Buzduga Valentin, Witters Donald M, Casamento Jon P, Kainz Wolfgang
Scantek, Inc, Columbia, MD 21046, USA.
IEEE Trans Biomed Eng. 2007 Sep;54(9):1679-86. doi: 10.1109/TBME.2007.893502.
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 1 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.
本文介绍了一种磁场系统以及所开发的用于测试有源植入式医疗设备对频率高达1MHz的连续波磁场抗扰度的方法。该系统能够在高达100kHz的频率下产生150A/m的磁场，在100kHz至1MHz之间磁场强度随1/f下降，测试体积内磁场均匀度在±2.5%以内。为模拟人体组织，将医疗设备及其导线放置在感应线圈磁场中的盐水槽内的塑料网格上。本文为现行标准中提供的用于评估植入式医疗设备免受高达1MHz磁场影响的注入电压方法提供了一种替代方案。本文介绍了所使用的设备和信号、测试程序以及美国食品药品监督管理局-器械与放射健康中心对植入式起搏器和神经刺激器进行的初步测试结果。新系统和测试方法对植入式医疗设备的电磁兼容性研究很有用。
