300004969171/B Page 127 of 148
Revolution
Acoustic Output Parameter B-Mode
SPPA
3
3
1. Uncertainty: +/- 29.1%
2. Uncertainty: +/-14.6%
TI: Thermal Index defined as TI=W
01x1
f
c
210
where:
W
01x1
is the bounded-square output in milliwatts
f
c
is the Center Frequency in MHz
MI: Mechanical Index MI=Pr.3/(f
c
1/2
)
I
SPPA.3:
Derated Intensity. Spatial Peak Pulse Average (mW/cm
2
)
I
SPTA.3:
Derated Intensity. Spatial Peak Temporal Average (mW/cm
2
)
Pr.3: Derated Peak Negative Pressure at a location of the maximum derated pulse
intensity integral (MPa)
W
0:
Total Power (mW)
PD: Pulse Duration (µs)
PRF: Pulse Repetition Frequency (Hz)
Measurement Accuracy
Measurements obtained with the Volcano system are subject to the following
measurement inaccuracies due to variations in tissue speed of sound and display
limitations. The measurement precision is limited in both relative and absolute ranges:
Distance Measurement: –4.5%, +7.0% of measured value ± 0.10mm
Area Measurement: –9%, +14% of measured value ± 0.10mm
2
These uncertainties apply to the entire range of measurement achievable with the
Volcano system. These are worst case measurement uncertainties and represent situations
where the ultrasound signals are entirely within tissue, such as muscle, which has a very
different speed of sound than blood. For measurement of luminal boundaries, where the
ultrasound only traverses through blood, the inaccuracy is: