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Assessment of Implantable Defibrillator Exposure to Low Frequency Magnetic Fields: No Malfunction for a Worst Case at 50/60 Hz up to 4 mT

, , , , and . (2013)

Abstract

Human exposure to electromagnetic (EM) sources has led to public concern about possible healthrelated effects. Power lines and domestic electrical appliances are a few examples of EM sources present in daily life. Meanwhile, the number of active medical implant wearers (pacemaker, implantable cardioverter defibrillator (!CD)) is rapidly increasing, with more than 3 millions worldwide. Assessment of human exposure to electromagnetic fields in the workplace, for persons wearing active implantable medical devices, is thus a current challenge for all the concerned electrical industries. Compliance with limits, defined by European directive 2004/40/EC on the limitation of workers' exposure to electromagnetic fields (EMF) led to the new standard EN 50527. Thus the employer must perform a specific risk assessment in some situations. Recently, European directive 2013/35/EU replaced European directive 2004/40/EC on rules to protect workers from electromagnetic fields in their work. In these directives, implanted workers are defined as workers at particular risk. The experimental methodology and a numerical approach were previously presented. This paper gives the experimental results for in vitro magnetic field characterization ofICD immunity A test bench has been modelled using a Helmholtz coil and an electronic interface. The EM generic source was designed to produce a magnetic field of up to 4 mT at 50 Hz and 3.9 mT at 60 Hz. This is twenty-fold higher than the reference level for the general public and four-fold higher than the reference level for people working at the frequency of 50 Hz, as stated in the ICNIRP guidelines. Four ICDs (3 St Jude and l Guidant) were tested for the nominal and minimum sensitivities in the air using with the experimental set up in air as well as in a gelatine phantom at 50 and 60 Hz. In the air, at 50 Hz, the 3 St. Jude implants showed no malfunction for fields up to 2,750 μT. The other type Guidant ICDs showed the same behaviour in a similar field .. At 60 Hz, the 4 I CDs were tested in the same conditions as in the air and showed no malfunction, for fields up to 2,750 μT. There was no case of false detection (inappropriate shock). Few slight dysfunctions were observed at 60 Hz only, and only in the air above 3 mT.

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