Ulthera DeepSEE DS 10 -1.5, Instructions For Use Manual

Page: 24 / 72

Page
24
Ulthera, Inc.
4.4.2. Acoustic Output Measurement
The acoustic output for the Ulthera was measured and calculated in
accordance with the “Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment” (AIUM, NEMA, 2004) and the “Standard for
Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment” (AIUM, NEMA, 2004) [2, 3].
Table 4.1 Acoustic Output Parameter Description
PARAMETER DESCRIPTION
MI Mechanical Index
TIS Soft Tissue Thermal Index in an auto-scanning mode.
I
PA.3
@MI
max
Derated pulse av erage intensity at MI maximum
I
SPTA.3
Derated spatial peak temporal av erage.
p
r
, p
r. 3
Peak, and derated peak rare factional pressure associated with
the transmit pattern giv ing rise to the v alue reported under MI
(megapascals).
PII, PII
.3
Pulse intensity integral, and derated PII.
W
o
Ultrasonic power (milliwatts).
f
c
Center frequency (MHz). For MI, fc is the center frequency
associated with the transmit pattern giv ing rise to the global
maximum reported v alue of MI.
The system meets the AIUM output display standard for MI and TI [3, 4]. The
system and transducer combination do not exceed an MI or TI of 1.0 in any
operating mode. Therefore, the MI or TI output display is not required and is
not displayed on the system for these modes [3, 4, 5].
Table4.2 Acoustic Output Tables
TRANSDUCER
MODEL
ISPTA.3
[MW/CM2]
TI TYPE TI VALUE MI
IPA.3@MIM
AX
[W/CM2]
DS 7 – 3.0 1.80 TIS 0.00039 0.170 17.0
DS 7 – 3.0N 1.80 TIS 0.00039 0.170 17.0
DS 4 – 4.5 1.47 TIS 0.00035 0.157 14.4
DS 7 – 4.5 1.47 TIS 0.00035 0.157 14.4
DS 10 – 1.5 1.80 TIS 0.00052 0.176 17.7
DS 10 – 1.5N 1.80 TIS 0.00052 0.176 17.7