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Electromagnetic Compatibility Testing of Implantable Neurostimulators Exposed to Metal Detectors

机译:暴露于金属探测器的植入式神经刺激器的电磁兼容性测试

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摘要

This paper presents results of electromagnetic compatibility (EMC) testing of three implantable neurostimulators exposed to the magnetic fields emitted from several walk-through and hand-held metal detectors. The motivation behind this testing comes from numerous adverse event reports involving active implantable medical devices (AIMDs) and security systems that have been received by the Food and Drug Administration (FDA). EMC testing was performed using three neurostimulators exposed to the emissions from 12 walk-through metal detectors (WTMDs) and 32 hand-held metal detectors (HHMDs). Emission measurements were performed on all HHMDs and WTMDs and summary data is presented. Results from the EMC testing indicate possible electromagnetic interference (EMI) between one of the neurostimulators and one WTMD and indicate that EMI between the three neurostimulators and HHMDs is unlikely. The results suggest that worst case situations for EMC testing are hard to predict and testing all major medical device modes and setting parameters are necessary to understand and characterize the EMC of AIMDs.
机译:本文介绍了三种植入式神经刺激器的电磁兼容性(EMC)测试结果,这些刺激器暴露于数个通过式和手持式金属探测器发出的磁场。该测试背后的动机来自食品和药物管理局(FDA)收到的涉及有源植入式医疗设备(AIMD)和安全系统的大量不良事件报告。使用暴露在来自12个穿行金属探测器(WTMD)和32个手持式金属探测器(HHMD)的辐射中的三个神经刺激器进行了EMC测试。对所有HHMD和WTMD进行了排放测量,并提供了摘要数据。 EMC测试的结果表明,其中一个神经刺激器和一个WTMD之间可能存在电磁干扰(EMI),并且表明三个神经刺激器和HHMD之间的EMI可能性很小。结果表明,EMC测试的最坏情况很难预测,并且测试所有主要医疗设备模式和设置参数对于理解和表征AIMD的EMC都是必要的。

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