Analiza i poboljšanje pouzdanosti sustava za pomoć pri pozicioniranju medicinskih instrumenata u neurokirurgiji

master's thesis

• Title (english): Reliability analysis and improvement of a system for assisting the positioning of medical instruments in neurosurgery
• Author: Jurica Batišta
• Mentor: Mario Štorga (mentor)
• Mentor: Tomislav Martinec (komentor)
• Granter: University of Zagreb; Faculty of Mechanical Engineering and Naval Architecture; Zagreb
• Defense date and country: 2022-07-20, Croatia
• Scientific / art field, discipline and subdiscipline: TECHNICAL SCIENCES; Mechanical Engineering; General Mechanical Engineering (Construction)

Abstract

Pri razvoju novih proizvoda se sve veća pozornost pridodaje aspektima pouzdanosti i sigurnosti, što je posljedica sve kraćeg trajanja razvojnih projekata uzrokovana specifičnim potrebama i konkurencijom na tržištu. Posebna pažnja na sigurnost i pouzdanost također se obraća u specifičnim tehnološkim granama, kao što je razvoj medicinskih uređaja. Stoga je cilj ovoga rada dati pregled te provesti i diskutirati različite metode za analizu pouzdanosti i sigurnosti na primjeru medicinskog robota. Prilikom izrade rada, posebna pažnja je posvećena teorijskom uvodu i opisu izabranih metoda. Metode su izabrane na temelju pregleda dostupne literature u područjima sigurnosti medicinskih uređaja. Nakon odabira metoda, svaka je predstavljena i opisana, te je prikazan postupak njihove provedbe. Prema utvrđenim postupcima, provedene su detaljne analize pouzdanosti i sigurnosti NERO sustava. Dobiveni rezultati su prikazani i opisani, te su na temelju njih provedene konstrukcijske promjene kritičnih podsustava. Svrha konstrukcijskih promjena je postizanje veće pouzdanosti i sigurnosti sustava, ali i svojevrsni zapisi znanja u obliku vodilja za daljnji konstrukcijski razvoj sustava. Prilikom provedbe navedenih postupaka, odrađene su sve pripremne radnje koje se izvode na temelju postupka odabranih metoda. Također je prije same provedbe analiza ukratko predstavljen i opisan NERO sustav, za koji su provedene analize pouzdanosti i sigurnosti.

Abstract (english)

When developing new products, more and more attention is paid to reliability and safety aspects, which is a consequence of the shorter duration of development projects caused by specific needs and competition in the market. Special attention to safety and reliability is also paid within specific technological branches, such as the development of medical devices. Therefore, this thesis aims to provide an overview, implementation and discussion of different reliability and safety analysis methods with an example from a medical robot development project. When preparing the work, special attention was given to the theoretical introduction and description of the chosen methods. The methods were selected based on a review of the available literature in the fields of medical device safety. After selecting the methods, each is presented and described, and the procedure for their implementation is laid out. According to established procedures, detailed analyses of the NERO system's reliability and security were carried out. Finally, the obtained results are presented and described, with design changes to critical subsystems made based on them. The design changes aim to achieve higher reliability and safety of the overall system but also to record knowledge needed to guide further system development. During the implementation of the above-mentioned procedures, all preparatory actions were carried out based on the selected methods. Also, before the actual implementation of the analysis, the NERO system is briefly presented and described, for which the reliability and security analyses were carried out.

• Keywords: Pouzdanost; sigurnost; rizik; FMEA analiza; analiza rizika.
• Keywords (english): Reliability; safety; risk; FMEA analysis; risk analysis.
• Language: croatian
• URN:NBN: urn:nbn:hr:235:554729
• Study programme: Title: Mechanical Engineering; Study programme type: university; Study level: graduate; Academic / professional title: magistar/magistra inženjer/inženjerka strojarstva (magistar/magistra inženjer/inženjerka strojarstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Embargoed access; Embargo expiration date: 2027-07-13
• Created on: 2022-07-13 13:13:53