• The Journal of the Acoustical Society of Korea
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• v.41 no.5
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• pp.589-600
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• 2022

In order to verify the reliability of Dry Test Bench (DTB) used for testing the output energy from ballistic extracorporeal shock wave therapeutic devices, the measurements with DTB were compared with the acoustic energy measured with a Laser Doppler Vibrometer (LDV) for a commercial ballistic ESWT device. It was shown that the mechanical energy detected with DTB had variability maintained within 5 % at the same output power setting and also had a linear correlation (adj. R² = 0.991) with the acoustic energy measured with the LDV for the entire output power settings. Using the correlation between the two methods and the correlation on the acoustic energy measured in between air and water with the LDV, the DTB measurement can be used to estimate the energy flux density in water with an average error of 7.85 % for the entire output power settings of the ballistic shock wave generator considered in the experiment. DTB provides information limited to the output mechanical energy and therefore it is not suitable for testing the various acoustic output parameters required in IEC61846 and IEC63045. However, DTB that is simple in measurement principles and easy to use is expected for manufacturers and clinical users to monitor the performance of ballistic Extracorporeal Shock Wave Therapy (ESWT) devices.

• The Journal of the Acoustical Society of Korea
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• v.41 no.5
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• pp.570-588
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• 2022

We scrutinized the acoustic outputs from the 70 shock wave generators of the 15 product models whose technical documents were available, among the 46 ballistic extracorporeal shock wave therapeutic devices of 11 domestic and 6 foreign manufacturers, approved by the Minster of Food & Drug Safety (Rep. Korea). We found that the acoustic Energy Flux Density (EFD), the most popular exposure parameter, was different by up to 563.64 times among shock wave generators at their minimum output settings and by up to 74.62 times at their maximum settings. In the same product model, the EFD was shown to vary depending on shock wave transmitters by up to 81.82 times at its minimum output setting and by up to 46.15 times at its maximum setting. The lowest EFD 0.013 mJ/mm² at the maximum output settings was much lower (2.1 %) than the maximum value 0.62 mJ/mm² at the minimum settings. The Large acoustic output differences (tens to hundreds of times)from the therapeutic devices approved for the same clinical indications imply that their therapeutic efficacy & safety may not be assured. The findings suggest the regulatory authority to revise her guideline to give clearer criteria for clinical approval and equality in performance, and recommend the authority to initiate a post-approval surveillance as well as a test in conformance between the data in technical documents and the real acoustic outputs clinically used.