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.
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 device has made contact with the
patient.
Interference produced by the operation of the 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.
Cautions
Always use the device in field of view of the camera and use caution when using
other devices so as not to damage device insulation.
Smoke-plume extraction may be necessary during electrosurgical cutting or
coagulation.
Device (including insulation) and device accessories must be inspected prior to
use to ensure integrity. In particular, electrode cables and endoscopically used
accessories should be checked for possible damage to the insulation.
To prevent the possibility of electrical shocks or burns, do not use devices with
breaks in the insulation.
When used in conjuction with laser equipment, always use caution (i.e. eye
protection).
If there are any variations between these instructions and either your facility's
policies and/or your cleaning/sterilization equipment manufacturer's instructions,
those variations should be brought to the attention of the appropriate responsible
hospital personnel for resolution before proceeding with cleaning and sterilizing
your devices.
Use of device for a task other than that for which it is intended will usually result in
a damaged or broken device.
Examples
1. Use of a delicate dissector as a grasper.
2. Use of a delicate scissor to cut suture.
3. Use of a dissector to remove clips.
4. Use of a 5mm grasper or dissector instead of a 10mm claw extractor forceps to
remove excised tissue through cannula.
Prior to use, inspect device to ensure proper function, insulation and condition. Do
not use devices if they do not satisfactorily perform their intended function or have
physical damage.
Inspect insulation. Any interruptions in the coating may compromise the safety
of the device. To prevent the possibility of electrical shocks or burns, do not use
devices with breaks in the insulation.
Avoid mechanical shock or overstressing the devices. Close distal ends prior to
insertion or removal through cannulas.
Only the cleaning and sterilization processes which are defined within these
instructions for use have been validated.
Always use caution when inserting or removing devices through cannula. Lateral
pressure on the device during removal can damage the working tip, shaft of the
device and/or insulation. Be sure the tips are closed and the device is pulled straight
out until completely clear of cannula to avoid catching the valve assemblies in
cannulas or dislodging the cannula.
Use only neutral pH (6-8) detergent solutions.
Rated Voltage
The maximum recurring peak voltage for electrosurgical devices applicable to this
IFU is 1kVp.
Note: Failure of the electrosurgical generator may result in an unintended increase
in output power.
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