Intended Use
The FORA TN'G Voice Blood Glucose Monitoring System is intended for
use in the quantitative measurement of glucose in fresh capillary whole
blood from the finger and the following alternative sites: palm, forearm or
upper-arm. It is intended for use by people with diabetes mellitus at home
as an aid in monitoring the effectiveness of diabetes control program. It is
not intended for the diagnosis of or screening for diabetes mellitus, and
is not intended for use on neonates. It is intended to be used by a single
person and should not be shared.
The alternative site testing in the FORA TN'G Voice Blood Glucose
Monitoring System can be used only during steady-state blood glucose
conditions.
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.
This system uses enzyme of Glucose Dehydrogenase (GDH) from E. coli.
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