Mindray Anesus ME7T, Operator'S Manual

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H - 6 Operator’s Manual
H Acoustic Output
H.8 Measurement Uncertainty
The total estimated measurement uncertainty (where the total uncertainty includes the uncertainties
in hydrophone response, measurement, calculation, and positioning) are:
H.9 References for Acoustic Power and Safety
• “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
• “Medical Ultrasound Safety” issued by AIUM in 1994
• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019.
Center for Devices and Radiological Health.
• Medical electrical equipment-Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment issued by
IEC in 2015
• IEC 62359, Ultrasonics-Field characterization-Test methods for the determination of thermal
and mechanical indices related to medical diagnostic ultrasonic fields, 2017.
Acoustic Quantities Total Uncertainties (Standard)
Power 26.48% for non-scan modes; 6.03% for scan modes.
Frequency 0.22%
Pressure 13.01%
I
ta
26.48% for non-scan modes; 26.95% for scan modes.
I
pa
26.5%
Mechanical Index 13.01%
Total Uncertainty for TIS Non-scan Modes: 26.48%; Scan-Modes: 6.03%
Total Uncertainty for TIB Non-scan Modes: 26.48% or 18.72%; Scan-Modes: 6.03%
Total Uncertainty for TIC Non-scan Modes: 26.48%; Scan-Modes: 6.03%