BD Veritor Plus Instrucciones De Uso página 24

BD Veritor™ Plus Analyzer Instructions for Use
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 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 the procedure for
interpreting a test result with the BD Veritor™ Plus Analyzer using Analyze Now operation is as follows:
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 Check the BD Veritor™ Plus Analyzer for an inserted device. If a device is present, remove it from the Analyzer.
4 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 for configuration instructions.
5 When the display window shows INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE, insert the fully
developed BD Veritor™ Test Device which has been prepared with an external control 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.
6 If the BD Veritor™ Plus Analyzer has been configured with barcode ID – Enable Operator ID, it will display SCAN OPERATOR ID.
When this message is displayed, after verifying that the Operator ID to be scanned is correct, the operator should scan his/her
identification barcode. This message is displayed for up to 30 seconds. If scans are not completed in this 30 second period, the
BD Veritor™ Test Device must be removed and the read process restarted with step 5. After a specific Operator Identification has been
recorded, that Operator Identification will be utilized for all subsequent tests until the BD Veritor™ Plus Analyzer is powered off. On the
next power cycle, the SCAN OPERATOR ID prompt will be repeated during the first test. A test result cannot be generated if the
Operator ID is not scanned when the Operator ID workflow option is enabled.
BD recommends reading Operator Identification barcodes with the BD Veritor™ Plus 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 In the case of Quality Control (QC) Tests, the barcode on the printed label of the swab control supplied with the kit is used as
the Specimen ID.
The display window will now display SCAN SPECIMEN ID. When this message is displayed, the operator should scan the barcode on
the printed label on the swab control supplied with the kit. This message is displayed for up to 30 seconds. If scans are not completed
in this 30 second period, the BD Veritor™ Test Device must be removed and the read process restarted with step 5. A test result
cannot be generated if the swab control barcode is not scanned.
BD recommends reading Quality Control (QC) 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.
8 In the case of Quality Control (QC) Tests, the barcode on the printed label of the test device kit box must be scanned.
The display window will show SCAN KIT LOT NUMBER whether the kit information workflow configuration setting is enabled or
disabled for normal operation. 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. If scans are not completed in this 30 second period, the
Test Device must be removed and the read process restarted with step 5. A test result cannot be generated if the Kit Lot Number is not
scanned.
If the BD Veritor™ Test Kit box label has two barcodes, scan only the upper barcode which starts with (17).
BD recommends reading Kit Lot Information barcodes with the BD Veritor™ Plus 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.
9 After all required scans are 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.
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NOTE
BD recommends that expired materials never be used.