[Safety of use assessment in a radio-frequency medical device]. / Valutazione della sicurezza d'impiego di un'apparecchiatura elettromedicale ad emissione di radiofrequenza.

ABSTRACT

The authors assessed the operating safety physical parameters of a bipolar radiofrequency device for aesthetic purposes. According to both Italian and EU guidelines, the authors considered magnetic field environmental emission levels, electricity induced in the opertator's limbs, operator's exposure and radiofrequency specific absorbance rate (SAR) in treated tissues. Measurements were carried out with isotropic sensors and an inductive current indicator. Results pointed out excellent safety levels regarding environment, operators and patients as well, although such radiofrequency equipment cannot be used on patients with pacemakers, neurostimulators and other vital function controlling devices.