Product Safety Information - Accu-Chek Aviva Expert Standard Owner’s Booklet

9.4 Product Safety Information

Electromagnetic Compatibility
This meter meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A. The chosen
basis for electrostatic discharge immunity testing was basic standard Iec 61000-4-2. In addition, it meets
the electromagnetic emissions requirements as per EN 61326. Its electromagnetic emission is thus low.
Interference from other electrically driven equipment is not to be anticipated.
Performance Analysis
The performance data for the Accu-chek Aviva Expert system (ACCU‑CHEK Aviva expert meter with
ACCU‑CHEK Aviva test strips) were obtained using capillary blood from diabetic patients (method comparison,
accuracy), venous blood (repeatability), and control solution (reproducibility). The system is calibrated with
venous blood containing various levels of sugar. The reference values are obtained using the hexokinase
method. For method comparison, the results were compared with results obtained using the hexokinase m
ethod with deproteinization (automatic analyzer). The hexokinase method is traceable to an NIST standard.
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