2017 iDesign - Advanced WaveScan Studio System
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i Design Advanced WaveScan Studio System YOUR SMARTEST CHOICE THE BRAIN POWERING THE ILASIK® TECHNOLOGY SUITE INDICATIONS: The STAR S4IR® Excimer Laser System and iDESIGN® Advanced WaveScan Studio (iDESIGN®) System is indicated for wavefront-guided LASIK in patients with myopia as measured by iDESIGN® System up to -11.00 D SE, with up to -5.00 D cylinder and in patients with mixed astigmatism as measured by iDESIGN® System where the magnitude of the cylinder (1.0 D to 5.0 D) is greater than the magnitude of the sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® System refraction of 1) SE: magnitude of the difference is < 0.625 D, and 2) cylinder: magnitude of the difference is < 0.5 D; with patients 18 years of age and older, and with refractive stability (a change of < 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).

MORE BRAIN POWER IN YOUR SURGERY 5 MEASUREMENTS IN 1 CAPTURE SEQUENCE 1 Wavefront aberrometry 2 Wavefront refraction 3 Corneal topography 4 Keratometry 5 Pupillometry EASY-TO-USE INTERFACE WITH ALIGNMENT AIDS AND ON-SCREEN TOOLS Screen is a simulated image SEAMLESSLY INTEGRATES WITH THE STAR S4 IR® EXCIMER LASER

WITH A HIGH-DEFINITION HARTMANN-SHACK WAVEFRONT SENSOR* Standard Wavefront iDESIGN® System High-Definition Wavefront Offering outstanding accuracy and ability to measure complex wavefronts • Up to 1,257 micro-refractions over a 7 mm pupil • 3X the dynamic range* • Captures more ocular aberrations unique to every eye* *As compared to the Hartmann-Shack sensor in the WaveScan WaveFront®

“The iDESIGN ® System gives us a mechanism to capture the entire wavefront in our LASIK patients. It really hits the target in terms of astigmatism and then allows that to be translated to the patient’s treatment plan and results.” –JAY S. PEPOSE, M

MORE PATIENT POWER IN YOUR PRACTICE Approved to treat patients Capture wide range of pupil sizes

DELIVER THE OUTCOMES PATIENTS EXPECT In a clinical trial, myopic patients reported significant improvements in ALL measures of visual functioning and well-being 6 months postoperatively, including:1* Satisfaction with Correction Near Vision Activity Limitations Difficulty Driving at Night Of myopia (with and without astigmatism) eyes at 6 months *Similar patient reported results seen in the clinical trial for mixed astigmatism.1 REFERENCE: 1. Clinical studies submitted to FDA via P930016 supplements 044 and 045. Of mixed astigmatism eyes at 3 months Where the magnitude of cylinder is greater...

“Clinical study in mixed astigmatism patients demonstrated refractive stability for patients at 3 months post-operative and no adjustments were needed for the complex correction, proving an accurate algorithm from the iDESIGN® System.” —ROBERT MALONEY

• Business Development o In-person and online education — practice-building tools and patient-marketing initiatives o Diagnosis and solutions to elevate practice performance • Clinical Training o On-site surgeon and technician training and support to help improve outcomes by maximizing team skills o Highly skilled application support team and renowned medical monitors — ongoing clinical consultation and analysis to enhance patient outcomes • Field Service Support o Multiple service plans to meet your practice needs — so you can be confident in your system’s performance o 10-time recipient...

MAKE THE iDESIGN SYSTEM YOUR SMARTEST CHOICE ® Contact your Sales Representative today

iDESIGN Advanced WaveScan Studio System ® Specifications For Site Preparation/ Installation Product Description The iDESIGN® Advanced WaveScan Studio (iDESIGN®) System measures the wavefront of the eye within a defined range using the Hartmann-Shack sensor. The sensor evaluates the deflection of rays emanating from a small beam of light projected onto the retina. The measurements determine regular (sphero-cylindrical) refractive errors and irregularities (aberrations) that cause reduced visual function. Laser vision-correction treatments can be calculated using measurements obtained from the...

Recommended Room Requirements • Do not place the unit near windows or in a room that cannot be sufficiently darkened to allow the patient’s eyes to dilate naturally • Ambient operational temperature range: 60°F–80°F (15°C–27°C) • Humidity: Relative humidity no less than 35% and no greater than 65% (noncondensing) • Barometric pressure range: 11–16 psi (76–110 kPa) Storing Requirements Before Installation When storing the iDESIGN® System before installation, adhere to the following site requirements: • Storage temperature must be between 41 and 104°F (between 5 and 40°C) at a relative...

System Specifications Cont. • Motorized Table o Physical dimensions: (L, W, H) 52.5", 28.3", 31.9"-46.7" (min.-max.), (133.4 cm, 71.8 cm, 81.0-118.6 cm) o Weight: 149 lbs (68 kg) o Electrical ratings are 120 V, 50/60 Hz, 6 A o Vertical position is controlled by a rocker control switch (vertical height can range from 630 to 1,030 mm) o Tabletop supports iDESIGN® System and USB v2.0 keyboard o Shelves hold printer and isolation transformer • High-resolution color printer included • Medical-Grade Isolation Transformer o Input: 100/120/220/240 VAC at 50/60 Hz o Power: 750 VA o Complies with IEC...

System Specifications Cont. • Measurement spatial resolution 0.177 mm (approximately 1250 measurement points for a 7 mm pupil) • Integrated corneal topographer 37 x 37 spot measurement grid • Topographer grid extent (X and Y) ±4.1 mm for eye with 8 mm radius of curvature • Illumination ranging from 535 to 940 nm Hardware Components The iDESIGN® System includes, a built-in power supply, computer, and monitor. The computer central processing unit (CPU) is housed inside the iDESIGN® System. The USB port is located on the right-hand side of the computer case. The computer keyboard and built-in...