Intercomparison of simulators used for the inspection of non-invasive blood pressure meters and new regulatory framework for medical devicesMAHMUTAJ, ERMIRA (Avtor) Begeš, Gaber (Mentor) Geršak, Gregor (Komentor) NIBP simulatorblood pressure measurementsNIBP monitorsmedical device legislationmedical device regulationMedical devices are of extreme importance for diagnosing and treatment of diseases. To ensure the proper diagnosis or treatment, it is of high importance that the devices are in good condition. A problem in the functioning of the device might lead in considerable consequences for the patient. For this reason, medical device verification is very important. This thesis concentrates on the role of metrology in the field of health care and the new regulatory framework for medical devices. Changes regarding the old and new legislation are presented as well. For the experimental part of the thesis, we have compared three different Noninvasive blood pressure (NIBP) simulators for different settings of systolic and diastolic pressure. We used a Clinical Dynamics Smart Arm NIBP simulator from LMK at the Faculty of Electrical Engineering in Ljubljana, Clinical Dynamics AccuSim Handheld NIBP simulator owned by KMA – Kosovo Metrology Agency and Rigel UNI-SIM NIBP simulator owned by a private medical equipment company in Kosovo N.T.SH MAM. Statistical methods according to ISO 13528 were used to compare the three simulators where En number was used to compare the simulators. Three blood pressure monitors: Omron M2, Omron M6, and Microlife BP A100 Plus were used as transfer standards to compare the three simulators. Clinical Dynamics Smart Arm NIBP simulator from LMK Laboratory was considered as reference simulator, therefore at the end of measurements one more cycle of measurements were performed to close the cycle of measurements. In addition, inspection of three NIBP monitors with three simulators were performed according to OIML R 149:2020. We used five different blood pressure settings as follows: 80/50, 100/70, 120/80, 150/100, 180/130. The pulse rate was set at 80 bpm in each case. For each simulator and each of the settings 10 measurements of systolic and diastolic pressure were taken. Our goal was to assess if En it is also suitable to compare NIBP simulators. We used three different transfer standards to compare the simulators, but also to assess how important it is that the transfer standard is in good condition by using a new monitor (Omron M2), used monitor (Omron M6) and worn-out monitor (Microlife). Finally we found out that En number is suitable for comparing simulators when the NIBP monitor used is within the tolerance limits prescribed in OIML R 149:2020. Disadvantages of using En number were found out for evaluation of results when using a worn-out NIBP monitor.[E. Mahmutaj]20212021-06-18 07:20:00Magistrsko delo/naloga127650VisID: 55901COBISS_ID: 67677699sl