Quality Control - HemoCue Glucose 201+ Manuel De L'utilisateur

After breaking the seal, the vial can be stored at room temperature
for up to 3 days. Close the lid immediately after cuvettes are
removed from the vial.
Storage for individually packaged cuvettes
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Store unopened HemoCue Glucose 201 Microcuvettes below
8 °C (46 °F) (incl. storage in a freezer). Note, microcuvettes
stored in a freezer must be allowed to reach room temperature
(approx. 30 minutes) before analysis. The individually packaged
cuvettes can be stored at room temperature for up to 3 days.
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HemoCue ® Glucose 201 Analyzer
The analyzer can be stored at 0 – 50 °C (32 –122 °F). Operating
temperature is 15– 30 °C (59– 86 °F). Allow the analyzer to reach
ambient temperature before use. The analyzer should not be oper-
ated at high (i.e. > 90 % non-condensing) humidity.

Quality Control

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The HemoCue Glucose 201 Analyzer has an internal quality
control, the "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
is left turned on. If quality control checks are required for regula-
tory reasons they should be performed using liquid controls recom-
mended by HemoCue.
Results
The measuring range is 0 – 22.2 mmol/L (0–400 mg/dL). Results
above 22.2 mmol/L (400 mg/dL) will be displayed as HHH.
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Any results with HemoCue Glucose Systems suggesting clini-
cal intervention in the hyperglycemic range on pre-term neonates
(<37 weeks), should be verified against a suitable laboratory
reference method. The measuring range may be extended to
44.4 mmol/L (800 mg/dL) by dilution with saline 1+1. Mix the
sample thoroughly before dilution and measurement. The result on
the display should be multiplied by a factor of 2.
Note: Dilution may reduce accuracy. For specific performance
characteristics, see the HemoCue Glucose 201 Microcuvettes
instructions for use.
Limitations
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HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic
use only. The HemoCue Glucose 201
together with HemoCue Glucose 201 Microcuvettes. For further
limitations of the procedure, see the HemoCue Glucose 201
Microcuvettes instructions for use.
Expected values
Fasting glucose values, whole blood, adults 3.5– 5.3 mmol/L
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(65–95 mg/dL). For diagnosis of diabetes mellitus, follow local
recommendations or use the following value according to WHO:
Fasting whole blood glucose, capillary or venous ≥ 6.1 mmol/L
(≥ 110 mg/dL). 5
Technical Specifications
Dimensions: 8531603 43 mm
Weight: 350 g (batteries included)
4 batteries type AA or R6, 1.5 V
AC adapter: CE marked
Only use adapters as listed in the table at the end of
Specifications.
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.
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Analyzer is only to be used