# Investigation of induced voltage on cardiac implants under occupational low frequency electric field exposures

Mengxi Zhou, Djilali Kourtiche, Julien Claudel, Francois Deschamps, Isabelle

Magne, Mustapha Nadi, Patrice Roth, Pierre Schmitt

► To cite this version:

Mengxi Zhou, Djilali Kourtiche, Julien Claudel, Francois Deschamps, Isabelle Magne, et al. Investigation of induced voltage on cardiac implants under occupational low frequency electric field exposures. Congrès national de radioprotection – SFRP, Jun 2023, Dijon, France. 2023, 10.13140/RG.2.2.20945.75365. hal-04624338

HAL Id: hal-04624338

https://hal.science/hal-04624338

Submitted on 25 Jun 2024

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# Investigation of induced voltage on cardiac implants under occupational low frequency electric field exposures

Mengxi Zhou, Djilali Kourtiche, Julien Claudel, Francois Deschamps, Isabelle

Magne, Mustapha Nadi, Patrice Roth, Pierre Schmitt

► To cite this version:

Mengxi Zhou, Djilali Kourtiche, Julien Claudel, Francois Deschamps, Isabelle Magne, et al. Investigation of induced voltage on cardiac implants under occupational low frequency electric field exposures. Congrès national de radioprotection – SFRP, Jun 2023, Dijon, France. 2023, 10.13140/RG.2.2.20945.75365. hal-04624338

HAL Id: hal-04624338

https://hal.science/hal-04624338v1

Submitted on 25 Jun 2024

HAL is a multi-disciplinary open access
archive for the deposit and dissemination of sci-
entific research documents, whether they are pub-
lished or not. The documents may come from
teaching and research institutions in France or
abroad, or from public or private research centers.

L'archive ouverte pluridisciplinaire HAL, est
destinée au dépôt et à la diffusion de documents
scientifiques de niveau recherche, publiés ou non,
émanant des établissements d'enseignement et de
recherche français ou étrangers, des laboratoires
publics ou privés.

<figure><img src="image_2.png" /></figure>

Distributed under a Creative Commons Attribution 4.0 International License
# Investigation of induced voltage on cardiac implants under occupational low-frequency electric field exposures

Mengxi Zhou<fnref n="1" />, Djilali Kourtiche<fnref n="1" />, Julien Claudel<fnref n="1" />, François Deschamps<fnref n="2" />, Isabelle Magne<fnref n="3" />, Mustapha Nadi<fnref n="1" />, Patrice Roth<fnref n="1" />, Pierre Schmitt<fnref n="1" />

## INTRODUCTION

Targeting cardiology diagnosis and treatment, active implantable medical devices (AIMDs) have been rapidly developed and widely applied with constantly updated technologies in recent decades. It is important to investigate their performance in the information era in terms of the side effects on AIMD carriers under electromagnetic exposures, especially in the workplaces. In this

work, a thorough study was performed on an *in vitro* phantom to determine the voltages induced at the input of a cardiac implant subjected to high-intensity electric fields (EFs) at 50 Hz. The analysis on the immunity test for AIMDs were carried out as a risk assessment procedure for AIMD-employee mentioned in NF EN 50527-2.

## METHOD

Taking the virtual human body ANSOFT as the standard system representing the real case, an association between it and its equivalent systems was proposed based on the evaluation of the induced voltage at the input of cardiac implants under electric field exposure. The induced voltage on the cardiac implant was investigated by a measuring system designed for detecting micro-volt level voltages under high-intensity EFs.

<figure><img src="image_2.png" /></figure>

### EQUIVALENT SYSTEMS

The equivalent systems are proposed as alternatives for the real case study in the immunity test in the risk assessment procedure. Controlled EF exposure system was introduced to reproduce the interference under equivalent exposures in the experimental environment; voltage injection system was introduced to reproduce the interference with an easy manageable set-up in the workplace.

<figure><img src="image_3.png" /></figure>

## RESULTS

Immunity tests were performed on two ICDs (Secura DR and Evera XT VR) to obtain the interference thresholds in different sensitivity and sensing mode settings.

The estimations of the induced voltages of interference thresholds were carried out based on the association of exposure systems proposed in this study.

<table><thead><tr><th rowspan="3">Model</th><th rowspan="3">Tip-ring spacing</th><th colspan="3">Controlled exposure system</th><th colspan="2">Voltage injection system</th></tr><tr><th colspan="2">Sensitivity</th><th rowspan="2">TH.<sub>real case</sub></th><th rowspan="2">TH.</th><th rowspan="2">TH.<sub>real case</sub></th></tr><tr><th>mV</th><th>kV/m</th></tr></thead><tbody><tr><td rowspan="3">Secura DR</td><td rowspan="3">28 mm</td><td>0.15</td><td>0.67</td><td>2.44</td><td>0.42</td><td>2.31</td></tr><tr><td>0.3</td><td>1.52</td><td>5.53</td><td>0.95</td><td>5.23</td></tr><tr><td>0.6</td><td>3</td><td>10.91</td><td>1.91</td><td>10.51</td></tr><tr><td rowspan="3">Evera XT VR</td><td rowspan="3">10 mm</td><td>0.15</td><td>1.84</td><td>6.69</td><td>1.13</td><td>6.22</td></tr><tr><td>0.3</td><td>4</td><td>14.55</td><td>2.47</td><td>13.59</td></tr><tr><td>0.6</td><td>8.35</td><td>30.36</td><td>4.95</td><td>27.23</td></tr></tbody></table>

* TH: Interference thresholds

Reference induced voltage for 10 kV/m EF at 50 Hz

<figure><img src="image_4.png" /><figcaption>Interference threshold analysis on induced voltage for ICDs in voltage injection system</figcaption></figure>

<figure><img src="image_5.png" /></figure>

Survey on cardiac implant and its settings

Determination of exposure in the workplace

Immunity test to the exposure

Further assessment request to manufacturer

Documentation

Risk assessment procedure for AIMD-employee (adapted from NF EN 50527-2)

## PERSPECTIVES

This method can be conducted for the magnetic field exposures following the same pattern in different configurations. The immunity test configuration can be slightly adjusted to perform tests at 60 Hz (power frequency in North and Central America).

## References:

1. Zhou M, Kourtiche D, Claudel J, Deschamps F, Magne I, Roth P, Schmitt P, Souques M, Nadi M. Interference thresholds for active implantable cardiovascular devices in occupational low-frequency electric and magnetic fields: a numerical and in vitro study. Med Eng Phys. 2022 Jun;104:103799. doi: 10.1016/j.medengphy.2022.103799. Epub 2022 Apr 13. PMID: 35641069.

2. Gercek, C., Kourtiche, D., Nadi, M., Magne, I., Schmitt, P., Souques, M. and Roth, P., 2017. An in vitro cost-effective test bench for active cardiac implants, reproducing human exposure to electric fields 50 Hz. International Journal on Smart Sensing and Intelligent Systems, 10(1), pp.1-17.

3. EN 50527-2-2:2018; Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardioverter defibrillators (ICDs)

<footnote n="1">¹Département Nanomatériaux, électronique et Vivant, Institut Jean Lamour (UMR 7198), Université de Lorraine - CNRS, Nancy, France, 54000</footnote>

<footnote n="2">² RTE, Direction Développement Ingénierie, 7 place du Dôme, 92073 Paris la Défense</footnote>

<footnote n="3">³ EDF, Service des Etudes Médicales, 4 rue Floréal, 75017 Paris</footnote>
# Investigation of induced voltage on cardiac implants under occupational low-frequency electric field exposures

Mengxi Zhou<fnref n="1" />, Djilali Kourtiche<fnref n="1" />, Julien Claudel<fnref n="1" />, François Deschamps<fnref n="2" />, Isabelle Magne<fnref n="3" />, Mustapha Nadi<fnref n="1" />, Patrice Roth<fnref n="1" />, Pierre Schmitt<fnref n="1" />

## INTRODUCTION

Targeting cardiology diagnosis and treatment, active implantable medical devices (AIMDs) have been rapidly developed and widely applied with constantly updated technologies in recent decades. It is important to investigate their performance in the information era in terms of the side effects on AIMD carriers under electromagnetic exposures, especially in the workplaces. In this

work, a thorough study was performed on an *in vitro* phantom to determine the voltages induced at the input of a cardiac implant subjected to high-intensity electric fields (EFs) at 50 Hz. The analysis on the immunity test for AIMDs were carried out as a risk assessment procedure for AIMD-employee mentioned in NF EN 50527-2.

## METHOD

Taking the virtual human body ANSOFT as the standard system representing the real case, an association between it and its equivalent systems was proposed based on the evaluation of the induced voltage at the input of cardiac implants under electric field exposure. The induced voltage on the cardiac implant was investigated by a measuring system designed for detecting micro-volt level voltages under high-intensity EFs.

<figure><img src="image_3.png" /></figure>

### EQUIVALENT SYSTEMS

The equivalent systems are proposed as alternatives for the real case study in the immunity test in the risk assessment procedure. Controlled EF exposure system was introduced to reproduce the interference under equivalent exposures in the experimental environment; voltage injection system was introduced to reproduce the interference with an easy manageable set-up in the workplace.

<figure><img src="image_4.png" /></figure>

## RESULTS

Immunity tests were performed on two ICDs (Secura DR and Evera XT VR) to obtain the interference thresholds in different sensitivity and sensing mode settings.

The estimations of the induced voltages of interference thresholds were carried out based on the association of exposure systems proposed in this study.

<table><thead><tr><th rowspan="3">Model</th><th rowspan="3">Tip-ring spacing</th><th colspan="3">Controlled exposure system</th><th colspan="2">Voltage injection system</th></tr><tr><th colspan="2">TH.*</th><th rowspan="2">TH.<br>real case</th><th colspan="2">TH.*</th></tr><tr><th>Sensitivity</th><th>kV/m</th><th>kV/m</th><th>kV/m</th></tr></thead><tbody><tr><td rowspan="3">Secura DR</td><td rowspan="3">28 mm</td><td>0.15</td><td>0.67</td><td>2.44</td><td>0.42</td><td>2.31</td></tr><tr><td>0.3</td><td>1.52</td><td>5.53</td><td>0.95</td><td>5.23</td></tr><tr><td>0.6</td><td>3</td><td>10.91</td><td>1.91</td><td>10.51</td></tr><tr><td rowspan="3">Evera XT VR</td><td rowspan="3">10 mm</td><td>0.15</td><td>1.84</td><td>6.69</td><td>1.13</td><td>6.22</td></tr><tr><td>0.3</td><td>4</td><td>14.55</td><td>2.47</td><td>13.59</td></tr><tr><td>0.6</td><td>8.35</td><td>30.36</td><td>4.95</td><td>27.23</td></tr></tbody></table>

* TH: Interference thresholds

Reference induced voltage for 10 kV/m EF at 50 Hz

<figure><img src="image_5.png" /><figcaption>Interference threshold analysis on induced voltage for ICDs in voltage injection system</figcaption></figure>

<figure><img src="image_6.png" /></figure>

Survey on cardiac implant and its settings

Determination of exposure in the workplace

Immunity test to the exposure

Interference (N)
(Y)
Further assessment request to manufacturer

Documentation

Risk assessment procedure for AIMD-employee (adapted from NF EN 50527-2)

## PERSPECTIVES

This method can be conducted for the magnetic field exposures following the same pattern in different configurations. The immunity test configuration can be slightly adjusted to perform tests at 60 Hz (power frequency in North and Central America).

## References:

1. Zhou M, Kourtiche D, Claudel J, Deschamps F, Magne I, Roth P, Schmitt P, Souques M, Nadi M. Interference thresholds for active implantable cardiovascular devices in occupational low-frequency electric and magnetic fields: a numerical and in vitro study. Med Eng Phys. 2022 Jun;104:103799. doi: 10.1016/j.medengphy.2022.103799. Epub 2022 Apr 13. PMID: 35641069.

2. Gercek, C., Kourtiche, D., Nadi, M., Magne, I., Schmitt, P., Souques, M. and Roth, P., 2017. An in vitro cost-effective test bench for active cardiac implants, reproducing human exposure to electric fields 50 Hz. International Journal on Smart Sensing and Intelligent Systems, 10(1), pp.1-17.

3. EN 50527-2-2:2018; Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardioverter defibrillators (ICDs)

<footnote n="1">¹Département Nanomatériaux, électronique et Vivant, Institut Jean Lamour (UMR 7198), Université de Lorraine - CNRS, Nancy, France, 54000</footnote>

<footnote n="2">²RTE, Direction Développement Ingénierie, 7 place du Dôme, 92073 Paris la Défense</footnote>

<footnote n="3">³EDF, Service des Etudes Médicales, 4 rue Floréal, 75017 Paris</footnote>