Quality Control; Measuring Range - HemoCue Hb 201+ Manuel D'utilisation

Storage of the individually packaged cuvettes
The microcuvettes are to be stored at room temperature (59 – 86 °F,
15– 30 °C). Do not refrigerate. The individually packaged microcu-
vettes are stable until the date printed on each package.
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HemoCue Hb 201 analyzer
The analyzer can be stored at 32-122 ºF (0-50 ºC). Operating tem-
perature is 59-86 ºF (15-30 ºC). Allow the analyzer to reach ambi-
ent temperature before use. The analyzer should not
be operated at high (i.e. > 90 % non-condensing) humidity.

Quality Control

The HemoCue Hb 201 + analyzer has an internal electronic
"SELFTEST". Every time the analyzer is turned on, it will
automatically verify the performance of the optronic unit of the
analyzer. This test is performed every second hour 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. If use of liquid control material
is required by local or other regulations, contact HemoCue, Inc.
for control information.

Measuring range

0–25.6 g/dL (0 – 256 g/L, 0–15.9 mmol/L).
Results above 25.6 g/dL (256 g/L, 15.9 mmol/L) will be displayed
as HHH. Values above 23.5 g/dL (235 g/L, 14.6 mmol/L) must be
confirmed using a suitable laboratory method.
Limitations
HemoCue Hb 201 Microcuvettes are for in vitro diagnostic use
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only. The HemoCue Hb 201 analyzer is only to be used together
with HemoCue Hb 201 Microcuvettes. For further limitations of
the procedure, see the HemoCue Hb 201 Microcuvettes package
insert.
Expected values
Adult Males 13.0–17.0 g/dL (130 – 170 g/L, 8.1–10.5 mmol/L)
Adult Females 12.0–15.0 g/dL (120–150 g/L, 7.4–9.3 mmol/L)
Infants, after neonatal period 11.0–14.0 g/dL (110–140 g/L,
6.8–8.7 mmol/L)
Children, two years to teenage: gradual increase to adult normals.
Due to a wide range of conditions (dietary, geographical, etc)
which affect normal values, it is recommended that each laboratory
establish its own normal range.
Technical Specifications
Dimensions: 3.35 x 6.30 x 1.69 inches (85 160 43 mm)
Weight: 0.77 pounds (350 g) (with batteries installed)
4 batteries type AA
Power adapter: CE marked
Only use adapters recommended by HemoCue or equivalent, as
listed on page 28.
Pollution degree: 2
Overvoltage category: II
Atmospheric pressure: 700 hPa to 1060 hPa.
Equipment not suitable for use in the presence of flammable mixtures.
The instrument is tested according to IEC 61010-1, First edition,
1990 with Amendment 1, 1992 and Amendment 2, 1995 (EN
61010-1: 1993 with A2: 1995), EN 60601-1-2 and complies with
the IVD Medical Device Directive 98/79/EC.
Signal input and signal output
Accessory equipment connected to the analog and digital inter-
faces must be certified according to the respective UL standards
(i.e. UL 60950-1 for data processing equipment and IEC 60601-1
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