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 monitoring the
effectiveness of diabetes control. It is intended to be used for the
quantitative measurement of glucose (sugar) with capillary from
finger tip, and to measure β-hydroxybutyrate (Ketone) in fresh
whole blood samples from the finger. It should not be used for
the diagnosis of diabetes, or screening for diabetes mellitus.
The test for hematocrit (HCT) as part of the system, is intended
for use in the in vitro quantification of packed red blood cell
volume fraction in capillary whole blood as an aid in monitoring
the status of total volume of red blood cells. The reading of HCT is
only for determination of whether the blood test sample is within
the acceptable range of Blood Glucose Plus ß-Ketone monitoring
system. It should not be used for the diagnosis of anemia or
erythrocytosis.
Professionals may test blood glucose and hematocrit with
capillary from finger tip, and neonatal blood from the heel. Test
ß-Ketone with capillary from finger tip. Use only heparin for
anticoagulation of whole blood.
Home use is limited to capillary blood from finger tip.
For example:
1) 120 mg/dL ÷ 18 = 6.6 mmol/L
2) 7.2 mmol/L x 18 = 129 mg/dL approximately.
• The HCT is the volume percentage (%) of red blood cells in blood
sample. The Hb is haemoglobin (g/dL) levels in blood sample.
The approximate calculation rule for Hb is: Hb= HCT*0.34 (Note:
Haematocrit =HCT; Haemoglobin=Hb)
• The measurement unit used for indicating the concentration of
β-Ketone is mmol/L.
Summary of Contents for GD40
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