Accu-Chek Mobile User Manual page 134

16
Technical data
Performance
assessment
Calibration and
traceability
The Accu-Chek Mobile blood glucose monitoring system complies with the requirements of
EN ISO 15197.
Declaration of conformity
The Accu-Chek Mobile blood glucose meter conforms with the basic requirements and other relevant
regulations of the European Directive 1999/5/EC on radio and telecommunications terminal equipment
(R&TTE). The conformity declaration may be found at the following Internet address:
http://declarations.accu-chek.com
132
The performance characteristics of the Accu-Chek Mobile system (Accu-Chek
Mobile meter and Accu-Chek Mobile test cassette) were determined using
capillary blood from patients with diabetes (system accuracy), venous blood
(repeatability) and control solution (intermediate precision).
The system is calibrated with whole blood containing various glucose
concentrations as a calibrator. The reference values are obtained using the
hexokinase method which is calibrated using the ID-GCMS method. The
reference method is traceable to a NIST standard using the ID-GCMS method,
which is the method of highest metrological quality (order).