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Warnings and Cautions
Prior to using the AEM EndoShield Burn Protection System, read and review
these instructions, the instructions for use for the electrosurgical generator,
and the instructions for use for all instruments and accessories to be used.
Fire and Shock Hazards
WARNING:
Explosion Hazard. Do not use electrosurgery in the presence of ammable
liquids or in an oxygen enriched environment.
Fire Hazard. Electrosurgical accessories that are activated or hot from use can
cause a re. Do not place them near or touching ammable materials (such as
gauze or surgical drapes).
Electric Shock Hazard. Ensure that all accessories, cords, and adapters are
correctly connected.
Electric Shock Hazard. Do not attempt to connect or disconnect any cable
during power activation.
General
WARNING:
Conrm proper electrosurgical power setting before proceeding with surgery.
Use the lowest power setting that achieves the desired surgical eect.
Keep electrical connections dry while in use to prevent potential conduction of
High Frequency (HF) current to the user.
Only an AEM instrument provides active electrode monitoring. Other
conductive objects at or near the surgical site are not protected. Do not touch
those objects with the active instrument.
No modication of this equipment is allowed.
Caution:
Limit electrosurgical generator power settings as noted in the ESU Mode and
Power Limitation table in the System Setup section. Higher settings may result
in spurious insulation failure alarms and/or insulation breakdown.
Active Accessories and the AEM EndoShield Burn Protection System
WARNING:
Do not wrap accessory cords around metal objects. Wrapping cords around
metal objects may induce currents that could lead to shocks, res, or injury.
The electrode tip may remain hot enough to cause burns after the
electrosurgical current is deactivated.
When not in use, place accessories in a clean, dry, nonconductive and highly
visible area not touching the patient. Inadvertent contact with the patient
may result in burns.
Ensure that the insulation of conventional, nonshielded disposable and
reusable laparoscopic instrumentation is intact. Compromised insulation of
nonshielded instruments may lead to shocks or burns to the patient or surgical
personnel.
