Intended Use - Fora ADVANCED pro GD40 Manual Del Usuario

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 the blood
sample. The Hb is the haemoglobin (g/dL) levels in the 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.
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) with capillary from
finger tip, venous, arterial, 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 the 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 sampling from a finger tip or with venous, arterial, and
neonatal blood from the heel. Test ß-Ketone with a capillary
sampling from the finger tip. Use only heparin for anticoagulation
of whole blood.
Home use is limited to capillary blood from the finger tip.
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