Siemens DCA Vantage Operator's Manual

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DCA Vantage
A na l yz e r
®
REF 06489264 Rev. E, 2012-08
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© 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 Vant age
®
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.
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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
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Setting up the Serial Port Connection ...................................................33
Setting Baud Rate ......................................................................... 3 3
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
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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
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Customized QC Reminders ..........................................................93
6 Maintenance
Routine Cleaning.................................................................................95
Maintenance Schedule..........................................................................95
Turning Off the DCA Vantage System .................................... ...............95
Cleaning the Onboard Barcode Reader Window...................................96
Cleaning the External Barcode Reade r 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
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Setting the HbA1c Reference Range ..................................................152
HbA1c Testing and Results...............................................................152
Display, Print, and Transmit HbA1c Reference Ranges .....................153
Designating the Primary and Secondary HbA
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
Reporting Units........153
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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
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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 HbA Dual Reporting Calculations – HbA
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
Calculation ..................................................................182
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and IFCC Units.........................183
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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
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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
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Using this Guide

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

The DCA Vantage Operator’s Guide uses the following text and symbol conventions:
Convention Description
Biohazard statements alert you to
BIOHAZARD
WARNING
CAUTION
NOTE:
Bold
Italic
potentially biohazardous conditions.
Warning statements alert you to conditions that may cause personal injury.
Caution statements alert you to conditions that may cause product damage or loss of data.
Note statements alert you to important information that requires your attention.
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
refer to a system icon.
Screen
Next
A complete list of system icons and their equivalents is in Appendix D, Symbols.
Italic type refers to the title of a document or a section title in this manual.
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1 Overview

Intended Use

The DCA Vantage 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 DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed using the DCA Vantage 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.
Overview
Overview
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Overview

Hardware Overview

The DCA Vantage system consists of these functional areas:
reagent cartridge compartment
onboard barcode reader
display/touchscreen
•printer
1
Printer
2
Display Screen
3
Reagent Cartridge Compartment
4
Onboard Barcode Reader
Figure 1 DCA Vantage System
Interaction with the DCA Vantage 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.
CAUTION
Do not use anything hard or pointed on the touchscreen. It can damage the touchscreen.
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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 DCA Vantage system are stored in an onboard (non­removable) 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 DCA Vantage 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 DCA Vantage
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.
Y ou can connect a USB flash memory drive, a printer , an Ethernet device, and a handheld barcode reader to the system using the interface connectors.
Overview
Overview
DCA Vantage Operator’s Guide 15
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Overview
1
External Interface Connections
2
Power Plug
3
Power Switch
Figure 2 Power and External Connections
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Software Overview

The DCA Vantage system provides an easy-to-navigate and intuitive user interface.

Screen Components

The DCA Vantage system software screens use a consistent layout.
1
Screen Title
2
Module Icon and Title
3
Time and Date
4
Tit le Bar
5
Content Area
6
Navigation and Contextual Help Button Area
Overview
Overview
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 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 DCA Vantage 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
DCA V antage system.
cartridges and calibration cards. You can

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. T ouch the screen, open a cartridge compartment door or use the internal barcode scanner to resume operations.
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Overview

Menus and Screens

Home Screen

The Home screen displays after the DCA Vantage 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 p atient test and scan either an HbA
Notifications or error messages display at the Home screen and provide information about the state of the DCA Vantage 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 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
NOTE: The Events Notification window closes after you clear all events.
or a Microalbumin/Creatinine cartridge.
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Events.
Back.

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.
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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.
search by Patient ID or last name. You can
Patient ID/Name
Date Range
Comment 1
Results/Range
graph HbA 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. Y ou also can delete test results from this screen.
enter a Start and End Date to search patient results for a specific time period.
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.
Use the Set Lower Limit screen to set the HbA
1c
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
results using the Patient ID
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search filter value when doing a
Overview
Overview
The search returns any test result that is greater than the lower limit set.
results in graph format. After
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Graph
display HbA searching by patient ID, narrow the search
using a date range. The graph displays. You can print the graph to the external printer.
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Overview
Select . . . then . . . to . . .
MicroAlbumin View Last 10 see the last 10 results performed.
search by Patient ID or last name. The sort order is the reverse order in which the tests
Patient ID/Name
were run. If a Patient ID or Last Name is not entered for the patient, the field will be blank. Y ou 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.
search by the first comment of the up to 8
Comment 1
available comments. To perform a wildcard search, use the percent (%) sign at the end the entry.
Export
copy data to a USB storage device.

System Menu

Select Menu from the Home screen to access Control Tests, System Maintenance, System Settings, and System T ests. You can also schedule and change the configuration of control tests.
Table 2 Menu
Select . . . to . . .
see a read-only status of required and
Control Tests
System Maintenance
System Settings
System Tests
optional Control tests. Select
Log to see up
to 100 entries. 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.
change sound volume, adjust the display contrast, access Additional Settings menu, and view current settings.
perform system tests including testing printers, barcode readers, external ports, optical tests, and calibrating the touchscreen.
Additional Settings
Additional Settings from the System Settings screen to customize the
Select system and add external devices.
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To access Additional Settings, select Menu from the Home screen, select
System Settings, and then Additional Settings. Table 3 Additional Settings
Select . . . then . . . to . . .
specify the data and comments that are entered when a patient test is run such as
Patient Tests Data Entry
Sample ID, Patient ID, First Name, Last Name, Comments (1–8), Operator ID. You can also indicate if these are optional or required.
Urine Creatinine Units
set the creatinine results to either mg/dL or mmol/L.
specify the upper and lower reference range
Reference Range
values for HbA
results. Display, print, and
1c
transmit reference range values
Hb1Ac User Correction
Albumin User Correction
Creatinine User Correction
adjust the slope and offset for the HbA values.
adjust the slope and offset for the Albumin values.
adjust the slope and offset for the Creatinine values
turn the GFR Calculation on or off, and select
GFR Calculation
the unit of measurement to be used for plasma creatinine.
set the search criteria and display for patient Patient Recall List Options
results. When performing a search in Recall,
you can search by either Patient ID or Last
Name.
specify the data and comments that are
Control Tests Data Entry
entered when a control test is run and which
data is required or optional.
access to the Control Test Log and allows Reminders
you to view and change the schedule for the
Control Tests. New Lot
Reminder
set a reminder or require the user to run a
control when a new reagent calibration card
is scanned.
Overview
Overview
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Overview
Select . . . then . . . to . . .
view the Maintenance T ask log. You can also view and change the schedule for
Maintenance Reminders
maintenance tasks including changing the air filter, cleaning the onboard barcode reader, and cartridge compartment.
access screens that configure settings such
General
as language, time, and date that determine what displays on the screen during testing.
Language
Time
set the display language. The languages are sorted by country code.
set the current time and time format
(12 or 24 hours) Date set the current date and date format. Sequence
Number
specify whether or not the sequence number
resets daily, after 999 entries, or not reset.
select restricted, unrestricted, restricted plus, System Access
or fully restricted access to the Recall and
System Settings features.
prevent a patient test from running when
there is a control test failure for the curren t Test Lockout
test type. The remove patient test lock
function locks out all patient testing and is
enabled and disabled from a remote
computer. Settings Wizard
activate the wizard to run the next time the
system is powered on.
specify how patient and control tests are
deleted from the system; either automatic or Storage Mode
manual. Automatic deletion removes tests on
a first in-first out basis. Manual deletion
requires you to view and delete the tests. Save Data and
Settings
save data and system settings to a USB
device.
remove the patient information that Delete Data
associates the patient with the test results or
delete all patient and test results.
copy saved data from the USB device to the Restore Data
DCA Vantage system. This overwrites any
current data on the system.
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Select . . . then . . . to . . .
copy saved settings from the USB device to
Restore Settings
the DCA Vantage system. Existing settings are overwritten.
Install Software
install new software from a USB device to the DCA Vant age system.
enable or disable the onboard printer. You
Printers Onboard Printer
can specify whether reports print automatically and number of copies.
enable or disable an external printer. Y ou can
External Printer
specify whether reports print automatically and number of copies.
Report Headers
Report Type Reset Printer
Defaults
External Barcode Reader
create a customized report header that appears on printed reports.
select whether to print a full report or a short (partial) report (for faster printing).
return the printer settings to the factory settings.
disable or enable the external barcode reader and select the barcode symbology.
select serial or Ethernet port, choose data
Connectivity
transmission protocol, and configure port settings.
HbA1c Reporting Units
specify the primary (required) and secondary (optional) reporting units in calculating and displaying the HbA
value.
1c
Export Log save error log data to a USB device.
provide optional capability that is only
Activate
actionable with an activation code provided by Siemens Healthcare Diagnostics.
Factory Settings
provides authorized service personnel access to screens used to view or set options.
Overview
Overview
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2 Installation

This section provides detailed installation instructions for the DCA Vantage system. Follow the installation steps correctly to ensure proper installation, operation, and service.

Hardware Installation

Place the system where it will not be subjected to extreme temperature variations. Avoid proximity to open windows, direct sunlight, ovens, hot plates, open burners, radiators, and dry ice baths.
Do not place the DCA Vantage system on the same bench as a source of vibration.
Provide bench space large enough to allow free air circulation around the system (8 cm/3 inches on all sides).
CAUTION
Do not drop or handle the system roughly. This can disturb internal calibrated optics and electronics or cause other damage. Always handle the system with care. The DCA Vantage system is a precision system and must be handled accordingly.

Unpacking the System

Your DCA Vantage system is delivered in 1 shipping carton.
1. Carefully remove the contents of the shipping carton.
2. Inspect the carton and system for visible signs of damage.
3. If damage to the system exists, immediately file a complaint with the carrier.
4. Make sure all items are included with your system, and keep them for future use.
DCA Vantage system
Cleaning Kit
Optical Test Cartridge (in system cartridge compartment)
Power Cord for your region
Air Filter Replacement Kit
Spare Fuses
•HbA
Microalbumin/Creatinine Quick Reference Guide
Quick Reference Guide
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Installation
DCA Vantage Operator’s Guide 25
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Documentation CD
Paper Roll
Self Adhesive Label Stock for onboard printer
Installation
Figure 4 DCA Vantage System Parts
5. Retain the shipping carton and packing for several weeks. If you need to ship the system, the shipping carton provides the best
protection against damage.
6. Place the system on a firm, level work surface in the designated work area.
7. Ensure that the system is level, and that the back and sides of the system are at least 8 cm (3 inches) from any adjacent wall.
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Record the Warranty Information
1. Print or copy the Pre-service Checklist, and the Warranty Information‚ page 169.
2. Locate the serial number.
To find the serial number physically on the system, remove the air filter
from the back of the system. The serial number is on a label between the fan and the power connector.
To find the serial number from the user interface, select Menu >
System Settings > View Settings.
Installation
1
Serial number
Figure 5 Serial Number Location, Air Filter Removed
3. Write the installation date and serial number in the spaces provided in the Pre-service Checklist, and on the Warranty Information‚ page 169.
4. Contact your Siemens representative for your warranty information if the pre-service checklist is not included in your manual.
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Connect the System Power

1. Ensure that the system power switch is in the Off position.
2. Connect the power cord to the system and to an appropriate, grounded AC electrical outlet.
Installation
1
External Connections
2
Power Plug
3
Power Switch
Figure 6 External Connections and Power Connections
28 DCA Vantage Operator’s Guide
Page 29

Installing the Hardware and External Devices

If you are connecting an external printer, computer, or LIS system to the DCA Vantage system, you must configure the DCA Vantage system software before connecting the external hardware. Refer to Configuring Connectivity‚ page 32.
1
Ethernet Port (RJ 45)
2
USB Port
3
Barcode Reader
4
Serial Port (RS 232)
Installation

Installing the External Barcode Reader

If you ordered an external barcode reader, it is supplied in addition to the internal barcode reader. Refer to Appendix F, Installing the External Barcode Reader.

Installing Printers

Use the Printers menu to perform the following tasks:
enable/disable the onboard and external printer
configure the onboard and external printer
enter a customized report header that displays on printed reports
reset printer defaults
select the report type
DCA Vantage Operator’s Guide 29
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specify whether a report automatically prints to the onboard printer or external printer, if enabled, or both, when the result displays
specify the number of copies of the report that you want to print

Setting up the Onboard Printer

1. At the Home screen, select
2. At the System Settings menu, select
3. At the Additional Settings
4. Select
Onboard Printer.
System Settings.
Additional Settings.
menu, select Printers.
The Onboard Printer screen displays.
To enable the onboard printer, select
To disable the onboard printer, select
Enable.
Disable.
5. To automatically print the test results, select Automatically print.
NOTE: You must select Enabled to automatically print.
6. Use the up and down arrows to select the number of copies of the report you want to print.
Installation
7. To save the onboard printer setting, select
Save.

Setting up the External Printer

The DCA Vantage system supports only Printer Command Language (PCL) type printers for external printers. Network printers are not suppo r te d .
1. At the Home screen, select System Settings.
2. At the System Settings menu, select
3. At the Additional Settings
4. Select
External Printer.
menu, select Printers.
To enable the external printer, select
To disable the external printer, select
Additional Settings.
Enable.
Disable.
5. To automatically print the test results, select Automatically print.
NOTE: You must select Enabled to automatically print.
6. Use the up and down arrows to select the number of copies of the report you want to print.
7. To save the external printer setting, select
Save.
8. Connect the printer cable to the USB port on the DCA Vantage system and to the external printer.
9. Power on the printer.
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Setting up the Report Header

For information about setting up the optional report header, see Customizing Printed Report Headers‚ page 164.

Setting up the Report Type

For information about setting the optional report type, see Setting the Printed Patient Test Report Type‚ page 165.

Resetting Printer to Default

1. At the Home screen, select
2. At the System Settings menu, select
3. At the Additional Settings
4. Select

Loading Paper in the Onboard Printer

Install a roll of printer paper for the onboard printer and reinstall the printer cover. Refer to Loading Paper on the Onboard Printer‚ page 111.
The printer stops printing when it runs out of paper. If no paper is availab le at the start of printing, the printer does not attempt to print.
Reset Printer Defaults to restore the default printer settings.
This also deletes any report header text you have created.
System Settings.
Additional Settings.
menu, select Printers.

Software Setup

After the system is properly installed, start the DCA Vantage system by toggling the power button to the On position. The system displays the following information:
Model Name
System Software Version
Copyright Information
Installation

Start Up Tests

After you turn the power on, a message displays explaining that the system is starting up. The DCA Vantage system verifies that the compartment door is closed and performs hardware functionality tests to verify that the internal optics and the mechanical system are operating correctly.
CAUTION
Do not turn the system off while it is starting up, this can cause corruption to the stored data.
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Loading Configuration Settings

The first time you turn on the DCA Vantage system, the System Settings Wizard runs to help you update configuration settings. The wizard automatically displays the screens that are frequently used to set user preferences such as language, date, and time. Follow the instructions on the screens to enter configuration information.
The System Wizard includes:
setting current time and time format
setting current date and date format
setting sequence number options
selecting urine creatinine units
option to finish and proceed to the Home screen or proceed to the System Settings to further configure the system.
The System Settings Wizard only runs the first time you set up the DCA Vantage system. If you want the System Settings Wizard to run the next time the system is turned on, follow these procedures:
Installation
1. At the Home screen, select
2. At the System Settings menu, select
3. At the Additional Settings menu, select
4. Select
Settings Wizard.
5. To run the wizard the next time you turn the system on, select
Run System Settings Wizard at Next Power on.
6. To save this setting, select
System Settings.
Additional Settings.
General.
Save.

Verifying that the DCA Vantage System is Ready

The DCA Vantage system displays the current date and time and verifies that no errors occurred. If no errors occurred, the system is ready to run.
Optical Test
Siemens recommends running the optical test cartridge before you analyze samples for the first time. Refer to Optical Test‚ page 105 for more information.

Configuring Connectivity

If you are connecting the DCA V ant age system to a computer or LIS, you must choose the serial or Ethernet port before connecting to these external devices.
NOTE: Data transmission to a computer or LIS can only be active on one type
of port (Ethernet or serial) at a time.
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For both serial and Ethernet connections, if you change a baud rate, IP address, or port number in the port settings menu, then click Back to go to the Connectivity screen, you must select Save to make the changes to the port settings take effect on the DCA Vantage system. Otherwise, the previous setting remain in effect.

Setting up the Serial Port Connection

Use the Connectivity menu to enable the serial port and to select options for the serial port.
NOTE: The default setting for the serial port is disabled. NOTE: You must select Save on all of the screens to save your changes.
1. At the Home screen, select
2. At the System Settings menu, select
3. At the Additional Settings menu, select
4. Select Serial. ASTM automatically selects.
5. Select
Configure to continue setting Serial Port options.
The Serial Port options menu displays.
Setting Baud Rate
1. At the Serial Port menu, select
2. At the Baud Rate screen, select one of the following:
19,200 bps
9600 bps
4800 bps
2400 bps The default value is 9600 bps.
3. Select Save. The Serial Port menu displays.
System Settings.
Additional Settings.
Connectivity.
Baud Rate.
Installation
Setting Parity
1. At the Serial Port screen, select
Parity.
2. Select one of the following parity settings:
•None
Even
•Odd The default value is None.
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3. Select a string length for the data bits:
•8
•7 The default value is 8.
4. To save the parity settings, select Save. The Serial Port menu displays.
Setting Stop Bits
1. Select Stop Bits to set the number of stop bits.
2. Select a stop bit length:
•1
•2 The default value is 1.
3. To save the Stop Bits settings, select
Save.
The Serial Port menu displays.
Installation
5. Select
4. Select
Back to return to the Connectivity screen. Save to save the Connectivity settings.
Resetting Serial Port Options to Default
To reset the Serial Port options to the factory default settings:
1. At the Home screen, select
2. At System Settings, select
System Settings.
Additional Settings.
The Additional Settings menu displays.
3. At the Additional Settings menu, select
Connectivity.
4. Select Serial. ASTM automatically selects.
5. Select
6. Select
Configure. Reset Defaults.

Setting up the Ethernet Port

Use the Ethernet Port menu to access the system setting to configure Ethernet communication.
Use the Connectivity menu to enable and disable the Ethernet port. You can access the screen to select different options for the Ethernet port.
NOTE: The default setting for the Ethernet port is disabled.
1. At the Home screen, select
2. At the System Settings menu, select
34 DCA Vantage Operator’s Guide
System Settings.
Additional Settings.
Page 35
3. At the Additional Settings menu, select Connectivity.
4. Select
5. Select
Ethernet. POCT1A or ASTM.
The default is POCT1A.
6. Select
Configure to continue setting Ethernet Port options.
Setting the Host Name
Use the Host Name screen to enter the alphanumeric name used to identify the DCA Vantage system on the network.
1. At the Ethernet Port screen, select Host Name.
2. Use the alphanumeric keypad to enter the host name.
3. Select
Save to save the Host Name information.
The Ethernet Port menu displays.
Setting the IP Address to Automatic or Static Mode
You can configure the system with either Automatic or Static IP settings. If you select Automatic IP Setting, IP Address, Subnet Mask, and Default Gateway selections are unavailable.
If you are using Static IP, you must configure the following settings:
IP Address
Subnet Mask
Domain Name Server
Default Gateway
Remote Computer
1. At the Ethernet Port menu, select
Automatic IP Setting or Static IP Setting.
The default is Automatic IP.
2. To save the IP setting, select
Save.
The Ethernet Port menu displays.
Installation
Setting the IP Address
If you are using Static IP, use the IP Address screen to enter the static IP address for the Ethernet port.
1. At the Ethernet Port menu, select
IP Address.
2. Use the alphanumeric keypad to enter the IP address.
3. To save the IP address, select
Save.
The Ethernet Port menu displays.
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Setting the Subnet Mask
Use the Subnet Mask screen to enter the subnet mask for the system.
1. At the Ethernet Port menu, select
Subnet Mask.
2. Use the numeric keypad to enter the subnet mask.
3. To save the subnet mask, select
Save.
The Ethernet Port menu displays.
Entering a Domain Name Server
Use the Domain Name Server screen to enter the Domain Server Name for the system.
1. At the Ethernet Port menu, select
2. Select
Domain Name Server.
Domain Server Name.
3. Use the alphanumeric keypad to enter the DNS.
4. To save the domain server name, select
Save.
The Ethernet Port menu displays.
Installation
Entering the Default Gateway
Use the Default Gateway screen to enter the default gateway for the system.
1. At the Ethernet Port menu, select
Default Gateway.
2. Use the numeric keypad to enter the default gateway.
3. To save the default gateway, select
Save.
Setting up the Remote Computer
Use the Remote Computer screen to enter the IP address or host name for the remote computer. After you enter the IP address or host name, you can communicate with the remote computer over the network.
1. At the Ethernet Port menu, select
2. Select
Remote Computer.
Remote Computer.
3. Use the alphanumeric keypad to enter one of the following for the remote computer:
IP address
host name
4. To save the remote computer, select
Save.
Setting the Port Number
Use the Port Number screen to enter the port number for the system.
1. At the Ethernet Port menu, select
36 DCA Vantage Operator’s Guide
Port Number.
Page 37
2. Use the numeric keypad to enter the Port Number.
3. To save the Port Number, select
Save.

Setting up Auto Send

When you have enabled communications with an LIS, you can configure the system to automatically send all patient and control test results to the LIS as soon as the test result has completed, or as soon as you have finished entering or modifying patient demographic data. Automatic sending of results (Auto Send) to an LIS is disabled by default. For more information about Auto Send, see Automatically Sending Data to an LIS‚ page 202.
To enable Auto Send, perform the following procedure:
1. From the Home screen, select
Settings > Connectivity
2. Select the type of connection, or
POCT1A.
3. To enable Auto Send, select the This selection is disabled by default. To enable manually sending selected results, clear this check box.
4. Select
Configure to set up the Ethernet or Serial port connection.
NOTE: At this stage, the system does not verify whether a connection
exists.
5. Continue configuring the Ethernet or Serial connection parameters.
6. When finished, select
Save.
Menu > System Settings > Additional
.
Ethernet or Serial, and the protocol, ASTM
Automatically Send check box.
Installation
The Auto Send setting is included in the backup and restore data so an administrator can copy the settings from one DCA system to another.
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Installing Software

CAUTION
If you are upgrading from Version 1.0 or 1.1 to Version 4.0, read the following important information:
During the upgrade, the analyzer deletes the patient, control, and calibration data. Before you upgrade the software, print the patient test data and the control test data, if needed. Consider exporting the data to a USB device. For details, see Exporting Patient Data‚ page 147. The system exports the data to a .txt file. You can view the data in a text file or worksheet.
Because of the number and complexity of changes in the software between Version 1.1 and 4.0, the system cannot retain certain system settings across the upgrade process. The system resets the values for HbA
Range, and HbA1c Reporting Units to the default values. For the HbA
reporting units, Primary is NGSP and Secondary is None.
1c
Installation
Before you upgrade the software, print the Full System Settings report. To do so, on the Home screen, select
Settings > Additional Settings
upgrade, print the report again. Compare the report to the report you printed before the upgrade. Change the system settings, if needed.
To start the software upgrade, perform these steps:
NOTE: If you are upgrading from Version 2.0 or higher to Version 4.0, the
HbA
reporting units are retained.
1c
1. On the Home screen, select
2. Select
System Settings > Additional Settings.
NOTE: If security is set on the analyzer, to display the Additional Settings
Menu.
screen, enter an authorized Supervisor ID or access code.
3. If you want to print the Full System Settings Report, be sure the printer is enabled and select Print. Otherwise, continue with step 4.
4. Select General.
5. Select the down arrow 3 times.
6. Select
Install Software.
User Corrections, HbA1c Reference
1c
Menu > System
, and select Print. After the
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7. Insert the USB storage device into the USB port.
CAUTION
Do not remove the USB storage device from the USB port or turn off the system while the software is installing. This can corrupt the data on the analyzer.
8. Select
Next.
A message at the Install Software screen indicates the software is installing.
When installation completes, a message instructs you to leave the USB device in the USB port and restart the system.
9. To restart the system, select
Restart.
To complete the installation, you must restart the DCA Vantage system and follow the next set of instructions.
1. After the DCA V antage analyzer restarts , if prompted to calibrate the touch screen, follow the onscreen instructions.
2. At the prompt for using the analyzer in Japan, select
Yes or No.
3. If you selected Yes, follow these steps. If you selected No, continue to step 4.
a. On the Report Type - Patient Results screen, select
Short Report and select Next.
b. On the HbA
secondary reporting units and select
Reporting Units screen, select the primary and
1c
Next.
Full Report or
c. Continue to step 4.
4. On the Set System Time screen, select the format and time and select
Next.
5. On the Set System Date screen, select the format and date and select
Next.
A list of key software changes displays. This list appears only the first time the analyzer restarts. To navigate the list, use the up and down arrows.
6. To display the Home screen, select
Back.
7. Remove the USB device.
8. Print and compare the system settings: a. To print the Full System Settings report, on the Home screen, select
Print.
b. Compare the report to the report you printed before the upgrade. c. Change any system settings, if needed.
DCA Vantage Operator’s Guide 39
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40 DCA Vantage Operator’s Guide
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3 Operating the System

System Access

You can set up the DCA Vantage system to have unrestricted or restricted system access.
There are 4 types of system access:
Unrestricted (default)
•Restricted
Restricted Plus
Fully Restricted
If the system is unrestricted, most features are available to an operator without having to enter an access code.
With Restricted, Restricted Plus, and Fully Restricted, some features require an access code to continue or are blocked from an operator.
After setting up the System Access level, you can manage Operator IDs and set up the access to features by individual operators. The access to features is controlled by the Operator Level (Levels 1, 2, and 3). Level 1 is the highest level, typically for a supervisor or system administrator. Levels 2 and 3 are more restrictive and are typically for an operator running daily tests and maintenance activities. Refer to page 42 for system access and operator access levels.
When you assign the security access for the system and the level of access to an operator, you can control the features that the operator can access. When the system access is set to one of the protected modes, the system displays a sign-in screen before the System Settings screen displays. When the system is set to fully restricted, the system displays a sign-in screen before the Recall screen. Operators must enter an access code to continue. If an operator is assigned a level that cannot access a function, a message appears indicating that the operator cannot access that feature.
To access the System Access screen:
1. At the Home screen, select
2. At the System Settings screen, select
3. At the Additional Settings Screen, select
4. At the General Screen, select
System Settings.
Additional Settings.
General.
System Access.
Operating the System
DCA Vantage Operator’s Guide 41
Page 42

Operator IDs and Access Codes

Operating the System
Fully Restricted
Restricted Plus Restricted Unrestricted
Function L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3
Run Patient Test
Run QC Test
Recall Patient, QC, or Calibration data
Edit and Delete Recalled Patient/QC data
Run System Tests
HbA
Set Reporting
Units Set
1c
Japanese
Mode
Configure System Settings
By default, the system access is Unrestricted. In this mode, the Operator button is always available. Selecting the Operator button displays a new screen that enables you to add, edit, and delete operators.
NOTE: The term Operator ID replaces the term User ID used in earlier
versions of DCA Vantage software. You can add up to 1000 operators. Each Operator ID and access code must
be unique. When system access is set to Fully Restricted or Restricted Plus, the operator enters his or her access code to continue. The system auto­populates the Operator ID data entry item according to the user's entered password (Access Code or Support ID of the Day) when the following conditions are true:
Patient or control test is being run
System access is configured as Fully Restricted or Restricted Plus mode
User has been authenticated after entering a valid password
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Operator Levels

Level 1 – All functions Provides access to all functions on the system.
Level 2
Level 3
Level 1 is the highest level, typically for a supervisor or system administrator. Levels 2 and 3 are more restrictive and are typically for an operator running daily tests and maintenance activities.

Adding an Operator

The system verifies that a Level 1 operator is configured in the system. If not, you will be prompted to add this operator first. At the initial system installation, there are no operators or access codes created.
The first operator added to the system must be a Level 1 operator. There must be at least one Level 1 operator on the system at all times. The system prevents the last Level 1 operator from being deleted, or the level changed.
The access code field is alphanumeric with the alpha characters entered as uppercase A–Z and 0–9. The access code can be up to 13 characters.
1. At the Home screen, select Menu.
2. Select
3. At the System Settings menu, select
4. Select
5. Select
6. Select the system access level (Unrestricted, Restricted, Restricted Plus,
7. Select
8. To add an operator, select
9. Select
10. To add an access code, select
11. Select
12. At the Add Operator screen, select
System Settings from the Menu screen.
Additional Settings. General. System Access.
or Fully Restricted). The Operator button enables after selecting a system access level.
Operator.
ADD.
Use the alphanumeric keypad or external barcode reader to enter an Operator ID in the Name field. The Operator ID can include letters and numbers. The maximum number of characters for an Operator ID is 16.
Enter to save the Operator ID.
Edit to the right of the ID field.
Use the alphanumeric keypad or external barcode reader to enter an access code.
Enter.
Save.
The operator information is saved.
Operating the System
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Editing an Operator

You can change the Operator ID, access code, and level for an operator.
1. At the Home screen, select
2. Select
System Settings from the Menu screen.
3. At the System Settings menu, select
4. Select
5. Select
General. System Access.
6. At the System Access menu, select
Menu.
Additional Settings.
Operators.
The Operators screen displays.
7. Highlight the operator you want to edit.
8. Select
Edit.
9. Edit the Operator ID or the Access code with the keypad or external barcode reader.
10. Select
Save.

Displaying an Operator

1. At the Home screen, select Menu.
2. Select
3. At the System Settings menu, select
4. At the Additional Settings menu, select
5. Select
6. At the System Access menu, select
System Settings from the Menu screen.
Additional Settings.
General.
System Access.
Operators.
A list of operators displays.
Operating the System

Deleting an Operator

1. At the Home screen, select Menu.
2. Select
3. At the System Settings menu, select
4. At the Additional Settings menu, select
5. Select
6. At the System Access menu, select
System Settings from the Menu screen.
Additional Settings.
General.
System Access.
Operators.
A list of operators displays.
7. Highlight the Operator ID you want to delete.
8. Select
Delete.
A message displays verifying that you want to delete the Operator ID.
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9. Select Yes to delete the Operator ID.

Performing Tests

You can test blood for the percent concentration of HbA1c, and urine for concentrations of microalbumin and creatinine. Results are available in
approximately 7 minutes.
NOTE: You can use DCA 2000
DCA Vantage system.

Opening and Inspecting the Reagent Foil Package

Before running an HbA1c test or Microalbumin and Creatinine test, open and inspect the contents of the Reagent Cartridge foil package.
Opening the Reagent Foil Package
1. Remove one foil package (containing a reagent cartridge) from storage. For more information, see Recommended Procedures for Handling
Reagent Cartridges in the DCA Systems Reagent Kit package insert.
®
and DCA 2000+ cartridges on the
Operating the System
DCA Vantage Operator’s Guide 45
Page 46
2. Open the foil package as shown in Figure 7.
CAUTION
Do not use scissors to cut open the foil package. Scissors can damage the reagent cartridge, the flexible plastic pull-tab on the cartridge, or the desiccant bag.
Operating the System
Figure 7 Opening Reagent Cartridge Package
3. Remove the contents of the package.
46 DCA Vantage Operator’s Guide
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Inspecting the Contents of the Foil Package
The foil package includes the contents displayed below:
CAUTION
When handling the reagent cartridge, do not touch or otherwise contaminate the optical window as this may generate error codes during testing.
1
Flexible Pull-tab
2
Reagent Cartridge
3
Desiccant bag
4
Optical Window
Operating the System
Figure 8 DCA Systems Reagent Cartridge Package
Discard the reagent cartridge if any of the following conditions exist:
The cartridge is damaged.
The flexible pull-tab is loose or missing.
The desiccant bag is missing or open.
Loose desiccant particles are found inside the foil package.
If the foil package is open for more than 60 minutes.
DCA Vantage Operator’s Guide 47
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Hemoglobin A1c Test

The following section explains the test sequence for an HbA1c test.
Operating the System
Preparing Patient Samples and Controls for Hemoglobin A
1c
Test
Materials Required:
DCA Systems Hemoglobin A
Reagent Kit (for use with the DCA Vantage
1c
system)
Patient sample
Control Kit or other control
Lint-free tissue
Clock or timer For information on preparing controls, refer to Quality Control‚ page 87. For information on calibrating, refer to Calibrating for Hemoglobin A1c
page 83.
Performing a DCA Hemoglobin A
BIOHAZARD
1c
Te st
Wear personal protective equipment, including safety glasses and gloves. Use universal precautions. Refer to Safety Information‚ page 167, for recommended precautions when working with biohazardous materials.
NOTE: You can save unused capillary holders and use them with any lot of
DCA Hemoglobin A
reagent cartridges.
1c
1. Open and inspect the Reagent Cartridge Foil Package.
2. Open the plastic wrap of the capillary holder by tearing the wrap at the serrated edge with the arrow.
3. Inspect the capillary holder for the presence of the following parts:
absorbent pad
glass capillary
latching mechanism If the capillary holder is missing any of the above parts or is damaged,
discard the capillary holder.
48 DCA Vantage Operator’s Guide
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Fill the capillary using blood from either a finger stick or venipuncture.
1
Glass Capillary
2
Absorbent Pad
3
Latching Mechanism
Figure 9 Capillary Holder
Operating the System
DCA Vantage Operator’s Guide 49
Page 50
Filling the Glass Capillary with Blood from Finger Stick
When the capillary is filled with the sample, analysis must begin within 5 minutes.
1. Hold the capillary holder at an angle.
2. Touch only the tip of the capillary to a small drop of blood on the finger until the capillary fills.
NOTE: 1 µL of blood is required to fill the capillary.
Operating the System
1
Glass Capillary Tip
Figure 10 Filling Capillary Holder with Blood from Finger Stick
Filling Glass Capillary with Blood Obtained by Venipuncture
When the capillary is filled with the sample, analysis must begin within 5 minutes.
1. Mix the sample well (by inversion or use of a tube mixer) to prevent separation of red blood cells and plasma.
2. Remove stopper from blood collection tube in such a way that a small sample of blood remains on the stopper.
3. Hold the capillary holder at an angle.
4. Touch only the tip of the capillary to the blood sample on the stopper.
NOTE: Do not attempt to fill the capillary by touching the glass capillary to
blood in a blood collection tube. Attempting to fill the capillary in this manner most often results in blood touching the capillary holder. If blood touches the capillary holder, discard the capillary holder.
50 DCA Vantage Operator’s Guide
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1
Glass Capillary Tip
2
Blood Sample
Figure 11 Filling Capillary with Blood from Venipuncture
DCA Vantage Operator’s Guide 51
Operating the System
Page 52
5. Using a lint-free tissue, carefully wipe the outside of the glass capillary.
Figure 12 Wiping Outside of the Glass Capillary
Do not allow the tissue to touch the open end of the glass capillary.
NOTE:
Contact with the open end of the capillary could result in loss of sample (by wicking into the tissue). If sample loss is obvious, discard the capillary holder. Repeat the procedure using a new capillary holder.
6. Inspect the glass capillary for the presence of bubbles. If bubbles are obvious, discard the capillary holder and repeat the
procedure using a new capillary holder.
Operating the System
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Inserting Capillary Holder into Reagent Cartridge
CAUTION
Avoid harsh insertion of the capillary holder into the cartridge. Do not dislodge the sample from the glass capillary or erroneous results may occur.
After filling the capillary, carefully insert the capillary holder into the reagent cartridge until the holder gently snaps into place.
Operating the System
1
Glass Capillary
2
Reagent Cartridge
Figure 13 Inserting Capillary Holder into a Reagent Cartridge
DCA Vantage Operator’s Guide 53
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Scanning the Reagent Cartridge
Before a lot of Reagent Cartridges can be used on the system, the Calibration Card for the lot must be scanned. If a Reagent Cartridge is scanned on the Home screen and there is no Calibration Data for the lot of Reagent Cartridges, you must scan in the Calibration Data. Scanning the Calibration Card enters information about the Reagent Cartridge Lot into the system. This screen has a 10-second time-out. Refer to Running a Control Test‚ page 90 for
more information.
CAUTION
If you have stored the reagent cartridge in a refrigerator, bring the reagent cartridge to room temperature before starting a test. Refer to the specific product insert for more information.
1. Locate the dot (on the system) next to the barcode track.
2. Locate the barcode on the reagent cartridge.
3. Hold the reagent cartridge so that the barcode faces to the right.
4. Insert the reagent cartridge (above dot) into the barcode track.
Operating the System
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5. Smoothly, slide the reagent cartridge down. A beep sounds to signal a successful scan.
NOTE: If no beep sounds, repeat procedure. If a beep repeatedly fails to
sound, refer to Troubleshooting‚ page 121.
Operating the System
1
Barcode track dot
Figure 14 Scanning the Reagent Cartridge
DCA Vantage Operator’s Guide 55
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Inserting the Reagent Cartridge into the System
1. Open the cartridge compartment door.
2. Hold the reagent cartridge so that the barcode faces to the right.
3. Insert the reagent cartridge into the cartridge compartment until a gentle click is heard or felt.
NOTE: The cartridge is designed to fit only one way into the system. Do not
force the cartridge into system.
Operating the System
Figure 15 Inserting the Reagent Cartridge into the Cartridge Compartment
4. Using a smooth, slow, continuous motion, pull the flexible pull-tab completely out of the reagent cartridge.
5. Close the door and dispose of the flexible pull-tab. Five seconds after the door is closed, a beep sounds and the assay
begins.
NOTE: If you accidentally close the door before you pull the flexible plastic tab,
you have 5 seconds to reopen the door and pull the tab.
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Entering Patient Sample Data

The Sample Data screen displays when the system detects that the system door is closed. The appearance of this screen after the 5-second delay, indicates that a test is in progress.
NOTE: You can enter data during the test only if you have configured the
system to enable data entry. You can enter the following sample demographic information using the
touchscreen or external barcode reader:
Sample ID
Patient ID
Last Name
•First Name
Comment 1–8
Operator ID

Entering Patient Information Using the Tou chscreen

1. Select Sample ID.
2. Enter the
3. Select The Sample ID displays next to the Sample ID button.
4. Select
5. Enter the
6. Select Enter. The Patient ID displays next to the Patient ID button.
7. Select
8. Select
9. Select
10. Select The Operator ID is pre-populated (and read-only) if the system is in
Restricted Plus mode or Fully Restricted mode.
NOTE: If GFR is enabled, you can calculate the GFR.
Sample ID.
Enter.
Patient ID.
Patient ID.
Last Name. First Name. Comments 1–8. Operator ID.
Operating the System

Rules for Entering Patient Data Using the Barcode Reader

The following rules apply to data entered by the external barcode reader:
You can enter and display the following characters: A–Z, a–z, 0–9, space, and punctuation characters. The system accepts the following punctuation characters: ! " # $ & ' ( ) * + , - . / : ; < = > ? @ [ \ ] ^ _ ` { | } ~
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NOTE: The percent sign (%) is valid only on Recall Search screens, where
it is used as a wildcard character in the search.
When creating barcodes, use only the characters that are allowed for the corresponding input fields.
The system accepts data input of user-entered information from user-supplied barcodes read on the external barcode reader for the following Operator Management screen fields for adding or editing:
Operator ID
Access Code
A search to recall the samples associated with the data entered by barcode is not case sensitive.
The system accepts data input of user-entered information from user supplied barcodes read on the external barcode reader whenever a user is prompted to enter an Access Code.
The barcode symbols, and the labels themselves, must meet certain specifications, detailed below:
Number of Characters: 1–24 data characters. (A maximum of 24 characters
can be displayed, stored, printed, and transmitted by the DCA Vantage system.)
The Interleaved 2 of 5 (I2of5) symbology requires an even number of characters. If a scanned barcode has an odd number of characters, the symbology adds a leading zero, up to the maximum of 24 characters. For example, 1 becomes 01.
Narrow Bar Width: 0.15–0.51 mm (0.006–0.02 inches). It is better to be closer
to the upper limit (0.51 mm/0.02 inches), as long as the entire barcode can be contained within the maximum length.
Operating the System
This measurement affects both the symbol length and how far away from the label you can hold the handheld reader. If the narrow bar width is at the minimum, the symbol length can be no greater than 90 mm (3.5 inches), including quiet zones, and the reader can be held no more than 75 mm (3 inches) away.
Narrow to Wide Ratio: Must be within the specifications for the format being
used. This is generally 2.0–3.0.
Symbol Length: Variable. See Narrow Bar Width for more information. Quiet Zone: Minimum of 10 times the narrow bar width at each end of the
symbol.
Symbol Height: Minimum of 10 mm (0.40 inches). Total Size of Label: May be greater than the size of the symbol to allow for
printing of human readable information. Printing of the specimen ID number in alphanumeric digits is strongly recommended.
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Symbol grade: Minimum grade of “C” as defined by ANSI X3.182-1990
(available from American National Standards Institute, 1430 Broadway, New York, NY 10018).
Wavelength of Light: 630 nm (visible red LED).

Entering Patient Data Using the Barcode Reader

When the Sample Data screen displays, you can use the external barcode reader to scan the patient barcodes in each selection to add the patient data (First Name, Last Name, Patient ID, Sample ID, Operator ID, Access code (if required), and Comments).
1. Select Sample ID.
2. Scan the Sample ID barcode. The Sample ID displays next to the Sample ID button when the scan
completes.
3. Select
4. Scan the Patient ID barcode.
5. Continue selecting the Sample Data fields (First Name, Last Name,
Patient ID.
The Patient ID displays next to the Patient ID button when the scan completes.
Operator ID, Comments), and scanning the barcodes to enter the information.
NOTE: The Operator ID is pre-populated (and read-only) if the system is in
Restricted Plus mode or Fully Restricted mode.
Operating the System
Cancelling a test
Y ou can cancel a test anytime.While a test is running, a display shows the time remaining and a Cancel button. If a test in progress is cancelled, you must discard the sample.
To cancel a test, select Cancel.

Displaying, Printing, and Sending Results

The Result screen displays when the system finishes analyzing the sample. This screen displays result values and demographics for each test. You can edit the sample demographics and comments at the Sample Data screen, and you can print the result.
If you have enabled automatic printing, the test result prints automatically as soon as the test result displays. If you edit the data, you must manually select Print if you want a printed record of the change.
To print manually, select printer is disabled in Setup, or there is no paper.
DCA Vantage Operator’s Guide 59
Print. If the print button is not enabled, then the
Page 60
If you select the Full Report option, all of the information that displays on the screen prints in the report.
If you select the Short Report option, a subset of the displayed information prints in the report.
If you have enabled Auto Send, the system sends the test results automatically to the LIS as soon as the test has completed. If you enter or modify the patient demographic data, the system automatically saves the changes and sends the test results to the LIS when you select
Next on the Edi t
User Data screen.

HbA1c Test Results

Operating the System
The system displays the following information for each patient HbA
1c
test.
You have to enable some of the data entries in System Settings. For more information, see Setting Patient Data Entry‚ page 151.
Result Description
System Serial Number
Test Name
The serial number of the DCA Vantage system.
The type of test, either Microalbumin/ Creatinine test or HbA
1c
test.
Sample Sequence Number The sample sequence number. Transmission Status The transmission status of the record. Cartridge Lot Number The lot number of the cartridge.
Test Cartridge Scan Date and Time
Sample ID
Patient ID
Patient Last Name
Patient First Name
Operator ID
Comment 1–8
The date and time the test cartridge was scanned.
The sample ID, if you entered one into the system.
The patient ID, if you entered one into the system.
The last name of the patient, if you entered one into the system.
The first name of the patient, if you entered one into the system.
The Operator ID, if you entered one into the system.
Any comments you entered regarding the patient.
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Result Description
The GFR calculated measurement Glomerular Filtration Rate (GFR) and input data items
based upon data input. The GFR is
displayed if calculated. Refer to
Configuring GFR for a Patient‚ page 81. HbA
% The percentage of HbA1c.
1c
Primary and Secondary Reporting Units)
User correction slope and offset
The primary and secondary (if selected)
HbA
Reporting Units names display.
1c
The user correction slope and offset if
one is applied to HbA
.
1c
For information about printing reports, see Printed Reports‚ page 183.
Result Details
The HbA1c Test displays the Hemoglobin A1c in percent or the IFCC standard units of mmol/mol.
Table 4 HbA1c Reporting Range (%) (Only for NGSP Reporting Units)
Sample Type Reporting Range
Patient 2.5–14.0% Control 2.5–16.0%
The test is linear throughout the range. A result preceded by a less than (<) sign in the display indicates that the
concentration is below the lower limit of the test, that is < 2.5%. A result preceded by a greater than (>) sign in the display indicates that the
concentration is above the upper limit of the test, that is > 14.0% for patient samples and > 16.0% for control samples.
If you set the Reference Range for the HbA1c Patient Test at 3.5% to 12%, a value of 3.2% is displayed as "3.2% -" showing that it is within the Reporting
Range but below the Reference Range. Similarly a value of 12.5% is displayed as "12.5% +" showing that it is within the Reporting Range but above the Reference Range. A value of 5.2% is displayed as "5.2%" because it is within both the Reference and Reporting Ranges.
Operating the System
Result Details Using Single or Dual Reporting Units
You can display and print the HbA
results in single or dual reporting units.
1c
For example, the system can report test results in IFCC standard or NGSP units, or both.
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A supervisor (that is, a Level 1 operator) can designate the required primary and optional secondary HbA
reporting units for printing data. Based on this
1c
setting, the system displays the appropriate primary, and optional secondary
reporting units. See Designating the Primary and Secondary HbA1c
HbA
1c
Reporting Units‚ page 153.
NOTE: You can print, enter, or edit the sample da ta while the results are
displayed.

Removing the Reagent Cartridge

When the tests are complete, remove the reagent cartridge from the system.
1. Open the cartridge compartment door.
2. Locate the button on the right side of the cartridge compartment.
3. Push and hold it down with your right hand.
4. With your left hand, gently push the tab on the cartridge to the right. This action releases (unlocks) the cartridge.
Operating the System
1
Reagent Cartridge
2
Release Button
Figure 16 Removing the Reagent Cartridge
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5. Pull the reagent cartridge out of the compartment.
CAUTION
When handling the reagent cartridge, do not force the removal of the cartridge. This can cause physical injury to you and damage to the system.
6. Close the system door.
7. Discard the cartridge in a proper container, according to your standard laboratory procedures.

Microalbumin/Creatinine Test

The following sections explain the test sequence for a Microalbumin/ Creatinine test.
Preparing Patient Samples and Controls for the Microalbumin/Creatinine Test
Materials Required:
DCA Systems Microalbumin/Creatinine Reagent Kit (For use with the DCA V antage system)
•patient sample
Creatinine Control Kit or other control
lint-free tissue
For information on preparing controls, refer to Quality Control‚ page 87. For information on calibrating, refer to Calibrating for Microalbumin/Creatinine
page 85.
Operating the System
Performing a DCA Microalbumin/Creatinine Test
BIOHAZARD
Wear personal protective equipment, including safety glasses and gloves. Use universal precautions. Refer to Safety Information‚ page 167 for recommended precautions when working with biohazardous materials.
You can save unused capillary holders and use them with any lot of DCA Systems Microalbumin/Creatinine reagent cartridges.
1. Open and inspect the contents of the Reagent Cartridge foil package. Refer to Opening and Inspecting the Reagent Foil Package‚ page 45.
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2. Remove a capillary holder and a plunger from the plastic bag.
3. Inspect the capillary holder for the presence of the parts. Refer to Figure 17.
1
Glass Capillary
2
Starch Plug
3
Absorbent Material
4
Plunger
Figure 17 Capillary Holder
If the capillary holder is missing any of the above parts or parts are damaged, discard the capillary holder; also discard it if the starch plug is at the bottom of the capillary tube.
Operating the System
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Filling the Capillary Tube with Urine from a Container with a Large Sample Volume
If the urine sample was refrigerated, allow the sample to come to room temperature before running any tests. Mix the urine specimen thoroughly before use.
1. Immerse the tip of the capillary tube in the thoroughly mixed urine sample.
2. Allow enough time for the urine sample to flow into the capillary tube and come in contact with the starch plug, approximately 5 seconds.
Wetting the starch plug seals the capillary tube and keeps the urine within the tube.
3. Remove the capillary tube from the urine sample. If the urine flows back down the tube, reimmerse the capillary tube in the
urine sample again, and allow enough time to ensure that the starch plug becomes saturated.
4. Using a lint-free tissue, carefully wipe the outside the capillary tube.
Operating the System
1
Starch Plug
Figure 18 Filling the Capillary with Urine
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Filling the Capillary Tube with Urine from a Container with a Small Sample Volume
If the urine sample was refrigerated, allow the sample to come to room temperature before running any tests. Mix the urine specimen thoroughly before use.
1. Immerse the tip of the capillary tube in the thoroughly mixed urine sample.
NOTE: 40 µL is required to fill the capillary.
2. Tilt the sample container and the capillary holder to a more horizontal position to increase the rate of flow into the capillary.
Take care not to spill the urine sample.
3. Allow enough time for the urine specimen to flow into the capillary tube and come in contact with the starch plug.
Wetting the starch plug seals the capillary tube and keeps the urine within the tube.
4. Remove the capillary tube from the urine specimen. If the urine flows back down the tube, r-immerse the capillary tube in the
urine specimen again, and allow enough time to ensure that the starch plug becomes saturated.
5. Using a lint-free tissue, carefully wipe the outside of the glass capillary tube.
Operating the System
Figure 19 Wiping the Outside of the Glass Capillary Tube
Do not allow the tissue to touch the open end of the glass capillary.
NOTE:
Contact with the open end of the capillary tube could result in loss of sample (by wicking into the tissue). If sample loss is obvious, discard the capillary holder; then repeat the procedure using a new capillary holder.
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6. Inspect the glass capillary tube for the presence of bubbles. If bubbles are obvious, discard the capillary holder; then repeat the
procedure using a new capillary holder.
Operating the System
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Inserting the Capillary Holder into Reagent Cartridge
1. Carefully insert the capillary holder into the reagent cartridge until the holder gently snaps into place.
CAUTION
Avoid harsh insertion of the capillary holder. Do not dislodge the sample from the glass capillary or erroneous results may occur.
Operating the System
1
Glass Capillary
2
Reagent Cartridge
Figure 20 Inserting the Capillary Holder into Reagent Cartridge
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Scanning the Reagent Cartridge
1. Locate the dot (on the system) next to the barcode track.
2. Locate the barcode on the reagent cartridge.
3. Hold the reagent cartridge so that the barcode faces to the right.
4. Insert the reagent cartridge (above dot) into the barcode track.
5. Smoothly, slide the reagent cartridge down.
NOTE: After a 1 second pause, a beep sounds to signal a successful scan.
If no beep sounds, repeat the procedure. If a beep repeatedly fails to sound, refer to Troubleshooting‚ page 121.
Operating the System
1
Barcode Track Dot
Figure 21 Scanning the Reagent Cartridge
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Inserting the Reagent Cartridge into System
1. Open the reagent cartridge compartment door.
2. Hold the reagent cartridge so that the barcode faces to the right.
3. Insert the reagent cartridge into the cartridge compartment until you hear a gentle snap.
NOTE: The cartridge is designed to fit only one way into the system. Do not
force the cartridge into the system.
Operating the System
Figure 22 Inserting Reagent Cartridge into System
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4. Insert the plunger into the hole at the top of capillary holder.
5. Press the plunger into the capillary holder. The plunger locks into the capillary holder.
1
Plunger
Operating the System
Figure 23 Inserting Plunger into the Capillary
6. Using a smooth, slow, continuous motion, pull the flexible pull-tab completely out of the reagent cartridge.
7. Close door and dispose of the flexible pull-tab. Five seconds after the door is closed, a beep sounds and the assay
begins.
NOTE: If you accidentally close the door before you pull the flexible tab, you
have 5 seconds to reopen the door and pull the tab. The test resumes once the door is closed.
Cancelling a test
You can cancel a test anytime. While a te st is running, a display shows the time remaining and a Cancel button. If a test in progress is cancelled, you must discard the sample.
To cancel a test, select Cancel.
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Operating the System
Results of a Microalbumin/Creatinine Test
The system displays the following information for each patient Microalbumin/ Creatinine test.
NOTE: You have to enable some of the features in System Settings for the
data to display.
Result Description
System Serial Number
Test Name
The serial number of the DCA Vantage system.
The type of test, either Microalbumin/ Creatinine test or HbA1c test.
Sample Sequence Number The sample sequence number. Transmission Status The transmission status of the record.
Sample ID
The sample ID, if you entered one into the system.
Cartridge Lot Number The lot number of the cartridge. Test Cartridge Scan Date and Time
Patient ID
Patient Last Name
Patient First Name
Operator ID
Comment 1–8
The date and time the test cartridge was scanned.
The patient ID, if you entered one into the system.
The last name of the patient, if you entered one into the system.
The first name of the patient, if you entered one into the system.
The Operator ID, if you entered one into the system.
Any comments you entered regarding the patient.
The GFR calculated measurement Glomerular Filtration Rate (GFR) and input data items
based upon data input. The GFR is
displayed if calculated. Refer to
Configuring GFR for a Patient‚ page 81. Albumin concentration results
Creatinine concentration results
The albumin concentration results
display in units of mg/L.
The creatinine concentration results
display in mg/dL or mmol/L.
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Result Description
Albumin/Creatinine ratio The Albumin/Creatinine ratio results
display in mg/g units if Creatinine units are mg/dL, or in mg/mmol if creatinine units are mmol/L.
Albumin user correction slope and offset
Creatinine user correction slope and offset
The Albumin user correction slope and offset display.
The Creatinine user correction slope and offset display.
Result Details
The Microalbumin/Creatinine test displays 3 values:
Albumin concentration
Creatinine concentration
Albumin/Creatinine ratio Both the albumin and creatinine tests are linear throughout their ranges.
NOTE: If there is an asterisk next to the result percent, this indicates that the
results were user corrected. The following table displays the reporting range for each test.
Test Reporting Range
Albumin 5–300 mg/L Creatinine 15–500 mg/dL (1.3–44.2 mmol/L) Albumin/Creatinine ratio 1–2000 mg/g (0.11 to 226 mg/mmol)
Operating the System
NOTE: If creatinine units are mg/dL, then the Albumin/Creatinine (A/C) ratio is
reported as mg/g. If the creatinine units are mmol/L, then the Albumin/ Creatinine (A/C) ratio is reported as mg/mmol.
An albumin or creatinine value preceded by a less than sign (<) in the display, indicates that the concentration is below the lower limit of the test, that is < 5 mg/L for albumin or < 15 mg/dL for creatinine.
An albumin or creatinine value preceded by a greater than sign (>) in the display, indicates that the concentration is above the upper reporting limit of the test, that is > 300 mg/L for albumin and > 500 mg/dL for creatinine.
An Albumin/Creatinine ratio preceded by a less than (<) sign or greater than (>) sign or (---) in the display, indicates that either the albumin and/or creatinine value is above or below the Reporting Range. In certain cases, no ratio is reported (---).
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Example 1: If the albumin result is > 300 mg/L and the creatinine result is 100 mg/dL (8.84 mmol/L), the ratio is reported as > 300 mg/g (> 33.9 mg/mmol).
Example 2: If the albumin result is 75 mg/L and the creatinine result is < 15 mg/dL (< 1.33 mmol/L), the ratio is reported as > 500 mg/g (> 56.4 mg/mmol).
Example 3: if the albumin result is > 300 mg/L and the creatinine result is > 500 mg/dL (> 44.2 mmol/L), no ratio is reported (---).
Example 4: if the albumin result is < 5 mg/L and the creatinine result is < 15 mg/dL (< 1.33 mmol/L), no ratio is reported (---).
As with HbA1c Patient Tests, you can configure Reference Ranges for Albumin and Creatinine concentrations and the Albumin/Creatinine ratio for Patient
Tests. Values above or below the Reference Range limits, but within the Reporting, are followed by the applicable plus (+) or minus (-) sign.
NOTE: You can print, enter, or edit the sample da ta while the results are
displayed. For information about printing a report of patient microalb umin/creatinine test
results, see Displaying, Printing, and Sending Results‚ page 59. For a summary of the contents of full and short patient reports, see Patient
Test Report Contents‚ page 183.
Removing the Reagent Cartridge
When the test is complete, remove the reagent cartridge from the system.
Operating the System
CAUTION
When handling the reagent cartridge, do not force the removal of the cartridge. This can cause physical injury to you and damage to the system.
1. Open the cartridge compartment door.
2. Locate the button on the right side of the cartridge compartment.
3. Push and hold it down with your right hand.
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4. With your left hand, gently push the tab on the cartridge to the right. This action releases (unlocks) cartridge.
1
Reagent Cartridge
2
Release Button
Figure 24 Removing the Reagent Cartridge
5. Pull the cartridge out of compartment.
6. Close the system door.
7. Discard the cartridge in a proper container, according to your standard laboratory procedures.
Operating the System

Recalling Patient Data, Control Tests, and Calibration Data

Use the Recall Menu to access patient tests, control tests, and calibration data. You can restrict edit and delete functionality in the Recall menu in System Settings. Refer to Customizing the System‚ page 151.
The Enter Access Code screen displays when you attempt to access the Recall Menu if system access is set to Fully Restricted in System Settings. If System Access is set to Unrestricted, Restricted, or Restricted Plus, this screen does not display.
NOTE: The default security setting is set to Off so that an access code is not required
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Page 76

Recalling Patient Tests

Use the Patient Tests menu to access data for HbA1c or Microalbumin/ Creatinine test, or to export data to an external storage device via the USB
port.
NOTE: If there is an asterisk next to the result percent, this indicates that the
results were user corrected.
Viewing the Last 10 Patient Tests
Operating the System
Use the View Last 10 patient test screens for HbA
and Microalbumin/
1c
Creatinine to view the last 10 test results performed at the system. The sort order starts with the most recent test performed.
1. From the Home screen, select
2. From the Recall menu, select
Recall.
Patient T ests.
3. Select one of the following types of patient tests:
To view HbA
patient test results, select HbA1c.
1c
To view microalbumin/creatinine patient test results, select
Microalbumin/Creatinine.
4. Select View Last 10. The last 10 patient tests display.
You can delete patient tests at this screen by performing the following steps:
1. While viewing the patient tests, select a test. The patient test is highlighted.
2. Select
Delete.
A message displays verifying that you want to delete the patient test result.
3. Select
OK.
4. Delete all of the last 10 patient tests, if needed: a. Select
Delete All.
A message displays verifying that you want to delete all of the last 10 patient tests.
b. Select
OK.
Searching for a Patient ID or Name
Use the Patient ID/Name screen to search by either patient ID number or name.
NOTE: To use the search feature, this option is configured in System Settings,
Additional Settings.
1. From the Home screen, select Recall.
2. From the Recall menu, select
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Patient T ests.
Page 77
3. Search for one of the following:
To search for patient ID or name for an HbA1c patient test result, select
HbA1c.
To search for patient ID or name for a microalbumin/creatinine patient test result, select Microalbumin/Creatinine.
4. Select Patient ID/Name.
5. Enter the patient ID or patient name that you want to find with the keypad or external barcode reader.
Use the percent (%) character as the wildcard for searching.
6. Select
Next.
The search results display.
7. Delete a patient test, if needed: a. Select the test. b. Select
Delete.
A message displays verifying that you want to delete the patient test result.
c. Select
OK.
8. Delete all of the patient tests, if needed: a. Select
Delete All.
A message displays verifying that you want to delete all the patient tests.
NOTE: Only the tests that are recalled in the search are deleted.
b. Select
OK.
Operating the System
Searching for a Specific Comment
Use the Comment 1 screen to search for a specific comment.
1. At the Home screen, select
2. From the Recall menu, select
Recall.
Patient T ests.
3. Search for one of the following:
T o search for a specific comment for an HbA
HbA1c.
patient test result, select
1c
To search for a specific comment for a microalbumin/creatinine patient
test result, select Microalbumin/Creatinine.
4. Select
Comment 1.
5. Enter the comment using the keypad or external barcode reader.
6. Select
Next.
The search results display.
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Operating the System
Searching within a Specific Date Range
Use the Start Date and End Date screens to set the start and end dates when you want to search by a specific date range.
1. At the Home screen, select
2. From the Recall menu, select
Recall.
Patient T ests.
3. Search for one of the following:
To search within a specific date range for an HbA
HbA1c.
select
patient test result,
1c
To search within a specific date range for a microalbumin/creatinine patient test result, select Microalbumin/Creatinine.
4. Select Date Range. The Start Date screen displays.
5. Use the up and down arrows to select the Month, Day, and Year.
6. Select
Next.
The End Date screen displays.
7. Use the up and down arrows to select the Month, Day, and Year.
8. Select
Next.
The search results display.
To delete a patient test from the date range results:
1. Highlight the test.
2. Select
Delete.
A message displays verifying that you want to delete the patient tests.
3. Select
4. To delete all the patient tests select
OK.
Delete All.
A message displays verifying that you want to delete all the patient tests.
NOTE: Only the tests that are recalled in the search are deleted.
5. Select OK.
Searching by Result Range
Use the Set Lower Limit screen to set the lower HbA1c value when you search by result range.
1. At the Home screen, select Recall.
2. From the Recall menu, select
The HbA
HbA1c.
Patient Test screen displays.
1c
3. Select
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Patient T ests.
Page 79
4. Select Result Range. The Lower Limit screen displays.
5. Use the up and down arrows to set a HbA
NOTE: For NGSP only, the lower limit cannot be lower than 2.0%.
6. Select
Next.
value.
1c
The search results display.
Viewing the H bA1c Results in Graph Format
You can view the HbA
test results in a graph format. You can search by
1c
patient ID and then narrow the search by using a date range.
NOTE: Recalled results and trend graphs adapt to your configured Reporting
Units, Patient Reference Range, and User Corrections.
1. At the Home screen, select
2. From the Recall menu, select
The HbA
HbA1c.
Patient test List screen displays.
1c
Graph.
3. Select
4. Select
Recall.
Patient T ests.
5. Use the keypad or external barcode reader to enter a Patient ID.
6. Select
Next.
All HbA1c results that match the patient ID are graphed.
7. To change the graph date range, select
8. To print the graph to an external printer, select
NOTE: The internal printer does not support printing graphs.
Change.
Print.
Viewing Patient Test Results
Use the Patient T est Result screen to view information about a specific patient.
1. At the Home screen, select
2. From the Recall menu, select
Recall.
Patient T ests.
3. Select one of the following:
To view patient results for an HbA
patient test result, select HbA1c.
1c
To view patient results for an microalbumin/creatinine patient test
result, select Microalbumin/Creatinine.
4. Select View Last 10.
NOTE: You can view patient results from any search finding.
Operating the System
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Operating the System
5. At the Last 10 HbA1c or A/C patient tests screen, select the patient and
View.
select The Patient Test Result screen displays.
6. To print a copy of the patient results, select
7. To send the data to an LIS or computer, select
NOTE:
When recalling any type of results, Auto Send does not
Print.
Send.
automatically send the data to the LIS. You must select Send to transmit the record.
8. To edit the patient test results, select Edit.
Editing Patient Data
You can recall patient data to enter new data or edit previously entered data.
1. At the Home screen, select
2. Select
Patient Tests.
Recall.
3. Select the test and the patient record.
4. Select Edit. The Edit button is available only if at least one patient demographic setting
option is enabled (including GFR).
NOTE: If you are using the I2of5 barcode, scan the provided I2of5 barcode
before entering or editing any data.
5. To enter new patient data in the recall mode, select the desired patient data button.
6. Edit the data using the keyp ad or sca n data using the barcode. The selected patient data field populates.
7. To edit previously entered patient data, select the desired patient data button.
8. To erase previously entered data, select
9. Scan the desired barcode information, then select
CE.
Enter.
Selecting a Printer
If both the onboard and external printer are enabled, use the Printer Selection screen to select the printer.
NOTE: This screen displays only when both printers are configured and ready
to print.
1. At the Patient Test Result screen, select Print. The Printer Selection screen displays.
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2. Select one of the following printer options:
Onboard Printer
External Printer
3. To print the patient test results, select The patient test results print.
Configuring GFR for a Patient
The Glomerular Filtration Rate (GFR) describes the flow rate of filtered fluid through the kidney. While running a patient test, the Sample Data Entry screen displays. Use the GFR screen from the Sample Data Entry screen to enter patient data including age, race, gender, and plasma creatine to calculate the GFR for the patient.
1. At the Sample Data Entry screen, select GFR.
2. Enter the following data, which calculates the GFR for the patient: a. Select the 2-digit age value for the patient.
The patient age range is between 18 and 70. b. Select c. Select the Gender of the patient. d. Select e. Select the Race of the patient. f. Select g. Select the Plasma Creatinine value. h. Select
Next.
Next.
Next.
Next.
The GFR Calculation results screen displays the GFR value calculated
from the information entered at the GFR calculation screen.
Print.
Operating the System

Reports

Patient Test Reports

Patient T est Report s contain the results of HbA1c and Microalbumin/Creatinine tests that you generate during analysis and display at the results screen. You
can generate printed reports at analysis time and when print requests are issued at Data Recall. You can also generate a printed report when you perform a Demonstrated Patient Test.

Report Components

You can specify whether to print a long or a short report of the patient test results. For a summary of the contents of patient test printed reports, see Printed Reports‚ page 183. Regardless of the printed report type setting, the system transmits the long-form report.
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Patient Trend Graph Report

The printed Patient Trend Graph Report prints from the Data Recall menu to an external printer. To print a graph, you must have an external printer connected to the DCA Vantage system. For a description of the contents of this report, see Patient Trend Graph Report Contents‚ page 185.

Control Test Report

The Control Test Report prints the results for Control Tests generated during analysis, and displays at the Results screen. For a description of the contents of this report, see Control Test Report‚ page 186.
NOTE: The patient printed test report has no effect on the Control Test Report.

Calibration Data Report

The Calibration Data Report prints the results generated when the HbA1c and Microalbumin/Creatinine cards are scanned into the system. The report prints
the lot number, date and time that the calibration cards were scanned. The printed reports for a single cartridge scan are generated when you select print when you scan. Calibration Data Reports for all the calibration data stored on the system print when a request is issued at Data Recall.
NOTE: Select Print after scanning the calibration card to print the calibration
data report.

Viewing and Printing System Settings Reports

The View System Settings option lets you display and print a partial list of the configuration settings for the system. The printed partial System Settings Report contains the same subset of the system settings that appears on the View System Settings screen.
Operating the System
From the Additional Settings screen, you can print a full System Settings Report by selecting report contains all of the configuration settings for the system.
For a list of the contents of the full and short System Settings Report, see
System Settings Report‚ page 188.
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Print at the bottom of the screen. The full System Settings
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4 Calibration

Overview

The DCA Vantage system is calibrated by the manufacturer and every time the calibration card is scanned. The instrument automatically self-adjusts during first-time power-up and during each assay.
Values for reagent calibration parameters are encoded on the calibration card provided with each of the reagent cartridges. Scan the calibration barcode before using the reagent cartridges. The DCA Vantage system stores 16 distinct calibrations for the DCA Vantage Hemoglobin A
Creatinine Assay. Each calibration is for a different lot. Scan the lot number and test name before you analyze the sample reagent cartridge barcode. This allows access to the appropriate calibration parameter values and calibration curve for the particular lot of reagent in use.
NOTE: If you do not scan the calibration curve into the system for the particular
lot number of cartridges that are in use, the system software prompts you to scan the calibration card.
and Microalbumin/
1c
Calibrating for Hemoglobin A
You must scan the calibration card for a lot of reagent cartridges befo re you can use the lot on the DCA Vantage system. Scanning the calibration card enters the information on the DCA Vantage system.
1. Locate the dot on the system next to the barcode track.
2. Locate the barcode on the calibration card.
3. Hold the card so that the barcode faces to the right.
4. Insert the Calibration card into the top of the barcode track.
1c
Calibration
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5. Hold the Calibration card gently against the right side of the track and smoothly slide the card down.
A beep sounds to signal a successful scan.
NOTE: If no beep sounds, repeat the scanning procedure. If you
repeatedly fail to hear a beep, refer to Troubleshooting‚ page 121.
1 Figure 25 Scanning Hemoglobin A1c calibration card
6. To return to the Home screen, select OK.
Calibration
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Barcode track dot
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Calibrating for Microalbumin/Creatinine

The calibration card for the Microalbumin/Creatinine reagent cartridges has data on 2 sides. You must scan both sides of the calibration card for the lot of reagent cartridges before you can use the reagent cartridges on the DCA V antage system.
1. Locate the dot on next to the barcode track.
2. Locate the barcode on one side of the Calibration card.
3. Hold the card so that the barcode faces to the right.
4. Insert the calibration card into the top of the barcode track.
Figure 26 Scanning the Microalbumin/Creatinine calibration card
5. Hold the calibration card gently against the right side of the track and smoothly slide the card down.
A beep sounds to signal a successful scan. If no beep sounds, repeat the scanning procedure. If you repeatedly fail to
hear a beep, refer to Troubleshooting‚ page 121.
6. Locate the barcode on the second side of the calibration card.
7. Repeat steps 3–5.
8. To return to the Home screen, select
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OK.
Calibration
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Calibration Data

Use the Calibration Data screen to access calibration data including scan date and time, and lot number for DCA HbA
Viewing Calibration Data Display
1. At the Home screen, select Recall.
2. At the Recall menu, select
Calibration Data.
3. Select one of the following options:
a. HbA1c
The HbA1c calibration data displays.
b. Microalbumin/Creatinine
The Microalbumin/Creatinine calibration data displays.
4. Highlight the calibration data that you want to display, and select
5. To print the calibration data, select
6. To return to the Recall menu, select
or Microalbumin/Creatinine.
1c
Print.
Recall.
View.
Calibration
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5 Quality Control

Run controls according to your laboratory’s accrediting agency. Quality Control (QC) testing ensures that the reagent cartridges are reacting and being read correctly. Quality control testing also detect errors resulting from user techniques. Refer to your laboratory quality assurance program to ensure quality throughout the entire testing process. Follow the manufacturer’s storage and handling instructions for quality control material. Improper storage and handling of control materials can cause erroneous results. Refer to the control material package insert for proper handling instructions.
Run controls under the following conditions:
at regular intervals determined by the laboratory procedures
when using a new shipment of reagents
when using a new lot number of reagent
each time a calibration card is scanned
whenever test results are in doubt
when training new operators
All control results must be within the acceptable range before any patient sample is tested and the results are reported. If a control result is out of range, troubleshoot the system, correct any problems identified, and run the controls again. When control results are within range, you can test and report on patient samples.
For information about ordering control kits, refer to Appendix C, Orderable Supplies.
Quality Control
Quality Control

Collecting Control Specimens

Use the following procedure to collect control specimens:
NOTE: Prepare the controls according to the manufacturer’s instructions.
1. Remove and unwrap the capillary holder from the Reagent Kit.
2. Mix the sample well by inversion or using a tube mixer.
3. Open the control bottle.
NOTE: Avoid introducing air bubbles into the sample.
4. While applying pressure to the bulb of the dropper (found in the control kit), insert the tip of the dropper into the control solution.
5. Release the pressure on the bulb to aspirate a small amount of control solution.
6. Fill the glass capillary tube by touching it to the tip of the dropper and fill the tube.
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NOTE: Touch only the tip of the capillary tube to the control material. If an air
bubble is present in the filled tube, discard the capillary holder and fill a new one.
Quality Control
7. Squeeze any excess control material out of the dropper into the control bottle.
8. Close the control bottle.
9. Wipe any control solution off the sides of the glass capillary tube using a lint-free tissue.
10. Inspect the capillary holder for the presence of any bubbles.
NOTE: If bubbles are obvious, discard the capillary and repeat the collecting
procedure.
CAUTION
Prevent the control material from coming in contact with the plastic part of the capillary holder. If control material comes in contact with the capillary holder, discard the capillary holder.
CAUTION
Do not touch the tissue to the open end of the tube. Contact with the open end could result in a loss of sample.
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Inserting Capillary Holder into the Reagent Cartridge

1. Place the capillary holder in the correct position to insert it into the reagent cartridge.
2. Insert the capillary holder into the reagent cartridge until the holder gently snaps into place.
CAUTION
Avoid harsh insertion of capillary holder. Do not dislodge the sample in the glass capillary because erroneous results may occur.
Quality Control
Quality Control
Figure 27 1
Capillary holder
2
Reagent cartridge
Figure 28 Inserting Capillary Holder into Reagent Cartridge
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Running a Control Test

1. Ensure you are at the Home screen. You must start the control test from the Home screen; otherwise the
system does not recognize that a QC test is being run. The system will not save data to memory or prompt that a QC test due (if reminder is set).
2. Locate the control card.
NOTE: One side of the control card is for a normal control and the other
Quality Control
side is for an abnormal control.
3. Locate the dot on the system next to the barcode track.
4. Locate the barcode on the Control card.
5. Hold the card so that the barcode faces to the right.
6. Insert the Control card into the top of the barcode track.
7. Hold the Control card gently against the right side of the track and smoothly slide the card down.
1
Barcode track dot
Figure 29 Scanning the HbA1c Control Card
A beep sounds to signal a successful scan.
NOTE: If no beep sounds, repeat the scanning procedure. If you
repeatedly fail to hear a beep, refer to Troubleshooting‚ page 121.
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To scan the reagent cartridge, refer to Scanning the Reagent Cartridge‚ page 54.
To insert the reagent cartridge, refer to Inserting the Reagent Cartridge into the System‚ page 56.
1
Barcode track dot
Quality Control
Quality Control
Figure 30 Scanning the Microalbumin/Creatinine Control Card

Quality Control Errors

If the control results fall outside the values stated in the package insert, the following sources of error may have occurred:
Possible Cause Corrective Action
Deterioration of the reagent cartridge test areas due to exposure to light, ambient moisture, or heat.
Deterioration of the control solution.
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Use a new reagent cartridge to repeat the quality control procedure.
Use a fresh box of reagent cartridges, or a new lot. If the new reagent cartridge fails to give results within the
expected values, proceed to the next possible cause. Use a fresh control solution to repeat the quality control
procedure.
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Setting a Required QC Reminder or Displaying a QC Reminder for New Reagent Lots

The DCA Vantage system can display a reminder message when a QC test is due. Y ou can set the QC test reminder message to display only or display and require a QC test for selected control tests each time a patient test is run.
If you set the system to require a QC, you must run and pass the QC test before you can continue with patient tests.
Quality Control
Setting a QC Reminder
1. At the Home screen, select Menu.
2. Select
3. Select
4. Select
5. Select At the New Lots Reminders screen, checkboxes labeled Enabled and
Required display for each of the following control tests:
•HbA1c Normal
•HbA1c Abnormal
A/C Low
A/C High
6. T o activate a QC reminder for the selected reagent test, select the Enabled checkbox.
Do not check the Required checkbox.
Repeat step 6 for any additional tests, as needed.
7. Select
8. The next time you scan a cartridge to begin a patient test, the following occurs:
If you activated a reminder, the system checks to see if a QC test is
System Settings. Additional Settings. Control Tests. New Lot Reminders.
Save.
needed. If so, a reminder message displays prompting you to perform a QC test.
New Lot Reminder
When the new lot reminder feature is set to required, you must perform QC before you can use reagent cartridges from that new lot. You may still use a reagent cartridge from an existing lot to run patient tests.
When the new lot reminder feature is only set to enabled, then the system issues you a warning message to perform QC on the new reagent cartridge lot, but the system allows you to use the new lot with or without the QC and any existing lots.
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Setting a Required QC Reminder
1. At the Home screen, select
2. Select
3. Select
4. Select
5. Select
System Settings. Additional Settings. Control Tests. New Lot Reminders.
Menu.
At the New Lots Reminders screen, checkboxes labeled Enabled and Required display for each of the following control tests:
•HbA1c Normal
•HbA1c Abnormal
A/C Low
A/C High
6. To activate a Required QC reminder for the selected reagent test, select the Enabled checkbox and Required checkbox.
The Enabled checkbox must be selected before the Required checkbox.
Repeat step 6 for any additional tests, as needed.
7. Select Save.
8. The next time a patient test cartridge is scanned, the following occurs:
The system checks to see if a record of the Required QC was run. If a
record is found, the patient test is run.
If the system does not find a record, a message displays requiring you
to perform a QC and the patient test is stopped.
NOTE: You cannot run the selected test until the required QC is performed.
Quality Control
Quality Control
Customized QC Reminders
You can specify the QC reminder cycle in days. The available range is 7 to 60 days. This enables you to define a reminder cycle that supports variable site requirements. You also can select daily, weekly, or monthly QC reminder cycles.
To customize QC Reminders:
1. At the Home screen, select
2. Select
3. Select
4. Select
5. Select
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System Settings. Additional Settings. Control Tests. Control Test Reminder.
Menu.
Page 94
6. At the Control Test Reminder screen, select 1 of the following:
•HbA1c Normal
•HbA1c Abnormal
A/C Low
A/C High Once selected, the Schedule button to the right of the control test selected
becomes active.
7. Select
8. Select
9. Select
10. Select
Schedule for the selected test. Change. Optional or Required, and then select Next. Custom.
A screen displays that enables you to select a number between 7 and 60 by pressing up or down arrow keys. The selected number displays above the arrow keys. The default value is 14.
Both up and down arrow keys cycle continuously through the 7 to 60 number range. For example, if 7 displays, pressing the down arrow key displays 60. Press the down arrow again to display 59, then 58, and so on.
11. Press an arrow key until the number you want displays.
12. Select
Next.
13. Select the time in hours and minutes, using the arrow keys.
14. Select
15. Select
AM or PM. Next.
The Settings screen displays. Verify the settings you entered are correct. If a setting is incorrect, select
16. Select
Save.
Change, and update the settings, as needed.
The Control Test Reminders screen displays.
17. Repeat steps 6 to 16 to set additional QC reminders, as needed.
Quality Control
Quality Control
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6 Maintenance

Routine Cleaning

Maintenance Schedule

Weekly
Cleaning the Onboard Barcode Reader Window Cleaning the Exterior
Quarterly
Removing and Cleaning the Cartridge Spring and Cartridge Area Changing the Air Filter Optical Test
As Needed
Cleaning the Exterior Changing the Air Filter Removing and Cleaning the Cartridge Spring and Cartridge Area Cleaning the Onboard Barcode Reader Window Optical Test Calibrating the Touchscreen Replacing the Fuse
WARNING
Turn the power off and disconnect the power cord before cleaning the DCA Vantage system.

Turning Off the DCA Vantage System

Perform these steps to turn the system off:
NOTE: You do not have to reconfigure system settings when turning the power
on, the system stores the saved settings.
Maintenance
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1. At the Home screen, select Turn Off. A message displays asking if you want to shut down the system.
2. To shut down the system, select
Yes.
The system begins shutting down.
3. After shutdown completes, turn the power switch to the off position.
NOTE: Wait until shutdown completes before turning the power switch to the
off position.

Cleaning the Onboard Barcode Reader Window

WARNING
Turn the power off and disconnect the power cord before cleaning the barcode window.
Materials Required:
lint-free cloth
Maintenance
water or ethanol
1. Clean the barcode window with a lint-free cloth dampened with water or ethanol.
1
Onboard Barcode Reader
Figure 31 Cleaning the Onboard Barcode Reader Window
2. Connect the power cord after the barcode window is clean and dry.
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Cleaning the External Barcode Reader Window

To clean the external barcode reader window, follow the manufacturer’s instructions.

Cleaning the Exterior

WARNING
Turn the power off and disconnect the power cord before cleaning the exterior of the system.
CAUTION
Do not allow liquid to drip into system. If liquid drips into the system, you can damage the optics.
Materials Required:
lint-free cloth
water or ethanol
1. Clean the exterior with a lint-free cloth dampened with water or ethanol.
2. Connect the power cord after the exterior is clean and dry.
NOTE: If you want to disinfect the exterior of the system, expose the surface to
0.5% sodium hypochlorite for 10 minutes. Remove any liquid blood on the system before disinfection.
CAUTION
Do not use any other type of solvent, oil, grease, or silicone spray on any part of the system.
Maintenance
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Removing and Cleaning the Cartridge Spring and Cartridge Area

WARNING
Turn the power off and disconnect the power cord before cleaning the cartridge compartment.
CAUTION
Do not allow liquid to drip into system. If liquid drips into the system, you can damage the optics.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety Information‚ page 167, for recommended precautions when working with biohazardous materials.
Maintenance
Materials Required:
lint-free cloth
water or ethanol
paper clip or similar device
mild detergent
sponge swab
1. Ensure the power is off.
2. Open the cartridge compartment door as far as possible.
3. Wipe the inside surface of the compartment door and surfaces on both sides of the compartment using a lint-free cloth dampened with water or ethanol.
4. Dry the surface using a clean, dry, lint-free cloth.
5. Locate the cartridge return spring inside the cartridge holder.
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6. Insert the tip of a straightened paper clip (or other like device) into the top hole on the spring.
Figure 32 Return Spring in Cartridge Compartment 1
Top Hole
2
Leaf Spring
3
Bottom Hole
Maintenance
7. Gently pull the metal end towards the center of the cartridge compartment to release one side of the spring from the cartridge holder.
8. Repeat step 6 to release the other side of the spring from the cartridge holder.
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9. Pull the cartridge return spring completely out of the system.
10. Clean the cartridge return spring using any of the following items:
warm solution of mild detergent and water
lint-free cloth dampened in water or ethanol
NOTE: Ensure the leaf springs are not bent or damaged while cleaning.
Damaged leaf springs do not function properly.
Maintenance
1
Spring Cut-out
2
Leaf Springs
Figure 33 Return Spring
11. Dry the cartridge return spring with a clean, lint-free cloth.
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