Clinical Safety - FujiFilm SonoSite X-Porte User Manual

Clinical Safety

WARNINGS
9-8
To avoid injury, inspect all fasteners and connections.
To avoid the risk of a burn hazard, do not use the transducer with high
frequency surgical equipment. Such a hazard may occur in the event of a defect
in the high frequency surgical neutral electrode connection.
The maximum temperature of the transducer scan head may be greater than
41 °C (105.8 °F), but is less than 43 °C (109.4 °F) when in contact with the
patient. Special precautions should be considered when using the transducer on
children or on other patients who are sensitive to higher temperatures.
Do not use the system if it exhibits erratic or inconsistent behavior.
Discontinuities in the scanning sequence are indicative of a hardware failure that
must be corrected before use.
Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. FUJIFILM SonoSite recommends
identifying your latex- and talc-sensitive patients and being prepared to treat
allergic reactions promptly.
Perform ultrasound procedures prudently. Use the ALARA (as low as
reasonably achievable) principle and follow the prudent use information
concerning MI and TI.
FUJIFILM SonoSite does not currently recommend a specific brand of acoustic
standoff. If an acoustic standoff is used, it must have a minimum attenuation of
.3dB/cm/MHz.
Use market-cleared, sterile transducer sheaths and sterile coupling gel for
transrectal, transvaginal, or guided-needle procedures. Do not apply the
transducer sheath and coupling gel until you are ready to perform the
procedure. After use, remove and discard the single-use sheath, and clean and
disinfect the transducer using a FUJIFILM SonoSite recommended disinfectant.
Safety