[pt] Observa-se um crescente interesse na determinação da incerteza de medição para a avaliação de conformidade e garantia da qualidade, principalmente nos setores de meio- ambiente, segurança, saúde e indústria, nos quais o resultado da medição é considerado crítico por lidar diretamente com seres humanos. Na medição da pressão arterial, conforme estudos realizados em países como a Austrália, Inglaterra, Turquia e Brasil, observa-se uma grande preocupação com a confiabilidade dos resultados obtidos por esfigmomanômetros mecânicos não invasivos. Nestes estudos, erros de até 4,4 kPa (33 mmHg) foram encontrados nos instrumentos avaliados, contra o valor de erro máximo de 0,53 kPa (4 mmHg) definido na OIML R 16-1:2002. Atualmente, a avaliação da confiabilidade dos esfigmomanômetros mecânicos é obtida considerando apenas o erro de medição, sem considerar a incerteza de medição. Com a motivação de contribuir para a garantia da confiabilidade metrológica dos esfigmomanômetros mecânicos não invasivos, usados mundialmente em hospitais e residências, o presente trabalho tem por objetivo associar a incerteza de medição na avaliação da confiabilidade metrológica destes instrumentos. Para a realização das medições foi montado um aparato envolvendo instrumentos de monitoração ambiental conforme recomendações internacionais (OIML R-16-1:2002) e nacionais (ABNT NBR-14105:1998 e NIEDIMEL- 006). Os dados do presente trabalho foram obtidos por meio de medições diretas em esfigmomanômetros novos e usados utilizando um padrão de pressão. Foram avaliados: o erro de medição, a histerese, o erro fiducial e a incerteza de medição. Os resultados obtidos com o presente trabalho mostram que, em função da incerteza de medição, o erro máximo permissível de 0,53 kPa (4 mmHg) pode não fornecer a confiabilidade adequada. Se for considerado apenas o erro de medição do manômetro conforme a OIML R 16- 1:2002, 60 % dos esfigmomanômetros avaliados foram aprovados. Se for considerado o erro e a incerteza de medição do manômetro, conforme proposto, apenas 12 % dos esfigmomanômetros foram aprovados. Com base nos resultados obtidos no presente trabalho, propõe-se reduzir o erro máximo admissível para estes instrumentos, incorporando a incerteza de medição, sem a necessidade de realizar na prática o seu cálculo. Com base nos resultados do presente trabalho recomenda-se uma revisão na faixa de erro máximo permissível na avaliação da OIML, em conjunto com a proposta de uma nova especificação do manômetro usado nos esfigmomanômetros, com redução do erro intrínseco e melhora de sua resolução. / [en] It is observed an increasing interest on the estimation of measurement uncertainty to deciding on conformity and quality assurance, mainly in the fields of environment, safety, health and industry, in which the measurement results are critical once they directly deal with human beings. According to studies performed in Australia, England, Turkey and Brazil, a great concern is observed with the reliability of the results obtained for blood pressure measurements by noninvasive mechanical sphygmomanometers. In these studies, errors of up to 4,4 kPa (33 mmHg) were obtained in the evaluated instruments, against the value of maximum error of 0,53 kPa (4 mmHg) required by OIML R 16-1:2002. Nowadays, the evaluation of the reliability of these measurement instruments for medical diagnosis is obtained considering only the measurement error (according to OIML R 16-1:2002), without taking into account the measurement uncertainty. Motivated to contribute for the metrological reliability of non- invasive mechanical sphygmomanometers, globally used in hospitals and residences, the present work aims at developing a model to associate the measurement uncertainty on the metrological reliability evaluation of these instruments. In order to perform the measurements with the sphygmomanometers, a set-up were prepared with environmental monitoring according to international recommendation (OIML R-16:2002) and national standards (ABNT NBR-14105:1998 and NIE-DMEL-006). The data of the present work were obtained by means of direct measurements in new and in use sphygmomanometers, utilizing a pressure pattern. Calculation of the following parameters was performed: measurement error, hysteresis, fiducial error and measurement uncertainty. The obtained results show that, as a function of the measurement uncertainty, the maximum permissible error of 0.53 kPa (4 mmHg) can be overcome. Considering the manometer measurement error, according to OIML R 16-1:2002, 60 % of the non- invasive mechanical sphygmomanometers evaluated were approved. When considering not only the measurement error, but also measurement uncertainty of the manometer, only 12% of the non-invasive mechanical sphygmomanometers were approved. Based on the present results, a reduction of the maximum permissible error for these instruments, incorporating the measurement uncertainty, without the need to calculate it in the verification procedure, is proposed. This work recommends not only a review of OIML maximum permissible error for sphygmomanometers, but also proposes a new configuration of the instrument, with reduction of intrinsic error and improvement of resolution.

A study was performed on a recently developed prototype of the Yong-Geddes surrogate arm design to collect compliance data of the various system components and determine the accuracy of measurements made through the bench top model. The study was performed to perceive the effectiveness of the model as a tool for validating non-invasive blood pressure detection monitors. Three stages of testing were performed to gather pressure and volume data from an artificial artery component, a sphygmomanometer, and the surrogate arm system to produce compliance estimations. Mathematical equations from supported arterial hemodynamics studies and clinical trials were applied to the pressure and volume data. Dr. Drzewiecki’s equation for arterial compliance was capable of predicting the region of the highest compliance of the artificial artery and produced an overall value of 38.81% for the data. A second degree inverse polynomial was developed and modeled the sphygmomanometer compliance measurements with a of 99.09%. Significant error was observed throughout all stages of the compliance testing, which was attributed to factors such as excessive noise due to faulty data collection equipment and irreparable leaks in the fluid flow system.

Student Number :9900127Y - MSc (Eng) dissertation - Faculty of Engineering and the Built Environment / Arterial pulse wave analysis studies the wave shape of the blood pressure pulse. The pulse wave provides more information than the extreme systolic and dia- stolic pressures, measured with a cuff sphygmomanometer. The aim of the research is to investigate the design issues in a pulse wave analysis system, and to compare these to a commercially available system. The system was compared and validated by measuring the pulse wave at the radial artery (wrist) using the non-invasive technique of arterial tonometry. The design conformed to the IEC-601 safety standard to ensure patient safety. The data was compared against the data from the commercial system and analysis was performed in the time and frequency domain. The performance of the design suggests that, in some respects, the design was comparable to the commer- cial system, however, a number of performance characteristics fell short of the commercial system. Suggestions have been made to address these problems in further research.