Izdelava EKG naprave za 24 urno spremljanje srčne funkcije z upoštevanjem Uredbe o medicinskih pripomočkih 2017/745

Elektrokardiografija je neinvazivna metoda merjenja in snemanja električne aktivnosti srca. S pomočjo elektrokardiografije spremljamo delovanje srca, pri čemer merimo potencialne razlike med različnimi deli telesa ob srčni aktivnosti s pomočjo elektrod, ki zajemajo napetost v različnih točkah. Časovni zapis napetostnih razlik, ki jih izmerimo, imenujemo elektrokardiogram (EKG). Običajni EKG posnetek pacienta v mirovanju služi kot najbolj uporabljena metoda za ugotavljanje nepravilnosti v delovanju srca, vendar zelo pogosto ne pokaže različnih bolezenskih sprememb, ki se pri pacientu pojavljajo tekom dneva, tako ob naporu, kakor tudi v mirovanju. V tem primeru zdravnik predpiše 24-urni EKG monitor, ki omogoča celodnevno snemanje in shranjevanje EKG-ja pacienta v digitalni obliki. Uredba o medicinskih pripomočkih 2017/745 je namenjena uskladitvi zakonov, ki se nanašajo na medicinske naprave znotraj Evropske Unije. Vsak proizvajalec medicinskih pripomočkov, ki le-te želi prodajati, mora predložiti tehnično dokumentacijo naprave s katero dokazuje, da izpolnjuje vse zahteve, določene v Uredbi. S tem pridobi certifikacijsko oznako (ang. CE – certification mark) za evropski trg. V pričujočem magistrskem delu je prikazan razvoj 24-urne EKG naprave, ki meri električno aktivnost srca in rezultate shranjuje na pomnilniško kartico. Pri razvoju in izdelavi naprave smo upoštevali Uredbo o medicinskih pripomočkih 2017/745 tako, da smo preučili potrebno tehnično dokumentacijo, določili potrebne splošne zahteve glede varnosti in učinkovitosti ter priložili potrebne standarde za njihovo izpolnitev. Vse to v prihodnosti lahko pripomore k pridobitvi certifikacijske oznake za prodajo naprave na evropskem trgu. V uvodnem delu je opisana metoda elektrokardiografije in potreba po 24-urni EKG napravi. Sledi opis EKG elektrod, računanja EKG odvodov ter primer tipičnega EKG zapisa. V drugem poglavju je opisan razvoj strojne ter programske opreme. Opisan je podroben postopek izdelave prototipnega vmesnika za mikroprocesorsko ploščico Genuino 101, od začetka razvoja, blokovne sheme, potrebnih elementov, do končne sheme in prikaza naprave. Predstavljena je tudi programska oprema, uporabljena na napravi, z diagramom poteka ter načinom branja in shranjevanja rezultatov. Tretje poglavje je namenjeno tehnični dokumentaciji, kjer so opisani dokumenti in podane zahteve, ki jih moramo upoštevati pri dokazovanju skladnosti naprave z Uredbo. Na koncu so podani še zaključki, problemi in izzivi pri izdelavi naprave, možne izboljšave ter ideje za delo v prihodnosti.Electrocardiography is a non-invasive method for measuring and recording the electrical activity of the heart. With this medical method, we monitor the heart activity by measuring potential differences between different parts of the body using electrodes placed on the skin. The graph of voltage versus time, produced by this method is called an electrocardiogram (ECG). Although the ordinary ECG is the most common method used for detecting cardiac abnormalities, it does not always show different signs of heart issues that can be monitored during the day. In that case, the doctor prescribes a 24-hour ECG monitor, which allows recording and storage of the ECG signal in digital form. Medical Device Regulation 2017/745 is intended to harmonize the laws relating to medical devices within the European Union. Each manufacturer of medical devices, who wants to sell the medical device on the European market must submit technical documentation providing evidence of conformity with the Regulation in order to obtain certification mark (CE) for the European market. In this thesis we present the development of a 24-hour ECG device which measures the electrical activity of the heart and stores the results on a memory card. During the development and manufacturing phase, we took into account the Regulation by studying the technical documentation needed to obtain a certification mark, setting the general requirements regarding design and construction and providing the necessary standards for their fulfilment. The introductory part describes electrocardiography as a medical procedure and explains the need for a 24-hour electrocardiograph. A description of ECG electrodes, calculation of ECG leads and example of typical ECG signal are given. The second chapter describes the development of the hardware and software for the device. A detailed procedure for the development of a prototype ECG shield for Genuino 101 board is described, from the beginning with the block diagram and necessary elements for the circuit to the final schematic and interpretation of the device. The software used on the device includes a flow diagram, explanation of the working function of the device and description of the methods for reading and storing the results. The third chapter is dedicated to the technical documentation, where all necessary documents and requirements to demonstrate compliance with the Regulation are described. Finally, conclusions are given with all problems and challenges during the development of the device, possible improvements and ideas for future work