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.
Fig. 1 Measured and simulated
pressure distribution
Fig. 2 Pressure
distribution in front
of a 2D sparse array
Fig. 3 pressure
distribution of a single element transducer
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.
