Chapter 6: Technical Information 75Protection class IIIMeter type The ACCU-CHEK Aviva meter is suitable for continuous operationAltitude Up to 10,150 feetLancing device depths 0.80, 0.95, 1.10, 1.25, 1.40, 1.55, 1.70, 1.85,2.00, 2.15, 2.30 mmElectromagnetic CompatibilityThis meter meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A. The chosen basis forelectrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, it meets the electro -magnetic emissions requirements as per EN 61326. Its electromagnetic emission is thus low. Interference fromother electrically driven equipment is not to be anticipated.Performance AnalysisThe performance data for the ACCU-CHEK Aviva system (ACCU-CHEK Aviva 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 variouslevels of glucose. The reference values are obtained using the hexokinase method. For method comparison, theresults were compared with results obtained using the hexokinase method with deproteinization (automatic analyzer).The hexokinase method is traceable to an NIST standard.The ACCU-CHEK Aviva system meets the EN ISO 15197 requirements.
