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A Case Study of Medical Device Wireless Coexistence Evaluation

Published

Author(s)

Mohamed Al-Kalaa, Joshua Guag, Seth Seidman, Yao Ma, Jason Coder

Abstract

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.
Citation
IEEE Electromagnetic Compatibility Magazine
Volume
9
Issue
4

Keywords

wireless communication, performance evaluation, medical devices, electromagnetic compatibility, risk management, testing, signal to noise ratio

Citation

Al-Kalaa, M. , Guag, J. , Seidman, S. , Ma, Y. and Coder, J. (2020), 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 June 16, 2024)

Issues

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Created October 1, 2020, Updated February 15, 2022