HemoCue Hb 301 Manual De Operación página 30

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 Micro-
cuvettes. The HemoCue Hb 301 system is for In Vitro Di-
agnostic 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
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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
factory calibrated 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.
HemoCue Hb 301 Analyzer
The analyzer can be stored and transported in tempera-
tures between 0-50 ºC (32-122 ºF). Operating tempera-
ture is 10-40 ºC (40-104 ºF). Allow the analyzer to reach
ambient temperature before use. The analyzer should
not be stored or operated at < 5 % or > 90 % non-con-
densing humidity.
Specimen collection and preparation
Capillary, venous or arterial blood may be used. Ap-
propriate 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 tempera-
. The system is ture before mixing
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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 electronic
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
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