HemoCue Manuel D'utilisation page 25

Specifications
GB/US
Intended Purpose/Intended Use
The HemoCue Plasma/Low Hb system is used for quantitative
determination of low levels of hemoglobin in plasma and serum
specimens, aqueous solutions, or stored or banked erythrocytes
using a specially designed photometer, the HemoCue Plasma/Low
Hb Photometer and specially designed microcuvettes, the HemoCue
Plasma/Low Hb Microcuvettes. The HemoCue Plasma/Low Hb
Microcuvettes are for In Vitro Diagnostic use only. The HemoCue
Plasma/Low Hb Photometer is only to be used with HemoCue Plasma/
Low Hb Microcuvettes.
IVD Medical Device Directive
The HemoCue Plasma/Low Hb system complies with the IVD Medical
Device Directive 98/79/EC and carry the CE mark.
Principle of the method/procedure
Principle of the method
The reaction in the microcuvette is a modified azidemethemoglobin
reaction. The erythrocytes are hemolyzed to release the hemoglobin.
The hemoglobin is converted to methemoglobin and then combined
with azide to form azidemethemoglobin. The measurement takes
place in the photometer in which the transmittance is measured and
the absorbance and hemoglobin level is calculated. The absorbance is
directly proportional to the hemoglobin concentration.
Principle of the procedure
The system consists of an photometer together with microcuvettes.
The microcuvette serves both as a pipette and as a measuring cuvette
and is for single-use only. A sample of approximately 20 µL is drawn
into the cavity by capillary action. The photometer measures at two
wavelengths in order to compensate for a certain degree of turbidity,
and the hemoglobin level is calculated and presented (limitations
apply as described in 'Limitation of the procedure').
The HemoCue Plasma/Low Hb system is calibrated against the
international reference method for hemoglobin determination, ICSH
and needs no further calibration.
Warning and precautions
The microcuvettes are for In Vitro Diagnostic use only. Non-
laboratory personnel should receive adequate training before
using this system for the first time. Always handle blood specimens
with care as they may be infectious. Consult local environmental
authorities for proper disposal.
Storage and handling
Operating temperature for the system is 15–30°C (59–86°F). The
system should not be operated at < 5 % or > 90 % non-condensing
humidity.
HemoCue Plasma/Low Hb Microcuvettes
®
The microcuvettes are to be stored at 15–30°C (59–86°F). Do not
refrigerate. Use the microcuvettes prior to the expiration date that
is printed on the package. Once the seal of the vial is broken, the
microcuvettes are stable for three months. Keep the vial properly
closed. All unused microcuvettes should remain in the original
package.
HemoCue Plasma/Low Hb Photometer
®
The photometer can be stored and transported in temperatures
between 0–50°C (32–122°F). Allow the photometer to reach ambient
temperature before use. The photometer should not be stored at
< 5 % or > 90 % non-condensing humidity.
Specimen collection and preparation
Plasma/serum specimens and aqueous solutions containing
hemoglobin, such as irrigating fluid from surgical procedures, may
be used. Mix the specimen thoroughly before use. Supernatant
from erythrocyte suspensions may be used. Carefully separate
the supernatant from the erythrocytes using accepted laboratory
procedure.
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