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Directions for use
4
4-6. Electrosurgery
Warning
• Thoroughly read the manual provided with the high frequency generator and device before
using them, and always perform a pre - use inspection. Ensure that the high frequency
generator and device are ready for use by performing the safety checks specified in the
manual. Use of the endoscope in combination with the electrosurgical device could result in
increased leakage of current to the patient.
• Ensure that the released energy from the high - frequency does not affect the peripheral
device such as pacemaker and to use the minimum necessary output level of high- frequency
when using it near the heart. It may stimulate the heart.
• Use an endoscopic device having insulated insertion portion other than the distal tip (active
portion). Failure to do so may result in burns from high-frequency current.
• Do NOT use the high frequency generator in flammable surroundings, such as an oxygen-rich
environment. If there is a possibility of a flammable gas being present within a body cavity,
dilute the gas with a nonflammable gas prior to electrosurgery. Using the high frequency
generator in flammable surroundings may result in combustion or an explosion.
• Ensure that the active portion of the endoscopic device does NOT come into contact with the
peripheral tissues, as it may result in patient injuries.
• Set the high - frequency output level and waveform mode appropriately according to usage.
Minimize the duration of time during which high - frequency current is delivered, as prolonged
exposure to electrosurgical energy can result in patient injury.
• Check the entire surface of the endoscope for any abnormalities such as cracks and exposure
of internal metals before using an electrosurgical device. Failure to do so may result in burns.
Caution
• Users as well as the assisting personnel should always wear insulated gloves. Failure to do
so may result in burns from high- frequency current.
• High frequency generator may be of the floating (Type BF or Type CF) or non - floating (Type
B) types. Use only floating -type high frequency generator to avoid patient and user burns.
• During use, follow the precautions below, as failure to do so may result in endoscope damage,
burns, and /or mucosal injury.
– Maintain an adequate distance between the distal end of the endoscope and the insulated
tip and active portion of the endoscopic device. Ensure that the distal tip of the endoscopic
device is adequately projecting from the distal end of the endoscope before operating it.
– Users and assisting personnel should NOT touch the patient during device use.
– Turn on the high frequency generator just before the procedure and turn it off immediately
after the procedure.
1. Insert the electrosurgical device into the inlet seal as described in “4 - 3. Using an endoscopic device”.
2. Operate the electrosurgical device according to the IFU provided with it.
3. When the procedure is complete, withdraw the electrosurgical device from the inlet seal (OF - B190)
as described in “4 - 3. Using an endoscopic device”.