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ADVIA® Chemistry XPT

System

ADVIA® Chemistry XPT System

Operator’s Guide

11314536 Rev. 01, 2018-04


Legal Information ADVIA Chemistry XPT System

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.

This product includes open source software. Such software is provided by


Siemens under the terms of the open source software licenses applicable to
such software, and is distributed WITHOUT ANY WARRANTY, as set forth in
the corresponding licenses. Those terms require that Siemens provide the
following notices and information to the purchaser of this product. Where
required by the specific license terms, Siemens will make the source code
for such open source software available upon request from Siemens in
accordance with the terms of the relevant open source license.
The components of open source software included in this product are as
follows:
NLog, v2.0.1, © 2004 – 2016 Jaroslaw Kowalski <jaak@jkowalski.net>, Kim
Christensen, Julian Verdurmen, All Rights Reserved

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ADVIA Chemistry XPT System Legal Information

TreeGridView, No Version Specified, © 2011 Mark Rideout (MSFT)


Modifications © 2016 Siemens Healthcare Diagnostics Inc.
DotNetZipLib DevKit, v1.9, © 2010 Don Chiesa
Modifications © 2016 Siemens Healthcare Diagnostics Inc.
Each component of open source software included in this product is
licensed under at least one of the following licenses:
BSD 3-Clause License
(The BSD 3-Clause License is available at www.opensource.org)
THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND
CONTRIBUTORS “AS IS” AND ANY EXPRESS OR IMPLIED WARRANTIES,
INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE
DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT HOLDER OR
CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL,
SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT
NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER
CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT,
STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE)
ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED
OF THE POSSIBILITY OF SUCH DAMAGE.
Microsoft Public License (MS-PL)
(The Microsoft Public License (MS-PL) is available at www.opensource.org)
The information in the customer documentation was correct at the time of
issue. However, Siemens Healthcare 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 Healthcare Diagnostics, the protection provided by the equipment
may be impaired. See warning and hazard statements.

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Legal Information ADVIA Chemistry XPT System

4 11314536 Rev. 01
ADVIA Chemistry XPT System Using this Guide

Using this Guide


The operator’s guide provides information for the following clinical
laboratory professionals who use the ADVIA® Chemistry XPT system:

• System operators who perform daily operating tasks such as preparing


the system, processing samples, reviewing results, and performing
maintenance
• System key operators who perform daily and other tasks such as
reviewing control data, managing data files, and modifying system
parameter

Conventions
The operators guide uses the following symbol and text conventions.

Convention Description
BIOHAZARD Biohazard statements alert to potentially
biohazardous conditions.

LASER Laser Warning statements alert to the risk of


WARNING exposure to lasers.

WARNING Warning statements alert to conditions that may


cause personal injury.

CAUTION Caution statements alert to conditions that may


cause product damage or loss of data. On the
system, this symbol indicates to refer to the
operator’s guide for more information.
Note Note statements alert to important information
that requires attention.
Bold Bold type indicates commands on the user
interface, keys, or the exact text that an operator
needs to type.
For example, if the word save appears as Save, it
refers to selecting the Save button on the user
interface.
Another example is typing a specific entry into a
text box. If the word welcome appears as
welcome, it means that it should be entered into
the specified field.

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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

Legal Information ....................................................................................... 2


Using this Guide.......................................................................................... 5
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Chapter 1: System Features ...................................................................... 15
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Key Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
About the Workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
About the Command Bar Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
About the Status Bar Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Online Help Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
About the Dashboard Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Test States and Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Monitoring Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
About Sample Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
About Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
About the Maintenance Window Schedule Tab . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Using the LIS Communication Status Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
About Patient Demographics Received from an LIS . . . . . . . . . . . . . . . . . . . . . . . 31
Software Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Chapter 2: Operating the System ............................................................. 39
Daily System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Signing into the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
About the Operator Event Log Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Responding to a Maintenance Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Checking System Components and Conditions. . . . . . . . . . . . . . . . . . . . . . 41
Checking Ancillary Reagent Volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Checking ISE Baseline Solution Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Checking Reagent Inventory and Calibration Status . . . . . . . . . . . . . . . . . . 44
Processing Samples Using LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Processing STAT Patient Samples on the Sample Tray . . . . . . . . . . . . . . . . . . . . . 46

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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 5: Calibration ............................................................................... 73


About Calibration Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Adding Calibrator Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Loading Calibrators, QC, and Water Blank. . . . . . . . . . . . . . . . . . . . . . . . . . 74
Analyzing Single Point Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Analyzing Multipoint Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Analyzing Absolute Calibration (Reagent Blank) . . . . . . . . . . . . . . . . . . . . . 81
Viewing Results of Calibration Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Viewing ISE Calibrator Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
About the Calibration Order Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Viewing Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Viewing Calibration Reaction Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Viewing Absorbance Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Viewing Cuvette Blank Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
About Wavelengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Deleting Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Viewing Wavelength Reaction Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Viewing ISE Historical Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Viewing Results of Reagent Blank Checks . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Scheduling Automatic Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Chapter 6: Quality Control ........................................................................ 87
Adding New Control Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Manually Adding a QC Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Scheduling QC Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Adding an Automatic QC By QC Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Adding an Automatic QC By Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
QC Statistics Application Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Navigating Advanced QC Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
QC Statistics Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Additional Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
About Reviewing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

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Analyzing Results in the Review Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 91


Analyzing Results in a Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
About the Levey-Jennings Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
About the Z-score Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Patient Median Analysis View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
About the Analysis Tab Split Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Adding Comments to the Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
About Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
About Advanced QC Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Creating and Printing Advanced QC Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
QC Statistics Database Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
QC Database Current and Maximum Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Performing Database Maintenance with QC Files . . . . . . . . . . . . . . . . . . . . . . . 101
Exporting Control Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Exporting Patient Median Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Advanced QC Print Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Chapter 7: Maintenance......................................................................... 103
About the Maintenance Window Schedule Tab . . . . . . . . . . . . . . . . . . . . . 103
About the Maintenance Window Log Tab . . . . . . . . . . . . . . . . . . . . . . . . . 105
Viewing Online Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . 106
Exporting a Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Printing the Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Chapter 8: Identifying System Problems................................................ 107
Managing System Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Starting Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Using Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Disconnecting System Power in Emergency. . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Shutting down the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Restarting the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Recovering from an Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Recovering from a Slow User Interface or System Lockup . . . . . . . . . . . . . 112
Recovering from a Power Disruption to the System. . . . . . . . . . . . . . . . . . 113
Safely Shutting Down the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

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Visible Status Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116


Accessing Troubleshooting Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Using Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Checking the Keyboard Cable Connections. . . . . . . . . . . . . . . . . . . . . . . . 117
System Version Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Chapter 9: Managing Data ...................................................................... 119
Maintaining the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Viewing Automatic File Management Activities. . . . . . . . . . . . . . . . . . . . . . . . . 119
Editing Automatic File Management Activities . . . . . . . . . . . . . . . . . . . . . . . . . 120
Managing Files Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Performing an Automatic File Management Activity Manually . . . . . . . . . . . . . 120
Performing Database Backup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Performing the Database Backup Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Restoring Data to the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Saving Results Data to Archive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Archiving or Deleting a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Editing Automated Database Archive and Delete . . . . . . . . . . . . . . . . . . . . . . . 123
Exporting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Exporting Results Data Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
About System Defined File Names. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Chapter 10: Configuring the System....................................................... 127
Configuring and Modifying Assay Reagents . . . . . . . . . . . . . . . . . . . . . . . 128
Adding Reagent Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Editing Reagent Container Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Configuring and Modifying Assay Options . . . . . . . . . . . . . . . . . . . . . . . . 128
ADVIA Chemistry XPT Test Definition Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Adding an Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Configuring Assay Sample, Reagent, and Diluent . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Configuring Assay Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Configuring Assay Calculations and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Configuring Assay Realtime Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Configuring Assay Reagent Blank Values (RBL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Configuring Specimen Type Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Configuring Carryover Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

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ADVIA Chemistry XPT System

Configuring Container and STT Position Options . . . . . . . . . . . . . . . . . . . . 138


Editing Container Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Editing STT Position Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
About Check Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Editing a Check Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Editing a Linearity Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Changing Test Order Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
About Test Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
About Ratios & Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Reference Ranges, Result Interpretation, and Reflex Testing. . . . . . . . . . . 142
About Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Adding a Reference Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
About Predefined Interpretation Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Editing Predefined Interpretation Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
About Operator-Defined Interpretation Ranges . . . . . . . . . . . . . . . . . . . . . . . . . 146
Adding an Operator-Defined Interpretation Range . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
About Reflex Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Defining Calculated Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Adding a Ratio Test Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Modifying System Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Editing Operation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Configuring Visible Status Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
About Informatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Setting up Informatics Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Enabling LIS Configuration Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Completing the Application Layer LIS Configuration Settings . . . . . . . . . . . . . . 152
Completing the General LIS Configuration Settings. . . . . . . . . . . . . . . . . . 156
Configuring LAS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Appendix A: Safety................................................................................. 159
Protecting Yourself from Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Protection from Barcode Scanner Lasers . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Laser Safety Classification of the ADVIA Chemistry XPT System . . . . . . . . . . . . 161
Laser Safety Classification of the Barcode Scanners. . . . . . . . . . . . . . . . . . . . . . 161

12 11314536 Rev. 01
ADVIA Chemistry XPT System

Reagent and Sample Barcode Scanners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162


Dilution and Sample Noise Reduction Cover Locks . . . . . . . . . . . . . . . . . . 163
Location of Safety Hazard Symbols on the System Exterior . . . . . . . . . . . 164
Location of Safety Hazard Symbols on System Interior. . . . . . . . . . . . . . . 165
Location of the I/O Panels and Main Power Switch . . . . . . . . . . . . . . . . . . 167
Power Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Using Approved Cleaning Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Appendix B: Service, Ordering, and Warranty ........................................ 175
Limited Instrument Warranty and Service Delivery Policy. . . . . . . . . . . . . 175
Warranty Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
ISE Electrode Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Additional Service Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Service During Normal Hours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Extent of a Service Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Service Outside Normal Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Replacement of Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Design Changes and Retrofitting of Instruments . . . . . . . . . . . . . . . . . . . 178
Key Operator Designation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
OSHA Requirements (US Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Warranty and Service Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Information for Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Addresses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Appendix C: Reagent Water and System Fluids...................................... 181
Reagent Water Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
What is Reagent Water? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Purifying Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Maintaining Water Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Storing Reagent Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Testing Reagent Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Maintaining the Purification System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Problems Caused by Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

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ADVIA Chemistry XPT System

System Fluids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187


Appendix D: Supplies ............................................................................. 189
System Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Appendix E: Specifications ..................................................................... 193
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Safety Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Electrical Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
About Container Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Appendix F: System Symbols ................................................................. 203
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Appendix G: Sample Volume.................................................................. 211
Sample Volume Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Glossary .................................................................................................. 217
Index....................................................................................................... 231

14 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 1: System Features

Chapter 1: System Features


The ADVIA Chemistry XPT System is an automated, clinical chemistry
analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in
random access and batch modes at a throughput rate of both 1800
photometric tests per hour and 600 electrolyte (ISE) tests per hour.

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:

• Maximum system efficiency.


• Maintenance tasks performance.
• Test processing sequence performance.
The system uses several areas while processing samples. Access is available
to some of these areas while the system processes samples. For more
information on the function of these subsystems, refer to system online
help.

16 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 1: System Features

Figure 1: Front View of the System

1 Operate Switch 5 Reaction Bath Oil 9 Reaction (RRV)


Pump Bath Oil
2 Emergency Stop 6 Cuvette 10 ISE Buffer 2
Detergent
3 Reaction Bath Oil 7 Saline 11 Horizontal Pumps
Filter
4 Reaction Bath Oil 8 Cuvette 12 Pure Water
Heater Conditioner

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Chapter 1: System Features ADVIA Chemistry XPT System

Figure 2: Top View of the System

1 Sample (STT) and 6 Dilution Cuvette 11 Reagent Pipetting


Calibration/QC Washer (DWUD) Probe 2 (RPP2)
(CTT) Tray
Turntable
2 Reaction Tray 7 Sample Pipetting 12 Reagent Tray
(RRV) Probe (SPP) Turntable 2
(RTT2)
3 Sample-Dilution 8 Reaction Cuvette 13 Reagent Pipetting
Probe (DPP) Washer (WUD) Probe 1 (RPP1)
4 Dilution Mixer 9 Reaction Mixer 2 14 Reagent Tray
(DMIX) (MIXR2) Turntable 1
(RTT1)
5 Dilution Tray 10 Reaction Mixer 1
Turntable (DTT) (MIXR1)

18 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 1: System Features

Figure 3: Back View of the System

1 Visible Status Light


2 Manufacturing Label
3 Rating Label
4 Main Power Switch
5 Main Power Input
6 100ACV 10A Max Receptacles
7 Circuit Breaker Panel
8 Water Supply and Drainage Panel
9 Connectivity Panel

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Chapter 1: System Features ADVIA Chemistry XPT System

Figure 4: System Workstation

1 Keyboard
2 Touchscreen Monitor
3 Mouse
4 Printer (optional)
5 Personal Computer (PC)

20 11314536 Rev. 01
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.

About the Workspace


The Workspace is the part of the window between the Command Bar and
the Status Bar.
When a Command Bar button is selected, the workstation displays a set of
tabs or a window containing tasks or information.

Figure 5: Command Bar

The Status Bar near the bottom of the workspace provides access to
windows that display information about the condition of the entire system.

Figure 6: Status Bar

When the Workspace displays rows of information, the information can be


sorted by selecting the Sort tool at the top of the data columns. Information
is then sorted by that column in ascending or descending order according
to the last sort.
When a Filter button is available, the information can be filtered by certain
criteria to view or print the tab information as necessary.
When the Search area is available, a column type can be selected with a
criteria entered to narrow down the search. Selecting Search moves the
focus to the row that contains matching information.

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Chapter 1: System Features ADVIA Chemistry XPT System

About the Command Bar Tools


The tools on the command bar enable you to perform and manage your
laboratory activities.

Table 2: Command Bar Tools

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.

The Reagents tool enables you to view and manage


primary reagents and wash solutions in reagent trays.

The Calibration tool gives you access to information about


your calibrations and defines calibrators.

The Maintenance tool enables you to Schedule and create


maintenance procedures as well as monitor and modify
automated procedures. You can view maintenance logs,
monitor Lamp Energy, and ISE Operations.
The Diagnostics tool has Diagnostic procedures and
information about the system status, clot detection, and
manual operation .

The Orders tool enables you to create, view, and edit


Patient, and Batch orders.

The Test Results tool enables you to perform result related


tasks such as repeating tests, accepting results, and
designating a different active result. You can also set up a
Watch List to monitor specific results as necessary.

22 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 1: System Features

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.

The Utilities tool enables you to manage all system


databases and the system configuration. Also, you can
monitor Assay Utilization and download Available
Updates.
The Events tool displays logs recording actions by the
Operators, LIS and LAS (where applicable), and keeps an
Audit Trail of the events. You also can access procedures
for troubleshooting events.

About the Status Bar Icons


The Workstation Status Bar reports current system information and has
selectable icons that allow you quick access to functions.
This information is posted in the Status Bar in addition to the selectable
icons:

• Operator ID
• Current status
• Current date and time

Table 3: Status Bar Selectable Icons

Icon Description
The Help icon on the Status Bar accesses general help about
the workstation including topics like this one.

The Sign In icon displays a window for signing in or out of


the system.

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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.

The LIS Communication icon displays the current status of


the LIS connection. Using this tool, you can change the
status, and run diagnostics on the connectivity between the
system and the LIS.
The Dashboard icon displays a quick count of all samples and
tests currently being managed by the system. Selecting a
Dashboard counter button opens the Test Results >
Dashboard tab to review the individual results.
Selecting the STAT icon opens the Test Results > STAT tab
displaying all STAT results.

The Quick Find icon enables you to search for a specific


Patient or QC Result.

The File Explorer icon enables you to manage your files.

The Reconnect icon displays the connection status of the


workstation with the system.

Volume for system alarms is audible.

Volume for system alarms is muted.

24 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 1: System Features

Icon Description
Select the Instrument status icon to display the Instrument
Status window.

The LAS Communication icon displays the current status of


the LAS connection. You can reset the status and view the
LAS queue.

Online Help Overview


The system provides online help and procedures to answer questions about
operating the system, maintaining the system, and correcting system
problems.
The system also provides online documentation that can be viewed and
printed as necessary.
When online help is accessed, the help window can be moved or the size
changed to make it easier to view the workspace while the help is read.

• 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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Chapter 1: System Features ADVIA Chemistry XPT System

About the Dashboard Window


The Dashboard window posts a quick view of samples and tests by their
current Sample State or Test State.
The system updates the counters for the samples and the tests in real time
until the sample or test is deleted or moved to Historical. The Dashboard
counters have alert icons indicating that samples or tests are STAT tests or
have a critical result.
If more than one alert occurs in the indicated Sample State or Test State,
only the highest priority counter is shown. One exception is when you have
a STAT test paired with an acknowledged critical result.
Selecting one or more counter on either tab launches the Test Results >
Dashboard tab. Selecting a counter with an alert acknowledges the alert or
you can acknowledge alerts on the Dashboard window.

Test States and Counters


A test request is always in a mutually exclusive test state as described in the
following table. On the Dashboard Test tab, each test counter represents
the total number of patient and control samples in that test state.

Table 4: Test States

Test State Description


Pending New Test request is created and all of these criteria are
true:
• Request is not downloaded to the system.
• Request does not have a manually added result.
• Request is not in the Historical state.
Inprocess Test request is downloaded to the system and no
result or error is received.
Error Test request is downloaded to the system but
never completed because of sampling or testing
errors.
Incomplete The test state of even one ratio component is
Pending New and any other is Complete.
Pending Repeat Test state when a Repeat order is created.
Results on Hold Test has an Active Result with a result disposition
of Hold.
Transmission Failed Test request failed to transmit to the LIS.

26 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 1: System Features

Test State Description


Waiting for Bracket No applicable.
Completed Results Test result was Accepted, Omitted, or
Transmitted.
Transmitted Test result successfully transmitted to the LIS.
Historical When the order is moved to Historical.
NOTE: This test state is not displayed as a
Dashboard counter.

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.

About Sample Status


The Sample Status consists of a message and a color indicator. Sample
Status is determined by the combination of the following conditions:

• Order specifications for SID and container position


• Presence of the container and sample in the system
• Presence, readability, and validity of the barcode

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Chapter 1: System Features ADVIA Chemistry XPT System

Sample Status is accessed by selecting a tube in a Sample Tray:

Table 5: Sample Status

Message Color Description


Aspirated Neutral All tests for this sample have been aspirated.
Clot Detected Yellow The system detected a clot in the sample
probe. Check sample for clots.
Insufficient Yellow Not enough sample volume exists for the
requested tests.
Integrity Error Yellow An irregular sample aspiration. Check sample
for bubbles or foam, or check the sample-
probe tubing and tip-probe connection for
leaks. If a sample produces an integrity error,
all tests for that sample display an Integrity
Error.
LIS Query Yellow A request to the LIS from the system for an
Pending order entry is pending.
No Barcode Yellow The system did not read the sample barcode.
No Request Yellow The system does not have any test requests for
the sample. Order tests from the LIS or by
selecting Orders > Create Patient Orders.

About Reagent Status


Use RTT1 Status or RTT2 Status to view reagent status on Reagent Tray 1
(RTT1) or Reagent Tray 2 (RTT2). The status information can be sorted either
by reagent name or by slot position.
The information on reagent status is available in printed format within the
inventory report.
Use RTT1 or RTT2 Status to complete the following tasks:

• 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.

28 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 1: System Features

To access the inventory report, select Reagents > RTT1 Status or RTT2
Status then Print.

About the Maintenance Window Schedule Tab


When a maintenance activity fails or is overdue, the Maintenance button
on the command bar flashes yellow or red. Selecting the Maintenance
button enables you to view, edit, or cancel the activity that triggered the
warning or error.
When you open the Maintenance window Schedule tab, the Maintenance
button no longer flashes and returns to its normal color. When you clear the
issue in the Schedule tab, the row on the Schedule tab returns to its normal
color.
When you complete a Maintenance activity successfully, the system
updates the Schedule tab to display the next due date or the system resets
the current count.
When scheduled Maintenance activity fails, the row the activity is on in the
Schedule tab is red and the due date is not updated. The system makes a
Maintenance Log entry recording the Failed status. If a step in the
maintenance activity fails and a retry is allowed, a Maintenance window
displays enabling you to Retry or Cancel.

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The table on the Schedule tab displays information about all defined
maintenance activities:

Table 6: Maintenance Schedule Tab Table

Column Head Description


Interval Displays the type of interval used for the
maintenance activity.
• Scheduled Date and Time
• As Needed
[blank] A symbol representing the current status of the
activity.
Activity The name of the activity, when appropriate, a
symbol indicating the activity was operator-defined.
NOTE: If you do not recognize the symbol, hover the
pointing device over the symbol or the blank area and
a tool tip displays a label.
[blank] Displays a clock when you postpone a maintenance
activity. To see the date and time the activity is set to
resume, hover your pointing device over the clock.
Frequency Displays the frequency selected in the activity
definition. Also indicates whether or not the activity
is automated.
Date Due / Depending on the type of interval set for the activity,
Current Count this column displays the following information:
• Date and Time scheduled for the activity.
• As Needed.
[blank] Displays a symbol indicating whether the activity is
performed by the system, the operator, or a
combination of system and operator.

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Using the LIS Communication Status Window


1. On the Status Bar, select the LIS connection icon.
The Status Bar icon indicates the current state:

• Red indicates the LIS connection is Offline.


• Gray indicates the system LIS is connecting and awaiting initialization.
• Yellow indicates the LIS connection is in Standby. This occurs when a
transmission is not sent or received in a timely manner.
• Green indicates the LIS connection is Online.
2. On the LIS connection window, select options as needed:

• To open a connection to the LIS, select Online.


• To change from Routine to Development mode (available only to
developers), select the Shutdown state and then change modes.
• To perform diagnostics on the connection, select Diagnostics.
• To clear the Results queue, put the LIS connection in an Online or
Standby status and select Clear Results.
• To clear the Queries queue, put the LIS connection in an Online or
Standby status and select Clear Queries.

About Patient Demographics Received from an LIS


When a patient order is received or updated from a networked LIS, the
following system behaviors apply to patient demographics contained in the
order:

• You cannot edit patient demographic data that is in an order received


from an LIS.
Only an update from the LIS can overwrite patient demographic data
that originated with the LIS.
• If the LIS updates any patient demographic field, then all patient
demographic data is considered to have originated from the LIS, and no
further manual edits are allowed.
• Patient demographics that are manually entered on the system are not
transmitted to the LIS.
• When an order received from the LIS is set to Anonymous by the
system, the Patient Name and Patient ID are not transmitted back to
the LIS.
• If an order received from the LIS contains at least one anonymous test,
the system hides the Patient Name and Patient ID.

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Software Maps
Command bar buttons open windows that contain related information and
tasks.

Figure 7: System Operations

Figure 8: Samples

Figure 9: Reagents

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ADVIA Chemistry XPT System Chapter 1: System Features

Figure 10: Calibration

Figure 11: Maintenance

Figure 12: Maintenance – Auto Start

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Chapter 1: System Features ADVIA Chemistry XPT System

Figure 13: Diagnostics

Figure 14: Orders

Figure 15: Test Results

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ADVIA Chemistry XPT System Chapter 1: System Features

Figure 16: QC

Figure 17: Setup

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Chapter 1: System Features ADVIA Chemistry XPT System

Figure 18: Setup – Test Definition

Figure 19: Setup – Dictionaries

Figure 20: Setup – Security

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ADVIA Chemistry XPT System Chapter 1: System Features

Figure 21: Setup – Settings

Figure 22: Setup – System Configuration

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Chapter 1: System Features ADVIA Chemistry XPT System

Figure 23: Utilities

Figure 24: Events

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ADVIA Chemistry XPT System Chapter 2: Operating the System

Chapter 2: Operating the System


This chapter provides a routine workflow. For more detailed information
about operating the system, refer to the respective chapters in this guide.

Daily System Operation


Use the following list to perform daily operations using a Laboratory
Automation System (LAS). For more information about daily operation
without an LAS, refer to the system online help.

• Sign into the workstation.

• Ensure there are no alerts in the Event log.

• Perform required maintenance.

• Check system components and conditions.


• Check status of assay reagents, ancillary reagents, calibrations, and
quality control.
• Process routine and STAT samples using the LIS and LAS.

• Accept and release results to LIS.

Signing into the Workstation


1. Verify that the Operate switch on the front of the instrument is in the
vertical (middle) position.
2. On the Workstation > Status Bar select the sign-in/out (door) icon.
3. Enter your Operator Name.
4. Enter your Password.
5. Select Sign In.

About the Operator Event Log Tab


The Events > Operator Event Log tab displays all system events as they
occur. The system lists the events in the log with the most recent event at
the top of the list by default.
Locate any Event using the Find in Page or Filter functions. You also can
filter by the Severity of the Operator Events by selecting a severity in the
Severity drop-down box.

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You can sort the events by ascending or descending date order using the
toggle in the Date column.

Table 7: Operator Events Log Fields

Operator Event Log


Field Description
Code A number unique to this event type.
Event Information describing the event.
Date Date and time of the system cycle when the event
occurred.
Cycle The point in the incremental cycle at which the
event occurred.
Subsystem On a system with subsystems, the subsystem on
which the event occurred.
Acknowledge Double-select the event to acknowledge the event.
If the event occurs multiple times, the system
prompts to acknowledge all occurances of this
event.

Responding to a Maintenance Alert


1. On the command bar, select Maintenance > Schedule.
2. Review all maintenance activities displaying color:

• Yellow for overdue maintenance activities.


• Red for maintenance activities that failed.
3. If necessary, select the Log tab for information about each activity that
has an alert.
4. To remove the alert color from the command bar, resolve the issue or
perform the necessary maintenance.

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ADVIA Chemistry XPT System Chapter 2: Operating the System

Checking System Components and Conditions


1. Visually inspect the following system components:
• Probes

• Mixing rods

• Dilution cuvette washers (DWUD)

• Reaction cuvette washers (WUD)

• Probe wash cups

• STT, CTT, RTT, DPP, and SPP covers

• Pumps for leaks


2. Verify system operating conditions:
a. Select the Instrument Status icon from the Status bar at bottom.
b. View each field to confirm correct conditions for system operation.
NOTE: OK (green) indicates that a specific operational condition is
within range. NG (red) indicates that the operational condition is not
within range.
c. Select Close.
3. Visually check the levels of the following:

• Controls and calibrators on CTT.

• Wash solutions in CTT and RTT.


• Lamp coolant

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Chapter 2: Operating the System ADVIA Chemistry XPT System

Checking Ancillary Reagent Volumes


1. Select the Instrument Status icon from the Status bar at bottom.
2. View each field to confirm correct conditions for system operation.
NOTE: OK (green) indicates that a specific operational condition is
within range. NG (red) indicates that the operational condition is not
within range.

Figure 25: Fluids Doors

3. To replace or replenish an ancillary reagent except ISE Baseline Solution,


open both fluids doors and pull out fluids tray.

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ADVIA Chemistry XPT System Chapter 2: Operating the System

Figure 26: Ancillary Reagents

1 Pure Water Bottle


2 ISE Baseline Solution
3 ISE Buffer 2
4 Reaction (RRV) Bath Oil
5 Cuvette Conditioner
6 Saline
7 Cuvette Detergent

4. Locate and replenish required reagent.


NOTE: Never replenish the ISE Buffer 2. Replace the bottle when level is
low.
5. Return fluids tray to its original position and close both fluids doors.

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Checking ISE Baseline Solution Level


If the ISE Baseline Solution is under 200 tests, the ISE baseline solution
should be replaced. Do not replenish ISE Baseline Solution - replace the pack
with a new one. The system may stop processing samples if the baseline
solution is empty.
1. Select the Instrument Status icon from the Status bar at bottom.
2. Verify that there is enough ISE baseline solution under Supplies for daily
run.
NOTE: Siemens recommends replacing the ISE baseline solution when
the level is under 200.
3. If the level is under 200, replace the ISE baseline solution.

Checking Reagent Inventory and Calibration Status


1. Select Reagents > Inventory.
2. Check the number of remaining tests in the Pair Inventory column for
each assay.
NOTE: This number indicates the lowest number of the assay pair. If no
tests are left, this row is red and the reagent requires replacement.
Diluents and wash solutions can be replenished.
3. Perform calibration on any assays that display red in the Calibration
Interval column.
NOTE: The letter “C” indicates the reagent requires calibration. A
recalibration is required when a negative number displays.
4. Check QC status for all assays in the QC Status column.
NOTE: QC Status displays the results of the most recent QC check.
Results include OK, Warning, or Error.

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Processing Samples Using LIS

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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Processing STAT Patient Samples on the Sample Tray

BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.

1. Verify that the system status is READY.


NOTE: STAT samples from the tray will not be processed if the system is
processing samples from the automation track. The sampling on the
track must be stopped before sampling from the sample tray can begin.
2. Load 1 or more STAT samples on the Sample Tray (STT), noting the
position of the samples on the STT.
3. Select System Operations > Start/Restart.
4. If a Reagent Scan message appears, do the following steps:
a. Select OK > Cancel.
b. Scan reagents.
c. Repeat Step 3.
5. In the Routine area, select Analyze > Temporary Sample Assignment.
6. Select STAT and Container Type for the Position of the sample on the
STT.

Transmitting Results
1. On the command bar, select Test Results > Overview.
2. Locate the results to transmit.

• To find 1 result, use Search.


• To find today’s results, select Predefined Filter.
• To find a group of results, use the Filter button to create a custom filter.
3. Select the results to transmit.
4. Select Transmit.

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Releasing Results to LIS

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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48 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 3: Reagent Management

Chapter 3: Reagent Management


This chapter provides information about managing assay and ancillary
reagents on the system.
For more information about reagents, refer to the system online help.

Viewing Reagent Inventory


1. Select Reagents > Inventory.
2. Choose one of the following options:
• Select Summary to view a list of the number of tests that can be
performed for each assay.
• Select Lot Maintenance to enable or disable reagent lots on
Reagent Tray 1 (RTT1) and Reagent Tray 2 (RTT2).
• Select Reagents > Inventory > Depletion Forecast to view a
window showing any reagents that are forecasted to be depleted
today, based on the previous 30 days of usage data.
• Select Scan to perform a reagent barcode scan.
• Select Print.
• Select Close.

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.

A reagent barcode scan is done after loading or unloading a reagent pack.


A scan is also done after moving a reagent pack to a different position on
the reagent tray.
To access Scan, choose 1 option:

• Select System Operations > Reagent Scan.


• Select Reagents > Inventory > Scan.
• Select Reagents > RTT1 Status > Scan .
• Select Reagents > RTT2 Status > Scan.

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Table 8: Processing Order during Reagent Barcode Scans

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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ADVIA Chemistry XPT System Chapter 3: Reagent Management

Reagent barcode labels contain the following information:

• Reagent code (R-code)


• Reagent type
• Serial number of the reagent pack
• Size of the reagent pack
• Lot number
• Expiration date
• Security check data

About Reagent Pack Usage


The usage designation indicates the reagent pack in use when multiple
packs are loaded on a reagent tray for a single assay. The first pack on that
tray to be used is designated as the primary pack. All other packs of that
same reagent on that tray are designated as backups. The system
automatically switches to a backup pack when the primary is empty and
that pack becomes the primary pack.

Table 9: Order of Reagent Pack Usage

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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To access the usage designations of reagent packs, choose 1 option:

• 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.

Enabling or Disabling Reagent 1 and Reagent 2 Lots


1. Select Reagents > Inventory > Lot Maintenance.
2. Select Enable for 1 or more reagent lots to enable or disable the
selected lots.
3. Select Save > Close.

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.

Figure 27: Reagent Tray 1

The Reagent Probe 1 (RPP1) aspirates the required reagent and dispenses it
into the reaction tray (RRV) cuvettes for analysis.

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ADVIA Chemistry XPT System Chapter 3: Reagent Management

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.

About RTT1 Status


Use RTT1 Status to view the status of reagents on Reagent Tray 1 (RTT1).
The status information can be sorted either by reagent name or by slot
position.
The information on RTT1 Status is available in printed format on the RTT1
Inventory Report.
RTT1 Status is also used to do the following tasks:
• Access the Edit Pack window.
• Access the Activate Pack or Inactivate Pack feature.
• Access the Activate Lot or Inactivate Lot feature.
• Access Lot Maintenance to enable or disable reagent lots.
• Scan reagent barcodes.
• Print the RTT1 Inventory Report.
To access RTT1 Status, select Reagents > RTT1 Status.
To access the RTT1 Inventory Report, select Reagents > RTT1 Status > Print.

Activating or Inactivating Reagent 1 Packs


1. Select Reagents > RTT1 Status.
2. Select a reagent.
3. Select Activate Pack or Inactivate Pack to change the status of the
reagent pack.
NOTE: Status change is displayed in Pack Status column. The first pack
on that tray to be used is designated as the primary pack. All other packs
of that same reagent on that tray are designated as backups. The system
automatically switches to a backup pack when the primary is empty and
that pack becomes the primary pack.
4. If applicable, select Yes to inactivate the paired reagent pack on Reagent
Tray 2 (RTT2).

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Activating or Inactivating Reagent 1 and Reagent 2 Lots


1. Select Reagents > Inventory > Lot Maintenance.
2. Select or deselect 1 or more reagent lots to activate or inactivate the
selected lots.
3. Select Save > Close.

Enabling or Disabling Reagent 1 Lots


1. Select Reagents > RTT1 Status > Lot Maintenance.
2. Select Enable for 1 or more reagent lots to enable or disable the
selected lots.
NOTE: Status change is displayed in Pack Status column.
3. Select Save > Close.

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.

Figure 28: Reagent Tray 2

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.

About RTT2 Status


Use RTT2 Status to view the status of reagents on Reagent Tray 2 (RTT2).
The status information can be sorted either by reagent name or by slot
position.
The information on RTT2 Status is available in printed format on the RTT2
Inventory Report.
RTT2 Status is also used to do the following tasks:
• Access the Edit Pack window.
• Access the Activate Pack or Inactivate Pack feature.
• Access the Activate Lot or Inactivate Lot feature.
• Access Lot Maintenance to enable or disable reagent lots.
• Scan reagent barcodes.
• Print the RTT2 Inventory Report.
To access RTT2 Status, select Reagents > RTT2 Status.

Activating or Inactivating Reagent 2 Packs


1. Select Reagents > RTT2 Status.
2. Select a reagent.
3. Select Activate Pack or Inactivate Pack to change the status of the
reagent pack.
NOTE: Status change is displayed in Pack Status column.

Activating or Inactivating Reagent 2 Lots


1. Select Reagents > RTT2 Status.
2. Select a reagent.
3. Select Activate Lot or Inactivate Lot to change the status of the
reagent lot.
NOTE: Status change is displayed in Pack Status column. The first pack
on that tray to be used is designated as the primary pack. All other packs
of that same reagent on that tray are designated as backups. The system

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automatically switches to a backup pack when the primary is empty and


that pack becomes the primary pack.

Enabling or Disabling Reagent 2 Lots


1. Select Reagents > RTT2 Status > Lot Maintenance.
2. Select Enable for 1 or more reagent lots to enable or disable the
selected lots.
NOTE: Status change is displayed in Pack Status column.
3. Select Save > Close.

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ADVIA Chemistry XPT System Chapter 3: Reagent Management

Loading Reagent Packs

BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.

NOTE: Reagent packs can be replaced when system is in READY or PAUSE


status. Remove empty reagent packs and replace with new reagents packs.
NOTE: The position of an empty reagent pack from a non-Siemens
manufacturer must be reassigned when the pack is replaced. Replace non-
Siemens packs before they become empty.
1. If not in READY status, select System Operations > Pause Reagent to
temporarily stop operating the system.
NOTE: The system status display is PAUSE - PREPARING FOR REAGENT
ADDITION (Do not replace reagents). A digital timer counts down the
time required for the system to complete its current operation.
2. Ensure that the reagent is ready to load, according to the reagent’s
Instructions for Use (IFU).
3. Verify that the system status is REAGENT MODE - ADD REAGENT (OK to
replace reagents).

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Figure 29: Reagent Trays and Covers

1 Top right cover


2 Reagent Tray 2 (RTT2) cover
3 Reagent Tray 1 (RTT1) cover
4 Cover holster

4. Open the top right cover.


5. Lift off the required reagent tray cover.
6. Place this reagent tray cover in the cover holster.

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ADVIA Chemistry XPT System Chapter 3: Reagent Management

Figure 30: Reagent Pack

7. Remove the existing reagent pack from the reagent tray.


NOTE: The reagent tray adapters can remain on the system when
removing reagent packs.

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Figure 31: Reagent Packs

1 20-mL reagent pack


2 70-mL wedge-shaped reagent pack
3 40-mL reagent pack
4 40-mL reagent pack adapter
5 20-mL reagent pack adapter

• 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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8. Remove the cap from the replacement reagent pack.


NOTE: The caps for R1 packs are clear.
9. Dispose of the cap according to laboratory procedure.
10. Examine the replacement reagent pack for any bubbles.
11. If necessary, use a pipette to remove bubbles.

12. Place the reagent pack into reagent tray slot.


NOTE: When holding the special adapter with the 40-mL or 20-mL
container, squeeze the adapter on the sides to keep the container
wedge from falling out.
13. Position reagent pack so that the barcode label faces outward and is
visible through the reagent tray slot.
14. Ensure that the reagent pack is properly seated.
15. To replace additional reagent packs, repeat steps 7–14.
16. Replace the reagent tray cover.
17. Ensure that the reagent tray cover is seated properly.
18. Close the top right cover.
19. If in READY status, select System Operations > Reagent Scan.
20. If in the PAUSE status, select Reagent Scan.

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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.

Figure 32: Ancillary Reagents

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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Table 10: System Ancillary Reagents

Ancillary Reagent System Purpose


Pure Water Provides deionized water for system
cleaning.
ISE Baseline Solution Provides a baseline reference between
each sample measurement to ensure
electrodes are functioning properly.
ISE Buffer 2 Mixes with sample and ISE Baseline
Solution for ISE Analysis.
Reaction (RRV) Bath Oil Used in the circulation system as the inert
fluorocarbon oil.
Cuvette Conditioner Used in cuvette wash cycles.
Saline Used in automated sample dilution.
Cuvette Detergent Used in cuvette wash cycles.

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64 11314536 Rev. 01
ADVIA Chemistry XPT System Chapter 4: Sample Management

Chapter 4: Sample Management


This chapter provides information about ordering samples, monitoring
status, and managing results.
For more information about managing samples, refer to the system online
help.

Manually Creating Orders


Before scheduling patient, calibrator, or control samples, perform the
following tasks:

• Define calibrators.
• Define controls.
• Load reagents, system fluids, and supplies.

Entering Patient Sample Information


1. On the command bar, select Orders > Create Patient Orders.
2. To initialize the order, enter a Sample ID or Tray-Cup ID or both and
then select Search.
3. Continuing in the Sample Information area, select a Specimen Type, one
or more tests, and other sample information as needed, including
Patient Demographics.
4. For the Patient ID, enter up to 20 alphanumeric characters.
In the Patient Name area, you can select Additional Information to
add more patient information.
5. Select Save.

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Creating a STAT Order


1. On the command bar, select Orders > Create Patient Orders.
2. To initialize the order, enter a Sample ID or Tray-Cup ID or both and
then select Search.
3. Continuing in the Sample Information area, select a Specimen Type, one
or more tests, and other sample information, as needed including
Patient Demographics.
4. For the Patient ID, enter up to 20 alphanumeric characters.
In the Patient Name area, you can select Additional Information to
add more patient information.
5. In the Priority area, select STAT.
6. Select Save.

About Creating Orders


If another operator modifies or deletes a Test Definition, Test Profile
Definition, or Ratio Test Definition while you are creating an order with a
request for the modified or deleted test, the system posts an error message.
If, while creating an order, you move to a different tab and make changes,
and then move back to the Create Orders tab, the same error message
occurs.
In either situation, clear the applicable test selections and make other
selections.

About Batch Orders


When you process batch orders, these rules and behaviors apply:

• The Starting Tray-Cup ID and Last Tray-Cup ID must both be unique.


The Starting and Last Tray-Cup IDs cannot match any Starting Tray-Cup
or Ending Tray-Cup ID already defined in active and pending batch
orders until that batch is closed.
• You can load Tray Cups in any order between the starting Tray-Cup and
the ending Tray-Cup.
• You cannot specify a priority for a batch order.
The priority defaults to Routine for all samples in the batch. Sample Tray
Cups loaded with a STAT priority are not recognized as part of a batch.
• The system does not process a sample in a batch if either of the
following conditions exist:

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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.

Creating a Batch Order


1. On the command bar, select Orders > Create Batch Orders.
2. Complete mandatory fields.
Mandatory fields display color.
3. Select a Specimen Type.
4. Enter the Manual Dilution factor, if applicable.
5. Select one or more Tests.
6. Enter Comments, as necessary.
7. Select Save.

Managing Orders
Pending orders can be edited or deleted.

Editing Pending Orders


1. On the command bar, select Orders > View Pending Orders.
2. Select each Order to edit.
If you are editing multiple orders, the orders must be the same sample
type.
3. Select Edit/View.
4. Edit fields as necessary.
5. Select Save.

Deleting Pending Orders


1. On the command bar, select Orders > View Pending Orders.
2. Select each pending order to delete.
3. Select Delete Order.
4. To confirm the deletion, select Yes.

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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.

Table 11: Results Flags

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.

Accessing Sample or Test Details


1. On the command bar, select Test Results > Overview.
2. Locate the sample or test to view.

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• 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.

Assigning a Disposition to a Result


1. On the command bar, select Test Results > Overview.
2. Select the result that needs a disposition assigned.
3. Select Edit/View.
4. Complete the Sample Details window:
a. Select the result or group of results to assign a disposition to.
NOTE: You cannot apply a Repeat disposition to a Control result or an
off-system result.
b. Select the checkbox for the disposition you are applying.
To apply the same disposition to a selected group of results, select
the check box in the table heading.
5. Select Save.

Printing Displayed Results


1. On the command bar, select Test Results.
2. Select any tab in the Test Results window that displays the results to
print.
3. On the selected tab, select the checkbox for each result you are printing.
4. Select Print.
5. On the Results Report Selection window, select a Report Type.
6. Select the Use Results Screen Selections and Filter checkbox.
7. On the Results Report Selection window, select Print.
8. On the Print Options window, enter settings as necessary.
9. Select Preview to view your report or OK to print a report without a
preview.

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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.

About Calibration Requests


Use Calibration Requests to display general information about ISE and
photometric calibrator replicates. The information can be sorted on any
column. The information on Calibration Requests is available in a printed
format on the Calibration Requests Report.
Calibration Requests is also used to do the following tasks:

• Access the Calibration Order Filter.


• Access the Calibration Requests View window.
• Delete calibration Requests.
• Print Calibration Requests Reports.
To access the Calibration Requests window, select Calibration >
Calibration Requests.

Adding Calibrator Definitions


1. Select Calibration > Calibrator Definitions > Add Calibrator
Definition.
2. Enter the following information about the calibrator:
• Name
• Lot
• Expiration
3. If adding a reagent blank definition, select RBL Definition.
4. Select 1 or more assays.
NOTE: An assay can only be assigned to one calibrator.
5. Enter the coefficient factor values (FV) for each assay.
6. Select Save.

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Loading Calibrators, QC, and Water Blank

BIOHAZARD
Wear personal protective equipment. Use universal
precautions. See the recommended safety information section
when working with biohazardous materials.

1. Verify that the system status is READY.

Figure 33: Top Left Cover

2. Open top left cover.

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Figure 34: Sample Tray and Control/Calibration Tray Covers

1 Calibration/Control Tray evaporation cover


2 Sample Tray evaporation cover

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:

Calibrator, QC, or Water Blank Tray


Single-point calibrator CTT
Multipoint calibrator STT
Water blank CTT-1
QC CTT

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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.

8. To load another calibrator or QC, repeat Steps 4–7.


9. Replace the CTT and STT covers.
10. Close the top left cover.

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Analyzing Single Point Calibrations

BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.

1. Prepare the required calibrators according to their Instructions for Use


(IFU).
2. Verify that the system status is READY.

Figure 35: Top Left Cover

3. Open the top left cover.

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Figure 36: Sample Tray and Control/Calibration Tray Covers

1 Control/Calibration Tray Evaporation Cover


2 Sample Tray Evaporation Cover

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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11. Select OK > OK > Yes.


NOTE: The system status is SAMPLING - PROCESSING SAMPLES. Do not
replace samples or reagents while system is in this status.
12. To view calibration progress, select Samples > Sample Trays.
13. Verify calibration status.
a. Select Calibration > Calibration Results.
b. Verify that the Calibration Status is Pass for each required assay.

Analyzing Multipoint Calibration

BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.

1. Prepare the required calibrators according to the Instructions for Use


(IFU).
2. Verify that the system status is READY.

Figure 37: Top Left Cover

3. Open top left cover.

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Figure 38: Sample Turntable Tray Cover

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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13. Select OK > OK > Yes.


NOTE: The system status is SAMPLING - PROCESSING SAMPLES. Do not
replace samples or reagents while system is in this status.
14. To view calibration progress, select Samples > Sample Trays.
15. Verify calibration status.
a. Select Calibration > Calibration Results.
b. Verify that the Calibration Status is Pass for each required assay.

Analyzing Absolute Calibration (Reagent Blank)

BIOHAZARD
Wear personal protective equipment. Use universal precautions.
See the recommended safety information section when
working with biohazardous materials.

1. Select System Operations > Start/Restart.


2. Select Analyze Single Point > Assay Selection > Yes.
3. Select the required assays.
4. Select RBL Only, if applicable.
5. Select OK > OK > Yes.
NOTE: The system status is SAMPLING - PROCESSING SAMPLES. Do not
replace samples or reagents while system is in this status.
6. To view calibration progress, select Samples > Sample Trays.
7. Verify calibration status.
a. Select Calibration > Calibration Results.
b. Verify that the Calibration Status is Pass for each required assay.

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Viewing Results of Calibration Checks


1. Select Calibration > Chemistry.
2. To view additional results, filter the chemistry calibrations.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an assay that is calibrated with a single point or multipoint
method.
NOTE: Calibration checks are only completed for single point and
multipoint calibration methods.
4. Select Details > Cal Check.

Viewing ISE Calibrator Results


1. Select Calibration > ISE.
2. To view additional results, filter the calibration orders.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an ISE calibration result.

About the Calibration Order Filter


Use the Calibration Order Filter to set criteria on the display of calibration
orders. The results that display on the Calibration Results window must
meet the specified criteria. The current filter criteria are displayed at the top
of the Calibration Results window.
Calibration orders can be filtered on the following criteria:

• Order date
• Assay
• Order status
To access the Calibration Order Filter, select Calibration > Calibration
Results > Filter.

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Viewing Calibration Results


1. Select Calibration > Calibration Results.
2. To view additional results, filter the calibration orders.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an assay.
4. Select View.

Viewing Calibration Reaction Curves


1. Select Calibration > Calibration Results.
2. To view additional results, filter the calibration orders.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an assay.
4. Select View > Reaction Curve.
5. Select a level and replicate.

Viewing Absorbance Measurements


1. Select Calibration > Calibration Results.
2. To view additional results, filter the calibration orders.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an assay.
4. Select View > Reaction Curve.
5. Select a level and replicate.
6. Select Measurements.

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Viewing Cuvette Blank Measurements


1. Select Calibration > Calibration Results.
2. To view additional results, filter the calibration orders.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an assay.
4. Select View > Reaction Curve.
5. Select a level and replicate.
6. Select Cuvette Blank.

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.

Deleting Calibration Results


1. Select Calibration > Calibration Results.
2. To view additional results, filter the calibration orders.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select the assays.
4. Ensure that only the check boxes for assays to be deleted are selected.

CAUTION
Ensure care when deleting a calibration result. Deleting a
calibration result permanently removes all associated data
from the database.

5. Select Delete > Yes.

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Viewing Wavelength Reaction Curves


1. Select Calibration > Calibration Results.
2. To view additional results, filter the calibration orders.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an assay.
4. Select View > Reaction Curve.
5. Select a level and replicate.
6. Select Wavelengths.
7. (Optional) Remove wavelength curves from the display:
a. Select the check box for each wavelength to remove the curve from
the display.
b. Select Refresh Graph.

Viewing ISE Historical Graphs


1. Select Calibration > ISE > Historical Graph.
2. Select Serum or Urine from Specimen Type drop-down menu.

Viewing Results of Reagent Blank Checks


1. Select Calibration > Chemistry.
2. To view additional results, filter the chemistry calibrations.
a. Select Filter.
b. Set the filter criteria.
c. Select OK.
3. Select an assay.
4. Select Details > RBL Check.

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Scheduling Automatic Calibrations


1. Select Calibration > Auto Cal Settings.
2. Select a test.
3. If applicable, select RBL Only to schedule only the reagent blank.
4. To schedule a control after an automatic calibration, select a control
from the Control drop-down menu.
5. To schedule an automatic calibration when the reagent switches from a
primary reagent pack to a backup, select Pack Switch.
6. To schedule an automatic calibration after a selected time interval:
a. Select Scheduled.
b. Enter the calibration interval in Days and Hours.
7. To schedule additional automatic calibrations or controls, repeat Steps
2–6.
8. Select Save.

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Chapter 6: Quality Control


This chapter contains information about performing quality control,
reviewing statistics and exporting QC data.
For more information about quality control, refer to the system online help.

Adding New Control Definitions


The control definition information can be manually entered.

Manually Adding a QC Definition


1. On the command bar, select QC > QC Definitions.
2. Select Add QC Definition.
NOTE: Ensure that you use the range values in the manufacturer’s
product insert.
3. On the Add New QC Definition window, complete all mandatory fields.
In the Test section, select at least one test and provide Low and High
Range values or mean and 2 standard deviation range values for each
selected test.
4. Select Save.

Scheduling QC Samples
Control samples can be scheduled according to day and time, test count, or
control.

Adding an Automatic QC By QC Definition


1. Select QC > Auto QC By QC Definition.
2. In Select Control, enter the new control.
3. Select Save.
4. In Number of Assays, enter the number of samples to process before the
controls process.
Remaining Assays counts the number of tests processed before the
system analyzes the control.
5. Select Save.

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Adding an Automatic QC By Test


1. On the command bar, select QC > Auto QC By Test.
NOTE: If Auto QC By Test is not available, select Setup > System
Configuration > System Parameters and configure Auto QC By Test.
2. Enter the new assay in Select Assay.
3. In Number of Assays, enter the number of tests you want to process
before the system runs every control that has the assay as part of its
definition.
Remaining Assays displays the number of tests that remain to be
processed before the controls run.
4. Select Save.

QC Statistics Application Overview


The QC Statistics application is intended for professional use in a laboratory
environment only.
The QC Statistics application provides both real time and long term
evaluation of analyzer and method performance. The QC Statistics
application features include:

• Collection of control results


• Calculation and display of statistical data

• Assessing data for errors


• Notification of QC violations

• Tools for reviewing and managing control results

• Tools for creating printed reports

• Identification and reporting of events such as lot change and calibration


date
For more information about QC Statistics refer to the system online help.

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Navigating Advanced QC Windows


The Advanced QC windows provide access to all parts of the application
through these tabs: Review, Analysis, Messages, Tools, and Setup.

QC Statistics Tabs

Tab Label Description


Review Displays current QC results.
Analysis Displays results of controls selected in the Review tab.
Messages Displays Advanced QC event messages: informational,
Warning, and Error. Colors indicate the severity of the
message.
Tools Displays maintenance activities that you can perform on
the control and patient median files: export, backup, or
restore.
Setup Displays windows that enable you to configure the
Advanced QC settings such as customizing displays, setup
QC rules, predefining comments, and setting up Patient
Median.

Additional Features

Button Label Description


Refresh Refreshes the data from the database.
The Chart tab, the QC tab and the PM tab are populated
with newly retrieved QC and PM data points, subject to
filter and selection criteria.
Customize Displays the sub-tab of the Setup>Customize>Analysis
tab dedicated to the type of data currently displayed in
the Analysis tab.
For example: if Analysis > PM is in focus, then selecting
Customize displays the Setup > Customize > Analysis >
PM-tab.
Statistics Displays the Statistics-Summary screen.

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Button Label Description


Statistics is enabled only if there is control and/or patient
median data currently displayed on the Analysis tab.
Events Displays the Events screen.
Events is enabled only if there is control and/or patient
median data currently displayed on the Analysis tab.
Reports Displays the Reports screen.
The files that were selected on the Review screen or the
Analysis screen will be pre-selected on the Reports
screen.
Exclude You can exclude data points from the statistical
calculation.
Include You can select data points to include in the statistical
calculation.
Comment You can add a comment to a result.
QC Details Displays error details for data points that are part of the
selected rule violation.

About Reviewing QC Results


At the Review tab you can review current QC results. The left panel displays
a list of open control files, ordered by control or test. Select the plus sign (+)
next to each top level of the list to display associated data, or select the
minus sign (-) to collapse a list. Also, you can select Collapse/Expand All to
fully display or reduce the nested data.
The right panel displays the results for each control file you select from the
open control files.
For each control file you select, the application displays results in the results
table.
Select or deselect individual control files.
Select the Select button to select all or deselect all of the check boxes.
Select the top level of any group to select all of the associated lower level
files.
Select Auto-select Issues to automatically select all control files that contain
issues, including new control files.
NOTE: If you select Auto-select and then deselect a control file with issues,
the Auto-Select function no longer applies and the application clears the

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Auto-Select check box. Any new control files with issues are listed but are
not automatically selected.

Analyzing Results in the Review Window


1. At the QC > QC Statistics window, select Review.
2. Select 1 or more control files.
3. Select Analyze.

The Advanced QC application displays the Analysis window with the


selected control files displayed in a chart.

Analyzing Results in a Chart


1. At the Advanced QC window, use the Review tab or the Analysis >
Filter window to select the controls you want to review.
a. To define a date range for the control files you are viewing, at the
Analysis tab, select Filter > Apply Time Filter.
NOTE:If a filter is already defined for the Analysis window, a filter icon
is displayed on the filter button and the defined time is displayed next
to the Filter button.
2. On the Analysis tab, select Chart.
3. Select the controls you want to review.
If you select more than 1 control file, use the vertical scroll bar to view
the other selected files. You can also select Hide to remove an individual
chart from the current view.
4. In the Display drop-down box, select the type of chart you want to use:
• Levey-Jennings
• Z-score
• RiliBÄK
NOTE:RiliBÄK is only available if the RiliBÄK feature is active.

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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:

To perform this task... Select...


mark a data point as reviewed, Reviewed
exclude 1 or more data points from participating in Exclude
statistical calculations,
reinstate 1 or more excluded data points for Include
statistical calculations, select an excluded data point,
and then
add a comment to data points, Comment
view details about a QC violation, QC Details

About the Levey-Jennings Chart


The chart area of the Analysis window displays a Levey-Jennings chart for
each open control file in the database. You can use the Filter window to
display selected control files and to set a date range of files to display.
The Levey-Jennings chart in the Analysis window displays data along 2 axes:

• +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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Figure 39: Mean Change

1 Target mean change

• -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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About the Z-score Chart

A Z-score Chart displays values based on the standard deviation.

Z-score Chart Structure

The structure of the Z-score chart is similar to the Levey-Jennings chart


using z-score values. However, where the Levey-Jennings chart displays
actual values for a control file, the Z-score chart shows relative values for all
selected control files using a standard deviation.
• The Y-axis marks represent the distance from the mean for all displayed
controls:
• +3SD
• +2SD
• +1SD
• Mean
• -1SD
• -2SD
• -3SD
• 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 that date range at 1 time.

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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Patient Median Analysis View


This view displays the details of the patient data currently displayed on the
Analysis > Chart tab. This view enables you to investigate individual points
of the patient median file.
If the Events window is open, selecting a patient median point displays the
Event screen > Patient Median tab with the closest event in time to the
selected point.

This Field ... Contains ...


Date the date and time when the median point was
calculated. The format of this field is
determined by Setup/Local Settings.
Median the middle patient result in the ordered bin or
the average of the 2 when the bin has 2
middle values.
Partial an indication whether the bin is a full bin or a
partial bin.
Last Result Date the date and time of the most recent patient
result in the bin.
First Result Date the date and time of the oldest patient result in
the bin.
97.5% the concentration of patient results within a
bin that are equal to or below the 97.5
percentile (97.5%).
75% the concentration of patient results within a
bin that are equal to or below the 75th
percentile (75%).
25% the concentration of patient results within a
bin that are equal to or below the 25th
percentile (25%).
2.5% the concentration of patient results within a
bin that are equal to or below the 2.5
percentile (2.5%).
Analyte the assay name associated with the data point.
Unit the display unit of the assay. Up to 15
characters.

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This Field ... Contains ...


Analyzer the name of the Analyzer instrument. Up to
31 characters.
Module the module name or ID of the Analyzer. For
integrated instruments you can have
Chemistry and IA modules. Up to 4 characters.
Inactive the state of the patient median file; either
active or inactive. In an inactive state, the
Advanced QC application does not collect any
patient sample results from the instrument.
Statistics are not calculated and displayed.
Excluded a Yes or No as to whether the median point is
excluded from the statistical/summary
calculations by the user.
Reviewed a Yes or No as to whether the median point
was reviewed by the user.
Reviewer the userid who reviewed the median point.
This field can be a User ID or System.
Review Date the date and time that the median point was
reviewed.
Reagent Lot the primary reagent lot number from the
analyzer instrument. Up to 20 characters.
Ancillary Reagent Lot the secondary reagent lot number from the
analyzer instrument. Up to 20 characters.
Reagent Pack the primary reagent pack number from the
analyzer instrument. Up to 14 characters.
Ancillary Reagent Pack the secondary reagent pack number from the
analyzer instrument. Up to 14 characters.
Comment any comments including a date and time
associated with the median point.

About the Analysis Tab Split Window


The Analysis Split Window layout displays the Analysis information with the
chart and table on a single window.
You configure the split window layout by selecting Split panel at the Setup
> Customize > Analysis > Chart.
The chart and chart functions display on the top panel and the data (table)
displays on the bottom panel.

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Adding Comments to the Library


1. At the QC window, select Setup > Comments.
2. Select Add.
3. Enter the new comment in the text box.
You can add up to 20 comments and each comment can have up to 50
characters.
4. Select Save.
Verify that the new comment displays in the Predefined Comment list.

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.

About Advanced QC Reports


Selecting Reports from either the Review window or the Analysis window
displays the control and patient median files on the Reports window. If you
apply a time filter, only the filtered QC and Patient median points display for
reporting.
You can generate reports to a printer or save to a file.
The Report Name drop down provides types of reports you can create:

• Monthly
• Summary
• Exception
• Custom Report 1
• Custom Report 2
• Patient Median Report

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Data Points Options Description


None No data points are printed
All All data points that are filtered, using the time filter
and selected control files, are printed.
Only violations All data points from selected and time-filtered
control files that violated active QC rules, and
system-omitted data points are printed.

Sort By Options

Sort By Options Description


Analyte Orders control files alphanumerically by Test Name and
Test Unit.
Control Orders control files alphanumerically by Control Name,
Control Level, and Control Lot number. For each group,
the sort order is Control Name and Control Level.

Options

Options for QC Data Description


Charts include Levey-Jennings chart with data points
based on the applied time filter.
Comments include all (time-filtered) comments associated
with the data point.
Events include (time-filtered) events associated with
the data point.
Cumulative summary include statistics associated with the data point.
Time filtering does not apply: statistics take into
consideration all data points contained in the
control file.
Timeframe.Summary include time-filtered statistics associated with
the data point
Cycle Summary include cycle-related statistics associated with
selected, time-filtered control files.

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Creating and Printing Advanced QC Reports

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.

QC Statistics Database Capacity


View the current values and maximum limits of the QC Statistics database
by selecting QC > QC Statistics > Tools > Database/Backup.

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QC Database Current and Maximum Values


The current values and maximum limits of the Advanced QC database
display for these data types:

Data Type Contents


Control Sample Results Total number of data points (results
and associated information) for all
control files, open and closed.
Patient Median Points Total number of patient median data
points (bins and associated
information) for all patient files, open
and closed.
Control Files Total control files, open and closed.
Patient Median Files Total patient files, open and closed.
NOTE: This field is not visible if the
Patient Median feature is disabled for a
user.
Unprocessed Control Sample Total number of data points not yet
Results assigned to control files.
Messages Total number of messages posted in
the message log.

In addition to the database files, this process backs up configurations


specific to your application:

• Reports Setup
• Local Settings
• Window Configuration

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Performing Database Maintenance with QC Files


1. At the QC > QC Statistics > Tools window, select Maintenance > QC.
2. Select a Patient Median file.
3. You can delete, close, or view file information.
a. Select Delete to delete the selected file.
b. Select Close to close the selected file.
c. Select File Info to view information about the control file.
d. Select File Info > Comment to add a comment to a file.
4. Select Archive Data before delete for the system to automatically
archive the patient median file to a saved location before the file is
deleted.

NOTE: Archived data cannot be restored to the system application.

Exporting Control Files


1. At the QC > QC Statistics > Tools window, select Export > QC.
2. At the Show by panel, select Control or Test.
3. On the QC checklist on the left, select the control or test files to export.
NOTE: Selecting the Expand button causes this checklist to expand into
a larger separate window. The Expand button displays a larger number
of files to make file selection easier. Selecting Close transfers your
selections to the original screen and the expanded view goes away.
4. In the Current Time Filter panel, select, change, or remove time filters as
needed.
5. Select the export file type: XML or TXT.
NOTE: Some systems require you to enter a destination path and file
name for the export file.
NOTE: If you export the files as .TXT, use the Move Up and Move down
buttons to change the order of the fields.
6. Select Restore Default to return the list to the default state.
7. Select Export.

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Exporting Patient Median Files


1. At the QC > QC Statistics > Tools window, select Export > Patient.
2. On the QC checklist on the left, select the test files to export.
NOTE: Selecting the Expand button causes this checklist to expand into
a larger separate window. The Expand button displays a larger number
of files to make file selection easier. Selecting Close transfers your
selections to the original screen and the expanded view goes away.
3. In the Current Time Filter panel, select, change, or remove time filters.
4. Select the export file type: XML or TXT.
Some systems require you to enter a destination path and file name for
your export file.
NOTE: If you export the files as .TXT, you can use the Move Up and Move
down buttons to change the order of the fields.
5. Select Restore Default to return the list to the default state.
6. Select Export.

Advanced QC Print Options

1. At the QC > QC Statistics > Review window, select Reports.


2. At the Reports window, select a report name and report contents.
3. Select Print.
4. At the Print Options window, select the printer from the list of printers
connected to the system.
5. Select Properties to change the printing preferences.
The Properties preferences are printer-driver dependant.
The localization settings may not apply in the Properties window.
6. Select the paper size.
7. Select Print to file to save report as a file.
Selecting Print to file does not allow you to select a page range or
change number of copies.
8. Select Print to send report to the printer.
a. Select the page range: selected pages or all pages of the report.
b. Select the number of copies to print.

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ADVIA Chemistry XPT System Chapter 7: Maintenance

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.

About the Maintenance Window Schedule Tab


When a maintenance activity fails or is overdue, the Maintenance button
on the command bar flashes yellow or red. Selecting the Maintenance
button enables you to view, edit, or cancel the activity that triggered the
warning or error.
When you open the Maintenance window Schedule tab, the Maintenance
button no longer flashes and returns to its normal color. When you clear the
issue in the Schedule tab, the row on the Schedule tab returns to its normal
color.
When you complete a Maintenance activity successfully, the system
updates the Schedule tab to display the next due date or the system resets
the current count.
When scheduled Maintenance activity fails, the row the activity is on in the
Schedule tab is red and the due date is not updated. The system makes a
Maintenance Log entry recording the Failed status. If a step in the
maintenance activity fails and a retry is allowed, a Maintenance window
displays enabling you to Retry or Cancel.

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Chapter 7: Maintenance ADVIA Chemistry XPT System

The table on the Schedule tab displays information about all defined
maintenance activities:

Table 12: Maintenance Schedule Tab Table

Column Head Description


Interval Displays the type of interval used for the
maintenance activity.
• Scheduled Date and Time
• As Needed
[blank] A symbol representing the current status of the
activity.
Activity The name of the activity, when appropriate, a
symbol indicating the activity was operator-defined.
NOTE: If you do not recognize the symbol, hover the
pointing device over the symbol or the blank area and
a tool tip displays a label.
[blank] Displays a clock when you postpone a maintenance
activity. To see the date and time the activity is set to
resume, hover your pointing device over the clock.
Frequency Displays the frequency selected in the activity
definition. Also indicates whether or not the activity
is automated.
Date Due / Depending on the type of interval set for the activity,
Current Count this column displays the following information:
• Date and Time scheduled for the activity.
• As Needed.
[blank] Displays a symbol indicating whether the activity is
performed by the system, the operator, or a
combination of system and operator.

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About the Maintenance Window Log Tab


The Maintenance window Log tab records all maintenance activities. The
Log can contain a maximum of 10,000 entries. When the Log reaches that
maximum capacity, it starts purging the oldest entries, up to 6 entries at a
time.
The Log tab table contains details of the recorded maintenance activities:

Table 13: Maintenance Window Log Tab Table

Column Head Description


Activity Name of the activity.
[blank] When an activity has a comment, a comment symbol is
displayed in the left-hand side of the column. Double-
select the Comment symbol to view the comment in
the text box at the bottom of the table.
The right-hand side of the column displays a symbol
representing the current status of the activity.
Operator Name of the operator performing the activity:
• For a manual activity, it is the person who selected
the Completed button.
• For a semi-automated and automated activity
initiated by a person using the Perform button, the
Log displays that person’s sign in ID.
• For a semi-automated or automated activity initiated
by the system, the Log displays System.
Start Date/ For semi-automated and automated activities, the Log
Count displays the date the activity started and, when
applicable, the current system cycle count.
For a manual activity, when applicable, the system
displays the cycle count at the time the operator selects
Completed.
End Date For semi-automated and automated activities, the
column displays the date the activity ended.
For manual activities, the column displays the date and
time the operator selects Completed.
Scheduled Date/ This column displays the date and time this activity is
Count scheduled to be performed.
Cycle Displays the cycle count at the time the operator
selects Completed.

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Viewing Online Maintenance Procedures


Online maintenance procedures provide instructions for the maintenance
activities.
1. On the command bar, select Maintenance > Schedule.
2. Select the maintenance activity.
3. Select Procedure.

Exporting a Maintenance Log


1. On the command bar, select Maintenance > Log.
2. Prepare the Log:

• To export the entire Maintenance Log, remove all filters.


• To export specific log data, select Filter and select your criteria.
3. Select Export.
The File Name field displays at the top of the Export window.
4. In the Export window, perform these steps:
a. Select a File Type Location.
b. If your storage location is different than the system default, enter or
Browse for a Location.
c. Select Export.

Printing the Maintenance Schedule


1. On the command bar, select Maintenance > Schedule.
2. Select Print.

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ADVIA Chemistry XPT System Chapter 8: Identifying System Problems

Chapter 8: Identifying System Problems


This chapter provides information about identifying and correcting system
problems.
For more information about correcting system problems and event codes
refer to the system online help.
For more information retrieving system name, serial number, and version of
software before contacting technical assistance, refer to Information for
Technical Assistance in Service Ordering and Warranty chapter.

Managing System Power


The system may require a shutdown, a startup after a shutdown, or an
emergency power disconnect.

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.

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Shutting Down the System

Use when there is advance notice of an upcoming power outage.


1. Select the Sign-in icon from the Status bar.
2. On the Sign Out confirmation dialog box, select Yes.
3. If changes have not been saved, a confirmation message box displays:

• Select Yes to save changes


• Select No to not save the changes.
4. Select Shutdown > Yes.

WARNING
Do not open system covers when shutting down the system
because probes and trays move during this process.

5. Once the workstation shuts down, turn the system off.

CAUTION
Do not turn on system power for at least 3 minutes after a
system shutdown has completed.

Starting Up the System


1. Ensure that power has been restored, if applicable.
2. Turn on Operate switch, if applicable.
NOTE: Power to the workstation computer will automatically resume
when the Operate switch is turned on.

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Figure 40: System Power- Front of System

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.

7. Select System Operations > Initialize.

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Using Emergency Stop


NOTE: Use the emergency stop button when there is an obstruction that
could cause system or physical damage. The emergency stop button is
located on the front of the system.
1. Select the Emergency stop on front panel.

Disconnecting System Power in Emergency

Follow this task when there is a risk of electrocution or injury to the


operator. This task should not be used to interrupt sample processing in an
emergency. Follow Using Emergency Stop.
NOTE: Disconnecting the system from power turns off the entire system,
including the tray refrigeration and workstation. Disconnecting the plug
stops all sample processing and loss of all test results.
1. Disconnect system power cord from source.

CAUTION
Do not turn on system power for at least 3 minutes after a
system shutdown has completed.

Shutting down the Workstation

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.

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1. Select the Sign-in icon from the Status bar.


2. On the Sign Out confirmation dialog box, select Yes.
3. At the Sign-In window, select Shutdown.
4. At the prompt, select Yes to continue.
5. Wait while the system powers down.

Restarting the Workstation

BIOHAZARD
Wear personal protective equipment. Use universal
precautions. See the recommended safety information section
when working with biohazardous materials.

1. Select the Sign-in icon from the Status bar.

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.

2. On the Sign Out confirmation dialog box, select Yes.


3. Select Restart the Workstation.
4. Select Yes to continue.
5. Login to the system.
6. Wait while the workstation reconnects to the system.
7. Check for obstructions before restarting the system.
NOTE: The workstation is connected to the system when the connection
arrows are green and the emergency button light displays.
8. Select System Operations > Initialize.
9. Wait until the system status is READY and then return to normal
operation.

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Recovering from an Emergency Stop


Use the emergency stop button when there is an obstruction that could
cause system or physical damage. The emergency stop button is located on
the front of the system.

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.

Recovering from a Slow User Interface or System Lockup


Contact technical assistance if one or more of the following conditions exist:
• The software responds very slowly after you make a selection
• The software locks up

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Recovering from a Power Disruption to the System


Use this procedure to recover from a power outage or power surge.

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.

If the power disruption is brief enough that there is no opportunity to turn


the main power switch off, reset the system.
1. Turn system power to Standby status.
2. Turn the main power switch off.
3. Wait 30 seconds and then turn the main power switch on.
NOTE: Power to the workstation computer will automatically resume
when the main power switch is turned on.
4. Check for and remove any obstructions in the following areas before
restarting the system:
• Sample probes
• Reagent probes
• System covers
• Cuvette trays

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Chapter 8: Identifying System Problems ADVIA Chemistry XPT System

• 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.

Safely Shutting Down the System


Shutting down the system is the last process to resolve system problems. If
the pointing device, touchscreen, or keyboard is not responding, follow the
actions described in the table below to safely reboot the system. Refer to
Shutting Down the System for each action.

WARNING
Do not open system covers when shutting down the system
because probes and trays move during this process.

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Input Device Actions


Pointing device If the pointing device does not respond, use the
touchscreen to perform the system shutdown.
Touchscreen If the touchscreen does not respond, use the
keyboard to perform the system shutdown.
Keyboard If the keyboard does not respond, use the pointing
device or the touchscreen to perform the system
shutdown.

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.

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Visible Status Light


The status light on the system, visible from most positions in the room,
displays colors that correspond to system events.

Status Light Description


Off No error or warning conditions exist and the user
interface screen saver and status buttons are neutral.
• The system is turned off.
• The light is disabled.
NOTE: If the status light is off for an extended period of
time, check the user interface error conditions.
Yellow At least 1 warning condition exists.
Red At least 1 critical condition exists that may cause the
system to stop aspirating or processing samples.
Blinking Yellow • A new event has occurred.
or Blinking Red • 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.
Blinking Green A remote update is in progress.
If an error occurs during a remote update, the status
light changes to blinking red.

Accessing Troubleshooting Help


1. On the command bar, select Events > Operator Event Log.
2. Select the Event for which you need help.
3. Select Troubleshooting Help.

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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.

Checking the Keyboard Cable Connections


1. If the keyboard does not respond, check the cable connection for the
keyboard.
NOTE: The cable connection to the back of keyboard is located below
the system monitor. Ensure that the keyboard cables at the back of the
keyboard and below the system monitor are firmly connected.
2. Check all the keyboard connections

System Version Information


Use About in Setup Settings to display current software version
information, system version information, and legal notices.

View Action
Software version Select Setup > Settings > About.
System version Select Setup > Settings > About > Instrument Info.
Legal notices Select Setup > Settings > About > Legal Notices.

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ADVIA Chemistry XPT System Chapter 9: Managing Data

Chapter 9: Managing Data


The section provides information about the following data management
functions:

• Maintaining the database

• Performing data backup

• Saving results to an archive


• Exporting quality control and test utilization data
For more information about managing data, refer to the system online help.

Maintaining the Database


The system maintains the database automatically by default. Edit the
default settings for the automatic maintenance to fit the workload
schedule. Manually perform database maintenance when necessary. When
performing the database maintenance, the system deletes worklist entries
and associated results based on parameter settings. The system creates an
archive of results data before deleting them.
This section provides information about the following activities:

• Move data (patient results, orders, calibrations and QC) to Historical

• Archive data
• Delete data

Viewing Automatic File Management Activities


1. On the command bar, select Maintenance > Schedule.
2. In the activity area, select an automatic file management activity:

• Database Backup
• Database Archiving
• Move to Historical
• Database Optimization
3. Select Edit/View to review the automatic activity settings.

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Chapter 9: Managing Data ADVIA Chemistry XPT System

Editing Automatic File Management Activities


1. On the command bar, select Maintenance > Schedule.
2. In the activity area, select an automatic file management activity:
• Database Backup
• Database Archiving
• Move to Historical
• Database Optimization
3. Select Edit/View.
4. At the Edit/View window:

• deselect Start Automatically to disable automatic file management


• select Postpone Next Occurrence and select the hours and minutes to
delay the start time of the automatic file management activity

Managing Files Manually


In the Manual File Management area you can select all samples of a
specific status for deletion or move them to Historical. The Sample Count
displays how many samples are in each Sample Status.
1. On the command bar, select Utilities > Orders Capacity.
2. In the Manual File Management area, select the check box for each
Sample Status to Delete or Move To Historical.
3. Select one of the following options:

• Delete
• Move to Historical

Performing an Automatic File Management Activity Manually


1. On the command bar, select Maintenance > Schedule.
2. In the activity area, select an automatic file management activity:

• Database Backup
• Database Archiving
• Move to Historical
• Database Optimization
3. Select Perform.

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Performing Database Backup


Ensure the system is connected to Siemens Remote Service (SRS). System
can be configured to automatically back up and send the following data
daily to the server:

• Customer-changeable parameters

• Customer-defined setup options

• Event log
• Maintenance log

• System settings

• Tube types

• Reagent inventory

• Quality control data


• Assay calibration data

• System calibrations

Performing the Database Backup Manually

The database backup is part of the automatic Daily Maintenance activity.


The database backup occurs when the daily maintenance is performed.
1. On the command bar, select Maintenance > Schedule.
2. Select Database Backup in the Activity column.
3. Select Perform.

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Restoring Data to the System


1. On the command bar, select Utilities > Data Restore.
2. Select Browse.
3. Select a backup file and then select Open.
4. In the Perform Data Restore area:

• 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.

Saving Results Data to Archive


The system saves results data automatically to an archive according to the
maintenance settings in Maintenance Schedule.
NOTE: Must be logged in with appropriate security level to add or edit
system maintenance activities.
Save the data manually to an archive or choose not to save the results data.
Use local drive, CD, DVD, or other storage media to save files to an archive.
Records saved to an archive are not deleted until the system performs a
database maintenance activity.
The results data archive is in a format compatible with Microsoft Excel or
similar spreadsheet application.
NOTE: Archived data cannot be restored to the system.
For more information about archiving data, refer to the Maintenance
Schedule online help.

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Archiving or Deleting a Database


1. Select Maintenance > Schedule > Database Archiving and Deletion >
Perform.
2. On the Confirmation dialog box, select Yes.
3. In Database Archiving, enter the information for setting up archive and
deletions.
NOTE: The archive and delete function creates a CSV file of raw reaction
data for the archived records in F:\USERROOT\Database Archives and
Deletions. The amount of data archived may be large and split into 2 or
more files.
When the maximum of 7 is reached, the system deletes the oldest file
before saving a new one. If the raw data stored in the CSV files is
required, copy the data off the system promptly.

Editing Automated Database Archive and Delete


1. Select Maintenance > Schedule.
2. Select Database Archiving and Deletion.
3. Select Edit/View.
4. In Settings, select Historical Patient Samples Age and set the number
of days to 14.
5. In Frequency, select Daily.
6. Select the double arrows and select a day and time at least 15 minutes
after Move to Historical.
NOTE: Select a day and time when the system will be in READY, WAIT,
or DISCONNECTED state.
7. Select the double arrows to return to the previous menu.
8. Select Start Automatically.
9. Select Save.
NOTE: The first and second time the archive task is performed, no data
is archived or deleted. The third time the archive task is performed, data
that is older than 14 days (one week’s worth) will be archived or deleted.
Fourteen days of data remain in the active or historical database.

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Exporting Data
For more information about exporting data, refer to the system online help
for the required feature window.

Exporting Results Data Files


1. On the command bar, select Test Results > Overview.
2. Select Export.
3. On the Export Test Results window, make your selections and export
your file:
a. To include patient order files with your export files, select Patient
Orders.
b. To mask patient identities, select the Hide Patient Name and ID
checkbox.
c. To include control files in the export data, select the Control Orders
checkbox.
d. Enter the earliest date of the historical files to be exported in the
From date and time area.
4. Select Export.
The Export Files window automatically provides a filename for the
export file.
5. In the location area, browse to a folder location to save the export file.
6. In the File Type area, select a file type for the saved files:
• XML Data (*.xml)
• Text (tab delimited)(*.txt), default
7. Select Export.

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About System Defined File Names


The system creates a filename using the following format:
prefix_systemserial_categorytype_YYYY_MM-DD-HH_MM_SS.
An example of an exported test results files with a user-defined prefix:
Sys76_K54321_TestResultsExport_2014_3_16_17_36_14.xml
An example of an exported test results file without a customer-defined
prefix:
K54321_TestResultsExport_2014_3_16_17_36_14.xml
An example of a database backup file without a customer-defined prefix:
K54321_DatabaseBackup_2014_3_16_17_36_14.zip

Table 14: File Naming Convention

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).

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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

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Chapter 10: Configuring the System


The sample options, test parameters, and system options can be
customized for the laboratory with the appropriate level of security. Select
Setup to access various setup options.

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.

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Configuring and Modifying Assay Reagents


Reagents must be configured before the assay. Configure and modify
reagents in Setup > Reagent Setup. Modify reagent location in Setup >
System Configuration > Reagent Container Configuration.

Adding Reagent Information


1. Select Setup > Reagent Information > Add.
2. Enter the following from the reagent Information for Use (IFU).
• Assay Name
• Reagent Code
• OnBoard Stability
• Comment
• Calibration Interval
• R1 and R2 Fill Volumes
3. Select OK.

Editing Reagent Container Configuration


1. Select Setup > System Configuration > Reagent Container
Configuration.
2. Enter Reagent Tray 1 (RTT1) and Reagent Tray 2 (RTT2) position
numbers.
NOTE: Valid reagent container position values are 1–60 for RTT1 and
1–59 for RTT2. Multiple position numbers and/or ranges are separated
by commas, such as 1,3,5–8.
3. Select Save.

Configuring and Modifying Assay Options


Configure and modify assay definitions and calculations, such as assigned
reagent, calibration method, repeat and dilution parameters, sample
volume, reference ranges, result units, the number of decimal places for
results, and the number of sample replicates in Setup Test Definitions.
Assays installed from the Test Definitions Documentation disk have a
predefined Common or SI unit of measure. All assay test definitions must be
reviewed. If different units of measure are required by the laboratory, edit
the test definition before calibration. The system contains preset ISE assay
(Sodium, Potassium, and Chloride) configurations. All ISE test definitions
must be reviewed. If different units of measure or numbers of decimal

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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.

ADVIA Chemistry XPT Test Definition Disk


The test definition disk enables parameters and ranges updates for pre-
defined Siemens assays only. This includes updates to chemistry, serum
indices, A1c Ratios, and calibrator definitions.
Pre-defined assays are located in analytical condition numbers 1–150. User-
defined assays, located in analytical condition numbers 151–200, are not
affected by this disk and must be maintained manually.
The update of the test definition disk can be customized to report in
Common Units or SI Units.
Within the pre-defined assays, there are several user-defined fields. During
update of the test definition disk, choose to keep or overwrite the following
user-defined fields:

• Defined normal ranges


• Qualitative judgment settings
The test definition disk does not change parameters for ion selective
electrode (ISE) assays:

• 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.

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Configuring Assay Sample, Reagent, and Diluent


1. Select Setup > Test Definition > Chemistry > Analytical Conditions.
2. Select the next available condition number.
3. Enter a version number.
NOTE: Change the version number when settings are edited.
4. Refer to the Instructions for Use (IFU) for configuration settings.
5. Select a reaction time.
6. Select > > to select the required reagent code.

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.

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Configuring Assay Definition


1. Select Setup > Test Definition > Chemistry > Definition.
2. Enter an assay Name or mnemonic.
NOTE: The maximum of 10 character mnemonic populates the Display
Name, Print Name, or LIS Code.
3. Refer to the IFU for configuration settings.
4. If different from Name, enter the Display Name, Print Name, or LIS
Code.
5. Select either Enable or Disable.
6. Select the main wavelength.
7. Select the secondary wavelength, if applicable.
8. Configure a serum repeat dilution definition, if applicable:
a. Enter the Reaction Sample Volume.
b. Select the Dilution Method.
c. Enter the Dilution Sample Volume, Diluent Volume, and the
Diluent Position.
d. Enter a second serum repeat definition, if applicable.
9. Configure a urine repeat dilution definition, if applicable:
a. Enter the Reaction Sample Volume.
b. Select the Dilution Method.
c. Enter the Dilution Sample Volume, Diluent Volume, and the
Diluent Position.
d. Enter a second urine repeat definition, if applicable.
10. Select Save.

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Configuring Assay Calculations and Calibration


1. Select Setup > Test Definition > Chemistry > Calculation.
2. Refer to the IFU for configuration settings.
3. Configure units of measure:
a. Select SI or Common for type of unit.
b. Select the unit.
c. Verify the unit of measure and the number of decimals are correct.
4. Enter the maximum limit, limit value, and variance.
5. Select the calculation method.
a. IF EPA is required, select EPA Method and enter the reanalysis
absorbance (u) and (d), then select Continue.
b. If IMA is required, select IMA Method and enter IMA method
settings, then select Continue
6. Select the reaction type.
7. Configure the abnormal values, if applicable:
a. Enter high and low values for serum.
b. Enter high and low values for urine.
8. Configure Qualitative Judgement, if applicable:
a. Select No to disable qualitative setting configuration.
b. Select Yes to enable qualitative setting configuration, then select
specimen type, enter settings, and select Continue.

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9. Enter reaction detection forward and checkpoint 1 points.


10. Select prozone detection point formula and enter limit.
11. Enter start and end points for main and secondary measurements.
12. Enter start and end points for prozone main and secondary
measurements.
13. Select prozone judge.
14. Enter prozone judge limit.
15. Configure the calibration method:
a. If Single-point is required, select Single-Point Settings and
complete configuration.
b. If Multipoint is required, select Multipoint Settings and complete
configuration.
c. Select Continue.
16. Select Save.

Configuring IMA Methods


1. Select Setup > Test Definition > Chemistry > Calculation > IMA
Method.
2. Enter the automatic limits for:

• Blank (u)
• Blank (d)
• Sample (u)
• Sample (d)
• Prozone Value
3. Select Auto. set to define an automatic setting.
4. Select Continue.

Configuring Qualitative Settings


1. Select Setup > Test Definition > Chemistry > Calculation >
Qualitative Settings.
2. Select specimen type.
3. Enter specimen type ranges and characters.
4. Select Continue.

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Configuring Reaction Rate Settings


1. Select Setup > Test Definition > Chemistry > Calculation > Reaction
Rate Settings.
2. Enter the values for:
• cycle
• factor
• blank (u)
• blank (d)
• sample (u)
• sample (d) values
3. Select E2 Correction, if applicable.
4. Select Continue.

Configuring Absolute Calibration

Configure absolute calibration when assay Information for Use (IFU)


indicates that the assay is a fixed factor value (FV) assay.
1. Select Setup > Test Definition > Chemistry > Calculation.
2. Select required assay.
3. Select Absolute from the Calibration Method drop-down list.
4. Select Save.
5. To enter the fixed FV:
a. Select Calibration > Calibrator Definitions.
b. Select Water Blank.
c. Select Edit.
d. Locate the required test and ensure the required assay is enabled.
NOTE: The assay added from Setup will display in the assay list under
Assay Selection. To enter the FV value, the assay must be enabled
(displays with a check mark). To enable the required assay, select it from
the list. Once enabled, that assay will display at the bottom of the list of
assays on the right side of Assay Selection.
e. Enter the required fixed FV from the assay IFU in the FV-1 column.
f. Select Save.

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6. To ensure the fixed FV assay was added to Water Blank:


a. Select Samples > Cal/QC Sample Settings.
b. Locate water blank position.
c. Ensure the required assay is listed under Assay Selection.

Configuring Single-Point Calibration


1. Select Setup > Test Definition > Chemistry > Calculation.
2. Select Single-Point from Calibration Method.
3. Enter the minimum and maximum deviation replicates.
4. Enter the minimum, maximum, and maximum deviation calibration
factors.
5. Select Continue.

Configuring Multipoint Calibration


1. Select Setup > Test Definition > Chemistry > Calculation.
2. Select Multipoint from Calibration Method.
3. Select Multipoint Settings.
4. Select a formula and axis conversion type.
5. Enter the number of points.
6. Select the curve type.
7. Enter the minimum replicates and abstract separation with the
maximum RMS of FIT.
8. Select whether the RBL blank should be zero or any value.
9. Enter the dilution configuration:
a. Select a dilution method.
b. Enter the dilution sample, diluent volume, and CTT diluent location.
c. Enter the maximum fit deviation and maximum replicates.
10. Select Continue.

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Configuring Repeat Conditions for Instrument Flags


1. Select Setup > Test Definition > Chemistry > Calculation > Repeat
Conditions for Instrument Flags.
2. Ensure the assay is configured before repeat conditions can be edited.
3. Select each flag for reanalysis, if applicable.
4. Select the dilution option.
5. Select Save > Close.

Configuring Assay Realtime Correction


1. Select Setup > Test Definition > Chemistry > Realtime Correction.
2. Refer to the IFU for configuration settings.
3. Configure serum correction, if applicable:
a. Enter formula and factors.
b. Select Verify.
4. Configure urine correction, if applicable:
a. Enter formula and factors.
b. Select Verify.
5. Select Save.

Configuring Assay Reagent Blank Values (RBL)


1. Select Setup > Test Definition > Chemistry > Reagent Blank Settings.
2. Refer to the IFU for configuration settings
3. Configure replicates:
a. Enter the minimum number of RBL replicates.
b. Enter the maximum allowed deviation of RBL replicate.
4. Configure values:
a. Enter the minimum reagent blank value.
b. Enter the maximum reagent blank value.
c. Enter the maximum allowable reagent blank value when compared
to the mean of the past three good reagent blanks.
5. Select Save.

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Configuring Specimen Type Mapping


1. Select Setup > Test Definition > Chemistry
2. Select required assay.
3. Select Analytical Conditions > Specimen Type Mapping.
4. Select Specimen Type Mapping to configure specimen type by
highlighting type and moving it to either serum or urine.
5. Select a specimen type then select >> to assign it to either serum or
urine.
6. To remove a specimen type from either serum or urine, select that type
then select <<.
7. Select Continue > Save.

Configuring Carryover Set


1. Select Setup > Test Definition > Chemistry > Analytical Conditions >
Carryover Set.
2. To add a carryover configuration for the reagents probes:
a. Select Add under Reagent Probe Contamination Avoidance.
b. Select the probe, contaminating substance, and preventive
detergent.
c. Enter Influence Effect.

• Enter 1 if contamination can be avoided with deionized water.


• Enter 999 to automatically carry out detergent wash. Use this setting if
contamination is heavy.
• Enter a number in the range 901–905 for RTT1.
• Enter 906–910 for RTT2.
3. To add a carryover configuration for the RRV cuvettes:
a. Select Add under RRV Cuvette Contamination Avoidance.
b. Select the contaminating substance and detergent for both RTT1
and RTT2.
4. Select Continue.

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Configuring Container and STT Position Options


Use Setup System Configuration to define sample or reagent container
options such as area and LLS sensitivity. Use Setup STT Position Settings to
define sample.

Editing Container Settings


1. Select Setup > System Configuration > Container Settings.
2. Edit the required reagent or sample tube container settings.
3. Select Save.
4. Select Yes at Warning confirmation.

Editing STT Position Settings


1. Select Setup > System Configuration > STT Position Settings.
2. Scroll to position to be edited.
3. Select container type.
4. Select Priority, if applicable.
5. Select Save.

About Check Ranges


You must have the appropriate security permissions to make modification
to the Ranges tabs.
A Check range is a range that falls within the concentration range or the
limits of the system with an above, in range, or below range check.
If you create a Check range that is greater than the Concentration or Index
range, the system posts a warning message but does not stop you from
saving the range.
You can delete or edit the predefined Check range if you have the
appropriate permissions. However, the system must always have a Check
range.
The system validates all ranges when you select Save.

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The Check tab Details area contains the following fields:

Table 15: Check Range Details

Detail Rules for Use


Limits Values are absolute.
Flag Result Clear the Repeat, Reflex, and Comment fields to clear the
Flag Result check box.
Repeat When available and selected, the system automatically
repeats any test that exceeds the range limits.
No. of Repeats
The system can repeat 1 time.
Dilutions
Check ranges only allows the Original dilution or no
dilution.
Reflex Lists all currently defined tests, except off-system tests,
that support the specimen type.
Comment Contains predefined comments or allows you to add your
own comment of up to 60 characters.

Editing a Check Range


NOTE: Before editing a check range, move any existing test results to Historical.
1. On the command bar, select Setup > Test Definition.
2. Select a test and then select Ranges > Check.
3. Select Edit.
4. Optionally, modify the Range Name.
5. Enter one or both Check Range values, Low or High:

• To set Below Range values, enter the Low limit.


• To set Above Range values, enter the High limit.
• To set all values, enter both limits.
• The Below Range and Above Range values cannot be equal.
6. Select Save.

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Editing a Linearity Range


1. On the command bar, select Setup > Test Definition.
2. Select a test and then select Ranges > Linearity.
3. Select Edit.
4. Optionally, modify the Range Name.
5. Enter one or both In Range values, Low or High:
• To set Below Range values, enter a low limit.
• To set Above Range values, enter a high limit.
• To set all values, enter both limits.
• The Below Range value and the Above Range value cannot be the
same.
6. Select Save.

Changing Test Order Display


1. Select Setup > Test Definition > Chemistry > Test Display Order.
2. Select the required assay to change the process order.
3. Select Move Up or Move Down.
4. Select Save.

About Test Profiles


A Test Profile is a collection of tests, allowing you to add a defined group of
tests to an order without selecting the tests individually. A Test Profile does
not control the grouping or order of tests on a screen, on a printed report,
or for result transmission.
When working with Test Profiles, understand the following behaviors:

• 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

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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.

About Ratios & Profiles


The Ratios & Profiles tab in the Setup window allows you to define, edit,
and delete operator-defined ratios, dilution profiles, and test profiles:
• Permissions to access the Ratios & Profiles tab functions are set in the
Security window.
• You may search the Ratios & Profiles tab by any column information
except the Enabled / Disabled column.

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Table 16: Ratios & Profiles Summary Table

Column Heading Description


[check box] Allows you to select one or more profiles or tests to
delete or print.
Ratio/Profile Displays the operator-defined name of the ratio or
profile.
LIS Code Displays the operator-defined LIS name of the ratio or
profile.
The Ratio/Profile name and the LIS Code can be
identical
Profile Type Displays the type of ratio or test.
Details Information about the test or profile displays.
[blank] When a test or profile is enabled, the area to the right
of the Type column is blank.

Reference Ranges, Result Interpretation, and Reflex Testing


You can define reference ranges for your patient population, result
interpretations for results within a certain range, and repeat and reflex tests
for samples with certain test results.

About Reference Ranges


You must have the appropriate security permissions to make modification
to the Ranges tabs.
You can create up to 10 Reference ranges for each test. If you create a
Reference range that is greater than the Concentration or Index range,
the system posts a warning message but does not stop you from saving the
range.
If you define multiple Reference ranges, the system flags all values that are
outside the specified range in each definition. This can result in overlapping
out-of-range values and multiple flags. When this occurs, the system posts
a message stating that the result has a ranges conflict.
Demographic values default to All in each area. This means all
demographic values are valid for the range. You cannot create a range that
has the same demographic values as a previously saved Reference range.

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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:

Table 17: Reference Range Details

Detail Rules for Use


Limits Values must be in ascending order.
Use absolute values from 0.000 to 999,999.9999.
Enter a Low value and a High value to enable the Critical
Low and Critical High fields. The system computes the
Normal value.
Flag Result The system automatically flags Reference results that are
outside the reference range.
Repeat When available and selected, the system automatically
repeats any test that exceeds the specified range limits.
The system can repeat 1 time.
Dilutions
Reference ranges only allow the Original dilution or no
dilution.
Reflex Lists all currently defined tests, including off-system tests,
that support the specimen type.
Comment Contains predefined comments or allows you to add your
own comment of up to 60 characters.

Adding a Reference Range


NOTE: Before editing a reference range, move any existing test results to
Historical.
1. Select Setup > Test Definition > Chemistry.
2. Select a test and then select Ranges > Reference.
3. In Range, select Add Range.
4. In Range Name, enter a name for the new range.
5. In Details, enter the values according to the type of range:

• To create a range between two values, enter the Low value and the High
value.

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• 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.

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About Predefined Interpretation Ranges


You must have the appropriate security permissions to edit a Predefined
Interpretation range.
The Predefined tab Details area contains the following fields:

Table 18: Interpretation Field Descriptions

Field Name Descriptions


Limits Not available for edit.
Result Review Selecting Edit enables the drop-down list.
Repeat Not available.
Reflex Lists all currently defined tests, except off-system tests.
Dilution
Lists all dilution values allowed for the currently
selected reflex test.
Replicates
Contains a drop-down list from no value to 30. When
you select no value, the system uses the same number
of Replicates as the Original test definition. The system
can replicate 1 time.
Comment Contains predefined comments or allows you to add
your own comment of up to 60 characters.

Editing Predefined Interpretation Ranges

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.

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About Operator-Defined Interpretation Ranges


You must have the appropriate security permissions to add an Operator-
Defined Interpretation range.
You can create up to 10 Operator-Defined Interpretation ranges for each
test. Operator-Defined Interpretation ranges can overlap. When overlap
occurs, the system flags the patient with all of the matching Operator-
Defined Interpretations.
The Operator-Defined Interpretation tab Details area contains the following
fields:

Table 19: Operator-Defined Interpretation Range Details

Detail Rules for Use


Limits Selecting Add Ranges enables 2 Limit fields.
Result Review Selecting Add Ranges enables the drop-down list.
Repeat Not available.
Reflex Lists all currently defined tests, except off-system tests.
Dilution
Lists all dilution values allowed for the currently
selected reflex test.
Reflex
Contains a drop-down list from no value to 30. When
you select no value, the system uses the same number
of Replicates as the Original test definition. The system
can replicate 1 time.
Comment Contains predefined comments or allows you to add
your own comment of up to 60 characters.

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Adding an Operator-Defined Interpretation Range


NOTE: Before adding an interpretation range, move any existing test results to
Historical.
1. On the command bar, select Setup > Test Definition > Chemistry.
2. Select a test and then select Ranges > Interpretation.
3. On the Range list area, select Add Range.
4. Enter the Range Name.
5. Enter range values in the Limits text boxes.
The range values must be absolute values. The system does not validate
these values against any defined interpretations.
6. Complete other range information.
7. Select Save.

About Reflex Tests


Reflex tests are supplemental tests or profiles the system schedules in
response to low or high results for specific tests. You can define a reflex
tests for results that are outside a range or interpretation range.
For more information about Reflex tests, refer to the system online help.

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Defining Calculated Parameters


The system uses the results from one or more standard tests or off-system
tests in a formula to calculate user defined ratios, combination, or a
multicomponent test result. Combination or multicomponent formulas are
included in the calculated assay test definition.
For more information about assays with calculated test results, refer to the
system online help for Setup > Test Definition.

Adding a Ratio Test Definition

You may add up to 100 Ratio Tests.


1. On the command bar, select Setup > Ratios & Profiles.
2. Select Add Ratio.
3. On the Ratio Test Definition window, complete each section as
necessary:
a. The Ratio Test Name must begin with an alpha character and
contain up to 8 alphanumeric characters.
b. In the select boxes, select the Units, Decimal configuration, and
Result Review Mode to use for this test.
c. Select whether to Enable or Disable the Ratio Test.
d. Build an equation using elements from Operators, Numbers, and
Tests including Specimen types.
4. Select Verify.
5. Select Save.

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Modifying System Options


You can view or modify system options. Refer to the system online help for
more information about the following settings:

• System serial number

• System name

• Full screen system dashboard options

• Alarm volume

• Visible status light


• Low reagent status

• Pointing device
• Storage location for data export

• Report options

• Accepting remote installation


• Selecting remote access

• Remote software administration

Editing Operation Mode


1. Select Setup > System Configuration > Operation Mode.
2. Edit the required setting.
3. Select Save.
4. If a restart of the system is required, select OK.

Configuring Visible Status Light


1. Select Setup > System Configuration > Alarm Settings.
2. In the Visible controls area, select Enable Visual Display.
3. Select Save.

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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.

Setting up Informatics Connections


1. On the command bar, select Setup > Settings > Informatics Setup.
2. Select Edit.
3. Select Enable Informatics Connection.
4. If you are sending data to the Remote Server, select the data and set a
time:
a. Select each data type to send in the Data included in Daily Updates
area.
b. Enter or select the Time to send Daily Update.
c. Enter the number of days worth of data to send in Predefined
Queries to return data for that number of days.
d. To send only selected event codes, select Event Code Filter, then
select the codes you wish to send.
NOTE: If Event Code Filter is not selected, all event codes are sent.
5. Select Save.

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Enabling LIS Configuration Settings


1. On the command bar, select Setup > LIS Configuration.
2. Select Enable LIS Configuration.
3. Continue to each LIS Configuration area:
a. Complete the General Settings area.
b. Complete the Application Layer area.
c. Complete the Data Link Layer area.
d. Complete the Physical Layer for Serial Connection area or the
Physical Layer for TCP/IP Connection area.
4. Select Save.

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Completing the Application Layer LIS Configuration Settings


1. On the command bar, select Setup > LIS Configuration.
2. In the Application Layer area, select each option that applies to your LIS.
3. In the General Settings area of the Application Layer, select each option
that applies to your LIS.

Automatically Send Status The system sends reagent status


messages to the LIS.
Perform Diagnostics at Startup The system sends diagnostic
messages to the LIS when the
system starts up. By default, the
system does not transmit
diagnostic messages to the LIS.
Send Rack IDs with Results Not applicable.

4. In the Query Settings area, select each option that applies to your LIS
connection:

Query First Select Host LIS or Instrument to


specify which system is queried
first for an order.
Automatically Query Host LIS The system queries the Host LIS
for worklist entries as the system
identifies each sample.
Respond to Query for Results The system sends results in
response to a query from the Host
LIS.
Respond to Query for Orders The system sends an order in
response to a query from the LIS.

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5. In the Patient Result Settings area, select each option that applies to
your LIS.
NOTE: Some options are mutually exclusive with other options.

Automatically Send All Patient The system automatically sends


Results Except Results on Hold all patient final results to the LIS
computer except results on hold.
For rerun results when the
default setting of Transmit
Results Test by Test is in place,
preliminary results are sent when
available and final results are sent
when available.
Automatically Send All Patient The system automatically sends
Results and Additional Data all preliminary and final results,
Except Results on Hold except results on Hold. (For rerun
results, see above.)
Send Unresulted Test Status The system sends information to
the LIS computer about any test
that could not be resulted. This
option is not available if you
select Automatically Send All
Results Except Results on Hold.
Notify LIS for non-transmitted The system sends a message to
Orders: Deleted or Moved to the LIS when any untransmitted
Historical orders (Pending New, InProcess,
Intervention Needed, Completed
Sample States) are deleted or
moved to Historical.

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6. In the QC Result Settings area, select each option that applies to you LIS.

Automatically Send All QC Results The system automatically sends


Except Results on Hold all QC final results to the LIS
except results on hold.
Automatically Send All QC Results The system sends all preliminary
and Additional Data Except and final QC results, except
Results on Hold results on Hold.
Send Unresulted Test Status The system sends information to
the LIS computer about any test
that could not be resulted.
Notify LIS for non-transmitted The system sends a message to
Orders: Deleted or Moved to the LIS when any untransmitted
Historical orders (Pending New, InProcess,
Intervention Needed, Completed
Sample States) are deleted or
moved to Historical.

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7. In the Patient and QC Result Settings area, select each option that
applies to your LIS.

Send Ratio Components The system sends the results of


ratio test components with the
ratio test result to the LIS
computer.
Transmit Results by Sample The system transmits results for
patient or QC tests only when all
tests in each sample order have
final results. If you do not select
this option, the system transmits
test results for a patient or QC
order as the final test results
become available (test-by-test).
The default setting is unselected
(results are transmitted test by
test).
Send Ratio Check Component If a constituent of a ratio has any
Flag flag that needs to be promoted
Check Component Flag displays
on the ratio test result.

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Completing the General LIS Configuration Settings


1. On the command bar, select Setup > LIS Configuration.
2. After enabling LIS Configuration, select Start LIS Client
Automatically.
3. In the System Name text box, enter the name to use for your system
identifier.
4. In the LIS ID text box, enter the name to use for your LIS identifier.
5. In the Discard Host LIS Specimen Type area, select this feature to
discard the specimen types sent by the host LIS.
If your LIS is sending specimen types, leave this feature unchecked
(disabled). When checked, or enabled, this feature is used with the Treat
Blank Specimen Type setting to process order requests. the online help
for information about how enabling this feature affects the Reference
Ranges and Delta checks.
The specimen type sent by some systems may not be compatible. This
feature allows the host LIS specimen type to be discarded and uses a
specimen type defined by the Treat Specimen Type As parameter.
If this feature is enabled, this impacts the results on the Results Ranges
and the Delta Check ranges. For example, the Reference Ranges and
Delta Ranges demographic specimen types must be All or Unknown for
the order to process.
6. In the Treat Blank Specimen Type As area, select a specimen type to
allow the system to handle a work order, sent by the LIS, that contains
a blank specimen type.
7. In the Protocol area, select the protocol for your connection:
ASTM protocol uses 8-bit, single-byte characters.
NOTE: Using ASTM protocol and sending non-8 bit ASCII values in the
records to the LIS causes invalid data in those fields.
8. Select Keep Send Alive to have the system send messages to the LIS to
keep the LIS communication active. The default is On.

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9. Continue with the next area, Application Layer.


NOTE: Ensure the LIS uses the system flag specification outlined in the
ADVIA Chemistry XPT System Interface Specification Guide. Failure to
follow system flag specification may result in truncated flag text.

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.

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ADVIA Chemistry XPT System Appendix A: Safety

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

Protecting Yourself from Biohazards


Use this summary for general information only. It is not intended to replace
or supplement the laboratory or hospital biohazard control procedures.
By definition, a biohazardous condition is a situation involving infectious
agents biological in nature, such as the hepatitis B virus, the Human
Immunodeficiency Virus (HIV), and the tuberculosis (TB) bacterium. These
infectious agents may be present in human blood, blood products, and
other body fluids.
The following are the major sources of contamination when handling
potentially infectious agents:

• 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

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Appendix A: Safety ADVIA Chemistry XPT System

To prevent accidental contamination in a clinical laboratory, strictly adhere


to the following procedures:
• Wear gloves while servicing parts of the instrument that have contact
with body fluids such as serum, plasma, urine, whole blood, or cerebral
spinal fluid (CSF).
• Wash your hands before going from a contaminated area to a
noncontaminated area, or when you remove or change gloves.
• Perform procedures carefully to minimize aerosol formation.
• Wear facial protection when splatter or aerosol formation is possible.
• Wear personal protective equipment such as safety glasses, gloves, lab
coats, or aprons when working with possible biohazard contaminants.
• Keep your hands away from your face.
• Cover all superficial cuts and wounds before starting any work.
• Dispose of contaminated materials according to the laboratory’s
biohazard control procedures.
• Disinfect tools and other items that have been near any part of the
instrument sample path or waste area with a 10% solution of bleach.
• Do not eat, drink, smoke, apply cosmetics, or handle contact lenses
while in the laboratory.
• Do not mouth pipette any liquid, including water.
• Do not place tools or other items in your mouth.
• Do not use the biohazard sink for personal cleaning, such as rinsing
coffee cups or washing hands.
To prevent needlestick injuries, needles should not be recapped, purposely
bent, cut, broken, removed from disposable syringes, or otherwise
manipulated by hand.

References
1. Centers for Disease Control. 1988. Update: Universal precautions for
prevention of transmission of human immunodeficiency virus, hepatitis
B virus and other bloodborne pathogens in healthcare settings. MMWR,
37:377–382, 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.

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ADVIA Chemistry XPT System Appendix A: Safety

3. Federal Occupational Safety and Health Administration. Bloodborne


Pathogens Standard. 29 CFR 1910. 1030.

Protection from Barcode Scanner Lasers


To avoid damage to the eyes, never look directly at the laser beam or at its
reflection from a shiny surface. Never point a hand-held barcode scanner at
anyone.

Laser Safety Classification of the ADVIA Chemistry XPT System


During normal operation, with all of the protective housings in place, the
ADVIA Chemistry XPT system is classified as Center for Devices and
Radiological Health (CDRH) Class 2 and EN60825-1 Class 2. No direct
exposure to laser hazard exists for persons in the immediate area.

Figure 41: CDRH class 2 Label

Some field service procedures require the removal of the protective


housings that prevent human access to the laser radiation. All field service
procedures must be followed precisely. Only Siemens-trained field service
personnel should perform procedures related to laser assemblies.
The laser labels are positioned on the instrument as shown below.

Laser Safety Classification of the Barcode Scanners


The laser safety classification of the reagent and sample barcode scanners
when they are unprotected by the system housings is CDRH Class 2 and EN
60825-1 Class 2. The laser safety classification of the hand-held barcode
scanner used with the system is CDRH Class 2 and EN 60825-1 Class 2.

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Appendix A: Safety ADVIA Chemistry XPT System

Reagent and Sample Barcode Scanners


Operator’s guide procedures for testing the reagent or sample barcode
scanners contain the following laser warning:

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.

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Dilution and Sample Noise Reduction Cover Locks


The system includes locking noise reduction covers to protect the operator
from moving dilution and sample probes. Use the key to unlock the DPP and
SPP Noise Reduction Covers.

Figure 42: DPP and SPP Noise Reduction Covers and Locks

1 Top Left Cover


2 SPP Noise Reduction Cover
3 DPP Noise Reduction Cover Lock
4 DPP Noise Reduction Cover
5 SPP Noise Reduction Cover Lock

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Appendix A: Safety ADVIA Chemistry XPT System

Location of Safety Hazard Symbols on the System Exterior


Symbols displayed on the exterior of the system indicate safety hazards and
warnings for proper operation of the system. The locations of the symbols
on the exterior of the system are shown below.
For more information refer to System Symbols.

Figure 43: Exterior Rear System Symbols

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ADVIA Chemistry XPT System Appendix A: Safety

Figure 44: Exterior Front System Symbols

Location of Safety Hazard Symbols on System Interior


Symbols displayed on the interior of the system indicate safety hazards and
warnings for proper operation of the system. The locations of the symbols
on the interior of the system are shown below.
For more information refer to System Symbols.

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Appendix A: Safety ADVIA Chemistry XPT System

Figure 45: System Interior Front Symbols

Figure 46: System Interior- Top Covers Open- System Symbols

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ADVIA Chemistry XPT System Appendix A: Safety

Figure 47: System Interior- DPP and SPP Covers Open- System Symbols

Location of the I/O Panels and Main Power Switch

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.

Contact technical assistance when the ADVIA Chemistry XPT system is


received or if it is necessary to to relocate the system within the facility.
Cables for specific components of the system connect to 1 of the 3 input/
output (I/O) panels located at the back of the system.

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Figure 48: Rear View of the ADVIA Chemistry XPT System

1 Visible Status Light


2 Manufacturing Label
3 Rating Label
4 Main Power Switch
5 Main Power Input
6 100ACV 10A Max Receptacles
7 Circuit Breaker Panel
8 Water Supply and Drainage Panel
9 Connectivity Panel

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Figure 49: System Waste and Drainage Panel

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

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Appendix A: Safety ADVIA Chemistry XPT System

Figure 50: System Connectivity Panel

1 Laboratory Information System (LIS)


2 Laboratory Automated System (LAS)
3 Pilot S (connects the SAM for the computer monitor, mouse and
Keyboard receptacles when using the Pilot System)
4 Pilot M (connects the Octet service switch for connection to the
local monitor, mouse and keyboard when using the Pilot
System)
5 LIS Communication
6 Printer

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ADVIA Chemistry XPT System Appendix A: Safety

Figure 51: Side USB Port

Figure 52: Front View of the ADVIA Chemistry XPT System

1 Emergency stop button


2 System power: On-Standby-Off
3 Workstation latch and computer power switch

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Appendix A: Safety ADVIA Chemistry XPT System

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.

Using Approved Cleaning Materials

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.

For more information about system cleaning procedures, refer to the


system online help. Each cleaning procedure identifies the specific cleaning
materials to be used. Contact technical assistance to check compatibility of
any other cleaning materials before use.

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Table 21: System Approved Cleaning Materials

Preventative Maintenance Required Materials


Cleaning or Replacing the Wash Deionized water
Solution Reagent Containers
Cleaning the Dilution Bowl Distilled water, lint-free cloth,
and a cotton stick
Cleaning the Waste Drain Nozzle Pipette
Conditioning the ISE Na nd K 1:4 dilution of pooled serum
Electrodes using ISE buffer solution,
deionized water
Cleaning the Large Water Pump Cloth, container, brush, and
(LWP) Line Filters deionized water
Cleaning the Mixer Rods and Lint-free cloth or foam-tipped
Wash Cups applicator and deionized water
Cleaning the Reaction (WUD) and Lint-free cloth, alcohol prep pad
Dilution (DWUD) Cuvette Washers or lint-free cloth soaked in
5% bleach solution, and a stylet
Checking Lamp Coolant 5% lamp coolant
Cleaning the Chiller Filter Screwdriver, tap water, and a
paper towel
Inspecting and Cleaning Splash Lint-free cloth and deionized
Covers water
Cleaning and Replenishing Deionized water
Cuvette Detergent Bottle
Cleaning the Ancillary Reagent 10% bleach solution, beaker, lint-
Bottle Filters free cloth, 5% bleach solution,
and distilled water
Cleaning and Replenishing the Deionized water
Cuvette Conditioner Bottle
Cleaning the Dilution Tray 5% Probe Wash 3
Cuvettes
Cleaning and Replenishing the 0.9% saline diluent
Saline Dilution Bottle
Cleaning System Covers, Panels, Lint-free cloth, 10% bleach
and Doors solution or 70% isopropyl alcohol,
and deionized water

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Preventative Maintenance Required Materials


Cleaning the Probes Using Lint-free cloth, 5% bleach
Automatic Advanced Probe solution or alcohol prep pad, and
Motion distilled water
Cleaning the Probes Using Lint-free cloth, 5% bleach
Manual Probe Motion solution or alcohol prep pad, and
distilled water
Cleaning the Pure Water Bottle Pliers, 18R filter, 5% Probe Wash
and Filters 3, 10% bleach solution, paper
towel, 10R filter, deionized water,
5% bleach solution, and distilled
water
Inspecting the Reaction (WUD) Lint-free cloth
and Dilution (DWUD) Cuvette
Washers
Cleaning the Interior Turntables Lint-free cloth
(STT/CTT and RTT)
Inspecting and Cleaning the Lint-free cloth, 5% bleach
Probes solution or alcohol prep pad, and
distilled water
Replacing the Dilution Pipetting Screwdriver and replacement DPP
Probe (DPP) Probe
Replacing the Ancillary Reagents Replacement filter and deionized
Bottle Filters water
Replacing the Lamp Replacement lamp
Replacing the Sampling Pipetting Screwdriver and replacement SPP
Probe (SPP) Probe
Replenishing the Reaction (RRV) Pliers and RRV Bath Oil
Bath Oil
Storing the ISE Electrode Deionized water and ISE Buffer
Washing the ISE Lines Deionized water and Probe Wash
3
Replacing the ISE Baseline Replacement ISE Baseline
Solution Solution pack
Replacing the Reagent Pipetting Screwdriver and replacement RPP
Probe (RPP) Probe

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ADVIA Chemistry XPT System Appendix B: Service, Ordering, and Warranty

Appendix B: Service, Ordering, and Warranty


This section provides the following information:

• Address of the Siemens authorized representative, which is the Siemens


contact within the European community
• Addresses for obtaining service and technical information and for
ordering supplies
• System warranty and service delivery policy information

Limited Instrument Warranty and Service Delivery Policy


Siemens and its authorized distributors may provide customers who acquire
new Siemens instruments with a limited warranty either in a specific
agreement or in standard language on their invoices. This limited warranty
is designed to protect customers from the cost associated with repairing
instruments that exhibit malfunctions due to defects in materials and/or
workmanship during the warranty period.
Siemens, at its election, will provide warranty service either by providing
repair service of the instrument on site, or by exchanging the defective
instrument or component, subject to the limitations and exclusions set
forth in Replacement of Parts and Warranty and Service Exclusions, repairs,
replacements or exchanges of instruments or components provided during
the warranty or any additional service period, will not extend the warranty
or service period beyond the initially agreed upon period.
When the customer calls for service, the Siemens representative or
authorized distributor will inform the customer of the type of service
available for the customer’s instrument, and will instruct the customer as to
how to obtain that service.

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.

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Appendix B: Service, Ordering, and Warranty ADVIA Chemistry XPT System

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).

ISE Electrode Warranty


The chloride, sodium, potassium, and reference electrodes are warranted
for whichever occurs first:
• analyzing up to 30,000 samples
• 3 months from the time the electrode was placed on the system
• until the expiration date stamped on the electrode box
This warranty is not applicable to dialysis samples, samples left at room
temperature longer than 24 hours after blood collection, or samples that
are decomposed.

Additional Service Period


The customers, with some exceptions, may purchase additional service
coverage beyond any initial warranty period as part of the original
instrument acquisition for second or subsequent years beyond the original
installation date. The customer’s original Purchase Invoice or appropriate
Agreement Addendum must indicate the term in months for additional
service coverage.

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ADVIA Chemistry XPT System Appendix B: Service, Ordering, and Warranty

Service During Normal Hours


The customer may obtain service for instruments during normal business
hours by contacting the nearest Siemens technical support provider or
authorized distributor.

Extent of a Service Call


Warranty or service calls generally include onsite repair or exchange of
instruments or components, travel to the location of the instrument, and
onsite labor during normal business hours. A warranty or service call is
initiated by the customer by following the instructions on how to obtain
service for the customer’s instrument. The service call is considered
complete when any defects in material or workmanship have been
corrected by repair or replacement and the instrument conforms to the
applicable specifications. When service is complete, the customer receives
a copy of the documentation detailing all work performed by the Siemens
representative or authorized distributor.

Service Outside Normal Hours


Customers, with some exceptions, may also request service to be delivered
or an exchange to be initiated outside normal business hours, including
evenings, weekend days, or nationally observed holidays, by contacting the
nearest Siemens location or authorized distributor. Service performed
outside normal hours is subject to a surcharge unless the customer has in
place a service product option that provides service at the time requested.

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.

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Appendix B: Service, Ordering, and Warranty ADVIA Chemistry XPT System

Design Changes and Retrofitting of Instruments


Siemens reserves the right to change the design or construction of specific
models of instruments at any time without incurring any obligation to make
such changes available to individual customers or instruments. If Siemens
notifies customers of a change that improves the performance or reliability
of their instrument, and requests to retrofit that instrument, the customer
must agree to allow Siemens or an authorized distributor, at Siemens
expense, to retrofit components or make design changes, which will not
adversely affect the instrument’s performance characteristics.

Key Operator Designation


Each customer designates a key operator who is available to Siemens
representatives to describe instrument malfunctions by telephone and/or to
perform simple adjustments and corrections as requested. If a key operator
is not designated or is unavailable when the customer requests service, the
delivery of service may be delayed.

OSHA Requirements (US Only)


When service is required at a customer location, the customer must provide
the Siemens representative with adequate facilities that comply with the
regulations of the Secretary of Labor under the Occupational Safety and
Health Act (OSHA) of 1970, as amended.

Warranty and Service Exclusions


The following exclusions are in addition to any exclusions provided for in
any written warranty or service agreement.
If any of the following events occur, the warranty or service provisions do
not apply:

1. Repairs or modifications have been made to the instrument by someone


other than an authorized Siemens representative.
2. Repairs or modifications have been made to the instrument by someone
other than an authorized Siemens representative.
3. The instrument has been operated using accessories and supplies other
than Siemens brand accessories, or consumable supplies and/or
reagents not having the same grade, quality, and composition as
defined in the system operator’s manuals.
4. Siemens has notified customers of a change that improves the
performance or reliability of their instrument and customer has not
agreed to retrofit or make design changes to the instrument.

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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.

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Appendix B: Service, Ordering, and Warranty ADVIA Chemistry XPT System

Information for Technical Assistance


When you call for technical assistance, you may need information about the
system name, serial number, and the version of software used on your
ADVIA Chemistry XPT system.
Use this procedure to locate system information.

1. At the workspace, select Setup > Settings > Operator Setup.


NOTE: System Name and Serial Number are displayed under System
Configuration.
2. Select Settings > About Workstation.
NOTE: Version information is displayed.

Addresses
This section provides the following information:

• the address of the Siemens authorized representative, which is the


Siemens contact within the European community
• the Siemens addresses for obtaining service and technical information
and for ordering supplies
For technical assistance, customer service, or additional information,
contact your local technical support provider or distributor.

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ADVIA Chemistry XPT System Appendix C: Reagent Water and System Fluids

Appendix C: Reagent Water and System Fluids


This information describes handling requirements for reagent water and
system fluids.

Reagent Water Quality


Water quality is an important consideration in the laboratory because it can
significantly affect the outcome of laboratory procedures and the
measurement of patient samples.
This document provides an overview of reagent water quality guidelines as
specified by the Clinical Laboratory and Standards Institute (CLSI, formerly
NCCLS).1, 2 Use these guidelines to evaluate the reagent water quality in
your laboratory and to determine the best method for obtaining the water
quality you need.
Good laboratory practices suggest that the laboratory establish a protocol
that supports the manufacturer’s requirement for the instrument to:

• ensure optimum performance of automated laboratory instruments.


• eliminate water quality as a source of problems when troubleshooting.
• help the laboratory meet requirements for state and federal laboratory
certification.

What is Reagent Water?


Reagent water is laboratory water that meets specifications for clinical
laboratory use.3, 4
The CLSI has defined 6 grades of reagent water2:

• Clinical Laboratory Reagent Water (CLRW)– the highest grade


• Special Reagent Water (SRW)
• Instrument Feed Water (IFW)– the intermediate grade
• Water supplied by a method manufacturer
• Autoclave and wash water
• Purified water, commercially bottled

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Appendix C: Reagent Water and System Fluids ADVIA Chemistry XPT System

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:

• Resistivity > 10.0 Megohm-cm to 25ºC


• Bacteria ≤ 10 CFU/mL
• Silica < 0.05 mg/L
• Total Organic Carbon < 500 ng/g (ppb)
• Total Dissolved Solids < 1.0 mg/L
In addition, the following specifications should be met to ensure proper
operation:
• Temperature of water entering the system is between 10ºC and 30ºC
• Dissolved Oxygen ≤ 7.0 mg/L
The following table lists the CLSI specifications for CLRW. Use this
information to determine the water quality in the laboratory. Refer to the
CLSI guidelines for common laboratory uses of CLRW.

Table 22: CLSI Specifications for CLRW

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.

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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.

Table 23: 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.

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Appendix C: Reagent Water and System Fluids ADVIA Chemistry XPT System

Figure 53: Water Purification System

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

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ADVIA Chemistry XPT System Appendix C: Reagent Water and System Fluids

Maintaining Water Quality


Ensure that the reagent water supply in your laboratory consistently meets
CLSI guidelines by:

• Storing reagent water properly.


• Testing for resistivity and contamination.
• Maintaining water purification system.
Establishing procedures for maintaining reagent water quality is also
required for laboratory inspection and accreditation by the College of
American Pathologists (CAP).5

Storing Reagent Water


CLRW cannot be stored. Use it immediately it is produced because it
degrades quickly and no longer meets CLRW specifications. Additionally,
CLRW cannot be purchased because its purity is not reliable.

Testing Reagent Water


To monitor water quality and detect problems with your water purification
system, test reagent water regularly for resistivity and bacterial
contamination. You may also want to send reagent water out of the
laboratory periodically for independent evaluation. Record your test results
and any corrective action.
Refer to the CLSI specifications for information about recommended water
testing methods.1, 2

Maintaining the Purification System


Efficient operation and regularly scheduled maintenance of your water
purification system is the key to optimizing the performance of the system
and consistently obtaining reagent quality water. Preventative
maintenance reduces the chance of the purification system introducing
additional contaminants into source water and ensures that reagent water
retains its purity when it is introduced into the laboratory instrument.
The following are suggested guidelines for maintaining water purification
systems to ensure smooth operation and prevent system problems.
For Customized Water Systems:

• Change filters on carbon or membrane filter systems as required.


• Use a recirculating pump to optimize performance and reduce
contamination.

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Appendix C: Reagent Water and System Fluids ADVIA Chemistry XPT System

• Filter the source water before treatment in reverse osmosis systems,


and recirculate deionizers in closed loops to extend resin life.
For Distillation Systems:
• Check the water vessels regularly for the presence of a slippery film.
• Clean and disinfect the vessels as required with an agent that rinses
well, such as hydrogen peroxide (H2O2).
• Clean the boiler regularly to remove deposits.
• Test routinely for contamination.
For complete information about operation and maintenance requirements
for your water purification system, refer to the manufacturer’s
specifications.

Problems Caused by Water


Using water that does not meet CLSI guidelines can cause problems with
clinical laboratory systems. Some common problems include:

• Contamination of system components


• Inaccurate patient and calibration results
• Out-of-range quality control results
• Deterioration of lyophilized quality control material
• Color changes and poor stability and performance of reagents
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 the water purification 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. 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.

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ADVIA Chemistry XPT System Appendix C: Reagent Water and System Fluids

3. Tietz, Norbert W. Fundamentals of clinical chemistry, 3rd ed.


Philadelphia: W.B. Saunders Company; 1987. 1010 p.
4. Kaplan, Lawrence A. Pesce, Amadeo J. Clinical Chemistry; theory,
analysis, and correlation, 2nd edition. St. Louis: C.V. Mosby Company;
1989. 1212 p.
5. College of American Pathologists, Laboratory General Checklist
GEN.41500, Quality of Water and Glassware, p. 40. Northfield, IL. 2013.

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.

Table 24: System Fluids Specifications

Fluid Name Stability (open) Ingredients


ISE Baseline 30 days Formaldehyde <1%, Na
Solution 65 mmol/L, K 1.75 mmol/L, and
Cl 42.5 mmol/L
ISE Buffer 2 30 days Formaldehyde <1%, Phosphate
<1%, and Triethanolamine <2%
Reaction (RRV) Use until expiration Non-reactive fluorocarbon
Bath Oil date
Cuvette 4 months K Sorbic acid 0.2%, Citric acid
Conditioner 0.076%, Triton X-100 1.6% in
water;
pH of 2% solution = 4.3–5.7
Saline Use until expiration 0.9% NaCl
date
Cuvette 3 months NaOH 4.0%, Polyoxyethylene
Detergent octylphenyl ether ≤ 0.9%,
Amphoteric surfactant ≤ 0.9% in
water
Lamp Coolant 13 weeks Alkanol Amine <10%,
Additive Benzotriazole <10%, antibacterial
and antirust agents

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Appendix C: Reagent Water and System Fluids ADVIA Chemistry XPT System

Fluid Name Stability (open) Ingredients


Probe Wash 0 3 months; 20% NaOH 2.0%, Non-ionic surfactant
working solution: <1.0% in water; pH = 11.3–12.7
30 days room
temperature
Probe Wash 1 4 months; onboard NaOH 3.6% in water;
stability: 30 days pH of 2% solution = 11.3–12.7
Probe Wash 2 4 months; onboard Oxalic acid 3.0% Hydroxyacetic
stability: 30 days acid 20%, Methyl alcohol 4.8%,
PEG-400 3.0% in water;
pH of 2% solution = 1.4–2.8
Probe Wash 3 4 months; 5% KOH 4.5% Na Hypochloride,
working solution: 4.7% Na Polyacrylic acid 4.0%,
30 days room Surfactants in water;
temperature pH of 2% solution = 11.3–12.7

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.

Table 25: Ancillary Reagent Container Usage

Volume Used per 1000 Container Capacity


Ancillary Reagent Samples Effective Volume
ISE Baseline Solution 180 mL 500 mL
ISE Buffer 2 2400 mL 3000 mL
Reaction (RRV) Bath Oil 60 mL/day 3000 mL
Cuvette Conditioner 112 mL 3000 mL
Saline 1800 mL 3600 mL
Cuvette Detergent 446 mL 3600 mL

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ADVIA Chemistry XPT System Appendix D: Supplies

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.

Table 26: System Supplies and REF

System Supply REF


Filter, LWP 10719219
Filter, Mesh (Strainer) 10719222
Bottle, Ancillary 4L 10719151
3L Empty bottle 10719150
Check Valve, Duck-Bill 10719183
Cover, CTT 10719165
Cover, ISE Electrode 10719198
Cover, Probe Arm, DPP 10719287
Cover, RTT1 10719253
Cover, RTT2 10719277
Cover, Splash, DPP 10719267
Cover, Splash, ISE 10719268
Cover, Splash, RPP1 10719269
Cover, Splash, RPP2 10719270
Cover, Splash, SPP 10719271
Cover, SPP 10719272
Cover, STT 10719274
Cuvette, RRV, 1X17 10323157
DI Water Reg. 100 PSI by SWT 11127670
Electrode, Cl 10309439
Electrode, K 10309440
Electrode, Na 10309441
Electrode, Ref 10309465

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Appendix D: Supplies ADVIA Chemistry XPT System

System Supply REF


ISE Dummy Electrode (2400) 10323464
Filter, Fan, w Fanguard 10373078
Filter 18R 10315254
Filter 10R 10309438
Halogen lamp BM#5 10723032
Knob, RTT 10719214
Latch, Splash Cover 11127693
Locking Clip, Splash Covers 10719192
Mixing Rod DMIX, MIX1, MIX2 11127670
O-Ring, ISE Baseline Solution, Cap 10719231
Reaction Cuvette (DTT) 11223485
Reaction Cuvette (RRV) 10323157
Probe, DPP 10337398
Probe, SPP 10337399
Probe, Reagent, RPP1/RPP2 10719298
Screw, ISE Nozzle, Dil Bowl 10719196
Screw, Overflow Sensor 10719258
Screw, Waste Nozzle, ISE 10321904
Tray, Loader, CTT 10719166
Tray, Loader, RTT1 10719254
Tray, Loader, RTT2 10719276
Tray, Loader, STT 10719275
Tube Holder, STT, CTT 10719308
Adapter, Reagent wedge, 70 – 40 mL 11312145
Adapter, Reagent wedge, 70 – 20 mL 11312144
Adapter, Reagent wedge, 40 – 20 mL 10316975
ADVIA Chemistry Sample Cup (ACSC) 10309450
Small Sample Container (SSC) 10472099
EZEE-NEST Sample Cups 10374179
Guide Sample Cup STT/CTT, pkg 50 10327496
Sample adapter 10327496

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ADVIA Chemistry XPT System Appendix D: Supplies

System Supply REF


Lamp coolant 10320912
Cuvette detergent 10718753
Cuvette conditioner 10311854
Probe wash 0 10718756
Probe wash 1 10311856
Probe wash 2 10311857
Probe wash 3 10311858
ISE Buffer 2 10718754
ISE Baseline solution 10718755
ISE Detergent 10311851
Bath oil 10311855

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Appendix D: Supplies ADVIA Chemistry XPT System

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ADVIA Chemistry XPT System Appendix E: Specifications

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.

Electromagnetic Compatibility (EMC)


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.

Table 27: System Dimensions

System Dimensions Description


Depth 985 mm (39 inches)
Height 1490 mm (59 inches)
Width 1770 mm (70 inches)
Weight 725 kg (1598 lb)

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Appendix E: Specifications ADVIA Chemistry XPT System

Figure 54: Recommended Installation Layout and Space Requirements

1 Drain
2 Water Tap
3 Distilled Water Supply
4 Power Receptacle Emergency Shutoff

Environmental

Table 28: System Environmental Specifications

Environmental Specifications Description


Ambient operating temperature 18ºC–30ºC (64ºF–86ºF)
Ambient humidity 20%–80%
Storage temperature 0.0–50.0ºC
Indoor use only
Altitude up to 2000 meters
IEC 61010-1 OVERVOLTAGE CATEGORY II
Equipment classification class I A medical device
classification of IVD
IEC60825-1 Class 2 Laser Product
IEC 61010-1 Pollution degree 2

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ADVIA Chemistry XPT System Appendix E: Specifications

Electrical Requirements

Table 29: System Electrical Requirements

Electrical Requirements Description


Supply voltage 200/220/230/240 VAC ± 10%
Input current 15/13/13/12 A
Frequency 50/60 Hz
Grounding Class III
Power plug Non-locking NEMA Qualified Plug (USA &
Canada); Non-locking IEC Qualified Plug (OUS)

Technical Specification
Table 30: Product Specification

Product Specification Description


System description Full random, continuous access,
batch, discrete processing
Throughput Maximum 2400 assays/hour: 1800
assays/hour colorimetric, 600 assays/
hour ISE
Assays onboard 59 assays including 3 ISE assays

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Appendix E: Specifications ADVIA Chemistry XPT System

Table 31: Sample Handling

Sample Handling Description


Sample tubes 5-mL, 7-mL, and 10-mL tubes; 1-mL
and 2-mL sample cups; user-
defined containers
Sample tray 84 samples, positive sample
identification
Validated sample types Serum, plasma, urine, cerebral
spinal fluid (CSF), and whole blood
Sample integrity check Quality check for hemolysis,
lipemia, and icterus
STAT Handling 84, not dedicated
Auto-repeat Automatic repeat testing from the
retained prediluted sample or
original sample
Auto-dilution Automatic dilution from retained
prediluted sample
Auto-reflex testing Automatic ability to analyze
additional assays based on result of
first assay
Primary sample probe Liquid level sensing, crash
(DPP) protection, clot/clog detection, and
liquid surface verification

Table 32: Barcodes

Barcodes Description
Sample barcodes 20 digits; interleaved 2 of 5, Code 39,
Code 128, Codabar; A, B, and special
characters (.-+/*$%)

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ADVIA Chemistry XPT System Appendix E: Specifications

Table 33: Microvolume Technology

Microvolume Technology Description


Automatic sample predilution Samples diluted 1:5 (30-µL
sample + 120-µL saline
generates up to 15 assay
results), retained for auto-
repeat until results are
available.
Predilution Tray (DTT) 120 dilution cuvettes
Original sample volume 2 to 30 µL; system uses an
average of 2–3 µL per assay
Average reagent volume 80–120 µL per assay

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Appendix E: Specifications ADVIA Chemistry XPT System

Table 34: Reaction Area

Reaction Area Description


Reaction tray 340 reusable plastic cuvettes
Cuvette optical path length Length 6 mm
Reaction bath Inert fluorocarbon oil
circulation system, 37ºC
Photometer 14 fixed wavelengths (340,
410, 451, 478, 505, 545,
571, 596, 658, 694, 751,
805, 845, and 884)
Light source 12 V, 50 W halogen lamp,
cooled by forced water
circulation
Assay methods Endpoint (EPA), rate reaction
(RRA), 2-point rate (2PA),
constant rate analysis (CRA),
immunoassay analysis (IMA),
prozone checking, substrate
depletion check, and sample
blank correction
Reaction times 3, 4, 5, and 10 minutes;
extended reaction times 15
and 21 minutes
Automatic correction Serum blank, cuvette blank,
measurement point change,
sample volume change in
reanalysis
Point forwarding Automatically extends
linearity over assay range
samples

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ADVIA Chemistry XPT System Appendix E: Specifications

Table 35: Reagent Handling

Reagent Handling Description


Reagent tray 2 trays, (R1=60 and R2=56
positions), refrigerated
between 6ºC and 13ºC
Reagent capacity onboard 56 colorimetric methods
Dispensing system 2 probes with Liquid Level
Sensing
Reagent packs 20, 40, and 70 mL
Barcode labeled packs Interleaved 2 of 5
Onboard stability Up to 60 days, depending on
assay
Reagent inventory Tracks assays remaining, lot
management number, onboard stability,
and expiration date
Reagent dilutions Capability to dilute
concentrated reagents
onboard

Table 36: Open System Capability

Open System Capability Description


Assays Maximum 200 assays,
includes user-defined assays

Table 37: Ion Selective Electrodes

Ion Selective Electrodes (ISE) Description


ISE Indirect simultaneous
measurement of Na+, K+, and
Cl-
Sample volume 22 µl for all three assays
Baseline solution 0.18 mL/sample
Buffer 2 3.4 mL/sample
Priming Automatic priming cycle
Electrode expected use life 30,000 samples, 3 months, or
whichever occurs first

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Appendix E: Specifications ADVIA Chemistry XPT System

Ion Selective Electrodes (ISE) Description


Throughput rate 600 assays per hour;
maximum 200 tubes per hour

Table 38: Calibration and Quality Control

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

Table 39: User Interface and Data Management

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

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ADVIA Chemistry XPT System Appendix E: Specifications

Table 40: Removable Media

Removable Media Description


DVD, CD-RW, USB

Table 41: General Specifications

General Specifications Description


Water requirements CLSI/CAP Clinical Laboratory
Reagent Water or ISO 3696
deionized water connected
directly to a pressurized water
source
Maximum water consumption 40 liters per hour
Drain requirements Minimum of 40 liters
(10.6 gallons) per hour
Compliance TUV, CE, RoHS
Noise Specifications Less than 62 db
Processing Heat Output 5374 BTU per hour
Load current 3 kVA

About Container Settings


Use Container Settings to configure the surface area of reagent container
and sample tube specifications. Nine containers of each can be configured.
To access Container Settings, select Setup > System Configuration >
Container Settings.
Perform the following tasks at this tab:

• Define and edit container settings


• View container setting
• Print container setting
• Import and export container setting

Table 42: Reagent Container Specifications

Reagent Container Specification Description


Name Identifies the container.
Section Area (mm2) Surface area of reagent container

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Appendix E: Specifications ADVIA Chemistry XPT System

Reagent Container Specification Description


LLS Sensitivity Liquid Level Sensor (LLS) Sensitivity
configured to low, medium, or
high.

Table 43: Sample Tube Specifications

Sample Tube Specification Description


Name Identifies name of container
D1 (measured in mm) First tube dimension measurement.
h1 (measured in mm) First tube height measurement.
D2 (measured in mm) Second tube dimension
measurement.
h2 (measured in mm) Second tube height measurement.
D3 (measured in mm) Third tube dimension
measurement.
h3 (measured in mm) Third tube height measurement.
LLS Sensitivity LLS Sensitivity configured to low,
medium, or high.
Volume Judge Volume at which the system
determines there is insufficient
sample volume

202 11314536 Rev. 01


ADVIA Chemistry XPT System Appendix F: System Symbols

Appendix F: System Symbols


This section describes the symbols that can appear on the interior or exterior
of the system, or on the system packaging. The symbols on the system
identify the location of certain components and, where necessary, display
warnings for proper operation. The symbols on the system packaging also
provide other important information.

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.

This symbol alerts you to a biohazard.

This symbol alerts you to the risk of exposure to


lasers.

This symbol alerts you to a potential electrical


hazard.

This symbol indicates a moving component that


can cause injury.

This symbol indicates the presence of a part


emitting high temperature.

This symbol indicates that the input electricity is


alternating current.

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Appendix F: System Symbols ADVIA Chemistry XPT System

Symbol Description
This symbol identifies the location of a protective
earth (GND) conductor terminal.

This symbol indicates STANDBY on the system


power switch.

This symbol indicates ON on the personal


computer (PC) button.

This symbol indicates that the main power supply


is on.
This symbol indicates that the main power supply
is off.

This symbol indicates the emergency stop


button.

This symbol indicates the the location of the


button to rotate the sample tray.

This symbol indicates the the location of the


button used to pause sampling.

This symbol indicates the the direction to move


the release mechanism in order to rotate the
monitor and keyboard assembly out from the
center of the system.
This symbol indicates the workstation/computer
is on.

This symbol indicates the system hard drive.

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ADVIA Chemistry XPT System Appendix F: System Symbols

Symbol Description
This symbol indicates the location of the barcode
scanner connector.

This symbol indicates the location of the system


power breaker.

This symbol indicates the location of the ethernet


connector.

This symbol indicates the location of a USB port.

This symbol indicates the material is corrosive.

This symbol indicates that the product has a


temperature limitation. In this example, you
need to store the product between -29° to 60°C.
This symbol indicates that a stacking limit is
present for this product. In this example, you
cannot stack more than 4 products on top of 1
another.
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.

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Appendix F: System Symbols ADVIA Chemistry XPT System

Symbol Description
This symbol indicates the serial number of a part
or product.

This symbol indicates the revision letter of a part


or product.
This symbol indicates the name and location of
the product manufacturer.

This symbol indicates the date of manufacture of


the product.

This symbol indicates the manufacturer’s


authorized representative within the European
community.
This symbol indicates that the product or
container should be oriented in the direction of
the arrows.

This symbol indicates not to use the product if


the package is damaged.

This symbol is intended to encourage recycling.

This symbol indicates that the materials are


recycled.

This symbol is intended to facilitate recycling of


corrugated materials. The number is licensed in
Germany and printed on corrugated shippers.
This symbol indicates that the package is printed
with soy ink.

This symbol indicates that the product complies


with the applicable directives of the European
Union.
This symbol indicates that the product was safety
tested by TUV for conformity to Canada and US.

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ADVIA Chemistry XPT System Appendix F: System Symbols

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.

This symbol indicates that the product is the


cuvette detergent.

This symbol indicates that the product is the


reaction (RRV) bath oil.

This symbol indicates that the product is the ISE


baseline solution.

This symbol indicates that the product is the ISE


buffer 2.

This symbol indicates that the product is saline.

11314536 Rev. 01 207


Appendix F: System Symbols ADVIA Chemistry XPT System

Symbol Description
The product conforms to established
requirements for quality and safety, and is a
certified product in the UKRSEPRO Register for
Ukraine.

The product conforms to all technical regulations


of the Eurasian Customs Union.

208 11314536 Rev. 01


ADVIA Chemistry XPT System Appendix F: System Symbols

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.

This symbol indicates that the product contains


Class 2 laser radiation with the caution to not stare
into the beam. The symbol is located on the rear of
the system.

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Appendix F: System Symbols ADVIA Chemistry XPT System

210 11314536 Rev. 01


ADVIA Chemistry XPT System Appendix G: Sample Volume

Appendix G: Sample Volume


This section summarizes the system sample volume requirements and dead
volume by container type.

Sample Volume Requirements


For assays processed on the system, the minimum required sample volume
for a reportable result depends on the following factors:

• Sample volume for the assay


• Volume of unusable sample specific to sample container

Table 45: Sample Specifications

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)

11314536 Rev. 01 211


Appendix G: Sample Volume ADVIA Chemistry XPT System

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.

212 11314536 Rev. 01


ADVIA Chemistry XPT System Appendix G: Sample Volume

Figure 55: Collection Tubes and Sample Cups

1 ADVIA Chemistry Sample Cup (ACSC)


2 Small Sample Container (SSC)
3 EZEE-NEST Sample Cups

11314536 Rev. 01 213


Appendix G: Sample Volume ADVIA Chemistry XPT System

Figure 56: Sample Cups Placement in Sample Adapter

1 ADVIA Chemistry Sample Cup (ACSC)


2 Thick End of Sample Adapter
3 Small Sample Container (SSC)
4 Thin End of Sample Adapter
5 EZEE-NEST Sample Cup
6 Thin End of Sample Adapter

214 11314536 Rev. 01


ADVIA Chemistry XPT System Appendix G: Sample Volume

Table 46: Dead Volume by Container Type

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

11314536 Rev. 01 215


Appendix G: Sample Volume ADVIA Chemistry XPT System

216 11314536 Rev. 01


ADVIA Chemistry XPT System Glossary

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.

11314536 Rev. 01 217


Glossary ADVIA Chemistry XPT System

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.

218 11314536 Rev. 01


ADVIA Chemistry XPT System Glossary

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.

11314536 Rev. 01 219


Glossary ADVIA Chemistry XPT 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.

220 11314536 Rev. 01


ADVIA Chemistry XPT System Glossary

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.

11314536 Rev. 01 221


Glossary ADVIA Chemistry XPT System

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.

222 11314536 Rev. 01


ADVIA Chemistry XPT System Glossary

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.

11314536 Rev. 01 223


Glossary ADVIA Chemistry XPT System

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.

224 11314536 Rev. 01


ADVIA Chemistry XPT System Glossary

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.

11314536 Rev. 01 225


Glossary ADVIA Chemistry XPT 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.

226 11314536 Rev. 01


ADVIA Chemistry XPT System Glossary

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.

11314536 Rev. 01 227


Glossary ADVIA Chemistry XPT System

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.

228 11314536 Rev. 01


ADVIA Chemistry XPT System Glossary

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.

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Glossary ADVIA Chemistry XPT System

230 11314536 Rev. 01


ADVIA Chemistry XPT System Index

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

11314536 Rev. 01 231


Index ADVIA Chemistry XPT System

automatic file management 119, 120 changing

B test display order 140


checking
backup
fluid levels 41
about 51 ISE baseline solution level 44
Batch order keyboard cable connections 117
about 66 reagent inventory and calibration status 44
create 67 chemistry calculation and calibration
biohazards configure 132
protection from 159 chemistry definition
configure 131
C
cleaning materials
cables 167 approved 172
calculated parameters command bar
define 148 tools
Calibration Order Filter description 22
about 82 configuring
calibration reaction curves absolute calibration 134
view 83 assay 128
calibration results assay calculations and calibration 132
assay definition 131
about 73 assay RBL 136
delete 84 assay realtime correction 136
view 83 assay sample, reagent, and diluent 130
calibrator check results carryover set 137
view 82 chemistry calculation and calibration 132
calibrator definitions chemistry definition 131
fixed factor value (FV) assays 134
add 73 IMA methods 133
calibrators multipoint calibration 135
load 74 qualitative settings 133
RBL 136
calls
reaction rate settings 134
service 177 reagents 128
capacity reference ranges 142
QC statistics database 99 reflex testing 142
repeat conditions for instrument flags 136
carryover set
result interpretation 142
configure 137 sample options 138
certifications single-point calibration 135
safety 193 specimen type mapping 137
visible status light 149
change
Configuring the System 127
to design 178

232 11314536 Rev. 01


ADVIA Chemistry XPT System Index

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

11314536 Rev. 01 233


Index ADVIA Chemistry XPT System

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

234 11314536 Rev. 01


ADVIA Chemistry XPT System Index

panels 167 designation 178


icons 23 keyboard cable connections
status bar 23 check 117
Identifying System Problems 107 L
IMA methods
laboratory
configure 133
server 16
inactivating
laboratory automation 16
reagent 1 packs 53
reagent 2 packs 55 LAS
reagent lots on Reagent Tray 1 54 enable 157
reagent lots on Reagent Tray 2 55 load samples 157
Informatics process patient samples 45
about 150 legal
connections 150 information 2
information notices 117
legal 2 light
input/output visible status 16
panels 167 linearity range 140
inspecting LIS
system components 41 general settings 156
instrument patient demographics 31
LIS communication status 31
retrofitting 178
warranty 175 LIS interface 15
intended use loading 157
system 15 calibrators, QC, and water blank 74
interior locating
system symbols 165 system name, serial number, and
interpretation range 145, 147 versions 180
locked cover
ISE
sample and dilution 163
electrode warranty 176
ISE baseline solution level M
check 44 maintaining
ISE calibrator results database 119
view 82 purification system 185
ISE historical graphs water quality 185
view 85 Maintenance 103
Log 105
K Schedule Window 29, 103
key operator maintenance

11314536 Rev. 01 235


Index ADVIA Chemistry XPT System

print 106 guide 25


procedures 25 operator’s guide
Maintenance Log terminology 6
about 105 Operator-defined Interpretation ranges
Maintenance log about 146
export 106 ordering
maintenance schedule supplies 189
print 106 Orders
managing about batch orders 66
orders 67 about creating orders 66
Managing Data 119 about test profiles 140
create batch order 67
Managing files
delete 67
Utilities 120 edit pending 67
modifying orders
assay options 128 create manually 65
reagents 128 manage 67
system options 149 OSHA
test definition 128
requirements 178
monitoring
outside normal hours
status 27
service 177
multi point calibration
overview
analyze 79
hardware 16
multipoint calibration
QC statistic application 88
configure 135
P
N
panels
Navigating Advanced QC 89
in/out 167
O parts

online replacement 177


Patient Demographics 31
help 25
operating system patient median

daily 39 analysis view 95


Operating the System 39 patient median files

operation mode export 102


patient order 65, 66
edit 128, 149
operator patient samples

designation 178 process via LAS 45


Operator’s Pending Orders

236 11314536 Rev. 01


ADVIA Chemistry XPT System Index

delete 67 Q
edit 67
performing QC

database backup 121 add definition 87


analyze results 91
period create definition 87
warranty 176 definition 87
postpone automatic file management load 74
activity 120 schedule samples 87
statistic application overview 88
power
statistics database capacity 99
safety 172
qualitative settings
switch 167
configure 133
preventing
quality
accidental contamination 160
reagent water 181
primary
Quality Control 87
about 51
print R
options 102 range
print displayed results about 142
report 72 about check ranges 138
printing about operator-defined interpretation 146
check range 139
displayed results reports 72
RBL
printing maintenance schedule 106
analyze 81
printing reports 99
configure 136
problems
RBL check results
caused by water 186
view 85
procedures
reaction rate settings
maintenance 25
configure 134
processing
reagent
patient samples via LAS 45
ancillary container usage 187
STAT samples 46
water 181
processing samples
reagent 1 lots
LIS 45
disable 54
purification system enable 54
maintain 185 reagent 1 packs
purifying activate 53
water 183 inactivate 53
reagent 2 packs
activate 55

11314536 Rev. 01 237


Index ADVIA Chemistry XPT System

inactivate 55 power outage


reagent blank recover 113
analyze 81 recovering from
reagent information slow user interface 112
add 128 system lockup 112
reagent inventory reference
view 49 add a range 143
reagent inventory and calibration status reference range
check 44 add 143
reagent lots reference ranges
disable 52, 56 configure 142
enable 52, 56 references
reagent lots on Reagent Tray 1 reagent water 186
activate 54 reflex testing
inactivate 54 configure 142
reagent lots on Reagent Tray 2 reflex tests
activate 55 about 147
inactivate 55
releasing
reagent packs
results to LIS 47
replenish 57
remote
reagent status
server 16
about 28
repeat conditions for instrument flags
reagent tray 1
configure 136
RTT1 52
replacement
reagent tray 2
parts 177
RTT2 54
replenishing
reagent water
reagent packs 57
issues 186
reports
quality 181
store 185 creating 99
test 185 print displayed results 72
reagent water quality printing 99
requirements
references 186
reagents electrical 195
OSHA 178
configure 128 sample volume 211
modify 128
restart 108, 111
recovering
restarting
emergency stop 112
from a power outage workstation 111

238 11314536 Rev. 01


ADVIA Chemistry XPT System Index

Restore data sample adapter 211


Utilities 122 sample cups 211
result interpretation Sample Management 65
configure 142 sample status
Results about 27
assigning a disposition 72 samples
export 124 configure 138
transmit 46 process through LIS 45
results track 68
evaluate 68 Samples and tests
release to LIS 47 access 71
save to archive 122
samples using LAS 157
retrofitting
saving
instrument 178
results data to archive 122
Review
Scan
about 90
about 49
review
scheduling
about 90
automatic calibrations 86
Review window 91
QC sample 87
RTT1 serial number, locating 180
reagent tray 1 52 service
RTT1 Status
additional period 176
about 53 calls 177
RTT2 delivery policy 175
reagent tray 2 54 exclusions 178
outside normal hours 177
RTT2 Status
service call extent 177
about 55
Service Ordering and Warranty 175
S shutting
Safety 159 down system safely 114
safety system down 108
sign-out 108, 111
certifications 193
instructions 159 single point calibration
power 172 analyze 77, 80
sample single-point calibration
dead volume 211 configure 135
information 65, 66 slow user interface
locked cover 163
volume 211 recover from 112
volume requirement 211 SMN

11314536 Rev. 01 239


Index ADVIA Chemistry XPT System

supplies 189 system


software approved cleaning materials 172
version 117 dimensions 193
features 15
software overview
fluid specifications 187
online help 25 inspect components 41
sources intended use 15
contamination 159 shut down 108
shut down safely 114
specifications 193
start 108
enviromental 194 supplies 189
system fluids 187 symbols 203
specimen type mapping verify operating conditions 41
configure 137 version 117
SSC 211 system features

starting front view of ADVIA XPT Chemistry system 16


top view of ADVIA XPT Chemistry system 16
system 108
system lockup
STAT samples
recover from 112
process 46
system name
status
locate 180
monitor 27
system operation
status bar 23
daily 39
LIS communication 31
system options
status bar icons 23
modify 149
status light
system power
visible 16
disconnect 110
stopping
system specifications 193
system using Emergency button 110
system symbols
storing
exterior 164
reagent water 185 interior 165
STT position settings
T
edit 138
supplies terminology
order 189 operator’s guide 6
system 189 test counter 26
switch test definition
power 167 modify 128
symbol test definition disk
conventions 5 about 129
system 203 test display order

240 11314536 Rev. 01


ADVIA Chemistry XPT System Index

change 140 ISE historical graphs 85


Test Profiles 140 RBL check results 85
reagent inventory 49
test state 26
wavelength reaction curves 85
testing visible
reagent water 185 status light 16
text visible status light 116
conventions 5 configure 149
tracking volume
samples 68 sample 211
Transmit results 46
troubleshooting
W
help 25, 116 warranty
exclusions 178
U instrument 175
usage ISE electrode 176
period 176
about 51
ancillary reagent container 187 water
user interface 15 issues 186
maintain quality 185
using
purify 183
Diagnostics 117 reagent 181
Using this Guide 5 water blank
Utilities load 74
data restore 122 wavelength reaction curves
managing files 120
view 85
V Wavelengths
verifying about 84
system operating conditions 41 window
version help 25
software and system 117 workstation
versions restart 111
locate 180
viewing
absorbance measurements 83
calibration reaction curves 83
calibration results 83
calibrator check results 82
cuvette blank measurements 84
diagnostics status 41, 42
ISE calibrator results 82

11314536 Rev. 01 241


ADVIA Chemistry XPT System Index

11314536 Rev. 01 242

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