A simulation approach to certify electrocardiography devices

Electrocardiography (ECG) devices record the heart´s electrical activity. These devices can be part of e-Health systems used to diagnose, treat, and monitor patients with cardiovascular diseases. Manufacturers must show to regulatory agencies the effectiveness of devices during the certification process. Nowadays, simulators are used to test and calibrate ECG devices. Besides, manufacturers can use formal methods to specify ECG device requirements to increase dependability. In this context, it is necessary to validate formal models to provide confidence in the specification. Validations can be performed comparing models and physical devices using the same data generated from simulators. However, the simulators available in the market do not enable one to control the amplitude and frequency of signals. This makes difficult the use of the same data into formal models and physical devices. We present in this paper an open and low cost ECG simulator to validate models of ECG devices. The simulator generates ECG signals from digitized characteristic and noise waveforms. We analyzed the quality of the simulator qualitatively using the MATLAB and the Proteus software.