Output Display; Transducer Surface Temperatures - SonoSite iLook 15 Guide D'utilisation

Output Display

Related Guidance Documents
• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems
and Transducers, FDA, 1997.
• Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. (A copy is
included with each system.)
• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-2004.
• 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 3 lists the measured surface temperature of transducers used on the 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 3: Transducer Surface Temperatures EN 60601-2-37
Standard
42.3(a) 1, Test
Method B
(IEC 60601-2-37,
Amendment 1)
C15 L25
Measured Measured
temperature temperature
T° C T° C
0.6° C rise 3.1° C rise
Temperature Limit
Allowed maximum temperature T° C
10° C from initial TMM measurement.
Temperature rise from ambient
temperature a of the test object (tissue
mimicking material or TMM) to
maximum temperature on the test
object within 1 mm of the active surface
of the transducer.
Chapter 5: Safety 7