Operation Manual

132
Technical data
16
Performance
assessment
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).
Calibration and
traceability
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).
Declaration of Conformity
Roche hereby declares that the radio equipment type Accu-Chek Mobile blood glucose meter is in
compliance with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following website:
http://declarations.accu-chek.com
man_08252963001_02_EN-AUS.indb 132 27.02.2018 10:12:52