A.R.C. Laser Nuvolas, User Manual

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User Manual NUVOLAS
April 2023
File: User Manual_NUVOLAS_rev3.docx 6
1.2 Intended Use
The NUVOLAS is intended to be used for treatments requiring coagulation or
carbonization/vaporization of tissue, bony structures or blood. At high power outputs,
tissue can be carbonized and removed or separated by vaporization.
At low power output, heating of tissue or blood results in enzyme denaturation and
coagulation e.g. of blood vessels. For this effect, the laser is used together with
application fibers aiming the laser beam at the target tissue either directly in contact or
non-contact or via further optics e.g. through handpieces.
The laser effect allows focused treatment of the disease area with minimal impact on the
surrounding tissue.
The laser can be applied both in unsterile environment, for instance at a physician’s
examination room, and in a sterile environment e.g. operating theater.
It can be used in conjunction with e.g. handpieces or endoscopes where the fiber is fed
through the fiber/working channel to allow the physician to treat the desired area with the
laser.
The NUVOLAS is intended to be used for the following applications:
Laryngology Otology
Rhinology General Surgery
Medical
field
Indication Risks Contraindication
General contraindication:
radiation exposure to the
eye! (exception:
Ophthalmology)
Laryngology/
Oropharynx
Treatments requiring
coagulation or
carbonization/vaporization of
tissue, bony structures or
blood:
•
Papillomatosis
•
Papillomatosis Varices
•
Reinke’s Edema
•
Polyps
•
Vascular lesions
•
Ectasia Varices
•
Contact Granuloma
•
Leukoplakia
•
Dysplasia
•
Early Glottic Cancer
•
Microvascular angiomata
•
Cancer
•
Nodule
•
Stenosis
•
Granulation Amyloid
•
Hematomas
•
Tonsillectomy
•
edema
•
bleeding/hemorrhage
•
pain
•
scar formation/web
formation
•
tissue injury (e.g. burning)
•
nerve injury
•
crusting
•
granulation
•
swelling
•
emphysema
•
synechia/stenosis
•
general or normal
conventional (non-laser)
operation collateral side
effects
Oxygen level can’t
be lowered below
30% due to previous
illness if used
nearby intubation
tube.