Accu-Chek Mobile User Manual - page 229
Technical data
229
Electromagnetic
compatibility
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 with other
electrically powered equipment is not to be anticipated.
Performance
evaluation
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 method comparison was conducted by comparing the results from the
system with those of the hexokinase method with deproteination using an automatic
analyzer. The hexokinase method is traceable to an NIST standard (traceability).
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 Directive 1999/5/EC. The conformity declaration may be found at the
following Internet address: http://mobile.accu-chek.com.