ECG calibration signal database construction based on IEC 60601-2-25 using MATLAB

Abstract

ECG machines should be calibrated and tested to assure their accuracy. IEC 60601-2-25 standard described signals for calibrating ECG amplitudes and frequencies. The problem was this standard does not clearly describe the formulas of the calibration signals nor the complete database of these signals. The aim of this study was to get a database of ECG calibration signals for testing based on IEC 60601-2-25 standard clause 201.12.1.101. Data were constructed with a series of sinus function in Matlab software to simulate P, Q, R, S, and T segments. The data were visually and statistically compared with the data from commercial CTS database. Data were constructed for 3 different lead of 12 ECG calibration data. Four ECG calibration data with elevation or depletion ST segment were excluded from this study. This study demonstrated that these ECG calibration signals were slightly visually different and statically had differences in some of S wave and most of T wave. This data can be used by designers or manufactures, but for the testing laboratory is recommended using a commercial product.