Olympus Winter & Ibe GmbH ESG200 User Manual

11

Safety information

Electrosurgical generator intended for tissue cutting and coagulation in conjunction with 

electrosurgical accessories and ancillary equipment.

Electrosurgical interventions are contraindicated if, in the judgment of the physician, 

tissue coagulation and cutting could have a negative effect on the state of the patient.  

Electrosurgical interventions may be contraindicated for patients with implanted electronic 

devices (e.g. pacemakers or cardioverter-defibrillators), a weakened immune system or 

blood coagulation disorders.

If there is an official standard on the applicability of high frequency treatment as defined by 

a national or local medical administration or other institutions, such as an academic society, 

follow that standard when performing the procedure.

Before performing any high frequency treatment, thoroughly study the properties, purposes, 

and effects as well as the nature, extent, probability and imminence of possible risks 

associated with the planned treatment. Furthermore, study any alternative therapeutic 

method that can be performed.

Carry out high frequency treatment only when its benefits outweigh its risks. Fully explain 

to the patient the possible benefits and risks of high frequency treatment as well as those 

of any therapeutic method that can be performed instead of electrosurgery. Perform high 

frequency treatment only after patient consent is granted.

During high frequency treatment, continue to evaluate the potential benefits and risks. Stop 

the treatment if the risks become greater than the possible benefits to the patient.

If the required qualification for medical personnel who uses electrosurgical generators 

is defined by a national or local medical administration or other institutions, such as an 

academic society, then follow that standard.

If there is no such standard:

 - The user must be a physician or medical personnel under supervision of a physician.

 - The user must have experience with electrosurgical procedures that are used for the 

therapy.

 - The user must have received appropriate training in using this electrosurgical generator. 

This training is provided during installation and commissioning of the CELON ELITE 

ESG-200 by trained qualified personnel that has been authorized by Olympus.

These instructions for use do not explain or discuss clinical procedures.

DRAFT 

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2017-01-17