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A coloured Petri nets-based system for validation of biomedical signal acquisition devices

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Abstract

Biomedical signal acquisition devices (e.g., Electrocardiography—ECG) are relevant for diagnosing and monitoring persons who have 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 and 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 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 providing evidence for certification and assisting healthcare facilities in conducting testing and corrective and preventive maintenance.

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Data availability

The data used in this article are publicly available on the PhysioNet database [36].

Notes

  1. https://bit.ly/3QJ8NUS.

  2. Regulatory agencies, such as the FDA, typically mandate medical device manufacturers to maintain assurance cases to provide evidence of correct functioning.

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Acknowledgements

The authors acknowledge the support provided by the Virtus Research, Development, and Innovation Center, including the VIRTUS-CC (EMBRAPII VIRTUS Competence Center – Intelligent Hardware for Industry), at the Federal University of Campina Grande. EMBRAPII (Brazilian Company for Industrial Research and Innovation) has made this initiative possible through funding from the Brazilian Ministry of Science and Technology (MCTI) under the PPI HardwareBR program. The authors also acknowledge the support provided by the Alagoas Research Foundation.

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Author notes

  1. José Irineu Ferreira Júnior, Álvaro Sobrinho, Leandro Dias da Silva, Paulo Cunha, Thiago Cordeiro, Angelo Perkusich, Antonio Marcus Nogueira Lima have contributed equally to this work.

Authors and Affiliations

  1. Electronics, Federal Institute of Alagoas, Rodovia estadual AL-110, Arapiraca, AL, 57.317, Brazil

    José Irineu Ferreira Júnior, Leandro Dias da Silva & Thiago Cordeiro

  2. Computing Institute, Federal University of Alagoas, Av. Lourival Melo Mota, S/n, Maceió, AL, 57072-900, Brazil

    José Irineu Ferreira Júnior & Paulo Cunha

  3. Center for Technological Innovation and Entrepreneurship, Federal University of the Agreste of Pernambuco, Av. Bom Pastor, s/n, Garanhuns, PE, 55292-270, Brazil

    Álvaro Sobrinho

  4. Department of Electrical Engineering, Federal University of Campina Grande, R. Aprígio Veloso, 882, Campina Grande, PB, 58429-900, Brazil

    Angelo Perkusich & Antonio Marcus Nogueira Lima

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  1. José Irineu Ferreira Júnior
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JIFJ, AS, LDS, PC, TC, AP, and AMNL contributed equally to this work.

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Correspondence to Álvaro Sobrinho.

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Júnior, J.I.F., Sobrinho, Á., Silva, L.D.d. et al. A coloured Petri nets-based system for validation of biomedical signal acquisition devices. J Supercomput 80, 14242–14271 (2024). https://doi.org/10.1007/s11227-024-06012-0

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