EXAMPLE FOR MOBILE ECG HOLTER DESIGN USING FMEA MODEL

Abstract

This paper describes an approach for evaluating the risk of components used in the Holter. Holter is a portable device for recording patients' electrocardiogram in medicine. Holter might hurt users as a result of a bad design, and might record incorrectly when malfunction happens. To prevent risk of injury, we analyze the potential failures of the Holter based on the Failure Mode and Effects Analysis, which is a risk assessment technique. Then, we calculate the Risk Priority Number (RPN) of each failure. According to the RPN, we give two strategies for reducing the risk. One is protection, and the other is alarm. The protection system is used to prevent hazards of the Holter from incorrect operations by the user, and the alarm system is used to detect the malfunction of the Holter. The experimental results show that the safety of the Holter is improved with these two circuits.