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Modern Digital Interfaces for Personal Health Monitoring Devices

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Modern Digital Interfaces for Personal Health Monitoring Devices Tampereen teknillinen yliopisto. Julkaisu 858 Tampere University of Technology. Publication 858 Sakari Junnila Modern Digital Interfaces for Personal Health Monitoring Devices Thesis for the degree of Doctor of Technology to be presented with due permission for public examination and criticism in Tietotalo Building, Auditorium TB222, at Tampere University of Technology, on the 27th of November 2009, at 12 noon. Tampereen teknillinen yliopisto - Tampere University of Technology Tampere 2009 ISBN 978-952-15-2277-2 (printed) ISBN 978-952-15-2281-9 (PDF) ISSN 1459-2045 ars longa, vita brevis ii Abstract The objectives of this work were to find out what interfacing technologies and emerging standards can be adopted from the personal computer market to medical devices targeted for personal and home use, and to gain understanding of technical and regulatory limitations regarding their use in medical applications through implementing prototypes of these interfaces. The growing demand for home health care services, attributed to the increase in population of elderly people in the society, requires development of new remote and home health care systems and services which can utilize cost-effective PC technologies and devices already present at homes. The Thesis studies modern digital interface technologies, emerging standards and their use in medical devices. The interface technologies of interest are computer system peripheral in- terfaces and wireless personal area networking (PAN) technologies. The work aims at gaining understanding of technical and regulatory limitations and benefits regarding their use in medical applications, especially in personal health monitoring applications at home. Several steps are taken and prototypes built to assess the feasibility of these technologies and to obtain results usable in practical design cases. The Thesis also presents the current state of medical device regulation and standardization, of which the latter especially has been under rapid development over the recent years. Although the safety aspects of the developed implementations are ad- dressed, the Thesis does not cover the full scope of risk analysis of networked medical devices or medical device software. The introductory part of the Thesis begins with the presentation of currently used digital interfaces and their design. Then, the medical device is defined, and safety, regulation, standard- ization, security, and privacy issues related to medical devices are presented, including current state of medical device interface standardization. Also, the use of PC and consumer electronics technology in medical devices and how medical device networking is changing the medical device design are discussed. The concept of personal health monitoring and its applications at home are presented, followed by a presentation of health monitoring needs and applications in various healthcare facilities. Finally, the direct contributions to the field of personal health monitoring system and device design contained in this work and derived conclusions are presented. A method for interfacing medical sensory devices of a commercial patient monitoring sys- tem to a standard PC was developed. This work shows how medical devices can be connected iii iv Abstract using a standard cable based (USB) interface, and presents different hardware implementation strategies and software related issues. Cable connected devices are more vulnerable to electrical hazards than wireless devices. This can be alleviated by electrical isolation of the cable inter- face. Different isolation strategies were studied and a method to isolate USB data signals was developed. A medical monitoring chair for ballistocardiogram (BCG) recording with a novel electrome- chanical film sensor based method was implemented both as a traditional analog amplifier design and as a wireless digital measurement system. The analog system was used in a clinical trial to gain experience of the medical device approval process. The digital system is shown to provide similar signal quality as the analog system with less costly equipment and with increased device mobility. The work also provides insight into the different data transfer needs of various human originated signals. Methods and technologies for wireless medical data-acquisition systems were studied and demonstrated. The application areas for wireless PAN devices in hospitals were surveyed and technologies assessed. The IEEE 802.15.4 wireless interface technology was selected for a wireless medical monitoring system (BCG chair) and further sensor network implementations. Network- ing of personal healthcare devices using the selected technology was studied by implementing a wireless sensor network. The interface technology was expanded to support networking by adding a Zigbee network communication protocol layer. Personal health monitoring devices were attached to the sensor network and fitted to a real-life home apartment. Current medical devices rely much on proprietary interfaces and even more on proprietary data presentation models making if often impossible to use devices from different manufactures together. The main claim of this work is that standardized interfaces should be used in med- ical devices to obtain reliable, safe, and more interoperable devices cost-effectively. A higher level standard to specify common nomenclature for physiological variables and to enable com- munication across different interface technologies is also needed, and attempts to develop one exist. Acknowledgments The research work presented in this Thesis has been accomplished in the Department of Sig- nal Processing and of Department of Computer Systems at Tampere University of Technology (TUT), Tampere, Finland. I wish to express my gratitude to my supervisors Adjunct Prof. Alpo V¨arri and Adjunct Prof. Jarkko Niittylahti for their support and guidance, and for making it possible to carry out the research presented in this Thesis. It was Adjunct Prof. Niittylahti how induced and motivated me to an academic career as a third year masters student, and supervised my work in the Department of Computer Systems until the end of his professorship. It is greatly thanks to Adjunct Prof. V¨arri, who took me into his research group in the Department of Signal Processing, that I could carry out my thesis work to this end. I would like to thank the reviewers of my Thesis, Malcolm Clarke, Ph.D., and Prof. Raimo Sepponen for their time and efforts and especially for their in-depth and constructive comments on the manuscript. I am also thankful for Prof. Irek Defee and Prof. Jari Hyttinen with whom I have had the privilege to work with. I would also like to thank my co-authors, friends and colleagues of the past years at Tampere University of Technology, especially Alireza Akhbardeh, Dr. Tech., Juha Alakarhu, Dr. Tech., Jarmo Alamets¨a,M.Sc., Magnus Armholt, M.Sc., Laurentiu Barna, Dr. Tech., Florean Curtica- pean, Dr. Tech. Harri Kailanto, M.Sc, Mikko Koivuluoma, M.Sc, Jouni Paulus, M.Sc., Jarkko Ruoho, Tero Sihvo, M.Sc., Jarno Tanskanen, Dr. Tech., Riku Uusikartano, M.Sc., Antti-Matti Vainio, M.Sc., Antti Vehkaoja, M.Sc., and Mari Zakrzewski, M.Sc. During the past years, I have had the pleasure to work in collaboration with GE Health- care Finland (formerly Datex-Ohmeda), Nokia, VLSI Solution, Tampere University Hospital, Arcticare Technologies, Kotosalla-s¨a¨ati¨o,Lemp¨a¨al¨ansosiaali- ja terveystoimi (Lemp¨a¨al¨aSocial Welfare and Health Services), STT Condigi (formerly Pikosystems), Suomen ensiapupalvelu, TeliaSonera, Tieto (formerly TietoEnator), Turun Orthofysio, UPM-Kymmene Corporation, VTT Technical Research Centre of Finland, YH L¨ansi,University of California, Aarhus Uni- versity, Alexandra Institute and the TUT departments of Automation Science and Engineering, Biomedical Engineering, Electronics, and Mechanics and Design. I would especially like to thank V¨ain¨oTurjanmaa, MD, Ph.D., Dos. Tiit K¨o¨obi,MD, Teemu Koivistoinen, M.Sc., MD., v vi Acknowledgments and Marjaana Sipil¨a,BM, RN, and Pirjo J¨arventausta, RN, Tampere University Hospital, Prof. Jukka Lekkala, Lab. Mgr. Jarmo Poutala, Sr. Lab. Tech. Seppo Mikkola, Lasse Kaila, M.Sc., Jarmo Verho, M.Sc., and Timo Vuorela, M.Sc from Tampere University of Technology, Juho Merilahti, M.Sc, from VTT Technical Research Centre of Finland, Simon B. Larsen, Ph.D., from the Alexandra Institute, and Aki Backman, M.Sc., MBA, and Markku Roiha, M.Sc. from the former Datex-Ohmeda, for their contributions, including comments, guidance, performed measurements, and technical assistance. The financial assistance from the following funding organizations and programmes is hereby greatly acknowledged: The Finnish Funding Agency for Technology and Innovation (Tekes) - Electronics for the Information Society Technology Programme (ETX) (1997-2001), The Academy of Finland - The Finnish Centre of Excellence Programme (2000-2005) and The Proactive Infor- mation Technology Programme (2002-2005), Tampere Graduate School in Information Science and Engineering (TISE), Industrial Research Fund at the Tampere University of Technology - Pekka Ahonen foundation, and Finnish Cultural Foundation - Artturi and Aina Helenius Foun- dation. I wish to express my deepest gratitude to my parents, Kirsti and Jyrki Junnila, and to all my relatives and friends for their support and encouragement through my studies. Most of all, I thank you Heidi, for your loving support. Tampere, November 2009 Sakari Junnila Abbreviations AIMD Active Implantable Medical Devices A/D Analog
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