Our Commitment To You

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1 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. Our Commitment To You

2 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: Standard Components: Optional Accessories: Power Requirements: Size Main Console: Weight: Straight slit, cross-shaped slit, or round 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 CCD color video camera (NTSC), CCD monitor stand, Foot controller (X, Y and Z adjustment), Laser goggles, Calibration plates, Gas cylinder stand 220V, 50 / 60Hz, Max. 3.3k VA 54 (L) x 30 (W) x 60 (H) 650kg / 1430 lbs. *Specifications and design are subject to change without notice for improvement. Nidek Inc Westinghouse Drive, Fremont, CA 94539, U.S.A. Telephone: , ; Facsimile: 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 D) spherical equivalent at the spectral plane, uncomplicated by refractive astigmatism (i.e D in any meridian); (b) for moderate myopia with astigmatism ranging in severity from to D spherical equivalent MRSE with astigmatism from to 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 to D, in terms of MRSE, with refractive astigmatism less than or equal to 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 D) and 4.8% (> 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. The promise of a brighter vision EC5000-B-9910

3 Nidek EC-5000 Refractive Laser System EC5000 The promise of a brighter vision

4 What You Want Designed to deliver excellence, the Nidek EC-5000 Refractive Laser System incorporates high quality components and advanced instrumentation. For precise visualization of the corneal surface, we have implemented the highresolution ZEISS operating room microscope. With an eye towards ergonomic considerations, the EC is designed as a turnkey refractive system for both surgeon and patient alike. Computer-Controlled Microscope Computerized instrumentation means heightened control. The high-resolution ZEISS microscope ensures excellent visualization of the corneal surface. External Illumination Unique external illumination facilitates precise removal of corneal epithelium, and provides rapid, consistent and continuous laser alignment. The Nidek slit beam illuminators, immediately assess patient alignment in a 3-axis orientation. Delivering Performance Refractive surgery performed with the Nidek EC-5000 Refractive Laser System is the ultimate in precision laser surgery. Scientifically EC-5000 Scan Pattern Images 1 through 6 show engineered features breakdown of the Nidek and controls allow scanning laser, treating all areas using different axis. for smooth delivery of patented scanning slit laser energy. This scanning light energy can ablate the cornea 360 degrees smoothly. Its linearshaped laser beam sweeps the corneal surface in six directions each cycle, homogenizing the excimergenerated light energy. Nidek EC-5000 Refractive Laser System EC5000

5 Outstanding Performance From A Company You Can Count On The fully integrated Nidek EC-5000 Refractive Laser System is extending today s boundaries in photorefractive surgery performance. Improved functionality facilitates excellent results. With an intuitive design that ensures ease in operability, computer-based state-of-the-art technological enhancements display important parameters and patient data immediately to ensure optimal precision. Delivering Precision Nidek s laser beam control technology reduces the need for frequent maintenance and complicated optical adjustments. Combined with computer-based innovations the EC-5000 ensures excellent blending of the ablated and non-ablated areas producing a smooth transition zone while virtually eliminating central islands on the cornea. Visual Calibration PMMA calibration plate offers a clean crisp image once calibration is successfully completed. Delivering Convenience For outstanding performance, Nidek integrates practical features like the visual lensometer calibration check which requires no calculations to assess accurate calibration of the laser. Easy-to-use software and display screens provide complete information during every procedure, and an optional foot-controller is available for hands-free alignment for surgeon convenience. The EC-5000 s three-axis joystick allows quick, precise alignment to the patient with the simple movement of your fingers. Ablation Plane The Nidek EC-5000 produces an ablation plane that is smooth and consistent with every scan. Hands-Free Control With an eye towards evolving growth and technology needs, the system is designed to address both present requirements, while supporting and allowing for upgrading, to meet future requirements. 3-Axis Joystick Convenient joystick allows the surgeon to move the laser to the patient and offers precise control.

6 The promise of a brighter vision To Deliver Vision Comprehensive Displays Software and system displays are easy-to-use and contain complete information and parameters for procedures. With An Eye To The Future The Nidek EC-5000 Refractive Laser System has been designed with the growth and upgrade of your refractive surgery requirements in mind an important consideration in this age of rapid technological advancement. The system monitor displays critical and precise measurements affording safety, convenience and accuracy. You are ensured continued access to technological enhancements as they come along, with minimal capital investment required. Every Nidek EC-5000 Refractive Laser System is built from the ground up of the finest quality materials, from the high-performance laser, to the ZEISS operating microscope head. This is a commitment to dependable performance and economical maintenance. Nidek s extensive network of direct service representatives is ready to respond when service is needed. Additionally, Nidek offers level 3 technical service training. Following the initial one-year warranty period, several service contract options are available to ensure proper operation of your Nidek EC-5000.