ADVIA Centaur XP Reference Manual - 078D0473!03!2007-10 - en
ADVIA Centaur XP Reference Manual - 078D0473!03!2007-10 - en
ADVIA Centaur XP Reference Manual - 078D0473!03!2007-10 - en
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2007 Siemens Medical Solutions Diagnostics. All rights reserved. No part of this operators guide or the products it describes may be reproduced by any means or in any form without prior consent in writing from Siemens Medical Solutions Diagnostics. ADVIA Centaur, ReadyPack, BR (CA 15-3), CA 125 II, CA 15-3, CA 19-9, and TnI-Ultra are trademarks of Siemens Medical Solutions Diagnostics. RealTime Solutions is a servicemark of Siemens Medical Solutions Diagnostics. Corvac and Monoject are trademarks of Sherwood Medical Company. Lexmark is a trademark of Lexmark International, Inc. Microsoft Excel is a trademark of Microsoft Corporation. Microtainer and Vacutainer are trademarks of Becton, Dickinson and Company. Monovette is a trademark of Walter Sarstedt Kunststoff-Spritzgusswerk. Origin: Ireland
The information in this operators guide was correct at the time of printing. However, Siemens Medical Solutions Diagnostics continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice. If the system is used in a manner differently than specified by Siemens Medical Solutions Diagnostics, the protection provided by the equipment may be impaired. See warning and hazard statements.
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Contents
1 2 3 4 5 6 7 8 System Overview Operating the ADVIA Centaur XP System Calibration Quality Control Performing Maintenance Identifying System Problems Managing Data Configuring the System
Appendix A: Safety Instructions Appendix B: Service, Ordering, and Warranty Appendix C: Reagents and System Fluids Appendix D: Supplies Appendix E: Specifications Appendix F: System Symbols Appendix G: Installation and Relocation Appendix H: Glossary
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Index
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Organization
The following table describes how this operators guide is organized.
If you want to . . . learn about system features such as no-pause reloading and onboard refrigeration, learn about user interface components, how to use online information, and view software maps, review the hardware and the operating sequence, review principles of chemiluminescence and assay reaction formats, process samples, monitor status, or manage sample results, review Master Curve and 2-point calibration principles, define Master Curves and calibrators, process calibrators, learn about accessing ADVIA QC, define quality control materials, perform scheduled maintenance activities, record maintenance activities, investigate and correct system problems, learn about saving results data files to an archive, learn about backing up your system configuration files, Then refer to . . . Section 1: System Features Hardware Overview, Software Overview, Technology.
Section 2: Operating the System. Section 3: Calibration. Section 4: Quality Control. Section 5: Maintenance. Section 6: Troubleshooting. Section 7: Data Management.
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If you want to . . . modify test definition parameters, modify system parameters, set up LIS and LAS parameters, review biohazard precautions, review laser precautions, view warranty, legal, and support information, view contact information, view information about primary reagents, ancillary reagents, and system fluids, view information about ordering supplies, view system specifications, view system symbols, view the glossary,
Then refer to . . . Section 8: System Configuration. Appendix A: Safety. Appendix B: Warranty and Support Information. Appendix C: Reagents and System Fluids. Appendix D: Supplies. Appendix E: Specifications. Appendix F: Symbols. Appendix G: Glossary.
Conventions
The ADVIA Centaur XP Operators Guide uses the following text and symbol conventions:
Convention BIOHAZARD LASER WARNING: WARNING: CAUTION: Description Biohazard statements alert you to potentially biohazardous conditions. Laser Warning statements alert you to the risk of exposure to lasers. Warning statements alert you to conditions that may cause personal injury. Caution statements alert you to conditions that may cause product damage or loss of data. On the system, this symbol indicates that you should refer to the operators guide for more information. Note statements alert you to important information that requires your attention.
NOTE:
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Convention Bold
Description Bold type indicates commands on the user interface, keys, or the exact text that an operator needs to type. For example, if the word save appears as Save, it refers to the selecting the Save button on the user interface. Another example is typing a specific entry into a text box. If the word welcome appears as welcome, it means that you should type that word into the specified field. Italic type refers to the title of a document or a section title in this operators guide. For example, Operating the ADVIA Centaur XP System refers to Section 2 of this operators guide.
Italic
Terminology
The following table explains some of the special terminology used in this operators guide and the specific actions that you need to take when you see the terminology:
Term Select Description To select an item, use your finger to touch the item on the touch-screen monitor or select the item with the system pointing device. The background of the item changes color or displays a black frame to indicate that you selected the item. Type the specified information using the keyboard and then press the Enter key. Move the hand-held barcode scanner over the specified barcode to enter the information.
Enter Scan
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1 System Overview
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
ADVIA Centaur XP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Visible Status Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Sample Loading Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Reagent Loading Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Test Sequence Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Supplies and Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
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Functions, Applications View RealTime Solutions and IFUs . . . . 1-32 Functions, Application View Print . . . . . . . . . . . . . . . . . . . . . . . . 1-32
Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Direct Chemiluminescence. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Antibody Binding Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34 Paramagnetic Particles and Magnetic Separation . . . . . . . . . . . . . 1-34
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
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System Features
The ADVIA Centaur XP system is an automated, immunoassay analyzer that offers optimal productivity and efficiency. Comprehensive assay groups provide for cost-effective workstation consolidation. The assay groups include fertility, thyroid function, oncology, cardiovascular, anemia, therapeutic drug monitoring, infectious disease, allergy, adrenal function, and metabolic. All the assays use direct chemiluminescent technology. Tests performed using the ADVIA Centaur XP system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis is not based on the results of a single test. Only a physician can make a diagnosis after evaluating all clinical and laboratory findings.
Intended Use
This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. The ADVIA Centaur XP has many features for enhancing laboratory operations:
Feature No-pause Reloading Optimal Productivity Automatic Reflex Testing Onboard Refrigeration Description You can load samples, reagents, and supplies at any time, even while the system processes samples. The throughput is up to 240 tests per hour and the walkaway time is up to 840 tests. The system automatically schedules reflex tests based on parameters that you define. Reagents remain in the refrigerated reagent areas, so you can process samples without time-consuming system preparation. The system efficiently processes Stat requests via a dedicated Stat port without disrupting sample processing. The system ensures sample integrity by detecting complete obstructions in the sample probe, notifying you of the condition, and then performing management and recovery tasks. The system ensures the integrity of the reagent aspiration and dispense in the reagent and the ancillary probes.
Bubble Detection
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Description The system automatically performs the daily cleaning. You can set up the system to automatically schedule and log the daily cleaning procedure in the Maintenance Log. The intuitive graphical user interface is via a touch-screen monitor making it possible for you to perform your daily tasks directly on the screen without using the keyboard. Context-sensitive help is available for any window or field. Bidirectional laboratory information system (LIS) interface allows you to send to and receive information from your LIS. The system supports the ASTM interface protocol. The ADVIA Centaur XP STS sample transport system is an optional feature that enables you to use the ADVIA Centaur XP system with any laboratory automation system. The ADVIA Centaur XP system has integrated, pro-active service features that assist in problem detection and remotely initiated diagnosis of problems, having the effect of faster support resolution. The system supports remotely initiated activities like software updates and on-line documentation updates. The ADVIA Centaur XP system has a status light that is visible from most positions in the room. The status lights correspond to events that occur on the ADVIA Centaur XP system.
LIS Interface
Laboratory Automation
Hardware Overview
The Hardware Overview section introduces the operating sequence of the system and describes the location and function of the major subsystems and components. This information helps you to perform the following tasks: operate the ADVIA Centaur XP system for maximum efficiency perform the maintenance tasks understand the basic test processing sequence, which is essential for effective troubleshooting
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Water bottle Waste bottle Primary reagent compartment Sample tip loader Visible status light Cuvette loader
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Sample exit queue Stat entry Sample entry queue Cleaning solution System fluids
Figure 1-1
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The ADVIA Centaur XP system uses several areas of the system while processing samples, as shown in Figure 1-2.
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Primary reagent compartment Primary reagent probes Incubation ring Luminometer Base probe Waste probe Cuvette loading bin Aspirate probes Magnets Wash block Acid probe
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Ancillary probe Sample probe Ancillary reagent queue Sample tip tray Inprocess queue Sample entry queue Sample rack Stat entry Sample exit queue User Interface workstation
Figure 1-2
Yellow
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At least 1 critical condition exists that may cause the system to stop aspirating or processing samples. A new event has occurred. When you open the status window to view the new condition, the status light maintains the current color and stops blinking. When you correct all warning or critical conditions, the status light turns off. When you correct all critical conditions and warning conditions remain, the status light changes to steady yellow. A remote update is in progress. If an error occurs during a remote update, the status light changes to blinking red.
Blinking Green
Figure 1-3
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Samples are placed in the sample racks, which hold 5 primary sample tubes or sample cups.
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Figure 1-4
You load the racks in the sample entry queue and remove them from the sample exit queue. You can enter stat samples into the stat queue.
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Figure 1-5
Sample Queues
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Racks enter the inprocess queue where the sample barcode scanner reads the barcode labels on the rack and on each sample cup or tube. When the sample rack is in the inprocess queue, the sample probe aspirates the sample.
1 2 3
Figure 1-6
Inprocess Queue
After each sample in the rack is aspirated, the rack moves from the inprocess queue to the sample exit queue.
Figure 1-7
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Figure 1-8
Light-emitting diodes (LEDs) on the primary reagent door indicate the status of the primary packs: Green indicates that the reagent pack is loaded and available for use. Blinking green indicates that the system detected that a reagent pack is present but cannot read the barcode. Neutral indicates that no reagent pack is loaded in that position or that the pack is depleted, expired, inactivated, or has no barcode.
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You load ancillary reagent packs in the ancillary reagent entry. The system delivers the packs to the ancillary reagent queue. The ancillary reagent queue stores the packs at a temperature of 4 to 8C (39 to 46F). You remove ancillary packs at the ancillary reagent entry.
1 2 3
Figure 1-9
Ancillary Queue
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Figure 1-10
Inprocess Queue
The sample probe aspirates sample from a container in the inprocess queue and then dispenses sample into a cuvette in the incubation ring.
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The incubation ring is a circular, insulated track that advances the cuvette at 15-second intervals and incubates the cuvette at 37C (98.6F).
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Figure 1-11
The incubation ring moves the cuvette from the sample probe to the ancillary probe and to the reagent probes. The ancillary probe aspirates the ancillary reagents from the packs in the ancillary reagent queue and dispenses the reagents into the cuvette in the incubation ring.
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The rinse station rinses the probe with reagent water before each ancillary reagent aspiration.
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Figure 1-12
The incubation ring moves the cuvette to the reagent probes. The 3 reagent probes move independently of each other to aspirate primary reagents from the primary packs and to dispense the reagents into the cuvette in the incubation ring.
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Between samples, the rinse stations rinse the probes with reagent water.
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Figure 1-13
The incubation ring moves the cuvette to the wash station. After the magnetic particles are pulled to the side of the cuvette by magnets positioned along the incubation ring, the aspirate probes draw fluid out of the cuvette. The wash station dispenses wash fluid into the cuvette to wash the magnetic particles.
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Figure 1-14
Wash Block
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The incubation ring moves the cuvette to the acid probe, which dispenses acid reagent into the cuvette. The incubation ring moves the cuvette to the elevator, which lifts the cuvette from the incubation ring into the luminometer. The luminometer has 3 parts: a photomultiplier tube (PMT) with photon-counting electronics, a base probe, and a waste probe. When base reagent is dispensed into the cuvette, the chemiluminescent reaction occurs. The luminometer measures the light emitted as relative light units (RLUs). The central processing unit (CPU) processes the data from the PMT and converts the RLUs into results. The system sends the results to an LIS or a printer. The waste probe aspirates the waste fluid from the cuvette and the cuvette drops into the cuvette waste bin. As cuvettes exit the incubation ring, the system continuously adds new cuvettes to the incubation ring. You load cuvettes in the cuvette loading bin, then the system moves the cuvettes to the orientation chute. The orientation chute correctly positions the cuvettes before they enter the vertical cuvette chute. The vertical cuvette chute connects to the preheater, which warms the cuvettes to a temperature of 37C (98.6F) before the cuvettes enter the incubation ring.
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4 5
Figure 1-15
Cuvette Cycle
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Computer Hardware
The ADVIA Centaur XP computers control system functions and processes data. The applications module is equipped with a CD-RW drive for software updates and for data storage. The computer has several serial ports, as well as an Ethernet port that expands the communication link between Siemens and your laboratory, allowing for enhanced remotely initiated diagnostics and proactive service. The monitor, keyboard, mouse, and barcode scanner are all connected to the computer.
Keyboard
The keyboard offers special icon keys.
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Symbol keys for the status or task areas Sign In key Print key Help key
Figure 1-16
You can use the keyboard to make selections, open windows, and enter information.
If you want to . . . open a window from the workspace, close a window, close all windows, go to the previous window, go to the next window, Then . . . Press the symbol key for the status or the task area. Press the key of the underlined character of the window title. press the Close Win key. press the Close All key. press the Prev Win key. press the Shift key and the Prev Win key.
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Then . . . Press the Print key. Use the down arrow to select the Report Options button and then press the Enter key. Press the Print key. Use the down arrow to select the Print Workspace button and then press the Enter key. Press the QC icon key on the keyboard. Press the Sign In key. Use the Tab key to move to the New Operator field and then enter your initials. Use the Tab key to move to the Password field and then enter the password. Use the Tab key to move to the Sign In button and then press the Enter key. Move to the field on which you want help and then press the help key.
access help,
Barcode Scanner
LASER WARNING
Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. Use the hand-held barcode scanner to enter barcoded information, such as the information on Master Curve cards or Calibrator Assigned Value cards. Place the scanner on the top barcode of the Master Curve card or Calibrator Assigned Value card. Slowly move the scanner down the card over the barcodes. The scanner beeps after successfully reading a barcode. You can also use the hand-held barcode scanner to enter the Sample ID for patient samples. Refer to Scheduling Patient Samples Using a Hand-Held Barcode Reader page 2-52.
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Monitor
NOTE: The touch screen may not respond correctly if it is wet or if your finger or gloves are wet.
The graphical user interface is via a touch-screen monitor, making it possible for you to perform your daily tasks directly on the screen without using the keyboard. The monitor is located on a flexible arm so you can adjust the position of the monitor. The area of software called the workspace is always visible on the monitor.
Software Overview
Use the ADVIA Centaur XP user interface workstation to control the operation of the system. The user interface workstation consists of hardware and software that you use to interact with the system.
Workspace
The workspace provides access to all system functions and information that an operator requires to operate the system. The workspace is similar to a benchtop. At a benchtop, you can pull several reports (windows) from different files (workspace buttons), and spread them out to review or to enter information. Although you can work on only 1 document at a time (active window), the others are ready for you. You can return the report to the file (close the window) or you can leave the report on the benchtop (leave the window open). The workspace has 2 views: system view, offering access to system functions Unless otherwise specified, when the procedure says At the workspace,... it refers to the system view workspace. applications view, offering access to a set of applications including the ADVIA QC analyzer, the RealTime Solutions service, and the online documentation browser
To change from the 1 view to the other view, press the QC symbol key on the system keyboard.
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Workspace Toolbar
The toolbar buttons are grouped into 3 areas at the top of the workspace: status buttons, task buttons, and function buttons. These buttons open windows that contain related information and tasks.
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Figure 1-17
Workspace Buttons
Status Buttons
The status buttons open windows that provide information on the condition of the entire system, specific system areas, supplies, and reagents. The status buttons are only available in the system view.
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System status Date and time field Supplies status Sample status Exception button
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Current system state field Reagent status button Maintenance status Event log status
Figure 1-18
The System Status button provides access to diagnostic tools and the system information The Supplies Status button opens a window that displays information about the cuvette supply, the sample tip supply, system fluid levels, and waste levels.
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The Sample Status button opens a window that displays information about the status of samples that are in process. The Exception Status button directs you to the applications view and the ADVIA QC application. The Reagent Status button opens windows that display information about the onboard primary and ancillary reagents. The Maintenance Status button opens a window that accesses the maintenance schedule, the maintenance log, the maintenance definitions, and the maintenance procedures. The Event Log Status button opens a window that displays the events that occurred on the system and provides access to troubleshooting procedures.
Task Buttons
The task buttons provide access to windows associated with specific tasks. When selected, each button displays a list of the windows that are available.
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Workspace Toolbar Task Buttons System View accesses tasks associated with analyzing samples: scheduling samples, performing dilutions, reviewing results accesses control definition windows accesses calibration tasks: defining Master Curves, defining calibrators, reviewing calibration results accesses setup tasks: defining dilutions, profiles, tube types, and LIS communications Applications View inactive
Setup
accesses setup tasks: data management, enabling the visible status light
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Function Buttons
The function buttons provide additional capabilities related to the workspace, such as signing in, closing all windows, and requesting printed reports.
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Close All Sign In RealTime Solutions - available in the Applications View Instructions for Use - available in the Applications View Print
Figure 1-20
Function Buttons
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Software Windows
The windows are designed with a common organization. because the purpose of each window is unique, the organization of each window may vary to best achieve the objective of each window.
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Title bar with Help button View, Sort, and Search fields Information display area Bottom buttons Side buttons
Figure 1-21
The title bar indicates the task area and the name of the specific window. The title bar also contains buttons that access window help, move the window behind other windows, or close the window. The View, Sort, and Search fields control the amount or type of information that is displayed, control the order of information displayed, and locate specific items. The information display area displays the information that you selected in View, Sort, and Search fields. The buttons on the bottom of the window perform actions on all information in the information display area or in open related windows. The buttons on the side of the window perform actions or open windows that provide more information about an item you selected in the information display area.
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Moving Windows
When you open multiple windows, you can move the windows to more easily review information or perform tasks To move a window to a new position in the workspace: Using the touch screen, hold your finger on the window title bar and drag the window to a new position. Using the system mouse, position the pointer on the title bar and hold down the left mouse button while dragging the window to a new position.
Window Elements
Window elements enable you to make selections and interact with the windows. To move a window behind other open windows, select the Move Back button. Tables allow you to review information and to select items. Dropdown lists display options. Data fields allow you to enter or display information. Scroll bar arrows scroll the view to display items that are not visible in the list. You can usually select as many options as required in a table. A check mark displays next to the selected options. You can enable 1 item from the group of options using a diamond option button. You can turn an option on or off by selecting or deselecting the option.
Online Information
The ADVIA Centaur XP system provides online help and procedures to answer your questions about operating the system, maintaining the system, and correcting system problems. The system also provides online documentation that you can view and print as necessary.
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For more information about using the online browser, perform the following steps: 1. At the system view workspace, press the QC icon key on the keyboard. 2. At the applications view workspace, select the Instructions for Use button. The workspace displays the browser with instructions for using the browser displayed on the page.
Help
To access help for a window element, place the pointer on field or button and press the right mouse button. You can also move the cursor to a window element and press the ? key on the keyboard.
Window Help
Window help provides information about options available at each window and brief instructions for using the window. To access window help, touch the ? button in the title bar or select the ? using the mouse.
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Maintenance Procedures
To access maintenance procedures, select a maintenance activity at the Status Maintenance window, and then select Procedure. Refer to Performing Maintenance page 5-1.
Software Maps
Workspace buttons open windows that contain related information and tasks.
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System
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Status
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Worklist
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Calibration
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Technology
Chemiluminescence is a chemical reaction that emits energy in the form of light.15 When used in combination with immunoassay technology, the light produced by the reaction indicates the amount of analyte in a sample. Direct chemiluminescent reactions directly measure the light energy without the use of added steps or amplifying molecules.6 The ADVIA Centaur XP assays use acridinium ester (AE) as the chemiluminescent label, because AE does not require the addition of a catalyst or substrate.6
Direct Chemiluminescence
It is easy to automate direct chemiluminescence using AE and provides many benefits, such as long reagent shelf life, fast reaction time, and assay sensitivity. The ADVIA Centaur XP assays use the dimethyl form of AE because its stability allows long reagent shelf life.6,8
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In ADVIA Centaur XP assays, hydrogen peroxide oxidizes AE and maximizes the light emission by changing the environment from acidic to basic. Oxidation of AE occurs rapidly, with peak light emission occurring within 1 second. The rapid reaction time and very low background make direct chemiluminescence with AE faster than RIA or EIA methods.6,8
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Figure 1-22
The AE molecule is much smaller than the alkaline phosphatase molecule used in EIA assays. This smaller size decreases blockage of binding sites, increases diffusion rates, and increases the assay sensitivity.8
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Figure 1-23
Molecule Comparison
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Figure 1-24
Antibody Binding
AE can be covalently bound to an antibody without altering the ability of the antibody to bind to an antigen. To measure an antigen, many ADVIA Centaur XP assays use antibodies that are covalently bound to AE.
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During incubation, coated PMP in the cuvette bind to the target antigen or antibody. When the system exposes the cuvette to a magnetic field, the magnets draw the PMP bound to antigen or antibody toward them. While the magnets hold the PMP in place, the system washes away sample and reagent not bound to the coated PMP.
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PMP Antibody
Figure 1-25
Free PMPs
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Sandwich Format
Sandwich formats use AE-labeled antibody in the Lite Reagent. 1. The system adds Lite Reagent, containing AE-labeled antibody, to the sample. The AE-labeled antibody binds specifically to the analyte-specific antigen in the sample.
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Figure 1-26
Sandwich Format
2. The system adds Solid Phase containing PMP that are coated with antibody specific for the antigen in the sample. The system incubates the cuvette at 37C (98.6F). PMP bind to the antigens that are bound to AE-labeled antibody.
PMP-Antibody-Antigen-Antibody-AE complex
Figure 1-27
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3. The cuvette is exposed to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, sample and reagent not bound to PMP are washed away. The cuvette now contains AE bound to antigen, which is bound to PMP by antibody.
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Figure 1-28
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4. The System adds acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in relative light units (RLUs). When the system quantitates the light produced from the oxidation of AE, the system calculates the concentration of antigen. In a sandwich format, the analyte-specific antigen concentration in the sample and the light emission in RLUs have a direct relationship. If more analyte-specific antigen molecules are present in the sample, then more AE is present, and therefore light emission is greater.
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Figure 1-29
Competitive Format
Competitive formats include: AE-labeled antigen in the Lite Reagent AE-labeled antibody in the Lite Reagent
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AE-labeled Antigen
1. The system adds Lite Reagent, containing AE-labeled antigen, and Solid Phase, containing antibody-labeled PMP, to the sample. The system incubates the cuvette at 37C (98.6F). The AE-labeled antigen competes with analyte-specific antigen in the sample for limited binding sites on the antibody, which is bound to PMP. If more analyte-specific antigen is present in the sample, then less AE-labeled antigen is bound. Alternatively, if less analyte-specific antigen in the sample is present, then more AE-labeled antigen is bound.
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Antibody PMP
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Figure 1-30
AE-labeled Antigen
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2. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away sample and reagent not bound to PMP. The cuvette now contains analyte-specific antigen from the sample and AE-labeled antigen bound to PMP by antibody.
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Figure 1-31
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3. The system adds Acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in RLUs. When the system quantiates the light produced from the oxidation of AE, the system calculates the concentration of the analyte. If the sample has a low concentration of analyte-specific antigen, most binding sites on the antibody are bound to AE-labeled antigen. This causes an elevated reading of RLUs from the oxidation of AE. If the sample has a high concentration of analyte-specific antigen, most binding sites on the antibody are bound to antigen from the sample, and few sites are bound to AE-labeled antigen. This causes a lower reading of RLUs from the oxidation of the AE. In a competitive assay with AE-labeled antigen, the concentration of antigen in the sample and the light emission in RLUs have an inverse relationship.
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Figure 1-32
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AE-labeled Antibody
1. The system adds Lite Reagent, containing AE-labeled antibody, and Solid Phase, containing antigen-labeled PMP, to the sample. The system incubates the cuvette at 37C (98.6F). Antigen bound to PMP competes with analyte-specific antigen in the sample for limited binding sites on AE-labeled antibody. If the sample has more analyte-specific antigen, then it binds less PMP-labeled antigen. Alternatively, if the sample has less analyte-specific antigen, then it binds more PMP-labeled antigen.
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Figure 1-33
AE-labeled Antibody
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2. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away sample containing analyte-specific antigen and reagent not bound to PMP. The cuvette now contains PMP-antigen bound to AE by antibody.
PMP-Antigen-Antibody-AE complex
Figure 1-34
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3. The system adds acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in RLUs. When the system quantitates the light produced from the oxidation of AE, the system calculates the concentration of analyte. If the sample has a low concentration of analyte-specific antigen, the PMP-labeled antigen binds to most binding sites on the antibody. This causes an elevated reading of RLUs from the oxidation of AE. If the sample has a high concentration of analyte-specific antigen, the antigen from the sample binds to most binding sites on the antibody, and few sites are bound to PMP-labeled antigen. This causes a lower reading of RLUs from the oxidation of AE. In a competitive assay with AE-labeled antibody, the concentration of analyte in the sample and the light emission in RLUs have an inverse relationship.
1 2
Figure 1-35
Antibody-capture Format
When the substance being measured in the sample is an antibody, the system uses the antibody-capture format. The assay uses a reagent containing an additional antibody that is specifically directed against the antibody in the sample. Antibody-capture formats are usually characterized by 2 cycles of incubation and wash. The purpose of the first incubation and wash is to remove excess interfering substances in the sample. The purpose of the second incubation and wash is to measure the antibody in the sample.
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Antibody-capture assays detect specific IgG antibody or IgM antibody in patient samples. The following example is an antibody-capture assay that detects human IgM antibody in a patient sample. 1. The system adds Solid Phase, containing anti-human IgM antibody bound to PMP, to the sample. The system incubates the cuvette at 37C (98.6F). The IgM antibody in the sample binds to anti-human IgM antibody bound to PMP.
1 2
Figure 1-36
Antibody-capture Format
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2. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away sample and reagent not bound to PMP. The cuvette now contains IgM antibody from the sample captured by specific anti-human IgM antibody, which is bound to PMP.
Figure 1-37
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3. The system adds Lite Reagent, containing AE-labeled antigen, to the cuvette and incubates it at 37C (98.6F). The AE-labeled antigen binds to the sample IgM antibody in the sample.
AE-labeled antigen
Figure 1-38
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4. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away the reagent not bound to PMP. The cuvette now contains AE-labeled antigen bound to sample IgM antibody, which is bound to anti-human IgM antibody, bound to PMP.
Figure 1-39
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5. The system adds acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in RLUs. When the system quantitates light produced from the oxidation of the AE, the system calculates the concentration of the analyte. In this example of an antibody-capture assay, the sample concentration and the light emission have a direct relationship. If more sample IgM antibody is present, then more AE is present, and therefore the light emission is higher.
1 2
Figure 1-40
References
1. Whitehead TP, Kricka J, Carter JN, Thorpe G. Analytical luminescence: its potential in the clinical laboratory. Clin Chem 1979; 25/9: 15311546. 2. Woodhead JS, Campbell AK, McCapra F, Beheshti I, Weeks I. Acridinium esters as high specific-activity labels in immunoassays. Clin Chem 1983; 29/ 8: 147479. 3. Weeks I, Woodhead JS. Chemiluminescence immunoassays. J. Clin Immunoassay 1984; 7/1: 8289. 4. Patel A, Morton MS, Woodhead JS, Ryall MET, McCapra F, Campbell AK. A new chemiluminescent label for use in immunoassay. Biochem Soc Trans 1982; 10: 2245. 5. Tietz NW. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B. Saunders Company, 1987; 1010. 6. Kricka LJ. Chemiluminescence immunoassay. The immunoassay handbook, 1st ed. New York: Stockton Press, 1994; 341343. 7. Dudley R. The immunoassay handbook, 1st ed. New York: Stockton Press, 1994; 161164.
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8. Dudley R. Chemiluminescence immunoassay: an alternative to RIA. Lab Med 1990; 21/4; 216221.
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Loading Samples Using Laboratory Automation Systems . . . . . 1-6 Verifying Barcode Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Locating Specific Sample Information . . . . . . . . . . . . . . . . . . . . . . . .1-7
Removing Sample Racks from the Inprocess Queue. . . . . . . . . 1-8 Locating Sample Racks in the Sample Exit Queue . . . . . . . . . . 1-8
Replacing the Cleaning Solution. . . . . . . . . . . . . . . . . . . . . . . . 1-31 Adding Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32 Adding Sample Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Emptying the Sample Tip Waste Bin . . . . . . . . . . . . . . . . . . . . 1-33
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Emptying the Sample Tip Tray Waste . . . . . . . . . . . . . . . . . . . 1-35 Emptying the Cuvette Waste Bin . . . . . . . . . . . . . . . . . . . . . . . 1-35 Replacing System Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
Displaying Calibrator Results at the Worklist . . . . . . . . . . . . . . 1-42 Suspending Update of the Worklist . . . . . . . . . . . . . . . . . . . . . 1-43 Rescheduling Samples for Control-bracketed Tests. . . . . . . . . 1-43
Reasons for Discarded Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 Rescheduling Samples with Discarded Results . . . . . . . . . . . . . . . 1-44
Locating Specific Samples in the Sample Exit Queue . . . . . . . 1-44 Moving Final Results to the Historical Worklist. . . . . . . . . . . . . 1-45
Handling SID Mismatches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-52 Scheduling Patient Samples Using a Hand-Held Barcode Reader 1-52
Entering Patient Demographics . . . . . . . . . . . . . . . . . . . . . . . . 1-53 Entering Comments for a Patient Sample . . . . . . . . . . . . . . . . 1-54 Scheduling Stat Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54 Scheduling Batches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 Scheduling Calibrators and QC Samples . . . . . . . . . . . . . . . . . 1-56 Entering Dilution Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-56 Entering Reagent Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-57 Changing the Number of Replicates. . . . . . . . . . . . . . . . . . . . . 1-58 Using Control-bracketed Tests . . . . . . . . . . . . . . . . . . . . . . . . . 1-58
Scheduling Control Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Loading Control Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scheduling Start-of-bracket and End-of-bracket Tests . . . . . . . . . . Scheduling Calibrators for a Control-bracketed test . . . . . . . . . . . . 1-58 1-58 1-59 1-59
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Do not interfere with the normal loading movement of sample racks into the inprocess queue. Interfering with the normal loading movement of the sample racks can cause sample queue movement errors and sample queue barcode read errors. You can load samples on to the system at any time, even while the system processes samples. The inprocess queue holds up to 16 racks. Before loading samples ensure that you have met the following conditions: You are using defined tube types Refer to Specifications page E-1. You configured the sample racks for the tube types you are loading. Refer to Specifying Sample Tube Types page 8-5. Requests are available for the samples you load. Refer to Managing the Worklist page 2-39. You have sufficient sample volume. Refer to Appendix C, Sample Volume Requirements page C-12.
When the Tube-Type Selector is in position 2, 3, or 4, you can use only the tube type that corresponds with the tube type you selected in the Setup Tube-Type & Barcode window.
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ADVIA Centaur XP racks have labels for tube-type selector positions: A, 2, 3, and 4.
1 2 3 4
Tube-type selector in position A Sample tube barcode label Rack barcode Tube-type positions (A, 2, 3, and 4)
Figure 2-1
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Loading Samples
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. If you use sample cups, label them with the appropriate barcode labels and dispense the sample into the labeled sample cups.
Barcode label
Figure 2-2
Sample tube
2. Position the barcode label vertically on the sample cup approximately 2 cm (0.8 in) from the top. 3. Move the tube-type selector to the position for the tube type you are loading in the rack or for multiple tube types. 4. Place the sample tubes or cups in the rack. 5. Ensure that the barcode labels are clearly visible above or between the slots in the rack. 6. Ensure that the tube-type selector is positioned correctly for a single tube type or multiple tube types.
CAUTION
Do not manually push a rack into the inprocess queue and do not manually place sample racks near the entrance to the inprocess queue without using the raised area of the sample entry queue as a positioning guide. Failure to follow this instruction can lead to a misread of the sample tube positions in the rack.
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7. Load the rack in the sample entry queue. Ensure that the notch in the rack rests on the raised area of the sample entry queue.
1 2
Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 8. If the LED above the Sample Start button is not lit, press the button. The system moves the rack to the inprocess queue. Refer to Verifying Barcode Scanning page 2-6.
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NOTE: If you remove the Tube-Type Selector, it is the same as moving the Tube-Type Selector to position 1.
1 2 3 4
Tube-type selector in position 1 Sample tube barcode label Rack barcode Tube-type positions (1, 2, 3, and 4)
Figure 2-4
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NOTE: If the system cannot read a rack barcode, the system does not test the samples, the rack field at the Status Samples window is empty, and the system ejects the rack.
3. Enter a specific search criterion in Search for. If the system did not read the barcode, the No Barcode message displays in the Status column and the system does not test the sample. If the SID for the tube with the No Barcode status is available (for example, from a sample loading list) manually enter the tube barcode.
4. To manually enter the SID, select the sample and then select Enter SID.
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NOTE: If you select Now, the system may not eject the sample rack
immediately. The system schedules the rack for ejection and ejects the rack during the next available cycle. This may cause a slight delay before the system ejects the sample rack into the sample exit queue. If sampling stopped due to a problem with the sample tip loader, sample probe, or a fluid sensor, remove the sample racks from the inprocess queue using diagnostic tools. Refer to Using Diagnostic Tools.
2. Select Exit Queue to open the Status Exit Queue window. Use the Status Exit Queue window to locate and determine the status of samples in the sample exit queue. View the rack position indicators to determine the approximate location in the exit queue of the 24 most recently ejected sample racks. View the exit queue table to determine status of the 48 most recently ejected sample racks.
3. If a flag is associated with the sample and the sample matches a worklist request, select the sample and then select Result Details for more information.
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NOTE: If you select the Exit Queue button at the Worklist Summary window with a specific sample or test selected in the worklist table, the Status Exit Queue window opens and displays the sample rack position. NOTE: If you select the Exit Queue button at the Worklist Summary
window with no sample or test selected in the worklist table, the Status Exit Queue window opens with no sample rack position selected.
Monitoring Status
The system tracks the status of supplies, samples, QC exceptions, reagents, maintenance, and events and alerts you if a system area needs attention. Using the status buttons on the workspace, you can monitor the status of the different system areas.
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Description You selected Turn System Mechanics Off in the System Status menu. Power is removed from the robotics. The system is not able to process samples because of a critical condition such as depleted supplies or a system error. The daily or monthly cleaning is incomplete. You must restart the cleaning procedure at the Status Maintenance window.
System Status
Use System Status to monitor the condition of the system and determine which area of the system needs attention. To open the System Status window, at the workspace select the System Status button and then select System Status in the menu. Do not allow the system to remain in the Inprocess state or the Check Status state for longer than 2 hours without processing samples. Refer to Managing Nonsampling System Status page 6-8. Areas change color to indicate they require your attention. Select the area to obtain more detailed information. Select the area to obtain more detailed information. For example, if the cleaning solution is low, the color of the Supplies Status button and the cleaning solution area changes to yellow. If an error occurs in the cuvette loading area that causes the system to stop, the Event Log button and the cuvette loading area change to red. When you position the pointer over an area, the system displays the name of the area. You can select a button to obtain more detailed information on the status of supplies, reagents, samples, maintenance, and the various subsystems.
Supplies Status
Use Supplies Status to monitor the level of system supplies. At the workspace, the Supplies Status button changes color to indicate the status of system supplies: Yellow indicates that the system is using the reserve. The main supply is removed, the supply is depleted, or the waste is more than 80% full or using the reserve. Red indicates that a supply and its reserve are depleted, the waste and its reserve are full, or an error condition occurs.
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Select the Supplies Status button to open the Status Supplies window and determine which supply needs attention. The system does not start if a supply status is yellow. The system stops processing samples if a supply status is red. The system displays status messages in the field below the supply name. For a description of the status messages for each supply and the procedure for replenishing the supply, move the pointer to the supply field and select the help (?) button. The system displays these messages on the Status Supplies window:
Supply Area Cuvettes Message OK No Cuvette Detected Tips OK <120 Tips Depleted Cuvette Waste OK >80% Full Not Present Sampling Stopped Full Tip Waste OK >80% Full Not Present Sampling Stopped Full Tip Tray Waste OK >80% Full Sampling Stopped Liquid Waste OK Color Neutral Red Description At least 1 cuvette is available. The cuvette supply is depleted or an error in cuvette loading occurred and the system stopped sampling. At least 120 sample tips are available. Less than 120 sample tips are available. No sample tips are available and the system stopped sampling. The bin is less than 80% full. The bin is more than 80% full. The bin was removed. The system is using the reserve. The system stopped sampling because the cuvette bin is full. The bin is full. The bin is less than 80% full. The bin is more than 80% full. The bin was removed. The system is using the reserve. The system stopped sampling because the tip bin is full. The bin is full. The waste area is less than 80% full. The waste area is more than 80% full. The system stopped sampling because the waste area is full and the current tip tray is empty. The bottle is present and has enough space to continue testing.
Neutral Yellow Red Neutral Yellow Yellow Red Red Neutral Yellow Yellow Red Red Neutral Yellow Red
Neutral
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Supply Area
Message Not Present, Using Reserve Full, Using Reserve Sampling Stopped
Color Yellow
Description The bottle was removed. The system is using the reserve. The bottle is full. The system is using the reserve. The system stopped sampling because the reserve is almost full. The bottle is present and contains enough fluid to continue testing. The bottle was removed. The system is using the reserve. The system stopped sampling because the reserve is almost empty. The bottle is present and contains enough fluid to continue testing. The bottle was removed. The system is using the reserve. The bottle is empty. The system is using the reserve. The system stopped sampling because the reserve is almost empty. The system stopped sampling because the bottle and the reserve are empty. The bottle is present and contains enough fluid to continue testing. The bottle was removed. The system is using the reserve. The bottle is empty. The system is using the reserve. The system stopped sampling any test that uses this solution because the reserve is almost empty. The bottle and the reserve are empty. The system stopped sampling any test that uses this solution. The bottle is present and contains enough fluid to clean the system.
Water
Acid, Base
OK Not Present, Using Reserve Present, Using Reserve Sampling Stopped Reserve Depleted
Yellow
OK Not Present, Using Reserve Present, Using Reserve Sampling Stopped Reserve Depleted
Yellow
Red
Red
Cleaning Solution
OK
Neutral
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Supply Area
Description The bottle does not contain enough fluid to clean the system. The bottle was removed. The system cannot perform the cleaning procedure.
Sample Status
Use Sample Status to monitor the samples that are loaded on the system. At the workspace, the Sample Status button changes color to indicate the status of samples that are in the inprocess queue and the lab automation queue: Yellow indicates that testing for a sample is not complete because of a problem with a sample. Red indicates that testing for all samples in a sample rack is not complete because of a problem with the sample rack barcode label.
Select the Sample Status button to open the Status Samples window and review the status of the samples in the inprocess queue and the lab automation queue.
NOTE: The Lab Automation Queue view is only available when lab automation is enabled. Refer to Defining LAS Communication Options page 8-47.
Yellow
Yellow Yellow
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Description A request to the LIS from the system for a worklist entry is pending. The system did not read the sample barcode. Select the sample and then select Enter SID to manually enter the SID. This message applies to control-bracketed tests only. The system cannot process this sample at this time because the start-of-bracket controls were not processed or at least 1 of the control results is unacceptable. The system processes the sample after the start-of-bracket controls are processed and produce acceptable results. The system does not have any test requests for the sample. Schedule tests at your LIS or at the Worklist Schedule window. If you use a non-Siemens barcode label for kit controls in a control-bracketed test, the system does not recognize the control samples and displays the No Request flag. You requested this sample rack or tube to be removed from the system. The system removes the rack or tube when sample aspiration is complete. NOTE: If you are at the Lab Automation Queue view, Removal Pending refers to removing a sample tube instead of a rack. This message displays only when the system identifies samples by Rack and the system detects an inconsistency in the SID of the sample tube barcode label. For example, the SID Mismatch message displays if you schedule a patient sample with an SID at a specific rack and rack position, the system aspirates that sample, and then you schedule another sample with a different SID at the same rack and rack position. Verify that the sample tube is in the correct position in the rack.
No Bracket
Yellow
No Request
Yellow
Removal Pending
Neutral
SID Mismatch
Yellow
Exception Status
Selecting this button displays a message directing you to the applications view and ADVIA QC.
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Reagent Status
Use Reagent Status to monitor the status of primary and ancillary reagents on the system. The Reagent Status button changes to yellow to indicate that a reagent pack cannot be used. Select the Reagent Status button to open the status window of the reagent that requires attention or to open the Worklist Reagent Inventory window.
If . . . a primary reagent needs attention or if no reagent needs attention, an ancillary reagent needs attention a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist a primary reagent and an ancillary reagent need attention a primary reagent needs attention and a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist an ancillary reagent needs attention and a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist a primary reagent and an ancillary reagent need attention, and a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist Then . . . the system displays the Status Primary Reagent window. the system displays the Status Ancillary Reagent window the system displays the Worklist Reagent Inventory window the system displays the Status Primary Reagent window and the Status Ancillary Reagent window the system displays the Status Primary Reagent window and the Worklist Reagent Inventory window the system displays the Status Ancillary Reagent window and the Worklist Reagent Inventory window the system displays the Status Primary Reagent window, the Status Ancillary Reagent window, and the Worklist Reagent Inventory window
Primary Reagents
If a primary reagent requires attention or if no reagent requires attention when you select the Reagent Status button, the system displays the Status Primary reagent window. Pack indicators change color to indicate if a pack is available for use. The numbers on the pack indicators and the table correspond to the spaces in the primary reagent compartment. The system displays Status messages for each reagent pack that requires attention.
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An ellipsis (. . .) after a status message indicates that more than 1 status message exists. Select Details to display information about the pack. The following messages indicate the status of a reagent:
Message Cal Due Color Neutral Description The calibration interval for the test expires within 24 hours or within 25% of the calibration interval, whichever is shorter. Schedule a calibration at the Worklist Schedule window. You can waive a calibration with a Due status at the Calibration Summary window if Waive Cal is selected at the Test Calibration window. The calibration for the reagent lot expired. Schedule a calibration at the Worklist Schedule window. You can waive an expired calibration at the Calibration Summary or Calibration Data windows if Waive Cal is selected at the Test Calibration window. No valid calibration exists for the reagent lot. Schedule a calibration at the Worklist Schedule window. The test requires a specific primary reagent, ancillary reagent, and calibrator lot combination. Ensure that you use primary reagent, ancillary reagent, and calibrators from kits with the same lot number. No valid calibration exists for the lot of sIgE universal reagent associated with the specific IgE tests. Schedule a calibration for the reference allergen. The reagent pack is empty. The reagent lot expired. Load a new lot of reagent. If necessary, define a Master Curve for the new reagent lot at the Calibration Master Curve Definition window. The total number of tests (primary reagent, vial) or milliliters (ancillary reagent) for all onboard packs is equal to or less than the Reagent Warning Counts you entered at the Setup Additional Options window. This message only displays at the Worklist Reagent Inventory window. The test requires an ancillary reagent. Load the appropriate ancillary reagent. The system cannot read the barcode for the reagent pack. The system opens the Status Enter Primary Barcodes window at which you can enter the barcode. No valid information exists for the vials in the carrier. Use the barcode scanner to enter the information for the vials and carrier at the Status Scan Carrier window.
Cal Expired
Yellow
Yellow Yellow
Yellow
Yellow Yellow
Low Reagent
Yellow
No Ancillary No Barcode
Yellow Yellow
No Carrier Definition
Yellow
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Color Yellow
Description No Master Curve exists for the reagent lot. Define a Master Curve at the Calibration Master Curve Definition window and then schedule a calibration at the Worklist Schedule window. An optional diluent for this test is present. If you want to perform dilutions, load the appropriate diluent. This test requires a diluent. Load the appropriate diluent. No sIgE universal reagent is present onboard or the pack that is on the system is empty. Load an sIgE universal reagent pack. No test definition exists for the test. Samples are scheduled for this test and no reagent packs are loaded. This message only displays at the Worklist Reagent Inventory window. The pack is inactivated. At the Status Primary Reagent window, you can activate the pack by selecting the pack and then selecting Activate Pack. If you want to specify that the system use an inactive pack for a particular calibrator, control, or patient sample, you can select an inactive pack at the Worklist Reagent Options window. You selected Remove Pack at the Status Primary Reagent window or Remove Carrier at the Status Primary Reagent window. You can remove the pack or carrier now. You requested to remove this pack or carrier. After the system completes the tests that use this pack or carrier, the system notifies you that you can remove this pack or carrier. The reagent pack or carrier is not positioned for optimal result throughput. You can improve result throughput by moving the pack or carrier to the location in the primary reagent compartment indicated by the arrow and the color on the reagent pack or carrier. The reagent pack or vial exceeded the stability date. Replace the reagent pack or vial. The test is inactivated. At the Status Primary Reagent window, you can activate the test by selecting a pack for the test and then selecting Activate Test. All packs loaded for this test display this status message. At the Status Carrier Details window, you can activate a specific IgE test when the system is not inprocess by deselecting the Inactivate Test button for that test vial.
No Optional Diluent No Required Diluent No sIgE Universal No Test Definition Not Onboard
Yellow Yellow
Pack Inactive
Neutral
Removable
Neutral
Removal Pending
Neutral
Reposition
Neutral
Yellow Neutral
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Color Neutral
Description The reagent pack or 1 or more vials in the carrier exceeded the stability date. The system uses the reagent for testing because you selected Use Beyond for this test at the Test Definition window. NOTE: The manufacturer has set some prove wash reagents to Use Beyond in the test definition and you cannot change it. If you do not want to run these reagents beyond their stability, remove and discard them when the system displays the Verify Stability status. One or more vials in the carrier are inactivated. At the Status Carrier Details window, you can activate the vial by deselecting the Inactivate Vial button for that vial.
Vial Inactive
Neutral
Ancillary Reagents
If an ancillary reagent requires attention and you select the Reagent Status button, the Status Ancillary Reagent window is displayed. The following messages indicate the status of a reagent:
Message Depleted Lot Expired No Test Definition Removal Pending Stability Expired Verify Stability Color Yellow Yellow Yellow Neutral Description The reagent pack is empty. The reagent lot expired. Load a new lot of reagent. No test definition exists for the test. You requested to remove this pack. After the system completes the tests scheduled for this pack, the system ejects the pack. The reagent pack exceeded the stability date. The reagent pack exceeded the stability date. The system uses the reagent for testing because you selected Use Beyond for this test at the Test Definition window.
Yellow Neutral
Maintenance Status
Use Maintenance Status to monitor maintenance activities and automated procedures. At the workspace, the Maintenance Status button changes color to indicate the status of maintenance: Yellow indicates that a maintenance activity is due or overdue. Red indicates that an automated maintenance procedure did not complete.
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Select the Maintenance Status button to display the Status Maintenance window and display the procedures that require attention. In the Schedule view, the date column displays the date the activity is due. In the Log view, the date column displays the date the activity was completed.
The ADVIA Centaur XP system monitors maintenance activities and notifies you when a scheduled activity is due. The system provides a maintenance schedule for you to record the completion of scheduled maintenance activities. The system then uses this information to automatically update the maintenance schedule with the next time the activity is due. Refer to Defining Maintenance Activities page 5-3.
The ADVIA Centaur XP system monitors system events and notifies you when an error condition occurs. Refer to Using the Event Log page 6-1.
Replenishing Reagents
You manually mix the primary packs and load them on the reagent holders in the primary reagent compartment, which stores the reagents at 4 to 8C (39 to 46F). The primary reagent shelf mixes the packs to keep the reagents in suspension. The arrow indicator and color on each pack indicate where you can load the packs to optimize sample throughput. Refer to Appendix C, Handling Reagents, in the ADVIA Centaur Assay Manual.
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Each ancillary pack contains 1 ancillary reagent. The system tracks the volume in the pack. Refer to the ADVIA Centaur Assay Manual. Some ancillary packs are customer-fillable packs.
Loading Reagents
You can monitor the volumes of primary and ancillary reagents using the Worklist Reagent Inventory window. To open the Worklist Reagent Inventory window from the workspace, perform the following steps: 1. Select Worklist. 2. Select Reagent Inventory. The Worklist Reagent Inventory window fields display reagent information: The Available column displays the total amount of shared reagent that is onboard and available. The Shortage column displays the amount of reagent needed to complete the scheduled tests. The Status column displays the primary reagent status and the ancillary reagent status.
Inventory for primary reagents is expressed in number of tests. Inventory for ancillary reagents, diluents, and ancillary wash solutions is expressed in milliliters.
NOTE: Do not add reagent to reagent packs. Each reagent pack contains enough
reagent to process a predetermined number of tests. Each time the system accesses a reagent pack, reagent volume inventory tracks the amount of reagent used. The system does not recognize additional fluid placed in a reagent pack. If you have multiple systems in your laboratory, record the following information before you move a reagent pack from 1 system to another: the number of tests remaining in a primary reagent pack the stability information that displays at the Status Primary Pack Details window the volume remaining in an ancillary reagent pack the stability information that displays at the Status Ancillary Pack Details window
Enter this information in the appropriate fields at the Status Primary Pack Details window and the Status Ancillary Pack Details window when you load the reagents on a different system.
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Enter this information in the appropriate fields at the Status Primary Pack Details window and the Status Ancillary Pack Details window when you load the reagents on a different system.
Neutral indicates that the pack can be removed because the system is not using that pack or that no pack is loaded in that position.
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You can select a pack indicator to display information about the reagent pack in that position. The colors underneath the pack indicator denote the type of pack loaded in that pack position. The number in the Status column indicates the number of tests available in the pack.
Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 3. Press the sample start button for the system barcode scanner to rescan the reagent barcodes and acknowledge any reagent changes. Refer to Appendix C, Handling Reagents, in the ADVIA Centaur XP Assay Manual.
1. At the Status Primary Reagent window, select the reagent pack. 2. Select Remove Pack. 3. When prompted, select Complete or select Now.
If you want the system . . . to complete tests scheduled for the pack, to discontinue using the pack without completing the tests, Then . . . Select Complete. Select Now.
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CAUTION
Do not remove a primary pack when the system is inprocess if the LED on the primary reagent door is green. Removing a primary pack when the system is inprocess and the LED is green can cause erroneous results and mechanical damage to the system. Wait until the LED is neutral before you remove the primary pack. When the status changes to Removable and the LED changes to neutral, remove the reagent pack.
1 2 3
Figure 2-5
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1. At the Status Ancillary Reagent window, select an ancillary pack. 2. Select Remove Pack. 3. When prompted, select Complete or select Now.
If you want the system . . . to complete tests scheduled for the pack, to eject the pack without completing the tests, Then . . . Select Complete Select Now
The system ejects the pack into the ancillary reagent entry. An LED next to the ancillary reagent entry turns orange to indicate that the pack is exiting the system. 4. Remove the pack from the ancillary reagent entry. If the system is not processing samples, you can remove ancillary reagent packs from the ancillary queue using diagnostic tools. Refer Emptying the Ancillary Queue page 6-69.
Replenishing Supplies
You can select the Supplies Status button at the workspace to open the Status Supplies window and review the status of supplies. Refer to Supplies Status page 2-10. You can also move the pointer to the supply field and press the help (?) button on the pointing device for a description of the status messages for each supply and the procedure for replenishing each supply. The system has the following capacity for supplies:
Supply Cuvettes Tips Cuvette Waste Tip Tray Waste Tip Waste Liquid Waste Water Acid Base Wash 1 Capacity 1000 cuvettes 840 tips 700 cuvettes 8 trays 1000 tips 7.5 L 10.0 L 1500 mL 1500 mL 2500 mL
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1 2 3 4 5
Waste and water drawer Water tubing Water bottle lid Cap Water bottle
Do not grasp the tubing when disconnecting the tubing from the top of the water bottle or reservoir. Pulling the tubing can cause crimps. Grasp the fittings, not the tubing.
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c. Disconnect the water tubing from the water bottle and then set the tubing on lint-free tissues or gauze to absorb drips. d. Lift the water bottle up and out. 2. Remove the cap. 3. Fill the spare, clean water bottle with fresh reagent water and install the cap. Refer to Reagent Water Quality page C-4. 4. Install the spare, full water bottle: a. Place the water bottle in the waste and water drawer. b. Connect the water bottle tubing to the bottle. A blue spiral wrap designates this tubing. c. Lower the water bottle lid. d. Push in the waste and water drawer.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. b. Disconnect the tubing from the top of the waste bottle and then set the tubing on lint-free tissues or gauze. c. Move the clamp on the sensor aside, remove the sensor from the waste bottle.
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Sensor tip
Figure 2-7
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2. Insert the Waste Bottle Stopper into the sensor and tubing openings.
1 2 3 4 5
Waste bottle Sensor clamp Sensor opening Waste bottle stopper Tubing opening
Figure 2-8
3. Remove the waste bottle from the waste and water drawer. 4. Empty the waste bottle: a. At the location in your laboratory designated for waste disposal, loosen the waste bottle cap.
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Figure 2-9
Waste Bottle
c. Close the waste bottle valve, ensuring that the waste bottle valve is closed completely. d. Tighten the waste bottle cap. 5. Replace the waste bottle: a. Install the waste bottle in the drawer. b. Remove the waste bottle stopper. c. Clean the stopper using lint-free tissues or gauze and cleaning solution. d. Replace the stopper under the waste bottle handle. Refer to Attaching the Waste Bottle Stopper page 2-30. e. Install the sensor and move the clamp to cover the sensor. f. Connect the tubing to the waste bottle. An orange spiral wrap designates this tubing.
g. Lower the waste bottle lid. 6. Push in the waste and water drawer. 7. When prompted, verify the waste bottle tubing is reconnected. 8. Select Continue. 9. Close the waste and water drawer.
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stopper. 1. Open the waste and water drawer. 2. Lift the waste bottle lid to expose the waste bottle handle.
1 2 3 4
Waste bottle handle Waste bottle stopper Waste bottle lid Cable tie
Figure 2-10
3. Thread the cable tie through the hole on the Waste Bottle stopper. 4. Wrap the cable tie around the handle of the waste bottle. 5. Insert the tip of the tie into the cable tie lock. Adjust the tie as necessary. Do not secure the cable tie too tight. The stopper needs to move freely around the handle and be able to reach the tubing and sensor openings.
NOTE: The cable tie cannot be adjusted after you lock it.
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Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. Open the sample tip waste area door. 2. Remove the cleaning solution bottle: a. Pull out the drawer and the cleaning solution bottle. b. Lift the lid.
1 2 3 4
Lid Sample tip waste area door Cleaning solution bottle Drawer
Figure 2-11
c. Remove the bottle. 3. Empty any cleaning solution from the bottle.
NOTE: Use ADVIA Centaur XP Cleaning Solution to achieve optimum assay and system performance. Do not use other cleaning solutions.
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4. Prepare the cleaning solution: a. Carefully pour a container of ADVIA Centaur XP Cleaning Solution concentrate into the cleaning solution bottle. b. Fill the bottle with reagent water up to the bottom rim of the opening. 5. Install the bottle on the system. 6. Lower the lid onto the bottle, ensuring that the tubing is in the bottle. 7. Push in the drawer. 8. Close the sample tip waste area door. 9. If you did not empty the sample tip waste bin, select No at the prompt.
Adding Cuvettes
You can fill the cuvette loading bin any time, even while the system processes samples. 1. Open the supplies access cover.
1 2
Do not leave the top cover open when you add cuvettes to the cuvette loading bin. Leaving the top cover open allows cuvettes to fall into another part of the system where it may obstruct normal operation. Close the top cover when adding cuvettes to the cuvette loading bin. 2. Load the cuvettes in the cuvette loading bin.
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1 2 3
Figure 2-13
3. Install the sample tip trays, ensuring that the tab is facing you and that the notches in the trays are on the right. 4. Pull the tab to release the strap from the trays and then remove the strap. 5. Close the supplies access cover.
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. Open the sample tip waste area door. 2. Pull the sample tip waste bin toward you. 3. Remove the sample tip waste bin.
1 2
Figure 2-14
4. Dispose of the contents of the liner into a container approved for biohazardous waste.
NOTE: The liners for the cuvette waste bin and the sample tip waste bin are
not interchangeable. Ensure that the sample tip waste bin liner is installed in the sample tip waste bin. 5. If the liner is damaged, install a new liner. 6. Install the sample tip waste bin, ensuring that the bin is pushed in completely. 7. Close the sample tip waste area door.
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Figure 2-15
3. Dispose of the contents into a waste container. 4. Close the cuvette waste area door.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. Open the cuvette waste area door.
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2. Pull the cuvette waste bin toward you. 3. Remove the cuvette waste bin.
Figure 2-16
4. Dispose of the contents of the bin into a container approved for biohazardous waste.
NOTE: The liners for the cuvette waste bin and the sample tip waste bin are not interchangeable. Ensure that the cuvette waste bin liner is installed in the cuvette waste bin.
5. If the liner is damaged, install a new liner. 6. Install the cuvette waste bin, ensuring that the bin is pushed in completely. 7. Close the cuvette waste area door.
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You can replace the system fluids any time, even while the system processes samples. The system fluid reservoirs hold enough fluid to allow the system to complete the contents of the incubation ring.
WARNING
Do not allow contact of Acid and Base reagents with skin and eyes. Acid and Base reagents are irritating to the skin. Wear suitable eye, face, and skin protection, which include wearing gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse the eyes immediately with plenty of water and seek medical advice. In case of accident or if you feel unwell, seek medical advice. If possible, show the bottle label and the Material Safety Data Sheet. In case of accidental ingestion of reagent, call a physician immediately.
NOTE: Replace Acid and Base reagents at the same time to manage lot numbers and to obtain optimum reagent performance.
Do not touch the tubing or sensors. Touching the tubing or sensors can cause contamination. 2. Lift a fluid bottle lid at the front edge.
CAUTION
Dispose of Acid and Base reagents in accordance with local, state, and federal regulations. Refer to the Material Safety Data Sheets for each material for additional information.
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3. Remove a bottle and discard the fluid into an approved fluid waste container and discard the bottle into an approved solid waste container.
1 2 3 4 5
Fluid bottle lid Wash 1 and 3 Base Acid System fluid drawer
Figure 2-17
System Fluids
5. Place the bottle in the drawer and remove the cap, ensuring that you do not dislodge the tubing on the fluid bottle lid. 6. Lower the lid onto the bottle, ensuring that the tubing is in the bottle and that the lid fits securely. 7. Repeat steps 2 through 6 for each bottle. 8. Push in the system fluid drawer.
NOTE: If the system is inprocess when you change the system fluids, you do not need to prime the bottles.
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setting of this button if you perform 1 of the following actions: delete a worklist request edit a result add or change a request at the Worklist Schedule window
2. When you are finished at the Worklist Summary window, select Resume Updating to allow the system to continue the update.
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The following table describes the View and Sort combinations you can use to perform some routine tasks:
Task Display the list of all current requests Display batch requests as a batch, before the ending rack is scanned Display sample results, not all tests are complete Display samples that have tests that are scheduled or inprocess, but not complete Display Stat sample results Display sample results, all tests are complete Display calibrator results Display samples with tests that have RLU values, but not a calculated concentration Display a list of patient results that have been moved to the historical worklist. Display the list of all current tests for a patient Display a list of samples that need to process an end-of-bracket set of controls before the system reports the results NOTE: This view applies to control-bracketed tests only. The Repeat and Release buttons are unavailable in this view because the results are retained until the end-of-bracket controls are processed and acceptable. Display a list of samples with discarded test results For more information on discarded test results, refer to Reasons for Discarded Results page 2-43. NOTE: This view applies to control-bracketed tests only. The Release button is unavailable in this view because the results have already been discarded. View Current Pending Batches Current Results Pending Tests Stats Historical Calibrators Stored RLUs Historical Current Waiting for Controls Sort SID Scanned SID SID SID SID SID SID PID PID SID Results Conc or Index NA* Conc or Index NA* Conc or Index Conc or Index Conc or Index RLU Conc or Index Conc or Index NA*
Results Discarded
SID
NA*
NA = Not Applicable
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Symbol
Description This symbol displays only for control-bracketed tests. It represents a Results Discarded test. The test result was discarded for 1 or more of the following reasons: An open bracket is a control-bracketed test that has acceptable start-of-bracket control results but the end-of-bracket controls have not been processed. The system did not process the end-of-bracket controls within the acceptable time interval. At least 1 of the end-of-bracket control results was unacceptable. The system aspirated a calibrator before aspirating the end-of-bracket set of controls for an open bracket. The calibration expired before the system processed the end-of-bracket set of controls for an open bracket. The reagent lot expired before the system processed the end-of-bracket set of controls for an open bracket. A field service provider performed controller diagnostics before the system processed the end-of-bracket set of controls for an open bracket. A field or setting for the control-bracketed test was modified at the Test Definition window before the system processed the end-of-bracket set of controls for an open bracket. You performed 1 of the following functions at the Setup Data Administration window before the system processed the end-of-bracket set of controls for an open bracket: Test Definition, Update Test Definition, Restore Reagent Inventory, Restore Calibration Data, Restore Quality Control Data, Restore Worklist, Delete
CAUTION
Use caution when deleting a worklist with unreleased results. When you delete a worklist with unreleased results, the system permanently removes the associated unreleased results from the database. If the unreleased results are from an open bracket, the associated samples do not display in the Results Discarded report generated at the Print Report Options window or the Results Discarded view at the Worklist Summary window.
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Message Invalid
Description The calibration exceeds either the defined or the observed range for 1 or more calibration expected values. Schedule another calibration at the Worklist Schedule window. The calibration is outside the observed range but within the defined range and an operator accepted the calibration. Schedule another calibration at the Worklist Schedule window.
Verify
delete a worklist request edit a result add or change a request at the Worklist Schedule window
2. When you are finished at the Worklist Summary window, select Resume Updating to allow the system to continue the update.
Use caution when deleting a worklist with unreleased results. When you delete a worklist with unreleased results, the system permanently removes the associated unreleased results from the database. If the unreleased results are from an open bracket, the associated samples do not display in the Results Discarded report generated at the Print Report Options window or the Results Discarded view at the Worklist Summary window.
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1. Print a list of samples with discarded results: a. At the workspace, select Print. b. Select Report Options. c. At the Print Report Options window, select Results Report. d. Enter the Starting Date and Ending Date and select the Sort option. e. At the View drop-down list, select Results Discarded. f. Select Print Report. 2. At the Worklist Summary window View drop-down list, select Results Discarded. When you access this view, the system automatically selects all listed samples. 3. If required, deselect any samples you do not want to reschedule. 4. Select Repeat.
NOTE: Ensure that you reschedule the start-of-bracket and end-of-bracket sets of controls also. The system does not process the samples that you rescheduled until the bracket is opened with acceptable start-of-bracket control results. The system does not report the sample results until the acceptability of the results of the end-of-bracket controls is established.
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2. Select Exit Queue. The system opens the Status Exit Queue window. If the specified sample is in 1 of the 48 most recently ejected sample racks, the system selects and displays the sample rack position for that sample. If the system cannot locate the requested sample, the system displays a message box. 3. Locate the ejected sample in the sample exit queue. If you select the Exit Queue button and no sample or test is selected in the worklist table, the Status Exit Queue window opens with no sample rack position selected.
Before scheduling patient or control samples, ensure that you perform the following tasks: Enter test definitions and customize them for your laboratory. Refer to Modifying or Viewing Test Options page 8-9. Define Master Curves for each reagent lot.
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Refer to Defining a Master Curve page 3-10. Define calibrators. Refer to Defining Calibrator Values page 3-14. Define controls. Refer to Using Quality Control Features page 4-1. Load reagents. Refer to Loading Reagents page 2-20.
Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 2. If the LED above the Sample Start button is not lit, press the button. The system moves the rack to the inprocess queue. 3. If you schedule by SID and the sample tube does not have a barcode label, you can enter the SID after the sample is scanned: a. At the workspace, select the Sample Status button. b. At the Status Samples window, select the sample with a No Barcode status and then select Enter SID. c. At the Status Enter SID window, enter the SID.
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You can enter the SID only while the sample is in the Inprocess Queue.
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Configuring the LIS to Accept Results beyond the Dose Response Curve Range
If concentration results are beyond the dose response curve range, the ADVIA Centaur XP system transmits the results to the LIS as > [the value representing the high limit of the Master Curve or linearity range]. For example, if the highest value on the Master Curve Card is 204, the system transmits the result as > 204, with a space between the > symbol and the concentration value. Ensure that your LIS is configured to accept this format.
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1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist Schedule window, select Patient.
CAUTION
For most sample processing, do not schedule by Rack ID. If, however, it is necessary to schedule a sample by rack ID, be aware that the system ejects the sample to the exit queue after aspirating the sample. Reflex or other testing cannot complete once the system ejects the sample to the exit queue. To obtain final results for reflex or other testing, reintroduce the sample rack to the front of the sample entry queue. If you are scheduling samples for a control-bracketed test, you must schedule by SID. The system does not allow you to schedule samples for control-bracketed tests by Rack. 4. Select how you want the system to identify the sample: If the sample identifier selected at the Setup Tube Type & Barcode window is SID, you can select Schedule by SID or Schedule by Rack. Refer to Specifying Sample Identification page 8-4. If the sample identifier selected at the Setup Tube Type & Barcode window is Rack, you can only select Schedule by Rack. Refer to Scheduling Non-barcoded Samples by Rack ID page 2-50 and Scheduling Barcoded Samples by Rack ID page 2-51.
NOTE: After entering the SID or the Rack ID, you must press Enter on the keyboard. If you do not press Enter after entering the SID or the Rack ID, the test selection table and the functions at the bottom of the window do not become active.
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You can enter up to 13 alphanumeric characters for the SID. Do not use the % symbol as part of an SID. The Rack ID consists of 4 numbers (0001 9999) followed by a letter (A E). Enter the letter in uppercase.
6. If you want to process the sample before routine samples, select Stat. 7. Select or enter the tests or the profiles for the sample. If you use the keyboard to enter the tests or profiles in the Test field or the Profile field, you must enter the test name or profile exactly as it displays on the schedule window. 8. Select Save. You can select Summary to view the requests in the worklist.
NOTE: If you have groups of samples with the same tests, scheduling the tests in batch is the most efficient method of scheduling without using an LIS. Refer to Scheduling Batches page 2-54 for more information.
Scheduling by Rack ID
NOTE: Move results to historical before reusing a rack for samples scheduled by Rack ID. Moving results to historical prevents merging new results with current results when scheduling samples by rack ID. Scheduling Non-barcoded Samples by Rack ID
The following table contains information about manually scheduling non-barcoded samples by rack ID:
If . . . the system has not scanned the rack and you want to add or modify tests for a request, the system has scanned the rack, and the rack position is in the current worklist, and you want to add or modify tests for a request, the system has scanned the rack, and the rack position is in the current worklist, and you want to create a new request for a new sample for that rack position, Then . . . select the rack position at the Worklist Summary window and then select Schedule. select the rack position at the Worklist Summary window and then select Schedule. The system . . . recalls the existing request for that rack position which you can modify.. recalls the existing request for that rack position which you can modify.
select Worklist from the workspace and then select Schedule. or do not make any selections at the Worklist Summary window and then select Schedule.
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If . . . the rack position is not in the current worklist and you want to create a new request for it,
Then . . . select Worklist from the workspace and then select Schedule. or do not make any selections at the Worklist Summary window and then select Schedule.
The system . . . creates a new worklist request for the rack position.
The system functions similarly when the LIS schedules samples by rack ID. If the system has not scanned the rack, the system recalls the existing request for that rack position and merges additional tests to that request. If the system has scanned the rack or the rack is not in the current worklist, the system creates a new worklist request for the rack position.
When a sample is scheduled by rack ID, the system does not use the SID to process that sample even if the tube has a barcode label. In some cases, if the system scans a barcode label for that sample tube, the system enters the SID from the barcode label to the worklist request for the rack position. This provides a check to identify a possible conflict between the SID in the worklist and the SID on the sample tube barcode label. When the system identifies a possible conflict, it alerts the operator by displaying the SID Mismatch sample status message. The following table contains information about how the system uses the SID for samples scheduled by rack ID:
Did the system previously scan the rack position that is in the current worklist? no
System Action makes the SID part of the rack ID in the worklist request displays the SID Mismatch message; possibly incorrect tube displays the SID Mismatch message; possibly incorrect tube assumes that the sample is the same tube and performs pending or new tests
no
present
yes, with no barcode label on the tube yes, with no barcode label on the tube
not present
present
not present
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Did the system previously scan the rack position that is in the current worklist? yes, with a barcode label on the tube yes, with a different barcode label on the tube
System Action displays the SID Mismatch message; possibly incorrect tube displays the SID Mismatch message; possibly incorrect tube
present
To clear an SID Mismatch sample status message, perform 1 of the following corrective actions: Edit the SID in the worklist to match the SID on the sample tube barcode label. Enter the SID on the sample tube barcode label into the worklist request. Enter the SID from the sample tube barcode label at the Status Enter SID window. Eject the rack and place the correct sample tube in the rack position.
Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. You can use the hand-held barcode scanner to enter the Sample ID for patient samples: 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist Schedule window, select only Patient and Schedule by SID. These are the default options and are already selected when the window displays.
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4. Select Scan Data. The system displays a Scan Data dialog box. 5. Aim the hand-held barcode scanner at the SID barcode and press the trigger. The system displays the progress of the scan in the Scan Data dialog box. When the barcode scanner completes its scan, the Scan Data dialog box closes. 6. Select Save.
After you enter the SID or the Rack ID and select or enter the tests or profiles, perform the following procedure to enter patient demographics: 1. At the Worklist Schedule window, select Demographics. 2. At the Worklist Demographics window, enter the demographic information:
Field Name PID Name Description You can enter up to 11 alphanumeric characters for the patient identifier. You can enter up to 30 alphanumeric characters for the patients name. An LIS expects the patient name to be formatted Last Name, First Name. Use the DD MMM YYYY format (for example: 11 Aug 1975). Use the following abbreviations for months: Jan, Feb, Mar, Apr, May, Jun, Jul, Aug, Sep, Oct, Nov, Dec. You can select M (male) or F (female). You can enter up to 12 alphanumeric characters for the location of the patient in the facility. You can enter up to 12 alphanumeric characters for the physicians name. You can enter up to 12 alphanumeric characters for optional information about the patient or sample.
DOB
3. Select Continue. 4. Select Save at the Worklist Schedule window and continue with additional scheduling activities.
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comments. 1. At the Worklist Summary window, select the sample and then select Schedule. 2. At the Worklist Schedule window, select Demographics. 3. At the Worklist Demographics window, select Comments. 4. At the Comments window, enter a comment. You can enter up to 3 comments. Comments can be up to 120 alphanumeric characters. The system enters your initials and the date. 5. Select Save. 6. Select Continue at the Worklist Demographics window. 7. At the Worklist Schedule window, select Summary to return to the Worklist Summary window.
Scheduling Batches
When the LIS is not operational or not connected, the most efficient method of scheduling tests is to schedule them in batch at the Worklist Schedule window. The system performs the requested tests on all samples loaded in the starting rack, ending rack, and all racks in between. 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist Schedule window, select Batch.
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4. Enter the rack number of the starting rack in Starting Rack. Rack numbers contain a 4-digit rack identifier. It is not necessary to enter a letter. 5. Enter the rack number of the ending rack in Ending Rack. 6. Select or enter the tests or profiles. If you use the keyboard to enter the tests or profiles in the Test field or the Profile field, you must enter the test name or profile exactly as it displays on the schedule window. 7. Select Save. 8. Load racks.
NOTE: You can load racks in any order between the starting rack and the ending rack. Racks loaded before the starting rack and after the ending rack are not included in the batch even if the Rack ID is numerically between the Rack IDs of the starting rack and the ending rack.
As samples are scanned, individual requests are added to the worklist using the primary sample identifier. Batches display at the Worklist Summary window in the Pending Batches view. When the system scans the ending rack, the system removes the batch from the Pending Batches view. Sample racks loaded in the Stat entry are not recognized as part of a batch and batch test requests are not added to the Stat test request. If you schedule a sample in a batch and also schedule an individual test request for that same sample, the system processes all tests for that sample. If you select SID for sample identification in Setup, you must use SID barcode labels to identify the samples. If sample identification is by SID and the SID barcode label is not recognized by the system, no request is created for the sample. To create a request for the sample, reload the sample with a readable SID barcode label before the ending rack for the batch is loaded.
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Use this procedure after you enter the SID or the Rack ID and select or enter the tests or profiles to enter dilution information for a specific sample: 1. At the Worklist Schedule window, select Dilutions.
NOTE: You must dilute all samples with the correct ADVIA Centaur XP diluent specified for each test. Physiological saline or commercial albumin are not acceptable diluents for ADVIA Centaur XP assays. Refer to the ADVIA Centaur Assay Manual. NOTE: If the sample has a test selected for which manual dilutions are not
allowed, the Manual Dilution field is not available. 2. For manual dilutions, enter the dilution factor in the Manual Dilution field at the Worklist Dilutions window. The results are automatically corrected for the specified dilution factor. 3. To define a system-performed dilution option for a specific sample, select a dilution option for each test performed on the sample: If the sample is to be tested as defined in the test definition, select Default. If the sample is not to be diluted, select Undiluted Only. If the sample is to be tested only with the specified dilution factor, select Diluted Only. If the sample is to be tested both undiluted and also with the specified dilution factor, select Undiluted & Diluted. If the sample is to be diluted only if the undiluted value is greater than the dilution point defined at the Test Ranges window, select Dilute if Over.
NOTE: If a dilution profile is scheduled for the test, Dilution Option displays only Profile, which you cannot change. Dilution profiles are defined at the Test Dilution Profile Definition window. Refer to Defining Dilution Profiles page 8-31.
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If you schedule the start-of-bracket controls and wait until they are processed and have acceptable results before scheduling the end-of-bracket controls, schedule the controls by SID.
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You do not need to enter the rack ID and position of the controls. You can use the same rack for the start-of-bracket controls and end-of-bracket controls as long as the system processed the previous set of controls with acceptable results and ejected the rack.
If you want to . . . select multiple adjacent samples or tests in the worklist summary table,
2. Hold down the Shift key while using the pointing device to select the last sample or test to be included in the selection.
The system selects all samples or tests in the worklist summary table between and including the first and the last selected item.
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NOTE: If you select samples on the left side of the worklist summary table, all tests for the sample are selected.
If you start selecting on the left side of the worklist summary table, the system assumes that you want to select samples even if your last selection at the time is on the right side of the table. The system selects all tests for the samples in the selected rows. If you select tests on the right side of the worklist summary table, you can select specific tests for a sample. If you start selecting on the right side of the worklist summary table, the system assumes that you want to select tests even if your last selection at the time is on the left side of the table. The system selects only tests in the selected rows. If you need to scroll to continue selecting multiple samples or tests, release the Shift or Ctrl key, scroll to the desired location, and then again hold down the Shift or Ctrl key while selecting the sample or test. When you select multiple tests and then select the Delete button, the following information applies: The system cannot delete tests that are part of a ratio test and calibrators. The system only deletes the tests that it can delete. The system can only delete a predetermined number of tests at a time. If tests remain highlighted, select the Delete button again to delete more tests.
Editing Requests
Use this procedure to perform the following actions: add tests change how the system processes a sample (Stat or routine) change dilutions specify reagent lots or packs change the number of replicates change demographics
To edit worklist requests, perform the following steps: 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist Summary window, select a sample or a test. 4. Select Schedule. 5. At the Worklist Schedule window, edit the request. 6. Select Save to save the change.
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Deleting Requests
Use this procedure to delete selected samples or tests. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist Summary window, select a sample, a test, or a batch.
If you want to . . . delete a sample or a test, delete a batch, Then . . . select a sample or a test. select Pending Batches in View and then select a batch.
If tests have not started or if tests are complete, the entire request is deleted immediately from the worklist. If tests are inprocess, the tests are stopped, the cuvettes are discarded, and the tests, including any completed results, are deleted from the worklist.
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The Worklist Summary window provides pop-up windows that display additional information about the samples and tests. To view these pop-up windows for a specific sample or test, use the following options:
If you want to view . . . the manual dilution factor that you selected at the Worklist Dilutions window for a sample, the operator specified dilution option and factor that you selected at the Worklist Dilutions window for a sample, the units, up to 4 defined reference ranges, the defined check range, and the defined linearity range for a patient result, NOTE: If the selected result is outside of a range, the range displays in bold text. the units for a control result, the 3 highest priority result flags for a sample,
NOTE: If multiple flags are associated with a result, an
Then select . . . the dilution symbol in the manual dilution column. the dilution symbol in the system dilution column. a patient result in the result column.
a control result in the result column. the flag in the flag column.
Pop-up windows do not display in the following circumstances: The system processes the dilution using operator-specified parameters defined at the Test Ranges window. The result is outside of the calculation range. The result is for a calibrator.
At the Worklist Result Details window, you can review additional information to help you evaluate results: replicate and mean results reference ranges units complete list of flags for each result access to reagent lot and pack information for each replicate result
To view results and flags, perform the following steps: 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist Summary window, select a result. 4. Select Result Details. The system lists results alphabetically by test and in chronological order. The window displays the final result in bold.
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NOTE: You can view a control-bracketed test result at the Worklist Result Details window when the system releases the result.
If the system has not released the result, the Worklist Result Details window displays the Waiting for Controls symbol. If the system discarded the result, the window displays the Results Discarded symbol. Refer to System Symbols page F-1. If the control-bracketed test is waiting for controls or the results are discarded, the Worklist Result Details window does not display RLUs.
Result Flags
Flag Above Check Description The result is above the check range entered in the test definition. The test is repeated if you select Repeat if > for Check Range at the Test Ranges window. The system automatically repeated this test as specified in the test definition. The result is below the check range entered in the test definition. The test is repeated if Repeat if < is selected for Check Range at the Test Ranges window. The result was obtained using an operator-accepted calibration for this test. The result was obtained after you assigned a valid calibration for this test at the Worklist Summary window. The calibration is invalid for this test. If an RLU is displayed for the test and you have the appropriate level of security, you can assign the previous valid calibration. At the Worklist Summary window, select the result and then select Assign Cal. No valid calibration is available for the reagent lot. Schedule a calibration at the Worklist Schedule window. A test was cancelled and unable to complete because of a conflict or resource problem while processing. A result was not obtained for the ratio test because of an error flag for 1 or more of the ratio variables. Check the variables for the ratio. A result was not obtained because a clot was detected in this sample. The result is above the high value for the concentration calculation defined at the Calibration Master Curve Definition window. The test is repeated if you select Repeat if > Conc Range at the Test Ranges window.
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Description The result is below the low value for the concentration calculation defined at the Calibration Master Curve Definition window. The test is repeated if you select Repeat if < Conc Range at the Test Ranges window. The system cannot calculate a result for a confirmatory test on this sample. The system processed this sample as part of a group of samples for a specific test that began and ended with a set of controls. The system does not process samples until it establishes the acceptability of the results of the beginning set of controls. The system does not report sample results until it establishes the acceptability of the results of the ending set of controls. The system displays this flag at the Worklist Result Details window and the Worklist Summary window. If your system transmits results to a laboratory information system (LIS), this flag is transmitted also. The system processed this sample with a control-bracketed test in the restricted mode. A control-bracketed test is a test that requires evaluating a set of controls at the beginning and end of a group of patient samples. The system does not process samples until it establishes the acceptability of the results of the beginning set of controls. The system does not report sample results until it establishes the acceptability of the results of the ending set of controls. The restricted mode is a mode of processing in which the system performs the same test on a group of samples loaded between defined starting and ending racks without the interruption of any other test or samples. The system displays the Control bracketed restricted flag at the Worklist Result Details window and the Worklist Summary window. If your system transmits results to a laboratory information system (LIS), this flag is transmitted also. The result was obtained on a sample that the system automatically diluted. The result is above the dilution point defined for this test at the Test Ranges window. You modified the result that was reported by the system. You manually entered the test result (usually for an off-system test). The quality control result caused a defined quality control rule violation. The quality control result is excluded from statistics or the calibrator replicate is excluded from the calibration. The result is above the reference range (normal range) entered in the test definition.
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Description The CV (coefficient of variation) for replicates of the sample is above the acceptable CV entered in the test definition. One of the calibrator levels is not loaded on the system. Ensure that both the high calibrator and the low calibrator are loaded. The result is equal to or above the defined low limit and equal to or below the defined high limit of the range. The test is repeated if the appropriate Repeat if criteria is selected for Check Range at the Test Ranges window. The result is above the high value for the index calculation defined at the Calibration Master Curve Definition window. The test is repeated if Repeat if > Index is selected at the Test Ranges window. The result is below the low value for the index calculation defined at the Calibration Master Curve Definition window. The test is repeated if Repeat if < Index is selected at the Test Ranges window. Not enough sample volume is available for the requested tests. A result was not obtained because the system detected an irregular sample aspiration. Check the sample for bubbles or foam, or check the sample probe tubing and the tip-probe connection for leaks. This test is for investigational use only. The result is above the linearity you entered at the Test Ranges window. The test is repeated if Repeat if > is selected for Linearity at the Test Ranges window. The result is below the linearity you entered at the Test Ranges window. The test is repeated if Repeat if < is selected for Linearity at the Test Ranges window. The reagent lot expired. Define a Master Curve for a new reagent lot at the Calibration Master Curve Definition window. The result is below the reference range (normal range) entered in the test definition. Insufficient acid reagent is available on the system to perform the test. Insufficient base reagent is available on the system to perform the test. Insufficient number of sample tips are available to perform the test. Insufficient wash 1 reagent is available on the system to perform the test. Insufficient wash 3 reagent is available on the system to perform the test.
< Linearity
Lot Expired
Low Low Acid Low Base Low Tips Low Wash 1 Low Wash 3
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Flag Low Probe Wash Low Water Manual Dilution No Ancillary No Bracket
Description Insufficient probe wash is available on the system to perform the test. Insufficient water is on the system to perform the test. A manual dilution was specified for this test result. The result is automatically corrected for the specified dilution factor. The test requires an ancillary reagent. Load the appropriate ancillary reagent. The system cannot process this sample at this time because the start-of-bracket controls were not processed or at least 1 of the control results is unacceptable. The system will process the sample after the start-of-bracket controls are processed and produce acceptable results. A result was not obtained because a calculation error occurred. For example, the RLUs for the sample are off the curve. For more information, call for technical assistance. The test requires a specific primary reagent and calibrator lot combination. Ensure that you use the primary reagent and the calibrators from the same kit. The system cannot calculate this result because a dilution is not allowed for this test. An automatic dilution is scheduled and no diluent is loaded for this test. The test requires a specific primary reagent and ancillary reagent lot combination. Ensure that you use the primary reagent and the ancillary reagent from the same kit. No primary reagent is loaded for this test. If you are processing control-bracketed test and you get a No Primary flag when you are not out of primary reagent, the system is indicating that patient samples were not processed because insufficient time remained to complete the bracket. No sIgE universal reagent is onboard or the pack that is on the system is empty. No allergen reagent is loaded for this test. The result for this control is above or below the limits entered in the control definition. This flag does not display when quality control rules are defined and enabled for a test. A result was not obtained because the diluted sample result is below the overdilution point defined at the TestRanges window. The system cannot perform the test because the system needs to schedule priming for a probe or a pump. Dilute and repeat the test.
No Calculation
No Primary
Overdiluted
Priming Redilute
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Flag repeated
Description The system automatically repeated the test or you repeated the test by selecting the test and then selecting the Repeat button at the Worklist Summary window or the Worklist Result Details window. The system processed this sample as part of a group of samples for a specific test loaded between defined starting and ending racks without the interruption of any other test or samples. The system displays this flag only at the Worklist Result Details window. If your system transmits results to a laboratory information system (LIS), this flag is transmitted also. A result was not obtained because a signal error occurred. For example, the RLUs for the sample are near zero, because of a low light count to dark count ratio, or of noise. Contact your local technical support provider or distributor. The system cannot perform the test because a subsystem is offline. The test is inactivated. At the Status Primary Reagent window, you can activate the test by selecting a pack for the test and then selecting Activate Test. At the Status Carrier Details window, you can activate a specific IgE test when the system is not inprocess by deselecting the Inactivate Test button for that test vial. The system cannot perform the test because the cuvette bin, the sample tip bin, the tip tray bin, or the waste bottle is full. Primary or ancillary reagent with the specified pack serial number is not loaded for this test. Allergen reagent with the specified vial serial number is not loaded for this test. The result was obtained using an operator waived calibration for this test.
restricted
Signal Error
Repeating a Test
Use this procedure to manually schedule a repeat for a completed test. Refer to Defining Automatic Repeats for Sample Error Conditions page 8-27. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist Summary window, select a test on the right side of the worklist.
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4. Select Repeat.
If . . . the sample is in the inprocess queue when the repeat test is scheduled, the sample has been ejected from the inprocess queue before the repeat test is scheduled, Then . . . the system automatically performs the repeat test on the sample. you must reload the sample.
When the repeat completes, you can review the initial results and the repeated results at the Worklist Result Details window.
Editing Results
Use this procedure to change the concentration or index value of a result. You can also use this procedure to enter the result for an off-system test. You must have the appropriate level of security to edit results. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist Summary window, select a sample. 4. Select Result Details. 5. At the Worklist Result Details window, select a result. 6. Select Edit Result. 7. At the Worklist Edit Results window, edit the value: If the result is a concentration value, change or enter the value in Conc. If the result is an index value, change or enter the value in Index. If the result has both concentration and index values, both fields display at the Worklist Edit Results window; however, you can only edit the Conc field.
8. Enter comments, as needed, to record why you edited the result: a. Select Comments. b. At the Comments window, enter a comment. You can enter up to 3 comments. Comments can be up to 120 alphanumeric characters. The system enters your initials and the date. If you are not currently signed in, you must sign in to the system. c. Select Save.
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a. c.
Select Result Details. Ensure the result is selected and then select Release.
5. At the Worklist Release Results window, you can select how you want the system to release the hold status for results.
If you want to . . . release the status for the result selected at the Worklist Summary window, release the status for all results for the test selected at the Worklist Summary window, release the status for all results the system is holding for review, release the status for results within a specific date range, Then . . . select Release Only Selected Results. select Release All Results on Hold for the Selected Test. select Release All Results on Hold. a. Select Release Results on Hold within Date Range.
6. Select Continue. When the system releases the hold status for a result, it automatically sends the result to an LIS if automatic transfer of results is defined for your system. Refer to Defining LIS Communication Options page 8-45.
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NOTE: To perform this procedure, at the Setup LIS Communication window, you must have selected the option System Automatically Sends All Results and Additional Data except Results on Hold.
Use the following procedure to release all results on hold for the selected test: 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist Summary, select the test with the hold status. 4. Select Release. 5. At the Worklist Release Results window, select Release All Results on Hold for the Selected Test and then select Continue. The system transmits all results on hold to the LIS.
6. Select Continue. The system sends all results to the LIS that match the criteria you defined.
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4. Select LIS Communications. 5. At the Worklist LIS Communications window, select Send All Selected Results. 6. Select Continue. The system sends all selected results, except results on hold, to the LIS.
Deleting Results
Use this procedure to delete results.
NOTE: Before deleting a worklist, ensure that the system has posted all results
from the worklist. If you delete a worklist while the system is posting results from that worklist, the system may stop processing samples.
NOTE: You must have the appropriate level of security to access Data Administration. NOTE: Do not delete results or worklists if the system is in the Cleaning Failed state. Ensure that the system is in the Ready or the Warming Up state and then delete the results or worklists.
1. At the workspace, select Setup. 2. Select Data Administration. 3. At the Setup Data Administration window, select Worklist.
CAUTION
Use care when deleting results. Deleting results permanently removes the results from the database.
CAUTION
Use caution when deleting a worklist with unreleased results. When you delete a worklist with unreleased results, the system permanently removes the associated unreleased results from the database. If the unreleased results are from an open bracket, the associated samples do not display in the Results Discarded report generated at the Print Report Options window or the Results Discarded view at the Worklist Summary window.
NOTE: When you delete a worklist from an open control-bracketed test, the
system does not close the bracket. The system discards any retained patient results. However, it does not delete the controls. 4. Select Delete. 5. At the Setup Data Administration Options window, you can delete the entire worklist or part of the worklist: Select Delete Entire Worklist to request the deletion of the entire worklist. Continue with step 6.
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Select Delete Selected Worklist to request deletion of part of the worklist. Select the date ranges and tests that you want to delete from the current or the historical worklist.
Then . . . in result, select Current and in Test, select All. in result, select Current and in Test, select the test for the results you want to delete. in result, select Historical and in Test, select All. in result, select Historical and in Test select the test for the results you want to delete. in result, select Current & Historical and in Test, select All. in result, select Current & Historical and in Test, select the test for the results you want to delete.
If you want to delete . . . results for all tests in the current worklist, results for a specific test in the current worklist, results for all tests in the historical worklist, results for a specific test in the historical worklist, all results for all tests, all results for a selected test,
For the dates, the worklist, and the tests you selected, you can also select the status of the results you want to delete.
If you want to delete . . . pending requests, tests that have results, printed results, results that were sent to the LIS, Then . . . Select Pending. Select Resulted. Select Printed. Select Sent.
Printing Results
The system offers 3 printed report types for managing patient results: Results Report Test Report Runtime Report
When you select a report, the system displays the options for that report type.
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2. Select Report Options. 3. At the Print Report Options window, select Results Report. 4. Enter the starting and ending date, view, and sort. Select Save as Default to save the selections as default selections. 5. Select Print Report. View determines the information that is printed. You can select 1 of the following options: Results requests with results Pending Tests requests that do not have results All all requests Stats Stat requests with results Results Discarded requests with discarded test results for a control-bracketed test The Results Discarded list can help you locate and reload control-bracketed test samples that require repeat testing. Refer to Reasons for Discarded Results page 2-43
NOTE: Ensure that you print the Results Discarded list before selecting
Repeat at the Worklist Summary window. When you select Repeat at the Worklist Summary window, the printed Results Discarded list is no longer available. Sort determines the order in which the data is printed. You can select 1 of the following options: RLU Measured in chronological order by the time when the system generated the RLU measurements for the results SID in ascending alphanumeric order by the sample identifier (SID) Rack in ascending alphanumeric order by the rack identifier Test in alphabetical order by test name
The Test Report is a report of all results for tests that are defined on the system. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print Report Options window, select Test Report.
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4. Enter the starting and ending date, test, and sort. Select Save as Default to save the selections as default selections. 5. Select Print Report. Results are collated by calibration, starting with the earliest calibration. This report can include all results stored by the system. Sort determines the order in which the data is printed. You can select 1 of the following options: RLU Measured in chronological order by the time when the system generated the RLU measurements for the results Interpretation in alphabetical order by the interpretation of the results
Printing Notes
When you turn off or disconnect the printer at your system, ensure that you deselect the Automatic Runtime Results Report option at the Setup Print Options window and do not request any other printed report. If the ADVIA Centaur XP system responds to an automatic or manual print request when your printer is turned off or disconnected, a software error can occur. If you request a printed report when no printer is available, use the following procedure to cancel the print request: 1. At the workspace, select Print. 2. Select Cancel Reports. If you want to stop printing reports and you select Cancel Reports, printing does not stop until everything in the printer buffer prints.
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3 Calibration
Using a Master Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Performing a 2-point Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Referencing Serum Calibration for T Uptake . . . . . . . . . . . . . . . 3-4
Accepting an Invalid Calibration . . . . . . . . . . . . . . . . . . . . . . . 3-24 Assigning a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 Managing Calibrations Examples . . . . . . . . . . . . . . . . . . . . . . . 3-25
No Current Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26 Current Valid Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26 Expired Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
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Calibration
The ADVIA Centaur XP system uses a Master Curve and a 2-point, operator-initiated calibration to calibrate qualitative and quantitative assays. The Master Curve and the 2-point calibration method eliminate the need to measure a full standard curve or to include a calibration each time the assay is performed.
1 2
Figure 3-1
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The Master Curve for a sandwich assay has a positive slope, which indicates that the analyte concentration is directly proportional to the light emission in RLUs.
1 2
Figure 3-2
When patient samples or quality control samples are assayed using a quantitative assay, the system matches the adjusted RLU value to its corresponding analyte concentration using the Master Curve. Qualitative assays have a cut-off point that remains constant for each lot number of reagent. The manufacturer establishes this cut-off during product development and bases it on extensive population studies. Manufacturing assigns the analyte concentration associated with the cut-off as, for example, an index value of 1.0. See the method specific product insert for the method cut-off value.
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The RLU relative to the cut-off is the basis for a Master Curve consisting of 6 to 10 standards. The cut-off or index value is represented as a specific level on the Master Curve in Figure 3-3.
1 2 3 4 5
Figure 3-3
As with quantitative assays, the assay is calibrated using 2 calibrators of known value in replicate. If the calibrators meet defined validity criteria, then the system compares the calibrator RLUs to the Master Curve and determines an instrument-specific correction formula. When the system assays patient or quality control samples, the RLUs the system reads are adjusted by the formula derived from the 2 known calibrators. The system compares the sample RLUs to the calibration curve, and determines the RLU associated index value. See the method specific insert for the interpretation of results rule for the method. For example, the method may have the following interpretation of results. If the index value is greater or equal to 1.0, the system interprets the sample as reactive. If the index value is less than 1.0, the system interprets the sample as nonreactive.
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The reference serum factor is printed on the Calibrator Assigned Value Card provided with Calibrator A. To report results as % T Uptake, the system requires a % T Uptake reference (normal) range. The system multiplies the T Uptake ratio by the midpoint of the % T Uptake reference range to obtain % T Uptake results. For example, if the % T Uptake reference range is defined as 25 to 35% (midpoint of 30) and a sample has a T Uptake ratio of 0.82, the system calculates the % T Uptake as follows:
0.82 30 = 24.6%
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To open the Calibration Evaluation Ranges window, perform the following steps: 1. At the workspace, select Calibration > Data. 2. Select Evaluation Ranges. The values on the Calibration Evaluation Ranges window Slope is a comparison of high and low calibrator RLUs to the Master Curve. This value describes the relationship of the RLUs expected from the Master Curve data to the measured calibrator RLUs.
Slope = (High Cal Expected RLU - Low Cal Expected RLU)/ (High Cal Measured RLU - Low Cal Measured RLU
Ratio is a comparison of low and high calibrator RLUs. For sandwich assays, this value is the difference between the mean RLU value of the high calibrator and the mean RLU value of the low calibrator divided by the mean RLU value of the low calibrator.
Ratio = (High Cal Mean RLU - Low Cal Mean RLU)/ Low Cal Mean RLU
For competitive assays, this value is the difference between the mean RLU value of the low calibrator and the mean RLU value of the high calibrator divided by the mean RLU value of the high calibrator.
Ratio = (Low Cal Mean RLU - High Cal Mean)/High Cal Mean
The low and high cal deviations are a measure of how well the high and the low calibrator RLUs fit the Master Curve.
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These values are a relative measure of the deviation of the average RLUs of the low calibrator and the high calibrator from the Master Curve.
1 2 3 4 5
RLUs High cal deviation Master curve Low cal deviation Concentration
Figure 3-4
CV is the precision of the calibrator replicates based on RLUs. Acceptable CV is the maximum CV that is acceptable for a valid calibration. The percent coefficient of variation (CV) of the individual calibrator replicates must not exceed a defined acceptable value. This is the first criterion that the system checks after performing a calibration.
Critical Precision determines whether an outlier is too far out to automatically exclude it.
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Because the observed ranges are specific for your system, they are narrower than the defined ranges and therefore increase the quality of calibration monitoring over the defined ranges. Whenever a calibration is outside of the observed ranges but within the defined ranges, you can accept the calibration. Figure 3-5 shows both defined and observed ranges.
14 5 6 7 8
First 4 valid calibrations Observed ranges begin Valid calibration Invalid calibrations
Figure 3-5
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In Figure 3-5, the first 4 calibrations (1 4) of a reagent lot and calibrator lot combination are valid. The system begins calculating observed ranges (5) after the fourth valid calibration. Given this information, you can interpret the following information correctly: The point labeled 6 is a valid calibration because it is within the observed range. The point labeled 7 is an invalid calibration because it is outside of the defined range. The point labeled 8 is an invalid calibration because it is outside of the observed range.
Retained Calibration
To reduce unnecessary adjustments from calibration to calibration that can cause minor calibration drift or trends, you can use the Retain Cal feature. The Retain Cal feature retains a previously valid calibration to calculate patient and control results. Select the Retain Cal option at the Test Calibration window. Refer to Defining Calibration Options page 8-16. For the first 4 calibrations of a reagent lot and calibrator lot combination, the system gathers statistical data and uses these calibrations, in turn until expiration, to calculate results. When you select the Retain Cal option, at the fifth and subsequent calibrations the system can use data from a previous valid calibration to calculate results if the new calibration is not statistically different from that previous calibration. When the system uses data from a previous calibration to calculate results, the calibration interval expiration date is based on the date of the new calibration. The system continues to use the same data to calculate results as long as calibrations do not statistically differ from the retained calibration. When a new calibration is not statistically different from a previous valid calibration, it meets the retained calibration limits.
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If a new calibration does not meet the retained calibration limits, the system uses the new calibration to calculate results and set the calibration interval expiration date. The system repeats the process until you use a new reagent lot or calibrator lot. The process starts over with 4 new valid calibrations as in Figure 3-6.
14 5 7
Figure 3-6
In Figure 3-6, the first 4 calibrations (1-4) of a reagent lot and calibrator lot combination are valid. The system calculates observed ranges after the fourth valid calibration. When the fifth calibration is a valid calibration that is not statistically different from the fourth calibration, the system retains the fourth calibration and uses it to calculate results. The system bases the calibration interval expiration date on the date of this (fifth) calibration. The sixth calibration is a valid calibration that is statistically different from the fourth calibration. The system uses data from this calibration to calculate results and set the calibration interval expiration date. The seventh calibration is a valid calibration that is not statistically different from the sixth calibration, so the system retains the sixth calibration and uses it to calculate results. The system bases the calibration interval expiration date on the date of this (seventh) calibration. The system bases the calibration interval expiration date on the date of this (seventh) calibration.
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The system excludes as many replicates as needed to obtain a valid calibration; however, the system ensures that the minimum number of replicates defined in the test definition are included in the calibration.
Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. 1. At the workspace, select Calibration. 2. Select Master Curve Definition. 3. At the Calibration Master Curve Definition window, select Scan Data.
NOTE: You can delete a Master Curve if no calibrations are run against the Master Curve.
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4. Scan the barcodes on the Master Curve Card from top to bottom.
Figure 3-7
5. Select Save.
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b. Enter the lot number and the expiration date. c. Enter the stability data. Manual entry of information into the Stability Data field requires 12 digits. Enter the 3 digit stability data on the Master Curve Card and follow it with 9 zeros (0). d. Enter a concentration value and an RLU value. e. Select Save Value. f. Repeat steps c. and d. to enter additional values for concentration and RLU.
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Positions of Ratio and Slope on the Master Curve Card are reversed from those positions on the user interface. When manually entering the information, be sure to enter the information into the correct field.
1 2
Calibration Master Curve Definition window values Calibration Lot Details window values
Figure 3-8
5. Enter the values for lot-specific components, if necessary: a. Select Details. b. At the Calibration Lot Details window, enter the values from the Master Curve Card. c. Select Continue. 6. At the Calibration Master Curve Definition window, select Save.
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Procedural Notes
Manual entry of information into the Stability Data field requires 12 digits. Enter the 3-digit stability data on the Master Curve Card and follow it with 9 zeros (0). Positions of Ratio and Slope on the Master Curve Card are reversed from those positions on the user interface. When manually entering the information, ensure you enter the information into the correct field.
Do not process samples for a test and reagent lot combination after deleting a Master Curve for that test unless you reboot the system. If you do not reboot the system before running that test, the system may continue processing the samples and never release the results or the system may require a software reload. Use this procedure to delete a Master Curve before calibrations have been performed against it. For example, if you typed incorrect information into 1 of the fields and selected Save before you noticed the error, you can delete the Master Curve and start over. 1. At the workspace, select Calibration. 2. Select Master Curve Definition. 3. At the Calibration Master Curve Definition window, select the test and lot number. 4. Select Delete. This button is not available if a calibration has been performed for the Master Curve. 5. Select Yes.
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Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. 1. At the workspace, select Calibration. 2. Select Calibrator Definition. 3. At the Calibration Calibrator Definition window, select Scan Data. 4. Scan the barcodes on the Calibrator Assigned Value Card. 5. Ensure that the calibrator values are correct.
NOTE: After you select Save, you cannot add or delete a test from a calibrator definition.
6. Select Save.
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Use care when deleting a calibrator definition. Deleting a calibrator definition permanently removes all associated calibration data and sample results from the database. 4. Select Delete. 5. Select Yes.
Performing Calibrations
Use the procedures in this section to review the status of calibrations and to schedule a calibration. Calibration intervals are assay specific. Refer to the ADVIA Centaur Assay Manual.
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Description The calibration for the reagent lot expired. Schedule a calibration at the Worklist Schedule window. You can waive an expired calibration at the Calibration Summary or Calibration Data windows if you select Waive Cal at the Test Calibration window. The calibration exceeded either the defined or the observed range for 1 or more calibration expected values. Schedule another calibration at the Worklist Schedule window. No Master Curve exists for the reagent lot. Define a Master Curve at the Calibration Master Curve Definition window, and then schedule a calibration at the Worklist Schedule window. An operator accepted a calibration that was outside the observed ranges but within the defined ranges. A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist Schedule window as soon as possible.
Invalid
No Master Curve
You can display specific information by selecting the appropriate View and Sort: The View that you select determines the information that the system displays. For example, if you select All Tests, the system displays calibration information for all the tests. The Sort that you select determines the order in which the system displays the calibrations. For example, if you select Status, the system displays the tests in reverse chronological order starting with expired calibrations, calibrations that are due, and then current calibrations. The following table describes the View and Sort combinations you can use to perform some routine calibration tasks:
Task Display, in order of calibration status, the calibration information for all tests Display, in alphabetical order of test, the calibration information for all tests Display, in order of calibration status, the calibration information for tests using reagents that are currently loaded on the system Display, in alphabetical order of test, the calibration information for tests using reagents that are currently loaded on the system Display the calibration history for a reagent lot and calibrator lot combination for a specific test View All Tests All Tests Available Reagents Available Reagents Historical Sort Status Test Status
Test
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Valid Valid, Operator Accepted Valid, using Date of the Retained Calibration Waived
Scheduling Calibrators
Calibrate an assay in the following instances: the calibration interval expires a calibration is invalid you use a new lot of assay reagents controls are repeatedly out of range
CAUTION
Do not schedule and load the calibrators before processing the end-of-bracket controls of an open bracket for control-bracketed tests. If you schedule and load calibrators for a control-bracketed test and the system aspirates a calibrator before processing the end-of-bracket controls, the system discards any retained patient test results. For all tests, you must load the reagent lot you want to calibrate before you schedule a calibrator. 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist Schedule window, select Calibrator. 4. Select how you want the system to identify the calibrator:
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If the sample identifier selected at the Setup Tube Type & Barcode window is SID, you can select Schedule by SID or Schedule by Rack. If the sample identifier selected at the Setup Tube Type & Barcode window is Rack, you can only select Schedule by Rack.
Refer to Specifying Sample Identification page 8-4. 5. Select or enter a test for the calibrator. If you use the keyboard to enter the test in the Test field, you must enter the test name exactly as it is displayed on the schedule window. The system automatically displays the calibrators previously defined for the test. You define the calibrator SIDs at the Calibration Calibrator Definition window. Calibrators do not display in the following situations: calibrators are not defined Master Curves are not defined no reagent is onboard the calibration material for defined lots is expired When scheduling by SID, select the appropriate SID. The system fills in the Rack ID. When scheduling by Rack, you can select specific racks for the calibrators.
6. Select a calibrator.
7. You can select a reagent lot. 8. If you schedule by rack, enter the Rack ID in Rack. The Rack ID consists of 4 numbers (00019999) followed by a letter (AE). Enter the letter in uppercase. 9. Select Save. 10. Repeat steps 4 through 9 to schedule additional tests for a calibrator. 11. Load low and high calibrators in a rack. 12. Load the rack in the sample entry queue.
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If you schedule a calibration and schedule a control-bracketed test without waiting for the calibration results, if the calibration is not valid, your controls are also invalid. If a bracket is open, ensure that you schedule and load the end-of-bracket controls that close the bracket before loading any calibrators. If the system aspirates a calibrator before aspirating the end-of-bracket controls of an open bracket, the system discards any retained patient test results.
Expired, Retained
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Description An operator accepted a calibration, and then the system retained the calibration. The system uses this retained calibration to calculate results. The system uses this calibration to calculate results. The values of this calibration are almost mathematically identical to the most recent calibration. A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist Schedule window as soon as possible.
Waived
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Description The calibration is outside the range for the ratio that is defined at the Calibration Master Curve Definition window. Schedule another calibration at the Worklist Schedule window. The calibration is outside the range for the slope that is defined at the Calibration Master Curve Definition window. Schedule another calibration at the Worklist Schedule window. The calibration exceeded the high calibrator deviation that is calculated by the system. Schedule another calibration at the Worklist Schedule window. The calibration exceeded the low calibrator deviation that is calculated by the system. Schedule another calibration at the Worklist Schedule window. The calibration is outside the range for the ratio that is calculated by the system. Schedule another calibration at the Worklist Schedule window. The calibration is outside the range for the slope that is calculated by the system. Schedule another calibration at the Worklist Schedule window. The neutralizing reagent did not reduce the assay signal for the high calibrator to the defined level. Schedule another calibration at the Worklist Schedule window. The calibration did not yield the expected results for the Reagent A stability check. Schedule another calibration at the Worklist Schedule window. The calibration did not yield the expected results for the Reagent B ratio check. Schedule another calibration at the Worklist Schedule window. The CV (coefficient of variation) for the replicates of the calibrator is above the acceptable CV entered in the Master Curve definition. You can manually exclude a replicate at the Calibration Data window if you have processed more than the minimum number of replicates and Autoexclude Cal Replicates is not selected at the Test Calibration window. If you cannot manually exclude a replicate, schedule another calibration at the Worklist Schedule window. The CV (coefficient of variation) for the high calibrator replicate RLU values for Reagent A was too large. Schedule another calibration at the Worklist Schedule window. The CV (coefficient of variation) for the low calibrator replicate RLU values for Reagent A was too large. Schedule another calibration at the Worklist Schedule window. The CV (coefficient of variation) for the high calibrator replicate RLU values for Reagent B was too large. Schedule another calibration at the Worklist Schedule window.
Failed Defined Slope Failed Observed High Cal Deviation Failed Observed Low Cal Deviation Failed Observed Ratio Failed Observed Slope Failed % Neut
High CV
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Description The CV (coefficient of variation) for the low calibrator replicate RLU values for Reagent B was too large. Schedule another calibration at the Worklist Schedule window. The system automatically excluded a calibrator replicate RLU. This flag only displays if Autoexclude Cal Replicates is selected at the Test Calibration window. The number of acceptable replicate results is less than the number required to calibrate the test. The minimum number of acceptable replicates is defined at the Test Calibration window. Schedule another calibration at the Worklist Schedule window.
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10. Close and reopen the Calibration Data window to display the symbol indicating that the calibrator RLU is excluded. 11. If required, you can select Include and then select Save to include an excluded calibrator RLU in the calibration.
Waiving a Calibration
CAUTION
Do not waive calibrations unnecessarily. Waiving Cals repeatedly may cause misreported results. When the calibration interval for a test expires while samples are in process, you can finish processing samples scheduled for the test by waiving the calibration. Use the Waive Cal option only when tests are Inprocess. The system calculates results for the samples and displays the results for the test as Waived. You must have the appropriate level of security to waive a calibration and you must select Waive Cal at the Test Calibration window. When you waive a calibration, enter a comment and recalibrate immediately after this. Waiving calibrations repeatedly may cause misreported results. A waived calibration remains waived until the next calibration interval.
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1. At the workspace, select Calibration. 2. Select Data. 3. At the Calibration Data window, select the test and the test lot number. 4. Select the most recent calibration date in Calibrated. 5. Select Accept.
Assigning a Calibration
If a calibration is invalid, you can assign a valid calibration to samples that the system processed with that invalid calibration. You can assign the last valid calibration or recalibrate and assign the next valid calibration. The system calculates results for the samples and displays the results for the test as Cal Assigned. You must have the appropriate level of security to assign a calibration to results and you must enable Assign Cal at the Test Calibration window. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist Summary window, select a final result with RLU instead of a concentration value in the result column. 4. Select Assign Cal. 5. At the Worklist Assign Calibration window, select the results to which you want to assign a calibration. 6. The system displays the sample SID for the result you selected at the Worklist Summary window. 7. Select Continue. 8. At the Worklist Summary window, select Save.
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No Current Calibration
If all of the following conditions apply: You have no current valid calibration for the reagent lot that you are using because it is a new lot. You process patient and control samples with calibrators. You perform a calibration and the calibration is invalid because it exceeds the defined ranges.
The system performs the following actions: Stops aspirating samples for that test. Continues with inprocess patient and control samples and displays RLUs for results if Assign Cal is selected in the test definition.
You can perform the following actions to report patient results: You must repeat the calibration and any patient and control samples that were not processed. The repeated calibration must be valid. You can use the Assign Cal feature to assign the new valid calibration to the patient and control samples with RLU results from the invalid calibration. Control values that are within range indicate that the RLUs of patient samples processed with the invalid calibration are accurate.
The system performs the following actions: Stops aspirating samples for that test. Continues with inprocess patient and control samples and displays RLUs for results if you selected Assign Cal in the test definition.
You can perform the following actions to report patient results: Because the calibration is still valid, you can use the Assign Cal feature to assign the calibration to patient and control samples with RLU results from the invalid calibration.
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Control values that are within range indicate that the RLUs of patient samples processed with the invalid calibration are accurate. You must repeat any samples that were not aspirated with a rescheduled calibration. The repeated calibration must be valid. The system does not process samples with requests for tests with an invalid calibration.
Expired Calibration
If all of the following conditions apply: You have an expired calibration. You process patient and control samples with calibrators. You perform a calibration and the calibration is invalid because it exceeds the defined ranges.
The system performs the following actions: Stops aspirating samples for that test. Continues with inprocess patient and control samples and displays RLUs for results if Assign Cal is selected in the test definition.
You can perform the following actions to report patient results: You can waive the expired calibration and use the Assign Cal feature to assign the waived calibration to the patient and control samples with RLU results from the invalid calibration. Control values that are within range indicate that the RLUs of patient samples processed with the invalid calibration are accurate.
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To select multiple adjacent calibrations, select the first calibration and then hold down the Shift key while selecting the last calibration. The system selects all calibrations in the table between and including the first and the last selected calibration.
To select multiple non-adjacent calibrations, hold down the Ctrl key while selecting each calibration. If it is necessary to scroll to continue selecting multiple calibrations, release the Shift or Ctrl key, scroll to the desired calibration, and then again hold down the Shift or Ctrl key while selecting the calibration.
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4 Quality Control
Adding a New Control Definition . . . . . . . . . . . . . . . . . . . 4-1
Entering Expected Values for a New Lot Number . . . . . . . . . . . 4-2 Deleting a Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Lot Number and the Expiration Date . . . . . . . . . . . . . . . . . . . . . 4-3 Pool Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Test Name and Expected Values . . . . . . . . . . . . . . . . . . . . . . . . 4-3
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NOTE: Use only the barcode labels that are manufactured for the kit controls.
Do not create your own barcode labels. If you use a non-Siemens barcode label, the system does not recognize the control as a kit control and does not process it. The name that you enter displays on the quality control windows.
NOTE: If you are adding a new control definition for a control-bracketed test, ensure that you select Kit in the Type field. The system allows only the
kit-type format for a control SID in a control-bracketed test. 5. In the Type field, select Routine or Kit.
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Routine controls are not provided with the assay reagent kits. Control such as Ligand Plus or Tumor Marker Plus are routine controls. Kit control have specific assay reagent kits.
NOTE: If you are defining a control that does not have a leading K in the barcode, select SID and edit that field to match the barcode of the control. You can select SID only after entering the lot number.
6. Enter the information for the new lot of control, such as type, lot, and expiration date. The lot number and the expiration date are located on the quality control material packaging. You must enter a lot number and an expiration date to save the control definition. You can enter up to 7 characters for the lot number. Enter the date in the format DD MMM YY, for example 26 Oct 99. The system fills in the SID field with the control lot number preceded by K. The SID can be up to 13 characters. If the control is a Routine type and your QC SIDs are different than the lot number, you can edit the SID. 7. Select a Test: a. Select the Test button. The TestSelection window displays. b. Select a test. c. To close the TestSelection window, select Continue. 8. Enter the expected values. 9. Select Save Test. 10. Repeat steps 3 through 9 for all tests for the control. 11. Select Save.
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control, which is a type of control provided with specific assay reagent kits. 1. Select the name of the control, if required. 2. Select Edit. 3. Enter the information for the new lot of control, such as type, lot, and expiration date. Refer to Lot Number and the Expiration Date page 4-3. 4. Select a Test: a. Select the Test button. The TestSelection window displays. b. Select a test. c. To close the TestSelection window, select Continue. 5. Enter the expected values. 6. Select Save Test. 7. Repeat steps 3 through 5 for all tests for the control. 8. Select Save.
Deleting a Control
1. At the workspace, select Quality Control. 2. Select Control Definition. 3. Select the name of the control. 4. Select the information for the lot of control, such as lot and type.
CAUTION
Use care when deleting a test from a control definition. Deleting a test from a control definition permanently removes all associated stored data and results from the database. 5. Select Delete. 6. Select Yes. 7. To delete a test from a control definition, select the test, and then select Delete Test.
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You can enter up to 7 characters for the lot number. Enter the date in the format DD MMM YY, for example 26 Oct 99. The system fills in the SID field with the control lot number preceded by K. The SID can be up to 13 characters. If the control is a Routine type and your QC SIDs are different than the lot number, you can edit the SID.
Pool Number
You can enter up to 4 numbers for the pool number. For customers using the QC Online service, the pool number is assigned by the service. If you use your own quality control pools, you can assign a pool number to track results.
Editing a QC Definition
Use this procedure to edit a QC definition: 1. At the workspace, select Quality Control. 2. Select Control Definition. 3. At the Quality Control Control Definition window, select a control name and a lot number. 4. Select Edit. 5. Edit the QC definition.
CAUTION
Use care when deleting a test from a control definition. Deleting a test from a control definition permanently removes all associated stored data and results from the database.
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Then . . .
a.
b. In the fields below the table, edit the low and high limits, or edit the mean and 2SD values. c. Select Save Test. Select Test. The Test Selection window displays. b. Select a test. c. Select Continue to close the Test Selection window. d. Enter the low and high limits or enter the mean and 2SD values. e. Select Save Test. a.
edit the pool number. You can enter up to 4 numbers for the pool number. The pool number is assigned by the QC Online service.
a. c.
6. Select Save.
Scheduling QC Samples
Use this procedure to schedule controls. As a minimum requirement, you must assay 2 levels of quality control material on each day that samples are analyzed. You must also assay quality control samples when performing a 2-point calibration. Refer to the ADVIA Centaur Assay Manual for assay-specific QC recommendations. 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist Schedule window, select Control.
NOTE: If you are scheduling controls for a control-bracketed test, you must schedule by SID. The system does not allow you to schedule samples for control-bracketed tests by Rack.
4. Select how you want the system to identify the control: If the sample identifier selected at the Setup Tube Type & Barcode window is SID, you can select Schedule by SID or Schedule by Rack. The control SIDs are defined at the Quality Control Control Definition window.
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If the sample identifier selected at the Setup Tube Type & Barcode window is Rack, you can only select Schedule by Rack.
Refer to Specifying Sample Identification page 8-4. 5. Select or enter the tests or the profiles for the control. If you use the keyboard to enter the tests or profiles in the Test field or the Profile field, you must enter the test name or profile exactly as it displays on the schedule window. The controls previously defined for the tests are automatically displayed. 6. Select the controls. 7. If you schedule by rack, enter the Rack ID in Rack. The Rack ID consists of 4 numbers (00019999) followed by a letter (AE). Enter the letter in uppercase. 8. Select Save. 9. Repeat steps 4. through 8. to schedule tests or profiles for additional controls. 10. Load sample cups of QC material in a rack. 11. Load the rack in the sample entry queue.
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Ensure that the start-of-bracket control set and the end-of-bracket control set are in different racks. Ensure that all of the controls within a set are in the same rack. If you schedule the start-of-bracket controls and wait until they are processed and have acceptable results before scheduling the end-of-bracket controls, schedule the controls by SID. You do not need to enter the rack ID and position of the controls. You can use the same rack for the start-of-bracket controls and end-of-bracket controls as long as the system processed the previous set of controls with acceptable results and ejected the rack. You must schedule and load the end-of-bracket controls within the acceptable time interval displayed in the Control Warning field at the Test Definition window. Failure to do so causes the system to discard retained patient results. Refer to Viewing Control Bracketing Features page 8-17.
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Ensure that the rack ID for the end-of-bracket controls is different from the rack ID of the start-of-bracket controls.
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5 Performing Maintenance
Reviewing Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Recording Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Accessing Online Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Reviewing the Maintenance Log. . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Printing Maintenance Reports . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
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Performing Maintenance
The ADVIA Centaur XP system monitors maintenance activities and notifies you when a scheduled activity is due. In addition, the system notifies you through a color change at the Maintenance Status button and the Status Maintenance window when routine and extended certification procedures are due. When a certification is due, contact your local technical support provider to schedule the procedure as soon as possible. The system provides a maintenance schedule for you to record the completion of scheduled maintenance activities. The system then uses this information to automatically update the maintenance schedule with the next time the activity is due.
Reviewing Maintenance
At the Status Maintenance window, the background of the maintenance activities changes color to indicate status: Yellow indicates that a maintenance activity is due or overdue. Red indicates that an automated maintenance procedure did not finish.
At the workspace, the background of the Maintenance Status button also changes color to indicate status. You can select the Maintenance Status button to open the Status Maintenance window and display information about maintenance activities. Select the appropriate View and Sort combinations to display specific information at the Status Maintenance window: The View that you select determines the information that the system displays. For example, if you select Schedule, the system displays the scheduled maintenance activities. The Sort that you select determines the order in which the system displays the scheduled activities. For example, if you select Activity, the system sorts and displays the scheduled activities in alphabetical order.
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The following table describes the View and Sort combinations you can use to perform some routine tasks:
Task Determine which maintenance activities are due Find a specific maintenance activity Review the maintenance activities that were performed most recently Review the history of a specific maintenance activity View Schedule Schedule Log Log Sort Time Due Activity Time Completed Activity
Recording Maintenance
After performing a scheduled maintenance activity you can record that activity as complete. You can also enter and review comments.
NOTE: If you are not currently signed in, you must sign in to the system.
1. At the workspace, select Maintenance Status. 2. At the Status Maintenance window, select an activity. 3. Select Completed. The system automatically enters your initials and calculates the date when the activity is due next. 4. You can enter Comments, such as a note that indicates if the maintenance was performed to correct a system problem: a. Select Log in View. b. Select Time Completed in Sort. c. Select an activity. d. Select Comments. e. At the Comments window, enter a comment. You can enter up to 3 comments. Comments can be up to 120 alphanumeric characters. The system enters your initials and the date. f. Select Save.
Repeat these steps to update the maintenance schedule and enter comments for another activity.
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3. Select Procedure. An online help window opens and displays the maintenance procedure.
5. If you selected Log, enter the Starting Date and Ending Date.
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2. At the Status Maintenance window, you can define or edit a maintenance activity.
If you want to . . . Then . . .
a. a. c.
Select Add. Select an activity that you defined. At the Status Maintenance Definition window, select Edit. Select Perform Daily Cleaning. At the Status Maintenance Definition window, select Edit. Enter the time that the system should perform the procedure. Specify time in a 4 digit, 24-hour format, for example: 0130 is 1:30 a.m. and 1445 is 2:45 p.m.
schedule the Daily Cleaning Procedure to occur at a particular time every day
a. c.
b. Select Definition.
d. Select Autoschedule. e.
3. At the Status Maintenance Definition window, enter or edit the appropriate information. 4. Select Save. The system displays a symbol next to the maintenance activity you defined at the Status Maintenance window.
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Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield.
CAUTION
Do not neglect to perform daily cleaning. Choosing to not perform the cleaning procedure can result in bacterial contamination, paramagnetic particle buildup, protein buildup, and crystallization, which can affect patient results.
NOTE: You cannot process samples while the cleaning procedure is in progress.
1. If the bottle is more than half full, empty the waste bottle. 2. If necessary, replenish the cleaning solution. Refer to Preparing the Cleaning Solution page 5-17. 3. Ensure that the water bottle is at least 1-quarter full (approximately 2.5 L).
NOTE: If the diluter drawer is not closed (up), the daily cleaning procedure
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Diluter drawer
Figure 5-1
Diluter Drawer
5. At the workspace, select Maintenance Status. 6. Select Perform Daily Cleaning. 7. Select Perform. The system starts the cleaning procedure.
NOTE: If the cleaning procedure stops before it completes, the maintenance button turns red and the system prevents you from testing samples until it completes the cleaning procedure or completes a rinse cycle. NOTE: If the cleaning procedure has an error but the rinsing completes
successfully, the maintenance button turns yellow. 8. If an error occurs before the cleaning procedure finishes, perform the following steps: a. At the workspace, select Event Log. b. At the System Event Log window, look for an event that would indicate the cause of the error. c. Correct the error. d. If you are able to correct the error, reschedule the cleaning procedure to remove the cleaning failed status or select Rinse System With Water. e. If the error persists, call for technical assistance.
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Waste and water drawer Water tubing Water bottle lid Cap Water bottle
Do not grasp the tubing when disconnecting the tubing from the top of the water bottle or reservoir. Pulling the tubing can cause crimps. Grasp the fittings, not the tubing. c. Disconnect the water tubing from the water bottle and set aside on lint-free tissues or gauze to absorb drips. d. Lift the water bottle up and out. 2. Remove the cap. 3. Fill the spare, clean water bottle with fresh reagent water and install the cap. Refer to Reagent Water Quality page C-4.
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4. Install the spare, full water bottle: a. Place the water bottle in the waste and water drawer. b. Connect the water bottle tubing to the bottle. c. Lower the water bottle lid. 5. Remove the cap and empty the water bottle you just removed from the system. 6. Rinse the water bottle with reagent water and invert the bottle to dry.
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. Ensure that the spare water bottle is clean. 2. At the workspace, select System Status.
WARNING
Do not clean the primary reagent compartment while the probes are accessing reagent packs. Injury can result.
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Use care when handling the glass sensors. Glass sensors are fragile and errors occur on the system when the sensors are damaged. a. Move the clamps that cover the sensors aside, carefully remove the sensors, and let them hang in the drawer.
CAUTION
Do not grasp the tubing when disconnecting the tubing from the top of the water bottle or reservoir. Pulling the tubing can cause crimps. Grasp the fittings, not the tubing. b. Disconnect the water tubing fittings and set them aside on paper towels.
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1 2 3 4 5 6 7
Reservoir cap Sensor Water tubing fittings Sensor Manifold Water reservoir Water bottle
Figure 5-3
6. Remove the reservoir cap and empty any water from the reservoir. 7. Remove the manifold and install the water reservoir cleaning cover: a. Loosen the 3 knurled captive screws. b. Remove the manifold from the reservoir.
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1 2
Figure 5-4
d. Set the reservoir and manifold aside. 8. Install the spare manifold on the spare reservoir: a. Place the manifold onto the spare reservoir and push down into position. b. Tighten the 3 knurled screws. 9. Install the spare water reservoir and clean the sensors: a. Place the spare reservoir in the waste and water drawer.
CAUTION
Do not leave cleaning solution residue on the sensors. Residual cleaning solution on the sensors can affect assay results. Clean and rinse the sensors thoroughly. b. Clean the sensors by wiping the sensors with lint-free tissues or gauze saturated with cleaning solution. c. Rinse the sensors by wiping the sensors with lint-free tissues or gauze saturated with reagent water. d. Repeat step c. with fresh lint-free tissues or gauze. e. Install the sensors in the top of the reservoir. f. Secure the sensors with the clamps.
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g. Connect the 2 water tubing fittings to the top of the reservoir. 10. Remove the water bottle: a. Pull out the waste and water drawer. b. Open the water bottle lid. c. Disconnect the water tubing from the water bottle and set aside on paper towels to absorb drips. d. Lift the water bottle up and out.
1 2 3 4 5
Waste and water drawer Water tubing Water bottle lid Cap Water bottle
Figure 5-5
e. Set the water bottle aside. 11. Install the spare water bottle: a. Fill the spare, clean water bottle with fresh reagent water and install the cap. b. Place the spare water bottle in the waste and water drawer. c. Connect the water bottle tubing to the bottle. d. Lower the water bottle lid. e. Push in the waste and water drawer. 12. Select Turn System Mechanics On.
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13. Prime the reservoir: a. At the workspace, select Maintenance Status. b. Select Prime Water from Reservoir to Manifolds. c. Select Perform. d. After the priming is complete, the system is ready for operation. 14. Clean and rinse the water reservoir: a. Pour approximately 1 L of cleaning solution into the reservoir. b. Place the cleaning cover on the reservoir and close tightly. c. Invert the reservoir and swirl the solution a few times. d. Soak the inverted reservoir for 5 minutes. e. Swirl the solution again and then soak the reservoir upright for an additional 5 minutes. f. Empty the solution from the reservoir. g. Remove the cleaning cover.
CAUTION
Do not leave cleaning solution residue in the water reservoir. Residual cleaning solution in the water reservoir tubing can affect assay performance. Rinse the water reservoir thoroughly with fresh reagent water. h. Thoroughly rinse the inside of the reservoir, and the reservoir cleaning cover at least 3 times to ensure that there is no residual cleaning solution on the components. i. j. Fill the reservoir with reagent water. Install the cleaning cover on the reservoir.
k. Invert the reservoir, swirl the water a few times, and return the reservoir to the upright position. l. Remove the cleaning cover and empty the water from the reservoir. m. Invert the reservoir to dry. 15. Clean and rinse the water bottle: a. Remove the cap and empty any water from the water bottle that was removed in step 10.. b. Pour approximately 1 L of cleaning solution into the water bottle. c. Place the cap on the bottle and close tightly. d. Swirl the solution around the inside of the bottle a few times. e. Press some gauze over the holes in the top of the bottle and hold the gauze with your fingers. f. Invert the bottle, swirl the solution a few times and then return the bottle to the upright position.
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g. Soak the bottle in the upright position for 5 minutes. h. Repeat steps e. and f. i. Swirl the solution again and then empty the bottle.
CAUTION
Do not leave cleaning solution residue in the water bottle. Residual cleaning solution in the water bottle tubing can affect water filter and assay performance. Rinse the water bottle thoroughly with fresh reagent water. j. Rinse the inside of the bottle including the tubing at least 5 times with fresh reagent water.
k. Invert the bottle to dry. 16. Clean the manifold: a. Empty the fluid from the tubing using a transfer pipette.
1 2
Figure 5-6
Manifold
b. Fill the tubing with cleaning solution using a transfer pipette. c. Soak the water reservoir manifold in cleaning solution for 5 minutes. d. Empty the fluid from the tubing using a transfer pipette.
CAUTION
Do not touch the tubing or sensors. Touching the tubing or sensors can cause contamination.
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e. Rinse each tubing by filling it with reagent water using a clean transfer pipette, removing the fluid and repeating 5 times.
CAUTION
Do not leave cleaning solution residue on the manifold. Residual cleaning solution on the manifold can cause corrosion. Rinse the manifold thoroughly with fresh reagent water, including caps, captive screws, and clamps. f. Thoroughly rinse the manifold and remove excess water from the manifold and tubing.
Do not remove the water trap when the system is in the Inprocess state or the Cleaning state. Removing the water trap while the system is in one of these states can cause a low vacuum error and cause the system to stop sampling and cancel all of the tests in the ring. 1. Ensure that the system is in 1 of the following states: Ready Warming Up Diagnostic Mechanics Off Check Status
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 2. Pull out the waste and water drawer.
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Water trap
Figure 5-7
Water Trap
4. Remove any liquid from the water trap. The liquid in the water trap is waste condensation. 5. Ensure that the float ball moves freely in the water trap. 6. Ensure that the inner seal of the lid is not missing or damaged. 7. Tightly install the water trap lid and install it in the bracket. Ensure the tubings are still attached. 8. Close the waste and water drawer.
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You need the following materials to perform the Monthly Cleaning Procedure: approximately 4 L of prepared ADVIA Centaur XP Cleaning Solution for the automated portion of the Monthly Cleaning Procedure approximately 2 L of prepared ADVIA Centaur XP Cleaning Solution used for soaking and wiping system components reagent water large maintenance brush lint-free tissues, gauze, and paper towels spare air filter
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Use this procedure to prepare the cleaning solution for soaking and wiping system components. 1. Carefully pour 1 container of ADVIA Centaur XP Cleaning Solution Concentrate into the container used for soaking system components. You can soak the components in a sink, the cuvette waste bin liner, or another suitable container. 2. Add 2 L of water to the container.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield.
CAUTION
Do not bend the probe. Bending the probe can cause system errors. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.
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3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.
WARNING
Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 4. Remove the reagent probes cover by lifting the cover up and then out.
Figure 5-8
Reagent Compartment
5. Clean the 3 reagent probes: a. Push the reagent probe assemblies toward the incubation ring by pushing the motors: Push reagent probe 1 to the right and then toward the incubation ring. Push reagent probe 2 to the left and then toward the incubation ring.
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1 2 3 4 5
Reagent probe 1 Reagent probe 2 Reagent probe 3 Probe side view. Motor.
Figure 5-9
b. Use a gentle downward motion to wipe each probe with lint-free tissues or gauze saturated with cleaning solution. c. Check the probes for damage and to ensure that they are not bent.
CAUTION
Do not leave cleaning solution residue on the probe. Residual cleaning solution on the probe can damage the probe. Follow the instructions for rinsing the probe. d. Thoroughly rinse the reagent probe, especially the middle of the probe.
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Rinse the probe using a gentle downward motion to wipe each probe with lint-free tissues or gauze saturated with reagent water.
Reagent probe
Figure 5-10
Reagent Probe
6. Install the reagent probes cover. 7. Close and secure the top cover. 8. Select Turn System Mechanics On.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.
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3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.
WARNING
Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 4. Using cleaning solution, clean the ancillary probe:
Refer to Preparing the Cleaning Solution page 5-17. a. Move the inprocess queue to the right.
CAUTION
Do not bend the probe. Bending the probe can cause system errors. b. Pull the probe toward you by holding the top of the probe assembly. c. Check the probe for damage and to ensure that it is not bent. d. Use a gentle downward motion to wipe the probe with lint-free tissues or gauze saturated with cleaning solution. e. Thoroughly rinse the ancillary probe, especially the middle of the probe.
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Rinse the probe using a gentle downward motion to wipe each probe with lint-free tissues or gauze saturated with reagent water.
1 2
Figure 5-11
Ancillary Probe
5. Close and secure the top cover. 6. Select Turn System Mechanics On.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.
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3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 4. Carefully lift the probe arms up to the highest position.
NOTE: It is not necessary to remove the aspirate probes. Clean only the visible portion of the probe.
5. Wipe the visible portion of the probes with lint-free tissues or gauze saturated with cleaning solution. Refer to Preparing the Cleaning Solution page 5-17. 6. Wipe the probes with lint-free tissues or gauze saturated with reagent water.
1 2
Wash Block
Use care that you do not damage probes. To prevent damage to the probe, ensure that each clip is in its locked position. 7. Move the aspirate probes down approximately 1.27 cm (0.5 in) from the highest position. 8. Close and secure the top cover. 9. Select Turn System Mechanics On.
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Do not install a wet or damp air filter. The moisture can cause system damage. 3. Install the spare, dry air filter in the bracket. 4. Install the bracket and the filter.
CAUTION
Do not wash the air filter with cleaning solution. The cleaning solution can damage the filter. 5. Rinse the air filter with water and allow it to dry thoroughly.
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Perform the appropriate monthly cleaning procedure for your system configuration: If your system uses the system water bottle, perform the Monthly Cleaning Procedure for Systems Using the System Water Bottle page 5-25. If your system uses direct plumbing for the system water, perform the Monthly Cleaning Procedure for Systems Using Direct Plumbing page 5-28.
Monthly Cleaning Procedure for Systems Using the System Water Bottle
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield.
CAUTION
Do not put cleaning solution in the water bottle until after you select Perform Monthly Cleaning. If cleaning solution is in the water bottle too soon, it is pumped throughout the system. Follow all instructions as written. 1. At the workspace, select Maintenance Status. 2. At the Status Maintenance window, select Schedule in View. 3. Select Perform Monthly Cleaning. 4. Select Perform. 5. Select Yes. The system empties the waste reservoir.
First Prompt
1. Fill the water bottle with 4 L of cleaning solution: a. When prompted, pull out the waste and water drawer. b. Remove the water bottle. c. Carefully pour 2 containers of ADVIA Centaur XP Cleaning Solution Concentrate into the empty water bottle. d. Add 4 L of water to the water bottle. 2. Load the water bottle on to the system.
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Use care when handling the glass sensors. Glass sensors are fragile and errors occur on the system when the sensors are damaged. a. Disconnect the tubing and remove the sensors and cap from the water reservoir. b. Remove the water reservoir.
CAUTION
Do not leave water in the water reservoir during the cleaning procedure. Water in the reservoir dilutes the cleaning solution. Empty the water reservoir completely. c. Empty the water reservoir. d. If the system uses an onboard waste bottle, remove the waste bottle and empty the contents into a container approved for biohazardous waste. 4. Ensure that the water trap is emptied and the bottle lid is tight. 5. Load the empty water reservoir and waste bottle onto the system: a. Install the empty water reservoir on the system. b. Connect the tubing and install the sensors. c. Ensure that the cap on the waste reservoir is tight. d. Install the waste bottle on the system.
CAUTION
Do not select Cancel during the First Prompt. If you select Cancel, you must remove the cleaning solution from the system and install the reagent water in a clean water bottle before you select Continue. 6. Select Continue.
Second Prompt
1. Rinse the water bottle. Remove and thoroughly rinse the water bottle and cap with reagent water. 2. Add 2 L of reagent water to the water bottle. Do not add more than 2 L of water to the water bottle. Excess water causes the waste bottle to fill before the end of the cleaning procedure, causing the procedure to fail. 3. Place the water bottle on the system. 4. Ensure that the water reservoir contains no more than 1.27 cm (0.5 in) fluid. 5. Select Continue.
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Third Prompt
1. Rinse the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors from the water reservoir. b. Remove the water bottle and the water reservoir. c. Thoroughly rinse the water bottle and the water reservoir with reagent water to remove residual cleaning solution. 2. Fill the water bottle with 2 L of water and load it onto the system. 3. Load the empty water reservoir onto the system. Ensure that you connect the tubing and install the sensors. 4. Select Continue.
Fourth Prompt
1. Remove the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors from the water reservoir. b. Remove the water bottle and the water reservoir and set them aside. 2. Fill the alternate water bottle with reagent water and install it on the system: a. Install the empty alternate water reservoir on the system. b. Ensure that you connect the tubing and install the sensors. c. Close the waste and water drawer. 3. Select Continue. 4. Observe the water filter. 5. If required, vent air through the air vent filter. When priming is complete, the system returns to the Ready state. 6. Thoroughly rinse the water bottle and the water reservoir that you removed from the system with reagent water, and then invert them to dry.
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield.
CAUTION
Do not put cleaning solution in the water bottle until after you select Perform Monthly Cleaning. If cleaning solution is in the water bottle too soon, it is pumped throughout the system. Follow all instructions as written. 1. At the workspace, select Maintenance Status. 2. At the Status Maintenance window, in the View drop down, select Schedule. 3. Select Perform Monthly Cleaning. 4. Select Perform. 5. Select Yes. The system empties the waste reservoir.
First Prompt
1. Fill the water bottle with 4 L of cleaning solution: a. When prompted, pull out the waste and water drawer and remove the water bottle. b. Carefully pour 2 containers of ADVIA Centaur XP Cleaning Solution Concentrate into the empty water bottle. c. Add 4 L of water to the water bottle. 2. Load the water bottle onto the system.
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Use care when handling the glass sensors. Glass sensors are fragile and errors occur on the system when the sensors are damaged. a. Disconnect the tubing and remove the sensors and float switch from the water reservoir.
CAUTION
Do not leave water in the water reservoir during the cleaning procedure. Water in the reservoir dilutes the cleaning solution. Empty the water reservoir completely. b. Remove the water reservoir and then empty it. c. If the system uses an onboard waste bottle, remove the waste bottle and empty the contents into a container approved for biohazardous waste. 4. Ensure that the water trap is emptied and the bottle lid is tight. 5. Install the empty water reservoir and waste bottle onto the system: a. Install the empty water reservoir. b. Ensure that you connect the tubing and install the sensors and float switch. c. Install the waste bottle on the system. d. Ensure that the cap on the waste reservoir is tight.
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1 2
Do not select Cancel during the First Prompt. If you select Cancel, you must remove the cleaning solution from the system and install the reagent water in a clean water bottle before you select Continue. 7. Select Continue.
Second Prompt
1. Rinse the water bottle. Remove and thoroughly rinse the water bottle and cap with reagent water. 2. Add 2 L of reagent water to the water bottle. Do not add more than 2 L of water to the water bottle. Excess water causes the waste bottle to fill before the end of the cleaning procedure, causing the procedure to fail. 3. Place the water bottle on the system. 4. Ensure that the water reservoir contains no more than 1.27 cm (0.5 in) fluid. 5. Select Continue.
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Third Prompt
1. Rinse the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors from the water reservoir. b. Remove the water bottle and the water reservoir. c. Thoroughly rinse the water bottle and the water reservoir with reagent water to remove residual cleaning solution. 2. Fill the water bottle with 2 L of reagent water and load it onto the system. 3. Load the empty water reservoir onto the system. Ensure that you connect the tubing and install the sensors. 4. Select Continue.
Fourth Prompt
1. Remove the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors and float switch from the water reservoir. b. Remove the water bottle and the water reservoir and set them aside. 2. Install the empty alternate water reservoir and the empty alternate water bottle on the system. Connect the tubing to the water reservoir and the water bottle. 3. Clean the float switch and sensors. Clean the water reservoir float switch and the sensors using gauze soaked with cleaning solution. 4. Rinse the water reservoir float switch and the sensors twice: a. Rinse the water reservoir float switch and the sensors in a container of reagent water. b. Using fresh reagent water, rinse the water reservoir float switch and the sensors again.
CAUTION
Do not touch the tubing or sensors. Touching the tubing or sensors can cause contamination. 5. Install the float switch and sensors in the water reservoir. Ensure that the float switch is securely seated in the water reservoir.
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6. Move the direct plumbing switch to the On position. a. Ensure that the dot is visible on the direct plumbing switch, which indicates that direct plumbing is enabled.
1 2
b. Close the waste and water drawer. 7. Select Continue. 8. Observe the water filter. 9. If required, vent air through the air vent filter. When priming is complete, the system returns to the Ready state. 10. Thoroughly rinse the water bottle and the water reservoir that you removed from the system with reagent water, and then invert them to dry.
As-Needed Maintenance
For online information about performing maintenance procedures, perform the following steps: 1. At the workspace, select the Status Maintenance button. 2. At the Status Maintenance window, select the appropriate maintenance task: 3. Select Procedure. 4. Follow the instructions in the online help.
NOTE: Most of these procedures are also available in this section of the ADVIA Centaur XP Operators Guide.
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Do not access the system when it is in the Inprocess state or the Cleaning state. In these states, the system can move a subassembly that could cause injuries. 1. Ensure that the system is in 1 of the following states: Ready Warming Up Diagnostic Mechanics Off Check Status
2. Open the cuvette waste area door. 3. Using a Phillips screwdriver, loosen the screw in the top cover.
Screw
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield.
WARNING
Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.
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Do not bend the probe. Bending the probe can cause system errors. 5. Push the reagent probe assemblies toward the incubation ring by pushing the motor. Push reagent probe 1 to the right and then toward the incubation ring. Push reagent probe 2 to the left and then toward the incubation ring.
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1 2 3 4 5
Figure 5-16
6. Gently push the sample probe and ancillary probe assemblies back toward the incubation ring by pushing the motors. 7. Use a disposable transfer pipette to add 0.5 to 1.0 mL of cleaning solution to each rinse station. Refer to Preparing the Cleaning Solution page 5-17. 8. Clean each rinse station using the small maintenance brush.
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9. Gently insert the brush into the rinse station to a depth of 6.3 cm (2.5 in), and swirl the brush inside the rinse station.
1 2
Figure 5-17
Rinse Station
10. Remove the brush and then remove the cleaning solution with a transfer pipette. 11. Clean each rinse station: a. Wipe the rinse station with lint-free tissues or gauze saturated with cleaning solution. b. Wipe the rinse station with lint-free tissues or gauze saturated with reagent water. 12. Close and secure the top cover. 13. Select Turn System Mechanics On.
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 4. Remove the primary reagent packs from the primary reagent compartment and refrigerate them. 5. Remove the reagent probes cover by lifting the cover up and then out.
Figure 5-18
Reagent Compartment
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6. Push the reagent probe assemblies toward the incubation ring by pushing the motors. Push reagent probe 1 to the right and then toward the incubation ring. Push reagent probe 2 to the left and then toward the incubation ring. Push reagent probe 3 toward the incubation ring.
1 2 3 4 5
Figure 5-19
7. Remove the reagent probe shutter: a. Lift the shutter drive arm up and off the shutter drive. b. Slide the shutter to the left until the screw slots are under the screws.
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1 2 3
Figure 5-20
8. Clean the shutter: Refer to Preparing the Cleaning Solution page 5-17. a. Wipe the shutter with gauze soaked with cleaning solution. b. Rinse the shutter with water. c. Thoroughly dry the shutter. 9. Wipe the surface under the shutter with lint-free tissues or gauze saturated with cleaning solution. 10. Dry the surface under the shutter. 11. Install the shutter by sliding it to the right until the screw slots are under the screws, and then placing the shutter drive arm down on the shutter drive. 12. Install the reagent probes cover. 13. When the system is in the Ready state, return the reagent packs to the primary reagent compartment. 14. Close and secure the top cover. 15. Select Turn System Mechanics On.
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not clean the primary reagent compartment while the probes are accessing reagent packs. Injury can result. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Open the primary reagent door.
Figure 5-21
4. Remove the primary reagent packs from the primary reagent compartment and refrigerate them. 5. Wipe excess water from the primary reagent compartment.
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6. Wipe the surfaces of the primary reagent compartment with lint-free tissues or gauze saturated with water.
1 2 3 4
Figure 5-22
7. If reagent has spilled onto the reagent pack holders, wipe the reagent pack holders with lint-free tissues or gauze saturated with water. 8. Dry the primary reagent compartment. 9. Select Turn System Mechanics On. 10. When the system is in the Ready state, return the reagent packs to the primary reagent compartment.
NOTE: Reagent mixing does not occur when System Mechanics are off. Some settling of the Solid Phase reagents can occur if the reagents have not been mixed for 2 hours.
11. Ensure that reagents are resuspended before resuming normal operation. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual for information on checking for a Solid Phase pellet and mixing reagent packs by hand. 12. Close the primary reagent door.
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution page 5-17. 1. Carefully wipe the following components with lint-free tissues or gauze saturated with cleaning solution: sample entry queue exterior covers sample exit queue ancillary entry Stat entry pointing device system fluids tray tray under the system fluids reservoirs tray under the waste and water bottles
2. Rinse the components with lint-free tissues or gauze saturated with water.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution page 5-17. 1. Open the cuvette waste area door. 2. Remove any empty sample tip trays and covers from the tip tray bin. 3. With a Phillips screwdriver, remove the screw at the left of the tip tray waste.
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4. Lift the tip tray bin up and then out of the system.
Figure 5-23
5. Remove the cuvette waste bin, empty it, and set it aside.
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6. Remove the cuvette waste chute by releasing it from the magnetic fitting. Slightly rotate the cuvette waste chute, then pull it out and down.
Figure 5-24
7. Soak the cuvette waste chute in cleaning solution for 5 minutes. 8. While the cuvette waste chute is soaking, clean the cuvette waste reservoir: a. Open the cuvette waste bin drawer.
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b. Wipe the reservoir with lint-free tissues or gauze saturated with cleaning solution.
Figure 5-25
c. Rinse the reservoir with lint-free tissues or gauze saturated with reagent water.
WARNING
Do not splatter yourself or work area with cleaning solution. The cleanins solution is a biohazardous material and must be used carefully. Scrub the cuvette waste
Do not pinch or trap cables or tubing when installing the chute. Pinching the cables or tubing can cause system errors. 10. Install the cuvette waste chute: a. Place the locator pins at the bottom of the chute in the reservoir.
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b. Push up the top of the chute until it attaches to the magnetic fitting.
1 2 3
Figure 5-26
c. Rinse the reservoir with lint-free tissues or gauze saturated with reagent water.
WARNING
Do not splatter yourself or work area with cleaning solution. The cleanins solution is a biohazardous material and must be used carefully. Scrub the cuvette waste
Do not pinch or trap cables or tubing when installing the chute. Pinching the cables or tubing can cause system errors.
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12. Install the cuvette waste chute: a. Place the locator pins at the bottom of the cuvette waste chute in the cuvette waste reservoir. b. Push up the top of the chute until it attaches to the magnetic fitting. Move the top of the cuvette waste chute up until you feel the magnets connect
1 2 3
Cuvette waste reservoir Top of the cuvette waste chute at the magnets Locator pins
Figure 5-27
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13. Ensure that no wires or cables are interfering with the correct positioning of the cuvette waste chute.
1 2
Figure 5-28
14. Install the sample tip tray bin. 15. Install the cuvette waste bin in the drawer and close the door. 16. If you emptied the cuvette waste bin, select Yes at the prompt. 17. If you emptied the tip tray bin, select Yes at the prompt.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution page 5-17. 1. At the workspace, select System Status.
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2. Select Turn System Mechanics Off. 3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 4. Remove the sample tip remover and sample tip waste tube: a. Gently push the sample probe and ancillary probe back toward the incubation ring. b. Loosen the knurled knob on the sample tip remover. c. Lift the sample tip remover and sample tip waste tube up and out of the system.
1 2 3 4
Sample tip waste tube Sample tip remover Sample probe Knurled knob
Figure 5-29
5. Access the sample tip waste chute: a. Open the sample tip waste area door. b. Remove the sample tip waste bin, empty it, and set it aside. c. Pull out the drawer. d. Lift the lid to the cleaning solution bottle and ensure that it remains in the up position. e. Ensure that the checkvalve remains on the end of the tubing. f. Remove the cleaning solution bottle.
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g. Wipe the cleaning solution tubing with fresh lint-free tissues or gauze to remove excess cleaning solution from the outside and tip of the tubing.
WARNING
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 6. Remove the sample tip waste chute by pulling it up and out.
1 2
Do not splatter yourself or work area with cleaning solution. The cleanins solution is a biohazardous material and must be used carefully. Scrub the cuvette waste
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8. Soak the sample tip remover, sample tip waste tube, and sample tip waste chute in cleaning solution for 5 minutes. 9. Clean the sample tip waste reservoir: a. While the sample tip remover, sample tip waste tube, and sample tip waste chute are soaking, wipe the sample tip waste reservoir with lint-free tissues or gauze saturated with cleaning solution. b. Wipe the sample tip waste reservoir with lint-free tissues or gauze saturated with water. c. Dry the sample tip waste reservoir with lint-free tissues or gauze. 10. Clean the sample tip remover, sample tip waste tube, and sample tip waste chute: a. Use the large maintenance brush to clean the inside of the sample tip waste tube and sample tip waste chute. b. Rinse the sample tip remover, sample tip waste tube, and sample tip waste chute with water. c. Set the sample tip waste tube and sample tip waste chute aside to dry completely. d. Thoroughly dry the sample tip remover. e. Connect the sample tip remover to the spare sample tip waste tube. 11. Install the sample tip remover and sample tip waste tube: a. With the slot on the sample tip remover facing away from you, place the bottom of the sample tip waste tube into the opening below the sample probe. b. Align the 2 locator pins on the right side with the holes on the mounting block. c. Turn the knurled knob until the sample tip remover is secure. 12. Close and secure the top cover.
CAUTION
Use care installing the sample tip waste chute. If the sample tip waste chute is not installed correctly on the reservoir or is installed upside down, tip jams can result. Install the chute so that the bottom fits completely in the sample tip waste reservoir. 13. Align the pins on top of the sample tip waste chute with the hooks inside the system, and install the bottom of the chute in the reservoir.
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14. Ensure the wires do not interfere with the sample tip waste chute.
1 2 3 4 5
Reservoir Sample tip waste chute Pin Hook Sample tip waste area wires
Figure 5-31
15. Install the cleaning solution bottle: a. Place the bottle in the drawer. b. Close the lid. c. Close the drawer. 16. Install the sample tip waste bin. 17. Close the sample tip waste area door. 18. Select Turn System Mechanics On.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status.
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3. Select Turn System Mechanics Off. 4. Access the luminometer: a. Remove the reagent probes cover.
Reagent Compartment
Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. b. Slide the retaining clip back and remove the waste probe from the luminometer.
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1 2 3 4
Figure 5-33
Luminometer Assembly
5. Wipe the probe and the cuvette ejector rod with gauze moistened with water. 6. Dry the waste probe and cuvette ejector rod with lint-free tissue or gauze. 7. Install the luminometer cover but do NOT replace the nut. 8. With the cover ajar, reinstall the waste probe so it sits on the white collar in the luminometer. 9. Slide the retaining clip back to lock the probe in position. 10. Ensure that the luminometer cover is securely in place and hand-tighten the nut. 11. Install the reagent probe cover. 12. Close and secure the top cover. 13. Select Turn System Mechanics On. 14. Dry the components thoroughly.
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution page 5-17. 1. Wipe the racks with gauze soaked in cleaning solution.
NOTE: Soaking the rack could cause the labels to come off.
2. Rinse the racks with water. 3. Allow the racks to dry thoroughly.
Do not use sample racks with duplicate numbers. Using sample racks with duplicate sample rack identification barcode numbers can result in sample processing errors. When you receive additional sample rack identification barcode labels, ensure that the number range is different from ranges you currently use on your system. 1. If the sample racks are not labeled, position a sample rack identification barcode label on the rack. The A label indicates multiple tube types. The vertical numbers2, 3, and 4on the sample rack identification barcode label correspond to the tube-type
NOTE: If you are using ADVIA Centaur racks, ensure that you use
ADVIA Centaur labels1, 2, 3, and 4 for the Tube-Type Selector and use the correct barcode. a. Firmly place the sample rack identification barcode label on the right side of the rack and carefully wrap the label around to the front of the rack.
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b. Ensure that the sample rack identification barcode label does not
cover the indents on the front left side of the rack. c. Ensure that you do not have duplicate sample rack identification numbers.
1 2
Figure 5-34
To prepare sample racks to use exclusively for calibrators or QC material, use a Cal or QC label to identify sample racks that contain calibrators or QC material.
1 2
Figure 5-35
The Cal and QC labels remind you where to place the tube-type selector to match the calibrator or QC material tube type in the sample rack. Refer to the Setup Tube Type & Barcode window to verify the tube-type positions specified for your system.
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On the front of the sample rack identification barcode label, apply a Cal or QC label at the position corresponding to the tube type you use for calibrators or QC material.
Figure 5-36
For the remaining racks, you can use the tube-type labels to represent the 4 types of tubes you specified at the Setup Tube Type & Barcode window. The vertical numbers, 1 to 4, on the sample rack identification barcode label correspond to the 4 tube-type positions specified at the Setup Tube Type & Barcode window. For example, if you select Large Transfer as Tube Type 1, you can select 1 of the tube type labels to represent large transfer tubes. You can use the blank labels to create your own tube-type labels or color-coded system. Use a permanent marker to write on the blank labels. 1. Apply the tube-type labels to the front of the sample rack identification barcode label, matching each tube-type label to the tube type position you specified at the Setup Tube Type & Barcode window. For example, if Tube Type 1 is Large Transfer, place the tube-type label you selected to represent large transfer tubes at position 1 on the sample rack identification barcode label. The tube-type labels remind you where the tube-type selector should be located to match the type of tube you place in the sample rack. 2. On the front of the sample rack, align the top and left edge of the first tube-type label with the top and left edge of the sample rack identification barcode label.
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3. Without overlapping the labels, position the next tube-type label directly below the previous tube-type label. Up to 4 tube-type labels can be placed on the sample rack identification barcode label.
1 2
Sample rack label top, left edge Sample rack next label
Figure 5-37
4. Install a tube-type selector on the labeled sample rack: a. Install a tube-type selector on the front of the labeled sample rack. b. Move the tube-type selector to the position corresponding to the type of tube you are using in the sample rack.
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c. Ensure that the tube-type selector does not cover the sample rack identification barcode number.
1 2
Figure 5-38
Clip
Figure 5-39
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Resetting the Thermals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70 Performing the Vacuum Test . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70 Performing the Sample Barcode Read Test . . . . . . . . . . . . . . . 6-71 Priming Functions Prime System . . . . . . . . . . . . . . . . . . . . . 6-72 Priming Functions Prime Fluid Line. . . . . . . . . . . . . . . . . . . . 6-74 Priming Functions Prime System Fluid Bottle . . . . . . . . . . . . 6-76 Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77
Barcode Scanning Technique. . . . . . . . . . . . . . . . . . . . . . . . . . 6-89 Barcodes Reserved for ADVIA Centaur XP Systems. . . . . . . . 6-89
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Assay Specific Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-106 Investigating Failed Proficiency Testing Results. . . . . . . . . . . 6-106
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-107
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Use the System Event Log window to identify errors and access online information about possible causes and corrective action procedures. The system has 3 types of event codes that can display in the event log:
Event Type Critical Warning Symbol Red triangle Yellow triangle Definition This type of error indicates that the system stopped processing samples. This type of error indicates that a problem exists with a subassembly or supply. The system continues to process samples.
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Symbol No symbol
Definition This type of event is not an error condition, but provides a record of when normal operation occurrences happened.
You can display specific information at the System Event Log window by selecting the appropriate View and Sort combinations: The View that you select determines the information that the system displays. For example, if you select Errors, the system displays only the events that are errors. The Sort that you select determines the order in which the system displays the events. For example, if you select Severity, the system displays the events in order of most severe to least severe.
The following table describes the View and Sort combinations you can use to perform some routine tasks:
Task Display the events in reverse chronological in order of when the events occurred Display the critical and warning events in order of most severe to least severe Display the events by subsystem View Events Errors Events Sort Date Severity Subsystem
1. At the workspace, select Event Log. 2. Select the appropriate view and identify the problem you want to solve. To search for a specific event code in the event log, select Event Code in Search for and then enter the event code. 3. Locate the possible causes and corrective action procedures for the error: a. At the System Event Log window, select Procedure. b. At the online information window, select Search. c. At the Simple Search window, type the event code exactly as it displays in the event log, including spaces. You can also enter words that describe the event. d. Select Enter. The system displays a list of possible causes and corrective actions. 4. Select a corrective action item to display the procedure on how to perform that corrective action. 5. If you perform a procedure that is a maintenance activity, log the activity at the Status Maintenance window. 6. Enter a comment, if necessary, to provide additional information about the cause or resolution of an individual event code: a. Select the event.
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b. Select Comments. c. At the Comments window, enter a comment. You can enter up to 3 comments. You can enter comments of up to 120 alphanumeric characters. The system enters your initials and the date. If you are not currently signed in, you must sign into the system. d. Select Save. If the procedure does not correct the problem or if the problem occurs again, call for technical assistance.
If you see this event, write down the event code or print the window and then call for technical assistance.
Do not disconnect the system. Disconnecting the system turns off the thermal components of the primary reagent compartment and ancillary queue. Shut down the system instead. 2. Select Turn System Off. 3. At the prompt, press any key to continue. 4. Wait approximately 2 minutes while the system powers down. This does not remove power from the thermal devices such as reagent refrigeration and probe heaters. 5. Check for obstructions in the following areas before rebooting the system: sample entry queue sample exit queue sample tip loader ancillary entry Stat entry
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Figure 6-1
7. Log in as centaur and then press Enter twice. Use all lower case letters for the login. A password is not required. 8. Wait until the system state is Ready, and then resume normal operation.
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Figure 6-2
After pressing a fast stop button, perform the following steps: 1. At the prompt, select Continue. 2. Remove the obstruction.
CAUTION
Do not disconnect the system. Disconnecting the system turns off the thermal components of the primary reagent compartment and ancillary queue. Shut down the system instead. 3. Check for obstructions in the following areas before rebooting the system:
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rack loader rack exit pusher sample tip loader ancillary entry
Figure 6-3
5. Wait until the system state is Ready. 6. If an error occurs during homing, check the event log and follow the steps prescribed in online troubleshooting. 7. At the workspace, select System Status. 8. Select Diagnostic Tools. 9. At the System Diagnostic Tools window, select Home System.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 10. Select Perform. 11. At the System Diagnostic Tools window, select Empty & Fill Ring.
WARNING
Ensure that you are clear of subassemblies that can move before closing the System Diagnostic Tools window. The system returns subassemblies to their home positions and can cause injury.
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12. Close the System Diagnostic Tools window. 13. When the process completes successfully, resume normal operation.
Do not leave the system on if the power is disrupted for an extended period of time. Leaving the power on could cause serious damage to the system when the power is restored.
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If the power disruption is so brief that you do not have the opportunity to turn the main power switch off, reset the system. 1. Turn the main power switch off.
1 2
Figure 6-4
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Do not leave the top cover open when you add cuvettes to the cuvette loading bin. Leaving the top cover open allows cuvettes to fall into another part of the system where it may obstruct normal operation. Close the top cover when adding cuvettes to the cuvette loading bin.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.
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1 2 3 4
5 6 7
Figure 6-5
4. Check to see if the cuvettes are stacked in the bin and are preventing loading. You can mix the cuvettes in the bin until they are no longer stacked. 5. Inspect the cuvettes in the bin and remove any damaged or deformed cuvettes. A cuvette can be damaged and contaminated if it was dropped, stepped on, and then loaded into the cuvette loading bin. A deformed cuvette can have a string of plastic coming off of it or be imperfectly molded. 6. Notify your technical representative if you find many deformed cuvettes. 7. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.
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8. Remove and discard all cuvettes from the orientation chute and vertical cuvette chute using a disposable transfer pipette.
1 2
Figure 6-6
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1 2
Figure 6-7
10. Look for the cuvette at the bottom window of the vertical cuvette chute. 11. If the cuvette does not appear in the bottom window, there is an obstruction in the vertical cuvette chute.
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12. Remove the obstruction: a. Loosen the thumbscrew at the bottom window of the vertical cuvette chute.
Thumbscrew
Figure 6-8
b. Remove the window. c. Pull any jammed cuvettes or other obstruction down and out of the system or use a transfer pipette to dislodge the obstruction. d. Loosen the 2 screws and remove the vertical cuvette chute. e. Check the vertical cuvette chute for obstructions. f. Replace the vertical cuvette chute. g. Replace the vertical cuvette chute window and tighten the thumbscrew.
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13. Manually move the conveyor upward and look for binding.
1 2
Figure 6-9
Cuvette Conveyor
14. Ensure that no cuvettes are jammed in the preheater. 15. Select Turn System Mechanics On. 16. At the Status Supplies window, select Prime Cuvettes.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 17. Select Perform. 18. Check for air blowing down from the ionizer, which means the conveyor is online even if it does not move. 19. Ensure that cuvettes are loaded onto the cuvette conveyor and orientation chute correctly. 20. Watch the movement of the cuvette conveyor. The conveyor should move freely. 21. Close and secure the top cover. 22. Return to normal operation. 23. If the error persists, call for technical assistance.
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To improve the system recovery time after any of these events, perform the Empty
& Fill Ring procedure:
1. At the Workspace window, select System > Diagnostic Tools. 2. At the System Diagnostic Tools window, select Empty & Fill Ring. Performing the procedure immediately rather than waiting for the system-initiated procedure to empty and fill the incubation ring reduces the system recovery time. 3. Select Load Tip Tray.
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1 2 3
4 5 6
Figure 6-10
Preheater Assembly
7. Look for any obstructions in the preheater. 8. Remove any jammed cuvettes. 9. Ensure that there are 14 cuvettes in the preheater and that there are no spaces between the cuvettes.
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1 2
Figure 6-11
11. Replace the preheater cover and tighten the thumbscrew. 12. Close and secure the top cover. 13. Select Turn System Mechanics On. 14. Return to normal operation. 15. If the error persists, call for technical assistance.
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Do not turn the knob for the rotor until you move the waste probe up. Turning the knob before moving the waste probe can damage the waste probe. 6. Move the waste probe to the up position.
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7. Turn the knob on the left bottom of the luminometer and listen for cuvettes dropping into the waste bin.
Knob
Figure 6-13
Luminometer
8. If the cuvettes do not drop into the waste bin and the luminometer does not turn, check for obstructions in the cuvette waste chute and clean the cuvette waste chute. 9. Remove the black elevator cover by loosening the thumbscrew.
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10. If a cuvette dropped into the elevator as you were rotating the luminometer, remove the cuvette.
Thumbscrew
Figure 6-14
Elevator Cover
11. Put your finger into the luminometer through the elevator and check for evidence of fluid in the luminometer. If your glove is wet, call for technical assistance. 12. Install the elevator cover, ensuring that the left side is flush with the edge of the elevator. 13. Verify that the luminometer is operating correctly: a. Select Turn System Mechanics On. b. At the workspace, select System Status. c. Select Diagnostic Tools. d. At the System Diagnostic Tools window, select Home Luminometer.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. e. Select Perform. f. If the error persists, select Dark Count with Cuvettes.
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g. Select Perform.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 14. Close the System Diagnostic Tools window. 15. Install the reagent probes cover. 16. Close and secure the top cover. 17. Return to normal operation. 18. If the error persists, call for technical assistance.
Replacing Probes
This section contains procedures for replacing these probes: ancillary probe reagent probes aspirate probe waste probe
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials.
WARNING
Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.
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2. At the workspace, select System Status. 3. Select Turn System Mechanics Off.
NOTE: It is not necessary to remove the tubing from the volume check sensor when disconnecting the tubing from the probe.
5. Remove the old probe from the sleeve and discard it in a container approved for sharp objects.
1 2 3 4
Figure 6-15
Ancillary Probe
6. Install a new ancillary probe. 7. Tighten the sleeve using the pliers. 8. Connect the tubing. 9. Ensure that the top and bottom gaskets are in place. 10. Select Turn System Mechanics On.
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11. Check for leaks: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System Diagnostic Tools window, select Dispense Test.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. d. Select Perform. e. Observe the ancillary probe as it moves. If the probe movement is binding, check for interference from tubing or wiring.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 12. Close the System Diagnostic Tools window. 13. Close and secure the top cover. 14. Return to normal operation. 15. If the error persists, call for technical assistance.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Open the top cover.
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4. Remove the reagent probes cover by lifting the cover up and then out.
Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 5. Push the tubing off of the top of the reagent probe. 6. Loosen the probe sleeve.
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1 2 3
Figure 6-17
Reagent Probe
7. Pull the probe down and remove the old reagent probe and sleeve from the holder. 8. Remove the old probe from the sleeve and discard it in a container approved for sharp objects. 9. Install a new reagent probe. 10. Tighten the probe sleeve using the pliers. 11. Connect the tubing. 12. Select Turn System Mechanics On. 13. Verify that the probe is operating correctly: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System Diagnostic Tools window, select Dispense Test.
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Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. e. Select Perform. f. Ensure that the fluid dispense is steady and straight, with no sputtering. g. Ensure that there are no leaks at the tubing connection.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 14. Close the System Diagnostic Tools window. 15. Close and secure the top cover. 16. Install the reagent probes cover. 17. Return to normal operation. 18. If the error persists, call for technical assistance.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Turn System Mechanics Off.
WARNING
Use care when working with the aspirate probe. The probe tips are sharp and can cause skin punctures.
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4. Remove and discard the aspirate probe: a. Slide the probe clip away from the probe.
1 2 3
Figure 6-18
Wash Block
NOTE: To prevent the aspirate probe from bending, grasp the probe with
the index finger and thumb and carefully disconnect the grounding wire from the aspirate probe.
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b. If you are removing a grounded aspirate probe, disconnect the grounding cable from the aspirate probe.
1 2 3
Figure 6-19
c. Carefully push the tubing off of the probe. d. Carefully lift the probe straight up until it clears the port and then lift the probe towards the front of the system to remove it from the probe holder without bending it. e. Discard the probe in a container approved for sharp objects.
NOTE: Ensure that you use the correct type of aspirate probe. The
grounded aspirate probe has connections for a grounding cable and tubing. 5. Install a new aspirate probe: a. Insert the probe tip into the probe entrance port. b. Push the probe into place. c. Connect the tubing to the new aspirate probe.
NOTE: To prevent the aspirate probe from bending, grasp the probe with
the index finger and thumb and carefully push the grounding wire onto the new aspirate probe. d. If you are installing a grounded aspirate probe, connect the grounding cable to the aspirate probe.
CAUTION
Ensure that you return the probe clip to its locked position to hold the probe firmly in place. Failure to do so can cause mechanical error or poor results.
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1 2
Figure 6-20
Wash Block
6. Close and secure the top cover. 7. Select Turn System Mechanics On. 8. Verify that the probe is operating correctly: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System Diagnostic Tools window, select Dispense Wash Fluid & Aspirate. d. Select the probe you replaced. e. Select a fluid.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. f. Select Perform.
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Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window. 10. Return to normal operation. 11. If the error persists, call for technical assistance.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Turn System Mechanics Off.
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Figure 6-21
5. Remove the waste probe: a. Slide the probe clip away from the probe. b. Push the tubing off of the probe.
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c. Carefully lift the probe up until it clears the waste probe guide and then lift the probe forward to remove it from the probe holder without bending it.
1 2 3
Figure 6-22
Luminometer
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1 2
Figure 6-23
Luminometer Assembly
6. Wipe the top of the waste probe guide with an alcohol prep pad. 7. Place the luminometer cover over the luminometer. Do not secure it at this time.
NOTE: Ensure that you use the correct type of probe. The aspirate probes are
cupped at the tip. The waste probe is flat at the tip. 8. Install a new waste probe: a. Attach the waste tubing to the new waste probe. b. Lift up the luminometer cover slightly to insert the probe tip into the waste probe guide. c. Lower the luminometer cover and push the probe into place.
CAUTION
Ensure that you return the probe clip to its locked position to hold the probe firmly in place. Failure to do so can cause mechanical error or poor results. d. Slide the probe clip into place, locking the probe.
CAUTION
Do not pinch the base pump tubing and wiring under the luminometer cover. Pinching the tubing or wiring can lead to malfunctions.
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9. Install the nut that secures the luminometer cover. 10. Close and secure the top cover. 11. Install the reagent probes cover. 12. Select Turn System Mechanics On. 13. Verify that the waste probe is operating correctly: a. Select Diagnostic Tools. b. At the System Diagnostic Tools window, select Home Luminometer.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. c. Select Perform. d. If the waste probe is binding, check the routing of the tubing and the position of the probe clip.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 14. Close the System Diagnostic Tools window. 15. Return to normal operation. 16. If the error persists, call for technical assistance.
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Remove the main waste bottle fluid sensor: a. Pull out the waste and water drawer. b. Lift the waste bottle lid. c. Move the clamp on the sensor aside and remove the sensor from the bottle. d. Close the waste bottle lid. e. Twist the sleeve on the connector counterclockwise to remove the old waste bottle fluid sensor.
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f.
1 2
Figure 6-24
4. Twist the sleeve on the connector clockwise to tighten the new waste bottle fluid sensor.
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5. Install the fluid sensor in the waste bottle and move the clamp to cover the sensor.
Figure 6-25
6. Push in the waste and water drawer. 7. Select Turn System Mechanics On. 8. Verify the installation: a. At the workspace, select the Supplies Status button. b. At the Status Supplies window, ensure that the Liquid Waste field displays the OK status message. 9. Resume normal operation.
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3. Remove cuvettes and sample tips that may be obstructing the inprocess queue. 4. Manually move the inprocess queue to the right. 5. Remove the used sample tip tray from the tip tray support.
1 2
3 4
Figure 6-26
6. Lift the sample tip trays out of the sample tip loader. 7. Open the cuvette waste area door.
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Do not bend the latch while removing the jammed sample trays from the sample tip loader. Bending the latch can cause more sample tip tray jams.
Latch
Do not bend pull a jammed tray up through the top of the sample tip loader. Pulling a jammed trays through the top of the sample tip loader can damage the spring clips. Pull jammed trays down through the sample tip tray waste area. 9. If a sample tip tray is stuck in the loader, carefully pull the sample tip tray down through the sample tip tray waste area.
NOTE: If you find a deformed sample tip or sample tip tray in the system, notify your technical representative .
10. Load a new sample tip tray into the sample tip loader: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System Diagnostic Tools window, select Load Tip Tray.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury.
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d. Select Perform. 11. Ensure that the sample tip tray loader and inprocess queue perform the following sequence of events as a new tray is loaded: latch snaps over the new sample tip tray cover new sample tip tray drops down smoothly sample tip trays in the loader are not stuck together sample tip tray drops down over the pins on the tip tray support when the inprocess queue moves right, the sample tip tray is locked completely onto the pins as the sample tip tray is pulled out of the loader when the inprocess queue moves right, the cover stays in the loader the cover drops down into the tip tray waste area the empty sample tip tray drops smoothly down into the tip tray waste area
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 12. Close the System Diagnostic Tools window. 13. Close and secure the top cover. 14. Return to normal operation. 15. If the error persists, call for technical assistance.
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Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. Remove all the sample racks from the sample exit queue.
Figure 6-28
2. Remove any objects from the sample exit queue. The sensor under the plate of the sample exit queue is magnetic and is able to detect metal objects such as pens and eye glasses at the right end of the sample exit queue. 3. Clean the sample exit queue. 4. If the error persists, call for technical assistance.
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Troubleshooting Leaks
Use this procedure if you find substantial amounts of liquid in or around the system.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions page A-1 for recommended precautions when working with biohazardous materials. 1. Press 1 of the fast stop buttons.
Figure 6-29
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Do not disconnect the system. Disconnecting the system turns off the thermal components of the primary reagent compartment and ancillary queue. Shut down the system instead. 3. Select Turn System Off and then select Yes. 4. Access the area of the system where you believe the leak might be originating from. 5. Look for the following problems: tubing that is not connected to its fitting leaky valves reservoirs not installed correctly clogs in rinse stations
6. Reconnect the tubing. 7. Check for obstructions in the following areas before rebooting the system: sample entry queue sample exit queue sample tip loader ancillary entry
Figure 6-30
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9. Wait until the system state is Ready. 10. At the workspace, select System Status. 11. Select Diagnostic Tools. 12. At the System Diagnostic Tools window, select Prime Functions and then select Prime Fluid Line. 13. Select the fluid you want to prime.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 14. Select Perform.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 15. Close the System Diagnostic Tools window. 16. If the process completes successfully, resume normal operation.
Do not use diagnostic tools or perform troubleshooting without observing all safety rules. System components move and can cause injury. Only individuals trained by Siemens Medical Solutions Diagnostics should perform troubleshooting. Diagnostic Tools allow you to prime the system, test the operation of system components, and move system components when you perform corrective action procedures.
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3. Select a test and then select Perform. For some tests, the system prompts you to perform certain actions.
Empty Ring
Use this test to empty the cuvettes from the incubation ring. During this test, the system performs the following actions: checks that the cuvette waste bin can accept another 115 cuvettes homes all subassemblies moves a cuvette into the luminometer and then the incubation ring indexes to advance 1 cuvette The system repeats these steps until all cuvettes are out of the incubation ring. During this test, the cuvette pusher is not active. You can observe that the system correctly empties cuvettes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Empty Ring.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury.
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5. Select Perform. This process takes approximately 12 minutes to complete. 6. As the system moves all cuvettes out of the incubation ring, watch and listen as the incubation ring, elevator, and luminometer move. 7. If cuvettes are jamming, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
During this test, the system performs the following actions: checks that the cuvette waste bin can accept another 115 cuvettes homes all subassemblies elevator moves a cuvette into the luminometer, the incubation ring indexes to advance 1 cuvette and then the cuvette loader loads a cuvette into the incubation ring. The system repeats these steps until all cuvettes are out of the incubation ring and replaced with clean cuvettes. During this test, the cuvette pusher is active.
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You can observe that the system correctly empties cuvettes and fills the ring with cuvettes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Empty & Fill Ring.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. As the system moves all cuvettes out of the incubation ring and loads new cuvettes into the ring, watch and listen as the cuvette pusher, incubation ring, elevator, and luminometer move. This process takes approximately 12 minutes to complete. 7. If cuvettes are jamming, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
Prime Cuvettes
Use this test to perform the following: start the cuvette conveyor after the cuvette supply is replenished start the cuvette conveyor after you recover from a cuvette loading jam
During this test, the system performs the following actions: cuvette conveyor moves to fill the vertical cuvette chute with cuvettes
During this test, the cuvette pusher is not active. You can observe that the system correctly loads cuvettes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status.
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3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Prime Cuvettes.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the cuvette conveyor moves. The ionizer is also activated when the cuvette conveyor is operating. You can verify that the ionizer is on by feeling for air blowing down under it as the cuvette conveyor moves. 7. If the cuvettes are jamming, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
Dispense Test
Use this test to perform the following: observe the integrity of the stream of water dispensed into the rinse station by ancillary and reagent probes verify correct installation of a new probe investigate vacuum or water errors
During this test, the system performs the following actions: homes all subassemblies homes all probes over the rinse stations turns the vacuum and the water pump on activates the rinse station vacuum valve dispenses water into the rinse station repeats the dispense for a selected number of repetitions
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the wash station diluters correctly. 1. Ensure that the diluter drawer is in the closed, upright position.
.
1 Diluter drawer
Figure 6-31
Diluter Drawer
2. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 3. At the workspace, select System Status. 4. Select Diagnostic Tools. 5. At the System Diagnostic Tools window, select Dispense Test. 6. Select the probe you want to test. 7. Select the number of times you want the probe to dispense.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 8. Select Perform. The system homes all subassemblies. 9. Look at the stream of fluid as the system dispenses. 10. Ensure that the stream is straight and steady, with no dripping. 11. If the probe is dripping, look for a leaking valve.
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12. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 13. Close the System Diagnostic Tools window.
Home Probes
Use this test to perform the following: move the 3 reagent probes, their associated diluters, and the ancillary probe into primary positions identify probe move errors caused by interfering tubing or wiring replace a reagent or ancillary probe verify the installation of a new reagent or ancillary probe clean the reagent probe shutter verify the installation of the reagent probe shutter access the luminometer, preheater, or elevator
During this test, the reagent probe moves to the following positions: homes vertically homes horizontally toward the cuvette homes horizontally toward the reagent pack homes horizontally to its rinse station homes the associated diluter
This test does not home the reagent probe shutter or the reagent mixer. During this test, the ancillary probe performs the following actions: homes vertically, then homes horizontally in the pack-cuvette direction and then horizontally to its rinse station homes the associated diluters
You can observe that the system correctly homes the primary and ancillary reagent probes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools.
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Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the reagent and ancillary probes move. 7. If the probes do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
Home Probe
Use this test to perform the following: move the sample probe into its primary position investigate sample probe movement errors
During this test, the sample probe moves to the following positions: homes vertically homes the probe horizontally in the rack-to-cuvette direction moves the probe horizontally toward the ring moves down as if ejecting a tip moves horizontally to the tip remover moves up and stays above the tip remover sample diluter homes
You can observe that the system correctly homes the sample probe: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status.
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3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Home Probe.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the sample probe and inprocess queue move. 7. If the probe does not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
During this test, the system performs the following actions: homes the sample probe, inprocess queue, rack loader, rack exit pusher, stat pusher, and sample tip loader checks for the presence of a tip tray and the absence of a tip band removes the current tray loads a new tip tray
You can observe that the system correctly loads a tip tray: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.
CAUTION
Do not leave tips on the sample tip tray on the inprocess queue when you eject the tray. If tips are are on the tray when you eject the tray, a jam occurs. Ensure that the sample tip tray on the inprocess queue is empty before you select this tool. 2. Remove the sample tip tray from the inprocess queue: a. Manually move the inprocess queue so you can access the sample tip tray.
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b. Move the sample tip tray to the left to disengage the tray from the locking pins.
1 2
3 4
Figure 6-32
c. Lift the sample tip tray off the tray support. 3. At the workspace, select System Status. 4. Select Diagnostic Tools. 5. At the System Diagnostic Tools window, select Load Tip Tray.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 6. Select Perform. 7. Select Continue. The system resets the counter that determines which tip to pick up next.
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8. Watch and listen as the sample tip loader loads a new sample tip tray. 9. If the sample tip tray does not load correctly, check the event log for related errors and then correct the problem or call for technical assistance. 10. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 11. Close the System Diagnostic Tools window.
Luminometer Tools
Use the following diagnostic tools to test the luminometer.
During this test, the system performs the following actions: homes all subassemblies turns vacuum and water on, but they are not used verifies that there are enough empty, sequential cuvettes to perform the selected number of repetitions loads an empty cuvette in to the luminometer takes a PMT reading when the empty cuvette is moved to the PMT
During this test, the luminometer stays empty after the last cuvette is ejected. New cuvettes are not automatically loaded into the incubation ring, but the system knows the location of the empty slots. You can evaluate the performance of the PMT and luminometer: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Dark Count with Cuvette.
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4. In Number of Cuvettes, select the number of cuvettes you want to use for the test.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. The System Dark Count Data window opens at the completion of the test. If you select 8 cuvettes, the system displays values for the RLU 1 fields. If you select 16 cuvettes, the system displays values for the RLU 1 fields and RLU 2 fields. If you select 24 cuvettes, the system displays values for the RLU 1 fields, RLU 2 fields, and RLU 3 fields. 6. Record the Total Mean. Ensure that the difference between the values for Total Mean obtained in this test and Total Mean obtained in the Dark Count without Cuvettes test is less than 25. RLUs higher than 25 may indicate light leaks. Refer to the procedure Dark Count without Cuvette page 6-54. 7. If the dark count test does not meet specifications, call for technical assistance.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System Diagnostic Tools window.
During this test, the system performs the following actions: homes all subassemblies ejects all cuvettes from the luminometer turns vacuum and water on, but they are not used takes PMT readings at empty slots in the luminometer
During this test, the incubation ring and elevator are not used.
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You can evaluate the performance of the PMT and luminometer: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Dark Count without Cuvette. 4. In Number of Cuvettes, select the number of readings you want for the test. When you select the Dark Count without Cuvette test, the system uses the selection from this list as the number of readings it performs at empty slots in the luminometer.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. The System Dark Count Data window opens at the completion of the test. If you select 8 cuvettes, the system displays values for the RLU 1 fields. If you select 16 cuvettes, the system displays values for the RLU 1 fields and RLU 2 fields. If you select 24 cuvettes, the system displays values for the RLU 1 fields, RLU 2 fields, and RLU 3 fields. 6. Record the Total Mean and Total SD values: a. Ensure that the value for Total Mean is less than 600.
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RLUs higher than 600 may indicate a defective PMT, a wet or dirty luminometer, electronic noise, or light leaks.
1 2
Figure 6-33
b. Find the Total Mean value that you obtained in the dark count test on the x-axis and determine the corresponding Total SD specification limit from the curve on the chart. c. Verify that the Total SD value that you obtained in the dark count test is at or below the Total SD specification limit. For example, if the Total Mean value of the dark count test is 80, according to the chart, the corresponding Total SD specification limit is 15.00. A Total SD value of 15.00 or less in the dark count test is within specifications. 7. If the dark count test does not meet specifications, call for technical assistance.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System Diagnostic Tools window.
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Home Luminometer
Use this test to perform the following: move the luminometer and its associated subsystem components into their primary positions investigate waste probe home sensor errors investigate luminometer home sensor errors recover from a cuvette jam in the luminometer or elevator
During this test, the system performs the following actions: checks and homes the elevator down position homes the waste probe moves luminometer to the next load position rotates and pauses luminometer at the remaining 7 positions while the cuvette ejector rod moves down homes luminometer
You can observe that the system correctly homes the luminometer: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. At the System Diagnostic Tools window, select Home Luminometer.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. 5. Select Perform. 6. Listen as the luminometer moves. 7. If the luminometer does not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
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Home Probes
Use this test to perform the following: move the aspirate probes to their primary positions (up) If they are already up, they move down slightly and then back up. identify errors caused by interfering tubing or wiring replace or clean aspirate probes
You can observe that the system correctly homes the aspirate probes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Home Probes.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the aspirate probes move. 7. If the aspirate probes do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
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During this test, the system performs the following actions: homes all subassemblies turns vacuum on moves inprocess queue right so you can see the aspirate probes indexes and moves incubation ring opens fluid valves homes diluter dispenses selected fluid into a cuvette through the selected fluid path and dispense port or location selected aspirate probe moves down and aspirates fluid out of the cuvette incubation ring indexes and moves the cuvette to the elevator elevator moves the cuvette into the luminometer incubation ring indexes and moves the cuvette to the selected aspirate probe, if necessary luminometer moves and the system ejects the cuvette
This sequence is repeated for the selected number of repetitions. You can observe that the system correctly dispenses and aspirates wash fluid:
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NOTE: If the diluter drawer is not closed, the system does not prime the wash station diluters correctly.
Diluter drawer
Figure 6-34
Diluter Drawer
2. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 3. At the workspace, select System Status. 4. Select Diagnostic Tools. 5. Select Dispense Wash Fluid & Aspirate. 6. Select the dispense port and aspirate probe pair you want to test. 7. You can select the fluid you want the probe to dispense. 8. Select the number of times you want the selected probe to dispense the selected fluid.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 9. Select Perform. 10. Watch the port dispense the fluid. The stream should be straight and steady.
NOTE: Some dispense ports dispense fluid from 2 locations.
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Dispense port 1 dispenses from the right and left sides of aspirate probe 1.
1 2
Figure 6-35
Wash Block
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Dispense port 2 dispenses from the right and left sides of aspirate probe 2.
1 2
Figure 6-36
Wash Block
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Dispense port 3 dispenses from the right and left sides of aspirate probe 3.
1 2
Figure 6-37
Wash Block
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The wash displacement port dispenses from the area between aspirate probe 2 and aspirate probe 3 and the resuspension ports are on the right end of the manifold.
1 2 3 4 5
Wash displacement port Resuspension port 2 for water Resuspension port 3 for wash 1 Acid Resuspension port 1 for wash 3
Figure 6-38
Wash Block
11. Watch the aspirate probe aspirate the fluid. All fluid should be aspirated. 12. If the system does not home or if there is a problem with the dispense or aspirate, check the event log for related errors and then correct the problem or call for technical assistance. 13. If the process completes successfully, close and secure the top cover and then resume normal operation. 14. Install the cover behind the sample entry queue.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 15. Close the System Diagnostic Tools window.
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1. At the workspace, select Event Log. 2. At the System Event Log window, select Communication Diagnostics. 3. To temporarily stop communications between your system and the LIS, select Suspend Communications and then select Save. The ADVIA Centaur XP system does not send information to the LIS, but can receive information. Information received by the ADVIA Centaur XP system is not scheduled in the worklist until you select Reset LIS Communications. 4. To investigate LIS communication problems, select Perform Diagnostics.
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During this test, the vacuum and water pump are off. You can observe that the system correctly homes the system: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Home System.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. Select Perform. 5. If the subassemblies do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 6. If the process completes successfully, resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 7. Close the System Diagnostic Tools window.
You can observe that the system correctly homes the inprocess queue:
NOTE: If the inprocess queue is in the home position, move it out of the home
position before performing this procedure. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools.
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Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the inprocess queue and sample probe move. a. If the inprocess queue and sample probe do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. b. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 7. Close the System Diagnostic Tools window.
You can evaluate if the system correctly homes the ancillary queue: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Home Ancillary Queue.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. Select Perform. 5. Listen as the ancillary queue moves. a. If the ancillary queue does not move correctly, check the event log for related errors and then correct the problem or call for technical assistance.
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Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 6. Close the System Diagnostic Tools window.
checks that the exit queue is not full moves the inprocess queue slot to the rack exit position extends and retracts the rack exit pusher stat/sample pusher pushes the rack right
The system repeats these steps until all sample racks are ejected from the inprocess queue or until the sample exit queue is full You can observe that the system correctly empties the inprocess queue: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Empty Inprocess Queue.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform.
NOTE: The sample exit pusher moves even if there is no rack in that position of
the inprocess queue. 6. Watch and listen as the sample exit pusher pushes the racks out of the inprocess queue.
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7. If the inprocess queue and sample probe do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
checks that an ancillary pack is not in the ancillary entry moves the next slot in the ancillary queue to the exit position opens the ancillary door extends the ancillary entry pusher moves the ancillary queue counterclockwise retracts the ancillary entry pusher and pack closes the ancillary door waits until the ancillary pack is removed from the ancillary entry
The system repeats these steps for all slots in the ancillary queue. You can observe that the system correctly empties the ancillary queue: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Empty Ancillary Queue.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. Select Perform. 5. Remove the ancillary pack from the ancillary entry.
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6. Store the ancillary packs in a refrigerator if you need to continue checking this area. 7. If the ancillary queue and ancillary probe do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System Diagnostic Tools window.
1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Reset Thermals. 4. Select Perform. 5. Close the System Diagnostic Tools window.
1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Vacuum Test. 4. Select Perform. Wait until the system displays Vacuum Low, Vacuum Normal, or Vacuum High at the System Vacuum Test window. 5. Select Cancel Test to stop the system vacuum and conclude the test.
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6. If the system displayed Vacuum Low or Vacuum High, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the Vacuum Test completes successfully, resume normal operation. 8. Close the System Diagnostic Tools window.
LASER WARNING
Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Sample Barcode Read Test. 4. Perform the appropriate action:
If you want to... test sample barcode scanning when a rack enters the system through the sample entry queue, test sample barcode scanning when a rack enters the system through the Stat entry, WARNING Then select...
Routine. Stat.
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. Wait until the System Sample Barcode Read Test window opens with the test results.
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6. If the test results are unacceptable, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the test results are acceptable, return to normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System Diagnostic Tools window.
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NOTE: If the diluter drawer is not closed (up), the system does not prime the
wash station diluters correctly. 1. Ensure that the diluter drawer is in the closed, upright position.
Diluter drawer
Figure 6-39
Diluter Drawer
2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Prime Functions, and then select Prime System.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. If the system does not prime correctly, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the process completes successfully, resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System Diagnostic Tools window.
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You can observe that the system correctly primes the fluid line:
NOTE: If the diluter drawer is not closed (up), the system does not prime the
wash station diluters correctly. 1. Ensure that the diluter drawer is in the closed, upright position.
Diluter drawer
Figure 6-40
Diluter Drawer
2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System Diagnostic Tools window, select Prime Functions and then select Prime Fluid Line.
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5. Select the fluid line you want to prime. 6. Select the fluid you want to prime. 7. Select the number of times you want to prime the fluid.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 8. Select Perform. 9. You can observe the diluters while the system is performing the test: a. Access the area of the system where you suspect a problem:
To test the... sample or ancillary diluters, reagent probe diluters, other system diluters, Perform these steps... loosen the screw on the left side of the system that secures the top cover and then open the top cover. loosen the 2 thumbscrews on the left side of the system and then lift the cover up and off. open the diluter drawer to observe the diluters move.
1 2
Figure 6-41
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1 2 3
From left to right: Reagent Probe 3 Diluter, Reagent Probe 2 Diluter, Reagent Probe 1 Diluter From left to right: Sample Diluter, Ancillary Diluter From left to right: Resuspend Dispense Diluter, Dispense 1 Diluter, Dispense 2 Diluter, Wash Displacement Diluter, Dispense 3 Diluter
Figure 6-42
c. Ensure that the stream is straight and steady. 10. If the test fails or you see leaks, check for disconnected or kinked tubing. 11. If the process completes successfully, close and secure the top cover and then resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 12. Close the System Diagnostic Tools window.
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During this test, the system performs the following actions: homes all subassemblies turns vacuum and water pump on closes vent valve for the selected system fluid bottle associated pump or diluter primes fluid from system fluid bottle opens and closes associated valves aspirates fluid out of the cuvette incubation ring moves the cuvettes to the elevator elevator moves the cuvettes to the luminometer luminometer moves and the system ejects the cuvettes
You can evaluate if the system correctly primes the system fluid bottle: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System Diagnostic Tools window, select Prime Functions, and then select Prime System Fluid Bottle. 4. Select the fluid you want to prime.
WARNING
Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. If the fluid does not prime correctly, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the process completes successfully, resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System Diagnostic Tools window.
Remote Access
If you are not using the RealTime Solutions service and your system is connected to a modem, select remote access to make your files accessible for technical assistance. This feature allows Siemens Medical Solutions Diagnostics to collect SID and RLU data. Refer to Selecting Remote Access page 8-42.
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Siemens cannot view the workspace by modem. To show a Siemens technical assistance representative information on a window, perform the following steps: 1. At the Workspace, select Print. 2. Select Print Workspace. 3. Fax the printout to the Siemens technical assistance representative.
Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. Use the following procedures to resolve problems with the hand-held barcode scanner.
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2. For the check digit option, at the Setup Tube Type & Barcode window, select Disable. 3. Check the barcode scanner, cable, and port. 4. If the problem persists, call for technical assistance.
Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. Use the following procedures to resolve problems with the sample barcode scanner.
Do not allow racks to get stuck as they are loaded. If the rack hesitates or binds in the input queue, the barcode scanner might not read all the sample barcode labels in the rack or the rack label. If a rack gets stuck as it enters the inprocess queue, remove the rack and then reload it. 4. Ensure that the sample racks load smoothly into the inprocess queue. 5. Ensure that the upright panel behind the sample entry queue is installed. 6. The panel prevents the barcode scanner from reading racks that are already loaded in the inprocess queue. 7. If the problem persists, call for technical assistance.
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Do not remove, reposition, or clean the barcode scanner. These actions can damage the scanner or cause additional problems. 1. Ensure that the sample barcodes do not have quality defects such as faded or inconsistent print. Refer to Barcode Quality page 6-85. 2. Ensure that the barcode labels are positioned correctly on the sample rack and the sample tubes or cups. 3. Ensure that the information on the Setup Tube Type & Barcode window is correct.
CAUTION
Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 4. Press the sample start button and then look for a red light reflection on the rack as the scanner reads the barcode label.
1 2
5. If you cannot determine the cause, you can enter the SID at the Status Enter SID window. 6. If the problem persists, call for technical assistance.
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Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. Use the following procedure to resolve problems with the reagent barcode scanner.
Do not remove, reposition, or clean the barcode scanner. These actions can damage the scanner or cause additional problems. When the system cannot read the primary pack barcode, the system displays the Status Enter Primary Barcodes window. You can manually enter the barcode in the appropriate field.
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To determine why the system could not read the barcode, use the following tips. If the problem persists, contact your local technical support provider or distributor. Ensure that the reagent packs are seated correctly on the reagent shelf in the primary reagent compartment. If only 1 pack is not being read, move it to another position in the primary reagent compartment and then notify your field service representative. Wipe off any condensation from the reagent pack labels and the reagent shelf. If the barcode labels are not correctly placed on the reagent packs, call for technical assistance. Ensure that the reagent barcodes do not have quality defects such as faded or inconsistent print. Refer to Barcode Quality page 6-85. Open and close the primary reagent door and then look for a red light reflection on the back of the primary reagent compartment as the scanner reads the barcode labels. Ensure that the reagent barcode reader moves and that the reagent barcode shutter opens.
1 2 3
Figure 6-43
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If you are unable to resolve the problem, manually enter the barcode at the
Status Enter Primary Barcode window. Contact your local service provider about the problem.
Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. Use the following procedure to resolve problems with the ancillary barcode scanner.
Do not remove, reposition, or clean the barcode scanner. These actions can damage the scanner or cause additional problems. When the system cannot read the ancillary pack barcode, the system displays the Status Enter Ancillary Barcodes window. You can manually enter the barcode in the appropriate field. To determine why the system could not read the barcode, use the following tips. If the problem persists, contact your local technical support provider or distributor. Check the ancillary pack labels for condensation. Ensure that the barcode labels are positioned correctly on ancillary packs. Ensure that the ancillary barcodes do not have quality defects such as faded or inconsistent print. Refer to Barcode Quality page 6-85. Place an ancillary pack in the ancillary entry and then look for a red light reflection as the scanner reads the barcode label.
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The ability of the ADVIA Centaur XP system to scan a barcode can be affected by the following barcode characteristics: size color quality positioning symbology fixed or variable length check digit reserved characters
Barcode Size
The required dimensions of the label and the barcode are listed below:
Dimension maximum label length quiet zone at each end maximum barcode length minimum barcode height minimum narrow bar width Size (cm) 8.89 0.64 7.60 0.64 0.02 Size (in) 3.50 0.25 3.00 0.25 0.01
Barcode Color
Since barcode scanners read at a visible wavelength, the preferred background color is white. The preferred print color of symbols is black. Use of other colors can affect the ability of the system to read the barcode.
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Barcode Quality
The ideal barcode label has clean, clear, straight fine lines with high contrast between light and dark areas.
1 2 3 4 5 6
Barcode ink is smeared or smudged Barcode ink is faded Barcode lines are wavy Barcode ink is scratched Barcode ink is slanted Barcode label contains void
Figure 6-44
Problem Barcodes
Problems with the barcode label that may interfere with scanning can include problems with the material or surface on which barcodes are printed, poor quality printing, environmental factors that damage the barcodes during storage or use, and incorrect placement of the barcode label on the sample tube or sample cup.
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The following table contains the quality components and factors causing scanning problems:
Quality Components environmental factors during storage and use Factors Causing Scanning Problems abrasion aging chemicals frost fungi and mildew humidity lubricants packaging preservatives protective coatings salt spray solvents and cleaners tape temperature ultraviolet light conspicuous grain high porosity low opacity coating or overlaminate too thick (> 0.076 mm or 0.003 in) high gloss laminates highly textured laminates high matte laminates polarized laminates very coarse surface very smooth surface crooked faded areas irregularities low scan or symbol contrast no leading or trailing quiet zone scratches smears smudges streaks very dark or very light barcodes very thin or thick lines voids wavy, slanted, or curved lines
label material
label surface
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Barcode Positioning
Position the barcode vertically on the primary sample tube or sample cup, approximately 2 cm (0.8 in) from the top. If the barcode label is twisted, the barcode scanner might not read the label. Ensure that the labels are placed firmly on the sample cup. It is recommended that you do not place more than 2 labels on a primary sample tube or sample cup.
Figure 6-45
Sample Tube
Barcode Symbology
At the Setup Tube Type and Barcode window, select the appropriate symbologies: Codabar Interleaved 2 of 5 Code 39 Code 128 Code 128 is the system default symbology and is always active since it is used for all Siemens labels for sample racks, primary reagent packs, ancillary reagent packs, calibrators, and controls.
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This reduces the chance of substitution or omission errors. If you specify a variable-length value, the system then reads and decodes all labels in the active symbology, regardless of their length.
This information does not apply to the master curve, calibrator, and control information that is read by the barcode scanner. 1. At the Workspace, select Setup. 2. Select Summary. 3. Select Tube Type & Barcode. 4. For each active symbology, select the appropriate Check Digit option: Enable Disable nw7 (Codabar standard check digits) mod16 (Codabar standard check digits) nw7mod16 (Codabar standard check digits)
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Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. The barcode scanner is active after selecting Scan at the Calibration Master Curve Definition window or when the Calibration Calibrator Definition window is open. Use the following techniques when scanning a barcode: Center the barcode scanner over the barcode. Move the barcode scanner from the top of the card to the bottom of the card. Ensure that the system beeps after scanning a barcode before proceeding to the next barcode. Ensure that the tip of the scanner is directly contacting the barcode and that you are not pressing down so hard that you mar the barcode.
8 or 9
ADVIA Calibrators
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3. In the list of available reports, select Event Log. 4. Select the View.
If you want to print... all event codes, including informational events as well as errors, only informational event, only warning and critical errors, Then select...
All. Events. Errors.
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To help find a pattern or a trend, collect and print the following data: patient sample results quality control results calibration data replicate CVs
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Defined ranges are specified for each lot at the time of reagent manufacture. Observed ranges are established by the system.
7. Determine if the values for slope, ratio, low cal deviation, or high cal deviation are within the defined or observed ranges.
If the value is... out of the defined range out of the observed range but within the defined range Then... use the tables that follow to evaluate flagged calibration metrics for sandwich or competitive assays. you can accept the calibration. Accepting an invalid calibration due to a failed observed range is acceptable when parts have been replaced on the system, such as probes, tubing, or filters. Refer to Accepting an Invalid Calibration page 3-25.
No
Yes
No
No
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Slope No
Ratio No
Possible Causes and Corrective Actions Cleaning solution in the water supply. Ensure that the water bottle is rinsed thoroughly after it is cleaned. Calibrator used was incorrect for the assay. Check the calibrator package insert or the ADVIA Centaur XP Assay Manual to determine the correct calibrator to use with an assay. Ensure that the correct calibrator was poured into the correctly labeled sample tube.
If you cannot resolve the problem, load new reagent packs and calibrators and then schedule another calibration at the Worklist Schedule window. If the problem persists, call for technical assistance.
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Slope Yes
Ratio Yes
Possible Causes and Corrective Actions Cleaning solution in the water supply. Ensure that the water bottle is rinsed thoroughly after it is cleaned. Poor water quality. Ensure that the water quality integrity meets requirements. Refer to Reagent Water Quality page C-4. Water supply is contaminated. Check the integrity of your reagent water system and ensure that it has been maintained. Refer to Reagent Water Quality page C-4. Calibrator stability has been compromised. Ensure that calibrators (lyophilized, reconstituted, or liquid) are being stored as recommended in the calibrator package insert. Incorrect volume was used to reconstitute lyophilized calibrators. Ensure that the correct volume was used by referring to the calibrator package insert for reconstitution instructions. Reagents have been frozen. Check reagent storage temperature and ensure that reagents are stored upright at 2 to 8 C. Reagents have exceeded their opened stability. Ensure that reagent packs are stored upright at 2 to 8 C, and discard any reagents that exceed stability. Cleaning solution in the water supply. Ensure that the water bottle is rinsed thoroughly after it is cleaned. Calibrator used was incorrect for the assay. Check the calibrator package insert or the ADVIA Centaur XP Assay Manual to determine the correct calibrator to use with an assay. Ensure that the correct calibrator was poured into the correctly labeled sample tube.
No
Yes
No
No
No
No
No
No
If you cannot resolve the problem, load new reagent packs and calibrators and then schedule another calibration at the Worklist Schedule window. If the problem persists, call for technical assistance.
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2. Ensure that the pipette is calibrated correctly. 3. Check the integrity of the reagent water.
Refer to Reagent Water Quality page C-4.
4. Reconstitute fresh lyophilized calibrators or open fresh liquid calibrators. 5. Recalibrate the assay.
1. Ensure that calibrators are discarded after being on the system and are not poured back into their respective bottles.1
The calibrators were on the system and then were poured back into the bottle
2. Pour a fresh aliquot of calibrators. 3. If necessary, reconstitute fresh lyophilized calibrators or open fresh liquid calibrators. 4. Recalibrate the assay.
1. Check the calibrator vial for uniform reconstitution.
2. Check the calibrator package insert for calibrator preparation instructions. 3. If necessary, reconstitute fresh lyophilized calibrators or open fresh liquid calibrators. 4. Recalibrate the assay.
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Corrective Actions 1. Check the calibrator package insert for the storage requirements of lyophilized, reconstituted, and liquid calibrators.
2. If, according to the calibrator package insert, calibrators can be aliquotted and frozen, mix calibrators gently by inversion to ensure a homogeneous solution before aliquotting. 3. If the storage temperature is outside the recommended temperature range, reconstitute fresh lyophilized calibrators or open fresh liquid calibrators that have been stored correctly. 4. Recalibrate the assay.
The calibrators were expired 1. Check the calibrator bottle for the expiration date.
2. Check the calibrator package insert for the stability requirements of lyophilized, reconstituted, and liquid calibrators. 3. Prepare fresh calibrators.
Refer to the calibrator package insert.
2. Ensure that the correct calibrator was poured into the correctly labeled sample tube. 3. If the calibrators were poured into mislabeled tubes, discard the mislabeled tubes, and pour a fresh aliquot of calibrators into new correctly labeled tubes. 4. Prepare fresh calibrators.
Refer to the calibrator package insert.
2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have tips that have been damaged by a failure in the tip tray exchange. 4. Recalibrate the assay.
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Possible Cause Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Recalibrate the assay.
1. Ensure that reagent packs are stored upright at 2 to 8 C.
The reagent pack was stored at room temperature for a prolonged period
2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Recalibrate the assay.
1. Discard the old reagent pack and use a fresh reagent pack.
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Recalibrate the assay.
1. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.
2. Discard the old reagent pack and use a fresh reagent pack. 3. Recalibrate the assay.
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Discrepant QC Results
Possible Cause The controls were reconstituted incorrectly: with tap water, with the incorrect volume, with an uncalibrated pipette, or with contaminated reagent water Corrective Actions 1. Ensure that the correct volume was used for reconstitution. Refer to the control package insert for reconstitution instructions.
2. Ensure that the pipette is calibrated correctly. 3. Check the integrity of the reagent water.
Refer to Reagent Water Quality page C-4.
The controls were on the system and then were poured back into the bottle
2. Pour a fresh aliquot of controls. 3. If necessary, reconstitute fresh lyophilized controls or open fresh liquid controls. 4. Perform quality control again.
1. Check the control vial for uniform reconstitution.
2. Check the control package insert for control preparation instructions. 3. If necessary, reconstitute fresh lyophilized controls or open fresh liquid controls. 4. Perform quality control again.
1. Check the control package insert for the storage requirements of lyophilized, reconstituted, and liquid controls.
2. If, according to the control package insert, controls can be aliquotted and frozen, then mix controls gently by inversion to ensure a homogeneous solution before aliquotting. 3. If the storage temperature is outside the recommended temperature range, then reconstitute fresh lyophilized controls or open fresh liquid controls that have been stored correctly. 4. Perform quality control again.
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Corrective Actions 1. Check the control bottle for the expiration date, for the stability
2. Check the control package insert for the stability requirements of lyophilized, reconstituted, and liquid controls. 3. Prepare fresh controls.
Refer to the control package insert.
2. To determine the correct control to use with an assay, check the ADVIA Centaur XP Assay Manual. 3. Check the control label to ensure that the correct control is being used. 4. Ensure that the correct control was poured into the correctly labeled sample tube. 5. If the controls were poured into mislabeled tubes, discard the mislabeled tubes, and pour a fresh aliquot of controls into new correctly labeled tubes. 6. Prepare fresh controls.
Refer to the control package insert.
2. If the values are incorrect, enter the correct values into the Quality Control Control Definition window.
Refer to Defining QC Values page 4-2.
2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have tips that have been damaged by a failure in the tip tray exchange. 4. Perform quality control again.
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Possible Cause Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again.
1. Ensure that reagent packs are stored upright at 2 to 8 C.
The reagent pack was stored at room temperature for a prolonged period of time
2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Perform quality control again.
1. Discard the old reagent pack and use a fresh reagent pack.
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again.
1. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.
2. Discard the old reagent pack and use a fresh reagent pack. 3. Recalibrate the assay. 4. Perform quality control again.
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2. Collect a fresh sample from the patient. 3. Perform the assay again.
1. Thoroughly mix thawed specimens before use.
The sample was frozen more than once or not mixed thoroughly after thawing The sample contains heterophilic antibodies Incorrect patient sample, the sample was labeled with the wrong patient ID The sample was stored at room temperature longer than 8 hours or refrigerated longer than 48 hours The sample and reagent storage areas are outside the recommended storage temperature range
2. Freeze specimens only once. 3. Collect a fresh sample from the patient. 4. Perform the assay again.
Call for technical assistance to further investigate the probable cause. 1. Collect a fresh sample from the patient.
1.
1.
Monitor reagent and sample storage areas and correct temperatures, as required.
2. 3. 4. 5. 6.
1.
Collect a fresh sample from the patient. Use a fresh reagent pack. Perform quality control again. Recalibrate the assay if necessary. Perform the assay again.
Rim the sample with applicator sticks and centrifuge the sample.
2. Remove the bubbles. 3. Redraw a fresh sample. 4. Perform the assay again.
1. Store sample tips upright.
The sample tips were bent from storage on their side or damaged by a tray exchange failure
2. Do not place tip tray on counter, resting on tips. 3. Do not use trays that have been damaged by a failure in the tip tray exchange. 4. Perform the assay again.
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Possible Cause Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again. 6. Recalibrate the assay if necessary. 7. Perform the assay again.
1. Ensure that reagent packs are stored upright at 2 to 8 C.
The reagent pack was stored at room temperature for a prolonged period of time
2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Perform quality control again. 5. Recalibrate the assay if necessary. 6. Perform the assay again.
1. Discard the old reagent pack and use a fresh reagent pack.
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again. 4. Recalibrate the assay if necessary. 5. Perform the assay again.
1. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.
2. Discard the old reagent pack and use a fresh reagent pack. 3. Perform quality control again. 4. Recalibrate the assay if necessary.
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The sample tips were bent from storage on their side or damaged by a tray exchange failure
1.
2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have been damaged by a failure in the tip tray exchange. 4. Perform the assay again.
1. Ensure that reagent packs are stored upright at 2 to 8 C.
Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again. 6. Recalibrate the assay if necessary. 7. Perform the assay again.
1. Ensure that reagent packs are stored upright at 2 to 8 C.
The reagent pack was stored at room temperature for a prolonged period of time
2. 3. 4. 5. 6.
1.
Discard any reagent that exceeds opened stability. Obtain a fresh reagent pack. Perform quality control again. Recalibrate the assay if necessary. Perform the assay again.
Discard the old reagent pack and use a fresh reagent pack.
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again. 4. Recalibrate the assay if necessary. 5. Perform the assay again.
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Corrective Actions 1. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.
2. Discard the old reagent pack and use a fresh reagent pack. 3. Perform quality control again. 4. Recalibrate the assay if necessary.
2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have been damaged by a failure in the tip tray exchange. 4. Perform the assay again.
1. Ensure that reagent packs are stored upright at 2 to 8 C.
Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, or expired or clumped reagents
2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again. 6. Recalibrate the assay if necessary. 7. Perform the assay again.
1. Ensure that reagent packs are stored upright at 2 to 8 C.
The reagent pack was stored at room temperature for a prolonged period
2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Perform the assay again.
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Possible Cause Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
Corrective Actions 1. Discard the old reagent pack and use a fresh reagent pack.
2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again. 4. Recalibrate the assay if necessary. 5. Perform the assay again.
1. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.
2. Discard the old reagent pack and use a fresh reagent pack. 3. Perform quality control again. 4. Recalibrate the assay if necessary.
Reagent mixing was turned off for longer than 2 hours but reagent refrigeration remains on: mechanics off, diagnostic tools window open, database maintenance, severe software errors indicated by event codes starting 700 xx xx Both reagent mixing and reagent refrigeration were turned off for longer than 2 hours: FSE maintenance, power outage 1. Mix all primary reagent packs following the unpierced or pierced primary reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual.
2. Place the reagent packs back on the system. 3. Verify reagent performance based on acceptable QC results or by criteria established for your laboratory.
1.
2. Mix all primary reagent packs following the unpierced or pierced primary reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual before placing the reagent packs back on the system. 3. Verify reagent performance based on acceptable QC results or by criteria established for your laboratory.
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2. Ensure that the fluid is not expired. 3. Ensure that the fluid onboard stability is not exceeded. 4. Replace the fluid.
1. Ensure that daily, weekly, and monthly maintenance is performed. Refer to Performing Maintenance Procedures page 5-4.
2. Prime the system fluid line at the System Diagnostic Tools window and look for fluid flow. 3. Call for technical assistance.
Insufficient aspiration of wash solution 1. Ensure that the aspirate probes clips are slid completely across the probe holder and are firmly against the probe.
2. Perform dispense wash fluid and aspirate at the System Diagnostic Tools window and look for complete fluid aspiration. 3. Call for technical assistance.
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If you have had prior issues with proficiency testing results or have any questions or concerns, call for technical assistance before you submit your results. To help the product specialist in assisting you, be sure to have the following information available: Obtain calibration and control data from the day of testing, including lot number and expiration date. Check all control results and determine if they are within acceptable limits. Ensure that all survey sample preparation procedures have been followed. Note any unusual occurrences such as error flags and non-reproducible results. Check that reagent and instrument reporting categories have been entered correctly.
References
1. Kaplan, Lawrence A. Pesce, Amadeo J. Clinical Chemistry; theory, analysis, and correlation, 2nd edition. St. Louis: C.V. Mosby Company; 1989. 1212 p.
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7 Managing Data
Maintaining the Database . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Using the Status Maintenance Window . . . . . . . . . . . . . . . . . . 7-1 Editing Database Maintenance Settings. . . . . . . . . . . . . . . . . . . 7-1
Manually Initiating a Database Maintenance Activity. . . . . . . . . . . . .7-2 Defragmenting the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
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Managing Data
Data management includes the following functions: Database maintenance Performing data backup Creating data archives Exporting data
maintenance activities. The ADVIA Centaur XP system maintains the database automatically by default. You can edit the default settings for the automatic maintenance to make it better fit the schedule of your workload. You can also manually perfom database maintenance, when necessary. When performing the database maintenance, the system deletes worklist entries and associated results based on the parameters set at the Status Maintenance Definition window. The system creates an archive of results data before deleting them. If you choose not to autoschedule the Archive data maintenance activity, the system does not save the results to an archive before deleting them. Refer to Saving Results Data to an Archive page 7-4
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To edit database maintenance parameters, perform the following steps: 1. At the workspace, select the Status Maintenance button. 2. At the Status Maintenance window, select Perform database maintenance. 3. Select Edit. 4. At the Status Maintenance Definition window, use the Database Threshold dropdown list to select the threshold you want on your system. The default database threshold is 15,000 tests, including replicates. When the database exceeds 15,000, the database maintenance activity trims it down to 15,000. 5. Use the Retain for field drop-down list to select the number of days to keep results not transmitted to the LIS at the time of the database maintenance activity, before the results are deleted. The default value is 4. 6. In the Time field, enter the time of day for the autoscheduled maintenance to occur. The time is a 24-hour format, HHMM. For example, enter 0230 for 2:30 a.m. and enter 1430 for 2:30 p.m. The default value is 0230. 7. Select Save.
To manually initiate a database maintenance activity, perform the following steps: 1. At the workspace, select the Status Maintenance button. 2. At the Status Maintenance window, select Perform database maintenance. 3. Select Perform.
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Do not place the storage medium on the sample entry queue. The magnets under the queue can erase the information on the storage medium. 6. Label the storage medium with the following information: date
NOTE: You cannot restore data from 1 system on to another system.
Restoring Data
CAUTION
Do not perform the Restore function. Performing the Restore function incorrectly can cause corruption of the system software. To avoid potential corruption of the system software, only a trained technical support provider should perform the Restore function at the Setup Data Administration window. Restore data only when updating the system software. To restore data, the system searches the storage devices for the most current back up in the following order: 1. removable media (CD or DVD) 2. system local drive The system stops the search when at least 1 backup is found. The system restores the latest backup from that location.
maintenance activities. The ADVIA Centaur XP system can save results data automatically to an archive according to the maintenance settings in the Status Maintenance Definition window. You can also chose to save the data manually to an archive or chose not to save your results data. You can use your local drive, a CD or a DVD to save files to an archive. Records that you save to an archive are not deleted until the system performs a database maintenance activity. Refer to Maintaining the Database page 7-1 The results data archive is in a format compatible with Microsoft Excel or similar spreadsheet application. Refer to Archived Data page 7-5.
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The system saves results data by worklist. If you edit a record that is already saved to an archive, the edited record and all records in that worklist are saved again at a future automatic or manual archive maintenance activity. If you edit an component test of a ratio that is already stored in an archive, the ratio test and its component test are saved to an archive at a future automatic or manual archive maintenance activity. Control-bracketed tests are only eligible for an archive after the system releases them. The system does not save control-bracketed tests that are waiting for controls. The system does not save control-bracketed tests with discarded results.
Archived Data
This table displays the field name and field format that is displayed in the archive spreadsheet. Explanatory comments are included, where necessary. The field name is the column head of the spreadsheet and the field format is how the data is displayed. Data is sorted in the spreadsheet in ascending order by the SID with a secondary sort on the Result Date and Time. Autoscheduled archive files and archives created by selecting Archive All on the StatusArchive Options window are named using the following format: A_RA_<system serial number>_<date><time>
Field Name SID Field Format Alphanumeric; maximum of 13 characters Alphanumeric; 5 characters Comment Sample identification for patient, control, or calibrator samples First 4 digits is the Rack ID Fifth character is the Position Example: 0001A
Rack
Result Date and Time Patient Name PID Sex Test Name
DD MMM YY HH:MM Last Name, First Name; 30 characters maximum Alphanumeric; 11 characters maximum M, F, or U Alphanumeric; 8 characters maximum
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Field Format Neat only Neat and diluted Dilute if over Dilute only Dilution profile Alphanumeric; 6 characters maximum
Comment You can select a dilution option at the Worklist Dilutions window or it can come from the LIS. The result is corrected for the dilution factor specified at the WorklistDilutions window. Assay dependent; defined in the TestRanges window. You can select it in the WorklistDilutions window.
Manual Dilution
System Dilution
Numeric 2 digits, maximum Alpha, 4 characters maximum INTR DOSE INDX COFF RLU CLSS (Allergy Class) Alphanumeric; 15 characters maximum Printable ASCII; 10 characters maximum Alpha Name: Alphanumeric, Low and High Limits: Numeric, 7 characters, a decimal delimiter, and the number of decimal places defined for this system L, H, <, > Alpha, <, >; 60 characters maximum
Results data For example: LU/mL There is no value if it is a qualitative result. The status of the result. Example: Name of range: Male Low Limit: 123.4 High Limit: 1234567.8
F or P Normal Ranges
The top 3 result flags displayed in the Worklist Result Details window. This is only for meaned replicate results.
CV
Numeric
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Field Name Primary Reagent Lot Ancillary Reagent Lot Control Lot Calibrator Lot Control Name
Field Format Numeric Numeric Alphanumeric Alphanumeric Alphanumeric; 11 characters maximum Alphanumeric
Comment From the Control field of the Quality ControlControl Definition window. From the Calibrator field of the CalibrationCalibrator Definition window.
Calibrator Name
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NOTE: For autoschedule archives, you must ensure that the selected storage device is in place for the scheduled archive event.
Frequency: Enter a number from 1 31 to indicate how many days between archive events. The default is 7. Time: Enter a time of day for the archive event to occur. Use a 24-hour format, from 0000 to 2359. The default is 0200.
Starting on: Select the day of the week for the start of the archive event. The default is Sunday.
To edit the Autoschedule options, perform the following steps: 1. At the system view Workspace window, select Status Maintenance. 2. At the Status Maintenance window, select Archive result data. 3. Select Definition. 4. At the Status Maintenance Definition window, select Edit. 5. Select Autoschedule. 6. Change 1 or more of the Autoschedule options: Frequency, Time, or Started on. 7. Select Save.
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Use manual archive in the following cases: to set the archive procedure to As needed to perform an archive when the system does not perform an automatic archive on schedule to create an archive for investigative work
There are 2 options for manually saving result data to an archive: Date-defined Archive This saves a specific date range of available result data to an archive using the date range entered into the Status Archive Options window. Archive All Archives all result data that was not previously saved to an archive during an autoscheduled archive activity.
To create a date-defined archive, perform the following steps: 1. At the system view Workspace window, select Status Maintenance. 2. At the Status Maintenance window, select Archive result data. 3. Select Perform. 4. At the Status Archive Options window, enter the starting date and ending date into the appropriate fields. 5. Enter an alphanumeric value into the File Prefix field to identify the date-defined archive. 6. If you want to allow the dated archive to overwrite the current archive storage medium when it is full, select Overwrite Media 7. Select Continue.
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4. Select Continue.
Do not place the storage medium on the sample entry queue. The magnets under the queue can erase the information on the storage medium. You can export test utilization data to a CD or DVD. The system exports it in a spreadsheet compatible format. The system exports test utilization data in the following order: test name assigned by the manufacturer calibrator product code number of patient orders number of calibrators number of controls number of total tests used. The first record of the file contains the system serial number and the date and time that you performed the export activity. The system separates each area by tabs and writes the exported data to the file assay.csv. If the data exceeds the size of the CD or DVD, the system notifies you and does not export the data. If this happens, you can reduce the time interval between the starting date and ending date and then export the data again.
NOTE: You must have the appropriate level of security to export data.
1. At the system view Workspace window, select Setup. 2. Select Data Administration. 3. Insert the storage medium into the appropriate drive. 4. At the Setup Data Administration window, select Test Utilization Data.
NOTE: Exporting data overwrites any existing storage medium.
5. Select Export. 6. At the Setup Data Administration Options window, select the starting date and ending date. The default for the starting date is 30 days before the current date and time. The default for the ending date is the current date and time.
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The date and time format is DD MMM YY HH:MM. Example: 17 Mar 99 16:30.
7. Select Continue. To view the exported data, set up the following options in the spreadsheet program: Delimit each area of information by a tab. Format the column width to display the data and time correctly, if required.
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Deleting a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 Modifying a Test Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 Modifying the Reagent Stability Option. . . . . . . . . . . . . . . . . . . 1-13 Modifying Sample Replicates . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Defining Anonymous Results . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 Defining Units and Decimal Places. . . . . . . . . . . . . . . . . . . . . . 1-15 Defining Calibration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
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Modifying the Test Display Order . . . . . . . . . . . . . . . . . . 1-37 Modifying System Options . . . . . . . . . . . . . . . . . . . . . . . 1-38
Reviewing System Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38 Viewing the System Serial Number . . . . . . . . . . . . . . . . . . . . . 1-38 Defining the System Name. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38 Specifying Screen Saver Options. . . . . . . . . . . . . . . . . . . . . . . 1-38 Defining Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Defining Low Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Defining the Control Bracket Reagent Reserve . . . . . . . . . . . . 1-40 Adjusting the Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Specifying the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40 Entering a Time Correction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
Adjusting the Pointing Device. . . . . . . . . . . . . . . . . . . . . . . . . . 1-42 Specifying Print Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42 Selecting Remote Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 Selecting Remote Software Administration . . . . . . . . . . . . . . . 1-43
Remote Software Administration . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43
Enabling the Visible Status Light . . . . . . . . . . . . . . . . . . 1-45 Defining Backup, Restore, and Archive Options. . . . . . 1-45 Defining LIS Communication Options . . . . . . . . . . . . . . 1-45 Defining LAS Communication Options . . . . . . . . . . . . . 1-48
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Do not customize options without ensuring that you select the appropriate value for your laboratory and continuing to evaluate the integrity of that value. Failure to do so can cause reporting of unexpected results. For example, if you configure the system to send all results and additional data except results on hold to your LIS, and the LIS is not configured to accept the information, the LIS may identify the additional data inappropriately and fail to distinguish between the final results and the additional data. Your laboratory is responsible for ensuring that all configurations are correct: sample options, test parameters, and system options. This is true regardless of whether your lab personnel set the values, Siemens Medical Solutions Diagnostics personnel set the values to specifications your laboratory provides, or Siemens Medical Solutions Diagnostics personnel set the values to the original default values established at the time of manufacture.
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3. At the Setup Summary window, select Sample Handling. 4. At the Setup Sample Handling Options window, select the appropriate throughput options:
If you want to . . . automatically perform tests in the most efficient order, perform every test for each sample in the order you load samples, Then . . . select With Optimized Throughput. select In the Order the Operator Loads Samples. The system does not perform tests in the most efficient order and your system does not have optimal throughput.
5. Select Save.
5. Select Save.
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4. At the Setup Sample Handling Options window, select the appropriate Stat-handling options.
If your laboratory... does not process Stat samples, Then... select 0 Stat racks. Selecting 0 maximizes sample throughput because the system can use all of the positions in the inprocess queue for routine samples. select 1 Stat rack. The system can process 1 Stat rack (containing up to 5 samples) before the routine samples that are loaded in the sample entry queue. This minimizes the impact on sample throughput. select 2 Stat racks. The system can process 2 Stat racks (each containing up to 5 samples) before the routine samples that are loaded in the sample entry queue. Selecting 2 Stat racks can affect sample throughput because the system does not use the reserved Stat rack positions for routine samples.
5. Select Save.
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1 2
Do not identify samples by rack ID unless absolutely necessary. If it is necessary to identify a sample by rack ID, be aware that the system ejects the sample to the exit queue after the sample is aspirated. Reflex or other testing does not occur after the sample moves to the exit queue. To obtain final results for reflex or other testing, you must reintroduce the sample rack to the front of the sample entry queue. Whenever possible, set the system to identify samples by SID.
NOTE: If you specify SID, you can override this selection for a sample by selecting Schedule by Rack at the Worklist Schedule window. If you specify Rack, the system always identifies samples by rack position number and you cannot select Schedule by SID at the Worklist Schedule window.
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3. At the Setup Summary window, select Tube Type & Barcode. 4. At the Setup Tube Type & Barcode window, select SID or Rack. 5. Select Save.
NOTE: Ensure that you make all of the changes to the Setup Tube Type &
Barcode window before you reboot the system. If you do not make all of the changes, you must reboot the system more than 1 time. 6. Reboot the system.
You can specify up to 3 specific types of sample tubes to use on the system or you can use multiple tube types. Refer to Tube Types page E-2. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup Summary window, select Tube Type & Barcode.
CAUTION
Do not move the tube type selector without verifying the tube type you are using. Ensure that the tube type selector on each sample rack points to the correct tube type as defined at this window. If the tube type selector points to an incorrect tube type, the system can experience problems with sample handling and system errors can result. 4. At the Setup Tube Type & Barcode window, use Tube Types 2, 3, and 4 to select up to 3 types of sample tubes. The ADVIA Centaur XP system reserves Tube Type 1 for multiple tube types. Regardless of what you enter here, if the tube-type selector is in position A, the rack allows multiple tube types. If you use an ADVIA Centaur rack, you must select a tube type in Tube Type 1. When you load samples, use the tube type selector on the rack to indicate the tube type you are loading. Place the tube-type selector in position A for multiple tube types. Refer to Managing Sample Racks page 2-2. 5. In the LAS Tube Type field, select the tube type you want to use when no tube type is specified in the LAS. The default is Auto, meaning it allows multiple tube types. 6. Select Save.
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NOTE: Ensure that you make all of the changes to the Setup Tube Type & Barcode window before you reboot the system. If you do not make all of the changes, you must reboot the system more than 1 time.
Code 128 is always active. For most symbologies, you can choose the format, the use of check digits, and the use of SID mapping. Refer to Resolving Barcode Problems page 6-78. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup Summary window, select Tube Type & Barcode.
NOTE: If you are using Code 128, you must exclude the ASCII characters ESC, Bell, and CR (Return) from your barcode labels because the system reserves these for use in the calibrator and control barcode labels.
4. At the Setup Tube Type & Barcode window, select a barcode symbology. 5. Select Fixed or Variable in Type. If you select Fixed, select the number of characters in your SID barcode label, not including the check digit. 6. Select the number of characters for a barcode of fixed length.
NOTE: Select Enable for the check digit for Code 128. Code 128 is the barcode symbology for the Master Curve Card, Calibrator Card, and calibrators.
7. If the barcode uses a check digit, select Enable in Check Digit. 8. Repeat steps 4. through 7. for each symbology. 9. Select Save.
NOTE: Ensure that you make all of the changes to the Setup Tube Type & Barcode window before you reboot the system. If you do not make all of the changes, you must reboot the system more than 1 time.
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system generates an event code when you load a patient sample with a barcode. Without SID mapping information, the system cannot interpret the patient sample barcode or process the sample. The ADVIA Centaur XP system accepts barcodes with a maximum length of 20 characters. However, the system accepts SID codes with a maximum length of 13 characters. If the SID code is embedded in a longer barcode, you can use the SID mapping procedure to specify up to 13 characters of the barcode for use. The SID mapping procedure affects only patient sample barcode labels. This procedure does not affect the barcode labels for calibrators or Siemens QC controls. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup Summary window, select Tube Type & Barcode.
CAUTION
Use care when entering the SID mapping information. The system uses only the characters specified in this procedure as patient sample SID codes.
NOTE: You can select a position of the barcode only once.
4. Enter the barcode positions that you want to use starting with the 1 position field at the bottom of the window. To map the SID, select up to 13 positions of the barcode to display as the 13 characters of the SID in the worklist. You can select the positions to display in any order. For example, if you select the number 6 in the third position, whatever is in the sixth position in the barcode displays in the third position in the SID. For positions you do not want to display, select a number greater than the number of positions in the longest barcode. For example, if you have a 6-character barcode and you want to display the last 3 characters as the SID, select 4, 5, and 6 for the 1, 2, and 3 position fields, and then select a number greater than 6 for the 4 through 13 position fields. If the 6-character barcode is as follows: ABCDEF The system reads the following SID code: DEF
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You can select some symbols to display as characters in the SID, for example +, -, /, *, #. The symbols display in the specified positions for all SIDs. Do not select the % symbol because the system does not accept a % symbol in the SID. 5. Select Save.
NOTE: Ensure that you make all of the changes to the Setup Tube Type &
Barcode window before you reboot the system. If you do not make all of the changes at 1 time, you must reboot the system each time you make changes. 6. Reboot the system.
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4. At the Setup Sample Handling Options window, enter or edit the number of hours for the interval used by the system to automatically move the results from the current database to the historical database. The number of hours must be a factor of 24 (1, 2, 3, 4, 6, 8, 12, or 24). The time interval starts at midnight. 5. Select Save. The system moves data to the historical database in the approximate time interval that you specify, depending on when testing for the samples is completed.
Reviewing Tests
At the Test Summary window, you can review the tests defined on your system. Use this window to edit the test definitions, enable or disable tests, and add or delete ratio and off-system tests. 1. At the workspace, select Setup. 2. Select Test Definition Summary. Select Definition to modify the opened stability date and number of replicates for each test. Select Ranges to define reference ranges for each test. Select Display Order to define the order in which tests are displayed and printed.
Select the appropriate View and Type to display specific information at the Test Summary window: The View that you select determines the information that the system displays. For example, if you select All, the system displays all tests. The Type that you select determines the order in which the system displays the tests. For example, if you select All, the system displays all tests in alphabetical order. The following table describes the View and Type combinations you can use to perform some routine tasks:
Task display all tests View All Type All
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Task display the tests the system is using display the tests the system is not using display tests of a specific type display the enabled tests of a specific type display the disabled tests of a specific type
Type All All Standard, Ratio, Off-System, Component, Combination, Allergen, sIgE Universal Standard, Ratio, Off-System, Component, Combination, Allergen, sIgE Universal Standard, Ratio, Off-System, Component, Combination, Allergen, sIgE Universal
Combination
Component Allergen
sIgE Universal
Enabling a Test
An enabled test is included in the test menu displayed at the ADVIA Centaur XP windows and the system performs the test if it is scheduled.
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When you enable a test, you do not have to perform the following tasks: reenter any Master Curves activate an active reagent lot recalibrate a valid calibration
NOTE: If your laboratory wants to enable the HBs or Conf test, ensure that you turn system mechanics off, turn system mechanics on, and then perform a Daily Cleaning Procedure after enabling the test.
1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test Summary window, select the test. 4. Select Enable.
Disabling a Test
NOTE: You cannot disable tests that are part of a combination test, ratio test, profile, or sIgE universal test. NOTE: If you schedule the test before disabling it, the disabled test is displayed at the Worklist Summary window. WARNING
Do not disable a test without updating interference information. If you do not update the interference information, the system may fail to perform the necessary washes and that could potentially cause erroneous results. If you disable a test on your ADVIA Centaur XP system, the interference information for that test changes. The following procedure ensures that the system updates the interference information correctly. If you do not use this procedure, the system requires you to load wash packs to perform unnecessary washes, and may not perform a wash when required.
NOTE: To minimize maintenance time, plan to disable tests just before you perform your routine daily cleaning procedure. Refer to Performing Daily Cleaning page 5-5.
1. Ensure you delete all pending orders for the test before disabling it. Refer to Deleting Requests page 2-61. 2. At the workspace, select Setup. 3. Select Test Definition Summary. 4. At the Test Summary window, select the test.
NOTE: Disable HBs if your laboratory does not use it. If you are disabling Conf, also select Reagent A and Reagent B.
5. Select Disable.
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NOTE: Turning system mechanics off and then turning system mechanics on ensures that the HBs test is disabled.
6. At the workspace, select System Status. 7. Select Turn System Mechanics Off. Wait until the system mechanics are off. 8. Select Turn System Mechanics On.
NOTE: The daily cleaning procedure (DCP) provides the system with the required probe washes, preventing the need to have the disabled assay-specific wash pack loaded on the system.
9. At the workspace, select Maintenance Status. 10. Select Perform Daily Cleaning. 11. Select Perform.
NOTE: If your laboratory wants to enable a test in the future, ensure that you
turn system mechanics off, turn system mechanics on, and then perform the DCP after enabling the test. If you are enabling Conf, enable Reagent A and Reagent B also.
Deleting a Test
Deleting a test permanently removes it from the test menu and permanently removes any results associated with the test from the database. You can only delete tests that are defined by your laboratory, such as ratio or off-system tests. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Complete the appropriate tasks.
If you want to . . . temporarily stop performing the test, add the test to your system test menu, remove the test from your system test menu, Then select . . .
Disable. Enable. Delete.
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Do not select the Reset Defaults button at the Test Definition window. Selecting this button restores the original options the manufacturer defined and removes any options that your laboratory defined or modified. This global change can have unexpected consequences for your laboratory and, in some instances, creates an unrecoverable error. To change your test definition, refer to Modifying or Viewing Test Options page 8-9. 6. Change the test name information from the default test name, if necessary: a. At Display, enter the test name that you want the system to display. You can enter up to 8 alphanumeric characters for the name the system displays. b. At Print, enter the test name that you want to appear on printed reports. You can enter up to 20 alphanumeric characters for the name the system displays on printed reports. 7. Select Save. If you want to restore the original system values for all options at this window, select Reset Defaults.
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3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Definition.
NOTE: If you select the Use Beyond option, refer to the ADVIA Centaur Assay Manual for assay-specific information.
6. Select Save.
6. Select the number of replicates in the Replicates field. You can select up to 30 replicates. 7. If the number of replicates is greater than 1, enter the acceptable CV. 8. Select Save.
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1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Definition. 5. At the Test Definition window, select Edit. 6. Select Anonymous. 7. Select Save.
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7. Select the units for test results. If required, change the conversion factor to convert Master Curve units to the selected units reported by the system. Refer to SI Unit Conversion Factors page C-9. 8. Complete the appropriate task:
If you want to define . . . the number of decimal places for a concentration result, the number of decimal places for an index result, Then . . . select the number of decimal places in Conc Decimal. select the number of decimal places in Index Decimal.
1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Definition. 5. At the Test Definition window, select Edit. 6. Select Calculate Results. 7. At the Test Result Calculation window, select Calibration. 8. At the Test Calibration window, complete the appropriate tasks.
NOTE: The number of calibrator replicates in Minimum and the system
limits for a retained calibration in Retained Cal Limits are established at the time of manufacture.
If you want to . . . define the number of days between required calibrations, Then . . . Enter the new values in Cal Interval You can only enter an interval that is less than the default defined by the manufacturer.
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If you want to . . . define the number of calibrator replicates to perform the first time a calibrator lot is used, define the number of calibrator replicates for the current lot,
Then . . . select a number in New Lot. This number must be larger or equal to the number of replicates for Current Lot and Minimum. New Lot Current Lot Minimum select a number in Current Lot. This number must be smaller or equal to the number of replicates for New Lot and larger or equal to the number of replicates for Minimum. New Lot Current Lot Minimum select Waive Cal. select Accept Cal.
enable the system to allow you to use an expired calibration, enable the system to allow you to accept a calibration that falls outside the observed range but within the defined range, enable the system to allow you to assign a valid calibration to results at the Worklist Summary window, enable the system to automatically use data from a previous calibration when new calibration values are almost mathematically identical to previous values, enable the system to automatically exclude a calibrator replicate result when it is outside of the defined ranges for precision,
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This feature allows laboratories to comply with procedural recommendations for certain tests that are regulated very closely. The ADVIA Centaur XP system can perform tests with control bracketing when you enable the feature in the test definition.
5. Ensure the Control Bracket button is activated or deactivated for a test, depending on your laboratory requirements. If your laboratory does not require control bracketing for a particular test or if you want to activate control bracketing for a test that has this capability, your local technical support provider can change the selection at the Control Bracket button.
NOTE: Only certain tests allow control bracketing. Your local technical support provider can edit the Control Levels field only if Siemens Medical Solutions Diagnostics allows control bracketing for the test.
6. View the Control Levels field for the number of control levels required for each start-of-bracket or end-of-bracket control set when the control-bracketing feature is activated for the test. Your local technical support provider can edit the field for a test that has control bracketing capability, provided the value is between 1 and 5, inclusive.
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7. View the Control Warning field for the maximum allowable time in hours between the start and end-of-bracket controls, as defined by Siemens Medical Solutions Diagnostics. When the system issues the Control Warning, you must process the end-of-bracket controls immediately or any retained patient test results are discarded.
Refer to Using Control-bracketed Tests page 2-58 or consult the index under Control Bracketing.
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NOTE: If you select Reset Defaults, the system resets all options at the Test
Ranges window in addition to the reference range options. 7. Reset the ranges to the original values, if necessary: a. Select Reset Defaults. b. Select Ranges.
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8. Reset all the parameters and ranges to the original values, if necessary: a. Select Reset Defaults. b. Select All. 9. If required, define reflex tests for test results that are outside the reference ranges. Refer to Defining Reflex Tests for Reference Ranges page 8-23. 10. Select Save.
NOTE: You cannot edit the interpretation names and ranges that the manufacturer predefined.
7. At the Test Result Calculation window, define a result interpretation in the fields below the table using the following procedure: a. Select Add New to activate the interpretation edit field, which is the third field in the row below the table. b. Enter an interpretation in the interpretation edit field. Enter up to 15 alphanumeric characters for the interpretation that you want the system to use for results within a certain range. The remaining fields below the table become active.
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c. Enter the lower and upper limits of the range. Enter up to 6 numeric characters for the lower and upper limits for the interpretation. d. Select Hold at the left field in the row if you want to review results before releasing them to the LIS. e. If required, define a reflex test or profile for test results within a result interpretation range. Refer to Defining Reflex Tests for Interpretation Ranges page 8-23. 8. Select Add Row to add the result interpretation information to the table. 9. Select Continue. 10. At the Test Definition window, select Save.
reflex test or profile is on the system. Refer to Defining Test Profiles page 8-36.
NOTE: The system performs a reflex test automatically if the sample is still in the inprocess queue when the system receives the request. If the system ejects the sample before it receives the request, the reflex test remains pending until you reload the sample. NOTE: If both automatic repeat tests and reflex tests are defined for a test, and a
result meets the criteria defined for both, the system does not process the reflex test based on the initial result. The system repeats the test with the defined number of replicates and if any of the repeat replicates meet the reflex criteria, the reflex test is performed. The system does not perform the reflex test if none of the repeat replicates have a result that meets the reflex criteria. For example, the system handles reflex confirmatory tests for a reactive Hepatitis B surface Antigen test (HBsAg) in the manner described below. The recommended protocol for performing the HBsAg test is as follows: 1. Perform the HBsAg test. 2. If the result is reactive, repeat the test in replicates of 2 or more. 3. If 1 or more of the repeat replicates has a reactive result, perform the HBsAg confirmatory test.
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If a reactive test result initiates an automatic repeat, the system schedules an HBsAg confirmatory test only after the system shows the initial reactive result of the HBsAg screen test to be repeatably reactive.
If . . . either repeat replicate is reactive, the initial result is reactive and none of the repeat replicates have a reactive result, Then . . . the system schedules an HBsAg confirmatory test. the system does not schedule an HBsAg confirmatory test.
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3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Definition. 5. At the Test Definition window, select Edit. 6. Select Calculate Results. 7. At the Test Result Calculation window, select the table row that contains the range that requires a reflex test. The system copies the information to the fields below the table. 8. At the Reflex Tests field, select the reflex test or profile that you want the system to perform automatically if a result is within the range. 9. Perform the appropriate action:
If you selected . . . a reflex test. a reflex profile or ratio, Then . . . use the list at the Replicates field to select the appropriate number of replicates. continue with step 10. You cannot select replicates for a reflex profile or ratio.
10. To add the reflex test information to the table, select Add Row . 11. Select Continue. 12. At the Test Definition window, select Save.
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You can select whether you want to hold samples in the inprocess queue for repeat tests and the types of samples you want to hold.
Then . . . you do not need to interact with the system to repeat a test. The system holds the racks in the inprocess queue until it completes the results. If the sample requires a repeat test, the system automatically schedules and performs it. If the inprocess queue is full, the system can load an additional sample rack after it ejects a sample rack from the inprocess queue. you must reload the sample to repeat a test. The system automatically schedules repeat tests for results outside the defined ranges and the tests remain pending until you reload the sample.
1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Ranges. 5. At the Test Ranges window, select Edit.
NOTE: You do not need to define both a low and a high value for the check
range.
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6. Define the check range. The system flags results that are outside the check range limits. a. Enter or edit the low limit of the check range. b. Enter or edit the high limit of the check range. 7. Define whether to repeat tests on samples with results outside of the check range:
If you want to repeat tests with results . . . less than the low limit of the check range, greater than the high limit of the check range, Then . . . select Repeat if < in Check Range. select Repeat if > in Check Range.
8. Define the linearity: The system flags results that are outside the linearity limits. a. Enter or edit the low limit of linearity. b. Enter or edit the high limit of linearity. 9. Define if you want to repeat tests on samples with results outside the linearity limits:
If you want to repeat tests with results . . . less than the low limit of linearity, greater than the high limit of linearity, Then . . . select Repeat if < in Linearity. select Repeat if > in Linearity.
NOTE: If you select Reset Defaults, the system resets all options at the Test Ranges window in addition to the check range and linearity options.
10. You can reset the ranges at the Test Ranges window to the original values: a. Select Reset Defaults. b. Select Ranges. 11. You can reset all options and ranges at the Test Ranges window to the original values: a. Select Reset Defaults. b. Select All. 12. Select Save.
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3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Ranges. 5. At the Test Ranges window, select Edit.
NOTE: If repeats are not allowed for a test, repeat options are not available.
6. Define whether you want the system to repeat tests outside the concentration or index calculation range on the Master Curve card:
If you want the system to . . . automatically repeat tests with values below the concentration calculation range, automatically repeat tests with values above the concentration calculation range, automatically repeat tests with values below the index calculation range, automatically repeat tests with values above the index calculation range, Then select . . .
Repeat if < Conc Range. Repeat if > Conc Range. Repeat if < Index. Repeat if > Index.
NOTE: If you select Reset Defaults, the system resets all options at the
Test Ranges window in addition to the concentration and index calculation range options. 7. You can reset the options to the original values: a. Select Reset Defaults. b. Select All. 8. Select Save.
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3. At the Setup Summary window, select Sample Handling. 4. At the Setup Sample Handling Options window, select the appropriate repeat options. Select Repeat if Insufficient Sample is Detected to repeat the sample aspiration when the system detects insufficient sample volume. Select Repeat if Clot is Detected to repeat the sample aspiration when the system detects obstructions in a sample tip. Select Repeat if Sample Integrity Error is Detected to repeat the sample aspiration when the system detects an irregular sample aspiration.
5. Select Save.
leave the Repeat Replicates field blank. The system uses the number of replicates for repeat testing that was used when the test was initially performed. If you enter a different number of replicates at the Worklist Reagent Options window, the system uses that number for the current sample.
NOTE: If you are manually scheduling a repeat test, the field at the Test Ranges
window does not apply. To manually schedule a repeat test, change the number of replicates at the Worklist Reagent Options window, as described in Manually Scheduling Samples page 2-48. Use this procedure to define the number of replicates for samples processed in automatically repeated tests. 1. At the workspace, select Setup. 2. Select Test Definition Summary.
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3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Ranges. 5. At the Test Ranges window, select Edit. 6. Enter the number of replicates for patient samples processed in automatically repeated tests in the Repeat Replicates field. 7. Select Save.
a test on a sample 2 times, you must manually reload the sample for the second repeat test even if you select the hold options. The system automatically ejects samples after repeat tests are aspirated. Define the sample types that you want to hold in the inprocess queue: 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup Summary window, select Sample Handling. 4. In Hold Samples for Repeats & Reflex Tests, select each sample type that you want the system to hold in the inprocess queue for additional testing. 5. Select Save.
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Select the Hold Sample for Repeat option for each test: 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test Summary window, select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 4. Select Definition. 5. At the Test Definition window, select Edit. 6. Select Hold Sample for Repeat. This holds samples in the inprocess queue for additional testing based on the repeat criteria you defined at the Test Ranges window. 7. Select Save.
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NOTE: The Dilution Point, Dilution, or Overdilution Point field may not be available depending on the displayed test. NOTE: If you define a Dilution Point, you must also define a Dilution and Overdilution Point. If a you do not define a Dilution, the system does not have enough information to automatically dilute a sample. If you do not define an Overdilution Point, the system does not have enough information to check the diluted result.
6. In Dilution Point, enter the concentration above which you want the system to perform an automatic dilution. If the result is above the concentration limit that you enter in this field, the system flags the test result and automatically schedules a dilution. 7. In Dilution, select the dilution factor. 8. In Overdilution Point, if it is not defined, enter the concentration below which you do not want the system to determine a result for the specific dilution. The Overdilution Point should be equal to the Low Limit of the Linearity range specified at the Test Ranges window. If no Low Limit is defined, the Overdilution Point should be equal to the sensitivity limit of the assay, as reported in the product instruction in the ADVIA Centaur Assay Manual. The Overdilution Point provides an indication that the system should have diluted the sample at a lower level or not at all. The system compares the uncorrected diluted concentration to the value displayed in Overdilution Point. If the concentration is below the Overdilution Point, the system does not report a result for the sample. For example, if the Overdilution Point for ThCG is 5.0 mIU/mL (IU/L) and the uncorrected result is 4.5 mIU/mL (IU/L) on a sample diluted 1:200, the system does not determine a result for the sample because the concentration is below the specified concentration. The system flags the test result and does not schedule or repeat the test. To obtain a result, you can process the sample undiluted or diluted at a lower level, such as 1:5.
NOTE: If you select Reset Defaults, the system resets all options at the Test
Ranges window in addition to the automatic dilution options. 9. Reset all options to the original values, if necessary: a. Select Reset Defaults. b. Select All. 10. Select Save.
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2. Select Profile Summary. 3. At the Test Profile Summary window, define or edit a dilution profile.
If you want to . . . define a dilution profile, edit a dilution profile, Then . . . select Add Dilution Profile. Select a dilution profile. Select Profile Definition. At the Test Dilution Profile Definition window, select Edit.
available at the Test Dilution Profile Definition window. If Siemens Medical Solutions Diagnostics did not define dilution levels for a test, selections for dilution levels are not available. 4. At the Test Dilution Profile Definition window, enter or edit the appropriate information. a. Select Edit. b. In Profile, edit or add the name of the profile. c. In LIS Code, edit or add the LIS code for the profile. d. In Test, enter the name of the test. e. In Dilution, enter up to 5 dilution factors. 5. Select Save. The system adds the dilution symbol next to the Dilution Profile name on the Test Profile Summary window.
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When you request a ratio test, the system automatically schedules all tests defined as part of the ratio. If you request a ratio test and also request a test that is part of the ratio test, the system performs the test twice. One result is used in the calculation of the ratio test and the other result is reported independently.
NOTE: When you edit an element of a ratio test, the system automatically recalculates the ratio test result and reports the result with an Edited flag.
1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test Summary window, define or edit a ratio test:
If you want to . . . define a ratio test, edit a ratio test, Then . . .
a. a. c.
Select Add Ratio. Select a ratio test. At the Test Ratio Definition window, select Edit.
NOTE: Use the formula displayed at the Test Ratio Definition window to
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a.
Select Tests from the list in the first field under the appropriate variable.
b. Select a test from the list in the second field under the variable.
to enter a number for the variable,
a.
Select Variable from the list in the first field under the appropriate variable. You can enter a 0 (zero) if you do not want to include Variable a or Variable b in the calculation.
b. Enter a value in the second field under the variable. You can enter a 1 if you do not want to include Variable c or Variable d in the calculation
Examples are as follows: a. RBC Folate = FOLATE 2100 / HCT Enter the following variables for an RBC Folate: a = Tests, FOL b = Variable, 0 c = Tests, HCT d = Variable, 2100 b. FTI = T4 %Uptake / 100 Enter the following variables for FTI: a = Tests, T4 b = Variable, 0 c = Variable, 100 d = Tests, TUp (%) 6. Select Save.
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Percent 1 the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the percent uptake reference range defined in the first range field at this window. Percent 2 the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the reference range defined in the second range field at this window. Percent 3 the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the reference range defined in the third range field at this window. Percent 4 the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the reference range defined in the fourth range field at this window. Ratio the system calculates T Uptake results as a ratio by default.
a. a. c.
Select Add Off-System. Select an off-system test. At the Test Off-System Definition window, select Edit.
4. At the Test Off-System Definition window, enter or edit the appropriate information.
If you want to . . . enter the LIS code for a test, enter the units, enter the number of decimal places, enter a reference range, Then . . . enter the LIS code. select a unit of measure. select the number of significant digits in Decimal. enter the low limit and the high limit.
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5. Select Save.
a. c.
4. At the Test Profile Definition window, enter or edit the appropriate information. a. Add or edit the name of the profile. b. Add or edit the LIS code for the profile. c. Select the tests you want in the profile. 5. Select Save.
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3. At the Test Summary window, select Display Order. 4. At the Test Display Order window, select Edit. 5. Select a test. a. Select Test. The TestSelection window displays. b. Select a test. c. Select Continue to close the TestSelection window. 6. Select the target position. 7. Select the appropriate option:
If you want to . . . change the position of the test with the test in the target position, insert the test before an existing test in the table, Then . . . select Move. The test changes positions with the test in the target position. select Insert. The test is inserted before the target position.
8. Select Save.
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3. At the Setup Summary window, select Additional Options. 4. At the Setup Additional Options window, view the serial number assigned to your system in the System Serial Number field.
Defining Alarms
You can define alarms for Message Boxes, and Warning or Failure conditions. Refer to Monitoring Status page 2-9. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup Summary window, select Alarms. 4. At the Setup Alarms window, select Message Box, Warning, or Failure. 5. Select Alarm On or Alarm Off.
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6. Select Continuous Repetitions or Specify Repetitions. 7. If you select Specify Repetitions, enter a number from 1 to 99 in Repetitions to specify the number of times you want the alarm to repeat. 8. Enter a number from 0 to 100 in Volume. A higher number increases the volume of the alarm. 9. Repeat steps 4 through 8 for each condition. 10. Select Save.
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3. In the Control Bracket Reagent Reserve field at the Setup Additional Options window, enter the number of control sets for which the system reserves reagent to process the end-of-bracket controls. You can enter from 1 to 5 sets. For example, if you enter 2 control sets and a test has 3 control levels, the system reserves reagent required to evaluate the following number of quality control samples: 2 3 the number of control replicates defined at the Test Definition window. 4. Select Save.
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4. At the Setup Additional Options window, enter the time correction for the system clock:
If you are entering a . . . new time correction that was not used in the previous setting for this window, Then . . . enter the number of seconds with a plus sign to increase the time or a minus sign to decrease the time (example: +300 to increase the time 5 minutes or 300 to decrease the time 5 minutes).
time correction that was used in the previous setting for this window (example: you entered a time correction of +300 seconds, the system adjusted the time by this amount, and you want to adjust the time by +300 seconds again),
a.
Enter 0 (zero) in the Time Correction field. Enter the number of seconds with a plus sign to increase the time or a minus sign to decrease the time (example: +300 to increase the time 5 minutes or 300 to decrease the time 5 minutes).
b. Select Save. c.
5. Select Save. The system gradually adjusts the time on the system clock according to the number of seconds that you entered in the Time Correction field. It can take 3 hours or longer for a correction of 10 minutes.
NOTE: Do not reboot after entering a time correction until the system
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2. Select Summary. 3. At the Setup Summary window, select Print Options. 4. At the Setup Print Options window, select the appropriate printer and paper size. 5. You can print an automatic runtime results report, which is a report of all sample results as the results are being generated: a. Select Automatic Runtime Results Report. b. Enter the interval in hours at which you want page numbering to reset to 1 in Reset Page Numbering. c. Enter the number of full pages of results to print at 1 time in Page Interval. 6. If applicable, you can enter the customer number assigned to you by QC Online. 7. You can enter the laboratory information you want to appear on printed reports In Laboratory Name, enter up to 30 characters of text for your laboratory name that you want to print on reports. In Report Header, enter up to 80 characters and up to 6 lines of text that you want to print in the report header.
8. Select Save.
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The system cannot perform a remote update if it is in 1 of the following states: Inprocess Restricted Cleaning Failed Cleaning Diagnostics Performing Data Administration
headings.
5. Select Save.
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3. Select Setup. 4. In the Target Backup/Archive Device drop-down list, select the device you want to use for backing up data, restoring data, or storing your archive. 5. If you are using the RealTime Solutions service, select Access to Server. You must select this option to enable the other backup/archive options. 6. Select each option that your laboratory uses:
If you want to . . . send your results data to the RealTime Solutions server, send your backup data to the RealTime Solutions server, send your logfiles to the RealTime Solutions server, Then select . . . Result Data to Server. Backup Data to Server. Logfiles to Server.
7. In Time of Day, enter the time of day for the system to send files to the RealTime Solutions service. Specify time in a 4-digit, 24-hour format HHMM. For example: 0130 is 1:30 a.m. and 1330 is 1:30 p.m. 8. Select Save.
4. At the Setup LIS Communications window, select the appropriate options for the LIS. a. In System Name, enter up to 10 alphanumeric characters. The system name must match the name required by the LIS. b. In LIS ID, enter up to 10 alphanumeric characters. The LIS ID must match the name required by the LIS.
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c. In the upper section of the Setup LIS Communications window, select options and enter the appropriate parameters for your LIS. 5. Select all of the appropriate options for the ADVIA Centaur XP system. In the lower section of the Setup LIS Communications window, select options for your ADVIA Centaur XP system. Refer to the documentation for the LIS to determine the appropriate options.
If you want to enable the system to . . . automatically query the LIS for worklist entries as the system identifies each sample, automatically send all final results to the LIS, except the results on hold, Then select . . .
System Automatically Queries Host for Worklist.
You can define the results that the system holds at the Test Definition and the Test Result Calculation windows.
System Automatically Sends All Results except Results on Hold and System Automatically Sends All Results & Additional Data except Results on Hold.
automatically send all interim and final results to the LIS, except the results on hold,
Interim and final results include all results except invalid manual dilution results and RLU-only results. The following results are examples of interim results: replicate results results of all of the levels in a dilution profile dilution results that are under range or overdiluted results that the system cannot calculate because the RLUs are above or below the Master Curve If the LIS does not receive the interim results, contact the LIS administrator to review the result records in the LIS interface. You can define the results that the system holds at the Test Definition and the Test Result Calculation windows. automatically send reagent status messages to the LIS, send a worklist in response to a query from the LIS, send results in response to a query from the LIS,
System Automatically Sends Status to LIS. Respond to LIS Query for Worklist. Respond to LIS Query for Results.
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If you want to enable the system to . . . send Rack IDs with sample results to the LIS, remove leading spaces from SIDs when the system receives or sends SIDs, transmit diagnostic messages to the LIS when the system starts up,
Then select . . .
Send Rack IDs with Results. Remove Leading Spaces from SIDs.
Perform Diagnostics at Startup. The LIS acknowledges the messages, indicating successful communications.
6. Select Save.
NOTE: If you modified the Setup LIS Communications window on your
ADVIA Centaur XP system, turn system mechanics off and then turn system mechanics on. This procedure ensures that the LIS option is updated. 7. At the workspace, select System Status. 8. Select Turn System Mechanics Off.
NOTE: The Turn System Mechanics On option is not available until the
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If you want to enable . . . hardware flow control between the system and the LAS,
Then select . . .
Handshaking.
5. Select the appropriate baud rate, ensuring that the communication configuration of the LAS agrees with your selection. If your LAS cannot operate at the baud rate selections listed, call for technical assistance. 6. Enter the appropriate timeout information:
At . . . No Response Timeout, No Supplies Timeout, Enter the number of . . . seconds the system waits for the LAS to reply to a command or response. minutes the system allows a sample tube to remain in the lab automation queue while the operator replenishes low supplies or reagents or empties full waste containers. minutes the system allows a sample tube to remain in the lab automation queue while the system determines if the sample has any test requests. 15-second intervals (cycles) the system allows to wait for a response to the Index Queue command. In an Index Queue command, the system requests the LAS to release the sample tube at the sample access position and then move the next sample into the sample access position. 15-second intervals (cycles) the system allows a sample tube to travel from the first barcode reader to the second barcode reader (the sample access position). 15-second intervals (cycles) the system allows to wait for a response to the Send SID command. In a Send SID command, the system requests the LAS to send the SID of the sample tube at the sample access position.
No Request Timeout,
7. Select Save.
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To prevent accidental contamination in a clinical laboratory, strictly adhere to the following procedures: Wear gloves while servicing parts of the instrument that have contact with body fluids such as serum, plasma, urine, or whole blood. Wash your hands before going from a contaminated area to a noncontaminated area, or when you remove or change gloves. Perform procedures carefully to minimize aerosol formation. Wear facial protection when splatter or aerosol formation are possible. Wear personal protective equipment such as safety glasses, gloves, lab coats or aprons when working with possible biohazard contaminants. Keep your hands away from your face. Cover all superficial cuts and wounds before starting any work. Dispose of contaminated materials according to your laboratorys biohazard control procedures. Keep your work area disinfected. Disinfect tools and other items that have been near any part of the instrument sample path or waste area with 10% v/v bleach. Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the laboratory. Do not mouth pipet any liquid, including water. Do not place tools or any other items in your mouth. Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or washing hands.
To prevent needlestick injuries, needles should not be recapped, purposely bent, cut, broken, removed from disposable syringes, or otherwise manipulated by hand.
References
1. Centers for Disease Control. 1988. Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus and other bloodborne pathogens in healthcare settings. MMWR, 37:377382, 387, 388. 2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005). 3. Federal Occupational Safety and Health Administration. Bloodborne Pathogens Standard. 29 CFR 1910. 1030.
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laserclass1
.
Figure A-1 CDRH Class 1 Label
Some field service procedures require the removal of the protective housings that prevent human access to the laser radiation. The removal of the protective housings may change the classification of the system to CDRH Class 2 and EN60825-1 Class 2. All field service procedures must be followed precisely. Only Siemens-trained field service personnel should perform procedures related to laser assemblies.
Figure A-2
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Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. The specifications for the laser optical assemblies in the ADVIA Centaur XP ancillary reagent, primary reagent, and sample barcode scanners are summarized in the following table:
Characteristic Maximum Power Output Wavelength Pulse Duration Units of Beam Divergence Specification 1.0 mW 670 nm Continuous Wave (cw) 0.7 mr
The locations of the reagent and sample barcode scanners and their associated laser safety labels are shown below. The laser apertures for the sample and ancillary reagent barcode scanners are directed into the system away from the operator. During normal operation, reflections from the sample barcode scanner laser beam may be visible to persons in the immediate area, but no laser safety hazard is associated with this exposure. The laser aperture for the primary reagent barcode scanner is directed toward the barcode labels at the end of the reagent packs inside the primary reagent compartment.
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During normal operation, the barcode scanner does not scan the reagent packs until the primary reagent compartment door is closed. When the primary reagent compartment door is closed, no operator exposure to the laser exists.
1 2 3
Primary Reagent Barcode Scanner Sample Barcode Scanner Ancillary Reagent Barcode Scanner
Figure A-3
Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers.
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This table contains a summary of the specifications for the laser optical assembly in the ADVIA Centaur XP hand-held barcode scanner:
Characteristic Maximum Power Output Wavelength Pulse Duration Units of Beam Divergence Specification 1.0 mW 650 nm 7.4 ms 2mr
The laser aperture and laser safety label for the hand-held barcode scanner are on the other side of the barcode scanner window:
Hand-Held3
Figure A-4
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Warranty Period
The limited warranty period generally commences upon installation of the original instrument at the customers location and extends for a period of 1 year thereafter, unless otherwise specifically agreed to by and between Siemens Medical Solutions Diagnostics (or its authorized distributors) and customer in a writing signed by duly authorized representatives of both parties (sales representatives are generally not authorized representatives of Siemens for these purposes).
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Replacement of Parts
In performing service, Siemens Medical Solutions Diagnostics or its authorized distributors provide appropriate parts to repair the instrument, or arranges for the exchange of the instrument or affected parts, at no charge with the exception of certain parts or subassemblies that are considered Customer Maintenance Items. Customer Maintenance Items include, but are not limited to, the following items: lamps, electrodes or sensors (which are covered by a separate warranty), reagents, calibrators, controls, paper, and pens. Consult the appropriate system operators manuals for a complete list of Customer Maintenance Items for any specific model of instrument.
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6. The customer has not performed appropriate customer maintenance procedures, as outlined in the system operators manuals. 7. The instrument has been misused or used for a purpose for which it was not intended. 8. The instrument has been damaged in transit to the customer or damaged by the customer while moving or relocating it without supervision by a Siemens representative. 9. Damage was caused by floods, earthquakes, tornados, hurricanes, or other natural or man-made disasters. 10. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil commotion. 11. Damage was caused by electrical surges or voltages exceeding the tolerances outlined in the system operators manuals. 12. Damage was caused by water from any source external to the instrument. 13. The customer has purchased an alternative agreement whose terms of warranty or service supersede these provisions. Siemens Medical Solutions Diagnostics or its authorized distributors can invoice customers, at current standard labor and parts rates, for instruments repaired to correct damage or malfunctions due to any of the reasons listed above. OTHER THAN AS STATED ABOVE, THERE ARE NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE INSTRUMENT, ITS SALE TO THE CUSTOMER, ITS LEASE TO THE CUSTOMER, OR THE SALE OF THE INSTRUMENT TO THE CUSTOMER AT THE EXPIRATION OR TERMINATION OF THE LEASE AGREEMENT. SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIABILITY FOR BREACH OF ANY WARRANTY OR SERVICE AGREEMENT SHALL BE LIMITED ONLY TO THE REPAIR OR REPLACEMENT OF DEFECTIVE EQUIPMENT AND SHALL NOT INCLUDE ANY DAMAGES OF ANY KIND, WHETHER DIRECT, INDIRECT, INCIDENTAL, CONTINGENT, OR CONSEQUENTIAL. SIEMENS SHALL NOT BE LIABLE FOR DELAY FROM ANY CAUSE IN PROVIDING REPAIR OR EXCHANGE SERVICE. ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC WRITTEN AGREEMENT DO NOT APPLY TO CUSTOMERS IN THOSE JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS.
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The following table describes the View and Sort combinations you can use to perform some routine tasks:
Task Display the events in reverse chronological in order of when the events occurred Display the critical and warning events in order of most severe to least severe Display the events by subsystem View Events Errors Events Sort Date Severity Subsystem
1. At the workspace, select Event Log. 2. Select the appropriate view and identify the problem you want to solve. To search for a specific event code in the event log, select Event Code in Search for and then enter the event code.
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Contacts
This section provides the following information: the address of the Siemens authorized representative, which is the Siemens contact within the European community the Siemens addresses for obtaining service and technical information and for ordering supplies
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Addresses
For technical assistance contact your local technical support provider. For customer service or additional information contact your local technical support distributor.
Siemens Medical Solutions Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 Siemens Medical Solutions Siemens Medical Solutions Diagnostics Pty Ltd ABN 65 007 436 651 885 Mountain Highway Bayswater Victoria 3153 Australia
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Unpierced Pierced
components move and can cause injury. Only Siemens-trained personnel should perform troubleshooting
Unpierced
For all other assays, use this procedure if the primary reagent pack is unpierced. 1. With the film side up, hold the reagent pack loosely at the ends with the thumb and index or middle finger of each hand. 2. Carefully raise 1 end of the pack 90 so that the pack is in a vertical position.
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3. Carefully raise the other end of the pack 90 so that the pack is again in a vertical position. Carefully return the pack to a horizontal position. 4. Repeat steps 2 and 3 a minimum of twenty times or until: the pellet is broken up and no longer visible on the bottom of the pack no large aggregates are visible floating inside the pack.
5. Adjust the mixing speed to minimize foaming. 6. Mix 5 to 10 times more to ensure complete mixing. 7. Load the unpierced primary reagent pack onto the system. When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the primary reagent pack with self-sealing laboratory film and place the pack in the reagent storage tray at 2 to 8C. Store pierced primary reagent packs upright in the storage tray to minimize spillage. Follow the pierced primary reagent pack procedure before placing the reagent pack back on the system. Reagents left on a system with the power on are automatically mixed by the system and do not require further mixing.
Pierced
Use this procedure if the primary reagent pack is pierced. 1. Press gently on the self-sealing laboratory film that covers the pierced film area while mixing. This prevents reagent leakage. 2. With the film side up, hold the reagent pack loosely at the ends with the thumb and middle finger of each hand. 3. From a horizontal position, carefully raise 1 end of the pack 45 and carefully return the pack to a horizontal position. 4. Carefully raise the other end of the pack 45 and carefully return the pack to a horizontal position. 5. Repeat steps 3 and 4 a minimum of twenty times or until 1 of the following actions is true: the pellet is broken up and no longer visible on the bottom of the pack. no large aggregates are visible floating inside the pack.
6. Adjust the mixing speed to minimize foaming. 7. Mix 5 to 10 times more to ensure complete mixing. 8. Remove the self-sealing laboratory film and load the pierced reagent pack onto the system.
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When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the primary reagent pack with self-sealing laboratory film and place the pack in the reagent storage tray at 2 to 8C. Store pierced primary reagent packs upright in the storage tray to minimize spillage. Follow the pierced primary reagent pack procedure before placing the reagent pack back on the system. Reagents left on a system with the power on are automatically mixed by the system and do not require further mixing.
NOTE: If reagent mixing is turned off for longer than 2 hours but reagent refrigeration remains on, mix all primary reagent packs following the unpierced/ pierced primary reagent pack procedures and place the reagent packs back on the system. Verify reagent performance based on acceptable quality control results or by criteria established for your laboratory.
If both reagent mixing and reagent refrigeration are turned off for longer than 2 hours, put the primary reagent packs in the reagent storage tray at 2 to 8C. Mix all primary reagent packs following the unpierced/pierced primary reagent pack procedures before placing the reagent packs back on the system. Verify reagent performance based on acceptable quality control results or by criteria established for your laboratory.
NOTE: The onboard stability of a primary reagent pack is calculated from the time that the system reads the barcode after the reagent pack is placed on the system for the first time. If a pack is removed from the system, it is recommended that you reload the pack onto the same system. If you load the reagent pack onto a different system, you must track onboard stability and you must adjust reagent test inventory to account for tests previously removed from the pierced reagent pack while on the other system.
Unpierced
Gently invert ancillary reagent packs several times before loading them into the ancillary queue. It is important to minimize foaming. Do not shake the ancillary reagent pack. When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the ancillary reagent pack with self-sealing laboratory film and store the pack at 2 to 8C. Store pierced ancillary reagent packs upright to minimize spillage. Follow the pierced ancillary reagent pack procedure before placing the reagent pack back on the system.
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Pierced
Use this procedure if the ancillary reagent pack is pierced. 1. Press gently on the self-sealing laboratory film that covers the pierced film area while mixing. This prevents reagent leakage. 2. Gently invert the pack several times. 3. Remove the self-sealing laboratory film and load the pierced ancillary reagent pack onto the system. When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the ancillary reagent pack with self-sealing laboratory film and store the pack at 2 to 8C. Store pierced ancillary reagent packs upright to minimize spillage. Follow the pierced ancillary reagent pack procedure before placing the reagent pack back on the system. Do not add reagent to ancillary reagent packs. Each ancillary reagent pack contains enough reagent to process a predetermined number of tests. Each time the system accesses an ancillary reagent pack, reagent volume inventory tracks the amount of reagent used until the pack is empty. The system does not recognize additional fluid placed in an ancillary reagent pack.
NOTE: If reagent refrigeration is turned off for longer than 2 hours, store the ancillary reagent packs at 2 to 8C. Mix all ancillary reagent packs following the unpierced/pierced ancillary reagent pack procedures before placing the reagent packs back on the system. Verify reagent performance based on acceptable quality control results or by criteria established for your laboratory. NOTE: The onboard stability of an ancillary reagent pack is calculated from the time that the pack is first pierced. If a pierced pack is removed from the system, it is recommended that you reload the pack onto the same system. If you load the reagent pack onto a different system, you must track onboard stability and you must adjust reagent volume inventory to account for any reagent previously removed from the pierced reagent pack while on the other system.
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Good laboratory practices suggest that you establish a protocol that supports the manufacturers requirement for the instrument to: ensure optimum performance of automated laboratory instruments eliminate water quality as a source of problems when troubleshooting help you to meet requirements for state and federal laboratory certification
NOTE: The ADVIA Centaur XP supports the use of Type I and Type II grade reagent water.
The following table lists the CLSI specifications for the 3 types of reagent water. Use this information to determine the water quality in your laboratory. Refer to the CLSI guidelines for common laboratory uses of Type I, Type II, and Type III reagent water.
Specification Maximum bacterial content colony forming units per mL (CFU/mL)* pH Minimum resistivity (megohm/centimeter at 25 C) Maximum silicate (mg/L) Particulate matter (m) 0.05 smaller than 0.22 m (water is passed through a 0.22 m filter) pretreat with activated carbon or distillation or reverse osmosis 0.1 not applicable not applicable 1.0 not applicable not applicable Type I 10 (preferably bacteria free) Type II 1000 Type III not applicable 5.08.0 0.1
Organic compounds**
* *
*Bacterial content: The number of colony forming units in water. Bacterial content is a water contaminant you measure to determine water quality. Resistivity: The ability of water to resist electrical conduction due to the ion content. Resistivity is the standard test measurement for determining water quality. The higher the resistivity, the lower the ion content and the better the water quality.
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* * *
Silicates: Compounds you remove to produce Type I reagent water. Particulate matter: Undissolved (insoluble) substances larger than 0.22 m are removed by the filter. **Organic compounds: Compounds you remove to produce Type I reagent water.
Purifying Water
As with all diagnostic testing procedures, good laboratory practices suggest that you establish a protocol that supports the manufacturers requirements for selecting the appropriate type of reagent water. You can then produce reagent water in your laboratory by setting up and maintaining a water purification system which uses the purification methods described in the following table. The following table describes some of the typical laboratory water purification methods.
Method Distillation Deionization Reverse Osmosis Adsorption Filtration Description Changes water from liquid to vapor and leaves behind impurities such as particulates and bacteria Uses synthetic resins to remove ionized impurities by ion exchange Forces water under pressure through a semipermeable membrane to remove dissolved solids and organic impurities Uses activated carbon, clays, silicates, or metal oxides to remove organic impurities Forces water through a semipermeable membrane to remove insoluble matter, emulsified solids, pyrogens, and microorganisms
The quality of the reagent water you produce depends on the quality of the water you start with (source water), and the performance of your water purification system. To produce the type of water you require, you may need a purification system that uses a combination of methods. For example, if you want to produce Type I water, you need a system that uses adsorption to remove organic impurities, deionization to remove ionized impurities, and filtration to remove particulates.
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Figure C-1 displays a water purification system that combines adsorption, deionization, and filtration to produce Type I water.
1 2 3 4 5 6 7 8 9 10
Pump Source Water Check Valve Flow Controller Resistivity Indicator Valve Filter Type I Water Output Ion Exchange Carbon
Figure C-1
Establishing procedures for maintaining reagent water quality is also required for laboratory inspection and accreditation by the College of American Pathologists (CAP).4
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For Distillation Systems: Check the water vessels regularly for the presence of a slippery film. Clean and disinfect the vessels as required with an agent that rinses well, such as H2O2. Clean the boiler regularly to remove deposits Test routinely for contamination
For complete information about operation and maintenance requirements for your water purification system, refer to the manufacturers specifications.
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These problems are caused by failure to use the appropriate type of reagent water, bacterial contamination, and inadequate maintenance of the water purification system. Refer to the troubleshooting section in your system manual for more detailed information about problems caused by water that does not meet reagent water specifications.
References
1. Clinical and Laboratory Standards Institute (formerly NCCLS). Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline- Third Edition. NCCLS document C3-A3 (ISBN 1-56238-336-1). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 1997. 2. Tietz, Norbert W. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B. Saunders Company; 1987. 1010 p. 3. Kaplan, Lawrence A. Pesce, Amadeo J. Clinical Chemistry; theory, analysis, and correlation, 2nd edition. St. Louis: C.V. Mosby Company; 1989. 1212 p. 4. College of American Pathologists, Laboratory General Inspection Checklist Section 1, Quality of water, p. 8. Northfield, IL. 1989.
Do not enter values in SI units when you enter Master Curve data or calibrator assigned values. Using SI units may cause erroneous results.
NOTE: Do not enter an SI conversion factor for assays that do not list a factor. The system does not accept an SI conversion factor for these tests.
If you report results in SI units, enter the appropriate units and conversion factor for each test at the Test Result Calculation window.
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NOTE: Some assays are not available for some locales. Assay AFP Allergy Screen (ALSCRN) BNP BR (CA 15-3) CA 125 II CA 15-3 CA 19-9 Carbamazepine (CARB) CEA CKMB Cortisol (COR) C-peptide (CpS) Digitoxin (DGTN) Digoxin (DIG) Estradiol-6 (E2-6) Estradiol-6 III (E2-6 III) Ferritin (FER) Folate (FOL) FrT4 FSH FT3 Gentamicin (GENT) Her-2/neu (H2n) HAV Total (aHAVT) HAV IgM (aHAVM) HBc Total (HBcT) HBc IgM (aHBcM) Anti-HBs (aHBs) HBs AG (HBs) HBS AG Confirmatory (Conf) HCV HCY Common Units ng/mL mIU/mL pg/mL U/mL U/mL U/mL U/mL g/mL ng/mL ng/mL g/dL ng/mL ng/mL ng/mL pg/mL pg/mL ng/mL ng/mL ng/dL mIU/mL pg/mL g/mL ng/mL mIU/mL S/CO Index Index mIU/mL Index Index Index mol/L SI Units IU/mL mIU/mL pmol/L U/mL U/mL U/mL U/mL mol/L g/L nmol/L nmol/L ng/mL nmol/L nmol/L pmol/L pmol/L pmol/L nmol/L pmol/L IU/L pmol/L mol/L ng/mL mIU/mL S/CO none none mIU/mL none none none mol/L Conversion Factor 0.83 1 0.289 1 1 1 1 4.23 1 0.0125 27.59 1 1.307 1.28 3.67 3.67 2.20 2.265 12.9 1 1.54 2.09 1 1 1 1 1 1 1 1 1 1
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Assay HIV 1/0/2 Enhanced (eHIV) Total IgE (tIgE) Intact PTH (iPTH) Insulin (IRI) LH Myoglobin (MYO) Phenobarbital (PHNB) Phenytoin (PHTN) Progesterone (PRGE) Prolactin (PRL) PSA cPSA Rubella G (Rub G) Rubella M (Rub M) Specific IgE (sIgE) T3 T4 anti-TG (aTG) anti-TPO (aTPO) Testosterone (TSTO) Theophylline 2 (THEO-2) TnI-Ultra Tobramycin (TOBR) Total hCG (ThCG) Toxoplasma G (Toxo G) Toxoplasma M (Toxo M) TSH TSH-3 TUp Valproic Acid Vancomycin VB12
Common Units Index IU/mL pg/mL mU/L mIU/mL ng/mL g/mL g/mL ng/mL ng/mL ng/mL ng/mL IU/mL Index kU/L ng/mL g/dL U/mL U/mL ng/dL g/mL ng/mL g/mL mIU/mL IU/mL Index IU/mL IU/mL Index g/mL g/mL pg/mL
SI Units none IU/mL pmol/L mU/L IU/L g/L mol/L mol/L nmol/L IU/mL g/L g/L IU/mL none kU/L nmol/L nmol/L U/mL U/mL nmol/L mol/L g/L mol/L IU/L IU/mL none mIU/L mIU/L none mol/L mol/L pmol/L
Conversion Factor 1 1 0.106 1 1 1 4.31 3.96 3.18 21.2 1 1 IU/mL 1 1 1.54 12.9 1 1 0.0347 5.55 1 2.14 1 1 1 1 1 1 6.93 0.69 0.738
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For example, for a TSH-3 scheduled in a small transfer tube, the values are as follows:
200 L + 20 L + 100 L = 320 L
For example, for 2 replicates of a T4 scheduled in a large transfer tube, the values are as follows:
(25 L + 10 L) 2 + 250 L = 320 L
For multiple tests scheduled for a sample, use the following formula:
Sum of (Sample Volume + Tip Prime Volume) for all replicates for all tests + Unusable Volume = MRV
For example, for 2 replicates of a TSH-3 and 3 replicates of a T4 scheduled in an SMSD Sample Cup, the values are as follows:
(200 L + 20 L) 2 +(25 L + 10 L) 3 + 150 L = 695 L
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Refer to Appendix E, Specifications, for the list of tube types you can use.
System Fluids
The fluids described in the table below are for In Vitro Diagnostic Use only. Use the fluids until the expiration date stated on the bottle labels. Use Acid and Base reagents until the expiration date stated on the bottle label or until 28 consecutive days after loading the reagent on the system. Dispose of Acid and Base reagents and cleaning solution using approved disposal techniques for hazardous corrosive liquid wastes. Dispose of Acid and Base reagents in accordance with local, state, and federal regulations. Refer to the Material Safety Data Sheets for each material for additional information.
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Siemens Medical Solutions Diagnostics is not responsible for the performance of the ADVIA Centaur XP system when reagents other than Acid and Base reagents are used.
WARNING
Do not allow contact of Acid and Base reagents with skin and eyes. Acid and Base reagents are irritating to the skin. Wear suitable eye, face, and skin protection, which include wearing gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse the eyes immediately with plenty of water and seek medical advice. In case of accident or if you feel unwell, seek medical advice. If possible, show the bottle label and the Material Safety Data Sheet. In case of accidental ingestion of reagent, call a physician immediately.
Fluid Name Acid Reagent Base Reagent Wash 1 Reagent Volume 1500 mL 5000 tests/bottle 1500 mL 5000 tests/bottle 2500 mL Ingredients 0.5% hydrogen peroxide 0.1 N nitric acid < 0.25 N sodium hydroxide and surfactant phosphate buffered saline (pH 7.2) with < 0.1% sodium azide and surfactant phosphate buffered saline (pH 7.4) with < 0.1% sodium azide and surfactant ~52.5 g/L sodium hypochlorite Storage 425 C 425 C 425 C
Wash 3 Reagent
2500 mL
425 C
100 mL
28 C
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Appendix D: Supplies
The following is a list of supplies with catalog numbers and REF to assist in the ordering process. The catalog numbers in parentheses are included in the list for reference only.
Description Barcode Labels, Sample Identification Brush, Small Maintenance (10) Cleaning Solution Concentrate Cuvettes (package of 3000) Cuvette Waste Bin Filter, Air Intake Filter, Water Labels, Sample Rack range 001 100 range 101 200 range 201 300 range 301 400 range 401 500 Organizer, Master Curve Cards, Barcode Labels, and Calibrator Cards Pointing Device Convertor Printer Paper (8.5 x 11 paper, 1-part) Printer Paper (8.5 x 11 paper, 3-part) Probe, Ancillary and Reagent Probe, Ungrounded Aspirate Probe, Grounded Aspirate Reagent Storage Tray Reagents, Acid and Base (5000 tests per bottle) Sample Cups (bag of 1500) Sample Cup Caps (package of 1000) Sample Racks, unlabeled (box of 60) 9391302 3828105 8579502 1160808 2115415 03364923 06097004 02884702 00016339 04042237 03040281 02873484 06104191 03852677 03832935 07286900 7609246 (078-0333-01) (078-0334-01) (078-0335-01) (078-0336-01) (078-0337-01) (672003) (115625) (20764) (751046) (571233) (571843) (125669) (119147) (112219) (078-K137-01) (672010) (078-K225-01) REF 05296798 4934626 09908593 08044064 06412376 03918457 02757433 Catalog Number (23531) (27081) (112748) (078-K138-01) (572615) (572165) (26970)
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REF 8072505 02339151 7247778 01734022 04213589 0177324 08621789 07121359 01776434 07413317 00939496 00942365 00528879 00367719 2894082 07319604 03514445 08083183
Catalog Number (078-K191-01) (115896) (078-0432-01) (571638C)* (572258B) (078-0370-01) (112247) (112248) (26134) (078-K139-01) (078-0066-02) (078-0067-02) (078-K116-01) (078-B029-01) (078-0359-01) (078-B046-01) (571101) (112524)
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Appendix E: Specifications
This section summarizes the design specifications for the ADVIA Centaur XP system.
Safety Certifications
Refer to the DECLARATION OF CONFORMITY shipped with the ADVIA Centaur XP system.
Dimensions
Depth Height Width Weight 104.2 cm (41.0 in) 130.9 cm (51.5 in) 194.3 cm (76.5 in) 559 kg (1,232 lbs); system has casters
Environmental Specifications
Ambient Operating Temperature Relative Humidity Storage Temperature Indoor Use Only Altitude Ventilation IEC 1010-1 Installation Category II IEC 1010-1 Equipment Classification Class I IEC 1010-1 Pollution Degree 2 up to 2000 meters 10,000 BTU/hour 18.0 to 30.0 C 20% to 80%, non-condensing, actively controlled 0.0 to 50.0 C
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Electrical Requirements
Electrical Rating Power Requirements 220 to 240VAC 10% ~8A 50/60Hz
Tube Types
This section lists the primary sample tubes, sample transfer cups, transfer tubes, and microsample containers you can use on your system.You can specify up to 3 tube types at the Setup Tube Type & Barcode window. Refer to Specifying Sample Tube Types page 8-5. The tube type fields at the Setup Tube Type & Barcode window list the tubes you can use on your system. The + symbol before the tube type indicates that you need to place it into a holder before loading it into the sample rack. Ensure that translucent plastic sample tubes have barcode labels or a printed label facing the barcode reader when you load the tubes onto the system. The system might not detect a translucent tube with no label or a white label with very little printing.
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This symbol alerts you to the risk of exposure to lasers. This symbol alerts you to a potential electrical hazard. This symbol indicates a moving component that can cause injury. This symbol indicates the presence of a part emitting high temperature. This symbol indicates that the input electricity is alternating current. This symbol identifies the location of a protective earth (GND) conductor terminal. This symbol indicates the main power switch.
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Symbol
Description This symbol indicates that the main power supply is off. This symbol indicates the fast stop button.
This symbol indicates the computer startup button. This symbol indicates the system hard drive.
This symbol indicates the location of the fan filter. This symbol indicates the location of the cable connections. This symbol indicates the location of a printer port. This symbol indicates the location of the barcode scanner connector. This symbol indicates the location of the laboratory information system (LIS) connector. This symbol indicates the location of the uninterrupted power supply (UPS) connector. This symbol indicates the location of the external modem connector.
CAUTION: Do not connect external devices to the user interface (UI) to real time (RT) connector. Connecting external devices can cause system damage. This symbol indicates the location of the user interface (UI) to real time (RT) connector. This connector is for system connections only.
This symbol indicates the location of the small computer system interface (SCSI) connector. This connector is not used at this time. This symbol indicates the location of the keyboard connector. This symbol indicates the location of the monitor connector. This symbol indicates the location of the sample transport system (STS) connector. This symbol indicates where ancillary reagent packs are loaded or removed. This symbol indicates the sample loading area.
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Symbol
Description This symbol indicates the Stat entry. This symbol indicates where cuvettes are loaded. This symbol indicates where sample tips are loaded. This symbol identifies the system fluid bottle for Acid reagent. This symbol identifies the system fluid bottle for Base reagent. This symbol identifies the system fluid bottle for wash 1 solution. This symbol identifies the system fluid bottle for wash 3 solution. This symbol identifies the system fluid bottle for cleaning solution.
This symbol identifies the ADVIA Centaur Cleaning Solution concentrate used to prepare the cleaning solution. This symbol identifies the water bottle. This symbol identifies the lid that provides access to the liquid waste bottle. This symbol identifies the door that provides access to the sample tip tray waste. This symbol identifies the door that provides access to the cuvette waste bin. This symbol identifies the door that provides access to the sample tip waste bin. This symbol is used as a guide for placement of the sample rack pusher in the sample entry queue when the system is configured with the ADVIA Centaur XP Universal Rack Option. This symbol indicates that the product has a temperature limitation. In this example, you need to store the product between 2 to 8 C. This symbol indicates that a stacking limit is present for this product. In this example, you cannot stack more than 4 products on top of 1 another.
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Symbol
Description This symbol indicates that you should protect the product from strong magnetic fields. This symbol indicates an in vitro diagnostic device or an in vitro diagnostic medical device. This symbol indicates that you should consult instructions for use.
This symbol indicates that the product is fragile and you need to handle it with care. This symbol indicates that you should keep the product dry.
This symbol indicates the number used for ordering a part or product. This symbol indicates the serial number of a part or product. This symbol indicates the revision letter of a part or product. This symbol indicates the name and location of the product manufacturer. This symbol indicates the date of manufacture of the product.
This symbol indicates the manufacturers authorized representative within the European community. This symbol indicates that the product or container should be oriented in the direction of the arrows.
This symbol indicates not to use the product if the package is damaged. This symbol is intended to encourage recycling. This symbol indicates that the materials are recycled.
This symbol is intended to facilitate recycling of corrugated materials. The number is licensed in Germany and printed on corrugated shippers. This symbol indicates that the package is printed with soy ink.
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F-5
Symbol
Description This symbol indicates that the product complies with the applicable directives of the European Union. This symbol indicates that the product is CSA approved for safety (Canada). This symbol indicates that the product is UL approved for safety (United States). The WEEE symbol indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive. It must be recycled or disposed of in accordance with applicable local requirements.
The following symbols can also display on the exterior of the ADVIA Centaur XP system or 1 of its components.
Symbol Description This symbol indicates that the product is a Class 1 laser product, with no laser exposure during normal operation. This symbol indicates that the product is a Class 2 laser product, with potential exposure to a laser beam.
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F-6
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Do not move or install your ADVIA Centaur XP system. Unauthorized movement or installation can damage your system and void your warranty and/or service contract. Unauthorized movement can also affect your instrument calibrations. A Siemens technical support provider should install or relocate your ADVIA Centaur XP system.
Contact Siemens Medical Solutions Diagnostics when you receive your ADVIA Centaur XP system or if you need to relocate your system within your facility.
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I/O Panel at the back of the system I/O Panel on the applications module I/O Panel on the user interface module
Figure G-1
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Touch-screen monitor Keyboard Mouse Applications module User interface module Input/Output panel Handheld barcode scanner
Figure G-2
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Barcode scanner cable I/O Panel at the back of the system Touch-screen connector in Touch-screen connectors out to the Applications Module and the User Interface Module (as labeled) Video connector in Video connectors out to the applications module and the user interface module (as labeled) Keyboard connector Cable routing channel Lab Automation cable connector
Figure G-3
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G-4
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AC power cord connector Temperature sensor connector Printer connector USB port Printer connector parallel port Status indicator connector Mouse connector Power switch User Interface module connector Video connectors Touch-screen connector Keyboard connector
Figure G-4
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G-5
1 2 3 4 5 6 7 8 9
Power control connector Touch-screen connector Modem connector AC power cord connector Monitor connector User Interface (UI) to Real Time (RT) connector (This is for system connections only. Do not connect external devices to this connector.) Small Computer System Interface (SCSI) Connector (This connector is not used at this time.) Keyboard connector Printer connector
Figure G-5
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G-6
To access the Input/Output panel, perform the following steps: 1. At the back of the system, lift the I/O panel cover.
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G-7
Figure G-7
2. Lift the cable panel away and put it safely to the side to expose the back of the 2 modules.
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G-8
Do not slide the user interface module too far. You can damage the user infterface module if you slide it off the support rails. Be careful with the cables and the user interface module when sliding the user interface module. 1. At the back of the system, locate and loosen the anchor screw or screws for the selected module. The Applcations module has 1 anchor screw and the User Interface module has 2 anchor screws. These are captive screws that remain in place when you unscrew them from the module.
NOTE: The figure displays the back of the system without the cable panel. In
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Applications module Applications module support rail Applications module anchor screw User Interface module User Interface module support rails User Interface module anchor
Figure G-8
2. Slide the module toward the front of the system until the I/O panel is accessible.
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Appendix H: Glossary
accept acid probe Function used to indicate that a value is valid. For example, you can accept a result or accept an invalid calibration. Mechanical component that dispenses acid reagent into a cuvette to resuspend the magnetic particles and prepare the acridinium ester for light emission. Solution of 0.5% hydrogen peroxide and 0.1N nitric acid. Acid reagent is added to the magnetic particles in the cuvette after the wash cycle and reacts with the acridinium ester at a low pH. This readies the acridinium ester for light emission. Chemical tag responsible for the flash when base reagent is added to the acidified magnetic particle/analyte/AE mixture in the cuvette. Abbreviation: AE. Function used to enable a test or a pack for full use on the system. Available for full use on the system. An enabled test or a reagent pack can be active or inactive. Test from the menu that is enabled for use on the system. Substance of unknown concentration in a sample. Subassembly and area of the system where the operator loads and unloads ancillary packs. Container for the additional reagents required for an assay, such as Releasing Agent, DTT, or sample diluent. Additional reagents required for an assay, such as Releasing Agent, DTT, or sample diluent. Component that aspirates ancillary reagents from the ancillary queue and dispenses them into cuvettes. Protein (immunoglobulin molecule) produced by the body in response to the presence of an antigen. Antibodies are used as part of the bodys resistance to disease. Abbreviation: Ab. Antibody-antigen reaction in which the antibody of unknown concentration in a sample is captured by an additional antibody specifically directed against it. The additional antibody is bound to Solid Phase. Excess interfering substance is washed from the sample. Antigen labeled with acridinium ester is added and binds with the captured antibody from the sample. The measurable signal produced by the reaction is directly proportional to the concentration of antibody in the sample.
acid reagent
acridinium ester
activate active active test analyte ancillary entry ancillary pack ancillary reagent ancillary reagent probe antibody
antibody-capture assay
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antigen
Substance that stimulates the production of and combines specifically with corresponding antibodies. Abbreviation: Ag. See also immunogen. A comprehensive collection of data. A file designed for space-efficient, long-term storage. Mechanical device used to draw fluid (water or wash reagent) from the cuvette. The system has 4 aspirate probes: aspirate probe 1, aspirate probe 2, aspirate probe 3, and aspirate probe 4. Generic term that refers to the chemical analysis for a specific analyte in a sample. Each assay possesses a unique test protocol. Also called test. The sequence of events during an assay, including incubation time, wash and aspirate cycles, and addition of reagents. Dilutions performed by the system when a result exceeds the dilution point defined at the Test Ranges window. Dilutions performed by the system when scheduled by the operator at the Worklist Dilutions window. Option used to automatically send test results from the system to a remote device, or to automatically receive worklist requests from a remote device. Electronic signal of the photomultiplier tube (PMT) in the absence of light. Process of copying the data files contained on the system hard disk to diskettes. Encoded information that is read by an optical scanner. A label containing encoded information that is placed on reagent vials and sample cups. See also barcode. Optical device that scans and decodes barcoded information from the label on a reagent pack, a sample cup, or a primary sample tube. ADVIA Centaur barcode scanners include: ancillary barcode scanner, hand-held barcode scanner, sample barcode scanner, and reagent barcode scanner. Mechanical component that dispenses base reagent into a cuvette causing the chemiluminescent reaction. Solution of < 0.25N sodium hydroxide. Base reagent is dispensed into the cuvette in the luminometer. The pH shift and accompanying electron excitation cause the chemiluminescent reaction. Method of order entry that provides the convenience of specifying 1 or more tests on multiple samples.
assay
assay format
automatic dilutions
automatic transfer
batch
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Speed of data transmission in bits per seconds (bps) between the system and a remote device. Interface configuration allowing information to be transferred to and from another device. Solution composed of a weak acid or base and its salt that is used for controlling ionic strength. Buffers maintain the pH of a solution. Data storage used to compensate for differences in information flow rate or in the time that events occur when data is transmitted between devices. The use of 2 samples of known concentrations that you process on your system. The calibration data is then used to normalize your system against a stored master curve. The system calculates results from the normalized curve. Data that normalizes the system against stored Master Curve data for the tested analyte. The calibration data compensates for current running conditions and instrument variability. The system calculates the required sample dose from the normalized curve. Details of the calibration including the SID, concentration, RLU, CV, and flags for the low and high calibrators. Number of days or hours between required calibrations. Solution that contains a known concentration or a known reactivity of 1 or more analytes and that provides a reference for converting measured signals into concentrations. Calibrators are analyzed with reagents to obtain calibration data points. See calibration data. Card that contains the calibrator information for a specific lot of calibrators. The card contains the lot number and expiration date, and the high and low calibrator values for each analyte contained in the calibrator. This information is on the card in text and barcodes for you to enter in the system. Function used to ignore changes made at a window. A unique number associated with each Siemens product. The number is used when ordering the product. Compact disc read-only memory. An electronic storage medium on which you can store data but does not allow you to edit or write over the data Compact disc rewritable. An electronic storage medium that allows you to overwrite the current files on the CD. Main printed circuit board of a computing system that interprets instructions and directs the system operations. Abbreviation: CPU.
buffer (electronic)
calibration
calibration curve
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H-4
character parity
Transmission setting used to check for transmission errors between the system and a remote device. This setting must be the same at the system and the remote device to maintain compatibility between the systems. Digit at the end of the barcode used to verify that the barcode was correctly scanned. Value entered in the test definition beyond which the operator can program the system to automatically repeat tests. Also called alert range or action range. Variable, 2-digit, hexadecimal number that is part of the data link message frames and supports error detection. Variable hexadecimal number that ensures the Master Curve and the Calibrator definition values entered are valid. Oxidation reaction of an organic chemical compound. The chemiluminescent reaction emits light. Assay that uses an antibody-antigen reaction to determine the presence of an analyte. The amount of analyte is quantitated by a chemiluminescent reaction. Light-emitting chemical transformation caused by the oxidation of an organic chemical compound. Percent coefficient of variation among the replicates for a sample. Serial RS-232 ports on the system that can connect the system to an external, remote device, such as an LIS or a data management system. Antibody-antigen reaction in which the antigen (Ag) of unknown concentration in a sample and a labeled antigen in an assay reagent compete for a limited amount of antibody (Ab) in an assay reagent. The measurable signal produced by the Ab/labeled-Ag reaction is inversely proportional to the unknown concentration of Ag in the sample. Antibody-antigen reaction in which the antibody of unknown concentration in a sample and a labeled antibody in an assay reagent compete for a limited amount of antigen in an assay reagent. The measurable signal produced by the Ag/labeled-Ab reaction is inversely proportional to the unknown concentration of Ab in the sample. Assay for which a valid result was generated or for which all required sample aspirations are complete. Required reagent aspirations may not have completed. Amount of analyte measured. Abbreviation: Conc. A statistical value that describes how likely the statistical results are to be accurate. Settings of software and hardware.
checksum
competitive assay
completed assay
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H-5
Information that is about the operators current task and that is accessible without interrupting the current task. Measurement of a wide range of resolvable fluid levels. For example, sample levels can be measured at any volume. Operation allowing the system to process samples without interruptions to add or remove samples, empty waste containers, or replenish supplies. Quality control material used to determine if the system is reporting valid results. A test that requires you to begin and end a group of patient samples with a set of controls. The system does not process samples until it establishes the acceptability of the results of the start-of-bracket controls. The system does not report sample results until it establishes the acceptability of the results of the end-of-bracket controls is established. A setting that allows you to ensure that the system has enough reagent to complete the end-of-bracket controls of a control-bracketed test that is in process. A system reminder that you should process end-of-bracket controls soon to prevent the system from discarding retained patient test results. The control reminder applies only to control-bracketed tests. The timing for the control reminder is configurable at the Test Definition window. A system warning that you must process the end-of-bracket controls as soon as possible or the system discards retained patient test results. The control warning applies only to control-bracketed tests. The timing for the control warning is established by the manufacturer. Range of acceptable results established by the quality control material manufacturer. The control value range is provided in the assay manual. Activity performed by the operator to solve a problem. A bar at the window that indicates where you can enter data. Medical decision point for a qualitative assay. Results above the cut-off point are reported with a different qualitative interpretation than those below the cut-off point. Plastic, disposable container that holds the reaction mixture on the system. The chemiluminescent reaction occurs inside the cuvette. Each time the sample probe picks up a sample tip, the cycle count increments by 1. Electronic background signal of the photomultiplier tube (PMT) in the absence of light.
control warning
cuvette
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H-6
Number of bits transmitted between a system and a remote device. Value defined and preset by Siemens. Establish a value for a variable or symbol, or to establish what the variable represents. Function used to remove an object, such as a file, from the database. Information about a patient or sample such as name, identification number, date of birth, sex, location, and physician. Protein-based solution used to dilute a sample. See dilution setpoint. Value that indicates the concentration beyond which the system dilutes the sample and repeats the test. Command or condition that does not allow a specific event to proceed. Function used to remove a test from the menu. Device that writes information to, and reads information from, a 3.5-inch diskette. Digital Versatile Disc Rewritable. A rewritable optical storage medium having greater capacity than a CD. Command or condition that permits a specific event to proceed. Function used to add a test to the menu. Interpretation of a qualitative assay for which a definitive result is not possible. Certain qualitative assays have equivocal zones that are established as a range on either side of the cut-off point. Also called indeterminate. Abbreviation: Equiv. A network connection that allows a computer to connect to other computers on the same network. System activity such as a manual operation or an error recorded by the system in the event log. List of system occurrences (events) including errors, from the most recent to the oldest. This information includes the date and time of each occurrence. Area on the system where sample racks are moved after leaving the inprocess queue. You can remove the sample racks from the exit queue. The date beyond which the manufacturer does not guarantee correct performance of the reagent or material. Software that the system downloads to the Machine Controller boards.
equivocal
exit queue
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H-7
flag flash
Remark or message about the status of a result. The flag is next to the result at the window and on printed reports. Short burst of light produced during the chemiluminescent reaction when acridinium ester is oxidized. Acridinium ester is oxidized when the pH rapidly changes from acidic to basic with the addition of base reagent. Tool for communicating information to the operator using graphics on the system monitor. Abbreviation: GUI. System hardware tool that outputs a laser beam across a barcode and decodes the reflected laser light on return to the laser scanner engine. Device that stores data and contains all system programming. Physical components of the system. System interface setup that specifies that the system request a remote device such as an LIS to upload requests or information. Identification. Used in SID (sample identification) and PID (patient identification). Chemical test that uses an antibody-antigen reaction to determine the presence of a specific analyte or to quantify a specific analyte. The test measures an antibody or an antigen. Type of sandwich assay in which the measurable signal produced by the reagent-labeled antibody-antigen reaction is proportional to the unknown concentration of antigen or antibody in a sample. See also sandwich assay. Abbreviation: ICMA. Substance of appropriate size and species specificity which, when introduced to the body, stimulates the production of antibodies. An immunogen can be an antigen or a hapten conjugated to a large protein. Function used to limit the use of a test or a pack on the system. Not available for full use on the system. You can schedule only calibrators and controls for inactive tests and reagent packs. Test that is not enabled for use on the systems. Function used to add a value for consideration with other values.
graphical user interface hand-held barcode scanner hard disk drive hardware host query
ID immunoassay
immunochemiluminometric assay
immunogen
inactivate inactive
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H-8
incubation ring
Area where cuvettes are incubated at 37C to prepare the sample and reagent for the chemiluminescent reaction. The incubation ring also positions the cuvettes for sample and reagent dispenses and magnetic particle washes and resuspensions. Also called ring. Qualitative result that represents the relative concentration of an analyte based on a cutoff. Status of a test when the sample is in the inprocess queue and is detected by the system or the sample is in progress. Status of the system when it is processing samples. Factor used with slope to correlate the assay results with another method. You obtain the intercept and the slope from a regression equation based on method comparison studies. Designated operator available to Siemens representatives to describe instrument malfunctions by telephone and/or to perform simple adjustments and corrections as requested. System component you use to type information or to respond to a system prompt. Substance coupled to an antigen or antibody that provides the measurement signal for an immunoassay. Laboratory computer system that can be interfaced to the system. Abbreviation: LIS. Measured electronic signal of the photomultiplier tube (PMT) during the chemiluminescent reaction. Electronic device made from semiconductor materials that emits light when current flows through it. Abbreviation: LED. Method of directly accessing information or data. A link in the user interface transfers information to a related window based on a selection. Required data must be present for the information to transfer. In the online information system, a link is a quick way to access more information about a topic. Alphanumeric code that identifies a test, profile, or calibrator to your hospital or laboratory computer. Assay reagent containing antibody or antigen labeled with acridinium ester in buffer. Subassembly and component of the system where the chemiluminescent reaction occurs and is measured. A liquid material that is freeze-dried to a powder for long term stability. Reconstitute lyophilized material with water or other liquid before use. A dilution of the sample made before placing the sample on the system.
index inprocess
intercept
key operator
keyboard label laboratory information system light count light emitting diode
link
manual dilution
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Master Curve
Multi-point curve that is generated for each lot of Solid Phase and Lite Reagent for a particular test. The Master Curve is the reference curve used to convert a measured signal into sample concentration. Calibration data normalizes the system against stored Master Curve data for the tested analyte. Smallest reagent or sample volume detectable by the system. Also called base volume. Device that converts the digital signals generated by the computers serial port to the modulated analog signals required for transmission over a telephone line and transforms incoming analog signals to their digital equivalent. Device that produces an on-screen display. Antibody produced through the fusion of a myeloma cell and a B lymphocyte. Antibodies produced by a single fusion event have identical structure, affinity, and specificity for a given antigen. Nonreactive result. A result below the cut-off limit for a reactive result. See reference range. Keys that are labeled with numbers and mathematical symbols and are on the right side of the keyboard. Range calculated by your system for each test after the fourth valid calibration of a reagent and calibrator lot combination. The system uses data from additional valid calibrations of the reagent and calibrator lot combination to continually recalculate this range. Test that is not run on the system but whose results are entered in the result database and printed on a patient report. You can use off-system test results in ratio tests. Function that indicates where to place reagent packs so that reagent probes can most efficiently operate. Identification code contained in the barcode on a reagent pack that the system recognizes as unique to that pack. Magnetic particles used in the Solid Phase reagent. Abbreviation: PMP. Unique code that identifies the patient from whom a sample is obtained. Abbreviation: PID. Samples for which tests are scheduled or inprocess, but not complete. Tests that are scheduled or inprocess, but not complete.
off-system test
optimize placement Pack ID paramagnetic particles patient identification code pending samples pending tests
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photomultiplier tube
Sensitive photodetector that captures individual photons of light. The photodetector consists of a vacuum-filled photo tube with a cathode (usually 9 diodes) and an anode that the system uses to generate a signal (pulse) during the measurement phase. The signal is directly proportional to the amount of illumination produced by the reaction and can be converted into sample concentration. Abbreviation: PMT. Unit of light; quantum of radiant energy. Patient identification code. Apparatus, such as a mouse or a trackball used to interact with system software through the user interface. Antibody produced through injection of antigen into animals. Electronic subsystem that converts the AC voltages in the power line to the DC voltages used inside the system. Process that occurs to prepare a sample for testing. For example, pretreatment can include sample dilution to meet assay requirements or addition of a pretreatment agent to a sample to protect the analyte from releasing agent. Primary reagent pack containing the Solid Phase and Lite Reagent. Tube used to collect patient blood samples by venipuncture. Function that introduces reagents into the fluidic system in preparation for analyzing samples. Group of related tests or a group of the same test with different dilution specifications. Questions, instructions, or commands that help you complete the current task. Quality control. Process of verifying the performance of the system using products containing specific analytes within a predetermined concentration range. Abbreviation: QC. Product containing 1 or more specific analytes with a predetermined concentration range or reactivity used to verify the performance of the system. Protein-based product containing specific analytes within a predetermined concentration range used to verify the performance of the systems. Maximum number of seconds required for a remote device to respond to a query from the system. Sample rack. Device used to present sample tubes to the system. The sample rack contains space for up to 5 sample tubes.
primary pack primary sample tube prime profile prompt QC quality control
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Rack ID
Positional identification code. The unique code that identifies each sample rack and the positional location of the sample in the rack. Called Rack at the windows. Mode of operation in which the system processes samples for multiple assays in the most efficient order. Formula the system uses to calculate the results of a ratio test. Test that calculates results from the results of other tests. FTI is an example of a ratio test. Total photon count that the system received for a flash. The raw data is not corrected. Three independent components that aspirate reagents from the primary packs and dispense them into cuvettes. Water that meets specification for clinical laboratory use. Range of values for each assay from a defined population. Each laboratory should establish its own reference ranges for the diagnostic evaluation of patient results. The normal range is a reference range for the healthy population and can be defined by sex, age, or other patient attribute. Reference ranges can also exist for various pathological states. For example, there may be reference ranges for hypothyroid, euthyroid, and hyperthyroid states. The assay manual provides the expected values for each assay. Counts generated when the PMT detects light during the chemiluminescent reaction. A relative light unit is calibrated against a tritium source and is unique to its measurement. Abbreviation: RLU. Number of times that a sample is performed for a scheduled test. The system calculates the mean value from the results of the replicates of the calibrator, the control, or the patient sample. A container holding water, waste fluid, waste cuvettes, waste sample tips, or system fluids to allow for continuous operation while the operator empties the waste containers or replenishes the supplies. Dose concentration, ratio cutoff, or qualitative answer (positive, negative, reactive, nonreactive) for an assay performed on a sample. Specimen used for testing such as a patient sample, control, or calibrator. Disposable container that holds patient, control, or calibrator samples. Unique code that identifies each sample. Abbreviation: SID.
random access ratio definition ratio test raw data reagent probe 1, 2, or 3 reagent water reference range
replicate
reservoir
results
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H-12
Component that picks up a sample tip and then aspirates a sample and dispenses it into a cuvette. Antibody-antigen reaction in which the antigen of unknown concentration in a sample is sandwiched between antibody bound to solid phase and antibody labeled with acridinium ester. The measurable signal produced by the reaction is directly proportional to the concentration of antigen in the sample. Function used to add an object to the database or to include updates to an object in the database. Component of the monitor that displays windows, programs, menus, data, prompts, messages, and other operating information. Function used to locate an item in a list. To enter a password or code to access the system or an area of the system. To indicate that you are finished working in the system or an area of the system. International system for units of measure. Sample identification. Factor used along with intercept to correlate the assay results with results from another method. You obtain the slope and the intercept from a regression equation based on method comparison studies. Computer instructions that generate and carry out commands to control system operation. An assay reagent consisting of paramagnetic particles covalently bound to antigen or antibody suspended in a buffer. Function used to change the order of items in a list. For example, you can sort the worklist by patient name or by SID. Degree of a reagents resistance to chemical change or degradation. The events that occur when the system uses the software to initialize the hardware. Information about the current operating condition of the system. Number of data bits that maintain synchronization between the system and a remote device during data transmission. A hardware functional area of the system, such as incubation ring, luminometer, and reagent probes. Machine controller boards drive subsystems.
save screen
sort
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subsystem failure
Message classification category meaning subsystem failure; may be operator-recoverable. The message has a red background. Message classification category meaning subsystem goes offline if the operator does not interact. The message has a yellow background. Set of rules for encoding information in a barcode. Twenty-four hour clock that the system uses to monitor various system functions, such as calibration intervals, and to track the time of events. Determining the cause of a system or assay performance problem. An assay calibration that uses 2 known concentrations to normalize the Master Curve for current operating conditions. Function used to overwrite information with new information. For example, when a new master test definition is issued, you update the master test definition for access to the latest version. Universal Serial Bus, provides a serial bus standard
subsystem warning
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H-14
078D0473-03 Rev. A
Index
Numerics 4676_1511_CPrmRgt 41 4677_1512_CRgtShr 38 4678_1513_CCovers 43 4679_1514_CSplRck 56 4688_1507_CAirFil 23 4693_1527_EmtyWaTrap 15 4694_1528_CWPrbCEjR 53 4695_1529_CExReagPrb 17 4696_1530_CExAncPrb 20 A accepting an invalid calibration 25 acid probe 4, 14 Acid Reagent composition 13 acid reagent dispensing 14 replacing 37 acridinium ester 33, 35 adding control requests 5 ADVIA Centaur system topview figure 4 AE antibody binding 34 air filter cleaning 23 alarms defining 38 ancillary barcode scanner 83 ancillary entry cleaning 43 ancillary pack 12, 20 barcode 9 loading 9 removing 9 storing 9 ancillary probe 4, 12 cleaning 20 ancillary queue troubleshooting 67 ancillary reagent 12 status 18 ancillary reagent entry 9 ancillary reagent pack removing 24 ancillary reagent queue 4, 9, 12 anonymous results defining 15 antibody 34 AElabeled 36 antibodycapture assay 35, 44 antigen 34, 36 aspirate probe exterior cleaning 22 aspirate probes 4, 13 cleaning 22 illustration 14 replacing 26 troubleshooting 58 aspirated message 13 assay antibodycapture 35 competitive 35, 38 reaction time 35 sandwich 35 technology 35 assay problem 103, 104 assay specific factors 106 assigned value card calibrator values 14 assigning calibrations 25, 17 authorized representative 1, 6, 7 autoexclude calibrator replicates 10 automatic dilutions defining 30 automatic runtime results report resetting page numbers 75 specifying 41 automatic sample repeats check range 25 concentration calculation range 26 defining 24 defining number of replicates 28 holding options 29 index calculation range 26 linearity 25
078D0473-03 Rev. A
sample error conditions 27 autoschedule daily cleaning procedure 3 B backing up calibration data 3 quality control data 3 reagent inventory 3 test definition 3 backing up event log 3 backing up maintenance log 3 backing up setup 3 backing up system 3 backing up tube types 3 barcode ancillary pack 9 check digit 88 color 84 error messages 78 length 87 positioning 87 quality 85 reserved 89 sample 6 scanning technique 89 size 84 specifications 83 symbology 87 troubleshooting 78 barcode labels defining custom 7 barcode read test 71 barcode scanner 16 barcode symbology selecting 6 base probe 4, 14 Base Reagent composition 13 base reagent replacing 37 batches loading sample racks 55 scheduling 55 blinking yellow status button 9
button fast stop 5 buttons function 19 status blinking 18 task 19 workspace 17 C calibration accepting invalid 25, 17 assigning 25, 17 autoexclude calibrator replicates 10 defined ranges 6 discrepant 95 due to expire, managing 26 evaluation criteria 4 examples of managing calibrations 25 expired, managing 27 history 18 invalid, managing 25 master curve 1 observed ranges 7 print report 27 retained 8 retaining 17 software map 28 status 16 T Uptake 4 two-point 1 waiving expired 24, 17 Calibration button 19 calibration data backing up 3 printing 27 replicate results 20 review 20 status messages 20 calibration display sort 17 view 17 calibration evaluation criteria 4 calibration history 18 calibration options
078D0473-03 Rev. A
defining 16 calibration status 18, 20 cal required 16 current 16 due 16 expired 17, 20 expired, retained 20 historical 17, 18 invalid 17 invalid, exceeded defined ranges 20 invalid, exceeded observed ranges 20 no master curve 17 operator accepted 17 valid 20 valid, met retained cal limits 20 valid, operator accepted 20 valid, operator accepted, retained 21 valid, retained 21 waived 17, 21 calibrator autoexcluding a replicate 17 display at Worklist Summary window 42, 25 excluding RLU 23 scheduling 56, 18 calibrator values defining 14 capacity cuvette 25 cuvette waste 25 fluid waste 25 inprocess queue 6 reagent water 25 sample exit queue 7 sample rack 6 sample tip tray waste 25 sample tip trays 25 system fluid reservoir 37 tip waste 25 central processing unit 14 check digit 88 check range defining 25 chemiluminescent
immunoassay 34 chemiluminescent reaction 14 Cleaning aspirate probe exterior 22 cuvette waste area 43 sample time waste area 49 water bottles and reservoirs 8 cleaning air filter 23 ancillary entry 43 ancillary probe 20 aspirate probes 22 covers 43 cuvette waste chute 43 cuvette waste reservoir 43 drip trays 43 pointing device 43 primary reagent compartment 41 probe rinse stations 34 reagent pack holders 41 reagent probe shutter 38 reagent probes 17 rinse stations 34 sample entry queue 43 sample exit queue 43 sample racks 56 sample tip remover 49 sample tip waste chute 49 sample tip waste reservoir 49 sample tip waste tube 49 Stat entry 43 system fluids tray 43 waste probe and cuvette ejector rod 53 water bottle and reservoir 8 cleaning solution for soaking and wiping system components 17 preparing 32 replacing 31 clearing cuvette jams vertical cuvette chute 9 clearing jams elevator 17 orientation chute 9
078D0473-03 Rev. A
clot detected message 13 clot detection repeating samples 27 color on primary pack 8 comments deleting 3 editing 3 entering 69 symbol 41 comments for patient samples entering 54 competitive assay 35, 38 master curve 1 concentration calculation ranges automatic repeats 26 Control Bracket button 18 control bracket reagent reserve defining 39 Control Bracketing 17 archive 5 control reminder 19 control-bracketed tests 58 evaluating results 63 reagent options 57 reasons for discarded results 43 rescheduling samples 43 scheduling controls for 6 scheduling patient samples 49 viewing features 18 Control Levels field 18 Control reminder modifying 19 control requests adding 5 Control Warning field 18 control-bracketed test scheduling and loading samples 58 Control-Bracketing Messages Incomplete Set 13 controls editing 4 scheduling requests 5 covers
cleaning 43 critical condition 9 current calibration status 16 custom barcode labels defining 7 customer service 6 customer tube types restoring 4 cut-off point qualitative assays 3 cuvette loading 14 cuvette ejector rod cleaning 53 cuvette jams 9 cuvette loading clearing jams 9 cuvette loading bin 4, 14 filling 32 cuvette waste area cleaning 43 cuvette waste bin 14 emptying 35 cuvette waste chute cleaning 43 cuvette waste reservoir cleaning 43 cuvettes loading 46 D Daily Cleaning Procedure autoscheduling 3 daily cleaning procedure 5 Dark Count with Cuvette 53 data collection 77 data files maintaining 1 decimal places defining 15 defaults resetting 20, 26, 27, 31 defined ranges for calibration 6
078D0473-03 Rev. A
defined validity criteria qualitative assay 3 quantitative assay 2 defining alarms 38 anonymous results 15 automatic dilutions 30, 31 automatic repeats, number of replicates 28 automatic sample repeats 24 calibration options 16 calibrator replicates 17 check range 25, 26 control bracket reagent reserve 39 custom barcodes 7 decimal places 15 dilution factor 31 dilution point 31 dilution profiles 31 inprocess queue timeout 3 LAS communication options 47 linearity 25, 26 LIS communication options 45 low reagent status 39 maintenance activities 3 off-system tests 35 opened stability 14 overdilution concentration 31 print options 41 ratio tests 33 reference ranges 20 reflex tests 22 repeats for the concentration calculation ranges 26 result interpretations 21 screen saver options 38 sensitivity 26 Stat options 2 system name 38 T Uptake result options 34 test profiles 36 units 15 defining calibrator values 14 defining master curve using keyboard 11
using scanner 10 defining sample handling maximizing tests 2 minimizing unusable volume 2 optimizing throughput 2 Defining SID Codes from Barcode Labels 7 deleting dilution profiles 32 entire worklist 72 requests 61 selected sample results 72 selected worklist 72 test 10, 11, 12 deleting tests from a QC definition 5 determining supplies status 10 diluters 76 dilution symbol 41 dilution factor defining 31 dilution options entering 56 specifying 57 dilution point defining 30 dilution profiles defining 31 deleting 32 dilutions automatic 30 manual 56 direct plumbing specifying 44 disabled symbol 41 disabling a test 10, 11, 12 discarded results 74 Discarded results reasons for 43 discrepant calibration 95
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patient results 101 QC results 98 discrepant results 91, 95 Dispense Test 47 displaying samples by rack identifier 7 by sample identifier 7 error messages 7 in chronological order 7 drip trays cleaning 43 due calibration status 16 due, calibration managing 26 E editing control definition 4 QC expected values 4 requests 61 results 69 elevator 14 clearing jams 17 Empty Ancillary Queue 69 Empty Inprocess Queue 68 Empty Ring 44 emptying cuvette waste bin 35 sample tip tray waste 35 sample tip waste bin 33 enabling a test 10 entering comments for patient samples 54 dilution options 56 patient demographics 53 rack numbers 55 reagent options 57 error codes identifying 1 evaluating results 62 event code not in online help 3
event log 1 backing up 3 restoring 4 status 19 excluded symbol 41 excluding a calibrator replicate automatically 17 excluding a calibrator RLU 23 exit queue clearing obstructions 40 locating sample racks 8 locating samples 44 expired calibration status 17, 20 expired calibration managing 27 waiving 24 expired, retained calibration status 20 exporting quality control data 8, 3, 10 F failure condition 9 fast stop button 5 field help 23 filter water 30 flags calibration data 23 defining 21 fluid sensor replacing 34 function buttons 19 functions software map 29, 31 H Hand-held barcode scanner Master Curve 16 patient samples 16 scanning patient samples 52 HBsAg reflex confirmatory test 22 help explaining 22
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field 23 help button 23 help key 23 historical database moving results 8 historical results deleting 73 historical worklist manually moving results 45 holding samples for repeat 29 Home Probes 49 Home System 65 I Incomplete Set message 13 incubation ring 4, 14 magnets 11 temperature 11 index value nonreactive 3 qualitative assays 3 reactive 3 indicators pack 21 information online 22 information display area 20 inprocess queue 4, 5, 6, 7 capacity 6 removing sample racks 8 symbol 41 inprocess queue timeout defining 3 insufficient message 13 insufficient sample volume repeating samples 27 interpretation ranges reflex tests 23 Invalid 42 invalid calibration status 17 invalid calibration accepting 25, 17 assigning 25 managing 25
invalid, exceeded defined ranges calibration status 20 invalid, exceeded observed ranges calibration status 20 L label chemiluminescent 33 laboratory automation loading samples 6 LAS communication options 47 light emission 14, 33 lightemitting diode 8 linearity defining 25 LIS communication options 45 querying 47 releasing results on hold 70 requesting a worklist 47 scheduling samples 46 Sending results not on hold 71 sending results to 71 Sending selected results 71 Load Tip Tray 51 loading batches 55 primary pack 8 primary reagent pack 22 sample racks illustration 5 samples 5 illustration 4 laboratory automation 6 samples for control-bracketed tests 58 locating sample racks exit queue 8 sample exit queue 8 locating samples exit queue 44 lot-specific barcodes master curve 1 low reagent warning defining 39
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luminometer 4, 14 cleaning 53 troubleshooting 53, 57 M magnetic particles 13 magnets 4, 11, 13 maintaining acid and base reagents 37 cuvette loading bin 32, 33 data files 1 sample tip waste bin 35 waste bottle 27 water bottle 25 maintenance status 18 maintenance log backing up 3 restoring 4 maintenance procedures 23 Maintenance Status button 18, 19 managing the worklist 39 managing calibrations examples 25 manifold cleaning 14 manually adding test requests 47 master curve calibration 1 competitive assay 1 concentrations 10 defining 10 qualitative assays 3 quantitative assays 1, 2 relative light units 10 sandwich assay 2 specific lot 1 standard concentrations 1 standard curve 1 master curve card barcodes 1 master curve definition 10 maximizing number of tests 2
message Aspirated 13 Clot Detected 13 Incomplete Cal Set 13 Incomplete Set 13 Insufficient 13 Integrity Error 13 LIS Query Pending 14 Low Reagent 39 No Barcode 14 No Bracket 14 No Request 14 Removal Pending 14 SID Mismatch 14 Stat 2 Messages Incomplete Set 13 messages reagent status 18 sample status 13 minimizing unusable volume 2 Mismatch SID 52 modem accessing files 42 modifying control reminder 19 reagent stability option 13 sample replicates 14 sample replicates for automatic repeats 24 system options 37 test options 9 Modifying control reminder 19 monitor 17 monitoring status 9 multiple flags symbol 41 N No Barcode message 14, 16 No Bracket message 14 no calibration calibration status 16 no master curve
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calibration status 17 No Request message 14 O observed ranges for calibration 7 off-system tests defining 35 onboard plumbing specifying 44 online information explaining 22 operating sequence 2 optimized throughput defining 1 order modifying test display 36 ordering supplies 1 orientation chute 14 clearing cuvette jams 9 overdilution concentration defining 31 P pack indicators 21 Pack ID selecting 57 paramagnetic particles 35 patient demographics 53 entering 53 patient samples scheduling 49 pending requests deleting in worklist 73 photomultiplier tube 14 pointing device 43 adjusting 41 pop-up window view 62 positioning the rack indicator illustration 4 power failure
recovering from 7 preheater 14 clearing jams 15 temperature 14 primary pack loading 8 primary pack status 21 primary reagent status 8, 18 primary reagent compartment 3, 4 cleaning 41 temperature 8 primary reagent door 8 primary reagent pack loading 22 removing 22 primary reagent probes 4 primary reagent shelf 8 primary reagent status 8 primary sample tube 6 Prime Cuvettes 46 Prime Fluid Line 74 Prime System 72 Prime System Fluid Bottle 76 principles antibody binding 34 printed results deleting 73 printer specifying 41 printing calibration data 27 reagent loading report 21 sample results 73 test results 74 printing information for technical assistance 5 printing report type reagent loading report 21 results report 73 test report 74 printing system information 5 probe rinse stations cleaning 34 probes
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troubleshooting 47 problem multiple assay 104 single assay 103 procedure button 23 procedures 22 event codes 23 maintenance 23 processing batch requests 55 Stat requests 54 proficiency testing investigating failed 106 profiles dilution, defining 31 dilution, deleting 32 test, defining 36 test, deleting 36 Q QC discrepant 98 QC definition editing 4 QC statistics exporting 8, 10 qualitative assay cut-off point 3 index value 3 master curve 3 two-point calibration 3 quality control deleting tests 5 editing control definitions 4 editing expected values 4 software map 27 quality control data backing up 3 exporting to diskette 3 quantitative assay calibration 1 master curve 1 two-point calibration 1 user-initiated calibration 1 quantitative two-point calibration.
See
two-point calibration. querying an LIS 47 R rack specifying for sample identification 4 rack barcode 6 racks loading illustration 5 range concentration calculation 26 interpretation 21 patient population 20 reference 20 ratio test calculated 4 reference serum 4 T Uptake 4 ratio tests defining 33 reaction chemiluminescent 14 reagent defining opened stability 14 stability option, modifying 13 reagent barcode scanner 81 reagent holder 8 reagent inventory backing up 3 reagent lots and packs specifying 57 reagent options entering 57 reagent pack holders cleaning 41 reagent probe 13 reagent probe shutter cleaning 38 reagent probes cleaning 17 replacing 23 reagent status 15 Reagent Status button 18
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Reagent status messages 18 Depleted 18 Lot Expired 18 No Test Definition 18 Removal Pending 18 Stability Expired 18 Verify Stability 18 reagent water 3 Reasons for Discarded Results 43 red status button 9 reference ranges defining 20 reflex tests 23 reference serum calibration T Uptake 4 reflex tests defining 22 interpretation ranges 23 reference ranges 23 reflex tests for HBsAg test 22 refrigeration ancillary reagent queue 9 primary reagent compartment 8 remote access 77 selecting 42 Removal Pending message 14 removing sample racks from inprocess queue 8 repeat symbol 41 repeating a test 68 repeating samples check range 25 concentration calculation range 26 holding options 29 index calculation range 26 linearity 25 sample error conditions 27 Replacing cleaning solution 31 replacing acid and base reagents 37 aspirate probe 26
cleaning solution 31 reagent probe 23 waste bottle fluid sensor 34 waste probe 30 replicate symbol 41 replicate calibrator results 20 replicates entering 58 modifying 14 specifying 57, 58 reports laboratory name and heading 41 print options 41 printing 73 representative authorized 1, 6, 7 requesting tests manually 47 requests deleting 61 editing 61 rescheduling samples control-bracketed tests 43 Reset Thermals 70 resetting defaults 20, 26, 27, 31 restoring customer tube types 4 restoring event log 4 restoring maintenance log 4 restoring setup 4 restoring system data 4 result flags defining 21 result interpretations defining 21 result on hold releasing 70 symbol 41 results defining flags 21 defining interpretations 21 deleting 73 discarded 74
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discrepant assay 103, 104 discrepant calibration 95 discrepant patient 101 discrepant QC 98 editing 69 evaluating 62 printing 73 reporting without patient names or PIDs 15 T Uptake options 34 Results Discarded symbol 42 results in worklist deleting 73 resume update worklist 39, 43 retained calibration 8 retaining a calibration 17 reviewing calibration data 20 calibration status 16 rinse station 12, 13 rinse stations cleaning 34 RLU troubleshooting 53 See also relative light unit. runtime report resetting page numbers 75 specifying 41 S sample identification 4 integrity error, repeating samples 27 loading 5 minimum volume 12 optimization 2 options, modifying 1 status 13 messages 13 throughput options 1 tube types 5, 2 sample barcode 6 sample barcode read test 71 sample barcode scanner 7, 79 sample cup 6
barcode illustration 4 loading illustration 4 sample entry queue 3, 4, 5, 6 cleaning 43 sample exit queue 3, 4, 5 capacity 7 cleaning 43 clearing obstructions 40 locating sample racks 8 locating samples 44 sample loading area 5 sample position identifying 55 sample probe 4, 7 sample rack 4, 6 capacity 6 clips 60 loading 6 sample racks 2 cleaning 56 sample results printing 73 sample start button 6 Sample Status button 18 sample status messages 13 sample tests repeating 68 sample tip troubleshooting 51 sample tip remover 10 cleaning 49 sample tip tray 4, 7 loading jam 36 sample tip waste emptying 33 sample tip waste area cleaning 49 sample tip waste chute cleaning 49 sample tip waste reservoir cleaning 49 sample tip waste tube
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cleaning 49 samples deleting selected results 72 sandwich assay 35, 36 master curve 2 scanner sample barcode 7 Scanning patient samples hand-held barcode reader 52 scheduling batches 55 calibrator 18 calibrators 56 control requests 5 patient samples 49 samples for control-bracketed tests 58 Stat samples 54 screen saver options specifying 38 selecting multiple samples in the worklist 60 selecting multiple tests in the worklist 60 sending results manually to an LIS 71 sensitivity defining 26 separation bound from free 37 serial number viewing 37 service 1, 6, 7 under warranty 1 setup backing up 3 restoring 4 Setup button 19 setup summary software map 28 SI unit conversion factors 9 SID Mismatch 52
specifying for sample identification 4 SID mismatch preventing 52 signing in 1 signing out 1 software maps 23 Calibration 28 functions 28, 31 Quality Control 27 SetupSummary 28 status 25 system 24 worklist 26 Software Overview 17 sort calibration display 17 View and Sort 7 specific reagent symbol 41 specifications 1 barcode 83 specifying ancillary reagents 57 dilution options 57 reagent lots and packs 57 replicates 57 stability ancillary reagent 20 stability option modifying 13 standard concentrations master curve 1 standard curve master curve 1 Stat defining a message 2 defining the number of racks 2 options, defining 2 symbol 41 Stat entry 3, 4 cleaning 43 Stat samples scheduling 54 stat/sample barcode scanner 79
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Status system 18 status ancillary reagent 18 event log 19 maintenance 18, 19, 18 monitoring 9 primary pack 21 primary reagent 8 reagents 18, 15 samples 18, 13 messages 13 software map 25 supplies 18, 10 status button color 9 status buttons blinking 18 status message calibration 18, 20 stop button 5 storing ancillary pack 9 summary window type 9 view 9 supplies ordering 1 status 10 suspend update worklist 39, 43 symbol at Status Exit Queue window 41 comment 41 dilution 41 ejected from inprocess queue 41 excluded 41 inprocess queue 41 multiple flags 41 repeat 41 replicate 41 reschedule 41 result on hold 41 results discarded 42 specific reagent 41
stat 41 time due for test completion 41 waiting for controls 41 symbols 1 event log 1 system backing up 3 bottles, specifying 44 clock, changing 40 name, defining 38 options, modifying 37 restoring 4 signing in 1 signing out 1 software map 24 system fluid reservoir capacity 37 system fluids tray cleaning 43 system state description 9 System Status button 18 T T Uptake calculating result 4 defining result options 34 master curve card 4 ratio test 4 reference serum calibration 4 task buttons 19 technical assistance printing information 5 temperature ancillary queue 9 primary reagent compartment 8 troubleshooting 70 test definition backing up 3 test display order modifying 36 test name modifying 13 test options modifying 9
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test profiles defining 36 deleting 36 test results printing 74 test type all 10 allergen 10 combination 10 component 10 off-system 10 ratio 10 sIgE universal 10 standard 10 tests deleting 10, 11, 12 deleting from a QC definition 5 disabling 10 enabling 10 modifying name 13 reviewing 9 sample repeating 68 threshold reagent warning 39 time entering time correction 40 specifying time zone 40 tip tray loading 51 title bar 20 top cover opening 33 troubleshooting aspirate probe 26 barcode 78 clearing jams from vertical cuvette chute 9 cuvette jams in cuvette loading 9 cuvette jams in preheater 15 tube sizes 6 tube types 5 backing up 3 tube-type selector 6 two-point calibration
adjusted signal 2, 3 defined validity criteria 2, 3 instrument specific correction formula 3 qualitative assays 3 quantitative assay 1, 2 user-initiated 1 type summary window 9 test 10 tube 5 U units defining 15 user interface workstation 4 using sample cups 4 V vacuum test 70 Valid 42 valid, met retained cal limits calibration status 20 valid, operator accepted calibration status 20 valid, operator accepted, retained calibration status 21 valid, retained calibration status 21 Verify 42, 25 verifying barcode scanning 6 vertical cuvette chute 14 clearing cuvette jams 9 view calibration display 17 pop-up window 62 summary window 9 view, Calibration Summary historical 18 Viewing control bracketing features 18 W Waiting for Controls symbol 41 waived calibration status 17, 21
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waiving calibrations 24, 17 warning defining low reagent 39 warning condition 9 warranty 1 wash block 4 wash fluid 13 wash station 13 waste bin cuvette emptying 35 sample tip emptying 33 sample tip tray waste emptying 35 waste bottle emptying 27 waste bottle fluid sensor replacing 34 waste fluid from cuvette 14 waste probe 4, 14 aspirating waste fluid 14 cleaning 53 replacing 30 water bottle 7 filling 25 water bottle and reservoir cleaning 8 water bottles and reservoirs cleaning 8 water filter 30 water trap emptying 15 windows closing 21 elements 21 moving 21 opening 21 structure 20 title bar 20 worklist deleting requests 61 editing requests 61
managing 39 results deleting 73 resume update 39, 43 software map 26 suspend update 39, 43 Worklist Reagent Options window plus sign 57 Worklist button 19 workspace 17 workspace buttons 17 Y yellow status button 9
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