8
Intended Use
Your system is intended for use outside the body (
in vitro
diagnostic
use) by people with diabetes at home and by healthcare professionals
in clinical settings as an aid to monitor the effectiveness of diabetes
control. It is intended to be used for the quantitative measurement of
glucose (sugar) in fresh whole blood samples (from the finger, palm,
forearm and upper arm).
It should not be used for the diagnosis of diabetes or testing on
newborns.
Professionals may test with capillary and venous whole blood; home
use is limited to capillary whole blood testing.
Test Principle
Your system measures the amount of sugar (glucose) in whole blood.
The glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent in the strip.
Your meter measures the current, calculates the blood glucose level
then displays the result. The strength of the current produced by the
reaction depends on the amount of glucose in the blood sample.
Summary of Contents for 311-4277100 SERIES
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