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Phantom Model Testing of Active Implantable Cardiac Devices at 50/60 Hz Electric Field.
Bioelectromagnetics ( IF 1.8 ) Pub Date : 2020-01-05 , DOI: 10.1002/bem.22245
Cihan Gerçek 1, 2 , Djilali Kourtiche 1 , Mustapha Nadi 1 , Isabelle Magne 3 , Pierre Schmitt 1 , Patrice Roth 1 , Martine Souques 3
Affiliation  

Exposure to external extremely low-frequency (ELF) electric and magnetic fields induces the development of electric fields inside the human body, with their nature depending on multiple factors including the human body characteristics and frequency, amplitude, and wave shape of the field. The objective of this study was to determine whether active implanted cardiac devices may be perturbed by a 50 or 60 Hz electric field and at which level. A numerical method was used to design the experimental setup. Several configurations including disadvantageous scenarios, 11 implantable cardioverter-defibrillators, and 43 cardiac pacemakers were tested in vitro by an experimental bench test up to 100 kV/m at 50 Hz and 83 kV/m at 60 Hz. No failure was observed for ICNIRP public exposure levels for most configurations (in more than 99% of the clinical cases), except for six pacemakers tested in unipolar mode with maximum sensitivity and atrial sensing. The implants configured with a nominal sensitivity in the bipolar mode were found to be resistant to electric fields exceeding the low action levels, even for the highest action levels, as defined by the Directive 2013/35/EU. Bioelectromagnetics. 2020;41:136-147. © 2020 Bioelectromagnetics Society.

中文翻译:

有源植入式心脏设备在50/60 Hz电场下的虚拟模型测试。

暴露于外部极低频(ELF)电场和磁场会诱发人体内部电场的发展,电场的性质取决于多种因素,包括人体特征,电场的频率,幅度和波形。这项研究的目的是确定有源植入的心脏设备是否会受到50或60 Hz电场的干扰以及处于何种水平。使用数值方法来设计实验装置。通过在50 Hz时高达100 kV / m和60 Hz时高达83 kV / m的实验台试验在体外测试了包括不利情况,11种植入式心脏除颤器和43种心脏起搏器在内的几种配置。对于大多数配置(在超过99%的临床病例中),ICNIRP公众暴露水平未观察到失败,除了以最大灵敏度和心房感应在单极模式下测试的六个起搏器外。根据指令2013/35 / EU,发现在双极模式下以标称灵敏度配置的植入物可抵抗超过低作用水平的电场,甚至对于最高作用水平也是如此。生物电磁学。2020; 41:136-147。©2020生物电磁学会。
更新日期:2020-01-17
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