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, upper arm, calf and thigh).
This system is not intended for the diagnosis of or screening for
diabetes and is not intended to be used on neonates. Alternative site
testing (AST) in this system can be used only during steady-state blood
glucose conditions described in the section “about AST”.
This meter has some speaking functions but is not intended for use by
the visually impaired.
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.
