SonoSite titan, Дополнение к руководству пользователя

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Chapter 6: Safety 11
Labeling Symbols
Table 7: Transducer Surface Temperatures IEC 60601-2-37 (Internal Use)
C8 ICT Temperature Limit
Standard Measured
tempera-
ture T° C Measured
tempera-
ture T° C Allowed max. temperature T° C
42.3(a) 1, Test
Method B
(IEC 60601-2-37,
Amendment 1) 1.1° C rise 3.3° C rise 6° 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) 7.7° C rise 7.3° 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.
Table 8: Labeling Symbols
Symbol Definition
Device complies with relevant Australian regulations for electronic devices.
Device complies with relevant Brazilian regulations for electro-medical devices.
Device complies with relevant FCC regulations for electronic devices.