Electro - Mechanical Safety Test of Portable ECG Devices for e - healthcare Application

& Drug Administration (KFDA) in 2009 and the Ministry of Knowledge Economy (MKE) and Korea Industrial Technology Foundation (KOTEF) through the Human Resource Training Project for Strategic Technology and the Seoul R&BD Program, Republic of Korea (10526) and the Brain Korea21 Project for Medicine Science Yonsei University, Republic of Korea. JuHyun Kim is with the Brain Korea 21 Project for Medical Science, Yonsei University, College of Medicine, Seoul, Korea (e-mail: jhkim222@ yuhs .ac) EunJeong Cho is with the Graduate Program in Biomedical Engineering, Univ. of Yonsei, Seoul, Korea (e-mail: [email protected]) ChunKi Lee is with the Graduate Program in Biomedical Engineering, Univ. of Yonsei, Seoul, Korea (e-mail: [email protected]) SuKang Park is a manager at Korea Electric Testing Institute.(e-mail: [email protected]) JiYoung Nah is post doctor at the Dept.of Medical Engineering, Univ.of Yonsei, Seoul, Korea(e-mail : [email protected]) ByungYoung Lee is a manager at National Institute of Food and Drug Safety Evaluation.(e-mail:[email protected]) KiJung Park is a manager at National Institute of Food and Drug Safety Evaluation.(e-mail:[email protected]) ByungChae Lee is a professor at the Dept. of Medical Information System, Yong-In Songdam College (e-mail: [email protected]) *Sun K. Yoo is a professor at the Dept. of Medical Engineering, Center for Emergency Medical Informatics, Yonsei University, College of Medicine, Seoul, Korea (e-mail: [email protected]) Abstract The aim of this paper is about electrical-mechanical safety measurements which evaluated with belt type equipment. Electrical mechanical safety was determined using by International Electro-technical Commission (IEC) guidelines which are widely used as important factor for assessment and local guidelines. Based on IEC, safety guidelines suited for the actual Korean circumstances have been required, and it is suggested that a new experimental procedure of the home-healthcare device is feasible with standard guideline of electrical-mechanical and environmental safety. This belt type device measures the electrocardiogram (ECG) and heart rates by attaching to the chest. Examination lists were selected by analyzing the common standard on electricalmechanical safety (IEC 60601-1) and environment test (IEC 60068-1, IEC 60068-2) of home-healthcare equipments. Essential electrical safety which was required to RS300G3 as medical devices was evaluated and minimum examination lists were selected by considering circumstances for the users. Moreover this study more focuses on environmental safety. As results, the device passed all selected lists which are applicable to Korean environment. This study was limited to the most common heart-rates equipment. According to industrial and technological development, there are the infinite possibilities of the advance of home-healthcare equipments, so more examination lists for safety are being added as well as what we have done.