HemoCue Hb 201+ Manuel D'utilisation page 43

Storage for individually packaged cuvettes
The microcuvettes are to be stored at room temperature (15– 30 °C
59– 86 °F). Do not refrigerate.
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HemoCue Hb 201 analyser
The analyser can be stored at 0 – 50 °C (32 – 122 °F). Operating
temperature is 15– 30 °C (59– 86 °F). Allow the analyser to reach
ambient temperature before use. The analyser should not
be operated at high (i.e. > 90 % non-condensing) humidity.
Quality Control
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The HemoCue Hb 201 analyser has an internal electronic
"SELFTEST". Every time the analyser is turned on, it will
automatically verify the performance of the optronic unit of the
analyser. This test is performed every second hour if the analyser
remains switched on.
If quality control checks are required for regulatory reasons
they should be performed using liquid controls recommended
by HemoCue.
Measuring range
0 – 256 g/L (0–25.6 g/dL, 0–15.9 mmol/L).
Results above 256 g/L (25.6 g/dL, 15.9 mmol/L) will be displayed
as HHH.
Limitations
HemoCue Hb 201 Microcuvettes are for In Vitro Diagnostic use
only. The HemoCue Hb 201 + analyser is only to be used together
with HemoCue Hb 201 Microcuvettes. For further limitations of
the procedure, see the HemoCue Hb 201 Microcuvettes instructions
for use.
Expected values
Adult Males 130 – 170 g/L (13.0–17.0 g/dL, 8.1–10.5 mmol/L)
Adult Females 120–150 g/L (12.0–15.0 g/dL, 7.4–9.3 mmol/L)
Infants, after neonatal period 110–140 g/L (11.0–14.0 g/dL,
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: 85 160 43 mm
Weight: 350 g (batteries included)
4 batteries type AA or R6, 1.5 V
Mains adaptor: CE marked
Only use adaptors recommended by HemoCue, see on page 44.
Pollution degree: 2
Overvoltage category: II
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.
Warranty
The analyser carries a 24-month warranty from the day of receipt.
After the warranty period service/repair is carried out at fixed prices.
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