10
Intended Use
The
CLEVER CHOICE 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: the palm, the forearm, the upper-arm, the calf and the 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. The alternative site testing
in this system can be used only during steady-state blood glucose
conditions.
The
CLEVER CHOICE Voice+
Blood Glucose Monitoring System is
intended to be used by a single person and should not be shared.
This system contains a speaking functionality which provides step by
step instructions to aid visually impaired persons.
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.
Summary of Contents for Voice+
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