Kit Quality Control (Qc) Test Procedure - Walk Away Operation - BD Veritor Plus Analyzer Instrucciones De Uso

BD Veritor™ Plus Analyzer Instructions for Use
10 When the analysis is complete, the test result will be displayed with the control swab identification, the name of the test, a result, and
an overall "QC PASS" or "QC FAIL" indication. Refer to the package insert for the BD Veritor Test Device for specific result
interpretations. If a printer is connected to the unit and powered on, the test result will automatically be sent to the printer.
11 Verify that the test type and QC swab control are correct.
12 Once the test type and swab control are verified and the result noted, remove the test device by pulling it out. The display will show
INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE to indicate the Analyzer is ready to perform another
test.
13 If an InfoSync Module is installed, the ENVELOPE symbol will appear to indicate that results are being transmitted over the secure
cellular connection. The symbol will disappear after the results have been transmitted. In the event that the BD Veritor Plus Analyzer
does not detect adequate cellular network strength, it will queue all results to be transmitted and continuously attempt to transmit the
results while it is powered on. If the Analyzer is powered off while the ENVELOPE symbol is still present, the Analyzer will queue the
result and transmit it the next time that it is powered up.
14 To initiate a new test, repeat steps 5–13 above, or turn off the power by depressing the front panel power button for at least half a
second and releasing it. If the Analyzer is left unattended for 15 minutes (when operating on the internal battery), or 60 minutes (when
operating on the external power adapter), the BD Veritor Plus Analyzer will automatically shut off and the test result will not be retained
on the screen.
4.5 Kit Quality Control (QC) Test Procedure – Walk Away Operation
To utilize the Analyzer's QC Test documentation feature, the Analyzer must be equipped with either a BD Veritor
The Analyzer records the Kit Lot and Control Swab expiration dates in the test record but does not restrict the use of
expired reagents. Management of expired materials is the responsibility of the user per local site regulations or practices.
The AC power adapter must be connected to the Analyzer and plugged into a facility power source to use
If the Analyzer is left unattended for 60 minutes after completion of the test run, the power will automatically shut off and
The BD Veritor Plus Analyzer is intended for use with BD Veritor Test Devices. Specific instructions for performing a BD Veritor Quality
Control (QC) Test can be found in the package insert included with each test kit. After following those instructions up to sample preparation
in the reagent tube, the procedure for interpreting a test result with the BD Veritor Plus Analyzer using Walk Away operation is as follows.
DO NOT DISPENSE THE CONTROL INTO THE TEST DEVICE SAMPLE WELL AT THIS TIME.
1 Place the BD Veritor Plus Analyzer on a flat, dry, stable surface.
2 Ensure that the BD Veritor Plus Analyzer is not in direct sunlight or exposed to a bright light.
3 Ensure that the AC power adapter is connected to the Analyzer and plugged into a facility power source.
4 Check the BD Veritor Plus Analyzer for an inserted device. If a device is present, remove it from the Analyzer.
5 Press the front panel power button. The BD Veritor Plus Analyzer will complete a self-test before it is ready for use. After the self-test
completes, the display window shows SCAN CONFIG BARCODE. This is an optional step, no action is required. After 2 seconds, the
display window shows INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE. To perform instrument
configuration, refer to section 4.6–Workflow Configuration for configuration instructions.
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InfoScan Module or a BD Veritor InfoSync Module, and must have been configured
with barcode–Enable Specimen ID.
BD recommends that expired materials never be used.
Walk Away operation.
the test result will not be retained on the screen.
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