7
Intended Use
This system is intended for use outside the body (
in vitro
diagnostic
use) by people with diabetes at home and by health care professionals
in clinical settings as an aid to monitoring 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). Professionals may test with capillary and venous
blood sample; home use is limited to capillary whole blood testing.
It should not be used for the diagnosis of diabetes, or testing on
newborns.
Professionals may test with capillary and venous blood sample; 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 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.
