HemoCue Glucose 201 RT, Руководство по эксплуатации

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Storage and handling
HemoCue Glucose 201 RT Microcuvettes
The microcuvettes are to be stored at 0–30 °C (32–86 °F).
Unused HemoCue Glucose 201 RT Microcuvettes should be
kept in the original package but once an individual pack-
age is opened, the microcuvette must be used immediately
or discarded. Use the microcuvettes prior to the expiration
date that is printed on the package.
HemoCue Glucose 201 RT Analyzer
The analyzer can be stored and transported at 0–50 °C
(32–122 °F). Operating temperature is 15–27 °C (59–80 °F).
Allow the analyzer to reach ambient temperature (app.
30 minutes) before use. The analyzer should not be oper-
ated at high (i.e. >90 % condensing) humidity.
Specimen collection and preparation
Capillary, venous or arterial blood may be used. To achieve
optimal result quality the specimen collection technique is
essential. Make sure, regardless of type of blood, to do col-
lection according to instructions for use. If venous or arte-
rial specimen are used one of the following anticoagulants
EDTA, sodium heparin and lithium heparin with and with-
out gel and the glycolysis inhibitors sodium fluoride, sodium
oxalate and potassium oxalate shall be used. Glycolysis is a
major concern in all glucose measurements. To minimize the
effect of glycolysis, measure the blood sample as soon as
possible after taking the sample. Samples of blood collected
in containers with recommended anticoagulants should be
analyzed within 30 minutes. Mix all specimen tubes thor-
oughly on a mechanical mixer for at least 2 minutes or invert
the tube 8–10 times by hand.
Note! Lithium heparin with gel can not be used after
centrifugation.
Note! Plasma specimen can not be used.
Materials required
• HemoCue Glucose 201 RT Analyzer
• HemoCue Glucose 201 RT Microcuvettes
• Lancet (capillary samples)
• Pipette or other transfer device (venous or arterial
samples)
• Lint-free tissue (non-fraying)
Quality control
The HemoCue Glucose 201 RT Analyzer has an internal
quality control, the “selftest”. The selftest checks that the
output signal from the detector is linear with the input sig-
nal of the LEDs. Every fifth second it checks that the blank
values are stable. This provides a check on the stability of
the intensity of the LEDs, ensuring that the measuring elec-
tronics are free from disturbance. The analyzer will give an
error code E01–E07 if the measuring electronics is unstable
in any way. Upon passing the selftest, the display will show
the HemoCue symbol and three flashing dashes, indicat-
ing that the analyzer is ready to perform a measurement.
Follow local guidelines regarding quality control procedures.
If a quality control test is to be performed, only use quality
controls recommended by HemoCue, see relevant package
insert for more information.
Expected values
Fasting glucose values (reference interval):
Whole blood glucose, adults 3.6–5.3 mmol/L (65–95 mg/dL).
Plasma glucose, adults 4.1–5.5 mmol/L (74–99 mg/dL).
For diagnosis of diabetes mellitus, follow local recommenda-
tions or use the following value according to WHO and ADA:
Fasting whole blood glucose capillary or venous
≥
6.1 mmol/L
(
≥
110 mg/dL).
Fasting plasma glucose capillary or venous
≥
7.0 mmol/L
(
≥
126 mg/dL).