Hong Kong specified in this application, (2) compliance statement labeling pursuant to the Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. 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 applicable rules, and (3) compliance of the equipment with the applicable technical rules. Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. 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. The Patient Interface is intended for single use only. 2019 ASCRS ASOA Annual Meeting. View the latest owner's manuals for your car. Evaluation and comparison of the new swept source OCT-based IOLMaster 700 with the IOLMaster 500. Jan 15, 2021. * Requires VERION Digital Marker L (with LenSx, The Alcon Cataract Refractive Suite allows you to experience complete. I confirm that: 0000089128 00000 n
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k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP If you are unable to find your user manual, follow our step-by-step instructions below: Please note: Not all devices and appliances have a digital user manual available online. Nikon AF-S Zoom-Nikkor Instruction Manual. 2017;43:480485. ATTENTION: Refer to the ARGOS User Manual for a complete description of proper use and maintenance, optical and technical specifications, as well as a complete list of warnings and precautions. To request a consultation, click here: http://goo.gl/AvJ4aa Kerry Solomon, MD1101 Clarity RdMt Pleasant, SC 29464(843) 881-3937 That could rise more than two-fold to $744 million, provided sales . Ophthalmic Res. described a lens fragmentation technique creating concentric circles before aspiration in eyes with posterior polar cataracts.27 Conventional hydrodelineation, referenced in that study, includes a risk for inadvertent cortical cleaving that does not present when using the femtosecond laser. 2016;11(3):e0152088. Overall, published data demonstrate improved incision quality and less endothelial cell loss during cataract surgeries when the LenSxLaser is used. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. Pages: 34. HVoF~7/t|:/ @c]f{H:c R[)d#eG#yyZUl^IM~"[,ZE@I.2*l6oPz8@RU,$dH4|~e
_OC.0#e ]ED']S;Fyei"/2I"_e3TkJ,T*DiKu#c%fOA!IEK]*C Reduction of ultrasound energy has been associated with a reduced risk for lens capsule complications and corneal endothelial injury.5,2022 In a study on ex vivo porcine eyes, phacoemulsification with femtosecond laser phacofragmentation resulted in significant reductions in phacoemulsification power and time (51 and 43%, respectively) compared with phacoemulsification alone (p0.001 for both comparisons).5 In the same study, these procedures were performed in an initial series of nine patients undergoing cataract surgery. 2014;40(3):510. 2016;42:14701476. Select below for other countries. 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. United Kingdom - English, Americas 0000002575 00000 n
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and nurses, 15+ years of clinical/surgical experience, All CAS undergo rigorous training each year to The information below is intended to provide guidance on cleaning and disinfection for LenSx Laser System. The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. Optical Radiation - This device is equipped with a Class 1 laser light source. 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. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). 13. Rayon / Hemp. Were committed to providing service and repair information in accordance with EU guidelines. hb``a``x
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VERION Reference Unit User Manual Part II. "H Djd3X$v H(q If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? 2016;100:1201-1205. The LenSx laser uses a curved contact lens which is integrated with a sterile limbal suction ring (SoftFit PI). The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. Get ready to discover the ARGOS Biometer the smart planning solution. Sci Rep. 2018;8(1):13732. 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. 66 0 obj
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In this side-by-side video comparison video, Dr. Robert Weinstock highlights the evolved efficiencies of the LENSAR Laser System and the key differences between procedures performed with the LENSAR Laser versus the LenSx Laser, from patient data entry to toric IOL implantation. found laser CCIs improved relative to manual CCIs, as measured by endothelial and epithelial gaping and misalignment. Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. 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. China 2018;13(12):e0209356. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. 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. however, the applicant remains responsible for all statements in this application. Wed love to hear your feedback on this activity. h[o9ylUE*R`7yY2sa B`g|~
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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. Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. LENSX LASER SYSTEM OPERATOR'S MANUAL. endstream
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1. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. Request Quote. Holladay et al. In 2015, there were approximately 900 million individuals older than 60 years worldwide and about 20 million cataract surgeries performed annually.1,2, These demographic factors exist against a backdrop of heightened patient expectations for refractive results from cataract surgery. Chan T, et al. definition of a "party" for these purposes. The growing body of evidence on the use of LCS is consistently showing certain advantages over manual techniques, while noting differences among the platforms.6,7,13,18,19,32,36,41 Reported complication rates are low and may be platform-related rather than category-dependent. J&J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to Alcon in Europe. VERION Digital Marker 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. 2019;19:7. See 47 CFR 1.2002(b) for the Click to search Enter search text. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Alcon LenSx User Manuals User manual instruction guides for Alcon LenSx devices. Ophthalmology. BUY A NEW CAR ONLINE. AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. (U.S. CODE, TITLE 47, SECTION 503). See Prices; Nikon Camera Lens 17-35mm. 5 - Manejo de las complicaciones. Sci Rep. 2018;8(1):13732. Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. 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 Uruguay 2. Whang W, Yoo Y, Kang M, et al. Value in Health. 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. Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. The ARGOS Biometer is faster than other market-leading biometers.1-5 With a biometric data capture time of less than1second and a higher scanning speed, 50% faster than IOLMaster* 700, the ARGOS Biometer allows for enhanced efficiency and accuracy of eye measurements.1,9. Shajari M, et al. hbbd```b``"'@$=da1`v3I`eq +XVDJ8m"`qM)sA
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Aperio ImageScope DX. 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. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. International Journal of Open Access Ophthalmology. These are not permanent solutions. 16. reported significantly worse corrected distance visual acuity at one month in eyes operated with manual versus laser techniques, which they attributed to the possible inducement of higher-order aberrations secondary to lens tilt in the manual group that could not be corrected with spectacles.13 The authors noted 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. VERION Digital Marker M User Manual. Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). Electrified. Shammas HJ, Ortiz S, Shammas MC, et al. ^>{.4Ke- Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? Toric Lenses with Manual Marking. Show all Leica Laboratory Equipment manuals. Alcon says the LenSx SoftFit Patient Interface delivers: Compared to IOLMaster* 700 (1,4), IOLMaster* 500 (2,3), LENSTAR* LS900 (2). integration for intelligent planning and empowered execution with excellent Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. LenSx Laser Important Product Information. contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? John Davidson, MD, received compensation from Alcon for his contributions to this Femtosecond laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy and effectiveness, with no operative complications. Trademarks are the property of their respective owners. Peru With online access at any time, you can find the information that you need when you need it most. The degree of precision, control, and reproducibility of laser arcuate incisions cannot be matched with manual techniques. 2019;19:1-13. 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. 0
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. This non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. Phacoemulsification energy, a potential source of postoperative inflammation that can manifest as iritis, corneal edema, increased cell and flare, and hyperalgesia or pain, is reduced with LCS.5,20,21,34,39 It has been suggested that LCS may be advantageous as it may help mitigate the physiologic changes (including anterior segment inflammation as measured via laser flare photometer).34, Surgical Efficiency The LenSx Laser typically performs a surgical time under two minutes (direct suction time). J Cataract Refract Surg. Mexico hb``g``01G830220 eFWFk|:yv_-VMfa`) w
stay up-to-date with equipment certification They can be under the "exhibits" tab below. Smart Clock CD-24501F Manual. `eoo (B?A This platform is intended to provide general product information for education and illustration purposes. Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. In accepting a Grant of Equipment Authorization as a result of the representations made in this The company says the new interface uses a proprietary soft contact lens technology designed to enable the natural curvature of the cornea to conform to a soft contact lens insert, allowing a secure and gentle fit to a patient's eye while minimizing corneal distortion. The ARGOS Biometer utilises SS-OCT-enhanced keratometry with angle-to-angle, cornea-to-retina, real-time OCT guidance, allowing the user to monitor patient alignment and fixation and helping acquisition of accurate measurements every time.2,13, Correlation of keratometry measurements between ARGOS Biometer and competitor biometers2,13. precision at every step. The LenSx Laser System should only be operated by a physician trained in its use. ManualsLib has more than 563 Lexus manuals. SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. Accuracy of predicting refractive outcomes using swept-source optical coherence tomography in nuclear cataracts. 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. Colombia 862 because of a conviction Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. This page is available in English. All CAS are classified by their surgical skillset and Colombia It is not intended to provide information to the general public or medical advice. 0000093732 00000 n
1. Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. authorization which includes information to enable the agent to respond to the above section You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). Alcon sponsored the publication of this promotional piece. Comparison of the refractive outcomes in patients with dense nuclear cataract between the ARGOS Biometer and IOLMaster* 70012. Roberts T V, et al. The LenSx Laser also has the ability to produce cylinder and grid/cube patterns that can be widely customized. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements The PI design is a critical differentiating factor in the various platforms. q7WRz#]2vn^-,\_+D\qH~.Qo_ manuals. LenSx empowers efficient treatment for a variety of lens densities9 and significantly reduces phaco time and energy14. It helps us to continually improve our products. Caution: Data accurate at time of publishing, latest test results . Precisely execute, Plan arcuate incision using the nomogram integrated into the Vision Planner or personal nomograms added to the planner software, Import surgical plans from the Vision Planner via USB, LAN (Local Area Network) or SMARTCataract to reduce the risk of transcription errors, Ensure precision of arcuate location with image-guided registration to the pre-op image. The microadhesions that were demonstrated in three cases in the LenSx group did not lead to intraoperative or postoperative complications. Generational improvements in software and hardware have already produced additional laser patterns, auto pre-positioning, speed and improvements in the PI, the latter of which confers greater control of the globe and more precise laser delivery. J Cataract Refract Surg. 2017. Other systems may take more total suction time, depending on both platform and programmed degree of lens softening.19,40 Of the LCS platforms, only LenSx Laser offers a single-piece PI without the need for water. 0000016974 00000 n
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