HemoCue Hb 301, Operating Manual

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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 Microcuvettes.
The HemoCue Hb 301 system is for
In Vitro Diagnostic 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
2
isobestic point. The analyzer
measures at two 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
3 . The
system is factory calibrated and needs no further calibration.
Composition
The microcuvette is made of polystyrene plastic and contains no active
ingredients.
Storage and handling
Operating temperature for the system is 10–40 °C (50–104 °F). The
system should not be operated at <5 % or >90 % non-condensing
humidity.
HemoCue
®
Hb 301 Microcuvettes
Microcuvettes are to be stored at 10–40 °C (50–104 °F). Microcuvettes
in an opened or unopened vial are stable until expiration date printed
on package. Use microcuvettes prior to expiration date. An unopened
vial of microcuvettes can be stored for a shorter period of time (6 weeks)
between -18–50 °C (0–122 °F). Keep vial properly closed. All unused
microcuvettes should remain in original package.
HemoCue
®
Hb 301 Analyzer
The analyzer can be stored and transported in temperatures between
0–50 °C (32–122 °F). Operating temperature is 10–40 °C (50–104 °F).
Allow the analyzer to reach ambient temperature before use. The
analyzer should not be stored at < 5 % or > 90 % non-condensing
humidity.
Specimen collection and preparation
Capillary, venous or arterial blood may be used. EDTA or heparin should
be used as anticoagulant, 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 temperature before mixing
2
.
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 quality control the
“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 remains switched on. Upon passing the selftest,
the display will show the HemoCue symbol and three flashing dashes,
indicating that the analyzer is ready to perform a measurement. An
error code will be displayed if the selftest fails. Follow local guidelines
regarding quality control procedures. If a quality control test is to be
performed, only use controls recommended by HemoCue, see relevant
package insert for more information.
Specifications
GB/US