Olympus BF-UC180F - Appendix C: Acoustic Output Information in Accordance; Clearance of Diagnostic Ultrasound Systems and; Transducers; Acoustic Output Table with Olympus Compact Endoscopic Ultrasound Center

Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
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ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Appendix C: Acoustic Output
Information in Accordance with the FDA
Guidance: “Information for
Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound
Systems and Transducers”
Acoustic output table with Olympus compact
endoscopic ultrasound center
The terms used in the acoustic output table are as follows:
I
SPTA.3
is the derated spatial peak, temporal average intensity in milliWatts/cm
2
.
TI type is the applicable thermal index for the transducer, imaging mode, and
exam type.
TI value is the thermal index value for the transducer, imaging mode, and exam
type.
MI is the mechanical index.
I
pa.3
@MImax in W/cm
2
is the derated pulse average intensity at the maximum
MI.