Introduction; Intended Use; Product Description - Abbott DIGIVAL LFR-024 User Manual

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Introduction

1.1

Intended Use

The DIGIVAL is a small bench top instrument to be used in conjunction with
™
Abbott rapid assays. It is intended for professional and laboratory use only.
This document describes the setup, configuration and operation of the DIGIVAL
for the qualitative detection of selected Abbott Rapid Tests. Please refer to each
specific package insert for details on running the individual tests.

1.2 Product Description

The DIGIVAL captures, interprets, and transmits results of select Abbott
Rapid Tests. It can be used in the laboratory and point of care settings. It is a
camera-based instrument that detects the presence and identity of a completed
rapid test, analyzes the test and control line, and displays the results (positive,
negative or invalid) on a display screen. Results can be printed using an accessory
printer connected via USB. In addition, patient test results can be uploaded to a
compatible data management system via Ethernet.
When a test is placed in the DIGIVAL, the DIGIVAL identifies the test device
type and type of assay by reading the barcodes. It then selects the appropriate
test parameters, performs the analysis, and reports results on the screen. Results
are stored in memory, and can be printed, if desired, on an optional printer. If
connected to a data management system, results are uploaded and are no longer
available in memory.
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