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Abstract(s)
A maioria dos dispositivos médicos são alvos de manutenção preventiva pelo fabricante/representante, e por fornecedores multimarca. Todos eles possuem procedimentos diferentes, sendo que para validação dos resultados obtidos, consideram critérios de aceitação diferentes, não existindo consenso no critério de aceitação dos equipamentos mencionados. Estas incongruências estimularam a necessidade de criar um procedimento completo e detalhado para monitores multiparamétricos, de modo a melhorar a fiabilidade das medições utilizadas no apoio ao diagnóstico clínico. No presente documento, tendo por base monitores multiparamétricos, pretendeu-se construir um procedimento de manutenção preventiva detalhado considerando o instituído nas normas IEC 60601-1, IEC 62353, ISO/IEC 17025, IEC 6061-2-X, IEC 80601-2-x e ISO 80601-2-x. Este procedimento visa a estrutura recomendada na norma IEC 62353, sendo dividido em 4 partes fundamentais: Inspeção Visual, Teste de Segurança Elétrica, Testes de Desempenho e Calibrações. No que diz respeito aos critérios de aceitação, foram considerados os intervalos estipulados pelas respetivas normas. Uma das diferenças face aos procedimentos atuais é a análise do erro, dado que estas não consideram as incertezas existentes, quer seja durante as medições, quer nos monitores e simuladores utilizados. A negligência da incerteza, pode levar à incorreta validação da operacionalidade do dispositivo. Neste estudo foram avaliados 12 monitores multiparamétricos, de um serviço crítico, seguindo o procedimento proposto. Os equipamentos são todos da mesma marca e modelo, a fim de se poder avaliar o erro máximo médio, referente ao respetivo modelo, assim como a estabilidade e padrão de funcionamento destes. Adicionalmente, nos ensaios de pressão arterial, utilizou-se uma braçadeira de uma marca diferente do dispositivo, com o intuito de analisar o comportamento e viabilidade desta, face à do OEM. O procedimento desenvolvido permitiu verificar a necessidade de criar legislação, no que diz respeito à metrologia dos equipamentos médicos, mostrando-se promissor na avaliação dos monitores multiparamétricos.
Biggest part of the medical devices are targets of preventive maintenance from the manufacturer/representative, and from the multi-brand suppliers. All of them have different procedures, and the output validation values encounters different acceptance criteria, which may lead to non consensual acceptance conclusions. These incongruences stimulated the urge to create a complete and detailed procedure for multi-parameter monitors. By improving measurement reliability, one can expect to contribute to better decision making at the clinical level. In this document the focus is on multiparametric monitor devices, a detailed preventive maintenance procedure is presented, that takes in consideration standards IEC 60601-1, IEC 62353, ISO/IEC 17025, IEC 80601-2-x, ISO 80601-2-x and IEC 6061-2-X. The key procedure relies on the standard IEC 62353, and it’s divided in 4 core parts: Visual Inspection, Electrical Safety Test, Performance Test and Calibrations. The proposed acceptance criteria are based on the specified values from the mentioned standards. Another difference between this procedure and existing ones, is the error analysis, which takes in consideration uncertainties, either within measurements, or in the monitor devices and simulators. Neglecting uncertainty, may induce wrong conclusions regarding the device working conditions. In this study, 12 multiparametric monitor devices have been evaluated, from an hospital critical care service, following the proposed procedure. The devices are from the same brand and model, with the goal to evaluate the maximum mean error, referred to the respective model, as the stability and the operating pattern of them. Additionally, in the blood pressure tests, a different brand armlet was used, in order to analyse its behaviour and viability, when compared to the OEM. The proposed procedure overcomes some of the limitations identified and the results indicate that could be used in the evaluation of multiparametric monitors.
Biggest part of the medical devices are targets of preventive maintenance from the manufacturer/representative, and from the multi-brand suppliers. All of them have different procedures, and the output validation values encounters different acceptance criteria, which may lead to non consensual acceptance conclusions. These incongruences stimulated the urge to create a complete and detailed procedure for multi-parameter monitors. By improving measurement reliability, one can expect to contribute to better decision making at the clinical level. In this document the focus is on multiparametric monitor devices, a detailed preventive maintenance procedure is presented, that takes in consideration standards IEC 60601-1, IEC 62353, ISO/IEC 17025, IEC 80601-2-x, ISO 80601-2-x and IEC 6061-2-X. The key procedure relies on the standard IEC 62353, and it’s divided in 4 core parts: Visual Inspection, Electrical Safety Test, Performance Test and Calibrations. The proposed acceptance criteria are based on the specified values from the mentioned standards. Another difference between this procedure and existing ones, is the error analysis, which takes in consideration uncertainties, either within measurements, or in the monitor devices and simulators. Neglecting uncertainty, may induce wrong conclusions regarding the device working conditions. In this study, 12 multiparametric monitor devices have been evaluated, from an hospital critical care service, following the proposed procedure. The devices are from the same brand and model, with the goal to evaluate the maximum mean error, referred to the respective model, as the stability and the operating pattern of them. Additionally, in the blood pressure tests, a different brand armlet was used, in order to analyse its behaviour and viability, when compared to the OEM. The proposed procedure overcomes some of the limitations identified and the results indicate that could be used in the evaluation of multiparametric monitors.
Description
Trabalho Final de Mestrado para obtenção do grau de Mestre em Engenharia Biomédica
Keywords
Equipamento médico Monitor multiparamétrico Ensaio Manutenção Procedimento Medical devices Multiparametric monitor Testing Maintenance Procedure
Citation
MOTA, Vanessa Sofia da Silva – Planos de manutenção preventiva de monitores multiparamétricos. Lisboa: Instituto Superior de Engenharia de Lisboa e Escola Superior de Tecnologia da Saúde de Lisboa, 2018. Dissertação de Mestrado.
Publisher
Instituto Superior de Engenharia de Lisboa e Escola Superior de Tecnologia da Saúde de Lisboa