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 effectiveness of diabetes control. It is intended
to be used for the quantitative measurement of glucose
(sugar) in fresh capillary (from the finger, palm, forearm, and
upper arm) and venous blood samples. It should not be used
for the diagnosis of diabetes, or testing on newborns.
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 finger tip.
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.
For example:
1) 120 mg/dL ÷ 18 = 6.6 mmol/L
2) 7.2 mmol/L x 18 = 129 mg/dL approximately
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
