User`s manual

237

For sighted persons: Using the meter and cleaning the devices

Safety class III

LED/IRED Class 1

Electromagnetic compatibility

This device meets the electromagnetic immunity requirements as per ISO 15197 Annex A. The

chosen basis for the immunity tests (for electrostatic discharge) 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 powered equipment is

not expected.

Performance analysis The performance data for the Accu-Chek Compact Plus system (Accu-Chek Compact Plus

meter with Accu-Chek Compact 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 glu-

cose. The reference values are obtained using the hexokinase method. For method comparison,

the results were compared with results obtained using the hexokinase method with deproteini-

zation (automatic analyzer). The hexokinase method is traceable to an NIST standard.

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