WaveLight Ophthalmology

Transcription

1 werbersbuero.de 02/06 International Version WaveLight Ophthalmology WaveLight AG Am Wolfsmantel Erlangen, Germany WaveLight S.A. C/Herrerías, Tres Cantos, Madrid, Spain WaveLight, Inc Center Oak Plaza Sterling, VA 20166, U.S.A. our vision is the future

2 On the forefront of technology with WaveLight Commitment Competence Communication WaveLight is the leader in the development of innovative diagnostic and surgical technologies for better vision. From wavefront- to asphericity-guided laser vision correction, we have brought the most cutting edge technologies to the refractive market in the past si years. And, we are more committed than ever to continue our research for even better ways to improve your practice and provide patients with more safety, precision and quality. If you are looking for a partner rather than a technology provider, your search is over. With WaveLight, you can stay on the forefront of technology, while improving your workflow and reducing costs. Choose from the largest product portfolio in refractive laser surgery to customize your practice eactly to your needs. Our dedicated team of eperts in clinical application, technical support and research is ready to work with you. Right. From the Start. More than 250 employees in Germany, the US, Spain and France Publicly traded on the German stock echange since 1999 Installed base of more than 600 laser systems and 300 diagnostic devices

3 Process-oriented solutions for your practice The Circle of Ecellence From diagnostics to treatment and post sale service and support: WaveLight offers a wide range of solutions for your practice. You can choose from several products for every segment of the surgery process and customize technology precisely to your needs. This also provides you with maimum fleibility, as you can always integrate additional technology over time; based on your eperience, financial considerations, and marketing objectives. WaveLight DIAGNOSIS WaveLight CUSTOMIZATION WaveLight TREATMENT WaveLight SUPPORT

4 Production site Pressath, Germany State-of-the-Art Manufacturing Since November 2004 all medical products from WaveLight have been manufactured in the custom built production facility in Pressath, Southern Germany. The new modular production floor is one of the first state-of-the-art facilities of this kind in Europe. Here, WaveLight systems are manufactured under the highest possible technological standards. Several regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the German Landesgewerbeanstalt (LGA) have successfully audited the facility for consistent and safe production in accordance with their regulations, and issued positive certifications for our manufacturing processes.

5 Treat more patients With a range of diagnostic and customization tools, WaveLight enables you to treat the widest range of clinical indications from high myopia to corneal scars. Epanded Treatment Range Our high precision technology keeps re-treatments at a minimum, providing you with more time to focus on your practice. If a patient is qualified for refractive surgery, technology should not be an obstacle for treatment. That is why ALLEGRETTO WAVE lasers come with a reliable eyetracker that follows even large pupils and perform tissue friendly ablations with the wavefront-optimized algorithm. WaveLight Treatment Range Cylinder +3 Sphere Treatment range depends on VD and optical zone Convert cylinder into plus notation Treatment indications*: Myopia up to -14D Hyperopia up to + 6D Astigmatism up to +/- 6 D Mied astigmatism Irregular corneas Corneal scars Aberrations Decentrations Small optical zones Presbyopia (Monovision and Custom Q) *(indications may vary based on technology and patient characteristics)

6 Improve the bottom line Meeting Epectations Accuracy ensures satisfied patients and the uninterrupted performance of your clinic. WaveLight s eact diagnostics, carefully tailored treatment methods, and high precision laser technology provide for outcomes that meet epectations. Furthermore, the once-a-day calibration routine ensures a smooth and reliable performance of the laser and shortens preparation times. With an improved workflow, more precise outcomes and a wider treatment spectrum you can effectively improve the bottom line of your practice even more so since WaveLight does not charge additional per procedure fees. New technology reduces re-treatments Enhancement rate (%) 15% 10% Accurate results with: High precision calibration routine Smart energy control for stable energy delivery Advanced fast track eyetracking system for accurate placement of laser pulses Integrated nomogram adjustment based on FDA clinical trial results Previous platform WaveLight Model. Results may vary. 5% WaveLight with nomogram optimization

7 Partner with competence in technology and service The acquisition of a WaveLight system is only the beginning of a long-term partnership. Our competent support is committed to provide you and your patients with the highest standards in clinical application and technical performance. Certified Support In addition, our practice development program for patient marketing and education supports the successful integration of our technologies into your clinic marketing. In order to ensure continuous quality in the field, WaveLight has built a wide spread support network for technical and non-technical issues. Our customers are eclusively supported through factory certified service technicians and clinical trainers. And we can be reached through a direct service hotline from anywhere in the world. Represented in more than 70 countries through factory certified partners WaveLight subsidiaries in Europe and North America Quality Management WaveLight maintains a quality management system according to the following standards and directives: EC Directive 93/42/EEC on Medical Devices, Anne CAN/CSA-ISO DIN EN ISO 9001:2000 DIN EN ISO 13485:2003 The ALLEGRETTO WAVE is FDA approved in the USA according to the following documents: 21 CFR 820 (USA) - Hyperopia (PMA No. P030008) 21 CFR 820 (USA) - Myopia (PMA No. P020050) WaveLight SUPPORT

8 Join a community of eperts Interaction and Echange WaveLight users share a commitment to quality, safety and ecellence. Over the years, our customers have grown into a community of eperts who echange their eperience and thoughts. The WaveLight Campus serves as a platform for interaction and echange for our customers and their peers with regular events, meetings and courses. Campus is subdivided into four areas: Didactics: clinical training, practice development and practice management Events: educational seminars and annual user meetings Becoming a WaveLight user also means to become part of the community and gaining access to a world of information and epertise. WaveLight Community Member WaveLight Ambassadors: a selected group of peers who ecel in education and research and who serve as mentors, preceptors and luminaries Campus Online: secured internet area providing information, materials and downloads and an echange forum WaveLight SUPPORT

9 ALLEGRO Analyzer An ecellent device for customized refractive vision correction, the ALLEGRO Analyzer is perfectly aligned with the WaveLight laser systems. Wavefront Technology The ALLEGRO Analyzer works in the visible spectrum according to the Tscherning principle: on the basis of the same principle as the human eye. As the first company to introduce wavefront technology, WaveLight is the only company to apply the Tscherning principle in its diagnostic devices, because it prevents false positive results, enhances the accuracy of readings and thus minimizes the risk of false treatments. Pre-Op (raw data) Especially designed to deliver wavefront data needed to perform wavefront-guided laser vision correction, all components of the ALLEGRO Analyzer, such as software, resolution and algorithms have been optimized for WaveLight s laser systems. Pre-Op Ablation profile Tscherning principle No false positive results Accurate autorefractor Integrated accomodation Automated centration Wavefront-guided treatments in conjunction with the with the WaveLight laser systems WaveLight DIAGNOSIS

10 ALLEGRO Topolyzer Corneal Topography The ALLEGRO Topolyzer was designed to measure and generate high-resolution treatment data of the corneal surface. With an etraordinarily high resolution of the cornea, achieved by 22,000 measuring points, the ALLEGRO Topolyzer is a high-precision tool for customized refractive surgery. The ALLEGRO Topolyzer works in perfect synchronization with the WaveLight laser systems. Its integrated keratometer and automatic measuring release allow for precise image centration with a peripheral standard deviation of only 4 micrometers. Pre-Op Combined with the WaveLight laser systems, the ALLEGRO Topolyzer enables the surgeon to perform a precise topography-guided correction of advanced clinical indications. Ablation profile High precision measurement with 22,000 measurement points Provides asphericity data Integrated keratometer Automatic measurement release Topography-guided treatments in conjunction with the WaveLight laser systems Post-Op WaveLight DIAGNOSIS

11 Customize your practice! Meet your Needs Custom Q Customization does not start with the treatment, it begins with the customized outfitting of your surgery practice. That is why WaveLight offers a range of diagnostic and laser technology that can be eactly tailored to your requirements. Whether you are a high-volume clinic with the goal to optimize patient flow, or an individual specialist wanting the capability to treat comple clinical indications: WaveLight provides the right technology and support to achieve the bestpossible results. The WaveLight customization toolkit comprises several different customization tools that can be combined with our laser systems and diagnostic devices to maimize your capabilities: Custom Treatment Ranges 0-14 sphere -6 cylinder -12 sphere -3 cylinder sphere -6 cylinder -14 sphere -6 cylinder Wavefront-optimized A-CAT (Wavefront-guided) T-CAT (Topography-guided) Custom Q 3D Wavefront Wavefront-optimized Wavefront-guided Topography-guided Custom Q for asphericity-guided treatments, customized refraction and optical zone entries 3D Topography WaveLight CUSTOMIZATION

12 RONDO RONDO is the first mechanical microkeratome developed by WaveLight. With more predictability, safety and precision it meets our high quality standards and further completes the refractive surgery process. The Cutting Edge The unique design of the RONDO minimizes the risk of flap complications. With an elevated suction ring it will even work in very narrow eyes. The ultrathin performance blades of the RONDO are inserted with a special blade shooter, and create predictably thin flaps and very smooth cuts. Its integrated quality assurance using barcode scanning and data storage provides physicians with more control and patients with a higher level of safety. And lastly, RONDO comes with an integrated thermal printer so that you can keep the surgery records with your files. WaveLight TREATMENT RONDO features at a glance: Elevated suction ring with active vacuum adjustment Integrated peristaltic pump to connect aspiration lid retractor Oscillation: 8,000 rpm Automatic head advancement Variable hinge position and size Pre-assembled head for quick application onto the eye Flap thickness: 100, 130 and 150 m Flaps with very large diameter possible (8.0, 8.5, 9.0, 9.5, 10.0 mm) Low intraocular pressure ( 100mm Hg) Integrated barcode scanner and thermal printer

13 ALLEGRETTO WAVE Right. From the Start. The ALLEGRETTO WAVE is the gold standard in refractive surgery. With a speed of 200 Hz, it uses PerfectPulse Technology for intelligent laser pulse control providing safety and accuracy in combination with outstanding visual results. It is the first European laser to receive approval by the US Food and Drug Administration FDA. Having performed the first global wavefrontguided treatment in 1999, the ALLEGRETTO WAVE today is the most successfully sold WaveLight laser system in the market with more than 400 installations around the world. Developed to provide accuracy and safety at high speed for WaveLight systems, PerfectPulse Technology combines several state-of-the-art technologies to control every single laser pulse from start to finish: Smart Energy Control Thermally optimized ablation pattern Automated fast track eyetracking Systematic peripheral pulse placement 200 Hz ablation rate 0.95 mm (0.68 mm FWHM) Gaussian laser beam 200 Hz active eyetracker PerfectPulse Technology WaveLight TREATMENT

14 ALLEGRETTO WAVE Eye-Q The ALLEGRETTO WAVE Eye-Q takes the proven ALLEGRETTO WAVE technology one step further. With its additional customization capabilities it is geared towards the advanced refractive surgeon who seeks to further improve the surgery process. A 400 Hz ablation rate makes the Eye-Q one of the fastest lasers in the world and its unique PerfectPulse Technology ensures safety and accuracy in combination with outstanding visual results. The Eye-Q s cross line projector enables the control of head movement and improves precision. the first treatment module that allows the customization of corneal asphericity. Aside from tailoring the corneal curvature, Custom Q also permits the fine tuning of optical zones to 1/10 mm and refraction to 1/100 diopter in order to maimize treatment potential. As an alternative to other customization methods, Custom Q creates very large, functional optical zones with minimized transition zones. With the goal to provide the best suitable outcomes to your patients, Custom Q adds a fourth dimension to your treatment portfolio. One Step Further Aside from the ability to perform wavefrontoptimized, wavefront-guided or topographyguided treatments, the Eye-Q features Custom Q, 400 Hz ablation rate 0.95 mm (0.68 mm FWHM) Gaussian laser beam 400 Hz active eyetracker PerfectPulse Technology Cross line projector Custom Q treatment module WaveLight TREATMENT

15 ALLEGRETTO WAVE Concerto Perfection in Detail As the flagship of the WaveLight laser family, the Concerto system is the first laser that fully integrates diagnostic and treatment capabilities into one laser platform. As such, the Concerto is more than a demonstration of what is possible in refractive technology today. For the first time ever, it meets the demands for complete quality control. The name Concerto was not chosen randomly because it describes the perfect harmony and interactivity of the elements safety, perfection, quality, and individuality. With the Concerto, the user can achieve the ecellent results of already eisting WaveLight lasers while going one step further. The eclusiveness of the ALLEGRETTO WAVE Concerto is defined by several factors: 500 Hz ablation rate 0.95 mm (0.68 mm FWHM) Gaussian laser beam 500 Hz active eyetracker Cross line projector SmartView Microscope No-touch pachymetry Online spectrometry Advanced PerfectPulse Technology with Single Pulse Registration Custom Q, topography- and wavefrontguided treatment modules Comes with diagnostic devices for wavefront and topography measurements and with the RONDO microkeratome Custom design in several different color schemes Innovative technical components A progressive design and the use of only highest-quality materials Ecellent operability and a comprehensive package of technical and non-technical services Personalized, individual and direct support by WaveLight WaveLight TREATMENT

16 Technical Data & References Specifications at a Glance ALLEGRETTO WAVE ALLEGRETTO WAVE Eye-Q ALLEGRETTO WAVE Concerto For detailed technical data and references ask for the WaveLight product brochures. Repetition rate (Hz) Treatment time Optical zone: 6.5 mm Eyetracker (Hz) Treatment range sphere (D) cylinder (D) Optical zone (mm) Applications PTK ablation depth: m, OZ 2-8 mm Standard wavefrontoptimized refractive treatment Custom Q treatment A-CAT treatment 200 4s/D to to + 6 Myopia: 4.5-8, in 0.5 mm steps, without 7.5; Hyperopia: 6-7 in 0.5 mm steps Optional Optional s/d to to + 6 Myopia: 4.5-8, in 0.5 mm steps, without 7.5; Hyperopia: 6-7 in 0.5 mm steps Optional 500 2s/D to to + 6 Myopia: 4.5-8, in 0.5 mm steps, without 7.5; Hyperopia: 6-7 in 0.5 mm steps ALLEGRO Analyzer ALLEGRO Topolyzer RONDO in conjunction with the ALLEGRO Analyzer T-CAT treatment Optional Optional Working principle Tscherning Principle Resolution dots (168 as the central point is not measured) Measurable pupil 3 to 8 mm diameter Measurement range -12 to D sphere -6 to D astigmatism Centration Eyetracking function (centered on the gravity center of the pupil) Accuracy of the refrac- +/ D tion measurement Repeatability +/ D in consecutive measurements Accuracy of the Zernike polynomials up wavefront measurement to the 6th order Acquisition time app. 250 ms Dimensions (L W H) cm (optical unit) Weight 15 kg (optical unit) Measuring range Accuracy Reproduceability Number of rings 11 Working distance 3 to 38 mm (corneal radius) 9 to 99 D (refractive power) 0.1 D 0.1 D 80 mm Data points evaluated 22,000 Dimensions (D W H) Weight (measuring head) 2.3 kg cm Suction ring diameter Flap diameter Cutting head Oscillation Vacuum User interface Dimensions (LWH) Weight 19.0 mm 8.0 mm 8.5 mm 9.0 mm 9.5 mm 10.0 mm variable hinge: min. 4.0 mm Flap thickness: 100 m 130 m 150 m 8,000 rpm mmhg Touch screen cm 20 kg in conjunction with the ALLEGRO Topolyzer Notebook Online Measurement of pachymetry cornea thickness before and after flap cutting Spectrometer Measurement of liquid on the cornea surface Slit lamp Plume evacuation Working distance (cm) Single pulse registration Cross line Patient alignment projector N2 connection Internal / eternal Dimensions (LWH) Weight - - Optional Eternal cm 320 kg (incl. bed) - - Optional Eternal cm 320 kg (incl. bed) Internal PC Integrated 29 Integrated cm 400 kg (incl. bed, ecl. gas) CAUTION: The products mentioned in this brochure are not available for sale in the US! Specifications are subject to change!