• DO NOT place instruments near or in contact with flammable
materials (such as gauze or surgical drapes). Instruments
that are activated or hot from use may cause a fire.
• INSPECT instruments and cables for damage prior to each
use, especially the insulation of laparoscopic/endoscopic
instruments. This may be done visually under magnification or
with a high voltage insulations testing device. Insulation failures
may result in burns or other injuries to the patient or operator.
• The surface of the active electrode may remain hot enough
to cause burns after the RF current is deactivated.
• Due to concerns about the carcinogenic and infectious
potential of electrosurgical byproducts (such as tissue
smoke plume and aerosols), protective eyewear, filtration
masks, and effective smoke evacuation equipment should be
used in both open and laparoscopic procedures.
• To reduce capacitive coupling, the insert assembly should
only be activated when positioned to deliver energy to the
target tissue.
• Activating the electrosurgical unit while simultaneously
utilizing the suction/irrigation may alter the intended path of
the electrical energy away from target tissue.
• Improper connections of accessories may result in inadvertent
accessory activation or other potentially hazardous conditions.
• Connect adaptors and accessories to the electrosurgical unit
only when the unit is off. Failure to do so may result in an
injury or electrical shock to the patient or operating room
personnel.
• The use of accessories, transducers, and cables other than
those specified, with the exception of transducers and cables
sold by the manufacturer of this device as replacement parts
for internal components, may result in increased emissions
or decreased immunity of insert assembly.
• Start with the lowest possible power setting on the
electrosurgical generator. To achieve the desired cutting
and coagulation, check the patient circuit and then gradually
increase the power setting.
Note: The output power selected should be as low as possible
for the intended purpose.
• Do not activate the electrosurgical unit until the insert
assembly has made contact with the patient.
• Interference produced by the operation of HF surgical
equipment may adversely influence the operation of other
electronic equipment.
• Use of low-frequency power could result in neuromuscular
stimulation.
• Failure of the electrosurgical generator may result in an
unintended increase in output power.
• No modification of this equipment is allowed.
• Ensure the diameter of the trocar is compatible with the size
of the insert assembly diameter (3 mm). Failure to do so
may compromise the instruments insulation.
• Extended energized periods of time without contact to target
tissue will increase the opportunity for insulation degradation.
• Visual inspection alone may not be sufficient to ensure the
insulation is intact.
• USE CAUTION when using hybrid trocar systems,
(i.e. a combination of metal and plastic) with monopolar active
components, as use of these trocars may result in alternate
site burns due to capacitive coupling. Only use hybrid trocar
systems when metal is in continuous and complete contact
with the patient's tissue, creating an adequate electrical return
path. Refer to trocar manufacturer for further clarification.
• The insert assembly should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use is
necessary, the insert assembly should be observed to verify
normal operation in the configuration in which it will be used.
• Portable and mobile RF communications equipment can
affect Medical Electrical Equipment.
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