Clinical Safety - FujiFilm SonoSite Edge II User Manual

Clinical safety

W ARNINGS
Safety
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. Such behavior
could indicate a hardware failure. Contact FUJIFILM SonoSite Technical Support.
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.
To avoid injury or reduce the risk of infection to the patient, observe the following:
Follow Universal Precautions when inserting and maintaining a medical
device for interventional procedures.
Appropriate training in interventional procedures as dictated by current
relevant medical practices as well as in proper operation of the ultrasound
system and transducer is required. During vascular access, the potential exists
for serious complications including without limitation the following:
pneumothorax, arterial puncture, and guidewire misplacement.
To avoid device damage or patient injury, do not use the P10x or rP19x needle
guide bracket on patients with pacemakers or medical electronic implants. The
needle guide bracket for the P10x and rP19x transducers contains a magnet that
is used to ensure the bracket is correctly oriented on the transducer. The
magnetic field in direct proximity to the pacemaker or medical electronic implant
may have an adverse effect.
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