HemoCue Albumin 201 Manuel D'utilisation page 50

Whenever the analyzer is turned ON, it will automati-
cally verify the performance of the optronic unit of
the analyzer. The system can be verified according to
local guidelines by measuring a urine albumin control.
Considerable variability exists in different types and
production methods for liquid urine controls. Note that
local, state, or other accreditating agencies may require
additional quality control testing. If a quality control test
is to be performed, only use controls recommended by
HemoCue, see relevant package insert for more informa-
tion.
Measuring range
5–150 mg/L. Measurements below 5 mg/L are displayed
as "LLL". Results above 150 mg/L are displayed as "HHH".
To obtain results within the measuring range, samples
up to 2000 mg/L can be diluted with isotonic sodium
chloride. The result shown in the display must be mul-
tiplied by the dilution factor. Note that dilution might
affect the accuracy of the measurement.
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 Microcu-
vettes. For specific performance characteristics, see the
package insert for HemoCue Urine Albumin Microcu-
vettes.
Expected values
According to the literature, the following results are
indicators for normal and pathological urine albumin
results respectively.
Country Type
EU/US/UK FW7333M/12
AU FW7555M/12
World wide HCA01
U-Albumin U-Albumin/overnight Interpretation
Spot sample Urine collected
(morning urine) overnight
<20 mg/L <20 µg/min
20–200 mg/L 20–200 µg/min
>200 mg/L >200 µg/min
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
Recommended power adapter:
Technical Specifications
Dimensions: 170 X 115 X 66 mm
Weight: 350 g
Power Adapter
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 analyzer 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 IEC 60601-1 and
IEC 60601-1-2 and complies with the IVD Directive
98/79/EC.
Input
100–240 V
100–240 V
100–240 V ~/50–60 Hz. <500 mA
50
normal
micro-
albuminuria
albuminuria
1 .