troubleshooting Other Problems

Instrument problems that do not display alarm warnings, errors, or messages are listed below along with
suggested operator actions.

Item Problem Suggested Actions

1 Instrument Make sure the bar code label is not damaged or dirty.
doesn’t See Restriction Map.
recognize rack Verify that you are using a bar code format supported by the system. See Bar
Code Definitions Setup.
Check that the rack flag (the part of the rack that is inserted and detected) is
not broken or defective.
Call Service.
2 Rack labels not Do not continue to use rack as loose labels will cause racks to jam.
secured to rack Clean rack label area carefully so labels are not damaged.
or fall off
3 Rack jams upon Verify that tubes are pushed all the way down into the rack position.
insertion Be sure you are using the correct sample containers and sample racks. See
Samples and Restriction Map.
Check that bottles and containers are held on center within rack.
4 Sample tube or Check that there is no buildup on the rack. IL recommends that all exposed
reagent surfaces be cleaned as needed with a cloth moistened with 10% bleach
bottles/auxiliary solution and rinsed with deionized water. Alternatively, Cavicide® can be
containers not used for surface decontamination.
held in center Use only sample containers specified for the ACL TOP instrument.
within rack See Sample Containers and Adapters.
Be sure to use correct bottles and correct adapters for the 4 mL and 10 mL
reagent bottles. See Reagents and Material Definition.
5 Cuvette supply Call Service.
warning LED
doesn’t light
6 Cuvette supply Call Service.
warning LED
constantly on
even when
cuvette supply
is full
7 Material not Be sure to place material that needs stirring in position 1 or 2 of a reagent
stirred rack.
Check that the correct magnetic stir bar (IL Part Number 00009746606) is
placed into the bottle with the solution to be stirred. See Material Definition
and Parts and Consumables List.
8 Reagent and/or Be sure there is no obstacle preventing the magnetic lock from engaging. See
sample cover Instrument Description/AM Safety Covers.
won’t close Call Service.

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Item Problem Suggested Actions

9 Frequent Remove and clean air filters periodically. Replace air filters as needed. See
reagent Parts and Consumables List.
temperature If problem persists, call Service.
warnings
10 Rinse or clean Check that the Rinse or Clean bottle has no cracks. If so, replace rinse or clean
fluid leak bottle with an undamaged bottle.
external to Be sure rinse or clean bottle caps are tightened.
instrument Be sure all tubing is intact and connected, without bending or kinking. If the
tubing has holes or is internally clogged, replace tubing assembly.
See Parts and Consumables List and Rinse Fluid or Clean Fluid.
11 Waste fluid Check that the waste bottle has no cracks. If so, replace the waste bottle with
leak external to an undamaged bottle.
instrument Be sure the waste bottle cap is tightened.
Be sure all tubing is intact and connected, without bending or kinking. If the
tubing has holes or internally clogged, replace tubing assembly. The TOP 300
CTS liquid waste line cannot rest in a horizontal position across the table or
bench that holds the instrument. It must maintain a negative slope across the
entire length of the tubing to minimize the backup of waste fluids. There must
be no crimping in the tubing.
See Parts and Consumables List and Fluid Waste.
If none of the above cases are true and the waste fluid leak is due to bottle
overflow, the waste sensors may be defective. Call Service.

See Also
l Alarm Messages
l Data Flags
l Reference Section Overview

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Data Flags Chapter 12 – Alarms and Troubleshooting

Data Flags
Data Flags are associated with test results and can be either warning-level or error-level. Also, data flags are
categorized into groups. See Accessing Data Flags. Data flag codes are always transmitted with the results to
the LIS.

Warning Data Flags

A warning data flag indicates that a test result has been generated, but a condition has been detected, or a
limit exceeded, that may affect the quality of the result.

Error Data Flags

An error data flag indicates a condition has been detected, or an error limit exceeded, that will result in no
test results generated.
In normal conditions, samples are displayed on the screen with no flags. If a flag exists, it is displayed in
capital letters, for example, CE (coagulation error), CW (coagulation warning). If a test and/or sample has
multiple flags, the flag with the highest priority is displayed/printed with both capital letters underlined to
indicate that there are more flags beyond what is displayed/printed. All flags and codes are listed in Test
Details screen.

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Data Flag Groups

Data flags are categorized into the following groups (listed from highest to lowest priority):

Data Flag Group Description

Blank No error
IU Investigational use only
SE Sampling error
HE Hardware error
CE Coagulation error
RE Individual result error
HC Out of calibration range high
LC Out of calibration range low
HW Hardware warning
CW Coagulation warning
RW Individual result warnings
QC Quality control flag
NP NPP flag
HT Out of test range high
LT Out of test range low
HL Out of linear range high
LL Out of linear range low
HH Out of therapeutic range high (mean value)
LH Out of therapeutic range low (mean value)
HN Out of normal range high (mean value)
LN Out of normal range low (mean value)
CR Out of calibration range (high or low)
TR Out of test range (high or low)
LR Out of linear range (high or low)
HR Out of therapeutic range (high or low)
NR Out of normal range (high or low)
CA Calibration flag
MT Maintenance Flags
ME Material Errors/Warnings

NOTE: An underlined data flag group on the screen (for example, HR), indicates there are multiple
data flags associated with the result, even only one is type displayed. And among data flags associated with
the sample, the underlined type is the highest priority.

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Data Flags List

Data Flags
Code Flag Message Error/ Description
Warning

5000 HE LLD Error E The AM has detected liquid where liquid should not be
(a false positive).

5002 HE Error detected E General ORU error. If the signal check for a particular
in ORU test is disabled, all ORU flags are treated as an error.

5003 HE Air read failure E The reading of the air just prior to acquisition is outside
of the stored air read value plus/minus some tolerance
amount.

5004 HE Aspiration E The probe did not stay immersed in the liquid properly
Baseline Error during an aspiration or the liquid was not properly
detected prior to the aspiration.

5005 HE Unexpected E Liquid has been detected, but it is not in the proper
LLD Error location (it is found too early) so we suspect a false
positive reading.

5050 CE (Data) First E Out of starting point range

point out of
range

5051 CE (Data) Baseline E baseline average too low

average low

5052 CE (Data) Baseline E Baseline SD is out of range

SD exceeds
error limit

5053 CE (Data) Baseline E baseline average too high

average high

5054 CE (Data) E Endpoint SD is out of range

Endpoint SD
exceeds error
limit

5055 CE (Data) E endpoint average too high

Endpoint
average high

5056 CE (Data) Too E too many invalid raw - points do not fall within specified
many invalid signal range or have an ORU error associated with them
raw data points

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Data Flags
Code Flag Message Error/ Description
Warning

5057 CE (Data) Curve E invalid curve max after min -- curve behaves in an
min. and max. unexpected manner - raw data should go from maxima to
not in correct minima value (on ACL-Advance). User specifies correct
sequence sequence on Top.

5058 CE (Data) Last E curve drifting -- the last point in the raw data is outside
point out of specified % of curve
range

5059 CE (Data) Incorrect E too few or too many data points in curve -- indicates an
number of raw error in scheduler, should never occur.
data points

5060 CE (Data) E delta of curve invalid -- indicates that raw data does not
Normalized have enough signal across curve
curve delta too
low

5061 CE (Data) E calculation error -- i.e. divide by zero

Calculation
error

5062 CE (Coag) First E didn't reach first threshold -- not enough signal in curve
threshold limit to find threshold limit value
not found

5063 CE (Coag) Second E second threshold not found -- not enough signal in curve
threshold limit to find threshold check value and user has configured the
not found algorithm to fail if check value not located (otherwise a
warning)

5064 CE (Coag) Max E time exceeded -- too much time (or too little time)
(min) time span between threshold limit-check or derivative min-max
violation peaks.

5065 CE (Data) Curve E Unable to determine curve sequence

sequence
unknown

5066 CE (Reaction) E SD out of range in Linear Regression

Linear
Regression SD
exceeds error
limit

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Data Flags
Code Flag Message Error/ Description
Warning

5067 CE (Range) Below E measured result fails -- does not meet test range (low)
measured result
test range

5068 CE (Range) Above E measured result fails -- does not meet test range (high)
measured result
test range

5069 CE (Data) Missing E ORU Blank correction is enabled, but the Blank value for
ORU blank that channel is unavailable
value

5070 CE (Data) E endpoint average too low

Endpoint
average low

5071 CE (Coag) First E Not identified any maximum peak meeting the criteria
derivative peak
not found

5072 CE (Coag) Second E No maximum or minimum peak meeting the criteria

derivative peak
not found

5073 CE (Data) E The Interference Check of the Statistics Algorithm has

Interference failed
error

5074 CE (Data) Number E Too many spikes were detected in the data.
of spikes
exceeds error
limit

5075 CE (Params) No E The user has disabled the primary algorithm so there will
algorithm be no measured result
selected

5076 CE (Reaction) E The slope of the initial part of the reaction curve was
Initial slope greater than the maximum slope allowed.
exceeds error
limit

5077 CE (Prep) E The AM has detected that there was not enough sample
Insufficient material to run the test
liquid detected
(Sample)

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Data Flags
Code Flag Message Error/ Description
Warning

5078 CE (Prep) E The AM has detected that there was insufficient reagent
Insufficient material with which to run the test.
liquid detected
(Reagent)

5079 CE (Prep) Liquid E A hardware error has occurred with the probe.
level detection
error

5080 CE (Data) E Due to points being removed from the original data curve
Insufficient due to either the signal check, the spike removal check,
points or the moving SD check, the number of points in the
remaining for remaking data curve is too few to perform an operation
calculation that requires a specific number of data points.

5081 CE (ORU) E A hardware error has occurred that will prevent the
Hardware error measured result from being computed

5082 CE (Prep) Missing E A missing dispense rinse and/or clean step has been
post dispense detected by the SW.
rinse/clean
detected

5083 CE (Data) E The delta of the sample is less than the delta of the
Normalized lowest calibrator (minus some tolerance amount).
curve delta less
than lowest
calibrator delta

5084 CE (Coag) Too E Too many peaks were found within the first derivative
many first and the specified window, indicating that the data curve
derivative is noisy.
peaks

5085 CE (Coag) Too E Too many peaks were found within the second derivative
many second curves specified window, indicating that the data curve is
derivative noisy.
peaks

5086 CE (Data) Result E The measured result is more negative than the maximum
exceeds negative value allowed (zero if no negative values are
Negative Value allowed)
Limit

5087 CE (Data) Result E The Result Check measured result failed.

Check failed

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Data Flags
Code Flag Message Error/ Description
Warning

5088 CE (Prep) E Error when performing the aspiration baseline check

Aspiration
Baseline Error

5089 CE (Prep) E AM reported an unexpected LLD error

Unexpected
LLD Error

5090 CE (Prep) Material E AM reported a material dispense error. An unexpected

dispense error material dispense error was detected by the AM software.
Not expected behavior.

5091 CE (Data) E delta of curve invalid -- indicates that raw data exceeds
Normalized allowed signal change across curve
curve delta too
high

5092 CE (Data) E The threshold error value is found more than one time in
Normalized the data and the time between each of the consecutive
data contains occurrences of the threshold is greater than the defined
multiple time span.
thresholds

5093 CE (Coag) First E The Error Threshold value has been found in the first
derivative derivative curve.
negative check
failed

5100 RE Measured result E The result unit is the measured result and DR has been
failed unable to compute it

5101 RE NPP undefined E ratio denominator undefined. This could occur if not
properly set up by the user or, in the case of an NPP
material, if it was not executed prior to computing results
that require it.

5102 RE NPP failed E NPP result used in result calculation is failed.

5103 RE ISI undefined E ISI value undefined

5104 RE Estimation E result cannot be calculated

failed

5105 RE Paired partner E The result is based on paired tests and one of them is not
test not available due to being not configured properly.
available

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Data Flags
Code Flag Message Error/ Description
Warning

5106 RE Paired partner E The result is based on paired tests and one or both of
test failed them are failed

5107 RE Inconsistent E The paired results do not have consistent result units with
test units which to perform the paired result calculation. If using
between paired the measured result, the measured result units must be the
tests same (i.e. both seconds). If using the calibrated result unit,
the calibrated result units must be the same (i.e. both %
activity).

5108 RE Unable to E Unable to compute the Corrected Result for this

compute determination and/or concentration
parallelism CR

5109 RE Unable to E Unable to compute the mean of the corrected result (CR)
compute excluding the 100% parallelism concentration.
parallelism
mean of CR

5110 RE Unable to E Unable to compute the mean of the corrected result (CR)
compute including the 100% parallelism concentration
parallelism
mean of CR
and 100%

5111 RE Unable to E Unable to compute the mean result of the 100%

compute parallelism concentration
parallelism
mean 100%

5112 RE Unable to E Unable to compute the %CV of the corrected result (CR)
compute from each concentration excluding the 100%
parallelism concentration
%CV of CR

5113 RE Unable to E Unable to compute the %CV of the Corrected Result

compute (CR) from each concentration including the 100%
parallelism concentration
%CV of CR
and 100%

5114 RE Unable to E
compute
parallelism
slope

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Data Flags
Code Flag Message Error/ Description
Warning

5115 RE Unable to E
compute
parallelism y-
intercept

5116 RE Unable to E
compute
parallelism r2

5117 RE Below E The result value was computed using the secondary
Secondary algorithm and was less than the minimum value allowed.
Algorithm
Range

5118 RE ISI value E Unable to obtain ISI value because the lot of material is
undefined. Lot no longer defined.
not defined.

5119 RE Active E The calibrated unit in the active calibration does not
calibration unit match the calibrated unit in the calibration definition.
and calibration
unit in the test
definition do
not match

5120 RE Maximum E The result value was negative and was more negative
negative value than allowed for this unit.
exceeded

5121 RE Above E The result value was computed using the secondary
Secondary algorithm and was greater than the maximum value
Algorithm allowed.
Range

5122 RE Calibrated E For polynomial regression. The measured result is larger

result is out of than the measured value for the highest calibration point,
Calibration but the calibrated value is below the highest target value.
Range High

5190 HW Temperature W Generic flag indicating that at least one temperature

out of range reading was out of range. All temperature out of range
alarms are mapped to a single flag within each
determination

5191 HW Warning W Generic ORU warning. If signal checks are enabled in the
detected in test definitions for the particular test, all ORU flags are

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Data Flags
Code Flag Message Error/ Description
Warning

ORU treated as warning.

5192 HW Material W The AM has detected that the material stirring mechanism
stirring is not stirring the material and this is a coagulation test
warning (stirring prolongs material stability)

5200 CW (Data) First W Out of starting point range

point out of
range

5201 CW (Data) Baseline W Baseline SD is out of range

SD exceeds
warning limit

5202 CW (Data) Baseline W Baseline average too low

average low

5203 CW (Data) Baseline W Baseline average too high

average high

5204 CW (Data) Invalid W At least one data point has been found out of the
point(s) acceptable range or with an ORU flag associated with it.

5205 CW (Data) W Endpoint SD is out of range

Endpoint SD
exceeds
warning limit

5206 CW (Data) W endpoint average too low

Endpoint
average low

5207 CW (Data) W endpoint average too high

Endpoint
average high

5208 CW (Data) Delta of W curve delta below valid delta

Curve Lower
Limit below
warning limit

5209 CW (Coag) Maxima W first derivative peak below limit

of 1st
derivative
below warning
limit

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Data Flags
Code Flag Message Error/ Description
Warning

5210 CW (Coag) Maxima W 2nd derivative maxima peak below limit

of 2nd
derivative
below warning
limit

5211 CW (Coag) Minima W 2nd derivative minima peak below limit

of 2nd
derivative is
below warning
limit

5212 CW (Reaction) W maximum SD exceeded for linear regression

Linear
regression SD
exceeds
warning limit

5213 CW (Coag) Second W second threshold not found

threshold limit
not found

5214 CW (Coag) Max W time exceeded on threshold/derivative check

(min) time
violation

5216 CW (Data) Last W curve drifting -- the last point in the raw data is outside
point out of specified % of curve
range

5217 CW (Coag) 1st W max peak to baseline delta below minima

derivative peak
delta below
warning limit

5218 CW (Coag) 1st W max peak to baseline delta percent lower than warning
derivative max limit
peak delta %
below warning
limit

5219 CW (Coag) 2nd W peak delta below minima

derivative peak
delta below
warning limit

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Data Flags
Code Flag Message Error/ Description
Warning

5220 CW (Coag) 2nd W peak delta percent lower than warning limit
derivative peak
delta % below
warning limit

5221 CW (Data) W The Interference Check of the Statistics Algorithm failed.

Interference
warning

5222 CW (Data) Number W At least one spike has been detected in the data
of spike(s)
exceeds
warning limit

5223 CW (Reaction) W The initial slope of the reaction curve is greater than the
Initial slope specified warning limit
exceeds
warning limit

5224 CW (Coag) W The clotting time selected for the derivative curve
Derivative first corresponds to the first data point in the derivative curve
point

5225 CW (Coag) W The result found using the backwards threshold check is
Threshold not within the valid range of the result found using the
Check first or second derivative algorithm.

5227 CW (Data) W The delta of the normalized data curve is less than the
Normalized warning tolerance amount based upon the delta of the
curve delta less lowest calibration point.
than lowest
calibrator delta

5228 CW (Coag) 2nd W max peak to baseline delta below minima

derivative max
peak delta
below minima

5229 CW (Coag) 2nd W max peak to baseline delta percent lower than warning
derivative max limit
peak delta %
below warning
limit

5230 CW (Data) Result W The algorithm used with the result check produced a
Check failed failed measured result.

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Data Flags
Code Flag Message Error/ Description
Warning

5231 CW (Data) Delta of W curve delta above valid delta

Curve Upper
Limit above
warning limit

5232 CW (Data) W The threshold warning value is found more than one time
Normalized in the data and the time between each of the consecutive
data contains occurrences of the threshold is greater than the defined
multiple time span.
thresholds

5250 RW Missing W Less determinations than currently configured

determinations

5251 RW Too many W More concentrations than currently configured

concentrations

5252 RW %Max W Max Difference between replicates greater than allowed

difference of
replicates
exceeded

5253 RW Max. variance W The difference between each dilution and the 100%
of parallelism dilution of the parallelism result is exceeded
dilution out of
range

5254 RW Slope out of W

range

5255 RW Parallelism r2 W
out of range

5256 RW Too many W More determinations than currently configured

determinations

5257 RW Missing W Less concentrations than currently configured

concentrations

5259 RW %CV of the W Calculated CV exceeds the limits

CR is greater
than the
maximum
%CV allowed

5260 RW %CV of the W Calculated CV exceeds the limits

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Data Flags
Code Flag Message Error/ Description
Warning

CR and the
100% dilution
is greater than
the maximum
%CV allowed.

5261 RW Parallelism has W Calculated variance exceeds the limits

one or more
dilutions that
exceeds the
max.variance

5262 RW Results W This test has had its results recalculated.

recalculated

5266 RW DR warning on W The measured result that was used to compute this result
measured result had a warning associated with it.

5267 RW One or more W One or more replicate result(s) is failed.

failed replicates

5268 RW One or more W One of the component results used to calculate a paired
component result contains a flag (error or warning).
results used to
calculate the
paired result
contains a flag

5301 QC QC overdue E The expiration date for a QC has been reached.

5302 QC QC failed E QC rules have failed. It is a hint to detect problems in the

measurement.

5400 NP NPP has W NPP used to compute result from the same test definition
warning had a warning (only true if NPP is configured to run as a
material). This flag may be set for paired results (that use
NPP in their calculation) as well as R and INR results.
The flags within the NPP sample that will result in this
flag are the following:
1. There is a warning on the NPP measured result.
2. There is an error on the NPP measured result.
3. There is a warning on the NPP calibrated result (if

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Data Flags
Code Flag Message Error/ Description
Warning

computed).
4. The measured result is outside of one of the
enabled ranges.
5. One of the materials used to generate the NPP
sample has expired.
6. One of the materials used to generate the NPP
sample has expired stability.
7. The NPP frequency has expired.
8. A maintenance procedure was expired or failed
when the NPP material was run.
9. One of the materials used to generate the NPP
sample had a stirring warning.
NOTE: NPP from master test is not checked for this flag

5401 NP NPP overdue E Job executed when NPP frequency was expired.
Job is using NPP during the calculation and the NPP is
from the same test definition (Master Test NPP in a
Master/Paired relation is not checked for this flag).

5500 HT Above Test W One or more results is out of test range high
Range

5501 LT Below Test W One or more results is out of test range low
Range

5502 HL Above Linear W One or more results is out of linear range high
Range

5503 LL Below Linear W One or more results is out of linear range low
Range

5504 HH Above W One or more results is out of Therapeutic range high

Therapeutic
Range

5505 LH Below W One or more results is out of Therapeutic range low

Therapeutic
Range

5506 HN Above Normal W One or more results is out of Normal range high
Range

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Data Flags
Code Flag Message Error/ Description
Warning

5507 LN Below Normal W One or more results is out of Normal range low
Range

5508 HC Above E The computed calibrated result value is greater than the
Extrapolation maximum calibrated result value allowed.
Range

5509 LC Below E The calibrated result value is less than the minimum
Extrapolation value allowed for a calibrated result.
Range

5510 CR One or more W One or more results is out of Calibration Range

results are out
of Calibration
Range (High or
Low)

5511 TR One or more W One or more results is out of Test range.

results are out
of Test Range
(High or Low)

5512 LR One or more W One or more results is out of Linear range

results are out
of Linear
Range (High or
Low)

5550 CA Valid W Calibration has been disabled or there is no validated

calibration is calibration with the same reagent lots or the validated
not available calibration is failed and the job requires a calibration to
complete its result computations.

Calibration is imported by results data from a non-

validated or non existing master calibration.

5551 CA Calibration E Job has been executed with the calibration in overdue
overdue status.

5552 CA Calibration E calibration does not have result

estimation
failed

5553 CA Calibration E calibration slope out of range

slope out of
range

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Data Flags
Code Flag Message Error/ Description
Warning

5554 CA Calibration r2 E Coefficient of determination out of range

out of range

5555 CA Calibration E not enough "good" points

failed due to
lack of data

5556 CA Calibration y- E y-intercept out of range

intercept out of
range

5557 CA Calibration E The %CV of a particular dilution is greater than the

%CV of maximum CV allowed
dilution
exceeded

5558 CA Calibration has E Calculated CV exceeds the limits

one or more
dilutions that
exceeds %CV

5560 CA First and last E The measured results of the calibration are not valid. The
calibration data generated is not consistent with what is expected for
points cannot calibration data.
be the same

5563 CA Calibration E The minimum number of replicates for the particular

minimum dilution do not have good result values.
number of
replicates for
dilution is not
found.

5564 CA Calibration has E At least one dilution does not have the minimum number
one or more of replicates as specified.
dilutions that
do not have the
minimum
number of
replicates

5565 CA Calibration E The lot of material that was used to generate the original
failed. Lot not calibration results is no longer defined and therefore the
defined. calibration cannot be recalculated.

5566 CA Calibration E The results of the calibration do not follow a consistent

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Data Flags
Code Flag Message Error/ Description
Warning

results trend trend, either all values must increase or all values must
not consistent decrease, but they cannot increase and decrease as the
concentration levels change

5567 CA Calibration E The calibration curve will be flagged as not monotonic, if

curve not the monotonic check is enabled and detects multiple
monotonic results for the one or more measured value in one or more
segment within the tested range. For Spline calibrations,
the range is the limit of the spline calibration points. For
Polynomial calibrations, the range is the limit of the
extrapolation range.

5568 CA Calibration and W Calibration transformations do not match parallelism

parallelism transformations. User modified the parallelism
transformations transformation values and has not recalculated the
do not match calibration results.

5569 CA Dilution mean Dilution mean exceeded tolerance range.

exceeded
tolerance range

5600 MT Maintenance W Job executed with some maintenance activity in overdue

overdue or status.
failed

5650 ME Material W One or more materials stability has expired for this
stability determination

5651 ME Material W One or more of the materials used to run this

expired determination has expired.

5653 ME Alternate lot in W An alternative lot was in use when the job was run
use

5654 ME Alternate lot in W An alternative lot was used for jobs that this job uses to
use compute results.(Calibration, NPP or master job)

5657 ME One or more E Remaining stability for last vial expired.

determinations
has a material
stability
warning

5658 ME One or more E The present date is greater than the expiration date of the
determinations last available vial/lot.

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Data Flags
Code Flag Message Error/ Description
Warning

has a material
expiration
warning

5659 ME One or more W The stirring mechanism for a material requiring stirring is
determinations no longer functional.
has a material
stirring
warning

5660 ME LAS Sample W LAS Sample Expired during processing

expired during
processing

5700 SE Volume E Error indicating that there was insufficient sample to

Tracking - pipette. If this happens during a dilution preparation, all
Insufficient replicates for that dilution are flagged.
Liquid
(Sample)

5701 SE Volume E The AM determined that there was insufficient reagent to

Tracking - pipette. If this happens during a dilution preparation, all
Insufficient replicates for that dilution are flagged.
Liquid
(Reagent)

5702 SE Missing post E Error indicating missing dispense of rinse or clean was
dispense detected in the software.
rinse/clean
detected

5703 SE Material E Because of a scheduling error, a material that should have

dispense error been dispensed into the reaction cuvette was not
dispensed. This check is done for safety purposes and it
is intended that this error will never be seen.

5800 IU For W The test parameters have been developed for

Investigational investigational use only.
Use Only

5801 IU Software in W The instrument is running experimental or debug version

experimental software and/or an IL Service or an IL Specialist is
operation currently logged on.
and/or Service
or Specialist AM SW has been told to run in a special mode (fake

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Data Flags
Code Flag Message Error/ Description
Warning

logged-in LLD, disable heartbeat, short init, etc) via the CM.INI
file.

NA (not CA Calibration W The user has manually entered the measured result value
displayed value manually of this calibration point
as text) entered

NA (not CA Calibration W The user has deleted this calibration point (measured
displayed point deleted result) and it is no longer used to compute the calibration
as text) results

* For calibrations combined with dilutions, where some of the replicates have CW flags, the calibration is
still acceptable. The calibration can be validated as long as the DR Parameters (r2 and %CV check) meet the
criteria used for acceptability. The results with CW warnings show as italicized numbers and the warning
code is seen on the reactions information screen. The sample results derived from these calibrations do not
have any flags associated with them indicating that the result is based on the calibration that contained a
coagulation warning(s).

See Also
l Accessing Data Flags
l Alarm Messages
l Troubleshooting Other Problems

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Accessing Data Flags

You can view data flags in the following areas of the ACL TOP instrument:

Sample List
To view data flags in the Sample List:
1. Select Analysis > Sample List in the menu bar.

2. View the data flags in the Sample Highest Error column headed by a red exclamation point . The
highest priority data flag group is displayed for each sample.
See Sample List.
See Sample List Display Settings to display hidden columns.

Sample Details Screen

To view data flags on the Sample Details screen:
1. Select Analysis > Sample List in the menu bar.

2. In the Sample List, place focus1 on a sample ID and select the Sample Details icon in the
toolbar to open the Sample Details screen below the Sample List.
3. Select the Test Information tab in the Sample Details screen.

4. View the data flags in the Test Highest Error column headed by a red exclamation point . The
highest priority data flag group is displayed for each sample.
See Sample Details.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Test Details Screen

To view data flags on the Test Details screen:
1. Select Analysis > Sample List in the menu bar.

2. In the Sample List, place focus1 on a sample ID and select the Sample Details icon in the
toolbar to open the Sample Details screen below the Sample List.
3. In the Sample Details screen select the Test Information tab.

4. In the Test Information tab place focus on a test and select the Test Details icon in the toolbar
to open the Test Details screen.

5. <Optional> Select the Previous Job and Next Job icons in the toolbar to scroll
through the test results for the sample ID in focus in the Sample List.
6. View the data flags in the Errors and Warnings section. All data flags (group and description) are
displayed for each replicate and test unit.
See Test Details.

Calibration Details Screen

To view data flags on the Calibration Details screen:
1. Select Calibration > Status List in the menu bar.
2. In the Calibration Status List, double-click a test code, or select a test code and select the

Calibration Details icon in the toolbar. By default, the Calibration Details screen opens
displaying the validated calibration. If a test has no validated calibration, the Calibration Details
screen displays Calibration 1.
3. Select one of the following tabs and view data flags in the Errors and Warnings area.

l Calibration Information tab – Data flags appear specific to the calibration.

l Reaction Information tab – Data flags appear for replicate and test unit.

See Calibration Details.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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QC Statistics Screen
To view data flags on the QC Statistics screen:
1. Select QC > Results List in the menu bar.
2. Double-click a material name or test code in the Results List to open the QC Statistics screen.

3. View the data flags in the Error Status column headed by a red exclamation point . If a check
mark appears in that column, click it to see a list of all data flags (group and description).
See Reviewing QC Results.

NPP Details Screen

To view data flags on the NPP Details screen:
1. Select NPP > Status List in the menu bar.
2. Double-click a test in the NPP Status List.
3. Select one of the following tabs and view data flags in the Errors and Warnings area.

l General Information tab – Data flags appear that are not specific to the reaction.
l Reaction Information tab – Data flags appear that are specific to the reaction.

See NPP Status Details.

See Also
l Data Flags
l Sample List
l Sample Details
l Test Details
l Calibration
l QC Statistics
l NPP Details

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CHAPTER 13
SYSTEM

Maintenance Schedule
The ACL TOP instrument is a precision instrument. To maintain it in good functional condition, IL
recommends the following operations be carried out by a trained operator at the specified frequencies.

NOTE: For the best possible results, keep the instrument powered ON at all times. The standby
condition consumes minimum power and rinse fluid while affording maximum readiness for operation.

Daily Maintenance
During operation the automatic rinse and clean cycles are performed by the instrument, thus reducing to a
minimum the daily maintenance operations required of the operator.
Once each day the operator must perform the following maintenance activity:
l Enhanced clean for all probes
l Empty Cuvette Waste – ACL TOP 300 models only
See Performing Maintenance Activities for instructions on how to perform the enhanced clean.
The time required by the system to perform the Enhanced clean for all probes is about 5 minutes.

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Weekly Maintenance
Once each week the operator must perform the following maintenance activities:
l Clean the Cuvette Waste Drawer.
l Clean the Deep Wash and Clean Cup Area
l Empty Waste Fluid – ACL TOP 300 models only
l Wipe-down Sample Probe – Non-CTS Instruments Only
l Wipe-down LAS Probe

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid
damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible.
Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.
See Perform a Maintenance Activity for instructions on how to perform the above.

Monthly and Quarterly Maintenance

No maintenance activity is currently scheduled to be performed on a monthly or quarterly basis.

Annual and Semi-Annual Maintenance

l Preventive maintenance is to be performed by authorized Service personnel every 6 months.
l It is recommended that Syringe Tip Replacement be performed every 6 months.

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As Needed Maintenance

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid
damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible.
Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.
l Automatic Fluidic Line Priming Cycle.
l Automatic Routine Clean for all Probes
l Clean Rack Areas
l Cuvette Evacuation Cycle
l Enhanced Clean for LAS Probe
l Enhanced Clean for Reagent 1 and Reagent 2 Probes
l Enhanced Clean for Reagent 1 Probe
l Enhanced Clean for Reagent 2 Probe
l Enhanced Clean for Sample Probe
l Replace LAS Syringe
l Replace Reagent 1 Syringe
l Replace Reagent 2 Syringe
l Replace Sample Syringe
l Rinse/Clean Priming Cycle for all Probes
l Rinse/Clean Priming Cycle for LAS Probe
l Rinse/Clean Priming Cycle for Reagent 1 Probe
l Rinse/Clean Priming Cycle for Reagent 2 Probe
l Rinse/Clean Priming Cycle for Sample Probe
l Routine Clean for all Probes
l Wipe-down all Probes

By Number of Piercings Maintenance

l Replace CTS Filter and clean Clean Cup Area every 5000 cap piercings.

Good Laboratory Practice

As part of good laboratory practice, the operator is responsible for making sure that the system is kept clean.
Visually inspect the system (sample and reagent areas, cuvette drawer, etc.) and perform maintenance
activities as needed. See Performing Maintenance Activities for instructions.

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Different laboratories may require different maintenance schedules. See Viewing and Configuring a
Maintenance Activity and Adding a New Maintenance Activity for customization.

NOTE: When importing a maintenance activity, the Frequency field is overwritten if the imported
activity is more frequent than the system default frequency. Frequency is not overwritten if the imported
activity is less frequent than the system default frequency.

See Also
l Maintenance Definitions
l Viewing and Configuring a Maintenance Activity
l Performing Maintenance Activities

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Maintenance List

Accessing Maintenance Activities

To access Maintenance activities:
1. Select System > Maintenance to open the Maintenance List.
2. Double-click a maintenance activity in the table to review its definition in the Maintenance Activity
Configuration window.

3. To perform a maintenance activity, select1 the activity in the list, and select the Perform icon
in the toolbar, or select Actions > Activity > Perform in the menu bar.

Filtering the Maintenance List

To filter the table on the Maintenance List:
1. Select System > Maintenance to open the Maintenance List.

2. Select the Filter icon in the toolbar.

3. Configure the filter options in the Maintenance Activity Filter.

l If you select Manual from the Activity Type drop down list then select Apply Filter,
only manual activities are displayed on the Maintenance screen.
l If you select both Manual Activity Type and Overdue from the Frequency Status drop
down list, only manual activities that are overdue are displayed.
l If you also select Annual from the Frequency drop down list, only annual manual
activities that are overdue are displayed.
l The All Activities option removes all filters.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Printing the Maintenance List

To print the Maintenance List:
1. Select System > Maintenance to open the Maintenance List.

2. Select the Print icon to print the Maintenance screen. Whatever activities are displayed using
the filter option are printed, including all the fields for each activity.

NOTE:

l The Enable Warning Threshold option on the Maintenance Activity Configuration dialog box
specifies whether a warning message is generated when the activity is due.
l IL pre-defines automatic and semi-automatic maintenance activities. You cannot add or delete these
activities. However, you can modify these maintenance activities if you have the appropriate security
privileges.
l You can add, delete, or modify any manual maintenance activity, regardless of whether it was created
by IL or not.

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Maintenance Actions Menu

Configuration
Opens a submenu containing the Filter and Warning Thresholds menu options:

Filter
See Filter the Maintenance List.
Opens the Maintenance Activity Filter window, where you can configure the types of activities to display in
the Maintenance Activity Table. It contains the following fields:

NOTE: You can select multiple options. For example, you can filter on Activity Type = Semi-
Automatic and Frequency Status = OK and Frequency = Every 6 months.
Filter Options
l Enable filter by activity – Select one of the following:
o Manual
o Semiautomatic
o Automatic
l Enable filter by frequency status – Select one of the following frequency statuses:
o OK
o Due
o Overdue
l Enable filter by frequency – Select one of the following frequencies:
o Annually
o Every 6 months
o Every 3 months
o Monthly
o Weekly
o Daily

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o Number of tests
o Number of piercings
o As needed
l All activities – Displays all maintenance activities in the Maintenance Activity Table.

W arning Thresholds
Opens the Maintenance Warning Threshold Configuration window where you can define the warning
threshold for each frequency (For example: Number of piercings for activity, Number of tests for activity,
Daily activities, Weekly activities, etc.). See Warning Thresholds.

Activity
Opens a submenu containing the Add, Delete and Perform menu options:

A dd
Adds a manual maintenance activity. See Add New Maintenance Activity.

D elete
Deletes the selected manual maintenance activity.

Perform
Performs the selected maintenance activity. See Performing Maintenance Activities.

Print Preview
Opens a submenu containing the Print Preview Maintenance Activities Report and Print Preview
Maintenance Log Report menu options:

Print Preview Maintenance A ctivities R eport

Previews the Maintenance List Report that contains the all the maintenance procedures available on the
ACL TOP instrument and their configurations.

Print Preview Maintenance Log R eport

Opens the Print Maintenance Log Report Filter dialog box where you can filter the information to display
on the report. Click OK to preview the Maintenance Log Report. Select the All log entries option to print a
complete log report of all maintenance activities that have been performed on the ACL TOP instrument.

Print
Opens a submenu containing the Print Maintenance Activities Report and Print Maintenance Log Report
menu options:

Print Maintenance A ctivities R eport

Prints the Maintenance List Report that contains the all the maintenance procedures available on the ACL
TOP instrument and their configurations.

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Print Maintenance Log R eport

Opens the Print Maintenance Log Report Filter dialog box where you can filter the information to display
on the report. Click OK to print the Maintenance Log Report. Select the All log entries option to print a
complete log report of all maintenance activities that have been performed on the ACL TOP instrument.

Export
Opens a submenu containing the Export Maintenance Activities Report and Export Maintenance Log
Report menu options:

Export Maintenance A ctivities R eport

Exports the Maintenance List Report that contains the all the maintenance procedures available on the ACL
TOP instrument and their configurations. In the Export dialog box, select the Format and Destination in the
respective fields, then click OK.

Export Maintenance Log R eport

Opens the Print Maintenance Log Report Filter dialog box where you can filter the information to display
on the report. Click OK to export the Maintenance Log Report. Select the All log entries option to export a
complete log report of all maintenance activities that have been performed on the ACL TOP instrument. In
the Export dialog box, select the Format and Destination in the respective fields, then click OK.
See Exporting Data.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

Review
Opens a submenu containing the Previous screen and Activity Definition menu options:

Previous screen
Returns you to the previous screen.

A ctivity D efinition
Opens the Maintenance Activity Configuration window where you can review the selected maintenance
definition.

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Operations Toolbar

Select the following icons to perform the associated tasks:

Add New Maintenance Activity

Activity Definition

Delete Item

Perform Activity

Warning Thresholds

Filter Maintenance List

Print

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Maintenance Activity Table

Description
This column lists the activities that can be performed in Maintenance. These activities include both IL-
defined and user-defined activities.

Type
This displays whether the activity is a Manual, Semi-Automatic, or an Automatic Maintenance activity.
l Manual – Performed by the operator.
l Semi-Automatic– Performed by the instrument with some operator instructions.
l Automatic – Performed by the instrument without any operator instructions.

IL Predefined Activity
A check mark indicates the maintenance activity is an Instrumentation Laboratory predefined activity.

Frequency
The frequency at which the maintenance activity is configured to run. Options include the following:
l Annually
l Every 6 Months
l Every 3 Months
l Monthly
l Weekly
l Daily
l Number of Tests

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l As Needed
l Number of Piercings

# Tests or Piercings
A value indicates that the maintenance activity is performed after the specified number of tests have run, or
the specified number of piercings has occurred.

Frequency Status
Status and frequency of a maintenance activity. The following values can display:
l <blank> – No warning threshold is set; or frequency is as needed.
l OK – Activity has been performed, and is not due.
l Due – The activity is due to be performed. The warning threshold has been met.
l Overdue – The warning threshold for the activity has passed.

NOTE: Some maintenance activities can be performed individually or as a group activity. For
example, if you individually perform the Rinse/Clean Priming Cycle for the Reagent 1 Probe, the Reagent 2
Probe and the Sample Probe, each activity's frequency status updates, but the frequency status for the group
activity Rinse/Clean Priming Cycle for All Probes does not update. However, if the group activity is
performed, the status of the group activity and all the included individual activities are updated.

Last Execution D&T

This column displays the date and time of the last execution of the activity.

Next Execution D&T

This column displays the date and time the next execution of activity is due to be performed, providing a
time interval has been defined for that activity.

Cover Open
A check mark indicates the maintenance activity requires the cover(s) to be open before performing the
activity.

See Also
l Maintenance Definitions
l Performing Maintenance Activities
l Viewing and Configuring Maintenance Activities
l Deleting a Maintenance Activity
l Adding a New Maintenance Activity
l Warning Thresholds

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Viewing and Configuring a Maintenance Activity

Viewing and Editing a Maintenance Activity

To view and edit a maintenance activity:
1. Select System > Maintenance in the menu bar.

2. To filter the Maintenance List, select the Filter icon in the toolbar, configure the filter options,
and select Apply Filter.
3. Place focus1 on the maintenance activity to view.

4. Select the Activity Definition icon in the toolbar to open the Maintenance Activity
Configuration dialog box. This fields vary depending on the activity selected.
5. After viewing, select Cancel to close the dialog box without saving.
6. To edit the maintenance activity, edit the configuration parameters and select OK.

Adding a Manual Maintenance Activity

To add a new manual maintenance activity:
1. Select System > Maintenance in the menu bar to open the Maintenance List.

2. Select the Add icon in the toolbar.

3. In the Maintenance Activity Configuration dialog box, enter a description of the maintenance
activity. The Description field accepts up to 70 alphanumeric characters.
4. Select a frequency in the Frequency drop down list. If you select Number of tests as the frequency, a
field is enabled where you specify the number of tests for the frequency interval.
5. <Optional> Select the Enable warning threshold and/or Cover opening required option, as
necessary.
6. Select OK. The new manual maintenance activity appears in the Maintenance List.

1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

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Configuring a Warning Threshold

To configure a warning threshold for a maintenance activity:
1. Select System > Maintenance in the menu bar.

2. To filter the Maintenance List, select the Filter icon in the toolbar, configure the filter options,
and select Apply Filter.
3. In the Maintenance Activity List, select1 the maintenance activity for which to set a warning
threshold.

4. Select the Warning Threshold icon in the toolbar, or select Actions > Configuration >
Warning Thresholds in the menu bar.
5. In the Maintenance Warning Threshold Configuration dialog box, configure the required warning
thresholds.
6. Select OK.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Maintenance Activity Configuration dialog box

Example 1 – Rinse/Clean Priming Cycle
The following Maintenance Activity Configuration dialog box opens for Rinse/Clean Priming Cycle for All
Probes, a semi-automatic activity.

IL Locked
For authorized service personnel only.
Ensures critical maintenance activities are not modified.
When this option is enabled you can only select and deselect the Enable warning threshold option.
When this option is disabled you can configure the rinse, clean and syringe strokes activities.

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Example 2 – Enhanced Clean for All Probes

The following Maintenance Activity Configuration dialog box opens for the Enhanced Clean for All Probes
activity.

Frequency
Drop down list where you select one of the following time intervals to run the activity:
l Annually
l Every 6 Months
l Every 3 Months
l Monthly
l Weekly
l Daily

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l Number of Tests
l As Needed – If selected, you cannot configure a warning threshold.

IL Locked
For authorized service personnel only.
Ensures critical maintenance activities are not modified.
When this option is enabled you can only select and deselect the Enable warning threshold option.
When this option is disabled, you can configure the following fields:
l Clean Material
l Airgap
l Material Volume
l Transport Airgap
l Hold Time
l Agitation
l Aspiration Number
l Rinse Time After Clean
l Clean Cycle Number for:
l sample probe
l reagent probe
l LAS probe
l Air Gap
l Material Volume
l Transport Air Gap

See Also
l Maintenance Definitions
l Maintenance List
l Deleting a Maintenance Activity
l Warning Thresholds
l Performing Maintenance Activities

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Adding a New Maintenance Activity

You can add only a manual maintenance activity.
You cannot add automatic or semi-automatic maintenance activities.

NOTE: When creating a new maintenance activity, the data in the Last Executed D&T column will
default to the date and time the new activity was created. The frequency status be OK.

Adding a Manual Maintenance Activity

To add a new manual maintenance activity:
1. Select System > Maintenance in the menu bar to open the Maintenance List.

2. Select the Add icon in the toolbar.

3. In the Maintenance Activity Configuration dialog box, enter a description of the maintenance
activity. The Description field accepts up to 70 alphanumeric characters.
4. Select a frequency in the Frequency drop down list. If you select Number of tests as the frequency, a
field is enabled where you specify the number of tests for the frequency interval.
5. <Optional> Select the Enable warning threshold and/or Cover opening required option, as
necessary.
6. Select OK. The new manual maintenance activity appears in the Maintenance List.

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Maintenance Activity Configuration dialog box

Enable warning threshold

Option to generate a warning before the activity is due. See Warning Thresholds. This option is not available
for the As needed frequency.

C over opening required

When this option is selected, the instrument cover must be opened before performing the activity.

See Also
l Viewing and Configuring a Maintenance Activity
l Warning Thresholds
l Performing Maintenance Activities
l Maintenance List

Deleting a Maintenance Activity

You can delete only manual maintenance activities. You cannot delete semi-automatic or automatic
maintenance activities.
To delete a maintenance activity:
1. Select System > Maintenance to open the Maintenance screen.

2. To filter the Maintenance List, select the Filter icon in the toolbar, configure the filter options,
and select Apply Filter.
3. Select1 the maintenance activity to delete.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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4. Select the Delete icon in the toolbar, or select Actions > Activity > Delete in the menu bar.
5. Confirm the deletion when prompted.

See Also
l Deleting an Item
l Maintenance Definitions
l Maintenance List
l Viewing and Configuring a Maintenance Activity
l Warning Thresholds
l Performing Maintenance Activities

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Maintenance Definitions

NOTE: Maintenance activities specific to any given TOP Family model are displayed on that TOP
model's Maintenance Activities screen. For example, a maintenance activity such as Enhanced Clean for LAS
Probe is only displayed on the Maintenance Activities screen on an LAS instrument.
The following are maintenance activities for all the ACL TOP instruments covered in this manual.

See Also
l Performing Maintenance Activities

Automatic Fluidic Line Priming Cycle

See Automatic Fluidic Line Priming Cycle.

Description Automatic Fluidic Line Priming cycle

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Duration of rinse pumping 2

Duration of clean pumping 2

Number of syringe strokes 2

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Automatic Routine Clean for All Probes

See Automatic Routine Clean for All Probes.

Description Automatic Routine Clean for All Probes

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Air gap 15

Material volume 130

Hold time 0

Agitation Disabled

Aspiration number 1

Rinse time after clean 1

Clean cycle number 1

LAS arm:
Air gap 50
Material volume 750

Clean Cuvette Waste Drawer

See Clean Cuvette Waste Drawer.

Description Clean Cuvette Waste Drawer

Frequency Weekly

Enable warning threshold Enabled

Cover opening required Disabled

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Clean Deep Wash and Clean Cup Area

See Clean Deep Wash and Clean Cup Area.

Description Clean Deep Wash and Clean Cup Area

Frequency Weekly

Enable warning threshold N/A – TOP 700 (includes TOP Base)

N/A – TOP 700 LAS
Disabled – TOP 700 CTS (includes TOP CTS)
Disabled – TOP 500 CTS
Disabled – TOP 300 CTS

Cover opening required Enabled *

Clean Rack Areas

See Clean Rack Areas.

Description Clean Rack Area

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

CTS Foot Cleaning

See CTS Foot Cleaning.

Description CTS Foot Cleaning

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

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Cuvette Evacuation Cycle

See Cuvette Evacuation Cycle.

Description Cuvette Evacuation Cycle

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Empty Cuvette Waste – Daily (Manual Activity)

See Empty Cuvette Waste.

Description Empty Cuvette Waste

Frequency Daily

Enable warning threshold Disabled

Cover opening required Disabled

Empty Waste Fluid – Weekly (Manual Activity)

See Empty Waste Fluid.

Description Empty Waste Fluid

Frequency Weekly

Enable warning threshold Disabled

Cover opening required Disabled

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Enhanced Clean for All Probes

See Enhanced Clean for All Probes.

Description Enhanced Clean for All Probes

Frequency Daily

Enable warning threshold Enabled

Cover opening required Disabled

Clean material Clean B

Air gap 15

Material volume 150

Transport air gap 10

Hold time 3

Agitation Enabled

Aspiration number 2

Rinse time after clean 5

Clean cycle number 5

LAS arm:
Air gap 50
Material volume 600
Transport air gap 30

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Enhanced Clean for LAS Probe

See Enhanced Clean for LAS Probe.

Description Enhance Clean for LAS Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Clean material Clean B

Air gap 50

Material volume 750

Transport air gap 30

Hold time 3

Agitation Enabled

Aspiration number 2

Rinse time after clean 5

Clean cycle number 5

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Enhanced Clean for Reagent 1 and Reagent 2 Probes

See Enhanced Clean for Reagent 1 and Reagent 2 Probes.

Description Enhanced Clean for Reagent 1 and Reagent 2 Probes

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Clean material Clean B

Air gap 15

Material volume 150

Transport air gap 10

Hold time 3

Agitation Enabled

Aspiration number 2

Rinse time after clean 5

Clean cycle number 5

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Enhanced Clean for Reagent 1 Probe

See Enhanced Clean for Reagent 1 Probe.

Description Enhanced Clean for Reagent 1 Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Clean material Clean B

Air gap 15

Material volume 150

Transport air gap 10

Hold time 3

Agitation Enabled

Aspiration number 2

Rinse time after clean 5

Clean cycle number 5

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Enhanced Clean for Reagent 2 Probe

See Enhanced Clean for Reagent 2 Probe.

Description Enhanced Clean for Reagent 2 Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Clean material Clean B

Air gap 15

Material volume 150

Transport air gap 10

Hold time 3

Agitation Enabled

Aspiration number 2

Rinse time after clean 5

Clean cycle number 5

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Enhanced Clean for Reagent Probe

See Enhanced Clean for Reagent Probe.

Description Enhanced Clean for Reagent Probe

Frequency Daily

Enable warning threshold Enabled

Cover opening required Disabled

Clean material Clean B

Air gap 15

Material volume 150

Transport air gap 10

Hold time 3

Agitation Enabled

Aspiration number 2

Rinse time after clean 5

Clean cycle number 5

LAS arm:
Air gap 50
Material volume 600
Transport air gap 30

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Enhanced Clean for Sample Probe

See Enhanced Clean for Sample Probe.

Description Enhanced Clean for Sample Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Clean material Clean B

Air gap 15

Material volume 150

Transport air gap 10

Hold time 3

Agitation Enabled

Aspiration number 2

Rinse time after clean 5

Clean cycle number 5

Foot and Probe Inspection

See Foot and Probe Inspection.

Description Foot and Probe Inspection

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

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Replace CTS Filter and clean Clean Cup Area

See Replace CTS Filter and clean Clean Cup Area.

Description Replace CTS Filter and clean Clean Cup Area

Frequency N/A – TOP 700 (includes TOP Base)

N/A – TOP 700 LAS
5000 Piercings – TOP 300 CTS
5000 Piercings – TOP 500 CTS
5000 Piercings – TOP 700 CTS (includes TOP CTS)

Enable warning threshold Disabled

Cover opening required Enabled *

Replace CTS Piercer

See Replace CTS Piercer.

Description Replace CTS Piercer

Frequency N/A – TOP 700 (includes TOP Base)

N/A – TOP 700 LAS
As Needed– TOP 300 CTS
As Needed – TOP 500 CTS
As Needed– TOP 700 CTS (includes TOP CTS)

Enable warning threshold Disabled

Cover opening required Enabled *

Replace LAS Syringe

See Replace LAS Syringe.

Description Replace LAS Syringe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

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Replace LAS Syringe Tip

See Replace LAS Syringe Tip.

Description Replace LAS Syringe Tip

Frequency Every 6 Months

Enable warning threshold Enabled

Cover opening required Enabled *

Replace Reagent 1 and Reagent 2 Syringe Tips

See Replace Reagent 1 and Reagent 2 Syringe Tips.

Description Replace Reagent 1 and Reagent 2 Syringe Tips

Frequency Every 6 Months

Enable warning threshold Enabled

Cover opening required Enabled *

Replace Reagent 1 Syringe

See Replace Reagent 1 Syringe.

Description Replace Reagent 1 Syringe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

Replace Reagent 1 Syringe Tip

See Replace Reagent 1 Syringe Tip.

Description Replace Reagent 1 Syringe Tip

Frequency Every 6 Months

Enable warning threshold Enabled

Cover opening required Enabled *

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Replace Reagent 2 Syringe

See Replace Reagent 2 Syringe.

Description Replace Reagent 2 Syringe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

Replace Reagent 2 Syringe Tip

See Replace Reagent 2 Syringe Tip.

Description Replace Reagent 2 Syringe Tip

Frequency Every 6 Months

Enable warning threshold Enabled

Cover opening required Enabled *

Replace Reagent Syringe

See Replace Reagent Syringe.

Description Replace Reagent Syringe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

Replace Reagent Syringe Tip

See Replace Reagent Syringe Tip.

Description Replace Reagent Syringe Tip

Frequency Every 6 Months

Enable warning threshold Enabled

Cover opening required Enabled *

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Replace Sample Syringe

See Replace Sample Syringe.

Description Replace Sample Syringe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

Replace Sample Syringe Tip

See Replace Sample Syringe Tip.

Description Replace Sample Syringe Tip

Frequency Every 6 months

Enable warning threshold Enabled

Cover opening required Enabled *

Rinse/Clean Priming Cycle for All Probes

See Rinse/Clean Priming Cycle for All Probes.

Description Rinse/Clean Priming Cycle for All Probes

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Duration of rinse pumping 5

Duration of clean pumping 5

Number of syringe strokes 5

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Rinse/Clean Priming Cycle for LAS Probe

See Rinse/Clean Priming Cycle for LAS Probe.

Description Rinse/Clean Priming Cycle for LAS Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Duration of rinse pumping 5

Duration of clean pumping 5

Number of syringe strokes 5

Rinse/Clean Priming Cycle for Reagent 1 Probe

See Rinse/Clean Priming Cycle for Reagent 1 Probe.

Description Rinse/Clean Priming Cycle for Reagent 1 Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Duration of rinse pumping 5

Duration of clean pumping 5

Number of syringe strokes 5

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Rinse/Clean Priming Cycle for Reagent 2 Probe

See Rinse/Clean Priming Cycle for Reagent 2 Probe.

Description Rinse/Clean Priming Cycle for Reagent 2 Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Duration of rinse pumping 5

Duration of clean pumping 5

Number of syringe strokes 5

Rinse/Clean Priming Cycle for Reagent Probe

See Rinse/Clean Priming Cycle for Reagent Probe.

Description Rinse/Clean Priming Cycle for Reagent

Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Duration of rinse pumping 5

Duration of clean pumping 5

Number of syringe strokes 5

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Rinse/Clean Priming Cycle for Sample Probe

See Rinse/Clean Priming Cycle for Sample Probe.

Description Rinse/Clean Priming Cycle for Sample Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Duration of rinse pumping 5

Duration of clean pumping 5

Number of syringe strokes 5

Routine Clean for All Probes

See Routine Clean for All Probes.

Description Routine Clean for All Probes

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Disabled

Air gap 15

Material volume 130

Hold time 0

Agitation Disabled

Aspiration number 1

Rinse time after clean 1

Clean cycle number 1

LAS arm:
Air gap 50
Material volume 750

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Wipe Down All Probes

See Wipe Down All Probes.

Description Wipe Down All Probes

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

Wipe Down LAS Probe

See Wipe Down LAS Probe.

Description Wipe Down LAS Probe

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

Wipe Down Reagent Probes

See Wipe Down Reagent Probes.

Description Wipe Down Reagent Probes

Frequency As Needed

Enable warning threshold Disabled

Cover opening required Enabled *

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Wipe Down Sample Probe

See Wipe Down Sample Probe.

Description Wipe Down Sample Probe

Frequency Weekly

Enable warning threshold Enabled

Cover opening required Enabled *

* When you open the cover to perform a maintenance activity, tracking information for the on-board
materials is maintained for one hour, as long as you remove the racks before you open the cover. The
maintenance activity must finish and the racks re-inserted into the instrument within one hour to maintain the
tracking of on-board materials.

See Also
l Performing Maintenance Activities
l Maintenance List
l Viewing and Configuring a Maintenance Activity
l Warning Thresholds
l Deleting a Maintenance Activity

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Performing Maintenance Activities

NOTE:

l Always wear personal protective equipment (PPE) when performing maintenance cleaning activities.
l Any maintenance activity that requires the opening of the covers automatically invokes a system
recovery when the activity is finished and the covers are closed.
l Unlocking the instrument cover may take a few seconds.
l When you open the cover to perform a maintenance activity, tracking information for the on-board
materials is maintained for one hour, as long as you remove the racks before you open the cover. The
maintenance activity must finish and the racks re-inserted into the instrument within one hour to
maintain the tracking of on-board materials..
l You cannot leave the maintenance functional area or log out while a maintenance activity is in
progress.
l Some maintenance activities can be performed individually or as a group activity. For example, if you
individually perform the Rinse/Clean Priming Cycle for the Reagent 1 Probe, the Reagent 2 Probe
and the Sample Probe, each activity's frequency status updates, but the frequency status for the group
activity Rinse/Clean Priming Cycle for All Probes does not update. However, if the group activity is
performed, the status of the group activity and all the included individual activities are updated.
l When moving the probe arm manually, lift it to its highest position to prevent damage during the
move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from the
front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.

See Also
l Maintenance Definitions
l Adding a New Maintenance Activity

Maintenance Activities (listed alphabetically)

Automatic Fluidic Line Priming Cycle

This is performed automatically by the instrument. You cannot perform this manually.

NOTE: A Rinse Flow Verification Test is automatically performed by the instrument at the end of
Fluidic Line Priming. However, it will not start if the cuvette loader is empty, or if there is a rinse bottle
low warning or empty error. If a probe fails this test (each probe can retry 1 additional time), a Rinse Flow
Test Failure message displays.

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Automatic Routine Clean for all Probes

This is performed automatically by the instrument. You cannot perform this manually.

NOTE: A Rinse Flow Verification Test is automatically performed by the instrument at the end of
Fluidic Line Priming. However, it will not start if the cuvette loader is empty, or if there is a rinse bottle
low warning or empty error. If a probe fails this test (each probe can retry 1 additional time), a Rinse Flow
Test Failure message displays.

Clean Cuvette Waste Drawer – Weekly (Manual Activity)

1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Perform the maintenance work first, and then press OK.
5. Remove the cuvette waste drawer.
6. Remove the liner from the cuvette waste drawer, clean it with 10% bleach or other laboratory
approved antimicrobial cleanser and replace it in the drawer; or replace the used liner with a new one.
7. Replace the cuvette drawer.
8. Select OK.
9. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

CAUTION Biohazard: Cuvette waste is biohazardous. Use precautions when emptying the
cuvette waste drawer. Refer to local and state regulations for disposal of potentially hazardous materials.

NOTE: If you periodically decontaminate the waste container using a bleach solution, rinse it
sufficiently with tap water afterward to remove excess bleach residue. For all models except the ACL TOP
300, the capacitance liquid level sensor may occasionally detect the residual bleach on the inner wall of the
container and cause a false Waste Full trip on the sensor. The false trip disappears within a few minutes.
Rinsing the container with water removes the false trip.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Clean Deep Wash and Clean Cup Area – Weekly (Manual Activity)

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Perform the maintenance work first, and then press OK.
5. Open the appropriate cover as indicated by the message prompt.
6. Clean the deep wash and clean cup with a lint-free cotton swab, then rinse both areas with deionized
water to remove any debris. Leaving the filter in prevents loose debris from falling into unprotected
areas. Use the filter to collect debris around the clean area. Use a maximum of 10 mL of deionized
water; more than that may cause the accumulator to overflow.
7. Wipe excess deionized water that may have splashed onto the covers or the clean cup/deep wash area
with a lint-free cotton swab. Unlocking the instrument cover may take a few seconds.
8. Close the covers and select the OK button on the window.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Clean Rack Areas – As Needed (Manual Activity)

NOTE: When you open the cover to perform a maintenance activity, tracking information for the on-
board materials is maintained for one hour, as long as you remove the racks before you open the cover. The
maintenance activity must finish and the racks re-inserted into the instrument within one hour to maintain the
tracking of on-board materials.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Perform the maintenance work first, and then press OK.
5. Remove the racks from the sample and reagent areas.
6. Open the covers. Unlocking the instrument cover may take a few seconds.
7. Remove the clear plastic cover plate in the reagent area.
8. Clean the rack areas using a 10% bleach solution or Cavicide®. Then rinse with tap water to remove
excess bleach residue on the inner walls of the container.
9. Replace the cover plate.
10. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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CTS Foot Cleaning – As Needed (Manual Activity) – CTS Models Only

NOTE: When selected, the CTS arm needs to move over the clean cup. It may be there already.

1. Select System > Maintenance in the menu bar.

2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Open the sample area cover, perform the maintenance work, close the
covers once again and press OK. When you see this message, open the cover. Unlocking the
instrument cover may take a few seconds.

WARNING Piercing Hazard: The piercer probe assembly is very sharp. When lifting the
foot, DO NOT place fingers in the area marked with a RED X shown in the following picture.

5. Clean the CTS foot with a lint-free swab soaked in deionized water.
6. Clean the clean cup area with a maximum of 10 mL of deionized water. Do not apply a stream of
deionized water to the foot and probe assembly, as splashing or spilling may cause water to leak into
the instrument. Be careful not to cause the clean cup (accumulator) to overflow.
7. Close the cover and click OK.
8. <Optional> Enter a comment in the field provided and click OK.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Cuvette Evacuation Cycle – As Needed (Semi-automatic Activity)

1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. The system moves all cuvettes currently on the system, except those in the loader transport area, to the
cuvette waste area where they are dumped into the cuvette waste drawer.

Empty Cuvette Waste – Daily (Manual Activity) – 300 CTS Models Only
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select2 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Perform the maintenance work first, and then press OK.
5. Remove the cuvette waste container and discard the contents into biohazard waste.
6. Replace the cuvette waste container.

NOTE:

l The cuvette waste container may be cleaned periodically with 10% bleach or other
laboratory approved antimicrobial cleanser, or replaced with a new container.
l After decontamination with bleach you should always rinse with tap water to remove
excess bleach residue on the inner walls of the container.
l Used containers should be discarded in biohazard waste.

7. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

CAUTION Biohazard: Cuvette waste is biohazardous. Use precautions when emptying the
cuvette waste drawer. Refer to local and state regulations for disposal of potentially hazardous materials.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Empty Waste Fluid– Weekly (Manual Activity) – 300 CTS Models Only
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Perform the maintenance work first, and then press OK.
5. Disconnect the waste tank and dispose of its contents in a manner consistent with local regulations.
6. Reconnect the waste tank.

NOTE: You can disconnect the liquid waste line while the system is running. However, you
must replace the liquid waste line within 5 minutes, or the system performs an emergency stop. The
TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table or bench that
holds the instrument. It must maintain a negative slope across the entire length of the tubing to
minimize the backup of waste fluids. There must be no crimping in the tubing.
7. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

CAUTION Biohazard: System fluid waste is biohazardous. Use precautions when

changing or emptying the fluid waste container. Always follow local regulations when disposing of liquid
waste.

NOTE: You may periodically decontaminate the waste tank using a 10% bleach solution or other
laboratory approved antimicrobial cleanser. After decontamination with bleach you should always rinse with
tap water to remove excess bleach residue on the inner walls of the container.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Enhanced Clean for All Probes – Daily for all probes together (Semi-
automatic Activity)

NOTE:

l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, Thrombin Time, or Heparin assays) per day, it is strongly recommended that the Enhanced
Clean be performed on all probes once per shift. For users running fewer than 50 thrombin-based or
Factor Xa-based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove the Clean B solution from the instrument after the maintenance activity
is complete.
1. Place a full 10 mL bottle of Clean B on the appropriate reagent rack as indicated in the following
table:

Model No. of Track Positions Covers to Open

Clean B Bottles
TOP 300 CTS 1 D1 None
TOP 500 CTS 2 D1 None
R3
TOP 700 (includes TOP Base) 3 D1, D2 None
D3, R1, R2
R5, R6
TOP 700 CTS (includes TOP CTS) 3 D1, D2 None
D3, R1, R2
R5, R6
TOP 700 LAS 4 D1, D2 LAS
D3, R1, R2
R5, R6
LAS Aspiration Point

2. Select System > Maintenance in the menu bar.

3. In the Maintenance screen, select1 the activity to run.

4. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
5. <TOP 700 LAS only> Place Clean B reagent in a 20 mL vial.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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NOTE: The LAS cover is manually operated, but if the LAS cover is opened during normal
activities, an emergency stop is performed by the instrument. In the case of this enhanced clean, the
cover can be opened without invoking an emergency stop.
6. The enhanced clean for all the probes is performed by the instrument.
7. At the completion of the enhanced clean, a message prompts you to remove the Clean B vial from the
LAS cover aspiration point. Select OK. The Maintenance Activity Execution box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.
8. Remove all the remaining bottles of Clean B when the activity is finished.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

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Enhanced Clean for LAS Probe – As Needed (Semi-automatic Activity)

– LAS Models Only

NOTE:

l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, Thrombin Time, or Heparin assays) per day, it is strongly recommended that the Enhanced
Clean be performed on all probes once per shift. For users running fewer than 50 thrombin-based or
Factor Xa-based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove the Clean B solution from the instrument after the maintenance activity
is complete.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Place a 20 mL vial containing Clean B in the LAS cover aspiration point
and close the cover. Unlocking the instrument cover may take a few seconds.
5. Open the LAS arm cover and place the Clean B.
6. Close the cover. Select OK.

NOTE: The LAS cover is manually operated, but if the LAS cover is opened during normal
activities, an emergency stop is performed by the instrument. In the case of this enhanced clean, the
cover can be opened without invoking an emergency stop.

7. At the completion of the enhanced clean, a message prompts you to remove the Clean B vial from the
LAS cover aspiration point. Select OK. The Maintenance Activity Execution box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Enhanced Clean for Reagent 1 and Reagent 2 Probes – As Needed

(Semi-automatic Activity) – TOP 700 Models Only

NOTE: If you select both Enhanced Clean for Sample Probe and Enhanced Clean for Reagent 1 and
Reagent 2 Probes individually, you cannot run them both at the same time. You must initiate one activity
and wait until it is completed before initiating the second.

NOTE:

l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, Thrombin Time, or Heparin assays) per day, it is strongly recommended that the Enhanced
Clean be performed on all probes once per shift. For users running fewer than 50 thrombin-based or
Factor Xa-based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove the Clean B solution from the instrument after the maintenance activity
is complete.
1. Place full 10 mL bottles of Clean B on reagent racks, and place the racks into track D3, R1 or R2, and
R5 or R6. Identify the material as Clean B.
2. Select System > Maintenance in the menu bar.
3. In the Maintenance screen, select1 the activity to run.

4. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
5. The enhanced clean for the reagent probes is performed by the instrument.
6. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.
7. Remove the bottle of Clean B when the activity is finished.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Enhanced Clean for Reagent 1 Probe – As Needed (Semi-automatic

Activity)

NOTE:

l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, Thrombin Time, or Heparin assays) per day, it is strongly recommended that the Enhanced
Clean be performed on all probes once per shift. For users running fewer than 50 thrombin-based or
Factor Xa-based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove the Clean B solution from the instrument after the maintenance activity
is complete.
1. Place a full 10 mL bottle of Clean B on the appropriate reagent rack as indicated in the following
table:

Model Track Positions

TOP 300 CTS D1
TOP 500 CTS R3
TOP 700 (includes TOP Base) D3, R1, R2
TOP 700 CTS (includes TOP CTS) D3, R1, R2
TOP 700 LAS D3, R1, R2

2. Select System > Maintenance in the menu bar.

3. In the Maintenance screen, select1 the activity to run.

4. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
5. The enhanced clean for reagent 1 probe is performed by the instrument.
6. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.
7. Remove the bottle of Clean B when the activity is finished.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Enhanced Clean for Reagent 2 Probe – As Needed (Semi-automatic

Activity) – TOP 700 Models Only

NOTE:

l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, Thrombin Time, or Heparin assays) per day, it is strongly recommended that the Enhanced
Clean be performed on all probes once per shift. For users running fewer than 50 thrombin-based or
Factor Xa-based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove the Clean B solution from the instrument after the maintenance activity
is complete.
1. Place full 10 mL bottles of Clean B on reagent racks, and place the racks into track R5 and/or R6.
Identify the material as Clean B.
2. Select System > Maintenance in the menu bar.
3. In the Maintenance screen, select1 the activity to run.

4. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
5. The enhanced clean for reagent 2 probe is performed by the instrument.
6. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.
7. Remove the bottle of Clean B when the activity is finished.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Enhanced Clean for Reagent Probe – As Needed (Semi-automatic

Activity) – 300/500 CTS Models Only

NOTE:

l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, Thrombin Time, or Heparin assays) per day, it is strongly recommended that the Enhanced
Clean be performed on all probes once per shift. For users running fewer than 50 thrombin-based or
Factor Xa-based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove the Clean B solution from the instrument after the maintenance activity
is complete.
1. Place a full 10 mL bottle of Clean B on the appropriate reagent rack as indicated in the following
table:

Model Track Positions

TOP 300 CTS D1
TOP 500 CTS R3

2. Select System > Maintenance in the menu bar.

3. In the Maintenance screen, select1 the activity to run.

4. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
5. The enhanced clean for reagent 1 probe is performed by the instrument.
6. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.
7. Remove the bottle of Clean B when the activity is finished.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Enhanced Clean for Sample Probe – Daily (Semi-automatic Activity)

NOTE:

l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, Thrombin Time, or Heparin assays) per day, it is strongly recommended that the Enhanced
Clean be performed on all probes once per shift. For users running fewer than 50 thrombin-based or
Factor Xa-based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove the Clean B solution from the instrument after the maintenance activity
is complete.
1. Place a full 10 mL bottle of Clean B on the appropriate reagent rack as indicated in the following
table:

Model Track Positions

TOP 300 CTS D1
TOP 500 CTS D1
TOP 700 (includes TOP Base) D1, D2
TOP 700 CTS (includes TOP CTS) D1, D2
TOP 700 LAS D1, D2

2. Select System > Maintenance in the menu bar.

3. In the Maintenance screen, select1 the activity to run.

4. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
5. The enhanced clean for the sample probe is performed by the instrument.
6. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.
7. Remove the bottle of Clean B when the activity is finished.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Foot and Probe Inspection – As Needed (Manual Activity) – CTS

Models Only

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid
damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible.
Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Open the sample area cover, perform the maintenance work, close the
cover once again and press OK. When you see this message, open the cover. Unlocking the
instrument cover may take a few seconds.
5. Inspect the CTS foot and probe by lifting up the left side of the CTS foot. (The foot is the white
component in the following picture.)

WARNING Piercing Hazard: The piercer probe assembly is very sharp. When lifting the
foot, DO NOT place fingers in the area marked with a RED X shown in the following picture.

NOTE: The frequency counter for Clean CTS Deep Wash Station and Clean Cup is not reset
after performing this activity.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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6. Close the cover and click OK.

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Replace CTS Filter and clean Clean Cup Area – 5000 Piercings (Manual
Activity) – CTS Models Only

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Open the sample and reagent area covers, perform the maintenance work,
close the covers once again and press OK. Unlocking the instrument cover may take a few seconds.
5. Open the sample area cover. (Open main cover for TOP 300 CTS and TOP 500 CTS models.)
6. Clean the deep wash and clean cup with a lint-free cotton swab, then rinse both areas with deionized
water to remove any debris before removing the filter to prevent loose debris from falling into
unprotected areas. Use the filter to collect debris around the clean area. Use a maximum of 10 mL of
deionized water; more than that may cause the accumulator to overflow.

7. Wipe excess deionized water that may have splashed onto the covers or the clean cup/deep wash area
with a lint-free cotton swab.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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8. Inspect the new filter to ensure there are no rips in the filter material.
9. Insert the CTS filter replacement tool provided into the filter in the probe's deep wash location on the
left of the rinse/clean cup. Lightly push down on the top of the tool to allow it to grab the filter.
Remove the filter from the deep wash and replace it with a clean filter, again using the tool to seat the
filter. (If you push hard on the top of the tool you apply greater pressure, making it more difficult to
remove the filter.)

CAUTION Biohazard: The CTS filter is disposable and should be thrown away
after one use. Used CTS filters are biohazardous. Use precautions when disposing of the used filter.

10. Close the sample area cover and select OK to display a comment window.
11. Select OK to close the comment window.

Replace CTS Piercer – Every 120,000 piercings (Manual Activity) – CTS

Models Only
l See Replace CTS Piercer/Probe Procedure.

WARNING Piercing Hazard: Discard the used piercer into a sharps container.

Replace LAS Syringe – As Needed (Semi-automatic Activity)

l See Replacing the Syringe and Syringe Tip.

Replace LAS Syringe Tip – Every 6 months (Semi-automatic Activity)

l See Replacing the Syringe and Syringe Tip.

Replace Reagent 1 and Reagent 2 Syringe Tips – Every 6 months

(Semi-automatic Activity)
l See Replacing the Syringe and Syringe Tip.

Replace Reagent 1 Syringe – As Needed (Semi-automatic Activity)

l See Replacing the Syringe and Syringe Tip.

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Replace Reagent 1 Syringe Tip – Every 6 months (Semi-automatic

Activity)
l See Replacing the Syringe and Syringe Tip.

Replace Reagent 2 Syringe – As Needed (Semi-automatic Activity)

l See Replacing the Syringe and Syringe Tip.

Replace Reagent 2 Syringe Tip – Every 6 months (Semi-automatic

Activity)
l See Replacing the Syringe and Syringe Tip.

Replace Reagent Syringe – As Needed (Semi-automatic Activity)

l See Replacing the Syringe and Syringe Tip.

Replace Reagent Syringe Tip – Every 6 months (Semi-automatic

Activity)
l See Replacing the Syringe and Syringe Tip.

Replace Sample Syringe – As Needed (Semi-automatic Activity)

l See Replacing the Syringe and Syringe Tip.

Replace Sample Syringe Tip – Every 6 months (Semi-automatic

Activity)
l See Replacing the Syringe and Syringe Tip.

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Rinse/Clean Priming Cycle for All Probes – As Needed (Semi-

automatic Activity)
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

Rinse/Clean Priming Cycle for LAS Probe – As Needed (Semi-

automatic Activity)
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select2 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

Rinse/Clean Priming Cycle for Reagent 1 Probe – As Needed (Semi-

automatic Activity)
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select3 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. The rinse/clean priming cycle is performed by the instrument.
5. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
3Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Rinse/Clean Priming Cycle for Reagent 2 Probe – As Needed (Semi-

automatic Activity)
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. The rinse/clean priming cycle is performed by the instrument.
5. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

Rinse/Clean Priming Cycle for Reagent Probe – As Needed (Semi-

automatic Activity)
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select2 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. The rinse/clean priming cycle is performed by the instrument.
5. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Rinse/Clean Priming Cycle for Sample Probe – As Needed (Semi-

automatic Activity)
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. The rinse/clean priming cycle is performed by the instrument.
5. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

Routine Clean for All Probes – As Needed (Semi-automatic Activity)

NOTE: Instrumentation Laboratory recommends performing a routine clean once per shift. This
recommendation is based on 1200 clotting tests (such as PT and APTT) per shift. The frequency of cleaning
may vary depending upon the types of tests being routinely performed. Tests such as Antithrombin, Clauss
Fibrinogen, or Thrombin Time may require additional cleaning frequency. See the Enhanced Clean
procedures, above.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select2 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. The routine clean for all probes is performed by the instrument.
5. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.
2Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Wipe Down All Probes – As Needed (Manual Activity) – Non-CTS

Models Only

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to open the appropriate cover(s). Select OK.
5. Open the covers indicated by the message prompt. Unlocking the instrument cover may take a few
seconds.

NOTE: When you open the cover to perform a maintenance activity, tracking information for
the on-board materials is maintained for one hour, as long as you remove the racks before you open
the cover. The maintenance activity must finish and the racks re-inserted into the instrument within
one hour to maintain the tracking of on-board materials.
6. Using an alcohol pad, wipe clean probe exteriors and tips.
7. Close the covers.
8. Select OK on the screen.
9. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Wipe Down LAS Probe – Weekly (Manual Activity)

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Open the Sample area cover, perform the maintenance work, close the
cover once again and press OK.
5. Open the Sample area cover. Unlocking the instrument cover may take a few seconds.
6. Using an alcohol pad, wipe clean the probe's exterior and tip.
7. Close the cover.
8. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Wipe Down Reagent Probes – As Needed (Manual Activity)

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A Maintenance Activity Execution window opens.
5. Select the OK to unlock the covers.
6. Open the Reagent side or Main cover. Unlocking the instrument cover may take a few seconds.

NOTE: When you open the cover to perform a maintenance activity, tracking information for
the on-board materials is maintained for one hour, as long as you remove the racks before you open
the cover. The maintenance activity must finish and the racks re-inserted into the instrument within
one hour to maintain the tracking of on-board materials.
7. Using an alcohol pad, wipe clean the reagent probe exteriors and tips.
8. Close the cover.
9. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Wipe Down Sample Probe – Weekly (Manual Activity) – Non-CTS

instruments Only

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
1. Select System > Maintenance in the menu bar.
2. In the Maintenance screen, select1 the activity to run.

3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to open the appropriate cover. Select OK.
5. Open the Sample area or Main cover. Unlocking the instrument cover may take a few seconds.

NOTE: When you open the cover to perform a maintenance activity, tracking information for
the on-board materials is maintained for one hour, as long as you remove the racks before you open
the cover. The maintenance activity must finish and the racks re-inserted into the instrument within
one hour to maintain the tracking of on-board materials.
6. Using an alcohol pad, wipe clean the probe's exterior and tip.
7. Close the cover.
8. Select OK on the screen.
9. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

See Also
l Maintenance Definitions
l Maintenance List
l Viewing and Configuring a Maintenance Activity
l Warning Thresholds
l Deleting a Maintenance Activity
l System Decontamination

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Replacing the Syringe and Syringe Tip Chapter 13 - System

Replacing the Syringe and Syringe Tip

Replacing the syringe tip is an Every 6 Months, Semi-automatic activity.

CAUTION: This procedure should be performed only by a properly trained technician.

Hamilton Syringe Procedures

Removing the Hamilton Syringe
Replacing the syringe is an As Needed, Semi-automatic activity.

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
To remove the Hamilton syringe.
1. Select System > Maintenance in the menu bar to open the list of maintenance procedures.
2. Select1 the appropriate Replace <Arm> Syringe procedure in the Maintenance Activities List.

3. Select the Perform icon in the toolbar.

4. Follow instructions in the popup window to remove the sample or reagent racks, and click OK.
5. Open the access cover. The syringe plunger moves down approximately 1 cm from the initialized
position to facilitate removal.
6. Loosen the thumbscrew securing the syringe collar, and remove the syringe collar.
7. Loosen the thumbscrew securing the plunger to the drive stem.
8. Unscrew the old syringe barrel from the valve fitting.
9. Remove the syringe.

H amilton Pump, Syringe and C ollar

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Replacing the Hamilton Syringe Tip

Replacing the syringe tip is an Every 6 Months, Semi-automatic activity.
To replace the Hamilton syringe tip:
1. <Optional> Remove the Hamilton syringe.
2. Make sure the syringe collar is removed. See Removing the Hamilton Syringe
3. Pull the metal plunger from the glass tube.
4. When initially inserting a new plunger into a GASTIGHT syringe barrel, wet (lubricate) the tip with
deionized water.
5. <Optional> Install the syringe tip by inserting the plunger with the pre-installed Teflon tip attached
into the syringe glass tube.

H amilton Pump, Syringe and C ollar

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Installing the Hamilton Syringe

To install the Hamilton syringe:
1. Screw the syringe glass tube onto the syringe pump valve.
2. Manually lower the plunger so the metal knob at the bottom of the syringe plunger seals in the thumb
wheel block.
3. Tighten the thumb wheel until it is finger-tight.
4. Hand-tighten the syringe screw connection.
5. Slide the collar over the glass portion of the syringe.

6. Slide the collar up to the metal hub on the syringe.

7. Rotate the collar to the left until it contacts the front plate of the syringe pump. Then tighten the
collar thumb screw to secure the collar over the metal hub.

NOTE: Do not tighten collar thumb screw onto glass portion of the syringe.

8. Move the probes over the rinse/clean cup area.

9. Visually inspect the syringe and verify it is free from bubbles and leaks.

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Removing the Cavro Syringe

Replacing the syringe is an As Needed, Semi-automatic activity.

CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
To remove the Cavro syringe:
1. Select System > Maintenance in the menu bar to open the list of maintenance procedures.
2. Select1 the appropriate Replace <Arm> Syringe procedure in the Maintenance Activities List.

3. Select the Perform icon in the toolbar.

4. A message prompts you to remove the appropriate racks. Remove the racks from the instrument and
select OK in the message window.
5. Another message prompts you to Remove the syringe and replace it. Close covers when finished and
press OK.
6. Open the access cover. The syringe plunger moves down approximately 1 cm from the initialized
position to facilitate removal.
7. To guard against leaking, carefully move the probe over its rinse station.
8. Completely loosen the thumbscrew from the plunger end.
9. Unscrew upper end of the syringe, push down and remove syringe assembly from pump.

C avro Pump and Syringe

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Replacing the Cavro Syringe Tip

Replacing the syringe tip is an Every 6 Months, Semi-automatic activity.
To replace the Cavro syringe tip:
1. Remove the metal plunger from the syringe glass cylinder.
2. Using pliers, pull the Teflon syringe tip from the metal plunger.

3. With the open side of the Teflon tip facing up, slide the Teflon tip into the ISE slot on the
installation tool.

4. Place the rubber O-ring on the tip of the metal plunger.

5. Insert the end of the plunger with the rubber O-ring installed into the ISE slot of the installation tool.
Push the plunger in so the Teflon tip snaps onto the tip of the metal plunger.
6. Remove the plunger from the ISE slot and wipe it with reagent grade alcohol.
7. Insert the plunger with the Teflon tip attached into the glass syringe cylinder.

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Installing the Cavro Syringe

To install the Cavro syringe:
1. Insert the upper end of the syringe glass cylinder into the pump valve and rotate until it is tight.
2. Pull the plunger down so the end sits in the channel of the plunger drive stem.
3. Hold the plunger and fully tighten the thumbscrew into the syringe.
4. Close the cover.
5. Select OK in the message window that prompted you to Remove the syringe and replace it.
6. The TOP initializes.
7. Verify during re-initialization that the syringe moves up and down correctly.

See Also
l Performing Maintenance Activities
l CTS Piercer/Probe Replacement Procedure Overview

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CTS Piercer/Probe Replacement Procedure Overview

The Closed Tube Sampling (CTS) piercer provides:
l Piercing and sampling of capped sample tubes for all CTS model in CTS mode
l Sampling only of uncapped sample tubes.
The piercer is a part of the sample arm and is not present on the Base TOP model. See Global Definitions
Setup for enabling CTS Mode.
The CTS Piercer has three components:
l Sample Probe and Seal Assembly – Located in the telescoping CTS assembly.
l CTS Piercer Probe – Consists of 1) the piercing probe that pierces the cap of a sample tube; and 2)
the sample probe inside the piercer probe that aspirates and dispenses sample material. The sample
probe is protected by the piercer probe during piercing.
l Telescoping CTS Assembly – All parts except the Sample Probe and Seal Assembly and the CTS
Piercer Probe are non-replaceable.

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid
damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible.
Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.

CTS Piercer/Probe Replacement Procedures

Each of the following procedures also contains a video clip:
l Probe and Seal Assembly Removal Procedure
l Probe and Seal Assembly Installation Procedure
l Piercer Probe Removal Procedure
l Piercer Probe Installation Procedure

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Probe and Seal Assembly Removal Procedure

This is an As Needed, Manual activity.

CAUTION: This procedure should be performed by trained personnel.

WARNING Piercing Hazard: Do not put hand inside instrument while sample arm is in motion.

CAUTION Biohazard: Probes are Biohazardous. Use caution when removing and
installing them.

Removing the Probe and Seal Assembly

To remove the probe and seal assembly:
1. Select the Controllers, Covers and Racks tab from the Diagnostics screen.
2. Select the Unlock Sample Cover button (Cover button for 300 CTS and 500 CTS models).
3. Open the Sample cover on the instrument (cover for 300 CTS and 500 CTS models).
4. Power off the instrument by turning off the main power switch.
5. Placing a blue absorbent pad over the sample area can be of help in collecting small parts or droplets
during the procedure.
6. Manually move the CTS Piercer Arm into the sample area. Ensure the piercer probe and the sample
probe stay above the skins as the arm is moved.

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To
avoid damaging the probe arm during the move, grasp it from the back, as near to the back wall as
possible. Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm
causes inaccurate coordinates adjustment and other errors.

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7. Air Tube:

a. Disconnect the 1/4” air line from the front of the Probe and Seal Assembly.

b. Loosen the Tube Support Bracket screw by turning it counter-clockwise until the
bracket can be removed.

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c. Remove the fluid line from the top of the Probe and Seal Assembly by sliding the
sleeve back over the tubing, then removing the tubing.

8. Gently pull on the connector to remove the Sampling Probe LLD cable from the front of the CTS
Telescoping Assembly.

9. Loosen the thumbscrew on the side of the Telescoping CTS Assembly by turning it counter-
clockwise. The thumbscrew is spring loaded and pops out when loosened all the way. The
Piercer/Probe Hold Down Bracket that is attached to the thumbscrew should also pop outward
enabling the removal of the Probe and Seal assembly.

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10. Push the Z-drive rack down so that it is just above the Sample Plate. Push down on the top of the Z-
drive rack.

11. Carefully pull the Probe and Seal assembly up and out of its mounting. Do not bend the sample probe
as the probe is pulled out of its mounting. (The Probe and Seal Assembly can be loosened by gently
rocking it.)

NOTE: To remove the sample probe without bending it, the Z-drive must first be pushed
down as far as possible. With the Z-drive in this position, the Robotic Arm is cleared when pulling
the sample probe out of its mounting.

See Also
l Probe and Seal Assembly Installation Procedure
l Piercer Probe Removal Procedure
l Piercer Probe Installation Procedure

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Probe and Seal Assembly Installation Procedure Chapter 13 - System

Probe and Seal Assembly Installation Procedure

This is an As Needed, Manual activity.

CAUTION: This procedure should be performed by trained personnel.

WARNING Piercing Hazard: Do not put hand inside instrument while sample arm is in motion.

CAUTION Biohazard: Probes are Biohazardous. Use caution when removing and
installing them.

Installing the Probe and Seal Assembly

To install the probe and seal assembly:
1. Ensure the main power switch for the instrument is turned off.
2. Push the Z-drive rack down so that it is just above the Sample Plate. (Push down on the top of the Z-
drive rack.)

NOTE: The Z-drive Rack must be down to insert the Probe and Seal Assembly without
bending it.
3. Ensure the Probe and Seal Hold Down Bracket is not blocking the hole.
4. Insert the Probe and Seal Assembly into its mounting and gently push down on the Assembly until it
seats and the Probe and Seal Hold Down Bracket can be slid over its lip.

NOTE: Make sure the Telescoping CTS Assembly is held to prevent motion of the Assembly
as the Probe-n-Seal Assembly is seated. Otherwise, damage to the CTS Piercer Probe may occur.

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5. Push the Piercer Probe Hold Down Bracket over the top lip of the Probe-n-Seal Assembly.
6. Tighten the thumbscrew on the side of the Telescoping CTS Assembly by turning it clockwise.
(Make the thumbscrew finger-tight.)
7. Connect the Sampling Probe LLD cable to the front of the Telescoping CTS Assembly.

8. Install the fluid line to the top of the Probe and Seal Assembly by sliding the fluid line over the steel
tube and sliding the sleeve over the end of the tubing.

a. Reinstall the Tube Support Bracket and tighten the screw by turning it clockwise until
the bracket is tight.
b. Connect the 1/4” air line to the front of the Probe and Seal Assembly.

9. It is recommended the system be powered up and the Piercer Loop Test be executed with a count of
50 as found in Piercer Loop Test on the CTS tab screen in Diagnostics.

See Also
l Piercer Probe Removal Procedure l Probe and Seal Assembly Removal Procedure
l Piercer Probe Installation Procedure

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Piercer Probe Removal Procedure

This is an As Needed, Manual activity.

CAUTION: This procedure should be performed by trained personnel.

WARNING Piercing Hazard: Do not put hand inside instrument while sample arm is in motion.

CAUTION Biohazard: Probes are Biohazardous. Use caution when removing and
installing them.

Removing the Piercer Probe

To remove the piercer probe:
1. Select the Controllers, Covers and Racks tab from the Diagnostics screen.
2. Select the Unlock Sample Cover button (Cover button for 300 CTS and 500 CTS models).
3. Open the Sample cover on the instrument (cover for 300 CTS and 500 CTS models).
4. Power off the instrument by turning off the main power switch.
5. Remove the Probe and Seal Assembly as described in Probe and Seal Assembly Removal Procedure.
6. Raise the Telescoping CTS Assembly as high as necessary to access the knurled nut on the bottom of
the Piercer.
7. Loosen the knurled nut by turning it counter-clockwise. Pliers may be needed to do this. Loosen the
nut until it falls into the foot.

8. Push the Z-drive rack down until the Foot is just above the Sample Plate. Push down on the top of
the Z-drive rack.

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9. Push and hold in the CTS Piercer Lock on the right-hand side of the Telescoping CTS Assembly to
release pressure on the piercer probe.
10. While holding the CTS Piercer Lock in, remove the piercer probe by pulling up on the probe top. Do
not use tools to pull out the piercer probe. It may be necessary to twist and move the probe back and
forth to remove it.

CAUTION Biohazard: The piercer probe is sharp and may cause serious
injury if it is improperly handled. Dispose of used piercer probes in a “Sharps” container.

See Also
l Piercer Probe Installation Procedure
l Probe and Seal Assembly Removal Procedure
l Probe and Seal Assembly Installation Procedure

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Piercer Probe Installation Procedure Chapter 13 - System

Piercer Probe Installation Procedure

This is an As Needed, Manual activity.

CAUTION: This procedure should be performed by trained personnel.

WARNING Piercing Hazard: Do not put hand inside instrument while sample arm is in motion.

CAUTION Biohazard: Probes are Biohazardous. Use caution when removing and
installing them.

Installing the Piercer Probe

To install the piercer probe:
1. Ensure the main power switch for the instrument is turned off.
2. Push in the CTS Piercer Lock on the side of the Telescoping CTS Assembly, and hold it all the way
to the back.
3. Remove the vinyl protective tip from the new piercer.

NOTE: Failure to remove the vinyl tip from the piercer may result in the sample probe
jamming.
4. While holding in the CTS Piercer Lock, guide the piercer probe into its mounting.

NOTE: As the piercer probe is inserted into its mounting, the flat side of the piercer
probe threads must face the front of the instrument. This is required for proper seating of the
probe.

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5. Push down on the piercer probe until it locks into the “down” position.
6. Apply a drop of Loctite #222 (Low Strength), available in the installation kit, to the thread on the top
of the piercer probe.

CAUTION: Failure to follow this step may result in a malfunction.

7. Re-fasten the piercer probe knurled nut, ensuring the nut is tight.

8. Install the Probe and Seal Assembly as described in Probe and Seal Assembly Installation Procedure.
9. After the Probe and Seal Assembly is installed, it is recommended the system be powered up and the
Piercer loop test be executed with a count of 50 as found in Piercer Loop Test on the CTS tab screen
in Diagnostics.

See Also
l Piercer Probe Removal Procedure
l Probe and Seal Assembly Removal Procedure

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l Probe and Seal Assembly Installation Procedure

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Warning Thresholds Chapter 13 - System

Warning Thresholds
Configuring a Maintenance Activity Warning Threshold
To configure a warning threshold for a maintenance activity:
1. Select System > Maintenance in the menu bar.

2. To filter the Maintenance List, select the Filter icon in the toolbar, configure the filter options,
and select Apply Filter.
3. In the Maintenance Activity List, select1 the maintenance activity for which to set a warning
threshold.

4. Select the Warning Threshold icon in the toolbar, or select Actions > Configuration >
Warning Thresholds in the menu bar.
5. In the Maintenance Warning Threshold Configuration dialog box, configure the required warning
thresholds.
6. Select OK.

1Click in the Selection column of a table. A red check mark indicates selection. You can typically select
more than one object.

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Warning Thresholds Chapter 13 - System

Maintenance Warning Threshold Configuration dialog box

Configure the warning threshold for each frequency type in the Maintenance Warning Threshold
Configuration dialog box. When the defined interval elapses, a warning appears before the scheduled
activity is to occur. In the example above, a warning appears eight hours before a daily activity is scheduled
to occur.
As Needed activities do not have warning thresholds.

See Also
l Viewing and Configuring a Maintenance Activity
l Maintenance List
l Performing Maintenance Activities
l Deleting a Maintenance Activity
l Maintenance Definitions

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System Decontamination Chapter 13 - System

System Decontamination
System decontamination is an As Needed activity.

NOTE: After decontamination with bleach you should always rinse with tap water to remove excess
bleach residue on the inner walls of the container.
To decontaminate the ACL TOP instrument:
1. Perform the Enhanced Clean for each probe using Clean B. See Parts and Consumables List.
2. Clean the optical window in the LAS, Sample, and Reagent access doors using only a mild cleaning
agent and soft cloth to prevent scratching and damage to the window surface.
3. Manually remove all cuvettes, racks, samples, reagents and any other vials from the instrument. Wipe
down all inside and exposed module surfaces, including the LAS, sample, and reagent modules and
loader. Clean all racks using Cavicide® or 10% bleach solution and rinse with deionized water.

NOTE: Do not use alcohol to clean the racks. The alcohol degrades the bar code labels so
they are unreadable by the bar code reader.
5. Empty and decontaminate the cuvette waste drawer. Replace the drawer liner with a new one or
decontaminate or autoclave the liner and return to the waste drawer.

CAUTION Biohazard: Cuvette waste is biohazardous. Use precautions when

emptying the cuvette waste drawer. Refer to local and state regulations for disposal of potentially
hazardous materials.
6. Decontaminate all external surfaces, including the table and instrument back cover.
7. Decontaminate the rinse and clean bottle stations.
8. Decontaminate the waste container and the outside of the waste line and its connectors.

CAUTION Biohazard:

l System fluid waste is biohazardous. Use precautions when changing or emptying the
fluid waste container. Always follow local regulations when disposing of liquid waste.
l The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table
or bench that holds the instrument. It must maintain a negative slope across the entire
length of the tubing to minimize the backup of waste fluids. There must be no crimping
in the tubing.

9. Close out of the application and shut down the computer. (See Shutting Down the Instrument.) Turn
off power to the monitor, keyboard, and instrument. Decontaminate the computer, monitor, and
keyboard including any power cords, using a cloth moistened with 10% bleach or Cavicide®.

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NOTE: Only IL representatives should shut down, decontaminate and prepare the instrument
for transportation. The Decontamination Form issued by Instrumentation Laboratory accompanies the
system and must be signed by the Service representative.

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Cleaning the Monitor Chapter 13 - System

Cleaning the Monitor

WARNING: To avoid risk of electric shock, do not disassemble the power converter or display unit
cabinet. The unit is not user serviceable. If liquid does get inside the monitor, have a qualified service
technician check it before turning it on again.
This is an As Needed activity.
To clean the touch screen monitor:
1. Unplug the monitor from the power source.
2. Put some window or glass cleaner on a cleaning cloth and wipe the touch screen. Do not apply the
cleaner directly to the touch screen. Do not wipe the screen with a cloth or sponge that could scratch
the surface.
3. To clean the display unit cabinet, use a cloth lightly dampened with a mild detergent. Do not use
alcohol (methyl, ethyl or isopropyl) or any strong dissolvent. Do not use thinner or benzene, abrasive
cleaners or compressed air.

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Cleaning the Reagent Cooling Filter Chapter 13 - System

Cleaning the Reagent Cooling Filter

Cleaning the reagent cooling filter is a Manual activity.
The filter is replaced during routine service every 6 months. However, it may be necessary to clean the filter
before it is replaced, depending on the lab setting.
To clean the reagent cooling filter:
1. Locate the filter under the Reagent Area of the instrument.
2. Remove the filter by sliding it forward.
3. Pass the filter under running water to remove the debris.
4. Allow the filter to dry completely.
5. Install the dry filter on the instrument.

NOTE: It is recommended that an alternate filter be used to replace the newly washed filter until the
washed filter is dry. The alternate filter can then be used for the next replacement.

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Diagnostics Overview Chapter 13 - System

Diagnostics Overview
Diagnostics is intended to be used by the Lab Administrator for Probes/Coordinates Adjustment, and ORU
blanking.

CAUTION:

l Contact an IL Service Representative before using any functionality other than probe alignment or
ORU blanking in Diagnostics. If necessary the service representative will walk you through the
diagnostic procedure step by step.
l Diagnostics is part of ordinary maintenance. The lab administrator is responsible for ensuring that
those who are not trained in diagnostic procedures are prevented from accessing the Diagnostics
screens. See Software Access Screen.

Accessing the Diagnostic Area

To access the Diagnostics area:
1. Make sure the instrument is in the Ready or Error state.
2. Select System > Diagnostics in the menu bar.

Diagnostics Screen
The following tabs appear in the Diagnostics screen. Certain tabs may be disabled depending on the ACL
TOP model.
l Cuvettes
l ORU
l ORU Linearity Test
l Controllers, Covers and Racks
l Fluids
l Probes
l Voltages
l CTS
l Universal Arm
l Fluid Precision Test

See Also
l Probes/Coordinates Adjustment
l ORU blanking

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Cuvettes Chapter 13 - System

Cuvettes
Available only to IL personnel.

Viewing the Cuvettes Screen

To view the Cuvettes screen:
1. Select System > Diagnostics in the menu bar.
2. Select the Cuvettes tab.

Cuvettes Tab

See Also
l Diagnostics Overview

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Optical Reading Unit Chapter 13 - System

Optical Reading Unit

ORU Cleaning Procedure

1. Select System > Diagnostics in the menu bar.
2. Select the Controllers, Covers and Racks tab.
3. In the Cover status section, select Reagent area and select Unlock.
4. Using a clean, dry, lint-free applicator, carefully wipe an ORU cuvette slot from front to rear.
5. Inspect the applicator for dirt or foreign substances and repeat until the slot is clean.
6. Repeat for each ORU.
7. When finished, close the cover.

ORU Blanking Procedure

NOTE: If you perform an action on the ORU screen before the optical reading units are at the proper
operating temperature, the action will not occur. A message displays: Blanking is not available until the
ORUs have reached operating temperature.

NOTE: IL recommends that you perform an enhanced clean before performing the ORU blanking
procedure.
1. Clean the ORU.
2. Perform an enhanced clean on the probes.
3. Prime the instrument.
4. If necessary, perform a probe coordinates adjustment.
5. Select System > Diagnostics in the menu bar.
6. Select the ORU tab.
7. Verify that all ORUs on the instrument are enabled.

l Green is enabled.
l Red is disabled.

8. To enable an ORU place a check mark in the box next to it and select the Save button.
9. Select the Start Air Blanking for All ORUs button.
10. After approximately four minutes, the Activity Results window opens. It contains the following
information:

l Current Maintenance Activity Results

l Previous Values Stored in Database
l Air blanking values for both the 405 and 671 wavelengths. The minimum value for the
current air blanking is 500,000. The maximum value is 1,200,000.

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l % Drift – The % change between the current blanking value and the stored value.

11. If all specifications are met, select the Overwrite button. If specifications are not met, select the
Cancel button and call for Service.
12. Select the Start Factor Diluent Blanking for all ORUs button. The CM asks for a 10 mL bottle of
Factor Diluent to be placed on board. Fill the 10 ml bottle to the neck, but not into the neck. This
procedure takes about 30 minutes.

NOTE: All mechanical assemblies must be initialized or the blanking fails. In addition,
cuvettes, rinse, and Clean A (the regular on-board clean) must be on-board.
13. The Activity Results window opens again. Apply the same specifications. If they all pass, select
Overwrite. Otherwise select Cancel and call Service.
14. Exit Diagnostics.

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ORU Tab

ORU Blanking area

Each ORU may be manually disabled by unchecking the box next to it and selecting the Save button. The
ORU is automatically disabled when one of the following conditions is detected for any of its four channels:
l The current air reading is lower than 500,000.
l The current air reading is higher than 1,200,000.
l The difference between the current air reading and the stored air reading is greater than 6%.
l A detector voltage error is reported by the ORU.

NOTE: Any error that causes the automatic disabling of an ORU must be corrected before the ORU
can be re-enabled.
After the error is corrected, place a check mark in the box next to the ORU and select the Save button.
Perform the ORU cleaning procedure followed by the ORU blanking procedure.

Temperatures area
The current temperature and the lower and upper limits are displayed for each ORU head and incubator. Red
text indicates a temperature reading that is outside of normal range.

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Reference Readings area

The reference channel readings come from one ORU. The reference readings are used with the analytical
channels.
For each wavelength the following values are displayed for the DAC:
l Minimum DAC value (Min. DAC)
l Maximum DAC value (Max. DAC)

Dark Readings Area

The dark reading is the reading of the analytical channel without the emitter. This value depends on the
electronics (dark current) and stray light.
The upper dark limit, valid for all the channels and all the ORUs and displayed as “Limit”, is displayed for
reference.

See Also
l Diagnostics Overview
l Wavelength Definition

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ORU Linearity Test Chapter 13 - System

ORU Linearity Test

Available only to IL personnel.

Viewing the ORU Linearity Test Screen

To view the ORU Linearity Test screen:
1. Select System > Diagnostics in the menu bar.
2. Select the ORU Linearity Test tab.

ORU Linearity Test Tab

See Also
l Diagnostics Overview
l Optical Reading Unit

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Controllers, Covers and Racks Chapter 13 - System

Controllers, Covers and Racks

Viewing the Controllers, Covers and Racks Screen

To view the Controllers, Covers and Racks screen:
1. Select System > Diagnostics in the menu bar.
2. Select the Controllers, Covers and Racks tab.

Controllers, Covers and Racks Tab

Reagent block temperature
This tab displays the reagent block actual temperature, reagent block lower limit, and reagent block upper
limit.

See Also
l Diagnostics Overview

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Fluids Chapter 13 - System

Fluids
Available only to IL personnel.

Viewing the Fluids Screen

To view the Fluids screen:
1. Select System > Diagnostics in the menu bar.
2. Select the Fluids tab.

Fluids Tab

See Also
l Diagnostics Overview

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Probes Coordinates Adjustment Chapter 13 - System

Probes Coordinates Adjustment

Accessing the Probes tab

To open the Probes tab:
1. Select System > Diagnostics in the menu bar.
2. Select the Probes tab.
3. <Optional> Select a button (Initialize All Probes, Home All Probes, etc.) to perform the associated
task.

Preparing for Adjusting Probe Coordinates

Before adjusting probe coordinates perform the following steps:
1. Initialize the bar code reader. Contact service.
2. Disable the arm. Select the respective Disable <Arm> Probe button in the Diagnostics Probe tab.
3. Unlock the Sample Area and Reagent Area covers, and remove all interior covers in the Sample and
Reagent Areas.
4. Clean the following components thoroughly using alcohol swabs with 70% isopropyl alcohol by
volume (the coordinate adjustment fails if you omit this step):

l Probe tips
l Waste station deck, rim and cup (see: Figure 3).
l Screws on sample plate/diluent plate
l Screws on reagent plate
l Screws on the incubators and ORUs (see: Figure 1)
l Screws in the LAS area.

NOTE: Clean all parts of the screws including the top, the edges, the side, and inside
the hole in the screw head, where appropriate. See: Figure 2.

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Figure 1. Screw Locations on the Incubators and ORUs

Figure 2. Types of Screws Used

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Figure 3. Waste well area

Figure 4. Screw locations for LAS probe

CAUTION: This procedure should only be performed by individuals who have been properly
trained.

NOTE:

l Failure to disable the arms can result in the arms crashing into the waste well.
l If there are racks in the modules, or the bar code reader is not in the home position, this operation
cannot be performed. If the operation can be performed, the bar code reader cannot be moved by either
the AM or CM track buttons until the operation is finished.

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Adjusting Probe Coordinates

The adjustment is performed for each probe individually when the arm status for that probe is Ready. This
procedure is performed when the probe needs to be adjusted for the first time, or after mechanical repair.
To adjust probe coordinates:
1. Perform all the steps in the Preparing for Adjusting Probe Coordinates procedure.
2. Bring the arm to READY status.
3. Open the Diagnostics Probes tab.
4. Select the probe to adjust in the Probe drop-down list.
5. Select the Start button in the Coordinate Adjust section on the Probes tab.

Setting the LAS Aspiration Point Manually

To manually set the LAS aspiration point:
1. Open the Diagnostics Probes tab.
2. Select the Disable LAS arm button on the Probes tab.
3. Select the LAS probe to adjust in the Probe drop-down list.
4. Select the Set LAS aspiration point button on the Probes tab.
5. Open the LAS cover.
6. Place a sample tube onto a rack on the LAS track and position the tube directly below the LAS probe.
7. When prompted by the system, manually raise the LAS probe to the liquid level detection start
position. Move the probe tip down to approximately 1 inch below the top of the sample tube and
center it within the tube.
8. Select OK.
9. When prompted by the system, manually lower the LAS probe to the maximum reachable position in
the sample tube. Move the probe down until it touches the bottom of the sample tube, then move it
slightly higher.
10. Select OK.
11. A window displays with the coordinates for the LAS probe. If the values are correct select OK, or
select Cancel.
12. A warning appears stating: The arm is going to move back into the instrument. Select OK to return
the arm to its home position.
13. Close the LAS cover.

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Setting the LAS Aspiration Point Semi-Automatically

This procedure uses a tool located inside the cover of the LAS arm.
To set the LAS aspiration point semi-automatically:
1. Open the Diagnostics Probes tab.
2. Select Disable LAS arm on the Probes tab.
3. Select the LAS probe to adjust in the Probe drop-down list.
4. Select the Measure LAS aspiration point button on the Probes tab.
5. The system prompts you to place the Aspiration Point Alignment Tool at the LAS Aspiration Point to
proceed.
6. Open the LAS cover and locate the tool stored inside.
7. Place the tool onto a rack on the LAS track, and position the tube directly below the LAS probe,
centered in that location.
8. Select OK in the prompt dialog box. The LAS probe moves to the tool at the aspiration point to
check the alignment.
9. When the procedure is complete, the system prompts you to remove the alignment tool from the LAS
track aspiration point.
10. Remove the tool and select OK.
11. Close the LAS cover.

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Probes Tab

NOTE: With the exception of the Initialization command, commands sent to a non-initialized arm
that involve arm movements are ignored in order to avoid errors.

Initialize All Arms button

This button initializes all the probe arms. To prevent collisions and potential leakage, the arms cannot be
initialized individually. Initialization performs the following actions:
l Returns the arms to their home position.
l Moves the arms to the wash/clean station.
l Primes the rinse.
l Primes the clean.
An Arm Status field displays the initialization status in the status bar.
Errors and causes display in the Alarms section of the status bar.

Home All Arms button

This button returns all arms to their home position.

Probes
Select the arm to diagnose in this drop-down list.

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See Also
l Diagnostics Overview
l Replacing the Syringe and Syringe Tip
l CTS Piercer/Probe Replacement Procedure Overview

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Voltages Chapter 13 - System

Voltages
Available only to IL personnel.

Viewing the Voltages Screen

To view the Voltages screen:
1. Select System > Diagnostics in the menu bar.
2. Select the Voltages tab.

Voltages Tab

See Also
l Diagnostics Overview

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Universal Arm Chapter 13 - System

Universal Arm
Available only to IL personnel.

Viewing the Universal Arm Screen

To view the Universal Arm screen:
1. Select System > Diagnostics in the menu bar.
2. Select the Universal Arm tab.

Universal Arm Tab

See Also
l Diagnostics Overview

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Fluid Precision Test Chapter 13 - System

Fluid Precision Test

Available only to IL personnel.

Viewing the Fluid Precision Test screen

To view the Fluid Precision Test screen:
1. Select System > Diagnostics in the menu bar.
2. Select the Fluid Precision Test tab.

Fluid Precision Test Tab

See Also
l Diagnostics Overview

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Instrument Status Chapter 13 - System

Instrument Status
The Instrument Status screen displays the following information:
l Current and previous versions of the ACL TOP software installed on the instrument, including
associated components and other information.
l Hardware updates performed on the instrument, if available.
l Alarms history.
The Instrument Status screen is typically used to view alarms history for diagnostic purposes. Some areas are
used exclusively by authorized service personnel for advanced troubleshooting.

NOTE: The functionality accessed through the toolbar icons described in this topic can also be
accessed in the menu bar as follows:

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Viewing Instrument Status

To view instrument status:
1. Select System > Instrument Status in the menu bar to open the Instrument Status screen.
2. On the Versions tab:

l In the System version drop-down list, select the current or previous version of the ACL
TOP software installed on the instrument. A comprehensive list of components
associated with the selected version displays in the Software versions table.
l In the Event drop-down list, select a hardware update previously performed on the
instrument. The date and time, description and components details (if any) of the
selected hardware event display in the fields below.

3. On the Alarms grid and Alarms chart tabs:

l Select the Alarms Display Settings icon in the toolbar and configure the
information to display on these tabs. See Configuring the Alarms grid and Alarms chart
tabs.

l Select the Alarms Filter icon in the toolbar and configure the information to
display on these tabs. See Filtering the Alarms grid and Alarms chart tabs.

4. To print the information displayed on a tab, select the Print icon in the toolbar.

Configuring the Alarms Grid and Alarms Chart tabs

To configure the alarms to display on the Alarms grid and Alarms chart tabs by ACL TOP software version
and by hardware event over a selected time span:
1. Open the Alarms grid or Alarms chart tab in the Instrument Status screen.
2. Select the Alarms grid or Alarms chart tab.

3. Select the Alarms Display Settings icon in the toolbar to open the Alarms Display Settings
dialog box.
4. On the Software Versions tab, use the arrow buttons to move the ACL TOP software versions whose
alarms you want to view to the Selected columns list.
5. On the Hardware Events tab, use the arrow buttons to move the hardware updates whose alarms you
want to view to the Selected columns list.
6. On the Chart Settings tab, configure the time span and alarm grouping to use when charting the
history of an alarm.
7. Select OK.
The Alarms grid tab now displays the alarm sets you chose to view, and the and Alarms chart tab displays
the number of times the selected alarm triggered during the time span you configured.

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Filtering the Alarms Grid and Alarms Chart tabs

To filter by category the alarms that appear on the Alarms grid and Alarms chart tabs:
1. Open the Alarms grid or Alarms chart tab in the Instrument Status screen.

2. Select the Filter icon in the toolbar.

3. In the Alarms filter dialog box, select one or more filters options.
4. Configure the filter criteria for the filters enabled in the previous step. See Alarms filter dialog box.
5. Select OK. The filtered results appear on the Alarms grid and Alarms chart tabs.

Viewing Status Statistics

To view status statistics:
1. Open the Instrument Status screen.
2. Select Actions > Review > Status Statistics in the menu bar.
3. View status statistics in the Status Statistics screen.
4. Select the Reset button to reset the dynamic values in the Time and % columns back to zero and reset
the time stamp in the From field to the current date and time.

Instrument Status Operations Toolbar

The Instrument Status operations toolbar includes the following:

Select the following icons to perform the associated tasks:

Add Hardware Event – Adds a new hardware update to display on the Versions
tab. For authorized service personnel only.

Edit Hardware Event – Edits an existing hardware update displayed on the

Versions tab. For authorized service personnel only.

Alarms Display Settings – Opens the Alarms display settings dialog box where you
configure the information displayed on the Alarms grid and Alarms chart tabs.

Alarms Filter – Opens the Alarms filter dialog box where you filter the alarms to
display in the Alarms grid and Alarms chart tabs.

Print – Prints the contents of the selected tab.

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Versions tab

Software versions

System versions
Drop-down list of current and previous ACL TOP software versions installed on the instrument. The table
displays the following information and components associated with the ACL TOP version selected in the
list:
l System information
l Control Module versions
l Software component versions
l Language (other than English) use on the system
l Reports versions
l System DLL versions

Hardware events

Event
Drop-down list of hardware updates performed on the instrument.

D ate & Time

Date and time the selected hardware update was performed on the system.

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D escription
Description of the selected hardware update entered by the authorized service representative.

H ardware components version

Table of installed hardware components and versions, if available, associated with the update selected in the
Event list.

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Alarms Grid Tab

Displays the alarms generated on the instrument by ACL TOP software version and by hardware event.
Statistics for the alarm appear in the Total, Total% and Busy% columns.

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Total
Total number of times the alarm triggered during the time period configured in the Alarms filter.

Total %
Total number of times the alarm (in that row) triggered expressed as a percentage of all the alarms (all rows)
triggered during the time period configured in the Alarms filter.

B usy %
Percentage of time the instrument was in this error state (for alarm in that row) while the instrument was in
the Busy state.
See Filtering and Configuring the Alarms grid and Alarms chart tabs.

Alarms Chart Tab

This tab charts the number of times a selected alarm has triggered over a given time period.

D isplayed alarm
List of alarms configured on the ACL TOP instrument. Select an alarm in the list to display in the Alarms
chart tab.
See Filtering and Configuring the Alarms grid and Alarms chart tabs.

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Alarms Display Settings Dialog Box

Use this dialog box to configure the alarms set (by ACL TOP software version) to display on the Alarms
grid tab and to chart on the Alarms chart tab. See Configuring the Alarms grid and Alarms chart tabs.

Software Versions tab

Use this tab to display current and previous versions of the ACL TOP software installed on the instrument,
including associated components and other information.
Each ACL TOP software version displays in a separate column in the Instrument Status – Alarms grid tab, as
follows:

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A vailable columns
List of current and previous versions of the ACL TOP software installed on the instrument. Alarms associated
with the ACL TOP software versions listed in this column will not display in the Alarms grid and Alarms
chart tabs after you select OK.

Selected columns
Use the arrow buttons to move ACL TOP software versions to and from this list. Alarms associated with the
ACL TOP software versions listed in this column will display in the Alarms grid and Alarms chart tabs after
you select OK.

Hardware Events tab

This tab is used by authorized service personnel for advanced troubleshooting.

A vailable columns
List of hardware updates performed the instrument. Hardware alarms associated with the ACL TOP software
versions listed in this column will not display in the Alarms grid and Alarms chart tabs after you select OK.

Selected columns
Use the arrow buttons to move ACL TOP software versions to and from this list. Hardware alarms associated
with the ACL TOP software versions listed in this column will display in the Alarms grid and Alarms chart
tabs after you select OK.

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Chart Settings tab

Use this tab to configure a time period and grouping for the alarms to display on the Alarms chart tab.

D isplayed time period

Configure the time range parameters for alarms to chart as follows:
l From – Select a beginning time stamp to display on the Alarms chart tab.
l To – Select an end time stamp to display on the Alarms chart tab.

Grouping
Configure the grouping parameters for alarms to chart as follows:
l Grouping value – Number of bars to group together on a chart for visual purposes. Select 1-99.
l Grouping by – Time span for the grouping value (minutes-years).

OK
This button applies the alarm display settings configured in the current dialog box session to the Alarms grid
and Alarms charts tabs.

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Alarms Filter Dialog Box

Use this dialog box to filter by category the alarms listed on the Alarms grid tab and charted on the Alarms
chart tab. See Filtering the Alarms grid and Alarms chart tabs.

Enable filter by alarm code

Option to filter the alarms by the alarm codes. To use this filter, select this option and configure the range of
alarm codes to display in the From and To fields.

Enable filter by type

Option to filter the alarms by type. To use this filter, select this option and choose one of the following in
the Alarm type drop-down list.
l Error – Displays error alarms.
l Warning – Displays warning alarms.

Enable filter by date/time

Option to filter the alarms by date range or by the current date. To use this filter, select this option, then do
one of the following:
l Select the Filter by current date option.
l Configure the date range in the From and To fields.

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Enable filter functional area

Option to filter the alarms by function. To use this filter, select this option and choose one of the following
in the Functional area drop-down list.
l Materials – Displays material alarms.
l QC – Displays QC alarms.
l Analyzer – Displays analyzer alarms.
l External Communications – Displays external communications alarms.
l Maintenance – Displays maintenance alarms.
l Job Frequency – Displays job frequency alarms.
l Setup – Displays setup alarms.
l Other – Displays the alarms that are not included in the above categories.

All alarms
Option to cancel all filters. This option displays all alarms in the Alarms grid and Alarms charts tabs.

OK
This button applies the alarm filters and criteria configured in the current dialog box session to the Alarms
grid and Alarms charts tabs.

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Instrument Status Chapter 13 - System

Status Statistics Screen

The Status Statistics screen displays a dynamic set of statistics relating to the operation of the ACL TOP
instrument. See Viewing status statistics.

From
Date and time the instrument began collecting the statistics currently displayed.

R eset
This button does the following:
l Resets the dynamic statistics displayed in the Time and % columns back to zero.
l Sets the time stamp in the From field to the current date and time.
l Immediately starts collecting a new set of statistics.

C olumn D escriptions
l Time – The amount of time the instrument has spent in the state indicated by the <row name> since
the date and time displayed in the From field.
l % – Percentage of operational time the instrument has spent in the state indicated by the <row
name> since the date and time displayed in the From field.

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Statistics D escriptions
The time values displayed for the following statistics represent the total amount of time the instrument has
spent in that state since the time displayed in the From field:
l Power up – Time the instrument spent physically powering up.
l Initializing – Time the instrument spent starting up installed programs.
l Ready – Time the instrument spent in the idle state while prepared to run tests.
l Busy – Time the instrument spent performing activities.
l Error – Time the instrument spent partially or fully incapacitated because of an unresolved error.
l Emergency stop – Time the instrument spent in emergency stops.
l Unknown – Time the instrument spent in an unidentified state.
l Diagnostics – Time the instrument spent performing diagnostic operations.
l Maintenance – Time the instrument spent performing maintenance activities.
l Warming up – Time the instrument spent warming up before entering the Ready or Busy state.
l Controlled stop – Time the instrument spent in controlled stops.

See Also
l Maintenance List
l Instrument Temperatures
l Analytical Versions

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Instrument Temperatures Chapter 13 - System

Instrument Temperatures

Viewing Instrument Temperatures

To view instrument temperatures:
1. Select System > Temperatures in the menu bar to open the Instrument Temperatures window.
2. To print the temperature data displayed in the window, select the Print button.

Instrument Temperatures Window

The Instrument Temperatures window displays the temperatures for the following instrument areas:
l Incubators
l 2-4 ORUs
l Reagent block area
l Cuvette shuttle
l Probes.
Values displayed in red are outside the accepted temperature range.

See Also
l Maintenance List
l Instrument Status
l Analytical Versions

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Analytical Versions Chapter 13 - System

Analytical Versions
Accessing Analytical Versions
To access the analytical versions of the installed test parameters:
1. Select System > Analytical Versions in the menu bar to open the Analytical Versions window.
2. To print the contents of this window, select the Print button.

Analytical Versions Window

C omponent
Name of the test parameter installed.

Installed Version
Current version of the test parameter installed.

Print
Prints the contents of this window.

See Also
l Maintenance List
l Instrument Status
l Instrument Temperatures

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General Log List Chapter 13 - System

General Log List

In addition to error and warning-level alarms, the General Log contains informational alarm messages. These
messages contain information about an event that has affected system performance.
The General Log displays a maximum of 10,000 entries. Entries are deleted on a first in/first out basis when
the log is full.

HINT: If the result of an Enhanced Clean maintenance activity does not display in the General Log

List in a timely manner, select the Refresh icon in the toolbar. If the Enhanced Clean has completed,
the log entry will appear in the refreshed log list.

Accessing the General Log List

To access the General Log List:

1. Select System > General Log List in the menu bar or the General Log icon located on the left
side of the status bar.

2. Select the Add icon or select Actions > Log > Add to open a General Log Entry Creation
window. You can add only informational entries.

Printing a Report
To print a General Log Detail report:

1. Double-click the log entry, or select it and click the Details icon.
2. Click Print in the General Log Entry Details window.
3. Configure print options in the Print dialog box and click OK. All the information displayed in the
General Log Entry Creation window prints.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

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Exporting a Report
l Select Actions > Export to export the General Log List report or the General Log Detail report. A
window opens that allows you to specify the format and select the destination. See Exporting Data.

NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application
window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press
ALT+Tab to display the Print or Export dialog box.

Clearing the Log List

To clear all log events from the General Log List:
l Select Actions > Results > Clear All Events in the menu bar.

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General Log List Toolbar Icons

Log D etails icon

Select this icon or double-click an alarm message to view Description, Cause, Operator Action and
Comment details. You can select the up/down arrow icons to quickly scroll through the log list.
The log can be filtered to display data generated manually, automatically or semi-automatically. The default
time span is monthly, which displays data from the current date to the same date of the previous month.

R efresh icon
Select this icon to update the log.

Filter icon
Select this icon to open the General Log Filter dialog box. You can choose to filter the archived list by code,

type, start/end date, functional area, or user name. Select the Filter button to view your filtered list of
alarm messages.

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A dd C omment icon
Select the icon or select Actions > Log > Add Comment in the menu bar to add a comment to an existing
log entry; a check mark is then placed in the box to the right of the entry in the General Log to indicate that
a comment has been added.

Print R eport icon

To print a General Log List report you must have the General Log List screen displayed, then select the
print report icon or select Actions > Print in the menu bar.
A General Log List report includes the following information:
l Date/Time of the report
l Hospital Name
l Laboratory Name
l Instrument and Serial Number
l Description/Comment
l Code
l Type
l Date/Time
l Functional Area
l User Name

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General Log Entry Creation window

Functional area
This includes the major areas of the system: Analyzer, Job Frequency, LIS, Maintenance, Materials, QC,
Setup, Others.

D escription
Enter the information you want kept in the General Log.

C omment
Enter a comment about this log entry.

OK
Select OK to add this entry to the list. After you select OK, you cannot delete your entry without deleting
the entire log.

See Also
l Status Bar
l Alarm Messages

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CHAPTER 14
BACKUP AND RESTORE

Backup and Restore

Overview
This topic provides instructions on how to backup and restore the database. The database contains all
definitions and data. Backup and restore are both performed outside the ACL TOP instrument application.

NOTE:

l By default, the ACL TOP instrument uses the following editable naming convention when creating
backup files:
<serial number>_<date>_<time>.tzb
<serial number>_<date>_<time>.tzb

l A backup performed on an instrument that does not have the Serial Number information in the System
Identification area of Global Definitions cannot be restored. See Global Definitions.
l You can only restore to the same instrument on which the backup was performed.
l The security information fields displayed on this screen are for use by IL Test Developers and IL
Service personnel only.

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Full Backup of Database

1. Remove any CD from the CD drive, if present.
2. Shutdown the ACL TOP application.
3. Select Start > Programs > ACL TOP > ACL TOP – Database Backup and Restore.
4. <Optional> For databases that are too large to fit onto one CD, select the Enable multi-volume
backup option.
5. <Optional> To delete patient information from the backup, select the Delete patient information
from backup option. to support patient confidentiality
6. Select Backup. A Save As dialog box opens.

NOTE: If you are asked to insert a disk into a drive, select Cancel to display the “Save As”
window.
7. Navigate to the desktop.
Alternatively, create a folder C:\ACL TOP Backups\, and save all database backups to this location.
8. Accept the default name for the backup file, or enter different name, and select Save.

NOTE: Use only alphanumeric characters, spaces, dashes and underscores for folder and
filenames.
9. Upon completion of the backup, the following message appears: The database backup has been
executed successfully.
10. Copy the backup file from the desktop to another location to prevent accidental deletion.

Example To CD or another accessible location on the hard drive.

11. Select OK, then Close to close the ACL TOP – Database Backup and Restore utility.

NOTE: At this point, if your system is using the CIS RecordNow application, refer to
Section 3.0, Burn Backup of Database to CD using CIS RecordNow, for instructions on how to
burn the database to a CD. If you are using the Nero Express Essentials application, refer to Section
4.0, Burn Backup of Database to CD or DVD using Nero Express Essentials for instructions on how
to burn the database to a CD or DVD.
12. Select Start > Programs > NTI CD-Maker > NTI CD-Maker 6 Gold.
13. In the NTI CD-Maker Gold window, select Data, then select Data CD.
14. Verify the correct CD Drive is selected in the drop down box at the top right of the window.

15. Select the Add icon (or Edit > Add). Navigate to the same location on the hard drive where
the database was previously saved (see Step 7. : C:\ACL TOP Backups\).

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16. Insert a blank CD-R into the CD Drive, then select the Write Disc icon (or File > Write Disc).
17. Select Start to burn the to the CD.

NOTE: It is recommended to run no other applications, including the ACL TOP application,
while the data is being copied to the CD.
18. When the data has finished coping, a message displays: Congratulations, The disc was recorded
successfully at…
19. Remove the CD from the CD Drive, and with a permanent marker, label the CD with the same
name as in Step 8. : “Backup_<SN>_MMDDYY”, where <SN> is the serial number of the
instrument.

Example Backup_SN02110027_ 022804

20. Select OK, then close the NTI CD-Maker Gold application.

NOTE: If a message box is displayed asking if you want to save changes to the CD, select
No.
21. Start the ACL TOP application, and verify that the system initializes and the instrument goes to the
Ready state.

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Full Restore of Database

NOTE: You can restore only backup files that were created on the same instrument where they are
stored.
A database can be restored from either the local hard drive, from a network drive or from a CD.
If you are restoring from a network drive or CD, select Enable network and CD access to enable that field.
1. Close the ACL TOP application.
2. Select Start > Programs > ACL TOP > ACL TOP – Database Backup and Restore.
3. Choose Select to display the Open window.
4. In the Look in field navigate to the location of the database that you wish to restore (either on the
CD; the local hard drive, C:\ACL TOP Backups\; or the network).
5. Select the appropriate TZB file and then select Open. The suggested standard naming convention for
full database backups is: “Backup_<SN>_MMDDYY”, where <SN> is the serial number of the
instrument. Example Backup_SN02110027_ 022804.
6. Verify that the Installed Version fields on the left side are later than or equal to the Version for
Restoring fields on the right side. If the database being restored was created on a later software
version than the currently installed version, the ACL TOP instrument application fails to start.
7. Select Restore. Upon completion of the database restore the following message appears: “The
database restore has been executed successfully.”
8. Select OK, then select Close to close the ACL TOP – Database Backup and Restore utility.
9. Start the ACL TOP application and verify that the system initializes and the instrument goes to the
Ready state.

NOTE: The ACL TOP - Creation and Upgrade utility is for IL use only.

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Burn Backup of Database to CD or DVD using Nero Express Essentials

1. From the desktop, double click the following Nero Express Essentials icon.
2. Select Data CD or Data DVD.

3. You can either drag-and-drop items into the window, or select the Add button to add files to the
disc. An Add files and folders browse window opens where you can select the files.
4. Select the files, then close the Add files and folders window.
5. Select Next.
6. In the Current Recorder field make sure the correct drive is selected.
7. Enter a disc name.
8. Select the Verify data on disc after burning option.
9. Disable the Allow files to be added later (multisession) option.
10. Insert a blank disc into the drive.
11. If the CD Drive (D:) window opens, select Cancel to close it.
12. Select the Burn button.
13. When the burn is complete, the drive automatically opens. Remove the disc and close the drive door.
14. A popup indicates if the verification of the disc is successful. If it is, select OK.
15. Select the Next button.
16. Close the Nero Express application. When asked to save the project, select No.

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Backup and Restore screen

Backup splitting configuration

Enable multi-volume backup

Option to store large backup files on multiple disks.

Volume size
Size of the disks used to store the backup file.

Backup content configuration

D elete patient information from backup

Option to delete patient information from the backup file. This supports patient confidentiality.

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CHAPTER 15
PARTS AND CONSUMABLES

Parts and Consumables List

l Most Frequently Ordered Items
l Less Frequently Ordered Items
l Reagent Racks, Diluent Racks, and Bottle Adapters
l Sample Racks and Bottle Adapters

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Most Frequently Ordered Items

Item Part Number
HemosIL® Clean A 00009831704
Cleaning Solution
4 x 500 mL
HemosIL Clean B 00009832700
Cleaning Agent
1 x 80 mL
HemosIL Factor Diluent 00009757600
1 x 100 mL
HemosIL Rinse 00020009700
1 x 4000 mL
Bar code Labels for Factor Diluent, Clean B, Diluted Clean B 00028525200
Bottles, Plastic, 30 mL (with cap) 00018902000
10/package
Bottles, Glass, 20 mL 00019085463
8/package
Bottles, Glass, 10 mL 00018924100
10/package
Bottles, Glass, 4 mL 00018924104
10/package
Cups 2.0 mL, Sample 00005575100
1000/package
Cuvettes 00029400100
2400 cuvettes – 600 strips (4 cuvettes/strip)
300 CTS 00027344900
Cuvette Waste Bin
10/package
500 CTS 00029506900
Cuvette Waste Liner
10/package
All Models Except 300 CTS and 500 CTS 00029401100
Cuvette Waste Liner
10/package
300 CTS 00027333801
Filter, Reagent Cooling Fan
500 CTS 00029528901
Filter, Reagent Cooling Fan
All Models Except 300 CTS and 500 CTS 00028617301

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Item Part Number

Filter, Reagent Cooling
Magnetic Stir Bars 00009746606
6/package
Syringe Tip/Shaft 250 µL, PE, PSD4 00028754001
Waste Container 00018901300
10 L plastic bottle
CTS Filter 00029403501
12/pkg

Less Frequently Ordered Items

Item Part Number
ACL TOP Family Operator's Manual, Version 5.2, PDF (CD) 00027503447
Power Cable 110V 00014882100
Power Cable 220V 00019725500
Printer/Printer Cable/Printer Consumables Refer to your local representative.
Pump/Probe Tubing Assembly 00028741600
Rinse Aspirator Assembly, 4L 00028713400
(Tube connecting ACL TOP instrument to the Rinse Bottle)
Clean Aspirator Assembly 00028713200
(Tube connecting ACL TOP instrument to the Clean Bottle)
Stylet Kit 00019006300
Syringe, 250 µL PE, PSD4 00028753201
LAS Syringe, 1000 µL, Tip/Shaft PE, PSD4 00028753401
Waste Sensor Assembly 00028771801
2D Bar Code Reader Upgrade Kit 00028210500
Tray, 6 Sample Racks (1 pc.) 00028780201
S/S CRU Sample Probe and Seal 00028660141
CTS Piercer 00029403601
CTS Filter Replacement Tool 00028386300

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Reagent Racks, Diluent Racks and Bottle Adapters

Item Part Number
4 mL Reagent Bottle Adapter 00028520501
10 mL Reagent Bottle Adapter 00028520901
4 mL Diluent Bottle Adapter (2 pcs.) 00028526001
10 mL Diluent Bottle Adapter (2 pcs.) 00028526101
20 mL Diluent Bottle Adapter (2 pcs.) 00028526201
Reagent Rack Set, RA - RF (6 pcs) 00029400601
Reagent Rack Set, RA - RD (4 pcs) 00029400641
Reagent Rack Set, RG - RM (7 pcs) 00029400602
Reagent Rack Set, RE - RH (4 pcs) 00029400642
Diluent Rack Set, DA - DC (3 pcs) 00029400711
Diluent Rack Set, DA - DB (2 pcs) 00029400741
Diluent Rack Set, DD - DF (3 pcs) 00029400712
Diluent Rack Set, DC - DD (2 pcs) 00029400742

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Sample Racks and Adapters

Item Part Number Comments
Aliquot Tube Adapter (10 pcs.) 00028533400
Pediatric Tube Adapter (10 pcs.) 00028533500
Micro Tube Adapter (10 pcs.) 00028533700
Tray, 6 Sample Racks (1 pc.) 00028780201
CTS Sample Tube Adapter (10 pcs.) 00028533600
CTS Sample Rack Set, 01 - 08 00029400941
CTS Sample Rack Set, 09 - 16 00029400942
CTS Sample Rack Set, 17 - 24 00029400943
CTS Sample Rack Set, 25 - 32 00029400944
CTS Sample Rack Set, 33 - 40 00029400945
CTS Sample Rack Set, 41 - 48 00029400946
CTS Sample Rack Set, 49 - 56 00029400947
CTS Sample Rack Set, 57 - 64 00029400948
Sample Rack Set, 1 - 8 00029400541
Sample Rack Set, 9 - 16 00029400542
Sample Rack Set, 17 - 24 00029400543
Sample Rack Set, 25 - 32 00029400544
Sample Rack Set, 33 - 40 00029400545
Sample Rack Set, 41 - 48 00029400546
Sample Rack Set, 49 - 56 00029400547
Sample Rack Set, 57 - 64 00029400548
Sample Rack Set, 01 - 12 00029400501
Sample Rack Set, 13 - 24 00029400502
Sample Rack Set, 25 - 36 00029400503
Sample Rack Set, 37 - 48 00029400504
Sample Rack Set, 49 - 60 00029400505
Sample Rack Set, 61 - 72 00029400506
Sample Rack Set, 73 - 84 00029400507
Sample Rack Set, 85 - 96 00029400508
CTS Sample Rack Set, 01 - 12 00029400901
CTS Sample Rack Set, 13 - 24 00029400902
CTS Sample Rack Set, 25 - 36 00029400903
CTS Sample Rack Set, 37 - 48 00029400904
CTS Sample Rack Set, 49 - 60 00029400905
CTS Sample Rack Set, 61 - 72 00029400906
CTS Sample Rack Set, 73 - 84 00029400907
CTS Sample Rack Set, 85 - 96 00029400908

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Item Part Number Comments

CTS rack adapter blue 48 / pk 00027500148
CTS rack adapter blue 96 / pk 00027500149
CTS Sarstedt Rack set 16.3 mm 01-08 00000051301
CTS Sarstedt Rack set 16.3 mm 09-16 00000051302
CTS Sarstedt Rack set 16.3 mm 17-24 00000051303
CTS Sarstedt Rack set 16.3 mm 25-32 00000051304
CTS Sarstedt Rack set 16.3 mm 33-40 00000051305 These rack sets are for use with Sarstedt
CTS Sarstedt Rack set 16.3 mm 41-48 00000051306 primary tubes with cap OD of 16.3 mm.
Example is Sarstedt part number
CTS Sarstedt Rack set 16.3 mm 49-56 00000051307 04.1902.100. There are eight racks per
CTS Sarstedt Rack set 16.3 mm 57-64 00000051308 set.
CTS Sarstedt Rack set 16.3 mm 65-72 00000051309
CTS Sarstedt Rack set 16.3 mm 73-80 00000051310
CTS Sarstedt Rack set 16.3 mm 81-88 00000051311
CTS Sarstedt Rack set 16.3 mm 89-96 00000051312
CTS Sarstedt Rack set 14.0 mm 01-08 00000051401
CTS Sarstedt Rack set 14.0 mm 09-16 00000051402
CTS Sarstedt Rack set 14.0 mm 17-24 00000051403
CTS Sarstedt Rack set 14.0 mm 25-32 00000051404
CTS Sarstedt Rack set 14.0 mm 33-40 00000051405 These rack sets are for use with Sarstedt
CTS Sarstedt Rack set 14.0 mm 41-48 00000051406 primary tubes with cap OD of 14.0 mm.
Example is Sarstedt part numbers
CTS Sarstedt Rack set 14.0 mm 49-56 00000051407 05.1165.100 or 05.1071.100. There are
CTS Sarstedt Rack set 14.0 mm 57-64 00000051408 eight racks per set.
CTS Sarstedt Rack set 14.0 mm 65-72 00000051409
CTS Sarstedt Rack set 14.0 mm 73-80 00000051410
CTS Sarstedt Rack set 14.0 mm 81-88 00000051411
CTS Sarstedt Rack set 14.0 mm 89-96 00000051412
CTS Sarstedt Rack set 16.3 mm 01-12 00000051501
CTS Sarstedt Rack set 16.3 mm 13-24 00000051502
CTS Sarstedt Rack set 16.3 mm 25-36 00000051503 These rack sets are for use with Sarstedt
CTS Sarstedt Rack set 16.3 mm 37-48 00000051504 primary tubes with cap OD of 16.3 mm.
Example is Sarstedt part number
CTS Sarstedt Rack set 16.3 mm 49-60 00000051505 04.1902.100. There are twelve racks per
CTS Sarstedt Rack set 16.3 mm 61-72 00000051506 set.
CTS Sarstedt Rack set 16.3 mm 73-84 00000051507
CTS Sarstedt Rack set 16.3 mm 85-96 00000051508

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Chapter 15 – Parts and Consumables

Item Part Number Comments

CTS Sarstedt Rack set 14.0 mm 01-12 00000051601
CTS Sarstedt Rack set 14.0 mm 13-24 00000051602
CTS Sarstedt Rack set 14.0 mm 25-36 00000051603 These rack sets are for use with Sarstedt
CTS Sarstedt Rack set 14.0 mm 37-48 00000051604 primary tubes with cap OD of 14.0 mm.
Example is Sarstedt part numbers
CTS Sarstedt Rack set 14.0 mm 49-60 00000051605 05.1165.100 or 05.1071.100. There are
CTS Sarstedt Rack set 14.0 mm 61-72 00000051606 twelve racks per set.
CTS Sarstedt Rack set 14.0 mm 73-84 00000051607
CTS Sarstedt Rack set 14.0 mm 85-96 00000051608

See Also
l Sample Containers and Adapters

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CHAPTER 16
REFERENCE

Reference Section Overview

The Reference section contains the following information:
l Toolbar Icons
l Grid Icons
l Graph Icons
l Sample Status Color Codes
l Reagent Color Codes
l LED Status Color Codes
l Measured Units

See Also
l Symbols
l Important Symbols
l Hazards

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Toolbar Icons Chapter 16 – Reference

Toolbar Icons
Icon Description

Activate Alternate Lot

Activate Material Lot

Activate Test Lots

Add

Add/Remove Material

Add Hardware Event

Add/Remove Tests

Alarms Display Settings

Analyzer Alarm

Analyzer Alarm Error

Analyzer Alarm Warning

Apply Checks

Assigned Values

Auto List

Bar Code and Comments

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Icon Description

Calibration Status List

Clear Rack

Clear QC Selection

Clear Tree Selection

Comment or View Comment

Copy

Copy Alternative Lot

Cuvette Holding Area

Delete

Delete Test

Details

Diluent Area

Edit Hardware Event

Enable/Disable Tests

Export

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Icon Description

External Communications Alarm

External Communications Alarm Error

External Communications Alarm Warning

Test Feasibility List

Filter

Filter in Use

Find

General Log

Go to Material Definition

Go to Test Definition

Help

Home Bar Code Reader

IL Logo/IL Test mode in Test List and Material List

Import

Insert Rack

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Icon Description

Instrument Configuration

Job Frequency Alarm

Job Frequency Alarm Error

Job Frequency Alarm Warning

Log

Maintenance Alarm

Maintenance Alarm Error

Maintenance Alarm Warning

Show Material List

Material Restriction Map

Material Alarm

Material Alarm Error

Material Alarm Warning

Next Job

Next Rack

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Icon Description

Omit Point

On-board Waiting for Volume

Open Calibration Status List

Open QC Results List

Open Sample Details

Patient Demographics

Perform Activity

Previous Job

Previous Rack

Previous Screen

Print or Print Report

QC Alarm

QC Alarm Error

QC Alarm Warning

QC Results or Status List

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Icon Description

Rack Details

Reagent Area

Recalculate

Refresh

Reset

Restore

Run Jobs

Sample Area

Sample Details

Sample List

Sample List Display Settings

Save

Scan Material Data

Select QC Profiles

Set Statistic as Target

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Icon Description

Show Reaction Curve

Test Details

Show Test List

Switch View – Chart Plus Grid View

Switch View – Chart View

Switch View – Grid View

Test/Material Tree View

Upload

User

Validate

View Item

Warning Threshold

See Also
l Graph Icons
l Grid Icons
l Toolbar

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Grid Icons Chapter 16 – Reference

Grid Icons
Icon Description
All Tests
Alternative Lot

Alternative Prediluted Test

Auto Execution Mode

Calibration

Calibration Feasibility

Comments

Cooling

Cover Opening

DR Flag

Edit

Error

Error Status/Sample Highest Error

Extended Test

Feasibility Test List

IL Material or IL Test

Information

Job Type

Error

Lock Status

Material On-board

Material Referenced

Material Status Enabled/Disabled

No Tests

Normal Test

NPP Feasibility

Parallelism

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Icon Description
Parallelism Feasibility

Partial Item or Partial Test

Patient Test

Print

Priority (Stat)

QC

QC Comment

QC Feasibility

QC Omitted Point

QC Status Enabled/Disabled

Reaction Curve

Rerun Test

Sample On-board

Sample Status

Selected Item/Test

Selection Column

Start Reagent

Stirring

Test Consistency

Test is a Rerun

Test Triggered a Rerun

Test Leaf

Enable/Disable Test or Show/Hide Test

Upload Status

Validation Status

Waiting for On-board Material Volume

Warning

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See Also
l Graph Icons
l Toolbar Icons
l Toolbar

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Graph Icons Chapter 16 – Reference

Graph Icons
Icon Description
Black Point - Calibration edited point
Blue Point
l Calibration omitted point
l Parallelism point
l QC active results
Green Point - Calibration normal point
Orange Point - QC alternate active results
Black Cross Point - Calibration deleted point
Blue Cross Point - QC active omitted point
Orange Cross Point - QC alternate omitted point
Blue up arrow - QC active out up
Blue down arrow - QC active out down
Orange up arrow - QC alternative out up
Orange down arrow - QC alternate out down
Blue line - Replicate 1 clot curve or Parallelism curve
Cyan line - Replicate 1 second derivative
Brown line - Replicate 3 second derivative
Dark gray line - Replicate 2 second derivative
Dark green line
l Calibration line
l Replicate 2 clot curve
l QC trend line
Violet line - Adjusted calibrated curve
Dark yellow line - Replicate 3 first derivative
Magenta line - Replicate 1 first derivative
Orange line - Replicate 3 clot curve
Red line
l Calibration curve (if it has failed)
l QC mean line
Black line - Replicate 2 first derivative

See Also
l Grid Icons
l Toolbar Icons

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l Toolbar

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Sample Status Color Codes Chapter 16 – Reference

Sample Status Color Codes

Icon Description
Not Placed Gray

To Do Light blue

To Do – Priority Light blue

Placed – Identified Blue

Placed – Unidentified Blue

Placed – Priority Blue

Pending – Identified Orange

Pending - Identified with Errors Orange

Pending – Priority Orange

Pending - Priority with Errors Orange

In Use – Identified Purple

In Use - Identified with Errors Purple

In Use – Priority Purple

In Use - Priority with Errors Purple

Complete – Identified Green

Complete - Identified with Errors Green

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Icon Description
Complete – Priority Green

Complete - Priority with Errors Green

Not Feasible - Identified Yellow

Not Feasible - Identified with Errors Yellow

Not Feasible - Priority Yellow

Not Feasible - Priority with Errors Yellow

NOTE: When the status of a sample rack is green, the rack can be removed. When the status changes
to amber the sample rack is locked and cannot be removed.

See Also
l Sample Rack Detail screen
l Reagent Area
l Diluent Area

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Reagent Status Color Codes Chapter 16 – Reference

Reagent Status Color Codes

Reagent Placement
Icon Description Color

Not Placed Gray

Placed – Unidentified Green

Placed – Identified Green

Placed – Warning Yellow

Placed – Error Red

In Use Green

In Use – Warning Yellow

In Use – Error Red

Reagent Remaining Stability

Icon Description Color

Stability OK Green

Stability Warning Yellow

Stability Alarm Red

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Reagent On-board Volume

Icon Description Color

Volume OK Green

Volume Warning Yellow

Volume Alarm Red

On-board Waiting for Volume

See Also
l Reference Section Overview
l Sample Rack Detail screen
l Reagent Area
l Diluent Area

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LED Status Color Codes Chapter 16 – Reference

LED Status Color Codes

Icon Color Description
Gray - Empty track
- Auto Run status is Disabled
- LAS status is Disabled
Green - Rack is inserted but is not in use
- AM status is Ready
- LIS status is Connected
- Auto Run status is Enabled
- LAS status is Ready
Blue - AM status is Busy

Amber - Rack is in use

- AM status is Error
- LIS status is Rejected
- Auto Run status is Stopped
- LAS status is Unavailable or Stopped
Red - Auto Run status is Error

Green - Cuvette Door is Open

Yellow - Waste Fluid status is Warning

- Clean Fluid status is Warning
- Rinse Fluid status is Warning
- Cuvette Waste status is Warning
- Cuvette Loader status is Warning
Gray - Cuvette Door is Closed
- Waste Fluid status is OK
- Clean Fluid status is OK
- Rinse Fluid status is OK
- Cuvette Waste status is OK
- Sensor is Off
- Sensor status is Unknown
Red - Waste Fluid status is Full
- Clean Fluid status is Empty
- Rinse Fluid status is Empty
- Cuvette Waste status is Full or Removed
- Cuvette Loader status is Empty

See Also
l Reference Section Overview

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Measured Units Chapter 16 – Reference

Measured Units

Measured Units
l Seconds
l Mean
l Transmittance
l % Transmittance
l Delta Transmittance
l Delta Transmittance/min
l Delta % Transmittance
l Delta % Transmittance/min
l Milliabsorbance
l Delta Milliabsorbance
l Delta Milliabsorbance/min
l 1st Derivative Peak Height
l 2nd Derivative Peak Height

Calculated Units
l Ratio
l INR
l Delta%
l PiCi%
l µg/L

Parallelism Units
l Mean of the 100% concentration
l Mean of corrected primary result (excluding 100%)
l Mean of corrected primary result (including 100%)
l r2 (Coefficient of Determination)
l Slope
l y-intercept
l % CV of corrected primary results (excluding 100%)
l % CV of corrected primary result (including 100%)
l % CV within Dilution

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Calibrated Units
l %
l g/L
l mg/L
l μg/mL
l mg/dL
l ng/mL
l U/mL
l IU/dL
l IU/mL
l mU/mL
l AU/mL
l μmol/L
l nmol/L
l [blank] = user defined

Calibration Units
l slope
l y-intercept
l r2

Statistical Units
l % CV
l SD
l slope

Derivative Units
l 1st der
l 2nd der -
l 2nd der +

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Measured Units Chapter 16 – Reference

Paired Results Units

l % Correction = ((Measured Result 1 - Measured Result 2) / (Measured Result 1 - NPP1)) * 100
l PiCi% = ((ThP-B - ThP-A) / ThP-B )*100=PiCi%
l Rosner Index = (Measured Result 1 - NPP2) / Measured Result 2) * 100
l Test Delta = (S1 - S2)
l Test Delta % = ((S1 - S2) / S1) * 100
l Test Delta - N = ((S1 - S2) / (NPP1 - NPP2))
l Test Delta - N% = ((S1 - S2) / (NPP1 - NPP2)) * 100
l Test Ratio = (S1/S2)
l Test Ratio - N = ((S1/S2) / (NPP1/NPP2))
l Test Ratio - N% = ((S1/S2) / (NPP1/NPP2)) * 100

See Also
l Measured Parameters

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CHAPTER 17
IL LOCATIONS

Instrumentation Laboratory Worldwide Locations

For countries not listed in this topic, visit the IL International website at
www.international.instrumentationlaboratory.com.
Instrumentation Laboratory and Izasa are companies of Werfen Group.

Instrumentation Laboratory Headquarters

Headquarters
Instrumentation Laboratory
180 Hartwell Road
Bedford, MA 01730-2443
USA
Phone: 781-861-0710
Fax: 781-861-1908
www.ilus.com

Werfen Group Corporate Headquarters

Headquarters
Izasa S.A.
Plaça d'Europa 21-23 - L'Hospitalet de Llobregat
08908 Barcelona
Spain
Phone: +34-93-4010101
Fax: +34-93-4010230
www.ilww.com
www.izasa.com

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US, Canada, Latin America, and South America

Brazil
Headquarters
Instrumentation Laboratory C.P.M.H. Ltda.
Estrada dos Romeiros Km 38,5 Condomínio Morro Grande
Modulo G9 06504-160 Santana de Parnaíba, SP
Brasil
Phone: +55-11-4154-3337
Fax: +55-11-4154-3337
Email: [email protected]

Canada
Instrumentation Laboratory (Canada) Ltd.
155 East Beaver Creek, Unit 24,
Suite 882 Richmond Hill
Ontario L4B 2N1
Canada
Phone: 800-552-2025 x6115
Fax: 800-732-3675
Email: [email protected]

Headquarters
IL USA, Bedford, MA
Phone: 781-861-0710
Fax: 781-861-1908

Mexico
Headquarters
IL Diagnostics S.A. DE C.V.
Lago Victoria No. 80
Col. Granada D.F.
Mexico
Phone: +52-55-5262-1760
Fax: +52-55-5262-1763
Email: [email protected]
www.ildiagnostics.com

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Chapter 17 – IL Locations

Uruguay
Isaza Uruguay
Dr. Alfredo Navarro 3136
11600 - Montevideo
Uruguay
Phone: +5982-481-81-33
Fax: +5982-481-81-33, Int.20
Email: [email protected]

Headquarters
IL Spain, Barcelona
Phone: +34-93-4010101
Fax: +34-93-4513745

USA
Headquarters
Instrumentation Laboratory
180 Hartwell Road
Bedford, MA 01730-2443
USA
Phone: 781-861-0710
Fax: 781-861-1908
www.ilus.com

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Pacific Region
Australia
Headquarters
IL Italy, Milan
Phone: +39-02-25221
Fax: +39-02-2575250
Email: [email protected]
www.il-italia.it

China
Headquarters
Instrumentation Laboratory SpA
North Room, 2nd Floor
Building B18B, Universal Business Park
#10 Jiuxianqiao Road
Chaoyang District, Beijing 100015
China
Phone: +86-10-5975-6032
http://international.instrumentationlaboratory.com

Hong Kong
Werfen Hong Kong Ltd.
Room 402, Taiping Tower, Phase One
8 Sunning Road
Causeway Bay
Hong Kong
Phone: 852-27927773
Fax: 852-27919972

Headquarters
IL Italy, Milan
Phone: +39-02-25221
Fax: +39-02-2575250
Email: [email protected]
www.il-italia.it

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India
Instrumentation Laboratory India Pvt Ltd
Office No. 271-274, Aggarwal Millenium Tower - II, Plot no. E-4
Netaji Subhash Place, Pitampura
New Delhi - 110034
India
Phone: +91-11-49029550
Fax: +91-11-49029567
Email: [email protected]
www.il-india.com

Headquarters
IL Italy, Milan
Phone: +39-02-25221
Fax: +39-02-2575250
Email: [email protected]
www.il-italia.it

Japan
Headquarters
Instrumentation Laboratory
Sigma Bldg. 6F
3-7-12, Shibaura, Minato-ku
Tokyo 108-0023
Japan
Phone: 81-3-5419-1301
Fax: 81-3-5419-1302
Email: [email protected]
www.il-japan.jp

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Europe, Middle East, Africa

Austria
Headquarters
Instrumentation Laboratory Gesellschaft m.b.H.
Tillmanngasse 5
1220 Vienna
Austria
Phone: 43-1-2565800 0
Fax: 43-1-2565800 88
http://international.instrumentationlaboratory.com

Belgium
Headquarters
Instrumentation Laboratory of Belgium N.V./S.A.
Excelsiorlaan 48-50 bus 8
1930 Zaventem (Brussels)
Belgium
Phone: +32-2-7252052
Fax: +32-2-7212409
www.instrumentationlaboratory.com/benelux

Czech Republic
Headquarters
Werfen Czech s.r.o
Pocernicka 272/96
108 00 - Praha 10
Czech Rep.
Phone: +420-246090931
Fax: +420-246090936
[email protected]

France
Headquarters
Instrumentation Laboratory S.A.
88-94 rue André Joineau
93310 Le Pré Saint Gervais
France
Phone: +33-1-82308600
Fax: +33-1-82308601
www.instrumentationlaboratory.com/fr

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Germany
Headquarters
Instrumentation Laboratory GmbH
Klausnerring 4
D-85551 Kircheim bei München
Germany
Phone: +49-89-909070
Fax: +49-89-90907116
www.instrumentationlaboratory.com/de

Hungary
Headquarters
Werfen Hungary Kft Budapest
Montevideo u 2/c
H-1037 Budapest
Phone: +36-1-882-7310
Fax: +36-1-882-7319
Email: [email protected]
http://international.instrumentationlaboratory.com

Italy
Headquarters
Instrumentation Laboratory SpA
Viale Monza 338
20128 Milan
Italy
Phone: +39-02-25-22-1
Fax: +39-02-25-75-250
Email: [email protected]
www.il-italia.it

Korea
Headquarters
Werfen Medical IL, Ltd.
101 Nashil Bldg. 604-1
Yeoksam-Dong - Kangnam-ku
135-907 Seoul
Korea
Phone: +82-2-571-9246
Fax: +82-2-571-9247
Email: [email protected]

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Lithuania
Headquarters
Instrumentation Laboratory (Lietuva) B.I.
Savanoriu 281A
50128 Kaunas
Lithuania
Phone: +370-37-313157
Fax: +370-37-313159
Email: [email protected]
www.ill.lt

Netherlands
Headquarters
Instrumentation Laboratory B.V.
Moskesbaan 2
4823 AH Breda
Netherlands
Phone: +31-0-76-5480100
Fax: +31-0-76-5480102
Email: [email protected]
www.il-nl.com

Poland
Headquarters
Werfen Polska Sp. z o.o.
Wolinska 4
03-699 Warszawa
Poland
Phone: +48-22-3361800
Fax: +48-22-3361872
Email: [email protected]
www.werfen.pl

Portugal
Headquarters
Izasa Portugal Lda
Rua do Proletariado, 1 - Quinta do Paizinho
2795-648 Carnaxide
Portugal
Phone: +351-21-4247300
Fax: +351-21-4176484
www.izasa.com

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Russia
Headquarters
Instrumentation Laboratory
16/2 Dmitry Ulyanov Street 328 Office
117292 Moscow
Russia
Phone: +7-499-124-45-59
Fax: +7-495-982-37-23
Email: [email protected]
http://international.instrumentationlaboratory.com

Spain
Headquarters
Izasa S.A.
Plaça d'Europa 21-23 - L'Hospitalet de Llobregat
08908 Barcelona
Spain
Phone: +34-93-4010101
Fax: +34-93-4010230
www.ilww.com
www.izasa.com

Turkey
Headquarters
IL Italy, Milan
Phone: +39-02-25-22-1
Fax: +39-02-25-75-250
Email: [email protected] (Semra Birincioglu)
www.il-italia.it

United Kingdom
Headquarters
Instrumentation Laboratory UK
Kelvin Close – Birchwood Science Park
Warrington, Cheshire
WA3 7PB
United Kingdom
Phone: +44-1925-81-0141
Fax: +44-1925-82-6708
http://international.instrumentationlaboratory.com

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Glossary
See "Terminology" on page 83 for more definitions.

acquisition time
The amount of time that optical data is collected by the system. Acquisition Time can be either
Standard or Extended. Standard Acquisition Time is the time spent collecting the required number
of data points to determine the clotting point or reaction rate for the majority of samples. With
Extended Acquisition Time, data is collected for a longer period of time to determine the clotting
point for samples which have prolonged clotting times.

aliquot
A known fraction of a whole, constituting a sample.

AM
The part of the instrument where sample processing and testing are performed. Also called the
Analyzer or the Analytical Module.

Analytical Module
The part of the instrument where sample processing and testing are performed. Also called the AM
or the Analyzer.

Analyzer
The part of the instrument where sample processing and testing are performed. Also called the AM
or the Analytical Module.

Cal
Calibrator. A type of sample with an assigned value used to calibrate a test.

calibrator
A type of sample with an assigned value used to calibrate a test.

carryover
Residual sample material left on the sample probe, after the probe has been rinsed, that carries over
to another sample when the probe enters it.

CM
A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the
User Interface and data management functionality. The CM connects to the Analytical Module and
provides the high level controls.

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Control Module
A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the
User Interface and data management functionality. The CM connects to the Analytical Module and
provides the high level controls.

cuvette strip
Four cells molded together in a disposable plastic piece. Used for testing samples. Multiple cuvette
strips clip together to form cuvette clips.

DI water
Deionized water.

error
An error message indicates that a condition has been detected that requires immediate action.
Failure to act may result in the instrument performing an emergency stop.

focus
To place focus on the unique identifier in a list, click a row in the table. A blue cell border
indicates focus. Only one unique identifier in a list can have focus.

indexer
The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism.

INR
International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time
(PT) worldwide.

ISI
International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and
used to calculate the International Normalized Ratio (INR).

LAS
Laboratory Automation System

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Glossary

mixture
A dilution that requires a two-step dilution process to achieve the required dilution ratio.

neat calibrator
Undiluted calibration plasma (100% strength).

NPP
Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the
International Normalized Ratio (INR) and when calculating test results that use the normalized
ratio.

object
A data item in the Working Area of the ACL TOP application. For example, the unique identifier in
a table, a maintenance activity, or function, etc.

reagent
A liquid material used as part of a test. When mixed with sample, a reagent provides the necessary
constituents to initiate or complete the desired biochemical reaction. For example: test reagents,
diluents, QC/NPP materials, calibrator materials, clean materials, etc.

rounded values
Values are calculated using full precision values. However, when displayed, these values are
rounded to a specified number (n) of decimal places. When rounding of an out-of-range value
results in a false in-range displayed value, the displayed value is flagged to indicate that it is out-of-
range.

select
Click in the Selection column of a table. A red check mark indicates selection. You can typically
select more than one object.

Select
Click in the Selection column of a table. A red check mark indicates selection. You can typically
select more than one object.

selected
Click in the Selection column of a table. A red check mark indicates selection. You can typically
select more than one object.

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Glossary

stat
In medical terminology, immediate; with no delay. Stat samples have highest priority.

test profiles
A test profile is a grouping of tests. When you associate the test profile with a sample, all the tests
in the profile run on sample.

usable volume
The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that
bottle.

validate
The acceptance of test results by the user.

validated
Test results accepted by the user.

warning
A warning message indicates that some user action may be required. Warnings do not affect the
operation of the instrument. However, an error condition may eventually occur if the operator does
not perform the required action.

ZMax
Maximum travel distance of a probe in the Z (vertical) direction, measured at the lowest possible
aspiration point of the probe.

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Index

ACTIVE Status 631

# Activity Definition 804, 807
# Tests or Piercing 806 Adapters 383, 430, 433, 436-437, 447, 453, 477,
770, 932
Add 115, 129, 135, 160, 167, 176, 178, 201, 212,
% 263, 333, 335, 343, 346, 348, 351, 379, 382,
%CV Max 289 392, 394, 406-407, 532, 547, 585, 615, 666,
800, 807, 812, 907, 921, 927, 930
%CV of Corrected Result (CR) 100% 301
Add - Icon 940
%CV of Corrected Results (CR) 304
Add a Comment 462, 480, 924
%CV of Corrected Results (CR) 100% 304
Add a Material 130, 176
Add a Material Load Cycle Definition 176
1 Add a New Maintenance Activity 804, 812
1D Bar Code Reader 412
Add a New Material 129, 333
Add a New Test Definition 940
2 Add a Result Unit 262
2D Bar Code Reader 52, 412, 934 Add a Test 158, 166, 176, 585
2D Bar Code Scanner 80, 412, 417 Add a User-Defined Test Definition 160, 167
Add an Item 115
A Add Hardware Event - Icon 940
Absolute Value of Referenced Curve 240 Add/Remove Material 410-411, 459, 468, 478, 486
Access Level 392, 399, 654 Add/Remove Material - Icon 940
Accessing Alarm Messages 666 Add/Remove Tests 524, 532, 542, 590, 592, 596,
599, 602-603, 615
Accessing Data Flags 792
Add/Remove Tests - Icon 940
ACL TOP Base Model 15
Add/Remove Tests and Profiles 592
ACL TOP Instrument Models 15
Adding a User 394
ACL TOP User Interfaces 79
Additional Preparation 409
ACL TOP Versions 908, 920
Adjusted Y Intercept 514
Acquisition Time 164, 171, 180, 223, 238, 325
Adjustment Volume 87
Acquisition Wavelength 179
After Each Dispensation of Same Material 147
Actions Upon Delivery 74
Airgap 148, 185, 194, 205, 293, 811
Activate Alternate Lot 153, 533, 558
Alarm Buttons 108, 768
Activate Alternate Lot - Icon 940
Alarm Messages 768, 921
Activate Material Lot 135
Alarms 666
Activate Material Lot - Icon 940
Alarms Chart 911
Activate Multiple Lots - Icon 940
Alarms Display Settings 906, 912
Active Lot 151-152, 156, 285, 337, 418, 523, 531,
533, 535, 542, 546, 595 Alarms Display Settings - Icon 940
Active Lot - 2D Bar Code Scan 420 Alarms Filter 906, 915

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Alarms Grid 910 Auto Execution Mode - Icon 947

Algorithm 212, 215, 232, 261, 267, 279, 327, 357, 643 Auto List 567, 592, 600
Aliquoting Area 87, 390 Auto List - Icon 940
Aliquoting Area Expiration Time 87 Auto Print Setup 403
Aliquoting area expiration time (LAS) 390 Auto Run 107, 122, 338, 341, 367, 384, 503-504,
All Results - Filter Option 652 536, 956
All Samples - Filter Option 658 Auto Run Status 107, 122, 956
All Tests - Icon 947 Auto Validation 53, 55, 58, 119, 355, 507
Allow Expiration - UID Option 398 Auto Validation Errors 357
Alternate Lot 133, 137, 156, 299, 336, 418, 469, Automatic Dilution 284
487, 518, 523, 531, 533, 536, 542, Automatic Fluidic Line Priming Cycle 797, 815, 835
546, 590, 947 Automatic Material Identification 412
Alternate Lot - Activate 533 Automatic NPP 532
Alternative Lot - Icon 947 Automatic Positive Material ID 410
Alternative Pre-diluted Test - Icon 947 Automatic QC 341, 543
Alternative Pre-dilution 201 Automatic Routine Clean for all Probes 797, 816, 836
Analytical Cycle Definition 147, 176, 190 Auxiliary Material Status 422-423, 425, 467, 484
Analytical Limitations 67
Analytical Module (AM) 15
B
Analytical Reference 83, 431
Backup 926
Analytical Versions 920
Backward Search Direction - Algorithm 241
Analyzer Alarms 667
Bar Code 12, 15, 52, 54, 57, 79, 129, 141, 360,
Analyzer Alarms - Icon 940 373, 375-376, 383, 410, 414, 417, 430,
Analyzer Status 21, 106, 109, 123, 665, 956 447-448, 459, 471, 478, 489, 505-506,
Analyzer Status Indicators 665 567, 586, 591, 598, 600, 640, 770, 882,
895, 933
Annual and Semi-Annual Maintenance 796
Bar Code - Icon 940
Apply Checks - Icon 940
Bar Code Definitions Setup 373
Apply Consistency Checks 167, 170, 178
Bar Code Errors 421
Apply Filter 666, 923
Bar Code Formats 374
As Needed Frequency Setting 811
Bar Code Label 152, 375-376, 417, 447, 595, 770
As Needed Maintenance 797
Bar Code Label Placement 376
Aspiration Cycles 148, 187, 195, 199, 207, 210,
294, 298 Bar Code Reader 12, 20, 27, 52, 54, 57, 80, 375,
410, 414, 448, 505-506, 567, 600,
Aspiration Information 184
895, 934
Aspiration Point 87, 503, 842, 898
Bar Code Reader Indicator 583
Assay Release Number 172
Bar Code Reading Configuration 373
Assay Settings 172
Bar Coded Samples 598, 600
Assigned Values 137, 155, 412, 417, 508, 510,
Baseline by Moving SD 223
535, 560
Baseline Check 228
Assigned Values - Icon 940
Baseline Time 236
ASTM-1394 Compatible Mode 379
Baseline/Endpoint Averages 236
ASTM-1394 Configuration 377
Batch 11, 288, 314, 598
Austria - IL Location 965
Before You Begin Calibration 522
Auto-Search 118
Before You Begin NPP 531

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Before You Begin QC 538 Calibrator 83, 138, 155, 227, 292, 301, 392, 431,
Belgium - IL Location 965 449, 508, 510, 522, 595
Between Changes in Material Only - Setting 147 Calibrator Lot Number 508, 510
BIOHAZARD - Symbol 7, 9 Calibrator Volume 289
Black Unbolded - Text Symbol 631-632, 635 Canada - IL Location 961
Blue Unbolded - Text Symbol 631-632, 635 Cancel an Operation 127
Bottle Adapters 430, 447, 932 Carriage - Cuvette Shuttle 84
Bottle Type 141, 420 Category Type - Material 140
Brazil - IL Location 961 CAUTION - Symbol 7-8
Bringing Into Operation 74 Cavro Syringe 862
BUSY Status 106 CD-ROM Drive 80
By Number of Piercings - Maintenance 797 CE Certification 47
Certification 75
Change Fluid Waste Container 429
C
Change Rinse Fluid 424
Calculated Units 266, 957
Chapter 1 About This Manual 1
Calculated Value 514
Chapter 10 Sample Analysis 566
Calibrated Result Delta Check 227
Chapter 11 Analyzer Status 665
Calibrated Unit Data 268
Chapter 12 Alarms and Troubleshooting 666
Calibrated Units 266, 958
Chapter 13 System 795
Calibration - DR Parameters 279
Chapter 14 Backup and Restore 926
Calibration - General Parameters 275
Chapter 15 Parts and Consumables 932
Calibration - Icon 947
Chapter 16 Reference 939
Calibration - Programming 522
Chapter 17 IL Locations 960
Calibration Curve 53, 55, 58, 153, 279, 301, 316,
322, 508, 510, 513, 638, 950 Chapter 2 General Information 10
Calibration Details 320, 507-508, 523, 793 Chapter 3 User Interfaces 79
Calibration Feasibility 495, 947 Chapter 4 Setup 128
Calibration Feasibility - Icon 947 Chapter 5 Preparing the System 409
Calibration Frequency 278 Chapter 6 Starting and Stopping the Instrument 499

Calibration Information 516, 793 Chapter 7 Calibration 507

Calibration Jobs Counter 654 Chapter 8 Normal Pool Plasma 525
Calibration Mode 275 Chapter 9 Quality Control 533
Calibration Points 950 Chart Icons 950
Calibration Points Definition 288 Chart View 546, 557-558, 562, 564
Calibration Report 511 Chart View - Icon 946
Calibration Result 275, 356, 507 Chart View Display Settings 560
Calibration Setup 272 Chart/Grid View - Icon 946
Calibration Statistics 513 Check Value - Data Curve 241
Calibration Status List 284, 508, 520, 793 China - IL Location 963
Calibration Status List - Icon 941 Chromogenic Absorbance Measurement 13
Calibration Units 275, 522, 958 Clean Airgap 148, 188, 195, 199, 207, 210, 294, 298
Calibration/NPP/AR 83 Clean and Rinse Cycles 187, 195, 199, 207, 210,
294, 298
Calibrations Counter 654

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Clean B Diluted 90, 148, 184, 188, 195, 199, 207, Confirm Password 398
210, 294, 298, 449-450, 575 CONNECTING Status 106
Clean Cup Area 480, 797, 817, 826, 837, 852 Connectors - Monitor 44
Clean Cuvette Waste Drawer 816, 836 Consistency 165, 178, 332, 493
Clean Deep Wash and Clean Cup Area 817, 837 Consistency Check 167, 175, 332
Clean Fluid 8, 36, 425, 467, 484, 771, 956 Containers 52, 54, 57, 86, 383, 433, 453, 770, 840
Clean Fluid Status 467, 484, 956 Control Module (CM) 15
Clean Material 22, 90, 148, 184, 188, 195, 199, Controlled Stop 35, 88, 106, 503, 665
207, 210, 294, 298, 384, 388, 449-
CONTROLLED STOP Status 106
450, 575, 811, 819-825
Controllers 893
Clean Monitor 884
Conversion Factor - Result Units 266
Clean Rack Areas 817, 838
Cooling - Icon 947
Clean Reagent Cooling Filter 885
Copy - Icon 941
Clean Solution System 15
Copy a Test 160
Clean Total Volume 149, 188, 195, 199, 207, 210,
294, 298 Copy Alternative Lot - Icon 941
Clean Transport Airgap 149, 188, 195, 199, 207, Copyright ii
210, 294, 298 Correction Factor - Calibration Setting 276
Clean Transport Volume 149 Correlation Range Minimum and Maximum 270
Clean Volume 148, 188, 195, 199, 207, 210, 294, 298 Cover 835, 893
Clear QC Selection - iCON 941 Cover Open - Maintenance Req. 806
Clear Rack - Icon 941 Cover Opening - Icon 947
Clear Tree Selection 539, 543, 557 Create a User-Defined Test 160, 167
Clear Tree Selection - Icon 941 CTS Foot Cleaning 817, 839
Closed Tube Sampling 52, 54, 453 CTS Parameters 372, 454
Clot Curve Analysis 643, 950 CTS Piercer/Probe Replacement 868
Coagulometric Turbidimetric Measurement 13 CTS Probe 455
Codabar NW(7) Japan 375 Curve Analysis 643
Code 128 375 Cut-off - Calibration Setting 283
Code 39 375 Cuvette 17, 57, 78, 83, 182, 192, 204, 285, 371,
Color Codes 21, 106, 122, 470, 488, 581, 628, 384, 389, 422, 467, 505, 585, 770, 816,
950, 952, 954, 956 887, 933, 956
Color, Visual Style 92 Cuvette Blind Volume 371
Comments 144, 336, 397, 462, 480, 508, 519, 525, Cuvette Box - Term 83
547, 558 Cuvette Cell - Term 83
Comments - Icon 941, 947 Cuvette Dead Volume 186, 192, 204, 290
Common Functions 110 Cuvette Door 956
Commonly Used Terms 5 Cuvette Evacuation Cycle 797, 818, 840
Communications - LIS 377 Cuvette Holding Area - Icon 941
Component Delimiter 380 Cuvette Holding Area - LAS 585
Compute Value from Calibration Curve Equation 322 Cuvette Loader 25, 84, 467, 485, 956
Concentration13, 83, 201, 279, 307, 318, 322, 566, 957 Cuvette Loading Area 25
Configure Display Settings 404 Cuvette Overflow Volume 371
Configure Maintenance Activity 807 Cuvette Shuttle 25, 84
Configuring NPP 320 Cuvette Slot - Term 85

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Cuvette Strip - Term 85 Delimiter - LIS 380

Cuvette Waste - Term 86 Delta - QC Results 563
Cuvette Waste Bin 85 Delta Algorithm 254
Cuvette Waste Container 39, 85, 840 Delta Checks 226, 247
Cuvette Waste Drawer 17, 86, 796, 816, 836, 882 Delta of Curve 235, 775
Cuvette Waste Status 467, 484, 956 Demographic 402
CV 60, 267, 304, 315, 563 Derivative Units 267, 958
CV% 511 Derived from Calibration 322, 514
Czech Republic - IL Location 965 Derived from Calibration - NPP 322
Details - Icon 941
D Diagnostics 886
Daily Maintenance 795 DIAGNOSTICS Status 106
Damage during Transportation 77 Diluent90, 197, 208, 296, 447, 460, 472, 476, 492, 568

Dangers 8 Diluent Area 17, 460, 472, 476-477, 492, 568

Dark Readings 891 Diluent Area - Icon 941
Data Flags 772, 792 Diluent Material 272, 314
Data Reduction Parameters 212 Diluent Rack 447, 473, 490, 538, 932
Date & Time - Sample Parameter 629 Diluent Rack Details 476, 490
Dead Volume 141, 186, 192, 204, 290 Diluent Volume 289
Dec. - Result Unit Setting 265 Diluted LIS Number 202
Decimals 268 Dilution Parameters 371
Decontamination 882 Dilution Point 279
Deep Wash Area 837 Dilution Process 314
Default File Path 369 Direct Delivery Mode 272
Deficient Plasma 90, 132, 140 Direct Test 13
Define Points by % Dilution 285 Disable a Test 162
Define Points by Target Concentration 285 Disclaimers 77
Defining QC Profiles 348 Diskette Drive 81
Delay Time 173, 180, 223, 276 Dispensation Information 185
Delete 116, 132, 161, 177-178, 263, 333, 342, Display Alternate Lot 560
382, 396, 585, 814 Display Derivative Curves 368, 641, 644
Delete - Icon 941 Display Diluent Area 567
Delete a Calibration Point Value 510 Display Overview - User Interface 404
Delete a Maintenance Activity 813 Display Reagent Area 567
Delete a Material 129 Display Sample List 567
Delete a Material Load Cycle Definition 177 Door Open Status 467
Delete a QC Profile 348 DR Errors 329
Delete a QC Test 333 DR Flag - Icon 947
Delete a Result Unit 263
Delete a Test 161, 342, 585, 622, 940 E
Delete an Item 116, 804 Edit - Icon 947
Delete Test - Icon 941 Edit a Parallelism Definition 312
Deleting a User 396 Edit a QC Profile 348

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Edit a User 395 Enable Import Calibration 275

Edit Assigned Values 155 Enable Incubation Time 186
Edit Global Options 370 Enable Initial Slope Check 238
Edit Hardware Event - Icon 941 Enable ISI Value 135
Edit NPP 320 Enable Keypad 370
Edited Point 950 Enable Keypad for Sample ID 370
Electrical Requirements 71 Enable Large Intercharacter Gap 375
Emergency Stop 20, 106, 499, 502, 505, 918 Enable LAS Track 388
Emergency Stop Button 20, 506 Enable Last Point Check 220
EMERGENCY STOP Status 106 Enable Linear Range 270
Empty Cuvette Waste 818, 840 Enable Linear Regression SD Error Check 237
Empty Material 90 Enable Linear Regression SD Warning Check 237
Empty Waste Fluid 818, 841 Enable LIS 378
Enable %CV Check 279 Enable Lot Management 151, 155, 358
Enable 0% Dilution Target Value 280 Enable Max Difference 265
Enable a Test 162, 173, 180 Enable Mix 186, 192, 204, 290
Enable Agitation 147, 149 Enable Monotonic Check 282
Enable Alternate Lot 153, 536 Enable Multiple Threshold Check 230
Enable Ambient On-Board Stability Tracking 135 Enable Normal Range 270
Enable as Paired Test 174 Enable Normalization Method 216
Enable as Shadow Test 173 Enable Normalized Curve Delta 226
Enable Auto-Validation 356 Enable Normalized Data Checks 225
Enable Automatic Execution 324 Enable NPP 321
Enable Bar Code 373 Enable Optical Interference Check 260
Enable Baseline by Moving SD 223 Enable Outlier Removal 279
Enable Baseline Check 228 Enable Paired Test Dependency 174
Enable Calibration 274 Enable Parallelism 313
Enable Check Wavelength 176, 366 Enable R2 Check 282, 318
Enable Checksum 375 Enable Range for Secondary Algorithm 261, 279
Enable CTS 454 Enable Raw Data Checks 219
Enable Curve Sequence Check 221 Enable Reagent Bar Code Reading 373
Enable Display of Derivative Curves 644 Enable Reference Method 215, 240
Enable Display Transformed Axes 514, 642 Enable Refrigerated On-board Stability Tracking 135
Enable Endpoint Check 229 Enable Rerun 326
Enable Expiration Tracking 143 Enable Result Correlation 269
Enable Extended Expiration Date 152 Enable Reverse Slope Check 283
Enable Extended Test Mode 181 Enable Rules 337
Enable Extrapolation 279 Enable Sample Bar Code Reading 373
Enable First Point Check 219 Enable Sample Pre-Dilution 190
Enable Frequency 278, 324 Enable Signal Check 220
Enable Global Reflex 368 Enable Slope Check 280, 316
Enable Global Rerun 368 Enable Spike Removal Check 222
Enable Host Communication 378 Enable Substitution Method 221

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Enable Test Range 271 Expected Y-Intercept 281

Enable Therapeutic Range 270 Expiration Date 133, 143, 420, 468, 470, 486, 488,
Enable Threshold Check 241 518, 529, 536, 563, 641
Enable Threshold Check Error 241 Export 125, 131, 137, 155, 158-159, 166, 170,
360-362, 623, 941
Enable Time Span Check 241
Export a Definition 361
Enable Trend Check 282
Export a Report 555, 638, 654, 799, 921
Enable Volume Threshold 143
Export a Test 361
Enable Warning Threshold 143, 278, 324, 338-339,
800, 809, 811, 815-834 Export a Test Definition 159
Enable Wavelength Warnings/Errors 215 Export Assigned Values 155
Enable Y-Intercept Check 280 Export Data 125, 360
Enable/Disable Test 162-163, 948 Export NPP Status List 527
Enable/Disable Tests - Icon 941 Extended Acquisition Mode Extension 370
Enabled Material 134 Extended Acquisition Time 181, 202, 325
Endpoint Algorithm 233 Extended Acquisition Time - Rerun Rule 325
Endpoint Check 229 Extended Jobs Counter 654
Endpoint Time 233 Extended Test - Icon 947
England - IL Location 968 Extended Tests Counter 654
Enhanced Clean for All Probes 819, 842 Extended Time 181, 262
Enhanced Clean for LAS Probe 797, 820, 844 External Communications Alarm - Icon 942
Enhanced Clean for Reagent 1 and 2 Probes 821, 845 External Communications Alarms 667
Enhanced Clean for Reagent 1 Probe 797, 822, 846 Extrapolate Substitution Method 221
Enhanced Clean for Reagent 1, 2 and Sample
Probes 835 F
Enhanced Clean for Reagent 2 Probe 797, 823, 847 Factor - Result Units 266
Enhanced Clean for Reagent Probe 824, 848 Factor Parallelism 301-302
Enhanced Clean for Sample Probe 825, 849 Factor Parallelism - Criteria 302
Enhanced Dispense 185 Factor Parallelism - Reporting Units 302
Environmental Conditions 73 Favorites 2
ERange 260 Feasibility Test List 492
Error - Icon 947 Feasibility Test List - Icon 942, 947
Error Alarm Buttons 768 Field Delimiter 380
Error Data Flags 772 Fill Volume 143, 372, 439
Error Limit 237 Filter 117, 128-129, 158, 163, 333, 335, 545-546,
Error Limit and Tolerance 260 550, 625, 658, 666, 799, 807-808, 813, 880,
Error Messages 108, 215, 666 906-907, 923
ERROR Status 106 Filter - Icon 942
Error Status - Icon 947 Filter by Current Date 659
Errors - Bar Code 421 Filter by Failed Jobs 661
Escape Delimiter 380 Filter by First Test Performed Date/Time 658
Events 908, 922 Filter by Job Error 664
Exact Start/End Time 236 Filter by Job Type 663
Exit the ACL TOP Software 127, 501 Filter by Last Test Performed Date/Time 658
Expected Slope 280 Filter by Ordered Date/Time 659

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Filter by Patient ID 661 General Feasibility 493

Filter by Patient Last Name 661 General Information - Tests 10, 169
Filter by Sample Highest Error 661 General Log 106, 665-666, 921
Filter by Sample ID 659 General Log - Icon 942
Filter by Sample On Board 662 General Log Button 921
Filter by Sample Print Status 660 General Log Detail Report 922
Filter by Sample Priority 659 General Log List Report 924
Filter by Sample Status 661 General Toolbar 99
Filter by Sample Upload Status 659 Germany - IL Location 966
Filter by Sample Validation Status 660 Getting Started 82
Filter by Test Code 618, 663 Global Definitions 366
Filter in Use - Icon 942 Glossary 83, 969
Filter Maintenance Activities 799, 804 Go to Test Definition - Icon 942
Filter Material List 128 Graph Icons 950
Filter QC Results 545-546 Greatest Max 232
Filter Report Data 550 Greatest Max Peak Search Method 251
Filter Test List 158, 163 Greatest Max/Min Couplet 246
Final Minus Initial Algorithm 256 Greatest Max/Min to Zero Couplet 232
Find 118, 617, 625 Grid Icons 947
Find - Icon 942 Grid View - Icon 946
Find a Material 130 Gripper 84
Find a Test 162
First and Second Derivative Algorithms 243, 950 H
First Concentration 282 Hamilton Syringe 862
First Derivative 243, 950 Hardware Components Version 909
First Derivative Bound Check 232 Hardware Events 908
First Peak Boundary Check 232 Hazards 8
Fluid Precision Test 904 Head Volume 184, 193, 205, 292
Fluid Precision Test Report 894 Head Volume Airgap 185, 194, 206, 293
Fluid Waste 36, 427, 771 Help 1
Fluids 427, 894 Help - Icon 942
Focus 112-113, 614 Hold Time 149, 188, 195, 199, 207, 210, 294, 298,
Foot and Probe Inspection 825, 850 811, 816, 819-825, 832
Footer 402 Holding Area - LAS 585
Formatting Reports 400 Home Bar Code Reader - Icon 942
Forward Search Direction - Algorithm 241 Hong Kong - IL Location 963
France - IL Location 965 Host Communications Configuration 377
Frequency 72, 108, 147, 278, 320, 338-340, 532, Host Configuration 378
543, 563, 805, 810, 815-834, 881 Host Downloading 377, 379
Futura Compatible Protocol 379 Host Uploading 377, 379
Hungary - IL Location 966
G
General Consistency 493

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Instrument Temperatures 919

I Intended Use 11
Icons 940, 947, 950 Interface Module Embedded System - IM 87
IL Corporate Headquarters 46, 960, 962 Interference 8, 66, 260, 301
IL Locked - Maintenance Setting 809, 811 Interleaved 2 of 5 - Setting 375
IL Logo - Icon 942 Intermediate Reagent 87, 132, 140, 430
IL Material/Test - Icon 947 ISI Value 130, 151-152, 266, 392, 417, 526, 549, 606
IL Revision Comment 172 Italicized Text Symbol 631-632, 635
IL Test - Default Criteria 302 Italy - IL Location 966
IL Test - Test Setting 171
IL World Wide Locations 960 J
IM - Interface Module Embedded System 87 Japan - IL Location 964
Immunological Measurements 14 Jaw - Cuvette Shuttle 84
Import - Icon 942 Job Frequency Alarm - Icon 943
Import a Definition 360 Job Frequency Alarms 667
Import a Test 363 Job Type - Icon 947
Important Symbols 7
Imported Calibration Unit 276 K
Imported Data Type 276 Keyboard 15, 53, 58, 80
Imported Test 161-162, 165, 276, 364 Keypad 21
Incubation Range 186 Known Material 90
Incubators 34, 87, 895, 919 Korea - IL Location 966
Indexer - Cuvette Loader 25, 84
India - IL Location 964
L
Indirect Delivery Mode 272
Label - Result Units 264
Indirect Test 13
Laboratory Header - Reports 401
Information - Icon 947
Language Setup 408
Information Panel 92, 109
LAS Adapters 441
Inherit LIS numbers from parent test 173
LAS Aliquoting Area 87
Initialize All Arms 900
LAS Arm 18, 87, 385, 388, 816, 819, 824, 832,
INITIALIZING Status 106 844, 898
Input Devices 79 LAS Configuration 387
INR Formula 152 LAS Cuvette Holding Area 87, 385, 448, 570, 585
INR Results - Reporting 136 LAS Manager 22, 88, 384
INR Unit Data 268 LAS Overview 383
INR Value 152 LAS Position ID 629
Insert Rack - Icon 942 LAS rack ID 629
Inserted Rack 413 LAS Sample 24, 88, 122, 357, 368, 390, 498
Installing the ACL TOP 68 LAS Status 88, 107, 956
Instrument Configuration - Icon 943 LAS Terminology 87
Instrument Decontamination 882 LAS Track 18, 87, 89, 384-385, 439, 503, 595,
Instrument Description 15 629, 898
Instrument Status 905 Last Concentration 282

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Last Days 557 Lot Management 151, 155, 299, 358, 532, 542,
Last Execution Date/Time 806 560, 590
Last Max 232 Lot Selection 595
Last Max Peak 246 Lot Specific Comment 153
Last Max/Min Couplet 232, 246 Low Fill Tubes Handling 372
Last Max/Min to Zero Couplet 232
Last Modification - Material Setting 153 M
Last Modification - User Security 398 Main Screen 93
Last Points - QC Results 557 Maintenance Activities 835
Layout - UI 92 Maintenance Alarm - Icon 943
Least Squares - Algorithm 232 Maintenance Alarms 667
LED Status Color Codes 956 Maintenance Definitions 815
Less Frequently Ordered Items 934 Maintenance List 799
Levey-Jennings Chart 558 Maintenance Overview 799
Limit Value - Algorithm 240 Maintenance Schedule 795
Limitations and Disclaimers 77 MAINTENANCE Status 106
Limited Warranty 68 Manual Material Identification 413
Linear - Result Units 265 Manufacturer 46, 139, 563
Linear Kinetic Algorithm 234 Master Paired Test 174
Linear Regression - Calibration 280 Material 90, 183, 410-411, 423, 425, 459, 468,
LIS - Laboratory Information 478, 486
System 80-81, 158, 164, 377 Material Alarm 422-423, 425
LIS Configuration 377 Material Alarm - Icon 943
LIS Host Alarms 666 Material Alarms 667
LIS Number 171, 181, 202, 313 Material Definition 128, 135
LIS Status 107, 956 Material Definition - Icon 942
Lithuania - IL Location 967 Material Definition Report 137
Load Cycle 182 Material Identification 410
Loading Racks 448 Material Index 133, 139
Locate 1 Material Information 412, 417, 529, 940
Location Information - Onboard Materials 145 Material List 128
Locations - IL Offices 960 Material List - Icon 942-943
Lock a User 394 Material Manufactured by IL 133
Lock Status - Icon 947 Material Name 139, 334, 336, 468, 486, 497
Locked Status Column 393 Material On-Board 128, 947
Log 106, 665, 921 Material Onboard - Icon 947
Log - Icon 943 Material Programming Window 407
Log Details 666, 923 Material Referenced 133
Log In 111 Material Referenced - Icon 947
Log On Name 397 Material Restriction Map 128
Log Out 127 Material Restriction Map - Icon 943
Log Report 921 Material Status Enabled/Disabled - Icon 947
Login Name 397 Material Type 140
Lot ID 133, 145, 152, 420, 468-469, 486-487, 536, 563 Material/Sample Volume 185

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Material/Test Tree View 940 Mode 1: Midpoint of Normal Range 320

Material/Tests Definition Tree 539 Mode 2: User Input NPP Value 320
Math Model 280, 305, 322, 509 Mode 4: Derived from Calibration (Default) 320
Math Model Low 280, 283, 509 Monitor 42, 53, 55, 58, 81, 884
Max 653 Monitor Volume Control 42
Max Difference 265, 357 Monitor, Clean 884
Max Tolerance 227 Monotonic Check - Calibration 282
Max Tolerance Warning 227 Monovette Tubes 436
Max. Consecutive Dispensations 366, 371 Monthly and Quarterly Maintenance 796
Max. Cuvettes per Dilution 371 Most Frequently Ordered Items 933
Max. Peak Delta % Check - Algorithm 232 Mouse 80
Max. Peak Delta Check - Algorithm 232
Max. Syringe Volume 366 N
Maxima Peak Check - Algorithm 232 Navigation Toolbar 101
Maximum Error Limit - Algorithm 238 Neglect and Misuse 77
Maximum Warning Limit - Algorithm 239 Nero Express Essentials 930
Mean 653 Netherlands - IL Location 967
Mean Check 228 New Scanned Data - 2D Bar Code 420
Mean of 100% 303 Next Execution Date/Time 806
Mean of Calibration Point Replicates 322 Next Job - Icon 943
Mean of Corrected Results - CR 303 Next Rack - Icon 943
Mean of Corrected Results - CR 100% 304 No Axis Transformation 514
Mean Value 514 No Scrollable Columns 620
Measured Parameters 13 No Tests - Icon 947
Measured Result Curve Display Settings 265 Non-IL Brand Product 78
Measured Units 957 Non-IL Brand Product Disclaimer 73
Menu Bar 94 Non-IL Reagents 73
Messages 666 Normal Jobs Counter 654
Method 214, 221, 223, 226, 236, 269 Normal Pool Plasma 320, 431, 525
Mexico - IL Location 961 Normal Range 165
Midpoint of Normal Range - NPP 322 Normal Test - Icon 947
Minima Peak Check - Algorithm 232 Normal Tests Counter 654
Minimum - Results Statistic 653 Normal, Therapeutic, Linear and Test Range 265
Minimum Aspiratable Volume 191, 203, 291 Normalized Curve delta 226
Minimum Cuvette Volume for Mix 366, 371 Normalized Data Checks 225
Minimum Cuvette Volume for Test 371 NOT CONNECTED 106
Minimum r2 272 NOT FEASIBLE 631
Minimum Replicates 289 NOT FEASIBLE Status 154
Minimum Syringe Volume 371 NOTE - Symbol 7
Misuse 77 NPP 83, 128, 155, 174, 320, 358, 431-432, 525,
Mix - Setting 186, 288, 290 531, 657
Mix Volume - Setting 186, 192, 204, 290 NPP - Configuring 320
Mixture Volume - Setting 289 NPP - Derived from Calibration 322

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NPP - Midpoint of Normal Range 322 ORU Linearity Test 892

NPP - Normal Pool Plasma83, 322, 431, 514, 525, 531 Other Alarms 667
NPP - Run as Sample 322 Output Devices 81
NPP - User Input NPP Value 322
NPP Counter 654 P
NPP Details 525, 529, 531, 794 P/Ns 433, 932
NPP Feasibility 496 Paired Result Data 268
NPP Feasibility - Icon 947 Paired Test
NPP Jobs Counter 654
Result Units 959
NPP List Report 526-527
Paired Units 267
NPP Mode 320, 514, 531
Parallel Jobs Counter 654
NPP Overview 525
Parallelism 53, 55, 58, 164, 171, 301, 312, 325,
NPP Results Report 527 355, 370, 389, 494, 605, 634, 642, 663,
NPP Status List 528 950, 957
NPP Value 514 Parallelism - Icon 947
Number of Cycles 186, 192, 204, 290 Parallelism Definition 312
Number of Dilutions 308, 314 Parallelism Detail 315, 634
Number of Entries 109 Parallelism Feasibility 494
Number of Points - Algorithm 232 Parallelism Feasibility - Icon 948
Number of Replicates 164, 182, 275, 314 Parallelism LIS Number 313
Number of Results 653 Parallelism Mode Extension 313, 370
Number of Seconds 215, 228 Parallelism Point Units 315
Parallelism Report 638
O Parallelism Result 302, 356, 642

Off Line Rack 410, 458, 581, 600 Parallelism Result Report 638

Offset 269 Parallelism Setup 312

Omit Point 548, 557 Parallelism Testing Options 302

Omit Point - Icon 944 Parallelism Tests Counter 654

Omitted Point 950 Parallelism Units 303, 316, 957

Onboard Racks 582 Parameter Input 166

Onboard Stability 144 Parent Test 161, 173, 180, 202

Onboard Volume 468, 486 Part Numbers i, 433, 932

Onboard Waiting for Volume - Icon 944 Partial Item/Test - Icon 948

Open Calibration Status List - Icon 944 Parts and Consumables List 932

Open QC Results List - Icon 944 Password 111, 398

Open Sample Details - Icon 944 Patient Demographics 369, 586, 592, 613, 623, 634,
636, 944
Operating Principles 13
Patient Demographics - Icon 944
Operations Toolbar 100
Patient Priority 367
Optical Reading Unit - ORU 888
Patient Report 171, 402, 611, 622-623
Orange Bold - Text Symbol 631-632, 635
Patient Result 265, 356, 549, 611
ORU - Optical Reading Unit 34, 91, 888
Patient Result Selection 265
ORU Blanking Area 890
Patient Samples 28, 53, 55, 58, 61, 372, 403, 567, 613
ORU Blanking Procedure 890
Patient Test - Icon 948

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Patient Tests Counter 654 Primary Unit Configuration 265

Peak Checks - Algorithm 249 Primary Wavelength 179, 212, 215
Peak Count Check - Algorithm 232 Print 4, 120, 129, 155, 158, 163, 623, 804
Peak Delta % Check - Algorithm 232 Print - Icon 944, 948
Peak Delta Check - Algorithm 232 Print a Calibration Report 511
Peak Search Method - Algorithm 232 Print a Results Statistics Report 651
Percentage of the Curve - Algorithm 241 Print a Test Counters List Report 654
Percentage of Time 223, 911 Print a Test Definition 159
Perform Activity 804 Print an NPP List Report 526
Perform Activity - Icon 944 Print an NPP Results Report 527
Performing a Calibration 522 Print Assigned Values 155
Performing a Normal Pool Plasma Measurement 531 Print Maintenance List 800
Performing a Quality Control Test 538 Print Material List 129
Performing Maintenance Activities 835 Print Preview 130, 622
Piercer Probe Installation Procedure 877 Print Report 526, 638, 654
Piercer Probe Removal Procedure 875 Print Report - Icon 944
Piercer/Probe Replacement 868 Print Screen 121, 131, 137
Pivot Arm 84 Print Status 628
Place Focus 112, 614 Print Test List 163
Placed Material 90 Printer 81
PLACED Status 629 Priority 24, 330, 367, 385, 430, 468-469, 486-487,
Plasma Collection 566 582, 590, 608, 617, 628, 659, 792, 952
Plasma Separation 566 Priority - Icon 948
Poland - IL Location 967 Priority Codes 595
Popup Alarms 667 Priority Status 385, 628
Port Configuration 381 Probe 9, 33, 52, 54, 57, 87, 184, 192, 204, 291,
371, 384, 425, 432-433, 453, 795, 809, 815,
Portugal - IL Location 967
836, 864, 868-869, 873, 875, 877, 882, 886,
Position in Rack 629 900, 934
Power Connector 19 Probe and Seal Assembly Installation Procedure 873
POWER UP Status 106 Probe and Seal Assembly Removal Procedure 869
Pre-Dilution - Diluent 190 Probe Coordinates Adjustment 898
Pre-Dilution - General 190 Probe Replacement 868
Pre-Dilution - Sample/Mixture 190 Probe Syringe 33
Preparation Cuvettes 89 Profile161, 342, 344-346, 348, 406, 540, 590, 599, 602
Previous Job - Icon 944 Profiles List 342, 346, 348-349
Previous Rack - Icon 944 Program All Levels of QC 538
Previous Screen 119, 131, 135, 137, 158, 160, 166- Program Material Placement 407
167, 169, 176-177, 190, 201, 212,
Program Tests and Profiles Placement 406
214, 218, 225, 232, 262-263, 272-
273, 312, 320, 325, 333, 335, 343, Programming a Bar Coded Sample 598
346, 348-349, 394, 508-510 Programming a Calibration 522-523
Previous Screen - Icon 944 Programming a Non-Bar Coded Sample 600
Primary Algorithm 232, 261, 267 Programming a QC Profile 543
Primary Unit 165, 265, 308, 315 Programming an NPP 531

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Programming QC 538, 542, 545 r2 Check 282, 301

Progress Bar - Operations 127 Rack Details 410, 458-459, 476-478, 524, 531-
Purge Data 549 532, 542, 586, 590, 599-602
Purple Bold - Text Symbol 631-632, 635 Rack Details - Icon 945
Push Buttons 80 Rack ID 597, 609, 629, 638
Rack Summary Information 597
Racks 27, 52, 54, 57, 131, 374, 385, 410-411, 414,
Q 430-431, 433, 436-437, 448, 453, 459-460,
QC - Icon 948 465, 470-471, 476-478, 483, 488-489, 543,
QC Alarm - Icon 944 567-568, 586, 592-593, 600, 602, 770, 834-
QC Alarms 667 835, 838, 858, 860-861, 893, 932

QC Comment - Icon 948 Raw Data Checks 218, 261, 357

QC Counter 654 Raw Data Report 623

QC Feasibility 492, 569 Reaction Curve 176, 223, 226, 241, 508, 525, 547, 641
Reaction Curve - Icon 948
QC Feasibility - Icon 948
QC Feasibility List 495, 569, 586 Reaction Cuvettes 422

QC Jobs Counter 654 Reaction Information 517, 525, 793

QC List 155, 333, 335, 539 READY Status 106

QC Material 90, 153, 333, 337, 537-538 Reagent and Diluent Map 458, 460, 476, 568

QC Omitted Point - Icon 948 Reagent Area 17, 53, 55, 58, 144, 188, 195, 199,
207, 210, 294, 298, 373, 430, 448,
QC Overview 533 458-460, 465, 472, 476-478, 483,
QC Point Number 562 492, 568, 838, 885, 888, 895
QC Points 950 Reagent Area - Icon 945
QC Profile 346, 348, 540 Reagent Arms 31
QC Profiles List 346, 348-349 Reagent Color Codes 468, 470, 486, 488
QC Results - Icon 944 Reagent Diluent Area 477
QC Results List 534, 545 Reagent Incubator 34, 87
QC Results Status List Report 554 Reagent Rack 27, 458-459, 462, 464, 477-478,
QC Setup Definition 335 480, 482, 505-506, 770, 932
QC Statistic Report 555 Reagent Rack Details 468, 486
QC Statistics 534, 538, 546, 794 Reagent Racks, Diluent Racks and Bottle
Adapters 935
QC Statistics Filter 557
Reagent Specifications 73
QC Status 337, 535, 563
Reagent Status Color Codes 954
QC Status Enabled/Disabled - Icon 948
Reagent Temperatures Area 893
QC Test Status List 537-538
Reagents 15, 52, 55, 57, 73, 78, 83, 128, 136, 276,
QC Tests Status Report 555
430, 458, 460, 465, 469, 476-477, 483,
QC Tracking 547 487, 568
QC Tracking Information 547 Recalculate 212, 508, 510, 526, 549, 605, 622
Quality Control Alarms 667 Recalculate - Icon 945
Quality Controls 431 Recalculate Calibration 508, 510
Query Point 89, 384 Recovery 505-506, 940
Red Bold - Text Symbol 631-632, 635
R Reference Readings 891
r2 147, 301, 513, 575 Reference Readings Area 891

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Reference Section 939 Result Ranges 327

Reflex Counter 654 Result Unit 60, 261-262, 327, 334, 336, 351, 562,
Reflex Definition 351 632, 635, 653
Reflex List 351 Result Unit Definition 262
Reflex Rules 351, 368 Result Unit Label 264
Reflex Test 351, 947 Result Unit to Test 327
Refresh 498, 666, 923 Results 526, 545, 625
Refresh - Icon 945 Results from Selected Jobs 653
Refresh/Close 498 Results Inside Normal Range 652
Refrigeration 133, 145 Results Statistics 624, 651
Remaining Stability 468, 470, 486, 488, 954 Results Statistics Filter 652
Repeat Delimiter 380 Results Statistics Report 651
Replace CTS Filter and clean Clean Cup Area 826, 852 Resume Auto Run 504
Replace CTS Piercer 826, 853 Retry - Button 421
Replace CTS Piercer/Probe 868 Return to Previous Screen 567
Replace LAS Syringe 826, 853 Review 137, 508, 622
Replace LAS Syringe Tip 827, 853 Reviewing QC Results 545
Replace Reagent 1 and 2 Syringe Tips 827, 853 Reviewing Sample Status 604
Replace Reagent 1 Syringe 827, 853 Reviewing Test Results 605
Replace Reagent 1 Syringe Tip 827, 854 Revision History Report 359
Replace Reagent 2 Syringe 828, 854 Rinse 21, 135, 186, 192, 204, 291, 423, 427, 449-
450, 455, 467, 484, 500, 575, 770, 795,
Replace Reagent 2 Syringe Tip 828, 854
835-836, 882, 889, 900, 933, 956
Replace Reagent Syringe 828, 854
Rinse After Mix 192, 204, 291
Replace Reagent Syringe Tip 828, 854
Rinse and Clean 35, 146, 187, 194, 198, 206, 209,
Replace Sample Syringe 829, 854 293, 297, 467, 485, 575, 795, 882
Replace Sample Syringe Tip 829, 854 Rinse Fluid 35, 423, 467, 484, 795, 956
Replace with Previous Value 221 Rinse Fluid Status 467, 484, 956
Replacing the Syringe 862 Rinse Solution System 15
Replacing the Syringe Tip 862 Rinse Time 147, 186-187, 194, 198, 206, 209, 293, 297
Replicate 265, 275, 377, 514, 525, 597, 639, 644, 950 Rinse Time After Mix 186, 190
Rerun 53, 55, 58, 144, 201, 325, 368, 384, 494, Rinse/Clean Priming Cycle for All
609, 631, 635, 641, 656, 663 Probes 829, 835, 855
Rerun Counter 654 Rinse/Clean Priming Cycle for LAS Probe 830, 855
Rerun Priority 330 Rinse/Clean Priming Cycle for Reagent 1
Rerun Rules Setup 325, 609 Probe 830, 835, 855
Rerun Test - Icon 948 Rinse/Clean Priming Cycle for Reagent 2
Reset - Icon 945 Probe 831, 856
Reset Counters 654 Rinse/Clean Priming Cycle for Reagent Probe 831, 856
Restore 119, 137, 170, 178, 333, 335, 505-506, Rinse/Clean Priming Cycle for Sample Probe 832, 857
510, 548, 623, 926, 929 Routine Clean for all Probes 816, 832, 836
Restore - Icon 945 Routine Clean for All Probes 857
Restore Point 548 Rrinse Solution System 150
Restriction Map 129, 448, 569, 586 Rules 144, 161, 173, 325, 337, 351, 360, 368
Result Correlation Formula 269 Rules for Deleting a Test 161

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Run 4, 27, 122-124, 367, 414, 462, 480, 504-505, Sample On Board 613, 662
523-524, 531-532, 540, 542, 593, 598-603 Sample Onboard - Icon 948
Run as Sample - NPP 322 Sample Pre-Dilution 190, 285, 314
Run Jobs - Icon 945 Sample Rack Details 524, 531, 542, 590, 640
Run Multiple QC's 940 Sample Rack Details Toolbar 592
Run Optimization 367 Sample Racks and Adapters 936
Run Tests 123, 569, 586, 591 Sample Result Report 613
Russia - IL Location 968 Sample Status 122, 384, 581, 604, 628, 632, 635,
661, 952
S Sample Status - Icon 948
Safety 8, 17, 68, 77, 375 Sample Status Color Codes 581, 628, 952
Safety Covers 15, 770 Sample Tube Queue 22, 89, 385
Sample 83, 432, 460, 476, 478, 492, 524, 532, Sample Type 91, 524, 532, 542, 595
542, 567-568, 585, 590-591, 598-603, Sample/Mixture 193, 205
606-607, 613, 615-616, 634, 637, 644, Sarstedt Rack 435, 437, 937
792-793
Sarstedt Rack with Monovette Tubes 436
Sample Area 52, 54, 57, 374, 406, 432, 448, 460,
Save 119, 138, 178
476, 478, 492, 523-524, 531-532,
538, 542, 567-568, 571, 581, 585, Save - Button 421
590, 598-603, 895 Save - Icon 945
Sample Area - Icon 945 Scale +/- 560
Sample Area Toolbar 591 Scan 129, 412, 414, 417-418
Sample Arm 23, 431, 453, 868 Scan - 2D Bar Code 128
Sample Aspiration Time 88, 390 Scan Material Data - Icon 945
Sample Collection and Storage 566 Scheduled Material 83
Sample Containers and Adapters 433 SCHEDULED Status 613
Sample Details 406, 591, 604, 606-607, 613, 615- Scrollable Columns 620
616, 634, 637, 644, 792-793 SD - Standard Deviation 653
Sample Details - Icon 945 SD Check 228
Sample Expiration Time 88, 357, 384, 390 SD Error Limit 237
Sample Highest Error 628, 661, 792 SD Value 562
Sample Highest Error - Icon 947 SD Warning Limit 237
Sample ID 344-345, 379, 432, 524, 532, 542, 581, Search Direction - Algorithm 241
595, 600, 606-608, 613, 615-617, 625,
Searching in Tables 118
634, 644, 659
Second Derivative - Algorithm 244, 950
Sample Incubator 34, 87
Secondary Algorithm 261, 279
Sample Information 940
Security Level 78, 109, 160-161, 167, 176-177,
Sample Life 369
180, 201, 212, 232, 317, 392-393,
Sample List 112, 264, 377, 404, 570, 591, 604- 395-397
613, 615-620, 634, 637-638, 644, 658,
Select 113-114, 132, 164, 264, 345, 393, 540, 543,
792-793, 945
562, 613-614, 618
Sample List Display 113, 404, 606, 608, 614-
Select QC Profiles 540, 543, 557
Settings 615, 617, 619-620, 625,
628, 792 Select QC Profiles - Icon 945
Sample List Display Settings - Icon 945 Selected Item/Test - Icon 948
Sample List Filter 625, 658 Selected Reflex Test List 351

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Selecting Objects 114 Stat 53, 55, 58, 383, 569, 586, 590, 595, 599, 601-
Selection Column - Icon 948 603, 628, 659
Sender 382, 630 Stat - Icon 947-948
Sender List 382 Stat Indicator 595
Sensor 956 Statistic Mean 535, 561
Serial Number 12, 372, 926 Statistical Units 267, 958
Set LAS Aspiration Point 898 Statistics Algorithm 259
Set of Filters 1 - Sample List 659 Statistics Start Time - Algorithm 259
Set of Filters 2 - Sample List 661 Statistics Time - Algorithm 259
Set of Filters 3 - Sample List 662 Status Bar 106, 769
Set Statistic as Target 557 Status List - Icon 944
Set Statistic as Target - Icon 945 Stirring 133, 145, 458, 477, 770
Setup Alarms 667 Stirring - Icon 948
Setup Language 408 Stirring Required - Material Setting 147
Shadow Test 173, 180, 312 Stop an Operation 127
Shipping - TOP Instrument 73 Stop the TOP Instrument 499, 501-503
Shock Hazard 8 Storage - TOP Instrument 73
show or Add Comments 947 Switch View - Icon 946
Show or Add Comments 547 Symbols 11
Show Reaction Curve - Icon 946 Syringe 33, 371, 432, 796, 809, 826, 853, 934
Shutting Down the Instrument 501 System Capacities 372
Single Dilution 288, 302, 314 System Decontamination 882
Site Requirements 68 System Fluids – Rinse and Clean 35
Size of Window - Setting 223 System Identification - Setting 372
Slope 235, 267, 276, 301, 316, 513, 957 System Security 109, 392
Slope Check 238, 280, 307, 316, 513 System Specifications 49
Slope of Curve 235 System Versions 908
Smallest Volume 141
Smoothing 216, 232 T
Software Access Screen 160, 167, 395-396, 399 Target Mean 157, 334, 535, 562
Software Version 893, 908, 929 Target SD 334, 535, 562
Sorting Lists 116, 613 Target Value 280
Spain - IL Location 960, 968 Target Value % 272
Spatial Requirements - TOP Instrument 69 TCP/IP Configuration 381, 391
Specifications - ACL TOP Models 50, 52, 54, 57 Temperatures Area 890, 919
Standard Deviation - SD 653 Terminology 83
Standard Factor - Parallelism 302 Terms - Commonly Used 5, 83
Standard Test Profile 344-345 Test & Unit Column - Result Statistics 653
Standard Time - Analytical Cycle 180 Test Cell - LAS 589
Start Reagent 31, 91, 132, 140, 430 Test Code 160, 171, 182, 202, 313, 334-335, 351,
Start Reagent - Icon 948 377, 497, 521, 535, 537, 597, 613, 638,
651, 654, 663
Start the TOP Instrument 499, 505
Test Code and Rerun - Filter 663
Start Time - Algorithm 235
Test Consistency - Icon 948

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Test Counter Statistics - Detailed 654 Time 52, 54, 58, 186, 233, 339-341, 390, 536
Test Counter Statistics - Simple 654 Time to Completion 109, 123, 633
Test Counters List Report 654 Title Page i
Test Counters Statistics 624, 654 TO DO - Status 613
Test De-selection 591 Toggle Lot - Button 421
Test Definition 158, 166, 169, 176, 368 Toggle Standard Profile - Icon 344
Test Definition Report 166 Tolerance 227, 260, 280, 316
Test Details 610, 634, 637, 644, 793 Toolbar 99
Test Details - Icon 943, 946 Toolbar Icons 940
Test Enabled/Disabled 165, 334 Tooltips 6
Test Feasibility 276, 337, 492, 558 Total Cuvette Volume 182
Test Feasibility List 492, 558, 569, 586 Total Number of Jobs 657
Test Filters - Sample List 663 Total Volume 149, 185
Test Information 635 Touch Screen 15, 42, 53, 55, 58, 70, 79, 884
Test is a Rerun - Icon 948 Track Control Panel 583, 601
Test Leaf - Icon 948 Tracking Information 518, 529, 639, 834-835, 838,
Test List 136, 158-162, 166-167, 169, 176-177, 858, 860-861
190, 201, 212, 214, 218, 225, 232, 262, Training Requirements 75
272-273, 312, 320, 325, 332, 492, 591, Transport 77, 84
644
Transport Airgap 149, 185, 194, 206, 293, 811
Test List - Icon 942, 946
Tree View 545
Test List Actions Menu 163
Trend Check 282
Test List Show/Hide - Icon 948
Trend Line 561, 950
Test Mode Extensions 370
Troubleshooting Alarm Messages 666
Test Modification Number 172
Troubleshooting Other Problems 770
Test Name 160, 171
Tubes 18, 24, 52, 57, 372, 374, 384, 388-389, 414,
Test Number 171, 799 433, 436-437, 453, 770
Test Performance 60 Turkey - IL Location 968
Test Profile 161-162, 165, 342, 344-345 Typical Linearity 66
Test Profile Name 345 Typical Method Comparison 61
Test Profiles Definition 342 Typical Precision Performance 60
Test Profiles List 342
Test Programming Window 404, 406, 524, 532, 615
U
Test Result Units 262
UI - ACL TOP 79
Test Selection 596
UK - IL Location 968
Test Triggered a Rerun - Icon 948
Underlined - Text Symbol 631-632, 635
Test/Material Tree View - Icon 946
Unidentified Material 91, 411
Test/Materials Definition Tree 538
Unit 165, 262, 275, 302, 315, 327, 334, 336, 351,
Tests and Profiles Window 596, 627 535, 553, 632, 635, 638, 651
Therapeutic Test Results 265 Unit Selection 266
Third Party Products 77 Unit Type 264
Threshold Algorithm 240 United Kingdom - IL Location 968
Throughput 15, 52, 54, 367, 389, 588 Units 302, 621
Throwaway Material 141 Universal Arm 903

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Unlocking a User 395 View Assigned Values 155

Upload 563, 605, 607-608, 613, 616-617, 625 View Calibration Status List Information 520
Upload - Icon 946 View Chart Information 546
Upload Status 563, 607-608, 616-617, 629, 640, 659 View Material Details 333
Upload Status - Icon 948 View QC Results 557
Uruguay - IL Location 962 View QC Results List 534, 545
USA - IL Location 46, 960, 962 View QC Test Status List 537
User-Defined Label 6, 268 View Result Unit Details 262
User-Defined Test 160-161, 176, 201, 212, 507 View Test Details 637
User-Defined Tests 78, 171, 176, 201, 218, 232, Virtual Rack 413, 471
308, 314 Virtual Sample Tube Queue 89
User - Icon 946 Visual Style - User Interface 92
User Input NPP Value 322 Volt-Amps Specifications 68
User Interfaces 79 Voltage Requirements 72
User Locked - Security 398 Voltages 902
User Name 111, 397 Volume - Monitor 42
User Revision Comment 172 Volume Tracking 141, 143
User Security List 392, 394-397

W
V Waiting for On-Board Material Volume 947
Valid Period - User Security 398 Waiting for Onboard Material Volume - Icon 948
Validate 113, 139, 275, 320, 355, 507-508, 524, WARMING UP Status 106
605-606, 613-615, 625
Warning - Icon 948
Validate - Icon 946
WARNING - Symbol 7-8, 423, 425, 808, 880
Validate a Calibration 289, 508
Warning Alarms 666, 768
Validated Sample Tubes 432
Warning Data Flags 772
Validation and Upload 613
Warning Limit 237
Validation Status 511, 529, 606, 608, 615, 617,
Warning Limit and Tolerance 260
628, 638, 660
Warning Period - User Security 398
Validation Status - Icon 948
Warning Threshold 278, 324, 339, 804, 808-809,
Variance Check 307, 318
811, 880
Versions 202, 908, 920
Warning Threshold - Icon 946
View 79, 115, 135-136, 155, 158, 166, 178, 182,
Warnings and Errors 468, 470, 486, 488
262, 290, 312, 320, 333, 342, 349, 492, 523,
525, 538-539, 543, 546-547, 557-558, 562, Warranty 73, 76, 78
564, 604, 637, 651 Warranty Claims 77
View a Maintenance Activity 807 Washed Cuvettes 78
View a Material Definition 129 Waste Bin 85
View a QC Profile 346, 348 Waste Container 37, 85, 427, 836, 882, 934
View a Reaction Curve 547 Waste Cuvette 86
View a Test Definition 158, 166 Waste Drawer 17, 86, 422, 796, 816, 836, 882
View Active Lot Data 557 Waste Fluid Status 467, 484, 956
View an Item 115 Waste Pump 427
View an Item - Icon 946 Wavelength Definition 214

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WEEE Certification 48
Weekly Maintenance 796
Welcome to Help 1
Werfen Corporate Headquarters 960, 968
Wipe-Down All Probes 858
Wipe-Down Reagent Probes 860
Wipe-Down Sample Probe 861
Wipe Down All Probes 833
Wipe Down LAS Probe 833, 859
Wipe Down Reagent Probes 833
Wipe Down Sample Probe 834
Working Area 104
World Wide Locations 960
WRange 260

X
X-Axis Transformation 281, 511

Y
Y-Axis Transformation 282, 511
Y-Intercept 280, 306, 513

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