NEW HORIZONS IN CORNEAL SURGERY VERSATILE FEMTOSECOND LASER WORKSTATION WE FOCUS ON PERFECTION



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NEW HORIZONS VERSATILE FEMTOSECOND IN CORNEAL LASER WORKSTATION SURGERY WE FOCUS ON PERFECTION

ADVANCED FEMTOSECOND LASER TECHNOLOGY COMMITTED TO VERSATILITY > ONE SYSTEM FOR ALL FEMTO-APPLICATIONS > ANATOMICALLY CORRECT EYE FIXATION > CUSTOMFLAP AND INNOVATIVE THERAPEUTIC PROCEDURES 2 > FREE CHOICE OF SURGICAL PARAMETERS Together, we make the future possible today. 20/10 PERFECT VISION is a leading research and development driven company. Every day, our innovative technology makes a difference in ophthalmic practice around the world. 20/10 PERFECT VISION is the company that brought the first FDA approved wavefront diagnostic system, the Wavescan*, to the market. With the introduction of the FEMTEC laser workstation, 20/10 PERFECT VISION has once more taken a leading position, this time with advanced femtosecond laser technology. At 20/10 PERFECT VISION, we are motivated to enter into a partnership with you, and give you full support, be it through the sharing of knowledge or via educational programs. Together, we make the future possible today. *Registered Trademark of AMO / VISX

FEMTEC WORKING PRINCIPLE In contrast to conventional laser systems for corneal and refractive surgery, the FEMTEC femtosecond pulsed laser uses infrared light with spot sizes as small as a few microns and a laser pulse duration which is several orders of magnitude shorter than that of an Excimer laser. The result of a single FEMTEC femtosecond laser pulse is a microscopic bubble at a predefined depth inside the cornea. A myriad of these pulses can create macroscopic effects such as laser generated LASIK flaps and other surgical incisions. As a FEMTEC user, you simply program your procedure through the graphical user interface, and then let the real time FEMTEC CustomShape software arrange the laser pulses according to a set of unique patterns previously selected in accordance with the desired treatment. FEMTEC NEW POSSIBILITIES IN CORNEAL SURGERY THE GENTLE WAY In order to generate a flap bed, for example, the laser spot is moved inside the cornea in a 3-dimensional spiral pattern. Since this pattern is aligned with the stromal lamellae, the FEMTEC s action is more accurately described as separating the lamellae (as opposed to cutting through them). Once the flap bed has been formed, the beam is moved in an arc-shaped trajectory along the circumference of the flap, and the focal point is gradually raised. This results in a perfectly defined edge, with the flap hinge located precisely where you want it to be. Because of its spherical design*, the FEMTEC Patient Interface avoids flattening the cornea during procedures. The corneal curvature varies only slightly, but is not applanated. This is anatomically correct eye fixation. *US Patent No. US 6,730,074 B2; amongst others >

A WORKSTATION FOR THE DISCERNING SURGEON WHEN CONTROL, SAFETY AND PREDICTABILITY COUNT With its many clinical applications, the FEMTEC is a very complete workstation for ophthalmic surgery. The CustomShape Software of the FEMTEC has been developed with the user in mind. Notice its ease of use when you navigate the menus. This makes it easy for you to select your preferred settings. Following your selection of treatment parameters, treatment summaries supported by schematics are displayed on the main screen. 4 The radial force display, the computer controlled vacuum with auto-off feature and the uninterruptible power supply (UPS) provide additional safety as well as the conventional safety features. Combined, these features are active COMPLEX TE

during the entire treatment from start to finish, i.e. from docking to undocking. Supported by the user-friendly software and the impressive range of safety features, the user can securely activate the FEMTEC laser beam by footswitch. Our innovative procedures scan the beam in the x-, y-, and z-axes, thus reaching every part of the cornea with precision and provide more predictable outcomes. CHNOLOGY MADE EASY SEE HOW A PATIENT INTERFACE MAKES ALL THE DIFFERENCE A: Proprietary FEMTEC spherical Patient Interface* approach, which does not applanate the cornea. During preparation of the flap bed, the laser beam s trajectory is also spherical, which means that it is aligned with the stromal lamellae. The FEMTEC uses eye-tracker-friendly circular patterns, and the Patient Interface is attached to the system via vacuum, which is under permanent computer control. B: Other femtosecond laser systems require applanation of the cornea with a flat contact piece, thereby compressing the cornea and inducing higher intraocular pressure. Suction is typically applied manually without system monitoring or control. Central bubble layers may interfere with Excimer eye-tracker systems. *US Patent No. US 6,730,074 B2; amongst others FEMTEC Anatomically Correct Approach (same eye) Applanating Approach (same eye) Neutral: normal eye (animal eye) >

THE FEMTEC FEATURES AN EXCITING ARRAY OF EASY-TO-USE INNOVATIVE PROCEDURE MODULES CUSTOMIZABLE TO THE PATIENT S The FEMTEC Workstation is a highly flexible tool for treating a broad variety of patients. FEMTEC procedures are highly customizable via the easy to use CustomShape Software. NEEDS 6 LASIK Flaps Success with LASIK begins with a perfect flap. Using the FEMTEC for a CustomFlap is easy, predictable, and customizable: > variable diameter > selectable flap thickness > free choice of hinge position > ease of flap repositioning due to individually selectable rim angles Arcuate Cuts for Astigmatic Keratotomy (AK) For the treatment of natural cylinder or the reduction of residual astigmatism after keratoplasty. This procedure is quick, gentle, and precise: > full control over cutting depth, diameter, and arc length > incisions are performed with previous unavailable precision, exactly as you specify them > both arcs are programmable separately > completion of procedure is very quick!

FEMTEC WORKING PRINCIPLE FLEK Femtosecond Laser assisted Endothelial Keratoplasty This new procedure is another confirmation that the FEMTEC is an extremely powerful tool in corneal surgery. Endothelial tissue can easily be removed and replaced by the donor button, which is itself also created with the FEMTEC. This leads to precise shapes, predictable outcomes and reduces manipulation of the cornea. Penetrating and Lamellar Keratoplasty (PKP/LKP) The FEMTEC is a highly precise solution for therapeutic treatment of the cornea. With our penetrating and lamellar keratoplasty software modules, we set standards for keratoplastic surgery: > variable depths selectable > variable diameters selectable > choice of rim angle, which realizes an even better wound closure > FLAM (FEMTEC Laser Assisted Marking) for precise orientation and improved fixation of the graft > NEW: In addition to the conventional circular rim cut, we also provide the possibility to add orientation teeth, or to select a polygonal shape for better fit and fixation Tunnels for Intrastromal Ring Segments (ICRS) The implantation of Intracorneal Ring Segments, a cumbersome task when the tunnel is created manually, suddenly becomes easy and elegant when you have access to the FEMTEC precision. The Patient Interface acts like a hard contact lens, allowing the tunnel to be prepared at a consistent depth using the pre-programmed diameters: > suitable for all types of Intra Corneal Rings > selectable number of incisions: zero, one, or two entrance cuts > provides full visualisation of the entire procedure > saves significant procedural time

SPECIFICATIONS Footprint > Width: 850 mm (33.46 inches), Length*: 1270 mm (50 inches), Height: 1300 mm (51.2 inches) Electrical Requirements > 230 V ± 10 %, 50/60 Hz, fusing 16A, System Integrated Uninterruptible Power Supply (UPS) Room Temperature > 18-24 C (Fahrenheit: 64-76 F) Relative Humidity > 30-50 % Pulse Duration > 500 800 fs, typically Microscope > Integrated microscope with motorized magnification selection for full visual control in all procedural steps. Software > Proprietary FEMTEC real time software offering a wide range of procedure modules Safety > Computer controlled suction for Patient Interface and suction ring as well as many other safety features. System Components > Main unit > Patient bed included > Sterile Patient Interface Kit *w/o application unit www.2010pv.com Design and specifications are subject to change without prior notice. Please inquire about availability of system and/or specific features in your respective country. FDA 510(k) clearance for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. Trademarks are property of the respective owners. 2007 by 20/10 PERFECT VISION AG, Heidelberg, Germany All rights reserved. 0483 WE FOCUS ON PERFECTION 20/10 PERFECT VISION AG, Am Taubenfeld 21/1, 69123 Heidelberg, Germany Phone + 49 6221 7502-0, Fax +49 6221 7502-166, E-Mail: info@2010pv.com Mkt.Doc.Femtec 07-001