Before You Begin; Intended Use; Test Principle - Fora GD20FM01 Operations & Procedures Manual

BEFORE YOU BEGIN

Severe dehydration and excessive water loss
may cause readings which are lower than actual
values. If the patient is suffering from severe
dehydration, consult a healthcare professional
immediately.
If the patient's blood glucose results are lower or
higher than usual, and do not have any
symptoms of illness, fi rst repeat the test. If
the patient has symptoms or continue to get
results which are higher or lower than usual,
follow the treatment advice of the healthcare
professional.
Use only fresh capillary or venous whole blood
samples to test patient's blood glucose. Using
other substances will lead to incorrect results.
If the patient has symptoms that are inconsistent
with the blood glucose test results and you have
followed all the instructions given in this owner's
manual, contact the healthcare professional.
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.

INTENDED USE

Test Concentration
This system is intended for use outside the
mg/dl
body (in vitro diagnostic use) by healthcare
professionals for multiple patient use in a pro-
fessional healthcare setting. Additionally, it is
intended to be used for the quantitative mea-
surement of glucose in fresh capillary blood
(from the fi nger, palm, forearm and upper arm)
or venous whole blood samples.
It should not be used for the diagnosis of
diabetes, or testing on neonates.
Alternative site testing should be done only dur-
ing steady–state times (when glucose is not
changing rapidly).

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 strength of the
current produced by the reaction depends on
the amount of glucose in the blood sample.
This system uses enzyme of FAD–dependent
glucose dehydrogenase.
% Bias at % Bias at
80±5 mg/dl 120±5 mg/dl
5