Intended Purpose - HemoCue Hb 201+ Manuel D'utilisation

Specifications
GB
General
The HemoCue Hb 201 + is a system used for the determination
of the total amount of haemoglobin in whole blood. The system
consists of a specially designed analyzer with specially designed
microcuvettes containing dried reagents. The microcuvette serves
as pipette, reaction vessel and as a measuring microcuvette. No
dilution is required. The haemoglobin measurement takes place
in the anayzer, which follows the progress of the reaction until
the end point has been reached. The system is factory calibrated
against the haemiglobincyanide (HiCN) method, the international
reference method for the determination of the haemoglobin
concentration in blood, and needs no further calibration.

Intended purpose

Quantitative determination of haemoglobin in capillary, venous
or arterial blood. The HemoCue Hb 201 + system is used for
quantitative determination of haemoglobin in whole blood using
a specially designed anayzer, the HemoCue Hb 201 + Analyzer,
and specially designed microcuvettes, the HemoCue Hb 201
Microcuvettes. HemoCue Hb 201 Microcuvettes are for In Vitro
Diagnostic use only. The HemoCue Hb 201 + Analyzer is only to
be used with HemoCue Hb 201 Microcuvettes.
IVD Medical Device Directive
The HemoCue Hb 201 + complies with the IVD Medical Device
Directive 98/79/EC and carries the CE mark.
Theory
Sodium deoxycholate haemolyses the erythrocytes and
haemoglobin is released. Sodium nitrite converts haemoglobin
to methaemoglobin which, together with sodium azide, gives
azidemethaemoglobin. The absorbance is measured at two
wavelengths (570 nm and 880 nm) in order to compensate for
turbidity in the sample.
Storage and handling
Operating temperature for the system is 15-30 °C (59-86 °F). The
system should not be operated at high (i.e >90 % non-condensing)
humidity. Use the HemoCue Hb 201 Microcuvettes prior to their
expiry date. The expiry date is printed on each package.
Storage for microcuvettes kept in a vial
The microcuvettes are to be stored at room temperature (15–30 °C,
59–86 °F) and in a dry place. The expiry date is printed on each
vial. Once the seal is broken the microcuvettes are stable for three
months. Always keep the vial properly closed.
Storage for individually packaged cuvettes
The microcuvettes are to be stored at room temperature (15–30 °C,
59–86 °F) and in a dry place. The expiry date is printed on each
package.
HemoCue Hb 201 + Analyzer
The analyzer can be stored and transported at 0–50 °C (32–122 °F).
Operating temperature is 15–30 °C (59–86 °F). Allow the analyzer
to reach ambient temperature before use. The analyzer should not
be stored at high (i.e. > 90 % non-condensing) humidity.
Specimen collection and preparation
Capillary, venous or arterial blood may be used. Appropriate
anticoagulants (e.g. EDTA or heparin) may be used, preferably
in solid form to avoid dilutional effects. 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
2
mixing .
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