8
Intended Use
This system is intended for use outside the body (
in vitro
diagnostic
use) by people with diabetes at home as an aid to monitoring the ef-
fectiveness of diabetes control. It is intended to be used for the quan-
titative measurement of glucose (sugar) in fresh whole blood samples
(from the
fi
nger, palm, forearm, upper arm, calf and thigh).
It should not be used for the diagnosis of diabetes, or testing on
neonates.
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 of the strip. The
meter measures the current, calculates the blood glucose level, and
displays the result. The strength of the current produced by the
reaction depends on the amount of glucose in the blood sample.