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Instructions For Use
EN
A3.4 Prudent Use Statement
Although no confirmed bioeffects on patients caused by exposure from present
diagnostic ultrasound equipment have ever been reported, the potential exists that
such bioeffects may be identified in the future. Therefore, the ultrasound should be
used prudently. High levels of acoustic output and long exposure time should be
avoided while acquiring necessary clinical information.
A3.5 References for Acoustic Output and Safety
1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
2. “Medical Ultrasound Safety” issued by AIUM in 1994
3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment,
Revision 3" issued by AIUM/NEMA in 2004
4. "Standard for real-time display of thermal and mechanical acoustic output indices on
diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004
5. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers" issued in 2008.
6. “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 2007.
A3.6 Transducer Acoustic Output Parameters List
A3.6.1 Test of Wireless Transducer (FTS-3)
12-Crystal Wafer Transducer
Acoustic output reporting table for IEC60601-2-37 (IEC60601-2-37, Edition 2.1, 2015-
06, table 201.103)
Operating Mode: PW mode Working Frequency: 1.0MHz
Index label
MI
TIS
TIB
TIC
At
surface
Below
surface
At
surface
Below
surface
Maximum index value
0.017
0.0079
0.064
N/A
Index component value
N/A
0.0079
N/A
0.064
Acoustic
Parameters
pr.
α
at z
MI
(MPa)
0.017
P
(mW)
9.69
9.69
N/A
P
1x1
(mW)
N/A
N/A
z
s
(cm)
6.55
z
b
(cm)
6.55
z
MI
(cm)
6.55
z
PII
.
α
(cm)
6.55
f
awf
(MHz)
1.00
1.00
1.00
N/A
