Evaluation the results of electromagnetic compatibility of a prototype device for ear stimulation in patients with tinnitus

Abstract

<b><br>Aim:</b> The aim of the study was to evaluate the results of electromagnetic compatibility of a prototype device for ear stimulation in patients with tinnitus.</br> <b><br>Material and methods:</b> The electromagnetic compatibility tests of the prototype device for electro- and magnetostimulation of the hearing organ were carried out at the Center for Attestation and Certification Tests OBAC Sp. z o. o. in Gliwice in 2020. The following product standards were used: PN-EN 60601-1-2:2015-11 – medical electrical equipment (general requirements for basic safety and essential functioning; PN-EN 55011:2012 - industrial, scientific and medical equipment [characteristics of radio frequency disturbances] ) PN-EN 61000-3-2:2014-10 – electromagnetic compatibility (EMC), permissible levels of harmonic current emissions (phase load current ≤ 16 A).</br> <b><br>Results:</b> The level of expanded uncertainty in the measurement of conducted disturbances in the range of 0.150–30MHz does not exceed the level specified in the PN-EN-55016-4-2:2011 standard. In the study of the emission of radiated disturbances up to 1GHz in the frequency range of 30–1000MHz (PN-EN 55011:2012 standard), it was found that the setting of the EUT during the tests was in accordance with the requirements of the standard. The level of expanded uncertainty in the measurement of radiated disturbances in the 30–1000MHz range does not exceed the level specified in the PN-EN 55016–4-2:2011 standard. The measured current harmonic levels (phase power supply current ≤16A) with a frequency range of 50Hz–2kHz do not exceed the permissible levels specified in the PN-EN 61000-3-2:2014-10 standard. The test of resistance to the magnetic field at the frequency of the power grid (PN-EN 61000-4-8: 2010 standard also showed that the setting of the EUT during the tests was in accordance with the requirements of the standard and the result was positive.</br> <b><br>Conclusions:</b> Testing of immunity to radiated radio frequency electromagnetic field (PN-EN 61000-4-3:2007 +A1:2008+A2:2011 standard) and testing of resistance to magnetic field at power frequency (PN-EN 61000-4-8 standard :2010) did not exceed the level specified in the standard and showed a positive result. The measured harmonic levels of the network current (phase supply current ≤16A) with the frequency range 50Hz–2kHz do not exceed the permissible levels specified in the PN-EN 61000- 3-2:2014-10 standard for a class A device.</br>