Accu-Chek Mobile User Manual page 240

18 Technical data
Electromagnetic
compatibility
Performance
evaluation
The Accu-Chek Mobile blood glucose monitoring system complies with the requirements of eN ISo 15197.
Roche diagnostics hereby declares that the Accu-Chek Mobile blood glucose meter conforms with the basic re-
quirements and other relevant regulations of the european directive 1999/5/eC. The conformity declaration may be
found at the following Internet address: http://mobile.accu-chek.com.
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This instrument meets the electromagnetic immunity requirements according to
eN ISo 15197 Annex A. The chosen basis for the immunity tests (on electrostatic
discharge) was basic standard IeC 61000-4-2.
In addition, the instrument meets the electromagnetic emissions requirements accor-
ding to eN 61326. Its electromagnetic emission is thus low. Interference on other
electrically-driven equipment is not anticipated.
The performance data for the Accu-Chek Mobile system (Accu-Chek Mobile meter with
Accu-Chek Mobile test cassette) were determined using capillary blood from patients
with diabetes (method comparison, accuracy), venous blood (repeatability) and control
solutions (reproducibility). The system is calibrated with venous blood containing
various levels of glucose. The reference values are obtained using the hexokinase
method. The reference method is traceable to a NIST standard using the Id-GCMS
method, which is the method of the highest metrological quality. The method compari-
son was conducted by comparing the results from the system with those of the
hexokinase method with deproteinization using an automatic analyzer.