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Operator’s Guide
Legal Information
© 2018 Siemens Healthcare Diagnostics. All rights reserved.
The ADVIA Chemistry XPT system is for in vitro diagnostics use.
No part of this operator’s guide or the products it describes may be
reproduced by any means or in any form without prior consent in writing
from Siemens Healthcare Diagnostics.
ADVIA is a trademark of Siemens Healthcare Diagnostics.
Windows and Excel are trademarks of Microsoft Corporation.
All other trademarks are the property of their respective owners.
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ADVIA Chemistry XPT System Using this Guide
Conventions
The operators guide uses the following symbol and text conventions.
Convention Description
BIOHAZARD Biohazard statements alert to potentially
biohazardous conditions.
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Using this Guide ADVIA Chemistry XPT System
Convention Description
Italic Italic type refers to the title of a document or a
section title in this operator’s guide.
Terminology
The following table explains some of the special terminology used in this
operator’s guide and the specific actions to take when this terminology is
used in a procedure.
Term Description
Select To select an item, use 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 the item
was selected.
Enter Type the specified information using the keyboard and
then press the Enter key.
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ADVIA Chemistry XPT System
Transmitting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Releasing Results to LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Chapter 3: Reagent Management ............................................................ 49
Viewing Reagent Inventory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
About Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
About Reagent Pack Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Enabling or Disabling Reagent 1 and Reagent 2 Lots . . . . . . . . . . . . . . . . . . 52
Reagent Tray 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
About RTT1 Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Activating or Inactivating Reagent 1 Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Activating or Inactivating Reagent 1 and Reagent 2 Lots . . . . . . . . . . . . . . . . . . . . . . . 54
Enabling or Disabling Reagent 1 Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Reagent Tray 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
About RTT2 Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Activating or Inactivating Reagent 2 Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Activating or Inactivating Reagent 2 Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Enabling or Disabling Reagent 2 Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Loading Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Ancillary Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Chapter 4: Sample Management.............................................................. 65
Manually Creating Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Entering Patient Sample Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Creating a STAT Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
About Creating Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
About Batch Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Creating a Batch Order. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Managing Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Editing Pending Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Deleting Pending Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Tracking Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Evaluating Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Accessing Sample or Test Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Assigning a Disposition to a Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Printing Displayed Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
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ADVIA Chemistry XPT System Chapter 1: System Features
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 is not based on the
results of a single test. Only a physician can make a diagnosis after
evaluating all clinical and laboratory findings.
Key Features
Table 1: Key Features
Feature Description
Optimal Maximum 2400 assays/hour: 1800 assays/
Productivity hour colorimetric, 600 assays/hour
electrolyte (ISE).
Automatic Reflex The system automatically schedules reflex
Testing tests based on the defined parameters.
Clot Detection The system utilizes a pressure transducer
to monitor the pressure in the sample
dilution probe line (DPP) for a complete
obstruction during the sample aspiration
and dispensation cycle.
User Interface The intuitive graphical user interface is via
a touchscreen monitor making it possible
to perform daily tasks directly on the
screen without using the keyboard.
LIS Interface Bidirectional laboratory information
system (LIS) interface allows information
to be sent and received from the LIS. The
system supports the ASTM interface
protocol.
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Chapter 1: System Features ADVIA Chemistry XPT System
Feature Description
Laboratory The STS sample transport system is an
Automation optional feature that enables use of the
system with any laboratory automation
system.
Remote and The system has integrated, proactive
Laboratory service features that assist in problem
Server detection and remotely initiated diagnosis
of problems, resulting in faster support
resolution. The system supports remotely
initiated activities such as software
updates and online documentation
updates. Process management
functionality is enhanced with a laboratory
dashboard and remote control of
interconnected laboratory
instrumentation.
Visible Status The system has a status light that is visible
Light from most positions in the room. The
status lights correspond to events that
occur on the system.
Direct Plumbing The system connects to external clinical
laboratory reagent water (CLRW) and
waste lines. Input water pressure to the
system is regulated.
STAT Sample The system processes priority samples
Processing before routine analysis.
Hardware Overview
This section describes the location of the major subsystems and
components. The location of this hardware enables:
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Chapter 1: System Features ADVIA Chemistry XPT System
1 Keyboard
2 Touchscreen Monitor
3 Mouse
4 Printer (optional)
5 Personal Computer (PC)
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ADVIA Chemistry XPT System Chapter 1: System Features
Software Overview
This section includes information on the system workspace and the online
help. Access to specific areas is restricted by login level.
The Status Bar near the bottom of the workspace provides access to
windows that display information about the condition of the entire system.
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Chapter 1: System Features ADVIA Chemistry XPT System
Tool Description
The System Operation tool enables you to perform
operations such as initialize the system, scan reagents, start
or restart the system, pause sampling, pause reagents,
prime the system, or washes.
The Samples tool enables you to manage, monitor, and
interact with sample information.
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Tool Description
The QC tool enables you to define rules for monitoring your
QC tests and then to view the statistics as they accumulate.
Also, you can create QC Definitions and QC Definition
Profiles.
The Setup tool provides access to all the information
required to set up your basic system operations.
• Operator ID
• Current status
• Current date and time
Icon Description
The Help icon on the Status Bar accesses general help about
the workstation including topics like this one.
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Chapter 1: System Features ADVIA Chemistry XPT System
Icon Description
The Remote Communications icon enables you to set up
and view up to 4 other workstations. There is limited access
to some functions on each of the connected workstations.
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Icon Description
Select the Instrument status icon to display the Instrument
Status window.
• Window Help
Window help provides information about options available at each
window and brief instructions for using the window. To access window
help, select the ? icon.
• Troubleshooting Help and Procedures
Event code procedures provide brief descriptions and procedures for
identifying and solving system events. Access event code procedures by
selecting an event on the Operator Event tab of the Events window
then select Troubleshooting Help.
• Maintenance Procedures
Maintenance procedures provide information about performing
maintenance tasks. Access maintenance procedures by selecting a
maintenance activity on the Schedule tab of the Maintenance window,
then select Procedure. Access printable maintenance procedures from
the Contents tab of the general help window, under Maintenance.
• Operator’s Guide
The operator’s guide provides information about routine operating
tasks. Access the electronic version of this operator’s guide from the
online help table of contents.
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ADVIA Chemistry XPT System Chapter 1: System Features
Monitoring Status
The system tracks the status of supplies, samples, QC exceptions, reagents,
maintenance, and events. An alert displays if a system area needs attention.
Use the status buttons on the workspace to monitor the status of the
different system areas.
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Chapter 1: System Features ADVIA Chemistry XPT System
• Edit packs.
• Activate or Inactivate packs.
• Activate Lot or Inactivate Lot feature.
• Enable or disable reagent lots.
• Scan reagent barcodes.
• Print the RTT1 or RTT2 Inventory Reports.
To access reagent status, select Reagents > RTT1 Status or RTT2 Status.
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To access the inventory report, select Reagents > RTT1 Status or RTT2
Status then Print.
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Chapter 1: System Features ADVIA Chemistry XPT System
The table on the Schedule tab displays information about all defined
maintenance activities:
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Chapter 1: System Features ADVIA Chemistry XPT System
Software Maps
Command bar buttons open windows that contain related information and
tasks.
Figure 8: Samples
Figure 9: Reagents
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Figure 16: QC
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ADVIA Chemistry XPT System Chapter 2: Operating the System
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Chapter 2: Operating the System ADVIA Chemistry XPT System
You can sort the events by ascending or descending date order using the
toggle in the Date column.
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• Mixing rods
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ADVIA Chemistry XPT System Chapter 2: Operating the System
BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.
The system can receive worklist entries from the LIS. The system can be
enabled to automatically request worklist entries from the LIS when a
sample is added to the inprocess queue.
1. Load the samples.
2. Verify that the system status is READY.
3. Select System Operations > Start/Restart.
4. If a Reagent Scan message displays:
a. Select OK > Cancel.
b. Scan reagents.
c. Repeat steps 3.
5. Select Analyze in LAS.
6. Select OK > Yes.
NOTE: The system status is SAMPLING - PROCESSING SAMPLES. Do not
replace samples or reagents while system is in this status.
7. To view patient processing progress, select Samples > Sample Trays.
8. Select the sample location on the LAS located to the left of the STT to
view the time progress of the sample.
NOTE: Colors indicate sample status.
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Chapter 2: Operating the System ADVIA Chemistry XPT System
BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.
Transmitting Results
1. On the command bar, select Test Results > Overview.
2. Locate the results to transmit.
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For more information about system settings and LIS test result release
options, refer to the system online help.
If enabled, the system can hold test results for review. To send the results
to the LIS, review the results, assign a disposition, and release the hold
status:
1. Select Test Results > Watch List.
2. Select a result or group of results.
3. Review the result replicates and flags.
4. Select Transmit.
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About Scan
Use Scan to do a reagent barcode scan and align each reagent pack with its
assay. A reagent scan also provides the system with operational information
about the reagent, such as its calibration interval and onboard stability.
CAUTION
Failure to scan after reagent containers have been loaded, moved,
or removed can cause erroneous results.
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Chapter 3: Reagent Management ADVIA Chemistry XPT System
Order Process
1 The Scanning barcode window displays, indicating the reagent
scan is in progress.
2 Reagent Tray 1 (RTT1) and Reagent Tray 2 (RTT2) revolve,
enabling the barcode scanners to read each barcode label.
3 The internal reagent database is updated with the scanned
barcode information for each position on RTT1 and RTT2.
4 The reagent pack is matched to an assay, according to the
R-code in the barcode label.
5 The Reagent Barcode Scan Confirmation window displays,
enabling a review of the scanned barcodes.
6 The Scanning volume window displays, indicating that the
reagent volume in each pack is being determined.
7 The reagent probe is lowered into each pack, measuring the
reagent level (or height) in each pack.
8 The volume of reagent in each pack is calculated from the
height measurement and the information contained in the
barcode.
9 The number of available tests is calculated by dividing the total
volume of reagent in a container by the volume required for a
test.
10 The reagent probe is washed after leaving each reagent pack to
avoid cross contamination.
11 The internal reagent database updates with the information
from the volume determination
12 The Scanning barcode window displays, indicating the reagent
barcode scan is finished.
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Order of
Usage Factor Description
1 Remaining The reagent pack with the least remaining
onboard stability OBS time is used first.
(OBS)
2 Expiration date If the remaining OBS is the same for all
reagent packs, the pack that expires first is
used first.
3 Number of If the remaining OBS and the expiration
remaining tests date is the same for all reagent packs, the
pack with the least number of tests
remaining is used first.
4 Slot position If the remaining OBS, the expiration date,
and the number of remaining tests is the
same for all reagent packs, the pack in the
lowest slot position on the reagent tray is
used first.
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Chapter 3: Reagent Management ADVIA Chemistry XPT System
• Select Reagents > Inventory for both Reagent 1 (R1) and Reagent 2
(R2) packs.
• Select Reagents > RTT1 Status for R1 packs.
• Select Reagents > RTT2 Status for R2 packs.
Reagent Tray 1
Reagent Turntable Tray 1 (RTT1) stores the reagents (R1) for the system
assays. An R1 reagent is the first reagent aspirated in the analysis process.
All 60 available reagent pack positions are refrigerated. Positions 1–56 are
used for assay reagents. Positions 57–60 are used for wash detergents that
prevent contamination. The RTT1 has a barcode reader (RBC-1) used during
reagent scan.
The Reagent Probe 1 (RPP1) aspirates the required reagent and dispenses it
into the reaction tray (RRV) cuvettes for analysis.
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A reagent pack can be used for more than one assay. Multiple R1 packs for
the same assay can be placed on RTT1. An assay may require two reagents.
The first reagent to be used (R1) is located on RTT1. The second reagent to
be used (R2) is located on RTT2.
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Reagent Tray 2
Reagent Turntable Tray 2 (RTT2) stores additional reagents (R2) for the
system assays. An R2 reagent aspirates after an R1 reagent in the analysis
process. There are 56 refrigerated reagent pack positions available.
Positions 1–52 are used for assay reagents. Positions 53–56 are used for
wash detergents that prevent contamination. The RTT2 has a barcode
reader (RBC-2) used during reagent scan.
The Reagent Probe 2 (RPP2) aspirates the required reagent and dispenses it
into the reaction tray (RRV) cuvettes for analysis.
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A reagent pack can be used for more than one assay. Multiple packs for the
same assay can be placed on RTT2. An assay may require two reagents. The
first reagent to be used (R1) is located on RTT1. The second reagent to be
used (R2) is located on RTT2.
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BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.
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• To remove a 70-mL pack, firmly grasp the pack and pull up and out.
• To remove a 40-mL pack, remove both the pack and the adapter that
holds the pack.
• To remove a 20-mL pack, remove the pack and adapter, if applicable.
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Ancillary Reagents
The system ancillary reagents are not assay specific. These reagents are
used in making sample dilutions, assay analysis, and cleaning the system.
1 Pure Water
2 ISE Baseline Solution
3 ISE Buffer 2
4 Reaction (RRV) Bath Oil
5 Cuvette Conditioner
6 Saline
7 Cuvette Detergent
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• Define calibrators.
• Define controls.
• Load reagents, system fluids, and supplies.
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○ An individual order for the sample exists and the sample is part of a
batch with a conflicting Manual Dilution request.
○ An individual order for the sample exists and the sample is part of a
batch with a conflicting Specimen type.
Managing Orders
Pending orders can be edited or deleted.
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Tracking Samples
Monitor the progress and status of samples and cuvettes on the system in
Samples.
For more information about sample tracking, refer to the system online
help.
Evaluating Results
In Test Results > Overview, hover the mouse over a column head to display
the type of flag that is found in that column.
Flag Description
Above Check Applied to a numeric result that is above a check
range as defined in range setup.
Absorbance Limit Photometric tests: Abnormal reaction absorbance
(d) (lower). Reaction absorbance is less than the Re.
Absorb (d) value. If main wavelength absorbance is
less than Sample (d) value, the subsequent points
are not used. A flag is triggered if there are
insufficient good points for rate calculation. When
Check D.P. 1 feature is used, D.P.1 absorbance is less
than Sample (d) value.
Absorbance Limit Cuvette Blank: The lamp energy during the cuvette
(D) blank check was too low. Photometric tests:
Abnormal reaction absorbance (lower). See
Absorbance Limit (d).
Absorbance Limit Photometric tests: Abnormal reaction absorbance
(u) (upper). Reaction absorbance is greater than the Re.
Absorb (u) value. If main wavelength absorbance is
greater than Sample (u) value, the subsequent
points are not used. A flag is triggered if there are
insufficient good points for rate calculation. When
Check D.P. 1 feature is used, D.P.1 absorbance is
greater than Sample (u) value.
Absorbance Limit Cuvette Blank: The lamp energy during the cuvette
(U) blank check was too high. Photometric tests:
Abnormal reaction absorbance (upper). See
Absorbance Limit (u).
Accepted Result Indicates an Accepted disposition.
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Flag Description
Reflexed A reflex test.
Auto Repeat A repeat test.
Below Check Result (numeric) that is below a check range as
defined in range setup.
Cal Invalid Calibration has either not been performed, or has
failed.
Calib Range H(j) The calibration high range was exceeded.
Calib Range L(k) The calibration low range was exceeded.
Cell Blank (N) Abnormal cuvette blank during the cell blank
measurement. During the cell blank measurement,
two readings are taken for each cuvette. N result
flag occurs if the readings differ by more than the
cell breakup limit value in the System Parameters
Settings window. The cuvette is not available for
assay.
Check Variable System cannot generate a ratio test result:
• Ratio component result has a non-numeric value.
• Result calculation produces a negative value.
• Result calculation yields indivisible by zero error or
other arithmetic error.
• Ratio component result exceeds the Test
Definition Result time limit setting and the system
cannot order an automatic repeat for that test.
Clock Estimated Time of Arrival (ETA) from the system.
Comment Result has a comment.
< Conc Range Less than the assay lower range limit defined in the
Test Definition abnormal low field.
> Conc Range Greater than the assay higher range limit defined in
the Test Definition abnormal high field..
Control Lot Expired A sample is loaded for an order after the control lot
expiration.
Critical High Result exceeds the reference range high value set in
Setup > Ranges.
Critical Low Result is less than the reference range low value set
in Setup > Ranges.
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Flag Description
Delta Check Failed Result failed a delta check.
Delta Check Passed Result passed a delta check.
Dilution Result calculated using a system dilution.
Dilution Error (d) The calculated ISE dilution factor is out of range.
Reference electrode value is less than 350.
High (Control) Result value is above the high limit for Primary or
Parallel control.
High (Patient) Result value is above the high limit for patient test.
Hold Result Test result with a Disposition of Hold.
Insufficient Sample Insufficient sample was detected by the liquid level
(s) sensor.
Insufficient Insufficient reagent was detected by the liquid level
Reagent (r) sensor.
Insufficient Diluent Insufficient diluent was detected by the liquid level
(t) sensor.
Insufficient Points Abnormal number of effective measurement points.
Less than Zero (Z) The result generated is less than zero.
Low (Patient) Indicates the result value is below the low limit for
patient.
Manually Added Patient result entered using the keyboard.
If this flag is applied to one or more ratio
component results, the ratio result is also flagged as
manually added.
Manual Dilution Sample’s manual dilution value is not equal to 1.
Not applied to a result for a manually entered test
request.
Max Absorbance The maximum absorbance limit was exceeded.
(K) This flag is linked to the Maximum Limit field at
Setup > Test Definition > Chemistry > Calculation.
Multiple Results Patient test has more than one result and at least
with a Previous one of these results has a Critical High or a Critical
Critical Result Low flag.
Multiple Results Patient test has more than one result and none of
Without a Previous the results has a Critical High or a Critical Low flag.
Critical Result
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Flag Description
Omitted Result Result with a Disposition of Omitted.
Patient QC Operator-specified QC event occurred on this test
prior to the performance of this patient test.
Prozone (P) Failed prozone check.
QC Failed A flag on a patient test result that indicates that an
operator-specified QC event occurred on this test
prior to the performance of this patient test.
Range Conflict More than one Range Flag applies to the result.
Repeat Repeat is requested by the operator for that test.
Auto Repeat and Repeat are mutually exclusive.
Safety (S) A system error, such as lamp energy out of range or
a reagent probe crash, occurred.
STAT Priority Test requested with a STAT priority.
Test Canceled Test canceled by the operator.
This is not the same as the Canceled flag.
Thermistor (T) Abnormal thermistor.
Variance (*) For Photometric Tests: Assay data was imprecise.
The imprecision or dispersion of assay data is
checked for EPA and CRA methods. The * flag occurs
if the dispersion exceeds the value in the Variance
field at Setup > Test Definition > Chemistry >
Calculation.
For ISE Tests: Calibration value error (H-STD or L-STD
error).The calibrator result is marked with the * flag
if the difference between the current and previous
ISE calibration after a maximum of 8 repetitions is
not less than the applicable Calibration Clear value
at Setup > Test Definition > ISE > Analytical
Conditions.
Within Check Result (numeric) that is within a check range
defined in range setup.
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Chapter 4: Sample Management ADVIA Chemistry XPT System
• To find 1 test, use Find in Page and then double-select the Sample ID or
Test Name.
• To find all tests in a selected test state or sample state, select a
Predefined Filter.
• To find a group of tests, use the Filter button to create a custom filter.
3. Select the samples or tests to view.
4. Select Edit/View.
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Chapter 5: Calibration
This chapter provides information about scheduling calibrators and
managing calibration data.
For more information about calibration, refer to the system online help.
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BIOHAZARD
Wear personal protective equipment. Use universal
precautions. See the recommended safety information section
when working with biohazardous materials.
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3. Remove and set aside the covers to the Sample Tray Turntable (STT) and
Calibration/Control Tray (CTT).
4. Determine the location for the calibrator, Quality Control (QC), or water
blank:
a. Select Samples > Cal/QC Sample Settings.
b. Select the appropriate tray from the Tray drop-down menu.
NOTE: Siemens recommends the following:
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Chapter 5: Calibration ADVIA Chemistry XPT System
c. View the container type and tray position for the calibrator, QC, or
water blank.
5. Prepare calibrators or QC according to its Instructions for Use (IFU).
6. Pour the calibrator, QC, or water into the container identified in Step 4c.
7. Place the calibrator, QC, or water into the position identified in Step 4c.
CAUTION
Failure to place the calibrators, QC, or water in the positions as
defined in Cal/QC Sample Settings would go undetected by
the system and yield erroneous results.
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BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.
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Chapter 5: Calibration ADVIA Chemistry XPT System
4. Remove and set aside the Control/Calibration Tray Turntable (CTT) and
the Sample Tray Turntable (STT) covers.
5. Load the required calibrators.
NOTE: Refer to Samples > Cal/QC Sample Settings for the correct
position of the calibrators.
6. Replace the STT and the CTT covers.
7. Close the top left cover.
8. Select System Operations > Start/Restart.
9. Select Analyze Single Point > Assay Selection > Yes.
10. Select the required assays.
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BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.
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Chapter 5: Calibration ADVIA Chemistry XPT System
4. Remove and set aside the Sample Tray Turntable (STT) cover.
5. Load the required calibrators.
NOTE: Refer to Samples > Cal/QC Sample Settings for the correct
position of the calibrators.
6. Replace the STT cover.
7. Close the top left cover.
8. Select System Operations > Start/Restart.
9. In Calibration, select Analyze Multi Point.
10. Select either MSTD1 or MSTD2.
11. Select Assay Selection.
12. Select the required assays.
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ADVIA Chemistry XPT System Chapter 5: Calibration
BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.
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Chapter 5: Calibration ADVIA Chemistry XPT System
• Order date
• Assay
• Order status
To access the Calibration Order Filter, select Calibration > Calibration
Results > Filter.
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Chapter 5: Calibration ADVIA Chemistry XPT System
About Wavelengths
Use the Wavelengths window to view the reaction curves for each
wavelength the system uses to measure absorbance. Absorbance is
measured at 14 different wavelengths—340, 410, 451, 478, 505, 545, 571,
596, 658, 694, 751, 805, 845, and 884 nanometers.
To access the Wavelengths window, select Calibration > Calibration
Results. Select an assay, and select View > Reaction Curve. Select a level
and replicate, and select Wavelengths.
CAUTION
Ensure care when deleting a calibration result. Deleting a
calibration result permanently removes all associated data
from the database.
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Chapter 5: Calibration ADVIA Chemistry XPT System
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ADVIA Chemistry XPT System Chapter 6: Quality Control
Scheduling QC Samples
Control samples can be scheduled according to day and time, test count, or
control.
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Chapter 6: Quality Control ADVIA Chemistry XPT System
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ADVIA Chemistry XPT System Chapter 6: Quality Control
QC Statistics Tabs
Additional Features
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ADVIA Chemistry XPT System Chapter 6: Quality Control
Auto-Select check box. Any new control files with issues are listed but are
not automatically selected.
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Chapter 6: Quality Control ADVIA Chemistry XPT System
5. To adjust the scale of time for the chart to display, use the sliding control
in the Scale area.
6. In either the chart or the table, select 1 or more data points to perform
any of the following functions:
• +3SD
• +2SD
• +1SD
• Target Mean
NOTE: If a control file has more than 1 target mean, the target means
and associated limits are plotted at their original value, resulting in an
offset view at the point of change.
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ADVIA Chemistry XPT System Chapter 6: Quality Control
• -1SD
• -2SD
• -3SD
X-axis
The X-axis represents the selected time frame. The Advanced QC application
allows you to scale the chart so that it displays only a portion of the date
range at 1 time.
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Chapter 6: Quality Control ADVIA Chemistry XPT System
Calculating a Z-score
1. Find the difference between the control result and the expected mean.
2. Divide the difference by the standard deviation observed for that control
material.
Example: For a control result of 110 on control material having a mean
of 98 and a standard deviation of 4, the z-score is 3.00 [(110 - 98)/4].
A z-score of 3.00 means that the observed control value is 3 standard
deviations above its expected mean, so this result exceeds a 2SD control
limit.
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ADVIA Chemistry XPT System Chapter 6: Quality Control
About Filters
Use the Filter window to perform the following tasks:
• Remove a time filter from the control files displayed on the Analysis
window
• Apply a time filter control files displayed on the Analysis window
• Select Control files to display on the Analysis window
• Select a time range for exporting files in Tools > Export.
When the Filter window has a time frame set, the Current Time Filter panel
displays the starting date and time and the ending date and time of the
current filter. The Apply Time Filter button also displays a Filter icon.
• Monthly
• Summary
• Exception
• Custom Report 1
• Custom Report 2
• Patient Median Report
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Chapter 6: Quality Control ADVIA Chemistry XPT System
Sort By Options
Options
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ADVIA Chemistry XPT System Chapter 6: Quality Control
Selecting Reports from either the Review window or the Analysis window
displays the control and patient median files on the Reports window. If you
applied a time filter, only the filtered QC and Patient median points display
for reporting.
1. At the QC > QC Statistics > Review or Analysis tab, select Reports.
2. At Report Name, select the type of report.
3. At Report Contents > Title enter a title for the report.
4. At Report Contents > Data Points select an option for data points.
NOTE: The Data Points options do not appy to Patient Median files.
5. At Report Contents > Sort By select the sort order.
NOTE: The Sort By options do not apply to Patient Median files.
6. At Report Contents > Options select the contents of the report.
NOTE: The Patient Median option may not appear on systems that do not
have the Patient Median feature.
7. Use the Time Filter to apply and remove time filters.
8. In the Show By area, select Control or Test to add the heading in the
first column of the report.
NOTE: Selecting Expand, to the right of the scrolling checklist on both
the QC tab and the Patient tab, causes this checklist to expand into a
larger separate window, thus showing a larger number of files at one
time and making file selection easier and quicker. When you select Close
on this expanded screen, the selections transfer to the original screen
and the expanded screen closes.
9. Select Setup to create report headings or footers.
NOTE: The Reports Header and Footer buttons may be hidden on some
systems.
10. Select Print.
NOTE: Reports can either be printed on paper or saved to a file.
Electronic reports are saved as Adobe PDF format.
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Chapter 6: Quality Control ADVIA Chemistry XPT System
• Reports Setup
• Local Settings
• Window Configuration
Chapter 7: Maintenance
This chapter provides information about system maintenance. The system
monitors maintenance activities and provides notification when a
scheduled activity is due.
For more information about preventative maintenance procedures and the
corresponding warnings and cautions, refer to the system online help.
WARNING
Use personal protective equipment (PPE) to reduce operator
exposure to hazards when operating the system. Do not attempt
maintenance inside the system unless the system is in the READY
status.
The table on the Schedule tab displays information about all defined
maintenance activities:
Action Description
Disconnecting the system from Turns off the entire system
power or turning off the main including the tray refrigeration and
power switch workstation.
Turning the system power off from Turns off the entire system except
front panel the tray refrigeration, workstation,
and ISE module.
Selecting the Emergency stop Stops all system processing and
button mechanical movement.
WARNING
Do not open system covers when shutting down the system
because probes and trays move during this process.
CAUTION
Do not turn on system power for at least 3 minutes after a
system shutdown has completed.
1 System Power
2 Computer Power Switch
3. Slide the computer power switch to the left and press the power button,
if applicable.
4. Wait for the Windows reboot to complete and the system workspace to
display on monitor.
5. Turn system power switch to ON.
6. Login to system.
NOTE: The workstation is connected to the system when the connection
arrows are green and the emergency button light displays.
CAUTION
Ensure that all probes and mixers are free to move without
obstruction and that all system covers are in place to avoid
possible injury and damage to the system.
CAUTION
Do not turn on system power for at least 3 minutes after a
system shutdown has completed.
BIOHAZARD
Wear personal protective equipment. Use universal
precautions. See the operator’s guide for your system for
recommended precautions when working with biohazardous
materials.
CAUTION
Do not disconnect the system or turn the main power switch
off. Disconnecting the system from power or turning off the
main power switch turns off the entire system including the tray
refrigeration and workstation.
BIOHAZARD
Wear personal protective equipment. Use universal
precautions. See the recommended safety information section
when working with biohazardous materials.
CAUTION
Do not disconnect the system or turn the main power switch
off. Disconnecting the system from power or turning off the
main power switch turns off the entire system including the tray
refrigeration and workstation.
BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when working
with biohazardous materials.
1. Check for and remove any obstructions in the following areas before
restarting the system:
CAUTION
Do not disconnect the system or turn the main power switch
off. Disconnecting the system from power or turning off the
main power switch turns off the entire system including the tray
refrigeration and workstation.
• Sample probes
• Reagent probes
• System covers
• Cuvette trays
• Wash stations
2. Perform a startup wash.
3. Select System Operations > Initialize.
4. Wait until the system status is READY and then return to normal
operation.
5. If an error occurs during initialization, correct the error.
6. If the error persists, contact technical assistance.
BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when working
with biohazardous materials.
CAUTION
If the power is disrupted for an extended period of time, turn the
system off to prevent serious damage to the system when the
power is restored.
• Wash stations
5. Perform a startup wash.
6. Wait for the Windows reboot to complete and the system workspace to
display on the monitor.
7. Sign in with user ID and password.
8. Select System Operations > Initialize.
9. Wait while the system equilibrates the temperature and Warming Up
appears in the status area.
10. Wait until the system state is READY then return to normal operation.
11. If an error occurs during initialization, correct the error.
12. If the error persists, contact technical assistance.
WARNING
Do not open system covers when shutting down the system
because probes and trays move during this process.
If the system does not respond to the actions listed in the table above:
1. Stop new samples coming to the system.
2. Allow current samples to finish processing.
3. Press the Emergency Stop button.
Using Diagnostics
Use Diagnostics to test the operation of system components and move
system components when corrective action procedures are performed.
Refer to the system online help for more information about Manual
Operations, Clot Monitor, and LLS Monitor.
View Action
Software version Select Setup > Settings > About.
System version Select Setup > Settings > About > Instrument Info.
Legal notices Select Setup > Settings > About > Legal Notices.
• Archive data
• Delete data
• Database Backup
• Database Archiving
• Move to Historical
• Database Optimization
3. Select Edit/View to review the automatic activity settings.
• Delete
• Move to Historical
• Database Backup
• Database Archiving
• Move to Historical
• Database Optimization
3. Select Perform.
• Customer-changeable parameters
• Event log
• Maintenance log
• System settings
• Tube types
• Reagent inventory
• System calibrations
• Select All Data to restore all the data from the file.
• Select All Data Except to restore all data except the data groups you
select in this area.
• You must leave at least one data group unselected.
5. Select Restore.
6. When Cancel All is displayed, you can cancel the restore process until
the process is in the final stages.
When the process is complete, the system displays the Sign-in window.
7. Sign in to the system.
Exporting Data
For more information about exporting data, refer to the system online help
for the required feature window.
Field Description
Prefix You can configure a prefix as part of the file name in
Setup > Settings > Operator Setup. The prefix can be
up to 10-alphanumeric characters. Special characters are
not allowed.
System Serial Serial number of the system.
Category This is the type of file that is exported:
• Audit Trail Log
• LIS Communication Log
• LAS Logs
• Maintenance Logs
• System Messages Log
• Test Results
• User Event Log
• Database Backup
Type Export, Database Backup
YYYY The year the activity was started.
MM The month the activity was started.
DD The Day of the month that the activity was started.
HH_MM_SS The hours, minutes, and seconds that the backup or
export was started (24-hour clock).
If the export is more than 1 volume, a -1, -2, is added to the file name. An
example of a multi-volume data export:
Sys76_K54321_TestResultsExport_2012_3_16_17_36_14-1.xml
Sys76_K54321_TestResultsExport_2012_3_16_17_36_14-2.xml
CAUTION
Do not customize options without ensuring that the appropriate
value is selected for the laboratory and continue to evaluate the
integrity of that value. Failure to do so can cause reporting of
unexpected results. For example, if the system is configured to
send all results and additional data except results on hold to the
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.
The laboratory is responsible for ensuring that all system configurations are
correct including sample options, test parameters, and system options. This
is true regardless of whether the laboratory personnel set the values,
Siemens personnel set the values to specifications the laboratory provided,
or Siemens personnel set the values to the original default values
established at the time of manufacture.
For more information about system configuration, refer to the system
online help.
places are required by the laboratory, edit the test definition before
calibration.
The ability to make modifications to test definition fields varies according to
user group. Recalibration is required only after certain test definition fields
are updated. An informational message displays whenever an update
occurs that requires recalibration. The modified Siemens-defined and user-
defined assay are not available for processing QC or patient samples until
the calibration passes.
• Chloride (CL)
• Potassium (K)
• Sodium (NA)
Adding an Assay
1. Ensure that the reagent code for the assay is configured before
proceeding.
2. Select Setup > Test Definitions > Chemistry > Add.
3. Ensure test definition Name does not include a space.
NOTE: Ratios are not applied to any test definition with a space in the
name.
4. Select Save.
7. Enter the RTT1 and RTT2 position, reagent volume, diluent volume, and
mix.
8. If a dilution can be performed on the assay, enter the following
information in either serum or urine sample definitions:
• sample volume
• dilution method
• dilution sample volume
• diluent volume
• diluent position
9. Select Continue > Save.
• Blank (u)
• Blank (d)
• Sample (u)
• Sample (d)
• Prozone Value
3. Select Auto. set to define an automatic setting.
4. Select Continue.
• Selecting a Test Profile automatically selects all the member tests in the
profile and adds them to the Selected Tests area.
• You can select or clear the individual check box of one or more profiles
members.
The Test Profile check box remains selected.
• When you save the order, only the individual member test selections are
saved.
If you open a saved order for viewing or editing, any previously selected
test profiles are unselected in the Test Profiles selection box. The tests
selected at the time the order was saved are still selected. Only selected
tests are displayed in the Selected Tests table. The Test Profile name is
not displayed.
• You can select one or more Test Profiles.
If an individual test is a member of more than one selected profile, only
one instance of the test is in the selected tests table. If you cancel the
selection of the common member, the Test Profile remains selected.
The system validates all ranges when you select Save. If the patient
matching option is selected in the Operator Setup area, all matching
ranges perform any Repeat or Reflex values used with the range for the
currently reported result.
The Reference tab Details area contains the following fields:
• To create a range between two values, enter the Low value and the High
value.
• To create a range where all results above a certain value are Normal,
enter a Low value only.
• To create a range where all results below a certain value are Normal,
enter a High value only.
• To add Critical Low or Critical High values, you must first add Low and
High values.
6. Complete other range information.
7. Enter Demographic information, if applicable.
8. Select Save.
9. Repeat steps 3–8 to define separate ranges based on age, sex,
specimen, or other criterion.
If you have the appropriate Security permissions, you can edit the Results
Review mode, the Reflex information, and the Comments in a Predefined
Interpretation range.
1. On the command bar, select Setup > Test Definition > Chemistry.
2. Select a test and then select Ranges > Interpretation.
3. Select the range to edit.
4. On the Range list area, select Edit.
5. To edit the Result Review mode, use the Result Review drop-down list
in each area.
6. Edit the Reflex section, as necessary.
7. Edit Comments, as necessary.
8. Select Save.
• System name
• Alarm volume
• Pointing device
• Storage location for data export
• Report options
About Informatics
Enabling Informatics allows the system to receive updates from the Remote
Server and send information to the Remote Server.
When the system receives an update, such as a software update or a new
customer bulletin, the system posts a message and logs the occurrence in
the Event Log. The update information is displayed on the Utilities >
Available Updates tab.
To send data to the Remote Server, you can select any or all of the data
types and event codes displayed on the Informatics Setup tab and select a
time convenient for the system to send the data. No patient demographics
or identifying information is included in any data sent to the Remote
Server.
When the Remote Server requests connection, the Operator can Reject the
connection.
4. In the Query Settings area, select each option that applies to your LIS
connection:
5. In the Patient Result Settings area, select each option that applies to
your LIS.
NOTE: Some options are mutually exclusive with other options.
6. In the QC Result Settings area, select each option that applies to you LIS.
7. In the Patient and QC Result Settings area, select each option that
applies to your LIS.
CAUTION
If the system flag specification is not followed, results that
should be held for review, repeat, or reflex may be released
incorrectly by the LIS.
Configuring LAS
When samples load from the LAS, the system uses communication from the
LAS to index samples moving past the side of the system on a conveyor. The
sample probe moves out of the left side of the system to aspirate the
samples. The system cannot process calibrator, QC, and patient samples
that are loaded in the STT/CTT at the same time as samples processed from
the LAS.
Ensure a default LAS sample tube type is defined in the Setup > System
Configuration > Container Settings.
Enable the LAS:
1. Select Setup > System Configuration > Operation Mode.
2. Select External Transport and Operate under LAS.
3. Select Save.
4. Restart the system using the system power button on front of system.
5. Load the sample racks on the LAS.
Appendix A: Safety
This section provides information about the following hazards:
• Biohazards
• Scanner lasers
• Moving components
This summary is based on the guidelines developed by the Centers for
Disease Control, the Clinical and Laboratory Standards Institute Document
M29-A3, Protection of Laboratory Workers from Occupationally Acquired
Infections, and the Occupational Safety and Health Administration’s
Bloodborne Pathogens Standard.1-3
• 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
• Splashes or aerosol contact with skin and eyes
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,
37:377–382, 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.
LASER WARNING
To avoid damage to the eyes, never look directly at the laser beam
or at its reflection from a shiny surface. Only trained field service
personnel should perform procedures related to laser assemblies.
Refer to Protecting Yourself from Lasers Emitted from Barcode
Scanners in the operator’s guide for more information.
The specifications for the laser optical assemblies in the ADVIA Chemistry
XPT ancillary reagent, primary reagent, and sample barcode scanners are
summarized in the following table.
Table 20: Specifications for Laser Optical Assemblies in the Reagent and
Sample Barcode Scanners
Characteristic Specification
Maximum Power Output 85 µW (STT, RTT)
Wavelength 650 nm (STT); 660 nm (RTT)
Pulse Duration 112 µs (STT, RTT)
Units of Beam Divergence 0.7 mr
The locations of the reagent and sample barcode scanners and their
associated laser safety labels are shown later in this chapter. 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.
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.
Figure 42: DPP and SPP Noise Reduction Covers and Locks
Figure 47: System Interior- DPP and SPP Covers Open- System Symbols
CAUTION
Do not move or install the ADVIA Chemistry XPT system.
Unauthorized movement or installation can damage the
system and void the warranty or service contract. Unauthorized
movement can also affect the instrument calibrations. Only
technical assistance should install or relocate the system.
1 Concentrated Waste 1
2 Cuvette Detergent Waste
3 Waste Overflow Sensor Connector
4 Concentrated Waste Overflow Sensor Connector
5 General Waste
6 Cuvette Detergent Waste
7 Pure Water Bottle Overflow
8 Concentrated Waste 2
9 Reagent Grade Water Inlet
Power Safety
WARNING
Ensure the approved protective grounding connection is in
place to prevent electrical shock. For more information on the
protective grounding connection, contact technical assistance.
CAUTION
Do not place any objects that interfere with power plug access.
Ensure there is sufficient space around the system to access all panels and
doors. The power plug should be located in a place easily accessed by the
operator.
Electrical Safety
CAUTION
To avoid exposure to shock hazards or damage to the system,
power off the system before proceeding with any electrical system
maintenance procedures.
CAUTION
Only approved decontamination or cleaning agents must be
used to prevent system damage. It is the operator's
responsibility to use decontamination or cleaning agents that
do not cause damage as a result of a reaction with system parts
or supplies.
CAUTION
Please observe the warning and hazard statements appearing
throughout the online Operator’s Guide. If the system is used in
a manner not specified by Siemens, the protection provided by
the equipment may be impaired.
Warranty Period
The limited warranty period generally commences upon installation of the
original instrument at the customer’s location and extends for a period of
one year thereafter, unless otherwise specifically agreed to by and between
Siemens (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).
Replacement of Parts
In performing service, Siemens or its authorized distributors will provide
appropriate parts to repair the instrument, or will arrange for the exchange
of the instrument or affected parts, at no charge with the exception of
certain parts or subassemblies that are considered Customer Replaceable
Items. Customer replaceable 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 operator’s guide for a complete list of
customer replaceable items for any specific model of instrument.
5. Customer did not purchase the instrument from Siemens or one of its
authorized distributors.
6. The instrument has not been installed within 90 days of shipment to the
customer’s facility unless otherwise specified.
7. The customer has not performed appropriate customer maintenance
procedures, as outlined in the system operator’s manuals.
8. The instrument has been misused or used for a purpose for which it was
not intended.
9. The instrument has been damaged in transit to the customer or
damaged by the customer while moving or relocating it without
supervision by a Siemens representative.
10. Damage was caused by floods, earthquakes, tornados, hurricanes, or
other natural or man-made disasters.
11. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil
commotion.
12. Damage was caused by electrical surges or voltages exceeding the
tolerances outlined in the system operator’s manuals.
13. Damage was caused by water from any source external to the
instrument.
14. The customer has purchased an alternative agreement whose terms of
warranty or service supersede these provisions.
Siemens or its authorized distributors will invoice customers, at current
standard labor and parts rates, for instruments repaired to correct damage
or malfunctions due to any of the reasons listed above.
OTHER THAN AS STATED ABOVE, THERE ARE NO OTHER WARRANTIES,
EXPRESS OR IMPLIED WITH RESPECT TO THE INSTRUMENT, ITS SALE TO THE
CUSTOMER, ITS LEASE TO THE CUSTOMER, OR THE SALE OF THE
INSTRUMENT TO THE CUSTOMER AT THE EXPIRATION OR TERMINATION OF
THE LEASE AGREEMENT.SIEMENS SPECIFICALLY DISCLAIMS ANY AND ALL
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
USE OR PURPOSE. SIEMENS LIABILITY FOR BREACH OF ANY WARRANTY OR
SERVICE AGREEMENT SHALL BE LIMITED ONLY TO THE REPAIR OR
REPLACEMENT OF DEFECTIVE EQUIPMENT AND SHALL NOT INCLUDE ANY
DAMAGES OF ANY KIND, WHETHER DIRECT, INDIRECT, INCIDENTAL,
CONTINGENT, OR CONSEQUENTIAL. SIEMENS SHALL NOT BE LIABLE FOR
DELAY FROM ANY CAUSE IN PROVIDING REPAIR OR EXCHANGE SERVICE.ANY
LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH APPLICABLE
LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC WRITTEN AGREEMENT
DO NOT APPLY TO CUSTOMERS IN THOSE JURISDICTIONS OR SUBJECT TO
THOSE AGREEMENTS.
Addresses
This section provides the following information:
The ADVIA Chemistry XPT system supports the use of CLRW CLSI/CAP or
ISO3696 specified water. At a minimum, the water supply must meet the
following parameters to ensure proper operation for each system:
Specification CLRW
Maximum bacterial content colony 10 (preferably bacteria free)
forming units per mL (CFU/mL)a
pH Not applicable
Minimum resistivity (megohm-cm 10 (in-line measurement by sensor
to 25ºC)b or resistor)
Maximum silicate (mg/L)c 0.05
Particulate matter (µm)d Smaller than 0.22 µm (water is
passed through a 0.22 µm filter)
Organic compoundse Pretreat with activated carbon,
distillation, or reverse osmosis
a. Bacterial content – The number of colony forming units in water. Bacterial content is a
water contaminant measured to determine water quality.
b. 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 subsequently the better the water quality.
c. Silicates – Compounds removed to produce CLRW.
d. Particulate matter – Undissolved (insoluble) substances larger than 0.22 µm that are
removed by the filter.
e. Organic compounds – Compounds removed to produce CLRW.
Purifying Water
As with all diagnostic testing procedures, good laboratory practices suggest
that you establish a protocol that supports the manufacturer’s 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 Changes water from liquid to vapor and leaves
behind impurities such as particulates and bacteria
Deionization Uses synthetic resins to remove ionized impurities
by ion exchange
Reverse Osmosis Forces water under pressure through a
semipermeable membrane to remove dissolved
solids and organic impurities
Adsorption Uses activated carbon, clays, silicates, or metal
oxides to remove organic impurities
Filtration Forces water through a semipermeable membrane
to remove insoluble matter, emulsified solids,
pyrogens, and microorganisms
The quality of the reagent water you produce depends on the quality of the
water you start with (source water), and the performance of your water
purification system.
To produce the type of water required, a purification system may be needed
that uses a combination of methods. For example, if producing CLRW, a
system is required that uses adsorption to remove organic impurities,
deionization to remove ionized impurities, and filtration to remove
particulates.
The following figure displays a water purification system that combines
adsorption, deionization, and filtration to produce CLRW.
1 Pump
2 Source water
3 Check valve
4 Flow controller
5 Resistivity indicator
6 Valve
7 Filter
8 CLRW output
9 Ion exchange
10 Carbon
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. Clinical and Laboratory Standards Institute. Preparation and Testing of
Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth
Edition. CLSI document GP40-A4-AMD (ISBN 1-56238-610-7). Clinical
and Laboratory Standards Institute, 950 West Valley Road, Suite 2500,
Wayne, Pennsylvania 19087-1898 USA, 2012.
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 container labels. All
system fluids must be stored as stated on the container labels.
Siemens is not responsible for the performance of the system when user
defined reagents are used.
The total volume of ancillary reagents used by the system can vary slightly
from the volumes provided in the table below. Usage volumes could vary
based on contamination settings, reruns, wash settings, and so on.
Use this information to plan ancillary fluid replenishing.
Appendix D: Supplies
In order to maintain operation of the system, ensure the following supplies
are available for preventative maintenance procedures.
System Supplies
The following is a list of system supplies with the REF to assist in the
ordering process.
Appendix E: Specifications
This section summarizes the system design specifications.
System Specifications
Safety Certifications
Refer to the DECLARATION OF CONFORMITY for the ADVIA Chemistry XPT
system. Contact the local technical support provider or distributor for a
copy.
Dimensions
Allow enough space to access all sides of the system. The area around the
system must be free of obstacles after installation and properly ventilated.
1 Drain
2 Water Tap
3 Distilled Water Supply
4 Power Receptacle Emergency Shutoff
Environmental
Electrical Requirements
Technical Specification
Table 30: Product Specification
Barcodes Description
Sample barcodes 20 digits; interleaved 2 of 5, Code 39,
Code 128, Codabar; A, B, and special
characters (.-+/*$%)
Calibration/QC Description
Calibration interval Up to 60 days, tracked by
software
Auto-calibration and auto-QC User-defined time interval or
with new reagent pack
View calibration Graphical display of
calibration curves
QC data Graphical display of QC,
realtime and QC monitoring;
Levy-Jennings or Westgard
rules
Calibration and control tray 61 refrigerated positions for
calibrators, controls, and
diluents
User Interface/Data
Management Description
Operating system Windows 7
System documentation Operator’s manual, quickstart
guide, quick reference guide,
and online help
Data storage 500,000 assay results
Onboard maintenance logs Schedule and monitor routine
maintenance activities via
software
Host interface TCP/IP bidirectional
Host query ASTM; system requests work
order or batch of work orders
from host
Symbols
Table 44: System Symbols
Symbol Description
This symbol is used for both warnings and
cautions.
• WARNING indicates the risk of personal injury
or loss of life if operating procedures and
practices are not correctly followed.
• 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.
Symbol Description
This symbol identifies the location of a protective
earth (GND) conductor terminal.
Symbol Description
This symbol indicates the location of the barcode
scanner connector.
Symbol Description
This symbol indicates the serial number of a part
or product.
Symbol Description
This symbol indicates compliance with the
restriction of hazardous substances used in
electrical or electronic equipment.
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.
This symbol indicates that the product is the
cuvette conditioner.
Symbol Description
The product conforms to established
requirements for quality and safety, and is a
certified product in the UKRSEPRO Register for
Ukraine.
The following symbols can also appear on the exterior of the system or one
of its components.
Symbol Description
This symbol indicates that the product is a Class 2
laser product, with no laser exposure during
normal operation.
This symbol indicates that the product contains
Class 2 laser radiation with the caution to not stare
into the beam. The symbol is located in the
reagent tray area of the system.
This symbol indicates that the product contains
Class 2 laser radiation with the caution to not stare
into the beam. The symbol is located in the sample
tray area of the system.
Item Description
Measurement Serum, plasma, urine, CSF (cerebral spinal fluid),
Sample oral fluids, and whole (blood). These are assay
dependent.
Collection Tubes 5-mL (13 X 75 mm), 7-mL (13 X 100 mm), and
10-mL (16 X 100 mm) collection tubes.
Sample Cups Small Sample Container (SSC), ADVIA Chemistry
Sample Cup (ACSC), or EZEE-NEST Sample Cup
placed in an STT sample adapter or tube.
Sample Turntable Used for patient samples, and calibrators for
Tray (STT) multipoint calibration assays.Two lines (outer and
inner) of 42 samples each. Total positions in STT
tray: 84. Sample barcode (20 digits): Code 39,
Codabar, and Interleaved 2 of 5, Code 128 format
A, B and special characters ( . - + / * $ % ).
Calibrator/ Control Used for calibrators for single point and reagent
Turntable Tray (CTT) blank only assays, controls, diluents, and wash
solutions. Two lines, 34 samples in outer line and
27 samples in inner line. Total positions in CTT
tray: 61. Liquid contents on CTT tray are cooled to
between 5°C and 15°C.
Original sample 2 to 30 µL
volume
Reaction sample 2 to 25 µL (0.1 µL increments)
volume (after
dilution)
Item Description
Reassay Container Dilution tray (DTT) cuvette
Reassay Minimum 2 µL
sampling volume
Redilution Diluted sample can be rediluted directly from tray.
Displays as D1 or D2 for the redilution or change in
sample volume.
Dilution Cuvette 300 µL
Maximum Volume
Dilution Cuvette 45 µL
Dead Volume
Barcode Capability I2 of 5, Codabar, Code 39, Code 128
To view required sample volumes for an order, select Orders > View
Pending Order. Total volume is displayed in Volume Required column and
does not include the dead volume for the sample.
Dead
Volume Container Type Description
50 µL SSC/Adapter SSC in an STT sample adapter
50 µL SSC/13 X 75 mm SSC in a 5-mL (13 X 75 mm)
50 µL SSC/13 X 100 mm SSC in a 7-mL (13 X 100 mm)
50 µL SSC/16 X 100 mm SSC in a 10-mL (16 X 100 mm)
50 µL ACSC/Adapter ACSC in an STT sample adapter
100 µL ACSC/16 X 100 mm ACSC in a 10-mL (16 X 100 mm)
50 µL EZEE-NEST /Adapter EZEE-NEST in an STT sample adapter
50 µL EZEE-NEST/16 X 100 mm EZEE-NEST in a 10-mL (16 X 100 mm)
350 µL 13x75 tube
350 µL 13x100 tube
700 µL 16x100 tube
Glossary
Term Definition
Activate Function used to enable a test or a pack for full
use on the system.
Active Test Test from the menu that is enabled for use on
the system.
ADVIA Chemistry See Sample cup. Abbreviation: ACSC.
Sample Cup
Analyte Substance of unknown concentration in a
sample.
Ancillary Reagent Additional reagents required for an ISE assay,
system wash, or sample dilution.
Archive A comprehensive collection of data. A file
designed for space-efficient, long-term
storage.
ACSC See ADVIA Chemistry Sample Cup.
Assay Generic term that refers to the chemical
analysis for a specific analyte in a sample. Each
assay possesses a unique test protocol. Also
called test.
Assay Format The sequence of events during an assay,
including incubation time, wash and aspirate
cycles, and addition of reagents.
Automatic Dilutions Dilutions performed by the system when a
result exceeds the dilution point defined at the
Test – Ranges window. Dilutions performed by
the system when scheduled by the operator at
the Worklist – Dilutions window.
Automatic Transfer Option used to automatically send test results
from the system to a remote device, or to
automatically receive worklist requests from a
remote device.
Backup Process of copying the data files contained on
the system hard disk to flash drives or writable
CDs/DVDs.
Barcode Encoded information that is read by an optical
scanner.
Term Definition
Barcode Label A label containing encoded information that is
placed on reagent vials and sample cups. See
also barcode.
Batch Method of order entry that provides the
convenience of specifying 1 or more tests on
multiple samples.
Baud Rate Speed of data transmission in bits per seconds
(bps) between the system and a remote
device.
Bidirectional Interface configuration allowing information
Interface to be transferred to and from another device.
Buffer (Chemistry) Solution composed of a weak acid or base and
its salt that is used for controlling ionic
strength. Buffers maintain the pH of a
solution.
Buffer (Electronic) Data storage used to compensate for
differences in information flow rate or in the
time that events occur when data is
transmitted between devices.
Calibration The use of 1 or more samples of known
concentrations that are processed on the
system. The system calculates results from the
normalized curve.
Calibration Curve Data that normalizes the system against stored
data for the tested analyte. The calibration
data compensates for current running
conditions and instrument variability. The
system calculates the required sample dose
from the normalized curve.
Calibration Data Details of the calibration including the SID,
concentration, CV, and flags for the low and
high calibrators.
Calibration Interval Number of days or hours between required
calibrations.
Calibration/Control Cooled component where calibrators,
Tray Turntable controls, and diluents are stored.
Abbreviation: CTT.
Term Definition
Calibrator Solution that contains a known concentration
or a known reactivity of 1 or more analytes
and that provides a reference for converting
measured signals into concentrations.
Calibrators are analyzed with reagents to
obtain calibration data points. See calibration
data.
Central Processing Main printed circuit board of a computing
Unit system that interprets instructions and directs
the system operations. Abbreviation: CPU.
Character Parity Transmission setting used to check for
transmission errors between the system and a
remote device. This setting must be the same
at the system and the remote device to
maintain compatibility between the systems.
Check Digit Digit at the end of the barcode used to verify
that the barcode was correctly scanned.
Check Range Value entered in the test definition beyond
which the operator can program the system to
automatically repeat tests. Also called alert
range or action range.
Checksum Variable, 2-digit, hexadecimal number that is
part of the data link message that frames and
supports error detection.
Clinical Laboratory Laboratory water that meets the highest grade
Reagent Water specifications for clinical laboratory use.
Abbreviation: CLRW.
CLRW See Clinical Laboratory Reagent Water.
Coefficient of Percent coefficient of variation among the
Variation replicates for a sample. Abbreviation: CV.
Collection Tube Tube used to collect patient blood samples by
venipuncture.
Communication Serial RS-232 ports on the system that can
Ports connect the system to an external, remote
device, such as an LIS or a data management
system.
Term Definition
Completed Assay Assay for which a valid result was generated or
for which all required sample aspirations are
completed.
Concentration Amount of analyte measured. Abbreviation:
Conc.
Confidence Interval A statistical value that describes how likely the
statistical results are to be accurate.
Configuration Settings of software and hardware.
Continuous Level Measurement of a wide range of resolvable
Sensing fluid levels. For example, sample levels can be
measured at any volume.
Continuous Operation allowing the system to process
Operation samples without interruptions to add or
remove samples or replenish supplies.
Control Quality control material used to determine if
the system is reporting valid results.
Control Value Range Range of acceptable results established by the
quality control material manufacturer. The
control value range is provided in the assay
manual.
Corrective Action Activity performed by the operator to solve a
problem.
CPU See Central Processing Unit.
CTT See Calibration/Control Tray Turntable.
Cut-off Point Medical decision point for a qualitative assay.
Results above the cut-off point are reported
with a different qualitative interpretation than
those below the cut-off point.
Cuvette Plastic set of containers that hold the reaction
mixture on the system. The reaction tray (RRV)
moves cuvettes containing reaction liquid
(sample and reagent) in front of a halogen
lamp beam that sends light through the
cuvettes. All wavelengths are measured with
each test.
Cuvette Conditioner Solution used in cuvette wash cycles.
Cuvette Detergent Solution used in cuvette wash cycles.
Term Definition
CV See Coefficient of Variation.
Data Bits Number of bits transmitted between a system
and a remote device.
Dead Volume Smallest reagent or sample volume detectable
by the system.
Default Value Value defined and preset by Siemens.
Define Establish a value for a variable or symbol, or to
establish what the variable represents.
Deionized Water Water that was filtered through synthetic
resins to remove ionized impurities by ion
exchange and an example of CLRW. Also
known as DI water.
Demographics Information about a patient or sample such as
name, identification number, date of birth,
sex, location, and physician.
Diluent Saline-based solution used to dilute a sample.
Dilution Pipetting See Sample Dilution Pipetting Probe.
Probe Abbreviation: DPP.
Dilution Tray Mixer Component that stirs the contents of the DTT
cuvettes brought to the mixer position. Mixing
is performed using a reciprocating and
rotating mixing rod. Abbreviation: DMIX.
Dilution Tray Component that contains cuvettes where the
Turntable sample is aspirated from the sample tray (STT)
or from the laboratory automation system
(LAS). Abbreviation: DTT.
Dilution Cuvette Component that washes the dilution tray
Washer (DTT) cuvettes after a sample analysis is
completed so the cuvettes can be reused
without risk of contaminating the next
sample. Abbreviation: DWUD.
Disable Command or condition that does not allow a
specific event to proceed. Function used to
remove a test or reagent lot from the menu.
DMIX See Dilution Tray Mixer.
DPP See Dilution Pipetting Probe.
Term Definition
DTT See Dilution Tray Turntable .
DWUD See Dilution Cuvette Washer.
Electrolyte Analyzer Component that measures the amount of
sodium (Na), potassium (K), and chloride (Cl)
in serum or urine samples through voltage
measurement by ion-selective electrodes (ISE).
Enable Command or condition that permits a specific
event to proceed. Function used to add a test
or reagent lot to the menu.
Ethernet A network connection that allows a computer
to connect to other computers on the same
network.
Event System activity such as a manual operation or
an error recorded by the system in the event
log.
Event Log List of system occurrences (events) including
errors, from the most recent to the oldest. This
information includes the date and time of each
occurrence.
Expiration Date The date beyond which the manufacturer does
not guarantee correct performance of the
reagent or material.
EZEE-NEST See Sample Cup.
Firmware Software that the system downloads to the
Machine Controller boards.
Flag Remark or message about the status of a
result. The flag is next to the result at the
window and on printed reports.
Host Query System interface setup that specifies that the
system request a remote device such as an LIS
to upload requests or information.
ID Identification. Used in SID (sample
identification) and PID (patient identification).
Inactivate Function used to limit the use of a test or a
pack on the system.
Term Definition
Inactive Not available for full use on the system. You
can schedule only calibrators and controls for
inactive tests and reagent packs.
Inactive Test Test that is not enabled for use on the
systems.
Include Function used to add a value for consideration
with other values.
In Process Status of an assay when the sample is in the
inprocess queue and is detected by the system
or the sample is in progress.
Intercept Factor used with slope to correlate the assay
results with another method. You obtain the
intercept and the slope from a regression
equation based on method comparison
studies. Status of the system when it is
processing samples.
ISE Ion-selective electrodes. See Electrode
analyzer.
ISE Baseline Solution Solution that provides a baseline reference
between each sample measurement to ensure
electrodes are functioning properly.
ISE Buffer 2 Solution that mixes with sample and ISE
Baseline Solution for ISE analysis.
Key Operator Designated operator available to Siemens
representatives to describe instrument
malfunctions by telephone and/or to perform
simple adjustments and corrections as
requested.
Keyboard System component you use to type
information or to respond to a system prompt.
LAS See Laboratory automation system.
Laboratory System that provides a high workload capacity
Automation System to ensure optimal workflow. The ADVIA
Chemistry XPT System can be operated
through this system. Abbreviation: LAS.
Laboratory Laboratory computer system that can be
Information System interfaced to the system. Abbreviation: LIS.
Term Definition
Link Method of directly accessing information or
data. A link in the user interface transfers
information to a related window based on a
selection. Required data must be present for
the information to transfer. In the online
information system, a link is a quick way to
access more information about a topic.
LIS See Laboratory information system.
LIS Code Alphanumeric code that identifies an assay,
profile, or QC to the laboratory information
system.
Liquid Level Sensing Component that detects the liquid surface
level for samples, controls/calibrators, and
reagents. Abbreviation: LLS.
LLS See Liquid Level Sensing.
Lyophilized Material A liquid material that is freeze-dried to a
powder for long term stability. Reconstitute
lyophilized material with water or other liquid
before use.
Manual Dilution A dilution of the sample made before placing
the sample on the system.
MIX1or MIX2 See Reaction Mixer 1 or 2.
Modem Device that converts the digital signals
generated by the computer’s serial port to the
modulated analog signals required for
transmission over a telephone line and
transforms incoming analog signals to their
digital equivalent.
Monitor Touchscreen device that produces an on-
screen display.
Normal Range See reference range.
Numeric Keys Keys that are labeled with numbers and
mathematical symbols and are on the right
side of the keyboard.
Patient Identification Unique code that identifies the patient from
Code whom a sample is obtained. Abbreviation: PID.
Term Definition
Pending Samples Samples for which tests are scheduled or
inprocess, but not complete.
Pending Tests Tests that are scheduled or in process, but not
complete.
PID See Patient Identification Code.
Pretreatment Process that occurs to prepare a sample for
testing. For example, pretreatment can
include sample dilution to meet assay
requirements or addition of a pretreatment
agent to a sample to protect the analyte from
releasing agent.
Primary Sample Tube Tube used to collect patient blood samples by
venipuncture.
Prime Function that introduces reagents, detergent,
or water into the fluidic system in preparation
for analyzing samples.
Profile Group of related tests or a group of the same
test with different dilution specifications.
Prompt Questions, instructions, or commands that
help you complete the current task.
Pure Water Water that meets specification for clinical
laboratory use. Provides deionized water for
system cleaning.
QC See Quality Control.
Quality Control Process of verifying the performance of the
system using products containing specific
analytes within a predetermined
concentration range. Abbreviation: QC.
Quality Control Product containing 1 or more specific assays
Material with a predetermined concentration range or
reactivity used to verify the performance of
the system.
Query Timeout Maximum number of seconds required for a
remote device to respond to a query from the
system.
Term Definition
Random Access Mode of operation in which the system
processes samples for multiple assays in the
most efficient order.
Ratio Definition Formula the system uses to calculate the
results of a ratio test.
Ratio Test Test that calculates results from the results of
other tests. A/G or BUN/CREA is an example of
a ratio test.
Raw Data The absorbances detected by the
spectrophotometer from the main and, if
applicable, the sub wavelengths.
Reaction (RRV) Bath Solution used in the circulation system of the
Oil reaction tank as the inert fluorocarbon oil to
maintain analysis temperature.
Reaction Cuvette Component that washes the reaction tray
Washer (RRV) cuvettes after a sample analysis is
completed so the cuvettes can be reused
without risk of contaminating the next
sample. Abbreviation: WUD.
Reaction Mixer 1 or 2 Two independent components that mix the
sample and reagent in the reaction tray (RRV)
cuvettes to produce the desired reaction.
Abbreviation: MIX1 and MIX2.
Reaction Tank Component that contains the non-reactive
(bath) oil, which keeps the temperature of the
liquid in the reaction tray (RRV) cuvettes at a
constant 37°C ±0.1 °C. The temperature is
controlled by a heater and a thermostat.
Reaction Tray Component that contains the cuvettes where
analysis of patient, control, or calibrator
sample with the reagent occurs. Tray is
submerged in bath oil. Abbreviation: RRV.
Reagent Solution used in the chemical analysis of
assay, wash or prime of system, or sample
dilution.
Term Definition
Reagent Packs Packs placed in RTT1 or RTT2 that contain a
reagent, diluent, or wash solution. These
include 20-mL, 40-mL, or 70-mL wedge-
shaped packs.
Reagent Pipetting Two independent components aspirate a
Probe 1 or 2 reagent from the reagent trays (RTT1 and
RTT2) and dispense it into reaction tray (RRV)
cuvettes for analysis, according to specified
conditions. Abbreviation: RPP1 and RPP2.
Reagent Pumps Two independent components that handle the
aspiration and dispensing functions of RPP1
and RPP2. Abbreviation: RP1 and RP2
Reagent Tray Two independent components where reagents
Turntable 1 or 2 (for assay analysis), wash solutions, and
diluents (for daily washing and contamination
avoidance) are placed. Abbreviation: RTT1 or
RTT2.
Reagent Water See Pure Water.
Reagent Wedge See Reagent Packs.
Reference Range Range of values for each assay from a defined
population. Each laboratory should establish
its own reference ranges for the diagnostic
evaluation of patient results. The normal
range is a reference range for the healthy
population and can be defined by sex, age, or
other patient attribute. Reference ranges can
also exist for various pathological states.
Replicate Number of times that testing is performed for
a scheduled assay. The system calculates the
mean value from the results of the replicates
of the calibrator, control, or patient samples.
Reservoir A container holding water, waste fluid, or
system fluids to allow for continuous
operation while the operator replenishes
reagents.
Results Numeric value for an assay performed on a
sample.
RPP1 or RPP2 See Reagent Pipetting Probe 1 or 2.
Term Definition
RRV See Reaction Tray.
Saline Solution used in automated sample dilution.
Sample Specimen used for testing such as a patient
sample, control, or calibrator.
Sample Cup Disposable container that holds patient,
control, or calibrator samples. These include
Small Sample Container (SSC), ADVIA
Chemistry Sample Cup (ACSC), and EZEE-NEST
sample cups placed in an STT sample adapter
or tube.
Sample Dilution Component that aspirates from the sample
Pipetting Probe tray turntable (STT) or from the laboratory
automation system (LAS) and dispenses it into
cuvettes in the dilution tray (DTT) or reaction
tray (RRV). Abbreviation: DPP.
Sample Unique code that identifies each sample.
Identification Code Abbreviation: SID.
Sample Pipetting Component that aspirates sample from the
Probe dilution tray (DTT) and dispenses it into
reaction tray (RRV) cuvettes for analysis,
according to specified conditions.
Abbreviation SPP.
Sampling Pump Component that handles the aspiration and
dispensing functions. Abbreviation: SP.
Sample Tray Component where patient samples, controls,
calibrators, and diluents are placed for
measurement. The tray rotates to move the
samples to the aspiration position. This tray
includes the STT and CTT.
Sample Tray Component where patient samples (collection
Turntable tubes and samples cups) are placed when not
utilizing an LAS. Abbreviation: STT.
Search Function used to locate an item in a list.
SID See Sample Identification Code
Siemens Material A unique number associated with each
Number Siemens product. The number is used when
ordering the product. Abbreviation: SMN.
Term Definition
Sign In To enter a password or code to access the
system or an area of the system.
Sign Out To indicate that you are finished working in
the system or an area of the system.
SI Units International system for units of measure.
SID Sample identification.
Slope Factor used along with intercept to correlate
the assay results with results from another
method. You obtain the slope and the
intercept from a regression equation based on
method comparison studies.
Small Sample See Sample Cup. Abbreviation: SSC.
Container
Spectrophotometer Component that measures the amount of light
absorbed at 14 specific wavelengths by liquids
contained in reaction cuvettes.
Sort Function used to change the order of items in
a list. For example, you can sort the worklist by
patient name or by SID.
Stability Degree of a reagent’s resistance to chemical
change or degradation.
Startup The events that occur when the system uses
the software to initialize the hardware.
Status Information about the current operating
condition of the system.
Stop Bits Number of data bits that maintain
synchronization between the system and a
remote device during data transmission.
STT See Sample Tray Turntable.
WUD See Reaction Cuvette Washer.
Index
A service 176
Advanced QC
about
print options 102
backup 51 reports, about 97
Calibration Order Filter 82
calibration results 73 analysis
container settings 201 analyzing results 91
Maintenance Schedule 29, 103 patient median 95
primary 51 analyze results
reagent status 28
QC 91
reflex tests 147
RTT1 Status 53 analyzing
RTT2 Status 55 absolute calibration 81
sample status 27 multi point calibration 79
Scan 49 reagent blank 81
test definition disk 129 single point calibration 77, 80
usage 51 analyzing results
Wavelengths 84
chart 91
absolute calibration
ancillary
analyze 81
reagent usage 187
configure 134
Archive
absorbance measurements
database 123
view 83
assay
accessing maintenance procedures 106
add new 129
accidental contamination
configure 128
prevent 160 modify 128
ACSC 211 assay calculations and calibration
activating configure 132
reagent 1 packs 53 assay definition
reagent 2 packs 55
configure 131
reagent lots on Reagent Tray 1 54
reagent lots on Reagent Tray 2 55 assay RBL
add configure 136
QC definition 87 assay realtime correction
adding configure 136
calibrator definitions 73 assay sample, reagent, and diluents
control definitions 87 configure 130
new assay 129 ASTM 156
reagent information 128
automatic calibrations
reference range 143
additional period schedule 86
container database
ancillary reagent usage 187 maintain 119
container settings database backup 121
about 201 perform 121
edit 138 dead volume
contamination sample 211
prevent accidental 160 defining
sources 159
calculated parameters 148
control files
Delete
export 101
database 123
controls
deleting
add new definitions 87
calibration results 84
conventions
delivery
symbol and text 5
service policy 175
create
description 23
QC definition 87
design
Create Batch Order 67
changes 178
creating
designation
orders manually 65
key operator 178
Creating Orders 66
Diagnostics
creating reports 99
use 117
cuvette blank measurements
diagnostics status
view 84
view 41, 42
D dilution
daily locked cover 163
system operation 39 dimensions
Daily Maintenance system 193
checking ISE baseline solution level 44 disable automatic file management 120
Dashboard disabling
about 26 reagent 1 lots 54
reagent lots 52, 56
dashboard
disconnecting
Test tab 26
system power 110
data
displayed results reports
export 124
print 72
Database
Dispositions 72
archive 123
delete 123
E extent
service call 177
editing
exterior
container settings 138
operation mode 128, 149 system symbols 164
STT position settings 138 EZEE-NEST 211
electrical F
requirements 195
features
electromagnetic compatibility (EMC) 193
system 15
EMC 193
file management
emergency
automatic 119, 120
disconnect system power 110
disable 120
Emergency button perform manually 120
use 110 postpone activity 120
emergency stop file names
recover 112 system defined 125
enable file types
LAS 157 .TXT 102
enabling .XML 102
reagent 1 lots 54 fixed factor value (FV) assays
reagent lots 52, 56 configure 134
enabling the LAS 157 fluid levels
environmental check 41
specifications 194 fluids
evaluating system specifications 187
results 68 G
Events
guide
about Operator Event Log 39
Operator’s 25
events 95
troubleshooting help 116 H
exclusions hardware
warranty and service 178 overview 16
Export help
results 124 online 25
export troubleshooting 25
control files 101 window 25
patient median files 102 I
exporting
I/O
data 124
delete 67 Q
edit 67
performing QC