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2017 iDesign - Advanced WaveScan Studio System

2017 iDesign - Advanced WaveScan Studio System
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2017 iDesign - Advanced WaveScan Studio System

Product catalog summary
Indications: The STAR S4 IR® Excimer Laser System and iDESIGN® Advanced WaveScan Studio System are indicated for wavefront-guided LASIK in patients with myopia up to -11.00 D SE and up to -5.00 D cylinder, and in patients with mixed astigmatism where the cylinder is greater than the sphere and they have opposite signs. Patients must be 18 years or older with refractive stability for at least 12 months.
System Features: The iDESIGN® System offers a comprehensive suite of measurements including wavefront aberrometry, wavefront refraction, corneal topography, keratometry, and pupillometry. It provides high accuracy with up to 1,257 micro-refractions over a 7 mm pupil and captures more ocular aberrations compared to previous systems.
Clinical Outcomes: Clinical trials showed significant improvements in visual functioning and well-being postoperatively. 83% of myopic eyes achieved 20/20 vision or better at 6 months, and 92% of mixed astigmatism eyes achieved similar results at 3 months.
Specifications: The iDESIGN® System requires specific environmental conditions for operation and storage, including temperature and humidity ranges. It includes an optical head, motorized table, high-resolution printer, and medical-grade isolation transformer. The system measures sphere and cylinder in 0.01 D increments and supports a wide range of pupil sizes.
Safety Information: Contraindications include patients with certain diseases, pregnant or nursing women, and those with specific corneal conditions. Warnings highlight the importance of not performing LASIK on patients with systemic diseases affecting wound healing, certain medications, and other specific conditions. Adverse events may include loss of visual acuity, severe dry eyes, and other complications.
Support and Training: The system is supported by business development, clinical training, and field service support to enhance practice performance and patient outcomes.
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Catalog excerpts

2017 iDesign - Advanced WaveScan Studio System-1

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).

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2017 iDesign - Advanced WaveScan Studio System-2

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

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2017 iDesign - Advanced WaveScan Studio System-3

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®

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2017 iDesign - Advanced WaveScan Studio System-4

“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

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2017 iDesign - Advanced WaveScan Studio System-5

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

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2017 iDesign - Advanced WaveScan Studio System-6

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 than...

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2017 iDesign - Advanced WaveScan Studio System-7

“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

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2017 iDesign - Advanced WaveScan Studio System-8

• 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 of...

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2017 iDesign - Advanced WaveScan Studio System-9

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

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2017 iDesign - Advanced WaveScan Studio System-10

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 iDESIGN®...

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2017 iDesign - Advanced WaveScan Studio System-11

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 humidity...

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2017 iDesign - Advanced WaveScan Studio System-12

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 60601-1...

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2017 iDesign - Advanced WaveScan Studio System-13

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 glidepad...

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