Modern Digital Interfaces for Personal Health Monitoring Devices
Junnila, Sakari (2009)
Tampere University of Technology
2009
Tieto- ja sähkötekniikan tiedekunta - Faculty of Computing and Electrical Engineering
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tty-200911177132
https://urn.fi/URN:NBN:fi:tty-200911177132
Tiivistelmä
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 interfaces 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 addressed, 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, standardization, 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 system to a standard PC was developed. This work shows how medical devices can be connected 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 interface. 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 electromechanical 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. Networking 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 medical 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 communication across different interface technologies is also needed, and attempts to develop one exist.
The interface technologies of interest are computer system peripheral interfaces 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 addressed, 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, standardization, 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 system to a standard PC was developed. This work shows how medical devices can be connected 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 interface. 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 electromechanical 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. Networking 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 medical 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 communication across different interface technologies is also needed, and attempts to develop one exist.
Kokoelmat
- Väitöskirjat [4924]