Intended Use And Principle Of Action - METRADO Gluceofine Pro Benutzerhandbuch

Intended Use and Principle of Action

Intended Uses
This system is intended for use outside the body (in vitro diagnostic use) by peo-
ple 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 capillary whole blood samples (from the finger, palm, forearm and upper
arm), and from venous whole blood.
It should not be used for the diagnosis of or screening for diabetes or testing on
newborns.
Professionals may test with capillary and venous blood sample; home use is
limited to capillary whole blood testing.
Principle of Action
The system measures the concentration of glucose in blood with an am-
perometric glucose biosensor embedded in the meter, that measures the
volume of electrical signal generated by the reaction of glucose in blood
sample with the metabolizing enzyme system (Glucose dehydrogenase (E.
coli)) implanted on test strips. The signal is translated into glucose concent-
ration and thereafter is displayed on the LCD screen of the meter.
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