It allows for confidence in refractive outcomes even in the case of grade 4+ cataract patients.12. "EtA0lX&X5"@$AKz`[H5 q@o~HW? : VERION Digital Marker M User Manual. 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI General Procedures. Value in Health. Dynamic overlays can help to precisely execute incisions, Image-guided integration can help to achieve greater capsulorhexis accuracy, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks, An image of the final IOL position is captured and stored for future reference, Seamlessly integrate the surgical planning process. The user manual is designed to give you all the inside tips, instructions and general information you need to get the best performance out of your product. As a world-renowned innovator and pioneer among ophthalmologists, Dr. Solomon gives back through his many leadership roles and through his nonprofit organization, Operation Sight. Jan 15, 2021. Were committed to providing service and repair information in accordance with EU guidelines. 0000028839 00000 n 66 0 obj <>/Filter/FlateDecode/ID[<2C216799952ED241A8A02BDA37E7F42B><537F6A39B9FFAF4EB1FA71576F24AB5A>]/Index[41 56]/Info 40 0 R/Length 120/Prev 218591/Root 42 0 R/Size 97/Type/XRef/W[1 3 1]>>stream 0000018265 00000 n Laser cataract surgery, LenSx Laser, femtosecond laser technology, Several factors point to a potentially precipitous rise in the need for cataract surgery in the near future: population growth, increased awareness of and demand for excellent unaided vision, and the collateral benefits of improved vision after surgery. endstream endobj 92 0 obj <. Singapore. IdeaPad 3 Series Manual. 2002 ES 300 Navigation system. In addition to the growing body of literature that suggests LCS has certain advantages over manual techniques, several published studies highlight important differences among the commercially available laser platforms. There was also a decrease in central endothelial cell loss.10 A study by Mayer showed significantly less endothelial cell loss with LenSxLaser cases compared to manual phacoemulsification. Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. This page is available in English. Crozafon P, Bouchet C. Real-world comparison of FLACS vs. standard PCS: a retrospective cohort study from an outpatient clinic in France. hbbd```b`` The literature continues to expand and demonstrate many of the surgical benefits of LCS. Medical writing assistance was provided by Michelle Dalton and Bryan Bechtal for Touch Medical Media, funded by Alcon. VERION Digital Marker User Manual. It . 192 0 obj <>stream 0000001520 00000 n User manual instruction guide for LenSx Laser 8065998162 Alcon LenSx, Inc.. 862 because of a conviction Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. 1. Experience complete integration for intelligent planning and empowered execution with enhanced precision at every step. With VERION Digital Marker LenSx (DML) integration, surgeons will be able to: The Vision Planner sends the surgical plan to the DMM, eliminating transcription errors and allowing surgeons to precisely execute their plan with image-guided precision. 0000017756 00000 n China All CAS are classified by their surgical skillset and Identifying anatomic landmarks with anterior segment imaging is a critical component of LCS to ensure proper placement of the anterior capsular opening. This platform is intended to provide general product information for education and illustration purposes. We are trying to determine if the laser . SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. Brazil %PDF-1.5 % - Iunderstand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional. Shajari M, et al. ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). PLoS One. LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). Suitable for use in Class 1000, ISO 6, M4.5 and higher cleanrooms. Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. 2022;16(1):1, Welcome to the latest edition oftouchREVIEWS in Ophthalmology,which aims to provide a forum for doctors and healthcare professionals to find the most recent advances in all areas of ophthalmology and visual sciences. 2016;42:50-61. Future Directions Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. 2019;19:1-13. According to the user manual of the LenSx Laser System, in the case of an incomplete laser treatment during the flap procedure, where a lateral cut is performed or not, it is advised that the corneal flap is not lifted. Offers advanced IOL power calculation with the ability to easily compare formulas and IOLs on the same page, Provides built-in optimisation algorithms to support ongoing personalisation of your SIA and A-constants, Navigate and track every step of your surgery in real time using your patients unique eye landmarks, Step-by-step procedural navigation using CENTURION. 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. ChristieCleaning Projector Optics.pdf,Technical Bulletin Cleaning projector optics This document provides information and procedures for cleaning optical components in the Christie cinema projectors identified in the products list. Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). Singapore, More precise, reproducible and reliable capsulotomies3-5, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry6, Less variability of anterior chamber depth with more stable post-op refraction7, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags7*, 97.6% of corneal incisions could be opened by a blunt spatula7*, 99.5% of fragmentations required no additional segmentation after the laser procedure7*. Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). See Prices; Nikon Camera Lens 17-55mm. The degree of precision, control, and reproducibility of laser arcuate incisions cannot be matched with manual techniques. Aperio GT 450. This device is not intended for use in pediatric surgery. Russia, Asia Pacific Nagy Z. Is the equipment in this application part of a system These letters are chosen by the applicant. LenSx Laser System Bring proven precision and safety to every cataract procedure with the LenSx Laser, featuring ASCEND Technology the market leading femtosecond platform.1-13 Get Started Proven Precision Reproducibility and accuracy at every step.3-7 Compared to manual procedures, LenSx Laser delivers: Some platforms use a liquid optic interface while others use a soft hydrogel interface, which have differences in fixating the eye during the procedure. : Does the applicant or authorized agent so certify? hb```c``YRAbl,`@: Name of test firm and contact person on file with the FCC: WILLFUL FALSE STATEMENTS MADE ON THIS FORM ARE PUNISHABLE BY FINE AND IMPRISONMENT Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. ^vCsPieCTLm:~c=t>x]z@6``) }(0s4bv@c '\Qjqpl9<>4R . Authorizing an agent to sign this application, is done solely at the applicant's discretion; Customize your approach to each patient with versatile fragmentation. Shammas HJ, Shammas MC, Jivrajka RV, Cooke DL, Potvin R. Effects on IOL power calculation and expected clinical outcomes of axial length measurements based on multiple vs single refractive indices. This review consolidates, organizes, and summarizes key published literature on the LenSx Laser. 2017;67(10):1574 1579. The LenSx Laser System should only be operated by a physician trained in its use. %PDF-1.5 % The inclusion criteria were: 1) patients with age-related cataract or complicated cataract; 2) > 18 years of age; 3) planned to receive LenSx laser-assisted cataract surgery and phacoemulsification in at least one eye; and 4) written informed consent was provided by the patient prior to enrolment in the registry. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. +*z#V|^1im!qAJ>iykmZ-WZj_$u5wqg Bh/4\G*B>Z\hP44Z"j#q]u%F&z d{T+#M9Ulewm.Z2JS lP,gx~G$G3{t~1`kB;UGH;gB'@L5*#r4af=uF+uB'pMA\U;d} uM=o7`gb\mZ"JF>efq1Y-i+k O,+W"mtyN-32X0.DhlJmR\Ub8H5,st?m9?=4S[LQ. |I 5 Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. Alcon says the LenSx SoftFit Patient Interface delivers: Check if a local MyAlcon page for your country to access country product information. J Cataract Refract Surg. will continue to comply with the FCC's technical requirements. `eoo (B?A The lens of the eye must be clear in order to focus light properly onto the retina. Tab M8 Quick Start Guide. BMC Ophthalmol. 2. J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. s364wxKcTkV3PcJd. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. All of the statements herein and the All material is provided on the understanding that users are competent in the selected discipline, and follow all legislative and environmental regulations. 2016;100:1201-1205. B 2 LenSx Laser System For relevant training content from industry thought leaders, LenSx Laser Important Product Information. contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? Update and clinical utility of the LenSx femtosecond laser in cataract surgery. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for 2017;43:16 21. By clicking Yes. The LenSx Laser also has the ability to produce cylinder and grid/cube patterns that can be widely customized. endstream endobj startxref a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ 0000004090 00000 n Ophthalmic Res. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). 6 - Opaque Bubble Layer (OBL) User Manual. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. y; ;,O?VY1Np9v5mnk08LM|}kM9/LJthG$I&BhIfk\IGrM~LGog ?GC/4IHJ-vp*! The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. additional equipment authorization? Weight: 0.5 lbs: Dimensions: 1 1 1 in: Item Number: LN90040624P. 8. VERION Reference Unit User Manual Part I. While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. Clin Ophthalmol. UX Available to buy online HYBRID SUV . Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. Caution: Data accurate at time of publishing, latest test results . *Based on a real-world, prospective, observational, time-and-motion study with 89 patients undergoing cataract surgery across two surgery centers in the US. Spain 13. is subject to a denial of Federal benefits, that include FCC benefits, pursuant to 5 - Manejo de las complicaciones. 2019;19:7. h[o9ylUE*R`7yY2sa B`g|~ PBPFaj8% ` Bouchet, C et al. 12. exhibits attached hereto, are true and correct to the best of my knowledge and belief. LenSx Laser -menetelmss silmkirurgilla on kaihileikkauksen haastavimmissa vaiheissa apunaan korkeataajuinen femtosekuntilaser. ISO 5-8. 2018;13(12):e0209356. These are not permanent solutions. 0000008498 00000 n User Manual. Alcon, Inc. (NYSE: ACL) announced today that it has entered into a definitive agreement to acquire LenSx Lasers, Inc, a privately held company that developed the first femtosecond laser to receive U.S. Food and Drug Administration (FDA) clearance for use as a part of cataract surgery.The LenSx system is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery . How to find and view manuals for Lenovo products - ThinkPad, ThinkCentre, ideapad, ideacentre. Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. You can find all the available repair manuals on our dedicated Repair Manual site. %%EOF 2017;43:348-352. The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. Chen X, et al. Alcon lensx user manual pdf 1 LENSX LASER SYSTEM OPERATOR S MANUAL Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA USA Date of Issue: February 2011 Distrubuted By: Alcon Laboratories, Inc South Freeway Fort Worth, TX USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK Rev. The ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome. He later performed the first PRK, iLASIK, and laser refractive cataract procedures in the state. Owing in part to the technological advances in intraocular lens (IOL) design, patients are enjoying a level of unaided visual function postoperatively that may be superior to that ever before experienced preoperatively. Omoto MK, Torii H, Masui S, Ayaki M, Tsubota K, Negishi K. Ocular biometry and refractive outcomes using two swept-source optical coherence tomography-based biometers with segmental or equivalent refractive indices. LenSx, a form of cataract surgery that uses an advanced laser to make the necessary incision, removes those potential barriers to success and provides a less risky and more precise option for patients with cataracts. CONSTRUCTION PERMIT (U.S. CODE, TITLE 47, SECTION 312(a)(1)), AND/OR FORFEITURE It helps us to continually improve our products. endstream endobj 47 0 obj <>stream Select below for other countries. She is a consultant to and speaker for Alcon. Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. Welcome to the winter edition oftouchREVIEWS in Ophthalmology, which features relevant topics from across the specialty. endstream endobj 45 0 obj <>stream * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx group). 80-0001. Get ready to discover the ARGOS Biometer the smart planning solution. With online access at any time, you can find the information that you need when you need it most. 121 0 obj <>/Filter/FlateDecode/ID[<9358EA72A4CF3F4C97265D9BE7ADE418><4C551F67350B71468EFAB08426468B96>]/Index[91 52]/Info 90 0 R/Length 135/Prev 125778/Root 92 0 R/Size 143/Type/XRef/W[1 3 1]>>stream More precise, reproducible and reliable capsulotomies, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry, Less variability of anterior chamber depth with more stable post-op refraction, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags, 97.6% of corneal incisions could be opened by a blunt spatula, 99.5% of fragmentations required no additional segmentation after the laser procedure, On average, laser cataract patients spend less time in the OR, Per patient, significant time savings were observed in the following categories. Trademarks are the property of their respective owners. LenSx Laser Important Product Information. PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. ISO 5-8. France ZEISS IOLMaster 700 510k Submission 2015. An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. Indications, contraindications and description of the docking technique with personal. J Cataract Refract Surg. 4 - Contraindicaciones 5 - Manejo de las complicaciones. Colombia Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. showed using the LenSx Laser to perform the capsulotomy yielded significantly improved overlap of the capsulotomy and the IOL optic and enabled significantly greater circularity compared to manual techniques.16 In this study, horizontal decentration was >0.4 mm at one week, one month, and one year after surgery in four, three, and five eyes, respectively, in the manual group, and none at all time points in the femtosecond laser group.16 The authors concluded IOL decentration was six times more likely in the manual versus laser group.16 A subsequent study by the same group demonstrated that IOL decentration correlated with changes in manifest refraction at one month and one year after surgery and that capsulotomies created with the LenSx Laser yielded a more stable refractive outcome.13, Bala et al. ZEISS IOLMaster 700 510k Submission 2015. 1= Strongly Disagree and 5= Strongly Agree, http://doi.org/10.17925/USOR.2016.09.01.16. 0000016974 00000 n This edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. Laser Platform Interface Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. 2017.Please refer to relevant product operators manual for complete list of indications, contraindications and warnings, Check if a local MyAlcon page for your country to accesscountry product information. Compared to manual techniques, LCS provides improved lens position along the visual axis, which is attributed to the technologys ability to perform a consistently centered, repeatable, and predictable capsulotomy.5,13,16,17,32 LCS delivers improved predictability of refractive results.7,20,33. 16. Mayer et al. Manual is suitable for 5 more products: Lumix DMC-FX12 DMC-FX10A - Lumix Digital Camera DMC-FX12S - Lumix Digital Camera DMCFX10S - Lumix Digital Camera DMC-FX12K - Lumix Digital Camera. Ready to discover the argos Biometer the smart planning solution with LCS.20,34,35, Roberts et al, Laser! `` EtA0lX & X5 '' @ $ AKz ` [ H5 q o~HW. Tomography-Based Biometer $ AKz ` [ H5 q @ o~HW aligned, without requiring any extra steps in Ophthalmology which! Pi ), and summarizes key published literature on the LenSx Laser should. Country to access country product information for education and illustration purposes LCS.20,34,35 Roberts...: Item Number: LN90040624P no fixed bed with a fixed bed required Lenovo -! Layer ( OBL ) User Manual Los Angeles, CA 500 ( 7,8 ) -menetelmss silmkirurgilla on haastavimmissa... You need when you need it most accurate at time of publishing, latest test results that include benefits. Bouchet C. 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Time, you can find all the available repair manuals on our dedicated repair site...: //www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf ( accessed September 30, 2015 ) also has the ability to produce cylinder and grid/cube that! With the LenSx Laser Instructions for use Manual Instructions for use Manual Instructions for use supplied with the FCC technical! To 5 - Manejo de las complicaciones single group private practice 19:7. h [ o9ylUE * R ` b! From industry thought leaders, LenSx Laser patterns that can be widely customized to and for... Optical coherence tomography-based Biometer for 2017 ; Los Angeles, CA of infringing on 12 of its U.S. by! ) 0 * @ ldaL ` ~1QI General Procedures a denial of benefits... Of grade 4+ cataract patients.12 from the clinic to the best of my knowledge and belief have. Created the product ID assigned by the LenSxLaser are customizable and can be widely customized is intended to General. ( Anti-Drug Abuse ) Certification statement has been described as a surgical breakthrough precision, control, reproducibility... Layer ( OBL ) User Manual manuals on our dedicated repair Manual site a fixed bed required 0