Stratus cs200 Operator Manual

Copyright © 2014 Siemens Healthcare Diagnostics
All rights reserved.

This publication, the software, and the reports generated by the software have
been provided pursuant to the following agreement containing restrictions on
their use. They are also protected by federal regulations and cannot be copied,
distributed, transmitted, transcribed or translated into any human or computer
language, in any form or by any means, to any third parties, without the
express written consent of Siemens Healthcare Diagnostics, Newark, DE
19714.
This Operator's Guide is intended for use with the
Stratus® CS 200 STAT Fluorometric Analyzer.
Siemens has validated the provided instructions, reagents, instrument,
software and customizable features for this system to optimize product
performance and meet product specifications. User defined modifications are
not supported by Siemens as they may affect performance of the system and
test results. It is the responsibility of the user to validate any modifications
made to these instructions, instruments, reagents or software provided by
Siemens.
The material in this manual is believed adequate for the intended use of the
system. If the system or its individual components are used for purposes other
than those specified herein, confirmation of their validity and suitability must
be obtained; otherwise, Siemens does not guarantee results and assumes no
obligation or liability. Siemens warrants that the material itself does not
infringe any United States patents. No further warranty is expressed or
implied.
This manual has been written to comply with CLSI GP2-A5 guidelines.
Stratus is a trademark of Siemens Healthcare Diagnostics.
Vacutainer and HEMOGARD are trademarks of Becton Dickinson Vacutainer
System, Franklin Lakes, N.J. 07417.
Krytox is a registered trademark of E. I. duPont de Nemours and Company,
Wilmington, DE, 19880.
Monovette is a registered trademark of SARSTEDT AG and Company,
Numbrecht, Germany.
i-2 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
2014/08 i-3
i-4 2014/08
Operator’s Guide
Stratus® CS 200 STAT Fluorometric Analyzer
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Using this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Contacting Siemens Technical Solutions Center . . . . . . . . . . . . . . . . . . 1-3
Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
TestPaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
DilPaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
CalPaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Cannulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Rotors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Sample Cups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Operation Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Processing Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Processing Plasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Processing Automated Dilutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Quality Control and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
System Check Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Optical Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Mechanical Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Fluid Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Changing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Using Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Power On/Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Controlled Power Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Restarting the System after Power Shutdown . . . . . . . . . . . . . . . . . . . 1-21
Processing Samples and Reporting Results . . . . . . . . . . 2-1

Daily Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Replacing the Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Verifying the Tip Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Verifying the Thermal Printer Paper Supply . . . . . . . . . . . . . . . . . . . . . 2-4
Running System Check – Electronic QC . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Reviewing the System Check Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Reviewing Calibration/Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Reviewing Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2014/08 i-1
Preparing to Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Checking Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Specimen Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Using or Retrieving a Tested Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Applying the Barcode Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Reviewing Testing Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Processing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Loading and Processing a Sample Tube . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Processing an Automated Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Processing a Manual Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Loading and Processing a Sample Cup . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Reporting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Reprinting Previous Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Principles of Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Updating Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Processing Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Evaluating the Calibration Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Addressing Failed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Checking Calibration Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Determining Expiration of TestPak Lot Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Deleting a Calibrated TestPak Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Transmitting Calibration with POCT1-A2 Enabled . . . . . . . . . . . . . . . . . 3-5
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Quality Control Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Quality Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
System Check – Electronic QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Quality Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Setting Up QC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Storing QC IDs and Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Setting Up System Check Lockout Parameters . . . . . . . . . . . . . . . . . . . 4-5
Setting Up QC Lockout Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Processing QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
QC Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Understanding the Quality Control Report . . . . . . . . . . . . . . . 4-9
Addressing an Out of Range QC Result . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Maintenance Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Accessory Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Standard Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Monthly Maintenance Overview . . . . . . . . . . . . . . . . . . . . . . . 5-3
Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . 5-4
Replacing and Cleaning the Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Cleaning Instrument Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Cleaning the Touchscreen and Stylus . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
i-2 2014/08
Other Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Replacing the Thermal Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Troubleshooting Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Troubleshooting Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Interpreting Processing Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Printing Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Miscellaneous Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
System Check Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Adjusting the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Adjusting the Fluorometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
Auto Aligning System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Cleaning the Carousel Springs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Cleaning the Carousel Reference Disk and Fluorometer Window . . . . 6-30
Cleaning the Pak Manager Lid Reference Disk . . . . . . . . . . . . . . . . . . . 6-33
Cleaning the Probe Sealing Pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
Cleaning the Rotor Containment Boot and Bracket . . . . . . . . . . . . . . . 6-37
Replacing AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40
Replacing DC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
Replacing the Cannula Chamber Lower Seal . . . . . . . . . . . . . . . . . . . . 6-43
Replacing the Cannula Chamber O-Ring Seal . . . . . . . . . . . . . . . . . . . . 6-45
Replacing a Corrupted USB Flash Drive . . . . . . . . . . . . . . . . . . . . . . . . . 6-47
Replacing the Fluorometer Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-49
Replacing the Pipettor Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53
Replace the Sample Manager Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . 6-56
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Configuration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Basic Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Advanced Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Basic Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Setting Audio Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Configuring Rotor Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Configuring Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Advanced Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Changing Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Configuring Collection Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Configuring LIS / Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Configuring Manual Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Configuring an Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Configuring Reference Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Configuring Sample Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Configuring Sample Tube Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Storing the Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Training Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Configuring Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Configuring External Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
2014/08 i-3
Safety and Specifications . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Safety Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Safety Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Safety Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Chemical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Safety Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Understanding Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Installation Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Customer Responsibilities Before Installation . . . . . . . . . . . . . . . . . . . . 8-7
Siemens Representative Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Customer Responsibilities After Installation . . . . . . . . . . . . . . . . . . . . . 8-7
Remote Transmission Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Specifications and Requirements . . . . . . . . . . . . . . . . . . . . . . . 8-8
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Recommended Service Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Transient Overvoltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Wire Size – North America only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Electromagnetic Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Computer Interface Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Thermal Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Noise Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Centrifuge Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Appendix A: Menu Navigation . . . . . . . . . . . . . . . . . . . . 9-1

Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Using the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Selecting a Menu Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Appendix B: Code Compliance . . . . . . . . . . . . . . . . . . . . 10-1

Code Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Safety Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Emission Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Laboratory Accrediting Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2
Appendix C: Qualified Sample Collection Tubes . . . . . . 11-1

Qualified Sample Collection Tubes . . . . . . . . . . . . . . . . . . . . . 11-2
i-4 2014/08
Appendix D: Maintenance Logs . . . . . . . . . . . . . . . . . . . 12-1

Stratus® CS 200 STAT Fluorometric Analyzer Maintenance Logs 12-1
Using the Maintenance Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Appendix E: Operator’s Training Checklist . . . . . . . . . . . 13-1

Stratus® CS 200 STAT Fluorometric Analyzer Training Checklist13-1
Using the Training Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
2014/08 i-5
i-6 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide System Overview
Chapter 1: System Overview
2014/08 1-1
System Overview Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
System Overview
The Stratus® CS 200 Analyzer is designed to be user-friendly and provide rapid
turnaround of diagnostics tests. It safely processes whole blood and plasma
samples, delivering the first result within 15 minutes of processing initiation. It
can process up to four tests per sample.
Intended Use
The Stratus® CS 200 STAT Fluorometric Analyzer is a microprocessor-controlled
instrument that measures analytes in body fluids for in vitro diagnostic use.
This instrument is for use by trained healthcare professionals in the clinical
laboratory and Point of Care (POC) settings.
Using this Guide

This guide has been written to comply with Clinical and Laboratory Standard
Institute (CLSI) GP2-A5 guidelines. Any modification to or deviation from the
manufacturer’s procedure must be clearly documented.
Information that is specific to the structure and operation of each facility
should be added. Only trained operators should operate the instrument and
perform the maintenance procedures in this guide.
1-2 2014/08
The guide provides the information required to operate and maintain the
Stratus® CS 200 Analyzer and is organized as follows:
Table 1-1: Stratus® CS 200 Analyzer Chapters
Chapter and Title Description
Chapter 1: System Overview Reviews mechanical instrument operation in general

terms and provides an overview of the software system.
Chapter 2: Processing Samples Provides step-by-step procedures for preparing and

and Reporting Results loading samples and paks, processing tests, interpreting
results and transmitting those results to a Laboratory
Information System (LIS).
Chapter 3: Calibration Provides step-by-step procedures for calibrating test

assays.
Chapter 4: Quality Control Provides procedures for collecting and interpreting quality
control data on the Stratus® CS 200 Analyzer.
Chapter 5: Maintenance Provides procedures for daily, monthly, and as needed

maintenance. This chapter also provides procedures for
removing and installing parts of the instrument
when needed for unscheduled maintenance and
troubleshooting.
Chapter 6: Troubleshooting Provides guidance to diagnose and correct problem

situations and error codes.
Chapter 7: Configuration Provides procedures for changing the system time and
date, and various other specifications for customizing the
instrument.
Chapter 8: Safety and Provides information about safe instrument operation,

Specifications and how to prepare the facility for instrument installation
Appendix A: Menu Navigation Provides a description of the touchscreen buttons and

icons with map of the software functions.
Appendix B: Code Compliance Provides code compliance information.
Appendix C: Qualified Sample Provides information on qualified collection tubes.

Collection Tubes
Appendix D: Maintenance Logs Provides a log sheet for recording maintenance activities.
Siemens recommends using these as the master and
make copies to track the maintenance performed.
Appendix E: Operator’s Training Provides an operator checklist to be used as a guide to

Checklist train operators. Siemens recommends using these as the
master and make copies to track all training.
Contacting Siemens Technical Solutions Center

Contact the Siemens Technical Solutions Center or refer to the local support
team. The local support team contact information is provided at installation. A
label is placed on the instrument noting this information.
2014/08 1-3
Supplies
The following supplies are designed specifically for use on the
Stratus® CS Analyzers.
WARNING: These supplies are single-use only. Never attempt to

reuse them.
TestPaks
TestPaks are configured with 5 wells and a reaction area. The wells contain
sufficient reagent to complete a single assay.
Figure 1-1: TestPak
DilPaks
DilPaks are used when a sample requires dilution. One DilPak contains
sufficient assay-specific diluent to dilute one sample.
Figure 1-2: DilPak
1-4 2014/08
CalPaks
CalPaks are used for calibrating TestPak lots. One CalPak contains sufficient
calibrator to run a single calibration.
Figure 1-3: CalPak
Cannulas
The cannula holds the stoppered tube in the sample manager. When
processing begins, the point inside the cannula pierces the tube stopper,
allowing the whole blood to flow to the rotor. Cannulas are designed to be
used with certain types of tubes. Always check the labeling for the appropriate
tube type. For more information, see “Appendix C: Qualified Sample Collection
Tubes” for approved tube types.
Figure 1-4: Cannula
WARNING: A sharp tip is recessed inside the cannula. Handle the

cannula from the outside only.
WARNING: Cannulas cannot be reused.
2014/08 1-5
Rotors
The rotors carry the transferred whole blood to the centrifuge. Each rotor
contains separation gel with a density between that of plasma and blood cells.
During centrifugation, the gel rises to the plasma-cell interface, where it forms
a barrier separating plasma from cells. The plasma is isolated in the rotor,
where it is aspirated by the pipettor and transferred to the TestPak for
processing.
CAUTION: Uneven gel distribution around the entire outer edge inside the
rotor may cause instrument malfunction.
WARNING: Rotors cannot be reused.

Figure 1-5: Rotor
1-6 2014/08
Sample Cups
Sample cups are used to introduce quality control (QC) material or previously
centrifuged plasma for processing.
WARNING: Use only Siemens Stratus® CS sample cups. Failure to do so

may result in erroneous patient results or damage to the
instrument.
WARNING: Sample cups cannot be reused.

Figure 1-6: Sample Cup
Tips
The tip manager holds two disposable tip trays of 40 tips each.
WARNING: Tips cannot be reused.

Figure 1-7: Tip Tray
2014/08 1-7
Tubes
Stoppered qualified blood collection tubes containing anticoagulant are used
with the Stratus® CS 200 Analyzer. For the appropriate tube types, see
“Appendix C: Qualified Sample Collection Tubes” .
Figure 1-8: B-D Sample Tube
Waste Container
The waste container holds used rotors, tips, cups, and paks. A red indicator on
the display indicates when the container is full and needs to be replaced.
WARNING: Reuse of waste containers will result in contamination of

the instrument.
Figure 1-9: Closed Waste Container
1-8 2014/08
System Components
Before operating the Stratus® CS 200 Analyzer, become familiar with the
components used to process tests and report results.
Figure 1-10: System Components
# Description
1 Sample Volume Gauge
2 Printer
3 Touchscreen
4 Tip Manager
5 Pak Manager Well
6 Sample Barcode Reader
7 Waste Container Area
8 Rotor Table
9 Sample Door
2014/08 1-9
Figure 1-11: Internal System Components
# Description
1 Touchscreen Board
2 Pipettor
3 Tip Manager
4 Pak Manager Well
5 Pak Barcode Reader
6 Rotor Table
7 Cannula Chamber (Sample Manager)
8 Sample Barcode Reader
1 - 10 2014/08
Figure 1-12: Instrument Power Switch
2014/08 1 - 11
Operation Overview
There are six primary areas involved in the operation of the Stratus® CS 200
Analyzer:
• Sample Manager
• Rotor Table/Centrifuge
• Pak Manager
• Tip Manager
• Display
• Waste Container area
Processing Whole Blood

Whole blood is collected in a qualified blood collection tube containing
anticoagulant. The Stratus® CS 200 Analyzer accepts only certain types of
tubes. For more information, see “Appendix C: Qualified Sample Collection
Tubes” .
The following is an overview of processing whole blood samples. For the
procedure to process whole blood samples, see “Processing Samples” on
page 7 of Chapter 2: Processing Samples and Reporting Results.
• If the tube is barcoded, the operator scans it using the sample barcode
reader on the front of the instrument.
• Either the patient ID or sample ID is read, stored in the instrument, and
displayed.
• The operator, after ensuring that the contents are well-mixed, inverts the
stoppered tube into a cannula.
• The cannula/tube assembly is placed in the sample manager and the
operator closes the door.
• The operator loads a rotor in the rotor table and TestPaks in the Pak
Manager Well.
• The screen either shows the scanned patient ID/sample ID or prompts the
operator to enter one.
• If the system is configured to require the operator ID/ collection time and
date entry, the operator manually enters or scans this information.
• The screen indicates which supplies need to be loaded. The supply
indicator turns red when the supply is empty; the Tip Tray indicator
highlights when one tip tray is empty. The Start button remains inactive
until all required supplies and data are present.
• The operator selects Start and the Pak Manager moves the first pak under
the pak barcode reader, which identifies the pak type and related
information.
• The pak carousel moves the pak to the next position. All paks are
inventoried to ensure that they can be used.
• The rotor moves under the sample manager where the cannula pierces the
tube stopper and sample flows into the rotor.
• The rotor is mounted on the centrifuge, which spins it, preparing the
sample for testing.
1 - 12 2014/08
• A pipettor with a clean tip aspirates sample from the rotor and transfers it
to the TestPak sample well.
• The pipettor then adds sample and reagents from TestPak wells to the glass
fiber paper.
• The tips are disposed of in the waste container after use to prevent fluid
carryover.
• While in the carousel, the TestPak is brought to testing temperature. The
results are displayed on the screen as they complete and print on a report
slip when all paks for the sample have been processed.
• The carousel moves the TestPak over the fluorometer, where the
fluorescent signal is measured.
• When processing is complete, the sample door opens and the operator
removes the tube/cannula assembly.
• The TestPaks are automatically sent to the waste container.
• If the rotor has been used for four tests, it is automatically sent to the
waste container. Otherwise, it can be held in the centrifuge, depending on
the system configuration.
Note: The waste indicator is red when the waste container is full.
The operator removes it, seals it with the provided lid, and
disposes of it according to local procedures for handling
biohazardous waste. A waste container must be present for
the instrument to operate.
Processing Plasma
A sample cup of plasma can be processed from a special position in the rotor
table. Plasma cannot be tested through the tube/cannula assembly.
The following is an overview of processing plasma samples. For the procedure
to process plasma samples, see “Loading and Processing a Sample Cup” on
• The operator either scans in the patient ID/sample ID or manually enters
one on the display.
• The operator places the plasma into a sample cup and places it in the
special position on the rotor table.
• The operator loads the TestPaks in the Pak Manager Well.
• The screen either shows the scanned patient ID/sample ID or prompts the
operator to enter one.
• If the system is configured to require the operator ID/ collection time and
date entry, the operator manually enters or scans this information.
• The screen indicates which supplies need to be loaded. The supply
indicator turns red when the supply is empty; the Tip Tray indicator
highlights when one tip tray is empty. The Start button remains inactive
until all required supplies and data are present.
• The operator selects Start and the Pak Manager moves the first pak under
the pak barcode reader, which identifies the pak type and related
information.
• The pak carousel moves the pak to the next position. All paks are counted
to ensure that they can be used.
2014/08 1 - 13
• A pipettor with a clean tip aspirates the plasma sample from the sample
cup and transfers it to the TestPak sample well.
• The pipettor then adds sample and reagents from TestPak wells to the glass
fiber paper.
• The tips are disposed of in the waste container after use to prevent fluid
carryover.
• While in the carousel, the TestPak is brought to testing temperature. The
results are displayed on the screen as they complete and print on a report
slip when all paks for the sample have been processed.
• The carousel moves the TestPak over the fluorometer, where the
fluorescent signal is measured.
• When processing is complete, the sample door opens and the operator
removes the sample cup from the rotor.
• The TestPaks are automatically sent to the waste container.
Note: The waste indicator is red when the waste container is full.
The operator removes it, seals it with the provided lid, and
disposes of it according to local procedures for handling
biohazardous waste. A waste container must be present for
the instrument to operate.
Processing Automated Dilutions

When a result is above the assay range, the rotor is not discarded automatically
if fewer than four tests have been processed. A dilution can be processed on
this centrifuged sample using a new TestPak and the assay-specific DilPak. The
DilPak provides the proper type and amount of diluent for the test.
Quality Control and Calibration

A System Check (electronic QC) must be run daily to satisfy routine quality
control requirements and to assess instrument performance. System Check
reports should be kept with Quality Control (QC) records.
Additional quality control materials are run to verify reagent performance.
Process at least two levels of control material:
• When a new TestPak lot is calibrated.
• When a new TestPak shipment is received for a previously calibrated lot.
• According to your internal QC procedures.
• According to government regulations or accreditation requirements for
quality control frequency.
• As otherwise recommended in this guide.
Quality Control requires one TestPak and a sample cup of control material to
process each level of QC. A sample cup of QC can be processed from a special
position in the rotor table.
Calibration requires one CalPak and three corresponding TestPaks for each
assay processed on the analyzer.
1 - 14 2014/08
System Check Description

The daily System Check interrogates four key areas of the system: optical
detection, mechanical alignment, fluid delivery, and temperature.
Optical Detection
The optical detection system includes a self-correcting, front-surface
fluorometer calibrated during instrument assembly to a NIST-traceable
reference in order to reduce between-instrument variability. A built-in
feedback diode and onboard references measure the signal at two levels of
fluorescence and correct the output to minimize between-run drift. An
additional internal, solid-phase, fluorescent standard confirms the optical
system integrity prior to each run. A detection response and noise factor
calculation for each sample’s enzymatic reaction rate ensures that each result
meets acceptable performance criteria.
Mechanical Alignment
A system of sensors and motion control software automates mechanical
alignment during instrument installation. The daily System Check verifies
critical alignment parameters through a series of similar routines.
Fluid Delivery
Each daily System Check verifies the integrity of the pneumatic fluid delivery
system through a series of in-line pressure determinations. In addition, fluid
transfers are monitored for atypical pressure profiles during sample
processing.
Temperature
The System Check verifies that the temperature of the thermal chamber and
fluorometer are 37°C ±0.2°C.
Test Results
The display screen indicates approximate time to completion of testing and the
test results as each test is completed. When all tests are finished, a report slip is
printed. The report slip includes the following:
• Patient and/or sample ID
• Instrument serial number
• Operator ID, if configured
• Collection date and time, if configured
• Assay names
• TestPak lot numbers
• Result for each assay
• Units of measurement
• Reference interval, if configured
2014/08 1 - 15
Error messages when applicable are printed next to or beneath the result. The
results can be transmitted to a remote computer system and also to an
optional external printer available from Siemens.
1 - 16 2014/08
Touchscreen
The touchscreen has many uses, including entering data, selecting functions,
and initiating processing.
Table 1-2: Touchscreen Description
Button/ Icons Description
Alarm Illuminates when there is a system alarm.
Arrows Select the arrows to move the cursor. The up arrow moves the cursor up or to the
left. The down arrow moves the cursor down or to the right.
Back Arrow Select the Back Arrow to return to the previously displayed screen or to initiate a
controlled shutdown. See “Software Overview” on page 19 of this chapter. This
button does not stop processing.
Change Mode Select to process data in a different mode. Only available from the Home screen.
Collection Time Select to enter specimen collection time.
Cup Illuminates when waiting to receive a sample cup for processing.
Delete Select Delete, followed by Enter, to delete the data in the current field.
Enter Select to store data entered in a field.
Help Select Help to display information about the current screen, if available. Select
the Back Arrow icon to return to the previous screen.
2014/08 1 - 17
Button/ Icons Description
Home Select Home to return to the Home screen.
ID Illuminates when waiting to receive a Patient ID or Sample ID for processing. This

will also illuminate if Operator ID input is required.
Menu Buttons Select the appropriate menu button to complete operating procedures.
Number Pad Select to enter numbers where required.
Pak Illuminates when waiting to receive a TestPak for processing.
Paper Advance Select Paper Advance to feed the printer paper through the paper slot.
Power Select Power to power on or off the instrument. See “Controlled Power
Shutdown” on page 21.
Reagent Status Select to check a TestPak lot’s status before processing a sample to determine if
QC or a calibration is required. Select when the message Check Calibration
Status appears on the System Check report to verify assay calibration expiration.
Rotor Illuminates when waiting to receive a rotor for processing.
Sample Illuminates when the sample door is open. Sample door must be closed to
process a sample.
Start Select Start to begin processing or to retrieve information about system needs.
Stop Select Stop to halt processing or stop the printing of a long report.
Tips Illuminates when under 8 tips are left in both tip trays.
Tip Tray Illuminates when one of the tip trays is empty. So long as there are at least 8 tips
present, processing can continue. A new tray should be loaded as soon as
possible.
Waste Illuminates when the waste container is full.
1 - 18 2014/08
Software Overview
The Stratus® CS 200 Analyzer software has two distinct operational sections:
• Modes: Active when the analyzer is processing. During normal operation,
mode screens are the primary display.
• Menus: Used for viewing and printing information, configuring and
maintaining the analyzer, and troubleshooting.
Modes
The Stratus® CS 200 Analyzer processes data in several modes, each of which
has its own screen:
Table 1-3: Process Data Modes
Mode Description
Home Utilized when processing patient samples.
System Check Mode Utilized when running a System Check.
QC Low Mode Utilized to process QC material.
QC High Mode Utilized to process QC material.
Calibration Mode Utilized to calibrate a TestPak lot.
QC Misc Mode Utilized to process QC material.
Manual Dilution Mode Select Man Dil Mode to enter a dilution correction
factor when processing a manual dilution.
Changing Modes
1. From the Home screen, select Change Mode.
2. Use the arrows to highlight the desired mode.
3. Select Accept.
Note: Selecting the Back Arrow without selecting Accept reverts to
the previous mode.
Menus
Display the Main Menu by selecting Menus from the Home screen. The menu
screen shows two main functions:
• Reports
• Maintenance
Using Menus
The Reset button displays on Main Menu screen. Reset is used during
troubleshooting. The Reports and Maintenance functions lead to additional
menus and functions. For more information on the about the mapping of
these relationships, see “Appendix A: Menu Navigation” .
2014/08 1 - 19
When using these menu options, you can select Home or the Back Arrow any
time to return to the Home screen.
1 - 20 2014/08
Power On/Power Off

The main power switch is at the back of the instrument above the power cord.
Controlled Power Shutdown

In the event a shutdown is required, always perform a controlled power
shutdown to ensure stored data integrity.
1. From the Home screen, select the Power icon.
2. Select Yes.
Note: Allow instrument shutdown to complete.
3. Turn the main power switch off.
Figure 1-13: Main Power Switch
Restarting the System after Power Shutdown

Note: Wait a minimum of 30 seconds after turning the main power
switch off before beginning this procedure.
1. Close the sample door.
2. Turn the main power switch on.
3. Press and hold the screen alignment target until it moves to the next
corner.
4. Repeat for all four corners of screen.
5. Wait for Power On Self Test (POST) to complete.
Note: Touchscreen displays POST tests Initiation In Progress. Once
complete, the results of the POST test prints. Troubleshoot
any FAILED tests.
2014/08 1 - 21
1 - 22 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Processing Samples and Reporting Results
Chapter 2: Processing Samples and

Reporting Results
2014/08 2-1
Processing Samples and Reporting Results Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Daily Setup
Note: Only trained operators should perform these procedures.
Training must include proper blood-handling techniques.
Perform the following procedures before processing patient samples.
Replacing the Waste Container
WARNING: Follow facility standard procedures for protection of

eyes and skin from biohazards and chemicals when
performing this procedure.
CAUTION: Always install a new, empty waste container after removing one;
otherwise the pak counter will be inaccurate and jams could
occur.
1. Open the left front door.
Figure 2-1: Waste Container
2. Carefully pull out the waste container.

Note: Removing the container resets the pak counter to zero. The
waste container is full after 16 TestPaks have been ejected.
3. Place lid on the used waste container.
4. Dispose of the used container according to facility specific procedures.
5. Insert a new waste container.
6. Close the left front door.
2-2 2014/08
Verifying the Tip Supply

The Tip Tray indicator illuminates when one tip tray is empty. So long as there
are at least 8 tips present, processing can continue. A new tray should be
loaded as soon as possible.
If the Tips indicator is red or the Tip Tray indicator is illuminated on the
touchscreen, replenish the tip supply as follows:
1. Open the tip manager door.
Figure 2-2: Tip Manager Door
# Description
1 Tip Manager Door
2 Tip Trays
2014/08 2-3
2. Remove empty tip trays.

Figure 2-3: Tip Tray
3. Insert new, full tip trays.

4. Close the tip manager door.
Verifying the Thermal Printer Paper Supply

1. Select the Paper Advance icon.
2. If the edges of the paper are pink, see “Replacing the Thermal Printer
Paper” on page 10 of Chapter 5.
Running System Check – Electronic QC

The System Check measures analyzer performance at two levels to ensure the
instrument maintains both accuracy and precision in the fluid handling system,
mechanical alignments, fluorometer, and temperature.
Note: No TestPak or sample is required for this procedure.
1. Select Change Mode on the Home screen.
3. Use the arrow buttons to highlight System Check; select Accept.
4. Enter the System Check ID; select Enter.
5. Enter the Operator ID; select Enter.
6. Select Start.
7. Retain the printout with QC records.
Note: Printouts on thermal paper will fade with time. Siemens
recommends copying the thermal printout for record
retention.
2-4 2014/08
Reviewing the System Check Report

The System Check Report is printed when System Check is complete.
Note: If the status of all components is PASS, proceed with
processing. However, if the status of any component is FAIL,
see “System Check Troubleshooting” on page 20 of Chapter
6: Troubleshooting.
Reviewing Calibration/Reagent Status

If the message Check Calibration Status appears on the System Check report,
select Reagent Status to review.
Review the report for calibrations that have expired or will expire within 72
hours and calibrate TestPaks accordingly. See “Checking Calibration Status” on
page 4 of Chapter 3: Calibration.
Reviewing Limits
The limits shown on the System Check report, except for System Fluorometer
Test Level 2, remain constant. Initial limits for the Level 2 test are based on an
internal stored value which is different for each instrument, and are set for
within ±2.5% of that value when the instrument is manufactured. The internal
value and the limits are updated automatically every 60 days. Retain System
Check reports with your QC records in order to track this updating function.
2014/08 2-5
Preparing to Process
Checking Reagent Status
Check a TestPak lot’s status before processing a sample to determine if QC or a
calibration is required.
1. Select Reagent Status from the Home screen.
2. Select Next Method until the appropriate assay is displayed.
3. Review the displayed QC or calibration status information to determine if
QC or calibration for a TestPak lot is required.
Specimen Collection
Successful processing includes good phlebotomy technique. See the most
current version of CLSI document H3, “Procedures for the Collection of
Diagnostic Blood Specimens by Venipuncture” for guidelines. Use only
collection tubes approved for use on the Stratus® CS 200 Analyzer. Important
information about specimen collection is included in the Specimen Collection
section of the TestPak Information for Use (IFU) and in the tube manufacturer’s
instructions.
Using or Retrieving a Tested Sample

The system will automatically place the rotor or sample cup in the waste
container after testing. However, the system provides options related to
controlling sample disposal. For more information, see “Configuring Rotor
Usage” on page 3 of Chapter 7.
Applying the Barcode Label

When applying the barcode label, ensure the label does not extend beyond the
bottom of the tube. An improperly applied label can interfere with processing
or tube/cannula retrieval.
Note: The barcode label is limited to 12 alphanumeric characters
for the Patient and Sample ID and 10 alphanumeric
characters for the Operator ID.
Reviewing Testing Needs

The red supply indicators on the left side of the touchscreen alert the operator
to missing supplies. Once the operator adds the required supplies, the
corresponding red indicator goes out and the Start text in the button becomes
green indicating the operator can initiate instrument processing.
Note: If the red indicator remains lit after adding the required
supplies, select the Help icon to display additional
information.
Note: Operators must perform Calibration and Quality Control prior
to processing Patient Samples with a new TestPak lot.
2-6 2014/08
Processing Samples
Loading and Processing a Sample Tube
CAUTION: Do not remove the tube stopper at any time when testing whole
blood. The instrument will not process tubes without vacuum.
To determine if you have enough sample to process up to four tests, compare
the sample volume in the tube against the sample volume gauge on the front
of the instrument.
Note: If using Sarstedt tubes, use the fill line on the tube, not the
sample volume gauge.
If the sample level in the tube is lower than the level shown on the gauge or
the fill line, do not use the tube. Draw a new sample or centrifuge the sample
externally and transfer the plasma to a cup.
Figure 2-4: Verifying Sample Volume with a Becton Dickinson Sample Tube
1. Select Home.
2014/08 2-7
2. If the tube has a barcoded label, scan it using the barcode reader located
on the front of the instrument. To scan, move the tube with label facing
the instrument across the front of the barcode reader.
Note: Tube must be vertical to the barcode reader and 4–6 inches
(10.2–15.2 cm) away from the barcode reader.
Figure 2-5: Scan Barcode Label
3. Verify the Patient ID or Sample ID is present in the correct display field. If

not, manually enter the information using the touchscreen or scan the
specimen using the barcode reader; select Enter.
Note: Limit for Patient ID or Sample ID is 12 characters; limit for
User ID is 10 characters.
If a barcode is scanned containing more characters than the
limit, the message Invalid Barcode displays and no ID data is
entered. Press Continue and follow the facility matching
patient sample procedure to enter a valid ID.
If ID is entered manually, the Stratus® CS 200 Analyzer alarm
beep will sound with each character added in excess of the
limit; characters will not be accepted beyond the limit. Follow
the facility matching patient sample procedure to enter a
valid ID.
4. Enter or scan the Operator ID, if required; select Enter.
5. Select Collection Time to enter Collection Date and Time data, if
required.
Note: Today’s date is the default.
2-8 2014/08
6. Enter a facility-defined comment code, if required; select Enter.

7. Select Accept.
8. Invert the stoppered tube gently a few times to ensure uniform
re-suspension of the red cells.
9. Gently place the tube, stopper down, into the cannula, ensuring the tube
snaps into place.
CAUTION: Do not pierce the tube stopper.

Figure 2-6: Tube Placement in Cannula
WARNING: A sharp tip is recessed inside the cannula. Handle the

cannula from the outside only.
2014/08 2-9
10. Insert the cannula/tube assembly into the sample door opening.
Figure 2-7: Load Sample

12. Place a new rotor in the rotor table.
CAUTION: Make certain that the small opening in the rotor and the
embossed text face up. Seat the rotor firmly, flat on the table.
Figure 2-8: Load Rotor
2 - 10 2014/08
13. Hold each TestPak by the edges and place flat into the Pak Manager well.
Make sure the arrow on each TestPak label points toward the instrument.
CAUTION: Do not push the TestPak into the slot.

Figure 2-9: Load TestPak
Note: The Pak Manager well can hold any combination of up to

four paks.
14. Select Start.
Note: If the Start button text is not green and the Sample supply is
red, select the Help icon to display what is required to begin
testing. If the Collection Date and Time are required, enter
both to activate the Start button.
Note: The Stratus® CS 200 Analyzer displays results as tests are
completed. The first result appears within 15 minutes. All
results are displayed within 30 minutes. The time to
completion shown on the screen is approximate.
15. If the Rotor Hold option is enabled or ON and fewer than four tests have
been processed, the prompt Would you like to run more tests on this
sample? displays.
16. Select Yes or No.
17. If Yes is selected, load additional TestPaks; select Start.
18. If No is selected, the Home screen displays.
2014/08 2 - 11
Processing an Automated Dilution

If a test result is above the assay range for the assay, the test report shows
asterisks instead of a result and the message Above Assay Range prints. If
fewer than four tests have been performed on the rotor, the prompt Do you
want to run a dilution? displays.
To run the Dilution:
1. Select Yes.
2. Load both a new TestPak and a DilPak into the Pak Manager well for the
assay requiring a dilution.
3. Select Start.
Note: The results report for the automated diluted sample displays
the message: Corrected for DilPak.
Note: See the appropriate assay IFU for dilution details.
Processing a Manual Dilution

WARNING: Manual dilution is not recommended for healthcare
professionals in the point of care (POC) setting.
If the result is still above the assay range after running a sample using a DilPak,
manually dilute the sample.
Note: See the appropriate assay IFU for dilution details.
Note: The manual dilution feature must be enabled prior to
performing this procedure. For more information, see
“Configuring Manual Dilution” on page 9 of Chapter 7.
1. From the Home screen, navigate to Change Mode > Man Dil Mode.
2. Enter the dilution factor; select Enter.
3. Select Accept.
Note: Manual Dilution Factor = x displays above Patient ID on
Home screen.
4. Select Home; enter the Patient ID or Sample ID and the Operator ID.
valid ID.
2 - 12 2014/08
5. Select Collection Time and enter a time and date with comment code, if
required.
6. Select Accept.
7. Place 500 µL of the diluted sample in a sample cup.
8. Place the cup in position on the rotor table.
9. Select Start.
Note: The result displayed on the screen, on the printed report, and
transmitted to the LIS is corrected for the dilution factor
entered.
Note: The results report for a manually diluted sample includes the
message: Corrected for Manual Dilution.
Loading and Processing a Sample Cup

1. Carefully pipette the plasma into the sample cup to prevent air bubbles.
Note: Ensure there are no particulates in the sample and no air
bubbles on the surface.
2. Fill the sample cup to the bottom edge of the rim (500 µL) or refer to
Table 2-1 to determine the plasma amount required to perform the test.
Figure 2-10: Sample Cup 500 µL Fill Line
Table 2-1: Sample Cup Volume
Number of Minimum Minimum

Tests Volume µL Volume cc
1 200 0.2
2 300 0.3
3 400 0.4
4 500 0.5
Note: The dead volume in a sample cup is 100 µL.
2014/08 2 - 13
3. Carefully place the sample cup in the cup position on the rotor table.
WARNING: Make certain the sample cup is seated firmly in the cup
position.
Figure 2-11: Load Sample Cup
4. On the Home screen, enter the Patient ID or Sample ID; select Enter.
valid ID.
6. Select Collection Time and enter a time and date with comment code, if
required.
7. Select Accept.
8. Hold the TestPak by the edges and place flat into the Pak Manager well.
Make sure the arrow on the TestPak label points toward the instrument.
2 - 14 2014/08
CAUTION: Do not push the TestPak into the slot.

Note: The Pak Manager well can hold any combination of up to
four paks.
9. Close the Sample Door.
10. Select Start.
Note: The Stratus® CS 200 Analyzer displays results as tests are
completed. The first result appears within 15 minutes. All
results are displayed within 30 minutes. The time to
completion shown on the screen is approximate.
11. If the Sample Retrieve option is OFF, the cup goes to the waste
container automatically.
12. If the Sample Retrieve option is ON, the message Sample being moved
out please wait. displays followed by Holding sample for retrieval,
press continue.
Note: To keep the sample for further use, remove the cup from the
instrument and press continue.
Note: If you do not want to keep the sample, press continue to
place the cup in the waste container.
2014/08 2 - 15
Reporting Results
Once all tests are processed, the analyzer prints a Results Report for the
Sample.
Figure 2-12: Sample Results Report
2 - 16 2014/08
The Results Report displays Asterisks (***) next to any test Result value that is
outside of the defined reference interval. An explanation of the messages
displayed are detailed in Table 2-2.
Table 2-2: Result Messages
Result Message Description
Above Cutoff of <value> Displays when the test result value is above the Cutoff Value.
For more information about using Cutoff Values, see
“Configuring Reference Intervals” on page 10 of Chapter 7.
Above Assay Range Displays when the test result value is above the Assay Range,
Asterisks (*** AAR) replace the Result value. If desired, rerun
the assay as a Dilution. For more information, see “Processing
an Automated Dilution” on page 12 of Chapter 2.
Below Assay Range Displays when the test result value is below the Assay Range,
Asterisks (*** BAR) replace the Result value. If desired, rerun
the assay.
Reprinting Previous Results

Note: The instrument stores results for the last 50 tests processed.
1. From the Home screen, navigate to Menus > Reports > Print Result.
2. Enter the required number of sample results for print.
3. Select Enter > Print.
2014/08 2 - 17
2 - 18 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Calibration
Chapter 3: Calibration
2014/08 3-1
Calibration Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Calibration Overview
To accurately measure the concentration of analyte in a sample, the assays
must be calibrated on the Stratus® CS 200 Analyzer. Calibration is
accomplished by a calibration update procedure which “fine-tunes” the
calibration, allowing the TestPak lot, CalPak lot, and analyzer combination to
work at optimal performance.
Principles of Calibration
A calibration update uses one CalPak and three TestPaks corresponding to the
method being calibrated. Information for the update is encoded on the CalPak
and TestPak Barcode labels.
When TestPaks are manufactured, calibration coefficients (C terms) are
assigned to each lot. The analyzer reads these coefficients from the TestPak
barcode and stores them in memory.
In Calibration Mode, the instrument automatically processes the three
TestPaks, using the contents of the CalPak. The mean of the three replicates is
used to mathematically update one of the calibration coefficients, the C1 term.
The instrument subsequently uses the updated C1 term, along with the other
coefficients from the TestPak barcode, to calculate test results when the
specific lot of TestPaks is used.
After calibration update, when a patient sample or QC material is processed,
the microprocessor within the instrument compares the test result to its
internal calibration data for that TestPak lot, as based upon the stored
coefficients. The test result is displayed and printed.
Updating Calibration
Routine Calibration is required:
• for any new TestPak lot.
• every 30 to 90 days, depending on the assay calibration stability claim.
• at the start of a new assay on the instrument.
• whenever Quality Control (QC) monitoring indicates.
• if the replacement of a part causes a change in the performance of QC.
Keep the following in mind regarding routine calibration:
• Refer to the TestPak IFU for calibration stability and calibration interval
information.
• The analyzer stores calibration data for three different TestPak lots of an
assay, allowing a new lot to be calibrated as soon as it is received rather
than waiting until it is time to use it.
• The analyzer will not process TestPaks off an uncalibrated lot. If a
calibration has expired or is due to expire within 72 hours, the message
Check Calibration Status displays on the System Check report. See
“Checking Calibration Status” on page 4 of this chapter.
3-2 2014/08
Processing Calibration
2. Use the arrows on the touchscreen to highlight Calibration Mode; select
Accept.
4. Load one CalPak per the assay being calibrated.
Note: Frozen CalPaks must be completely thawed at room
temperature and properly mixed prior to use. Refer to the
assay specific CalPak IFU for more details.
5. Load three TestPaks of the same lot number for the assay being
calibrated.
7. Select Start.
Note: When the calibration is complete, a report prints.
Evaluating the Calibration Report

Review the calibration status line in the center of the report slip:
• Calibration Pass – Confirm the calibration by running QC for the assay
before using the TestPak lot for processing samples.
• Calibration Fail – Follow the “Addressing Failed Calibration” on page 4. A
TestPak lot cannot be used until it has passed calibration.
Table 3-1 can help to interpret information about the calibration report.
Table 3-1: Calibration Report Terms
Term Definition
Run Time The date and time when Start was selected to begin the calibration.
TestPak Lot Number The lot number of the TestPaks included in the TestPak barcode.
CalPak Lot Number The lot number of the CalPak included in the CalPak barcode.
TestPak Coefficients Mathematical terms used to calculate the internal calibration curve.
C0, C1, C2, C3
Updated C1 Final C1 term used by the system after successful calibration.
%cv (C1) Percent coefficient of variation of updated C1.
2014/08 3-3
Addressing Failed Calibration

Follow this procedure if your calibration status is Fail.
1. If the error message on the calibration status line is Result Error, review
the error log for an error occurring at about the same time as the “Run
Time” on the calibration report. Troubleshoot the error. For more
information, See “Troubleshooting Procedures” on page 20 of Chapter 6:
Troubleshooting.
2. If the error message on the calibration status line is CV or Slope Error:
a. Align system components. See “Auto Aligning System Components”
on page 26 of Chapter 6: Troubleshooting.
b. Run System Check. See “Running System Check – Electronic QC” on
c. Rerun the calibration with a new CalPak and three new TestPaks
from the same lot.
d. If the calibration continues to fail, contact the Siemens Technical
Solutions Center or refer to the local support team.
Checking Calibration Status

Use this procedure to determine which TestPak lots have been calibrated.
1. From the Home screen, navigate to
Menus > Reports > Calibration Status.
2. Use the touchscreen as follows:
a. To list all lots calibrated for the displayed assay, select Status.
b. To display the status of another assay, select Next Method.
c. To display the status for the next calibrated lot of the current assay,
select ARROW until assay displays.
d. To print the status information for the assay displayed on the
screen, select Print. To print the status information for all assays,
select Print All.
3. Select Home.
Determining Expiration of TestPak Lot Calibration

Use this procedure to determine the amount of time remaining until a TestPak
lot’s calibration expires:
1. From the Home screen, select Reagent Status.
3. Review the time remaining for the TestPak lot’s calibration to determine
whether to run a calibration for a TestPak lot.
Note: To print the expiration information for the assay displayed on
the screen, select Print. To print the status information for all
assays, select Print All.
4. Select Home.
3-4 2014/08
Deleting a Calibrated TestPak Lot

Use this procedure to remove a calibrated TestPak lot.
2. Select Status to display the lots calibrated for the selected assay.
3. Highlight the lot to be removed; select Delete Lot.
Note: The message prompt Remove this Lot? displays at the top of
screen.
4. Select Yes to delete TestPak Lot.
5. Select Home.
Transmitting Calibration with POCT1-A2 Enabled

Use this procedure to transmit calibration data to LIS when POCT1-A2 is
enabled.
2. Select Transmit.
3. Verify calibration has been transmitted to LIS.
4. Select Home.
2014/08 3-5
3-6 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Quality Control
Chapter 4: Quality Control
2014/08 4-1
Quality Control Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Quality Control Overview

Quality Management
Quality Management on the Stratus® CS 200 Analyzer has two components:
• System Check – Electronic QC
• Quality Control (QC) Material
System Check – Electronic QC

System Check is run daily to monitor analyzer performance, including
fluorometer, fluid handling system, mechanical alignment and temperature.
System Check satisfies routine quality control requirements. Retain the System
Check printout. See “Running System Check – Electronic QC” on page 4 of
Chapter 2: Processing Samples and Reporting Results.
Quality Control Material

Additional quality control materials may be run to verify reagent performance.
Operators should process at least two levels of control material:
• When a TestPak lot is calibrated.
• When a new TestPak shipment is received for a previously calibrated lot.
• According to your internal QC procedures.
• According to government regulations or accreditation requirements for
quality control frequency.
• As otherwise recommended in this guide.
Note: Always retain the report data with QC records.
Review quality control data for differences which could indicate a change in
the instrument, such as:
Table 4-1: Quality Control Differences
QC Differences Description
Trends A trend is the gradual increase or decrease in the quality control results
over at least five data points per level for an assay.
Shifts A shift is a sudden rise or fall in at least five consecutive values per level.
Note: See “Miscellaneous Errors” on page 4 of Chapter 6:

Troubleshooting for information about trends and shifts.
Each assay on the instrument should be checked. Typical
performance characteristics for each assay are tabulated on
the TestPak Information for Use (IFU) and can be compared
to the data from the analyzer.
4-2 2014/08
Note: Analysis of a quality control chart is used to judge the

performance of an assay. Present performance is related to
past performance. Changes in the system such as calibration,
calibrator, or quality control product and reagent lot number
should be noted on the chart because they can affect
performance. Quality control data from several calibrations
and TestPak lots should be used to establish the mean and
standard deviations.
CAUTION: Only trained operators should perform these procedures.
2014/08 4-3
Setting Up QC Parameters
Storing QC IDs and Ranges

Use this procedure to store an identifier and a range of low and high values for
each level of QC material for specific methods.
The QC ID can be a control lot number or any ID chosen. These QC ID numbers
can also be used to interface with a remote computer system. The numbers
entered on this screen are automatically displayed in the QC ID field of the
related mode screen.
When QC is processed, the system compares the result to the stored range and
indicates whether the value is within or outside the range.
In addition to entering ranges, the Range Check setting can be set to be ON or
OFF. Range check applies only to those levels with IDs and ranges entered.
If Range Check is ON:
• Cannot process an assay if QC results are outside the specified range.
• Selected QC levels must run successfully or tests cannot be processed for
the assay.
• If the message Method Needs QC is displayed, the system will not process
a sample for the TestPak lot until QC is successfully completed.
Note: Low and high level QC must be processed and both must be
in range in order to process tests. Passing QC Low and QC HI
is considered successfully completed QC.
If Range Check is OFF, no message is generated by an out-of-range QC results
and samples can be processed.
To set the Range Check parameter and enter QC ID and ranges:
Menus > Maintenance > Setup > Advanced.
2. Enter the password; select Enter.
3. Select QC > QC Ranges.
5. Select Range On/Off until the appropriate Range Check Parameter
displays.
6. Move the cursor to ID field of the appropriate QC level to enter the QC
level lot number.
7. Enter the ID number; select Enter.
8. Enter the low range value; select Enter.
9. Enter the high range value; select Enter.
10. Repeat Step 6 through Step 9 for all levels to be entered or modified.
11. Select Accept.
Note: The message The changes have been stored. displays at the
top of the touchscreen.
4-4 2014/08
12. To enter ID and ranges for a different assay, select Next Method until the
appropriate assay is displayed.
13. Repeat Step 5 through Step 11 for all levels to be entered or modified.
14. When all levels for assays have been entered, select Home.
Setting Up System Check Lockout Parameters

The System Check Lockout feature prevents processing if System Check has
not been run within a certain number of hours. If the time period has been
exceeded, the message Sys Check expired, must run System Check displays.
To set up the System Lockout Feature:
2. Enter password; select Enter.
3. Select QC > Sys Chk Lockout.
4. Select Lock On/Off to activate or deactivate the lockout.
5. Use the arrows on the touchscreen to navigate to the Time field.
6. Enter the maximum hours (1 – 30) the system can process without
running System Check; select Enter.
7. Enter System Check ID; select Enter.
8. Select Accept.
9. Select Home.
Setting Up QC Lockout Parameters

The QC Lockout feature prevents processing if QC has not been run within a
certain number of hours. If the time period has been exceeded, the message
Method Needs QC displays. Once displayed, the operator is prevented from
processing a sample for a TestPak lot until QC has been successfully
completed. The QC Lockout alert is based on facility specified time (1 to 30
hours or 1 to 60 days).
Note: Operators can also specify which QC levels are governed by
the lockout parameter.
3. Select QC > QC Lockout.
4. Verify that both the assay and required level are displayed. To display
another assay, select Next Method.
5. Select Next Level until the required levels are displayed.
6. Select Next Time Units to select the desired time method
(hours or days).
2014/08 4-5
7. Select Accept.
Note: The message The changes have been stored displays at the
8. Select Home.
4-6 2014/08
Processing QC
Three levels of quality control material can be processed for each assay used
on the Stratus® CS 200 Analyzer.
QC Modes
The Stratus® CS 200 Analyzer provides three QC modes.
• QC Low for running a level of QC material
• QC Hi (high) for running a second level of QC material.
• QC Misc (miscellaneous) for running an optional third level of QC material.
CAUTION: Before following a QC Mode procedure, prepare the control

material according to the manufacturer’s instructions.
Thoroughly mix the material before placing it in a sample cup.
Fill the sample cup to the bottom edge of the rim (500 µL).
Figure 4-1: Sample Cup 500 µL Fill Line
Note: Make sure there are no particulates in the sample and no air
bubbles on the surface.
Table 4-2 shows the minimum volume required:
Table 4-2: Sample Cup Volume
Number of Minimum Minimum

Tests Volume µL Volume cc
1 200 0.2
2 300 0.3
3 400 0.4
4 500 0.5
Note: The dead volume in a sample cup is 100 µL.
2014/08 4-7
To process QC:
2. Use the arrows on the touchscreen to highlight the required QC Mode.
3. Select Next Method to select an assay.
Note: If multiple assays have the same QC ID, select any one of the
assays.
4. Select Accept.
Note: QC IDs that were previously entered on the QC Ranges screen
automatically populate on this screen. However, if the ID
field is blank, manual entry is required.
5. Select Enter.
6. Enter the Operator ID, if appropriate; select Enter.
7. Place the sample cup in the cup position on the rotor table.
9. Place one TestPak per assay, maximum 4, in the Pak Manager Well.
10. Select Start.
Note: Retain all QC records according to your facility accrediting
agency.
4-8 2014/08
Understanding the Quality Control Report

The quality control report is printed after processing is completed. The report
compares the measured concentration with the QC ranges manually entered
on the system (see “Setting Up QC Parameters” on page 4). If the
concentration is within the range, it is reported as OK. If it is outside the range,
the concentration is reported as OUT.
Addressing an Out of Range QC Result

If a Quality Control Result is out-of-range, execute the following procedures:
1. Align System Components. See “Auto Aligning System Components” on
page 26 of Chapter 6: Troubleshooting.
2. Run System Check. See “Running System Check – Electronic QC” on
3. Reprocess QC using a fresh, well-mixed vial of QC control material.
4. If the problem persists, contact the Siemens Technical Solutions Center
or refer to the local support team.
2014/08 4-9
4 - 10 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Maintenance
Chapter 5: Maintenance
2014/08 5-1
Maintenance Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Maintenance Overview
Training must include proper blood-handling techniques.
Maintenance is required to keep the Stratus® CS 200 Analyzer in working
order. There are standard, monthly, and "as needed" procedures included in
this chapter.
Note: Record all completed tasks on maintenance log sheets.
WARNING: Human body fluids are potential biohazards. Follow
facility specific biohazardous waste disposal procedures

when handling or discarding instrument parts or materials
that may have been in contact with patient samples.
Accessory Kit
An accessory kit containing tools, spare parts, and a fluorometer reference pak
comes with the instrument. Tools are required for both monthly and periodic
maintenance.
The replaceable parts described in the “Troubleshooting Procedures” on
page 20 of Chapter 6: Troubleshooting of this chapter, excluding the USB flash
drive and the fluorometer lamp, are also included in the kit.
Standard Maintenance
Standard maintenance activities include:
• Cleaning up spills immediately. The instrument and area around it should
be kept clean.
• Routinely cleaning the outside surfaces of the entire instrument following
facility specific biohazard procedures.
5-2 2014/08
Monthly Maintenance Overview

The procedures in this section should be performed at least once a month,
preferably in the order listed below:
• Replacing and Cleaning the Air Filter
• Cleaning Instrument Surfaces:
▪ Sample door area
▪ Lower cannula chamber seal
▪ Waste container area
▪ Tip chute
▪ Pak shield
▪ Touchscreen
2014/08 5-3
Monthly Maintenance Procedures

Replacing and Cleaning the Air Filter
1. Locate the air filter door on the top cover of the instrument.
2. Slide the black latch toward the center of the instrument and lift the
door.
Figure 5-1: Filter Door Latch
3. Slide the filter out.

4. Install the clean filter from the accessory kit with the metal grid side
visible.
Figure 5-2: Insert Filter with Metal Grid Visible
5-4 2014/08
5. Close the door, ensuring the latch is secure.

6. Clean the removed air filter under running water.
7. Dry air filter with lint-free cloth. Ensure the filter is completely dry before
placing it in the accessory kit.
Cleaning Instrument Surfaces

2. Insert a long, slender tool into the lid release; press firmly and lift the
instrument lid.
Figure 5-3: Lid Release
2014/08 5-5
3. Clean the sample door area with a damp cloth.

Figure 5-4: Clean Sample Door
4. Dry the area with a lint-free cloth.

5. Clean the lower cannula chamber seal using a damp cloth.
Figure 5-5: Lower Cannula Seal
5-6 2014/08
6. Loosen the captive screw on the pak shield.

Figure 5-6: Pak Shield Captive Screw
7. Remove the pak shield and clean it with a damp cloth; set aside.
8. Loosen the captive screw at the front of the tip waste chute.
Figure 5-7: Tip Waste Chute Captive Screw
2014/08 5-7
9. Slide the tip chute off the mounting pin and remove; clean with a damp
cloth.
Figure 5-8: Cleaning the Tip Chute with a Damp Cloth
10. Thoroughly dry both components with a lint-free cloth.

11. Reinstall the tip chute on the mounting pin and tighten the captive
screw.
12. Reinstall the pak shield and tighten the captive screw.
13. Remove the waste container, cover with the new waste container lid,
and dispose of the waste container according to facility procedure.
5-8 2014/08
14. Clean the waste container area using a damp cloth.

Figure 5-9: Waste Container Area
15. Dry the area with a lint-free cloth.

16. Insert a new, empty waste container.
17. Close the instrument lid and the left front door, ensuring the door is
securely latched.
Cleaning the Touchscreen and Stylus

1. To clean contaminants from the touchscreen area and stylus, use a
lint-free cloth dampened with isopropyl alcohol.
2. Dry the touchscreen and stylus with a dry, lint-free cloth.
2014/08 5-9
Other Maintenance
Replacing the Thermal Printer Paper
1. Lift the printer lid; remove and discard the used paper roll from the
spindle.
Figure 5-10: Thermal Printer Paper Feed
# Description
1 Spindle
2 Green Lever
3 Roller
2. Insert the spindle into the new thermal paper roll.

3. Position the spindle in the holder so that the paper feeds from the
bottom of the roll.
4. To release the roller, push the green lever toward the back of instrument.
5. Thread the paper through the roller.
6. Push the green lever forward to lock roller in place.
7. Select the Paper Advance icon three times.
8. Feed the paper through the slot in the printer lid and close the printer lid.
9. Select the Paper Advance icon until about 5 cm (2 inches) of paper are
visible.
5 - 10 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Troubleshooting
Chapter 6: Troubleshooting
2014/08 6-1
Troubleshooting Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Troubleshooting Overview
This chapter describes Stratus® CS 200 Analyzer errors and provides
instructions on how to resolve them.
Training must include proper blood-handling techniques. If
additional assistance is required, contact the Siemens
Technical Solutions Center or refer to the local support team.
Troubleshooting Error Codes

If an error occurs during processing, the error code is stored in the error log.
Menus > Reports > System Status > Error Log.
2. Use the arrows to select the error information to print.
3. Select More Info to print a single error.
4. Select Print Log to print all errors.
5. Select Stop to stop printing.
6. To locate the resolution for an error code, match the error code with the
4-character codes displayed in Table 6-2 on page 7.
Note: Troubleshoot the first error code that occurred. This is the
error that occurred closest to the Run Time on the result
report slip.
7. Follow the Steps in the Resolution column.
8. After completing a Step, try to resume normal operation. If the problem
still exists, go to the next Step.
9. Continue working through the resolution procedure in this manner until
the error clears.
10. Contact the Siemens Technical Solutions Center or refer to the local
support team if the problem persists or if you have any questions about
the procedure.
Note: Always save any printed reports resulting from
troubleshooting procedures.
Interpreting Processing Errors

When a Processing Error occurs, the word Error appears on both the
instrument display and the Report Slip. Operators can view the error codes
from the display or by printing the Error Log.
Note: Some Processing Errors will also trigger an audio alert. If this
occurs, select any button on the display to turn off the audio
alert.
For more information, Table 6-2, “Error Codes, Cause, and Resolution,” on
page 7.
6-2 2014/08
Printing Error Log

If an error occurs during processing, the error code is stored in the error log.
The Error Log includes the error code, the associated error message, the time
and the date of the error.
Menus > Reports > System Status > Error Log.
2. To print a single error:
a. Select the appropriate error.
b. Select More Info to print the error.
3. To print a list of all errors:
a. Select Print Log.
4. To stop printing, select Stop.
2014/08 6-3
Miscellaneous Errors
WARNING: If any panel, cover, or guard must be removed for

adjustment, be extremely careful to prevent personal injury.
Electrical power can be hazardous. Follow these instructions
carefully to avoid injury.
Table 6-1: Miscellaneous Errors
Symptoms Resolution
The analyzer does not 1. Power down the analyzer:

power on a. Select the Power icon.
b. Select Yes to shutdown the instrument.
The screen is blank c. Turn the main power switch off.
No lights are lit WARNING: When disconnecting or connecting the power

cord, ensure that the main power switch is OFF.
Always connect the cord to the analyzer before
plugging it into the wall outlet.
2. Ensure the power cord is plugged into both the analyzer and the
wall outlet. If it is unplugged, plug the power cord into the analyzer
and then into the wall. Turn the main power switch on.
3. Verify that power is supplied to the wall outlet.
4. Check the AC and DC fuses. Turn off instrument and replace if
necessary. For more information, see “Replacing AC Fuses” on
page 40 and see “Replacing DC Fuses” on page 42.
Processing does not begin 1. Check the screen for messages.

when Start is selected 2. Check for any red status indicators for required supplies.
The system does not 1. Check the DC fuse lights. If a DC fuse indicator light is not lit, this is
respond when the the fuse that requires replacement.
touchscreen buttons are 2. Turn the power switch off. Wait 30 seconds.
selected 3. Replace the fuse.
4. Close the sample door and turn the power switch on. Save the
report slip with maintenance records.
Expected report not 1. Open the printer door; tear off the paper and remove obstructions
printed that prevents the print head from moving to the left.
2. Select Paper Advance; feed the paper through the paper slot and
Printer Jam close the printer door.
3. From the Home screen, navigate to Menus > Reports > Print
Message: Printer Error, Results.
Possible Paper Jam 4. Using the keypad on the display, select the result to be printed.
5. Select Enter > Print.
6-4 2014/08
Symptoms Resolution
Pak Jam 1. Open the waste container door.

2. Insert a long, slender tool into the lid release. Press firmly and lift
the analyzer lid
3. Pull up the three release knobs on the pak carousel cover. Lift the
cover and place it on top of the rotor table.
4. Rotate the carousel so the pak is aligned with the pak shield.
5. Push the pak into the pak waste chute. Repeat for all paks in the
carousel.
6. Position the carousel cover on the carousel and push down the
three release knobs until they snap into place.
7. Close the analyzer lid and the waste container door.
8. Close the sample door. From the Home screen, navigate to
Menus > Reset > Home.
QC Trend 1. Repeat QC processing with fresh well-mixed QC material.

2. Clean the carousel reference disk and fluorometer window. See
“Cleaning the Carousel Reference Disk and
Fluorometer Window” on page 30.
3. Align system components. See “Auto Aligning System
Components” on page 26.
4. Run System Check. See “Running System Check – Electronic QC”
on page 4 of Chapter 2: Processing Samples and Reporting Results.
QC Shift 1. Ensure you are using the same QC lot and ranges used before the
shift.
Changing to a different QC 2. Ensure you are using the same TestPak and CalPak lots used
lot usually causes a QC before the shift.
shift 3. Repeat QC processing with fresh well-mixed QC material.
Changing to a different pak “Cleaning the Carousel Reference Disk and Fluorometer Window” on
lot can cause a slight QC page 30.
shift 5. Align system components. See “Auto Aligning System
Accuracy Problem 1. Rerun QC with fresh well-mixed material.

“Cleaning the Carousel Reference Disk and Fluorometer Window” on
page 30.
3. Align system components. See “Auto Aligning System
5. Calibrate the TestPak lot and rerun QC.
Precision Problem 1. Run a 4-TestPak precision using fresh, well-mixed material.

The CV value exceeds the “Cleaning the Carousel Reference Disk and Fluorometer Window” on
limits stated in the TestPak page 30.
Information for Use (IFU) 3. Align system components. See “Auto Aligning System
sheet Components” on page 26.
5. Run a 4-TestPak precision using fresh, well-mixed material.
2014/08 6-5
Symptoms Resolution
Touchscreen not aligned 1. Power down the analyzer:

a. Select the Power icon.
c. Turn the main power switch off.
2. Open the left front door and instrument lid.
3. Remove the data USB flash drive. To locate the data USB, see
Figure 6-33 on page 48.
4. Close the instrument lid.
5. Turn the main power switch on. The reboot will fail and system
clears the touchscreen alignment flag.
6. Power down the analyzer:
7. Open the Instrument lid.
8. Re-insert data USB flash drive.
9. Close the left front door and instrument lid.
10. Turn main power switch on.
Note: Operator must align touchscreen when the 4 calibration point
touchscreen alignment displays; select the target point until the
target highlights and moves to the next corner. Repeat for each
corner.
6-6 2014/08
Error Codes
WARNING: If any panel, cover, or guard must be removed for
adjustment, be extremely careful to prevent personal injury.
Electrical power can be hazardous. Follow these instructions
carefully to avoid injury.
Table 6-2: Error Codes, Cause, and Resolution
Code Cause Resolution
CH1H • Pak Problem Rerun the sample as a dilution. If result is normal, repeat
CH2H • Reaction is above analyzer undiluted.
CH3H read capability
(high sample)
CH1L • Pak Problem 1. Run System Check. See

“Running System
• Reaction is below analyzer
read capability
Check – Electronic QC” on page 4 of
(low sample) Chapter 2: Processing Samples and
Reporting Results.
2. Rerun the sample with a new TestPak.
CH1M Analyzer data error 1. Select the Power icon on the Home screen.
2. Select Yes to shutdown the instrument.
3. Turn the power switch off.
4. Close the sample door and turn the power switch on.
5. Be sure to save the report slip with maintenance
records.
6. Rerun with a new Test Pak.
CH1N Noisy rate 1. Rerun the sample with a new TestPak.

2. Clean the Fluorometer window and the Carousel and
Pak Manager Lid Reference disks. See “Cleaning the
Carousel Reference Disk and Fluorometer Window” on
page 30.
3. Adjust Fluorometer. See “Adjusting the Fluorometer” on
page 23.
CH5G Previously Used Pak Rerun with a new, unused Test Pak.
CR1A • Sensor problem 1. From the Home screen, navigate to Menus > Reset.
CR1B • Transport mechanism 2. Check the DC fuse lights. If a DC fuse indicator light is
CR1C problem not lit, this is the fuse that requires replacement.
CR1D • Level sense problem 3. Lift the analyzer lid. Look for and remove any
CR1F • I/O board problem obstructions around the rotor table. Close the lid.
CR1I • Rotor mechanism is 4. Power down the analyzer:
CR1N obstructed a. Select the Power icon.
• Rotor mechanism needs b. Select Yes to shutdown the instrument.
lubrication c. Turn the main power switch off.
d. Replace the DC fuse.
e. Wait 30 seconds then turn the power switch on.
2014/08 6-7
CR1K • Analyzer lid not latched 1. Make sure the analyzer lid is closed completely.
CR1O • Rotor or cup not seated 2. Check the position of the cup or rotor to make sure it is
CR1R properly positioned and seated correctly. Close the sample door.
CR1S • Rotor upside down (the 3. From the Home screen, navigate to Menus > Reset >
small opening should be Home.
up) 4. Power down the analyzer:
• Rotor or cup missing a. Select the Power icon.
• Sensor problem b. Select Yes to shutdown the instrument.
d. Wait 30 seconds then turn the power switch on. Save
the report slip with maintenance records.
CR1Q Rotor transport problem Contact the Technical Solutions Center or refer to the local
support team.
CR1X Rotor transport alignment 1. From the Home screen, navigate to

CR1Y problem Menus > Maintenance > Alignment > Auto All.
CR1Z 2. Close the sample door, select Start.
3. Lift the analyzer lid. Look for and remove any
obstructions or debris around the rotor table. Close the lid.
CR2D Rotor transport sensor or 1. From the Home screen, navigate to Menus > Reset.
CR2H solenoid problem 2. Close the sample door; select Home.
CR2L 3. Power down the analyzer:
CR2R a. Select the Power icon.
CR2V b. Select Yes to shutdown the instrument.
CR3A • Centrifuge elevator sensor 1. From the Home screen, navigate to Menus > Reset.
CR3B or mechanism problem 2. Close the sample door; select Home.
CR3C • I/O board problem
3. Check the DC fuse lights. If an DC fuse LED is not lit, this
CR3D • Centrifuge elevator is the fuse that requires replacement.
CR3E mechanism is obstructed
4. Lift the analyzer lid and remove the left side panel. Look
CR3F • Centrifuge elevator
for and remove obstructions around the centrifuge
CR3I mechanism needs elevator. Install the side panel and close the lid.
CR3N lubrication
CR3Q a. Select the Power icon.
e. Wait 30 seconds then turn the power switch on. Save
CR3Z Alignment Problem Align system components (auto align). See

“Auto
Aligning System Components” on
page 26.
CR4H Centrifuge did not perform as 1. From the Home screen, navigate to Menus > Reset.
CR4L expected 2. Close the sample door; select Home.
CR4R 3. Power down the analyzer:
CR4T a. Select the Power icon.
6-8 2014/08
CS1G Password Mode on 1. Power down the analyzer:

a. With the Home screen displayed, select the Power icon.
d. Wait 30 seconds then turn the power switch on.
CS1K Analyzer lid is open 1. Ensure lid is closed and latched.

2. Restart processing.
CS1L Momentary loss of AC power 1. Power down the analyzer:

a. With the Home screen displayed, select the Power icon.
CS1T Communication Failure 1. Retransmit results to the LIS.

2. Contact the LIS Administrator.
CS1U • Loose LIS communication 1. Check/reseat communication cable.

cable 2. From the Home screen, navigate to Menus > Reset.
• LIS down 3. Verify the LIS communication settings.
• Incorrect communication 4. Contact the LIS Administrator.
configuration
CS2G Stop was selected during Select Start to resume processing.

processing
CS2T The control board is having 1. Power down the analyzer:

CS2U problems processing a. With the Home screen displayed, select the Power icon.
CS2V b. Select Yes to shutdown the instrument.
CS2W c. Turn the main power switch off.
CS5Q d. Wait 30 seconds then turn the power switch on. Save
CS5R the report slip with maintenance records.
CS5S 2. Open the main instrument lid and ensure that the USB
CS5U flash drive is seated properly.
CS8T • Loose connections to 1. From the Home screen, navigate to Menus > Reset.
display 2. Close the sample door; select Home.
• Display problem 3. Check the DC fuses. If an LED is not lit, replace the fuse.
4. Lift the analyzer lid. Ensure the display cables are
connected and undamaged; close the lid.
FL1D Software error in chemistry Contact the Technical Solutions Center or refer to the local
profile support team.
2014/08 6-9
FL1E • Loose connections to lamp 1. From the Home screen, navigate to Menus > Reset.
FL1H manager or fluorometer 2. Close the sample door; select Home.
FL1K • Component not available 3. Check the DC fuse lights. If a DC fuse LED is not lit, this
FL1T when needed is the fuse that requires replacement.
FL1U 4. Lift the analyzer lid. Ensure the display cables are
connected and undamaged; close the lid.
e. Wait 30 seconds then turn the power switch on. Save
6. Run a System Check. See “Running System
Check – Electronic QC” on page 4 of
Chapter 2: Processing Samples and
Reporting Results.
7. Adjust the Fluorometer. See “Adjusting the
Fluorometer” on page 23.
FL1J Alignment problem. Align the system components (auto align). See “Auto
Aligning System Components” on
page 26.
PI1A • Pipettor carriage sensor or 1. From the Home screen, navigate to Menus > Reset.
PI1B mechanism problem 2. Close the sample door; select Home.
PI1C • I/O board problem 3. Check the DC fuses. If an LED is not lit, replace the fuse.
PI1D • Carriage mechanism is 4. Lift the analyzer lid. Look for and remove obstructions
PI1F obstructed to the pipettor carriage; close the lid.
PI1I • Carriage mechanism needs 5. Power down the analyzer:
PI1N lubrication a. Select the Power icon.
PI1Q • Component not available b. Select Yes to shutdown the instrument.
PI1T when needed c. Turn the main power switch off.
PI2A • Pipettor probe sensor or 1. From the Home screen, navigate to Menus > Reset.
PI2B mechanism problem 2. Close the sample door; select Home.
PI2C • I/O board problem 3. Check the DC fuses. If an LED is not lit, replace the fuse.
PI2D • Pipettor mechanism is 4. Lift the analyzer lid. Look for and remove any
PI2E obstructed obstructions to the pipette mechanism; close the lid.
PI2F • Pipettor mechanism needs 5. Power down the analyzer:
PI2I lubrication a. Select the Power icon.
PI2N b. Select Yes to shutdown the instrument.
PI2Q c. Turn the main power switch off.
PI2E • Not enough sample 1. Ensure the sample volume is adequate.

PI3R • Defective level sense cable 2. Repeat the test with another patient sample.
• Defective level sense board
P12H • Sample not mixed 1. Repeat the test with another tube from the patient.
properly, causing 2. Inspect the sample cup or used rotor for air bubbles,
aspiration problem clots, or other contaminants.
• Wrong type of sample tube
used
6 - 10 2014/08
PI2L • Not enough sample to 1. Repeat the test with another tube or cup, ensuring no
complete the test air bubbles are present in the sample.
• Air bubbles in sample 2. Inspect discarded rotor or cup for proper fluid level.
3. Run System Check. See “Running System Check –
Electronic QC” on page 4 of Chapter 2: Processing Samples
and Reporting Results.
PI2M Pak Problem 1. Repeat the test.

2. Run System Check. See “Running System Check –
PI2S • Air bubbles in sample 1. Repeat the test with another tube or cup, ensuring no
• Leak in pipetting system air bubbles are present in the sample.
• Level sense problem 2. Run System Check. See “Running System Check –
PM1A • Pak carousel sensor or 1. From the Home screen, navigate to Menus > Reset.
PM1B mechanism problem 2. Close the sample door; select Home.
PM1C • I/O board problem 3. Check the DC fuses. If an LED is not lit, replace the fuse.
PM1D • Carousel mechanism is 4. Lift the analyzer lid. Look for and remove obstructions
PM1E obstructed to the carousel mechanism.
PM1F • Carousel mechanism needs 5. Clean the carousel springs. See
“Cleaning the
PM1H lubrication
PM1I
Carousel Springs” on page 27.
PM1L
PM1N a. Select the Power icon.
PM1Q
PM1X Pak carousel alignment problem 1. From the Home screen, navigate to
PM1Y Menus > Maintenance > Alignment > Auto All.
PM1Z 2. Close the sample door; select Start.
3. Lift the analyzer lid. Remove the pak manager lid. Look
for and remove obstructions or debris around the
carousel; close the lid.
PM2A • Pak shuttle sensor or 1. From the Home screen, navigate to Menus > Reset.
PM2B mechanism problem 2. Close the sample door; select Home.
PM2C • I/O board problem 3. Check the DC fuses. If an LED is not lit, replace the fuse.
PM2D • Shuttle mechanism is 4. Lift the analyzer lid. Look for and remove obstructions
PM2F obstructed to the pak shuttle mechanism; close the lid.
PM2I • Shuttle mechanism needs 5. Power down the analyzer:
PM2N lubrication a. Select the Power icon.
PM2Q b. Select Yes to shutdown the instrument.
PM4A • Shuttle mechanism is 1. From the Home screen, navigate to Menus > Reset.
PM4B obstructed by paks 2. Close the sample door; select Home.
PM4C • Waste shuttle sensor or 3. Check the DC fuses. If an LED is not lit, replace the fuse.
PM4D mechanism problem 4. Lift the analyzer lid. Look for and remove obstructions
PM4F • I/O board problem to the waste shuttle mechanism; close the lid.
PM4I • Shuttle mechanism is 5. Power down the analyzer:
PM4N obstructed a. Select the Power icon.
PM4Q • Shuttle mechanism needs b. Select Yes to shutdown the instrument.
2014/08 6 - 11
PU1A • Sample syringe sensor or 1. From the Home screen, navigate to Menus > Reset.
PU1B mechanism problem 2. Close the sample door; select Home.
PU1C • I/O board problem 3. Check the DC fuses. If an LED is not lit, replace the fuse.
PU1F • Syringe mechanism is 4. Lift the analyzer lid. Look for and remove obstructions
PU1H obstructed to the syringe mechanism; install the top cover.
PU1I • Syringe mechanism needs 5. Power down the analyzer:
PU1N lubrication a. Select the Power icon.
PU1Q b.Select Yes to shutdown the instrument.
PU1P • Dispense greater than 1. Power down the analyzer:

PU2H aspirate a. With the Home screen displayed, select the Power icon.
PU2P • Aspirate greater than b. Select Yes to shutdown the instrument.
pump capacity c. Turn the main power switch off.
• Method profile problem d. Wait 30 seconds then turn the power switch on. Save
PU2A • Pipettor syringe sensor or 1. From the Home screen, navigate to Menus > Reset.
PU2B mechanism problem 2. Close the sample door; select Home.
PU2C • I/O board problem 3. Check the DC fuses. If an LED is not lit, replace the fuse.
PU2F • Syringe mechanism is 4. Lift the analyzer lid. Look for and remove obstructions
PU2I obstructed to the syringe mechanism; install the top cover.
PU2N • Syringe mechanism needs 5. Power down the analyzer:
PU2Q lubrication a. Select the Power icon.
PU3H • Valve problem 1. From the Home screen, navigate to Menus > Reset.
PU3L • I/O board problem 2. Close the sample door; select Home.
PU3P 3. Power down the analyzer:
PU3R a. Select the Power icon.
b.Select Yes to shutdown the instrument.
SM1A • Cannula chamber sensor or 1. From the Home screen, navigate to Menus > Reset.
SM1B mechanism problem 2. Close the sample door; select Home.
SM1C • I/O board problem 3. Check the DC fuses. If a light is not lit, replace the fuse.
SM1D • Chamber mechanism is 4. Lift the analyzer lid. Look for and remove obstructions
SM1F obstructed to the sample manager or rotor containment mechanism;
SM1I • Chamber mechanism close the lid.
SM1N needs lubrication 5. Power down the analyzer:
SM1Q • Rotor containment a. Select the Power icon.
SM2A mechanism is obstructed b.Select Yes to shutdown the instrument.
SM2B • Rotor containment c. Turn the main power switch off.
mechanism needs d. Wait 30 seconds then turn the power switch on. Save
lubrication the report slip with maintenance records.
• Sensor problem
• Containment home flag
mount is crooked
SM1H Low pressure after pump is reset Check that syringe thumbscrews are secure.
6 - 12 2014/08
SM1L • Problems with sample 1. Clean the sample door area and the cannula chamber
• Dirty sample door lower seal. See
“Cleaning Instrument
• Cannula chamber seal
problems
Surfaces” on page 5 of Chapter 5:
• Leak in sample tubing Maintenance.
2. Replace the cannula chamber lower seal and the
cannula chamber o-ring seal and lubricant. See
“Replacing the Cannula Chamber Lower
Seal” on page 43 and See “Replacing the
Cannula Chamber O-Ring Seal” on
page 45.
3. Use the plastic torque wrench to tighten the blue
fittings for the sample tubing.
4. Replace the sample tubing. See
“Replace the
Sample Manager Tubing” on page 56.
SM1P • Sample not mixed 1. Verify that correct tube type is in use and that the
thoroughly sample is mixed thoroughly.
• Wrong type of tube used 2. Rerun the test using a new cannula and stopper.
• Cannula problem 3. Prepare a plasma sample and process it in a sample cup.
SM1Z Alignment Problem 1. From the Home screen, navigate to

Menus > Maintenance > Alignment > Auto All.
2. Close the sample door; select Start.
SM2D • Sample door open switch Close the sample door. Make sure the sample light on the
SM2H or solenoid problem keypad is not lit.
SM2L • Misaligned sample door
SM2R open switch or solenoid
SM3K
2014/08 6 - 13
SM3O Problems with sample Make sure the cannula/tube assembly is properly seated
tube/cannula in the sample door.
TE1H • Heater problem 1. Power down the analyzer:

TE1K • Thermistor problem a. With the Home screen displayed, select the Power icon.
TE1L b.Select Yes to shutdown the instrument.
TE1R c. Turn the main power switch off.
TE2R d. Wait 30 seconds, close sample door then turn the
TE3H power switch on. Save the report slip with maintenance
TE3L records.
TE3R
TE4R
TE5H
TE5L
TE5R
TE6R
TM1A • Tip tray sensor or 1. From the Home screen, navigate to Menus > Reset.
TM1B mechanism problem 2. Close the sample door; select Home.
TM1C • Level sense problem 3. Check the DC fuses. If a light is not lit, replace the fuse.
TM1D • I/O board problem 4. Lift the analyzer lid. Look for and remove obstructions
TM1F • Tip tray transport to the tip tray transport mechanism; close the lid.
TM1I mechanism is obstructed 5. Power down the analyzer:
TM1N • Tip tray transport a. With the Home screen displayed, select the Power icon.
TM1Q mechanism needs b. Select Yes to shutdown the instrument.
TM1X Tip tray transport alignment 1. From the Home screen, navigate to Menus >
TM1Y problem Maintenance > Alignment > Auto All.
TM1Z 2. Close the sample door; select Start.
3. Lift the analyzer lid. Look for and remove obstructions
or debris around the tip tray transport table; close the lid.
UE1H Process error during calibration Review the error log and resolve process errors that
occurred during calibration.
6 - 14 2014/08
Table 6-3: Error Codes and Messages
Code System Component Message
Chemistry
CH1H Pak High initial fluorescence
CH1L Pak Pak reading negative rate
CH1M Pak Insufficient data points
CH1N Pak Noisy rate
CH2H Pak Data points above instrument read capability
CH3H Pak High fluorescence
CH5G Pak Previously used pak or pak paper missing
Centrifuge/Rotor Transport
CR1A Rotor transport Table stuck on home
CR1B Rotor transport Table can’t find home
CR1C Rotor transport Table lost steps toward back
CR1D Rotor transport Position sensor had no transition
CR1F Rotor transport Table lost steps toward front
CR1I Rotor transport Motor driver had a problem
CR1K Rotor transport Rotor removed after start
CR1N Rotor transport Motor fault/motor may be disconnected
CR1O Rotor transport Rotor orientation error
CR1Q Rotor transport Illegal error
CR1R Rotor transport Sample cup removed after start
CR1S Rotor transport Cup/rotor sensor does not clear
CR1X Rotor alignment Pipettor X to rotor table offset out of range
CR1Y Rotor alignment Pipettor Y to rotor table offset out of range
CR1Z Rotor alignment Pipettor Z to rotor table offset out of range
CR2D Rotor transport Table latch solenoid energized but sensor disconnected or open
CR2H Rotor transport Table latch solenoid shorted
CR2L Rotor transport Table latch solenoid disconnected or open
CR2R Rotor transport Table latch solenoid high leakage current
CR2V Rotor transport Table latch sol de-energized but sensor disconnected or open
CR3A Centrifuge elevator Elevator stuck on home
CR3B Centrifuge elevator Elevator can’t find home
CR3C Centrifuge elevator Lost steps moving up
CR3D Centrifuge elevator Elevator did not get to its full position
CR3E Centrifuge elevator Elevator position sensor had no transition
2014/08 6 - 15
CR3F Centrifuge elevator Lost steps moving down
CR3I Centrifuge elevator Motor driver had a problem
CR3N Centrifuge elevator Motor fault/motor may be disconnected
CR3Q Centrifuge elevator Illegal error
CR3Z Centrifuge alignment New alignment offset out of range
CR4H Centrifuge RPM high
CR4L Centrifuge RPM low/not reaching speed
CR4R Centrifuge Motor is spinning but rotor is not moving
CR4T Centrifuge Centrifuge will not stop
Control System
CS1G Password mode Result not valid
CS1K Main lid open Result not valid
CS1L Power fail detected Power fail signal detected from 24-volt power supply
CS1T Software Host LIS not acknowledging result transmission
CS1U Software Host LIS not responding to poll message
CS2G Processor User aborted processing
CS2T Processor Critical time missed
CS2U Processor Communication error w/processor
CS2V Processor Can’t reset process
CS2W Processor Can’t initialize process
CS5Q Software Unknown IOC error code
CS5R Software Calculation error
CS5S Software CSP error
CS5U Software Logic error/software
CS8T System control Display timeout
Fluorometer
FL1D Fluorometer Carousel moved during fluorometer read
FL1E Fluorometer A to D timeout
FL1H Fluorometer A to D overrun
FL1J Fluorometer New alignment value out of acceptable range
FL1K Fluorometer Fluorometer failed tests
FL1T Fluorometer Start time missed
FL1U Fluorometer A to D not responding
Pipettor
6 - 16 2014/08
PI1A Pipettor Carriage stuck on home
PI1B Pipettor Carriage can’t find home
PI1C Pipettor Carriage lost steps moving left
PI1D Pipettor Carriage position sensor not found
PI1F Pipettor Carriage lost steps moving right
PI1I Pipettor Carriage motor driver had a problem
PI1N Pipettor Carriage motor fault/motor may be disconnected
PI1Q Pipettor Carriage illegal error
PI1T Pipettor Start time missed
PI2A Pipettor Probe stuck on home
PI2B Pipettor Probe can’t find home
PI2C Pipettor Probe lost steps moving down
PI2D Pipettor Probe missed position error
PI2E Pipettor Probe position sensor had no transition
PI2F Pipettor Probe lost steps moving up
PI2H Pipettor aspiration Tip plugged during aspiration
PI2I Pipettor Probe motor driver had a problem
PI2L Pipettor aspiration Short sample during aspiration
PI2M Pipettor No fluid present - pak well
PI2N Pipettor Probe motor fault/motor may be disconnected
PI2Q Pipettor Probe illegal error
PI2S Pipettor No fluid present – sample cup/rotor
PI3R Level Sense Level was not detected or detected at wrong position
Pak Manager
PM1A Carousel Carousel stuck on home
PM1B Carousel Carousel not present/can’t find home
PM1C Carousel Carousel lost steps clockwise
PM1D Carousel Carousel missed position error
PM1E Carousel Carousel position sensor had no transition
PM1F Carousel Carousel lost steps counterclockwise
PM1H Carousel More than one home sensor transitioned per RPM
PM1I Carousel Carousel motor driver had a problem
PM1L Carousel Excess backlash detected due to loose drive belt
PM1N Carousel Carousel motor fault/motor may be disconnected
2014/08 6 - 17
PM1Q Carousel Carousel illegal error
PM1X Carousel alignment Pipettor X offset out of range
PM1Y Carousel alignment Pipettor Y offset out of range
PM1Z Carousel alignment Pipettor Z offset out of range
PM2A Loader Pak shuttle stuck on home
PM2B Loader Pak shuttle can’t find home
PM2C Loader Pak shuttle lost steps pushing pak
PM2D Loader Pak shuttle unused missed position error
PM2F Loader Pak shuttle lost steps toward front
PM2I Loader Pak shuttle motor driver had a problem
PM2N Loader Pak shuttle motor fault/motor may be disconnected
PM2Q Loader Pak shuttle illegal error
PM4A Waste Waste stuck on home
PM4B Waste Waste can’t find home
PM4C Waste Waste shuttle lost steps moving right
PM4D Waste Waste shuttle position sensor had no transition
PM4F Waste Waste shuttle lost steps returning from waste slot
PM4I Waste Waste shuttle motor driver had a problem
PM4N Waste Waste shuttle motor fault/motor may be disconnected
PM4Q Waste Waste shuttle illegal error
Pump System
Note: 5 mL syringe used for cannulation/sample to rotor; 100 µL syringe used for sample/reagent
pipetting to pak.
PU1A Pump Sample syringe (5 mL) stuck at home
PU1B Pump Sample syringe (5 mL) can’t find home
PU1C Pump Sample syringe (5 mL) lost steps aspirating
PU1F Pump Sample syringe (5 mL) lost steps dispensing
PU1H Pump Sample syringe (5 mL) dispense ≥ aspiration
PU1I Pump Sample syringe (5 mL) motor driver had a problem
PU1N Pump Sample syringe (5 mL) motor fault/motor may be disconnected
PU1P Pump Sample syringe (5 mL) aspirate ≥ pump capacity
PU1Q Pump Sample syringe (5 mL) illegal error
PU2A Pump Pipettor syringe (100 µL) stuck on home
PU2B Pump Pipettor syringe (100 µL) can’t find home
PU2C Pump Pipettor syringe (100 µL) lost steps aspirating
6 - 18 2014/08
PU2F Pump Pipettor syringe (100 µL) lost steps dispensing
PU2H Pump Pipettor syringe (100 µL) dispense ≥ aspirate
PU2I Pump Pipettor syringe (100 µL) motor driver had a problem
PU2N Pump Pipettor syringe (100 µL) motor fault/motor may be

disconnected
PU2P Pump Pipettor syringe (100 µL) aspirate ≥ pump capacity
PU2Q Pump Pipette syringe (100 µL) illegal error
PU3H Pump Valve solenoid shorted
PU3L Pump Valve solenoid disconnected or open
PU3P Pump Valve solenoid energized but pressure did not change
PU3R Pump Valve solenoid high leakage current
Sample Manager
SM1A Sample chamber Stuck on home
SM1B Sample chamber Cannot find home
SM1C Sample chamber Chamber lost steps down
SM1D Sample chamber Containment missed position
SM1F Sample chamber Chamber lost steps up
SM1H Sample chamber Low pressure after pump recharge
SM1I Sample chamber Chamber motor driver has a problem
SM1L Sample chamber Not sealed – low pressure
SM1N Sample chamber Chamber motor fault/motor may be disconnected
SM1P Sample chamber Vent not found – pressure
SM1Q Sample chamber Chamber illegal error
SM1Z Sample chamber Sample Manager to rotor table offset out of range
alignment
SM2A Sample manager Centrifuge containment shield stuck down
SM2B Sample manager Centrifuge containment shield stuck up
SM2D Sample manager door Door solenoid energized but switch disconnected or open
SM2H Sample manager door Door solenoid shorted
SM2L Sample manager door Door solenoid disconnected or open
SM2R Sample manager door Door solenoid high leakage current
SM3K Sample manager Door opened during processing
SM3O Sample manager Cannula/tube not placed properly
2014/08 6 - 19
Temperature
TE1H Temperature Carousel top heater shorted
TE1K Temperature Temperature outside limits during processing
TE1L Temperature Carousel top heater disconnected or open
TE1R Temperature Carousel top heater high leakage current
TE2R Temperature Carousel top thermistor measurement
TE3H Temperature Fluorometer heater shorted
TE3L Temperature Fluorometer heater disconnected or open
TE3R Temperature Fluorometer heater high leakage current
TE4R Temperature Fluorometer thermistor open
TE5H Temperature Carousel bottom heater shorted
TE5L Temperature Carousel bottom heater disconnected or open
TE5R Temperature Carousel bottom heater high leakage current
TE6R Temperature Carousel bottom thermistor disconnected or open
Tip Manager
TM1A Tip manager Stuck at home
TM1B Tip manager Cannot find home
TM1C Tip manager Lost steps moving toward front
TM1D Tip manager Missed position error
TM1F Tip manager Lost steps moving toward front
TM1I Tip manager Motor driver had a problem
TM1N Tip manager Motor fault/motor may be disconnected
TM1Q Tip manager Illegal error
TM1X Tip manager alignment Pipettor X offset out of range
TM1Y Tip manager alignment Tip tray to pipettor new align not accepted
TM1Z Tip manager alignment Pipettor Z offset out of range
Other
UE1H Calibration Aborted One or more Paks encountered process error during calibration
6 - 20 2014/08
Troubleshooting Procedures
The following procedures can be performed during a troubleshooting
investigation or as directed by the Siemens Technical Solutions Center or the
local support team.
System Check Troubleshooting

If a System Check fails, the report includes additional information related to
the cause of the failure:
Table 6-4: System Check Fail Report - System Statistics
Term Definition Pass Values
Dark slope mean Electronic “noise” from first level fluorometer No Pass or Fail results; used for
measurement; used to calculate 120 mV Noise. troubleshooting only.
Reference slope Electronic “noise” from second level fluorometer No Pass or Fail results; used for
mean measurement; used to calculate 120 mV Noise. troubleshooting only.
120mV Noise Fluorometer electronic “noise” calculated by 0 to 1.5

combining the values of Dark slope mean and
Reference slope mean.
Lid IR Third level fluorometer measurement. Within ±2.5% of the

instrument’s unique stored
value.
Run IR Second level fluorometer measurement. 650 or higher
Dark current First level fluorometer measurement. Below 200
System Fluidics System pressure readings. No Pass or Fail results; used for
troubleshooting only.
2014/08 6 - 21
When it has been determined which part of the system has failed, refer to
Table 6-5 for the appropriate troubleshooting procedure and where to find it in
the guide. For troubleshooting, do the first step, then rerun System Check. Do
the same for each step until the issue clears.
Table 6-5: System Check Troubleshooting
Failure Procedure Where to Find Procedure
Fluorometer 1. Clean the Carousel Reference See “Cleaning the Carousel Reference Disk
Disk and Fluorometer Window. and Fluorometer Window” on page 30,
2. Clean the Carousel Lid “Cleaning the Pak Manager Lid Reference
Reference Disk. Disk” on page 33, “Auto Aligning System
3. Align System Components. Components” on page 26, “Adjusting the
4. Adjust the Fluorometer. Fluorometer” on page 23, and “Replacing
5. Replace the Fluorometer Lamp. the Fluorometer Lamp” on page 49 of
Chapter 6: Troubleshooting.
Fluidic 1. Tighten loose fittings. See “Cleaning the Probe Sealing Pad ” on
System Test 2. Clean Probe Sealing Pad. page 35 of Chapter 6: Troubleshooting.
System Align System Components. See “Auto Aligning System Components” on

Alignment page 26 of Chapter 6: Troubleshooting.
Note: If a component fails after all troubleshooting steps have been

completed, contact the Technical Solutions Center or refer to
the local support team.
6 - 22 2014/08
Adjusting the Display

The Stratus® CS 200 Analyzer display can be darkened or lightened.
instrument lid.
2014/08 6 - 23
3. Locate the blue knob on the upper right corner of the display board.
Figure 6-2: Blue Knob on Display Board
# Description
1 Blue Knob
2 Display Board Area
4. To darken the display, turn the knob clockwise; to lighten the display,
turn the knob counterclockwise.
5. Close the instrument lid and left front door, ensuring the door is securely
latched.
Adjusting the Fluorometer

2. Remove the waste container, cover with a new waste container lid, and
dispose of the waste container per facility procedure.
3. Insert a new, empty waste container.
4. From the Home screen, navigate to Menus > Maintenance >
Mfg Tests > Module Diag/Test > Fluorometer.
5. Select Start located above the number keypad on the touchscreen.
6. Enter the Pak minus Dark value (mV number) using the Fluorometer
RefPak provided in the instrument accessory kit at the Enter External
Voltage Tab prompt.
7. Select Enter.
6 - 24 2014/08
8. Place the RefPak from the instrument accessory kit in the Pak Manager
Well; select Enter.
9. Select Enter when stabilizing is complete; stabilizing takes approximately
5 minutes.
Note: The Adj. Target Voltage value must match the Voltage
Target Calculated value within 1 mV. If the Fluorometer
RefPak is not ejected to the waste container, the Fluorometer
must be adjusted. If the Fluorometer RefPak was ejected to
the waste container, proceed to Step 11.
10. If an adjustment is required:
a. Open the left front door.
b. Insert a long, slender tool into the lid release; press firmly and lift
the instrument lid.
c. Locate the small hole in the center of the tip manager and remove
the plug to gain access to the lamp intensity adjustment screw; set
the plug aside.
d. Insert the recessed end of the small, blue, plastic tuning wand from
the instrument accessory kit into the adjustment screw, located
below the tip tray carriage.
2014/08 6 - 25
e. Loosen the two captive screws on the back of touchscreen display

board lowering screen to view adjustments.
Figure 6-3: Back of Touchscreen Captive Screws
# Description
1 Touchscreen Captive Screws
2 Back of Touchscreen
f. Turn the screwdriver until the Adj. Target Voltage value is within
1 mV of the Voltage Target Calculated value.
g. Close instrument lid; select Enter.
h. After a few minutes, the Voltage Target Calculated and Adj.
Target Voltage values display. If these are not within 1 mV, repeat
Step 10.
Note: If target and adjustment values do not match after the steps
have been repeated, contact the Siemens Technical Solutions
Center or refer to the local support team.
11. Select the Back Arrow icon.
13. Remove the Reference Pak from the waste container and return it to the
instrument accessory kit.
14. Close the left front door, ensuring the door is securely latched.
15. Reinstall the tip manager plug and close the instrument lid.
6 - 26 2014/08
16. Run a System Check. For more information, see “Running System Check –
Electronic QC” on page 4 of Chapter 2: Processing Samples and Reporting
Results.
17. Run Quality Control on all assays in use.
Auto Aligning System Components

1. Close the sample door, if open.
Menus > Maintenance > Alignments > Auto All.
3. Select Start located above the number keypad on the touchscreen.
Note: The alignment status displays above the arrow keys on the
touchscreen.
4. When the alignment is complete, select Accept.
Note: If the alignment does not complete successfully, contact the
Siemens Technical Solutions Center or refer to the local
support team.
5. Select Home.
Results.
2014/08 6 - 27
Cleaning the Carousel Springs

instrument lid.
6 - 28 2014/08
3. Pull up on the three release knobs holding the pak manager lid; place the
lid on the rotor table.
Figure 6-5: Pak Manager Lid Release Knobs
4. Hold the carousel with one hand while loosening the wing nut in the
center.
Figure 6-6: Carousel Wing Nut
WARNING: Be careful when handling the carousel, the springs
have sharp edges.

5. Lift the carousel out of the instrument and set aside.
2014/08 6 - 29
6. Carefully clean the bottom of the metal springs with an alcohol pad; dry
thoroughly with a lint-free cloth.
Figure 6-7: Metal Springs
WARNING: Do not bend the springs.
CAUTION: Make sure fluid does not come into contact with the reference
disk located on the opposite side of the carousel.
Figure 6-8: Reference Disk
7. Position the carousel in the instrument with the spring side up.
8. Hold the carousel and tighten the wing nut just enough to hold the
carousel firmly in position.
6 - 30 2014/08
9. Position the pak manager lid on the carousel and push down on the
release knobs until each snaps into place.
securely latched.
Results.
Cleaning the Carousel Reference Disk and

Fluorometer Window
instrument lid.
2014/08 6 - 31
4. Hold the pak carousel then loosen and remove the wing nut in the
center.
Figure 6-11: Pak Carousel Wing Nut
WARNING: Be careful when handling the carousel. The springs have

sharp edges.
6 - 32 2014/08
5. Lift the carousel out of the instrument and turn it over; locate the small
glass reference disk on the bottom.
Figure 6-12: Reference Disk
6. Lightly dampen lens paper with deionized water and clean the lens.
WARNING: Be certain water does not leak behind the glass onto the
reference disk.
7. Dry the area thoroughly with clean lens paper.
2014/08 6 - 33
8. Locate the fluorometer window in the black square to the right of the
center bolt.
Figure 6-13: Fluorometer Window
9. Clean the window with lens paper.

10. Position the carousel in the instrument with the springs up.
11. Hold it and tighten the wing nut just enough to hold the carousel firmly
in position.
12. Position the pak manager lid on the carousel and push down the release
knobs until each snaps into place.
securely latched.
Results.
Note: Keep the System Check report with QC records.
15. Run Quality Control for all assays in use.
Cleaning the Pak Manager Lid Reference Disk

6 - 34 2014/08
instrument lid.
3. Locate the disk in the pak manager lid; pull up on the two release knobs
and remove the lid disk; set the lid aside.
Figure 6-15: Pak Manager Lid Disk Release Knobs
2014/08 6 - 35
Note: The lid disk reference is located on the underside of this disk.
Figure 6-16: Lid Disk Reference
4. Lightly dampen lens paper with deionized water and clean the lid disk
reference disk.
5. Dry the area thoroughly with a clean lens paper.
6. Reinstall the pak manager lid disk in the carousel lid.
7. Press down on the two release knobs until they snap into place.
securely latched.
Results.
Note: Keep the System Check report with your QC records.
10. Run Quality Control for all assays in use.
Cleaning the Probe Sealing Pad

6 - 36 2014/08
instrument lid.
2014/08 6 - 37
4. Locate the gray, rubber sealing pad on the carousel to the left of the
carousel reference disk.
Figure 6-19: Gray Probe Sealing Pad
5. Clean the gray probe sealing pad using a damp cloth.

6. Position the pak manager lid on the carousel and push down the release
knobs until each snaps into place.
securely latched.
8. Run System Check. For more information, see “Running System Check –
Results.
Cleaning the Rotor Containment Boot and Bracket

1. Loosen the two captive screws at the back of the top instrument cover
with the screwdriver from the instrument accessory kit.
Figure 6-20: Top Cover Captive Screws on Top Instrument Cover
6 - 38 2014/08
2. Lift the cover and disconnect the ground strap from the clip on the back
of the instrument; set the cover aside.
instrument lid.
5. Loosen the captive screw at the front of the left side panel.
Figure 6-22: Left Side Panel Captive Screw
6. Disconnect the panel’s ground strap from the clip on the top rail of the
instrument.
2014/08 6 - 39
7. Lift the panel up off the mounting pins; set the panel aside.
8. Locate the rotor containment boot on the L-shaped bracket behind the
cannula chamber on the left side of the instrument.
Figure 6-23: Rotor Containment Boot
9. Reach into the instrument and loosen the thumbscrew, holding the boot
assembly against the sample manager.
10. Remove the boot assembly and flip it over to locate the rubber gasket.
6 - 40 2014/08
11. Clean rubber gasket of boot assembly with warm, deionized water.
Figure 6-24: Clean Boot Assembly
12. Thoroughly dry the boot assembly with a lint-free cloth.

13. Reinstall the boot assembly and tighten the thumbscrew.
14. Place the left side panel on its two mounting pins.
15. Tighten the captive screw.
16. Connect the ground strap to the clip on top of the instrument.
securely latched.
18. Support the top cover on the instrument while connecting the ground
strap to the clip on the back of the instrument.
19. Reinstall the cover and tighten the captive screws.
Replacing AC Fuses
AC fuses are located in the fuse holder above the instrument power switch.
a. Select the Power icon from the Home screen.
b. Select Yes.
2. Turn the instrument power switch off.
3. Disconnect the power cord from both the analyzer and the wall outlet.
2014/08 6 - 41
4. Open the latch on the fuse holder using the small flathead screwdriver
from the instrument accessory kit.
Figure 6-25: Lifting Latch on AC Fuse Holder
Note: Use the groove below latch to guide the small screwdriver in
place.
5. Slide the fuse holder out of the instrument.
6. Remove both fuses; discard per facility procedure.
7. Insert the replacement fuses.
Note: Always replace fuses with the same type, 6.3A, 250V AC, from the
instrument accessory kit. Follow facility reordering procedures to
restock instrument accessory kit fuses.
8. Install the fuse holder in the instrument, ensuring it is securely latched.
9. Close the sample manager door.
10. Connect the power cord to the analyzer before plugging it into the wall
outlet.
11. Turn the instrument power switch on.
6 - 42 2014/08
Replacing DC Fuses
Each DC fuse has an indicator light beneath it. If a light is OFF, replace the
fuse. The chart below indicates the types of DC fuses:
Table 6-6: DC Fuse Types
Position Amps Volts
F1 and F2 5.0 250
F3 through F7 3.15 250
1. Locate the fuse to be replaced.

Figure 6-26: DC Fuses
2014/08 6 - 43
2. If the touchscreen displays:

b. Select Yes.
4. Disconnect the power cord from both the analyzer and the wall outlet.
5. Use a small, flathead screwdriver to turn the appropriate fuse cap
counterclockwise until it ejects.
6. Remove and discard the fuse.
7. Insert the replacement fuse.
Note: Always replace fuses with the same type from the instrument
accessory kit. Follow facility reordering procedures to restock
instrument accessory kit fuses.
8. Insert the cap, turning it clockwise until it is secure.
9. Close the sample manager door.
10. Connect the power cord to the analyzer before plugging it into the wall
outlet.
11. Turn the instrument power switch on.
Replacing the Cannula Chamber Lower Seal

instrument lid.
6 - 44 2014/08
3. Locate the spring assembly and lower seal

Figure 6-28: Spring Assembly and Lower Seal
# Description
1 Spring Assembly
2 Chamber Lower Seal
4. Remove the chamber lower seal from the bottom of the spring assembly
and discard it.
5. Attach the new chamber lower seal to the rim of the spring assembly.
securely latched.
2014/08 6 - 45
Replacing the Cannula Chamber O-Ring Seal

2. Insert a long, slender tool into the lid release, press firmly and lift the
instrument lid.
6 - 46 2014/08
3. Grasp the black ring at the top of the spring assembly and unscrew the
assembly from the cannula chamber.
Figure 6-30: Black Ring
4. Remove the rubber O-ring from the top edge of the chamber and discard
it.
WARNING: Always wear gloves when using Krytox® lubricant.

Figure 6-31: O-Ring
5. Lubricate all surfaces of the new O-ring with Krytox® lubricant from the
2014/08 6 - 47
6. Install the new O-ring and screw the spring assembly into the cannula
chamber.
latched.
Replacing a Corrupted USB Flash Drive

A USB flash drive can become corrupted after an improper shutdown. The
following procedure replaces the corrupted operating system USB flash drive
with the replacement available for order through Siemens. The existing
alignments, calibration data, QC ID with ranges, and the Operator’s IDs are
stored on the data USB flash drive.This data copies over to the replacement
operating system USB flash drive during the restart of instrument.
Note: The operating system USB flash drive replacement must be
ordered and received prior to the start of this procedure.
1. If the touchscreen displays:
b. Select Yes.
instrument lid.
6 - 48 2014/08
5. Locate the existing operating system and the data USB flash drive ports
on the touchscreen board.
Figure 6-33: Operating USB and Data Flash Drive Ports
# Description
1 USB J2 Port
2 USB J1 Port
6. Remove the corrupted operating system USB flash drive; set aside.
7. Insert the spare operating system USB flash drive in the operating system
port.
8. Close instrument lid.
9. Restart the instrument. See “Restarting the System after Power
Shutdown” on page 21 of Chapter 1: System Overview.
10. Align touchscreen when the 4 calibration point touchscreen alignment
displays; select each point and move to the nearest corner of the screen.
Note: Repeat Step 9 and Step 10 if touchscreen is not aligned.
Results.
Note: Keep the System Check report with QC records.
2014/08 6 - 49
12. Run Quality Control on all assays in use. If Quality Control values are
outside acceptable ranges, refer to see “Addressing an Out of Range QC
Result” on page 9 of Chapter 4: Quality Control.
Replacing the Fluorometer Lamp

Note: A replacement fluorometer lamp must be available to
complete this procedure.
1. From the Home screen:
b. Select Yes to shut down the instrument.
3. Remove plug from back of analyzer and from the wall outlet.
4. Wait five minutes for the source lamp assembly to cool before
continuing.
instrument lid.
6 - 50 2014/08
7. Insert a long, slender tool in the right front door release; press firmly and
open the door.
Figure 6-35: Right Front Door Release
2014/08 6 - 51
8. Disconnect the lamp plug from the lamp manager.

Figure 6-36: Lamp Plug and Mounting Thumbscrew
# Description
1 Lamp Plug
2 Lamp Mounting Thumbscrew
9. Remove the lamp mounting thumbscrew; set aside.
WARNING: Source lamp assembly may be hot.
10. Follow the lamp cable from the plug to the lamp. Grasp the end of the
lamp and gently pull it straight out. Discard per facility procedure.
6 - 52 2014/08
11. Grasp the replacement lamp at the cable end; insert the new lamp.
WARNING: Do not touch the lamp bulb or the quartz envelope.

Figure 6-37: Handling New Lamp at Cable End
Note: The replacement lamp has a D-shaped housing that must be

aligned with the pin. The lamp may need to be rotated to
seat correctly.
12. Install and tighten the lamp mounting thumbscrew to the right of the
lamp.
13. Connect the lamp plug to the lamp manager.
14. Close the right front door.
15. Close the instrument lid and the left front door; ensuring the door is
latched.
16. Close the sample manager door and turn the instrument power switch
on.
17. Wait one hour for the lamp to stabilize before completing the next step.
WARNING: The fluorometer lamp must stabilize after replacement or

erroneous and misleading results may occur.
18. Perform a fluorometer adjustment. For more information, see “Adjusting
the Fluorometer” on page 23 of this chapter.
Results.
20. Run Quality Control on all assays in use. If Quality Control values are
outside acceptable ranges, refer to QC troubleshooting.
2014/08 6 - 53
Replacing the Pipettor Tubing

1. From the Home screen:
b. Select Yes to shut down the instrument.
2. Turn the power switch off.
instrument lid.
5. Locate the pipettor carriage, block holding the probe and red tube fitting,
and slide it to the center of the instrument.
Note: Before removing the red tubing, make note of how it threads
around the ribbon cable and pipettor carriage.
6. Disconnect the red tube fitting from the back wall of the instrument.
7. Disconnect the ribbon cable P512A below the removed red tube fitting.
8. Disconnect cable J513A next to the ribbon cable P512A connector.
Note: The cable J513A label is on the bottom side of the connector.
9. Completely loosen the two captive screws holding the pipettor to the
sample manager.
Figure 6-38: Pipettor Assembly Captive Screws
6 - 54 2014/08
10. Completely loosen the two captive screws attached to the back wall at
the right end of the pipettor assembly.
Figure 6-39: Right End Pipettor Assembly Captive Screws
11. Move the left side of the pipettor assembly towards the back of the
instrument; pivot the right end of the pipettor assembly towards the
front of the instrument.
12. Remove the pipettor assembly and place it on a work surface.
13. Open the two large plastic clamps.
Figure 6-40: Plastic Clamps
2014/08 6 - 55
14. Thread the red tubing through the ribbon cable opening.
15. Disconnect the other tube fitting and thread it through the opening in
the carriage.
Figure 6-41: Red Pipettor Tubing Threaded through Carriage
16. Remove the red tubing from all clamps and discard.
17. Thread the new red replacement tubing through the clamps and
openings.
18. Install and hand-tighten the red tube fitting at the pipettor carriage end.
19. Attach the red tubing into the small plastic clamps in the pipettor
carriage.
20. Close the large plastic clamps.
21. Insert the left end of the pipettor assembly into the instrument behind
the sample manager; hand tighten the two captive screws.
22. Align the right end with the back wall and the left end with the sample
manager; hand tighten the two captive screws.
23. Tighten the four captive screws with a screwdriver.
24. Install and hand-tighten the tube fitting to the back wall of the
instrument.
25. Connect cable J513A then cable P512A.
26. Tighten the two red tube fittings with the torque wrench from the
27. Close the instrument lid and the left front door; ensuring the door is
securely latched.
28. Close the sample manager door and turn the instrument power switch
on.
6 - 56 2014/08
Results.
Replace the Sample Manager Tubing

1. Loosen the two captive screws at the back of the top cover.
Figure 6-42: Top Cover Captive Screws
2. Lift the cover and disconnect the ground strap from the clip on the back
of the instrument; set the cover aside.
2014/08 6 - 57
instrument lid.
5. Loosen the captive screw at the front of the left side panel; disconnect
the panel’s ground strap from the clip on the top rail of the instrument.
6 - 58 2014/08
6. Lift the panel off its mounting pins; set panel aside.
7. Locate the blue plastic tubing attached to the upper cannula chamber.
Note: Before removing the blue tubing, make note of how it
threads from the upper cannula chamber to the T-fitting on
the side of the pump.
8. Unscrew the fitting to disconnect the blue tubing from the chamber.
Figure 6-44: Blue Plastic Tubing Fitting
9. Trace the blue tubing to the back of the instrument, removing the blue
tubing from the clamps.
2014/08 6 - 59
10. Disconnect the other end of the blue tubing from the T-fitting on the side
of the pump.
Figure 6-45: Disconnect Tubing from T-fitting
11. Discard the blue tubing per facility procedure.

12. Connect the new tubing to the T-fitting on the side of the pump.
13. Tighten the connector with the torque wrench in the instrument
accessory kit.
14. Insert the blue tubing into the clamps leading to the upper cannula
chamber, ensuring the tubing is not crimped.
15. Connect the other end of the blue tubing to the chamber.
6 - 60 2014/08
16. Tighten the tubing with the torque wrench.

Figure 6-46: Tighten Tubing with Torque Wrench
17. Place the left side panel on its two mounting pins.
18. Tighten the captive screw.
19. Connect the ground strap to the clip on top of the instrument.
20. Support the top cover on the instrument to connect the ground strap to
the clip on the back of the instrument.
21. Reinstall the top cover and tighten the captive screws.
securely latched.
2014/08 6 - 61
6 - 62 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Configuration
Chapter 7: Configuration
2014/08 7-1
Configuration Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Configuration Overview
Most of these settings have been configured during installation. However, if
changes are required, follow the procedures in this chapter.
Basic settings are not password-protected. Advanced settings require a
password for access.
Basic Settings
• Audio
• Rotor Usage
• Set Language
• Time and Date
Advanced Settings
• Change Password
• Collection Information
• LIS/Middleware Settings
• Manual Dilution
• Operator ID
• QC
• Reference Intervals
• Sample Barcode
• Sample Tube Type
• Serial Number
• System Check Lockout
• Training Mode
• Units
7-2 2014/08
Basic Settings
Setting Audio Alarms
Use to turn on/off audible signals for the alarm, key click, and beep. The
following audio components can be set independently:
Table 7-1: Audible Signals
Signal Description
Alarm A sequence of sounds indicating an error during processing.
Key Click A short sound when any key is pressed.
Beep A short sound indicating an input error.

Menus > Maintenance > Setup > Basic > Audio.
2. Use the arrows on the touchscreen to navigate to the appropriate field.
3. Select Next Setting to display ON or OFF options; select On or Off.
4. Select Accept.
Note: Wait until the message The changes have been stored.
displays at the top of the touchscreen before proceeding.
5. Select Home.
Configuring Rotor Usage

Use this setting to indicate if the system should discard the sample into the
waste container when sample processing is complete.
Table 7-2: Sample and Rotor Processing Options
Option Description On/ Off Function
Retrieve Sample Use this option to OFF –The rotor or sample cup is placed in the waste
retrieve a sample for container at the completion of processing.
investigation. ON – The rotor table returns the rotor or sample cup to
its starting position at the end of processing.
Rotor Hold Timeout Use this option to OFF– The rotor is placed in the waste container at the
run additional tests completion of processing.
on a sample. ON– The rotor remains in the testing position until the
amount of time specified in Timeout duration, up to
30 minutes, is surpassed.
Note: If both options are ON, rotor hold takes place before retrieve
sample.
1. From any mode screen, navigate to
Menus > Maintenance > Setup > Basic.
2. Select Rotor Usage.
3. To change the setting for Retrieve Sample select Retrieve On/Off.
2014/08 7-3
4. To change the setting for Rotor Hold select Hold On/Off.

5. To change the Timeout, use the number pad on the touchscreen to enter
the number of minutes (0 to 30); select Enter.
6. Select Accept.
7. Select Home.
Configuring Language
Use this setting to specify the language for screen and printouts.
Note: When Accept is selected in this procedure, the language
changes immediately. Be sure to verify the language
selection before proceeding.
1. From any mode screen, navigate to Menus > Maintenance > Setup.
2. Select Basic > Set Language.
3. Select Next Language until the appropriate language is displayed.
4. Select Accept.
5. Select No or Yes at the prompt Screens will change to new language.
Change language?
6. Select Home.
Setting the Time and Date

Use these settings to specify the date format and the time zone.
Note: Time is displayed using a 24-hour clock. The date is displayed
in one of the following formats:
MM/DD/YYYY
DD/MM/YYYY
YYYY/MM/DD
1. From any mode screen, navigate to Menus > Maintenance > Setup.
2. Select Basic.
3. Select Time/Date.
4. Use the arrows to change the hours, minutes, day or year.
5. Use the number pad on the touchscreen to enter the correct value; select
Enter.
6. To change the month, select Next Month until the correct
three-character abbreviation appears in the month field.
7. To select the date format, select Next Format and choose a format.
7-4 2014/08
8. Select Accept.
9. Select Home.
2014/08 7-5
Advanced Settings
Changing Password
Use this setting to change the Setup functions password. When entering an
Advanced screen, the system prompts the operator to enter a numeric
password. Only one password is accepted, but it can be changed as needed.
3. Select MORE three times.
4. Select Change Password.
Note: The password can be 1 to 8 numbers long.
5. Use the number pad on the touchscreen to enter a new password; select
Enter.
6. Enter the new password again; select Enter.
7. Select Home.
Configuring Collection Date and Time

Use this setting to require the collection date and time when entering a test
request. If the information is required, Start button text will not be green until
the data is entered.
3. Select MORE two times.
4. Select Collection Info.
5. To require the collection date and time when entering a test request,
select Collect On/Off to display ON.
Note: If not required, this setting must be set to OFF.
6. Select Accept.
7. Select Home.
Note: If the Start button text is not green and the Sample indicator
is red, select the Help icon to display what is required to
begin testing. If the Collection Date and Time are required,
enter both to activate the Start button.
7-6 2014/08
Configuring LIS / Network Settings

These settings establish the parameters of the interface between the
Stratus® CS 200 Analyzer and a remote computer system. Changes should be
determined by the remote system requirements. For more details, contact the
Siemens Technical Solutions Center or refer to the local support team and the
facilities’ LIS administrator.
If the interface is used, there are four options:
• Basic – ON
• POC – ON
• Enhanced – ON
• POCT1-A2 – ON
Note: The connectivity icon on Home screen is checked when
POCT1-A2 is configured and connected to a Data Manager.
The connectivity icon on Home screen is unchecked when
configured and disconnected from the POCT1-A2 Data
Manager.
The features for POCT1-A2 include the following:
• Busy and Ready status are sent from the analyzer to the Data Manager. The
Busy status displays when the analyzer is running an assay. The Ready
status displays when the analyzer is idle.
• Error messages are sent from the analyzer to the Data Manager.
• Lockout - the Data Manager sends a list of authorized operators to the
analyzer. The analyzer will prevent unauthorized operators from running
assays on the analyzer
Table 7-3: Remote Computer RS232 Serial Interface Cable Specifications
Stratus® CS 200 Analyzer Remote System Cable

25-pin Male Connector Pin # 25-pin Female Connector
Gnd 1 Gnd
TX data 2 RX data
RX data 3 TX data
Gnd 7 Gnd
Note: Consult with your LIS administrator for the proper settings
before changing these parameters.
3. Select MORE.
4. Select LIS Settings.
5. Use the arrows on the touchscreen to navigate to the appropriate field.
2014/08 7-7
6. Ensure that the Interface Mode is OFF before enabling another mode.
7. Select Next Setting until the appropriate setting is displayed.
Table 7-4: LIS/Network Settings
Field Setting Options
Interface Mode OFF, Basic – ON, Enhanced - ON, POC - ON,

POCT1-A2 – ON
Year Format 2 digits, 4 digits
Instrument ID Identifies the analyzer to the host computer. Required

if the Enhanced or POC option is utilized.
Transmit Enabled, Disabled (If enabled, secondary unit of

Secondary measure is transmitted to LIS, if disabled, secondary
unit of measure is not transmitted to LIS)
Baud Rate 300, 1200, 2400, 4800, 9600, 19200
Parity NONE, EVEN, ODD
Data Bits 7, 8
Stop Bits 1, 2
Remote IP Address (IPv4 only) of the Remote Computer/Data

Computer Manager
Port Port Number (1-5 digits)
IP Type DHCP, STATIC
IP Address IP Address of the instrument (IPv4 only), only editable

by user if IP Type is STATIC
Subnet Mask Subnet Mask of the instrument (IPv4 only), only

editable by user if IP Type is STATIC
Default Gateway Default Gateway of the instrument (IPv4 only), only

editable by user if IP Type is STATIC
MAC Address MAC address of the instrument (XX-XX-XX-XX-XX-XX),

never editable
8. Update the settings as appropriate; select Enter after each change.

9. Select Accept.
10. Select Home.
7-8 2014/08
Configuring Manual Dilution

Use this feature to enable or disable the function for processing manual
dilutions. After enabling this feature, selecting Man Dil Mode on the Change
Modes screen displays a screen where a dilution correction factor is entered.
2. Enter a password; select Enter.
3. Select MORE three times.
4. Select Manual Dil Mode.
5. Select Next Setting to change the value to ON or OFF; make selection as
appropriate.
6. Select Accept.
7. Select Home.
Configuring an Operator ID
Use this setting to indicate if a valid Operator ID must be entered for
processing functions and whether the Operator IDs should be securely
displayed when printed. This option is also used to enter a list of valid operator
IDs. If an ID is required, the red checklist ID light remains illuminated until a
valid ID is entered on the mode screen. If the Mask Operator ID option is ON
only the first 4 digits display followed by asterisks on all printouts displaying
the Operator ID. The Calibration screen is the only screen that displays the
Operator ID as masked when this option is ON.
If Operator ID is required for processing, the system can store up to 500 valid
Operator IDs.
3. Select MORE two times.
4. Select Operator ID.
5. Select Oper ID On/Off to display the appropriate setting; select Accept.
2014/08 7-9
6. If Operator ID is required:
a. Select Valid Oper IDs.
b. Use the arrows on the touchscreen to highlight the appropriate
field. Enter or change the ID number.
c. Select Enter.
7. If Operator IDs should be masked to display only the first 4 digits:
a. Select Mask ID On/Off.
b. Ensure option is ON.
c. Select Accept.
8. To print a list of Operator IDs, select Print.
Note: Operator IDs entry fields will print regardless of how many
valid Operator IDs have been entered.
9. Select Accept.
10. Select Home.
Configuring Reference Intervals

Assay specific values can be set for high reference intervals, low reference
intervals, and cutoffs. Test results are evaluated against these values and when
results are outside of the parameters, an indicator or message is printed on the
results report.
To enter the reference interval and cutoff values:
3. Select Ref Intervals.
5. Use the arrows on the touchscreen to highlight the appropriate field.
6. Use the number pad on the touchscreen to enter the value; select Enter.
7. Select Accept.
8. Select Home.
7 - 10 2014/08
Configuring Sample Barcode

Use this setting to indicate the type of barcode labels used on sample tubes.
The system works best with labels using check digits. Select an
auto-discriminate setting only if using more than one type of label. Otherwise,
use the setting specific to facility label type.
The choices are:
• Barcode Reader Off
• Code 128
• Code 39 - no check digit
• Code 39 - with check digit
• Interleaved 2 of 5 - no check digit
• Interleaved 2 of 5 - with check digit
• Codabar USS
• auto-discriminate - all
• auto-discriminate - 2D only
With this procedure, the destination field (Patient ID or Sample ID) for the first
barcode scanned during each processing of a sample can be specified.
Note: The barcode label is limited to 12 alphanumeric characters
for the Patient and Sample ID and 10 alphanumeric
characters for the Operator ID.
3. Select MORE.
4. Select Sample Barcode.
5. Select Next Setting until the appropriate barcode label type is displayed.
6. Use the arrows on the touchscreen to highlight the Barcode Reader Input
field; select Next Setting until the appropriate option is displayed.
7. Select Accept.
8. Select Home.
2014/08 7 - 11
Configuring Sample Tube Type

Use this setting to identify the type of sample collection tube. It is important
that the analyzer is configured for the specific stoppered sample collection
tube in use. When changing the sample tube type configuration, verify that
the correct cannula is selected as indicated in the following table:
Table 7-5: Tube Type and Appropriate Cannula
Tube Type Cannula
BD Clear
SARSTEDT Green

3. Select MORE.
4. Select Set Samp. Tube.
5. Select Next Setting to display tube type options; choose the appropriate
tube type.
6. Select Accept.
7. Select Home.
Storing the Serial Number

Use this function to store the instrument serial number. The serial number will
be required when contacting the Siemens Technical Solutions center or the
local support team during troubleshooting.
3. Select MORE twice.
4. Select Serial Number.
5. Locate the serial number printed on the instrument near the main power
switch below the DC fuses.
6. Use the number pad on the touchscreen to enter the serial number.
7. Select Enter > Accept.
8. Select Home.
Note: The serial number displays on the top of printed system
reports.
7 - 12 2014/08
Training Mode
Use this setting to allow or disallow the use of Training (TRNG) Paks. The Quick
Reference Guide that comes with the analyzer explains how to activate and
use this mode.
Note: Do not attempt to process samples when this mode is on.
Training Mode is deactivated when the analyzer is powered
down.
Configuring Units
Use this setting to specify the units for each assay. Units are displayed and
printed with test results, QC results and calibration results.
Primary units are the main unit of measure that will be reported for each assay
and are established during analyzer installation.
Secondary units are a second unit of measure that can be reported along with
the primary unit of measure. The secondary reporting unit will display in
brackets under the primary reporting unit. Secondary units cannot be
configured. The feature can be toggle on or off for the following assays:
Table 7-6: Assays Supporting the Reporting of Secondary Units
Assay Assay Title on Analyzer Secondary Unit
Troponin I cTnI ng/L
D-Dimer DDMR mg/L
hsCRP CCRP mg/dL
With the secondary units enabled, the operator has two options:
• The secondary units can be displayed on the result printout, but not
transmitted to the LIS.
• The secondary units can be displayed on the result printout and
transmitted to the LIS.
For more information to configure the Transmit Secondary feature, see
“Configuring LIS / Network Settings” on page 7.
Configuring reporting options for secondary units is as follows:
• To enable printing of secondary units: Set Sec. Unit On to Enabled.
• To disable printing of secondary units: Set Sec. Unit On to Disabled.
Use the following procedure to configure primary units of measure and
enable/disable reporting of secondary units of measure:
1. From any mode screen navigate to:
3. Select Units.
2014/08 7 - 13
4. Toggle Sec. Unit On/Off to on if secondary units are reported.

Note: Selecting ON sets secondary units on for all assays where
secondary units are available.
Note: If Secondary Units were already set to ON, Report Secondary
will automatically be set to ON for all assays. It will not apply
for those assays that do not support secondary unit reporting.
Toggling Sec. Unit On/Off on each method screen will impact
the settings previously set.
6. Select Next Unit until the appropriate primary units are displayed.
7. Select Accept.
8. Select Home.
Configuring External Printer

The Stratus® CS 200 Analyzer comes complete with an internal thermal
printer. To configure the external printer:
Note: Only the Lexmark® E460dn printer is supported.
1. Complete a controlled power shutdown. For more information, see
“Controlled Power Shutdown” on page 21 of Chapter 1: System
Overview.
2. Place the Lexmark® printer on a flat service and plug in power cord.
3. Turn printer ON.
7 - 14 2014/08
4. Connect printer cable to the port on the printer; connect the USB end of
cable to the USB port on the Stratus® CS 200 Analyzer located by the
power switch.
Figure 7-1: USB Port to Connect Printer Cable
5. For more information, see “Restarting the System after Power Shutdown”
on page 21 of Chapter 1: System Overview.
Note: The printer will automatically be configured and begin
printing with the next print request.
2014/08 7 - 15
7 - 16 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Safety and Specifications
Chapter 8: Safety and

Specifications
2014/08 8-1
Safety and Specifications Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Safety Overview
This chapter includes:
• Safety instructions
• Descriptions of the tasks to be performed by the installers and customers
• The space, power, and environmental requirements for the
Stratus® CS 200 Analyzer
• Software installation instructions
• Qualified sample collection tubes
8-2 2014/08
Safety Warnings and Cautions

General
Before operating, maintaining, or troubleshooting the
Stratus® CS 200 Analyzer, the operator should be familiar with all aspects of its
operation. Read this section thoroughly before installation and operation.
Basic precautions include the following:
• Always wear gloves when working with the Stratus® CS 200 Analyzer.
• Ensure all operators are trained in proper blood-handling techniques.
• Observe all warnings and cautions stated in the procedures.
Safety Notes
Warnings and cautions are included in this guide to emphasize important
instructions. The following examples provide definitions for warnings,
cautions, and notes:
WARNING: An operating procedure, step, or practice that, if not

followed, can result in personal injury, adversely affect
health, contaminate the environment, or cause erroneous
and misleading results.
CAUTION: An operating procedure, step or practice that, if not observed

strictly, can result in damage to the instrument or associated
equipment.
Note: Additional information included to clarify a particular step,
procedure or paragraph.
Safety precautions include the following:
• Do not operate the equipment with doors, lids, or access panels removed
unless specifically instructed.
• Do not defeat or bypass built-in equipment safety features.
• If the instrument must be relocated, the move should be executed by at
least three people capable of lifting 68 kilograms (150 pounds) together.
Be aware of pinch hazards. A System Check must be run after moving the
instrument. See “Running System Check – Electronic QC” on page 4 of
Chapter 2: Processing Samples and Reporting Results.
2014/08 8-3
WARNING: If the instrument or its individual components are used for

purposes other than those specified herein, safety
protections cannot be guaranteed.
Mechanical
WARNING: Keep fingers, hands and tools clear of moving

parts.
CAUTION: Route cables properly to eliminate tripping hazards.
Electrical
If a panel, cover, or guard must be removed for an electrical adjustment or
check, be extremely careful to avoid personal injury. Do not locate the
Stratus® CS 200 Analyzer within 50 feet (15.3 meters) in any direction of a
strong radiation source such as diathermy equipment.
Chemical
Refer to the assay Information for Use (IFU) for related chemistry safety
precautions.
Safety Labels
The labels described in Table 8-1 appear in various places on the instrument
and in this Operator’s Guide. Understand their meanings before opening the
doors and lids or completing procedures.
Table 8-1: Safety Labels
Potential Biohazard Indicates an area of the instrument that may contact biohazards. Do not
handle the contents or touch the area unless properly protected. Refer to
applicable facility procedures.
Attention Caution– consult accompanying documents.

Calls attention to a specific warning on instrument labels.
Calls attention to information in software.
Pinch/Crush Hazard Indicates an area of the instrument where the operator could be exposed
to moving parts. Use caution when performing procedures in these
areas.
Puncture Hazard Indicates an area of the instrument where the operator could be exposed
to sharp tips, particularly probes, that could puncture the skin. Use
caution when performing procedures in these areas.
8-4 2014/08
Lamp Precaution Do not touch the lamp bulb or the quartz envelope.
Protective Earth Terminal Indicates the terminal connecting power supply external earth (ground)
to the instrument.
Electrostatic Discharge Indicates the potential for damage to electronics from static discharge.
Always use the ground strap when handling static-sensitive instrument
components.
Burn Hazard Indicates a heated area of the instrument that can burn an
operator. Be sure to power off the instrument and let these
areas cool before touching them or performing diagnostic and
maintenance operations around them.
Electrical Disposal Equipment is subject to European Directive on Waste Electrical

and Electronic Equipment (WEEE) 2002/96/EC, amended by
Directive 2003/108/EC. This symbol indicates separate
collection and return required.
2014/08 8-5
Understanding Symbols
8-6 2014/08
Installation Responsibilities
Customer Responsibilities Before Installation

Before the Siemens representative arrives to set up the
Stratus® CS 200 Analyzer, be sure to complete the following:
• Check facility clearances for transporting the instrument to its final site.
• Verify that the wiring setup complies with the instrument specifications.
• Verify that the space requirements are met.
Siemens Representative Responsibilities

The Siemens representative performs the following tasks:
• Unpacks the instrument and move it into position.
• Tests the electromechanical systems.
• Tests the instrument operation.
• Evaluates performance of the assays.
• Assists with ordering additional supplies.
• Trains the in-house trainer.
Customer Responsibilities After Installation

After the instrument is installed, ensure that the in-house trainer and other key
operators are available for Stratus® CS 200 Analyzer training. The Siemens
representative will use the following training tools:
• The Operator Training Checklist located in “Appendix E: Operator’s Training
Checklist”
• The Instrument Quick Reference Guide
Remote Transmission Configuration

If you plan to send results from the Stratus® CS 200 Analyzer to a remote
system, review the configuration of the instrument and the remote system
with the Siemens representative. The Siemens representative ensures the
instrument connector is properly attached. You are responsible for configuring
the remote computer. For more information, see Table 7-3 on page 7 of
Chapter 7: Configuration.
2014/08 8-7
Specifications and Requirements
Space Requirements
Table 8-2: Instrument Space Specifications
Measurement Operating Clearance Service Clearance
Height 18 inches 46 cm 20 inches 51 cm 37 inches 94 cm
Width 28 inches 71 cm 31 inches 79 cm 39 inches 99 cm
Depth 23 inches 58 cm 24 inches 61 cm 34 inches 86 cm
Weight 150 pounds 68 kg
Power Requirements
Table 8-3: Instrument Power Specifications
Normal Voltage Continuous Maximum

Line Voltage Range Frequency Current Power
100VAC 90 to 100VAC 47 to 63 Hz ~2.1A 400 VA
Table 8-4: Compliance Requirements
Leakage Current Complies with the requirement of UL 61010-1, CSA C22.2

No. 1010-1, and EN61010-1 safety standards for non-patient
connected laboratory equipment (Table 8-5).
Ground Should initiate at distribution panel unless local codes prohibit
Table 8-5: Typical Leakage Current
Supply Voltage and Frequency 100VAC/ 50/60 Hz 115VAC/60 Hz 230VAC/50 Hz
Measurement Standard UL 61010-1 UL 61010-1 EN61010-1
Normal Supply Connections Under 30 µA Under 30 µA Under 45 µA
Ground Disconnected 370 µA 370 µA 430 µA
Neutral Disconnected Under 5 µA Under 5 µA Under 5 µA
Recommended Service Outlet

• EU: 230 vac, 50Hz, Single Phase, 16A
• UK: 230 vac, 50Hz, Single Phase, 13A
• North America: 115 vac, 60Hz, Single Phase, 20A
• Japan: 100 vac, 50/60 Hz, single phase, 20A
8-8 2014/08
Transient Overvoltage
Installation Category II (branch circuit)
Circuit
The instrument must have a separate, dedicated line with hot, neutral, and
isolated ground in its own conduit. The conduit should start at the distribution
panel and be continuous to the receptacle. Three-wire distribution to the
receptacle is required. Connect the third, green ground wire from the
distribution panel to the receptacle in accordance with NEC paragraph 250-74,
exception 4, unless local codes prohibit. The ground wire should not be tied to
grounds from other loads.
Receptacle
Customer must provide a Hospital Grade receptacle, installed by a qualified
electrician before arrival of the instrument. The receptacle must be accessible
to the 9 feet (2.7 meters) power cord furnished with the instrument. North
America requires NEMA #5-20R 20 amp straight blade receptacle (Hubbell
receptacle No. IG-8310 or equivalent).
Wire Size – North America only

12 AWG wire is required to minimize voltage drop between distribution panel
and receptacle when the instrument operates at full load.
Electromagnetic Radiation
Do not locate the instrument within 15 meters (50 feet) in any direction of an
electromagnetic radiation source such as diathermy apparatus.
Computer Interface Specifications

Table 8-6: Computer Interface Specifications
Type Quantity Description
Serial 1 RS-232; Laboratory Interface System (LIS)
USB 2 USB 2.0; External Printer
Network 1 Laboratory Interface System (LIS)
For more information about the computer interface, see “Configuring LIS /
Network Settings” on page 7 of Chapter 7 and the appropriate Interface
Specifications document supplied by Siemens Healthcare Diagnostics.
2014/08 8-9
Environmental Specifications
Waste Disposal
WARNING: Treat the waste container and its contents as potential

biohazards. Dispose of the container according to local
biohazard waste disposal procedures.
Temperature
• Maintain room temperature between 15° C to 30° C (59° F to 86° F)
• Do not exceed a maximum fluctuation of 3° C (5.4° F) per hour
Humidity
Relative humidity (non condensing) should range between 20 and 80 percent.
Thermal Output
200 W (682 BTU/hr)
Noise Output
Average noise under 65 dBA.
Noise Rating: NR 40.
Centrifuge Speed
During each processing run, a microprocessor independently verifies that the
centrifuge speed is between 18,000 rpm and 22,000 rpm. An error message is
generated if the speed is outside this range.
8 - 10 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Appendix A: Menu Navigation
Appendix A: Menu Navigation
2014/08 9-1
Appendix A: Menu Navigation Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Touchscreen
Table 9-1: Touchscreen Icons
Icon Description
Power Select Power icon to power on or off the instrument. See “Controlled
Power Shutdown” on page 21 of Chapter 1: System Overview.
Paper Advance Select Paper Advance icon to feed the printer paper up through the paper
slot.
Home Select Home icon to return to the Home screen at any time.
Back Arrow Select the Back Arrow to return to the previously displayed screen or to
initiate a controlled shutdown. See “Software Overview” on page 19 of
Chapter 1: System Overview. This button does not stop processing.
Help Select Help to display information about the current screen, if available.
Select the Back Arrow icon to return to the previous screen.
Using the Touchscreen

The operator can make a selection by using a finger or the stylus. For more
information on cleaning the touchscreen and stylus, see “Cleaning the
Touchscreen and Stylus” on page 9 of Chapter 5.
Note: Gloves can be worn when using the display.
Selecting a Menu Function

To access the Reset, Reports and Maintenance functions, select Menus from
any mode screen. The following tables show the sequence of function keys to
access a specific task.
Reset
Select Reset to move all components to their home positions. This function is
used primarily for troubleshooting.
9-2 2014/08
Reports
Select Reports to access the following functions:
Print Results
Transmit Results
Calibration Status
System Status ----> Error Log
About SCS
Maintenance
The following tables show the keys to select to access maintenance functions.
Setup functions are used primarily for system configuration.
Alignments functions are used primarily for troubleshooting.
Mfg Tests and Diagnostic should be used only when directed by the Siemens
Technical Solutions Center or the local support team.
2014/08 9-3
Setup ---> Basic ---> Rotor usage
Set Language
Audio
Time/Date
Advanced ---> QC
Ref Intervals
Units
MORE ---> Sample Barcode
Set Samp. Tube
LIS Settings
MORE ---> Operator ID
Collection Info
Serial Number
MORE ---> Manual Dil. Mode
Training Mode
Change Password
MORE (returns to
Advanced menu)
Alignments Auto All

Auto Individual
Manual
Manual Y align
Mfg Tests Power System

POST Test
Module Diag/Test
9-4 2014/08
Diagnostics
Sample System ----> Sample Manager Rotor Centrifuge Sample Pump

Init Init Init Init
Step Step Step Step
Jog Jog Jog Jog
Cycle Cycle Cycle Cycle
Pak Manager ----> Pak Entry Pak Carousel Pak Waste Misc Diagnostic
Init Init Init Temp
Step Step Step Pak Barcode
Jog Jog Jog Printer Test
Cycle Cycle Cycle MORE
KeyBoard
Test
Exercise
MORE
Pipettor ----> Tip Manager Pipettor Pipette Pump Level Sense

Init Init Init Rotor
Step Step Step Cup
Jog Jog Jog Pak
Cycle Cycle Cycle Rep Count
Fluorometer ----> Pak/Lid Ref Ref/Dark Lamp On/Off Next Pak
2014/08 9-5
9-6 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Appendix B: Code Compliance
Appendix B: Code Compliance
2014/08 10 - 1
Appendix B: Code Compliance Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Code Compliance
Safety Compliance
The Stratus® CS 200 STAT Fluorometric Analyzer complies with safety
standards UL61010-1, CSA C22.2 #1010.1 and EN61010-1 under the following
environmental conditions [subclause 1.4]:
Table 10-1: Environmental Conditions
Temperature 5°C (41°F) to 40°C (104°F)
Humidity Maximum 80% at 31°C to 50% at 40°C
Altitude Maximum 2,000 m (6,562 ft)
Mains supply 115 ±10% VAC or 230 ±10% VAC, 50/60Hz
Overvoltage Category Category II, connected to a branch circuit
Pollution Degree Degree 2, normal indoor laboratory environment. Air contains

only non-conductive pollutants with occasional condensation.
For more information, see “Environmental Specifications” on page 10 of

Chapter 8.
Emission Compliance
The Stratus® CS 200 Analyzer complies with CISPR 11 Class A. In a domestic
environment it may cause radio interference; if this occurs, take measures to
mitigate the interference by moving the Stratus® CS 200 Analyzer away from
the affected device or operate the Stratus® CS 200 Analyzer in a shielded
location.
Barcode Reader
The barcode reader uses Class I LED’s [light-emitting diodes]. There is no eye
hazard.
Laboratory Accrediting Agencies

Many laboratory accrediting agencies allow the use of electronic QC to
satisfy the routine Quality Control requirement for this type of instrument.
System Check for the Stratus® CS 200 Analyzer may meet the requirements
for electronic QC as defined by these agencies. When adopting electronic
controls agencies may suggest to initially run both electronic controls and
quality control material daily. As confidence is gained in the performance
of the system, and as part of the validation of the Quality Control
procedures, the frequency of running quality control material can be
reduced.
Ensure your procedures adhere to your country's regulatory agency
requirements.
10 - 2 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Appendix C: Qualified Sample Collection Tubes
Appendix C: Qualified Sample

Collection Tubes
2014/08 11 - 1
Appendix C: Qualified Sample Collection Tubes Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
Qualified Sample Collection Tubes

Table 11-1: Qualified Sample Collection Tubes
Cannula
Manufacturer Tube Type / Description
Color
BD Lithium Heparin (plastic) 13 X 75 mm Green Hemogard clear

4.0 mL draw, Lithium Heparin (Spray Dried)
60 USP units
BD Sodium Heparin (plastic) 13 X 75 mm Green Hemogard clear

4.0 mL draw, Sodium Heparin (Spray coated)
75 USP units
BD Sodium Citrate (glass) 13 X 75 mm Lt Blue Hemogard clear

4.5 mL draw,3.2% Sodium Citrate
BD Vacutainer® collection tubes with HEMOGARD ™ Closure must be used.
SARSTEDT Monovette® Lithium 13 X 65 mm Orange, 2.6 mL draw, 04.1906.001 green

Heparin
SARSTEDT Monovette® Sodium 13 X 65 mm Blue, 2.9 mL draw, 04.1902.001 green

Citrate
Note: Fill all sample collection tubes completely per manufacturer

guidelines.
Note: For (beta)hCG, CKMB, CTNI, CCRP, MYO and pBNP, use only
tubes containing lithium or sodium heparin anticoagulants.
Note: For DDMR TestPak processing, use only tubes containing
lithium heparin or sodium citrate anticoagulants.
11 - 2 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Appendix D: Maintenance Logs
Appendix D: Maintenance Logs
Stratus® CS 200 STAT Fluorometric Analyzer Maintenance Logs

ATTENTION!
Do Not Mark on These Log Sheets
Use Them as Masters and Make Copies as Needed
This package of Maintenance Log Masters contains 3 logs:

• Setup Log
• Monthly Maintenance Log
• Instrument Maintenance Log
Using the Maintenance Logs

1. Make copies of the Maintenance Logs.
2. Record maintenance information in the appropriate columns of the
maintenance logs as the procedures are performed.
3. Use the Instrument Maintenance Log to record maintenance that is not
part of scheduled maintenance.
4. Complete scheduled maintenance and record in the corresponding
Maintenance Log; refer to the procedures in the Operator's Guide as
necessary.
5. Complete documentation of maintenance procedures is beneficial in
instrument and chemistry troubleshooting.
Note: The Stratus® CS 200 STAT Fluorometric Analyzer is designed
to process patient specimens, which may be a biohazard.
Follow standard facility practice when handling potential
biohazards.
2014/08 12 - 1
Appendix D: Maintenance Logs Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
12 - 2 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Setup Log
Instrument Serial No. ___________________ Month & Year ________________________
Replace Waste Check Paper Run System Run QC Operator’s

# Comments
Container and Tip Supply Check (daily) (as needed) Initials
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2014/08 12 - 3
12 - 4 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Monthly Maintenance Log
Instrument Serial No. ________________________ Month & Year ________________________
Clean Clean Lower Clean Waste

Clean Air Clean Tip Clean Pak Operator’s
# Sample Cannula Container Comments
Filter Chute Shield Initials
Door Area Chamber Seal Area
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
2014/08 12 - 5
12 - 6 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Instrument Maintenance Log
Instrument Serial No. _________________________________
Date and Initials Procedure Performed Comments
2014/08 12 - 7
12 - 8 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Appendix E: Operator’s Training Checklist
Appendix E: Operator’s Training

Checklist
Stratus® CS 200 STAT Fluorometric Analyzer Training Checklist
ATTENTION!
Do Not Mark on These Operator’s Training Checklists
Use Them as Masters and Make Copies as Needed
There is one Operator Training Checklist Master contained in this section.
Using the Training Checklist

1. Make copies of the Training Checklist.
2. Assign one set to each operator in training.
3. Once training is completed, record the information in the appropriate
columns of the training checklist.
Note: The Stratus® CS 200 STAT Fluorometric Analyzer is designed

to process patient specimens, which may be a biohazard.
Follow standard facility practice when handling potential
biohazards.
2014/08 13 - 1
Appendix E: Operator’s Training Checklist Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
13 - 2 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator Training Checklist
Name/Title of Trainee: ________________________ Trainer: ______________
Department:______________________________Date: _____________________
Operator Topic: Training Materials Overview
Key Other Activity
  Review training materials: Online PEP Training, Quick Reference (flip chart), Basic Operation Sheet, Training Paks, and
Operator’s Guide
  Review proper sample handling: qualified collection tube with heparin; inverted to mix
Operator Topic: System Supplies
Key Other Activity
  Identify supplies and interpret keypad indicators
  Correctly use/replace: collection tubes, sample cups

barcoded label
cannula
rotor
TestPak, DilPak, CalPak
tips
waste container
printer paper
Operator Topic: System Overview
Key Other Activity
  Identify system components: system gauge

sample bar code reader
sample manager and door
printer
touchscreen
tip manager
pak manager
waste container (lower left front) door
rotor table
USB flash drive
Symbol Description
 Required
 Optional
2014/08 13 - 3
Department:______________________________Date: _____________________
Operator Topic: Operation
Key Other Activity
  Run System Check
  Interpret reports, reprint a report
  Use Training Paks to process Patient Tube; Identify when DilPaks are required
  Use Training Paks to process Quality Control
  Use Training Paks to process Assay Calibration
Operator Topic: Maintenance
Key Other Activity
  Perform monthly cleaning procedures and autoalignment
Operator Topic: Troubleshooting
Key Other Activity
  Turn off alarm (press any key)
  Print more information for an error
  Reset instrument, check fuses
  Power OFF instrument, power ON instrument
  Review procedure to contact facility personnel, biomed personnel, and the Siemens Technical Solutions Center or
local support team
Operator Topic: Configure with System Options
Key Other Activity
  Review Operator’s Guide, Chapter 4: Quality Control, Chapter 3: Calibration,

Chapter 7: Configuring the Stratus® CS 200 (for additional options)
Symbol Description
 Required
 Optional
13 - 4 2014/08
Department:______________________________Date: _____________________
Operator Other Training Items
Key Other Activity
2014/08 13 - 5
13 - 6 2014/08
Chapter 14: Index
A
above assay range
message 2-12
accessory kit
instrument 5-2
tools 5-2
adjusting
fluorometer 6-23
touchscreen display 6-22
advance
paper 1-19, 5-10
advanced settings
configure 7-6
after installation
customer responsibilities 8-7
air filter
replace and clean 5-4
alarm
setting sounds 7-3
turning off 7-3
alert
System Check message 4-5
aligning
system components 6-26
alignment
auto align 6-26
apply
barcode label 2-6
arrows
move cursor 1-17
asterisks
result report 2-17
audio alarms
set 7-3
automatic
dilution 1-14
B
back arrow
exit icon 1-17
icon 9-2
2014/08 14 - 1
Index Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide
barcode label 1-12

CalPak 3-2
configure 7-11
scanning 1-12
TestPak 3-2
types 7-11
barcode reader
description 1-12
pak 1-12
safety 10-2
sample 1-12, 2-6
blood collection
safety 2-6
C
C terms 3-2
calibration
coefficients 3-2
deleting TestPak lot 3-5
modes 3-3
overview 3-2
principles 3-2
processing 1-14, 3-3
report 3-3
review 2-5
status 2-6, 3-4
TestPak lot expiration 3-4
troubleshooting 3-4
when to perform 3-2
calibration status
messages 2-5
calibration with POCT1-A2 enabled
transmit 3-5
CalPak 1-5
barcode label 3-2
description 3-2
using 3-3
cannula 1-5
chamber seals 6-43
description 1-12
load 2-10
tube type 7-12, 11-2
cannula chamber lower seal
clean 6-43
cannula chamber o-ring seal
replace 6-45
cannula chamber seal
clean 5-6
carousel
pak 1-12
carousel reference disk
clean 6-30
carousel springs
clean 6-27
i-2 2014/08
Stratus® CS 200 STAT Fluorometric Analyzer Operator’s Guide Index
caution
chemical 8-4
electrical 8-4
general 8-3
mechanical 8-4
safety 8-3
centrifuge
description 1-12
installation speed 8-10
changing
date and time 7-4
checking
reagent status 2-6
thermal printer paper 2-4
tip supply 2-3
checklist
training 13-1
using 13-1
chemical
warning and cautions 8-4
circuit
power requirements 8-9
cleaning
cannula chamber lower seal 6-43
cannula chamber seal 5-6
carousel reference disk 6-30
carousel springs 6-27
fluorometer 6-30
instrument surfaces 5-2, 5-5
pak manager lid reference disk 6-33
pak shield 5-7
probe sealing pad 6-35
rotor containment boot and bracket 6-37
sample manager 5-6
tip chute 5-8
touchscreen 5-9
waste container area 5-9
code
compliance 10-2
error 6-7
coefficients
on calibration report 3-3
terms 3-2
collection
configure date and time 7-6
sample tubes 11-2
specimen 2-6
compliance
code 10-2
emission 10-2
safety 10-2
computer interface specifications
installation 8-9
configure
2014/08 i-3
external printer 7-14

configuring
advanced setting 7-6
barcode label 7-11
basic settings 7-3
collection date and time 7-6
language 7-4
LIS 7-7
manual dilution 7-9
network settings 7-7
overview 7-2
password 7-6
Patient ID 7-11
POCT1-A2 7-7
primary units of measure 7-13
reference cutoff 7-10
remote computer system 7-7
remote transmission 8-7
rotor usage 7-3
sample ID 7-11
sample tube type 7-12
secondary units of measure 7-13
tube type 7-12
units of measure 7-13
contacting Siemens Technical Solutions Center 1-3
container
waste 1-13
control
disposal of sample 2-6
control system
troubleshooting 6-9
controlled power shutdown 1-21
customer responsibilities
after installation 8-7
before installation 8-7
D
daily setup 2-2
data
delete 1-17
date
change 7-4
format 7-4
DC fuses
replacing 6-42
deleting
data 1-17
TestPak lot 3-5
description
CalPak 3-2
menus 1-19
modes 1-19
pipettor 1-13
rotor 1-12
i-4 2014/08
System Check 1-15

touchscreen 1-17
DilPaks 1-4
dilution
automatic 1-14
manual 7-9
messages 2-12
processing manual 2-12
disposal
tip 1-13, 1-14
waste 8-10
E
electrical
warnings and cautions 8-4
electromagnetic radiation
location of instrument 8-9
emission
compliance 10-2
enter
Operator ID 2-8
Patient ID 2-8
Sample ID 2-8
store data 1-17
environmental specifications
installation 8-10
error
codes and messages 6-14
log 6-3
message 6-2, 6-4
print 6-3
errors
codes 6-7
interpreting processing 6-2
miscellaneous 6-4
troubleshooting codes 6-2
exit
back arrow 1-17
icon 9-2
expiration
TestPak lot 3-4
external printer
configuring 7-14
F
failed
calibration 3-4
QC 4-9
flash drive
replace corrupted 6-47
flowchart
software 9-3
2014/08 i-5
fluid delivery
System Check 1-15
fluorometer
adjusting 6-23
clean 6-30
description 1-13, 1-14
lamp replacement 6-49
troubleshooting 6-9
window 6-30
format date 7-4
functions
menu 1-19
fuses
replace AC 6-40
replace DC 6-42
G
general
warning and cautions 8-3
H
help
icon 1-17, 9-2
hold
rotor option 7-3
home
icon 1-18, 9-2
home position
reset 9-2
humidity
specifications 8-10
I
icon
back arrow 9-2
exit 9-2
help 1-17, 9-2
home 1-18, 9-2
paper advance 1-18, 9-2
power 1-18, 9-2
ID
operator 3-3, 7-9
patient 2-8, 7-11
QC 4-4
sample 2-8, 7-11
System Check 2-4, 4-5
illuminating
tip trays 1-18
inspect
rotor 2-10
installation
centrifuge speed 8-10
computer interface specifications 8-9
i-6 2014/08
customer responsibilities 8-7

environmental specifications 8-10
planning 8-8
responsibilities 8-7
Siemens representative responsibilities 8-7
space requirements 8-8
instrument
accessory kit 5-2
clean surfaces 5-2, 5-5
emission compliance 10-2
maintenance log 12-7
shutdown 1-21
interpreting
processing errors 6-2
K
key
symbols 8-6
L
label
apply barcode 2-6
barcode 1-12, 7-11
safety 8-4
tube 2-6
language
changing 7-4
levels
QC 4-5
lid reference disk
clean 6-33
lights
DC fuses 6-42
limits
review system check 2-5
LIS
configure 7-7
list
Operator ID 7-9
loading
cannula 2-10
rotor 2-10
TestPak 2-12, 3-3, 4-8
lockout
QC 4-5
System Check 4-5
lockout parameters
QC 4-5
log
error 6-3
maintenance 12-1
monthly maintenance 12-5
2014/08 i-7
setup 12-3
M
maintenance
daily setup 2-2
instrument log 12-7
logs 12-1
menu functions 9-3
monthly log 12-5
monthly overview 5-3
overview 5-2
standard 5-2
using logs 12-1
manager
pak 1-12
sample 1-12
tip 1-12
manual
dilution 7-9
manual dilution
configure 7-9
processing 2-12
mechanical
mechanical alignment
System Check 1-15
menus
description 1-19
functions 1-19, 9-2
mode 1-19
reports 9-3
message
error 6-4
messages
above assay range 2-12
calibration status 2-5, 3-4
dilution 2-12
error 6-2, 6-4, 6-14
QC alert 4-4
System Check alert 4-5
modes
calibration 3-3
description 1-19
menus 1-19
modifying 1-19
processing 1-19
QC 1-19, 4-7
System Check 1-19
training 7-13
modifying
modes 1-19
mover cursor
arrows 1-17
i-8 2014/08
N
network setting
configure 7-7
noise output
specifications 8-10
North America
wire size 8-9
notes
safety 8-3
number pad 1-18
O
operation
overview 1-12
Operator ID
entering 2-8
list 7-9
required 7-9
optical detection
System Check 1-15
overview
calibration 3-2
configuration 7-2
maintenance 5-2
monthly maintenance 5-3
operation 1-12
QC 4-2
safety and specifications 8-2
software 1-19
system 1-2
troubleshooting 6-2
P
pak
barcode reader 1-12
pak carousel 1-12, 1-13
reference disk 6-30, 6-33
pak manager 1-13
lid reference disk 6-33
troubleshooting 6-11
pak shield
clean 5-7
paper
advance 1-19, 5-10
replace 5-10
paper advance
icon 1-18, 9-2
printer 5-10
touchscreen 1-19
parameters
setting up QC 4-4
2014/08 i-9
password
configure 7-6
patient
result 1-15
Patient ID
configure 7-11
entering 2-8
patient results
report 1-15
pipettor 1-14
tubing 6-53
placing instrument
electromagnetic radiation 8-9
planning
installation 8-8
plasma
in sample cup 1-13, 2-7
processing 1-13
specimen 1-13, 2-7
POCT1-A2
configure 7-7
POST test 1-21
power
controlled shutdown 1-21
icon 1-18, 9-2
ON/OFF 1-21
switch 1-21
power requirements
circuit 8-9
installation 8-8
receptacle 8-9
recommended service outlet 8-8
transient overvoltage 8-9
preparing
plasma 2-7
to process 2-6
primary units of measure
configure 7-13
principles
calibration 3-2
print
errors 6-3
printer
paper advance 5-10
paper replacement 5-10
probe sealing pad
clean 6-35
procedures
process
prepare 2-6
i - 10 2014/08
with sample cup 2-13

processing
automated dilution 2-12
calibration 1-14, 3-3
dilution 1-14
modes 1-19
plasma 1-13
QC 1-14
quality control 4-7
tests 2-7
time 2-15
whole blood 1-12, 2-7
with sample cup 1-13
with tube 1-12, 2-7
pump system
Q
QC
alert message 4-4
ID 4-4
levels 4-5, 4-7
lockout 4-5
lockout parameters 4-5
material 4-2
mode 1-19
modes 1-19, 4-7
overview 4-2
quality management 4-2
range check off 4-4
range check on 4-4
ranges 4-4, 4-9
report 4-9
setting up parameters 4-4
status 2-6
timeout 4-4
troubleshooting 4-9
QC result
OK 4-9
out 4-9
quality management
QC 4-2
R
range check
QC off 4-4
QC on 4-4
ranges
QC 4-4, 4-9
reagent status
check 2-6
review 2-5
2014/08 i - 11
receptacle
recommended service outlet
reference
configure cutoff 7-10
disk 6-30, 6-33
intervals 7-10
reference intervals
outside range 2-17
remote computer system
settings 7-7
transmit 1-16
remote transmission
configure 8-7
replacing
AC fuses 6-40
air filter 5-4
cannula chamber o-ring seal 6-45
corrupted USB flash drive 6-47
fluorometer lamp 6-49
pipettor tubing 6-53
sample manager tubing 6-56
thermal paper 5-10
waste container 2-2
report
calibration 3-3
function 9-3
patient results 1-15, 2-16
QC 4-9
reprinting
results 2-17
requiring
Operator ID 7-9
reset
function 9-2
responsibilities
install 8-7
result
patient 1-15
processing time 2-15
QC OK 4-9
report 2-16
reprinting 2-17
units of measure 7-13
result out
QC 4-9
result report
asterisks 2-17
retrieving
sample from instrument 7-3
test sample 2-6
reusing
sample 2-6
i - 12 2014/08
reviewing
calibration 2-5
reagent status 2-5
system check limits 2-5
System Check report 2-5
test needs 2-6
rotor
containment boot 6-37
description 1-12
hold option 7-3
inspection 2-10
load 2-10
table 1-12
timeout 7-3
usage configuration 7-3
rotor containment boot and bracket
clean 6-37
rotors 1-6
running
System Check 2-4
S
safety
barcode reader 10-2
blood collection 2-6
compliance 10-2
labels 8-4
notes 8-3
safety and specifications
overview 8-2
sample
barcode reader 1-12, 2-6
collection tubes 11-2
cup 4-8
manager 1-12
retrieve from instrument 7-3
reusing 2-6
volume 4-7
volume gauge 2-7, 7-12
sample collection
tube 11-2
sample cup 1-7
plasma 1-13, 2-7
Sample ID
entering 2-8
sample ID
configure 7-11
sample manager
troubleshooting 6-12, 6-13
tubing 6-56
sample manager tubing
replace 6-56
2014/08 i - 13
sample tube type

configure 7-12
scanning
barcode 1-12
barcode label 2-8
secondary units of measure
configure 7-13
selecting
menu function 9-2
serial number
enter 7-12
setting
audio alarms 7-3
settings
basic configuration 7-3
setup
daily 2-2
maintenance log 12-3
shutdown
instrument 1-21
Siemens representative responsibilities
install responsibilities 8-7
Siemens Technical Solutions Center
contact 1-3
software
corrupted USB flash drive 6-47
flowchart 9-3
overview 1-19
space requirements
installation 8-8
specifications
humidity 8-10
noise output 8-10
temperature 8-10
thermal output 8-10
specimen
collection 2-6
plasma 1-13, 2-7
tube 1-14, 11-2
whole blood 1-12
standard
maintenance 5-2
start key 1-18
troubleshooting 7-6
status
calibration 2-6
QC 2-6
stop
key 1-18
store data
enter button 1-17
storing
serial number 7-12
supplies 1-4
i - 14 2014/08
CalPaks 1-5
cannulas 1-5
DilPaks 1-4
rotors 1-6
sample cups 1-7
TestPaks 1-4
thermal paper 2-4
tips 1-7
tubes 1-8
warning 1-4
waste container 1-8
switch
power 1-21
symbols key 8-6
System Check
description 1-15
fluid delivery 1-15
ID 4-5
lockout 4-5
mechanical alignment 1-15
mode 1-19
optical detection 1-15
report review 2-5
run 2-4
temperature 1-15
system components 1-9
align 6-26
system overview 1-2
T
table
rotor 1-12
temperature
specifications 8-10
System Check 1-15
test
processing 2-7
retrieve sample 2-6
review needs 2-6
TestPak 1-4
barcode label 3-2
delete lot 3-5
load 2-12, 3-3, 4-8
thermal output
specifications 8-10
thermal printer paper
check 2-4
time
change 7-4
remaining to process 2-15
timeout
QC 4-4
2014/08 i - 15
rotor 7-3
tip 1-7
disposal 1-13, 1-14
installing tray 2-3
manager 1-12
trays 1-18
waste chute 5-7
tip chute
clean 5-8
tip manager
tip supply
check 2-3
tip tray
illuminates 1-18
tools
instrument accessory kit 5-2
reference pak 6-33
torque wrench 6-55
torque wrench 6-55
touchscreen
adjusting display 6-22
clean 5-9
description 1-17
number pad 1-18
paper advance icon 1-19
start key 1-18
stop key 1-18
training
checklist 13-1
mode 7-13
using checklist 13-1
transient overvoltage
transmitting
calibration with POCT1-A2 enabled 3-5
remote computer system 1-16
troubleshooting
calibration 3-4
control system 6-9
error codes 6-2, 6-14
fluorometer 6-9
overview 6-2
pak manager 6-11
patient results 2-16
pipettor 6-10
procedures 6-20
pump system 6-12
QC 4-9
sample manager 6-12, 6-13
start key 1-18, 7-6
System Check 6-20
temperature 6-13
tip manager 6-13
i - 16 2014/08
tube 1-8
barcode label 2-8
configure 7-12
label 2-6
specimen 1-14, 11-2
specimen collection 1-12, 2-6
type 7-12, 11-2
tube type
cannula 7-12, 11-2
tubing
pipettor 6-53
replace pipettor 6-53
replace sample manager 6-56
sample manager 6-56
U
units of measure
configure 7-13
result 7-13
updating
calibration 3-2
USB flash drive
replace corrupted 6-47
using
CalPak 3-3
maintenance logs 12-1
V
volume
sample 4-7
volume gauge
sample 2-7
W
warnings
chemical 8-4
electrical 8-4
general 8-3
mechanical 8-4
safety 8-3
supplies 1-4
waste
area 5-9
container 1-8, 1-13, 1-14
disposal 8-10
replace container 2-2
waste chute
tip 5-7
whole blood
specimen 1-12
wire size
North America only 8-9
2014/08 i - 17
i - 18 2014/08

Stratus cs200 Operator Manual

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Processing Samples and Reporting Results . . . . . . . . . . 2-1

Preparing to Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Other Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Safety and Specifications . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Appendix A: Menu Navigation . . . . . . . . . . . . . . . . . . . . 9-1

Appendix B: Code Compliance . . . . . . . . . . . . . . . . . . . . 10-1

Appendix C: Qualified Sample Collection Tubes . . . . . . 11-1

Appendix D: Maintenance Logs . . . . . . . . . . . . . . . . . . . 12-1

Appendix E: Operator’s Training Checklist . . . . . . . . . . . 13-1

Chapter 1: System Overview

Using this Guide

Chapter and Title Description

Chapter 1: System Overview Reviews mechanical instrument operation in general

Chapter 2: Processing Samples Provides step-by-step procedures for preparing and

Chapter 3: Calibration Provides step-by-step procedures for calibrating test

Chapter 5: Maintenance Provides procedures for daily, monthly, and as needed

Chapter 6: Troubleshooting Provides guidance to diagnose and correct problem

Chapter 8: Safety and Provides information about safe instrument operation,

Appendix A: Menu Navigation Provides a description of the touchscreen buttons and

Appendix B: Code Compliance Provides code compliance information.

Appendix C: Qualified Sample Provides information on qualified collection tubes.

Appendix E: Operator’s Training Provides an operator checklist to be used as a guide to

Contacting Siemens Technical Solutions Center

WARNING: These supplies are single-use only. Never attempt to

WARNING: A sharp tip is recessed inside the cannula. Handle the

WARNING: Cannulas cannot be reused.

WARNING: Rotors cannot be reused.

WARNING: Use only Siemens Stratus® CS sample cups. Failure to do so

WARNING: Sample cups cannot be reused.

WARNING: Tips cannot be reused.

WARNING: Reuse of waste containers will result in contamination of

1 Sample Volume Gauge

5 Pak Manager Well

6 Sample Barcode Reader

7 Waste Container Area

Figure 1-11: Internal System Components

4 Pak Manager Well

5 Pak Barcode Reader

7 Cannula Chamber (Sample Manager)

8 Sample Barcode Reader

Figure 1-12: Instrument Power Switch

Processing Whole Blood

Processing Automated Dilutions

Quality Control and Calibration

System Check Description

Button/ Icons Description

Alarm Illuminates when there is a system alarm.

Collection Time Select to enter specimen collection time.

Cup Illuminates when waiting to receive a sample cup for processing.

Enter Select to store data entered in a field.

Button/ Icons Description

Home Select Home to return to the Home screen.

ID Illuminates when waiting to receive a Patient ID or Sample ID for processing. This

Number Pad Select to enter numbers where required.

Pak Illuminates when waiting to receive a TestPak for processing.

Rotor Illuminates when waiting to receive a rotor for processing.