Measuring Principle; Intended Use - HMM Diagnostics SmartLab fit W Manual De Usuario

Measuring principle

The smartLAB
genie Self-Monitoring Blood Glucose System is
®
designed to allow rapid measurement of blood glucose by using
an electrochemical biosensor technology. This system employs
a disposable dry reagent strip technology, based on the glucose
oxidase method for glucose determination.
Each test strip features an electrode containing the glucose oxi-
dase from aspergillus niger. A capillary blood sample is applied
to the collecting area of the strip, and is automatically drawn
into the reaction zone, where the glucose oxidase catalyzes the
oxidation of glucose to produce glyconic acid. During the reac-
tion, a mediator transfers electrons to the electrode surface and
generates a current. The amount of the current is proportional to
the amount of glucose present in the blood sample. The glucose
concentration is measured by your smartLAB
genie meter and
®
displayed on the screen after 5 seconds.

Intended use

This blood glucose meter is a self-test IVD medical equipment
and intended for both home testing and for professional use to
monitor the blood glucose (B-D-glucose) value from capillary
whole blood.
It is used outside the body only (In-vitro diagnostic use). The
meter should be used only smartLAB
pro blood glucose test
®
strips. Testing is not valid on neonatal blood specimen.
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