Product Manual
Development Modes
When a patient sample is added to the Test Cassette, it begins to
flow through the test strip. The development time required varies by
test type. Refer to the assay-specific package insert to determine the
required development time of each test, and the required storage
conditions of the test and external controls.
The correct development time is required to get accurate results.
Sofia has been designed to operate in different development modes.
The Supervisor and User can identify the mode that works best with the
testing volume.
WALK AWAY Mode may be the most convenient for reading a single
patient sample, as the User can walk away during the development
mode. Sofia has the capability of three different WALK AWAY Modes:
User selected WALK AWAY Mode, Locked WALK AWAY Mode and
Forced WALK AWAY Mode.
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User Selected WALK AWAY Mode may be most convenient for
reading a single patient sample, as the User can walk away during
the development period. In this mode, the User dispenses the
patient sample into the Cassette and then immediately inserts
the Cassette into Sofia. Sofia will automatically allow the Cassette
to develop for the required time period (pre-programmed for
each test), scan the Cassette, analyze and interpret the data, and
automatically and objectively display the test result.
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Locked WALK AWAY Mode can only be selected while logged
in as a Supervisor. In this mode Sofia has been locked into WALK
AWAY development timing for ALL assays run on the instrument.
READ NOW development timing will not be available when this
Default Mode has been selected.
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Forced WALK AWAY Mode is used with certain Sofia assays.
Please refer to appropriate assay specific package insert
for information regarding this mode. In this mode Sofia will
automatically develop the Cassette for the required time period
(pre-programmed for each test), scan the Cassette, and display
the test result when completed. READ NOW development timing
will not be available for some assays that require Forced WALK
AWAY Mode.
READ NOW Mode may be most convenient for high volume situations
as Sofia can quickly read multiple patient samples sequentially. The
User dispenses the patient sample into the Cassette. The User then
manually times the development period outside of Sofia. This can be
done on the counter or bench top using a timer. Refer to the assay-
specific package insert for the required development time. Once the
development time is complete, the User inserts the Cassette into Sofia.
Sofia will immediately scan and display the test result within 1 minute.
System Components
Inspect the shipping container for obvious shipping damage prior
to opening. Unpack the shipping container and inspect the unit and
components for damage.
The following system components are supplied with the purchase of
each Sofia:
Sofia
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Sofia with integrated printer
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Printer Paper
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4x LR6-AA + 6V, 4.16 A
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AC Power Cord
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DC Power Cord
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Specific Country Adapter(s)
Installation Pack
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User Manual
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Quick Start Guide
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Warranty Card
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Barcode Scanner
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Barcode Scanner Stand
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SD Card(s) – Test Type Files (Blue), Language Files (Yellow),
and Blank SD Card
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Calibration Cassette
Contact Quidel Technical Support for additional supplies at 800.874.1517
(in the U.S.). For additional contact information (page 3).
Sofia consumable test kits, including Test Cassettes and External
Quality Control materials, are shipped separately.
Consult your Quidel representative for a listing of approved Sofia
assays.
Introduction
Introduction10
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