Fora 6 Plus - Introduction; Intended Use; Test Principle

6
Introduction
Intended Use
This system is intended for use outside the body (in vitro diagnostic use) by
people with diabetes at home and by health- care professionals in clinical
settings as an aid to monitor the effectiveness of diabetes control. It is intended
to be used for the quantitative measurement of the blood glucose, hematocrit,
hemoglobin, ß-ketone, total cholesterol and uric acid levels in whole blood. It
should not be used for the diagnosis of diabetes.
Professionals may test with capillary and venous blood sample. Use only heparin
for anticoagulation of whole blood.
Home use is limited to capillary blood from the nger tip and the approved sites.
Test Principle
With different types of test strips, your FORA 6 Plus / Connect Multi-functional
Monitoring System allows you to measure the amount of blood glucose,
hematocrit, hemoglobin, β-Ketone, total cholesterol and uric acid levels in whole
blood. The testing is based on the measurement of electrical current generated
by the reaction of different substance with the reagent of the strip. The meter
measures the current, calculates the blood glucose, hematocrit, hemoglobin,
β-Ketone, total cholesterol or uric acid, and displays the result.
The strength of the current produced by the reaction depends on the amount of
the substance in the blood sample.