Intended Use; Product Description; Before You Start Testing; Chapter 02. Introduction - SD Biosensor F200 User Manual

CHAPTER 02. Introduction

Intended Use

The STANDARD F200 Analyzer works for measuring quantitative or qualitative
biomarker with body fluid such as blood, urine, nasal mucus, and so on based
in vitro diagnostic assays in laboratory and point-of-care settings. The analyzer is
indicated for monitoring and diagnosing from the body fluid parameter in clinical
settings by healthcare professionals. The analyzer should be used with the
specified test device which produced by SD BIOSENSOR, Inc. Refer to assay-
specific package insert for details on specific tests.

Product Description

The STANDARD F200 Analyzer can read the lot of the specific test devices
in use by checking their 2D barcodes. While the test device is inserted into
the STANDARD F200 Analyzer, the application well of the test device would
be illuminated by UV or RGB LED (light-emitting diode) with scanning. Before
performing the measurement, the type of the light reflected determines the way
the test device is reflected. When the specimen is applied, the specimen would
act an enzymatic reaction with forming dye and the amount of formed dye would
be proportional to the concentration of specimen. The intensity of visual color or
fluorescence can be measured by illuminating with motor and LED, and detected
by reflectance photometry. The measured value takes into account the signal
strength of the light, measured blank value previously and the reads information
including 2D barcode data. Finally, the test result would display on its screen and
be stored in the memory of the analyzer simultaneously.

Before You Start Testing

Read and follow the instructions carefully in the user's manual and
Instructions for use of the test device and control. It is very important
to follow the instructions in order to prevent an incorrect result or
Note
improper treatment.
Before use, please check the latest version of software from your
distributor and head office. Then update and start measuring.
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