SonoSite titan, Дополнение к руководству пользователя

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Chapter 6: Safety 9
• 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 Table 7 list 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 5: Transducer Surface Temperatures EN 60601-2-37 (External Use)
C11 C15 C60 Temperature Limit
Standard Measured
temper-
ature T° C Measured
temper-
ature T° C Measured
temper-
ature T° C Allowed max. temperature T° C
42.3(a) 1, Test
Method B
(IEC 60601-2-37,
Amendment 1) 4° C rise 1.1° C rise 8.5° C rise 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.
a. The ambient temperature shall be 23
°
C ± 3
°
C
42.3(a) 2
(IEC 60601-2-37,
Amendment 1) 6.8° C rise 7.5° C rise 13.4° C
rise 27° C rise from ambient.
Temperature rise from ambient
temperature
b , as measured on
the active surface of the
transducer, over a 30 minute
time period.
b. Ibid.