Objective: This safety study was designed to investigate tissue heating close to the surface of transvaginal ultrasound transducers, with the objective of assessing the validity of manufacturing safety standards set by the International Electrotechnical Commission (IEC).
Methods: The transducers investigated in this study were held in contact with a layered soft-tissue mimicking material (TMM), and the temperature increase was measured at various depths using a miniature thermocouple. The temperature rise at 200 s was recorded, and the measured profiles of temperature rise with depth were compared with profiles predicted from both analytical and numeric models. Two transvaginal transducers of different manufacturers were investigated, operating in B-mode imaging, color-flow imaging and pulsed Doppler modes, using scanner settings giving acoustic output power towards the upper end of that available.
Results: The greatest heating always occurred at the interface between the transducer and the TMM, and it reduced to about 0.1 times the surface temperature rise at a depth of 1 cm. A local maximum was observed in pulsed Doppler mode. A three-dimensional finite-element model which accounted for transducer dimensions gave a better prediction of temperature increase than a simple analytical model. The temperature profiles were compared with the depth of fetal tissue measured from a small survey of clinical scans.
Conclusions: It is provisionally concluded that the transducer surface temperature rise of 6 degrees C allowed to manufacturers by the IEC may give rise to an associated worst-case contribution to temperature rise due to the transducer, in fetal tissue, of between 0.5 and 1 degrees C at 1-cm depth. The contribution to tissue heating at 2 cm and deeper is negligible. Published by John Wiley & Sons, Ltd.
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