Uma solução baseada em simulação para a validação de sistemas de aquisição de sinais biomédicos

Abstract

Biomedical signal acquisition systems are relevant for patient monitoring and diagnosis. Therefore, such systems must comply with current regulatory standards and undergo periodic maintenance, in accordance with the requirements defined in normative resolutions of the Ministry of Health and the National Health Surveillance Agency. Thus, the objective of this work is to define a reliable simulation-based approach to assist manufacturers, validation agencies, and healthcare facilities (in a maintenance context) in the validation of multiple equipment or biomedical signal acquisition systems. The proposed approach consists of two parts that complement each other: the software embedded in a computing device, represented by a graphical user interface, formal application logic model based on Colored Petri Nets (CPN) with a frequency-based filtering method; and the hardware, represented by a Biomedical Signals Transceiver (TSB) device, configurable by software, specially designed to work with ECG, EEG, EMG and EGG signals. The system was validated using Physionet’s database and comparison tests to verify expected signal and signal outputs based on MATLAB filters and Instramed’s commercial ECG instrument ENGC901448. The system has proven to be reliable, cost-effective, portable and relevant to provide evidence for certification and assist healthcare facilities in performing calibrations and maintenance.