A Case Study of Medical Device Wireless Coexistence Evaluation

摘要

This article aims to provide a narrative for addressing wireless coexistence in medical devices to help medical device developers, test engineers, and regulatory affairs per-sonnel throughout the device life cycle. Accordingly, we present a case-study covering the coexistence evaluation process including the risk analysis of the wireless functionality of a hypothetical medical device, determining the corresponding risk category, specification of the device functional wireless performance (FWP), wireless coexistence testing, and measurement of the intended/untended signal ratio. Also, we propose a simple method for translating the test outcome into user recommendations for minimum/maximum separation distances between the device, its intended companion, and the source of unintended signals.