Essential Performance; Technical Specifications - HemoCue Hb 301 Manuel D'utilisation

Point-of-care studies
Point-of-care studies have been performed at three individual district
health centers in primary care with both nursing and physician services.
The studies were performed on capillary samples in duplicates tested
on HemoCue Hb 301 vs HemoCue Hb 201
against the International Council for Standardization in Haematology
method (ICSH) 3 using venous blood (2).
Study N Min Max Regression
g/dL g/dL line
1 186 8.3 18.0 Y = 0.897x +
1.357
2 700 1.6 23.0 Y = 1.005x
-0.041

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, as listed under "Adapters".
Pollution degree: 2
Overvoltage category: II
Atmospheric pressure: 700 hPa to 1060 hPa.
Equipment not suitable for use in the presence of flammable mixtures.
The instrument is tested according to
IEC 61010-1, Second edition: 2001 and EN 61010-1: 2001, IEC/
EN 61010-2-101: 2002, IEC 61326-1: 2005 and EN 61326-1: 2006,
IEC 61326-2-6, First edition: 2005 and EN 61326-2-6: 2006, IEC
60601-1-2, Third edition: 2007 and EN 60601-1-2: 2007 and complies
with the IVD Medical Device Directive 98/79/EC.
The instrument is made for continuos mode.

Essential Performance

The essential performance is quantitative determination of hemoglobin
in capillary, venous or arterial whole blood.
AC Adapters
(1). The Hb 201 was verified
+ +
Region: EU/US/UK/Universal
Type: 12 V HCA01
Input: 100 V~-240 V~/50-60 Hz/≤250 mA
Correlation
coefficient (r)
0.930
0.999
38