A methodological approach for the characterization of cardiac pacemaker immunity to low frequency interferences: case of 50 Hz, 60 Hz, 10 kHz and 25 kHz led disruptions

Abstract

The goal of this work is the implementation of a metrological set up dedicated to the characterization of cardiac pacemakers' immunity at low frequency electromagnetic disruptions. The studied frequencies are 50 Hz, 60 Hz, 10 kHz and 25 kHz. The assessment methodology that is applied is in accord with the electromagnetic compatibility. The tests are carried out on single-chamber pacemakers. The first approach, consisting of the application of the interfering signal directly between the housing and the electrode, enabled us to point out the influence of a preset detection sensitivity on the signal levels induced between the terminal and the pacemaker's housing. These attempts are completed by in vitro tests using an electromagnetic model which allows one to take into account the interface which constitutes the human body, and thus to get closer to a real life situation. The visualization of the pacemaker generated signal illustrates the performance of the pacemaker according to different test configurations. It is an initial approach meant to create a base for the creation of a metrological protocol.

Electromagnetic interference in cardiac electronic implants caused by novel electrical appliances emitting electromagnetic fields in the intermediate frequency range: a systematic review

“…These studies are discussed in detail in the ‘Phantom Studies—Coupling Model’ section. Nevertheless, due to the data of these studies it can be summarized that the lowest detection levels were found from 55 mV (10 kHz) 62 and 95 mV (25 kHz) 64 depending on the sensitivity level of the PM 64 . Comparable detection levels were also found in an earlier study by the same research group 39 combining benchmark tests and phantom investigations.…”

“…Hedjiedj et al 62 developed a transfer function based on a simple phantom and found detection levels from >55/104 mV at 10/25 kHz for a sensitivity level of 0.7 mV. The authors also included benchmark tests and reported detection levels in two out of five PMs of >150/130 mV at 10/25 kHz for a sensitivity level of 1 mV.…”

“…In 4 of the 12 studies included, benchmark tests or tests in air were combined with other methods in order to establish a transfer function 62–65 . These studies are discussed in detail in the ‘Phantom Studies—Coupling Model’ section.…”

In Vitro Modeling of Implantable Cardiac Pacemakers Submitted to Conducted Disturbance

“…These two questions have been the subject of several studies over the last decades, in vivo and in vitro. A. Hedjeidj et al in 2002 showed that the exposure of certain PCs to NDEs under specific conditions caused their dysfunction [4]. J Silny et al, in 2014 they showed after the exposure of 110 patients (worn ICDs of 1,2, and 3 chamber) to strong electric and magnetic fields of 50 Hz ranging up to 30kv / m, and 2.55 mT in some work environments may cause inappropriate detection, which may lead to false detection of atrial/ventricular arrhythmic events [5].…”

Experimental study on malfunction of pacemakers due to exposure to different external magnetic fields

“…However, studies on lowfrequency electromagnetic fields as a cause of interference are rare, and mainly restricted to a power frequency of 50/60 Hz [15][16][17][18][19][20][21][22] or to frequencies of some specific device, such as an induction oven [23][24][25]. Studies carried out using Helmholtz coil systems are usually restricted to sinusoidal and pulse waveforms.…”