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Documentation set
VISULAS green
000000-2096-101-DokS-GB-181218
2 Safety notes
2.1 Intended user profile
This system may only be installed, operated, used and maintained
by persons who have the necessary training, knowledge and
experience. Please adhere to the additional national qualification
guidelines applicable in your country.
Persons who operate the system must have a basic knowledge of
ophthalmic examination, diagnosis methods and therapeutic lasers
in ophthalmology.
Persons working in the laser hazard area must be familiarized at
least once a year with safety regulations, safety precautions and
system operation. Keep a written record of these instructions,
listing the participants.
2.2 Intended field of application
This system may only be set up, operated and used for the specified
purpose and according to national regulations, consistent with the
applicable industry standards and occupational safety and accident
prevention regulations.
The country-specific laser protection requirements must be adhered
to.
2.2.1 Intended use
The VISULAS green is intended for use in photocoagulating ocular
tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina
• Trabeculoplasty for treatment of glaucoma
• Iridotomy for treatment of glaucoma
2.2.2 Patient population
If the respective clinical indications [} 10] are present and
contraindications [} 10] are excluded, the therapeutic laser
treatment can, in principle, be performed on patients of all age
groups.
The average patient undergoing retinal surgery with the
VISULAS green is between 40 and 80 years old, suffers from
diabetic retinopathy resulting from diabetes mellitus type II, is able
to sit on a chair (or wheelchair), has stable fixation and no disorder
that limits his/her movements (e.g. bedridden patients) or his/her
ability to assume a calm and stable position / fixation over a period
of 10 to 15 minutes.
Laser treatment of the following patient groups with the
u
VISULAS green and laser slit lamp applicator should be avoided:
2 Safety notes
2.1 Intended user profile
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