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. 2020;9(4):47-53.
doi: 10.1109/memc.2020.9328232.

A Case Study of Medical Device Wireless Coexistence Evaluation

Mohamad Omar Al Kalaa  1 , Joshua Guag  1 , Seth J Seidman  1 , Yao Ma  2 , Jason Coder  2
Affiliations

A Case Study of Medical Device Wireless Coexistence Evaluation

Mohamad Omar Al Kalaa et al. IEEE Electromagn Compat Mag. 2020.

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.

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Figures

Fig 1:
Fig 1:
Simplified wireless coexistence evaluation flowchart. The process streams from AAMI TIR69 for risk management to ANSI C63.27 for testing.
Fig 2:
Fig 2:
Test layout noting the placement of the equipment under test (EUT), the EUT companion, and the sources of unintended signals (SUS) transmitters (Tx) and receivers (Rx).
Figure 3:
Figure 3:
An example projection of test-driven separation distance recommendations between the EUT, EUT companion, and source of unintended signals.
See this image and copyright information in PMC

References

    1. U.S. Food and Drug Administration, Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2013. (Online). Available: https://www.fda.gov/media/71975/download
    1. American National Standards Institute (ANSI) ASC C63®, C63.27, American National Standard for Evaluation of Wireless Coexistence, Std, 2017.
    1. Association for the Advancement of Medical Instrumentation (AAMI), TIR69:2017 Risk Assessment of radio-frequency wireless coexistence for medical devices and systems, Std, 2017.
    1. IEEE Standard for High Data Rate Wireless Multi-Media Networks, IEEE Std 802.15.3–2016 (Revision of IEEE Std 802.15.3–2003), pp. 1–510, July 2016.
    1. IEC 60601–1-2:2014: Medical electrical equipment – Part 1–2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests, Std, 2014.

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