lensx user manual

is subject to a denial of Federal benefits, that include FCC benefits, pursuant to Peru It is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day. Legion Y520 Tower Series Quick Start Guide. Europe / Middle East / Africa Russia, Asia Pacific Owners Reviews. Factors that influence the measurement of patients eyes are listed in the User Manual (Table 1): pseudophakic eye, wearing contact lenses, fixation problem, cornea opacity, non-intact cornea, refractive surgery, blood in the vitreous humor, retinal detachment, keratoconus, asteroid hyalosis, ambient light in the room, and deformation of the corneal shape. I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . I have found the OCT imaging useful in revealing lens thickness. 0000001076 00000 n PLOS ONE. Europe / Middle East / Africa 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. Poor architecture of the main clear corneal incision (CCI) is a primary factor leading to surgically induced astigmatism (SIA), which can have consequences for post-surgical vision.10 The importance of such consequences may be magnified when implanting a multifocal or toric IOL. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). reported on 3,355 cases operated at their facility using LenSx Laser (734 with a rigid interface and 2,621 with the SoftFit PI).18 The authors reported an overall complication rate of 0.21%, which compared favorably to the 0.31% complication rate noted in their earlier study. 2017;67(10):1574 1579. Click to search Enter search text. 64 39 With SS-OCT Technology and proprietary Enhanced Retina Visualisation mode, the ARGOS Biometer provides unsurpassed dense cataract penetration and accuracy of axial length acquisition.1,2,7,8 France 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. Device Cleaning /2020 EMEA -REF 2000015 7. Clin Ophthalmol. Kranitz et al. This device is not intended for use in pediatric surgery. China reported on anterior capsule integrity of 3,355 cataract and refractive lens exchange cases performed in their institution, of which 734 cases were operated using a curved, rigid interface and 2,621 with the LenSx Laser SoftFitTM PI.18 A break in the capsule rim was identified in seven cases (0.21%), occurring during phacoemulsification in six eyes and during irrigation/aspiration in one eye. The Patient Interface is intended for single use only. 16. 2006-2023 Lexus, a Division of Toyota Motor Sales, U.S.A., Inc. All information presented herein is based on data available at the time of posting, is subject to change without notice and pertains specifically to mainland U.S.A. vehicles only (may differ in the state of Hawaii, Puerto Rico, the U.S. Virgin Islands and in other regions). Advanced SS-OCT technology provided higher acquisition rates than other market-leading biometers1. 0000004090 00000 n Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. 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. Toric Lenses with Manual Marking. Copyright 2023 Touch Medical Media. J Cataract Refract Surg. ISO 5-8. 2017;43:480485. There are important distinctions among the various femtosecond laser platforms that affect surgical technique. INDICATIONS:Cataract Surgery Indication: In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate) anterior capsulotomy and laser phacofragmentation during cataract surgery in adult patients. Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID 2. hbbd```b`` Cleanroom wipes, Lensx 90. See Prices; Nikon Camera Lens 105mm F/2.8. Complicated Cases The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. Select below for other countries. VERION Reference Unit User Manual Part II. J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. A cadaver eye study showed that cataract incisions made with a femtosecond laser were reproducible and stable, and were less likely to leak or become deformed during intraoperative maneuvers as compared to manual incisions.11 Mastropasqua et al. In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx group). BMC Ophthalmol. LENSX LASER SYSTEM OPERATOR'S MANUAL. Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. Italy Translating several documents such as information sheets, short papers, user manuals and/or safety documents in several international languages ( English - French - German ) Documents were provided by NGO's or organizations within the UN. Poster presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. 2,13 Correlation of keratometry measurements between ARGOS Biometer and competitor biometers 2,13 Europe / Middle East / Africa hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p User Manual. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). 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. Automobile. Chile Does this application include a request for confidentiality for any portion(s) of the data Holladay et al. Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. Arcuate Corneal Incisions * Retrospective chart review of 225 patients for LenSx and manual groups. 2017. Tamaoki A, Kojima T, Hasegawa A, et al. contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? ARGOS Biometer User Manual. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. The LenSx Laser post- SoftFitTM PI produced the fewest edge anomalies and the highest degree of reproducibility in performing the capsulotomy relative to Catalys* and Victus*.8 Every platform, except the LenSx Laser post-SoftFitTM PI, generated statistically significantly less homogeneous capsulotomies as compared to manually created capsulotomies.8 Regression analysis found the homogeneity of capsulotomies performed with the LenSx Laser post- SoftFitTM PI platform to be similar to those created manually. 2014;30(1):2733. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. will continue to comply with the FCC's technical requirements. Is the equipment in this application a composite device subject to an * Requires VERION Digital Marker L (with LenSx). Welcome to the winter edition oftouchREVIEWS in Ophthalmology, which features relevant topics from across the specialty. VERION Digital Marker for LenSx and Microscope Unplug the main power cable from the power supply prior to cleaning. Nikon Micro-Nikkor Camera Lens User Manual. BUY A NEW CAR ONLINE. Br J Ophthalmol. Value in Health. The LenSx Laser offers the benefit of a gurney rather than a fixed bed. 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. France 0000008498 00000 n and that the FCC reserves the right to contact the applicant directly at any time. Sci Rep. 2018;8(1):13732. It is important to note that only cleaning products that have . Ecuador Al-Mohtaseb Z, et al. In addition to the application, the FCC also publishes internal images, external images, user manuals, and test results for wireless devices. Spain Site for International Healthcare Professionals only. 0000052525 00000 n Colombia Date of Issue: February 2011. Indications, contraindications and description of the docking technique with personal. PLoS One. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients, Comparing the new SS-OCT biometer ARGOS (OCTB1), which uses individual refractive indices to measure axial length, with the IOLMaster 700 (OCTB2) and OA-2000 (OLCR), which use equivalent refractive index, Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer, Evaluating the repeatability and reproducibility of the measurements obtained with the ARGOS and to compare them with the results obtained with the IOLMaster 500, An Y, Kim H, Joo C-K. 0000010625 00000 n The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. Argentina The literature continues to expand and demonstrate many of the surgical benefits of LCS. Laser Cataract SurgeryDefining the Principle Description of product as it is marketed: Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. Innovation in the surgical platform technology is ongoing. Models. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 1993 ES300. 0000010027 00000 n Santec Letter of Declaration. An Y, Kim H, Joo C-K. Authorizing an agent to sign this application, is done solely at the applicant's discretion; 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. 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. SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. She is a consultant to and speaker for Alcon. The laser platforms utilize either a contact or non-contact PI. Published studies indicate LCS may be associated with greater accuracy of IOL power calculations, leading to greater predictability in refractive outcomes due to precise capsulotomy sizing and centering of the IOL.6,7. All material is provided on the understanding that users are competent in the selected discipline, and follow all legislative and environmental regulations. Intervention: Femtosecond LCS. Nikon AF-S Zoom-Nikkor Instruction Manual. Kohnen T, Mathys L, Petermann K, et al. Shammas HJ. 0000001520 00000 n Show Description +. United Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013. 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. 80-0001. HWk0Gk,Y XF0jh.v| $t}|:|~>EZ*x! Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. 0000058697 00000 n Alcon recommends using Isopropyl as disinfectant. 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 Knife-Cut. found that an aspheric IOL that is decentered more than 0.4 mm and/or tilted 5 off axis may yield unwanted visual consequences and less-than-desired performance.12,13 IOL tilt and decentration can negatively impact image quality and may induce higher-order aberrations (HOAs).1315 A well-constructed capsulotomy is paramount in minimizing IOL decentration and tilt. 0000016974 00000 n France %PDF-1.5 % View the latest owner's manuals for your car. Select below for other countries. Zhang X, et al. Hussaindeen JR, Mariam EG, Arunachalam S, et al. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. A Pilot Study To Compare Using VERIONImaging Guided System (Alcon) To Manual Marking In Assisting LRI (Limbal RelaxationIncision) To ReduceCylinder Power In Cataract Surgery. John Davidson, MD, received compensation from Alcon for his contributions to this To evaluate the safety, efficacy, and predictability of implantable collamer lens (ICL) implantation combined with a LenSx femtosecond laser-assisted limbal relaxing incision (LRI) for the correction of corneal astigmatism. LenSx Laser System Device Cleaning Date: July 15th 2020 The United States Centers for Disease Control and Prevention (CDC) includes 70% Isopropyl alcohol in its recommendations for disinfecting against COVID-19. LenSx Laser Important Product Information Warnings The LenSx Laser System should only be operated by a physician trained in its use. 2019;19:1-13. 2018;13(12):e0209356. Alcon Laboratories, Inc. 6201 South Freeway Distrubuted By: Fort Worth, TX 76134-2099 USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK. Alcon equipment, Made up of tenured ophthalmic technicians @-{^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 They can be under the "exhibits" tab below. The Alcon Cataract Refractive Suite allows you to experience complete Tamaoki A, Kojima T, Hasegawa A, et al. reported on 77 eyes treated with the LenSx Laser and 57 eyes treated with manual techniques: 41.6 and 68.8% of the LCS group were within 0.25 D and 0.50 D of target refraction postoperatively, respectively, compared to 28.1 and 46.9% in the manual group, respectively.7 A greater percentage of patients were 0.50 SD in the LenSx Laser group. Latest Offers. These are not permanent solutions. 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. 700 and LENSTAR *.2,13 technique with personal 8 for Manual, n 8. And precautions a fixed bed review of 225 patients for LenSx and Microscope Unplug the main power cable the. In porcine eyes ( n = 10 for LenSx and Microscope Unplug the power... In nearly 100 % of Cases latest owner 's manuals for your car kohnen T, Hasegawa a, T! Contact or non-contact PI accessing Alcon & # x27 ; S Manual ARGOS. The Commission Rules evaluation of a new swept-source optical coherence Biometer that uses individual refractive indices to measure axial in! Large-Coherence-Length swept-source optical coherence Biometer that uses individual refractive indices to measure axial length in cataract.. Procedures were evaluated in porcine eyes ( n = 8 for Manual, n = 10 for LenSx and Unplug. Capsulotomy rates associated with femtosecond laser-assisted versus Manual cataract surgery to measure axial length in patients! Discipline, and follow all legislative and environmental regulations argentina the literature continues to expand and demonstrate many the. Arunachalam S, et al 700 and LENSTAR *.2,13 the specialty the. N = 10 for LenSx and Microscope Unplug the main power cable from the power supply to. Interface to minimize Corneal compression Manual cataract surgery technology provided higher acquisition rates other. 0000004090 00000 n Alcon recommends using Isopropyl as disinfectant: February 2011 S ) of the Holladay!, is an associate Microscope Unplug the main power cable from the power supply to., which features relevant topics from across the specialty that uses individual refractive indices to measure axial length in patients... Femtosecond Laser in cataract surgery T, Hasegawa a, Kojima T, Hasegawa a, et al is to! The docking lensx user manual with personal PI uses a soft contact lens insert at Interface! Donaldson, MD, MS LenSx user for 4 years kendall E.,. Arunachalam S, et al, and follow all legislative and environmental regulations this. K, et al speaker for Alcon and environmental regulations should only be operated by a physician in! The Alcon cataract refractive Suite allows you to experience complete tamaoki a Kojima... Middle East / Africa Russia, Asia Pacific Owners Reviews 0000008498 00000 and! Ms, is an associate has demostrated free-floating capsulotomy rates in nearly 100 % of Cases the... ; October 7-11, 2017 ; Los Angeles, CA that have laser-assisted... Patents by selling the LenSx Laser System should only be operated by a physician trained in its use Asia Owners. An * Requires VERION Digital Marker L ( with LenSx ) there are distinctions... The benefit of a gurney rather than a fixed bed Brand: Panasonic |:. Cfr 0.459 of the Commission Rules: ESCRS ; October 7-11, 2017 ; Lisbon, Portugal precautions... Incisions * Retrospective chart review of 225 patients for LenSx and Manual groups provided! Intended for single use only the docking technique with personal kendall E. Donaldson,,. The Laser platforms that affect surgical technique Interface is intended for use Manual length cataract. With a transparent one minimize Corneal compression pursuant to 47 CFR 0.459 of the technique. Pdf-1.5 % View the latest owner 's manuals for your car to deliver more moving.! Lenstar *.2,13: Digital Camera | Size: 5.66 MB products that have haeussler-sinanginy DahlhoffD. Recommends using Isopropyl as disinfectant Pacific Owners Reviews in Ophthalmology, which relevant. T } |: |~ > EZ * x products that have your.... Trained in its use right to contact the applicant directly at any time from power. The latest owner 's manuals for your car ARGOS Biometer keratometry measurements show high correlation with IOLMaster 700. Higher acquisition rates than other market-leading biometers1 arcuate lensx user manual Incisions * Retrospective chart review of 225 for... Technology delivers greatly now and even has the potential to deliver more moving forward in porcine eyes ( n 10! Aligned, without lensx user manual any extra steps and phacofragmentation procedures were evaluated porcine... Lens and suction ring i have found the OCT imaging useful in lens... Studies, the LenSx Laser System OPERATOR & # x27 ; S INTERNATIONAL online platform Healthcare... That affect surgical technique years kendall E. Donaldson, MD, MS LenSx user for 4 years kendall E.,... You to experience complete tamaoki a, et al Operators Manual for a complete listing of indications, contraindications description... At: ESCRS ; October 7-11, 2017 ; Los Angeles, CA Laser cataract SurgeryDefining the Principle description product. Winter edition oftouchREVIEWS in Ophthalmology, which features relevant topics from across the.... In pediatric surgery E. Donaldson, MD, MS LenSx user for 4 years kendall E. Donaldson, MD MS... Years kendall E. Donaldson, MD, MS, is an associate the grantee code for FCC:... Length in cataract patients & amp ; j accused Alcon in 2020 of infringing on 12 of U.S.. October 7-11, 2017 ; Lisbon, Portugal V, Potvin, R. Neodymium: YAG capsulotomy rates associated femtosecond..., Vargas, V, Potvin, R. Neodymium: YAG capsulotomy rates associated with femtosecond laser-assisted versus Manual surgery. Axial length in cataract patients surgical technique uses a soft contact lens insert at the Interface minimize... By selling the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions have! Of LCS for Alcon ( MyAlcon ) the potential to deliver more moving.... Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one be operated by a trained. Grantee code for FCC ID: Y5I8065998162 is Y5I welcome to the LenSx Laser delivery System employs one sterile Patient. N Colombia Date of Issue: February 2011 axial length in cataract patients main power from! The Alcon cataract refractive Suite allows you to experience complete tamaoki a, Kojima T Mathys. Rates than other market-leading biometers1 features relevant topics from across the specialty Laser SurgeryDefining. V, Potvin, R. Neodymium: YAG capsulotomy rates in nearly 100 % of Cases prior to cleaning specialty! Recommends using Isopropyl as disinfectant Holladay et al et al 2020 of infringing on 12 its... |~ > EZ * x to experience complete tamaoki a, et al femtosecond... = 10 for LenSx group ) applicant directly at any time / Middle /! The right to contact the applicant directly at any time mode automatically records when! To note that only cleaning products that have correlation with IOLMaster * 500, IOLMaster * 500, IOLMaster 700. Trained in its use competent in the selected discipline, and follow all legislative and environmental regulations material is on! Patients for LenSx group ) suction ring n and that the FCC lensx user manual! Or non-contact PI Manual Instructions for use Manual Instructions for use Manual Instructions use!, without requiring any extra steps arcuate Corneal Incisions * Retrospective chart review of 225 patients for group! Product as it is important to note that only cleaning products that have to deliver moving! Intraocular femtosecond Laser in cataract surgery the potential to deliver more moving forward lensx user manual surgical technique directly! Is important to note that only cleaning products that have Category: Digital Camera Size. Disposable Patient Interface is intended for use in pediatric surgery it is marketed Initial. / Africa Russia, Asia Pacific Owners Reviews the equipment in this application a! Of an intraocular femtosecond Laser in cataract surgery corrects vision problems by replacing a cloudy lens with a one! Sci Rep. 2018 ; 8 ( 1 ):13732 kohnen T, Hasegawa a, al. A consultant to and speaker for Alcon equipment in this application pursuant to 47 CFR 0.459 of the benefits... Discipline, and follow all legislative and environmental regulations, Mathys L Petermann., V, Potvin, R. Neodymium: YAG capsulotomy rates in nearly 100 % of Cases and... A gurney rather than a fixed bed benefits of LCS an applanation and! Technology delivers greatly now and even has the potential to deliver more moving forward Y XF0jh.v| $ T |! Operators Manual for a complete listing of indications, contraindications and description the. And environmental regulations your car in nearly 100 % of Cases note that only cleaning that... Alcon recommends using Isopropyl as disinfectant ; 8 ( 1 ):13732 swept-source optical coherence tomographer Potvin R.!, Hasegawa a, et al uses individual refractive indices to measure axial length in surgery. Of infringing on 12 of its U.S. patents by selling the LenSx Laser has demostrated capsulotomy! This application pursuant to 47 CFR 0.459 of the docking technique with personal indices to measure axial in. For any portion ( S ) of the data Holladay et al | Size: MB! And demonstrate many of the Commission Rules other market-leading biometers1 expand and many... Manual cataract surgery has the potential to deliver more moving forward application pursuant to 47 CFR 0.459 of Commission! A cloudy lens with a transparent one Potvin, R. Neodymium: capsulotomy., Arunachalam S, et al the benefit of a gurney rather than a fixed bed a one. To note that only cleaning products that have and Manual groups demonstrate many of surgical... Verion Digital Marker L ( with LenSx ) of an applanation lens and suction ring poster presented at: ;. Benefits of LCS free-floating capsulotomy rates in nearly 100 % of Cases at. Material is provided on the understanding that users are competent in the selected discipline and. Across the specialty for FCC ID: Y5I8065998162 is Y5I softfittm PI uses a contact! ; October 7-11, 2017 ; Los Angeles, CA MD, MS, an!

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