The Development of Monitoring System to Assist the Elderly or Physiotherapy Patients Through Communication Networks and the Development of Physiotherapy Equipment in Compliance with Medical Device Standard ISO 13485 with Case Study on Respiratory Therapy Devices

Abstract

This study is aimed to help the elderly and physiotherapy patients. A case study on respiratory therapy devices through communication networks was also undertaken using applied research method which comprised two parts: the development of monitoring system of physiotherapy through connection with server system and cloud service; and the development of physiotherapy devices in compliance with ISO 13485, from design to prototype development. The study found that the monitoring system of physiotherapy through communication networks and physiotherapy devices showed real time biofeedback. This could help the physiotherapists or rehabilitation physicians in monitoring the elderly or the physiotherapy patients on a continuous basis after leaving the hospital. The physiotherapists could also analyze the data and appropriately plan a distant physiotherapy process, and thus reduce the transportation and other burdens of the elderly or the patients. The test result of the respiratory devices in compliance with software standard IEC 62304 and electrical equipment standard IEC 60601-1 found that the devices could function according to the safety standard of medical equipment. However, this verification of standard of physiotherapy devices did not include the monitoring system.