Creo Medical CROMA Instrucciones De Uso página 7

Safety Instructions
Intended Use
e Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical
Th
instruments, including the AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for
coagulation (ablation) of soft tissue.
The Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical
instruments, including the HS1 SlypSeal Instrument, intended for coagulation (hemostasis and
cauterization) of soft tissue.
The Electrosurgical Generator provides microwave (MW) and radiofrequency (RF) energy to compatible
Creo Medical instruments, including the Speedboat Instruments, intended for coagulation (hemostasis
and cauterization) and cutting soft tissue.
Indications and Contraindications
Indications for Use and Contraindications are identified in labeling for the compatible Creo Instrument
that is used with the Electrosurgical Generator. The instruments form the applied parts when attached
to the Electrosurgical enerator.
The Electrosurgical Generator and Instruments are not recommended for use in patients who have
electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g.
cardiologist). The Creo electrosurgical system (Generator with compatible accessories and instrument) is
not intended for use in cardiac procedures.
User Qualification
Operators of the Electrosurgical Generator and Instruments must be physicians 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 electrosurgical procedures.
Training in the operation of the Creo Medical Electrosurgical Generator is recommended and available
from Creo Medical.
4
Proprietary & Confidential - Page 7 of 391 - Uncontrolled if Printed