A Case Study of Medical Device Wireless Coexistence Evaluation
Mohamed Al-Kalaa, Joshua Guag, Seth Seidman, Yao Ma, Jason Coder
This article aims to provide a narrative for addressing wireless coexistence in medical devices to help medical device developers, test engineers, and regulatory affairs personnel 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.
, Guag, J.
, Seidman, S.
, Ma, Y.
and Coder, J.
A Case Study of Medical Device Wireless Coexistence Evaluation, IEEE Electromagnetic Compatibility Magazine, [online], https://doi.org/10.1109/MEMC.2020.9328232, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=930144
(Accessed December 7, 2023)