Intended Use; Test Principle - Active Care Medical TD-4121 Owner's Manual

Intended Use

This system is intended for use outside the body (in vitro diagnostic use) by
people with diabetes. It is designed for home use 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 capillary whole blood samples (from the finger, palm, forearm and upper arm)
and from venous whole blood. This system is intended to be used by a single
person and should not be shared.
It should not be used for the diagnosis of, or screening for diabetes, or testing on
neonates.
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 test 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.
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