Olympus EVIS EXERA II - Appendix D: Acoustic Output Information in Accordance; Systems and Transducers; Symbol Key

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Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix D: Acoustic Output
Information in Accordance with the FDA
Guidance: “Information for
Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound
Systems and Transducers”
Symbol key
MI Mechanical Index
TIS
scan
Soft Tissue Thermal Index in an auto-scanning mode
TIS
non-scan
Soft Tissue Thermal Index in a non-autoscanning mode
TIB Bone Thermal Index
TIC Cranial Thermal Index
TI type The applicable thermal index type
TI value The thermal index value
A
aprt
Area of the active aperture (square centimeters)
p
r.3
Derated peak rarefactional pressure associated with the transmit
pattern giving rise to the value reported under MI (megapascals)
W
0
Ultrasonic power except for TIS
scan
, in which case it is the ultrasonic
power passing through a one centimeter window (milliwatts)
W
.3
(Z1) Derated ultrasonic power at axial distance z
1
(milliwatts)
I
TA.3
(Z1) Derated spatial peak, temporal average intensity at axial distance z
1
(milliwatts per square centimeter)
z
1
Axial distance corresponding to the location of max [min (W
.3
(Z), I
TA.3
(Z) × 1 cm
2
)] where Z ≥ Z
bp
(centimeters)
z
bp
(centimeters)
z
sp
For MI, the axial distance at which
Pr.3
is measured for TIB, the axial
distance at which TIB is a global maximum (i.e., z
sp
= z
B.3
)
(centimeters)
z@PII.
3max
Axial distance corresponding to the maximum of the derated
spatial-peak pulse intensity integral (megapascals)
1.69
A
aprt