3.3 TARGET GROUP
This user manual is intended for physicians, nurses and other
medical and technical personnel involved in preparing,
operating or maintaining the device after appropriate training.
It is the duty of the customer or institution to instruct and train
all personnel who must use the Medical Device.
Additional service activities are not part of this user manual.
These activities will be carried out by staff specially trained in
this regard by OPTIKON 2000 S.p.A.
Scope of application
Purpose
The R-Evo Smart Surgical Medical Device has been designed to
be used in operating theatres by qualified medical personnel
(eye surgeon) for surgical procedures for the treatment of the
anterior ocular segment. The equipment was designed for
irrigation, irrigation/aspiration, crystalline phacoemulsification,
anterior vitrectomy, bipolar diathermy coagulation techniques.
The R-Evo Smart CR also features the functions of posterior
vitrectomy, air and silicone oil tamponade, endo-ocular
illumination. The Medical Device is intended for use in clinics,
hospitals and other institutions dealing with human medicine.
3.4 INTENDED USE
The R-Evo Smart is intended for use in surgical treatments such
as extracapsular extraction, phacoemulsification or glaucoma of
the anterior segment of the human eye, the R-Evo Smart CR
model also for surgical treatment of retinal detachment and
other pathologies of the vitreous body and the posterior
segment of the human eye. Any malfunctions occurring during
use are indicated by a message displayed on the display and by
alarm signals.
Any use other than the one stated above, is excluded as it
may cause unforeseeable risks. In particular, the use of this
system in brain or heart surgery is excluded.
WARNING Risk of injury to the patient!
• The diathermy section of the R-Evo Smart surgical
systems should not be used with patients with
pacemakers or other cardiac stimulators without
having previously consulted a cardiologist.
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