Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic
Medical Diagnostic and Monitoring Equipment and the United States Food and Drug
Administration’s Guidance Document, “Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers” limits..
Transmit Power: Transmit power controls the transmit voltage, and therefore the amplitude
of the transmitted ultrasonic waves. Both the TI and the MI will change when Transmit power
(A Output) is adjusted.
Automatic Limiting: For any adjustment described in the mode-specific section below,
when a user adjustment of an ultrasound system control causes the MI, TI, or any other
acoustic output or surface-temperature related parameter to reach a system control limit, the
ultrasound system will automatically decrease the transmit voltage, causing a decrease in
one or more of those parameters.
B-Mode Controls
Image Width: Narrowing the image width may increase the frame rate, which may increase
the TI.
Depth: Decreasing the depth may increase the frame rate, which may increase the TI.
Operating Frequency: Changing the operating frequency will affect the displayed MI and TI
values as the beam formation is affected and transducer efficiencies may differ between
frequencies.
Frame Rate: A lower frame rate may decrease the TI; however, due to an increase in the
Image Width, the TI stays roughly constant if the systems transmit pulse repetition stays
constant.
Zoom: Increasing or decreasing the zoom may affect the frame rate, which may increase or
decrease the TI.
Image Presets: Changing the image presets may indirectly change the acoustic line spacing
or the frame rate, which could change the TI values. An increasing spacing may decrease
the TI, and an increasing frame rate may increase the TI.
M-Mode Controls
Depth: Decreasing the depth may increase the frame rate, which may increase the TI.
Operating Frequency: Changing the operating frequency will affect the displayed MI and TI
values as the beam formation is affected and transducer efficiencies may differ between
frequencies.
Image Presets: Changing the image presets may indirectly change the acoustic line
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