Intended Use; Test Principle - Fora Premium V10 BLE Manual Del Propietário

Intended Use

The FORA Premium V10 BLE Blood Glucose Monitoring System is
intended for use in the quantitative measurement of glucose in fresh
capillary whole blood from your finger and the following alternative
sites: palm, forearm and 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 Premium V10 BLE 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 oxidase (GOD) from A. niger.
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