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21 June 1999 Acoustic intensity simulations for regulatory compliance
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Ensuring that an ultrasound imager complies with all aspects of the FDA 510(k) regulations is a complex task, because there are hundreds of thousands of discrete operating conditions available to the sonographer. Accurate measurements require `peaking' of the hydrophone in azimuth and elevation, and acquiring data as a function of range. Thus it is necessary to characterize the acoustic field in 3 dimensions. It is simply impossible to measure the imager's output under each condition, so algorithmic means are needed to reduce the dimensionality of the problem. Even when simple linear dependencies (such as pulse repetition frequency) are taken into account, the time to obtain Thermal and Mechanical Indices for a new probe is formidable. We must also repeat the experiment each time changes are made to the transmitter hardware, or its waveforms. In this paper, we explore how to speed the acquisition of data used for estimation of the output labeling parameters by guiding the water-tank measurements with a beam simulator.
© (1999) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Chris M. W. Daft, William M. Leue, Kai Erik Thomenius, Lars A. Odegaard, Michael C. MacDonald, and Alan S. Meyers "Acoustic intensity simulations for regulatory compliance", Proc. SPIE 3664, Medical Imaging 1999: Ultrasonic Transducer Engineering, (21 June 1999);

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