A.R.C. Laser FOX 514 - Intended Use

User Manual FOX 514
September 2021
File: User Manual_FOX 514_rev3 7
1.2 Intended Use
The FOX 514 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, removed or separated by vaporization.
At low power output, heating of tissue or blood results in enzyme denaturation and coagulation
of e.g. blood vessels. For this effect, the laser is used together with application fibers aiming
the laser beam to the target tissue either directly or in contact or non-contact or via further
optics e.g. through hand pieces.
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 thater.
It can be used in conjunction with e.g. hand pieces or endoscopes where the fiber is fed through
the fiber/working channel to allow the physician to to treat the desired area with the laser. In
Ophthalmology the FOX 514 can be used together with a laser indirect ophthalmoscope (LIO).
The Diode-Laser, model FOX 514, is intended to be used for the applications as follows:
Otology
General surgergy
Ophthalmology
Medical
application
Indication from clinical
data
Side and adverse effects
Contraindications
General contraindication:
radiation exposure to the
eye (exception:
Ophthalmology)
Otology
Coagulation (e.g. cholesteatoma,
glomus tumor, …), carbonization/
vaporization (e.g.
stapedotomy/stapedectomy,
cholesteatoma, glomus tumor, …)
of soft tissue and bony structures
• Acoustic trauma
• Mechanical trauma (e.g.
floating footplate)
• General or normal
conventional (non-laser)
operation collateral side
effects
-
General Surgery
Treatments requiring heating of
tissue and/or blood up to
coagulation or vaporization
• Edema
• Bleeding
• Pain
• Scar formation
• Granulation
• Swelling
• Tissue injury
• 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.