Iridex TxCell SSLA, Руководство оператора

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16 70375-EN Rev B
577 nm
Indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal photocoagulation of vascular and structural abnormalities of the
retina and choroid including:
Proliferative and nonproliferative diabetic retinopathy
Choroidal neovascularization
Branch retinal vein occlusion
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Retinal tears and detachments
Laser trabeculoplasty for the treatment of:
Primary open angle glaucoma
Laser iridotomy, iridoplasty for the treatment of:
Angle closure glaucoma
Contraindications
•
Any situation where the target tissue cannot be adequately visualized or stabilized.
•
Do not treat albino patients that have no pigmentation.
Potential Side Effects or Complications
•
Specific to retinal photocoagulation: inadvertent foveal burns; choroidal neovascularization;
paracentral scotomata; transient increased edema/decreased vision; subretinal fibrosis;
photocoagulation scar expansion; Bruch’s membrane rupture; choroidal detachment; exudative
retinal detachment; pupillary abnormalities from damage to the ciliary nerves; and, optic neuritis
from treatment directly or adjacent to the disc.
•
Specific to laser iridotomy or iridoplasty: inadvertent corneal or lens burns/opacities; iritis; iris
atrophy; bleeding; visual symptoms; IOP spike; and, rarely retinal detachment.
•
Specific to laser trabeculoplasty: IOP spike, and, disruption of the corneal epithelium.
Specific Warnings and Precautions
It is essential that the surgeon and attending staff be trained in all aspects of the use of this equipment.
Surgeons should obtain detailed instructions for proper use of this laser system before using it to perform
any surgical procedures.
For additional Warnings and Cautions, refer to Chapter 1, “Introduction.” For more clinical information,
see “Clinical References” at the end of this chapter.
Proper eye protection must be utilized for the specific treatment laser wavelength in use (532 nm or
577 nm).
Multi-spot mode is intended for retinal photocoagulation only.
For patients with wide variations in retinal pigmentation as evaluated by ophthalmoscopic observation,
select multi-spot patterns which cover a homogenously pigmented smaller area to avoid unpredictable
tissue damage.
Exercise caution while setting multi-spot parameters (pulse duration and the number of spots per pattern)
when CW laser burns are to be delivered in the macula; with longer grid completion times, the possibility
of patient movement increases the risk of treatment of unintended targets.