Intended Use
The Premium V12 Series 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, upper-arm, calf and thigh. 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 Premium V12 Series Blood Glucose
Monitoring System can be used only during steady-state blood glucose
conditions.
Premium V12 Voice 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.
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