Olympus Winter & Ibe GmbH ESG200 User Manual
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Safety information
2.6.8 Procedural hazards and complications
DANGER
Procedural hazards and complications
Insufficient knowledge of the user about the medical literature and about the specific
procedural hazards will result in severe complications that can result in death of the patient.
• The electrosurgical generator must only be used by physicians who have experience with
the electrosurgical procedure that is used for the specific therapy.
• To respond to possible complications during the procedure consider the following:
• Prepare at least one hemostatic procedure: coagulation, clipping or local injection.
• Make sure that emergency equipment for life-saving, intubation and appropriate
pharmaceuticals are located in or near the procedure room.
• Prepare a spare electrosurgical generator or an alternative procedure to avoid
interruption of treatment due to an unexpected electrosurgical generator failure during
the treatment.
• If any abnormal output is suspected during the operation, immediately terminate the
use of the equipment.
• If the foot switch does not react, switch off the electrosurgical generator. Malfunction
of the equipment can cause an unintended increase of output energy.
• Use physiological monitoring equipment throughout the entire procedure.
• Consider the use of a bipolar mode for procedures where the HF current could flow
through parts of the body with a relatively small cross sectional area.
• It is not recommended to use electrosurgery for circumcisions because of the risk of
thermal injuries. The risk can be reduced if metal parts of any kind (e.g. clamps) or
monopolar HF instruments are avoided.
WARNING
Electrosurgical smoke
Electrosurgical interventions produce smoke. When unfiltered smoke is inhaled, then this
can affect the health of the user and the medical personnel.
• Wear surgical masks during the procedure.
• Make sure that adequate ventilation, surgical smoke evacuators or other means is
provided in the operating room.
WARNING
Output performance
Tissue coagulum that builds up at the HF instrument can impede the output performance
of the electrosurgical generator. Increasing the output level can damage the electrosurgical
generator and can result in injury to the patient.
• Carefully clean eschar affected areas of the HF instrument. Refer to the instructions for
use of the HF instrument.
• If necessary, replace the HF instrument.
If non-insulated grasping forceps are used during endoscopic interventions, then the HF
current is dispersed via the endoscope which impedes the output performance and which
can result in injury to the patient.
• Only use isolated grasping forceps during endoscopic interventions.
DRAFT
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2017-01-17