Specifications - HemoCue WBC Manuel D'utilisation

Specifications

GB/US
Intended Purpose/Intended Use
The HemoCue WBC system is indicated for use for quan-
titative determination of white blood cell (WBC) count
in capillary or venous whole blood. The HemoCue WBC
system is for In Vitro Diagnostic use only. The HemoCue
WBC Analyzer is only to be used with HemoCue WBC
Microcuvettes. The HemoCue WBC system is indicated for
use in clinical laboratories and for point-of-care settings.
IVD Medical Device Directive
The HemoCue WBC system complies with the IVD Medical
Device Directive 98/79/EC and carries the CE mark.
Principles of the Method/Procedure
Principle of the method
A hemolyzing agent lyses the red cells in the microcu-
vette and a staining agent colors the white cells. An
image is taken of the stained white cells and the number
of cells is counted by image analysis in the analyzer.
Principle of the procedure
The microcuvette serves as a sample container and reac-
tion chamber. The microcuvette is for single-use only.
A blood sample of approximately 10 µL is drawn into the
cavity by capillary action. The microcuvette is placed in
the analyzer. The result is obtained within 3 minutes. The
system was designed and developed to establish agree-
ment with the manual light microscopy method for white
blood cell count. The system is factory calibrated and
needs no further calibration.
Warning and Precaution
The microcuvettes are for In Vitro Diagnostic use only.
Always handle blood specimens with care as they may
be infectious. Consult local environment authorities for
proper disposal. Always wear protective gloves when
handling blood specimens. The microcuvettes are for
single-use only.
Storage and Handling
HemoCue WBC Microcuvettes
The Microcuvettes are to be stored at 15–35 °C
(59–95 °F), <90 % non-condensing humidity. 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 (4 weeks) outside the
specified storage conditions down to 0 °C (32 °F) and up
to 50 °C (122 °F), <90 % non-condensing humidity. Allow
the microcuvettes to reach 15–35 °C (59–95 °F) before
use. 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.
HemoCue WBC Analyzer
The analyzer can be stored in temperatures between
0–50 °C (32–122 °F), <90 % non-condensing humidity.
Operating temperature is 15–35 °C (59–95 °F), <90 %
non-condensing humidity. Allow the analyzer to reach
ambient temperature before use.
Specimen Collection and Preparation
Capillary or venous whole blood may be used. EDTA
anticoagulant should be used, preferably in solid form to
avoid dilutional effects. Mix all specimen tubes thor-
oughly on a mechanical mixer for 1-2 minutes or invert
the tube 10–20 times by hand. The specimen can be
stored at room temperature (15–35 °C, 59–95 °F), or in a
refrigerator (2–8 °C, 35–46 °F) for 48 hours. If the speci-
men has been stored in a refrigerator, it will be viscous
and the blood should be allowed to warm up to room
temperature before mixing.
Materials Required
• HemoCue WBC Analyzer
• HemoCue WBC Microcuvettes
• Lancet (capillary samples)
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