Clinical Safety; Hazardous Materials - FujiFilm SonoSite sII Service Manual

Clinical safety

WARNING: Non-medical (commercial) grade peripheral monitors have not been verified or
validated by FUJIFILM SonoSite as being suitable for diagnosis.
WARNING: 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.
WARNING: 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
WARNING:
cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User
labeling for devices that contain natural rubber.
WARNING: Perform ultrasound procedures prudently. Use the ALARA (as low as
reasonably achievable) principle and follow the prudent use information
concerning MI and TI.
WARNING: 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.
WARNING: Some FUJIFILM SonoSite transducers are approved for intraoperative
applications if a market-cleared sheath is used.
WARNING: To avoid injury and reduce risk of infection to the patient, observe the following:
• Follow Universal Precautions when inserting and maintaining a medical
• Appropriate training in interventional and intraoperative procedures as
To avoid device damage or patient injury, do not use the P10x or rP19x needle
WARNING:
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.

Hazardous materials

WARNING: Products and accessories may contain hazardous materials. Ensure that
products and accessories are disposed of in an environmentally responsible
manner and meet federal and local regulations for disposing hazardous
materials.
device for interventional and intraoperative procedures.
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, guidewire misplacement, and
risks normally associated with local or general anesthesia, surgery, and
post-operative recovery.
Chapter 3: Safety 15