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.
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.
DCA Vantage Operator’s Guide11
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Conventions
The DCA Vantage Operator’s Guide uses the following text and symbol
conventions:
ConventionDescription
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.
12DCA Vantage Operator’s Guide
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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
DCA Vantage Operator’s Guide13
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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.
14DCA Vantage Operator’s Guide
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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 Guide15
Page 16
Overview
1
External Interface Connections
2
Power Plug
3
Power Switch
Figure 2 Power and External Connections
16DCA Vantage Operator’s Guide
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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.
DCA Vantage Operator’s Guide17
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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.
1c
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.
18DCA Vantage Operator’s Guide
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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 . . .
HbA1cView Last 10see 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
1c
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
1c
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.
DCA Vantage Operator’s Guide19
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Overview
Select . . .then . . .to . . .
MicroAlbumin View Last 10see 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.
20DCA Vantage Operator’s Guide
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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
1c
DCA Vantage Operator’s Guide21
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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)
Dateset 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.
22DCA Vantage Operator’s Guide
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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
PrintersOnboard 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 Logsave 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
DCA Vantage Operator’s Guide23
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24DCA Vantage Operator’s Guide
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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
1c
Installation
DCA Vantage Operator’s Guide25
Page 26
•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.
26DCA Vantage Operator’s Guide
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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.
DCA Vantage Operator’s Guide27
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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
28DCA Vantage Operator’s Guide
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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 Guide29
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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.
30DCA Vantage Operator’s Guide
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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.
DCA Vantage Operator’s Guide31
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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.
32DCA Vantage Operator’s Guide
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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.
DCA Vantage Operator’s Guide33
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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
34DCA 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
36DCA 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.
DCA Vantage Operator’s Guide37
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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
38DCA Vantage Operator’s Guide
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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 Guide39
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40DCA 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 Guide41
Page 42
Operator IDs and Access Codes
Operating the System
Fully
Restricted
Restricted
PlusRestrictedUnrestricted
FunctionL1L2L3L1L2L3L1L2L3L1L2L3
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
42DCA Vantage Operator’s Guide
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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
DCA Vantage Operator’s Guide43
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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.
44DCA Vantage Operator’s Guide
Page 45
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 Guide45
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.
46DCA 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 Guide47
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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.
48DCA Vantage Operator’s Guide
Page 49
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 Guide49
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.
50DCA Vantage Operator’s Guide
Page 51
1
Glass Capillary Tip
2
Blood Sample
Figure 11 Filling Capillary with Blood from Venipuncture
DCA Vantage Operator’s Guide51
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
52DCA Vantage Operator’s Guide
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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 Guide53
Page 54
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
54DCA Vantage Operator’s Guide
Page 55
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 Guide55
Page 56
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.
56DCA Vantage Operator’s Guide
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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:
! " # $ & ' ( ) * + , - . / : ; < = > ? @ [ \ ] ^ _ ` { | } ~
DCA Vantage Operator’s Guide57
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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.
58DCA Vantage Operator’s Guide
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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 Guide59
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.
ResultDescription
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 NumberThe sample sequence number.
Transmission StatusThe transmission status of the record.
Cartridge Lot NumberThe 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.
60DCA Vantage Operator’s Guide
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ResultDescription
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 TypeReporting Range
Patient2.5–14.0%
Control2.5–16.0%
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
62DCA Vantage Operator’s Guide
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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.
DCA Vantage Operator’s Guide63
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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
68DCA Vantage Operator’s Guide
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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.
ResultDescription
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 NumberThe sample sequence number.
Transmission StatusThe transmission status of the record.
Sample ID
The sample ID, if you entered one into
the system.
Cartridge Lot NumberThe 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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ResultDescription
Albumin/Creatinine ratioThe 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.
TestReporting Range
Albumin5–300 mg/L
Creatinine15–500 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.
74DCA Vantage Operator’s Guide
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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
DCA Vantage Operator’s Guide75
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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
76DCA Vantage Operator’s Guide
Patient T ests.
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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
78DCA Vantage Operator’s Guide
Patient T ests.
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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
DCA Vantage Operator’s Guide79
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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.
80DCA Vantage Operator’s Guide
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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.
DCA Vantage Operator’s Guide81
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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.
82DCA Vantage Operator’s Guide
Print at the bottom of the screen. The full System Settings
Page 83
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
DCA Vantage Operator’s Guide83
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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.
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
DCA Vantage Operator’s Guide85
OK.
Calibration
Page 86
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
86DCA Vantage Operator’s Guide
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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.
88DCA Vantage Operator’s Guide
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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.
90DCA Vantage Operator’s Guide
Page 91
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 CauseCorrective Action
Deterioration of the
reagent cartridge
test areas due to
exposure to light,
ambient moisture,
or heat.
Deterioration of the
control solution.
DCA Vantage Operator’s Guide91
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.
Page 92
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.
92DCA Vantage Operator’s Guide
Page 93
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
DCA Vantage Operator’s Guide93
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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Page 95
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
DCA Vantage Operator’s Guide95
Page 96
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.
96DCA Vantage Operator’s Guide
Page 97
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
DCA Vantage Operator’s Guide97
Page 98
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.
98DCA Vantage Operator’s Guide
Page 99
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.
DCA Vantage Operator’s Guide99
Page 100
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.
100DCA Vantage Operator’s Guide
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