Indications And Contraindications; User Qualification - Creo Medical 7-EMR-050 Instructions D'utilisation

Safety Instructions
Intended Use
The Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical
energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization)
and ablation of soft tissue, and is for use only with appropriate Creo Medical Instruments and
accessories

Indications and Contraindications

Indications for Use and Contraindications depend on the appropriate Creo Instrument that is
used with the Electrosurgical Generator. Please refer to the Instructions for Use for the
Instrument intended to be connected to the Electrosurgical Generator. E.g., the NP1
instrument is contraindicated for transluminal use.
It is recommended that the Electrosurgical Generator and Instruments are not used in patients
who have electronic implants such as cardiac pacemakers without first consulting a qualified
professional (e.g. cardiologist). The System is not intended for use in cardiac procedures.

User Qualification

The operator of the Electrosurgical Generator and Instruments must be a physician or medical
personnel under the supervision of a physician and must have received sufficient training in
clinical electrosurgical techniques. This manual does not explain or discuss clinical endoscopic
procedures.
Training in the operation of the Creo Medical Electrosurgical Generator is recommended and
available from the manufacturer.
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