Intended Use; Test Principle - Fora MD Manual Del Propietário

Intended Use

This system is intended for use outside the body (in vitro diagnostic
use) by professionals for multiple-patient use in professional healthcare
settings as an aid in 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 drawn from the fingertips.
It should not be used for the diagnosis of or screening for diabetes
mellitus, or testing on neonates.
This meter has some speaking functions but is not intended for use by
the visually impaired.
The system is only used with single-use, auto-disabling lancing devices.

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.
This system uses enzyme of FAD–dependent glucose dehydrogenase
(FAD-GDH) from E. coli.
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