Clinical Safety - FujiFilm SonoSite Edge II User Manual

To avoid the battery becoming damaged and causing equipment damage, observe the following precautions:
Caution

Clinical safety

WARNINGS
154
Do not immerse the battery in water or allow it to get wet.
Do not put the battery into a microwave oven or pressurized container.
If the battery emits an odor or heat, is deformed or discolored, or in any way
appears abnormal during use, recharging or storage, immediately remove it and
stop using it. If you have any questions about the battery, consult FUJIFILM
SonoSite or your local representative.
Use only FUJIFILM SonoSite batteries.
Do not use or charge the battery with non-FUJIFILM SonoSite equipment. Only
charge the battery with the system.
Non-medical (commercial) grade peripheral monitors have not been verified or
validated by FUJIFILM SonoSite as being suitable for diagnosis.
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.
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. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
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 attentuation
of .3dB/cm/MHz.
Some FUJIFILM SonoSite transducers are approved for intraoperative
applications if a market-cleared sheath is used.
Clinical safety