Acoustic Output Measurement

The accurate quantitative determination of the spatial and temporal characteristics of ultrasonic fields in diagnostic ultrasound devices is important for safety reasons. The precise determination of acoustic pressure and other field quantities, and how they vary in time and space, allows manufacturers of diagnostic ultrasound equipment to evaluate if certain system is within the safety margins or FDA preamendment values. As a complement to our research and development activities, Sigma Biomedical developed a system for measuring these parameters according to the most recent standards of the National Electric Manufactures Association (NEMA) and regulatory agencies such as the US Food and Drug Administration (FDA) . The result of this work is the Acoustic Power and Intensity Measurement System.

We offer a complete acoustic output measurement service. We will carry out acoustic output measurement in autoscanning and/or non-autoscanning modes and provide a report to use in the 510(k) submission to the FDA Office of Device Evaluation, Center for Devices and Radiological Health , or to the European Medical Device Directive (MDD). Reports include maximum acoustic field variables, statistical and uncertainty analysis, a description of the measurement system, description of the measurement process, and hydrophone calibration methods.

Pulse Waveform and Pulse Intensity Integral (PII) Plots, Zsp - Position of the maximum spatial PII . Center Frequency, Spatial Peak Pulse Average Intensity (Isppa), Spatial Peak Temporal Peak Intensity, Spatial Peak Temporal Average Intensity (Ispta), Intensity Maximum (Imax) values, Pulse Duration, In-Water Measured Intensity Values Derated (estimated in situ) Intensity values, Pressure Positive Peak and Pressure Negative Peak values, Acoustic Power, Beam Dimensions.