Professional Documents
Culture Documents
1-2
The information in this operators guide was correct at the time of printing.
However, Siemens Medical Solutions Diagnostics continues to improve
products and reserves the right to change specifications, equipment, and
maintenance procedures at any time without notice.
If the system is used in a manner differently than specified by
Siemens Medical Solutions Diagnostics, the protection provided by the
equipment may be impaired. See warning and hazard statements.
078D0473-03 Rev. A
Contents
1
System Overview
Calibration
Quality Control
Performing Maintenance
Managing Data
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Index
078D473-03 Rev. A
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 operators guide is organized.
If you want to . . .
Then refer to . . .
Section 1:
System Features
Hardware Overview,
Software Overview,
Technology.
Section 2:
Operating the System.
Section 3:
Calibration.
Section 4:
Quality Control.
Section 5:
Maintenance.
Section 6: Troubleshooting.
Section 7:
Data Management.
078D0473-03 Rev. A
If you want to . . .
Then refer to . . .
Section 8:
System Configuration.
Appendix A:
Safety.
Appendix B:
Warranty and Support
Information.
Appendix C:
Reagents and System Fluids.
Appendix D: Supplies.
Appendix E: Specifications.
Appendix F: Symbols.
Appendix G: Glossary.
Conventions
The ADVIA Centaur XP Operators Guide uses the following text and symbol
conventions:
Convention
NOTE:
078D0473-03 Rev. A
Description
BIOHAZARD
LASER WARNING:
WARNING:
CAUTION:
Convention
Description
Bold
Italic
Terminology
The following table explains some of the special terminology used in this
operators guide and the specific actions that you need to take when you see the
terminology:
Term
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.
078D0473-03 Rev. A
078D0473-03 Rev. A
1 System Overview
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
ADVIA Centaur XP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Visible Status Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Sample Loading Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Reagent Loading Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Test Sequence Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Supplies and Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
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Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Direct Chemiluminescence. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Antibody Binding Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34
Paramagnetic Particles and Magnetic Separation . . . . . . . . . . . . . 1-34
1-36
1-38
1-39
1-42
1-44
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
078D0473-03 Rev. A
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
Optimal Productivity
Automatic Reflex
Testing
Onboard Refrigeration
Bubble Detection
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Feature
Description
Automated Cleaning
Autoschedule Daily
Cleaning
User Interface
LIS Interface
Laboratory Automation
RealTime Solutions
service
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:
understand the basic test processing sequence, which is essential for effective
troubleshooting
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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
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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
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
Yellow
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Red
Blinking
Yellow or
Blinking
Red
Blinking
Green
1-5
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.
Figure 1-3
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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
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
Figure 1-5
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Sample Queues
1-7
Racks enter the inprocess queue where the sample barcode scanner reads the
barcode labels on the rack and on each sample cup or tube. When the sample rack
is in the inprocess queue, the sample probe aspirates the sample.
1
2
3
Figure 1-6
Inprocess Queue
After each sample in the rack is aspirated, the rack moves from the inprocess
queue to the sample exit queue.
Figure 1-7
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1
2
Figure 1-8
3
4
Reagent holders
LEDs
Light-emitting diodes (LEDs) on the primary reagent door indicate the status of
the primary packs:
Green indicates that the reagent pack is loaded and available for use.
Blinking green indicates that the system detected that a reagent pack is
present but cannot read the barcode.
Neutral indicates that no reagent pack is loaded in that position or that the
pack is depleted, expired, inactivated, or has no barcode.
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You load ancillary reagent packs in the ancillary reagent entry. The system
delivers the packs to the ancillary reagent queue. The ancillary reagent queue
stores the packs at a temperature of 4 to 8C (39 to 46F). You remove ancillary
packs at the ancillary reagent entry.
1
2
3
Figure 1-9
Ancillary Queue
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1
2
Figure 1-10
Inprocess Queue
The sample probe aspirates sample from a container in the inprocess queue and
then dispenses sample into a cuvette in the incubation ring.
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The incubation ring is a circular, insulated track that advances the cuvette
at 15-second intervals and incubates the cuvette at 37C (98.6F).
1
2
Magnets
Incubation ring
Figure 1-11
The incubation ring moves the cuvette from the sample probe to the ancillary
probe and to the reagent probes.
The ancillary probe aspirates the ancillary reagents from the packs in the ancillary
reagent queue and dispenses the reagents into the cuvette in the incubation ring.
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The rinse station rinses the probe with reagent water before each ancillary reagent
aspiration.
1
2
Ancillary probe
Rinse station
Figure 1-12
The incubation ring moves the cuvette to the reagent probes. The 3 reagent probes
move independently of each other to aspirate primary reagents from the primary
packs and to dispense the reagents into the cuvette in the incubation ring.
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Between samples, the rinse stations rinse the probes with reagent water.
1
2
Reagent probe
Rinse station
Figure 1-13
The incubation ring moves the cuvette to the wash station. After the magnetic
particles are pulled to the side of the cuvette by magnets positioned along the
incubation ring, the aspirate probes draw fluid out of the cuvette. The wash
station dispenses wash fluid into the cuvette to wash the magnetic particles.
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 37C (98.6F) before
the cuvettes enter the incubation ring.
1
2
3
Figure 1-15
4
5
Preheater
Incubation ring
Cuvette Cycle
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Computer Hardware
The ADVIA Centaur XP computers control system functions and processes data.
The applications module is equipped with a CD-RW drive for software updates
and for data storage. The computer has several serial ports, as well as an Ethernet
port that expands the communication link between Siemens and your laboratory,
allowing for enhanced remotely initiated diagnostics and proactive service. The
monitor, keyboard, mouse, and barcode scanner are all connected to the computer.
Keyboard
The keyboard offers special icon keys.
1
2
3
4
Figure 1-16
You can use the keyboard to make selections, open windows, and enter
information.
If you want to . . .
Then . . .
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,
go to the previous
window,
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If you want to . . .
Then . . .
print information,
sign in,
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:
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
The System Status button provides access to diagnostic tools and the system
information
The Supplies Status button opens a window that displays information about
the cuvette supply, the sample tip supply, system fluid levels, and waste
levels.
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The Sample Status button opens a window that displays information about the
status of samples that are in process.
The Exception Status button directs you to the applications view and the
ADVIA QC application.
The Reagent Status button opens windows that display information about the
onboard primary and ancillary reagents.
The Maintenance Status button opens a window that accesses the maintenance
schedule, the maintenance log, the maintenance definitions, and the
maintenance procedures.
The Event Log Status button opens a window that displays the events that
occurred on the system and provides access to troubleshooting procedures.
Task Buttons
The task buttons provide access to windows associated with specific tasks. When
selected, each button displays a list of the windows that are available.
1
2
3
4
Worklist button.
Quality Control button
Calibration button
Setup button.
Figure 1-19
Button
System View
Applications View
Worklist
inactive
Quality
Control
Calibration
inactive
Setup
078D0473-03 Rev. A
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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
078D0473-03 Rev. A
Function Buttons
1-21
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
Figure 1-21
The title bar indicates the task area and the name of the specific window. The
title bar also contains buttons that access window help, move the window
behind other windows, or close the window.
The View, Sort, and Search fields control the amount or type of information
that is displayed, control the order of information displayed, and locate
specific items.
The information display area displays the information that you selected in
View, Sort, and Search fields.
The buttons on the bottom of the window perform actions on all information
in the information display area or in open related windows.
The buttons on the side of the window perform actions or open windows that
provide more information about an item you selected in the information
display area.
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To open a window that provides more information about an item in the list,
select a side button with an ellipsis (...).
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.
Scroll bar arrows scroll the view to display items that are not visible in the list.
You can enable 1 item from the group of options using a diamond option
button.
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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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.
Operators 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.
Software Maps
Workspace buttons open windows that contain related information and tasks.
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System
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Status
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Worklist
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Calibration
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Technology
Chemiluminescence is a chemical reaction that emits energy in the form of
light.15 When used in combination with immunoassay technology, the light
produced by the reaction indicates the amount of analyte in a sample.
Direct chemiluminescent reactions directly measure the light energy without the
use of added steps or amplifying molecules.6 The ADVIA Centaur XP assays use
acridinium ester (AE) as the chemiluminescent label, because AE does not require
the addition of a catalyst or substrate.6
Direct Chemiluminescence
It is easy to automate direct chemiluminescence using AE and provides many
benefits, such as long reagent shelf life, fast reaction time, and assay sensitivity.
The ADVIA Centaur XP assays use the dimethyl form of AE because its stability
allows long reagent shelf life.6,8
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1
2
3
4
Light intensity
Seconds
Acridinium ester
Other methods
Figure 1-22
The AE molecule is much smaller than the alkaline phosphatase molecule used
in EIA assays. This smaller size decreases blockage of binding sites, increases
diffusion rates, and increases the assay sensitivity.8
1
2
Figure 1-23
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Molecule Comparison
1-35
1
2
3
Antigen
Binding site
Antibody
Figure 1-24
Antibody Binding
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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
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
Sandwich Format
2. The system adds Solid Phase containing PMP that are coated with antibody
specific for the antigen in the sample.
The system incubates the cuvette at 37C (98.6F). PMP bind to the antigens
that are bound to AE-labeled antibody.
PMP-Antibody-Antigen-Antibody-AE complex
Figure 1-27
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3. The cuvette is exposed to a magnetic field, which draws PMP toward the
magnets.
While the magnets hold PMP in place, sample and reagent not bound to PMP
are washed away. The cuvette now contains AE bound to antigen, which is
bound to PMP by antibody.
1
2
3
Magnets
PMP-Antibody-Antigen-Antibody-AE complex
Cuvette
Figure 1-28
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4. The System adds acid and base to initiate the chemiluminescent reaction.
The system measures the emission of light in relative light units (RLUs).
When the system quantitates the light produced from the oxidation of AE, the
system calculates the concentration of antigen.
In a sandwich format, the analyte-specific antigen concentration in the
sample and the light emission in RLUs have a direct relationship. If more
analyte-specific antigen molecules are present in the sample, then more AE
is present, and therefore light emission is greater.
1
2
Figure 1-29
Competitive Format
Competitive formats include:
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AE-labeled Antigen
1. The system adds Lite Reagent, containing AE-labeled antigen, and Solid
Phase, containing antibody-labeled PMP, to the sample.
The system incubates the cuvette at 37C (98.6F). The AE-labeled antigen
competes with analyte-specific antigen in the sample for limited binding sites
on the antibody, which is bound to PMP.
If more analyte-specific antigen is present in the sample, then less AE-labeled
antigen is bound. Alternatively, if less analyte-specific antigen in the sample
is present, then more AE-labeled antigen is bound.
1
2
Antibody
PMP
Figure 1-30
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4
AE-labeled Antigen
1-41
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.
1
2
PMP-Antibody-Antigen complex
PMP-Antibody-Antigen-AE complex
Figure 1-31
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3. The system adds Acid and base to initiate the chemiluminescent reaction.
The system measures the emission of light in RLUs. When the system
quantiates the light produced from the oxidation of AE, the system calculates
the concentration of the analyte.
If the sample has a low concentration of analyte-specific antigen, most
binding sites on the antibody are bound to AE-labeled antigen. This causes an
elevated reading of RLUs from the oxidation of AE.
If the sample has a high concentration of analyte-specific antigen, most
binding sites on the antibody are bound to antigen from the sample, and few
sites are bound to AE-labeled antigen. This causes a lower reading of RLUs
from the oxidation
of the AE.
In a competitive assay with AE-labeled antigen, the concentration of antigen
in the sample and the light emission in RLUs have an inverse relationship.
1
2
Figure 1-32
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AE-labeled Antibody
1. The system adds Lite Reagent, containing AE-labeled antibody, and Solid
Phase, containing antigen-labeled PMP, to the sample.
The system incubates the cuvette at 37C (98.6F). Antigen bound to PMP
competes with analyte-specific antigen in the sample for limited binding sites
on AE-labeled antibody.
If the sample has more analyte-specific antigen, then it binds less
PMP-labeled antigen. Alternatively, if the sample has less analyte-specific
antigen, then it binds more PMP-labeled antigen.
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.
PMP-Antigen-Antibody-AE complex
Figure 1-34
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3. The system adds acid and base to initiate the chemiluminescent reaction.
The system measures the emission of light in RLUs. When the system
quantitates the light produced from the oxidation of AE, the system calculates
the concentration of analyte.
If the sample has a low concentration of analyte-specific antigen, the
PMP-labeled antigen binds to most binding sites on the antibody. This
causes an elevated reading of RLUs from the oxidation of AE.
If the sample has a high concentration of analyte-specific antigen, the antigen
from the sample binds to most binding sites on the antibody, and few sites are
bound to PMP-labeled antigen. This causes a lower reading of RLUs from the
oxidation of AE.
In a competitive assay with AE-labeled antibody, the concentration of analyte
in the sample and the light emission in RLUs have an inverse relationship.
1
2
Figure 1-35
Antibody-capture Format
When the substance being measured in the sample is an antibody, the system uses
the antibody-capture format. The assay uses a reagent containing an additional
antibody that is specifically directed against the antibody in the sample.
Antibody-capture formats are usually characterized by 2 cycles of incubation and
wash. The purpose of the first incubation and wash is to remove excess interfering
substances in the sample. The purpose of the second incubation and wash is to
measure the antibody in the sample.
078D0473-03 Rev. A
1-46
1
2
Figure 1-36
078D0473-03 Rev. A
Antibody-capture Format
1-47
2. The system exposes the cuvette to a magnetic field, which draws PMP toward
the magnets.
While the magnets hold PMP in place, the system washes away sample and
reagent not bound to PMP. The cuvette now contains IgM antibody from the
sample captured by specific anti-human IgM antibody, which is bound to
PMP.
Figure 1-37
078D0473-03 Rev. A
1-48
3. The system adds Lite Reagent, containing AE-labeled antigen, to the cuvette
and incubates it at 37C (98.6F).
The AE-labeled antigen binds to the sample IgM antibody in the sample.
AE-labeled antigen
Figure 1-38
078D0473-03 Rev. A
1-49
4. The system exposes the cuvette to a magnetic field, which draws PMP toward
the magnets.
While the magnets hold PMP in place, the system washes away the reagent
not bound to PMP. The cuvette now contains AE-labeled antigen bound to
sample IgM antibody, which is bound to anti-human IgM antibody, bound to
PMP.
Figure 1-39
078D0473-03 Rev. A
1-50
5. The system adds acid and base to initiate the chemiluminescent reaction. The
system measures the emission of light in RLUs. When the system quantitates
light produced from the oxidation of the AE, the system calculates the
concentration of the analyte.
In this example of an antibody-capture assay, the sample concentration and
the light emission have a direct relationship. If more sample IgM antibody is
present, then more AE is present, and therefore the light emission is higher.
1
2
Figure 1-40
References
1. Whitehead TP, Kricka J, Carter JN, Thorpe G. Analytical luminescence: its
potential in the clinical laboratory. Clin Chem 1979; 25/9: 15311546.
2. Woodhead JS, Campbell AK, McCapra F, Beheshti I, Weeks I. Acridinium
esters as high specific-activity labels in immunoassays. Clin Chem 1983; 29/
8: 147479.
3. Weeks I, Woodhead JS. Chemiluminescence immunoassays. J. Clin
Immunoassay 1984; 7/1: 8289.
4. Patel A, Morton MS, Woodhead JS, Ryall MET, McCapra F, Campbell AK. A
new chemiluminescent label for use in immunoassay. Biochem Soc Trans
1982;
10: 2245.
5. Tietz NW. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B.
Saunders Company, 1987; 1010.
6. Kricka LJ. Chemiluminescence immunoassay. The immunoassay handbook,
1st ed. New York: Stockton Press, 1994; 341343.
7. Dudley R. The immunoassay handbook, 1st ed. New York: Stockton Press,
1994; 161164.
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1-59
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078D0473-03 Rev. A
2-2
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 configured the sample racks for the tube types you are loading.
Refer to Specifying Sample Tube Types page 8-5.
When you move the Tube-Type Selector to position Athe 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.
078D0473-03 Rev. A
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.
2-3
1
2
3
4
Figure 2-1
078D0473-03 Rev. A
2-4
Loading Samples
BIOHAZARD
Barcode label
Figure 2-2
Sample tube
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.
078D0473-03 Rev. A
2-5
1
2
Figure 2-3
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.
078D0473-03 Rev. A
2-6
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
Figure 2-4
078D0473-03 Rev. A
2-7
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.
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.
View
Sort
Inprocess Queue
Errors
Inprocess Queue
Scanned
Inprocess Queue
SID
Inprocess Queue
Rack
078D0473-03 Rev. A
2-8
Then select . . .
to finish sample aspiration for the tests in the rack, and then
remove the rack
Complete
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.
Select the Sample Status button to open the Status Samples window.
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.
078D0473-03 Rev. A
2-9
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.
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
Inprocess
Cleaning
Warming Up
Diagnostics
078D0473-03 Rev. A
2-10
System State
Description
Mechanics Off
Check Status
Cleaning Failed
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:
078D0473-03 Rev. A
Red indicates that a supply and its reserve are depleted, the waste and its
reserve are full, or an error condition occurs.
2-11
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
No Cuvette
Detected
Red
OK
Neutral
<120 Tips
Yellow
Depleted
Red
OK
Neutral
>80% Full
Yellow
Not Present
Yellow
Sampling
Stopped
Red
Full
Red
OK
Neutral
>80% Full
Yellow
Not Present
Yellow
Sampling
Stopped
Red
Full
Red
OK
Neutral
>80% Full
Yellow
Sampling
Stopped
Red
OK
Neutral
Tips
Cuvette Waste
Tip Waste
Liquid Waste
078D0473-03 Rev. A
2-12
Supply Area
Water
Acid, Base
Wash 1 and
Wash 3
Cleaning
Solution
078D0473-03 Rev. A
Message
Color
Description
Not Present,
Using
Reserve
Yellow
Full, Using
Reserve
Yellow
Sampling
Stopped
Red
OK
Neutral
Not Present,
Using
Reserve
Yellow
Sampling
Stopped
Red
OK
Neutral
Not Present,
Using
Reserve
Yellow
Present,
Using
Reserve
Yellow
Sampling
Stopped
Red
Reserve
Depleted
Red
OK
Neutral
Not Present,
Using
Reserve
Yellow
Present,
Using
Reserve
Yellow
Sampling
Stopped
Red
Reserve
Depleted
Red
OK
Neutral
Supply Area
2-13
Message
Color
Description
Low
Yellow
Not Present
Yellow
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:
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.
Color
Description
Aspirated
Neutral
Clot
Detected
Yellow
Incomplete
Cal Set
Yellow
Incomplete
Set
Yellow
Insufficient
Yellow
Integrity
Error
Yellow
078D0473-03 Rev. A
2-14
Message
Color
Description
LIS Query
Pending
Yellow
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
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
SID
Mismatch
Yellow
Exception Status
Selecting this button displays a message directing you to the applications view
and ADVIA QC.
078D0473-03 Rev. A
2-15
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 . . .
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.
The system displays Status messages for each reagent pack that requires
attention.
078D0473-03 Rev. A
2-16
Color
Description
Cal Due
Neutral
Cal Expired
Yellow
Cal Required
Yellow
Check Lot
Numbers
Yellow
Check
Universal
Cal
Yellow
Depleted
Yellow
Lot Expired
Yellow
Low Reagent
Yellow
No Ancillary
Yellow
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
078D0473-03 Rev. A
2-17
Message
Color
Description
No Master
Curve
Yellow
No Optional
Diluent
Neutral
No Required
Diluent
Yellow
No sIgE
Universal
Yellow
No Test
Definition
Yellow
Not Onboard
Yellow
Pack Inactive
Neutral
Removable
Neutral
Removal
Pending
Neutral
Reposition
Neutral
Stability
Expired
Yellow
Test Inactive
Neutral
078D0473-03 Rev. A
2-18
Message
Color
Description
Verify
Stability
Neutral
Vial Inactive
Neutral
Ancillary Reagents
If an ancillary reagent requires attention and you select the Reagent Status button,
the Status Ancillary Reagent window is displayed.
The following messages indicate the status of a reagent:
Message
Color
Description
Depleted
Yellow
Lot Expired
Yellow
No Test
Definition
Yellow
Removal
Pending
Neutral
Stability
Expired
Yellow
Verify
Stability
Neutral
Maintenance Status
Use Maintenance Status to monitor maintenance activities and automated
procedures. At the workspace, the Maintenance Status button changes color
to indicate the status of maintenance:
078D0473-03 Rev. A
2-19
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.
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.
The ADVIA Centaur XP system monitors system events and notifies you when an
error condition occurs. Refer to Using the Event Log page 6-1.
Replenishing Reagents
You manually mix the primary packs and load them on the reagent holders in the
primary reagent compartment, which stores the reagents at 4 to 8C (39 to 46F).
The primary reagent shelf mixes the packs to keep the reagents in suspension. The
arrow indicator and color on each pack indicate where you can load the packs to
optimize sample throughput. Refer to Appendix C, Handling Reagents, in the
ADVIA Centaur Assay Manual.
078D0473-03 Rev. A
2-20
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.
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 stability information that displays at the Status Primary Pack Details
window
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.
078D0473-03 Rev. A
2-21
the stability information that displays at the Status Primary Pack Details
window
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.
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 . . .
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.
078D0473-03 Rev. A
2-22
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.
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.
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.
Then . . .
Select Complete.
Select Now.
078D0473-03 Rev. A
2-23
CAUTION
Do not remove a primary pack when the system is inprocess if the LED on the
primary reagent door is green. Removing a primary pack when the system is
inprocess and the LED is green can cause erroneous results and mechanical
damage to the system. Wait until the LED is neutral before you remove the
primary pack.
When the status changes to Removable and the LED changes to neutral, remove
the reagent pack.
1
2
3
LEDs
Ancillary reagent entry
Ancillary pack displaying barcode
Figure 2-5
078D0473-03 Rev. A
2-24
Then . . .
Select Complete
Select Now
The system ejects the pack into the ancillary reagent entry. An LED next to
the ancillary reagent entry turns orange to indicate that the pack is exiting
the system.
4. Remove the pack from the ancillary reagent entry.
If the system is not processing samples, you can remove ancillary reagent
packs from the ancillary queue using diagnostic tools. Refer Emptying the
Ancillary Queue page 6-69.
Replenishing Supplies
You can select the Supplies Status button at the workspace to open the Status
Supplies window and review the status of supplies. Refer to Supplies Status
page 2-10.
You can also move the pointer to the supply field and press the help (?) button
on the pointing device for a description of the status messages for each supply
and the procedure for replenishing each supply.
The system has the following capacity for supplies:
Supply
Capacity
Cuvettes
1000 cuvettes
Tips
840 tips
Cuvette Waste
700 cuvettes
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
078D0473-03 Rev. A
Supply
Capacity
Wash 3
2500 mL
Cleaning Solution
2100 mL
2-25
1
2
3
4
5
Figure 2-6
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.
078D0473-03 Rev. A
2-26
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.
078D0473-03 Rev. A
2-27
Sensor tip
Figure 2-7
078D0473-03 Rev. A
2-28
2. Insert the Waste Bottle Stopper into the sensor and tubing openings.
1
2
3
4
5
Waste bottle
Sensor clamp
Sensor opening
Waste bottle stopper
Tubing opening
Figure 2-8
3. Remove the waste bottle from the waste and water drawer.
4. Empty the waste bottle:
a. At the location in your laboratory designated for waste disposal, loosen
the waste bottle cap.
078D0473-03 Rev. A
2-29
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.
078D0473-03 Rev. A
2-30
stopper.
1. Open the waste and water drawer.
2. Lift the waste bottle lid to expose the waste bottle handle.
1
2
3
4
Figure 2-10
3. Thread the cable tie through the hole on the Waste Bottle stopper.
4. Wrap the cable tie around the handle of the waste bottle.
5. Insert the tip of the tie into the cable tie lock.
Adjust the tie as necessary. Do not secure the cable tie too tight. The stopper
needs to move freely around the handle and be able to reach the tubing and
sensor openings.
NOTE: The cable tie cannot be adjusted after you lock it.
078D0473-03 Rev. A
2-31
1
2
3
4
Lid
Sample tip waste area door
Cleaning solution bottle
Drawer
Figure 2-11
078D0473-03 Rev. A
2-32
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
Figure 2-12
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.
078D0473-03 Rev. A
2-33
1
2
3
Figure 2-13
3. Install the sample tip trays, ensuring that the tab is facing you and that the
notches in the trays are on the right.
4. Pull the tab to release the strap from the trays and then remove the strap.
5. Close the supplies access cover.
078D0473-03 Rev. A
2-34
1
2
Figure 2-14
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.
078D0473-03 Rev. A
2-35
Figure 2-15
078D0473-03 Rev. A
2-36
Figure 2-16
4. Dispose of the contents of the bin into a container approved for biohazardous
waste.
NOTE: The liners for the cuvette waste bin and the sample tip waste bin are
not interchangeable. Ensure that the cuvette waste bin liner is installed in the
cuvette waste bin.
after expiration
insufficient volume.
078D0473-03 Rev. A
2-37
You can replace the system fluids any time, even while the system processes
samples. The system fluid reservoirs hold enough fluid to allow the system to
complete the contents of the incubation ring.
WARNING
Do not allow contact of Acid and Base reagents with skin and eyes. Acid and Base
reagents are irritating to the skin. Wear suitable eye, face, and skin protection,
which include wearing gloves, protective eye shield, and laboratory coat. In case
of contact with the eyes, rinse the eyes immediately with plenty of water and seek
medical advice. In case of accident or if you feel unwell, seek medical advice. If
possible, show the bottle label and the Material Safety Data Sheet. In case of
accidental ingestion of reagent, call a physician immediately.
NOTE: Replace Acid and Base reagents at the same time to manage lot numbers
and to obtain optimum reagent performance.
Do not touch the tubing or sensors. Touching the tubing or sensors can cause
contamination.
2. Lift a fluid bottle lid at the front edge.
CAUTION
Dispose of Acid and Base reagents in accordance with local, state, and federal
regulations. Refer to the Material Safety Data Sheets for each material for
additional information.
078D0473-03 Rev. A
2-38
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
Figure 2-17
System Fluids
5. Place the bottle in the drawer and remove the cap, ensuring that you do not
dislodge the tubing on the fluid bottle lid.
6. Lower the lid onto the bottle, ensuring that the tubing is in the bottle and that
the lid fits securely.
7. Repeat steps 2 through 6 for each bottle.
8. Push in the system fluid drawer.
NOTE: If the system is inprocess when you change the system fluids, you do
not need to prime the bottles.
078D0473-03 Rev. A
2-39
edit a result
078D0473-03 Rev. A
2-40
The following table describes the View and Sort combinations you can use to
perform some routine tasks:
Task
View
Sort
Results
Current
SID
Conc or
Index
Pending
Batches
Scanned
NA*
Current
Results
SID
Conc or
Index
Pending
Tests
SID
NA*
Stats
SID
Conc or
Index
Historical
SID
Conc or
Index
Calibrators
SID
Conc or
Index
Stored
RLUs
SID
RLU
Historical
PID
Conc or
Index
Current
PID
Conc or
Index
Waiting for
Controls
SID
NA*
Results
Discarded
SID
NA*
NA = Not Applicable
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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.
Description
Valid
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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.
edit a result
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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078D0473-03 Rev. A
2-45
Before scheduling patient or control samples, ensure that you perform the
following tasks:
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Define calibrators.
Refer to Defining Calibrator Values page 3-14.
Define controls.
Refer to Using Quality Control Features page 4-1.
Load reagents.
Refer to Loading Reagents page 2-20.
Do not press the sample start button until you close the primary reagent door and
ensure that all reagent barcodes were read correctly. Starting the system before all
reagent barcodes are read correctly can cause erroneous results. Closing the
primary reagent door allows the system barcode scanner to rescan the reagent
barcodes and acknowledge any changes.
2. If the LED above the Sample Start button is not lit, press the button.
The system moves the rack to the inprocess queue.
3. If you schedule by SID and the sample tube does not have a barcode label,
you can enter the SID after the sample is scanned:
a. At the workspace, select the Sample Status button.
b. At the Status Samples window, select the sample with a No Barcode
status and then select Enter SID.
c. At the Status Enter SID window, enter the SID.
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You can enter the SID only while the sample is in the Inprocess Queue.
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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.
Define calibrators.
Refer to Defining Calibrator Values page 3-14.
Define controls.
Refer to Using Quality Control Features page 4-1
078D0473-03 Rev. A
Load reagents.
2-49
For most sample processing, do not schedule by Rack ID. If, however, it is
necessary to schedule a sample by rack ID, be aware that the system ejects the
sample to the exit queue after aspirating the sample. Reflex or other testing cannot
complete once the system ejects the sample to the exit queue. To obtain final
results for reflex or other testing, reintroduce the sample rack to the front of the
sample entry queue.
If you are scheduling samples for a control-bracketed test, you must schedule
by SID. The system does not allow you to schedule samples for
control-bracketed tests by Rack.
4. Select how you want the system to identify the sample:
If the sample identifier selected at the Setup Tube Type & Barcode
window is SID, you can select Schedule by SID or Schedule by Rack.
Refer to Specifying Sample Identification page 8-4.
If the sample identifier selected at the Setup Tube Type & Barcode
window is Rack, you can only select Schedule by Rack.
Refer to Scheduling Non-barcoded Samples by Rack ID page 2-50 and
Scheduling Barcoded Samples by Rack ID page 2-51.
NOTE: After entering the SID or the Rack ID, you must press Enter on the
keyboard. If you do not press Enter after entering the SID or the Rack ID, the
test selection table and the functions at the bottom of the window do not
become active.
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You can enter up to 13 alphanumeric characters for the SID. Do not use
the % symbol as part of an SID.
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
Then . . .
The system . . .
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If . . .
Then . . .
The system . . .
The system functions similarly when the LIS schedules samples by rack ID.
If the system has not scanned the rack, the system recalls the existing request
for that rack position and merges additional tests to that request.
If the system has scanned the rack or the rack is not in the current worklist, the
system creates a new worklist request for the rack position.
When a sample is scheduled by rack ID, the system does not use the SID to
process that sample even if the tube has a barcode label. In some cases, if the
system scans a barcode label for that sample tube, the system enters the SID from
the barcode label to the worklist request for the rack position. This provides a
check to identify a possible conflict between the SID in the worklist and the SID
on the sample tube barcode label. When the system identifies a possible conflict, it
alerts the operator by displaying the SID Mismatch sample status message.
The following table contains information about how the system uses the SID for
samples scheduled by rack ID:
Did the system
previously scan
the rack position
that is in the
current worklist?
Worklist
SID
Barcode Label
System Action
no
not present
present
no
present
present, different
from worklist
SID
not present
present
present
not present
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Worklist
SID
Barcode Label
System Action
present
not present
present
present, different
from worklist
SID
Edit the SID in the worklist to match the SID on the sample tube barcode
label.
Enter the SID on the sample tube barcode label into the worklist request.
Enter the SID from the sample tube barcode label at the Status Enter SID
window.
Eject the rack and place the correct sample tube in the rack position.
Never look directly at the beam of a hand-held barcode scanner or point the
scanner at another person. Also, do not look at the reflection of the beam from a
shiny surface. Only trained field service personnel should perform procedures
related to laser assemblies. For more information about laser safety, refer to
Appendix A, Protecting Yourself from Barcode Scanner Lasers.
You can use the hand-held barcode scanner to enter the Sample ID for patient
samples:
1. At the workspace, select Worklist.
2. Select Schedule.
3. At the Worklist Schedule window, select only Patient and Schedule by
SID.
These are the default options and are already selected when the window
displays.
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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
Name
DOB
M or F
Location
Physician
Optional
3. Select Continue.
4. Select Save at the Worklist Schedule window and continue with additional
scheduling activities.
078D0473-03 Rev. A
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comments.
1. At the Worklist Summary window, select the sample and then select
Schedule.
2. At the Worklist Schedule window, select Demographics.
3. At the Worklist Demographics window, select Comments.
4. At the Comments window, enter a comment.
You can enter up to 3 comments. Comments can be up to 120 alphanumeric
characters. The system enters your initials and the date.
5. Select Save.
6. Select Continue at the Worklist Demographics window.
7. At the Worklist Schedule window, select Summary to return to the
Worklist Summary window.
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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As samples are scanned, individual requests are added to the worklist using the
primary sample identifier.
Batches display at the Worklist Summary window in the Pending Batches view.
When the system scans the ending rack, the system removes the batch from the
Pending Batches view.
Sample racks loaded in the Stat entry are not recognized as part of a batch and
batch test requests are not added to the Stat test request.
If you schedule a sample in a batch and also schedule an individual test request for
that same sample, the system processes all tests for that sample.
If you select SID for sample identification in Setup, you must use SID barcode
labels to identify the samples.
If sample identification is by SID and the SID barcode label is not recognized by
the system, no request is created for the sample. To create a request for the
sample, reload the sample with a readable SID barcode label before the ending
rack for the batch is loaded.
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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.
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
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.
078D0473-03 Rev. A
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5. Select Continue.
6. At the Worklist Schedule window, select Save.
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.
078D0473-03 Rev. A
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3. Select Continue.
4. At the Worklist Schedule window, select Save.
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.
If you want to . . .
Then . . .
1.
1.
078D0473-03 Rev. A
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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.
Editing Requests
Use this procedure to perform the following actions:
add tests
change dilutions
change demographics
078D0473-03 Rev. A
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Then . . .
And . . .
pending tests,
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 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.
078D0473-03 Rev. A
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Then select . . .
At the Worklist Result Details window, you can review additional information
to help you evaluate results:
reference ranges
units
access to reagent lot and pack information for each replicate result
078D0473-03 Rev. A
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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
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
Cal Assigned
Cal Invalid
Cal Required
Cancelled
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
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Flag
Description
Conf N/A
Control bracketed
Control bracketed
restricted
Diluted
> Dilution Pt
The result is above the dilution point defined for this test at the
Test Ranges window.
Edited
Entered
Exception
Excluded
High
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Flag
Description
High CV
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.
The result is above the high value for the index calculation
defined at the Calibration Master Curve Definition window.
The test is repeated if Repeat if > Index is selected at the Test
Ranges window.
The result is below the low value for the index calculation
defined at the Calibration Master Curve Definition window.
The test is repeated if Repeat if < Index is selected at the Test
Ranges window.
Insufficient
Integrity Error
Investigational
> 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
Lot Expired
Low
Low Acid
Low Base
Low Tips
Low Wash 1
Low Wash 3
078D0473-03 Rev. A
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Flag
Description
Low Water
Manual Dilution
A manual dilution was specified for this test result. The result is
automatically corrected for the specified dilution factor.
No Ancillary
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
No Dil Allowed
No Diluent
No Lot Match
No Primary
No sIgE Universal
No Vial Rgt
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
Priming
The system cannot perform the test because the system needs to
schedule priming for a probe or a pump.
Redilute
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Flag
Description
repeated
restricted
Signal Error
System Error
Test Inactive
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
Wrong Vial ID
Waived
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 . . .
When the repeat completes, you can review the initial results and the repeated
results at the Worklist Result Details window.
Editing Results
Use this procedure to change the concentration or index value of a result. You can
also use this procedure to enter the result for an off-system test. You must have the
appropriate level of security to edit results.
1. At the workspace, select Worklist.
2. Select Summary.
3. At the Worklist Summary window, select a sample.
4. Select Result Details.
5. At the Worklist Result Details window, select a result.
6. Select Edit Result.
7. At the Worklist Edit Results window, edit the value:
If the result has both concentration and index values, both fields display at
the Worklist Edit Results window; however, you can only edit the Conc
field.
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Then . . .
select Release.
a.
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 . . .
a.
6. Select Continue.
When the system releases the hold status for a result, it automatically sends
the result to an LIS if automatic transfer of results is defined for your system.
Refer to Defining LIS Communication Options page 8-45.
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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.
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.
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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.
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:
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Select the date ranges and tests that you want to delete from the current or
the historical worklist.
Then . . .
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.
Select Resulted.
printed results,
Select Printed.
Select Sent.
Printing Results
The system offers 3 printed report types for managing patient results:
Results Report
Test Report
Runtime Report
When you select a report, the system displays the options for that report type.
078D0473-03 Rev. A
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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:
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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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.
078D0473-03 Rev. A
3 Calibration
Using a Master Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Performing a 2-point Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Referencing Serum Calibration for T Uptake . . . . . . . . . . . . . . . 3-4
078D0473-03 Rev. A
078D0473-03 Rev. A
Calibration
The ADVIA Centaur XP system uses a Master Curve and a 2-point,
operator-initiated calibration to calibrate qualitative and quantitative assays. The
Master Curve and the 2-point calibration method eliminate the need to measure a
full standard curve or to include a calibration each time the assay is performed.
1
2
Figure 3-1
078D0473-03 Rev. A
3-2
The Master Curve for a sandwich assay has a positive slope, which indicates that
the analyte concentration is directly proportional to the light emission in RLUs.
1
2
Figure 3-2
When patient samples or quality control samples are assayed using a quantitative
assay, the system matches the adjusted RLU value to its corresponding analyte
concentration using the Master Curve.
Qualitative assays have a cut-off point that remains constant for each lot number
of reagent. The manufacturer establishes this cut-off during product development
and bases it on extensive population studies. Manufacturing assigns the analyte
concentration associated with the cut-off as, for example, an index value of 1.0.
See the method specific product insert for the method cut-off value.
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3-3
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
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.
078D0473-03 Rev. A
3-4
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%
078D0473-03 Rev. A
3-5
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
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.
078D0473-03 Rev. A
3-6
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
078D0473-03 Rev. A
3-7
Because the observed ranges are specific for your system, they are narrower than
the defined ranges and therefore increase the quality of calibration monitoring
over the defined ranges. Whenever a calibration is outside of the observed ranges
but within the defined ranges, you can accept the calibration.
Figure 3-5 shows both defined and observed ranges.
14
5
6
7 8
Figure 3-5
078D0473-03 Rev. A
3-8
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:
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.
078D0473-03 Rev. A
3-9
If a new calibration does not meet the retained calibration limits, the system uses
the new calibration to calculate results and set the calibration interval expiration
date. The system repeats the process until you use a new reagent lot or calibrator
lot. The process starts over with 4 new valid calibrations as in Figure 3-6.
14
5 7
Figure 3-6
In Figure 3-6, the first 4 calibrations (1-4) of a reagent lot and calibrator lot
combination are valid. The system calculates observed ranges after the fourth
valid calibration.
When the fifth calibration is a valid calibration that is not statistically different
from the fourth calibration, the system retains the fourth calibration and uses it to
calculate results. The system bases the calibration interval expiration date on the
date of this (fifth) calibration.
The sixth calibration is a valid calibration that is statistically different from the
fourth calibration. The system uses data from this calibration to calculate results
and set the calibration interval expiration date.
The seventh calibration is a valid calibration that is not statistically different from
the sixth calibration, so the system retains the sixth calibration and uses it to
calculate results. The system bases the calibration interval expiration date on the
date of this (seventh) calibration.
The system bases the calibration interval expiration date on the date of this
(seventh) calibration.
078D0473-03 Rev. A
3-10
If the deviation of an outlier does not exceed the critical precision limit,
the system excludes it and re-evaluates the calibration criteria.
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.
078D0473-03 Rev. A
3-11
4. Scan the barcodes on the Master Curve Card from top to bottom.
Figure 3-7
5. Select Save.
078D0473-03 Rev. A
3-12
078D0473-03 Rev. A
3-13
Positions of Ratio and Slope on the Master Curve Card are reversed from
those positions on the user interface. When manually entering the
information, be sure to enter the information into the correct field.
1
2
Figure 3-8
078D0473-03 Rev. A
3-14
Procedural Notes
Manual entry of information into the Stability Data field requires 12 digits.
Enter the 3-digit stability data on the Master Curve Card and follow it with 9
zeros (0).
Positions of Ratio and Slope on the Master Curve Card are reversed from
those positions on the user interface. When manually entering the
information, ensure you enter the information into the correct field.
Do not process samples for a test and reagent lot combination after deleting a
Master Curve for that test unless you reboot the system. If you do not reboot the
system before running that test, the system may continue processing the samples
and never release the results or the system may require a software reload.
Use this procedure to delete a Master Curve before calibrations have been
performed against it. For example, if you typed incorrect information into 1 of the
fields and selected Save before you noticed the error, you can delete the Master
Curve and start over.
1. At the workspace, select Calibration.
2. Select Master Curve Definition.
3. At the Calibration Master Curve Definition window, select the test and lot
number.
4. Select Delete.
This button is not available if a calibration has been performed for the Master
Curve.
5. Select Yes.
078D0473-03 Rev. A
3-15
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.
078D0473-03 Rev. A
3-16
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.
Description
Cal Required
Current
Due
078D0473-03 Rev. A
3-17
Calibration Status
Description
Expired
Invalid
No Master Curve
Operator Accepted
Waived
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
All Tests
Status
All Tests
Test
Available
Reagents
Status
Available
Reagents
Test
Historical
078D0473-03 Rev. A
3-18
Description
Invalid
Valid
Valid, Operator
Accepted
Waived
Scheduling Calibrators
Calibrate an assay in the following instances:
a calibration is invalid
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:
078D0473-03 Rev. A
3-19
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.
no reagent is onboard
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.
078D0473-03 Rev. A
3-20
Description
Expired
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
Invalid, Exceeded
Observed Ranges
Valid
Valid,
Met Retained Cal
Limits
Valid,
Operator Accepted
078D0473-03 Rev. A
3-21
Calibration Status
Description
Valid,
Operator Accepted,
Retained
Valid, Retained
Waived
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
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
078D0473-03 Rev. A
3-22
Flag
Description
The calibration is outside the range for the ratio that is defined
at the Calibration Master Curve Definition window. Schedule
another calibration at the Worklist Schedule window.
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
Failed Observed
Low Cal Deviation
Failed Observed
Ratio
Failed Observed
Slope
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.
The calibration did not yield the expected results for the
Reagent B ratio check. Schedule another calibration at the
Worklist Schedule window.
High CV
Rgt A
High Cal CV
Rgt A
Low Cal CV
Rgt B
High Cal CV
078D0473-03 Rev. A
3-23
Flag
Description
Rgt B
Low Cal CV
System Excluded
078D0473-03 Rev. A
3-24
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
078D0473-03 Rev. A
3-25
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.
078D0473-03 Rev. A
3-26
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.
Continues with inprocess patient and control samples and displays RLUs
for results if Assign Cal is selected in the test definition.
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.
You have a valid calibration that is due to expire for the reagent lot that you
are using.
Continues with inprocess patient and control samples and displays RLUs
for results if you selected Assign Cal in the test definition.
078D0473-03 Rev. A
Because the calibration is still valid, you can use the Assign Cal feature to
assign the calibration to patient and control samples with RLU results from
the invalid calibration.
3-27
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:
Continues with inprocess patient and control samples and displays RLUs
for results if Assign Cal is selected in the test definition.
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.
078D0473-03 Rev. A
3-28
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.
078D0473-03 Rev. A
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
078D0473-03 Rev. A
078D0473-03 Rev. A
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
078D0473-03 Rev. A
4-2
Routine controls are not provided with the assay reagent kits.
Control such as Ligand Plus or Tumor Marker Plus are routine controls.
NOTE: If you are defining a control that does not have a leading K in the
barcode, select SID and edit that field to match the barcode of the control. You
can select SID only after entering the lot number.
6. Enter the information for the new lot of control, such as type, lot, and
expiration date.
The lot number and the expiration date are located on the quality control
material packaging. You must enter a lot number and an expiration date to
save the control definition.
You can enter up to 7 characters for the lot number.
Enter the date in the format DD MMM YY, for example 26 Oct 99.
The system fills in the SID field with the control lot number preceded by K.
The SID can be up to 13 characters. If the control is a Routine type and your
QC SIDs are different than the lot number, you can edit the SID.
7. Select a Test:
a. Select the Test button.
The TestSelection window displays.
b. Select a test.
c. To close the TestSelection window, select Continue.
8. Enter the expected values.
9. Select Save Test.
10. Repeat steps 3 through 9 for all tests for the control.
11. Select Save.
078D0473-03 Rev. A
4-3
control, which is a type of control provided with specific assay reagent kits.
1. Select the name of the control, if required.
2. Select Edit.
3. Enter the information for the new lot of control, such as type, lot, and
expiration date.
Refer to Lot Number and the Expiration Date page 4-3.
4. Select a Test:
a. Select the Test button.
The TestSelection window displays.
b. Select a test.
c. To close the TestSelection window, select Continue.
5. Enter the expected values.
6. Select Save Test.
7. Repeat steps 3 through 5 for all tests for the control.
8. Select Save.
Deleting a Control
1. At the workspace, select Quality Control.
2. Select Control Definition.
3. Select the name of the control.
4. Select the information for the lot of control, such as lot and type.
CAUTION
Use care when deleting a test from a control definition. Deleting a test from a
control definition permanently removes all associated stored data and results from
the database.
5. Select Delete.
6. Select Yes.
7. To delete a test from a control definition, select the test, and then select Delete
Test.
078D0473-03 Rev. A
4-4
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.
Then . . .
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.
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.
078D0473-03 Rev. A
If you want to . . .
Then . . .
a.
4-5
b. In the fields below the table, edit the low and high
limits, or edit the mean and 2SD values.
c.
a.
Select Test.
The Test Selection window displays.
b. Select a test.
c.
d. Enter the low and high limits or enter the mean and
2SD values.
e.
a.
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.
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.
078D0473-03 Rev. A
4-6
If the sample identifier selected at the Setup Tube Type & Barcode
window is Rack, you can only select Schedule by Rack.
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.
078D0473-03 Rev. A
4-7
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.
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.
078D0473-03 Rev. A
4-8
Ensure that the rack ID for the end-of-bracket controls is different from the rack
ID of the start-of-bracket controls.
078D0473-03 Rev. A
5 Performing Maintenance
Reviewing Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Recording Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Accessing Online Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Reviewing the Maintenance Log. . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Printing Maintenance Reports . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1-24
1-25
1-25
1-26
1-27
1-28
1-28
1-29
078D0473-03 Rev. A
078D0473-03 Rev. A
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:
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.
078D0473-03 Rev. A
5-2
The following table describes the View and Sort combinations you can use to
perform some routine tasks:
Task
View
Sort
Schedule
Time Due
Schedule
Activity
Log
Time Completed
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.
Select Save.
Repeat these steps to update the maintenance schedule and enter comments for
another activity.
078D0473-03 Rev. A
5-3
3. Select Procedure.
An online help window opens and displays the maintenance procedure.
Select . . .
Time Completed
Activity
Select . . .
Schedule.
Log.
5. If you selected Log, enter the Starting Date and Ending Date.
078D0473-03 Rev. A
5-4
Then . . .
define a maintenance
activity
a.
edit a maintenance
activity
Select Add.
b. Select Definition.
c.
a.
b. Select Definition.
c.
d. Select Autoschedule.
e.
078D0473-03 Rev. A
5-5
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
078D0473-03 Rev. A
5-6
Diluter drawer
Figure 5-1
Diluter Drawer
078D0473-03 Rev. A
5-7
1
2
3
4
5
Figure 5-2
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.
078D0473-03 Rev. A
5-8
Do not clean the primary reagent compartment while the probes are accessing
reagent packs. Injury can result.
078D0473-03 Rev. A
5-9
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.
078D0473-03 Rev. A
5-10
1
2
3
4
5
6
7
Reservoir cap
Sensor
Water tubing fittings
Sensor
Manifold
Water reservoir
Water bottle
Figure 5-3
6. Remove the reservoir cap and empty any water from the reservoir.
7. Remove the manifold and install the water reservoir cleaning cover:
a. Loosen the 3 knurled captive screws.
b. Remove the manifold from the reservoir.
078D0473-03 Rev. A
5-11
1
2
Figure 5-4
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.
078D0473-03 Rev. A
5-12
1
2
3
4
5
Figure 5-5
078D0473-03 Rev. A
5-13
Do not leave cleaning solution residue in the water reservoir. Residual cleaning
solution in the water reservoir tubing can affect assay performance. Rinse the
water reservoir thoroughly with fresh reagent water.
h. Thoroughly rinse the inside of the reservoir, and the reservoir cleaning
cover at least 3 times to ensure that there is no residual cleaning solution
on the components.
i.
j.
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.
Invert the bottle, swirl the solution a few times and then return the bottle
to the upright position.
078D0473-03 Rev. A
5-14
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.
1
2
Manifold tubing
Manifold
Figure 5-6
Manifold
Do not touch the tubing or sensors. Touching the tubing or sensors can cause
contamination.
078D0473-03 Rev. A
5-15
e. Rinse each tubing by filling it with reagent water using a clean transfer
pipette, removing the fluid and repeating 5 times.
CAUTION
Thoroughly rinse the manifold and remove excess water from the
manifold and tubing.
Do not remove the water trap when the system is in the Inprocess state or the
Cleaning state. Removing the water trap while the system is in one of these
states can cause a low vacuum error and cause the system to stop sampling and
cancel all of the tests in the ring.
1. Ensure that the system is in 1 of the following states:
Ready
Warming Up
Diagnostic
Mechanics Off
Check Status
BIOHAZARD
078D0473-03 Rev. A
5-16
Water trap
Figure 5-7
Water Trap
078D0473-03 Rev. A
5-17
You need the following materials to perform the Monthly Cleaning Procedure:
approximately 4 L of prepared ADVIA Centaur XP Cleaning Solution for the
automated portion of the Monthly Cleaning Procedure
approximately 2 L of prepared ADVIA Centaur XP Cleaning Solution used
for soaking and wiping system components
reagent water
large maintenance brush
lint-free tissues, gauze, and paper towels
spare air filter
Do not bend the probe. Bending the probe can cause system errors.
1. At the workspace, select System Status.
2. Select Turn System Mechanics Off.
078D0473-03 Rev. A
5-18
3. Loosen the screw on the left side of the system that secures the top cover and
then open the top cover.
WARNING
Use care when working with the reagent probes and ancillary probe. The probe
tips are sharp and can cause skin punctures.
4. Remove the reagent probes cover by lifting the cover up and then out.
Figure 5-8
Reagent Compartment
078D0473-03 Rev. A
1
2
3
4
5
5-19
Reagent probe 1
Reagent probe 2
Reagent probe 3
Probe side view.
Motor.
Figure 5-9
b. Use a gentle downward motion to wipe each probe with lint-free tissues
or gauze saturated with cleaning solution.
c. Check the probes for damage and to ensure that they are not bent.
CAUTION
Do not leave cleaning solution residue on the probe. Residual cleaning solution
on the probe can damage the probe. Follow the instructions for rinsing the
probe.
d. Thoroughly rinse the reagent probe, especially the middle of the probe.
078D0473-03 Rev. A
5-20
Rinse the probe using a gentle downward motion to wipe each probe with
lint-free tissues or gauze saturated with reagent water.
Reagent probe
Figure 5-10
Reagent Probe
078D0473-03 Rev. A
5-21
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:
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.
078D0473-03 Rev. A
5-22
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
078D0473-03 Rev. A
5-23
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.
078D0473-03 Rev. A
5-24
Figure 5-13
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.
078D0473-03 Rev. A
5-25
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.
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
078D0473-03 Rev. A
5-26
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
078D0473-03 Rev. A
5-27
Third Prompt
078D0473-03 Rev. A
5-28
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
078D0473-03 Rev. A
5-29
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.
078D0473-03 Rev. A
5-30
1
2
Figure 5-14
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
078D0473-03 Rev. A
5-31
Third Prompt
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.
078D0473-03 Rev. A
5-32
1
2
As-Needed Maintenance
For online information about performing maintenance procedures, perform the
following steps:
1. At the workspace, select the Status Maintenance button.
2. At the Status Maintenance window, select the appropriate maintenance task:
3. Select Procedure.
4. Follow the instructions in the online help.
NOTE: Most of these procedures are also available in this section of the
ADVIA Centaur XP Operators Guide.
078D0473-03 Rev. A
5-33
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
Screw
078D0473-03 Rev. A
5-34
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.
078D0473-03 Rev. A
5-35
Figure 5-15
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.
078D0473-03 Rev. A
5-36
1
2
3
4
5
Reagent probe 1
Reagent probe 2
Reagent probe 3
Probe
Motor
Figure 5-16
6. Gently push the sample probe and ancillary probe assemblies back toward the
incubation ring by pushing the motors.
7. Use a disposable transfer pipette to add 0.5 to 1.0 mL of cleaning solution to
each rinse station.
Refer to Preparing the Cleaning Solution page 5-17.
8. Clean each rinse station using the small maintenance brush.
078D0473-03 Rev. A
5-37
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.
078D0473-03 Rev. A
5-38
Figure 5-18
078D0473-03 Rev. A
Reagent Compartment
5-39
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.
1
2
3
4
5
Reagent probe 1
Reagent probe 2
Reagent probe 3
Probe
Motor
Figure 5-19
078D0473-03 Rev. A
5-40
1
2
3
Shutter drive
Shutter drive arm
Reagent probe shutter
Figure 5-20
078D0473-03 Rev. A
5-41
Do not clean the primary reagent compartment while the probes are accessing
reagent packs. Injury can result.
1. At the workspace, select System Status.
2. Select Turn System Mechanics Off.
3. Open the primary reagent door.
Figure 5-21
4. Remove the primary reagent packs from the primary reagent compartment
and refrigerate them.
5. Wipe excess water from the primary reagent compartment.
078D0473-03 Rev. A
5-42
6. Wipe the surfaces of the primary reagent compartment with lint-free tissues
or gauze saturated with water.
1
2
3
4
Figure 5-22
7. If reagent has spilled onto the reagent pack holders, wipe the reagent pack
holders with lint-free tissues or gauze saturated with water.
8. Dry the primary reagent compartment.
9. Select Turn System Mechanics On.
10. When the system is in the Ready state, return the reagent packs to the primary
reagent compartment.
NOTE: Reagent mixing does not occur when System Mechanics are off.
Some settling of the Solid Phase reagents can occur if the reagents have not
been mixed for 2 hours.
11. Ensure that reagents are resuspended before resuming normal operation.
Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay
Manual for information on checking for a Solid Phase pellet and mixing
reagent packs by hand.
12. Close the primary reagent door.
078D0473-03 Rev. A
5-43
exterior covers
ancillary entry
Stat entry
pointing device
2. Rinse the components with lint-free tissues or gauze saturated with water.
078D0473-03 Rev. A
5-44
4. Lift the tip tray bin up and then out of the system.
Figure 5-23
5. Remove the cuvette waste bin, empty it, and set it aside.
078D0473-03 Rev. A
5-45
6. Remove the cuvette waste chute by releasing it from the magnetic fitting.
Slightly rotate the cuvette waste chute, then pull it out and down.
Figure 5-24
078D0473-03 Rev. A
5-46
b. Wipe the reservoir with lint-free tissues or gauze saturated with cleaning
solution.
Figure 5-25
c. Rinse the reservoir with lint-free tissues or gauze saturated with reagent
water.
WARNING
Do not splatter yourself or work area with cleaning solution. The cleanins solution
is a biohazardous material and must be used carefully. Scrub the cuvette waste
Do not pinch or trap cables or tubing when installing the chute. Pinching the
cables or tubing can cause system errors.
10. Install the cuvette waste chute:
a. Place the locator pins at the bottom of the chute in the reservoir.
078D0473-03 Rev. A
5-47
b. Push up the top of the chute until it attaches to the magnetic fitting.
1
2
3
Magnet fitting
Locator pins
Cuvette waste reservoir
Figure 5-26
c. Rinse the reservoir with lint-free tissues or gauze saturated with reagent
water.
WARNING
Do not splatter yourself or work area with cleaning solution. The cleanins solution
is a biohazardous material and must be used carefully. Scrub the cuvette waste
Do not pinch or trap cables or tubing when installing the chute. Pinching the
cables or tubing can cause system errors.
078D0473-03 Rev. A
5-48
1
2
3
Figure 5-27
078D0473-03 Rev. A
5-49
13. Ensure that no wires or cables are interfering with the correct positioning of
the cuvette waste chute.
1
2
Figure 5-28
078D0473-03 Rev. A
5-50
1
2
3
4
Figure 5-29
078D0473-03 Rev. A
5-51
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
1
2
Figure 5-30
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
078D0473-03 Rev. A
5-52
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.
078D0473-03 Rev. A
5-53
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
078D0473-03 Rev. A
5-54
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.
078D0473-03 Rev. A
5-55
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.
078D0473-03 Rev. A
5-56
Do not use sample racks with duplicate numbers. Using sample racks with
duplicate sample rack identification barcode numbers can result in sample
processing errors. When you receive additional sample rack identification barcode
labels, ensure that the number range is different from ranges you currently use on
your system.
1. If the sample racks are not labeled, position a sample rack identification
barcode label on the rack.
The A label indicates multiple tube types. The vertical numbers2, 3, and
4on the sample rack identification barcode label correspond to the
tube-type
NOTE: If you are using ADVIA Centaur racks, ensure that you use
ADVIA Centaur labels1, 2, 3, and 4 for the Tube-Type Selector and use
the correct barcode.
a. Firmly place the sample rack identification barcode label on the right side
of the rack and carefully wrap the label around to the front of the rack.
078D0473-03 Rev. A
5-57
b. Ensure that the sample rack identification barcode label does not
1
2
Figure 5-34
1
2
Calibrator label
Quality control label
Figure 5-35
The Cal and QC labels remind you where to place the tube-type selector to match
the calibrator or QC material tube type in the sample rack. Refer to the
Setup Tube Type & Barcode window to verify the tube-type positions specified
for your system.
078D0473-03 Rev. A
5-58
On the front of the sample rack identification barcode label, apply a Cal or QC
label at the position corresponding to the tube type you use for calibrators or QC
material.
Figure 5-36
For the remaining racks, you can use the tube-type labels to represent the 4 types
of tubes you specified at the Setup Tube Type & Barcode window. The vertical
numbers, 1 to 4, on the sample rack identification barcode label correspond to the
4 tube-type positions specified at the Setup Tube Type & Barcode window.
For example, if you select Large Transfer as Tube Type 1, you can select 1 of the
tube type labels to represent large transfer tubes.
You can use the blank labels to create your own tube-type labels or color-coded
system. Use a permanent marker to write on the blank labels.
1. Apply the tube-type labels to the front of the sample rack identification
barcode label, matching each tube-type label to the tube type position you
specified at the Setup Tube Type & Barcode window.
For example, if Tube Type 1 is Large Transfer, place the tube-type label you
selected to represent large transfer tubes at position 1 on the sample rack
identification barcode label. The tube-type labels remind you where the
tube-type selector should be located to match the type of tube you place in the
sample rack.
2. On the front of the sample rack, align the top and left edge of the first
tube-type label with the top and left edge of the sample rack identification
barcode label.
078D0473-03 Rev. A
5-59
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
Figure 5-37
078D0473-03 Rev. A
5-60
c. Ensure that the tube-type selector does not cover the sample rack
identification barcode number.
1
2
Figure 5-38
Clip
Figure 5-39
078D0473-03 Rev. A
5-61
078D0473-03 Rev. A
5-62
078D0473-03 Rev. A
078D0473-03 Rev. A
6-66
6-67
6-68
6-69
6-84
6-84
6-85
6-87
6-87
6-87
6-88
078D0473-03 Rev. A
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-107
078D0473-03 Rev. A
078D0473-03 Rev. A
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.
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
Warning
Yellow triangle
078D0473-03 Rev. A
6-2
Event Type
Symbol
Definition
Information
No symbol
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
Events
Date
Errors
Severity
Events
Subsystem
078D0473-03 Rev. A
6-3
b. Select Comments.
c. At the Comments window, enter a comment.
You can enter up to 3 comments. You can enter comments of up to
120 alphanumeric characters. The system enters your initials and the date.
If you are not currently signed in, you must sign into the system.
d. Select Save.
If the procedure does not correct the problem or if the problem occurs again, call
for technical assistance.
If you see this event, write down the event code or print the window and then call
for technical assistance.
Do not disconnect the system. Disconnecting the system turns off the thermal
components of the primary reagent compartment and ancillary queue. Shut down
the system instead.
2. Select Turn System Off.
3. At the prompt, press any key to continue.
4. Wait approximately 2 minutes while the system powers down.
This does not remove power from the thermal devices such as reagent
refrigeration and probe heaters.
5. Check for obstructions in the following areas before rebooting the system:
ancillary entry
Stat entry
078D0473-03 Rev. A
6-4
Figure 6-1
078D0473-03 Rev. A
6-5
Figure 6-2
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:
078D0473-03 Rev. A
6-6
rack loader
ancillary entry
Figure 6-3
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.
078D0473-03 Rev. A
6-7
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.
078D0473-03 Rev. A
6-8
If the power disruption is so brief that you do not have the opportunity to turn
the main power switch off, reset the system.
1. Turn the main power switch off.
1
2
Figure 6-4
078D0473-03 Rev. A
6-9
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.
078D0473-03 Rev. A
6-10
1
2
3
4
Ring loader
Elevator
Luminometer
Orientation chute
Figure 6-5
5
6
7
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.
078D0473-03 Rev. A
6-11
8. Remove and discard all cuvettes from the orientation chute and vertical
cuvette chute using a disposable transfer pipette.
1
2
Figure 6-6
078D0473-03 Rev. A
6-12
1
2
Cuvette
Bottom window
Figure 6-7
10. Look for the cuvette at the bottom window of the vertical cuvette chute.
11. If the cuvette does not appear in the bottom window, there is an obstruction
in the vertical cuvette chute.
078D0473-03 Rev. A
6-13
Thumbscrew
Figure 6-8
g. Replace the vertical cuvette chute window and tighten the thumbscrew.
078D0473-03 Rev. A
6-14
13. Manually move the conveyor upward and look for binding.
1
2
Conveyor slats.
Cuvette Conveyor
Figure 6-9
Cuvette Conveyor
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.
078D0473-03 Rev. A
6-15
UI lock-up error
To improve the system recovery time after any of these events, perform the Empty
& Fill Ring procedure:
078D0473-03 Rev. A
6-16
1
2
3
Ring loader
Preheater
Screw for the preheater cover
Figure 6-10
4
5
6
Preheater cover
Vertical cuvette chute window
Preheater assembly
Preheater Assembly
078D0473-03 Rev. A
6-17
1
2
Cuvette position.
Preheater
Figure 6-11
078D0473-03 Rev. A
6-18
Figure 6-12
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.
078D0473-03 Rev. A
6-19
7. Turn the knob on the left bottom of the luminometer and listen for cuvettes
dropping into the waste bin.
Knob
Figure 6-13
Luminometer
8. If the cuvettes do not drop into the waste bin and the luminometer does not
turn, check for obstructions in the cuvette waste chute and clean the cuvette
waste chute.
9. Remove the black elevator cover by loosening the thumbscrew.
078D0473-03 Rev. A
6-20
10. If a cuvette dropped into the elevator as you were rotating the luminometer,
remove the cuvette.
Thumbscrew
Figure 6-14
Elevator Cover
11. Put your finger into the luminometer through the elevator and check for
evidence of fluid in the luminometer.
If your glove is wet, call for technical assistance.
12. Install the elevator cover, ensuring that the left side is flush with the edge of
the elevator.
13. Verify that the luminometer is operating correctly:
a. Select Turn System Mechanics On.
b. At the workspace, select System Status.
c. Select Diagnostic Tools.
d. At the System Diagnostic Tools window, select Home Luminometer.
WARNING
Ensure that you are clear of subassemblies that can move before selecting
Perform. The system moves subassemblies and can cause injury.
e. Select Perform.
f.
078D0473-03 Rev. A
6-21
g. Select Perform.
WARNING
Do not close the System Diagnostic Tools window until you are clear of
subassemblies that can move. The system returns subassemblies to their home
positions and can cause injury.
14. Close the System Diagnostic Tools window.
15. Install the reagent probes cover.
16. Close and secure the top cover.
17. Return to normal operation.
18. If the error persists, call for technical assistance.
Replacing Probes
This section contains procedures for replacing these probes:
ancillary probe
reagent probes
aspirate probe
waste probe
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.
078D0473-03 Rev. A
6-22
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
078D0473-03 Rev. A
6-23
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.
078D0473-03 Rev. A
6-24
4. Remove the reagent probes cover by lifting the cover up and then out.
Figure 6-16
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.
078D0473-03 Rev. A
6-25
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.
078D0473-03 Rev. A
6-26
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.
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.
Use care when working with the aspirate probe. The probe tips are sharp and can
cause skin punctures.
078D0473-03 Rev. A
6-27
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
078D0473-03 Rev. A
6-28
1
2
3
Figure 6-19
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.
078D0473-03 Rev. A
6-29
1
2
Probe clip
Aspirate probe
Figure 6-20
Wash Block
Ensure that you are clear of subassemblies that can move before selecting
Perform. The system moves subassemblies and can cause injury.
f.
Select Perform.
078D0473-03 Rev. A
6-30
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.
078D0473-03 Rev. A
6-31
Figure 6-21
078D0473-03 Rev. A
6-32
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
078D0473-03 Rev. A
6-33
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
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.
078D0473-03 Rev. A
6-34
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.
078D0473-03 Rev. A
6-35
f.
1
2
Figure 6-24
4. Twist the sleeve on the connector clockwise to tighten the new waste bottle
fluid sensor.
078D0473-03 Rev. A
6-36
5. Install the fluid sensor in the waste bottle and move the clamp to cover the
sensor.
Figure 6-25
078D0473-03 Rev. A
6-37
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
Figure 6-26
3
4
Pin
Inprocess queue
6. Lift the sample tip trays out of the sample tip loader.
7. Open the cuvette waste area door.
078D0473-03 Rev. A
6-38
Do not bend the latch while removing the jammed sample trays from the sample
tip loader. Bending the latch can cause more sample tip tray jams.
Latch
Figure 6-27
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.
078D0473-03 Rev. A
6-39
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:
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.
078D0473-03 Rev. A
6-40
Figure 6-28
078D0473-03 Rev. A
6-41
Troubleshooting Leaks
Use this procedure if you find substantial amounts of liquid in or around
the system.
BIOHAZARD
Figure 6-29
078D0473-03 Rev. A
6-42
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:
leaky valves
ancillary entry
Figure 6-30
078D0473-03 Rev. A
6-43
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.
078D0473-03 Rev. A
6-44
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
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.
Ensure that you are clear of subassemblies that can move before selecting
Perform. The system moves subassemblies and can cause injury.
078D0473-03 Rev. A
6-45
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.
simultaneously empty the cuvettes from the incubation ring and load the ring
with new cuvettes
test the operation of the cuvette pusher and cuvette loading bin
checks that the cuvette waste bin can accept another 115 cuvettes
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.
078D0473-03 Rev. A
6-46
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 you recover from a cuvette loading jam
cuvette conveyor moves to fill the vertical cuvette chute with cuvettes
078D0473-03 Rev. A
6-47
Ensure that you are clear of subassemblies that can move before selecting
Perform. The system moves subassemblies and can cause injury.
5. Select Perform.
6. Watch and listen as the cuvette conveyor moves.
The ionizer is also activated when the cuvette conveyor is operating. You
can verify that the ionizer is on by feeling for air blowing down under it as
the cuvette conveyor moves.
7. If the cuvettes are jamming, check the event log for related errors and then
correct the problem or call for technical assistance.
8. If the process completes successfully, close and secure the top cover and then
resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of
subassemblies that can move. The system returns subassemblies to their home
positions and can cause injury.
9. Close the System Diagnostic Tools window.
Dispense Test
Use this test to perform the following:
observe the integrity of the stream of water dispensed into the rinse station
by ancillary and reagent probes
078D0473-03 Rev. A
6-48
.
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.
078D0473-03 Rev. A
6-49
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
During this test, the reagent probe moves to the following positions:
homes vertically
This test does not home the reagent probe shutter or the reagent mixer.
During this test, the ancillary probe performs the following actions:
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.
078D0473-03 Rev. A
6-50
Ensure that you are clear of subassemblies that can move before selecting
Perform. The system moves subassemblies and can cause injury.
5. Select Perform.
6. Watch and listen as the reagent and ancillary probes move.
7. If the probes do not move correctly, check the event log for related errors
and then correct the problem or call for technical assistance.
8. If the process completes successfully, close and secure the top cover and then
resume normal operation.
WARNING
Do not close the System Diagnostic Tools window until you are clear of
subassemblies that can move. The system returns subassemblies to their home
positions and can cause injury.
9. Close the System Diagnostic Tools window.
Home Probe
Use this test to perform the following:
During this test, the sample probe moves to the following positions:
homes vertically
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.
078D0473-03 Rev. A
6-51
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.
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
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.
078D0473-03 Rev. A
6-52
b. Move the sample tip tray to the left to disengage the tray from the locking
pins.
1
2
Figure 6-32
3
4
Locking pin
Inprocess queue
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.
078D0473-03 Rev. A
6-53
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.
luminometer errors
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
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.
078D0473-03 Rev. A
6-54
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.
luminometer errors
turns vacuum and water on, but they are not used
During this test, the incubation ring and elevator are not used.
078D0473-03 Rev. A
6-55
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.
078D0473-03 Rev. A
6-56
RLUs higher than 600 may indicate a defective PMT, a wet or dirty
luminometer, electronic noise, or light leaks.
1
2
Figure 6-33
b. Find the Total Mean value that you obtained in the dark count test on the
x-axis and determine the corresponding Total SD specification limit from
the curve on the chart.
c. Verify that the Total SD value that you obtained in the dark count test is at
or below the Total SD specification limit.
For example, if the Total Mean value of the dark count test is 80,
according to the chart, the corresponding Total SD specification limit is
15.00. A Total SD value of 15.00 or less in the dark count test is within
specifications.
7. If the dark count test does not meet specifications, call for technical
assistance.
WARNING
Do not close the System Diagnostic Tools window until you are clear of
subassemblies that can move. The system returns subassemblies to their home
positions and can cause injury.
8. Close the System Diagnostic Tools window.
078D0473-03 Rev. A
6-57
Home Luminometer
Use this test to perform the following:
move the luminometer and its associated subsystem components into their
primary positions
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.
078D0473-03 Rev. A
6-58
Home Probes
Use this test to perform the following:
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.
078D0473-03 Rev. A
6-59
dispense and aspirate wash fluid from selected dispense ports and aspirate
probes
turns vacuum on
moves inprocess queue right so you can see the aspirate probes
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 selected aspirate probe,
if necessary
078D0473-03 Rev. A
6-60
NOTE: If the diluter drawer is not closed, the system does not prime the wash
station diluters correctly.
Diluter drawer
Figure 6-34
Diluter Drawer
2. Loosen the screw on the left side of the system that secures the top cover and
then open the top cover.
3. At the workspace, select System Status.
4. Select Diagnostic Tools.
5. Select Dispense Wash Fluid & Aspirate.
6. Select the dispense port and aspirate probe pair you want to test.
7. You can select the fluid you want the probe to dispense.
8. Select the number of times you want the selected probe to dispense the
selected fluid.
WARNING
Ensure that you are clear of subassemblies that can move before selecting
Perform. The system moves subassemblies and can cause injury.
9. Select Perform.
10. Watch the port dispense the fluid.
The stream should be straight and steady.
NOTE: Some dispense ports dispense fluid from 2 locations.
078D0473-03 Rev. A
1
2
6-61
Dispense port 1 dispenses from the right and left sides of aspirate probe 1.
Figure 6-35
Wash Block
078D0473-03 Rev. A
6-62
1
2
Dispense port 2 dispenses from the right and left sides of aspirate probe 2.
Figure 6-36
078D0473-03 Rev. A
Wash Block
1
2
6-63
Dispense port 3 dispenses from the right and left sides of aspirate probe 3.
Figure 6-37
Wash Block
078D0473-03 Rev. A
6-64
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.
Figure 6-38
Wash Block
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.
078D0473-03 Rev. A
6-65
cuvette loader
waste probe
elevator
luminometer
reagent mixer
sample probe
rack loader
stat pusher
078D0473-03 Rev. A
6-66
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.
rack loader
stat pusher
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
078D0473-03 Rev. A
6-67
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.
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.
078D0473-03 Rev. A
6-68
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.
inprocess queue
rack loader
stat pusher
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
078D0473-03 Rev. A
6-69
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.
ancillary queue
ancillary pusher
ancillary door
moves the next slot in the ancillary queue to the exit position
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.
078D0473-03 Rev. A
6-70
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.
078D0473-03 Rev. A
6-71
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.
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
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...
Routine.
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.
078D0473-03 Rev. A
6-72
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.
dispenses water from reagent and ancillary probes into their rinse stations
dispenses fluid into cuvettes for all dispense ports and fluids
indexes incubation ring and moves all used cuvettes to the elevator
078D0473-03 Rev. A
6-73
NOTE: If the diluter drawer is not closed (up), the system does not prime the
Diluter drawer
Figure 6-39
Diluter Drawer
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.
078D0473-03 Rev. A
6-74
turns on vacuum
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
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
Diluter drawer
Figure 6-40
Diluter Drawer
078D0473-03 Rev. A
6-75
Ensure that you are clear of subassemblies that can move before selecting
Perform. The system moves subassemblies and can cause injury.
8. Select Perform.
9. You can observe the diluters while the system is performing the test:
a. Access the area of the system where you suspect a problem:
To test the...
sample or ancillary
diluters,
1
2
Figure 6-41
078D0473-03 Rev. A
6-76
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
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.
078D0473-03 Rev. A
6-77
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.
078D0473-03 Rev. A
6-78
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.
078D0473-03 Rev. A
6-79
2. For the check digit option, at the Setup Tube Type & Barcode window,
select Disable.
3. Check the barcode scanner, cable, and port.
4. If the problem persists, call for technical assistance.
Never look directly at the laser beam or at its reflection from a shiny surface.
Looking directly at the laser beam or its reflection could cause damage to the
eyes. Only trained field service personnel should perform procedures related to
laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner
Lasers, for more information.
Use the following procedures to resolve problems with the sample barcode
scanner.
Do not allow racks to get stuck as they are loaded. If the rack hesitates or binds in
the input queue, the barcode scanner might not read all the sample barcode labels
in the rack or the rack label. If a rack gets stuck as it enters the inprocess queue,
remove the rack and then reload it.
4. Ensure that the sample racks load smoothly into the inprocess queue.
5. Ensure that the upright panel behind the sample entry queue is installed.
6. The panel prevents the barcode scanner from reading racks that are already
loaded in the inprocess queue.
7. If the problem persists, call for technical assistance.
078D0473-03 Rev. A
6-80
Do not remove, reposition, or clean the barcode scanner. These actions can
damage the scanner or cause additional problems.
1. Ensure that the sample barcodes do not have quality defects such as faded
or inconsistent print.
Refer to Barcode Quality page 6-85.
2. Ensure that the barcode labels are positioned correctly on the sample rack
and the sample tubes or cups.
3. Ensure that the information on the Setup Tube Type & Barcode window
is correct.
CAUTION
Do not press the sample start button until you close the primary reagent door and
ensure that all reagent barcodes were read correctly. Starting the system before all
reagent barcodes are read correctly can cause erroneous results. Closing the
primary reagent door allows the system barcode scanner to rescan the reagent
barcodes and acknowledge any changes.
4. Press the sample start button and then look for a red light reflection on the
rack as the scanner reads the barcode label.
1
2
5. If you cannot determine the cause, you can enter the SID at the Status Enter
SID window.
6. If the problem persists, call for technical assistance.
078D0473-03 Rev. A
6-81
Never look directly at the laser beam or at its reflection from a shiny surface.
Looking directly at the laser beam or its reflection could cause damage to the
eyes. Only trained field service personnel should perform procedures related to
laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner
Lasers, for more information.
Use the following procedure to resolve problems with the reagent barcode
scanner.
Do not remove, reposition, or clean the barcode scanner. These actions can
damage the scanner or cause additional problems.
When the system cannot read the primary pack barcode, the system displays the
Status Enter Primary Barcodes window. You can manually enter the barcode in
the appropriate field.
078D0473-03 Rev. A
6-82
To determine why the system could not read the barcode, use the following tips. If
the problem persists, contact your local technical support provider or distributor.
Ensure that the reagent packs are seated correctly on the reagent shelf in the
primary reagent compartment.
If only 1 pack is not being read, move it to another position in the primary
reagent compartment and then notify your field service representative.
Wipe off any condensation from the reagent pack labels and the reagent shelf.
If the barcode labels are not correctly placed on the reagent packs, call for
technical assistance.
Ensure that the reagent barcodes do not have quality defects such as faded
or inconsistent print.
Refer to Barcode Quality page 6-85.
Open and close the primary reagent door and then look for a red light
reflection on the back of the primary reagent compartment as the scanner
reads the barcode labels.
Ensure that the reagent barcode reader moves and that the reagent barcode
shutter opens.
1
2
3
Figure 6-43
078D0473-03 Rev. A
6-83
If you are unable to resolve the problem, manually enter the barcode at the
Never look directly at the laser beam or at its reflection from a shiny surface.
Looking directly at the laser beam or its reflection could cause damage to the
eyes. Only trained field service personnel should perform procedures related to
laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner
Lasers, for more information.
Use the following procedure to resolve problems with the ancillary barcode
scanner.
Do not remove, reposition, or clean the barcode scanner. These actions can
damage the scanner or cause additional problems.
When the system cannot read the ancillary pack barcode, the system displays the
Status Enter Ancillary Barcodes window. You can manually enter the barcode in
the appropriate field.
To determine why the system could not read the barcode, use the following tips. If
the problem persists, contact your local technical support provider or distributor.
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.
078D0473-03 Rev. A
6-84
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)
8.89
3.50
0.64
0.25
7.60
3.00
0.64
0.25
0.02
0.01
Barcode Color
Since barcode scanners read at a visible wavelength, the preferred background
color is white. The preferred print color of symbols is black. Use of other colors
can affect the ability of the system to read the barcode.
078D0473-03 Rev. A
6-85
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
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.
078D0473-03 Rev. A
6-86
The following table contains the quality components and factors causing scanning
problems:
Quality Components
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
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
078D0473-03 Rev. A
6-87
Barcode Positioning
Position the barcode vertically on the primary sample tube or sample cup,
approximately 2 cm (0.8 in) from the top. If the barcode label is twisted, the
barcode scanner might not read the label. Ensure that the labels are placed firmly
on the sample cup. It is recommended that you do not place more than 2 labels on
a primary sample tube or sample cup.
Figure 6-45
Sample Tube
Barcode Symbology
At the Setup Tube Type and Barcode window, select the appropriate
symbologies:
Codabar
Interleaved 2 of 5
Code 39
Code 128
Code 128 is the system default symbology and is always active since it is used for
all Siemens labels for sample racks, primary reagent packs, ancillary reagent
packs, calibrators, and controls.
If you specify a fixed-length value, the system recognizes only barcode labels
with the specified number of characters.
078D0473-03 Rev. A
6-88
If you specify a variable-length value, the system then reads and decodes all
labels in the active symbology, regardless of their length.
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:
078D0473-03 Rev. A
Enable
Disable
6-89
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:
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.
Character
Position
Reserved
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
078D0473-03 Rev. A
6-90
Then select...
All.
Events.
Errors.
Then...
Date.
related subsystems,
Subsystem.
Events.
Severity.
Then select. . .
All.
Events.
Errors.
Then . . .
Date.
related subsystems,
Subsystem.
Events.
Severity.
078D0473-03 Rev. A
6-91
Does the problem affect only patient samples, controls, or calibrators or does
it affect a combination of sample types?
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?
To help find a pattern or a trend, collect and print the following data:
calibration data
replicate CVs
078D0473-03 Rev. A
6-92
Defined ranges are specified for each lot at the time of reagent
manufacture.
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...
Ratio
Low Cal
Deviation
High Cal
Deviation
Yes
Yes
No
Yes
No
Yes
No
No
078D0473-03 Rev. A
6-93
Slope
Ratio
Low Cal
Deviation
High Cal
Deviation
No
No
No
No
If you cannot resolve the problem, load new reagent packs and calibrators and
then schedule another calibration at the Worklist Schedule window. If the
problem persists, call for technical assistance.
Ratio
Low Cal
Deviation
High Cal
Deviation
Yes
Yes
No
Yes
078D0473-03 Rev. A
6-94
Slope
Ratio
Low Cal
Deviation
High Cal
Deviation
Yes
Yes
No
No
No
Yes
No
No
No
No
No
No
If you cannot resolve the problem, load new reagent packs and calibrators and
then schedule another calibration at the Worklist Schedule window. If the
problem persists, call for technical assistance.
078D0473-03 Rev. A
6-95
Corrective Actions
1.
Incomplete calibrator
equilibration after
reconstitution
078D0473-03 Rev. A
6-96
Possible Cause
Corrective Actions
1.
1.
1.
078D0473-03 Rev. A
1.
Possible Cause
Corrective Actions
1.
Reagent evaporation or
spill due to loss of the
pack membrane or tears
in the pack membrane
Improper resuspension
of pierced reagent packs
6-97
078D0473-03 Rev. A
6-98
Discrepant QC Results
Possible Cause
Corrective Actions
1.
Incomplete control
equilibration after
reconstitution
078D0473-03 Rev. A
Possible Cause
Corrective Actions
1.
6-99
Check the control bottle for the expiration date, for the
stability
1.
1.
1.
078D0473-03 Rev. A
6-100
Possible Cause
Corrective Actions
1.
Reagent evaporation or
spill due to loss of the
pack membrane or tears
in the pack membrane
Improper resuspension
of pierced reagent packs
078D0473-03 Rev. A
6-101
Corrective Actions
Incorrect sample
collection, handling, or
preparation
1.
Incorrect patient
sample, the sample was
labeled with the wrong
patient ID
1.
1.
1.
2.
3.
4.
5.
6.
1.
078D0473-03 Rev. A
6-102
Possible Cause
Corrective Actions
1.
Reagent evaporation or
spill due to loss of the
pack membrane or tears
in the pack membrane
Incorrect resuspension
of pierced reagent packs
078D0473-03 Rev. A
6-103
Corrective Actions
1.
Reagent evaporation or
spill due to loss of the
pack membrane or tears
in the pack membrane
1.
2.
3.
4.
5.
6.
1.
078D0473-03 Rev. A
6-104
Possible Cause
Corrective Actions
Incorrect resuspension
of pierced reagent packs
1.
Corrective Actions
1.
078D0473-03 Rev. A
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
1.
1.
078D0473-03 Rev. A
6-106
Possible Cause
Corrective Actions
The integrity of 1 of
the system fluids was
compromised
1.
Maintenance procedures
were not performed
1.
1.
078D0473-03 Rev. A
6-107
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.
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.
078D0473-03 Rev. A
6-108
078D0473-03 Rev. A
7 Managing Data
Maintaining the Database . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Using the Status Maintenance Window . . . . . . . . . . . . . . . . . . 7-1
Editing Database Maintenance Settings. . . . . . . . . . . . . . . . . . . 7-1
Manually Initiating a Database Maintenance Activity. . . . . . . . . . . . .7-2
Defragmenting the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
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Managing Data
Data management includes the following functions:
Database maintenance
Exporting data
maintenance activities.
The ADVIA Centaur XP system maintains the database automatically by default.
You can edit the default settings for the automatic maintenance to make it better fit
the schedule of your workload. You can also manually perfom database
maintenance, when necessary.
When performing the database maintenance, the system deletes worklist entries
and associated results based on the parameters set at the Status Maintenance
Definition window. The system creates an archive of results data before deleting
them.
If you choose not to autoschedule the Archive data maintenance activity, the
system does not save the results to an archive before deleting them. Refer to
Saving Results Data to an Archive page 7-4
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Do not place the storage medium on the sample entry queue. The magnets under
the queue can erase the information on the storage medium.
6. Label the storage medium with the following information:
date
NOTE: You cannot restore data from 1 system on to another system.
Restoring Data
CAUTION
Do not perform the Restore function. Performing the Restore function incorrectly
can cause corruption of the system software. To avoid potential corruption of the
system software, only a trained technical support provider should perform the
Restore function at the Setup Data Administration window.
Restore data only when updating the system software.
To restore data, the system searches the storage devices for the most current back
up in the following order:
1. removable media (CD or DVD)
2. system local drive
The system stops the search when at least 1 backup is found. The system restores
the latest backup from that location.
maintenance activities.
The ADVIA Centaur XP system can save results data automatically to an archive
according to the maintenance settings in the Status Maintenance Definition
window. You can also chose to save the data manually to an archive or chose not
to save your results data. You can use your local drive, a CD or a DVD to save
files to an archive.
Records that you save to an archive are not deleted until the system performs a
database maintenance activity. Refer to Maintaining the Database page 7-1
The results data archive is in a format compatible with Microsoft Excel or similar
spreadsheet application. Refer to Archived Data page 7-5.
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If you edit a record that is already saved to an archive, the edited record and
all records in that worklist are saved again at a future automatic or manual
archive maintenance activity.
If you edit an component test of a ratio that is already stored in an archive, the
ratio test and its component test are saved to an archive at a future automatic
or manual archive maintenance activity.
Control-bracketed tests are only eligible for an archive after the system
releases them.
The system does not save control-bracketed tests that are waiting for
controls.
The system does not save control-bracketed tests with discarded results.
Archived Data
This table displays the field name and field format that is displayed in the archive
spreadsheet. Explanatory comments are included, where necessary.
The field name is the column head of the spreadsheet and the field format is how
the data is displayed. Data is sorted in the spreadsheet in ascending order by the
SID with a secondary sort on the Result Date and Time.
Autoscheduled archive files and archives created by selecting Archive All on the
StatusArchive Options window are named using the following format:
A_RA_<system serial number>_<date><time>
Field Name
Field Format
Comment
SID
Alphanumeric;
maximum of 13 characters
Rack
Alphanumeric;
5 characters
DD MMM YY HH:MM
Patient Name
PID
Alphanumeric;
11 characters maximum
Sex
M, F, or U
Test Name
Alphanumeric;
8 characters maximum
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Field Name
Field Format
Comment
Dilution Protocol
Neat only
Neat and diluted
Dilute if over
Dilute only
Dilution profile
Manual Dilution
Alphanumeric;
6 characters maximum
System Dilution
Alphanumeric;
6 characters maximum
Replicate Number
Numeric
2 digits, maximum
Result Aspect
Alpha, 4 characters
maximum
INTR
DOSE
INDX
COFF
RLU
CLSS (Allergy Class)
Data Value
Alphanumeric;
15 characters maximum
Results data
Units
Printable ASCII;
10 characters maximum
F or P
Alpha
Normal Ranges
Name: Alphanumeric,
Low and High Limits:
Numeric, 7 characters,
a decimal delimiter,
and the number of decimal
places defined for this
system
Example:
Name of range: Male
Low Limit: 123.4
High Limit: 1234567.8
L, H, <, >
CV
Numeric
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Field Name
Field Format
Comment
Numeric
Numeric
Control Lot
Alphanumeric
Calibrator Lot
Alphanumeric
Control Name
Alphanumeric;
11 characters maximum
Calibrator Name
Alphanumeric
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NOTE: For autoschedule archives, you must ensure that the selected storage
device is in place for the scheduled archive event.
Starting on: Select the day of the week for the start of the archive event.
The default is Sunday.
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to perform an archive when the system does not perform an automatic archive
on schedule
Date-defined Archive
This saves a specific date range of available result data to an archive using the
date range entered into the Status Archive Options window.
Archive All
Archives all result data that was not previously saved to an archive during an
autoscheduled archive activity.
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4. Select Continue.
Do not place the storage medium on the sample entry queue. The magnets under
the queue can erase the information on the storage medium.
You can export test utilization data to a CD or DVD. The system exports it in a
spreadsheet compatible format. The system exports test utilization data in the
following order:
test name assigned by the manufacturer
calibrator product code
number of patient orders
number of calibrators
number of controls
number of total tests used.
The first record of the file contains the system serial number and the date and time
that you performed the export activity.
The system separates each area by tabs and writes the exported data to the file
assay.csv. If the data exceeds the size of the CD or DVD, the system notifies you
and does not export the data. If this happens, you can reduce the time interval
between the starting date and ending date and then export the data again.
NOTE: You must have the appropriate level of security to export data.
5. Select Export.
6. At the Setup Data Administration Options window, select the starting date
and ending date.
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The default for the starting date is 30 days before the current date and
time.
The default for the ending date is the current date and time.
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7. Select Continue.
To view the exported data, set up the following options in the spreadsheet
program:
Format the column width to display the data and time correctly, if required.
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Do not customize options without ensuring that you select the appropriate value
for your laboratory and continuing to evaluate the integrity of that value. Failure
to do so can cause reporting of unexpected results. For example, if you configure
the system to send all results and additional data except results on hold to your
LIS, and the LIS is not configured to accept the information, the LIS may identify
the additional data inappropriately and fail to distinguish between the final results
and the additional data.
Your laboratory is responsible for ensuring that all configurations are correct:
sample options, test parameters, and system options. This is true regardless of
whether your lab personnel set the values,
Siemens Medical Solutions Diagnostics personnel set the values to specifications
your laboratory provides, or Siemens Medical Solutions Diagnostics personnel set
the values to the original default values established at the time of manufacture.
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Then . . .
5. Select Save.
Then . . .
5. Select Save.
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Then...
receives an occasional
Stat request,
frequently receives
several Stat requests
at a time,
5. Select Save.
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SID means the system identifies samples by the sample barcodes that you
place on the sample tubes or cups.
1
2
Rack ID
Tube positions A, B, C, D, and E
Figure 8-1
CAUTION
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Barcode window before you reboot the system. If you do not make all of the
changes, you must reboot the system more than 1 time.
6. Reboot the system.
You can specify up to 3 specific types of sample tubes to use on the system or you
can use multiple tube types. Refer to Tube Types page E-2.
1. At the workspace, select Setup.
2. Select Summary.
3. At the Setup Summary window, select Tube Type & Barcode.
CAUTION
Do not move the tube type selector without verifying the tube type you are using.
Ensure that the tube type selector on each sample rack points to the correct tube
type as defined at this window. If the tube type selector points to an incorrect tube
type, the system can experience problems with sample handling and system errors
can result.
4. At the Setup Tube Type & Barcode window, use Tube Types 2, 3, and 4 to
select up to 3 types of sample tubes.
The ADVIA Centaur XP system reserves Tube Type 1 for multiple tube types.
Regardless of what you enter here, if the tube-type selector is in position A,
the rack allows multiple tube types. If you use an ADVIA Centaur rack, you
must select a tube type in Tube Type 1.
When you load samples, use the tube type selector on the rack to indicate
the tube type you are loading. Place the tube-type selector in position A for
multiple tube types. Refer to Managing Sample Racks page 2-2.
5. In the LAS Tube Type field, select the tube type you want to use when no tube
type is specified in the LAS.
The default is Auto, meaning it allows multiple tube types.
6. Select Save.
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NOTE: Ensure that you make all of the changes to the Setup Tube Type &
Barcode window before you reboot the system. If you do not make all of the
changes, you must reboot the system more than 1 time.
Codabar
Interleaved 2 of 5
Code 39
Code 128.
Code 128 is always active. For most symbologies, you can choose the format, the
use of check digits, and the use of SID mapping.
Refer to Resolving Barcode Problems page 6-78.
1. At the workspace, select Setup.
2. Select Summary.
3. At the Setup Summary window, select Tube Type & Barcode.
NOTE: If you are using Code 128, you must exclude the ASCII characters
ESC, Bell, and CR (Return) from your barcode labels because the system
reserves these for use in the calibrator and control barcode labels.
4. At the Setup Tube Type & Barcode window, select a barcode symbology.
5. Select Fixed or Variable in Type.
If you select Fixed, select the number of characters in your SID barcode label,
not including the check digit.
6. Select the number of characters for a barcode of fixed length.
NOTE: Select Enable for the check digit for Code 128. Code 128 is the
barcode symbology for the Master Curve Card, Calibrator Card, and
calibrators.
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system generates an event code when you load a patient sample with a barcode.
Without SID mapping information, the system cannot interpret the patient sample
barcode or process the sample.
The ADVIA Centaur XP system accepts barcodes with a maximum length of
20 characters. However, the system accepts SID codes with a maximum length of
13 characters. If the SID code is embedded in a longer barcode, you can use the
SID mapping procedure to specify up to 13 characters of the barcode for use. The
SID mapping procedure affects only patient sample barcode labels. This
procedure does not affect the barcode labels for calibrators or Siemens QC
controls.
1. At the workspace, select Setup.
2. Select Summary.
3. At the Setup Summary window, select Tube Type & Barcode.
CAUTION
Use care when entering the SID mapping information. The system uses only the
characters specified in this procedure as patient sample SID codes.
NOTE: You can select a position of the barcode only once.
4. Enter the barcode positions that you want to use starting with the 1 position
field at the bottom of the window.
To map the SID, select up to 13 positions of the barcode to display as the 13
characters of the SID in the worklist. You can select the positions to display in
any order. For example, if you select the number 6 in the third position,
whatever is in the sixth position in the barcode displays in the third position in
the SID.
For positions you do not want to display, select a number greater than the
number of positions in the longest barcode. For example, if you have a
6-character barcode and you want to display the last 3 characters as the SID,
select 4, 5, and 6 for the 1, 2, and 3 position fields, and then select a number
greater than 6 for the 4 through 13 position fields.
If the 6-character barcode is as follows:
ABCDEF
The system reads the following SID code:
DEF
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You can select some symbols to display as characters in the SID, for example
+, -, /, *, #. The symbols display in the specified positions for all SIDs. Do not
select the % symbol because the system does not accept a % symbol in the
SID.
5. Select Save.
NOTE: Ensure that you make all of the changes to the Setup Tube Type &
Barcode window before you reboot the system. If you do not make all of the
changes at 1 time, you must reboot the system each time you make changes.
6. Reboot the system.
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4. At the Setup Sample Handling Options window, enter or edit the number
of hours for the interval used by the system to automatically move the results
from the current database to the historical database.
The number of hours must be a factor of 24 (1, 2, 3, 4, 6, 8, 12, or 24).
The time interval starts at midnight.
5. Select Save.
The system moves data to the historical database in the approximate time
interval that you specify, depending on when testing for the samples is
completed.
Reviewing Tests
At the Test Summary window, you can review the tests defined on your system.
Use this window to edit the test definitions, enable or disable tests, and add or
delete ratio and off-system tests.
1. At the workspace, select Setup.
2. Select Test Definition Summary.
Select Display Order to define the order in which tests are displayed and
printed.
Select the appropriate View and Type to display specific information at the
Test Summary window:
The View that you select determines the information that the system displays.
For example, if you select All, the system displays all tests.
The Type that you select determines the order in which the system displays
the tests.
For example, if you select All, the system displays all tests in alphabetical
order.
The following table describes the View and Type combinations you can use to
perform some routine tasks:
Task
View
Type
All
All
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Task
View
Type
Enabled
All
Disabled
All
All
Enabled
Disabled
Definition
All
Standard
Ratio
Off-System
Combination
Component
Allergen
sIgE Universal
The Lite Reagent and Solid Phase the system uses in all of the
specific IgE tests. The sytem uses the sIgE universal reagents and
an allergen reagent to process a specific IgE test.
Enabling a Test
An enabled test is included in the test menu displayed at the ADVIA Centaur XP
windows and the system performs the test if it is scheduled.
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When you enable a test, you do not have to perform the following tasks:
NOTE: If your laboratory wants to enable the HBs or Conf test, ensure that you
turn system mechanics off, turn system mechanics on, and then perform a Daily
Cleaning Procedure after enabling the test.
Disabling a Test
NOTE: You cannot disable tests that are part of a combination test, ratio test,
profile, or sIgE universal test.
NOTE: If you schedule the test before disabling it, the disabled test is displayed at
the Worklist Summary window.
WARNING
1. Ensure you delete all pending orders for the test before disabling it.
Refer to Deleting Requests page 2-61.
2. At the workspace, select Setup.
3. Select Test Definition Summary.
4. At the Test Summary window, select the test.
NOTE: Disable HBs if your laboratory does not use it. If you are disabling
Conf, also select Reagent A and Reagent B.
5. Select Disable.
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NOTE: Turning system mechanics off and then turning system mechanics on
ensures that the HBs test is disabled.
turn system mechanics off, turn system mechanics on, and then perform the
DCP after enabling the test. If you are enabling Conf, enable Reagent A and
Reagent B also.
Deleting a Test
Deleting a test permanently removes it from the test menu and permanently
removes any results associated with the test from the database. You can only
delete tests that are defined by your laboratory, such as ratio or off-system tests.
1. At the workspace, select Setup.
2. Select Test Definition Summary.
3. At the Test Summary window, select a test.
a. Select Test.
The TestSelection window displays.
b. Select a test.
c. Select Continue to close the TestSelection window.
4. Complete the appropriate tasks.
If you want to . . .
Then select . . .
Disable.
Enable.
Delete.
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Do not select the Reset Defaults button at the Test Definition window. Selecting
this button restores the original options the manufacturer defined and removes any
options that your laboratory defined or modified. This global change can have
unexpected consequences for your laboratory and, in some instances, creates an
unrecoverable error. To change your test definition, refer to Modifying or
Viewing Test Options page 8-9.
6. Change the test name information from the default test name, if necessary:
a. At Display, enter the test name that you want the system to display.
You can enter up to 8 alphanumeric characters for the name the system
displays.
b. At Print, enter the test name that you want to appear on printed reports.
You can enter up to 20 alphanumeric characters for the name the system
displays on printed reports.
7. Select Save.
If you want to restore the original system values for all options at this window,
select Reset Defaults.
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Then . . .
6. Select Save.
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Then . . .
9. Select Continue.
10. At the Test Definition window, select Save.
limits for a retained calibration in Retained Cal Limits are established at the
time of manufacture.
If you want to . . .
Then . . .
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If you want to . . .
Then . . .
9. Select Continue.
10. At the Test Definition window, select Save.
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6. View the Control Levels field for the number of control levels required for
each start-of-bracket or end-of-bracket control set when the
control-bracketing feature is activated for the test.
Your local technical support provider can edit the field for a test that has
control bracketing capability, provided the value is between 1 and 5,
inclusive.
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7. View the Control Warning field for the maximum allowable time in hours
between the start and end-of-bracket controls, as defined by
Siemens Medical Solutions Diagnostics.
When the system issues the Control Warning, you must process the
end-of-bracket controls immediately or any retained patient test results are
discarded.
Then . . .
enter 0.
Refer to Using Control-bracketed Tests page 2-58 or consult the index under
Control Bracketing.
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Then . . .
the gender,
NOTE: If you select Reset Defaults, the system resets all options at the Test
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8. Reset all the parameters and ranges to the original values, if necessary:
a. Select Reset Defaults.
b. Select All.
9. If required, define reflex tests for test results that are outside the reference
ranges.
Refer to Defining Reflex Tests for Reference Ranges page 8-23.
10. Select Save.
Select the button at the lower left of the window if you want to review
results before releasing them to an LIS.
In the first field at the bottom of the window, the system displays
Predefined if the manufacturer defined the information and Operator if
you defined the information.
NOTE: You cannot edit the interpretation names and ranges that the
manufacturer predefined.
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reflex test or profile is on the system. Refer to Defining Test Profiles page 8-36.
NOTE: The system performs a reflex test automatically if the sample is still in
the inprocess queue when the system receives the request. If the system ejects the
sample before it receives the request, the reflex test remains pending until you
reload the sample.
NOTE: If both automatic repeat tests and reflex tests are defined for a test, and a
result meets the criteria defined for both, the system does not process the reflex
test based on the initial result. The system repeats the test with the defined number
of replicates and if any of the repeat replicates meet the reflex criteria, the reflex
test is performed. The system does not perform the reflex test if none of the repeat
replicates have a result that meets the reflex criteria.
For example, the system handles reflex confirmatory tests for a reactive Hepatitis
B surface Antigen test (HBsAg) in the manner described below.
The recommended protocol for performing the HBsAg test is as follows:
1. Perform the HBsAg test.
2. If the result is reactive, repeat the test in replicates of 2 or more.
3. If 1 or more of the repeat replicates has a reactive result, perform the HBsAg
confirmatory test.
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Then . . .
Select the test you want the system to schedule if the result is less than the
low limit.
Select the test you want the system to schedule if the result is greater than
the high limit.
8. Select Continue.
9. At the Test Ranges window, select Save.
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Then . . .
a reflex test.
10. To add the reflex test information to the table, select Add Row .
11. Select Continue.
12. At the Test Definition window, select Save.
You can define the result ranges that you want to repeat, such as samples
outside the check range or linearity, or samples outside the concentration
calculation range or index calculation range on the Master Curve card.
You can define the number of replicates for an automatically repeated test.
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You can select whether you want to hold samples in the inprocess queue
for repeat tests and the types of samples you want to hold.
If you select . . .
Then . . .
both automatic
repeat and hold
options,
automatic repeat
options and do not
select hold
options,
range.
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Then . . .
Then . . .
NOTE: If you select Reset Defaults, the system resets all options at the
Test Ranges window in addition to the check range and linearity options.
10. You can reset the ranges at the Test Ranges window to the original values:
a. Select Reset Defaults.
b. Select Ranges.
11. You can reset all options and ranges at the Test Ranges window to the
original values:
a. Select Reset Defaults.
b. Select All.
12. Select Save.
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6. Define whether you want the system to repeat tests outside the concentration
or index calculation range on the Master Curve card:
If you want the system to . . .
Then select . . .
NOTE: If you select Reset Defaults, the system resets all options at the
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5. Select Save.
Then . . .
NOTE: If you are manually scheduling a repeat test, the field at the Test Ranges
window does not apply. To manually schedule a repeat test, change the number of
replicates at the Worklist Reagent Options window, as described in Manually
Scheduling Samples page 2-48.
Use this procedure to define the number of replicates for samples processed in
automatically repeated tests.
1. At the workspace, select Setup.
2. Select Test Definition Summary.
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At the Setup Sample Handling Options window, select the sample types that
you want the system to hold.
The system holds the selected sample types in the inprocess queue only if you
also select the Hold Sample for Repeat option at the Test Definition
window. If you deselect a sample type, the system does not hold that type of
sample even if you select the Hold Sample for Repeat option at the Test
Definition window.
At the Test Definition window for each test that requires automatic repeats,
select Hold Sample for Repeat.
For each test with this option selected, the system holds only the sample types
selected at the Setup Sample Handling Options window.
NOTE: The system holds a sample for only 1 repeat test. If you need to repeat
a test on a sample 2 times, you must manually reload the sample for the
second repeat test even if you select the hold options. The system
automatically ejects samples after repeat tests are aspirated.
Define the sample types that you want to hold in the inprocess queue:
1. At the workspace, select Setup.
2. Select Summary.
3. At the Setup Summary window, select Sample Handling.
4. In Hold Samples for Repeats & Reflex Tests, select each sample type that
you want the system to hold in the inprocess queue for additional testing.
5. Select Save.
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Select the Hold Sample for Repeat option for each test:
1. At the workspace, select Setup.
2. Select Test Definition Summary.
3. At the Test Summary window, select a test.
a. Select Test.
The TestSelection window displays.
b. Select a test.
c. Select Continue to close the TestSelection window.
4. Select Definition.
5. At the Test Definition window, select Edit.
6. Select Hold Sample for Repeat.
This holds samples in the inprocess queue for additional testing based on the
repeat criteria you defined at the Test Ranges window.
7. Select Save.
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NOTE: The Dilution Point, Dilution, or Overdilution Point field may not be
available depending on the displayed test.
NOTE: If you define a Dilution Point, you must also define a Dilution and
Overdilution Point. If a you do not define a Dilution, the system does not have
enough information to automatically dilute a sample. If you do not define an
Overdilution Point, the system does not have enough information to check the
diluted result.
6. In Dilution Point, enter the concentration above which you want the system to
perform an automatic dilution.
If the result is above the concentration limit that you enter in this field, the
system flags the test result and automatically schedules a dilution.
7. In Dilution, select the dilution factor.
8. In Overdilution Point, if it is not defined, enter the concentration below which
you do not want the system to determine a result for the specific dilution.
The Overdilution Point should be equal to the Low Limit of the Linearity
range specified at the Test Ranges window. If no Low Limit is defined, the
Overdilution Point should be equal to the sensitivity limit of the assay, as
reported in the product instruction in the ADVIA Centaur Assay Manual.
The Overdilution Point provides an indication that the system should have
diluted the sample at a lower level or not at all. The system compares the
uncorrected diluted concentration to the value displayed in Overdilution
Point. If the concentration is below the Overdilution Point, the system does
not report a result for the sample.
For example, if the Overdilution Point for ThCG is 5.0 mIU/mL (IU/L) and
the uncorrected result is 4.5 mIU/mL (IU/L) on a sample diluted 1:200, the
system does not determine a result for the sample because the concentration
is below the specified concentration. The system flags the test result and does
not schedule or repeat the test. To obtain a result, you can process the sample
undiluted or diluted at a lower level, such as 1:5.
NOTE: If you select Reset Defaults, the system resets all options at the Test
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Then . . .
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When you request a ratio test, the system automatically schedules all tests defined
as part of the ratio. If you request a ratio test and also request a test that is part of
the ratio test, the system performs the test twice. One result is used in the
calculation of the ratio test and the other result is reported independently.
NOTE: When you edit an element of a ratio test, the system automatically
recalculates the ratio test result and reports the result with an Edited flag.
Then . . .
a.
a.
b. Select Definition.
c.
Then . . .
select Hold.
NOTE: Use the formula displayed at the Test Ratio Definition window to
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Then . . .
a.
Select Tests from the list in the first field under the
appropriate variable.
a.
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Then . . .
a.
a.
b. Select Definition.
c.
Then . . .
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5. Select Save.
Then . . .
a.
Select a profile.
078D0473-03 Rev. A
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Then . . .
select Move.
The test changes positions with the test in
the target position.
select Insert.
The test is inserted before the target
position.
8. Select Save.
Select the Print Options button to specify the printer, the paper size, the
automatic runtime results report options, and the report heading.
Select the Alarms button to define when you want the alarm to sound, the
volume of the alarm, and the type of sound.
Select the Additional Options button to define several options, including the
system name, time, screen saver options, pointing device options, reagent
warning counts, and water and waste options.
078D0473-03 Rev. A
8-38
Defining Alarms
You can define alarms for Message Boxes, and Warning or Failure conditions.
Refer to Monitoring Status page 2-9.
1. At the workspace, select Setup.
2. Select Summary.
3. At the Setup Summary window, select Alarms.
4. At the Setup Alarms window, select Message Box, Warning, or Failure.
5. Select Alarm On or Alarm Off.
078D0473-03 Rev. A
8-39
078D0473-03 Rev. A
8-40
078D0473-03 Rev. A
8-41
4. At the Setup Additional Options window, enter the time correction for the
system clock:
If you are entering a . . .
Then . . .
a.
b. Select Save.
c.
5. Select Save.
The system gradually adjusts the time on the system clock according to the
number of seconds that you entered in the Time Correction field. It can take
3 hours or longer for a correction of 10 minutes.
NOTE: Do not reboot after entering a time correction until the system
078D0473-03 Rev. A
8-42
2. Select Summary.
3. At the Setup Summary window, select Print Options.
4. At the Setup Print Options window, select the appropriate printer and
paper size.
5. You can print an automatic runtime results report, which is a report of all
sample results as the results are being generated:
a. Select Automatic Runtime Results Report.
b. Enter the interval in hours at which you want page numbering to reset to 1
in Reset Page Numbering.
c. Enter the number of full pages of results to print at 1 time in Page
Interval.
6. If applicable, you can enter the customer number assigned to you by QC
Online.
7. You can enter the laboratory information you want to appear on printed
reports
8. Select Save.
078D0473-03 Rev. A
8-43
Prompt
If you select Prompt, when a software update is available for download, the
system displays the Software Update Available window. In the Software
Update Available window, you can respond with 1 of the following actions:
Continue
If you select Continue, the system proceeds immediately with the software
update. Only select this option when the system is not inprocess.
Cancel
If you select Cancel, the system cancels the update.
Later
If you enter a date and timeMMM yy hh:mmand select Later, the system
schedules the update for a later time.
Proceed
If you select Proceed, the system automatically performs the software update
as soon as it is remotely initiated.
The system only performs an update when it is in an appropriate state. The
system enters the attempt into the event log and it makes no further attempts
to complete the software update. When you cannot update the software
automatically, you can update it using the RealTime Solutions service.
Deny
You can select Deny to prevent all remote updates. The system logs the
availability of new software.
The system can perform a remote update if it is in any of the following states:
Ready
Warming up
Mechanics off
Check Status
078D0473-03 Rev. A
8-44
Inprocess
Restricted
Cleaning
Failed Cleaning
Diagnostics
Then select . . .
headings.
5. Select Save.
078D0473-03 Rev. A
8-45
3. Select Setup.
4. In the Target Backup/Archive Device drop-down list, select the device you
want to use for backing up data, restoring data, or storing your archive.
5. If you are using the RealTime Solutions service, select Access to Server.
You must select this option to enable the other backup/archive options.
6. Select each option that your laboratory uses:
If you want to . . .
Then select . . .
Logfiles to Server.
7. In Time of Day, enter the time of day for the system to send files to the
RealTime Solutions service.
Specify time in a 4-digit, 24-hour format HHMM. For example: 0130 is 1:30
a.m. and 1330 is 1:30 p.m.
8. Select Save.
078D0473-03 Rev. A
8-46
Then select . . .
078D0473-03 Rev. A
8-47
Then select . . .
6. Select Save.
NOTE: If you modified the Setup LIS Communications window on your
ADVIA Centaur XP system, turn system mechanics off and then turn system
mechanics on. This procedure ensures that the LIS option is updated.
7. At the workspace, select System Status.
8. Select Turn System Mechanics Off.
NOTE: The Turn System Mechanics On option is not available until the
Then select . . .
LAS.
the system to save and log messages from the LAS so you can
view the messages at the System Communication Log window,
Data Capture.
078D0473-03 Rev. A
8-48
Then select . . .
Handshaking.
No Response Timeout,
No Supplies Timeout,
No Request Timeout,
7. Select Save.
078D0473-03 Rev. A
needlesticks
hand-to-mouth contact
hand-to-eye contact
direct contact with superficial cuts, open wounds, and other skin conditions
that may permit absorption into subcutaneous skin layers
078D0473-03 Rev. A
A-2
Wear gloves while servicing parts of the instrument that have contact with
body fluids such as serum, plasma, urine, or whole blood.
Wear personal protective equipment such as safety glasses, gloves, lab coats
or aprons when working with possible biohazard contaminants.
Cover all superficial cuts and wounds before starting any work.
Disinfect tools and other items that have been near any part of the instrument
sample path or waste area with 10% v/v bleach.
Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the
laboratory.
Do not use the biohazard sink for personal cleaning such as rinsing coffee
cups or washing hands.
References
1. Centers for Disease Control. 1988. Update: Universal precautions for
prevention of transmission of human immunodeficiency virus, hepatitis B
virus and other bloodborne pathogens in healthcare settings. MMWR,
37:377382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline - Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4].
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA, 2005).
3. Federal Occupational Safety and Health Administration. Bloodborne
Pathogens Standard. 29 CFR 1910. 1030.
078D0473-03 Rev. A
A-3
laserclass1
.
Figure A-1
Some field service procedures require the removal of the protective housings that
prevent human access to the laser radiation. The removal of the protective
housings may change the classification of the system to CDRH Class 2 and
EN60825-1 Class 2. All field service procedures must be followed precisely. Only
Siemens-trained field service personnel should perform procedures related to laser
assemblies.
Figure A-2
078D0473-03 Rev. A
A-4
Never look directly at the laser beam or at its reflection from a shiny surface.
Looking directly at the laser beam or its reflection could cause damage to the
eyes. Only trained field service personnel should perform procedures related to
laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner
Lasers, for more information.
The specifications for the laser optical assemblies in the ADVIA Centaur XP
ancillary reagent, primary reagent, and sample barcode scanners are summarized
in the following table:
Characteristic
Specification
1.0 mW
Wavelength
670 nm
Pulse Duration
0.7 mr
The locations of the reagent and sample barcode scanners and their associated
laser safety labels are shown below. The laser apertures for the sample and
ancillary reagent barcode scanners are directed into the system away from the
operator.
During normal operation, reflections from the sample barcode scanner laser beam
may be visible to persons in the immediate area, but no laser safety hazard is
associated with this exposure. The laser aperture for the primary reagent barcode
scanner is directed toward the barcode labels at the end of the reagent packs inside
the primary reagent compartment.
078D0473-03 Rev. A
A-5
During normal operation, the barcode scanner does not scan the reagent packs
until the primary reagent compartment door is closed. When the primary reagent
compartment door is closed, no operator exposure to the laser exists.
1
2
3
Figure A-3
Never look directly at the beam of a hand-held barcode scanner or point the
scanner at another person. Also, do not look at the reflection of the beam from a
shiny surface. Only trained field service personnel should perform procedures
related to laser assemblies. For more information about laser safety, refer to
Appendix A, Protecting Yourself from Barcode Scanner Lasers.
078D0473-03 Rev. A
A-6
This table contains a summary of the specifications for the laser optical assembly
in the ADVIA Centaur XP hand-held barcode scanner:
Characteristic
Specification
1.0 mW
Wavelength
650 nm
Pulse Duration
7.4 ms
2mr
The laser aperture and laser safety label for the hand-held barcode scanner are on
the other side of the barcode scanner window:
Hand-Held3
Figure A-4
078D0473-03 Rev. A
addresses for obtaining service and technical information and for ordering
supplies
Warranty Period
The limited warranty period generally commences upon installation of the
original instrument at the customers location and extends for a period of 1 year
thereafter, unless otherwise specifically agreed to by and between
Siemens Medical Solutions Diagnostics (or its authorized distributors) and
customer in a writing signed by duly authorized representatives of both parties
(sales representatives are generally not authorized representatives of Siemens for
these purposes).
078D0473-03 Rev. A
B-2
Replacement of Parts
In performing service, Siemens Medical Solutions Diagnostics or its authorized
distributors provide appropriate parts to repair the instrument, or arranges for the
exchange of the instrument or affected parts, at no charge with the exception of
certain parts or subassemblies that are considered Customer Maintenance Items.
Customer Maintenance Items include, but are not limited to, the following items:
lamps, electrodes or sensors (which are covered by a separate warranty), reagents,
calibrators, controls, paper, and pens. Consult the appropriate system operators
manuals for a complete list of Customer Maintenance Items for any specific
model of instrument.
078D0473-03 Rev. A
B-3
078D0473-03 Rev. A
B-4
078D0473-03 Rev. A
B-5
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
Events
Date
Errors
Severity
Events
Subsystem
078D0473-03 Rev. A
B-6
3. Select Print.
4. Select Print Workspace.
Contacts
This section provides the following information:
the Siemens addresses for obtaining service and technical information and for
ordering supplies
078D0473-03 Rev. A
B-7
Addresses
For technical assistance contact your local technical support provider. For
customer service or additional information contact your local technical support
distributor.
078D0473-03 Rev. A
B-8
078D0473-03 Rev. A
Unpierced
Pierce
Unpierced
Pierced
WARNING
Unpierced
For all other assays, use this procedure if the primary reagent pack is unpierced.
1. With the film side up, hold the reagent pack loosely at the ends with the
thumb and index or middle finger of each hand.
2. Carefully raise 1 end of the pack 90 so that the pack is in a vertical position.
078D0473-03 Rev. A
C-2
3. Carefully raise the other end of the pack 90 so that the pack is again in a
vertical position. Carefully return the pack to a horizontal position.
4. Repeat steps 2 and 3 a minimum of twenty times or until:
the pellet is broken up and no longer visible on the bottom of the pack
Pierced
Use this procedure if the primary reagent pack is pierced.
1. Press gently on the self-sealing laboratory film that covers the pierced film
area while mixing.
This prevents reagent leakage.
2. With the film side up, hold the reagent pack loosely at the ends with the
thumb and middle finger of each hand.
3. From a horizontal position, carefully raise 1 end of the pack 45 and carefully
return the pack to a horizontal position.
4. Carefully raise the other end of the pack 45 and carefully return the pack to a
horizontal position.
5. Repeat steps 3 and 4 a minimum of twenty times or until 1 of the following
actions is true:
the pellet is broken up and no longer visible on the bottom of the pack.
078D0473-03 Rev. A
C-3
When testing is complete you may remove the reagents from the system or leave
them on the system. If you remove the reagents, cover the pierced film area of the
primary reagent pack with self-sealing laboratory film and place the pack in the
reagent storage tray at 2 to 8C. Store pierced primary reagent packs upright in
the storage tray to minimize spillage. Follow the pierced primary reagent pack
procedure before placing the reagent pack back on the system. Reagents left on a
system with the power on are automatically mixed by the system and do not
require further mixing.
NOTE: If reagent mixing is turned off for longer than 2 hours but reagent
refrigeration remains on, mix all primary reagent packs following the unpierced/
pierced primary reagent pack procedures and place the reagent packs back on the
system. Verify reagent performance based on acceptable quality control results or
by criteria established for your laboratory.
If both reagent mixing and reagent refrigeration are turned off for longer than 2
hours, put the primary reagent packs in the reagent storage tray at 2 to 8C. Mix
all primary reagent packs following the unpierced/pierced primary reagent pack
procedures before placing the reagent packs back on the system. Verify reagent
performance based on acceptable quality control results or by criteria established
for your laboratory.
NOTE: The onboard stability of a primary reagent pack is calculated from the
time that the system reads the barcode after the reagent pack is placed on the
system for the first time. If a pack is removed from the system, it is recommended
that you reload the pack onto the same system. If you load the reagent pack onto a
different system, you must track onboard stability and you must adjust reagent test
inventory to account for tests previously removed from the pierced reagent pack
while on the other system.
Unpierced
Gently invert ancillary reagent packs several times before loading them into the
ancillary queue. It is important to minimize foaming. Do not shake the ancillary
reagent pack.
When testing is complete you may remove the reagents from the system or leave
them on the system. If you remove the reagents, cover the pierced film area of the
ancillary reagent pack with self-sealing laboratory film and store the pack at 2 to
8C. Store pierced ancillary reagent packs upright to minimize spillage. Follow
the pierced ancillary reagent pack procedure before placing the reagent pack back
on the system.
078D0473-03 Rev. A
C-4
Pierced
Use this procedure if the ancillary reagent pack is pierced.
1. Press gently on the self-sealing laboratory film that covers the pierced film
area while mixing.
This prevents reagent leakage.
2. Gently invert the pack several times.
3. Remove the self-sealing laboratory film and load the pierced ancillary reagent
pack onto the system.
When testing is complete you may remove the reagents from the system or leave
them on the system. If you remove the reagents, cover the pierced film area of the
ancillary reagent pack with self-sealing laboratory film and store the pack at 2 to
8C. Store pierced ancillary reagent packs upright to minimize spillage. Follow
the pierced ancillary reagent pack procedure before placing the reagent pack back
on the system.
Do not add reagent to ancillary reagent packs. Each ancillary reagent pack
contains enough reagent to process a predetermined number of tests. Each time
the system accesses an ancillary reagent pack, reagent volume inventory tracks
the amount of reagent used until the pack is empty. The system does not recognize
additional fluid placed in an ancillary reagent pack.
NOTE: If reagent refrigeration is turned off for longer than 2 hours, store the
ancillary reagent packs at 2 to 8C. Mix all ancillary reagent packs following the
unpierced/pierced ancillary reagent pack procedures before placing the reagent
packs back on the system. Verify reagent performance based on acceptable quality
control results or by criteria established for your laboratory.
NOTE: The onboard stability of an ancillary reagent pack is calculated from the
time that the pack is first pierced. If a pierced pack is removed from the system, it
is recommended that you reload the pack onto the same system. If you load the
reagent pack onto a different system, you must track onboard stability and you
must adjust reagent volume inventory to account for any reagent previously
removed from the pierced reagent pack while on the other system.
078D0473-03 Rev. A
C-5
Good laboratory practices suggest that you establish a protocol that supports the
manufacturers requirement for the instrument to:
help you to meet requirements for state and federal laboratory certification
NOTE: The ADVIA Centaur XP supports the use of Type I and Type II grade
reagent water.
The following table lists the CLSI specifications for the 3 types of reagent water.
Use this information to determine the water quality in your laboratory. Refer to
the CLSI guidelines for common laboratory uses of Type I, Type II, and Type III
reagent water.
Specification
Type I
Type II
Type III
1000
not
applicable
pH
not applicable
not
applicable
5.08.0
Minimum resistivity
(megohm/centimeter at
10 (inline measurement by
sensor or resistor)
1.0
0.1
0.05
0.1
1.0
not
applicable
not
applicable
Organic compounds**
not
applicable
not
applicable
25 C)
*
*
*Bacterial content: The number of colony forming units in water. Bacterial content is a water
contaminant you measure to determine water quality.
Resistivity: The ability of water to resist electrical conduction due to the ion content. Resistivity
is the standard test measurement for determining water quality. The higher the resistivity, the
lower the ion content and the better the water quality.
078D0473-03 Rev. A
C-6
*
*
*
Purifying Water
As with all diagnostic testing procedures, good laboratory practices suggest that
you establish a protocol that supports the manufacturers requirements for
selecting the appropriate type of reagent water. You can then produce reagent
water in your laboratory by setting up and maintaining a water purification system
which uses the purification methods described in the following table.
The following table describes some of the typical laboratory water purification
methods.
Method
Description
Distillation
Deionization
Reverse Osmosis
Adsorption
Filtration
The quality of the reagent water you produce depends on the quality of the water
you start with (source water), and the performance of your water purification
system.
To produce the type of water you require, you may need a purification system that
uses a combination of methods. For example, if you want to produce Type I water,
you need a system that uses adsorption to remove organic impurities, deionization
to remove ionized impurities, and filtration to remove particulates.
078D0473-03 Rev. A
C-7
1
2
3
4
5
6
7
8
9
10
Pump
Source Water
Check Valve
Flow Controller
Resistivity Indicator
Valve
Filter
Type I Water Output
Ion Exchange
Carbon
Figure C-1
Establishing procedures for maintaining reagent water quality is also required for
laboratory inspection and accreditation by the College of American Pathologists
(CAP).4
078D0473-03 Rev. A
C-8
Filter the source water before treatment in reverse osmosis systems, and
recirculate deionizers in closed loops to extend resin life.
Check the water vessels regularly for the presence of a slippery film.
Clean and disinfect the vessels as required with an agent that rinses well, such
as H2O2.
For complete information about operation and maintenance requirements for your
water purification system, refer to the manufacturers specifications.
078D0473-03 Rev. A
C-9
These problems are caused by failure to use the appropriate type of reagent water,
bacterial contamination, and inadequate maintenance of the water purification
system.
Refer to the troubleshooting section in your system manual for more detailed
information about problems caused by water that does not meet reagent water
specifications.
References
1. Clinical and Laboratory Standards Institute (formerly NCCLS). Preparation
and Testing of Reagent Water in the Clinical Laboratory; Approved
Guideline- Third Edition. NCCLS document C3-A3 (ISBN 1-56238-336-1).
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA, 1997.
2. Tietz, Norbert W. Fundamentals of clinical chemistry, 3rd ed. Philadelphia:
W.B. Saunders Company; 1987. 1010 p.
3. Kaplan, Lawrence A. Pesce, Amadeo J. Clinical Chemistry; theory, analysis,
and correlation, 2nd edition. St. Louis: C.V. Mosby Company; 1989. 1212 p.
4. College of American Pathologists, Laboratory General Inspection Checklist
Section 1, Quality of water, p. 8. Northfield, IL. 1989.
Do not enter values in SI units when you enter Master Curve data or calibrator
assigned values. Using SI units may cause erroneous results.
NOTE: Do not enter an SI conversion factor for assays that do not list a factor.
The system does not accept an SI conversion factor for these tests.
If you report results in SI units, enter the appropriate units and conversion factor
for each test at the Test Result Calculation window.
078D0473-03 Rev. A
C-10
Common Units
SI Units
Conversion
Factor
AFP
ng/mL
IU/mL
0.83
mIU/mL
mIU/mL
BNP
pg/mL
pmol/L
0.289
BR (CA 15-3)
U/mL
U/mL
CA 125 II
U/mL
U/mL
CA 15-3
U/mL
U/mL
CA 19-9
U/mL
U/mL
Carbamazepine (CARB)
g/mL
mol/L
4.23
CEA
ng/mL
g/L
CKMB
ng/mL
nmol/L
0.0125
Cortisol (COR)
g/dL
nmol/L
27.59
C-peptide (CpS)
ng/mL
ng/mL
Digitoxin (DGTN)
ng/mL
nmol/L
1.307
Digoxin (DIG)
ng/mL
nmol/L
1.28
Estradiol-6 (E2-6)
pg/mL
pmol/L
3.67
pg/mL
pmol/L
3.67
Ferritin (FER)
ng/mL
pmol/L
2.20
Folate (FOL)
ng/mL
nmol/L
2.265
FrT4
ng/dL
pmol/L
12.9
FSH
mIU/mL
IU/L
FT3
pg/mL
pmol/L
1.54
Gentamicin (GENT)
g/mL
mol/L
2.09
Her-2/neu (H2n)
ng/mL
ng/mL
mIU/mL
mIU/mL
S/CO
S/CO
Index
none
Index
none
Anti-HBs (aHBs)
mIU/mL
mIU/mL
HBs AG (HBs)
Index
none
Index
none
HCV
Index
none
HCY
mol/L
mol/L
078D0473-03 Rev. A
C-11
Assay
Common Units
SI Units
Conversion
Factor
Index
none
IU/mL
IU/mL
pg/mL
pmol/L
0.106
Insulin (IRI)
mU/L
mU/L
LH
mIU/mL
IU/L
Myoglobin (MYO)
ng/mL
g/L
Phenobarbital (PHNB)
g/mL
mol/L
4.31
Phenytoin (PHTN)
g/mL
mol/L
3.96
Progesterone (PRGE)
ng/mL
nmol/L
3.18
Prolactin (PRL)
ng/mL
IU/mL
21.2
PSA
ng/mL
g/L
cPSA
ng/mL
g/L
Rubella G (Rub G)
IU/mL
IU/mL
IU/mL
Rubella M (Rub M)
Index
none
kU/L
kU/L
T3
ng/mL
nmol/L
1.54
T4
g/dL
nmol/L
12.9
anti-TG (aTG)
U/mL
U/mL
anti-TPO (aTPO)
U/mL
U/mL
Testosterone (TSTO)
ng/dL
nmol/L
0.0347
Theophylline 2 (THEO-2)
g/mL
mol/L
5.55
TnI-Ultra
ng/mL
g/L
Tobramycin (TOBR)
g/mL
mol/L
2.14
mIU/mL
IU/L
Toxoplasma G (Toxo G)
IU/mL
IU/mL
Toxoplasma M (Toxo M)
Index
none
TSH
IU/mL
mIU/L
TSH-3
IU/mL
mIU/L
TUp
Index
none
Valproic Acid
g/mL
mol/L
6.93
Vancomycin
g/mL
mol/L
0.69
VB12
pg/mL
pmol/L
0.738
078D0473-03 Rev. A
C-12
For example, for a TSH-3 scheduled in a small transfer tube, the values
are as follows:
200 L + 20 L + 100 L = 320 L
For multiple tests scheduled for a sample, use the following formula:
Sum of (Sample Volume + Tip Prime Volume) for all replicates for all tests + Unusable Volume = MRV
078D0473-03 Rev. A
C-13
Sample Volume
Tip Prime
Volume
Unusable
Volume
50 L
> 50 L
10 L
20 L
50 L
150 L
Small Transfer
50 L
> 50 L
10 L
20 L
100 L
100 L
Large Transfer
50 L
> 50 L
10 L
20 L
250 L
450 L
Hitachi
50 L
> 50 L to 100 L
> 100 L
10 L
15 L
20 L
50 L
50 L
100 L
Sarstedt S
50 L
> 50 L
10 L
20 L
100 L
125 L
Sarstedt C
50 L
> 50 L
10 L
20 L
50 L
50 L
50 L
> 50 L
10 L
20 L
150 L
125 L
SmithKline Beecham
50 L
> 50 L
10 L
20 L
200 L
300 L
Refer to Appendix E, Specifications, for the list of tube types you can use.
System Fluids
The fluids described in the table below are for In Vitro Diagnostic Use only. Use
the fluids until the expiration date stated on the bottle labels. Use Acid and Base
reagents until the expiration date stated on the bottle label or until 28 consecutive
days after loading the reagent on the system.
Dispose of Acid and Base reagents and cleaning solution using approved disposal
techniques for hazardous corrosive liquid wastes. Dispose of Acid and Base
reagents in accordance with local, state, and federal regulations. Refer to the
Material Safety Data Sheets for each material for additional information.
078D0473-03 Rev. A
C-14
Do not allow contact of Acid and Base reagents with skin and eyes. Acid and Base
reagents are irritating to the skin. Wear suitable eye, face, and skin protection,
which include wearing gloves, protective eye shield, and laboratory coat. In case
of contact with the eyes, rinse the eyes immediately with plenty of water and seek
medical advice. In case of accident or if you feel unwell, seek medical advice. If
possible, show the bottle label and the Material Safety Data Sheet. In case of
accidental ingestion of reagent, call a physician immediately.
Fluid Name
Volume
Ingredients
Storage
Acid Reagent
1500 mL
5000 tests/bottle
425 C
Base Reagent
1500 mL
5000 tests/bottle
425 C
Wash 1 Reagent
2500 mL
425 C
Wash 3 Reagent
2500 mL
425 C
Cleaning Solution
Concentrate
100 mL
28 C
078D0473-03 Rev. A
Appendix D: Supplies
The following is a list of supplies with catalog numbers and REF to assist in the
ordering process. The catalog numbers in parentheses are included in the list for
reference only.
Description
REF
Catalog Number
05296798
(23531)
4934626
(27081)
09908593
(112748)
08044064
(078-K138-01)
06412376
(572615)
03918457
(572165)
Filter, Water
02757433
(26970)
9391302
(078-0333-01)
3828105
(078-0334-01)
8579502
(078-0335-01)
1160808
(078-0336-01)
2115415
(078-0337-01)
03364923
(672003)
06097004
(115625)
02884702
(20764)
00016339
(751046)
04042237
(571233)
03040281
(571843)
02873484
(125669)
06104191
(119147)
03852677
(112219)
03832935
(078-K137-01)
07286900
(672010)
7609246
(078-K225-01)
078D0473-03 Rev. A
D-2
Description
REF
Catalog Number
8072505
(078-K191-01)
02339151
(115896)
7247778
(078-0432-01)
01734022
(571638C)*
04213589
(572258B)
0177324
(078-0370-01)
Syringe Plunger, 5 mL
08621789
(112247)
Syringe Plunger, 2 mL
07121359
(112248)
01776434
(26134)
07413317
(078-K139-01)
00939496
(078-0066-02)
00942365
(078-0067-02)
00528879
(078-K116-01)
00367719
(078-B029-01)
2894082
(078-0359-01)
07319604
(078-B046-01)
03514445
(571101)
08083183
(112524)
078D0473-03 Rev. A
Appendix E: Specifications
This section summarizes the design specifications for the ADVIA Centaur XP
system.
Safety Certifications
Refer to the DECLARATION OF CONFORMITY shipped with the
ADVIA Centaur XP system.
Dimensions
Depth
Height
Width
Weight
Environmental Specifications
Ambient Operating Temperature
18.0 to 30.0 C
Relative Humidity
Storage Temperature
0.0 to 50.0 C
up to 2000 meters
Ventilation
10,000 BTU/hour
078D0473-03 Rev. A
E-2
Electrical Requirements
Electrical Rating
Power Requirements
50/60Hz
Tube Types
This section lists the primary sample tubes, sample transfer cups, transfer tubes,
and microsample containers you can use on your system.You can specify up to 3
tube types at the Setup Tube Type & Barcode window. Refer to Specifying
Sample Tube Types page 8-5.
The tube type fields at the Setup Tube Type & Barcode window list the tubes
you can use on your system. The + symbol before the tube type indicates that you
need to place it into a holder before loading it into the sample rack.
Ensure that translucent plastic sample tubes have barcode labels or a printed label
facing the barcode reader when you load the tubes onto the system. The system
might not detect a translucent tube with no label or a white label with very little
printing.
14 x 100 mm
Siemens
conical
Small Transfer
12 x 75 mm
Various
manufacturers
round
Large Transfer
13 x 100 mm
Various
manufacturers
round
13 x 38 mm
Hitachi
conical in 16 x
75 holder
+Microcup Sarstedt S
2.0 mL
Sarstedt
skirted in 13 x
75 holder
+Microcup Sarstedt C
1.5 mL
Sarstedt
conical in 13 x
75 holder
+EzeeNest 13 mm
1.0 mL
Elkay
conical in 13 x
75 holder
14 x 100 mm
Olympus
round
Sarstedt 15 x 93
15 x 93 mm
Sarstedt
conical
Starplex Transfer
15.5 x 96.5 mm
Starplex
Scientific
conical
078D0473-03 Rev. A
E-3
Large Gel
13 x 75 mm
Becton
Dickinson
Vacutainer
13 x 75 mm
Sherwood
Medical
Monoject
13 x 100 mm
Becton
Dickinson
Vacutainer
13 x 100 mm
Sherwood
Medical
Monoject,
Corvac
16 x 75 mm
Becton
Dickinson
Vacutainer
16 x 75 mm
Sherwood
Medical
Monoject
16 x 100 mm
Becton
Dickinson
Vacutainer
16 x 100 mm
Sherwood
Medical
Monoject,
Corvac
16.5 x 92 mm
Sarstedt
Luer Monovette
10.25 x 75 mm
Becton
Dickinson
Vacutainer
10.25 x 75 mm
Sherwood
Medical
Monoject
1.5 mL
Becton
Dickinson
Round bottom,
13x75 holder
Small Gel
078D0473-03 Rev. A
E-4
078D0473-03 Rev. A
Description
This symbol is used for both Warnings and Cautions.
A Warning indicates the risk of personal injury or loss of life if
operating procedures and practices are not correctly followed.
A Caution indicates the possibility of loss of data or damage to or
destruction of equipment if operating procedures and practices
are not strictly observed.
This symbol alerts you to a biohazard.
This symbol alerts you to a biohazard.
078D0473-03 Rev. A
F-2
Symbol
Description
This symbol indicates that the main power supply is off.
This symbol indicates the fast stop button.
078D0473-03 Rev. A
Symbol
F-3
Description
This symbol indicates the Stat entry.
This symbol indicates where cuvettes are loaded.
This symbol indicates where sample tips are loaded.
This symbol identifies the system fluid bottle for Acid reagent.
This symbol identifies the system fluid bottle for Base reagent.
This symbol identifies the system fluid bottle for wash 1 solution.
This symbol identifies the system fluid bottle for wash 3 solution.
This symbol identifies the system fluid bottle for cleaning solution.
078D0473-03 Rev. A
F-4
Symbol
Description
This symbol indicates that you should protect the product from strong
magnetic fields.
This symbol indicates an in vitro diagnostic device or an in vitro
diagnostic medical device.
This symbol indicates that you should consult instructions for use.
This symbol indicates that the product is fragile and you need to
handle it with care.
This symbol indicates that you should keep the product dry.
This symbol indicates the number used for ordering a part or product.
This symbol indicates the serial number of a part or product.
This symbol indicates the revision letter of a part or product.
This symbol indicates the name and location of the product
manufacturer.
This symbol indicates the date of manufacture of the product.
078D0473-03 Rev. A
Symbol
F-5
Description
This symbol indicates that the product complies with the applicable
directives of the European Union.
This symbol indicates that the product is CSA approved for safety
(Canada).
This symbol indicates that the product is UL approved for safety
(United States).
The WEEE symbol indicates that this equipment is classified as
Waste Electrical and Electronic Equipment under the European
WEEE Directive. It must be recycled or disposed of in accordance
with applicable local requirements.
The following symbols can also display on the exterior of the ADVIA Centaur XP
system or 1 of its components.
Symbol
Description
This symbol indicates that the product is a Class 1
laser product, with no laser exposure during
normal operation.
This symbol indicates that the product is a Class 2
laser product, with potential exposure to a laser
beam.
078D0473-03 Rev. A
F-6
078D0473-03 Rev. A
1
2
3
Figure G-1
078D0473-03 Rev. A
G-2
1
2
3
4
5
6
7
Touch-screen monitor
Keyboard
Mouse
Applications module
User interface module
Input/Output panel
Handheld barcode scanner
Figure G-2
078D0473-03 Rev. A
G-3
1
2
3
4
5
6
7
8
9
Figure G-3
078D0473-03 Rev. A
G-4
1
2
3
4
5
6
7
8
9
10
11
Figure G-4
078D0473-03 Rev. A
G-5
1
2
3
4
5
6
7
8
9
Figure G-5
078D0473-03 Rev. A
G-6
barcode scanner
lab automation
Video, in and out, for the Applications module and the UI module
Touch screen, in and out, for the Applications module and the UI module
Keyboard
Figure G-6
Cover
078D0473-03 Rev. A
G-7
Figure G-7
2. Lift the cable panel away and put it safely to the side to expose the back of the
2 modules.
078D0473-03 Rev. A
G-8
Do not slide the user interface module too far. You can damage the user infterface
module if you slide it off the support rails. Be careful with the cables and the
user interface module when sliding the user interface module.
1. At the back of the system, locate and loosen the anchor screw or screws for
the selected module.
The Applcations module has 1 anchor screw and the User Interface module
has 2 anchor screws. These are captive screws that remain in place when you
unscrew them from the module.
NOTE: The figure displays the back of the system without the cable panel. In
1
2
3
4
5
6
Applications module
Applications module support rail
Applications module anchor screw
User Interface module
User Interface module support rails
User Interface module anchor
Figure G-8
2. Slide the module toward the front of the system until the I/O panel is
accessible.
078D0473-03 Rev. A
Appendix H: Glossary
accept
acid probe
acid reagent
acridinium ester
activate
active
active test
Test from the menu that is enabled for use on the system.
analyte
ancillary entry
ancillary pack
ancillary reagent
antibody
antibody-capture assay
078D0473-03 Rev. A
H-2
antigen
archive
aspirate probe
assay
assay format
automatic dilutions
automatic transfer
background
back up
barcode
barcode label
barcode scanner
base probe
base reagent
batch
078D0473-03 Rev. A
H-3
baud rate
bidirectional interface
buffer (chemistry)
buffer (electronic)
calibration
calibration curve
calibration data
calibration interval
calibrator
Calibrator Assigned
Values card
cancel
catalog number
CD-ROM
CD-RW
078D0473-03 Rev. A
H-4
character parity
check digit
check range
checksum
chemiluminescence
chemiluminescent
immunoassay
chemiluminescent
reaction
coefficient of variation
communication ports
competitive assay
completed assay
Assay for which a valid result was generated or for which all
required sample aspirations are complete. Required reagent
aspirations may not have completed.
concentration
confidence interval
configuration
078D0473-03 Rev. A
H-5
context-sensitive online
information
continuous operation
control
control-bracketed test
control reminder
control warning
corrective action
cursor
A bar at the window that indicates where you can enter data.
cut-off point
cuvette
cycle count
Each time the sample probe picks up a sample tip, the cycle
count increments by 1.
dark count
078D0473-03 Rev. A
H-6
data bits
default value
define
delete
demographics
diluent
dilution point
dilution setpoint
disable
diskette drive
DVD-RW
enable
equivocal
ethernet
event
event log
exit queue
expiration date
firmware
078D0473-03 Rev. A
H-7
flag
flash
hand-held barcode
scanner
hardware
host query
ID
immunoassay
immunochemiluminometric
assay
immunogen
inactivate
inactive
Not available for full use on the system. You can schedule
only calibrators and controls for inactive tests and reagent
packs.
inactive test
include
078D0473-03 Rev. A
H-8
incubation ring
index
inprocess
intercept
key operator
keyboard
label
laboratory information
system
light count
link
LIS Code
Lite Reagent
luminometer
lyophilized material
manual dilution
078D0473-03 Rev. A
H-9
Master Curve
minimum detectable
volume
modem
monitor
monoclonal antibody
nonreactive
normal range
numeric keys
observed limits
off-system test
Test that is not run on the system but whose results are
entered in the result database and printed on a patient report.
You can use off-system test results in ratio tests.
optimize placement
Pack ID
paramagnetic particles
patient identification
code
pending samples
pending tests
078D0473-03 Rev. A
H-10
photomultiplier tube
photon
PID
pointing device
polyclonal antibody
power supply
pretreatment
primary pack
prime
profile
prompt
QC
Quality control.
quality control
query timeout
rack
078D0473-03 Rev. A
H-11
Rack ID
random access
ratio definition
ratio test
Test that calculates results from the results of other tests. FTI
is an example of a ratio test.
raw data
Total photon count that the system received for a flash. The
raw data is not corrected.
reagent probe 1, 2, or 3
reagent water
reference range
replicate
reservoir
results
sample
sample cup
sample identification
code
078D0473-03 Rev. A
H-12
sample probe
sandwich assay
save
screen
search
sign in
sign out
SI units
SID
Sample identification.
slope
software
Solid Phase
sort
stability
startup
The events that occur when the system uses the software to
initialize the hardware.
status
stop bits
subsystem
078D0473-03 Rev. A
H-13
subsystem failure
subsystem warning
symbology
system clock
troubleshooting
2-point calibration
update
USB
view
waive
waste bottle
water bottle
window
worklist
078D0473-03 Rev. A
H-14
078D0473-03 Rev. A
Index
Numerics
4676_1511_CPrmRgt 41
4677_1512_CRgtShr 38
4678_1513_CCovers 43
4679_1514_CSplRck 56
4688_1507_CAirFil 23
4693_1527_EmtyWaTrap 15
4694_1528_CWPrbCEjR 53
4695_1529_CExReagPrb 17
4696_1530_CExAncPrb 20
A
accepting an invalid calibration 25
acid probe 4, 14
Acid Reagent
composition 13
acid reagent
dispensing 14
replacing 37
acridinium ester 33, 35
adding
control requests 5
ADVIA Centaur system
topview figure 4
AE
antibody binding 34
air filter
cleaning 23
alarms
defining 38
ancillary barcode scanner 83
ancillary entry
cleaning 43
ancillary pack 12, 20
barcode 9
loading 9
removing 9
storing 9
ancillary probe 4, 12
cleaning 20
ancillary queue
troubleshooting 67
ancillary reagent 12
status 18
ancillary reagent entry 9
078D0473-03 Rev. A
button
fast stop 5
buttons
function 19
status
blinking 18
task 19
workspace 17
C
calibration
accepting invalid 25, 17
assigning 25, 17
autoexclude calibrator replicates 10
defined ranges 6
discrepant 95
due to expire, managing 26
evaluation criteria 4
examples of managing calibrations 25
expired, managing 27
history 18
invalid, managing 25
master curve 1
observed ranges 7
print report 27
retained 8
retaining 17
software map 28
status 16
T Uptake 4
two-point 1
waiving expired 24, 17
Calibration button 19
calibration data
backing up 3
printing 27
replicate results 20
review 20
status messages 20
calibration display
sort 17
view 17
calibration evaluation criteria 4
calibration history 18
calibration options
defining 16
calibration status 18, 20
cal required 16
current 16
due 16
expired 17, 20
expired, retained 20
historical 17, 18
invalid 17
invalid, exceeded defined ranges 20
invalid, exceeded observed ranges 20
no master curve 17
operator accepted 17
valid 20
valid, met retained cal limits 20
valid, operator accepted 20
valid, operator accepted, retained 21
valid, retained 21
waived 17, 21
calibrator
autoexcluding a replicate 17
display at Worklist Summary window 42,
25
excluding RLU 23
scheduling 56, 18
calibrator values
defining 14
capacity
cuvette 25
cuvette waste 25
fluid waste 25
inprocess queue 6
reagent water 25
sample exit queue 7
sample rack 6
sample tip tray waste 25
sample tip trays 25
system fluid reservoir 37
tip waste 25
central processing unit 14
check digit 88
check range
defining 25
chemiluminescent
immunoassay 34
chemiluminescent reaction 14
Cleaning
aspirate probe exterior 22
cuvette waste area 43
sample time waste area 49
water bottles and reservoirs 8
cleaning
air filter 23
ancillary entry 43
ancillary probe 20
aspirate probes 22
covers 43
cuvette waste chute 43
cuvette waste reservoir 43
drip trays 43
pointing device 43
primary reagent compartment 41
probe rinse stations 34
reagent pack holders 41
reagent probe shutter 38
reagent probes 17
rinse stations 34
sample entry queue 43
sample exit queue 43
sample racks 56
sample tip remover 49
sample tip waste chute 49
sample tip waste reservoir 49
sample tip waste tube 49
Stat entry 43
system fluids tray 43
waste probe and cuvette ejector rod 53
water bottle and reservoir 8
cleaning solution
for soaking and wiping system components
17
preparing 32
replacing 31
clearing cuvette jams
vertical cuvette chute 9
clearing jams
elevator 17
orientation chute 9
078D0473-03 Rev. A
078D0473-03 Rev. A
cleaning 43
critical condition 9
current
calibration status 16
custom barcode labels
defining 7
customer service 6
customer tube types
restoring 4
cut-off point
qualitative assays 3
cuvette
loading 14
cuvette ejector rod
cleaning 53
cuvette jams 9
cuvette loading
clearing jams 9
cuvette loading bin 4, 14
filling 32
cuvette waste area
cleaning 43
cuvette waste bin 14
emptying 35
cuvette waste chute
cleaning 43
cuvette waste reservoir
cleaning 43
cuvettes
loading 46
D
Daily Cleaning Procedure
autoscheduling 3
daily cleaning procedure 5
Dark Count with Cuvette 53
data collection 77
data files
maintaining 1
decimal places
defining 15
defaults
resetting 20, 26, 27, 31
defined ranges
for calibration 6
using scanner 10
defining sample handling
maximizing tests 2
minimizing unusable volume 2
optimizing throughput 2
Defining SID Codes from Barcode Labels 7
deleting
dilution profiles 32
entire worklist 72
requests 61
selected sample results 72
selected worklist 72
test 10, 11, 12
deleting tests
from a QC definition 5
determining
supplies status 10
diluters 76
dilution
symbol 41
dilution factor
defining 31
dilution options
entering 56
specifying 57
dilution point
defining 30
dilution profiles
defining 31
deleting 32
dilutions
automatic 30
manual 56
direct plumbing
specifying 44
disabled
symbol 41
disabling a test 10, 11, 12
discarded
results 74
Discarded results
reasons for 43
discrepant
calibration 95
078D0473-03 Rev. A
078D0473-03 Rev. A
event log 1
backing up 3
restoring 4
status 19
excluded
symbol 41
excluding a calibrator replicate automatically 17
excluding a calibrator RLU 23
exit queue
clearing obstructions 40
locating sample racks 8
locating samples 44
expired
calibration status 17, 20
expired calibration
managing 27
waiving 24
expired, retained
calibration status 20
exporting
quality control data 8, 3, 10
F
failure condition 9
fast stop button 5
field help 23
filter
water 30
flags
calibration data 23
defining 21
fluid sensor
replacing 34
function buttons 19
functions
software map 29, 31
H
Hand-held barcode scanner
Master Curve 16
patient samples 16
scanning patient samples 52
HBsAg
reflex confirmatory test 22
help
explaining 22
field 23
help button 23
help key 23
historical database
moving results 8
historical results
deleting 73
historical worklist
manually moving results 45
holding samples for repeat 29
Home Probes 49
Home System 65
I
Incomplete Set message 13
incubation ring 4, 14
magnets 11
temperature 11
index value
nonreactive 3
qualitative assays 3
reactive 3
indicators
pack 21
information
online 22
information display area 20
inprocess queue 4, 5, 6, 7
capacity 6
removing sample racks 8
symbol 41
inprocess queue timeout
defining 3
insufficient message 13
insufficient sample volume
repeating samples 27
interpretation ranges
reflex tests 23
Invalid 42
invalid
calibration status 17
invalid calibration
accepting 25, 17
assigning 25
managing 25
078D0473-03 Rev. A
luminometer 4, 14
cleaning 53
troubleshooting 53, 57
M
magnetic particles 13
magnets 4, 11, 13
maintaining
acid and base reagents 37
cuvette loading bin 32, 33
data files 1
sample tip waste bin 35
waste bottle 27
water bottle 25
maintenance
status 18
maintenance log
backing up 3
restoring 4
maintenance procedures 23
Maintenance Status button 18, 19
managing
the worklist 39
managing calibrations
examples 25
manifold
cleaning 14
manually adding
test requests 47
master curve
calibration 1
competitive assay 1
concentrations 10
defining 10
qualitative assays 3
quantitative assays 1, 2
relative light units 10
sandwich assay 2
specific lot 1
standard concentrations 1
standard curve 1
master curve card
barcodes 1
master curve definition 10
maximizing number of tests 2
078D0473-03 Rev. A
message
Aspirated 13
Clot Detected 13
Incomplete Cal Set 13
Incomplete Set 13
Insufficient 13
Integrity Error 13
LIS Query Pending 14
Low Reagent 39
No Barcode 14
No Bracket 14
No Request 14
Removal Pending 14
SID Mismatch 14
Stat 2
Messages
Incomplete Set 13
messages
reagent status 18
sample status 13
minimizing unusable volume 2
Mismatch
SID 52
modem
accessing files 42
modifying
control reminder 19
reagent stability option 13
sample replicates 14
sample replicates for automatic repeats 24
system options 37
test options 9
Modifying control reminder 19
monitor 17
monitoring
status 9
multiple flags
symbol 41
N
No Barcode message 14, 16
No Bracket message 14
no calibration
calibration status 16
no master curve
calibration status 17
No Request message 14
O
observed ranges
for calibration 7
off-system tests
defining 35
onboard plumbing
specifying 44
online information
explaining 22
operating sequence 2
optimized throughput
defining 1
order
modifying test display 36
ordering
supplies 1
orientation chute 14
clearing cuvette jams 9
overdilution concentration
defining 31
P
pack
indicators 21
Pack ID
selecting 57
paramagnetic particles 35
patient demographics 53
entering 53
patient samples
scheduling 49
pending requests
deleting
in worklist 73
photomultiplier tube 14
pointing device 43
adjusting 41
pop-up window
view 62
positioning
the rack indicator
illustration 4
power failure
recovering from 7
preheater 14
clearing jams 15
temperature 14
primary pack
loading 8
primary pack status 21
primary reagent
status 8, 18
primary reagent compartment 3, 4
cleaning 41
temperature 8
primary reagent door 8
primary reagent pack
loading 22
removing 22
primary reagent probes 4
primary reagent shelf 8
primary reagent status 8
primary sample tube 6
Prime Cuvettes 46
Prime Fluid Line 74
Prime System 72
Prime System Fluid Bottle 76
principles
antibody binding 34
printed results
deleting 73
printer
specifying 41
printing
calibration data 27
reagent loading report 21
sample results 73
test results 74
printing information for technical assistance 5
printing report type
reagent loading report 21
results report 73
test report 74
printing system information 5
probe rinse stations
cleaning 34
probes
078D0473-03 Rev. A
10
troubleshooting 47
problem
multiple assay 104
single assay 103
procedure button 23
procedures 22
event codes 23
maintenance 23
processing
batch requests 55
Stat requests 54
proficiency testing
investigating failed 106
profiles
dilution, defining 31
dilution, deleting 32
test, defining 36
test, deleting 36
Q
QC
discrepant 98
QC definition
editing 4
QC statistics
exporting 8, 10
qualitative assay
cut-off point 3
index value 3
master curve 3
two-point calibration 3
quality control
deleting tests 5
editing control definitions 4
editing expected values 4
software map 27
quality control data
backing up 3
exporting to diskette 3
quantitative assay
calibration 1
master curve 1
two-point calibration 1
user-initiated calibration 1
quantitative two-point calibration.
078D0473-03 Rev. A
See
two-point calibration.
querying
an LIS 47
R
rack
specifying for sample identification 4
rack barcode 6
racks
loading
illustration 5
range
concentration calculation 26
interpretation 21
patient population 20
reference 20
ratio test
calculated 4
reference serum 4
T Uptake 4
ratio tests
defining 33
reaction
chemiluminescent 14
reagent
defining opened stability 14
stability option, modifying 13
reagent barcode scanner 81
reagent holder 8
reagent inventory
backing up 3
reagent lots and packs
specifying 57
reagent options
entering 57
reagent pack holders
cleaning 41
reagent probe 13
reagent probe shutter
cleaning 38
reagent probes
cleaning 17
replacing 23
reagent status 15
Reagent Status button 18
11
cleaning solution 31
reagent probe 23
waste bottle fluid sensor 34
waste probe 30
replicate
symbol 41
replicate calibrator results 20
replicates
entering 58
modifying 14
specifying 57, 58
reports
laboratory name and heading 41
print options 41
printing 73
representative
authorized 1, 6, 7
requesting
tests
manually 47
requests
deleting 61
editing 61
rescheduling samples
control-bracketed tests 43
Reset Thermals 70
resetting defaults 20, 26, 27, 31
restoring customer tube types 4
restoring event log 4
restoring maintenance log 4
restoring setup 4
restoring system data 4
result flags
defining 21
result interpretations
defining 21
result on hold
releasing 70
symbol 41
results
defining flags 21
defining interpretations 21
deleting 73
discarded 74
078D0473-03 Rev. A
12
078D0473-03 Rev. A
barcode
illustration 4
loading
illustration 4
sample entry queue 3, 4, 5, 6
cleaning 43
sample exit queue 3, 4, 5
capacity 7
cleaning 43
clearing obstructions 40
locating sample racks 8
locating samples 44
sample loading area 5
sample position
identifying 55
sample probe 4, 7
sample rack 4, 6
capacity 6
clips 60
loading 6
sample racks 2
cleaning 56
sample results
printing 73
sample start button 6
Sample Status button 18
sample status messages 13
sample tests
repeating 68
sample tip
troubleshooting 51
sample tip remover 10
cleaning 49
sample tip tray 4, 7
loading jam 36
sample tip waste
emptying 33
sample tip waste area
cleaning 49
sample tip waste chute
cleaning 49
sample tip waste reservoir
cleaning 49
sample tip waste tube
cleaning 49
samples
deleting
selected results 72
sandwich assay 35, 36
master curve 2
scanner
sample barcode 7
Scanning patient samples
hand-held barcode reader 52
scheduling
batches 55
calibrator 18
calibrators 56
control requests 5
patient samples 49
samples for control-bracketed tests 58
Stat samples 54
screen saver options
specifying 38
selecting multiple samples
in the worklist 60
selecting multiple tests
in the worklist 60
sending
results
manually to an LIS 71
sensitivity
defining 26
separation
bound from free 37
serial number
viewing 37
service 1, 6, 7
under warranty 1
setup
backing up 3
restoring 4
Setup button 19
setup summary
software map 28
SI unit conversion factors 9
SID
Mismatch 52
13
078D0473-03 Rev. A
14
Status
system 18
status
ancillary reagent 18
event log 19
maintenance 18, 19, 18
monitoring 9
primary pack 21
primary reagent 8
reagents 18, 15
samples 18, 13
messages 13
software map 25
supplies 18, 10
status button color 9
status buttons
blinking 18
status message
calibration 18, 20
stop button 5
storing
ancillary pack 9
summary window
type 9
view 9
supplies
ordering 1
status 10
suspend update
worklist 39, 43
symbol
at Status Exit Queue window 41
comment 41
dilution 41
ejected from inprocess queue 41
excluded 41
inprocess queue 41
multiple flags 41
repeat 41
replicate 41
reschedule 41
result on hold 41
results discarded 42
specific reagent 41
078D0473-03 Rev. A
stat 41
time due for test completion 41
waiting for controls 41
symbols 1
event log 1
system
backing up 3
bottles, specifying 44
clock, changing 40
name, defining 38
options, modifying 37
restoring 4
signing in 1
signing out 1
software map 24
system fluid reservoir
capacity 37
system fluids tray
cleaning 43
system state
description 9
System Status button 18
T
T Uptake
calculating result 4
defining result options 34
master curve card 4
ratio test 4
reference serum calibration 4
task buttons 19
technical assistance
printing information 5
temperature
ancillary queue 9
primary reagent compartment 8
troubleshooting 70
test definition
backing up 3
test display order
modifying 36
test name
modifying 13
test options
modifying 9
test profiles
defining 36
deleting 36
test results
printing 74
test type
all 10
allergen 10
combination 10
component 10
off-system 10
ratio 10
sIgE universal 10
standard 10
tests
deleting 10, 11, 12
deleting from a QC definition 5
disabling 10
enabling 10
modifying name 13
reviewing 9
sample
repeating 68
threshold
reagent warning 39
time
entering time correction 40
specifying time zone 40
tip tray
loading 51
title bar 20
top cover
opening 33
troubleshooting
aspirate probe 26
barcode 78
clearing jams from vertical cuvette chute 9
cuvette jams in cuvette loading 9
cuvette jams in preheater 15
tube sizes 6
tube types 5
backing up 3
tube-type selector 6
two-point calibration
15
adjusted signal 2, 3
defined validity criteria 2, 3
instrument specific correction formula 3
qualitative assays 3
quantitative assay 1, 2
user-initiated 1
type
summary window 9
test 10
tube 5
U
units
defining 15
user interface workstation 4
using
sample cups 4
V
vacuum test 70
Valid 42
valid, met retained cal limits
calibration status 20
valid, operator accepted
calibration status 20
valid, operator accepted, retained
calibration status 21
valid, retained
calibration status 21
Verify 42, 25
verifying
barcode scanning 6
vertical cuvette chute 14
clearing cuvette jams 9
view
calibration display 17
pop-up window 62
summary window 9
view, Calibration Summary
historical 18
Viewing control bracketing features 18
W
Waiting for Controls
symbol 41
waived
calibration status 17, 21
078D0473-03 Rev. A
16
078D0473-03 Rev. A
managing 39
results
deleting 73
resume update 39, 43
software map 26
suspend update 39, 43
Worklist Reagent Options window
plus sign 57
Worklist button 19
workspace 17
workspace buttons 17
Y
yellow status button 9