Introduction To The System; Intended Use; Principle Of Measurement - Fora V12 Owner's Manual

INTRODUCTION TO THE SYSTEM

Intended Use

The system is intended for use outside the body (in vitro diagnostic
use). It should be used only for testing glucose (sugar) and only
with fresh capillary whole blood samples (from the finger, the palm,
the forearm, the upper arm, the calf and the thigh). It should not be
used for the diagnosis of diabetes or for the testing of newborns. It
is intended to be used by a single person and should not be shared.
AST in this system can be used only during steady-state blood glu-
cose conditions described in the section of "About Alternative Site
Testing (AST)".

Principle of Measurement

The test is based on the measurement of electrical current gener-
ated by the reaction of glucose with the reagent of the strip. The
meter measures the current and displays the corresponding blood
glucose level. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.
This system uses enzyme of GOD: glucose oxidase (GOD) from
A. niger.
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