| Summary: | 碩士 === 國立臺灣大學 === 電子工程學研究所 === 101 === Medical devices, which used to be designed by users with medical background, such as doctors, technicians, and other medical staff, have become insufficient for today’s needs because of there are more and more non-medical background users.
Design methods regulated by United States Food and Drug Administration (FDA) offers a refined solution for the problems in medical device design, as they do in many other medicine fields. In this study, applying these methods to the medical device design process, especially in telehealth system design, is going to be examined.
In this thesis, we propose a digital mobile healthcare system, which integrates wearable sensors, smart phone, and National Taiwan University Hospital (NTUH) telehealth center, to facilitate the management of point-of-care. The system utilizes wireless connection between wearable sensors and mobile devices with Bluetooth interface to automatically collect physiological signal, such as blood oxygen saturation, blood glucose, blood pressure, and electrocardiography (ECG). It allows users, especially seniors with chronic diseases, to conveniently record daily measurement results and track long term health condition changes regardless of their locations.
For interoperability consideration, we design our system as a ContinuaR- compatible manager. We also perform clinical trial in NTUH to validate our system usability.
FDA regulatory decision and security issue are also discussed in the thesis.
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