The information in this operator’s 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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ADVIA Centaur XP Operator’s Guide: Contents
Contents 1
System Overview
2
Operating the ADVIA Centaur XP System
3
Calibration
4
Quality Control
5
Performing Maintenance
6
Identifying System Problems
7
Managing Data
8
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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Using This Guide 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 Operator’s Guide provides information for the following clinical laboratory professionals who use the ADVIA Centaur XP system: •
system operators who perform daily operating tasks such as preparing the system, processing samples, reviewing results, and performing maintenance
•
system key operators who perform daily and other tasks such as reviewing control data, managing data files, and modifying system parameters
Organization The following table describes how this operator’s guide is organized. If you want to . . .
Then refer 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,
Section 1: System Features Hardware Overview, Software Overview, Technology.
process samples, monitor status, or manage sample results,
Section 2: Operating the System.
review Master Curve and 2-point calibration principles, define Master Curves and calibrators, process calibrators,
Section 3: Calibration.
learn about accessing ADVIA QC, define quality control materials,
Section 4: Quality Control.
perform scheduled maintenance activities, record maintenance activities,
Section 5: Maintenance.
investigate and correct system problems,
Section 6: Troubleshooting.
learn about saving results data files to an archive, learn about backing up your system configuration files,
Section 7: Data Management.
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If you want to . . .
Then refer to . . .
modify test definition parameters, modify system parameters, set up LIS and LAS parameters,
view warranty, legal, and support information, view contact information,
Appendix B: Warranty and Support Information.
view information about primary reagents, ancillary reagents, and system fluids,
Appendix C: Reagents and System Fluids.
view information about ordering supplies,
Appendix D: Supplies.
view system specifications,
Appendix E: Specifications.
view system symbols,
Appendix F: Symbols.
view the glossary,
Appendix G: Glossary.
Conventions The ADVIA Centaur XP Operator’s Guide uses the following text and symbol conventions: Convention
NOTE:
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Description
BIOHAZARD
Biohazard statements alert you to potentially biohazardous conditions.
LASER WARNING:
Laser Warning statements alert you to the risk of exposure to lasers.
WARNING:
Warning statements alert you to conditions that may cause personal injury.
CAUTION:
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 operator’s guide for more information. Note statements alert you to important information that requires your attention.
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Convention
Description
Bold
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
Italic type refers to the title of a document or a section title in this operator’s guide. For example, Operating the ADVIA Centaur XP System refers to Section 2 of this operator’s guide.
Terminology The following table explains some of the special terminology used in this operator’s guide and the specific actions that you need to take when you see the terminology: Term
Description
Select
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.
Enter
Type the specified information using the keyboard and then press the Enter key.
Scan
Move the hand-held barcode scanner over the specified barcode to enter the information.
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ADVIA Centaur XP Operator’s Guide: System Overview
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
Description
No-pause Reloading
You can load samples, reagents, and supplies at any time, even while the system processes samples.
Optimal Productivity
The throughput is up to 240 tests per hour and the walkaway time is up to 840 tests.
Automatic Reflex Testing
The system automatically schedules reflex tests based on parameters that you define.
Onboard Refrigeration
Reagents remain in the refrigerated reagent areas, so you can process samples without time-consuming system preparation.
True Stat Capabilities
The system efficiently processes Stat requests via a dedicated Stat port without disrupting sample processing.
Clot Detection and Management
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.
Bubble Detection
The system ensures the integrity of the reagent aspiration and dispense in the reagent and the ancillary probes.
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Feature
Description
Automated Cleaning
The system automatically performs the daily cleaning.
Autoschedule Daily Cleaning
You can set up the system to automatically schedule and log the daily cleaning procedure in the Maintenance Log.
User Interface
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.
LIS Interface
Bidirectional laboratory information system (LIS) interface allows you to send to and receive information from your LIS. The system supports the ASTM interface protocol.
Laboratory Automation
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.
RealTime Solutions service
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.
Visible Status Light
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.
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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ADVIA Centaur XP System The areas of the system that you can access while the system processes samples are shown in Figure 1-1.
1 2 3 4 5 6
Water bottle Waste bottle Primary reagent compartment Sample tip loader Visible status light Cuvette loader
Figure 1-1
7 8 9 10 11
Sample exit queue Stat entry Sample entry queue Cleaning solution System fluids
ADVIA Centaur XP System
Refer to Software Overview‚ page 1-17.
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The ADVIA Centaur XP system uses several areas of the system while processing samples, as shown in Figure 1-2.
1 2 3 4 5 6 7 8 9 10 11
Primary reagent compartment Primary reagent probes Incubation ring Luminometer Base probe Waste probe Cuvette loading bin Aspirate probes Magnets Wash block Acid probe
Figure 1-2
12 13 14 15 16 17 18 19 20 21
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
ADVIA Centaur XP System – top view
Visible Status Light The status light on the system, visible from most positions in the room, displays colors that correspond to events that occur on the ADVIA Centaur XP system. Off
No error or warning conditions exist and the ADVIA Centaur XP user interface screen saver and status buttons are neutral. • The system is turned off. • The light is disabled. NOTE: If the status light is off for an extended period of time, check the user interface error conditions.
Yellow
At least 1 warning condition exists.
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Red Blinking Yellow or Blinking Red
Blinking Green
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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.
Refer to Enabling the Visible Status Light‚ page 8-44.
Sample Loading Area The sample loading area consists of 3 areas as displayed in Figure 1-3: •
the sample entry queue where you load samples
•
the inprocess queue where the samples reside during processing
•
the sample exit queue where you remove samples
Figure 1-3
Sample Loading Area – top view
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Samples are placed in the sample racks, which hold 5 primary sample tubes or sample cups.
1 2
Tube-type selector Sample rack
Figure 1-4
ADVIA Centaur XP Sample Rack
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.
1 2 3
Sample entry queue Sample exit queue Stat entry
Figure 1-5
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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
Sample tip tray Rack Inprocess queue
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.
Reagent Loading Area You can load ReadyPack® primary reagent packs and ancillary reagent packs into their compartments, Figure 1-7, while the system processes samples.
Figure 1-7
Primary and Ancillary Reagent Compartments – top view
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Refer to Loading Reagents‚ page 2-20.
1 2
Primary reagent shelf Primary reagent door
Figure 1-8
3 4
Reagent holders LEDs
Primary Reagent Compartment
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 8°C (39° to 46°F). You remove ancillary packs at the ancillary reagent entry.
ADVIA Centaur XP Operator’s Guide: System Features
Test Sequence Hardware The test sequence starts at the inprocess queue and the sample probe where sample is dispensed into a cuvette. The inprocess queue moves the sample tip tray to the sample probe and the sample probe picks up a sample tip.
1 2
Sample tip tray Inprocess queue
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 37°C (98.6°F).
1 2
Magnets Incubation ring
Figure 1-11
Incubation Ring – top view
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.
1 2
Ancillary probe Rinse station
Figure 1-12
Ancillary Probe and Rinse Station
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.
1 2
Reagent probe Rinse station
Figure 1-13
Reagent Probe and Rinse Station
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.
1 2
Aspirate Probe 1 Aspirate Probe Clip
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 37°C (98.6°F) before the cuvettes enter the incubation ring.
1 2 3
Cuvette loading bin Orientation chute Vertical cuvette chute
Figure 1-15
4 5
Preheater Incubation ring
Cuvette Cycle
Supplies and Wastes You can load supplies and empty wastes anytime the system is processing samples. Refer to Replenishing Supplies‚ page 2-24.
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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.
1 2 3 4
Symbol keys for the status or task areas Sign In key Print key Help key
Figure 1-16
ADVIA Centaur XP Keyboard
You can use the keyboard to make selections, open windows, and enter information. If you want to . . .
Then . . .
open a window from the workspace,
Press the symbol key for the status or the task area. Press the key of the underlined character of the window title.
close a window,
press the Close Win key.
close all windows,
press the Close All key.
go to the previous window,
press the Prev Win key.
go to the next window,
press the Shift key and the Prev Win key.
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If you want to . . .
Then . . .
print information,
Press the Print key. Use the down arrow to select the Report Options button and then press the Enter key.
print the workspace,
Press the Print key. Use the down arrow to select the Print Workspace button and then press the Enter key.
access the Applications view,
Press the QC icon key on the keyboard.
sign in,
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.
access help,
Move to the field on which you want help and then press the help key.
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.
1 2 3
Status buttons Task buttons Function buttons
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.
1 2 3 4 5
System status Date and time field Supplies status Sample status Exception button
Figure 1-18
6 7 8 9
Current system state field Reagent status button Maintenance status Event log status
Workspace Toolbar Status Buttons
•
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.
Refer to Monitoring Status in Section 2.
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.
1 2 3 4
Worklist button. Quality Control button Calibration button Setup button.
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.
1 2 3 4 5
Close All Sign In RealTime Solutions - available in the Applications View Instructions for Use - available in the Applications View Print
Figure 1-20
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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.
1 2 3 4 5
Title bar with Help button View, Sort, and Search fields Information display area Bottom buttons Side buttons
Figure 1-21
Diagram of an ADVIA Centaur XP window
•
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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Opening and Closing Windows You can open and close windows as needed to perform system functions and access information. •
To close a window, select the Close button.
•
To open a window that provides more information about an item in the list, select a side button with an ellipsis (...).
•
To open a window that provides related information, select a bottom button.
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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Accessing Online Help Functions: When you access online help, you can move the window or change its size to make it easier to view your workspace window while you read the help. The online help topic sometimes offers additional information: •
To access additional information, select the hypertext link. A hypertext link, when selected, opens another help window containing more information on the current topic. In the online help windows, hypertext is blue and underlined.
•
To print a help topic or a procedure, select File and then select Print.
•
To move the help window, select the title bar and drag the window to a new position.
•
To resize the window, select the corner of the help window and drag the corner to resize the window.
Accessing Online Documentation The online document windows available in the browser are in the following list: •
Operator’s Guide
•
Customer Bulletins
•
Assays
•
Library
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.
Event Code Procedures Event code procedures provide brief descriptions and procedures for identifying and solving system events. Use the following steps to access event codes: 1. At the workspace window, select the Event Log button. 2. At the System – Event Log window, select Procedure. 3. At the online information window, select Search. 4. Enter an event code. 5. Select Find. 6. Select the event code from the list. Refer to Using the Event Log‚ page 6-1.
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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Quality Control, System View
Quality Control, Applications View
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Calibration
Setup, System View – Summary
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Setup – Test Definition Summary
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Setup, System View – Profile Summary and Data Administration
Setup, Applications View
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Functions, System View
Functions, Applications View – RealTime Solutions Service and IFUs
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Functions, Application View – Print
Technology Chemiluminescence is a chemical reaction that emits energy in the form of light.1–5 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
1 2 3 4
Light intensity Seconds Acridinium ester Other methods
Figure 1-22
Direct Chemiluminescence Comparison
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
1 2
Alkaline phosphatase (MW 68,000) AE (MW 481)
Figure 1-23
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Molecule Comparison
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Antibody Binding Principles Antibodies are proteins that are produced by the immune system in response to an antigen. Antibodies are ideal for use in immunoassays because they can be produced to bind to specific antigens. In immunoassays, the antigen is the analyte that is being measured.
1 2 3
Antigen Binding site Antibody
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.
Paramagnetic Particles and Magnetic Separation Paramagnetic particles (PMP) are iron oxide crystals that are attracted to a magnetic field.7 In the ADVIA Centaur XP assays, PMP coated with antibody or antigen are called Solid Phase.7 Coated PMP provide approximately 50 times the reactive surface area of coated tubes or beads.6
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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.
1 2
PMP Antibody
Figure 1-25
Free PMPs
Assay Reaction Formats The ADVIA Centaur XP system directly measures the amount of light that the chemiluminescent reaction emits. ADVIA Centaur XP assays use AE as the label in Lite Reagent and PMP as the Solid Phase. The system uses a variety of formats to detect antigens as well as antibodies. Refer to the ADVIA Centaur Assay Manual. The ADVIA Centaur XP system applies the immunoassay binding principles of antibodies using several formats: •
sandwich format
•
competitive format
•
antibody-capture format
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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.
1 2
Acridinium ester Antibody
Figure 1-26
3 4
Analyte-specific antigen in the sample Other antigens
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 37°C (98.6°F). PMP bind to the antigens that are bound to AE-labeled antibody.
1
PMP-Antibody-Antigen-Antibody-AE complex
Figure 1-27
Sandwich Format with Solid Phase
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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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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.
1 2
Light emissions (RLUs) Analyte concentration
Figure 1-29
Sandwich Format Result Analysis
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 37°C (98.6°F). 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.
1 2
Antibody PMP
Figure 1-30
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3 4
Analyte-specific antigen in the sample AE-labeled antigen
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.
ADVIA Centaur XP Operator’s Guide: System Features
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.
1 2
Light emissions (RLUs) Analyte concentration
Figure 1-32
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AE-labeled Format Result Analysis
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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 37°C (98.6°F). 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.
1 2 3
AE-labeled antibody PMP-labeled antigen Analyte-specific antigen in the sample
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.
1
PMP-Antigen-Antibody-AE complex
Figure 1-34
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PMP-antigent-antibody-AE Complex in the Cuvette
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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
Light emissions (RLUs) Analyte concentration
Figure 1-35
AE-labeled Antibody Result Analysis
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 37°C (98.6°F). The IgM antibody in the sample binds to anti-human IgM antibody bound to PMP.
1 2
Anti-human IgM Antibody bound to PMP Human IgM Antibody in sample
Figure 1-36
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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.
1
PMP-Anti-lgM Antibody-IgM complex
Figure 1-37
Antibody-capture Format in the Cuvette
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3. The system adds Lite Reagent, containing AE-labeled antigen, to the cuvette and incubates it at 37°C (98.6°F). The AE-labeled antigen binds to the sample IgM antibody in the sample.
1
AE-labeled antigen
Figure 1-38
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Antibody-capture Format in the Cuvette
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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.
ADVIA Centaur XP Operator’s Guide: System Features
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
Light emissions (RLUs) Analyte concentration
Figure 1-40
Antibody-capture Format Result Analysis
References 1. Whitehead TP, Kricka J, Carter JN, Thorpe G. Analytical luminescence: its potential in the clinical laboratory. Clin Chem 1979; 25/9: 1531–1546. 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: 1474–79. 3. Weeks I, Woodhead JS. Chemiluminescence immunoassays. J. Clin Immunoassay 1984; 7/1: 82–89. 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: 224–5. 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; 341–343. 7. Dudley R. The immunoassay handbook, 1st ed. New York: Stockton Press, 1994; 161–164.
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8. Dudley R. Chemiluminescence immunoassay: an alternative to RIA. Lab Med 1990; 21/4; 216–221.
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ADVIA Centaur XP Operator’s Guide: Operating the ADVIA Centaur XP System
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Operating the ADVIA Centaur XP System The ADVIA Centaur XP system accommodates many laboratory environments and workflow styles. Because of this flexibility, operating the ADVIA Centaur XP system can be as easy as loading samples, removing samples, and reviewing system and supply status. The online help for the ADVIA Centaur XP system also contains the most commonly used instructions and procedures.
Signing into or out of the System You must sign in if you need to enter comments or to access areas of the system that are a different level of security, such as selecting system options or editing test results. Use this procedure to sign into the system. 1. At the workspace, select Sign In. 2. Use the Tab key to move to the New Operator field and then enter your initials. 3. Use the Tab key to move to the Password field and then enter the password, if necessary. 4. Select Sign In. The operator ID and security level display on the Sign In button at the workspace. Use this procedure to sign out of the system. 1. At the workspace, select Sign In. 2. At the Sign In window, select Sign Out. The system signs out the current operator and closes the Sign In window.
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Managing Sample Racks CAUTION
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.
Using Sample Racks The ADVIA Centaur XP system has sample racks that can handle multiple tube types. The system can also use racks from the ADVIA Centaur system. Refer to ADVIA Centaur Sample Racks‚ page 2-5. •
When you move the Tube-Type Selector to position A—the Auto position— you may use multiple tube types in the rack. NOTE: You can either remove the tube-type selector or move the tube-type selector to position A to make the rack available for multiple tube types.
•
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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
ADVIA Centaur XP Sample Rack
Refer to the ADVIA Centaur Assay Manual.
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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.
1
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
Sample entry queue Sample start button
Figure 2-3
Sample Entry Queue
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. 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.
ADVIA Centaur Sample Racks When you uses an ADVIA Centaur rack, you can only use only 1 tube type in the rack. ADVIA Centaur racks display tube-type selector positions 1, 2, 3, and 4. The position of the Tube-Type Selector corresponds to the tube type selected in the Setup – Tube Type & Barcode window, indicating the tube type that is currently in the rack.
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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
ADVIA Centaur Sample Rack
Loading Samples Using Laboratory Automation Systems When you load samples using your laboratory automation system, the ADVIA Centaur XP system detects samples moving past the back of the system on a conveyor. The sample probe moves out of the back of the system to aspirate the samples. When you enable the laboratory automation system, the system can also process calibrator, QC, and patient samples that you load into the sample entry queue and the Stat entry. Refer to Defining LAS Communication Options‚ page 8-47.
Verifying Barcode Scanning Use the Status – Samples window to verify that the system read the sample barcode of the samples that you load on to the system. 1. At the workspace, select the Sample Status button to open the Status – Samples window. 2. To locate a specific sample or sample rack, select SID or Rack in the drop-down list.
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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.
Locating Specific Sample Information You can locate specific information by using the appropriate View and Sort combination: 1. At the workspace, select the Sample Status button. 2. To locate a specific sample or sample rack, select SID or Rack in the drop-down list. a. Select a View to determine the samples that the system displays. For example, if you select Inprocess Queue, the system displays the samples in the inprocess queue. The Lab Automation Queue view is only available when lab automation is enabled. Refer to Defining LAS Communication Options‚ page 8-47. b. Select a Sort to determine the order in which the system displays the samples. For example, if you select SID, the system sorts and displays the samples in ascending SID order. The following table describes the View and Sort combinations you can use to perform some routine tasks: Task
View
Sort
Display samples that have error messages
Inprocess Queue
Errors
Display samples in chronological order of when the system scanned the barcode
Inprocess Queue
Scanned
Display samples in ascending alphanumeric order by sample identifier
Inprocess Queue
SID
Display samples in ascending order by rack identifier
Inprocess Queue
Rack
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Removing Sample Racks from the Inprocess Queue You can schedule removal of a sample rack without completing sample aspiration for the scheduled tests, or after sample aspiration for the scheduled tests is completed. 1. At the Status – Samples window, select the sample. 2. Select Remove Rack. 3. When prompted, select Complete or Now. If you want the system . . .
Then select . . .
to finish sample aspiration for the tests in the rack, and then remove the rack
Complete
to cancel sample aspiration for the tests in the rack and remove the rack as soon as possible
Now
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.
Locating Sample Racks in the Sample Exit Queue You can locate specific sample racks in the exit queue. You can access the Status – Exit Queue window from the Status – Samples window or the Worklist – Summary window: 1. At the workspace, select 1 of the following options: •
Select the Sample Status button to open the Status – Samples window.
•
Select Worklist and then select Summary to open the Worklist – Summary window.
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.
Workspace Status Area The Workspace Status buttons are only available in the System View. Refer to Status Buttons‚ page 1-18. The system provides 2 visible status indicators—the status buttons and the visible status light—to alert you when the system needs attention. The status buttons and the visible status light change color from neutral to yellow or red to indicate that the system requires attention. •
Yellow indicates that a warning condition exists, such as a low supply.
•
Red indicates that a critical condition exists, such as an empty supply. A critical condition can cause the system to stop aspirating or processing samples.
The status buttons blink to indicate that a new condition has occurred since the last time you reviewed that status window. You can also select an audible alarm to complement the visual indicators. Refer to Defining Alarms‚ page 8-38. The status area also displays the current date, time, and state of the system. The status area can display the following system states: System State
Description
Ready
The system is ready to process samples.
Inprocess
The system is processing samples.
Cleaning
The system is performing the daily or monthly cleaning or priming.
Warming Up
The system is restarted. The thermals are equilibrating to the correct temperature.
Diagnostics
You opened the System – Diagnostic Tools window.
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System State
Description
Mechanics Off
You selected Turn System Mechanics Off in the System Status menu. Power is removed from the robotics.
Check Status
The system is not able to process samples because of a critical condition such as depleted supplies or a system error.
Cleaning Failed
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.
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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
Message
Color
Description
Cuvettes
OK
Neutral
At least 1 cuvette is available.
No Cuvette Detected
Red
The cuvette supply is depleted or an error in cuvette loading occurred and the system stopped sampling.
OK
Neutral
At least 120 sample tips are available.
<120 Tips
Yellow
Less than 120 sample tips are available.
Depleted
Red
No sample tips are available and the system stopped sampling.
OK
Neutral
The bin is less than 80% full.
>80% Full
Yellow
The bin is more than 80% full.
Not Present
Yellow
The bin was removed. The system is using the reserve.
Sampling Stopped
Red
The system stopped sampling because the cuvette bin is full.
Full
Red
The bin is full.
OK
Neutral
The bin is less than 80% full.
>80% Full
Yellow
The bin is more than 80% full.
Not Present
Yellow
The bin was removed. The system is using the reserve.
Sampling Stopped
Red
The system stopped sampling because the tip bin is full.
Full
Red
The bin is full.
OK
Neutral
The waste area is less than 80% full.
>80% Full
Yellow
The waste area is more than 80% full.
Sampling Stopped
Red
The system stopped sampling because the waste area is full and the current tip tray is empty.
OK
Neutral
The bottle is present and has enough space to continue testing.
Tips
Cuvette Waste
Tip Waste
Tip Tray Waste
Liquid Waste
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Supply Area
Water
Acid, Base
Wash 1 and Wash 3
Cleaning Solution
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Message
Color
Description
Not Present, Using Reserve
Yellow
The bottle was removed. The system is using the reserve.
Full, Using Reserve
Yellow
The bottle is full. The system is using the reserve.
Sampling Stopped
Red
The system stopped sampling because the reserve is almost full.
OK
Neutral
The bottle is present and contains enough fluid to continue testing.
Not Present, Using Reserve
Yellow
The bottle was removed. The system is using the reserve.
Sampling Stopped
Red
The system stopped sampling because the reserve is almost empty.
OK
Neutral
The bottle is present and contains enough fluid to continue testing.
Not Present, Using Reserve
Yellow
The bottle was removed. The system is using the reserve.
Present, Using Reserve
Yellow
The bottle is empty. The system is using the reserve.
Sampling Stopped
Red
The system stopped sampling because the reserve is almost empty.
Reserve Depleted
Red
The system stopped sampling because the bottle and the reserve are empty.
OK
Neutral
The bottle is present and contains enough fluid to continue testing.
Not Present, Using Reserve
Yellow
The bottle was removed. The system is using the reserve.
Present, Using Reserve
Yellow
The bottle is empty. The system is using the reserve.
Sampling Stopped
Red
The system stopped sampling any test that uses this solution because the reserve is almost empty.
Reserve Depleted
Red
The bottle and the reserve are empty. The system stopped sampling any test that uses this solution.
OK
Neutral
The bottle is present and contains enough fluid to clean the system.
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Supply Area
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Message
Color
Description
Low
Yellow
The bottle does not contain enough fluid to clean the system.
Not Present
Yellow
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.
The following messages indicate the status of a sample: Message
Color
Description
Aspirated
Neutral
All tests for this sample are aspirated.
Clot Detected
Yellow
The system detected a clot in the.sample probe. Check the sample for clots.
Incomplete Cal Set
Yellow
One of the calibrator levels is not loaded on the system. Ensure that both the high calibrator and the low calibrator are loaded.
Incomplete Set
Yellow
The complete set of controls for this control-bracketed test is not loaded on the system in the same rack. This message can apply to start-of-bracket or end-of-bracket controls. Ensure that all of the controls specified at the Test – Definition window are loaded on the system in 1 rack.
Insufficient
Yellow
Not enough sample volume exists for the requested tests.
Integrity Error
Yellow
The system detected an irregular sample aspiration. Check the sample for bubbles or foam, or check the sample probe tubing and tip-probe connection for leaks. When you perform multiple tests on a patient sample, if the sample produces an integrity error, all tests for that sample are flagged with the integrity error flag.
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Message
Color
Description
LIS Query Pending
Yellow
A request to the LIS from the system for a worklist entry is pending.
No Barcode
Yellow
The system did not read the sample barcode. Select the sample and then select Enter SID to manually enter the SID.
No Bracket
Yellow
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.
No Request
Yellow
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.
Removal Pending
Neutral
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.
SID Mismatch
Yellow
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.
Refer to Verifying Barcode Scanning‚ page 2-6.
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 . . .
Then . . .
a primary reagent needs attention or if no reagent needs attention,
the system displays the Status – Primary Reagent window.
an ancillary reagent needs attention
the system displays the Status – Ancillary Reagent window
a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist
the system displays the Worklist – Reagent Inventory window
a primary reagent and an ancillary reagent need attention
the system displays the Status – Primary Reagent window and the Status – Ancillary Reagent window
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
the system displays the Status – Primary Reagent window and the Worklist – Reagent Inventory window
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
the system displays the Status – Ancillary Reagent window and the Worklist – Reagent Inventory window
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
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
Color
Description
Cal Due
Neutral
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.
Cal Expired
Yellow
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.
Cal Required
Yellow
No valid calibration exists for the reagent lot. Schedule a calibration at the Worklist – Schedule window.
Check Lot Numbers
Yellow
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.
Check Universal Cal
Yellow
No valid calibration exists for the lot of sIgE universal reagent associated with the specific IgE tests. Schedule a calibration for the reference allergen.
Depleted
Yellow
The reagent pack is empty.
Lot Expired
Yellow
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.
Low Reagent
Yellow
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.
No Ancillary
Yellow
The test requires an ancillary reagent. Load the appropriate ancillary reagent.
No Barcode
Yellow
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 Carrier Definition
Yellow
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.
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Message
Color
Description
No Master Curve
Yellow
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.
No Optional Diluent
Neutral
An optional diluent for this test is present. If you want to perform dilutions, load the appropriate diluent.
No Required Diluent
Yellow
This test requires a diluent. Load the appropriate diluent.
No sIgE Universal
Yellow
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
Yellow
No test definition exists for the test.
Not Onboard
Yellow
Samples are scheduled for this test and no reagent packs are loaded. This message only displays at the Worklist – Reagent Inventory window.
Pack Inactive
Neutral
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.
Removable
Neutral
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.
Removal Pending
Neutral
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.
Reposition
Neutral
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.
Stability Expired
Yellow
The reagent pack or vial exceeded the stability date. Replace the reagent pack or vial.
Test Inactive
Neutral
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.
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Message
Color
Description
Verify Stability
Neutral
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.
Vial Inactive
Neutral
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.
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
Color
Description
Depleted
Yellow
The reagent pack is empty.
Lot Expired
Yellow
The reagent lot expired. Load a new lot of reagent.
No Test Definition
Yellow
No test definition exists for the test.
Removal Pending
Neutral
You requested to remove this pack. After the system completes the tests scheduled for this pack, the system ejects the pack.
Stability Expired
Yellow
The reagent pack exceeded the stability date.
Verify Stability
Neutral
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.
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.
Event Log Status Use Event Log Status to monitor the events that occur on the system. At the workspace, the Event Log button changes color to notify you of a system warning or critical condition: •
Yellow indicates that a system warning condition occurred. The system continues to operate but requires your attention.
•
Red indicates that a system critical condition occurred. The system stops and requires your attention.
Select the Event Log Status button to open the Status – Event Log window to review system events and resolve system problems. Find events you want to review by selecting a view and then sorting the event log using selected criteria, such as date or severity. •
Select Details to display additional information about the selected event.
•
Select Comments to display or add comments.
•
Select Procedures to access online procedures for troubleshooting events.
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 8°C (39 to 46°F). 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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Printing the Reagent Loading Report The reagent loading report lists the types and quantities of reagents required to perform testing for an existing worklist and is designed to help the operator load and unload reagents to support the worklist. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Reagent Loading Report. 4. Select Print Report.
Relocating Reagent Packs 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.
Managing Primary Reagents At the workspace, select the Reagent Status button to open the Status – Primary Reagent window. The pack indicators at the top of the Status – Primary Reagent window correlate to the LEDs on the primary reagent door. The LEDs and the pack indicators turn green or blink to indicate if a pack is available or if the system read the barcode: •
Green indicates that the pack should not be removed when the system is inprocess because the system may be using that pack.
•
Blinking green indicates that the system detected that a pack is present but cannot read the pack barcode. The system automatically opens the Status – Enter Primary Barcodes window.
If . . .
Then . . .
the displayed pack barcode information is correct,
select Save.
no pack barcode information is displayed or the information is not correct,
enter the correct pack barcode and select Save.
•
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.
Loading Primary Reagent Packs 1. Manually mix the primary packs and load them on the reagent holders in the primary reagent compartment. •
The primary reagent compartment stores the reagents at 4° to 8°C (39° to 46°F).
•
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.
2. Close the primary reagent door. 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. 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.
Removing Primary Packs NOTE: Before disposing of a reagent, refer to the ADVIA Centaur Assay Manual to identify any warnings or special instructions that may apply.
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 . . .
Then . . .
to complete tests scheduled for the pack,
Select Complete.
to discontinue using the pack without completing the tests,
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.
Managing Ancillary Reagents Each ancillary pack contains 1 cancillary reagent. The system tracks the volume in the pack. For information about ancillary reagent stability, refer to the ADVIA Centaur Assay Manual. Some ancillary packs are customer-fillable packs.
Loading Ancillary Reagent Packs Load the ancillary pack in the ancillary reagent entry with the barcoded side facing outward. An LED next to the ancillary reagent entry turns green to indicate that the pack is loading. The front edge of the pack fits in the notch on the ancillary entry pusher. The system moves the pack into the ancillary reagent compartment.
ADVIA Centaur XP Operator’s Guide: Operating the ADVIA Centaur XP System
Removing Ancillary Reagent Packs NOTE: Before disposing of a reagent, refer to the ADVIA Centaur Assay Manual to identify any warnings or special instructions that may apply.
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 . . .
Then . . .
to complete tests scheduled for the pack,
Select Complete
to eject the pack without completing the tests,
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
Capacity
Cuvettes
1000 cuvettes
Tips
840 tips
Cuvette Waste
700 cuvettes
Tip Tray Waste
8 trays
Tip Waste
1000 tips
Liquid Waste
7.5 L
Water
10.0 L
Acid
1500 mL
Base
1500 mL
Wash 1
2500 mL
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Supply
Capacity
Wash 3
2500 mL
Cleaning Solution
2100 mL
2-25
Filling the Water Bottle You can fill the water bottle any time, even while the system processes samples. You do not need to use this procedure if your system is directly plumbed to a water source. 1. Remove the water bottle: a. Pull out the waste and water drawer. b. Open the water bottle lid.
1 2 3 4 5
Waste and water drawer Water tubing Water bottle lid Cap Water bottle
Figure 2-6
Waste and Water Assembly
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.
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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.
Emptying the Waste Bottle You can empty the waste bottle anytime, even while the system processes samples. You do not need to use this procedure if your system is directly plumbed to a drain. 1. Remove the waste bottle: a. Pull out the waste and water drawer. Lift the waste bottle lid. BIOHAZARD
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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d. Wipe the sensor using lint-free tissues or gauze.
1
Sensor tip
Figure 2-7
Water and Waste Bottles
e. Set the sensor on lint-free tissues or gauze.
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2. Insert the Waste Bottle Stopper into the sensor and tubing openings.
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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b. Turn the waste bottle valve counterclockwise to open it.
1
Waste bottle valve
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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Attaching the Waste Bottle Stopper NOTE: This procedure is only applicable when installing or replacing a waste
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
Waste Bottle Stopper Cable Tie
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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Replacing the Cleaning Solution You can replace cleaning solution at any time, except when the system is performing the daily cleaning procedure or an aspirate or reagent probe cleaning procedure. Cleaning solution is stable for 7 days after preparation. WARNING
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
Cleaning Solution Cabinet
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
Supplies access cover Cuvette loading bin
Figure 2-12
ADVIA Centaur XP Cuvette Loading Bin
CAUTION
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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3. Close the supplies access cover.
Adding Sample Tips You can load sample tips any time, even while the system processes samples. 1. Open the supplies access cover. 2. Remove the protective cover from the bottom of the sample tip tray bundle.
1 2 3
Supplies access cover Tab Protective cover
Figure 2-13
ADVIA Centaur XP Tip Tray Loading Area
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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Emptying the Sample Tip Waste Bin You can empty the bin any time, even while the system processes samples. Sample tips are collected in a reservoir while the bin is removed from the system. The reservoir holds enough tips for approximately 5 minutes of operation. BIOHAZARD
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
Cleaning solution cabinet door Sample tip waste bin
Figure 2-14
Cleaning Solution Cabinet
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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Emptying the Sample Tip Tray Waste You can empty the sample tip tray waste any time, even while the system processes samples. 1. Open the cuvette waste area door. 2. Remove the sample tip trays.
1
Sample tip tray waste area
Figure 2-15
Cuvette and Sample Tip Tray Waste Area
3. Dispose of the contents into a waste container. 4. Close the cuvette waste area door.
Emptying the Cuvette Waste Bin You can empty the bin any time, even while the system processes samples. Cuvettes are collected in a reservoir while the bin is removed from the system. The reservoir holds enough cuvettes for approximately 5 minutes of operation. BIOHAZARD
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.
1
Cuvette waste bin
Figure 2-16
Cuvette Waste Cabinet
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.
Replacing System Fluids Replace Acid Reagent, Base Reagent, wash 1, and wash 3 when any of the following conditions exist: •
one month on the system
•
after expiration
•
insufficient volume.
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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.
1. Pull the system fluid drawer towards you. CAUTION
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
4. Write today’s date in the space provided on the new bottle. NOTE: Each system fluid bottle has a designated position in the system fluid drawer. Ensure that you place each system fluid bottle in its designated position.
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.
9. Prime the system fluid bottles.
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Managing the Worklist You can use the Worklist – Summary window for the following tasks: •
accessing the list of current requests
•
evaluating sample results.
•
reviewing the time due for pending tests
•
Moving Final Results to the Historical Worklist‚ page 2-45
•
Locating Specific Samples in the Sample Exit Queue‚ page 2-44
Viewing the Worklist The system updates the contents of the Worklist – Summary window every 15 seconds. A system update can temporarily interrupt your view of this window. You should suspend the update if you need to access information immediately. To suspend the update, perform the following steps: 1. At the Worklist – Summary window, select Suspend Updating. The system temporarily stops updating the worklist table and the label on the button changes to Resume Updating. NOTE: The system immediately updates the worklist table regardless of the
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.
Opening the Worklist To open the Worklist – Summary window from the workspace, perform the following steps: 1. Select Worklist 2. Select Summary. The sample information is on the left side of the table. The test information is on the right side of the table. The Results column displays time due or results.
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The following table describes the View and Sort combinations you can use to perform some routine tasks: Task
View
Sort
Results
Display the list of all current requests
Current
SID
Conc or Index
Display batch requests as a batch, before the ending rack is scanned
Pending Batches
Scanned
NA*
Display sample results, not all tests are complete
Current Results
SID
Conc or Index
Display samples that have tests that are scheduled or inprocess, but not complete
Pending Tests
SID
NA*
Display Stat sample results
Stats
SID
Conc or Index
Display sample results, all tests are complete
Historical
SID
Conc or Index
Display calibrator results
Calibrators
SID
Conc or Index
Display samples with tests that have RLU values, but not a calculated concentration
Stored RLUs
SID
RLU
Display a list of patient results that have been moved to the historical worklist.
Historical
PID
Conc or Index
Display the list of all current tests for a patient
Current
PID
Conc or Index
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.
Waiting for Controls
SID
NA*
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.
Results Discarded
SID
NA*
NA = Not Applicable
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Understanding Worklist Symbols For information on the other symbols displayed on the system software and hardware, refer to System Symbols‚ page F-1. Symbol
Description The tests are scheduled as Stat. A dilution is scheduled for the test. If this symbol displays on the left side of the worklist, it indicates a manual dilution. If this symbol displays on the right side of the worklist, it indicates an automatic dilution. A comment is entered. The sample is in the inprocess queue. In the Worklist, this symbol means the sample has been ejected from the inprocess queue. At the Status – Exit Queue window, this symbol means the sample was scheduled by rack and it has no SID. The system scheduled a repeat for the test or the result was obtained when the test was repeated. On a button, this symbol means the system opens a window when you select the button. In a table, this symbol means the result has multiple flags. The result is on hold so that it can be reviewed before it is released. The result is excluded or the test is disabled. In Worklist, this symbol means you changed the number of replicates for the test or specified a particular reagent lot or pack for the test. In Maintenance, this symbol indicates a maintenance procedure you defined for your laboratory. The test is due to complete at the time displaying to the left of this symbol. Tests for this sample did not complete. Reschedule the tests and reload the sample. This symbol displays only for control-bracketed tests. It represents a Waiting for Controls test, which is a test that needs an end-of-bracket set of controls to be completed before the system reports the result.
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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.
Displaying Calibrator Results at the Worklist For calibrators, instead of a numerical value, 1 of the following 3 messages displays in the results column of the Worklist – Summary window: Message
Description
Valid
The calibration is within the observed or defined ranges.
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Message
Description
Invalid
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.
Verify
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.
Suspending Update of the Worklist The system updates the contents of the Worklist – Summary window every 15 seconds. A system update can temporarily interrupt your view of this window. You should suspend the update if you need to access information immediately. To suspend the update: 1. At the Worklist – Summary window, select Suspend Updating. The system temporarily stops updating the worklist table and the label on the button changes to Resume Updating. NOTE: The system immediately updates the worklist table regardless of the 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.
Rescheduling Samples for Control-bracketed Tests The system carefully manages the reporting of results of control-bracketed tests.
Reasons for Discarded Results Test results are discarded for 1 or more reasons. Refer to Understanding Worklist Symbols‚ page 2-41, and refer to the Discarded Results symbol. 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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Rescheduling Samples with Discarded Results Use this procedure to reschedule control-bracketed test samples with discarded test results. NOTE: Print a list of samples with discarded results as described in Printing Results‚ page 2-72 before selecting Repeat at the Worklist – Summary window. A printed list of samples can help you find the samples for reloading. When you select Repeat at the Worklist – Summary window, the printed list of samples with discarded results is no longer available.
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.
Locating Specific Samples in the Sample Exit Queue You can view the Status – Exit Queue window to determine the status of the samples in the 48 most recently ejected sample racks. In addition, you can locate the approximate positions of the 24 most recently ejected sample racks in the exit queue. For more information about locating sample racks, refer to Locating Sample Racks in the Sample Exit Queue‚ page 2-8. 1. At the Worklist – Summary window, select a specific sample or a test for that sample.
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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.
Moving Final Results to the Historical Worklist To manually move worklist entries with final results to the historical worklist, perform the following steps: 1. At the workspace, select Worklist > Summary. 2. Select Move to Historical. Selecting Move to Historical schedules all completed samples, regardless of the date and time the results were obtained, to move to the historical worklist. The system moves up to 5000 worklist entries at a time, with a worklist entry consisting of all test results, flags, demographic information, and comments associated with 1 SID. Depending on the size of your worklist, it may take several minutes to an hour or more for the system to move all of the worklist entries with completed results. To avoid sample processing delays, wait until the system is in the Ready state before manually moving final results to the historical worklist. At the Setup – Sample Handling Options window, you can define the number of hours after which you want results to automatically move to the historical worklist. For more information about setting up an automatic process for moving results to historical, refer to Moving Final Results to the Historical Worklist in Section 8.
Scheduling Samples Using an LIS NOTE: Calibrator samples must be scheduled manually. Refer to Scheduling Calibrators‚ page 3-18, for more information.
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.
Automatically Scheduling Samples Using an LIS The ADVIA Centaur XP system can receive worklist entries from the LIS. You can also allow the system to automatically request worklist entries from the LIS when a sample is added to the inprocess queue. To automatically request worklist entries, perform the following steps: 1. At the workspace, select Setup > Summary. 2. Select LIS Communications. 3. At the Setup – LIS Communications window, select System Automatically Queries Host for Worklist.
Loading Samples in Host Query Mode If you set up your system in the Host Query mode and sample identification is by SID, load the sample in any rack and position. If sample identification is by Rack, load the sample in the appropriate rack and position. 1. Load the sample. Refer to Managing Sample Racks‚ page 2-2. 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. 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.
Manually Requesting a Worklist from an LIS If your system is not set up in Host Query mode, load the samples using a sample loading list generated by the LIS or manually request a worklist from the LIS and then load the samples. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select LIS Communications. 4. At the Worklist – LIS Communication window, select Receive Requests from LIS.
Entering First Names The LIS protocol does not support the use of 2-word first names. If these are used, the ADVIA Centaur XP system returns the second word of the first name to the LIS as a middle name. Insert a hyphen between the 2 words of the first name to keep the 2 parts together.
Suspending LIS Communications When your LIS is not operational or before LIS communications are automatically discontinued at the end of operation, suspend communications. If you do not suspend communications, the ADVIA Centaur XP system continues to send information to the LIS even though the LIS is unable to accept the information and system errors can result. To access the System – Communication Diagnostics window, perform the following steps: 1. At the workspace select Event Log. 2. At the System – Event Log window, select Communication Diagnostics. 3. At the System – Communication Diagnostics window, select Suspend Communications. Refer to Identifying System Problems‚ page 6-1.
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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.
Scheduling Samples Using an LAS If your lab uses a Laboratory Automation System (LAS), be mindful of the following procedural information: •
Do not place sample tubes with duplicate SIDs in the LAS queue of the ADVIA Centaur XP system. The system does not allow the processing of sample tubes with duplicate SIDs.
•
The System – Event Log window may include events associated with laboratory automation even if your laboratory does not have this feature enabled. You can ignore these events.
•
The ADVIA Centaur XP system may send a red LIS status to the LAS after a reboot and prevent sample processing. To avoid this problem, whenever the system is shut down and rebooted, process a sample with orders through the Inprocess queue. The system reinitializes the LIS and returns a green status to the LAS.
Manually Scheduling Samples Before scheduling patient, calibrator, 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. 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
•
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Refer to Loading Reagents‚ page 2-20.
Scheduling Patient Samples NOTE: Do not use the same SID for different samples within the same processing run. You must move the current SID information to the Historical worklist before it is safe to reuse the SID. If you are scheduling by batch, ensure that the SID is unique to the batch. If you use an SID more than once, the system processes only 1 sample request and rejects the other. NOTE: When you schedule Hepatitis B Surface Antigen (HBs) or Hepatitis Surface Antigen Confirmatory (Conf) tests, ensure that 2 Ancillary Probe Wash 1 packs (APW1) are in the ancillary reagent compartment or the system displays a Low Probe Wash message. The system may not process an HBs or Conf test with only 1 APW1 pack on the system.
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.
5. Enter the SID or the Rack ID and then press Enter.
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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 . . .
Then . . .
The system . . .
the system has not scanned the rack and you want to add or modify tests for a request,
select the rack position at the Worklist – Summary window and then select Schedule.
recalls the existing request for that rack position which you can modify..
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,
select the rack position at the Worklist – Summary window and then select Schedule.
recalls the existing request for that rack position which you can modify.
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,
select Worklist from the workspace and then select Schedule. or do not make any selections at the Worklist – Summary window and then select Schedule.
creates a new worklist request for the rack position.
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If . . .
Then . . .
The system . . .
the rack position is not in the current worklist and you want to create a new request for it,
select Worklist from the workspace and then select Schedule. or do not make any selections at the Worklist – Summary window and then select Schedule.
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.
Scheduling Barcoded Samples by Rack ID
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?
Worklist SID
Barcode Label
System Action
no
not present
present
makes the SID part of the rack ID in the worklist request
no
present
present, different from worklist SID
displays the SID Mismatch message; possibly incorrect tube
yes, with no barcode label on the tube
not present
present
displays the SID Mismatch message; possibly incorrect tube
yes, with no barcode label on the tube
present
not present
assumes that the sample is the same tube and performs pending or new tests
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Did the system previously scan the rack position that is in the current worklist?
Worklist SID
Barcode Label
System Action
yes, with a barcode label on the tube
present
not present
displays the SID Mismatch message; possibly incorrect tube
yes, with a different barcode label on the tube
present
present, different from worklist SID
displays the SID Mismatch message; possibly incorrect tube
Handling SID Mismatches To prevent an SID Mismatch, use 1 of the following procedures: •
Move results to historical before using the rack in a new worklist.
•
Use a rack that is not used in the current worklist.
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.
Scheduling Patient Samples Using a Hand-Held Barcode Reader 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. 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.
Entering Patient Demographics Entering patient demographic information is optional. You can enter patient demographic information at the following times: •
as you schedule samples in the worklist
•
after you create the worklist
•
while samples are processing
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
Description
PID
You can enter up to 11 alphanumeric characters for the patient identifier.
Name
You can enter up to 30 alphanumeric characters for the patient’s name. An LIS expects the patient name to be formatted “Last Name, First Name”.
DOB
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.
M or F
You can select M (male) or F (female).
Location
You can enter up to 12 alphanumeric characters for the location of the patient in the facility.
Physician
You can enter up to 12 alphanumeric characters for the physician’s name.
Optional
You can enter up to 12 alphanumeric characters for optional information about the patient or sample.
3. Select Continue. 4. Select Save at the Worklist – Schedule window and continue with additional scheduling activities.
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Entering Comments for a Patient Sample You can enter comments for a patient sample, such as the serum is hemolyzed or the patient is non-fasting. NOTE: If you are not currently signed in, you must sign in to the system to enter
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 Stat Samples When you load a sample scheduled as Stat in the sample entry queue, the system processes the sample before routine samples. You can have the system process an existing worklist request as Stat by performing 1 of the following: •
Load the sample into the Stat entry. When you load any sample into the Stat entry, the system processes the sample before routine samples.
•
Before you load the sample, edit the request at the Worklist – Schedule window to schedule the sample as Stat. Refer to Editing Requests‚ page 2-60.
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.
Scheduling Calibrators and QC Samples •
Refer to Scheduling Calibrators‚ page 3-18.
•
Refer to Scheduling QC Samples‚ page 4-6.
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Entering Dilution Options The ADVIA Centaur XP system provides both automatic and manual dilution options. •
You define automatic dilution options for a specific test, such as diluting all test results greater than a specified concentration limit, at the Test – Ranges window.
•
You define dilution profiles, which automatically schedule multiple dilutions for a test, at the Test – Profile Summary window. Refer to Defining Automatic Dilutions for Tests‚ page 8-30.
•
You define manual dilution options for a specific sample at the Worklist – Dilutions window.
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.
4. At Dilution, select a dilution factor .
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5. Select Continue. 6. At the Worklist – Schedule window, select Save.
Entering Reagent Options Use this procedure to specify the lot number and the pack of the primary reagent, the ancillary reagent, the diluent, and the vial for tests for a specific sample. Change the reagent options when you want to confirm the performance of the test with another lot number or pack or when you want to test multiple reagent lot numbers in parallel. 1. At the Worklist – Schedule window, after you enter the SID or the Rack and select or enter the tests or profiles, select Reagent Options. 2. After selecting a primary reagent lot number, at the Worklist – Reagent Options window, select the following options: •
a primary reagent pack
•
an ancillary reagent pack
•
a second ancillary reagent pack
•
a diluent pack
•
an allergen vial
3. Select Continue. 4. At the Worklist – Schedule window, select Save. NOTE: If you are performing control-bracketed tests, the list in the Lot field at the Worklist – Reagent Options window displays a plus sign (+) at the end of any reagent lot number used in an open control-bracketed test. An open control-bracketed test is a control-bracketed test that has acceptable start-of-bracket control results but the end-of-bracket controls are not processed. NOTE: The system allows several control-bracketed tests to be open at the same time, including tests using different lots of the same reagent.
Changing the Number of Replicates Use this procedure to change the number of replicates for tests for a specific sample. This option is not available for calibrator samples. You can specify the number of replicates to routinely perform on each test at the Test – Definition window. Refer to Modifying Sample Replicates‚ page 8-14. 1. At the Worklist – Schedule window, after you enter the SID or the Rack and select or enter the tests or profiles, select Reagent Options. 2. At the Worklist – Reagent Options window, enter the number of replicates for the test. You can specify up to 30 replicates for each test.
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3. Select Continue. 4. At the Worklist – Schedule window, select Save.
Using Control-bracketed Tests Refer to the scheduling and loading procedures described in these topics: •
Scheduling Samples Using an LIS‚ page 2-45
•
Manually Scheduling Samples‚ page 2-48
•
Managing Sample Racks‚ page 2-2
Scheduling Control Sets Schedule a complete set of controls at the beginning of a group of samples to open a bracket and at the end of a group of samples to close a bracket. A control set must contain the number of control levels defined at the Test – Definition window. The system does not allow a value of 0 or a value greater than 5. The system does not process extra controls but indicates their status with an Incomplete Set flag at the Worklist – Summary window. In addition, a control set must contain a numerically ascending sequence of control levels beginning with Level 1. For example, if a test requires 3 controls in a set, the controls must follow this sequence: Level 1, Level 2, and Level 3.
Loading Control Sets Place all of the controls within a set in 1 rack. Load the control rack through the sample entry queue or Stat entry. Use the end-of-bracket controls from 1 group of samples as the start-of-bracket controls for the next group of samples, provided the control results are acceptable and none of the system conditions force the system to cancel the control-bracketed test. Refer to Reasons for Discarded Results‚ page 2-43.
Scheduling Start-of-bracket and End-of-bracket Tests If you schedule the start-of-bracket controls and the end-of-bracket controls at the same time, you must perform the following tasks: •
Schedule the start-of-bracket controls with a specific rack ID for the set and a unique position for each control within the set.
•
Schedule the end-of-bracket controls with a different rack ID for the set and a unique position for each control within the set.
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.
Scheduling Calibrators for a Control-bracketed test 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. Retained patient test results are patient test results that are not reported by the system until an end-of-bracket set of controls is processed with acceptable results. Schedule samples for control-bracketed tests by SID only. The system does not allow you to schedule samples for control-bracketed tests by Rack.
Modifying the Worklist You can change entries on the worklist or delete entries from the worklist.
Selecting Multiple Samples or Tests You can select multiple samples or tests at the Worklist – Summary window. The samples or tests can be adjacent or non-adjacent in the worklist table. Use the multiple select feature to perform the following functions: •
delete multiple tests
•
repeat multiple tests
•
release results for multiple tests from hold
•
send results for multiple samples or tests to the LIS
If you want to . . .
Then . . .
select multiple adjacent samples or tests in the worklist summary table,
1.
Use the pointing device to select the first sample or test.
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.
3. When the samples or tests are selected, perform the function. select multiple non-adjacent samples or tests in the worklist summary table,
1.
Hold down the Ctrl key while using the pointing device to select each sample or test.
2. When the samples or tests are selected, perform the function.
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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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Modifying a Test for a Request Scheduled by Rack ID To modify a test for a worklist request scheduled by rack ID, perform the appropriate action: To process . . .
Then . . .
And . . .
pending tests,
check the worklist to identify sample racks with pending tests
reload the sample rack.
additional tests for a sample,
select the rack position at the Worklist – Summary window, select Schedule, select the tests, and then select Save or schedule tests for the SID required using an LIS
reload the sample rack.
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 . . .
Then . . .
delete a sample or a test,
select a sample or a test.
delete a batch,
select Pending Batches in View and then select a batch.
4. Select Delete. 5. Select Yes. NOTE: You cannot delete calibrators that are resulted.
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.
Evaluating the Results You can review results, interpretations, and flags at the Worklist – Summary window. Refer to Managing the Worklist‚ page 2-39.
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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 . . .
Then select . . .
the manual dilution factor that you selected at the Worklist – Dilutions window for a sample,
the dilution symbol in the manual dilution column.
the operator specified dilution option and factor that you selected at the Worklist – Dilutions window for a sample,
the dilution symbol in the system dilution column.
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.
a patient result in the result column.
the units for a control result,
a control result in the result column.
the 3 highest priority result flags for a sample,
the flag in the flag column.
NOTE: If multiple flags are associated with a result, an
ellipsis (...) is appended to the flag.
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.
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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
Description
Above Check
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.
Autorepeat
The system automatically repeated this test as specified in the test definition.
Below Check
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.
Cal Accepted
The result was obtained using an operator-accepted calibration for this test.
Cal Assigned
The result was obtained after you assigned a valid calibration for this test at the Worklist – Summary window.
Cal Invalid
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.
Cal Required
No valid calibration is available for the reagent lot. Schedule a calibration at the Worklist – Schedule window.
Cancelled
A test was cancelled and unable to complete because of a conflict or resource problem while processing.
Check Variable
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.
Clot Detected
A result was not obtained because a clot was detected in this sample.
> Conc Range
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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Flag
Description
< Conc Range
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.
Conf N/A
The system cannot calculate a result for a confirmatory test on this sample.
Control bracketed
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.
Control bracketed restricted
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.
Diluted
The result was obtained on a sample that the system automatically diluted.
> Dilution Pt
The result is above the dilution point defined for this test at the Test – Ranges window.
Edited
You modified the result that was reported by the system.
Entered
You manually entered the test result (usually for an off-system test).
Exception
The quality control result caused a defined quality control rule violation.
Excluded
The quality control result is excluded from statistics or the calibrator replicate is excluded from the calibration.
High
The result is above the reference range (normal range) entered in the test definition.
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Flag
Description
High CV
The CV (coefficient of variation) for replicates of the sample is above the acceptable CV entered in the test definition.
Incomplete Cal Set
One of the calibrator levels is not loaded on the system. Ensure that both the high calibrator and the low calibrator are loaded.
In Check Range
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.
> Index Range
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.
< Index Range
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.
Insufficient
Not enough sample volume is available for the requested tests.
Integrity Error
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.
Investigational
This test is for investigational use only.
> Linearity
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.
< Linearity
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.
Lot Expired
The reagent lot expired. Define a Master Curve for a new reagent lot at the Calibration – Master Curve Definition window.
Low
The result is below the reference range (normal range) entered in the test definition.
Low Acid
Insufficient acid reagent is available on the system to perform the test.
Low Base
Insufficient base reagent is available on the system to perform the test.
Low Tips
Insufficient number of sample tips are available to perform the test.
Low Wash 1
Insufficient wash 1 reagent is available on the system to perform the test.
Low Wash 3
Insufficient wash 3 reagent is available on the system to perform the test.
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Flag
Description
Low Probe Wash
Insufficient probe wash is available on the system to perform the test.
Low Water
Insufficient water is on the system to perform the test.
Manual Dilution
A manual dilution was specified for this test result. The result is automatically corrected for the specified dilution factor.
No Ancillary
The test requires an ancillary reagent. Load the appropriate ancillary reagent.
No Bracket
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.
No Calculation
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.
No Cal Lot Match
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.
No Dil Allowed
The system cannot calculate this result because a dilution is not allowed for this test.
No Diluent
An automatic dilution is scheduled and no diluent is loaded for this test.
No Lot Match
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
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
No sIgE universal reagent is onboard or the pack that is on the system is empty.
No Vial Rgt
No allergen reagent is loaded for this test.
Out
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.
Overdiluted
A result was not obtained because the diluted sample result is below the overdilution point defined at the Test–Ranges window.
Priming
The system cannot perform the test because the system needs to schedule priming for a probe or a pump.
Redilute
Dilute and repeat the test.
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Flag
Description
repeated
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.
restricted
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.
Signal Error
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.
System Error
The system cannot perform the test because a subsystem is offline.
Test Inactive
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.
Waste Full
The system cannot perform the test because the cuvette bin, the sample tip bin, the tip tray bin, or the waste bottle is full.
Wrong Pack ID
Primary or ancillary reagent with the specified pack serial number is not loaded for this test.
Wrong Vial ID
Allergen reagent with the specified vial serial number is not loaded for this test.
Waived
The result was obtained using an operator waived calibration for this test.
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 . . .
Then . . .
the sample is in the inprocess queue when the repeat test is scheduled,
the system automatically performs the repeat test on the sample.
the sample has been ejected from the inprocess queue before the repeat test is scheduled,
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.
Locating Samples that Require Further Attention You can use the Status – Exit Queue window to locate samples that do not have results, require dilutions, or require other attention due to errors. Refer to Locating Specific Samples in the Sample Exit Queue‚ page 2-44.
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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9. At the Worklist – Edit Results window, select Save .
Releasing Results That Are On Hold If the system is holding results for review before sending them to the LIS, use this procedure to remove the hold status. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select test results with the hold status. 4. Open the Worklist – Release Results window by performing 1 of the following actions: If you want to . . .
Then . . .
release the hold status for selected results,
select Release.
review result replicates and flags for a selected result before releasing the hold status,
a.
Select Result Details.
b. Review details for the result. c.
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 . . .
Then . . .
release the status for the result selected at the Worklist – Summary window,
select Release Only Selected Results.
release the status for all results for the test selected at the Worklist – Summary window,
select Release All Results on Hold for the Selected Test.
release the status for all results the system is holding for review,
select Release All Results on Hold.
release the status for results within a specific date range,
a.
Select Release Results on Hold within Date Range.
b. Enter the starting date and the ending date.
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.
Releasing Results on Hold At the Worklist – Release Results window, selecting Release All Results on Hold for the Selected Test does not transmit all interim and final results on hold for a selected test to the LIS.
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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.
Sending Results to an LIS If automatic transfer of results is not defined for your system, you can manually send results to an LIS. You can send all results except results that you are holding for review or you can select specific test results at the Worklist – Summary window and then release these results to the LIS.
Sending All Results Except Results On Hold to an LIS 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select LIS Communications. 4. At the Worklist – LIS Communications window, select Send All Results Except Results on Hold. 5. You can enter a starting date and an ending date. •
The default for the starting date field is the date and time of the earliest request in the current worklist.
•
The default for the ending date field is the date and time this window was opened.
6. Select Continue. The system sends all results to the LIS that match the criteria you defined.
Sending Selected Results to an LIS 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select the results you want to send to the LIS. Refer to Selecting Multiple Samples or Tests‚ page 2-59, .
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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.
If you want to delete . . .
Then . . .
results for all tests in the current worklist,
in result, select Current and in Test, select All.
results for a specific test in the current worklist,
in result, select Current and in Test, select the test for the results you want to delete.
results for all tests in the historical worklist,
in result, select Historical and in Test, select All.
results for a specific test in the historical worklist,
in result, select Historical and in Test select the test for the results you want to delete.
all results for all tests,
in result, select Current & Historical and in Test, select All.
all results for a selected test,
in result, select Current & Historical and in Test, select the test for the results you want to delete.
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 . . .
Then . . .
pending requests,
Select Pending.
tests that have results,
Select Resulted.
printed results,
Select Printed.
results that were sent to the LIS,
Select Sent.
6. Select Continue to begin the deletion.
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.
Printing Results by Sample The Results Report is a report of all results for samples in a specific date range according to the specified view and sort options. 1. At the workspace, select Print.
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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
Printing Results by Test NOTE: The test report for the HBs Confirmatory assay displays the RLUs for RgtA and RgtB in the wrong columns. The RgtA value is displayed on the RgtB column and the RgtB value is displayed in the RgtA column. The correct RLUs are displayed in the Runtime Result report. The system uses the correct RLUs in the calculation of results.
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
Resetting the Page Numbers for Runtime Reports The Runtime Report prints sample results as they are generated by the system if Automatic Runtime Results Report is selected at the Setup – Print Options window. Refer to Specifying Print Options‚ page 8-41. At the Print – Report Options window, you can restart the page numbers for the runtime report. For example, you can restart the page numbers at the beginning of each day, or at the beginning of each shift in your laboratory. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Runtime Report. 4. Select Reset Page Numbers.
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.
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.
Using a Master Curve The Master Curve is part of the manufacturing process for each assay lot number. Measuring the RLU response at multiple concentration levels is the means of performing full standard curves on lot numbers. The standard concentrations and corrected RLUs define the shape of the curve for a particular assay lot number. The manufacturing process uses reagents from a specific lot to generate a Master Curve by performing the assay on standards of varying concentrations on multiple systems over several days. The ensuing standard curve determines the relationship between the defined analyte levels and the RLUs. These concentrations and RLUs become the lot-specific Master Curve and Siemens provides them as barcodes on the Master Curve Card. The Master Curve for a competitive assay has a negative slope, which indicates that the analyte concentration is inversely proportional to the light emission in RLUs.
1 2
Light emissions (RLUs) Analyte concentration
Figure 3-1
Master Curve – Competitive Assay
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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
Light emissions (RLUs) Analyte concentration
Figure 3-2
Master Curve – Sandwich Assay
Performing a 2-point Calibration To minimize instrument-to-instrument variability and variability due to environmental factors and reagent age, you must perform a 2-point calibration at regular intervals. The calibration interval is assay specific. Refer to the ADVIA Centaur Assay Manual. To perform a 2-point calibration on the system, you process replicates for 2 calibrators of known value. If the calibrators meet defined validity criteria, the system compares the average RLUs for each calibrator to the Master Curve and determines a system-specific formula. The system then adjusts the observed RLUs to the Master Curve according to this formula: adjusted RLUs = observed RLUs × defined slope + defined intercept
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
Frequency Nonreactive Reactive Cutoff Index
Figure 3-3
Qualitative Assay Cut-off Point
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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Referencing Serum Calibration for T Uptake The T Uptake assay on the system provides an indirect measure of the number of unoccupied binding sites on thyroxine-binding proteins in a sample. In this assay, a direct relationship exists between the RLUs the system detects and the number of binding sites available on the thyroxine-binding proteins. This means a higher T Uptake ratio when fewer free binding sites exist and a lower ratio when more free binding sites exist. The T Uptake Master Curve Card provides only lot number and expiration date for the assay reagents. A Master Curve is not necessary for the T Uptake assay because it is a ratio test. The T Uptake assay compares the control and patient sample uptake results with a euthyroid reference serum of known uptake, such as Calibrator A. The T Uptake assay on the system uses Low Calibrator A as follows: T Uptake ratio = (Calibrator A RLUs/Unknown RLUs) * reference serum factor
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%
The system reports 24.6% as the % T Uptake.
Understanding Calibration Evaluation Criteria The ADVIA Centaur XP system evaluates a calibration using values entered from the Master Curve Card when you define a Master Curve for a reagent lot. The Master Curve definition includes the standard concentrations and related RLUs and target values used by the system to evaluate calibration data. The system defines Target values (ranges) for acceptable CV, ratio, slope, and calibrator deviation. The system determines a valid calibration based on whether the calibration data is within these defined ranges and system calculated observed ranges. Use the Calibration – Evaluation Ranges window to review values, review ranges, and review flags for the selected calibration. Refer to the ADVIA Centaur Assay Manual.
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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
Master Curve and Low/High Deviations
•
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.
Using Defined Ranges The defined ranges are the values for Slope, Ratio, Low Cal Deviation, and High Cal Deviation you enter from the Master Curve Card when you define a Master Curve for a reagent lot. The system always uses these values to evaluate calibrations, even when the system provides observed ranges. Because these ranges are reagent lot specific, the relatively narrow limits of the ranges ensure quality calibration monitoring.
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Using Observed Ranges After performing 4 valid calibrations for a reagent lot and calibrator lot combination, the system calculates observed ranges for Slope, Ratio, Low Cal Deviation, and High Cal Deviation. When you perform subsequent calibrations using the same reagent lot and calibrator lot combination, the system compares results to the defined ranges from the Master Curve definition and also to the observed ranges determined by the system. The system recalculates observed ranges with each valid calibration. Whenever you use a new reagent lot or calibrator lot, observed ranges do not apply until the system performs 4 new valid calibrations for the new reagent lot and calibrator lot combination and establishes new observed ranges. The system must also establish new ranges for the following reasons: •
whenever a calibration expires because the test definition is updated
•
whenever a field service representative resets the system after replacing a major hardware component
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.
1–4 5 6 7– 8
First 4 valid calibrations Observed ranges begin Valid calibration Invalid calibrations
Figure 3-5
Defined and Observed Ranges
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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.
1–4 5– 7
First 4 valid calibrations Valid calibrations in the observed range
Figure 3-6
Defined and Observed Ranges
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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Autoexcluding Calibration Replicates When you select Autoexclude Cal Replicates at the Test – Calibration window, the system evaluates the calibrator results for all replicates and excludes replicates based on Master Curve definition and test definition parameters. To evaluate calibrator replicates, the system performs the following steps: 1. The system checks the CV of the replicates. 2. If the CV of the replicates exceeds the defined Acceptable CV, the system checks for an outlier. 3. If the system finds an outlier (replicate causing the unacceptable CV), it then checks the critical precision. The critical precision is a value in the Master Curve definition used by the system to determine whether an outlier is too far out to exclude it. •
If the deviation of an outlier does not exceed the critical precision limit, the system excludes it and re-evaluates the calibration criteria.
•
If the deviation of an outlier exceeds the critical precision limit, the system cannot exclude the replicate and the calibration is invalid.
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.
Defining a Master Curve Each ADVIA Centaur XP assay kit includes a Master Curve Card that lists the analyte concentration and the RLUs for each Master Curve point. The Master Curve is entered into the system with each new lot number of reagent. You can use the barcode scanner or the keyboard to define the Master Curve.
Using the 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. 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.
1
Master curve card barcodes
Figure 3-7
Master Curve Card
5. Select Save.
Using the Keyboard 1. At the workspace, select Calibration. 2. Select Master Curve Definition. 3. At the Calibration – Master Curve Definition window, select Add. 4. Enter the Master Curve values. Master Curve values are displayed on the picture of the Calibration – Master Curve Definition window on the Master Curve Card: a. Select a test.
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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.
g. Enter the remaining values.
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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.
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.
Deleting A Master Curve CAUTION
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.
Defining Calibrator Values This section contains information about adding or deleting calibrator definitions.
Adding a New Calibrator Definition Use this procedure to add a new calibrator definition or to enter calibrator values for a new lot number of calibrator material. Each Calibrator Kit includes a Calibrator Assigned Value Card that provides the calibrator values for each analyte in the low and high calibrators. You can use the barcode scanner or the keyboard to enter the calibrator values.
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Using the 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. 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.
Using the Keyboard 1. At the workspace, select Calibration. 2. Select Calibrator Definition. 3. At the Calibration – Calibrator Definition window, select Add. 4. Enter the calibrator, the lot number, the expiration date, the LIS Code, and the checksum. 5. In the fields below the table, enter the calibrator values from the Calibrator Assigned Value Card. 6. Select a test. a. Select Test. The Test – Selection window displays. b. Select a test. c. Select Continue to close the Test – Selection window 7. At the Calibration – Calibrator Definition window, enter the low concentration value and the high concentration value. 8. Select Save Test. 9. Repeat steps 6 through 8 for each test. 10. Ensure that the calibrator values are correct. NOTE: After you select Save, you cannot add or delete a test from a calibrator definition. If you save an incorrect value, you must delete the calibrator definition and then reenter the test information.
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11. Select Save.
Deleting a Calibrator Definition 1. At the workspace, select Calibration. 2. Select Calibrator Definition. 3. At the Calibration – Calibrator Definition window, select a calibrator name and lot number. CAUTION
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.
Reviewing Calibration Status You can use the Calibration – Summary window to review the status and due dates of calibrations. To open the Calibration – Summary window from the workspace, select Calibration and then select Summary. The system calculates the next due date by adding the calibration interval to the date of the most recent calibration Calibration Status
Description
Cal Required
No valid calibration exists for the reagent lot. Schedule a calibration at the Worklist – Schedule window.
Current
The calibration is valid. The system uses this calibration to calculate results.
Due
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 you select Waive Cal at the Test – Calibration window.
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Calibration Status
Description
Expired
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.
Invalid
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
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.
Operator Accepted
An operator accepted a calibration that was outside the observed ranges but within the defined ranges.
Waived
A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist – Schedule window as soon as possible.
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
View
Sort
Display, in order of calibration status, the calibration information for all tests
All Tests
Status
Display, in alphabetical order of test, the calibration information for all tests
All Tests
Test
Display, in order of calibration status, the calibration information for tests using reagents that are currently loaded on the system
Available Reagents
Status
Display, in alphabetical order of test, the calibration information for tests using reagents that are currently loaded on the system
Available Reagents
Test
Display the calibration history for a reagent lot and calibrator lot combination for a specific test
Historical
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Reviewing Calibration History When you select Historical for the View at the Calibration – Summary window, you can display all the calibration information for a reagent lot and calibrator lot combination for a specific test. You can use this information for troubleshooting. Status
Description
Invalid
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.
Valid
The calibration is within the observed or defined ranges.
Valid, Operator Accepted
An operator accepted a calibration that was outside the observed ranges but within the defined ranges.
Valid, using Date of the Retained Calibration
The status the system displays in the historical view of the Calibration – Summary window for a Valid, Met Retained Cal Limits calibration.
Waived
A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist – Schedule window as soon as possible.
Waived, using Date of the Retained Calibration
The status the system displays in the historical view of the Calibration – Summary window for a Valid, Met Retained Cal Limits calibration that expired and then was 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
6. Select a calibrator. •
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.
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 (0001–9999) followed by a letter (A–E). 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.
Scheduling Calibrations for Control-bracketed Tests When processing control-bracketed tests, ensure that the minimum time interval for calibrations is at least 2 hours over the time entered in the Control Warning field at the Test – Definition window. If you do not, the system does not process the test. If the calibration for a control-bracketed test is invalid, do not schedule controls to start a new bracket until the system processes a valid calibration.
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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.
Managing Calibration Data This section contains information about reviewing calibration data, excluding a calibrator RLU, waiving a calibration, accepting invalid calibrations, and examples of step for managing calibration problems.
Reviewing Calibration Data Use the Calibration – Data window to review the details of a calibration, such as replicate results, status messages, and flags. To open the Calibration – Data window from the workspace, select Calibration and then select Data. Calibration Status
Description
Expired
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.
Expired, Retained
The calibration for the reagent lot expired, and then the system retained the calibration. The system uses this calibration to calculate results.
Invalid, Exceeded Defined Ranges
The calibration exceeds the defined range for 1 or more calibration expected values. Ranges display at the Calibration – Evaluation Ranges window. Schedule another calibration at the Worklist – Schedule window.
Invalid, Exceeded Observed Ranges
The calibration exceeds the observed range for 1 or more calibration expected values. Ranges display at the Calibration – Evaluation Ranges window. You can accept the calibration at the Calibration – Data window if you select Accept Cal at the Test – Calibration window.
Valid
The calibration was within the observed or defined ranges.
Valid, Met Retained Cal Limits
This calibration sets the expiration date and points to the retained calibration used to calculate results. The values of this calibration are almost mathematically identical to the values of a previous (retained) calibration.
Valid, Operator Accepted
An operator accepted a calibration that is outside the observed ranges but within the defined ranges.
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Calibration Status
Description
Valid, Operator Accepted, Retained
An operator accepted a calibration, and then the system retained the calibration. The system uses this retained calibration to calculate results.
Valid, Retained
The system uses this calibration to calculate results. The values of this calibration are almost mathematically identical to the most recent calibration.
Waived
A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist – Schedule window as soon as possible.
The following flags display at the Calibration – Data window: Flag
Description
Bad Replicate
One of the replicates was bad due to signal error. You can manually exclude the 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 the replicate, schedule another calibration at the Worklist – Schedule window.
Cal Accepted
An operator accepted a calibration that was outside the observed ranges but within the defined ranges.
Cal Timeout
One of the replicates was processed after the time allowed for an acceptable calibration. Schedule another calibration at the Worklist – Schedule window.
Excluded
An operator excluded a calibrator replicate RLU. You can view or include the replicate RLU at the Calibration – Data window.
Failed Critical Limit
The system could not exclude a calibrator replicate because it exceeded the critical precision limit defined at the Calibration – Master Curve Definition window. You can manually exclude the 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 the replicate, schedule another calibration at the Worklist – Schedule window.
Failed Defined High Cal Deviation
The calibration exceeded the high calibrator deviation that is defined at the Calibration – Master Curve Definition window. Schedule another calibration at the Worklist – Schedule window.
Failed Defined Low Cal Deviation
The calibration exceeded the low calibrator deviation that is defined at the Calibration – Master Curve Definition window. Schedule another calibration at the Worklist – Schedule window.
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Flag
Description
Failed Defined Ratio
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.
Failed Defined Slope
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.
Failed Observed High Cal Deviation
The calibration exceeded the high calibrator deviation that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.
Failed Observed Low Cal Deviation
The calibration exceeded the low calibrator deviation that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.
Failed Observed Ratio
The calibration is outside the range for the ratio that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.
Failed Observed Slope
The calibration is outside the range for the slope that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.
Failed % Neut
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.
Failed Rgt A Stability
The calibration did not yield the expected results for the Reagent A stability check. Schedule another calibration at the Worklist – Schedule window.
Failed Rgt B Ratio
The calibration did not yield the expected results for the Reagent B ratio check. Schedule another calibration at the Worklist – Schedule window.
High CV
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.
Rgt A High Cal CV
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.
Rgt A Low Cal CV
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.
Rgt B High Cal CV
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.
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Flag
Description
Rgt B Low Cal CV
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.
System Excluded
The system automatically excluded a calibrator replicate RLU. This flag only displays if Autoexclude Cal Replicates is selected at the Test – Calibration window.
Too Few Replicates
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.
Excluding a Calibrator RLU You can exclude calibrator RLUs that exceed the defined ranges. The system automatically recalculates the calibration data and rechecks the calibration criteria. RLUs are only excluded if more replicate results exist than the minimum number of replicates defined in the test definition. Further investigation may be appropriate to determine the cause of the outlier. You can have the system autoexclude calibrator RLUs or the operator can manually exclude them. You must have the appropriate level of security to change these settings. Refer to Defining Calibration Options‚ page 8-16. You can manually exclude calibrator RLUs at the Calibration – Data window if you do not select Autoexclude Cal Replicates at the Test – Calibration window. To manually exclude calibrator RLUs use the following procedure: 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 calibration date in Calibrated. 5. Review the calibrator RLUs. 6. Select the calibrator RLU from the table. 7. Select Exclude. 8. 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. 9. Select Save at the Comments window. The Comments window closes.
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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.
Waiving a Calibration at the Calibration – Summary Window 1. At the workspace, select Calibration. 2. Select Summary. 3. In the table at the Calibration – Summary window, select the most recently expired calibration for the test. 4. Select Waive.
Waiving a Calibration at the Calibration – Data Window 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 calibration date of the most recently expired calibration in Calibrated. 5. Select Waive.
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Accepting an Invalid Calibration You can accept an invalid calibration that falls outside of the observed range but is within the defined range. The system calculates results for the samples and displays the results for the test as Cal Accepted. You must have the appropriate level of security to accept an invalid calibration and you must enable Accept Cal at the Test – Calibration window. NOTE: If an invalid calibration is accepted, the Verify message displays at the Worklist – Summary window.
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.
Managing Calibrations Examples The following are examples of specific sets of conditions and the available options for those situations.
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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.
Current Valid Calibration If all of the following conditions apply: •
You have a valid calibration that is due to expire for the reagent lot that you are using.
•
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 you selected Assign Cal in the test definition.
You can perform the following actions to report patient results: •
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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.
Printing Calibration Data For additional information about operating the printer connected to your system, refer to Printing Notes‚ page 2-74. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Calibration Data. 4. Select a starting date and an ending date. 5. Press the Enter key. Calibration instances within the selected date range display in the table below the date fields. 6. To print all of the calibration data for the selected date range, select Print All. 7. To print data for 1 or more calibration instances, select the calibrations in the table and then select Print Selection.
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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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Using Quality Control Features The ADVIA Centaur XP system allows you to define each control for use on the system. The system has the following data storage capabilities: •
allows you to define up to 50 tests per control For example, for Ligand Plus 1 you can define up to 50 tests including TSH-3, TSH, T3, T4, FT3, FrT4, and TUp.
•
allows you to define up to 300 controls
•
ability to store results for up to 10 lots of data for each test/control combination For example, for the ADVIA Centaur XP PSA assay you can define 10 different lot numbers of Ligand Plus level 1, Ligand Plus level 2, and Ligand Plus level 3. This helps you manage transitions between lots of quality control material.
Adding a New Control Definition Use this procedure to add a new control definition, including defining the tests for the control and the expected control values for each test. 1. At the workspace, select Quality Control. 2. Select Control Definition. 3. At the Quality Control–Control Definition window, select Add. 4. Enter the name of the control. •
For Routine controls, you can enter up to 11 alphanumeric characters for the control name.
•
For Kit controls, you must enter 11 alphanumeric characters for the control name or the system will not accept it. Ensure that you enter the Kit control name exactly as displayed on the barcode label card.
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 Test–Selection window displays. b. Select a test. c. To close the Test–Selection 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.
Manually Entering Kit Control SID Information If the system cannot read a kit control barcode or if you run out of Siemens barcode labels, use this procedure to manually enter the kit control SID. 1. At the workspace, select the Sample Status button. 2. At the Status – Samples window, select the control with the No Barcode status. 3. Select Enter SID. 4. At the Status – Enter SID window, select Control. 5. Select Kit. 6. Enter the SID. 7. Select Save.
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Entering Expected Values for a New Lot Number NOTE: The system does not allow you to edit the control definition of a kit
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 Test–Selection window displays. b. Select a test. c. To close the Test–Selection 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.
Lot Number and the Expiration Date Locate the lot number and the expiration date on the quality control material packaging. You must enter a lot number and an expiration date to save the control definition.
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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.
Entering the Test Name and Expected Values In the fields below the table, select a test name and enter the QC expected values: If you want to enter . . .
Then . . .
low and high limits,
enter the low and high expected value limits from the expected values charts provided by the quality control manufacturer. The system automatically calculates the mean and 2SD values when you select Save Test.
mean and 2SD,
enter the mean and 2SD values from the expected values charts provided by the quality control material manufacturer. The system automatically calculates the low and high limit values when you select Save Test.
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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If you want to . . .
Then . . .
edit the control expected values,
a.
add tests to a defined control,
4-5
Select a test in the table.
b. In the fields below the table, edit the low and high limits, or edit the mean and 2SD values. c.
Select Save Test.
a.
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.
edit a pool number,
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.
delete tests from a control definition,
a.
Select a test in the table.
b. Select Delete Test. c.
Select Yes.
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 (0001–9999) followed by a letter (A–E). 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.
Scheduling Controls for Control-bracketed Tests When scheduling controls for control-bracketed tests, the following requirements apply: •
Each control set must contain a numerically ascending sequence of control levels beginning with Level 1. For example, if a test requires 3 controls in a set, the controls must follow this sequence: Level 1, Level 2, and Level 3.
•
Schedule a complete set of controls at the beginning of a group of samples to open a bracket and at the end of a group of samples to close a bracket. You define the number of levels required in a complete set of controls at the Test – Definition window. Refer to Viewing Control Bracketing Features‚ page 8-18.
•
You can use the end-of-bracket controls from 1 group of samples as the start-of-bracket controls for the next group of samples, if the control results are acceptable and the system is not forced to discard results. Refer to Managing the Worklist‚ page 2-39.
•
If you schedule the start-of-bracket controls and the end-of-bracket controls at the same time, you must perform the following tasks:
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schedule the controls by SID
•
enter a unique rack ID for each set of controls
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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.
Modifying Test Ranges When modifying test ranges, ensure that no samples are waiting for an ending bracket. If you modify test ranges for a control-bracketed test that has not completed, the system may not recognize the ending and the control bracket does not complete. The system discards results that are waiting for an ending bracket.
Clearing a No Request Message for End-of-Bracket Controls If you schedule the start-of-bracket controls with a unique rack ID and position for each control, and then schedule the end-of-bracket controls without a rack ID and position for each control, the system displays the No Request message for the end-of-bracket controls at the Status – Samples window. To clear the message and close the bracket, use the following procedure: Refer to Deleting Requests‚ page 2-61, or Scheduling Calibrators and QC Samples‚ page 2-54. 1. Delete the request for the end-of-bracket controls at the Worklist – Summary window. 2. Reschedule the end-of-bracket controls at the Worklist – Schedule window. To avoid receiving the No Request message, if you are scheduling the start-of-bracket and end-of-bracket controls at the same time, use the following guidelines: •
Schedule the start-of-bracket controls with a specific rack ID for the set and a unique position for each control within the set.
•
Schedule the end-of-bracket controls with a different rack ID for the set and a unique position for each control within the set.
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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.
Exporting Quality Control Data Access the ADVIA QC application and refer to online help for the ADVIA QC application Tools window.
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Checking the Rack Clips on the ADVIA Centaur Racks . . . . . . . . . 1-58
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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
View
Sort
Determine which maintenance activities are due
Schedule
Time Due
Find a specific maintenance activity
Schedule
Activity
Review the maintenance activities that were performed most recently
Log
Time Completed
Review the history of a specific maintenance activity
Log
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.
Accessing Online Procedures Online maintenance procedures provide instructions for some of the maintenance activities. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select a maintenance activity.
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3. Select Procedure. An online help window opens and displays the maintenance procedure.
Reviewing the Maintenance Log Use the Maintenance Log to review completed activities. You can review the most recent to the oldest activities as well as the history for a specific activity. The historical log is maintained for the last 5000 entries. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select Log in View. 3. Select the Sort. If you want to review . . .
Select . . .
the maintenance activities that were performed most recently
Time Completed
the history of a specific maintenance activity
Activity
Printing Maintenance Reports You can print a report of either the scheduled maintenance for the system or the maintenance log. 1. At the workspace, select Print. 2. Select Report Options. 3. In the list of available reports, select Maintenance. 4. Select the View. If you want to print . . .
Select . . .
the scheduled maintenance activities
Schedule.
the completed maintenance activities, including comments and the initials of the person who performed the activities
Log.
5. If you selected Log, enter the Starting Date and Ending Date.
Defining Maintenance Activities You can define maintenance activities that are specific to your laboratory. These activities are part of the regular maintenance schedule. You must have the appropriate level of security to perform these functions. 1. At the workspace, select Maintenance Status.
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2. At the Status – Maintenance window, you can define or edit a maintenance activity. If you want to . . .
Then . . .
define a maintenance activity
a.
edit a maintenance activity
schedule the Daily Cleaning Procedure to occur at a particular time every day
Select Add.
b. Enter the name of the maintenance activity. a.
Select an activity that you defined.
b. Select Definition. c.
At the Status – Maintenance Definition window, select Edit.
a.
Select Perform Daily Cleaning.
b. Select Definition. c.
At the Status – Maintenance Definition window, select Edit.
d. Select Autoschedule. e.
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.
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.
Deleting a Maintenance Activity Use this procedure to delete maintenance activities you defined. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select the maintenance activity that you defined. 3. Select Delete.
Performing Maintenance Procedures The online help also contains most maintenance procedures for the ADVIA Centaur XP system.
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Performing Daily Cleaning You can start the daily cleaning procedure when the system is not processing samples. Allow approximately 35 to 60 minutes for the system to complete the cleaning procedure, depending on the setup and status of your system. The cleaning procedure cleans the probes, the rinse stations, wash stations, and associated tubing. Schedule the cleaning procedure after your peak workload to optimize effectiveness of the cleaning procedure and enhance system performance. WARNING
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
does not prime the wash station diluters correctly.
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4. Ensure that the diluter drawer is closed.
1
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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Alternating the Water Bottle Allowing the water bottle to air dry in between uses helps prevent bacterial contamination. 1. Remove the water bottle: a. Pull out the waste and water drawer. b. Open the water bottle lid.
1 2 3 4 5
Waste and water drawer Water tubing Water bottle lid Cap Water bottle
Figure 5-2
Waste and Water Bottles
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. 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.
Rinsing the System with Water If the daily cleaning procedure failed, use this procedure to ensure that cleaning solution is completely rinsed from the system tubing. 1. At the workspace, select Maintenance Status. 2. Select Rinse the System with Water. 3. Select Perform. The system rinses the tubing with water.
Performing Weekly Maintenance You need the following materials to perform weekly maintenance procedures: • clean, spare water bottle • ADVIA Centaur XP Cleaning Solution Concentrate • 2 L of prepared cleaning solution • reagent water • maintenance screwdriver • lint-free tissues, gauze, or paper towels • transfer pipettes • clean, spare water reservoir • clean, spare manifold • water reservoir cleaning cover
Cleaning the Water Bottles and Reservoir WARNING
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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3. Select Turn System Mechanics Off. 4. Remove the water reservoir: CAUTION
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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5. Lift the water reservoir out of the system.
1 2 3 4 5 6 7
Reservoir cap Sensor Water tubing fittings Sensor Manifold Water reservoir Water bottle
Figure 5-3
Water and Waste Bottle Assembly
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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c. Install the reservoir cleaning cover on the reservoir.
1 2
Reservoir cleaning cover Water reservoir
Figure 5-4
Water Reservoir Assembly
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
Waste and Water Bottles
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.
Fill the reservoir with reagent water.
j.
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
Manifold tubing Manifold
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.
Emptying the Water Trap Use this procedure to remove condensation that has collected in the water trap. If the water trap fills with condensation, the system can have vacuum problems. CAUTION
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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3. Unscrew and remove the water trap.
1
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.
Performing Monthly Maintenance Perform the following tasks every month: • prepare the cleaning solution • clean the exterior of the reagent probes • clean the exterior of the ancillary probe • clean the exterior of the aspirate probe • clean the air filter • perform Monthly Cleaning Procedure
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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
Preparing the Cleaning Solution Use the cleaning solution for soaking and wiping system components. WARNING
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.
Cleaning the Exterior of the Reagent Probes. 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 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.
1
Reagent probes cover
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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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.
1
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.
Cleaning the Exterior of the Ancillary Probe 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. 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
Probe assembly Ancillary probe
Figure 5-11
Ancillary Probe
5. Close and secure the top cover. 6. Select Turn System Mechanics On.
Cleaning the Exterior of the Aspirate Probes 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. 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
Probe clip Aspirate probe
Figure 5-12
Wash Block
CAUTION
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.
Cleaning the Air Filter 1. Remove the air filter bracket.
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2. Push the air filter up and then out of the bracket.
1
Air filter and bracket
Figure 5-13
ADVIA Centaur XP – back view
CAUTION
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.
Performing the Monthly Cleaning Procedure Allow approximately 30 minutes to complete this procedure. You cannot use the system for testing during this procedure.
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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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3. Empty the water reservoir and waste bottle: CAUTION
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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Monthly Cleaning Procedure for Systems Using Direct Plumbing 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, 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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3. Empty the water reservoir and waste bottle: CAUTION
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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6. Move the direct plumbing switch to the off position.
1 2
Direct plumbing switch Off position
Figure 5-14
Direct Plumbing Switch
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. 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
Direct plumbing switch On position
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 Operator’s Guide.
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Opening the Top Cover WARNING
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.
1
Screw
4. Lift the top cover.
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Cleaning the Probe Rinse Stations Clean the rinse stations for the 3 reagent probes and the ancillary probe when you can see paramagnetic particles on the rinse stations. 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. 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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4. Remove the reagent probes cover.
1
Reagent probes cover
Figure 5-15
Primary Reagent Compartment
CAUTION
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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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
Small brush Rinse station
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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Cleaning the Reagent Probe Shutter Clean the reagent probe shutter when reagent probe shutter errors occur or splatter is visible on the reagent probe shutter. 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. 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.
1
Reagent probes cover
Figure 5-18
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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.
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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c. Lift out the shutter.
1 2 3
Shutter drive Shutter drive arm Reagent probe shutter
Figure 5-20
Reagent Probe Shutter Assembly
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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Cleaning the Primary Reagent Compartment and Reagent Pack Holders Clean the primary reagent compartment and reagent pack holders when it becomes difficult to load primary reagent packs. 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 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.
1
Primary reagent door
Figure 5-21
Primary Reagent Compartment
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
Primary reagent door Primary reagent shelf Reagent holders LEDs
Figure 5-22
Primary Reagent Compartment
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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Cleaning the Covers and Pointing Device 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. 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.
Cleaning the Cuvette Waste Area 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. 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.
1
Tip tray screw
Figure 5-23
Cuvette Waste Cabinet
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.
1
Cuvette waste bin
Figure 5-24
Cuvette Waste Cabinet
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.
1
Cuvette waste reservoir
Figure 5-25
Cuvette Waste Cabinet
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
chute gently to avoid splattering yourself and the work area. 9. Clean the cuvette waste chute: a. Use the large maintenance brush and cleaning solution to gently clean the chute. b. Rinse the chute with water. c. Dry the outside of the chute with paper towels. CAUTION
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.
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
chute gently to avoid splattering yourself and the work area. 11. Clean the cuvette waste chute: a. Use the large maintenance brush and cleaning solution to gently clean the chute. b. Rinse the chute with water. c. Dry the inside and the outside of the chute with paper towels. CAUTION
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
Cuvette waste area wires Cuvette waste chute
Figure 5-28
Cuvette Waste Cabinet
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.
Cleaning the Sample Tip Waste Area The sample tip waste area includes the tip remover, tube, chute, and reservoir. 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. 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
Sample Tip Waste Assembly
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.
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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
Sample tip waste chute Sample tip waste reservoir
Figure 5-30
Cleaning Solution Cabinet
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
chute gently to avoid splattering yourself and the work area. 7. Unscrew the sample tip waste tube from the sample tip remover.
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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
Sample Tip Waste Assembly
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.
Wiping the Waste Probe and Cuvette Ejector Rod Use this procedure to clean the waste probe and the cuvette ejector rod to prevent waste probe movement errors. BIOHAZARD
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.
1
Reagent probes cover
Figure 5-32
Reagent Compartment
WARNING
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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c. Remove the luminometer cover.
1 2 3 4
Nut Luminometer cover Waste probe Cuvette ejector rod
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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Maintaining the Sample Racks Clean the sample racks if they look dirty or the system has trouble loading them. Use this procedure to prepare sample racks for use on the ADVIA Centaur XP system. Label the sample racks to match the tube-type positions you specified at the Setup – Tube Type & Barcode window. BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials.
Cleaning the Sample Racks 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. 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.
Labeling Sample Racks CAUTION
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 numbers—2, 3, and 4—on 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 labels—1, 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
Sample rack barcode label Rack identification number
Figure 5-34
ADVIA Centaur XP Sample Rack
Applying Cal and QC Labels
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
Calibrator label Quality control label
Figure 5-35
ADVIA Centaur XP Sample Rack Labels
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.
1
Sample rack front labels
Figure 5-36
ADVIA Centaur XP Sample Rack – front view
Applying Numbered or Customized Labels
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
ADVIA Centaur XP Sample Rack
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
Tube type selector Sample rack Identification barcode number
Figure 5-38
ADVIA Centaur XP Sample Rack
Checking the Rack Clips on the ADVIA Centaur Racks 1. Ensure that each position on the rack has a clip. 2. If required, install clips in the rack: a. Push the clip down into the sample rack.
1
Clip
Figure 5-39
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b. Push the clip using a pen to lock it in place.
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ADVIA Centaur XP Operator’s Guide: Identifying System Problems
ADVIA Centaur XP Operator’s Guide: Identifying System Problems
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Identifying System Problems The ADVIA Centaur XP system provides features to help you identify and correct system problems: •
System Status provides a visual indicator that a component or subsystem has a warning or critical condition.
•
The event log provides information about system errors and accesses information about possible causes and corrective action procedures.
•
Diagnostic tools allow you to test the operation of system components and move system components when you perform corrective action procedures.
•
Remote access enables file accessibility through a modem or through RealTime Solutions service for technical assistance.
Viewing System Status Use System Status to monitor the condition of the system and determine which area of the system needs attention. To determine which area of the system has a warning or critical condition, select the System Status button at the workspace and then select System Status in the drop-down list. The System – Status window opens, and the affected system area and the corresponding button change color to indicate status. For example, when the cleaning solution volume is low, the color of the Supplies button and the cleaning solution area changes to yellow.
Using the Event Log Any warning or critical condition that is captured in the event log causes a change in the background color of the Event Log Status button: •
Yellow indicates that a warning condition exists.
•
Red indicates that a critical condition exists that may cause the system to stop aspirating or processing sample.
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
Symbol
Definition
Critical
Red triangle
This type of error indicates that the system stopped processing samples.
Warning
Yellow triangle
This type of error indicates that a problem exists with a subassembly or supply. The system continues to process samples.
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Event Type
Symbol
Definition
Information
No symbol
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
View
Sort
Display the events in reverse chronological in order of when the events occurred
Events
Date
Display the critical and warning events in order of most severe to least severe
Errors
Severity
Display the events by subsystem
Events
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.
Other Event Codes The following event code format indicates a data transfer error: Undefined event code. Call for technical assistance.
If you see this event, write down the event code or print the window and then call for technical assistance.
Rebooting the System 1. At the workspace, select System Status. 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. 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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6. Press the green computer startup button.
1
Computer startup button
Figure 6-1
ADVIA Centaur XP System – back of the system
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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What to Do after Pressing a Fast Stop Button Figure 6-2 displays the 2 fast stop buttons on the system. Use these buttons if there is an obstruction that could cause serious system or physical damage.
1
Fast stop buttons
Figure 6-2
ADVIA Centaur XP – front and back of the system
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
4. Press the green computer startup button.
1
Green startup button
Figure 6-3
ADVIA Centaur XP System – back of the system
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.
Recovering from a System Lockup or a Slow User Interface Call for technical assistance if 1 or more of the following conditions exist: •
the software responds very slowly after you make a selection
•
the software locks up
•
the event code 700 01 00 is in the event log
Restarting the System After an Error If the system stops due to an error, ensure that no racks are present in the Stat entry port and no ancillary packs are present at the ancillary entry queue before you restart the system. If a rack or an ancillary pack is present in these positions when you press the Sample Start button, a jam can occur at these positions. You must also note the position of cuvettes after a system error. Refer to Verifying the Status of Cuvettes in the Incubation Ring‚ page 6-15.
Recovering from a Power Disruption Use this procedure to recover from a power outage or power surge. CAUTION
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
Main power on/off switch Computer startup button
Figure 6-4
ADVIA Centaur XP – back of the system
Managing Nonsampling System Status Do not allow the system to remain in the Inprocess state or the Check Status state for longer than 2 hours without processing samples. These nonsampling system states can occur even though sample tubes are in the Inprocess queue and tests are pending, or all the sample rack are processed and ejected to the sample exit queue. The system can remain in a nonsampling Inprocess state because of the following conditions: •
sample exit queue is full To correct this, remove sample racks from the exit queue.
•
communication between the system and LIS is lost To correct this, investigate the communication issue with the LIS vendor to determine the root cause.
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Clearing Cuvette Obstructions Cuvette obstructions can occur for various reasons. You can troubleshoot and clear most problems with cuvettes by following the procedures in this section. CAUTION
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.
Checking Cuvette Handling Use this procedure to recover from cuvette jams in the cuvette loading bin, orientation chute, or vertical cuvette chute. BIOHAZARD
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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3. Ensure that the cuvette loading bin is not empty.
1 2 3 4
Ring loader Elevator Luminometer Orientation chute
Figure 6-5
5 6 7
Cuvette loading bin Vertical cuvette chute Preheater
Cuvette Loading Assembly
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
Vertical cuvette chute Orientation chute
Figure 6-6
Cuvette Loading Assembly
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9. Drop a clean cuvette into the vertical cuvette chute.
1 2
Cuvette Bottom window
Figure 6-7
Vertical Cuvette Chute
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.
1
Thumbscrew
Figure 6-8
Vertical Cuvette Chute
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
Conveyor slats. Cuvette Conveyor
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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Verifying the Status of Cuvettes in the Incubation Ring The system cannot verify the status of the cuvettes in the incubation ring after you press the fast stop button, or if any of the following events occurs: •
Real Time (RT) processor error
•
User Interface (UI) error If the UI recovers automatically, the status of the cuvettes in the incubation ring does not need to be verified.
•
UI lock-up error
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.
Clearing Cuvettes from the Preheater Use this procedure to recover from cuvette jams in the preheater. 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. Look for a cuvette jammed at the window at the bottom of the vertical cuvette chute. 5. Loosen the thumbscrew on the preheater cover.
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6. Remove the preheater cover.
1 2 3
Ring loader Preheater Screw for the preheater cover
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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10. Ensure that the cuvettes do not overlap.
1 2
Cuvette position. Preheater
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.
Clearing a Cuvette Jam from the Luminometer or Elevator 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Check the cuvette waste chute: a. Clear any obstructions from the cuvette waste chute. b. Clean the cuvette waste chute. 4. 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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5. Remove the reagent probes cover.
1
Reagent probes cover
Figure 6-12
Primary Reagent Compartment
CAUTION
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.
1
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.
1
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.
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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 System Elements This section contains information for replacing basic system elements.
Replacing the Preheater Cover Refer to Clearing Cuvettes from the Preheater‚ page 6-15. At step 10, install the new preheater cover. Continue with the instructions in Clearing Cuvettes from the Preheater.
Replacing Probes This section contains procedures for replacing these probes: •
ancillary probe
•
reagent probes
•
aspirate probe
•
waste probe
Replacing the Ancillary Probe BIOHAZARD
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.
4. Disconnect the tubing from the top of the ancillary probe. NOTE: It might be necessary to use pliers to loosen the probe sleeve.
5. Remove the old probe from the sleeve and discard it in a container approved for sharp objects.
1 2 3 4
Top gasket Bottom gasket Sleeve Probe
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.
Replacing a Reagent Probe BIOHAZARD
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.
1
Reagent probes cover
Figure 6-16
Primary Reagent Compartment
WARNING
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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NOTE: It might be necessary to use pliers to loosen the probe sleeve.
1 2 3
Tubing Probe sleeve Probe
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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d. Select the probe you replaced. 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.
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.
Replacing an Aspirate Probe BIOHAZARD
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
Probe clip Aspirate probe Probe entrance port
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
Tubing to the aspirate probe Grounding cable Aspirate probe
Figure 6-19
Grounded Aspirate Probe
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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e. Slide the probe clip into place, locking the probe.
1 2
Probe clip Aspirate probe
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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g. If the probe is binding, check the routing of the tubing. 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. 10. Return to normal operation. 11. If the error persists, call for technical assistance.
Replacing the Waste Probe BIOHAZARD
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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4. To access the luminometer, remove the reagent probes cover.
1
Reagent probes cover
Figure 6-21
Primary Reagent Compartment
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
Waste probe Probe clip Waste tubing
Figure 6-22
Luminometer
d. Discard the probe in a container approved for sharp objects.
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e. Remove the luminometer cover.
1 2
Nut Luminometer cover
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.
Replacing the Waste Bottle Fluid Sensor BIOHAZARD
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.
Discard the sensor in an approved container for biohazardous material.
1 2
Waste bottle fluid sensor Connector sleeve
Figure 6-24
Waste Bottle Assembly
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.
1
Waste bottle fluid sensor
Figure 6-25
Waste and Water Bottles
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.
Troubleshooting Obstructions and Leaks Recovering from a Sample Tip Tray Loading Jam If a tip tray jam occurs while the system is processing samples, allow the system to complete processing before clearing the jam. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. Manually move the inprocess queue to the right.
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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
Sample tip tray Hole in sample tip tray
Figure 6-26
3 4
Pin Inprocess queue
Sample Tip Tray Assembly
6. Lift the sample tip trays out of the sample tip loader. 7. Open the cuvette waste area door.
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8. Remove used sample tip trays and covers. CAUTION
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.
1
Latch
Figure 6-27
Sample Tip Tray Loader
CAUTION
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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Clearing Obstructions from the Sample Exit Queue BIOHAZARD
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.
1
Sample exit queue
Figure 6-28
ADVIA Centaur XP Entry, Stat, and Exit Queues
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.
1
Fast stop button
Figure 6-29
ADVIA Centaur XP System – front view and back view
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2. At the workspace, select System Status. 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. 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
8. Press the green computer startup button.
1
Computer startup button
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.
Using Diagnostic Tools WARNING
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.
Using the System Diagnostic Tools Window The System – Diagnostic Tools window puts the system in Diagnostics Mode. Any errors that occur while the system is in Diagnostics Mode appear in the event log. Wait until the system is not processing samples to use diagnostic tools. To open the System – Diagnostic Tools window from the workspace, perform the following steps: 1. At the workspace, select the System Status button. 2. Select Diagnostic Tools.
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3. Select a test and then select Perform. For some tests, the system prompts you to perform certain actions.
Accessing Diagnostic Tools For specific procedures for each diagnostic tool, perform the following steps: 1. At the workspace, select Event Log. 2. Locate the procedure: a. At the System – Event Log window, select Procedure. b. At the online information window, select Find. c. Enter Diagnostic Tools. You can also enter a word or phrase that describes your system problem. d. Select Enter. The system displays a list of Diagnostic Tools. 3. Select a topic to display a diagnostic procedure.
Cuvette Handling Tools Use the following diagnostic tools to test cuvette handling.
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.
Empty & Fill Ring Use this test to perform the following actions: •
simultaneously empty the cuvettes from the incubation ring and load the ring with new cuvettes
•
test the operation of the elevator
•
test the operation of the luminometer
•
test the operation of the incubation ring
•
test the operation of the cuvette pusher and cuvette loading bin
•
investigate sensor failures
•
expedite the startup process after performing troubleshooting or installing new software
•
recover from a power outage
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.
Reagent and Ancillary Probe Tools Use the following diagnostic tools to test the reagent and ancillary probes.
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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You can observe that the system correctly dispenses water: 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.
. 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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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 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.
Sample Probe Tools Use the following diagnostic tools to test the sample probes.
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.
Load Tip Tray Use this test to perform the following: •
load a new sample tip tray and reset the counter
•
check the operation of the sample tip loader
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
Sample tip tray Hole in sample tip tray
Figure 6-32
3 4
Locking pin Inprocess queue
Sample Tip Tray Assembly
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.
Dark Count with Cuvette Perform this test in conjunction with the Dark Count without Cuvette test. Use this test to perform the dark count test for a selected number of cuvettes to investigate the following areas: •
PMT errors due to light leaks
•
luminometer errors
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.
Dark Count without Cuvette Use this test to perform the dark count test for a selected number of readings to investigate the following areas: •
PMT errors due to light leaks
•
luminometer errors
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
Total SD specification limit Total mean
Figure 6-33
Standard Deviation Specifications
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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Aspirate Probe Tools Use the following diagnostic tools to test the aspirate probes.
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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Dispense Wash Fluid & Aspirate Use this test to perform the following: •
dispense and aspirate wash fluid from selected dispense ports and aspirate probes
•
investigate for pinched tubing
•
investigate for clogged probe
•
verify the installation of a new probe
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.
1. Ensure that the diluter drawer is in the closed, upright position.
1
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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•
1 2
6-61
Dispense port 1 dispenses from the right and left sides of aspirate probe 1.
Dispense port 1 for water Dispense port 1 for wash 1 or wash 3
Figure 6-35
Wash Block
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•
1 2
Dispense port 2 dispenses from the right and left sides of aspirate probe 2.
Dispense port 2 for water Dispense port 2 for wash 1 or wash 3
Figure 6-36
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ADVIA Centaur XP Operator’s Guide: Identifying System Problems
•
1 2
6-63
Dispense port 3 dispenses from the right and left sides of aspirate probe 3.
Dispense port 3 for wash 1 or wash 3 Dispense port 3 for water
Figure 6-37
Wash Block
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•
1 2 3 4 5
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.
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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Performing LIS Communication Diagnostics You can use the Communication Diagnostics window to investigate LIS problems and to suspend communications between the system and the LIS if your LIS is not operational. NOTE: If your LIS is not operational, it is important to suspend communications to avoid system errors. If you do not suspend communications, the ADVIA Centaur XP system continues to send information to the LIS. System errors can occur if the LIS is unable to accept the information.
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.
Troubleshooting Truncated PIDs in the LIS The system transmits 0 – 11 characters in the SID field of a result record. If the LIS sends a PID value longer than 11 characters with a worklist, or if a PID manual entry exceeds 11 characters, the PID is truncated when transmitted back with the result.
Using System Tools Use the following diagnostic tools to test the system.
Homing the System Use this test to move all system components to their primary positions. During this test, the system homes the following components: cuvette pusher
cuvette loader
aspirate probes 1, 2, 3, and 4
waste probe
elevator
luminometer
reagent probes 1, 2, and 3
reagent mixer
reagent barcode shutter
reagent probe shutter
reagent barcode scanner
sample probe
rack loader
rack exit pusher
stat pusher
sample tip loader
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inprocess queue ancillary probe
ancillary entry pusher
ancillary door
ancillary queue
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.
Homing the Inprocess Queue Use this test to move the inprocess queue to its primary position. During this test, the system homes the following components: sample probe
rack loader
rack exit pusher
stat pusher
sample tip loader
inprocess queue
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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4. At the System – Diagnostic Tools window, select Home 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. 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.
Homing the Ancillary Queue Use this test to move the ancillary queue to its primary position. During this test, the system homes the following components: ancillary probe
ancillary queue pusher
ancillary door
ancillary queue
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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b. 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. 6. Close the System – Diagnostic Tools window.
Emptying the Inprocess Queue Use this test to remove all sample racks from the inprocess queue. During this test, the system performs the following actions •
homes the following components: sample probe
inprocess queue
rack loader
rack exit pusher
stat pusher
sample tip loader
•
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.
Emptying the Ancillary Queue Use this test to remove all ancillary packs from the ancillary queue. During this test, the system performs the following actions: •
homes the following components: ancillary probe
ancillary queue
ancillary pusher
ancillary door
•
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.
Resetting the Thermals Use this test to reset system thermal components if there was a thermal error which caused 1 or more components to go offline. During this test, the system performs the following actions: •
sends the restart command to all thermal loops
•
equilibrates thermal components
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.
Performing the Vacuum Test Use this test to evaluate the system vacuum pressure. During this test, the system performs the following actions: •
turns the system vacuum on
•
evaluates the system vacuum pressure
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.
Performing the Sample Barcode Read Test Use this test to evaluate the ability of the sample barcode scanner to read the barcode on a sample rack and the barcodes on the sample tubes in the rack. During this test, the system performs the following actions: •
accepts a sample rack through the sample entry queue or the Stat entry
•
scans the barcode on the sample rack and the barcodes on the sample tubes in the rack
•
evaluates the status of each barcode on the sample tubes in the rack
•
displays the scanned information and barcode status in a table
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...
Then select...
test sample barcode scanning when a rack enters the system through the sample entry queue,
Routine.
test sample barcode scanning when a rack enters the system through the Stat entry,
Stat.
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. 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.
Priming Functions – Prime System Use this test to prime all fluid lines. During this test, the system performs the following actions: •
homes all subassemblies
•
turns vacuum and water pump on
•
dispenses water from reagent and ancillary probes into their rinse stations
•
opens and closes associated valves
•
dispenses fluid into cuvettes for all dispense ports and fluids
•
indexes incubation ring and moves all used cuvettes to the elevator
•
elevator moves the cuvette into the luminometer
•
luminometer moves and the system ejects the cuvette
You can evaluate if the system correctly primes:
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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.
1
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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Priming Functions – Prime Fluid Line Use this test to prime a selected fluid line with water, wash solution, acid, or base. During this test, the system performs the following actions: •
moves all subassemblies to their home positions
•
turns on vacuum
•
turns on water pump
•
when priming the reagent tubing, the system uses water and dispenses it into the rinse station (fluid primes for approximately 1 second)
•
when priming 1 of the system fluid lines, the system dispenses the selected fluid into a cuvette and then aspirate it
•
dispenses fluid from associated pump or diluter
•
opens and closes associated valves
•
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 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.
1
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...
Perform these steps...
sample or ancillary diluters,
loosen the screw on the left side of the system that secures the top cover and then open the top cover.
reagent probe diluters,
loosen the 2 thumbscrews on the left side of the system and then lift the cover up and off.
other system diluters,
open the diluter drawer to observe the diluters move.
1 2
Reagent diluter cover Thumbscrews
Figure 6-41
Primary Reagent Compartment
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b. Ensure that the diluter plunger moves.
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
System Diluter Locations
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.
Priming Functions – Prime System Fluid Bottle Use this test to prime wash solution, cleaning solution, acid, or base from the appropriate system fluid bottle to the reservoir and the associated valve or pump.
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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.
Resolving Barcode Problems Use this section to identify and resolve barcode problems. This section also contains specifications for creating and using your own SID barcode labels. Check the event log for error messages indicating barcode problems and their possible causes and solutions. If there is a problem with sample barcodes and you are not using Siemens barcode labels, test the system with a Siemens calibrator or control barcode label. If testing the system with a Siemens barcode label or using the suggested solutions does not solve the problem, call for technical assistance. If the barcode scanner is not operating correctly, you can manually enter the information at the appropriate window.
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.
Barcode Scanner Reads Sporadically 1. Check the scanning technique. Refer to Barcode Scanning Technique‚ page 6-89. 2. Assess the barcode print quality. Refer to Barcode Quality‚ page 6-85. 3. Check and tighten the cable connection between the scanner and the system.
Barcode Scanner Does Not Read 1. Check symbologies and options at the Setup – Tube Type & Barcode window.
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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.
Barcode Scanner Reads Sporadically 1. Assess the barcode print quality. Refer to Barcode Quality‚ page 6-85. If necessary, obtain new barcode labels and place them on the sample tube or sample cup. 2. Ensure that the barcode labels face the opening in the rack when you load sample tubes or cups in the sample rack. 3. Ensure that the sample rack barcode label is not falling off.
Refer to Maintaining the Sample Racks‚ page 5-80. CAUTION
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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Barcodes Do Not Display at Status – Samples Window CAUTION
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
Red Light Reflection Sample Rack
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.
Barcodes Do Not Display at Status – Primary Reagent Window CAUTION
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
Reagent barcode shutter Red light reflection Reagent barcode reader
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.
Barcodes Do Not Display at Status – Ancillary Reagent Window CAUTION
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.
Recommended Physical Specifications for Barcodes For optimum system performance use Siemens barcode labels for calibrator and control samples. However, if you are making your own labels, the specifications in this section are provided as a guide. The read rates for barcode labels not obtained from Siemens can vary depending upon the print quality of the labels.
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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
Size (cm)
Size (in)
maximum label length
8.89
3.50
quiet zone at each end
0.64
0.25
maximum barcode length
7.60
3.00
minimum barcode height
0.64
0.25
minimum narrow bar width
0.02
0.01
The minimum density ratio is 2:1.
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
Factors Causing Scanning Problems
environmental factors during storage and use
abrasion aging chemicals frost fungi and mildew humidity lubricants packaging preservatives protective coatings salt spray solvents and cleaners tape temperature ultraviolet light
label material
conspicuous grain high porosity low opacity
label surface
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
placement of label on sample cup
crooked
print quality
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
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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.
1
Barcode label position
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.
Fixed or Variable Length Barcode For some barcode symbologies, you can select either a fixed or variable barcode length. The maximum length for an SID is 13 characters. The maximum length of a barcode label in any symbology on ADVIA Centaur XP systems is 20 characters. Use the mapping options for longer barcodes. Use the Setup – Tube Type & Barcode window, to specify your barcode type and enter the barcode length. Use fixed-length values whenever possible. •
If you specify a fixed-length value, the system recognizes only barcode labels with the specified number of characters.
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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.
Barcode Scan Check Digit A check digit is a character included in a barcode symbol that is used with a mathematical algorithm to check the validity of the decoded data. The following table displays the use of check digits and the symbologies available on the system. In this symbology...
A check digit is...
Codabar
a recommended option.
Interleaved 2 of 5
a recommended option.
Code 39
a recommended option.
Code 128
included.
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:
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•
Enable
•
Disable
•
nw7 (Codabar standard check digits)
•
mod16 (Codabar standard check digits)
•
nw7mod16 (Codabar standard check digits)
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Barcode Scanning Technique 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. 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.
Barcodes Reserved for ADVIA Centaur XP Systems Certain characters are reserved by Siemens for all barcode symbologies. You cannot use the reserved characters in an SID code for barcodes of the specified length in the indicated position. The following displays the reserved SID character sequences for barcodes that use a check digit and for barcodes that do not use a check digit. Barcode Length
Character
Position
Reserved
8
K
1
ADVIA Controls
11
Bell Escape Carriage Return K
1 2 3 4
ADVIA Controls
8 or 9
Bell Escape Carriage Return C
1 2 3 4
ADVIA Calibrators
Printing Event Log Reports Use the following procedure to print information from the event log. 1. At the workspace, select Print. 2. Select Report Options.
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3. In the list of available reports, select Event Log. 4. Select the View. If you want to print...
Then select...
all event codes, including informational events as well as errors,
All.
only informational event,
Events.
only warning and critical errors,
Errors.
5. Select the Sort. If you want to print the event codes in the order of...
Then...
most recent first for a specified time period,
Date.
related subsystems,
Subsystem.
lowest event code number to highest event code number,
Events.
most severe to least severe,
Severity.
6. Enter the Starting Date and Ending Date.
Printing Event Log Reports Use the following procedure to print information from the event log. 1. At the workspace, select Print. 2. Select Report Options. 3. In the list of available reports, select Event Log. 4. Select the View. If you want to print . . .
Then select. . .
all event codes, including informational events as well as errors,
All.
only informational event,
Events.
only warning and critical errors,
Errors.
5. Select the Sort. If you want to print the event codes in the order of . . .
Then . . .
most recent first for a specified time period,
Date.
related subsystems,
Subsystem.
lowest event code number to highest event code number,
Events.
most severe to least severe,
Severity.
6. Enter the Starting Date and Ending Date.
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Investigating Assay Problems Use this section when trying to resolve assay problems. First review the following questions, then use the other information in this section to match the symptoms that you find with the problems that can cause them. To help find a pattern or a trend, answer the following questions: •
Does the problem affect only patient samples, controls, or calibrators or does it affect a combination of sample types?
•
Has the problem occurred once or does it appear consistently?
•
Does the problem occur only you use when certain lot numbers of calibrators, controls, or reagents?
•
Have you prepared, handled, and stored reagents, calibrators, controls, and samples?
•
Does the problem affect more than 1 assay?
•
What type of assay (competitive or sandwich) does the problem affect?
•
Is there a common factor affecting performance?
•
Are the RLUs increasing or decreasing in an assay?
To help find a pattern or a trend, collect and print the following data: •
patient sample results
•
quality control results
•
calibration data
•
replicate CVs
Using Calibration Evaluation Ranges You can use calibration evaluation ranges to resolve problems that cause failed calibrations. 1. At the workspace, select Calibration. 2. Select Data. 3. At the Calibration – Data window, review the status and the flags for the calibration data. 4. If the percent coefficient of variation (CV) of the individual calibrator replicates exceeds the defined acceptable value, refer to Discrepant Calibration Results‚ page 6-95. 5. If the calibration is invalid and has failed the defined or observed ranges for slope, ratio, low cal deviation, or high cal deviation, select Evaluation Ranges. 6. At the Calibration – Evaluation Ranges window, compare the Values to the Defined ranges and Observed ranges.
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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...
Then...
out of the defined range
use the tables that follow to evaluate flagged calibration metrics for sandwich or competitive assays.
out of the observed range but within the defined range
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.
Refer to Understanding Calibration Evaluation Criteria‚ page 3-4.
Evaluating Sandwich Assay Calibrations Is the value within the defined range? Slope
Ratio
Low Cal Deviation
High Cal Deviation
Possible Causes and Corrective Actions
Yes
Yes
No
Yes
Poor water quality. Ensure that the water quality integrity meets requirements. 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.
No
Yes
No
No
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.
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Slope
Ratio
Low Cal Deviation
High Cal Deviation
Possible Causes and Corrective Actions
No
No
No
No
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.
Evaluating Competitive Assay Calibrations Is the value within the defined range? Slope
Ratio
Low Cal Deviation
High Cal Deviation
Possible Causes and Corrective Actions
Yes
Yes
No
Yes
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.
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Slope
Ratio
Low Cal Deviation
High Cal Deviation
Possible Causes and Corrective Actions
Yes
Yes
No
No
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.
No
Yes
No
No
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.
No
No
No
No
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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Investigating Discrepant Results Use this section when you are trying to resolve discrepant calibration, control, and patient results.
Discrepant Calibration Results Possible Cause
Corrective Actions
The calibrators were reconstituted incorrectly: with tap water, with the incorrect volume, with an uncalibrated pipette, or with contaminated reagent water
1.
The calibrators were on the system and then were poured back into the bottle
Incomplete calibrator equilibration after reconstitution
Ensure that the correct volume was used for reconstitution. Refer to the calibrator 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.
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
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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Possible Cause
Corrective Actions
The calibrators were not stored correctly
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.
4. Recalibrate the assay. The incorrect calibrator was used for an assay, or high and low calibrators were poured into mislabeled tubes
1.
To determine the correct calibrator to use with an assay, check the ADVIA Centaur XP Assay Manual.
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.
5. Recalibrate the assay. The sample tips were bent from storage on their side or damaged by a tray exchange failure
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1.
Store sample tips upright.
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.
ADVIA Centaur XP Operator’s Guide: Identifying System Problems
Possible Cause
Corrective Actions
Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
1.
The reagent pack was stored at room temperature for a prolonged period
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
Improper resuspension of pierced reagent packs
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Ensure that reagent packs are stored upright at 2 to 8 ° C.
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.
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.
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
Corrective Actions
The controls were reconstituted incorrectly: with tap water, with the incorrect volume, with an uncalibrated pipette, or with contaminated reagent water
1.
The controls were on the system and then were poured back into the bottle
Incomplete control equilibration after reconstitution
The controls were not stored correctly
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.
4. Reconstitute fresh controls. 5. Perform quality control again. 1.
Ensure that controls are discarded after being on the system and not poured back into the respective bottles.1
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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Possible Cause
Corrective Actions
The controls were expired
1.
6-99
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.
4. Perform quality control again. The incorrect control was used for an assay, or the control was poured into a mislabeled tube
1.
Check the control package insert to be sure that the analyte being tested is present in the control.
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.
7. Perform quality control again. Incorrect expected values were entered for the control
1.
Ensure that the expected values are correct. Refer to the control package insert for the correct expected values or enter the QC ranges established for your laboratory.
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.
3. Perform quality control again. The sample tips were bent from storage on their side or damaged by a tray exchange failure
1.
Store sample tips upright.
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
Corrective Actions
Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
1.
The reagent pack was stored at room temperature for a prolonged period of time
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
Improper resuspension of pierced reagent packs
Ensure that reagent packs are stored upright at 2 to 8 ° C.
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.
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.
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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Discrepant Patient Results Possible Cause
Corrective Actions
Incorrect sample collection, handling, or preparation
1.
The sample was frozen more than once or not mixed thoroughly after thawing
For sample collection and handling information, refer to the ADVIA Centaur XP Assay Manual.
2. Collect a fresh sample from the patient. 3. Perform the assay again. 1.
Thoroughly mix thawed specimens before use.
2. Freeze specimens only once. 3. Collect a fresh sample from the patient. 4. Perform the assay again.
The sample contains heterophilic antibodies
Call for technical assistance to further investigate the probable cause.
Incorrect patient sample, the sample was labeled with the wrong patient ID
1.
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
The sample is lipemic or hemolyzed or contains fibrin clots or bubbles
The sample tips were bent from storage on their side or damaged by a tray exchange failure
Collect a fresh sample from the patient.
2. Perform the assay again.
1.
Collect a fresh sample from the patient.
2. Perform the assay again.
1.
Monitor reagent and sample storage areas and correct temperatures, as required.
2. 3. 4. 5. 6.
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.
1.
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.
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
Corrective Actions
Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
1.
The reagent pack was stored at room temperature for a prolonged period of time
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
Incorrect resuspension of pierced reagent packs
Ensure that reagent packs are stored upright at 2 to 8 ° C.
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.
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.
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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Problems with a Single Assay Possible Cause
Corrective Actions
Incorrect normal range or check range defined for the patient samples
1.
Ensure that test ranges have been entered correctly.
2. Modify test parameters, Refer to Modifying or Viewing Test Options‚ page 8-9.
3. Perform the assay again. The sample tips were bent from storage on their side or damaged by a tray exchange failure
Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents
The reagent pack was stored at room temperature for a prolonged period of time
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
1.
Store sample tips upright.
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.
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.
2. 3. 4. 5. 6.
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.
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.
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Possible Cause
Corrective Actions
Incorrect resuspension of pierced reagent packs
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.
Problems with Multiple Assays Possible Cause
Corrective Actions
The sample tips were bent from storage on their side, or damaged by a tray exchange failure
1.
Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, or expired or clumped reagents
The reagent pack was stored at room temperature for a prolonged period
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Store sample tips upright.
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.
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.
2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Perform the assay again.
ADVIA Centaur XP Operator’s Guide: Identifying System Problems
Possible Cause
Corrective Actions
Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane
1.
Incorrect resuspension of pierced reagent packs
6-105
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.
Place primary reagent packs in the reagent storage tray at 2 to 8 ° C.
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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Possible Cause
Corrective Actions
The integrity of 1 of the system fluids was compromised
1.
Maintenance procedures were not performed
Ensure that the fluid bottle is positioned correctly.
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. Call for technical assistance. A fluid system lost prime
1.
Check that the fluid bottle and reservoir have sufficient fluid, and if necessary, replace the fluid bottle. Refer to Replacing System Fluids‚ page 2-37.
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.
Assay Specific Factors Specific factors can affect the performance of each assay, including storage and handling requirements of the reagents, specimen type and collection requirements, and pretreatment of specimens, if required. In addition, the manufacturer may recommend restrictions on the use of an assay and identify known interferences. Refer to the ADVIA Centaur XP Assay Manual for information specific to each assay.
Investigating Failed Proficiency Testing Results Failed proficiency testing can be caused by the following factors: •
reagents, calibrators, and controls are incorrectly handled
•
routine maintenance of the system is not performed
•
system is not clean
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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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Managing Data Data management includes the following functions: •
Database maintenance
•
Performing data backup
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Creating data archives
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Exporting data
Maintaining the Database NOTE: You must have the appropriate security level to add or edit system
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
Using the Status – Maintenance Window The Status – Maintenance window displays the status of system database maintenance. If the system is unable to perform database maintenance at the time set in the Status – Maintenance Definition window, the system displays “Overdue” in the Cycle column on the Status – Maintenance window. You have the option to initiate a maintenance procedure manually or to wait for the next autoscheduled maintenance activity. If an error occurs during database maintenance, the maintenance activity ends and the system posts an event in the event log. The system restores the database to its original state and the maintenance activity occurs at the next scheduled time.
Editing Database Maintenance Settings NOTE: The system autoschedules database maintenance by default. The system does not perform the autoscheduled database maintenance while the system is inprocess or during a remote update.
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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.
Manually Initiating a Database Maintenance Activity When you perform a manual database maintenance activity, the system uses the settings in the database maintenance window. If the current database is not above the database threshold set in the Status – Maintenance Definition window, the system does not delete tests from the database during the database maintenance activity. NOTE: The system does not perform the manual database maintenance if the system is inprocess, performing an autoscheduled database maintenance procedure, or during a remote update.
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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Defragmenting the Database As data is added and then deleted from the computer, the data storage becomes fragmented, which can begin to affect system performance. You can perform a data storage defragmentation every 6 months. If your laboratory does not autoschedule database maintenance, the disk defragmentation occurs during the manual database maintenance activity performed at 180 days. After a data storage defragmentation, the system automatically reboots.
Performing Data Back Up Backing up is the process of organizing and storing data on a storage medium. If your system is connected to the RealTime Solutions server, the ADVIA Centaur XP system automatically backs up the following data daily and sends it to the server: • customer-defined test definition • customer-changeable parameters • customer-defined setup options • Event Log • Maintenance Log • system settings • tube types • reagent inventory • quality control data • assay calibration data • instrument calibrations
Initiating a Data Backup Manually If you are not connected to the RealTime Solutions server, you can back up data manually to a storage medium. You should perform the manual backup daily. You must have the appropriate level of security to back up data. 1. At the workspace, select Setup. 2. Select Data Administration. 3. At the Setup – Data Administration window, select All. 4. Insert the storage medium in the appropriate drive on the applications module.
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5. Select Back Up. The status changes to Backup Complete. CAUTION
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.
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number of the system, if your laboratory has more than 1 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.
Saving Results Data to an Archive NOTE: You must have the appropriate security level to add or edit system
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.
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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.
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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.
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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 Status–Archive Options window are named using the following format: A_RA__
