Kainz Wolfgang, Casamento Jon P, Ruggera Paul S, Chan Dulciana D, Witters Donald M
Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20851, USA.
IEEE Trans Biomed Eng. 2005 Mar;52(3):520-30. doi: 10.1109/TBME.2004.843293.
This paper describes a novel simulator to perform electromagnetic compatibility (EMC) tests for active implantable medical devices (AIMDs) with electromagnetic fields emitted by security systems. The security system simulator was developed in response to over 100 incident reports over 17 years related to the interference of AIMD's with security systems and the lack of a standardized test method. The simulator was evaluated regarding field homogeneity, signal distortion, and maximum magnetic field strength levels. Small three-axis probes and a three-axis scanning system were designed to determine the spatial and temporal characteristics of the fields emitted by 12 different types of walk through metal detectors (WTMDs). Tests were performed on four implanted pacemakers with a saline phantom and correlated to a newly developed test method performed "in air" (without the phantom). Comparison of the simulator thresholds with tests performed in real WTMDs showed that the simulator is able to mimic the pacemaker interference. The interference thresholds found in the simulator indicate that pulsed magnetic fields are more likely to cause interference in pacemakers than sinusoidal fields. The security system simulator will help biomedical engineers, manufacturers of medical devices, and manufacturers of security systems to identify incompatible combinations of WTMDs and AIMDs early in the development stage.
本文介绍了一种新型模拟器,用于对有源植入式医疗设备(AIMD)进行电磁兼容性(EMC)测试,该测试针对安全系统发出的电磁场。安全系统模拟器的开发是为了应对17年来100多份与AIMD对安全系统的干扰以及缺乏标准化测试方法相关的事件报告。对模拟器的场均匀性、信号失真和最大磁场强度水平进行了评估。设计了小型三轴探头和三轴扫描系统,以确定12种不同类型的通过式金属探测器(WTMD)发出的场的空间和时间特性。使用盐水模拟体对四个植入式起搏器进行了测试,并与新开发的“在空气中”(无模拟体)进行的测试方法相关联。将模拟器阈值与在实际WTMD中进行的测试进行比较表明,该模拟器能够模拟起搏器干扰。在模拟器中发现的干扰阈值表明,脉冲磁场比正弦磁场更有可能在起搏器中引起干扰。安全系统模拟器将有助于生物医学工程师、医疗设备制造商和安全系统制造商在开发阶段早期识别WTMD和AIMD不兼容的组合。