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

BD Veritor™ Plus Analyzer Instructions for Use
Specimen ID scan prompt is repeated for every test. A test result cannot be generated if the Specimen ID is not input when the
Specimen ID workflow option is enabled.
BD recommends reading Specimen Identification barcodes with the Analyzer positioned at the edge of a flat surface. The barcode
should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display
window.
c. If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Kit Lot Information, it will display SCAN KIT LOT
NUMBER. When this message is displayed, the operator should scan the barcode on the exterior of the BD Veritor Test Kit box. This
message is displayed for up to 30 seconds, after which the process restarts with step 6. The Kit Lot Number scan prompt is
repeated for every test. A test result cannot be generated if the Kit Lot Number is not input when the Kit Information workflow option
is enabled.
If the BD Veritor Test Kit box label has two barcodes, scan only the upper barcode which starts with (17).
BD recommends reading the Kit Information barcode with the Analyzer positioned at the edge of a flat surface. The barcode should
then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window.
7 The display window will now show ADD SPECIMEN TO TEST DEVICE AND INSERT IMMEDIATELY. This message is displayed for
up to 3 minutes, after which the process restarts with step 6. Apply the prepared specimen to the test device sample well as instructed
in the test device kit package insert and immediately insert the test device into the slot on the right side of the Analyzer, aligning the
insertion arrow on the test device with the arrow above the slot. Insert the device fully until it stops. A distinctive "click" will be noted
when the device is properly aligned in the Analyzer. During this process the test device must remain horizontal to prevent spilling the
specimen out of the sample well.
8 The display window will now show DO NOT DISTURB TEST IN PROGRESS. The incubation time is determined based on the test
device barcode. The incubation time remaining is shown on the display. Do not disturb the test device or Analyzer during the
incubation period. Do not remove the test device; doing so will cause the test to abort.
9 After the incubation is complete, the BD Veritor Plus Analyzer will progress through two processing steps: a reading step, followed by
an analyzing step. The display will show the remaining time for each step as they are performed. Do not touch the Analyzer or remove
the test device during this time.
10 When the analysis is complete, the test result will be displayed with the name of the test and a result. 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.
If an InfoScan or InfoSync module is installed:
If the BD Veritor Plus Analyzer has been configured with barcode ID–Enable Specimen ID, the specimen identification is also
displayed on-screen.
11 Verify that the test type and specimen identification (if appropriate) are correct.
12 Once the test type and specimen identification, if appropriate, is 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.
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.
13 To initiate a new test, repeat steps 6–12 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 60 minutes, the BD Veritor Plus Analyzer will automatically shut off and
the test result will not be retained on the screen.
4.4 Kit Quality Control (QC) Test Procedure – Analyze Now Operation
To utilize the Analyzer's QC Test documentation feature, the Analyzer must be equipped with either a BD Veritor
14
InfoScan Module or a BD Veritor InfoSync Module, and must have been configured
with barcode – Enable Specimen ID.
NOTE