HemoCue Albumin 201, Operating Manual

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quality control testing. If the control result is out of
range, please refer to the Operating Manual for correc-
tive action. Do not run patient samples unless the quality
control results are in the expected range. For CLIA waived
laboratories, HemoCue recommends the control material
Eurotrol AlbuTrol to be used on the days of testing, for
each new shipment of cuvettes and new lots.
• The HemoCue Albumin 201 Analyzer has an internal
electronic self test. Every time the analyzer is turned on it
will automatically perform the self test. The self test veri-
fies the performance of the optical unit of the analyzer.
Measuring range
7 –150 mg/L. The system is linear between 7-150 mg/L.
Results below 7 mg/L are displayed as “LLL”. Results
above 150 mg/L are displayed as “HHH”.
Limitations of the procedure
The HemoCue Urine Albumin Microcuvettes are for
In Vitro Diagnostic use only. The HemoCue Albumin
201 Analyzer is only to be used with HemoCue Urine
Albumin Microcuvettes. For further limitations, see
the package insert of the HemoCue Urine Albumin
Microcuvettes. For specific performance characteristics,
see the package insert for HemoCue Urine Albumin
Microcuvettes.
Expected values
According to the literature, the following results are
indicators for normal and pathological urine albumin
results respectively.
U-Albumin U-Albumin/overnight Interpretation
Spot sample Urine collected
(morning urine) overnight
<20 mg/L
<20 µg/min normal
20–200 mg/L 20–200 µg/min microalbuminuria
>200 mg/L >200 µg/min albuminuria
Measurements from spot urine during the day may give
slightly higher results due to physical activity. In these
circumstances, normal values are less than 30 mg/L
1
.
Technical Specifications
Dimensions: 6.89x2.56x4.53 inches
Weight: 0.77 lbs
Power Adapter
Type: HCA01
Input: 100-240 V
Output: 12 V DC/0.45 A
Pollution Degree: 2
Over voltage category: II
Atmospheric pressure: 700hPa to 1060 hPa
The instrument is made for continuous mode.
Choose power adapter according to the technical specifi-
cations above. The analyzer is CE marked.
Attention! See instructions for use. Equipment not suit-
able for use in the presence of flammable mixtures.
The analyzer is tested according to EN 60601-1 and IEC
60601-1-2 and complies with the IVD Directive 98/79/EC.
Country Type Input
USA FW7333M/12 100-240 V
HCA01