HemoCue Hb 301 Manual De Operación página 32

and physician services. The studies were performed on cap-
illary samples in duplicates tested on HemoCue Hb 301 vs
HemoCue Hb 201 + (1). The Hb 201
International Council for Standardization in Haematology
method (ICSH) using venous blood (2).
3
Study N Min Max
g/ g/dL
dL
1 186 8.3 18.0 Y = 0.897x
2 700 1.6 23.0 Y = 1.005x
Technical Specifications
Dimensions: 160 x 140 x 70 mm (6.29 x 5.51 x 2.76 inches)
Weight: 500 g (1.10 pounds) (with batteries installed)
4 batteries type AA
Power adapter: CE marked
Only use adapters approved by HemoCue, as listed under
"Approved Adapters".
Pollution degree: 2
Overvoltage category: II
Atmospheric pressure: 700 hPa to 1060 hPa.
Equipment not suitable for use in the presence of flam-
mable mixtures.
The instrument is tested according to
• IEC/EN 61010-1, 2001
• IEC/EN 60601-1 2:nd edition clause 19, 20 and 57.10
(Leakage current, dielectric strength and insulation
distance)
• IEC/EN 60601-1-2
• IEC/EN 61326
and complies with the IVD Medical Device Directive
98/79/EC.
+ was verified against the The instrument is made for continuos mode.
Approved Adapters
Country: EU/US/UK
Type: FW7333M/12
Manufacturer: Friwo
Regres- Correla-
Input: 100-240 V AC, 50-60 Hz, 200 mA
sion line tion
coeffi-
Warnings
cient (r)
The device is tested according to standard IEC/EN 60601-
1-2 and is found to comply with the standard.
0.930
Despite this compliance it is impossible to predict any
+ 1.357
possible effects by other nearby standing instruments,
(stationary, portable or mobile units) or the possible
0.999
impact of electromagnetic radiance. This is the reason
-0.041
we need to inform users of this analyzer that disturbance
from other equipment might affect the performance of
the analyzer. Should you note that this is the fact, please
contact your local HemoCue distributor.
The HemoCue Hb 301 is intended for use in the electro-
magnetic environment specified in Technical specifica-
tions. The customer or user of the HemoCue Hb 301 sys-
tem should assure that it is used in such an environment.
The HemoCue Hb 301 Analyzer uses RF energy only for
its internal function. Therefore, its RF emissions are very
low and not likely to cause any interference in nearby
electronic equipment.
The HemoCue Hb 301 system is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Accessory equipment connected to the analog and digi-
tal interfaces must be certified according to the respec-
tive IEC standards (i.e. IEC 60950-1 for data processing
32