User guide

102
Hazardous materials
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.
WARNING:
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.
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:
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.
WARNING:
Some SonoSite transducers are approved for intraoperative applications if a
market-cleared sheath is used.
WARNING:
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 and intraoperative procedures.
• Appropriate training in interventional and intraoperative 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, guidewire misplacement, and risks
normally associated with local or general anesthesia, surgery, and post-operative
recovery.
WARNING:
To avoid device damage or patient injury, do not use the P10x, P17x, or P21x
needle guide bracket on patients with pacemakers or medical electronic implants.
The needle guide bracket for the P10x, P17x, and P21x 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.
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.
WARNING:
The liquid crystal display (LCD) contains mercury. Dispose of the LCD properly in
accordance with local regulations.