Clinical Safety - FujiFilm SonoSite M-Turbo User Manual

Ultrasound system
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• If the battery emits an odor or heat, is deformed or discolored, or in any way appears
• Store the battery between -20°C (-4°F) and 60°C (140°F).
• Use only SonoSite batteries.
• Do not use or charge the battery with non-SonoSite equipment. Only charge the

Clinical safety

WARNING:
102
abnormal during use, recharging or storage, immediately remove it and stop using
it. If you have any questions about the battery, consult SonoSite or your local
representative.
battery with the system.
Non-medical (commercial) grade peripheral monitors have not been verified or
validated by 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.
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 SonoSite transducers are approved for intraoperative applications if a
market-cleared sheath is used.

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