Intended Purpose; Principle Of Operation - Saladax MyCare INSITE User Manual

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Consult Instructions for Use
in vitro Diagnostic Device
IVD
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Near Patient Testing
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INTENDED PURPOSE

The MyCare Insite is intended as an automated general-purpose laboratory instrument for the quantitative
determination of clinical wet chemistry parameters. The Analyser is intended to be used solely in conjunction with
MyCare Insite Test kits and is designed to be used either in a clinical laboratory or in a near-patient setting by
health-care professionals.

PRINCIPLE OF OPERATION

The MyCare Insite is used to quantify an analyte concentration in samples with an optical absorbance measurement.
To perform a test the MyCare Insite Analyser is loaded with a test cartridge containing reagents and the sample to
be tested.
The Analyser is equipped with an RFID card-reader module. RFID cards are necessary for performing any testing
procedures. They are included in the test kits and contain all the specific steps for the various tests, the lot data,
as well as the calibration data. The Analyser performs the tests automatically according to the information on the
RFID card. The test measured is dictated by the RFID card placed on the Analyser. RFID cards and tests are
color-coded. Numerous types of tests can be performed automatically.
The sample and the reagents are automatically mixed within the Analyser. The photometer unit performs the
analysis with a light emitting diode (LED). The absorption of light rays is determined during this process and the
measured values are then automatically converted into the test result using mathematical methods.
The test cartridge design is self-contained so that the Analyser has no contact with reagent or sample.
The result is displayed on the Touch Screen. Optionally, results can be exported to an external computer or an
HIS/LIS and can also be printed to an external printer.
After the test process the door opens automatically and the test cartridge can be removed and discarded. After
confirming the result on the Touch Screen and closing the door, the Insite is ready to perform the next analysis.
With LED technology the Insite requires no maintenance.
PI MCI-EUR-ML-PKG Rev 01 English 2 / 12
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