HemoCue Hb201 - User Manual

HemoCue
®
Hb 201 Microcuvettes
The HemoCue Hb 201 Microcuvettes are designed for use with the HemoCue
Hb 201
+
Analyzer and the HemoCue Hb 201 DM Analyzer (referred to as the HemoCue
Hb 201 Analyzer in this document). HemoCue Hb 201 Microcuvettes are available in
individual packages or in vials. Please read the relevant Operating Manual for proper
use of the system
1
.
Intended Purpose/Intended Use
Quantitative determination of hemoglobin in capillary, venous and arterial whole
blood, using a specially designed analyzer, the HemoCue Hb 201 Analyzer, and spe-
cially designed microcuvettes, the HemoCue Hb 201 Microcuvettes. HemoCue Hb 201
Microcuvettes are for In Vitro Diagnostic use only. The HemoCue Hb 201 Analyzer is
only to be used with HemoCue Hb 201 Microcuvettes.
IVD Medical Device Directive
The HemoCue Hb 201 Microcuvettes comply with the IVD Medical Device Direc-
tive 98/79/EC and carry the CE mark
Principles 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 analyzer in which the transmittance is measured and
the absorbance and hemoglobin level is calculated. The absorbance is directly pro-
portional to the hemoglobin concentration.
Principle of the procedure
The system consists of an analyzer together with microcuvettes. The microcuvette
serves both as a pipette and as a measuring cuvette and is for single-use only. A blood
sample of approximately 10 µL is drawn into the cavity by capillary action. The analyzer
measures at two wavelengths in order to compensate for turbidity, and the hemoglobin
level is calculated and presented. The HemoCue Hb 201 system is calibrated against
the international reference method for hemoglobin determination, ICSH
3
and needs
no further calibration.
Composition
The microcuvette is made of polystyrene plastic. Reagents; <600 μg/g microcuvette
sodium deoxycholate, <300 μg/g microcuvette sodium azide, <300 μg/g microcuvette
sodium nitrite, <350 μg/g microcuvette nonreactive ingredients.
Warning and precautions
The microcuvettes are for In Vitro Diagnostic use only. Always handle blood speci-
mens with care as they may be infectious. Consult local environmental authorities
for proper disposal.
Storage and handling
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) and
in a dry place. Once the seal is broken the microcuvettes are stable for three months.
Always keep the vial properly closed.
GB/US

Summary

Intended Purpose;Intended Use

Principles of the method;procedure

Principle of the method

Explains the modified azidemethemoglobin reaction used for hemoglobin determination.

Principle of the procedure

Describes the system using an analyzer and microcuvettes for capillary blood sample measurement.

Composition

Warning and precautions

Storage and handling

Storage for microcuvettes kept in a vial

Specifies storage conditions for microcuvettes in vials at room temperature and dry place.

Storage for individually packaged cuvettes

Specimen collection and preparation

Directions for use

Materials required

Lists necessary items for using the HemoCue Hb 201 system.

Procedure

Step-by-step guide on how to use the microcuvettes with the analyzer.

Limitations of the method

Expected values

Specific performance characteristics

Within-run and Total precision

Details the precision of the HemoCue Hb 201 system in different scenarios.

Accuracy

Presents results from comparison studies with ICSH methods.

Bibliography

Symbols used

HemoCue Hb201 Specifications

General

Sample Volume	10 µL
Hemoglobin Range	0 – 25.6 g/dL (0 – 256 g/L, 0 – 15.9 mmol/L)
Sample Type	Capillary, venous or arterial whole blood
Power Supply	AC adapter
Display	LCD
Data Storage	600 results
Calibration	Factory calibrated, no user calibration required
Operating Humidity	10-90% non-condensing
Altitude Range	Up to 3, 000 meters (9842 feet)
Precision	CV ≤ 2%.
Measurement Principle	Modified azide methemoglobin