SYSTEM SUPPORT
Quality-crafted, the system
boasts dependability with high
efficiency and low gas usage.
We provide responsive service
and maintenance contract
options, supported by our
nationwide direct service
network. We offer training
packages suited for your
specific needs.
Prior to, or following installation of the Nidek EC-5000
Refractive Laser System, comprehensive user and service
training is available and conducted by factory-trained
representatives. For those new to photorefractive surgery,
on-site clinical instruction by an experienced excimer laser
surgeon is also readily available.
With a reputation for excellence in service, innovation
and support, rely on the Nidek EC-5000 Refractive Laser
System to deliver the most advanced solution in photorefractive
laser therapy. Nidek, uniquely qualified and positioned
as the industry leader is delivering...
...the promise of a brighter vision.
Nidek EC-5000 Refractive Laser System*
Therapeutic Laser
Laser Medium:
ArF
Wavelength:
193nm
Repetition Rate:
40Hz
Aiming Laser
Laser Medium:
Laser Diode (Red)
Cooling System:
Air Cooled
Ablation Size
Optical Zone:
5.5mm diameter Max.
Transition Zone:
Outer Diameter: 7.0mm Max.
Microscope:
ZEISS®
Illumination
Type:
Dual and flexible illuminator
Shape:
Straight slit, cross-shaped slit, or round
Standard Components:
Computer including built-in printer, Display,
Footswitch,Exhaust duct, Dust cover, Laser
goggles, Gas tank, One set of calibration plates,
Ablation verifier (lensometer), Patient’s bed,
Surgeon’s chair
Optional Accessories:
CCD color video camera (NTSC), CCD monitor
stand, Foot controller (X, Y and Z adjustment),
Laser goggles, Calibration plates,
Gas cylinder stand
Power Requirements:
220V, 50 / 60Hz, Max. 3.3k VA
Size
Main Console:
54” (L) x 30” (W) x 60” (H)
Weight:
650kg / 1430 lbs.
The promise of a brighter vision
™
Nidek Inc. 47651 Westinghouse Drive, Fremont, CA 94539, U.S.A.
Telephone: 1-800-223-9044, 1-510-226-5700; Facsimile: 1-510-226-5750
www.nidek.com
*Specifications and design are subject to change without notice for improvement.
EC5000-B-9910
The NIDEK EC-5000 Excimer Laser System is approved to perform photorefractive keratectomy (PRK) for the reduction or elimination of; (a) myopia in low, moderate or high ranges (-0.75 to -13.00 D) spherical equivalent at the spectral plane, uncomplicated by refractive astigmatism (i.e. ≤0.75 D in any meridian); (b) for moderate myopia with astigmatism ranging in severity from -1.00 to -8.00 D spherical equivalent MRSE with astigmatism from -0.50 to -4.00 D cylinder by manifest refraction; and (c) LASIK (Laser in situ Keratomileusis) treatments for the reduction or elimination of myopia with or without astigmatism ranging in severity from -1.00 to -14.00 D, in terms of MRSE, with refractive astigmatism less than or equal to -4.00 D cylinder by manifest refraction; in subjects who are over 21 years of age; and in patients with documentation of stable manifest refraction as defined in the indications statement over the past year. This laser is not indicated to correct hyperopia (farsightedness). This device is not to be used in procedures other than those described in the approved Operator’s Manual.
Alternatives to PRK include; eyeglasses, contact lens, LASIK, radial keratotomy or automated lammellare keratoplasty. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lens, photorefractive keratectomy (PRK), radial keratotomy, astigmatic keratotomy or automated lammellare keratoplasty.
In PRK studies of 587 eyes (consistent cohort) after final treatment with refractive data at 6 months, 91.3% were corrected to 20/40 or better and 60.6% were corrected at 20/20 or better without spectacles or contact lens. For PRK for moderate myopia with astigmatism approval was based on clinical trials with 749 eyes treated, of which 635 eyes were followed for 6 months, together with supplemental safety and effectiveness information from the 9 through 24 months examination intervals. In these studies of 636 eyes with refractive data at 6 months of follow-up, 93.5% were corrected to 20/40 or better and 64.3% were corrected to 20/20 or better without spectacles or contact lens. The PRK for moderate myopia with astigmatism clinical investigation extended for 24 months, and long term risks beyond this time interval have not been studied. LASIK approval is based on a clinical trial of 1126 eyes (622 primary and 504 secondary) of which 722 eyes were treated for astigmatic myopia and 404 for spherical myopia. Of all eyes treated, 966 eyes were available for analysis at 3 months, and 758 eyes were followed for six months or more. Accountability was 88.3% at 3 months and 82.5% at 6 months. The data analysis was based on the refractive data at the 6-month follow-up examination for 758 eyes. This analysis showed that 640/758 (84.4%) eyes were corrected to 20/40 or better and 359/758 (47.4%) were corrected to 20/20 or better visual acuity without spectacles or contact lens. Long term risks of LASIK for myopia or myopic astigmatism have not been determined.
Adverse Events and Complications Reported: In PRK clinical trials the percentage of individuals with 20/20 or better pre-op had best corrected spectacle visual acuity worse than 20/25 in the following proportions: 4.0% (-6.00 to -9.00 D) and 4.8% (> -10.00 D). Complications reported by subjects in the PRK study: were an increase in fluctuation of vision (34.1% pre-op vs. 48.1% post-op); glare (26.9% pre-op vs. 34.4% post-op); and difficulty in night driving (23.5% pre-op vs. 48% post-op). In PRK for moderate myopia with astigmatism adverse events were reported by at least 1% of subjects at 6 months post final treatment; increased glare (3.7%); increase in fluctuation of vision (5.2%); and an increased difficulty in night driving (19.6%). The LASIK study showed that most adverse events occurred in trace amounts (< 1%). Those that were greater than 1% included 13 eyes (1.2%) that required surgical fixation of a loose flap; and foreign bodies or apparent infection were observed in 20 eyes (1.8%). In addition, at 6 months post final treatment, ghost/double images occurred at 1.3%.
Contraindications, Warnings & Cautions: PRK and LASIK are contraindicated in patients with autoimmune, immunodeficiency, or collagen vascular disease, signs of keratoconus, susceptibility to excessive keloid formation, or patients with certain irregular astigmatism, or who are pregnant or nursing, or on certain ocular of systemic steriod regimens. Laser surgery is NOT recommended for patients with a history of ocular Herpes simplex or ocular Herpes zoster. Caution should be exercised when considering performing laser eye surgery on patients with unstable refraction, systemic disease likely to adversely affect wound healing, active ocular disease, glaucoma/ocular hypertension, insulin-dependent diabetes or clinically significant atopic disease, corneal epithelial, stromal, or endothelial dystrophy, previous corneal scarring, previous penetrating ocular or corneal surgery, or in patients currently taking medications which may adversely affect corneal wound healing. The safety and effectiveness of performing laser eye surgery on these patients has not been determined.