Accu-Chek Compact Plus - Manual (Page 85)

Chapter 6: Technical Information 83
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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 on other electrically driven-equipment is not anticipated.
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 glucose. The reference values are obtained using the
glucose hexokinase method. For method comparison, the results were compared with results obtained using
the glucose hexokinase method with deproteinization (automatic analyzer). The glucose hexokinase method is
traceable to an NIST standard.
The ACCU-CHEK Compact Plus system meets the EN ISO 15197 requirements.
Measuring Principle
Determination of glucose in fresh capillary blood by reflectance photometry. When using different specimen
material, please refer to the package insert that came with the test strips.