Portable facial stimulator design and standardization: IEC 60601-1-2

Abstract

Electrical Stimulation (ES) is a famous and effective modality to restore of nerve and muscle dysfunction for facial nerve palsy. In fact, there are several parameters that strictly require controlling the ES. Additionally, the development of portable, cost-effective, and user-friendly device should be significantly improved accessibility and recovery rate of patients to induce the self-treatment at home rather than receiving therapy at hospital or rehabilitation center. To develop the proposed ES, the basic safety standard is a principal key -which is considered before applying the ES to the patients. The purpose of this study contributes the design of an established portable ES for facial nerve palsy with the manufacturing process, performance testing in lab scale, and the standardization. In the study, IEC 60601-1-2 was considered following to determine the safety from electromagnetic disturbances. The results of testing in this protocol indicated that the prototype design of ES could function normally in critical use underlying the various electromagnetic disturbances.