werbersbuer
o.de · 02/06
our vision is the future
WaveLight AG
Am Wolfsmantel 5 91058 Erlangen, Germany
WaveLight S.A.
C/Herrerías, 22 28760 Tres Cantos, Madrid, Spain
WaveLight, Inc.
46040 Center Oak Plaza Sterling, VA 20166, U.S.A. www.wavelight-laser.com
WaveLight Ophthalmology
International Version
On the forefront of technology with WaveLight
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 six years.
And, we are more committed than ever to con-tinue 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 re-fractive laser surgery to customize your practice exactly to your needs.
Our dedicated team of experts in clinical appli-cation, 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
exchange since 1999
· Installed base of more than 600 laser systems and 300 diagnostic devices
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Process-oriented solutions for your practice
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 maximum flexibility, as you can always integrate additional technology over time; based on your experience, financial considerations, and marketing objectives.
The Circle of Excellence
WaveLight
DIAGNOSIS
WaveLight
SUPPORT
WaveLight
TREATMENT
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State-of-the-Art Manufacturing
Since November 2004 all medical products from WaveLight have been manufactured in the cus-tom 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.
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Treat more patients
+6 +6 -6 -6 +3 -14 Cylinder Sphere 0 -3 -9 -3 +3
Convert cylinder into plus notation
Treatment range depends on VD and optical zone
Expanded Treatment Range
Treatment indications*: · Myopia up to -14D · Hyperopia up to + 6D · Astigmatism up to +/- 6 D · Mixed astigmatism · Irregular corneas · Corneal scars · Aberrations · Decentrations · Small optical zones
· Presbyopia (Monovision and Custom Q)
*(indications may vary based on technology and patient characteristics)
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.
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, tech-nology 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.
Accuracy ensures satisfied patients and the uninterrupted performance of your clinic. WaveLight’s exact diagnostics, carefully tailored treatment methods, and high precision laser technology provide for outcomes that meet expectations.
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.
Improve the bottom line
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
Meeting Expectations
New technology reduces re-treatments Enhancement rate (%)
Previous platform WaveLight
Model. Results may vary.
WaveLight with nomogram optimization
15% 10%
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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. 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 exclusively supported through factory certified service technicians and clinical trainers. And we can be reached through a direct service hotline from anywhere in the world.
Partner with competence in
technology and service
· Represented in more than 70 countries through factory certified partners · WaveLight subsidiaries in Europe and
North America
Certified Support
Quality Management WaveLight maintains a quality management system according to the following standards and directives:
The ALLEGRETTO WAVE is FDA approved in the USA according to the following documents:
EC Directive 93/42/EEC on Medical Devices, Annex || CAN/CSA-ISO 13485-98
DIN EN ISO 9001:2000 DIN EN ISO 13485:2003
21 CFR 820 (USA) - Hyperopia (PMA No. P030008) 21 CFR 820 (USA) - Myopia (PMA No. P020050)
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Join a community of experts
WaveLight users share a commitment to quality, safety and excellence. Over the years, our customers have grown into a community of experts who ex-change their experience and thoughts. The WaveLight Campus serves as a platform for interaction and exchange for our customers and their peers with regular events, meetings and courses. Becoming a WaveLight user also means to be-come part of the community and gaining access to a world of information and expertise.
Interaction and Exchange
WaveLight SUPPORT
Didactics: clinical training, practice development and practice management
Campus is subdivided into four areas:
WaveLight Ambassadors: a selected group of peers who excel in education and research and who serve as mentors, preceptors and luminaries
WaveLight
Community
Member
Events:
educational seminars and annual user meetings
Campus Online: secured internet area providing information, materials and down-loads and an exchange forum
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ALLEGRO Analyzer
Pre-Op (raw data)
Pre-Op
Ablation profile An excellent device for customized refractive vision
correction, the ALLEGRO Analyzer is perfectly aligned with the WaveLight laser systems. The ALLEGRO Analyzer works in the visible spec-trum 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. 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.
Wavefront Technology
· Tscherning principle · No false positive results · Accurate autorefractor · Integrated accomodation · Automated centration
· Wavefront-guided treatments in conjunction with the with the WaveLight laser systems
ALLEGRO Topolyzer
The ALLEGRO Topolyzer was designed to measure and generate high-resolution treatment data of the corneal surface.
With an extraordinarily high resolution of the cor-nea, achieved by 22,000 measuring points, the ALLEGRO Topolyzer is a high-precision tool for customized refractive surgery.
The ALLEGRO Topolyzer works in perfect synchro-nization 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 micro-meters.
Combined with the WaveLight laser systems, the ALLEGRO Topolyzer enables the surgeon to perform a precise topography-guided correction of advanced clinical indications.
Corneal Topography
Pre-Op
Post-Op 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
3D Wavefront
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 exactly 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 complex clinical indications: WaveLight provides the right technology and support to achieve the best-possible results.
The WaveLight customization toolkit comprises several different customization tools that can be combined with our laser systems and diagnostic devices to maximize your capabilities: · Wavefront-optimized · Wavefront-guided · Topography-guided
· Custom Q for asphericity-guided treatments, customized refraction and optical zone entries
Customize your practice!
Meet your Needs
3D Topography Custom Q
Custom Treatment Ranges 0 +6 -14 sphere +6 -6 cylinder +6 -12 sphere +3 -3 +6 -14 sphere +6 -6 cylinder +6 -14 sphere +6 -6 cylinder Wavefront-optimized A-CAT (Wavefront-guided) T-CAT (Topography-guided) Custom Q cylinder WaveLight CUSTOMIZATION
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 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.
RONDO
The Cutting Edge
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 150m
· 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 WaveLight TREATMENT
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ALLEGRETTO WAVE
™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 combina-tion 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 wavefront-guided treatment in 1999, the ALLEGRETTO WAVE today is the most successfully sold WaveLight laser system in the market with more than 400 instal-lations around the world.
· 200 Hz ablation rate · 0.95 mm (0.68 mm FWHM)
Gaussian laser beam · 200 Hz active eyetracker · PerfectPulse Technology 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
Right. From the Start.
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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. Aside from the ability to perform wavefront-optimized, wavefront-guided or topography-guided treatments, the Eye-Q features Custom Q,
ALLEGRETTO WAVE Eye-Q
the first treatment module that allows the custo-mization of corneal asphericity. Aside from tailor-ing 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 maximize 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 out-comes to your patients, Custom Q adds a fourth dimension to your treatment portfolio.
· 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
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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 demonstra-tion 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 excellent results of already existing WaveLight lasers while going one step further. The exclusiveness of the ALLEGRETTO WAVE Concerto is defined by several factors: · Innovative technical components · A progressive design and the use of only
highest-quality materials
· Excellent operability and a comprehensive package of technical and non-technical services · Personalized, individual and direct support by
WaveLight
ALLEGRETTO WAVE Concerto
· 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
wavefront-guided treatment modules · Comes with diagnostic devices for
wavefront and topography measurements and with the RONDO microkeratome · Custom design in several different color schemes
WaveLight TREATMENT
Specifications are subject to change! Working principle Tscherning Principle
Resolution 13 x 13 dots (168 as the central point is not measured) Measurable pupil 3 to 8 mm diameter
Measurement range -12 to +6 D sphere -6 to +6 D astigmatism Centration Eyetracking function
(centered on the gravity center of the pupil) Accuracy of the refrac- +/- 0.01 D tion measurement
Repeatability +/- 0.05 D in consecutive measurements Accuracy of the Zernike polynomials up wavefront measurement to the 6th order Acquisition time app. 250 ms Dimensions (L x W x H) 45 x21x 50 cm (optical unit) Weight 15 kg (optical unit)
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: 5-100 m, OZ 2-8 mm Standard „wavefront-optimized” refractive treatment Custom Q treatment A-CAT treatment in conjunction with the ALLEGRO Analyzer T-CAT treatment 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 / external Dimensions (L x W x H) Weight ALLEGRETTO WAVE 200 4 s/D 200 - 14 to + 6 - 6 to + 6 Myopia: 4.5 - 8, in 0.5 mm steps, without 7.5; Hyperopia: 6 - 7 in 0.5 mm steps x x Optional Optional Optional x -Optional External 20 -x 120 x 145 x 130 cm 320 kg (incl. bed) 400 2.5 s/D 400 - 14 to + 6 - 6 to + 6 Myopia: 4.5 - 8, in 0.5 mm steps, without 7.5; Hyperopia: 6 - 7 in 0.5 mm steps x x x Optional Optional x -Optional External 20 -x x 120 x 145 x 130 cm 320 kg (incl. bed)
ALLEGRETTO WAVE Eye-Q ALLEGRETTO WAVE Concerto
500 2 s/D 500 - 14 to + 6 - 6 to + 6 Myopia: 4.5 - 8, in 0.5 mm steps, without 7.5; Hyperopia: 6 - 7 in 0.5 mm steps x x x x x Internal PC x x x Integrated 29 x x Integrated 170 x 120 x 125 cm 400 kg (incl. bed, excl. gas)
ALLEGRO Analyzer ALLEGRO Topolyzer
Measuring range 3 to 38 mm (corneal radius) 9 to 99 D (refractive power) Accuracy 0.1 D Reproduceability 0.1 D Number of rings 11 Working distance 80 mm Data points evaluated 22,000 Dimensions (D x W x H) 17 x 26 x 42 cm Weight (measuring head) 2.3 kg
Suction ring diameter 19.0 mm
Flap diameter 8.0 mm 8.5 mm 9.0 mm 9.5 mm 10.0 mm variable hinge: min. 4.0 mm Cutting head Flap thickness:
100 m 130 m 150 m
Oscillation 8,000 rpm
Vacuum 400 - 600 mmHg
User interface Touch screen Dimensions (LxWxH) 37 x 50 x 25 cm
Weight 20 kg
RONDO
Technical Data & References
Specifications at a Glance
For detailed technical data and references ask forthe WaveLight product brochures.
