A Coloured Petri Nets-Based System for Validation of Biomedical Signal Acquisition Devices

Abstract

Biomedical signal acquisition devices (e.g., Electrocardiography - ECG) are relevant for diagnosing and monitoring persons who developed a variety of diseases, such as cardiovascular diseases. These devices comply with regulatory requirements before being marketed to prevent misleading measures, and they should also pass through corrective and preventive maintenance to keep them working correctly. We designed and implemented a simulation-based system to support these needs to assist manufacturers and healthcare facilities. This article focuses on demonstrating the effectiveness of our system for validating ECG devices. Our system comprises software in a computing device and a biomedical signals transducer. The system relies on Coloured Petri Nets (CPN) modeling language, a frequency-based filtering method, and publicly available databases. We validated the system using the Physionet database and comparison tests to verify the expected signal and outputs based on MATLAB filters and the commercial ECG device ENGC901448 from Instramed. The system was proven reliable, low-cost, and portable. Our proposal is relevant to provide evidence for certification and assisting healthcare facilities in conducting testing and corrective and preventive maintenance.