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3
The device is designed only for treatment purposes that
are described below.
Functional purpose of the device (intended use)
The Valon-laser proposes a radically different way to per-
form
photocoagulation
. A concept introduced by Meyer-
Schwickerath for the treatment of diabetic retinopathy in
the 1950s.
Photocoagulation entails the delivery of a laser beam to the
fundus of the eye with the assistance of a slit lamp (mi-
croscope) and a contact lens. A certified physician places
several hundred laser burns (“spots”) in selected areas of
the patients fundus. The burns are used to destroy the ab-
normal blood vessels that form in the retina of the diabetic
patient. This treatment has been shown to reduce the risk
of severe vi-sion loss for eyes at risk by 50%.
The treatment parameters for retinal photocoagulation
have remained relatively constant since the first descrip
-
tion of an argon laser coupled to a slitlamp delivery system
in 1970. The three separate but interdependent variables
available to the clinician are the
beam size, power, and
duration of the pulse
. Typically, for diabetic retinopathy,
retinal vascular applications, and the treatment of retinal
breaks, the retinal laser spot sizes range from 100 to 500
μm, the pulse durations from 100 to 200 milliseconds, and
the power from 100 to 750 mW.
Intended patient population and medical condition (in-
dication for use)
Photocoagulation has been shown to be effective in the
treatment of
proliferative diabetic retinopathy and ad-
vanced forms of nonproliferative diabetic retinopathy
associated with macular edema in large, prospective, multi-
center, randomized trials—the DRS and ETDRS.
3. Terms of Use
Caution!
This medi-
cal electrical
equipment is
inteded for use
by professional
healthcare per-
sonnel only
Caution!
Mobile RF
communica-
tions equip-
ment can effect
medical electri-
cal equipment
Caution!
Medical electri-
cal equipment
needs special
precautions
regarding EMC
and need to
be installed
according to
EMC infor-
mation
Содержание Multispot Laser
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