Siemens DCA Vantage Manual

PN 06489264 Rev. D
Operator's Guide - En
A5 Wire-O Front cover: 148 x 210 mm (5.8” x 8.3”)
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DCA Vantage®
Analyzer
Operator's Guide
REF 06489264 Rev. E, 2012-08

© 2012 Siemens Healthcare Diagnostics. All rights reserved.
No part of this manual or the products it describes may be reproduced by any
means or in any form without prior consent in writing from
Siemens Healthcare Diagnostics.
DCA 2000, DCA, DCA Vantage, and RAPIDComm are trademarks of
Siemens Healthcare Diagnostics.
All other trademarks are the property of their respective owners.
The information in this manual was correct at the time of printing. 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 DCA Vantage®analyzer is used in a manner differently than specified by
Siemens, the protection provided by the equipment may be impaired. Observe
all warning and hazard statements.

DCA Vantage Operator’s Guide 3
Contents
Using this Guide
Conventions.........................................................................................12
1 Overview
Intended Use........................................................................................13
Hardware Overview.............................................................................14
Memory..................................................................................................15
Connections and Power ........................................................................15
Software Overview ..............................................................................17
Screen Components..............................................................................17
Power Save...........................................................................................17
Menus and Screens.............................................................................18
Home Screen.........................................................................................18
Viewing Events Notification...........................................................18
Help Menu, Software Version, and System Serial Number...................18
Turn Off..................................................................................................18
Recall Menu...........................................................................................19
System Menu.........................................................................................20
Additional Settings........................................................................20
2 Installation
Hardware Installation..........................................................................25
Unpacking the System...........................................................................25
Record the Warranty Information .................................................27
Connect the System Power...................................................................28
Installing the Hardware and External Devices.......................................29
Installing the External Barcode Reader.................................................29
Installing Printers................................................................................29
Setting up the Onboard Printer....................................................30
Setting up the External Printer......................................................30
Setting up the Report Header.......................................................31
Setting up the Report Type...........................................................31
Resetting Printer to Default...........................................................31
Loading Paper in the Onboard Printer..........................................31
Software Setup ....................................................................................31
Start Up Tests ........................................................................................31
Loading Configuration Settings .............................................................32
Verifying that the DCA Vantage System is Ready .................................32
Optical Test...................................................................................32
Configuring Connectivity........................................................................32

4 DCA Vantage Operator’s Guide
Setting up the Serial Port Connection ...................................................33
Setting Baud Rate.........................................................................33
Setting Parity.................................................................................33
Setting Stop Bits ..........................................................................34
Resetting Serial Port Options to Default .......................................34
Setting up the Ethernet Port .................................................................34
Setting the Host Name..................................................................35
Setting the IP Address to Automatic or Static Mode.....................35
Setting the IP Address..................................................................35
Setting the Subnet Mask...............................................................36
Entering a Domain Name Server..................................................36
Entering the Default Gateway.......................................................36
Setting up the Remote Computer ................................................36
Setting the Port Number ...............................................................36
Setting up Auto Send..........................................................................37
Installing Software...............................................................................38
3 Operating the System
System Access ....................................................................................41
Operator IDs and Access Codes........................................................42
Operator Levels ...................................................................................43
Adding an Operator.......................................................................43
Editing an Operator.......................................................................44
Displaying an Operator.................................................................44
Deleting an Operator.....................................................................44
Performing Tests.................................................................................45
Opening and Inspecting the Reagent Foil Package ..............................45
Opening the Reagent Foil Package..............................................45
Inspecting the Contents of the Foil Package ................................47
Hemoglobin A1c Test.............................................................................48
Preparing Patient Samples and Controls for 
Hemoglobin A1c Test....................................................................48
Performing a DCA Hemoglobin A1c Test .....................................48
Scanning the Reagent Cartridge...................................................54
Inserting the Reagent Cartridge into the System..........................56
Entering Patient Sample Data.............................................................57
Entering Patient Information Using the Touchscreen.............................57
Rules for Entering Patient Data Using the Barcode Reader..................57
Entering Patient Data Using the Barcode Reader .................................59
Cancelling a test ...........................................................................59
Displaying, Printing, and Sending Results .......................................59
HbA1c Test Results......................................................................60
Removing the Reagent Cartridge .................................................62
Microalbumin/Creatinine Test ................................................................63

DCA Vantage Operator’s Guide 5
Preparing Patient Samples and Controls for 
the Microalbumin/Creatinine Test.................................................63
Performing a DCA Microalbumin/Creatinine Test.........................63
Scanning the Reagent Cartridge...................................................69
Inserting the Reagent Cartridge into System................................70
Cancelling a test ...........................................................................71
Results of a Microalbumin/Creatinine Test...................................72
Removing the Reagent Cartridge .................................................74
Recalling Patient Data, Control Tests, and Calibration Data...........75
Recalling Patient Tests..........................................................................76
Viewing the Last 10 Patient Tests.................................................76
Searching for a Patient ID or Name..............................................76
Searching for a Specific Comment ...............................................77
Searching within a Specific Date Range.......................................78
Searching by Result Range..........................................................78
Viewing the HbA1c Results in Graph Format ...............................79
Viewing Patient Test Results........................................................79
Editing Patient Data......................................................................80
Selecting a Printer.........................................................................80
Configuring GFR for a Patient.......................................................81
Reports.................................................................................................81
Patient Test Reports..............................................................................81
Report Components ..............................................................................81
Patient Trend Graph Report .................................................................82
Control Test Report................................................................................82
Calibration Data Report.........................................................................82
Viewing and Printing System Settings Reports .....................................82
4 Calibration
Overview...............................................................................................83
Calibrating for Hemoglobin A1c.............................................................83
Calibrating for Microalbumin/Creatinine ................................................85
Calibration Data.....................................................................................86
Viewing Calibration Data Display..................................................86
5 Quality Control
Collecting Control Specimens ...........................................................87
Inserting Capillary Holder into the Reagent Cartridge...........................89
Running a Control Test..........................................................................90
Quality Control Errors............................................................................91
Setting a Required QC Reminder or Displaying a QC Reminder for New
Reagent Lots.........................................................................................92
Setting a QC Reminder.................................................................92
New Lot Reminder........................................................................92
Setting a Required QC Reminder.................................................93

6 DCA Vantage Operator’s Guide
Customized QC Reminders ..........................................................93
6 Maintenance
Routine Cleaning.................................................................................95
Maintenance Schedule..........................................................................95
Turning Off the DCAVantage System ...................................................95
Cleaning the Onboard Barcode Reader Window...................................96
Cleaning the External Barcode Reader Window ...................................97
Cleaning the Exterior.............................................................................97
Removing and Cleaning the Cartridge Spring and Cartridge Area........98
Cleaning the Cartridge Compartment Optical Window........................102
Changing the Air Filter.........................................................................103
Performing Tests...............................................................................105
Optical Test ................................................................................105
Optical Test Values ....................................................................106
System Tests .......................................................................................108
Performing User System Tests...................................................109
Calibrating the Touchscreen.......................................................110
User System Test Results....................................................................110
System Settings...................................................................................110
Loading Paper on the Onboard Printer................................................111
Replacing the Fuse..............................................................................115
Setting Maintenance Reminders..........................................................117
Viewing System Maintenance Status...................................................118
System Maintenance Log....................................................................119
Viewing the Maintenance Log.....................................................119
7 Troubleshooting
System Messages ...............................................................................121
Troubleshooting the System................................................................124
Troubleshooting Reagent Messages...................................................129
Errors Codes and Corrective Actions..................................................129
8 File Management
Exporting Patient Data.........................................................................147
Restoring Data.....................................................................................147
Saving Data and Settings....................................................................148
Restoring Settings ...............................................................................148
Deleting Data.......................................................................................149
9 Customizing the System
Setting Patient Test Options.............................................................151
Setting Patient Data Entry...................................................................151
Setting Urine Creatinine Units .............................................................151

DCA Vantage Operator’s Guide 7
Setting the HbA1c Reference Range ..................................................152
HbA1c Testing and Results...............................................................152
Display, Print, and Transmit HbA1c Reference Ranges .....................153
Designating the Primary and Secondary HbA1c Reporting Units........153
Setting User Corrections .....................................................................155
Setting the HbA1c User Correction.............................................155
Setting the Albumin User Correction...........................................156
Setting the Creatinine User Correction.......................................156
Setting the GFR Calculation................................................................157
Setting the Patient Recall List Options ................................................157
Setting Patient and Control Test Delete Options ...........................158
Setting Control Test Options............................................................158
Setting Control Tests Data Entry .........................................................158
Setting Control Test Reminders...........................................................159
Control Test Limits...............................................................................160
Setting a Test Lockout.........................................................................160
Setting General Options ...................................................................161
Setting the Language ..........................................................................161
Setting the Time Format and Time .............................................161
Setting the Date Format and Current Date.................................162
Setting the Sequence Number Options ......................................162
Volume and Display.............................................................................163
Setting the Sound Volume..........................................................163
Setting the System Display.........................................................163
Viewing the Current System Settings..............................................164
Viewing and Printing a Partial System Settings Report.......................164
Printing a Full System Settings Report................................................164
Customizing Printed Report Headers..............................................164
Setting the Printed Patient Test Report Type .................................165
Appendix A: Safety Information
Protecting Yourself from Biohazards..............................................167
References..........................................................................................168
External Barcode Reader Beam Safety...........................................168
Electromagnetic Emissions Safety..................................................168
Appendix B: Warranty and Support Information
Legal Information ..............................................................................169
Siemens Authorized Representative...................................................169
Warranty Information........................................................................169
Installation Details ...............................................................................169
Manufacturer’s Warranty .....................................................................169
Support Information..........................................................................169

8 DCA Vantage Operator’s Guide
Contact Information...........................................................................170
Pre-service Checklist ........................................................................171
Appendix C: Orderable Supplies
Accessory Items................................................................................173
Hemoglobin A1c .........................................................................173
Microalbumin/Creatinine.............................................................173
Replacement Parts ...........................................................................173
Appendix D: Symbols
System and Packaging .....................................................................175
User Interface......................................................................................178
Appendix E: Specifications
System Specifications ......................................................................181
System Dimensions ..........................................................................181
Environmental Specifications ..........................................................181
Electrical Requirements.......................................................................181
Electrical Precautions..........................................................................181
Safety Certifications.............................................................................182
Electromagnetic Compatibility (EMC)..................................................182
Reporting Results Calculations .......................................................182
Percent HbA1c Calculation ..................................................................182
Dual Reporting Calculations – HbA1c and IFCC Units.........................183
Glomerular Filtration Rate Calculation.................................................183
Printed Reports..................................................................................183
Patient Test Report Contents...............................................................183
Patient Trend Graph Report Contents.................................................185
Control Test Report..............................................................................186
System Settings Report.......................................................................188
Appendix F: External Barcode Reader
Specifications ....................................................................................193
Barcode Formats.................................................................................193
Barcode Symbols and Labels Specifications.......................................193
Barcode Symbologies..........................................................................194
Installing the External Barcode Reader ......................................194
Disabling the External Barcode Reader...............................................195
Restoring the Barcode Reader default settings...................................195
Testing the External Barcode Reader..................................................195
Maintenance.......................................................................................197
Troubleshooting ................................................................................197

DCA Vantage Operator’s Guide 9
Appendix G: Computer Interface (LIS)
General Information ..........................................................................199
Ethernet Connections Using POCT1-A...............................................199
Ethernet Connections Using ASTM.....................................................200
Serial Connection..............................................................................200
Architecture.................................................................................201
Hardware Link.............................................................................201
Character Format........................................................................201
Ethernet Connection .........................................................................202
Displaying and Printing the MAC address...........................................202
Automatically Sending Data to an LIS.............................................202
Recovery from a Failed Ethernet Connection.................................204
Appendix H: Glossary
Hardware Terms ................................................................................205
Software Terms..................................................................................206
Acronyms...........................................................................................208
Index

10 DCA Vantage Operator’s Guide

DCA Vantage Operator’s Guide 11
Using this Guide
The DCA Vantage®Operator’s Guide provides information for physician’s
office and laboratory professionals who use the DCAVantage system.
The following table describes how this manual is organized.
If you want to . . . then refer to . . .
learn about the system principles,
the hardware, and the operating
sequence, Section 1, Overview.
install the system and configure
connectivity, Section 2, Installation.
process samples, manage sample
results, define security, enter
Operator IDs and access codes,
and manage reference ranges, Section 3, Operating the System.
learn about calibration and how to
print the calibration status, Section 4, Calibration.
process Quality Control samples, Section 5, Quality Control.
perform maintenance activities, Section 6, Maintenance.
investigate and correct system
problems, Section 7, Troubleshooting.
learn about managing data, Section 8, File Management.
learn about changing the system
settings, system configuration,
display the software version and
system serial number, Section 9, Customizing the System.
review additional information, such
as the glossary, safety, external
barcode reader, or the supplies list, Appendices.

12 DCA Vantage Operator’s Guide
Conventions
The DCA Vantage Operator’s Guide uses the following text and symbol
conventions:
Convention Description
BIOHAZARD Biohazard statements alert you to
potentially biohazardous conditions.
WARNING
Warning statements alert you to conditions
that may cause personal injury.
CAUTION
Caution statements alert you to conditions
that may cause product damage or loss of
data.
NOTE: Note statements alert you to important
information that requires your attention.
Bold Bold type indicates text or icons on the user
interface. For example, if the word save
appears as Save, it refers to the Save key
on the user interface.
System icons are also indicated by words in
bold type. For example, the words Next
Screen refer to a system icon.
A complete list of system icons and their
equivalents is in Appendix D, Symbols.
Italic Italic type refers to the title of a document or
a section title in this manual.

DCA Vantage Operator’s Guide 13
Overview
Overview
1 Overview
Intended Use
The DCAVantage system is a semi-automated, benchtop system. It is
designed to quantitatively measure the percent of Hemoglobin A1c in blood
and low concentrations of albumin in urine (microalbuminuria), creatinine in
urine, and the albumin/creatinine ratio in urine.
The DCAVantage system is intended for professional use in a physician’s
office or hospital laboratory. Tests performed using the DCAVantage system
are intended for in vitro diagnostic use. As with all diagnostic tests, do not
base a definitive diagnosis on the results of a single test. A physician should
make a diagnosis after all clinical and laboratory findings are evaluated.
The system is a spectrophotometer that analyzes the intensity of the light
transmitted through the cartridge optical window and reports the results in
clinically meaningful units. No calculations are required by the user. When you
swipe a calibration card, the barcode reader reads the card and the system
automatically performs the calibration.

14 DCAVantage Operator’sGuide
Overview
Hardware Overview
The DCAVantage system consists of these functional areas:
• reagent cartridge compartment
• onboard barcode reader
• display/touchscreen
•printer
Figure 1 DCAVantage System
Interaction with the DCAVantage system is via an integrated touchscreen.
Messages, options, and requests for information display, and responses are
made by selecting the appropriate key symbol on the screen.
1Printer
2Display Screen
3Reagent Cartridge Compartment
4Onboard Barcode Reader
CAUTION
Do not use anything hard or pointed on the touchscreen. It can
damage the touchscreen.

DCA Vantage Operator’s Guide 15
Overview
Overview
Use the onboard barcode reader to calibrate the system and scan the reagent
cartridges and control cards. The reagent cartridges are placed in the reagent
cartridge compartment where the tests are run, and when testing is complete,
an internal thermal printer prints the test results.
You also can use an external barcode reader to enter certain information into
the system.
Memory
The operating system, the system software, the test data, and the system
settings for the DCAVantage system are stored in an onboard (non-
removable) flash memory. You can insert a Universal Serial Bus (USB) Flash
memory drive into the system’s USB port to save data and system settings.
You can then insert the USB memory drive into another DCA Vantage system
and restore the data to the new system.
You can transfer patient data from one DCAVantage system to another using
the software backup and restore sequences in system settings. See File
Management‚ page 147.
NOTE: You cannot import data from a spreadsheet into a DCAVantage
system.
Connections and Power
Ensure that the power cord connects into the power cord receptacle. Turn the
system on by pressing the power switch to the On position.
You can connect a USB flash memory drive, a printer, an Ethernet device, and
a handheld barcode reader to the system using the interface connectors.

16 DCAVantage Operator’sGuide
Overview
Figure 2 Power and External Connections
1External Interface Connections
2Power Plug
3Power Switch

DCA Vantage Operator’s Guide 17
Overview
Overview
Software Overview
The DCAVantage system provides an easy-to-navigate and intuitive user
interface.
Screen Components
The DCAVantage system software screens use a consistent layout.
Figure 3 Screen Components
Some options require that you enter information. If selected, a numeric keypad
or an alphanumeric keypad displays. An onboard barcode reader is included
and reads only barcodes of DCA™cartridges and calibration cards. You can
use the optional external barcode reader to enter and edit certain patient and
control information, as described in Appendix F, External Barcode Reader.
NOTE: The DCAVantage system does not support the connection of an
external computer keyboard or a mouse to enter data.
Refer to Appendix D, Symbols, for a complete list of key symbols used on the
DCAVantage system.
Power Save
When the system is not in use for more than 30 minutes, Power Save
automatically turns on. The system checks to ensure that no tests are in
progress and data is not being imported or exported before entering power
save. Touch the screen, open a cartridge compartment door or use the internal
barcode scanner to resume operations.
1Screen Title
2Module Icon and Title
3Time and Date
4Title Bar
5Content Area
6Navigation and Contextual Help Button Area

18 DCAVantage Operator’sGuide
Overview
Menus and Screens
Home Screen
The Home screen displays after the DCAVantage system completes its
initialization. The Home screen displays the time and date and the state of the
system. It is the starting point for Patient and Control Test Sequences.
From the Home screen, you can select:
•Help
• Turn Off
• Recall
• Menu
If the system is in the Not Ready state and you cannot initiate a Patient or
Control Test Sequence, an alert message displays explaining why the system
is not ready. If the system is in the Ready state, you can start a patient test and
scan either an HbA1c or a Microalbumin/Creatinine cartridge.
Notifications or error messages display at the Home screen and provide
information about the state of the DCAVantage system.
Viewing Events Notification
An Event Notification window displays at the Home screen when a
maintenance task is due, an error event occurs, or a required or optional
control test notification is posted.
1. At the Home screen, select Events.
The Events List screen displays the information about the notification.
2. Use the up and down arrows to scroll through the notifications.
3. To return to the Home screen, select Back.
NOTE: The Events Notification window closes after you clear all events.
Help Menu, Software Version, and System Serial Number
The Help menu provides information about the DCA Vantage system. The
software version number and system serial number also appear on the Home
Help screen. To access the Help menu, select Help from the Home screen.
Turn Off
You can leave the DCA Vantage system powered on except during
maintenance and cleaning procedures. If you need to power off the system,
refer to Turning Off the DCA Vantage System‚ page 95.
NOTE: You do not have to reconfigure system settings when turning the power
on. The system stores the saved settings.

DCA Vantage Operator’s Guide 19
Overview
Overview
Recall Menu
The Recall menu provides access to patient test results, control test results,
and calibration data.
At the Patient Tests screen, you can recall patient test data and export to a
USB device for backup.
To access the Recall menu, select Recall from the Home screen, and select
Patient Tests.
Table 1 Patient Tests
Select . . . then . . . to . . .
HbA1c View Last 10 see the last 10 results performed.
Patient ID/Name
search by Patient ID or last name. You can
graph HbA1c results using the Patient ID
search. The sort order is the reverse order in
which the tests were run. If there is not an
entry for a Patient ID or Last Name, the field
is blank. You also can delete test results from
this screen.
Date Range enter a Start and End Date to search patient
results for a specific time period.
Comment 1 search by the first comment of the up to 8
available comments. To perform a wildcard
search, use the percent (%) sign at the end
the entry.
Results/Range
Use the Set Lower Limit screen to set the
HbA1c search filter value when doing a
search by result range. The Lower Search
Limit displays in the units of the primary
algorithm and cannot be set lower than the
following values:
• NGSP: 2.0%
• JDS: 1.7%
• mono-S: 1.0%
• IFCC: 3 mmol/mol
The search returns any test result that is
greater than the lower limit set.
Graph
display HbA1c results in graph format. After
searching by patient ID, narrow the search
using a date range. The graph displays. You
can print the graph to the external printer.

20 DCAVantage Operator’sGuide
Overview
System Menu
Select Menu from the Home screen to access Control Tests, System
Maintenance, System Settings, and System Tests. You can also schedule and
change the configuration of control tests.
Table 2 Menu
Additional Settings
Select Additional Settings from the System Settings screen to customize the
system and add external devices.
MicroAlbumin View Last 10 see the last 10 results performed.
Patient ID/Name
search by Patient ID or last name. The sort
order is the reverse order in which the tests
were run. If a Patient ID or Last Name is not
entered for the patient, the field will be blank.
You also can delete test results. You can use
a wildcard (%) character in the recall search.
Date Range enter a Start and End Date to search patient
results for a specific time period.
Comment 1 search by the first comment of the up to 8
available comments. To perform a wildcard
search, use the percent (%) sign at the end
the entry.
Export copy data to a USB storage device.
Select . . . to . . .
Control Tests see a read-only status of required and optional Control tests. Select Log to see up
to 100 entries.
System Maintenance
view the list of maintenance tasks and the
status of each one. A task that has been
performed can be selected and marked as
complete on this screen. This task also
appears on the System Maintenance Log
screen.
System Settings change sound volume, adjust the display contrast, access Additional Settings menu,
and view current settings.
System Tests perform system tests including testing
printers, barcode readers, external ports,
optical tests, and calibrating the touchscreen.
Select . . . then . . . to . . .