59
9.8 Uncertainty of measurement
Ispta
31.2%
Isppa
30.4%
center frequency (fc)
2%
Total power (W)
30.1%
（
5.6% Scan mode and combination mode
）
Peak negative pressure(pr)
15.5%
9.9 Reference literature for sound
power and its safety
(1)
“Bio-effects 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 by FDA 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.
9.10 Transducer surface temperature
EN60601-2-37:2008 according to the requirements of clause 201.11, the transducer surface
temperature was measured under two conditions: transducer suspension in the absence of air
circulation environment (Still Air) and probe contact phantom (Method B).
The maximum surface temperature and maximum temperature rise of the transducer are listed
below
：
Transducer
test method
Operation
mode
Ambient
(
°C
)
Initial
temper
ature
(
°C
)
Final Radiating
Surface temp.(TF)
and/or
Temp.Rise(TR)
(
°C
)
C5-2Fs
TMM
Normal(B
25.554
25.261
TF=30.020 TR=4.759
