HemoCue Hb 201+ Manuel D'utilisation page 42

Specifications
GB
General
The HemoCue Hb 201
of the total amount of haemoglobin in whole blood. The system
consists of a specially designed analyser 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 analyser, 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.
Intended purpose
Quantitative determination of haemoglobin in capillary, venous or
arterial blood. The HemoCue Hb 201
determination of haemoglobin in whole blood using a specially
designed analyser, the HemoCue Hb 201
designed microcuvettes, the HemoCue Hb 201 Microcuvettes.
HemoCue Hb 201 Microcuvettes are for In Vitro Diagnostic use
only. The HemoCue Hb 201
HemoCue Hb 201 Microcuvettes.
IVD Medical Device Directive
The HemoCue Hb 201
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
+
is a system used for the determination
+ system is used for quantitative
+
analyser, and specially
+
analyser is only to be used with
+ complies with the IVD Medical Device
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.
Reagents
40 % w/w Sodium Deoxycholate, 18% w/w Sodium Azide,
20 % w/w Sodium Nitrite, 22 % w/w nonreactive ingredients.
Sample material
Capillary, venous or arterial blood may be used. Appropriate
anticoagulants in solid form e.g. EDTA or Heparin/Fluoride are
recommended in order to avoid a dilution effect.
If the blood has been stored in a refrigerator, it must be
allowed to reach room temperature 15 – 30 °C (59 – 86 °F) before
analysis. Haemoglobin remains unchanged for days, provided that
the blood does not become infected. Mix all samples on a mechan-
ical mixer for at least two minutes or invert the tube 8 –10 times
by hand, alternatively follow local recommendations.
Storage and environmental requirements for
HemoCue Hb 201 Microcuvettes
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). Do not refrigerate.
Once the seal is broken the microcuvettes are stable for three
months. Always keep the container properly closed.
42