Transducer Surface Temperature Rise; Acoustic Output Measurement - FujiFilm SonoSite X-Porte User Manual

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 temperature rise

The tables in this section list the measured surface temperature rise from ambient (23°C ± 3°C) of
transducers used on the ultrasound system. The temperatures were measured in accordance with EN
60601-2-37 with controls and settings positioned to give maximum temperatures.
Table 10-1: Transducer Surface Temperature Rise, External Use (°C)
Test
Still air 8.8 13.5
Simulated 3.5 8.2(≤
(≤
use 10°C)
10°C)
Table 10-2: Transducer Surface Temperature Rise, Non-External Use (°C )
Test
Still air
Simulated use
Note

Acoustic output measurement

Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects) from
ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, AIUM
ratified a report from its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic
Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement). The report, sometimes referred to as
the Stowe Report, reviewed available data on possible effects of ultrasound exposure. Another report,
"Bioeffects and Safety of Diagnostic Ultrasound," dated January 28, 1993, provides more current
information.
10-10
13.4 14.8
9.1(≤ 9.5(≤
10°C) 10°C)
ICTxp
8.9
4.7 (<6°C)
For information about surface temperature rise for the TEExp transducer, refer to
the TEExp Transducer User Guide, included with the TEExp transducer.
10.4 11.1 13.8
7.0(≤ 9.0(≤ 7.9(≤
10°C) 10°C) 10°C)
12.8 12.9 15.4
8.6(≤ 9.0(≤ 9.2(≤
10°C) 10°C) 10°C)
Acoustic output
14.7
9.5(≤
10°C)