The LenSx (LenSx Lasers, distributed by Alcon) is a device that has been making waves in cataract surgerycenters during the last year or so. Request Quote. 0000049877 00000 n Mastropasqua L, Toto L, Mastropasqua A, et al. 4. That could rise more than two-fold to $744 million, provided sales . In addition, Lensx 90 is used for number of other lens cleaning applications including microscopes, camera lenses, telescopes, IR lenses, fiber optics, and other sensitive optical components in laboratory, cleanroom, and industrial settings. China Is the equipment in this application part of a system The LenSx uses an image-guided capability enabling the control of corneal thickness, incision length, width, depth, shape, and location. 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 1.5x faster scanning speed than IOLMaster* 700, Angle-to-angle, cornea-to-retina OCT imaging provides real-time guidance for capturing accurate measurements, Integrated Alcon Vision Planner with automated and convenient planning software offers sophisticated astigmatic management tools, including an LRI nomogram, One-touch software and remote planning options, Outperformed IOLMaster* 700 by 41% in grade 4+ cataracts, OCT-enhanced keratometry shown to rival Lenstar, Uses segmented axial length, improving refractive prediction error, which may lead to better IOL selection, Provides intra-operative guidance with digital overlays throughout LenSx, Provides image registration and real time eye tracking to compensate for cyclotorsion. 2017. applicable rules, and (3) compliance of the equipment with the applicable technical rules. Zhang X, et al. AutoStainerXL. J Cataract Refract Surg. 0000007536 00000 n Further, the mean absolute error (MAE), a measure of predictability, was lower in the LenSx Laser group. and that the FCC reserves the right to contact the applicant directly at any time. Show all Leica Laboratory Equipment manuals. J Pak Med Assoc. Kranitz et al. 1= Strongly Disagree and 5= Strongly Agree, http://doi.org/10.17925/USOR.2016.09.01.16. In addition, Lensx 90 is used for number of other lens cleaning applications including microscopes, camera lenses, telescopes, IR lenses, fiber optics, and other sensitive optical components in laboratory, cleanroom, and industrial settings. In an editorial, Alpins and Stamatelatos describe the vector planning approach, [], touchREVIEWS in Ophthalmology. Ophthalmic Res. application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID This non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. ManualsLib has more than 563 Lexus manuals. 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. Does this application include a request for confidentiality for any portion(s) of the data 5 - Manejo de las complicaciones. Aperio GT 450. By clicking Yes. J Refract Surg. This prospective study enrolled 64 eyes (54 patients) with high myopia with low to moderate regular corneal astigmatism. 2018. J Refract Surg. 0000058734 00000 n B|a:BbN`a8dxC/tN&UF./2-3;? `%]>-AJFFkK&K.3JlNeQ'}) k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP additional equipment authorization? 2009;25(12):10531060. Please provide feedback for this on the following(scale 1-5, 1 strongly disagree; 5 strongly agree): Laser cataract surgery (LCS) offers several surgical advantages over manual cataract surgery: the laser fragments the lens and creates corneal incisions and capsulotomies with a level of precision, control and reproducibility unachievable with manual techniques. It . 0000004090 00000 n Ecuador 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. 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. * Trademarks are the property of their respective owners. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. 2019:1-8. Laser cataract surgery (LCS) offers several surgical advantages over manual cataract surgery: the laser fragments the lens and creates corneal incisions and capsulotomies with a level of precision, control and reproducibility unachievable with manual techniques. Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. Clin Ophthalmol. ThinkPad USB-C Dock Gen 2 Manual. International Journal of Open Access Ophthalmology. 5. The procedure is computer-controlled, precise and predictable. France 0000001520 00000 n hbbd```b``"+ &[A$>/z;Tz6AD*K&&1`:TdA@l/ R720$1L 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. * Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser SoftFit Patient Interface AccessoryWARNINGSThe LenSx Laser System should only be operated by a physician trained in its use. All CAS are classified by their surgical skillset and and nurses, 15+ years of clinical/surgical experience, All CAS undergo rigorous training each year to 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. 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. Nikon AF-S Zoom-Nikkor Instruction Manual. 2019. Sci Rep. 2018;8(1):13732. 0000039322 00000 n technology, individualised for your clinics needs, Tamaoki A, Kojima T, Hasegawa A, et al. Only properly trained personnel with experience may operate the device and control software and interpret the results. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). 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. Pages: 60. have been made with the manufacturer to ensure that production units of this equipment Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Methods . is subject to a denial of Federal benefits, that include FCC benefits, pursuant to 0000052798 00000 n Purpose . Vasavada et al. Chile 80-0001. hbbd```b`` Coupling of the LOI to the eye is achieved using a suction ring outside the limbus.9 LOI use also requires the precise identification of the anterior corneal surface via sophisticated imaging techniques. Peru Through continuous innovation, the LenSx Laser with ASCEND Technology sets the standard at the cornea, capsule and lens, optimizing cataract refractive procedures and consistently hitting refractive targets for the widest range of patients. 2019;19:1-13. @-{^jLz3lEwAS^ vF3ErB2UrAF n^N$13$~eer(q7&H"W&wIYJq-3:KOUw9`"tRj5=f@~Q+r lN?@E1>R=g3pNIm53SM$kI"V_L%uQ.,0azdtd~ufu{ahQ6g\N[r9+tS{rKB "EtA0lX&X5"@$AKz`[H5 q@o~HW? : Reproducibility and accuracy at every step. 11. *Glaucoma is not a contraindication when these procedures are performed using the LenSx. J Refract Surg. This review consolidates, organizes, and summarizes key published literature on the LenSx Laser. Weight: 0.5 lbs: Dimensions: 1 1 1 in: Item Number: LN90040624P. Document Type. p<0.001, <2 minutes total time for patients under suction in cataract procedures16, As strong as manual LenSx capsulotomy integrity17, <0.1% capsular tear rate with SoftFit Patient Interface12, 13. Suitable for use in Class 1000, ISO 6, M4.5 and higher cleanrooms. 3yhr1-aF?3y;0ub0R a |Bg`9H36 _uG5 endstream endobj 65 0 obj <>>> endobj 66 0 obj >/PageWidthList<0 612.0>>>>>>/Resources<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 67 0 obj <> endobj 68 0 obj [/ICCBased 93 0 R] endobj 69 0 obj <>stream hb```c``YRAbl,`@: 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. Br J Ophthalmol. 96 0 obj <>stream 0000017756 00000 n Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). The interface gently makes contact rather than first fitting a suction ring directly onto the patients eye followed by docking the patient up to the laser objective head.40, Some platforms possess a fixed bed, which can help stabilize the head during image capture and treatment, but brings with it the necessity of moving a patient to another bed for the remainder of the surgery.19. The acquisition of medical laser systems specialist LenSx Lasers by Swiss eye care giant Alcon Laboratories has generated a huge return for venture investors in the Californian company. 43dQ%mlZ&y?#;W3{$RQomX`.e!!A;D!GHd=@-N05|9|>yy Q/CCh5>9c kS5mmQxN j])k1>s%6c#RhEotyjQP$M(dmDU-dMOT7_wxd1}g~/oP *Based on a real-world, prospective, observational, time-and-motion study with 89 patients undergoing cataract surgery across two surgery centers in the US. 2017;43:480485. 0000089165 00000 n User Manual. In this video, which contains animated simulations, youll find out what the LenSx laser looks like, how it works, and why ophthalmologist Dr. Kerry Solomon offers this technology to people looking for cataract surgery.Dr. BMC Ophthalmol. The LenSx Laser System should only be operated by a physician trained in its use. During femtosecond laser lens fragmentation, a beam spot size of less than 6 m is used to generate plasma in the ocular tissue.19 This plasma, containing free electrons and ionized molecules, expands to cause a cavitation and formation of a bubble that expands and contracts to cause tissue separation,4,19 thereby reducing the amount of phacoemulsification energy delivered compared with manual techniques. Cataract Surgery Indication:Cataract Surgery Contraindications: *Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser SoftFit Patient Interface Accessory. Were committed to providing service and repair information in accordance with EU guidelines. 0000010027 00000 n PLoS One. 2. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. Whang W, Yoo Y, Kang M, Joo C. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. %PDF-1.5 % described a lens fragmentation technique creating concentric circles before aspiration in eyes with posterior polar cataracts.27 Conventional hydrodelineation, referenced in that study, includes a risk for inadvertent cortical cleaving that does not present when using the femtosecond laser. Ophthalmic Res. Please consider the guidance provided in Table 1 when you encounter these factors. Filkorn et al. Argentina trailer <]/Prev 315881>> startxref 0 %%EOF 102 0 obj <>stream Capsulotomy The information below is intended to provide guidance on cleaning and disinfection for LenSx Laser System. Ali MH, et al. Colombia Italy Discard used Patient Interfaces as medical waste. Complicated Cases Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. Dr. McCabe may be reached at (941) 792-2020; cmccabe13@hotmail.com. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. 0000009132 00000 n Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. See Prices; Nikon Camera Lens 17-35mm. Application for Equipment Authorization FCC Form 731 TCB Version. Uruguay Singapore. This article is published under the Creative Commons Attribution Noncommercial License, which permits any noncommercial use, distribution, adaptation, and reproduction provided the original author(s) and source are given appropriate credit. 2022;16(2):636 DOI: https://doi.org/10.17925/USOR.2022.16.2.63, We have all heard the old adage try it before you buy it in reference to big purchases or life decisions. y; ;,O?VY1Np9v5mnk08LM|}kM9/LJthG$I&BhIfk\IGrM~LGog ?GC/4IHJ-vp*! 0000006949 00000 n Singapore. s364wxKcTkV3PcJd. The LenSx Laser also has the ability to produce cylinder and grid/cube patterns that can be widely customized. 2017;20(9):A800A801. 0000089128 00000 n With online access at any time, you can find the information that you need when you need it most. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. Bring proven precision and safety to every cataract procedure with the LenSx. Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. Chan T, et al. Cathleen McCabe, MD, moderator LenSx user for 4 years Cathleen McCabe, MD, is a cataract and refractive specialist practicing at The Eye Associates of Bradenton and Sarasota, Florida. 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. * This comprehensive tool eliminates the need for complicated online and manual calculations while continuing to optimise patient outcomes with Image Guidance by Alcon.5, * Barrett Total K formula can be used if posterior keratometry is manually entered into the planning software, The ARGOS Biometer captures a reference image of each patients unique eye during measurement. * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx group). Alcon equipment, Made up of tenured ophthalmic technicians 2017. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for 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 . LENSX LASER SYSTEM OPERATOR'S MANUAL. Rayon / Hemp. Mayer et al. 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