Fora 6 Connect - Introduction; Intended Use

EN-2
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 eectiveness of diabetes control. It is intended
to be used for the quantitative measurement of the blood
glucose, hematocrit, hemoglobin, β-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 dierent types of test strips, your FORA 6 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 dierent 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.
• We do not recommend using this product on severely
hypotensive individuals or patients in shock. Readings
which are lower than actual values may occur for
individuals experiencing a hyperglycaemic-hyperosmolar
state, with or without ketosis. Please consult the healthcare
professional before use.
• The measurement unit used for indicating the
concentration of blood glucose can have mg/dL or mmol/L.
The approximate calculation rule for conversion of mg/dL
in mmol/L is:
mg/dL Divided by 18 = mmol/L
mmol/L Times 18 = mg/dL
For example:
1) 120 mg/dL ÷ 18 = 6.6 mmol/L
2) 7.2 mmol/L x 18 = 129 mg/dL approximately