Testing the immunity of active implantable medical devices to CW magnetic fields up to 1 MHz by an immersion method
Testing the immunity of active implantable medical devices to CW magnetic fields up to 1 MHz by an immersion method
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DOI：
10.1109/tbme.2007.893502
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发表时间：
2007-09-01
影响因子：
4.6
通讯作者：
Kainz, Wolfgang
中科院分区：
文献类型：
--
作者：
Buzduga, Valentin;Witters, Donald A.;Kainz, Wolfgang
本文介绍了一种用于测试有源植入式医疗器械对频率范围达1 MHz的连续波磁场的抗扰度的磁场系统和方法。该系统能够产生150 A/m的磁场，频率高达100 kHz，强度在100 kHz和1 MHz之间以1/f递减，磁场均匀性在测试体积的+/- 2.5%范围内。为了模拟人体组织，将医疗器械及其电极导线放置在盐水罐中的塑料网格上，盐水罐被引入感应线圈的磁场中。本文提供了一种替代的注入电压方法中提供的实际标准，用于评估保护植入式医疗器械的影响，磁场高达1 MHz。本文介绍了在美国食品药品监督管理局器械和放射卫生中心对植入式起搏器和神经刺激器进行的初步测试所使用的设备和信号、测试程序和结果。新的系统和测试方法对植入式医疗设备的电磁兼容研究有一定的参考价值。
This paper presents a magnetic-field system and the method developed for testing the immunity of the active implantable medical devices to continuous-wave magnetic fields in the frequency range up to I MHz. The system is able to produce magnetic fields of 150 A/m for frequencies up to 100 kHz and strengths decreasing as 1/f between 100 kHz and 1 MHz, with uniformity of the field within +/- 2.5% in the volume for tests. To simulate human tissue, the medical device, together with its leads, is placed on a plastic grid in a saline tank that is introduced in the magnetic field of the induction coil. This paper offers an alternative for the injection voltage methods provided in the actual standards for assessing the protection of the implantable medical devices from the effects of the magnetic fields up to 1 MHz. This paper presents the equipment and signals used, the test procedure, and results from the preliminary tests performed at the Food and Drug Administration-Center for Devices and Radiological Health on implantable pacemakers and neurostimulators. The new system and test method are useful for the EMC research on the implantable medical devices.