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o Use monitoring systems incorporating high frequency
current limiting devices.
o DO NOT use electrosurgery in the presence of flammable
anesthetics or other flammable gases, near flammable
fluids or objects, or in the presence of oxidizing agents, as
fire could result.
• Inspect the device for breaks, cracks, nicks, or other damage
to the electrical insulation before use. Failure to observe this
caution may result in injury or electrical shock.
• Insulation failures may result in burns or other injuries. Visual
inspection alone may not be sufficient to confirm that the
insulation is intact, and dielectric strength testing should be
additionally considered.
The exposed metal surface of the device may remain hot
enough to cause burns after the radio frequency (RF) current
is deactivated.
• Install tips onto the ReNew Electrocautery Probe when not
connected to the electrosurgical unit (ESU) or when the
energy is off. Failure to do so may result in an injury or
electrical shock.
• Aspirate fluid pools from the area before activating RF current
to the device. Conductive fluids (e.g., blood or saline) in direct
contact with or in close proximity to the device may carry
electrical current or heat away from target tissues, which may
cause unintended burns
• Use the lowest setting possible on the ESU/RF Generator to
achieve the desired tissue effect to avoid overtreatment,
which could result in swelling, fluid, seroma or unintended
tissue necrosis.
• Use only with a legally-marketed ESU/RF Generator
• Use only with safety certified ESU/RF generators (IEC 60601-
2-2).
• Refer to the ESU/RF generator IFU for operating instructions
and warnings.
• Refer to the ESU/RF generator IFU for selection of cable and
neutral pad electrode consistent with handpiece ratings.
• CAUTION: To reduce risk of electrical burn or shock, do not
rest fingers or hands near metal parts during use, particularly
near cautery cap connector or between handles.
•
If an adverse event occurs using this device please report it to
Microline Surgical Customer Service as well as the
Competent Authority in your Member State (EU).
Following are the risks associated with reuse:
• Risk of mechanical failure from undue stresses
• Risk that cleaning and decontamination may be ineffective,
increasing the likelihood of cross contamination or infection
• Risk of residue from decontamination agents
• Risk of material alteration due to the decontamination
process, including the use of chemical agents and elevated
temperatures
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