EXPOSURE OF ACTIVE MEDICAL IMPLANTS BEARERS TO ELECTROMAGNETIC EMISSIONS FROM WIRELESS POWER TRANSFER SYSTEMS

Authors

  • ANDREI MARINESCU Romanian Academy of Technical Sciences, Craiova Branch and ACER
  • MIHAELA MOREGA University POLITEHNICA of Bucharest, Splaiul Independentei 313, Bucharest

Keywords:

Active implantable medical devices (AIMD), Wireless power transfer (WPT), Electromagnetic field (EMF), Intermediate frequency, Magnetic leakage field

Abstract

People with active implantable medical devices today are a growing category, due to the increase of health care interventions that replace or remedy physiological deficiencies with intelligent artificial medical solutions. These devices are built with electronic circuits, susceptible to electromagnetic interference that could affect their proper operation and could cause discomfort or even health damage to the patient. Manufacture of medical devices has been regulated for decades by international technical standards (such as IEC 60601-1-2 or ANSI / AAMI PC69 series), including immunity conditions; however, attention must always be paid to the continuous assessment of the electromagnetic environment enriched with new technologies, in order to harmonize the sensitivity of health care devices and the possible conditions of uncontrolled human exposure. In this context, the authors present an attempt to evaluate the current protection offered to bearers of implantable devices in the electromagnetic environment specific to modern electric vehicles and especially to those using wireless power transfer systems for battery charging, due to the magnetic leakage field. These specific exposure conditions and particular regulations are investigated and compared with some assessments performed on the Dacia Electron electric vehicle.

References

(1) A. Napp, D. Stunder, M. Maytin, T. Kraus, N. Marx, S. Driessen, Are patients with cardiac implants protected against electromagnetic interference in daily life and occupational environment?, European Heart Journal, 36, pp. 1798–1804 (2015), doi:10.1093/eurheartj/ehv135.

(2) A. Napp, S. Joosten, D. Stunder, C. Knackstedt, M. Zink, B. Bellmann, N. Marx, P. Schauert, J. Silny, Electromagnetic interference with implantable cardioverter-defibrillators at power frequency: an in vivo study, Circulation 129, pp. 441-450, (2014), doi: 10.1161/cir- culationaha.113.003081.

(3) S. Driessen, A. Napp, K. Schmiedchen, T. Kraus, D. Stunder, Electromagnetic interference in cardiac electronic implants caused by novel electrical appliances emitting electromagnetic fields in the intermediate frequency range: a systematic review, Europace 21, pp. 219-229, (2019), doi:10.1093/europace/euy155

(4) R. M. Baerov, A. M. Morega, M. Morega, Analysis of Magnetotherapy Effects for Post–traumatic Recovery of Limb Fractures, Rev. Roum. Sci. Techn.– Électrotechn. et Énerg., 65, 1-2, pp. 145–150, (2020).

(5) American Heart Association, Devices that may Interfere with ICDs and Pacemakers, (2016).

(https://www.heart.org/en/health-topics/arrhythmia/ prevention--treatment-of-arrhythmia/devices-that-may-interfere-with-icds-and-pacemakers last accessed on March 2022)

(6) D. Studner, T. Seckler, S. Joosten, M. D. Zink, S. Driessen, T. Kraus, N. Marx, A. Napp, In Vivo Study of Electromagnetic Interference with Pacemakers Caused by Everyday Electric and Magnetic Fields, Circulation 135, pp. 907-909, (2017), published by the American Heart Association, Inc., doi:10.1161/circulationaha.116.024558

(7) ETSI TR 103 409 V1.1.1:2016-10, System Reference document (SRdoc); Wireless Power Transmission (WPT) systems for Electric Vehicles (EV) operating in the frequency band 79 - 90 kHz, Harmonized European Standard. (https://www.etsi.org/standards-search last accessed on March 2022)

(8) A. Vassiliev, A. Ferber, C. Wehrmann, O. Pinaud, M. Schilling, A. R. Ruddle, Magnetic Field Exposure Assessment in Electric Vehicles, IEEE Trans. on EMC, 57, 1, pp. 35-43, (2015). doi:10.1109/TEMC.2014.2359687

(9) International Commission on Non-Ionizing Radiation Protection, Guidelines for limiting exposure to time-varying electric and magnetic fields (1 Hz to 100 kHz), Health Physics, 99, 6, pp. 818–836, (2010).

(10) IEEE Std. C95.1:2019, Safety Levels with Respect to Human Exposure to Electric, Magnetic, and Electromagnetic Fields, 0 Hz to 300 GHz, (2019). (Revision of IEEE Std C95.1:2005/Incorporates IEEE Std C95.1:2019/Cor 1-2019)

(11) A. Marinescu, Current Standards and Regulations for Wireless Battery Charging Systems, 2021 7th International Symposium of Electrical and Electronics Engineering (ISEEE-2021), 28-30 Oct. 2021, Vietnam, doi: 10.1109/iseee53383.2021.9628689

(12) A. Marinescu, A. Vintila, D. G. Marinescu, V. Nicolae, Development of a wireless battery charger for Dacia Electron EV, 2017 10th International Symposium on Advanced Topics in Electrical Engineering (ATEE-2017), 23-25 March 2017, Bucharest, Romania, pp. 241-247.

(13) Mayo Foundation for Medical Education and Research (MFMER) © 1998-2022 (https://www.mayoclinic.org last accessed on March 2022)

(14) M. Glikson, et. al., Guidelines on cardiac pacing and cardiac resynchronization therapy, Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC). With the special contribution of the European Heart Rhythm Association (EHRA) (2021).

(15) M. Hours, I. Khati, J. Hamelin, Interference between active implanted medical devices and electromagnetic field emitting devices is rare but real: results of an incidence study in a population of physicians in France, Pace - Pacing and clinical electrophysiology, 37, 3, pp. 290-296 (2014).

(16) E. Mattei, G. Calcagnini, F. Censi, I. Pinto, A. Bogi, R. Falsaperla, Workers with Active Implantable Medical Devices Exposed to EMF: In Vitro Test for the Risk Assessment. Environments, 6, 11 (119), pp. 1-13 (2019).

(17) E. Mattei, F. Censi, G. Calcagnini, R. Falsaperla, Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations, International Journal of Environmental Research and Public Health, 18(18), pp. 1-14, paper 9709 (2021).

(18) N. Varma, R. P. Ricci, Telemedicine and cardiac implants: what is the benefit? European Heart Journal, 34, pp. 1885-1893 (2013).

(19) M. Morega, I. M. Băran, A. M. Morega, H. K. L. Alnamir, On the assessment of human exposure to low-frequency magnetic field at the workplace, Rev. Roum. Sci. Techn.– Électrotechn. et Énerg., 63, 2, pp. 162–171 (2018).

(20) IEC 60601-1-2:2020, Medical Electrical Equipment—Part 1-2: General Requirements for Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility Disturbances—Requirements and Tests (Ed. 3 of 2007; Ed. 4.1 of 2020).

(21) Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the Minimum Health and Safety Requirements Regarding the Exposure of Workers to the Risks Arising from Physical Agents (Electromagnetic Fields) (2013).

(22) ANSI/AAMI PC69:2007, Active Implantable Medical Devices—Electromagnetic compatibility—EMC Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators, Association for the Advancement of Medical Instrumentation, Arlington VA (2007).

(23) ISO/TR 21730:2007, Health Informatics—Use of Mobile Wireless Communication and Computing Technology in Healthcare Facilities—Recommendations for Electromagnetic Compatibility (Management of Unintentional Electromagnetic Interference) With Medical Devices (2007).

(24) EC Directorate-General for Employment, Social Affairs, and Inclusion Unit B3, Nonbinding guide to good practice for implementing Directive 2013/35/EU – vol. 1, © European Union (2015)

(25) ANSI/AAMI/ISO 14117:2019, Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices (2019).

(26) IEEE Std. C95.3-2021, Recommended Practice for Measurements and Computations of Electric, Magnetic, and Electromagnetic Fields with Respect to Human Exposure to Such Fields, 0 Hz to 300 GHz (2021) (Revision of IEEE Std C95.3:2002 and IEEE Std C95.3.1:2010 )

(27) ANSI Std. C63.30:2021, American National Standard for Methods of Measurements of Radio-Frequency Emissions from Wireless Power Transfer Equipment (2021) (harmonized with IEEE Std. C95.:2019)

(28) SPEAG, Documentation by Schmid & Partner Engineering AG, Zurich, Switzerland, https://speag.swiss/ last accessed on March 2022)

(29) IEC TS 61980-3:2019, Electric Vehicle Wireless Power Transfer (WPT) Systems, Part 3: Specific requirements for the magnetic field wireless power transfer systems, Technical specification by TC69 (2019).

(30) IEC TR 62905:2018, Exposure assessment methods for wireless power transfer systems, Technical Report by TC106 (2018).

(31) ETSI EN 303 417 V1.1.1: 2017-09, Wireless power transmission systems, using technologies other than radio frequency beam in the 19 - 21 kHz, 59 - 61 kHz, 79 - 90 kHz, 100 - 300 kHz, 6 765 - 6 795 kHz ranges; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU Harmonized European Standard (2017).

(32) G. Trentadue, M. Zanni, G. Martini, Assessment of low frequency magnetic fields in electrified vehicles, EUR 30198 EN, Publications Office of the European Union, Luxembourg (2020), ISBN 978-92-76-18458-4, doi:10.2760/056116, JRC120312.

(33) American Association of Medical Instrumentation, Documentation on Electrical Safety (https://www.aami.org/ last accesed: 6.10.2021).

(34) ISO 19363:2020, Electrically propelled road vehicles —Magnetic field wireless power transfer — Safety and interoperability requirements, document published by ISO/TC22/SC37 Electrically propelled vehicles (2020).

(35) Society of Automotive Engineers, Surface Vehicle Standard - Wireless Power Transfer for Light-Duty Plug-in/Electric Vehicles and Alignment Methodology, SAE International J2954_202010 standardization document, (2020).

(36) T. Tudorache, A. Marinescu, The Computation of the Electric Field of an Inductive Coupler for Wireless Power Transfer, in Romanian at the symposium “Actualităţi şi perspective în domeniul maşinilor electrice, Ed. a XVI-a, SME’20”, Nov., 2020.

(37) T. Tudorache, A. Marinescu, Magnetic Field 3D Numerical Analysis of an Inductive Coupler with Magnetic Concentrators of Ferrite, in Romanian at the symposium “Actualităţi şi perspective în domeniul maşinilor electrice, Ed. a XIII-a, SME’20”, Nov., 2017.

(38) A. Marinescu, I. Dumbrava, G. Rosu, O. Baltag, New Magnetic Field Qualification & Standards for EV Wireless Power Transfer, The 11th International Workshop of Electromagnetic Compatibility (CEM-2018), Targoviste, Romania, September 2018.

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Published

03.07.2022

Issue

Section

Génie biomédical / Biomedical Engineering