For sterilisation with ethylene oxide, the clean products must be packaged in suitable gas-proof
pouches. An adequate ventilation time should be respected to ensure total dispersion of the ETO
residues.
For sterilisation in an autoclave, package the products in suitable pouches.
Avoid wrapping that is too tight and sharply twisting of the cord.
Advisable temperatures and times for steam autoclave are as follows:
Models for electrodes with 2,38mm connection and electrodes with 4mm connection (F4246-F4256):
Cycle
Pre-vacuum
134°C (273°F)
8min
121°C (250°F)
8min
NB: The pencils can NOT be sterilised by 137°C (279 °F) cycle.
ATTENTION: Should the products come in contact with the metal supports within the autoclave, their
life may be shortened. It is therefore necessary the use of appropriate means spacing or wrapping as
gauze.
PRODUCT LIFE
Correctly cleaned and sterilised, carefully managed and preserved, the pencil may be sterilised up to
100 times (models F4141 and F4151 can be re-sterilized up to 30 times). Electrodes and extension
with 2,38mm connection must be replaced after 20 sterilisations. Electrodes with 4mm connection must
be replaced after 100 sterilisations. Keep track of the number of sterilisations performed.
PREPARATIONS AND CONNECTIONS
Attach the grounding plate to the patient, preferably on the forearm or thigh. Be sure that the skin is free
of hair and grease. Do not apply the plate to wounds or scars. Apply conductive gel to the plate (if
plates without gel are used). Passage of the current within the patient's body should be as brief as
possible, and should proceed diagonally. The current must never flow in a transversal direction across
the body, nor cross the chest. The patient must be kept isolated from conductive parts, and the
operation table must be suitably "grounded". Use dry gauze to avoid areas of the skin coming in contact
with each other. Be sure that the electrode and extension (if present) is firmly inserted into the housing
of the pencil.
Please remember to connect the electrode to the extension before connecting the extension to the
pencil. By the way, if you need to replace the electrode, remove the extension from the pencil, than
replace the electrode and finally connect again the extension to the pencil.
Connect:
•
the grounding plate, by using a suitable connection cable,
•
the pedal switch (for pedal-controlled models),
•
the connector of the pencil cable ("active" electrode),
to the high-frequency generator.
The active cable must be kept from being in direct contact with the patient's skin, and must not be
twisted. Always refer to the manufacturer's instruction manual to ensure correct use of the high-
frequency generator and to the instructions provided by the manufacturer of the grounding plates,
whether these are reusable or disposable.
NB: If changes are made in the patient's position, always recheck all the connections
OPERATIONAL CHECK
Before each procedure, make a preliminary check of the functioning as follows:
1. Connect the patient to the grounding plate.
2. Connect the pencil to the electrosurgical unit.
3. Turn on the electrosurgical unit and select the 1-Watt outlet in the cutting and coagulation function.
4. Keep the pencil away from persons and objects, and activate the CUT function. Verify that
electrosurgical unit signals CUT function activation.
5. Repeat point 4 to verify the COAG function.
During the procedure, always select the lowest possible energy level. If the coagulation capacity of the
electrode is less than normal, do not increase the high-frequency output without previously carrying out
the following controls:
Exposure
134°C (273°F) 2,05 bar for 12 min
121°C (250°F) 1,05 bar for 20 min
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Drying
9 min
9 min