Multi-Channel Muscle Armband Implementation: Electronic Circuit Validation and Considerations towards Medical Device Regulation Assessment

Abstract

Multi-channel muscle arrays are commonly used as sensors in bionic prosthetic devices offering an innovative solution to recover motion in transradial amputees. This study presents preliminary assessments towards validation of a muscle armband for usage in transradial users. Analog and digital components were designed based on medical agencies’ recommendations to assess future compliance with Latin American medical device regulations. The study follows two approaches, an exploratory and pre-experimental design. Design was validated and confronted among research literature and medical device regulations. For validation, a pre-experimental design was guided by a quantitative paradigm. Muscle signal was assessed before and after the condition circuit for up to four muscle signals in real time. The present study considers both the conditioning muscle signal circuit and the embedded logic implementation to record signals from the designed muscle armband. Results show that the proposed device allows to record noninvasive signals with a frequency from 20-500 Hz.