Fora G20 - Introduction of the System; Intended Use; Principle of Measurement

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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 taken from the nger and the al-
ternative sites including the palm, the forearm, the upper arm, the calf
and the thigh. The system is intended for use in the home and in clinical
settings. It should not be used for the diagnosis of diabetes or for the
testing of newborns.
AST in this system can be used only during steady-state blood glucose
conditions described in the section of “About AST”.
Principle of Measurement
The test is based on the measurement of electrical current generated
by the reaction of glucose with the reagent of the strip. The meter mea-
sures 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.