Specifications; Materials Required; Quality Control - HemoCue Hb 301 Manuel D'utilisation

Specifications

GB/US
Intended Purpose/Intended Use
The HemoCue Hb 301 system is designed for quantitative point-of-
®
care hemoglobin determination in primary care or blood donation
settings using a specially designed analyzer, the HemoCue Hb 301
Analyzer, and specially designed microcuvettes, the HemoCue Hb 301
Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic
use only. The HemoCue Hb 301 Analyzer is only to be used with
HemoCue Hb 301 Microcuvettes.
Principle of the method/procedure
The system consists of an analyzer together with microcuvettes. The
microcuvette serves both as a pipette and as a measuring cuvette.
A blood sample of approximately 10 µL is drawn into the cavity
by capillary action. The measurement takes place in the analyzer,
which measures the absorbance of whole blood at a Hb/HbO
isobestic point. The analyzer measures at two wavelengths (506 and
880 nm) in order to compensate for turbidity. The HemoCue Hb 301
System is calibrated against the hemiglobincyanide (HiCN) method,
the international reference method for the determination of the
hemoglobin concentration in blood
and needs no further calibration.
Composition
The microcuvette is made of polystyrene plastic and contains no
active ingredients.
Storage and handling
HemoCue ® Hb 301 Microcuvettes
The microcuvettes are to be stored at 10–40 °C (50–104 °F). Once
the seal of the vial is broken, the microcuvettes are stable for 3
months. An unopened vial of microcuvettes can be stored for a
shorter period of time (6 weeks) between -18–50 °C (0.4–122 °F).
Use the microcuvettes prior to the expiration date that is printed on
the package. Keep the vial properly closed. All unused microcuvettes
should remain in the original package.
2
. The system is factory calibrated
3
44
HemoCue ® Hb 301 Analyzer
The analyzer can be stored and transported in temperatures
between 0–50 °C (32–122 °F). Operating temperature is 10–40 °C
(40–104 °F). Allow the analyzer to reach ambient temperature
before use. The analyzer should not be stored or operated at < 5 % or
> 90 % non-condensing humidity.
Specimen collection and preparation
Capillary, venous or arterial blood may be used. Appropriate
anticoagulant (eg EDTA or heparin) may be used, preferably in solid
form to avoid dilutional effects. Tubes containing flouride should not
be used. Mix all specimen tubes thoroughly on a mechanical mixer for
at least 2 minutes or invert the tube 8–10 times by hand. Hemoglobin
remains unchanged for days, provided that the blood does not
become infected. If the specimen has been stored in a refrigerator, it
will be viscid and the blood should be allowed to warm up to room
temperature before mixing 2 .

Materials required

• HemoCue Hb 301 Analyzer
• HemoCue Hb 301 Microcuvettes
• Lancet (capillary samples)
• Pipette or other transfer device (venous or arterial samples)
• Lint-free tissue (non-fraying)

Quality Control

The HemoCue Hb 301 Analyzer has an internal quality control the
"selftest". Every time the analyzer is turned on, it will automatically
verify the measurement perfomance. This test is performed at
regular intervals if the analyzer remains switched on. Upon passing
the selftest, the display will show the HemoCue symbol and three
flashing dashes, indicating that the analyzer is ready to perform a
measurement. An error code will be displayed if the selftest fails. If
quality control checks are required for regulatory reasons, contact
HemoCue or your distributor for current recommendations for
controls. Please refer to local guidelines for recommended frequency
of use.