• Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment,
American Institute of Ultrasound in Medicine, 1993.
• Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment, NEMA UD3-2004.
• Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH, BS EN
60601-2-37 reprinted at P05699.
Transducer Surface Temperatures
Table
5,
Table
6, and
SonoSite system. The temperatures were measured in accordance with EN 60601-2-37 section 42
where controls and settings were positioned to give maximum temperatures.
Table 5: Transducer Surface Temperatures EN 60601-2-37 (External Use)
Standard
42.3(a) 1, Test
Method B
(IEC 60601-2-37,
Amendment 1)
42.3(a) 2
(IEC 60601-2-37,
Amendment 1)
a.
The ambient temperature shall be 23
b.
Ibid.
Table 7
list the measured surface temperature of transducers used on the
C11
C15
Measured
Measured
temper-
temper-
ature T° C
ature T° C
4° C rise
1.1° C rise
6.8° C rise
7.5° C rise
°
°
C ± 3
C
C60
Temperature Limit
Measured
Allowed max. temperature T° C
temper-
ature T° C
8.5° C rise
10° C from initial TMM
measurement.
Temperature rise from ambient
temperature
(tissue mimicking material or
TMM) to maximum temperature
on the test object within 1 mm
of the active surface of the
transducer.
13.4° C
27° C rise from ambient.
rise
Temperature rise from ambient
temperature
the active surface of the
transducer, over a 30 minute
time period.
Chapter 6: Safety
a
of the test object
b
, as measured on
9