constellation VISION SYSTEM OPERATOR'S MANUAL Manufacturer: Alcon Laboratories, Ine. 6201 South Freeway Fort Worth, Texas 76134-2099 USA. Produced By: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618-3818 USA, Telephone: 949/753-1393 800/832-7827 FAX: 949/753-6614 8065752231 Rev. K, CATALOG NUMBER 905-2120.003 Rev. C, TEXT ONLY ‘Alcon Laboratories (UK) Ltd. Frimley Business Park Frimley, Camberley Surrey, GUI6 7SR, United Kingdom CE= Directive 93/42/EEC. ©2012, 2013 NovartisConsteliatior* Vision System Constellation Vision System Operator's Manual 8065752231 MANUAL REVISION RECORD DATE | REVISION ECN NUMBER AND DESCRIPTION ( (05/2012 H__[ECN 20120708 - initial Release for REL 3.00.22. aoeanie y | ECN20121420- Updated title page with new EU Representative address. Setup Guide added to manual assembly. Pages affected: i and i arogi2013 x __ | EGN 20130860 - ECN clarified the disposition of previous ECN only. No content| change. Pages affected: i and i, Revision Letters not used: A through G, | ‘™* Registered U.S. Patent & Trademark Office + ISPAN trademark of Ai iquide America Specialty Gases LLC * MIELE trademark of Miele & Cie. KG * HEINE trademark of Heine Optotechnik GmbH ( * ZEISS trademark of Carl Zeiss AG Corporation * MICROSOFT trademark of Microsoft Corporation {8065752231Constellation® Vision Systom TABLE OF CONTENTS TOPIC PAGE # Manual Revision Record ii Foreword . oe eee ate at eeenet ere Important Notice. xii SECTION ONE - GENERAL INFORMATION Introduction : p Indications for Use... .. oar easter System Configurations ...... a 5 ie eeu 12 System Installation........6..eeseceseeeee 19 Source Pressure Requirements (Ait OF N,).esescceececesereeessseeeeteeerseees peveeeeee LY Accessory Equipment. 19 Environmental Issues . i 1.10 ‘User Information - Environmental Considerations 1.10 Universal Precautions. .. ae 1 EMC Statement v.see.ssceeeserseeeeeee ‘ 1a Equipment contains radio transmitters: 2.02.60 ceeecsee See 113 USA - Federal Communications Commission (FCC) Compliance Statement... 113 FCC Radiation Exposure Statement. eee raicienatiy eet Canada = Industry of Canada (IC) Compliance Statement «00... ,ssccccscecscesseeseveeeeeese LI Industry of Canada (IC) Radiation Exposure Statement . : Ge ecueaila Antenna Notices . Sree ei Exposure of Humans to RF Fields . : Bonne ee Got one erg Furope ~ R&TTE Directive 99/5/EC : ees Cercaton ad Compliance Marks or Compact USB WiFi “Adapter WLIUC -ONM. 115 Warnings and Cautions..........+.5 eat Las Diathermy, Cautery, Coagulation 123 Product Service, ....ess+cccseeessesesesseecee seeevesteetesesteeeeees ee eaties) Limited Watranty «2... sera eae eee oe luminator Professional User's Information:....... 0.2. et enen 1.29 Laser Professional User's Information: fag He beeseeeeeevreees 130 Laser Safety .......csce0eees SECTION TWO - DESCRIPTION Introduction Front Panel : : 7 Rear Panel Footswitch . fete Becerra eater ens Remote Control... eee saree sees 29 Front Panel Displays And Touchscreen . 212 Startup Screen. ose secseeeeeeeeseesseeessteee ceeesseeseseeerteeeraeeessseeereeees BAZ Main Seren... ee feet wee 2S Menu Bar ...... : Moan satiate ensue voriadd Menu Bar: Footswitch leon - wee Dd ‘Menu Bar: Doctor Selection . ais) ‘Menu Bar: Help (2) Buton .......500cceeeecsssseeseesssssseeessesseteeseneseesecs «25 ‘Menu Bar: Procedure Selection......... : eet gueea 15) ‘Menu Bar: Opting ste sse rete eet tera eee vee 28, Menu Bar: Options - DOCTOR SETTINGS... 0... ccscscsess 2.18 ‘Menu Bar: Options - DOCTOR SETTINGS - GENERAL. 2219 Menu Bar: Options - DOCTOR SETTINGS ‘8086752201Constetlation® Vision System TABLE OF CONTENTS TOPIC PAGE# | Demo Mode i‘ bene 2.133 Probes and Handpieces. . 2.137 ‘The Constellation® Cassette a ve 2d Consumable Pack Configurati woes 2146 SECTION THREE - OPERATING INSTRUCTIONS Introduction... eee eee Power Up Sequence ........ Positioning The Instrument Tray - Connecting The Constellation® Vision System To A Facility Pressure Source Installation And Replacement Of Ispan* Gas Bottles Connecting A Parepoint Laser‘To ‘The Constellation® Vision System In “Tethered” Mode Video Overlay... ea Constellation® Procedure Pack . 3d 13.0 3.14 SECTION FOUR - CARE AND MAINTENANCE Introduction ae Cate And Cleaning . Upon Completion Of The Procedure Sterilization Instructions. Disposal Of Xenon Lamps Replacement Of Remote Control Batteries Laser Maintenance . ... Setting ‘The Calibration Factor (Terminal Efficiencies) Laser Calibration... SECTION FIVE - TROUBLESHOOTING System Messages System Fault Messages ee System Error Messages ......... System Advisory Messages Power Lost/Recovery ...... ‘System Information Messages . Event Log... SECTION SIX - ACCESSORIES AND PARTS. Constellation’? Vision System Accessories ...... ae 6.1 Alcon Purepoinf® Laser Indirect Ophthalmoscope (Lio) ......... i 69 BECTION SEVEN = INDEX fosters ajrtieann eterna aa Td "2085752251Constellaton® Vision System LIST OF ILLUSTRA’ FIGURE# TITLE PAGE# Figure 1-1 ‘The Constellation? Vision System. Seer Figure 1-2. Labels Used On The Constellation® Vision System... .....c.ccscscsevsvsesessseesel® Figure 1-3 loons Used With The Constellation? Vision System... s,s... ssssssvevsss 18 Figure 1-4 Diathermy Power Through 75 Ohm Load .......066cc00csecereeeesssseeseeeees D3 Figure 1-5 Diathermy Power vs. Load Impedance . Seat eaate 124 Figure 1-6 Diathermy Output Voltage vs. Output Control Setting... ee 1.24 Figure 1-7 Remote Connectot/Door Lamp Circuit Diagram. 131 Figure 2-1 The Constellation® Vision System Console Output Connectors. Figure 2-2 ‘The Constellation® Vision System Reat Panel ........26.50005 Figure 2-3 The Constellation? Vision System Footswitch : Figure 2-4 The Constellation? Vision System Remote Control ......... Figure 25 Remote Control Channel Selection Screen (Options\System\Remote Conteol tab)... 2.11 Figure 2-6 ‘The Startup Sereen i i Figure 2-7 The Main Screen... Figure 2-8 ‘The Main Sereen Menu Bar. Figure 2-9 Procedure Modify Sereen. Figure 2-10 The Doctor Settings Popup-General Tab . Figure 2-11 ‘The Doctor Settings Popup-Surgical/Inf/irr Tab ........ Figure 2-12 The Doctor Settings Popup-Surgical/Reflux Tab. .. Figure 2-13 ‘The Doctor Settings Popup-Surgical/General Tab Figure 2-14 Doctor Settings - Footswitch Buttons Screen : .... Figure 2-15 Footswitch Action Selection Popap . fee Figure 2-16 Doctor Settings - Footswitch Treadle Screen ... Figure 2-17 Doctor Settings - Laser Screen Figure 2-18 Doctor Settings - Sound Screen Figure 2-19 System Settings - Settings Screen . ure 2-20 System Settings - Connection Screen. 3 Figure 2-21 System Settings - Standard Definition Video Overlay Screen 233 Figure 2-22 System Settings - High Definition Video Overlay Screen .. 234 Figure 2-23 Auto Gas Fill Popup ..... : a Figure 2-24 _View/Copy/Delete Sereen ..... Figure 2-25 Sample View of a Doctor Settings Regot Figure 2-26 Event LOg .....cssssesevseee Figure 227 "About Constellation* Figure 2-28 Infusion Global Control Figure 2-29 FAX Global Control... Figure 2-30 Irrigation Global Control te Figure 2-31 Diathermy Global Control .......... Figure 2-32 Illuminator Global Control. . Figure 2-33 The System State Arca of the Main Screen « Figure 2-34 The Fluidics Setup Panels ...... Figure 2-35 The Probe Setup Panel... ..000.005 Figure 2:36 The Handpiece Setup Panel ........... Figure 2.37 The Accessories Setup Panel .... Figure 2-38 ‘The Illuminator Setup Panel. ...... Figure 239 The Lasers Setup Panel Figure 2-40 ‘The Status Setup Panel Figure 2-41 The Detailed Fluidie Setup Pancl. . Figure 2-42 The Detailed Probe Setup Panel. . Figure 2-43 The Detailed Handpiece Setup Panel 065762231Constellation® Vision System LIST OF ILLUSTRATIONS FIGURE # TITLE Figure 2-44 The Detailed Accessory Setup Panel Figure 2-45 ‘The Detailed Illuminator Setup Panel ........... Figure 2-46 ‘The Detailed Laser Setup Panel ‘ Figure 2-47 The Priming Tray Set Up Sereen ....... s Figure 2-48 Video Help Popups. Serie Figure 2-49 Prime & Test Status Bar Variations Figure 2-50 Consumables Popup... .. Seas Figure 2-51 ‘The Surgery Panel . Figure 2-52 Timer Configuration Popup Sere i Figure 2-53 Vacuum Control and More Information Popup ....-0.s.s.s.ssssse Figure 2-54 Surgical Control Option. Figure 2-55 Surgical Control with Dropdown List (Advanced ‘is Mode) « Figure 2-56 Aceurus® Classic Surgery Screen . : Figure 2-57 Surgical Step Panel - Custom Procedure... igure 2-58 Surgical Step Panel Scroll Buttons. .......... Figure 2-59 Standard versus Advanced Display Modes i Figure 2-60 Surgery Screen: Vitrectomy Mode - 3D Submode. . . ee Figure 2-61 Surgery Screen: Vitrectomy Mode-Momentary Submode.... Figure 2-62 Surgery Screen: Vitrectomy Mode-PropVac Submode . Pigure 2-61 Surgery Screen: Vitrectomy Mode-WetAnt Submode........ Figure 2-64 Surgery Screen: Vitrectomy Mode-VitDry Submode . Figure 2-65 Smart Pulse Indication. ae Figure 2-66 Surgery Screen: Phaco Mode-3D Submode. . Figure 2-67 Surgery Screen: Phaco Mode - 3D Submode- OZif® 3D... Figure 2-68 Surgery Screen: Phaco Mode - Burst Submode ieee Figure 2-69 Surgery Screen: Phaco Mode: Burst Submode - OZi Burst Figure 2-70 Surgery Screen: Phaco Mode - Custom Submode po Figure 2-71 Surgery Screen: Phaco Mode - Custom Submode - Zi? Custom Pulse... Figure 2-72 Surgery Screen: Phaco Mode - Pulsed Submode..........4..+ a Figure 2-73 Surgery Screen: Phaco Mode - Pulsed Submode OZif® Pulse Figure 2-74 Surgery Screen: Phaco Mode - Continuous Submode . Figure 2-75 Surgery Screen: Phaco Made - Continuous Submode - OZi1® Continuous Figure 2-76 Surgery Screen: Fragmentation Mode - 3D Submode . Figure 2-77 Surgery Screen: Fragmentation Mode - Fixed Submode......... 02.4. Figure 2-78 Surgery Screen: Fragmentation Mode - Linear Submode «0.0... Figure 2-79 Surgery Screen: Fragmentation Mode - Momentary Submode Figure 2-80 Surgery Screen: Irrigation/Aspiration Mode ....... Figure 2-81 Surgery Screen: Extrusion Mode : Figure 2-82 Surgery Screen: Laser Mode... 0... .ecceese Figure 2-83 Surgery Screen: Forceps Mode Figure 2-84 Surgery Screen: Scissors Mode - MultiCut Figure 2-85 Surgery Screen: Scissors Mode - Proportional. . Figure 2-86 Surgery Screen: VPC Mode - Extract Submode Figure 2-87 Surgery Screen: VEC Mode - Injection Submode End Case Screen: Anterior Tab... 0.0. .cccecseseeeeeeraee Figure 2-89 End Case: Setup Form Sereen Figure 2-90 Demo Mode Setup Screen . Figure 2-91 Demo Mode Main Screen : Figure 2-92 Footswitch Simulator Screens . Figure 293 Footswitch Simulator Treadle Depression a 13065752231Constollation* Vision Systom LIST OF ILLUSTRATIONS FIGURE # TITLE Figure 2-94 Laser Footswitch Simulator Figure 2.95 UltraVif® 20 GA Probe. Figure 2-96 Pneumatic Handle ‘ Figure 2-97 Fragmentation Handpiece. ..... Figure 2-98 Infiniti? Ultrasonic (U/S) Handpiece. Figure 2-99 OZiP* Torsional Handpiece . Figure 2-100 TurboSonies® Tips. i Figure 2-101 Infiniti® U/S Handpiece shown with Infusion Sleeve and Bubble Suppression Insert Figure 2-102 Ultraffow® I handpiece and tips Figure 2-103 Ultralow* I handpiece with infusion sleeve, reusable VA tip, and threaded tip attr 2.143 Figure 2-104 Ultraflow® O-ring tool with large and small O-rings. sate 2.143 Figure 2-105 Ultraflow® SP handpiece (handpiece shown with 3 mm 45° “) 2.143 Figure 2-106 Single use bipolar brush 5 cee 2d Figure 2-107 The Constellation® Combined Cassete 2.145 Figure 3-1. Positioning the Instrument Tray... Figure 3-2 Storing the Instrument Tray Figure3-3._Pressure Hose Configuration for Facility with an Air Pressure Source Figure 3-4 Connecting the Regulator to the ISPAN* Gas Bottle. .. Figure 3-5 Installed ISPAN* Gas Bottles 22.00... 000.00 Figure 3.6 Standard Video Overlay Screen... Figue 3-7 Standard Definition Video Overlay Connection Diagram»... Figure3-8 High Definition Video Overlay Screen Figure 39 High Definition Video Overlay Connection Diagram Piensa Figure4-1, Remote Control Battery Replacement . . Figure 5-1 System Fault Display Screen . Figure 5-2 System Error Popup Window. . Figure 5-3. System Advisory Popup Window. Figure 5-4 System Information Popup Window Figure 5-5 Power Lost and Power Recovered Screens Figure 5-10 The Event Log... Figure 5-11 Troubleshooting Guide Figure 6-1 ‘The PurePoint* Laser Indirect Cphtatmoscope, Pores Figure 6-2 PurePoint® LIO Labeling eee ates Figure 6-3. Adjusting the PurePoint® LIO Overband Figure 6-4 PurePoint® L1O Controls and Adjustments. ae Figure 6-5 Byecup Retainers and Ocular Lens on the PurePoin® LIO ........s.c.c. Figure 6-6 PurePoint® 1,10 Bulb Replacement : ce ‘3085752281Consietlation® Vision Systom LIST OF TABLES TABLE # TITLE PAGE # Table 1-1 System Configurations : tester seers Table 1-2 Constellation® Vision System Specifications... ....c.scccsvsseeseseveseeeesesd 3 Table 1-3 Terms And Abbreviations. As ‘Table I-4 Information on the Lacation of Hazardons Substances in the C 1.10 Table 1-5 Guidance and Manufacturer's Declaration - Electromagnetic Emissions . aT Table 1-6 Guidance and Manufacturer's Declaration - Electromagnetic Immunity... .. ol2 Table 1-7 Recommended Separation Distances Between Portable and Mobile RE ‘Communications Equipment and the Constellation® Vision System 13 Default Footswitch Button Actions . ote see ‘Surgical Modes And Submodes . ‘ Setanta rads MicroSmooth® Infusion Sleeves .........00.e cee. 2.141 Consumable Pack Contents . Se ate aaa aist oA: Initial System Setup : 32 ‘Table 4-1 Laser Energy Matrix for Calibration Ve 4g Table 6-1 General Accessories : Table 6-2 General Consumables. ....... Table 6-3 Laser Accessories and Consumables . ee Table 6-4 Posterior Segment Accessories ........ Table 6-5 Anterior Segment Accessories . Se ee ce Table 6-6 PurePoint® L1O Technical Specifications '8085752231Constotiaion® Vision System FOREWORD ‘This Operator's Manual is designed to acquaint the operator and operating room personnel with the Constellation? Vision System. ‘The manual presents an organized summary of the operating principles, main components, safety features, and instructions for care and use of the instrument. ‘The information in this manual should be supplemented with reference works on laser theory and the interaction of laser energy with biologic tissues. No attempt is made in this manuall to answer all the questions that arise during the use of the instrument in medical procedures. Questions concerning technique, safety and effectiveness should be referred to pertinent publications of recognized medical experts in laser surgery. Physicians should not attempt to treat patients with this instrument if not thoroughly familiar with its operation, or if in doubt as to its safe operation, AI personnel authorized to use this instrument should be required to be thoroughly familiar with this manual. Please contact Alcon for complete technical support and service if you have questions concerning any aspect of this instrument's operation or if it fails to perform satisfactorily. To order supplies in U.S.A. 800-862-5266 FAX: 800-241-0677 Outside U.S.A.: Contact your local Alcon representative for supplies. 13085752281Consteliotion® Vision System IMPORTANT NOTICE Equipment improvement is an on-going process and, as such, changes may be made to the equipment afier this manual is printed. Pay close attention to WARNINGS and CAUTIONS in this manual, WARNINGS are written to protect individuals from bodily harm. CAUTIONS are written to protect the instrument from damage. Mlustrations contained in this manual are for reference only, It is recommended that maintenance be performed by qualified Alcon Field Personnel. Alcon Surgical shall not be liable for any damage resulting from failure to comply with the enclosed instructions. ‘Alcon reserves the right to change specifications without further notice Operator Profile The Constellarion® Vision System is designed to be operated by two basic groups; surgeons and nurses/scrub techs. The surgeon focus is primarily constrained to the footswitch and display panel, ‘The design of the footswitch allows the surgcon to map any function to any switch position, assuming, the function is valid in a particular scenario. ‘The display sereen was designed to mount on an articulating arm to allow optimum placement of the display so the surgeon ean reference it at any time, The design also incorporates items specifically for nurses and scrub technicians, who routinely control the machine via the front panel and remote control. The design incorporates color coding on all connectors and tubing to facilitate easy identification of the ports. In addition, the graphical user interface closely resembles controls commonly found on web sites, which this operator profile is expected to be highly proficient at using. CAUTION U.S. Federal Law restricts this device to sale by or on the ordor of a physi WARNINGS! For systems containing the optional laser module: Use of controls or adjustments, or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. A qualified technician must perform a visual inspection of the following components every twelve months. In case of a deficiency, do not use the system; call Alcon Technical Services. - Warning Labels = Power Cord - Fuses ‘A qualified technician must check ground continuity and both polarities for leakage current every twelve months to ensure they are within the applicable standard (for ‘example: IEC 60601-1). Values must be recorded, and if they are above the applicable standard, or 50% above your first measurement, do not use the system; call Alcon Technical Services. Use of accessories and cables other than those provided may result in increased emissions or decreased immunity of the system. Portable and mobile RF ( communications equipment can affect this medical electrical equipment. '9065752231Constellation? Vision System If you have questions, or want additional information, please contaet your local Alcon representative or the Alcon Technical Services Department at: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618 (949) 753-1393 FAX (049) 753-6614 All rights reserved. No part of this manual may be reproduced, transmitted, or stored in a retrieval system, in any form or by any means; photocopying, electronic, mechanical, recording, ot otherwise: without prior written permission from Alcon Laboratories, Ine. ‘3065752281 xConstellation? Vision System ‘THIS PAGE INTENTIONALLY BLANK xv LAST PAGE OF THIS SECTION (8085752231Constellation Vision System SECTION ONE GENERAL INFORMATION Introduction Figure 1-1 8065762281 ‘The Constellation® Vision System is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The product’s capabilities include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding, Vacuum is used to remove ocular matter from the eye and is provided by connecting tubing from the handpiece to a port on the fluidics cassette. Irrigation/infusion capability is provided to replace fluid in the eye, and enters the eye directly through either an infusion cannula or a handpiece. The graphical operator interface is menu driven. The operator provides inputs using the touchscreen panel, the remote control, and the footswitch. An optional, fully integrated laser module is available that can be installed in the base. The laser delivers a visible 532 nm green treatment beam designed for ophthalmic use. “Table Top luminator Handpiece, Probe, and Accessory. Connector Panel \ Tray Arm Assembly Base 1V Pole (future) Laser Module The Constellation® Vision System - The Constellation® Vision System is a multifunctional ‘surgical instrument used in anterior and posterior segment ophthalmic surgeries. 14Constelfation® Vision System Indications for Use ‘The Constellation® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (.e., vitreoretinal) ophthalmic surgery in addition ( to the indications included with the optional Next Generation Laser (see laser indications on page 1.29). System Configurations The Constellation® Vision System is designed with a modular approach that allows the system to be highly configurable to meet the needs of many users. ‘The system is designed around the Table Top where the accessories listed below can be added for expanded functionality, + Table Top + Base + Laser Module * Auxiliary Muminator + Tray Arm Assembly (includes ballast and support column) The Table Top can operate as a standalone unit (Configuration 1), and is also the primary user interface that operates and controls the add-on accessories. All add-on accessories attach to the Base therefore, at a minimum, the Base must be installed prior to any system level customization. The table below shows the nine possible ( configurations for the Constellation® Vision System, Part numbers and ordering information is located in Section Six of this manual. TABLE 1-1_ SYSTEM CONFIGURATIONS Te 6 x x x x x ( 12 8065752231Constollation® Vision System TABLE 1-2 CONSTELLATION® VISION SYSTEM SPECIFICATIONS frasiero° inns eat x wc xh 5 cr 29) x48 cm (9a) x64 cm At) vist et eg (198) ase Birerlon: 74cm (29) x74 es (293m) x97 em (in) viet ‘Be fo son} 52.2 kg (1 8) ‘as wth Mar 649 (28 1B} ‘ao wh Maran Las, 68.59 (142218) reavarua Dimersins: "ray. 96 em (229) x38.om (149) bm Pally Extend 127 em (0) Support Clu 0 em (4) x 136m (ih) x15 en GN) wish ‘Tray and fr: 18,7 kg (25.810) Sopp Colom: 545 (723) paLLasr Dimes: 35cm (14n) x35 om (14m) x5.0m in) Progr 2585 45 (66.2 B) Not: ¥ = base other than th options Alcon bags ied, must be able to hold upto 250 pound ENVIRONMENTAL LMITATIONS: ‘Opoming Non Doertna ati: wie 700m 26 t6s000"m (ide a2 1009 (4100 943 ee) Temperate: wwcisre \ ID Wsec GOFF (Fe tSt FD Relatve Humiaty: "10% 095% 10% tose wth ‘aout condeneaton ——_eondenaion CODE Console: x0 Foote x8 ELECTRICAL REQUIREMENTS: Tho console aso th along Fangs or pst commercial power oinges ar! qantas ine leakagecurents spsfesn EC 6USOT.T Protection agar acres osc Css s00-120Vae soot *2Amax. 220240 Vac S60 He BAe |zoorswurcss bavensions gang x wath x nla: Jas em¢t7injxa8en (10.251n)x 1 en (55in) weicHt stg (12 pounds) ENVIRONMENTAL: The fotswtehconsrton swale ohn complanee wen IEC 6060%-t andlec BOCUT-22, sues 4.8 a8, ELECTRICAL: The fowl carmocad io tha conc i occ sable Al owe and communications elo a Tether PEREORIMNDE SPECIIGATIONS 'PRESSURWZED INFUSIONIRRGATION @SEALEVEL: ange: Die 120 mt pecracy 2% of stpone 5 ret ow Rel: {02 cami for naion (20 Ga) 1: Bo cami. for gator Solpot Transint [500 mam {OP CONTROLLED INFUSION: ‘Setpoet Range 0-120 mg Ropes s2mniy ‘Satpont Response Tena: =s00™ms (20 Ga) ‘ansiet Datura Rosporae Tina 600 mss om aga: 20cm 1 B89 ngatng Suton Dual char modo £650 gating Solio dur, 20 gauge high fow Canna, ‘tend slate canon arated Now rang 2 ranset conan om no wes 1ocimin ASPIRATIONSUCTION @SEALEVEL: ‘Slondard & Reduced Pressure ange 1-350 mts Vacuum anima Presse Range: 0-800 me) Vac Pressure acurcy [Om of Sti #3 mmHg) Posto Nedaton 0.20 comin ete Moda! O50camn ‘raion Response Tine (SiaraardPresaure gos, From 01-400 ming @O cin {0.90% Re Te 300 ese mae (0.10% Fat to 300 meso max VACUUM @ SEALEVEL: "veto. 010 650 meng Fragrant: Ot 0 meng Exnaon 60 meng eran 60 meg InigatetAepatin: 010650 mt ‘Phacoemsetaon: 1 650 meg {LOW PRESSURE AR SOURCE (LPtS) QSHALEVEL: Pressure ange = 120 mimi trate tow Proseue Asay: Siectectpan 1S mm Flow Rte 412m umn 120 reg ‘Submodes: 30, Momentary, Props, Viet Gi ate ‘trae 1500 Probe $000 7500 eam Urabe 000 Probe $00 5000 cpm {ahae 200 Probe 400 2500 pm Diaries Frequency snes 10%, Wiaveshape: Sinusoit Oia power {Wats maximum a 100% sting ouput vote 13 Upp mantra at 100% sang sathot oa Power ange DO maximum out power DIATHERMY ACCESSORIES Ral Vein: ‘Seo Uso siolr Caio: 84 Vip. Rowsaho Botar Cobos: 1200 Yoo rashes ‘AtForeeps 1410 ee ato ve oes762231 13Constellation® Vision System TABLE 1-2 CONSTELLATION® VISION SYSTEM SPECIFICATIONS...continued PERFORMANCE SPECIFIGATIONS.contaued hk.unanarion: {Ugh Output rough 20GA er robo: 0200 es 16:6 mans abt setpant Soi ete tamane ‘15% cept ign Cut ough 290A For Probe! 0-20 hr 23. 13 mene [115% ct pit" 20400 he! 284 19 nen 4198 at pt Lug ouput trough PEGA itor Prot 0-200 hen 23:19 umone Sh8% Stoke stti9% at pot! "Bez a partite nonin UFR FRAGMENTATION ‘Stbmaars Une, Fea, Momentary “Tp Seats @ 100%: 3.16.5 at 100% power Reconant requoncy. aaeesowe Prue Fae Range 0" 0p scissors: ‘Stoo: Propatons aat:cut Proportona rossre 050 pt eat evel Ce Rate Sade eu ts 80 opm PROPORTIONAL AND CONTINUOUS REFLUX @SEALEVEL: Pressure Range" ‘ta 120 tg Prose Aeracy 312% of Setpit +8 rong) Mono ReFtU ‘rossre ange 1002 50 ment une: is: 10m" “anes wth occa 20 Ge aU robe set asain wore viscous Fuio CONTROL: ‘Sbmodos ject nuaet Injecson Prosar: Otog51 8 Pascal (0480 pap {@ Recueus (01670 pa) tet Vacuum ‘aon Lovo o1essomata AUTO GAS FLUNG AGE ‘rm Gee Peer: some FP 7-99 erent ri) {auTO STOPCOCK spore Te: 0 sainge mara Prana: oan mata ote Flow ui: acer Presa PAS) O20 nny ated iow (PRS) 2mm PHACOEMULSIFIGATION ‘Samoces ur Puls, Continous Th Stoke @ 100% Ssrosmie Feconant Frequency: Saosza ne Pao Fate Renae (0500 patet per socond Burt Leng 25 200 user afistao ‘ura Puls curators: Smsto 600me ozre: ‘Longin! Froguency 83.5.4 3.0 KHe Tonlnal Naguoncy. 20201 Pula Rat Range: 000 poe Longiudinl rst engl 6 500 mS Tana Bust Longin 210500 mS ANTE}8OR VITRECTONY: Submosas Wit, Oy cut Rates 0 probe maximum LASER (optona Gane! 4 Boner 2 pW to 2W (raxirum) Wavelength Siam ‘ming bea eine! 2 Bouse fexetman 1 mi Wovelang ‘essa sam DOCTOR MENORIES: Storage Copsey; No ard mi advisory dpayod when less an To% of ak space Ie rata, Tver: Ranga ote906:00 Reodfon 1s REMOTE CONTROL; ‘Method inhres Channel: : 14 ‘3065752231‘Constollation® Vision System TABLE 1-3 _ TERMS AND ABBREVIATIONS ‘Term or Abbreviation Description ‘ACMI connector | The type of connector used on fiber optic probes. AGE ‘Auto-Gas Filing BSS PLUS® Intraocular — | Store intraocular rigating solution enriched with bicarbonate, dextrose, and glutathione. Irrigating Sokution clin ‘Aunit of few. a “Amandatory conformiy mark on many products placed on the single market inthe European Economic Area (EEA) comHz0 ‘Centimeters of water. A unil of pressure. opm Cuts Per Minute ‘Mark fo Indicate hata product, process or service has been tested to @ Canadian or sa U.S. standard and it meets the requirements of an applicable CSA standard or another recognized document used as a basis for certification. nee ‘Adiscrate footpedal position al which more force Is required to depress the footpedal to the next position. Diathermy “The production of heat In body tissues by electric current for therapoutic purposes. Extrusion ‘Amode where vacuum is available to remove fuidimatter. FAK Fluid Air Exchange. Frag Fragmentation cA ‘Gauge eran ‘Atunton whose ats and contoi ae dependent fe cont ipa pation WA Irigallon/Aspiration uo InputiOutput OP, Intraocular Pressure TEC International Electromechanical Commission 150, International Standards Organization 1PxOre Intemational Protection code - Sold objects X (nol speciied) water 6/0 (continuous Immersionino test required) W Intravenous, Leb Liquid Crystal Display rng ‘ilimater of Mercury. Aunit of vacuum and pressure. nau ‘System configuration in which the Constelation® tabletop and base are paired together. NA ‘Not Applicable PEL, Patient Eye Level A diference in height between the cassotto and the patient oye level PIN Personal identification Number psi Pressure per Square Inch. A unit of pressure. ps Pulses Per Second RS-282 ‘A standard for serial binary data signals commonly used in computer serial pots. slom ‘Standard Liters Por Minute ype BF ‘Aclasefication for devices thal have conductive contact with the patient, or have applied parts that are fixed in medium or long term contact with the patient us Ultrasound USB: Universal Serial Bus VEC’ Viscous Fluid Control VGA Video Graphios Array Vi Vitrectomy. Extraction of the vireous from the vitreous cavity, 3065782291 15LABELING Labels (including silk-s Constelation® Vision System seened labels) and icons may vary according to the date of manufacture of your system. To determine which label and icon version shown in Figures 1-2 and 1-3 apply to your system, compare the figures with the Inbels on your system and make the appropriate selection. constellation VISION SYSTEM. constellation VISION SYSTEM Sinan’ Ce orem CED mama Ce DANGER: eronmree memes ‘ANGER: mpmvengnent nee Alcori mae | pee | | eee | © became | age) LE Cee map| in| MH OK LO Ceo Alcon erate ‘These labels applicable to Table Top # 8065751847 only. constellation constellation MISION SYSTEM VISION SYSTEM ousee mRErRRRDeETS Tm CED DNGERaemeerenonee SSRI COD = =| AA Fe ere Alcon ep AAS [Pa St | ox Pea 2 Figure 1-2 here for reference only. LABELS USED ON THE CONSTELLATION® VISION SYSTEM - Labels used on the system console are identified and illustrated 153081 03-107 kPa 16 13065762231Constollotion® Vision System @ consteliation roorswrcr iw [REF] 9065750977 1Pxe Alcor alistior} roorswics 1085750977 exe A © em Alcor Z\warnine ‘STORE TRAY PRIOR TO, STORE TRAY PRIOR TO ‘TRANSPORTATION TRANSPORTATION ‘ADIT CTO. FORIEATAND SATETACTOF oR COMPLES tiramcre iota wos cor ronconmtenerineuNe Soulsonss Nase 2, Figure 1-2 Continued from previous page. outta SEESiS3su0: Labels for gas containers ‘od. masevereucoemueTo mL uae sioNOS FE Poon comet ronfeniap ewer ir Gre COLES ‘imino om:ti wean oer rorcevarcne rc Touusernotcena seam ara 065782231 17Constellation® Vision System A Gas Fg D [roca Extsion oer) A [patna caren D frevswen 000 C > @ Foran CE/CED | Emanonte Tan cmecn 7 Gos | Senator i voce naa Emeroeney a Sra || @® [aves fit rr, roving cea j= | aay eta &. to North, ec A ferseataietie iaauiaeeaes ‘eqarements or IrigateniAspatn maeal doves. om ae bie RIS Amn Pn Pero Loser mark provi ettcaen to" Sf ee @ _—_| sav rerctin ro ‘eats or e @ co retake aa eee Snecion ie ‘Seisors ‘Connection ])__| Neniontzne a () | cs Viscous ZX | pereorous votoae eerous Vag oO. Jor ; nl : ‘Dangerous Vorage aes A |eeoRee 1 [om Yeow Beckton) ( pore Operator @ Viator Rover @ [Semcre | LB Jen @ | reasy @ lez . Whew Remote Dace | evpotnaty SE | ree Help Video Follow instructions: Perea Remote Intelock fe he sesaround) > eaten Ve | saeco const Powe Yo [row > [evan nee By |v CO) | siansay siete S A |aae" ned [ac seeorpenyng Gg) | srsomraut ach __[acou ‘Genoa War Ge omccl tn stem oration AL see | | O__[snene © | amngBean x typo BF swPmuue iurioator Plpment =D | tat Figure 1-3 ICONS USED WITH THE CONSTELLATION® VISION SYSTEM - Icons used with the system console are identified and illustrated here for reference only. ta (8065752231Constellation® Vision Syston US Handpiece eye ‘Video Out us ana cous Flt Ln Blea etce _[rosou Peace ee FPF | vito tn Video Recover toe Figure 4-3 Continued from previous page. System Installation In the USA contact the Alcon Technical Services Department for uncrating and installation at (800) 832-7827. Outside the USA contact your local Alcon affiliate. Source Pressure Requirements (Air or Nz) The Constellation® Vision System is designed to operate using clean filtered air or GN2 with different levels of source pressure. The system operates automatically with pressures of 58 (4 bar) to 120 psi (8.3 bar). NOTES: Between 4 bar and 5 bar, vacuum performance is reduced. Between 4 bar and 5.5 bar, VFC inject performance is reduced. Accessory Equipment Accessory equipment connected to or used with this equipment must be certified according to the respective IEC Standard (e.g. IBC 60601-1 for medical equipment). ‘The Constellation® Vision System is shipped with English and metric fittings compliant with EN ISO 5359, Anyone connecting additional equipment or otherwise causing a different system configuration than provided by Alcon is responsible for continued compliance to the requirements of System Standard IEC 60601-1-1 and EN ISO 5359. If in doubt, consult the Technical Services department or your local Alcon representative. WARNING! Any non-medical equipment (i.e., VCR, monitor, MP3 player, etc.) must be placed ‘outside the patient environment (at least 1.5 meters away from patient). 085752291 19Constettation® Vision System Environmental Issues Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. User Information - Environmental Considerations ‘The equipment that you have purchased requires the use of natural resources for its production and operation. This equipment may also contain hazardous substances which could have a potential effect on the environment and human health if disposed of improperly. In order to avoid the entry of any such substances into our environment, and to promote natural resource conservation, please install, maintain, and operate the ‘equipment in accordance with the instructions. Information on the location of hazardous substances, resource consumption and emissions of the equipment can be found throughout this Operator's Manual. Please use the appropriate take-buck systems. Such take-baek systems reuse or reeycle many of the materials in your end-of-life equipment in a beneficial way. Please contact your local Alcon office for assistance in take-back options through Alcon or other providers. ‘The crossed-bin symbol located on this equipment reminds you to use take-back systems, while also emphasizing the requirement to collect waste equipment separately, and not dispose of it as unsorted municipal waste. The Pb notation, if TP _ present, indicates that the labeled device contains greater than 0.004% lead. If you need more information on the collection, reuse or recycle systems available to you, please contact your local or regional waste administration, or contact your local Alcon office for more information, Table 1-4 Information on the Location of Hazardous Substances in the Constellation® Vision System - The Constellation® Vision System contains hazardous substances which could have potential effect on the environment and human health if disposed of improperly. Materlal Location Hazardous Substances Contained Printed Circult Board Assembly ‘Lead, Polybrominated Biphenyls (PBB) ‘Other Electrical / Electronic Device ‘Lead, Polybrominated Biphenyls (PBB) Cable Assembly Lead Power Supply Lead, Polybrominated Biphenyls (PBB) Host PC Module Lead, Polybrominated Biphenyls (PBB) Liquid Crystal Display Lead Battery Lithium, Zn/hinOz Remote Control Lead Fluidics Assembly Lead Pheumatic Assembly Lead 170 8065752081CConstoliation® Vision System Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials. In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled in accordance with OSHA guidelines. EMC Statement Table 1-5 It is important install and use the equipment in accordance with the instructions in order to prevent harmful interference with other devices in the vicinity. If this equipment causes harmful interference to other devices (determined by turning the equipment off and on), the user is encouraged to try to correct the interference by one or more of the following measures: Reotient or relocate the other device(s). ‘+ Increase the distance between the equipment. * Connect this equipment into an outlet on a circuit different from that to which the other device(s) is connected. * Consult the manufacturer or your Alcon representative for help. Guidance and Manufacturer's Declaration - Electromagnetic Emissions - ‘The Constellation® Vision System is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment. Emissions Test | Compliance ciromagnetic Environment Guidance RF omissions Group 1 | The Constollation® Vision System uses RF energy only for its intemal function. CISPR 11 ‘Therefore its RF omissions are veryow and are not ikely ocause anyinterference in nearby electronic equipment. RF emissions ‘Glass A | Based on extensive field experience the Constellation® Vision System is suitable CISPR 11 {or use in all establishments other than domestic and those directly connected Harmonie omissions | Class A] 10 the public low voltage power supply network that supplios buildings used for IEC 61000-3-2 omestic purposes. Voltage fuctuatins/ | Complies | the EMC Statement provides guidance on stops o take in case of electromagnetic Flicker emissions Interference. IEC 61000-3-3 ‘3085752281‘Constefation® Vision System Table 1-6 Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The Constellation® Vision System is intended for use in the electromagnetic environment specified below. The customer or the user of the Constelfation® Vision ‘System should assure that it is used in such an environment. ‘immunity Test | 1EC 60801 Test Level | Compliance Level | _Electromagnotlo Environment Guidance Electrostatic + #6 KV contact + 46V contact | Floors should be wood, concrete, or coramic tle. If discharge (ESD) | + 8 kV air +48 KV air floorsare covered wih synthetic material, therelative EC 61000-4-2 humidity should bo at least 30%, Eleciricalfast [+ 22kVforpower | #2KVforpower | Mains power qualily should be that of a typical transientiburst | supply lines ‘supply lines ‘commercial or hospital environment, To avold laser 1EC61000-4-4 | + £1 kV for nputioutput |» #1 KV for input’ | stoppage duo to fast transients avoid powering the lines. ‘output lines. Consielfation® Vision System on the same branch reuit with sources thatcan generate fast transients {inductive switching; 0.9, high current motors) ‘Surge + ETKV differential [+ £1 KV differential [Mains power quality should be that of a typical 1eC'61000-45 | mode mode ‘Commercial or hospital environment. To avoid + 421eV common mede | + 42 kV common | laser stoppage duo to powerline surges consider mode powering the Consfelfaion® Vision System through branch circuit that has surge suppressor for protectlon against lightning surges (0.g., at power panel to surgicalotice suite). Voltage dips, short |» <5% Ur (295% dip in |» <6% Ur (95% dip | Mains power quality should be that of a typical interruptions, and | Ur) for 0.5 cycle In Ur) for 0.6 oycto | commercial or hogpital environment. Ifthe uses of voltage variations | + 40% Ur (60% dip in_] + 40% Ur (60% dip_| the Constellation® Vision System require continued ‘on power supply | Ur) for'S cycles In Uy) for5 cycles | operation during power mains interruptions, i is input lines + 70% (30% dip in Ur) | + 70% (80% dip in| recommended thatthe Constelaton® Vision Sysiom 1EC 61000-4-11 | for 26 oycles Ur) for 25 cycles | be powered fiom an uninterruptible power supply + <59% (295% dip in| +» <5% (95% dip in| with a minimum rating of 1200VA, Ur) for 5 sec. Ur) for 5 see. Powerfrequency [3A/m Alm Power frequency magnetic fieids should be at (50/60 Hz) levels characteristic of typical location in atypical magnetic feki ‘commercial or hospital environment. IEC 61000-4.8 Conductod RF | 3 ime 3 Vis Portable and mobile RF communications equipment 1EC61000-4-8 | 150 KHz to 80 MHz should be used no closer to any part of the Constetlation® Vision System, including cables, than the recommended separation distance calculated from the equation applicable to the trequoncy 10 ‘the transmiter. Recommended separation distance ‘80 MHz to 800 MHz 800 MHz to 2.5 GHz RadateaRF [3 vim IEC 61000-4-3 80 MHz to 2.5 GHz aa \Where P is the maximum output power rating fo the: transmitter in watts (W) according tothe transmitter ‘manufacturer andd isthe recommended separation distance in meters (mn). Fiold strength from fixed RF transmitters, as determined by an olectromagnotic site surveys, should be less than the compliance level in each frequency range. ltertrence ay ocean vy ot ((())) Seip kena loa a NNoter Ur the a. maine vollage pio to application ofthe teat aval Note 1: ALO MHz and 800 Az, the higher frequency range apps, [Note 2° These guidelines may not appy in all stustions. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and poole ® Floldstrengts from fxedifansritiers, such ae base stations for radio (cellrfcordees) and land mobile radios, amateurradio, AM and PM rad broadcast, and TV broadcast canal be predicted theoretical with accuracy. To access the lectromagnatic envionment ‘due to fied RF transmites, an olecircmagnetc site survey should be considered. ifthe measured Fld strength Inthe location fn \hichthe Constetlation® Vision System is used exceeds the applicable RF compliance level above, the Constalation® Vision System ‘should Be cbsorved fo verily normal operation. If abnormal perfomance s observed, addiional measures may be necassary, sch a reotlenting or relocating the Canstetaton® Vision System, Over the Trequency rango 150 Kz to 80 Miz led erengths shouldbe less than 3 Vim, 172, ‘3068762231Constellation® Vision System Table 1-7 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Constellation® Vision System - The Constellation® Vision System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Constellation® Vision System can help prevent electromag) interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Constellation® Vision System as recommended below, according to the maximum output power of the communications: equipment. ‘Separation distance according to frequency of transmitter (m) Rated maximum output 150 kHz to 60 MZ ‘80 Mz to B00 MHz (800 MHz to 2.5 GHz power of transmitter de t2iP da12NP d=2.0)P. oH) 0.01 0.42 012 0.28) on 0.38 0.38) 078) 1 12 12 23 10 38 38 73 100 12 12 23 For transmis rales ata maximum ouput power not Isied above, the recommended separation dstance d in mators (mean be estimated using the equation applicable tothe fraquoncy of the transmitter, where P is he maximum cufput power rating ofthe ‘ranamvter in watts (W) abcordng to the tranatier manufacturer, Note 1 At 80 Netz and 800 Mt, the separation dlstance forthe higher frequency range apples. Note 2- ‘These guielines may not apply inal situations. Elecomagnolic propagation I affected by absorplion and reflection trom structures, objects, and poopie Equipment contains radio transmitters: Radio Frequency Identification (RFID) device - Frequency or frequency band of transmission: 13.56 MHz, - Type and frequency characteristics of the modulation: ASK - The Bffective Radiated Power (ERP): -119 dBm, Wireless LAN device (Compact USB WiFi Adapter WLI-UC-GNM) = Frequency or frequency band of transmission: 2.412 ~ 2.462 GHz = Type and frequency characteristics of the modulation: DSSS, OFDM, SISO ~The Effective Radiated Power (ERP): 20.55 dBm for USA & Canada USA - Federal Communications Commission (FCC) Compliance Statement ‘This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, inclu cause undesired operation. ng interference that may CAUTION Change or modifications made to this equipment not expressly approved by Alcon may void the FCC authorization to operate this equipment. 3065752231 113Consteltation® Vision System FCC Radiation Exposure Statement CAUTION ‘To ensure that the radio transmitter complies with current FCC regulations limiting both maximum output RF power and human exposure to radio frequency radiation, a separate distance of at least 20 cm must be maintained between the unit's antenna and the body of the user and any nearby persons at all times, and unit's antenna must not bbe co-located or operating in conjunction with any other antenna or transmitte ‘The availability of some specific channels andlor operational frequency bands are country dependent and are firmware programmed at the factory to match the intended destination. This firmware setting is not accessible by the end user. Canada ~ Industry of Canada (IC) Compliance Statement, ‘This device complies with Industry Canada Radio Standards Specification RSS-210. Operation is subject to the following two conditions: 1. This device may not cause harmful interference 2. This device must aecept any interference, including interference that may cause undesired operation of the device. ‘This ISM device complies with Canadian ICES-001 Cet appareil ISM est conforme a la norme NMB-001 du Canada. Industry of Canada (IC) Radiation Exposure Statement GAUTION This device complies with the RF exposure limits set forth a uncontrolled environment. This device should be installed and operated with minimum 20 cm between the unit's antenna and the body of the user, To maintain compliance with Canada RF exposure compliance requirements, please follow operation instruction as documented in this manual, ‘This transmitter must not be co-located or operating in conjunction with another antenna or transmitter. Antenna Notices This device has been designed to operate with the antenna having a maximum gain of 5 dBi. Antenna having a gain greater than 5 dBi is strictly prohibited for use with this device. The required antenna impedance is 50 ohms. ‘To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (EIRP) is not more than that required for successful communicati Exposure of Humans to RF Fields ‘This device complies with the RF exposure limits for humans as called out in RSS- 102, 14 8085762251Constellation® Vision System Europe - R&TTE Directive 99/5/EC ‘This device complies with the requirements of the Council Directive 99/S/EC (R&TTE). CAUTION The radio equipment is intended to be used in all EU and AFTA countries. Outdoor use may be restricted to certain frequencies andor may require a license for operation. Contact local Authority for procedure to follow. Note: Combinations of power levels and antennas resulting in a radiated power of above 100mW equivalent isotropic radiated power (e..r-p) are considered as not compliant with the above mentioned directive and are not allowed for use within the European community and countries that have adopted the European R&TTE directive 1999/5/EC. Certification and Compliance Marks for Compact USB WiFi Adapter WLI-UC-GNM, as specified in the Buffalo ‘Technology labeling. United States China FCC 1D: FDI-09102085-0 MIT ID: 2010DJ1757 KOREA Canada IC ID: 61024-0382 Evens: BUF-WLLCGNMOT EU JAPAN € & onswwatooass ASIA PACIFIC TAIWAN N32 2068 ( ‘Complas th CAI 10LP0720T3 IDA Stansards Da vo3ate WARNINGS AND CAUTIONS - GENERAL Most of the warnings listed on the following pages are stated elsewhere in this manual); however, for easy reference they are repeated here. If additional information is required, please contact your local Alcon service representative, or the Technical Services Department, For locations outside the USA, please contact your local authorized Alcon Service/Sales office. ‘3065762291 4.45Consteltation® Vision Systom ‘There are no user serviceable components inside the Constellation® Vision System console or footswitch. Refer all service issues to your factory-trained Alcon service engineer. + Please contact Alcon for instrument setup and in-servi. training. + Good clinical practice dictates the testing for adequate irrigation, aspiration flow, and operation as applicable for each handpiece prior to entering the eye. * Initial setup instructions must be performed as outlined in this manual. If an exror message is displayed on the front panel, refer to the Troubleshooting section of this Manual. If a problem persists, DO NOT PROCEED. Contact your local Alcon Surgical Service Representative. + Do not use the Constellarion® Vision System near flammable anesthetics. Provide at least two feet of clearance at the rear of the unit for fan intakes and exhausts. This ensures unrestricted air flow for adequate console cooling. A handle on the optional base is used for moving the instrument. The cart should be pulled, not pushed, over elevator and door thresholds. Use only Alcon-supplied A.C. power cords WARNINGS! The Constellation® Vision System power cord is a medical grade power cord with the least leakage current per foot rating available. Extension of the power cord bby hospital staffis not recommended. Unauthorized extension of the power cord could result in injury. Do not use multiple portable socket (power strip) outlets with this system. ‘Store the tray arm priorto moving the instrument. See Section Three forinstructions ‘on placing the tray arm in the stored position. Route the footswitch cable, power cord and other cables connected to the Constellation® Vision System to avold tripping, Toavoid risk of electric shock, this equipment must only be connected to.a supply mains with protective earth (Ground). Modification of the equipmentis NOT allowed without prior authorization from the manufacturer, If this equipment is modified, appropriate Inspection and testing ‘must be conducted to ensure continued safe use of the equipment. Console isolation from mains is achieved through a two pole power switch. Turn OFF power switch or unplug the power cord from wall outlet to achieve isolation from mains. WARNINGS AND CAUTIONS - PRESSURIZED INFUSION/IIRRIGATION SOLUTIONS IN BAGS When using the Constellation® Vision System in a pressurized infusion/irrigation mode, or with IOP Control feature enabled, users need to take precautions to NOT use BSS® intigating solution or other infusion/itrigation mediums from pliable, collapsible containers (i.¢. bags). The Constellation® system, when used in these pressurized modes, forces pressure into the infusion/irrigation container in order to force the solution out of the container and into the cassette. ‘The pressure employed by the Constellation® system may cause some infusion/irrigation bags to rupture and cause disruption of the surgical procedures. Only glass containers should be used with the Constellation® Vision System when employing modalities of pressurized infusion/ inrigation, 16 (3085752291Constellation® Vision System WARNINGS AND CAUTIONS - PATIENT E) E LEVEL/INFUSION PRESSURE Patient eye level relative to the cassette can affect the infusion pressure being delivered to the eye. Be sure to enter the Patient Eye Level Offset to ensure that the displayed console readings reflect the true pressure being delivered to the eye. WARNINGS AND CAUTIONS - PROBES AND HANDPIECES WARNING! If in the medical opinion of the physician a patient with a prion related disease undergoes a high tisk procedure, the instrument should be destroyed or be processed according to local requirements. Vitreous Probes Do not operate vitreous probes in air, This could result in performance degradation and/or potential hazard. Ultrasonic (L/S) Handpicces The OZil® torsional and high performance U/S handpieces are surgical instruments and must be handled with care, The handpiece tip should not touch any solid object while in operation. Immediately following surgery the handpiece must be thoroughly cleaned. Be sure the cord plug is completely dry before connecting it to console. For cleaning and sterilization procedures, see the Directions for Use (DFU) supplied with the handpiece. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic ‘energy causing micro abrasion of the ultrasonic tip. If proper cleaning procedures are not performed immediately after each surgical procedure, tissue debris and salts from irrigating solution may collect. This could permanently damage the handpiece and could jeopardize cleanliness and/or create biohazard conditions for the patient, Remove all debris prior to autoclaving handpiece. The OZil® torsional and U/S handpieces must be at room temperature just before use, Allow the handpiece to air cool for at least 15 minutes after autoclaving; never immerse the handpiece in liquid when hot. Power loss may occur if handpiece tip is, not securely tightened into Fragmentation and Phaco handpieces. CAUTION Never ultrasonically clean the Fragmentation, OZil® torsional and ultrasonic handpleces; irreparable damage will result. Ensure that test chamber is filled with BSS® sterile irrigating solution before tuning the (0Zi#® torsional and U/S handpieces. Tuning a handpiece dry may result in premature tip failure and breakage. Do not test or operate the OZif® torsional and U/S handpieces unless the tip is immersed in BSS® sterile irrigating solution or distilled water or is in surgical use. Irreparable damage to the handpiece and tip can result if run dry. 3085752281Constellation® Vision System WARNINGS! Use of the OZil® torsional and U/S handplece in the absence of irrigation flow and! ‘rin the presence of reduced or lost aspiration flow can cause excessive heating and potential corneal and/or scleral buns. Use of the Fragmentation handplece in the absence of aspiration flow can cause excessive heating and potential scleral burns. Use of an ultrasonic handpiece other than the OZi® torsional or UIS, or use of a handpiece repaired without Aicon authorization, is not permitted, and may result in patient injury, including potential shock hazard to patient andior operator. Prior to sterilization, the OZ/I@ torsional and U/S handpieces should always have the connector end cap secured and placed in the sterilization tray. This will prevent damage to the connectors and handpieces during handling, and especially during autoclaving. Quenching a hot handpiece in water can cause damage and will void warranty. Be sure handpiece is completely dry before connecting it to console. Damage to handpiece and console may result if plugged in when wet. The UIS tips supplied in the Constellation® Vision System packs are only to be used on the OZif® torsional or U/S handpieces. Each UIS tip is intended to be used only once percase, and then disposed of according to local governing ordinances. Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye. Appropriate use of Constellation® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low irrigation pressure, high power settings, extended power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations, of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage Directing energy toward non-lens material, such as iris or capsule, may cause ‘mechanical and/or thermal tissue damage. WARNINGS AND CAUTIONS - HANDPIECE TIPS Scissors, frag, and phaco handpiece tips must be fully tightened to their handpieces. If not secured properly, the handpieces may not operate correctly. Ensure, however, that tips are not so tight that they cannot be removed after use. Use of a tool other than tip ‘wrenches supplied by Alcon may cause damage to the tip and/or handpiece. WARNING! Use 0.9 mm tips with 0.9 mm infusion sleeves. Use 4.1 mm tips with 4.1 mm infusion sleeves. Mismatch of consumable components and use of settings not specially adjusted for a particular combination of consumable components may create a patient hazard. Poor clinical performance will result if tip is not secured tightly to the handpiece, Te ‘8065752291Constellation® Vision Syston WARNINGS AND CAUTIONS - DIATHERMY FUNCTION ‘e085 752231 ‘To ensure safe operation of the Diathermy function, use only Alcon cables and accessories. Diathermy performance can be guaranteed only when using Alcon Surgical components or Alcon-endorsed components. Cables should always be positioned in such a way that contact with the patient is prevented. See Figures 1-4 through 1-6 for diathermy power specifications. WARNING! + Donot use the diathermy function on patients with pacemakers or implanted defibriliatory devices. If electrosurgery is used on patients with implanted cardiac pacemakers or defibrillatory devices or pacemaker electrodes, be aware that irreparable damage to the pacemaker or defibrillatory device andits function may occur and lead to ventricular fibrillation. Please check with the pacemaker or defibrillatory device manufacturers for their recommendations. + Failure of the HF surgical equipment (diathermy circuitry) could result in an unintended increase of output power. In this event the following advisory is displayed: “Handpiece power Is too high. Release footswitch button/treadie and try again.” Listed below are general precautions to be followed when using the Diathermy function: ‘+ To ensure safe operation of the Diathermy function, only approved cables and accessories must be used (See your Alcon representative). Diathermy performance can be guaranteed only when using Alcon components or Alcon-endorsed components. + To reduce the risk of accidental burns, caution should always be taken when operating high-frequency surgical equipment. + Interference produced by the operation of high-frequency surgical equipment may adversely influence the operation of other electronic equipment. + Accessories should be checked regularly; electrode cables should particularly be checked for possible damage to the insulation. ‘The lowest power level in Diathermy step should always be selected for the intended purpose. + Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze. When HF (high frequency) surgical equipment and physiological monitoring ‘equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended, In all cases, monitoring systems incorporating high frequency current-limiting devices are recommended. + The cables to the surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided, ‘Temporarily unused active electrodes should be stored so that they are isolated from the patient. ‘The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N20) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away. 1.19Constelation® Vision System + Non-flammable agents should be used for cleaning and disinfection wherever possible. + Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of HF surgery, Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the HF surgical equipment. + Accessories of the Diathermy function should have a rated voltage equal to or greater than the maximum diathermy output voltage. WARNINGS AND CAUTIONS - ILLUMINATOR FUNCTION WARNINGS! The illuminator bulbs become extremely hot. Never handle a bulb until it has cooled considerably from its operating temperature. Do not touch bulb directly with fingers at any time, ‘The bulb of the xenon lamp is under constant high pressure. There is a risk it may burst with explosive force if knocked or damaged. Protective measures: ~ Keep the lamp in its protective sleeve at all times during installation = Ifyou are handling the lamp without its protective sleeve, always wear safety goggles, a face mask, gloves with wrist protectors and a breast protector. {f the optional illuminator is not installed inside the Constellation® system base, be sure that your surgical set-up includes a back-up source for illumination, Use of controls or adjustments, or performances of procedures other than those specified herein may result in hazardous light exposure. To minimize hazardous light exposure, operate light source at lowest intensity setting consistent with adequate visibility of the surgical area. Light output from a new lamp may greatly exceed the output from an old lamp. Adjust to lower settings after installing a new lamp. Do not use this light source in the presence of flammable substances. The fiber optic endoilluminator probe connector and receptacle may be hot. Before each use, visually inspect the outer surface of the distal tip of the fiber ‘optic endoilluminator probe that will be inserted into the patient to ensure that there are no unintended foreign materials, rough surfaces, sharp edges, or protrusions, that may cause patient injury. Potentially hazardous radiated light is transmitted from the fiber optic endoilluminator probe. Refer to Retina Risk Factors to Consider During Operation of the Constellation® illuminator in this section of the manual for advice on how to minimize the effects of the light intensity used. Avold operation of any fiber in air on consoles capable of illumination levels and settings higher than 10 lumens. This may result in fiber probe deformation and/or high surface temperatures that may cause patient injury. WARNINGS AND CAUTIONS - FOOTSWITCH ‘Never pick up or move the footswitch by holding the cable. Damage may result. WARNING! Route the footswitch cable properly to avoid tripping. 120 "8065752251‘Constetlation® Vision Systern WARNINGS AND CAUTIONS - CAS SSETTE Manually rotating the hub roller in the cassette well when power is on and a cassette is not installed can cause incorrect cassette loading and/or can cause injury to fingers. WARNINGS! Allfluids aspirated during surgery shouldbe treated as biohazards. Takeappropriate precautions when handling instruments and lines in contact with aspirated fluids. Drain bag volume should not exceed 500 ml “Max. Capacity.” Exceeding this volume may result in a biohazardous condition. WARNINGS AND CAUTIONS - CONSUMABLES Do not use consumable packs beyond the expiration date stamped on the outer packaging. Sterile consumable medical devices should not be reused (Accreditation ‘Manual for Hospitals, 1982); they are intended for single use only. Improper usage or assembly could result in a potential hazardous condition for the patient, Alcon assumes no responsibility for complications that may arise as a result of the reuse or improper usage of consumables. WARNING! Potential risk from reuse or reprocessing the following products labeled for single use include: + Bipolar Coagulation Instruments - Thermal injury or electrical shock caused by 2 damaged bipolar instrument, and foreign particle introduction into the eye. + Fiber Optic Instruments -Phototoxicity from inconsistent laser or illumination by a damaged fiber or connector, reduced laseriillumination output, and foreign particle introduction into the eye. + Fluid Management Components - Fluid path leaks or obstruction resulting in reduced fluidics performance, and foreign particle introduction into the eye. ‘+ Phacoemulsitication Tips - Reduced tip cutting performance, presence of tip burrs, fluid path obstruction, and foreign particle introduction into the eye. + Vitreous Cutting Instruments - Reduced vitreous cutting performance, fluid path obstruction, and foreign particle Introduction into the eye. ‘The equipment used in conjunction with Alcon Constellation® Vision System consumables constitutes a complete system. Use of consumables other than Alcon consumables may affect system performance and create potential hazards, and if it is determined to have contributed to the malfunction of the equipment under service contract, could result in the voidance of the contract and/or invoicing at prevailing hourly rates. WARNING! Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections. ‘085752231 421Constettation® Vision System In all cases, the instrument setup instructions contained in this manual, and all label instructions in the package, should be thoroughly understood prior to using any of the Constellation® Vision System Pack configurations. Ensure that tubing is not occluded during any phase of operation. ‘Consumable Packs If any item in a consumable pack is received in a defective condition, Alcon is to be notified immediately, Do not use any of the contents if the sterile package is damaged or the seal is broken in any way. Packs are identified by lot number that provides, traceability and should be given to the Customer Service Department. Phone Alcon Customer Service At: Please Write To Alcon At (800) 862-5266 or Alcon (817) 293-0450 Attn: Product Complaints 6201 South Freeway Fort Worth, TX 76134-2099 WARNINGS AND CAUTIONS - IOP (INTRAOCULAR PRESSURE) ‘The closed loop system that adjusts JOP cannot replace the standard of care in judging IOP intraoperatively. The surgeon must continue the common practice of informally judging IOP using the following: Finger palpation on the globe * Tactile feedback of the surgical instruments (eye wall deformation with ‘manipulation of instruments) ‘+ Retinal vessel perfusion/pulsations + Presence of comeal edema If the surgeon believes the JOP (using the techniques above) is not responding to the system settings and is dangerously high, this may represent a system failure. The surgeon can do one or more of the following as they deem appropriate in this situation (with care to avoid sudden hypotony): + Close the infusion stop-cock ‘+ Pinch the infusion line * Remove the infusion line from the sclerotomy NOTE: To ensure proper IOP Compensation calibration, place infusion tubing and infusion canula on a sterile draped tray at mid-cassette level during the priming cycle. ie (8065762231CConstellation® Vision System WARNINGS AND CAUTIONS - LASERS ‘The footswitch, endoprobe, and LIO should be placed within 2 meters of the Constellation® Vision System WARNINGS! ‘Thereare potential hazards when inserting, steeply bonding, or improperly securing the fiberoptic. Not following the recommendations of the manufacturer may lead to damage of the fiber or delivery system and/or harm to the patient or user. Since the aiming beam passes down the same delivery system as the treatment beam, it provides a good method of checking the integrity of the delivery system. If the aiming beam spot is not present at the distal end of the delivery system, or its intensity is reduced or it looks diffused, this is a possible Indication of a damaged or not properly working delivery system. If there is any doubt, contact Alcon Technical Services. The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N20) and oxygen should be avoided. Some materials - for example cotton woo! when saturated with oxygen-may be ignited by the high temperatures producedin normal use of the laser equipment, The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used. There is also danger of ignition of endogenous gases. Diathermy, Cautery, Coagulation In the past, some of Alcon’s products have referred to the feature “Cautery” or "Coagulation." The Constellation® Vision System and this operator's manual use the word “Diathermy” based on the following definitions: * Diathermy - introducing an electric field into a body part to produce heat. + Cautery ~ cutting and burning method associated with two hot wires passing a current between them; cutting away skin; halting bleeding, + Coagulation - an isolated bipolar current supplied to conductors (e.g. forceps). Current passes between these electrodes, halting bleeding. s s € we a ae om ox 0% ‘20% Figure 1-4 —_Diathermy Power Through 75 Ohm Load 8065752251 123‘Constellation® Vision System + 100% Set Powor ~e- 76% Set Power -o 60% Set Power 26% Set Powor 06 Set Power toro accom Figure 1-5 _Diathermy Power vs. Load Impedance gem etiasbaeaaea cs d é B a i ie 5 em Figure 1-6 _Diathermy Output Voltago vs. Output Control Setting Note: Maximum output peak-to-peak voltage is about 140V without resistive load. 24 "8085752231of Constellation® Vision Systom PRODUCT SERVIC For product service, please contact Alcon’s Technical Services Department at the number provided below. Operators experiencing problems with the system should refer to the Operating Instruetions and Troubleshooting sections of this manual. A problem which persists should be referred to the Alcon Technical Services Department or your local authorized service representative. For optimum performance, it is the user's responsibility to schedule preventive maintenance service on the system and its accessories two times each year. Alcon’s Field Service Engineers are trained and equipped to provide the highest quality of workmanship. Safety performance should be verified by the user (¢.g., qualified service personnel) at least twice a year. Ground resistance must be under 0.1 ohms. Leakage current must be under 500 1 at 264 Vac or 300 jrA at 132 Vae. To avoid unnecessary shipping, please contact your Alcon Technical Services Department prior to the return of any system or accessories. If return of the equipment is deemed necessary, a Return Material Authorization will be issued with appropriate ipping instructions, Alcon Laboratories, Inc. ‘Technical Services Department 15800 Alton Parkway Irvine, California 92618-3818 (949) 753-1393 (800) 832-7827 ‘8086760281 1.25Consteifation® Vision System LIMITED WARRANTY Alcon Laboratories, Inc., will repair or replace at its option, any system or accompanying accessories (excluding the optical fiber) found to be defective in material and/or workmanship for a period of one (1) year from the date of initial installation. If optional laser is included, the laser core module will be warrantied three years from the date of initial installation, This warranty applies to the original purchaser of the system, when said system is properly installed, maintained, and operated in accordance with published instructions. Alcon Laboratories shall not be obligated to provide services under this warranty for damage to or destruction of systems covered where such damage or destruction is (i) aresult of or caused by fire or explosion of any origin, riot, civil commotion, aircraft, war, or any Act of God including, but not limited to lightning, windstorm, hail, flood, earthquake, or (ii) caused by customer’s misuse or improper servicing of said systems, ‘The express warranty above is the sole warranty obligation of Alcon, and the remedy provided above is in lieu of any and all other remedies, There are no other agreements, guarantees, or warranties - oral or written, express or implied - including without limitation warranty of merchantability or fitness for a partieular purpose. Alcon shall have no liability whatsoever for any incidental or consequential damages arising out of any defect, improper use, or unauthorized service or repair. WARNING! ‘The disposables used in conjunction with Alcon instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards. If it is determined that disposables or handpieces not manufactured by Alcon have contributed to the malfunction of the equipment during warranty period, service will be provided at prevailing hourly rates. 26 ‘3085762251‘Constefation® Vision System ILLUMINATOR PROFESSIONAL USER'S INFORMATION: RETINA RISK FACTORS TO CONSIDER DURING OPERATION OF THE CONSTELLATION® ILLUMINATOR Spectral Output The Constellation® illuminator comes equipped with internally- integrated, non- selectable, UV/IR filtration, No removable filters are used in the Constellation® illuminator since the retinal hazard is maintained at the levels specified by ISO 15752-2005. The Constellation® illuminator output spectrum complies with the requirements of ISO 15752-2005: “Ophthalmic Instruments - Endoilluminators - Fundamental Requirements and Test Methods for Optical Radiation Safety.” The Constellation® illuminator does not rely on fiber optic endoilluminator probe absorption to comply with spectral output requirements of ISO 15752-2005. It delivers light at the fiber optic illuminator connector within the spectrum recommended by ISO 15752-2005. Spectrally- Weighted Aphakic Irradiance ‘Aphakic irradiance for the Constellation® illuminator was determined using approved fiber optic endoilluminator probes approved for use with the Constellarion® illuminator. The value for Spectrally-Weighted Aphakic Irradiance (SWAN of the endoilluminator was determined with an effective 3 mm-diameter aperture at a distance of 5 mm in a plane perpendicular to the radiating fiber optic endoilluminator probe tip. Output Limits ‘To avoid potentially unsafe operations of the Constellation® illuminator, the system will warn or prevent the user when certain thresholds are exceeded. The Constellation® illuminator limits output and aphakic weighted irradiance to stay within safe limits based on the type of fiber used. Using RFID, the type of fiber is detected by reading information from the RFID tag within the inserted fiber probe. Utilizing the fiber type information the Constellation® illuminator sets a series of fimits on output. Four separate thresholds are used: Damage Limit - The Damage Limit corresponds to the maximum output of the illuminator that any given RFID recognized fiber can be safely operated without risking damage to the probe while operation in air. When the intensity of the output of the Constellation® illuminator is increased by the user beyond the damage limit, a pop up message is displayed that warns the user “Further increasing the output level in air can damage fiber tips. Would you like to continue?” If the user presses the [Yes] button, the request (turning on illuminator, changing the set point while the illuminator is on, or changing procedures while the illuminator is on) will be granted, If the user presses the [No] button, the system state will be unchanged. No interactions with the illuminators are allowed while the advisory is being displayed ‘e065752281Constetiatfon® Vision System Soft Limit - The Soft Limit for any given RFID recognized fiber corresponds toa peak aphakic weighted irradiance of 100.98 mW/em2 for a nominal fiber optic endoilluminator probe at a distance of 5 mm from the exiting aperture. The Constellations® system display is scaled so that the level will display 100% at the soft limit, When the output intensity of the Constellation® illuminator is increased by the user beyond the soft limit, a pop up message is displayed which warns the user “Further increasing the output level will reduce exposure time by 35%. Would you like to continue?” If the user presses the [Yes] button, the request (turning on illuminator, changing the setpoint while the illuminator is on, or changing procedures while the illuminator is on) will be granted. If the user presses the [No] button, the system state will be unchanged. If the advisory was brought up as a result of a procedure change, the setpoint(s) that exceeded the limit will remain at the previous value. No interactions with the illuminators are allowed while the advisory is being. displayed, Hard Limit - The Hard Limit for any given RFID recognized fiber corresponds to a peak aphakic weighted irradiance of 115.85 mW/cm2 for a nominal fiber optic endoilluminator probe at a distance of 5 mm from the exiting aperture, The displayed intensity percentage output of the Constellation® illuminator is scaled so that 115% corresponds the Hard Limit for that fiber. The user is not given the ability to exceed this limit. Port Limits - To further avoid potentially unsafe operation, the Constellation® illuminator will prevent more than two illuminator ports from being turned on at the same time. If the user attempts to tum on a third port, a pop up message is displayed which warns the user “Only two illuminators can be turned on simultaneously.” 128 (8088752251Constellation® Vision System LASER PROFESSIONAL USER’ S INFORMATION: ‘The following information is given to provide the operator with specific information regarding the Constellation® Vision System Laser ophthalmic laser, Indications The Constellation® Vision System Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and nonproliferative retinopathy (including diabetic) ~ Choroidal neovascularization secondary to age-related macular degeneration (AMD) - Retinal tears and detachments - Macular edema - Retinopathy of prematurity; - Choroidal neovascularization; - Leaking microaneurysms. Iridotomy/iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG), Acute Angle Closure Glaucoma (AACG), and refractory glaucoma. ‘Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG) and refractory glaucoma. And other laser treatments including: ~ Internal sclerostomy ~ Lattice degeneration ~ Central and branch retinal vein occlusion ~ Suturelysis ~ Vascular and pigmented skin lesions. 18068752251 1.28Constellation® Vision Systern LASER SAFETY General Safety Precautions (Refer to TEC 60825-1 or ANSI Z136.1) + Alaser safety officer should be appointed to supervise the installation and use of the system. + Install an indicator light outside the laser room warning of instrument operation, + Position all beam delivery devices (e.g. LIO, endo-probes) so that the laser beam is never directed toward a door, window, or reflective surface. * Use non-reflective matte finish wall paint. * Avoid covering laser room floor and walls with carpet or any other dust generating material. This will minimize the possibility of excess grime and dust on the instrument optics, and interference with equipment cooling. ‘+ The instrument requires a minimum of 0.5 meter of open space on all sides for proper cooling ventilation; therefore, the system should be set flat, resting on the legs provided on the bottom of the console. + Unauthorized use of this laser should be prevented by removing the On/Off key. + Entrances to areas or protective enclosures containing Class 4 lasers should be posted with appropriate warning signs. * Appropriate eye protection must be used in all hazard areas. Use eye protection with OD 4 or above at 532 nm. Nominal Ocular Hazard Distance (NOHD) “Accessory. Beam Divergence (NOHD) LIO 0.024 radians (20 meters) Endoprobe 0.23 radians (3 meters) * A qualified technician must verify that the power plug used is properly grounded * The remote interlock connector should be connected to an emergeney master disconnect interlock or to room/door/fixture interlocks, Please refer to figure 1-7. + The laser footswitch, endoprobe, and LIO should be placed within 2 meters of the Consteltation® Vision System Laser. CAUTION Before turning the instrument ON for the first timo aftor receipt of the system, wait one hour for the components and optics to normalize to avoid possible condensation that may have occurred during shipping, (8085750201Constellation® Vision System Figure 1-7 | ea smocomcea ee, Remote Connector/Door Lamp Circuit Diagram Laser Safety Features ‘The Constellation® Vision System Laser is designed for the highest degree of reliability and safety for both the operator and the patient. Any misuse of this laser system may be dangerous. Before using the laser system, the operator must be familiar with the commands and the operation of this type of instrument. The Constellation® Vision System Laser is fitted with the following safety systems which must be understood by every operator: * A protective housing covers the laser source so that no harmful laser radiation will be emitted. No part of this protective housing should be removed by the operator. ‘The laser system must not be used if the protective housing has been damaged or removed. + Aremote connection (interlock) is located on the rear panel and permits the installation of an external switch. This switch can be installed on the Taser room door and cuts off all Jaser emissions in case the door is opened during operation. ‘There is also a connector linked to an internal relay to activate a door warning lamp if desired. Akkey switch controls the laser power supply. Laser operation is not possible if the key has been removed. Access to the key should be limited to authorized and knowledgeable personnel. The key should not be left on or near the instrument when not in use. + During operation, laser status can be determined by visually checking the display to determine the laser mode: Standby or Ready. + An emergency switch is mounted on the front panel. Pushing this switch will cut off all laser emissions (treatment and aiming beam) at any time. The switch must be pulled out to the initial position to restore power. The laser will always restart in Standby mode, + Laser firing commands are microprocessor controlled and firings are prevented should any malfunction be detected in the instrument electronics. The instrument will only fire when all conditions are correct. + Output power of the laser beam is continuously monitored and controlled. In case an unusual power condition is detected, firing stops and the treatment laser emission is cut off, 8085752281 131Consteilation® Vision System Effects The laser beam is primarily absorbed by pigmented tissues within the eye, These primary pigments are hemoglobin/oxy-hemoglobin and melanin. In the case of ‘macular treatment, xanthophyll pigment is involved. The surgeon controls the power, spot size, and exposure time of the delivered laser beam to the targeted tissue. It is the combination of these effects that results in the thermal action of the laser beam upon tissue. One or all of the adjustable parameters can be changed. However, in normal clinical practice, power is usually varied, and spot size and exposure time are preset as a function of the application. ‘The 532 nm green laser beam has similar absorption characteristics to the 577 nm dye yellow laser beam?. This means that the absorption effects of the 532 nm wavelength are considerably higher in hemoglobin and melanin, and less in xanthophyll. In all cases, it is necessary to perform titrations until the desired treatment results are obtained, The 532 wavelength also requires less power than that required with the argon laser to obtain similar results. Therefore, you should begin your titration levels with lower power than required for similar procedures with the argon laser. WARNING! Failure to titrate delivered energy may result in patient injury. Use of this medical laser, as with any other instrument, requires training and experience to obtain maximum clinical performance. Titrating the dosage is recommended by initiating’a lesion formation in an area of normal retina with intact pigment epithelium. Power and exposure duration should be varied incrementally ‘until the desired lesion is produced. WARNING! Hfunsure which settings are required, select low power, short duration, and large ‘spot size. Failure to do so may result in patient injury. Delivery of Laser Energy The laser beam is delivered to tissue via an endoprobe, illuminated endoprobe, aspirating endoprobe, or Laser Indirect Ophthalmoscope (LIO). Reaction to applied laser energy by the eye is a function of many variables. ‘The pigmentation of the eye, technique or procedure used, laser settings, and pre- existing condition of the eye, such as cataract, will have an effect on the selected laser parameters and the results obtained. Therefore, itis very important to consider all the existing clinical conditions and titrate until the desired results are obtained. Always use minimal illumination while maintaining good visualization in order to reduce reflections and discomfort for the patient. Likewise, the aiming beam should be used at a minimum setting while maintaining proper targeting of the selected tissue. This will also minimize excessive reflections and scattering, particularly at smaller spot sizes, Tae "8065752251CConstettation® Vision System Doctor Protection Filter The Constellation® Vision System laser can only be fired when appropriate steps are taken to ensure that a doctor's filter is placed in the viewing device (e.g. surgical microscope, etc.). The Constellation® Vision System laser supports two types of doctor filters: + Non-tethered with fixed filter in viewing path. Tethered with manual switch to place filters in and out of the viewing path. The doctor protection filter must remain in the beam path during treatment, enabling the targeted tissue to be seen with complete protection for the operator. ‘The filter has virtually no effect on visualization (colored** view only). Rotation of the tethered filter with manual switch in or out of the beam path is, accomplished by means of a lever located on the right side of the filter. Note that if the doctor protection filter is in the open position in endo modes, the laser will not fire and the message “Please Engage Dr. Filter” will appear. Rotate the filter lever clockwise until the doctor protection filter is in the beam path and the message clears. Hf using a non-tethered fixed filter, and the system is switched from Standby to Ready mode, the message "Verify appropriate Dr. Filters are installed in all viewing devices" appears and the user must verify before the laser can switch to Ready mode. If two tethered filters are in place (see rear panel description), both filters must be switched into the beam path before the laser will operate. Switching either filter out of the beam path while the laser is in Ready mode switches the laser to Standby mode immediately. Inserting a filter tether into the machine while itis in Ready mode switches the machine back to Standby mode until all tethered filters have been verified to be in place. WARNING! Do not attempt treatment if aiming beam is not present. Patient injury may occur. The aiming beam passes down the same delivery system as the working beam; this provides a good method of checking the integrity of the delivery system. If the aiming beam spot is not present at the distal end of the delivery system, if reduced, or if looks diffused, these are possible indications of a damaged or not-properly-working delivery system. Nower Doctor Protection Fiters will have les tint than older ones. 086752291 1.33Consteifation® Vision System ‘Treatment Hazards A single treatment exposure will typically cause a blanching of target tissue. Exposure duration can be adjusted from 0.01 seconds to 2.0 seconds to result in the desired effect. A continuous treatment beam can also be selected. NOTE: In CW, depending on the thermal load of the system, the system may shut down in safety mode prior to the footswitch being released. Excessive combinations of power and exposure can cause undesirable tissue vaporization and charring. Reports | through 6 (listed as footnotes at the end of this section) indicate these hazards are no different from adverse effects from continuous wave argon lasers used at these same settings, No evidence of non-thermal effects has been observed. Contra Indications Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber or vitreous humor) are poor candidates for LIO delivered laser treatment. Side Effects Comeal burns, inflammation, loss of best-corrected visual acuity, loss of visual field, and transient elevations in intraocular pressure can occur as a result of ophthalmic Jaser treatment. Unintentional retinal burns can occur if excessive treatment beam. power or duration is used Laser Safety Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter. All personnel in the treatment room must wear protective eyewear, OD4 or above at 532 nm, when the system is in Standby/Ready mode as well as during treatment. The doctor protection filter is an OD greater than 4 at $32 nm. WARNING! Use of controls or adjustments or performance of procedures other than those ‘specified herein, may result in hazardous laser radiation exposure. CAUTION Federal (USA) law restricts this device to sale by, or on the order of, a physician. "8065752251CConstottation® Vision System Footnotes for Laser Saftey section: 1 Ludwig, K.; Lasser, Ts Sakowski, H.; Abramwoski, H.; Worz, G. (Augenklinik, Universitat Munchen) "Photocoagulation in the edematous and non-edematous retina with the cw-laser of different wavelengths." Ophthalmologe (GERMANY), December 1994, Volume 91, No. 6, p783-788. 2 Roider, 5; Schiller, M. el Hifhawi, E.S.; Bimgruber, R. (Augenkli Medizinische Universitat zu Lubeck) "Retinal photocoagulation with a pulsed, frequency-doubled Nd: YAG laser (532 nm)." Ophthalmologe GERMANY), December 1994, Vol. 91 No. 6, p777-182. 3. Wyman, D.; Wilson, B.; Adams, K. (Medical Physics Department, Hamilton Regional Cancer Cenire, Ontatio, Canada) "Dependence of laser photocoagulation on interstitial delivery parameters." Lasers Surgical Medical (UNITED STATES), 1994, Vol. 14 No. 1, p59-64. 4° Obana, A.; Miki, 7; Matsumoto, M.; Ohtsuka, H.; Moriwaki, M.; Kamo, M Mii, T.; Kijima, M. (Department of Ophthalmology, Osaka City University, Medical School, Japan) “An experimental and clinical study of chorioretinal photocoagulation using a frequeney-doubled Nd: YAG laser." Nippon Ganka Gakkai Zasshi (JAPAN), September 1993, Vol. 97 No. 9, p1040-1046 5- Mordon, S.; Beacco, C.; Rotteleur, G.; Brunetaud, J.M. (INSERM - National Institute of Health and Medical Research - Lille, France) "Relation between skin surface temperature and minimal blanching during argon, Nd-YAG 532, and CW dye 585 laser therapy of port-wine stains." Lasers Surg Med (UNITED STATES) 1993, Vol. 13 No. 1, p124-126. 6 Jalkh, A.E.; Pflibsen, K.; Pomerantzeff, O.; 'Trempe, C.L.; Schepens, C.L. (Eye Research Institute of Retina Foundation, Boston, MA 02114) "A new solid state, frequency-doubled neodymium-YAG photocoagulation system." Arch Ophthalmol (UNITED STATES) June 1988, Vol. 106 No. 6, p 847-849. 7 Wavelengths, Opthamology, July 1986, Volume 93, Number 7, Page 956. ‘3085752231 1.38Constelfation® Vision System THIS PAGE INTENTIONALLY BLANK 136) LAST PAGE OF THIS SECTION "8065752231CConsteltation® Vision System SECTION TWO. DESCRIPTION INTRODUCTION “The Constellation® Vision System is a multi microprocessor-controlled ophthalmic surgical instrument with associated memory and input/output (/O) circuitry. ‘The system communicates with the user via its Front Panel display, with voice confirmations, and with tones. ‘An automatic self-test is initiated each time the system power is turned on. If the system does not pass the self-test, either a Fault screen or an error message is displayed depending upon the cause of the issue. When the system successfully completes the self-test, it automatically goes into the Setup mode. ‘This section of the manual describes the system hardware, the user interface, and the accessories that may by used with the system. FRONT PANEL Fluidies Module ‘The fluidics module is located in the center of the front panel. The module allows fast and easy insertion of the cassette that contains all the fluidics connections required for surgery. Front Display Panel and ‘Touch Seren The 17-inch front display panel tilts and extends forward to allow casy positioning during setup and surgery. The front display is the user's main source of system control, allowing fingertip command of system functions throughout the enhanced graphical user interface. A data card slot is located just beneath the LCD display. A data card (SD Memory Card) can be inserted into this slot when the user wants to back up or restore system settings. A 2 GB SD memory card is the maximum size that the system will recognize. Larger capacity memory cards are not recognizable by the system and if inserted, will lock up the system until removed. Pneumatic and Electrical Connectors ‘The Constellation® Vision System console contains two vertical columns of connectors, located on the left side of the eassette, for surgical probes and handpieces. ‘The right ‘column is for pneumatic probes, and the left column is for electrical handpieces. LED Rings - The rings surrounding each front panel connector automatically illuminate in a particular color to guide the user in making the proper connection to the system as follows: + Blue ~ A surgical tool is selected by the user in Setup or a surgical tool i to the current Step in surgery. + Groen - The system has detected that the appropriate surgical tool has been connected to the port. + Amber - The system has detected, via RFID, a surgical tool that is not appropriate for the port or is invalid for other reasons. related ‘s086782231 2aConsteliation® Vision System Note: The green and amber lights haye higher priority than the blue light; therefore, it will illuminate only if no other light is applicable. WARNING! Connect only Alcon supplied consumables to console/cassette connectors. Do not connect consumables to patient intravenous connections. Footswitch Storage Hook ‘This footswitch storage hook is located at the bottom of the front panel. When the footswitch is not in use or the system is being moved, use this hook to store and protect the footswitch Instrument Tray (optional) Provides a movable instrument tray within the sterile field. There is a curved metal rod on either side of the tray that allows for creation of a sterile pouch when used with sterile tray arm cover. The tray is capable of accommodating a variety of positions in the operating room environment: right, left, front and rear of the surgeon as well as the front of the bed. Refer to Section Three for detailed instructions on adjusting the tray position. WARNINGS! The maximum allowable load on the instrument tray is 20 tb (9 kg). If the load exceeds this limit, the tray arm will automatically lower itself in order to avoid tipping the system over. Additionally, if the Instrument tray is positioned over a patient, a mayo stand should be placed beneath it to avoid a potential collapse of the tray arm onto the patient. Place the instrument tray in the stored position as shown in Figure 2-1 prior to transportation to avoid a situation that could cause the system to tip. IV Pole with Bottle Hanger (optional) A bottle of BS8® or BSS Pius® irrigating fluid is hung from the hook on top of this pole. The LY pole is used to raise and lower the bottle height, causing irrigation pressure fo increase or decrease. WARNING! agacy® IV pole extender with Constellation® Vision System IV pol 22 "8085752251Consteltation® Vision System ence) Power IV Polo. ‘wiBottlo Hanger (optional) SD Memory Siot umination Connectors Fluidics Module Instrument Tray Laser Module, (optional) (optional) Auliary / urination (optional) Not used Auto Gas Fig (AGF) IS and OZi#e Handpioce tutkFuncion Pot @ cane Figure 2-1 The Constollation® Vision System Console Output Connectors* * Labels and icons may vary according to the date of manutacture and are shown here for reference oy 3065762231 28Constelfation® Vision System Caster Wheels Four large caster wheels support the Constelfasion® Vision System. The wheels rotate 360” for ease of system mobility, and have a locking lever to secure the system in lace, The wheels should always be locked (handle down) when the uni isin use, and unlocked when being moved, ‘The locking levers have three positions as follows: + Up arrow position - The caster wheel directional movement will Lock in the 0 or 180 degree position, The wheel rotates freely. * Unlocked icon position - The caster wheel has 360 degrees of directional movement and the wheels rotate freely. * Locked icon position - The caster wheel directional movement and wheel rotation are both locked. Ilumination Primary illumination is provided by two independently controlled ports located Just below the display. The light output af these ports is based on xenon arc lamp technology that generates high brightness white light. Bach port will allow the uso of 20, 23, and 25 GA ACMI terminated fiber probes and provides the following ‘minimum output for the probes (100% setting; 0-200 hours of lamp use): + 20GA probes = 16 6 lumens (@115% set point!; 0-400 hours of lamp use) + 23GA probes = 23 £13 lumens (@115% set point!; 0-400 hours of lamp use) + 25GA probes = 23 +13 lumens (@115% set point!; 0-400 hours of lamp use) 1 Based on a representative nominal UFR fiber. Auxiliary illumination is available as an optional feature that provides for two additional channels of high brightness white light, Laser (optional) ‘The optional laser module is a diode-pumped solid-state type laser designed for ophthalmic use. This laser delivers a visible 532 nm green treatment beam, and a visible 635 nm Diode Laser aiming beam (635 nm is an approximate value between 630-640 nm) Footswitch Connector The footswitch connector is located on the front panel and is used to connect the Constellation® Vision System footswitch to the console. (In the monolith configuration shown in Figure 2-1, the footswitch connection is made in the front of the base,) Handles Handles are located on the sides and back of the instrument, and should always be used to move the unit. For safety and control, the unit should be pulled, not pushed. CAUTION ‘The system must be moved carefully, otherwise the system could tip over and become damaged. Do not push of pull the unit by the display, the tray, or the IV pole. Handles a located at the rear and sides of the unit are provided for moving the instrument. The unit should be pulled and not pushed, especially over elevator and door thresholds. 2a ‘3088752251Constotlation® Vision System REAR PANEL Barcode Reader Stationary DvDIRW ae Hanger ee our External Connector Semen Panel (see detail A) Main Power ‘Swit Power Moduio! ‘Footswitch Connector uminator (behind panel) Module Eject’ Facllty Pressure Source ‘Connector and AGF Tank Connection Ler Meco Conese Pana ‘Aux. iluminator (see Detail B) Miodle Got = =, ZF pecossory rower | = ISPAN Gas Tak Holders DETAIL B De. Filter Base Input Power! Equal Potentially Lug DETAIL A (System will use one of the two connector panels shown below) At A2 VGA ihe! USB _—_Commposite NGA ememet 4 US8 svideo HOM! Monfor (Mon eriy) Aleman) vie (7039 panna | MEY on ony) oe t Bartode Tethered RS-252 Adio ’ t parte Tehered REZ? so epi Bavode Tethered = REZI2 Ado Recorder (YOu) Reader Laser ideo Out Input Figure 2-2 The Constellation® Vision System Roar Panel 8065752231 26Constelfation® Vision System DVDRW ‘The DVD player/recorder allows for software upgrades to the system and data/ settings transfer. Bar Code Reader ‘The bar code reader allows the operator to quickly scan consumables into the system, When a consumable is scanned through the reader and the system recognizes the bar code as one that is preconfigured in the system, an audible beep is sounded and the associated consumable is added to the current surgical case. If the bar code is not recognized by the system then an advisory message is displayed along with an audible beep. The operator can verify the bar code has been properly entered into the system by tapping the Consumables button to bring up the Consumables list window. External Connectors This module, located in the middle of the rear panel, contains various connectors and outlets used for electrical interconnections. The system will have one of the two connector panels shown in Figure 2-2. Figure 2-2, Detail A-1 + VGA out - External VGA monitor connection Ethernet - Alcon use only USB Connector - Alcon use only Composite Video In/Out - Used for Video Overlay Antenna - Used for wireless communication Serial Connector - Used for Video Recording Bar Code scanner connection S-Video In/Out - Used for Video Overlay ‘Tethered Laser Connection - see Section Three for instructions on the tethered laser configuration. * Audio Input - MP3 player audio input Figure 2-2, Detail A-2 * VGA out - External VGA monitor connection * Ethernet - Alcon use only * USB Connector - Alcon use only + $-Video In - Used for Video Overlay + HDMI Video In/Out - Used for Video Overlay ‘+ WiFi - Used for wireless communication * Serial Connector - Used for Video Recording * Bar Code scanner connection + Tethered Laser Connection - see Section Three for instructions on the tethered laser configuration, + Audio Input - MP3 player audio input CAUTION ‘The USB connector (*€* ) and service ethernet connector located on the rear panel are for use by Alcon trained personnel only. Failure to comply will void warranty. 26 'g085752281Constatiation® Vision System Power Module/Footswitch Connector ‘This module contains the power and footswitch connection from the base unit. Facility Pressure Source Connectors ‘This connection is provided to connect the console to the facility pressure source (air or nitrogen), Refer to Section Three for detailed instructions on connecting a pressure source, Laser Module Connector Panel (Figure 2-2, Detail B) + Dr. Filter Connections - Provides connections to standard Alcon Dr. Filters. * Laser Footswitch Connection, + Remote Interlock - connection to accommodate the room-interlock functionality. ‘When a controlled entrance is opened, this interlock interrupts the operation of the laser until the door switch contact is closed. © Laser Status - Connection to accommodate a “Laser On” indicator. This provides an electrical signal to an external facility sign that indicates when the laser is in the ready state, Accessory Drawer One drawer allows the storage of miscellaneous accessories, Base Input Power Connection fo connect the Constellation® Vision System to facility power. Equipotential Ground Connector ‘The Equipotential Ground Connector may be used to provide a direct connection between the Constellation® Vision System and the potential equalization bus-bar of the electrical installation. This connector complies to the requirements of IBC/EI 60601-1. Auxiliary IMuminator Module Eject Button Pressing this button causes the optional auxiliary illuminator module to release and enables its removal from the front panel for lamp replacement by trained personnel only. Illuminator Module Eject Button Pressing this button causes the illuminator module to release and enables its removal from the front panel for lamp replacement by trained personnel only, NOTE: The illuminator module should only he ejected or inserted when the system powered off, Main Power Switch Connects AC power to the system. Standby Power Switch ‘This push-button switch is used to turn secondary power ON and OFF, If system freezes and is unresponsive to operator commands, press Standby switch for fifteen seconds to shut down system, then re-boot, Stationary Hanger Mount Used to hang a bottle of sterile intraocular irrigating solution. 13085752251 27Constelfation® Vision System FOOTSWITCH Functional operations of the Constellation® Vision System console ate controlled by the footswitch shown in Figure 2-3. The footswitch consists of a treadle, left and right horizontal/vertical switches, left and right heel switches, and a tension adjustment knob. An advisory popup window is displayed if the footswitch is not connected. Generally, the treadle is used to provide control of a parameter, such as vacuum, with the treadle's angle of depression proportional to the parameter output. In some modes of operation, the treadle is used to provide on/off control of a function, with any depression resulting in a fixed output of its parameter, ‘The footswitch treadle is used in a mode-dependent fashion during system operation. In U/S mode for example, when the treadle is depressed its range of travel is divided into ranges 0, 1,2 and 3. Bach range is separated from the previous range by a detent. Detent firmness levels are programmable in the Doctor Settings menu which is discussed later in this section of the manual (see Settings). The footswitch icon located in the upper left comer of the screen displays the current treadle position, Right and left switches are used to enable and disable system functions. The switches are nudged sideways (horizontal) for some funetions, and pressed down (vertical) for others, ‘The tension adjustment knob, located on the front of the footswitch, is used to adjust the pressure needed to depress the treadle, CAUTION Never pick up or move the footswitch by holding the cable. Damage may result. Tele Aestnert a ‘potahomn) ig Hentai! Sich NOTE: The Constellations footswich does not fire the optional laser. ge Mt Sates Figure 2-3 The Constellation® Vision System Footswitch 2a 'g085752281Constellation® Vision System REMOTE CONTROL ‘The Remote Control is a wireless, handheld, battery operated device that uses infrared light o communicate with the Constellation® Vision System console. Bach of the different keys on the Remote Control unit has its own unique key code that is transmitted to the Constellation® Vision System console when the key is pressed. The transmitted key codes are translated into commands that control the Constellation® Vision System console. WARNING! ‘The Alcon remote control is common to several Alcon instruments. To keep the remote from interfering with other Alcon instruments, each remote control must be set to match the unique channel (A, B,C, or D) of its associated instrument. Changing batteries will cause the remote to default to channel A; therefore the remote may need to be reset to the instrument's unique channel as described in “Selecting Remote Control Channel" on page 2.11. ‘CAUTION Do not sterilize the remote control as it will damage the unit. Figure 2-4 shows the Remote Control and the keys provided. When a Remote Control ‘Transmitter key is pressed, the Consiellation® Vision System console determines whether ornot the key press was valid and generates an appropriate valid or invalid key tone, (lobe Contos UrDown Key ea cons ingoton ey Bock tution 2) aaa i ‘Surgery Soreon aes ShoRight Osan Say oe Nest Sep Key Figure 2-4 The Constellation® Vision System Remote Control ‘The Remote Control is divided into three sections from top to bottom. The three sections of the display screen are 1) the top section is for Global Selection and adjustments of global values, 2) the main (middle) window is for surgery screen navigation and parameter settings, and 3) the bottom section is for selecting steps and ‘enabling/disabling selected controls. Some items on the Constellation® Vision System console display screens are not accessible with this Remote Control unit. 085752231 29Va Constetlation® Vision System Global Control Up/Down Keys ‘The Global Control up/down keys on the remote control function as they do on the Host Display touchscreen. Each individual press of the up arrow key increments the setting on the selected global control in the Globals panel on the touchscreen. Each individual press of the down arrow key decrements the setting on the selected global control. To move rapidly up or down, the key is pressed and held until the desired setting is reached. Global Controls Navigation Key ‘The Global Controls Navigation key enables the user to navigate to any control on the Globals panel and select a specific control, Pressing this button the first time selects the Infusion Control which is the first control on the Globals panel. The selected control will be highlighted with a golden outline. Each successive press of the Global Controls Navigation key causes the next available control on the Globals panel to be selected, An exception to this rule occurs if the Infusion Control is selected. In this case the JOP ‘Compensation button on the control is selected to adjust [OP settings, ‘Surgery Sereen Navigation Key ‘The Surgery Soren Navigation key is a four way switch that enables a remote control user to move up, down, left and right on the surgery sereen and to select the controls and/or panels on the screen. Once a control is selected, the user can press the Parameter Value Adjustment keys to increase/decrease the control parameters. ‘The Navigation Key is valid when the Surgery screen is being shown, but is invalid when a popup is displayed, Parameter Value Adjustment Up/Down Keys ‘The Parameter Value Adjustment Up/Down keys are used to adjust settings (parameters) in a Surgery Control Panel that have adjustment arrows (ie., pressure, vacuum, cut rate). Surgery control panels are selected via the Navigation Key and a blue border indicates the panel that is selected. Previous Step/Next Step Keys ‘The Previous Step/Next Step keys are used to move left and right through the surgery steps at the bottom of the Surgery screen. In the Surgery screens, when the Previous Step/Next Step key is pressed on the remote, the system selects the next step to the left or to the right. If i isa valid step, it will be selected immediately without having to press any other keys. Continuing to press the keys causes the system to move ‘through the steps and wrap around to the beginning step. It is not possible to access the submodes from the Remote Control Unit. ‘The Previous Step/Next Step keys can also be used in an information popup to select button (e.g., OK, Cancel, Save, ete.), Enter Key The Enter key is used to enable/disable a selected control. For example, if the vacuum control On/Off button is selected (highlighted with a gold border), pressing the Enter key alternately toggles the control On and Off. The Enter key is also used to move through the submodes of a surgery step. If the current surgery mode has submodes, pressing the Enter key once causes the submoces to be highlighted with a gold border. Additional presses of the Enter key (while the submodes are highlighted) causes the system to select the next submode to the right and eventually wrap around to the leftmost submode. 210 (8065752231Constelfation® Vision System Remote Control Batteries ‘When the batteries in the remote control are low, the status message “Remote Battery Low” will appear in a popup dialog the first time @ key is pressed after the system is turned on, ‘The message will disappear after new batteries are installed and a remote control key is pressed. A battery holder inside the remote holds three (3) AAA (LR3) batteries. Selecting Remote Control Channel The remote control can be configured (o operate on one of four channels. This feature allows four remote controls to independently control four Constellation® Vision ‘Systems operating in the same room or area, Remote controls are factory preset to channel A. For proper remote operation, the Constellarions® Vision System must be set to the same channel as the remote. ‘The Option/System Settings/Remote Control window allows the selection of four remote receive codes: A,B,C, & D. This selection must correspond to the channel selection on the remote control. Set the remote channel as instructed below. ‘To select a remote channel on the Constellation® Vision System: 1. Press the Options button to open the Options popup screen. 2. Press the System button to bring up the System Settings screen. 3. Press the Remote Control tab to display the Remote Control Settings screen (see Figure 2-5) 4. Hold the remote control in front of the Constellation® Vision System display screen and simultaneously press its parameter value adjustment upldown keys. ‘After the system emits a sound acknowledging the action, simultaneously release the buttons. 5. On the remote control, press the Navigation key corresponding to the new channel as labeled in the Remote Control Settings screen. 6. On the display, press the Save button to save the change (pressing Enter twice on the remote also saves the change), or press Cancel to return to the main screen without saving the changes. No additional steps are needed once the remote channel is set, and only one remote channel is stored per unit. NOTE: The Alcon remote control is common to several Alcon instruments. If necessary to distinguish between remote controls, identify the remote controls and the units with unique labels, CAUTION Do not sterilize the remote control as it will damage the unit. Figure 2-5 Remote Control Channel Selection ‘Screen (Options\System\Remote Control tab) 005752281 21Constelfation® Vision System FRONT PANEL DISPLAYS AND TOUCHSCREEN ‘The Constellarion® Vision System front display panel and touch screen has a flat, non-glare surface, and is mounted above the console. Control buttons are located within the aetive touch screen area. There are three basic types of push-button on the display screen: up/down arrow buttons, sliders, and momentary buttons. The user can press and hold the up/down arrow buttons until the desired adjustment is complete, or press the momentary buttons with a single push-and-release to activate a function, ‘The Constellation® Vision System emits an audible tone to indicate button activation, Activation of a valid touchscreen button or remote control button resuilts in a valid key tone; an invalid button results in an invalid key tone, and, in some circumstances, its icon symbol is ghosted to indicate an invalid function. ‘There are four types of display screens: the Setup screen, Surgery screens, End Case, and Popups (sometimes referred to as dialogs). + The Setup screen is used to prepare for surgery; ic., connecting instruments, priming the fluidic management system and testing the handpiece. + Surgery screens contain surgical settings for each of the current surgical procedures. Settings can be adjusted by pressing the touch screen buttons for the associated controls, * The End Case screen provides the user with a summary of the case and a tabbed. interface area for display of the various metrics associated with the case ‘+ Popups are displayed as a result of selecting an option from the Options drop list (ie., System Settings, Doctor Settings, etc.) or pressing the Footswitch button, Popups enable the user to view and modify system settings, doctor settings, and some surgical settings. There ate also popups displayed to advise or warn the user of a situation, or to indicate progress on a funetion in the Setup screen, Startup Screen Figure 2-6 Upon power-up of the system, an introductory sereen is displayed as shown in Figure 2-6 while the system completes initialization and self-test diagnostics. All user inputs are locked out while this screen is displayed. If initialization is successful, the main screen is displayed as shown in Figure 2-7. The Startup Screen bie "8085752231Consteltation® Vision System Main Screen “The main screen is divided into three areas: Menu Bar, Globals, and the System State area as shown in Figure 2-7. The Menu Bar provides selections that are available in any system state, The Globals area provides control of functions that are available in all surgical modes and for any system state. The System State area provides specific information for one of the following available states: Setup, Surgery, or End Case. ‘These states are selected by pressing the associated tab in the menu bar. Figure 2-7 shows the Setup state. TE. an @ rau of Qrvermn Qi imnrmene Figure 2-7 The Main Screen 18065752231 213Constelation® Vision System Menu Bar Figure 2-8 below shows the Menu Bar section of the screen. This portion of the sereen is always available regardless of the System State. The menu bar allows the user to change various high-level functions as well as certain system options. SoS 5. @ vem Q rns Footswitch Icon Sereen Navigation Tools Procedure Selection a oo Qa Greve, | Grmsnrs (GO ratwen rm @encne Gomme [Ginn Qomrme rm Qa Qe | Qrm looms | Ome Figure 2-8 The Main Screen Menu Bar Menu Bar: Footswitch Icon ‘The Footswitch icon provides feedback relating to the current state of the main console footswitch as follows: * The icon displays the current position of the treadle indicated by the number shown on the icon. + When a bution on the footswitch is pressed, the icon shows which button and, when applicable, which way it was pressed. baa ‘8085752231Constelfation® Vision System Selecting the Footswitch icon displays the Footswitch popup shown in Figure 2-8. ‘This popup shows the footswitch with labels indicating the current mapping for each bbutton, Pressing the Configure button closes the popup box and displays the Doctor Settings screen with the Footswitch tab selected. In this screen the footswitch can be configured as desired. Refer to Doctor Settings/Footswitch later in this section for detailed information on configuring the footswitch, ‘Menu Bar: Doctor Selection Menu Bat Pressing the Doctor Selection button displays a popup with the names of all available doctors, Selecting one of the entries will change the currently selected doctor and also update the current procedure and — if in surgery — the current step. New doctors can be added to the list by pressing the “Add Doctor” button, When this entry is selected, a keyboard is displayed allowing the user to enter a new doctor. The new doctor is automatically selected if the name is valid (the name cannot be more that 40 characters or a duplicate name). If the name is identical to a doctor already in the system, an advisory is displayed felp (?) Button Pressing the Help (?) button displays a popup that provides selections to display Help ‘Videos and the User Manual, Menu Bar: Procedure Selection ‘The Procedure Selection popup (see Figure 2-8) contains the names, sorted alphabetically, of all available procedures for the current doctor with the currently selected proceclure highlighted. To select another procedure, simply press the desired procedure. The procedure will become highlighted and the popup will close. The Close button can be used to exit the popup without changing the procedure. Pressing the "Add New Procedure" button starts the process of adding a new procedure to the list of available procedures for the currently selected doctor. Refer to the following section entitled "Adding a New Procedure" for detailed instructions on adding @ new procedure and a description of the screens used to setup the procedure. ADDING A NEW PROCEDURE... “To add a new procedure to the list of procedures available to the current doctor, follow the steps below: I. Press the "Add New Procedure” button in the Procedure Selection popup. A keyboard is displayed allo 1g the user (o name the new procedure. 2. Using the keyboard, enter the name of the new procedure then press "Save". ‘The keyboard popup closes and the Modify Procedure dialog is displayed as shown in Figure 2-9. ‘The Modify Procedure dialog is used to create custom surgical procedures. The popup presents a scrollable list of available surgical steps the user can add to the procedure being created or modified. Note: Procedures can also be modified in Surgical mode by pressing the Modify button. In addition to adding steps, the user can also remove, rename, and move steps within the current procedure. The steps can be manipulated using the buttons in the Modify Procedure dialog or by Drag-and- Drop functionality; ie., press and drag the step icon to the new location. ‘3085752281 218Figure 2-9 Constettation® Vision System In general, customization of a procedure is performed by selecting a step from the list of available source steps in the Procedure Manager and inserting the step into a list of destination steps in the upper panel named "In Procedure", Only the current procedure can be modified. The available steps in the Procedure Manager can be filtered as desired using the selections in the "Filter by:" drop down menus, Creating Or Editing Procedures As shown in Figure 2-9, the name of the current procedure is shown at the top of the screen. This is followed by the steps comprising the current procedure. Below the current procedure steps is the Procedure Manager which contains a complete library of steps that can be added to the current procedure. Procedure Modify Screen The items on the Modify Procedure dialog are defined and operate as follows: In Procedure: xxx - Displays the name of the procedure to be modified. Left bution - Moves the selected step one position to the left. Add to Favorites button - Adds the selected step to the Favorites panel Rename button - Opens the keyboard popup to enable renaming of the currently selected step. Delere button - Deletes the selected step from the list. Right button ~ Moves the selected step one position to the right. Arrow buttons - Scrolls the list of steps left or right. Procedure Manager Panel - This panel contains the list of steps available for insertion into the In Procedure list. Pressing the arrows on the scroll bar scrolls through the complete list. Also included in this panel are the following filters: + Add to Favorites button - Adds the selected step to the Favorites panel. + Add bution - Adds the selected step to the list of steps in the current "In Procedure" steps list * Doctor Step Filter - Restricts the available steps to those belonging to the specified doctor’s procedures. 218 8065762281Consteifation® Vision System + Procedure Step Filter ~ Restricts the available steps (o those belonging to the specified Procedure. + Mode Step Filter - Restricts the available steps (o those belonging to the specified Step. + Favorites - Pressing this button displays the steps that have been added to the current doctor's Favorites list. Trash icon - Allows for removal of the selected step from the In Procedure steps list or Favorites List by dragging the step onto the icon, Close button - Closes the popup and saves all changes to the current procedure Note: The changes are saved in temporary memory only. To save changes after the system has shut down, the procedure must be saved from the Quick Save popup. If ho steps are in the procedure an error message is displayed saying, “At least one step ‘must be added to the procedure”, Cancel button - Closes the popup and discards all changes made to the current procedure. EDITING THE CURRENT PROCEDURE: 1. To filter the available steps listed in the Procedure Manager, set the Doctor, Procedure, and Mode Step filters so that only the desired steps are shown. The system default is to show all available steps. 2, To adda step to the current procedure, select a step from the Procedure Manager steps list and then press the Add button. When pressed, the selected step is inserted into the In Procedure panel at the position immediately following the curently selected procedure step. Alternatively, the same action can be performed by selecting and dragging the step into the In Procedure panel. To ensure step name uniqueness, if the name of the added step matches the name of an existing step in the procedure, the step name is modified by appending a numeric suffix (e.g. Vitrectomy2). 3. To move a procedure step to the left or right, select the step and drag it to the left or right, Altematively, select the step and press the left or right buttons. 4, To remove a step from the procedure, select the step from the procedure then press the Delete button, EDITING THE FAVORITE STEPS LIST: 1. To adda step from the procedure to the list of Favorites steps, sclect the step from the procedure then press the Add to Favorites button. Upon being pressed, the procedure step will be added to the end of the Favorites list. If a step is added Which has the same name as an existing Favorite Step, a prompt is displayed stating: "Overwrite existing favorite step with the same name?" If the user replies Yes, the existing Favorite Step is overwritten. If the user replies No, the keyboard is displayed allowing a new step name to be entered. 2. To delete a Favorites step from the Favorites list: press the Favorites button, select the step from the list and press the Delete button (8085752231 BATConsteilation® Vision System ‘Menu Bar: Options Pressing the Options button on the Menu Bar displays the Option Selection popup shown in Figure 2-8, Each of the four tabs contains various options that may be adjusted. SETTINGS: Doctor; System MAINTENANCE: Test Instrument; Clean Cassette; Change Drainbag; Field Service EXTRAS: Auto Gas Fill; Consumables; Update INFO: View/Copy/Delete; Event Log; About DEMO MODE: The Constellation® System “Demo Mode” allows the user to interact with the user interface without being affected by missing or non-functional hardware. For example, in Demo Mode the user can program certain screens without having any source pressure connected. The only visible difference is that "DEMO MODE" is displayed in yellow text in the upper left corner of the display above the footswitch icon. For additional details on using the system in Demo Mode, refer to the section entitled "Demo Mode" later in this section of the manual. RESTART button: Pressing this button causes the system to reboot and then return to the setup screen. Restarting the system may be required if the system displays a system fault SHUTDOWN button: Pressing this button causes the system to shut down, CLOSE button: Exits the popup. Menu Bar: Options - DOCTOR SETTINGS Selecting Doctor from the Options menu displays the screen shown in Figure 2-10. Itallows the user to specify doctor specific configurations in the following areas as indicated by the tabs at the top of the popup window: * General Preferences Surgical Preferences Footswitch programming of buttons and treadle Laser settings including laser footswitch programming Volume levels for all sounds ‘The Save, Cancel, and Revert to Defaults buttons apply to all tabs. + Save Button - Saves the modified items on all the doctor settings tabs and also applies the settings to the current surgery sereen (if applicable). + Cancel Button - Exits the popup without saving or applying any settings. + Revert To Defaults Button - Resets all the configurable items on the current settings tab to default values 218 (6085752251Constellation® Vision System Menu Bar: Options - DOCTOR SETTINGS - GENERAL ‘The General Preferences tab contains the following items: + Language - Drop down list that allows the user to select the language for labels and annunciations. The drop list contains an entry for English and for each language pack installed on the machine. * Heel Double Click - This selection determines whether or not heel double click functionality is available. Choices: Enabled or Disabled + PIN - This section allows the user to add a Personal Identification Number (PEN) that must be entered before accessing that doctor’ 's settings. ~ Add Button - Pressing the Add button displays a numeric keypad that enables the user to enter a PIN. The PIN must be entered twice before if can be saved in the numeric pad dialog. Not present for Default Doctor. ~ Modify Button - Allows the user to change an existing PIN for a doctor. Not present for Default Doctor. - Delete Button - Allows the user to delete an existit present for Default Doctor. + Standard vs, Advanced Display Modes - The Standard display mode offers a minimum number of options on the associated panels. In Advanced display mode, the displayed panels offer optional controls for setting and configuring functions. the default mode is Standard. Advanced display mode is available in the following panels: Extraction, Vit Cutting, Ultrasound, and Vitrectomy Bimanual. + Display Submode in Custom Procedures -’This option applies to Custom procedures only. When enabled, submodes are automatically displayed on the step panel, When disabled, submodes are not diplayed unless the user taps the step icon in the step panel. PIN fora doctor. Not Languoae ‘tration spayed | ii ctl ccsatondecl Advanced. ..| estDouble ek ‘Mucutingbieplaytioas ito nee ccstit Atone Pw ‘Utresoundbepley ede Qu tenet il eu cn nara eae | Sorts | @ vss | puintimetocatoarencin | Snide Disable | Figure 2-40 13065752281 219Constellation® Vieion System Menu Bar: Options - DOCTOR SETTINGS - SURGICAL ‘The Surgical tab contains three sub-tabs that are related to surgery: Infusion/ Irrigation, Reflux, and General Menu Bar: Options - DOCTOR SETTINGS - SURGICAL - INF/ARR ‘The Inffirr (Infusion/Irrigation) Surgical sub-tab (shown in Figure 2-11) allows the user to change certain preferences related (o infusion and isvigation during surgery. * Infusion Units - Allows the user to specify the units (mmHg ot cmH20) used for the Infusion Global control. * Irrigation Units - Allows the user to specify the units (mlg or emH20) used for the Irrigation Global control and Continuous Reflux. + Blevated Infusion Alarm Set point - Allows the user specify which infusion Value should be regarded as elevated. When the current infusion setting equals or exceeds the specified value, the elevated infusion timer is started. NOTE: The timer is applicable to both liquid and air infusion. + IOP Control - The IOP Control mode compensates for the pressure drop caused by fluid flowing through the infusion tubing set to provide a constant IOP. IOP. ‘compensation is available only with premium cassettes in posterior and combined surgical modes, + IOP Control Limit - The IOP Control Limit specifies up to what infusion flow rate, compensation for the pressure drop in the infusion tubing set should be applied. At flow rates higher than the set infusion control limit, JOP will drop and no longer be maintained at the requested IOP set point. The IOP Control Limit is only applied when aspiration is turned off. Its main function is to reduce the fluid flowing out of the open trocar cannulas during instrument exchanges. rns = { testen bats hte ap | wees ona SablslicsDiledass] __totot | iat sai seit | 226810" ConeelL ess) 2IGAIOP Contain ny ROAIOFConvelL i 0s) ‘7s Cone me Figure 2-11 The Doctor Settings Popup - Surgical/intlrr Tab (Options\Settings-Doctor\Surgical\intier) 220 ‘3086752231Consteilation® Vision System Menu Bar: Options - DOCTOR SETTINGS - SURGICAL - REFLUX ‘The Reflux sub-tab (shown in Figure 2-12) allows the user change certain preferences related to reflux during surgery. + Postetior Reflux Mode - Allows the user to choose which reflux mode, Proportional or Micro, should be the default in the posterior steps. + Anterior Reflux Mode - Allows the user to choose which reflux mode, Continuous or Micro, should be the default in the anterior steps. + Proportional Reflux Set point - Allows the user to choose the set point for proportional reflux, Range: 0 — 120 mmlig. + Micro Reflux Set point - Allows the user to choose the set point for micro reflux. Range: 10, 25, 50, 75, or 100% + Continuous Reflux Set point - Allows the user to choose the set point for continuous reflux. Range: 0 — 163 cmH20. Peso Rectlode Ane enatage toe mate Cannan nena, <= Cs] Propaonal Ret Pe Mer Rex Cennaous namaste Figure 2-12 The Doctor Settings Popup - Surgical/Reflux Tab {Options\Settings-DoctoriSurgicaliReflux) 065752201 221Consteliation® Vision System Menu Bar: Options - DOCTOR SETTINGS - SURGICAL - GENERAL ‘The General sub-tab (shown in Figure 2-13) allows the user to change the following preferences related to surgery. OZil®/Phaco Sequence - When an OZil® torsional handpiece is being ised, the OZil®|Phaco Sequence setting selection determines whether the torsional or phaco pulse leads the sequence as shown in the illustration in Figure 2-13. Diathermy Control ‘Type - Allows the user to determine the type of dia Fixed or Proportional, to be used for the current doctor. Surgical Tool Preferences - Sclection determines the default tip selecte specified handpiece types Patient Bye Level Offset - The correct Patient Bye Level Offset setting thermy, cd for the is necessary to ensure that the displayed console readings reflect the true pressure being delivered to the eye. The Patient Eye Level Offset is the vertical di from the patient's eye (while lying on the operating table) to the bottom listance row of connectors on the cassette (see Figure 2-13). This variable distance represents an amount of fluidic pressure that may add or subtract from the pressure displayed on the console. The Patient Eye Level Offset allows the user to enter this distance so the system can compensate for the fluidic pressure variable, NOTE: On the Constellation® Vision System, the height or position of the infusion bottle does not affect infusion pressure delivered to the eye. Patient Eye Level Offset Units - Allows the user to determine the units associated with Patient Eye Level Offset values, The unit options are inches (range = 0-39) or centimeters (range = 0-100). bee "8065752051Constetlation® Vision System i ‘ai irkacosonunes ahey conta Type bee. J s A Sula Torte Patty Lavloneet Shcohibtonin woamemped iste oat tts mt Te Figure 2-13 The Doctor Settings Popup - Surgical/General Tab (Options\Settings-Doctor\Surgical\General) ‘8085752281 223Constellation® Viston System Menu Bar: Options - DOCTOR SETTINGS - FOOTSWITCH Figure 2-14 Selecting the Footswitch settings tab from the Doctor Settings screen allows the user to specify functions for footswitch buttons and configure the treadle detents and transitions (see Figures 2-14 through 2-16) °° Wa ee es eee Doctor Settings - Footswitch Buttons Screen (Options\Settings-Doctor\Footswitch) ‘Menu Bar: Options - DOCTOR SETTINGS - FOOTSWITCH BUTTONS ‘The Footswitch Buttons screen allows the user to change the action of each footswitch button associated with the currently connected surgical footswitch. Hach button is labeled with its currently programmed action, and tapping on the label displays a menu that lists the all possible actions for that button in the current mode (see Figure 2-15). Below the footswitch, each mode for the currently selected domain (Posterior or Anterior) is displayed. Table 2-1 lists the default button configuration for each mode and submode. The system is shipped with this default configuration and ‘apping the Revert to Defaults button returns all modes to the default configuration EXAMPLE: Changing the button configuration In the Footswitch Buttons Screen, follow the steps below to change button actions. 1, Select the domain: Posterior or Anterior. Select the mode. If applicable, select the submode. Select the label next to the button to be changed. The Footswitch Action Selection popup shown in Figure 2-15 appears with the available selections, 228 18065752031Constellation® Vision System 5, Select the desired action from the list shown on the popup. To show additional actions, use the scrollbar to the right of the list. 6. Select whether to apply the change to the current mode/submode or to all ‘modes/submodes for which the footswitch action is valid in the current domain Selecting cancel will close the popup without changing the button action. NOTE: When mapping the footswitch button actions to perform diathermy, the horizontal switches do not meet the specification of minimum activation force of 2.25 pounds. It is not in accordance to the governing standards, to have the diathermy activation mapped to the horizontal switches. GET ane azo ©) tepiainoos Figure 2-15 Footswitch Action Selection Popup 065752231 2.25Constellation Vision System Table 2-1, Default Footswitch Button Actions PosTERiOn moos | sutmode | VE, | vettina | tortion | RS, |g RM | mom 20 | ovary [kone [Tocoumose] mrenras | cures | noasien | Me emmy | oemeiy | Reka | avin son | Anes | MRO” [ne sien Prapiec | istmy [Rema ['eeSubro | AONPAR | Careoae | new up © | suvcmy [ rom [Rea] aoe [ose | secoen ee Hipear | Statrermy | Ronin | Prove Soe | Aires | US Tooue | Next step Ce ee ed 7 Binal OFF tarusin| =| oistemy | ren [Mat Suinod| nina Sten Nextt Sure Ca ee Ee ed ee Fro | o1anamy | norton [om ewnacl| TnsonFAX T Acton | nent Sop rowers |= oiatomy | norman [Vecumeil| ‘sina | A raton | nna up ee a ed a ( ee ee ee ee tomer |= [sister [ron [Neocon | Nocona | non up ee es ed ee eee ANTERIOR Mocs | Svbrod | vere | vonsona | toteel | aa, | ate, | memnen [__22__| emery | Renn | Mrevees Ss | Aiheg ne | wg ie | New Sep ee es ee ed Phaco ‘Custom Diathormy Reflun ledobl oe ‘eames iiaerae Next Stop Ee es ee ed ee ee ed ee uA = [_oemmrny [ret [ems] Troninaay [Cotas vx Sap ee weir, [ony | oman [ams Rings | ornoe [ame | a ee ee ee am SODSTeDTConstellation® Vision System Menu Bar: Options - DOCTOR SETTINGS - FOOTSWITCH TREADLE The Footswitch Treadle screen shown in Figure 2-16 enables the user fo program the treadle vibration, detent firmness, and spans. Depending on the current surgical mode and sub-mode, the treadle has either 2 or 3 functions and the user can program the treadle travel of each position. + 2-Function Footswitch Transition Position - Sets the transition position (% of treadle travel). Valid range: 20% - 80% + 3-Runction Footswitch Transitions = Point { - Sets the transition position (% of treadle travel) for transition point 1. Valid range: 15% - 31% - Point 2 - Sets the transition position (% of treadle travel) for transition point 2. Valid range: 50% ~ 100% + Vibration Enable/Disabled - Allows the user to enable/disable treadle vibration (for both treadle up and treadle down). * Vibration Frequency - Adjusts the vibration frequency of the treadle when it goes through detents. + Treadle Firmness - Adjust the firmness of the treadle in a range from 0 to 100%, * Ramping (%) - These controls set the ramping percentage (%) for each of the modes specified. The ramping percentage determines how quickly cach specified 3D mode (Vit 3D, Phaco 3D, or Frag 3D) will ramp up to its start value. For alll three modes the valid range is 15% - 90% and the default is 15%. ‘one sree any | a ae am These Figure 2-16 Doctor Settings - Footswitch Treadle Screen (Options\Settings-Doctor\Footswitch) 8085752281 227Constellation® Vision System ‘Menu Bar: Options - DOCTOR SETTINGS - LASER ‘The settings available in the Laser settings screen are for setting the Revert to Standby Timeout and Footswitch Configuration (see Figure 2-17). Footswitch Configuration The Footswitch Configuration setting allows the user to enable the side switches 10 control laser power and transition the system between Ready and Standby. Three options are available as follows: Power Control and Ready Standby ‘When this selection is enabled, the user can transition from Standby to Ready by pressing the right side switch longer than the selected (Hold) Duration. A tone sounds when the transition is complete. Similarly, pressing the left side switch longer than the selected (Hold) Duration will transition the system from Ready back to Standby. Pressing the side switches for intervals shorter than the selected (Hold) Duration will increase or decrease treatment laser power. Power Control Only This selection allows the side switches to increase (right switch) or decrease (eft switch) the treatment laser power, Standard This setting disables the side switches entirely. Power control and switching from Standby to Ready mode can only be done from the front panel of the system. ost ke Re. EE Foote ancl (oe craon i css teil itl Yo Feta torunton Serer cee | vette Tet i ec Ma a A ‘az Ondang yds | fe uo s Nila) |. pactee toss! {i Figure 217 Doctor Settings - Laser Screen (Options\Settings-DoctoriLaser) 228 18065752231Consteliafon® Vision System (Hold) Duration ‘The (Hold) Duration setting allows the user to select the duration of time that a side switch must be held in order to activate the transition to Ready mode (right switch) ot Standby mode (left switch). The range of selection is from 0.5 second to 1.5 seconds in 0.1 second increments. Revert to Standby Timeout ‘This setting determines the time period, in minutes, after which the system will revert to the Standby mode of operation due to inactivity. Inactivity is defined as no footswitch activation during the time period. The setting can be adjusted to 2, 5 or 10 minutes. Aiming Beam On During St: ndby Mode ‘This setting determines whether or not the aiming beam is on during Standby Mode. If "No" is selected, the aiming beam will be on in Ready mode only. Menu Bar: Options - DOCTOR SETTINGS - SOUND SETTINGS jure 2-18 Selecting the Sounds tab displays the screen shown in Figure 2-18. This screen enables the operator to set a volume for all continuous tones as well as voice confirmations for each doctor. In addition to volume level, the operator can also enable/disable a sound, except for the following, which can never be completely turned off: + Diathermy + Laser + Errors + Phaco Occlusion + Invalid Key + Voice © Infusion Alarm Each sound can be changed individually or all at once by enabling the Master Override button. a Doctor Settings - Sound Screen (Options\Settings-Doctor\Sound) ‘085752291 2.28Constellation Vision System ‘Menu Bar: Options - SYSTEM SETTINGS Selecting "System" from the Options menu displays the screen shown in Figure 2-19 This popup screen allows the user to configure settings that are part of the system's normal operation. Once saved by pressing the Save button, the settings become the default when the system is powered up. SYSTEM SETTINGS - SETTINGS ‘The Settings screen allows adjustments to the following system parameters: * Sereen Brightness - Sets the relative brightness of the touch screen. The allowable range is 1 ~9, with 7 as the default, * Language - Allows the user set the language used for system purposes such as end case reports, * The Current Printer field displays the currently connected printer by host name or IP address. Pressing the Configure Printer button displays the Configure Printer popup where the following selections can be made: ~ Print Format ~ Postscript or PCL - Printer Location! - Auto Search mode displays a list of printers found via UPnP (Universal Plug and Play) protocol (wireless connection). Manual entry mode provides a numeric keypad so the printer's IP address can be directly entered into the system. * Auto Gas Fill Purge Cycles - Allows the user determine the number of purge cycles (1-3) when performing an AGF. 1 If equipped for wireless connection. a ange iON ssl | mito ae Figure 249 System Settings - Settings Scroon (Options\Settings-System\Settings) 230 18065762281Constelation® Vision System ‘Menu Bar: Options - SYSTEM SETTINGS - CONNECTION ‘The Connection sereen shown in Figure 2-20 allows the operator to specify network connection information for the instrument to communicate with the Alcon Enterprise Server for remote service activities. Network Connection!: = Configure Button - Pressing the configure button displays the Network Configuration popup where the system displays all wireless networks that have been added to the system, The user can select the desired WiFi profile from the drop-down list or Add, Edit, and Delete profiles as necessary by pressing the associated button. Required information for configuring a wireless profile includes the 32 character SSID, Authentication, Encryption, and the Passphrase. Pressing the button to the right of the SSID and Passphrase fields will display a keypad for entering the required information. It is recommended to contact your Information Technology department for assistance in configuring the system for your network. + Bnabled ~ Indicates the connection is active and available for use. + Disabled - Connection is not active or not available for use. + Connection Status - Indicates the connection status of the network, printer, and barcode reader. ‘eConnectivity!: + Enabled ~ Indicates the connection is active and available for use. + Disabled - Connection is not active o not available for use. + Time of Day - Allows selection of time slots in 0.5 hour increments to schedule connection activities, + Recurring Frequency - Indicates at what frequency a connection will be made: Daily - Every day at the specified time. Weekly — Once a week at the specified time on the specified day of week. Monthly ~ Once a month on the specified day of month and time of day. Note: Selecting a day greater than 28 will prevent a connection from occurring in all months. 71 Ifequipped for wireless connection. 18065752231 231Consteltation® Vision Systom eat tad mie Kc eset A tote A Setanta | Eicape. ated Figure 2-20 System Settings - Connection Screen (Options\Settings-System\Connection) 232 18085762091Constelfation® Vision System Menu Bar: Options - SYSTEM SETTINGS - REMOTE CONTROL For information regarding the Remote Control settings, refer to the Remote Control description found earlier in this section. Menu Bar: Options - SYSTEM SETTINGS - VIDEO OVERLAY STANDARD DEFINITION VIDEO OVERLAY If a Standard Definition Video Overlay card is installed in the system, the Video Overlay setting screen shown in Figure 2-21 provides the settings to enable and setup the Video Overlay system with the Constellarion® Vision System. See Section Three for a diagram of connections made when connecting a camera, video recorder, and monitor to the system. + Video Overlay - Allows the user determine whether or not Video Overlay is available. Choices: Enabled ot Disabled. + Video Broadcast - Allows the user determine the video format (NTSC or PAL). + Video Connection - Allows the user set the type of cable (S-Video or Composite) used to connect to the video recording equipment. + Label Opacity - Allows the user determine the opa (range: 0 - 15). + Transparent Text - When Transparent Text is enabled, the text shown on the monitor is transparent so the image on the screen can be seen through the text, When disabled, text is displayed on an opaque box to provide greater contrast with the image. + Monitor Type - Selecting "Wide Screen" adjusts the position of the text/controls as appropriate for a wide screen monitor, ity of the video overlay output ce cated scm oa aria ‘Example of screen that overlays the five video displayed on an external monitor. Figure 2-21 System Settings - Standard Definition Video Overlay Screen (Options\Settings-System\VideoOverlay) 808575231 233Figure 2-22 Constellation® Vision System HIGH DEFINITION VIDEO OVERLAY If a High Definition Video Overlay card is installed in the system, the Video Overlay setting screen shown in Figure 2-22 provides the settings to enable and setup the ‘Video Overlay system with the Constellation® Vision System. See Section Three for a diagram of connections made when connecting a camera, video recorder, and monitor to the system. * Video Overlay - Allows the user determine whether o not Video Overlay is available, Choices: Enabled or Disabled * Video Connection - Allows the user set the type of cable (S-Video or HDMI) used to connect to the video recording equipment. * Force English - When enabled, forces the text on the overlay to be displayed in English regardless of the selected doctor or system language. + Hi-Def Margin - Allows the user to set a margin in percent that defines the area in which the overlay graphics and text should be contained (range is 0.0 to 5.0 percent). Example of screen that overlays the live video displayed on an external monitor, ‘System Settings - High Definition Video Overlay Screen {Options\settings-Systom\VideoOverlay) Video Recorder - There are no controls for configuring a Video Recorder other than footswitch mapping that allows the user to start recording and pause recording When the footswitch button is pressed. A Video Camera icon appears in the upper left hand comer of the Main Constellation® screen when the recorder is recording, See Section ‘Three for information on connecting the video recorder. Bae ‘3088762231Constetlaton® Vision System Menu Bar: Options - MAIN’ ‘ENANCE Maintenance options selectable from the Options popup (see Figure 2-8) include ‘Test Instrument, Clean Cassette, and Field Service. ‘Test Instrument - Similar to the Start Prime function available on the main screen, pressing this button displays a popup that allows the prime and test of the current setup. Clean Cassette - The Clean Cassette feature allows the operator to pump the aspirated fluids from the cassette into the drainbag without having to go through to End Case. Pressing the Clean Cassette button causes the process {o begin without further user interaction, Onee the cleaning process has begun, a popup appears providing feedback on the progress of the cleaning. Note: This popup also comes up automatically when the user transitions from the Surgery screen area to End Case, if the cassette has been primed and infusion, FAX, and irrigation are not on. Change Drainbag - Pressing this button displays the "Change Drainbag* popup. Changing the drainbag, then pressing the "Done" button informs the system that a new (empty) drainbag has been installed on the cassette Field Service - Used by the trained Alcon Field Engineer to aecess system information that will aid in the servicing of the instrument. A pass code is required to access this information, Menu Bar: Options - EXTRAS Extras options, selectable from the Options popup, include Auto Gas Fill, Consumables, and Update. Menu Bar: Options - EXTRAS - AUTO GAS FILL Figure 2-23 ‘The Auto Gas Fill popup shown in Figure 2-23 steps the operator through the process of filling syringes with the specified gas (either C3F8 or SF6), In Surgery Mode, the operator can optionally use the Auto Gas Fill button within the surgery header to launch this popup. © Waeomsaen : cad | lead | | 2 ee Ge | © raregese @~ Gas Mix Ratio Guide Auto Gas Fill Popup (Options\Settings-System\Extras\Auto Gas Fill) jaoes7ez231 285Consteilation® Vision System WARNING! Be sure to connect gas bottles to the proper connectors, Bottle valves, tubing, and connectors are color coded as follows: C3F8 = Red, SF6 = Blue, 1. Make Gas Selection: C3F8 or SF6 - Gas boitle(s) are connected to system through the mechanical regulator valve located at the back of the console. 2. Press Start To Begin Filling - Press the “Start” button to start filling the syringe with the selected gas type. The button is initially disabled and is only enabled during the time period between a gas selection and the commencement of a fill operation, 3. Fill Progress - Displays the status of the fill process. After the process is complete, the number of purge eycles is displayed. The number of purge cycles is set in the System Setting screen (Options\Settings\System) and has a range from 1 to 3 cycles, The number of purge cycles affects the gas concentration percentage in the Auto Gas Fill syringe according to the following table. Number of Purge |__ Minimum Gas Concentration, [Glmin Cycles ‘SF CF 4 97.3% 97.1% 2 99.4% 99.2% a 99.8% 99.7% ‘The status bar graphically illustrates the progress of the fill operation. If necessary, press the Stop button (o stop filling the syringe in the middle of a fill cycle. The button is initially disabled and is only enabled during a fill operation. ‘The Gas Mix Ratio Guide is a tool to assist the user in calculating the syringe volume adjustments required in order to achieve the desired mixture, NOTE: Adjusting the Gas Mix Ratio Guide does not automatically fill the syringe to the desired mixture. ‘The user must manually move the plunger to make the gas volume adjustment in the syringe after detaching the syringe assembly from the console. To achieve a specific gaslair mix ratio (after the system has purged then filled the syringe to 20cc of gas), use the Gas Mix Ratio Guide as follows: 1. Move the slider on the guide to the desired percent of gas mixture, The guide displays the syringe reading that the plunger must be moved to in order to achieve the displayed percentage of gas in the syringe (18% -> 10.8 cc in Figure 2-23), 2, Foran 18% gas mixture, push the plunger from 20 ec to 10.8 ce. Then pull the plunger out to 60 ce. The resulting mixture will be 18% of the selected gas, Menu Bar: Options - EXTRAS - CONSUMABLES This button and the Consumables button displayed on the Setup screen (Figure 2-7) both display the Consumables popup when pressed. The Consumables popup is described later in this section of the manual (see Figure 2-50). Menu Bar: Options - EXTRAS - UPDATE This feature is reserved for future enhancements, 236 '2086 752281Constetation® Vision System ‘Menu Bar: Options - INFO Info options selectable from the Options popup (see Figure 2-8) include View/Copy/ Delete, Event Log, and About (system information). Menu Bar: Options - INFO - VIEW/COPY/DELETE Figure 2-24 ‘The View/Copy/Delete sereen shown in Figure 2-24 allows the user to perform data management related tasks including: + Copy data from a source memory device to a destination memory device. This is essential to backup data or to move settings to another system. © Rename selected data items including doctor names, procedure names, and surgical end case names. + Delete selected data items including custom doctors and surgical end cases. + View selected data items including doctor settings and surgical end cases. + Print selected data items including doctor settings and surgical cases. Scroll crows Copy Data Button View/CopyiDelete Screen (Options\Settings-System\lnfo) ‘The Source tab of this screen shows information about the media used as the source of a data management or copy operation. The Destination section shows the information for the media used as the targeted location to move data to. Each section shows the media options available to manage data. To select a media option, simply press the selection and the display will show the current contents in a hierarchal structure. The media options are: + System — refers to the local Constellation® Vision System file, + CD/DVD ~ Removable media. + SD-Card ~ Removable Media card. If CD/DVD or SD-Card are selected and neither is inserted into the system, a popup «will appear indicating that no media has been detected and prompting the user to insert a valid media. ‘8005752291 2.37Constellation® Vision System At the top of each section, the status of the selected media is displayed. + xx% Free - Percent of total space available for storage. In Figure 2-24, the display indicates that 52% of the system data storage media is available for additional data. + Locked — Indicates that a read-only CD/DVD is inserted into the system. ‘The Data Structure Tree displayed after media selection allows the user to rename, delete, view, or print the selected item. If any of these operations can be performed on the item, the associated button, located at the bottom of the screen, will have a dark background color. There are items such as "Default Doctor" that cannot be renamed or deleted, Tf-an item has additional items below it in the structure, selecting it will expand the structure and selecting again will collapse the structure. If the structure tree expands beyond the screen limits, scroll arrow are available in each comer to scrolll to hidden parts of the structure. To Rename an item. 1. Press the item to select it then press the Rename button. Only doctor names, procedure names, and surgical end case data items can be renamed. 2. When the Keyboard popup appears, press the Backspace key or the Clear key to delete the current name then type in the new name, 3. Press Close to save the name and return to the previous screen. Pressing Cancel will close the keyboard popup without saving the changes. To Delete an item: 1. Press the item to select it then press the Delete button, Some items cannot be deleted such as the Default Doctor. 2. When the confirmation popup appears, press Yes confirm or No to cancel the delete action, VIEWING AND PRINTING DATA Doctor Settings and Surgical end case data items can be viewed and printed. To view the data associated with one of these items, select the item then press the View button, A detailed view of the item is displayed such as the sample shown in Figure 2-25. The Page arrow buttons are used to navigate to the previous page and next page. Pressing the close button will close the View screen and return to the View/Copy/Delete sereen. ‘To print a detailed report of an item, select the item then press the Print button. A popup will be displayed indicating that the report is being sent to the printer connected to the system. Printouts of data are identical to the layout of a reports, displayed using the View button. 238 18085752251Constottation® Vision System Figure 2-25 ‘Sample View of a Doctor Settings Report COPYING DATA Copying data between the source device and destination device is performed by first selecting a source data item and then pressing the Copy Data button, When pressed, the source data item is copied to the destination device at the same location defined by the source data item (i.¢., the hierarchy is preserved). To finish the process of copying data to a SD Card or a CD/DVD, the Write button must be pressed. If there is not enough space on the remote disk, you will be prompted to remove some items and try again. Hf an attempt is made to copy a file that already exists on the destination device, a popup will be displayed indicating the file already exists and the following options are available: + Overwrite - Replaces the destination file with the new source file. + Copy - Selecting Copy opens the keyboard popup so the user can rename the file ‘The old file is not overwritten in this case. + Cancel - Stops the Copy process with no changes. + Skip - This button is displayed only when copying multiple doctors that have already been saved to the destination. Pressing the Skip button skips the current doctor listed in the upper left comer of the popup and moves to the next doctor. 085762231 289Constetstion® Vision System Menu Bar: Options - INFO - EVENT LOG Figure 2-26 shows the Event Log where system messages are displayed that have occurred during the previous seven days. The list can be filtered to display a specific type of message by pressing the associated bution on the right side of the screen. To view the Event Log: 1. Press Options from the Menu bar. 2. Under the Info tab press "Event Log.” The default view is displayed showing a list of all faults, errors, advisories, and information messages. Pressing the associated button will hide that type of message on the list. If the list goes beyond the viewable area, a scroll bar is provided to move through the list. 3. To view the details of a specific message, select the message on the list, then press View Details. A pop up appears with a description of the message and the date and time it occurred. 4, Press Close to go back to the previous screen. Figure 226 Event Log (Options\Info) Menu Bar: Options - INFO - ABOUT The "About Constellation" popup (shown in Figure 2-27) displays the software configuration information for the Host and sub modules: A\ll Languages installed in the system are also listed here, Patent information for the Constellation® Vision System is displayed by pressing the Patents button Figure 2-27 “About Constellation” {Options\info) 2ag (8086762281CConstollation® Vision System Menu Bar - Sereen Navigation ‘The Constellation® Vision System operates in one of three “System States”: + Setup — Contains the sereens for setting up the system in preparation for surgery. + Surgery — Contains the sereens for controlling and viewing surgical functions (vacuum, ultrasound, etc.) + End Case - Contains the screens for completing and reporting a case. Navigation between the System States is associated with certain rules as stated in the following table: From. To Rules ‘Setup Surgery [None Surgery | End Case | Going from Surgery to End Case will “close” the case. This includes saving case related information. To avoid accidentally closing a case, the user is asked to confirm the transition. End case | Setup [None ‘Surgery | Setup | The intended use ofthe system is fo always end each case by going to End Case. However, the user isnot forced to go through End Case to start a new case, In order forthe system to know when a case ends without going through End Caso, ‘a pop-up is displayed when navigating from Surgery to Setup, This popup asks the user whether he wants to start a new case (oF just go back to Setup for the current case). End Case | Surgery _| Not possible Sotup | End Case | Going from Setup to End Gase will cose the case. This c includes saving case related information. To avoid accidentally ( ‘losing a case, the system prompts the user to confirm the transition 8086752231 241Constellation® Vision System GLOBAL CONTROLS The Globals area of the screen allows the user to control certain functions that are available in any of the system states (Setup, Surgery, and End Case). Global functions can typically be turned on or off independently of other surgical functions (vacuum, U/S power, ete.) although in some cases global functions are required to be on in order to perform surgery. When a global function is on, the On/Off button is green and the background becomes lighter in color. Infusion Global Control ‘The Infusion global control (see Figure 2-28) is a dual function that controls both infusion and JOP Compensation (if enabled in the Options/Doctor/Surgical popup). ‘The infusion global control allows the user to: * Turn infusion On/Off. + Adjust infusion setpoints ‘+ Enable IOP Compensation mode (secondary function buttons). * Display more information that allows the user to casily make detailed changes to the infusion settings. ‘The Elevated Infusion Timer is displayed when infusion rises above the setpoint entered in the Surgical Options popup (Options/Doctor/Surgical). It displays the amount of time infusion has been elevated above the setpoint. WARNING! The closed loop system that adjusts IOP cannot replace the standard of care in Judging IOP intraoperatively. The surgeon must continue the common practice of informally judging 1OP using the following: Finger palpation on the globe Tactile feedback of the surgical instruments (eye wall deformation with manipulation of instruments) Retinal vessel perfusion/pulsations Presence of comeal edema Ifthe surgeon believes the IOP (using the techniques above) is not responding to the system settings and is dangerously high, this may represent a system failure. ‘The surgeon can do one or more of the following as they deem appropriate in this situation (with care to avoid sudden hypotony): + Close the infusion stop-cock + Pinch the infusion line + Remove the infusion line from the sclerotomy ‘The More Information popup for Infusion allows the user to quickly set values for its two different set points: + Regular infusion - Infusion value the system will go to upon entering infusion mode, + Alternate infusion - Infusion value the system will go to when the footswitch button is pressed that is assigned the "InfusionFaxAltRegularToggle” action. Additionally, the popup contains a Change Bottle button that will open the Fluid Container Setup popup discussed later in this section. baa '8065752251Constellation® Vision Systern INFUSION GLOBAL CONTROL (IOP NOT ENABLED) {Infusion Ont OfButon_— ~e Ra Infusion Source ——™" NOTE: Moro information Popups have bulin tiers that alow them fo fade away attra fow seconds of Inacily, in addon, pressing “anywhere outside the popup causes It disappear. INFUSION GLOBAL CONTROL (IOP ENABLED) Infusion On! OffButton____ ay (Only displayed when IOP is: ‘enabled-soe Options monty) Infusion Flow’ Infusion Set point/Actual Value Infusion Units Increase Value Button Elevated Infusion Timor egy 0.0 _ ser) Decreases Value Button Infusion Flow Units More: {nformation Infusion Sot poinActual Value Infusion Units | — Increase Value Button (3 —Eovated Infusion Timer 9. — one ts at Figure 2-28 Infusion Global Control 19065752281 23Figure 2-29 Consteilation® Vision System Fluid/Air Exchange (FAX) Global Control The FAX global control turns Fluid/Air Exchange on/off and adjusts the setpoints ‘The More Information popup is designed to enable the user to quickly set values for its two setpoints: * Regular FAX - Value the system will go to upon entering FAX. mode. * Alternate FAX - Value the system will go to when the footswitch button is pressed that is assigned the "InfusionFax/AltRegularToggle" action, ‘The Elevated Infusion ‘Timer is displayed when infusion rises above the setpoint entered in the Surgical Options popup (Options/Doctor/Surgical). It displays the amount of time infusion has been elevated above the setpoint, FAX Set poinlActual Value FAX Onl Off Bution FAX Global Control Irrigation Global Control The Intigation global conttol tums Irrigation On/Off and adjusts setpoints. The More Information popup for Irrigation allows the user to quickly set values for its two different set points using the slider controls: * Regular Intigation - Irrigation value the system will go to upon entering Irrigation mode. + Alternate brigation - Irigation value the system will go to when the footswitch button is pressed that is assigned the "Irrigation AlVReg Toggle" action. Additionally, the popup contains a change hottle bution that will open the Fluid Container Setup popup discussed later in this section. aaa {8065752051Constelfation® Vision System Irigation Set point/Actual Value ito sr —-@, 65 Button = itt, Decrease Value button Irrigation Source’ lnigation Units More Information ti £ Rt ATES Figure 2-30 Irrigation Global Control Diathermy Global Control Diathermy Global displays the diathermy mode (fixed/proportional), displays the setpoint/actual value, and adjusts setpoints. The mode can be selected from the More Information dialog by selecting either Fixed or Proportional. Selecting Fixed diathermy provides a fixed percentage of diathermy power when the mapped footswitch bution is pressed. Proportional diathermy increases the diathermy power in proportion to the distance the footswitch treadle is depressed, In Proportional Diathermy mode, pressing the mapped footswitch button displays the Proportional Diathermy progression box. When the progression box is displayed, depressing the treadle increases the diathermy power. Foxod Increase Value button Decrease Value bulton se foe Figure 2-31 _Diathermy Global Control jaoas7s2291 245Figure 2-32 Constallation® Vision System Muminator Global Control ‘The Illuminator Global control turns up to four illuminators on/off and adjusts setpoints. The bulb usage indicator ting light that surrounds the On/Off button, shows how long the illuminator bulb has been in use, This indicator ring has three indication colors: * Green: 0 to 199 hours + Yellow: 200 to 399 hours + Orange: greater than or equal fo 400 hours lumination Onvort Muminator Set point/Actual Value Button and usage ring Increase Value bution Decrease Value button tursination Units |< — More information Mluminator Global Control ‘The More Information popup for the Muminators allows the user to set values for the setpoints and confirm lamp hours. ‘The system automatically sets the upper limit for each probe by reading the RFID tag for the probe. The surgeon has the ability to override this automatic upper limit for luminous flux, but if he does so, pop-up will appear that will alert him to the consequences of doing so (.¢. reduction in exposure time to give the equivalent aphakic energy exposure). If four illuminators are available, the More Information popup allows for the setup of all four illuminators in one screen. WARNING! ‘To minimize hazardous light exposure, operate light source at lowost intensity setting consistent with adequate visibility of the surgical area. CAUTION Avoid prolonged operation of any fiber optic endoilluminator probe in alt, This may result in tip deformation of plastic fiber optic endoilluminator probes. This system will display the following advisory to indicate this condition: "Further increasing the output level in air can damage fibor tins. Would you like to continue?” Avoid placing illuminated fiber optic endoilluminator probes in contact with materials such as sterile drapes. NOTE: Light output from a new lamp may greatly exceed the output from the old lamp. Adjust output to lower settings after installing a new lamp, ae (8065750231Constefation® Vision System SYSTEM STATE AREA Setup ‘The System State area provides specific information on one of the following available states : Setup, Surgery, or End Case. These states are selected by pressing the associated tab in the menu bar, ‘System setup can be accomplished using the seven setup panels shown in Figure 2-! the Detailed Setup screens, or a combination of both. The Detailed Setup screens are explained later in this section and include much more detailed information than the Setup panels. In both the Setup panels and Detailed Setup screens the user can perform the following actions: * View available surgical tools and consumables options. + Connect the surgical tools and options essential for the upcoming operation. + Prime/Test the surgical tools before commencing surgery. Basic Setup Figure 2-33 ‘The basic setup uses the seven setup panels shown in Figure 2-33, These panels are always displayed in the system state area during setup. Experienced Constellarion® Vision System users will normally use these panels to quickly setup the system. If desited, the detailed setup sereens can be displayed by pressing the Setup button in the ‘Menu Bar or pressing the More Information button Oo any of the seven panels. Note: Using the barcode scanner to scan a pack automatically sets up these panels for the accessories in that pack. ‘The seven panels displayed on the Setup Sereen are: + Fluidics + Accessories * Status * Probe + Iluminators + Handpiece * Lasers The System State Area of the Main Screen 085752281 247Constellation® Vision System Basic Setup: The Fluidics Setup Panel Figure 2-34 ‘The Fluidics Setup panel allows the user to view and update setup information relating to the cassette, fluid container, and associated surgical tools. Figure 2-34 shows the panel first without a cassette inserted then with a cassette inserted and primed. A trent A Pete Siena minis sien ae eng H easy Wo CassoteIsoriod ‘atomatc Sopccck Type Casslto Inserted and Primed The Fi ics Setup Panels Pressing the option buttons on these panels displays the following selections: Cannula Button: + 20GACannula * 23GACannula * 25GACannula + 27GACannula Source Button (Infusion/Intigation): * Gas Forced Infusion * Power Pole + Gravity Infusion Tubing: This information is displayed only when the cassette is inserted and shows the compatible infusion tubing (i.c., stopcock type: automatic or manual) for the inserted cassette, * Automatic Stopcock ~ User does not have to operate the stopcock when switching between air and fluid. * Manual Stopcock - User has to turn the switch on the tubing set to alternate between air and fluid flow. Pressing the More Information button @ opens the detailed setup popup that is covered later in this section, as 18085752001CConstellatio® Vision System Basic Setup: The Probe Setup Panel Figure 2-35 ‘This panel shows setup information related to the vitreous probe selection. Figure 2-35 shows the Probe Setup Panel: Ges @ 29GALow Speed SE Potent SE Mobs rates ———— Type Drop Down List ‘The Probe Setup Panel “Type Button - Pressing this button displays the drop down list that has the various options for vitreous probe selection (see second screen in Figure 2-35). Pressing one of the selections makes that probe type the active selection. ‘When the system detects that a probe has been connected, the probe type is automatically selected and the “connected” icon BBB appears next to the selection list. Skip Prime Option Button - Selecting this option tells the system to skip priming the selected vitreous probe. This button is a toggle switch that displays a check mark in the center of the button when active. When the check mark is present, the system ‘will not prime nor tune the vitreous probe in the next Prime/Tune request. ‘More Information Button @. Pressing the More Information button opens the detailed setup popup that is covered later in this section, robe status is displayed at the bottom of the setup panel and indicates whether the probe has been primed and tested. A "V"indicates that the priming and/or testing have been completed, while an ** indicates that they have not. 2085752231 249Consteifation® Vision System Basic Setup: The Handpiece Setup Panel This panel shows setup information related to handpiece selections. Figure 2-36 shows the Handpiece Setup Panel. @Qirve ms | Qe trmrmsost ie anus 5 ten Figure 2-36 The Handpiece Setup Panel ‘Type Button - Pressing the Type button on the panel displays the list of handpieces that may be used with the system. When the system detects that the user has plugged in the handpiece, the handpiece name is automatically selected and the “connected” icon RH appears next to the selection list The following handpiece types are selectable from the drop list: + Extrusion + Bxtrusion SoftTip + Frag* (Fragmentation) * LA (hrigation/Aspiration) * OZil®* Handpiece * Phaco* + None Handpicces that are marked with an asterisk (*) are automatically detected by the system. ‘Tip Button - Pressing the Tip button displays the tips that the operator ean choose for the currently selected/inserted handpiece, The tip selection button is hidden if the currently selected handpiece is “None” More Information Button @ Pressing the More Information button opens the detailed setup popup that is covered later in this section, Handpiece status is displayed at the bottom of the setup panel and indicates whether the probe has been primed and/or tuned. A "V"indicates that priming and/or tuning have been completed, while an "A" indicates that they have not. 250 085752281Constellation® Vision System Basie Setup: The Accessories Setup Panel Figure 2-37 Figure 2-37 shows the Accessories Setup Panel. On the panel, pressing a button next to an accessory will display a popup with specific selections for that accessory. ‘The following accessories selections are available: * Auto Gas Fill (AGF) + VEC (Viscous Fluid Control) = Forceps * Scissors + Diathermy @ wenn @Qrvionc @w« @ 22201 portion @ Diahermy —_———_———————I The Accessories Setup Panel ‘Auto Gas Filling (AGF) - Pressing this button illuminates the ring on the AGF port ‘on the front panel. When the system detects connection of the AGF syringe assembly, the connected icon EHH appears next to Auto Gas Fill. VEC (Viscous Fluid Control) - Pressing this button illuminates the ring on the VEC port on the front panel. When the system detects connection of the VFC tubing set, the connected icon E28 appears next to VEC. Forceps - When the system detects that the user has plugged in the Forceps handpiece the connected icon BBSBEI appears next to the selection list. In addition, when the operator presses this button, the system illuminates the LED on the forceps port on the front panel aoes7s22a1 251Constolation® Vision System Scissors - Pressing the button next fo Scissors shows the following scissors options: * Proportional © Multicut ‘When the system detects that the user has plugged in the Scissors handpiece, the scissors type is automatically selected and the connected icon MSSM appears next to the selection list. In addition, when the user selects a scissor type from this list, the system illuminates the LED on the scissors port on the front panel. Diathermy - Pressing this button illuminates the ring on the Diathermy port on the front panel. More Information Button @D - Pressing the More Information button opens the detailed setup popup that is covered later in this section. Basic Setup: Muminators Setup Panel This panel shows setup information related to illuminator selections. Figure 2-38 shows the Iluminators Setup Panel. Uluminator Ports - Pressing any one of the illuminator ports allows the user to select between a straight, wide angled, or chandelier endoilluminator probe. In addition, When the user makes a selection from the drop list, the system illuminates the ring on the associated illuminator port on the front [iLLOMINATORS, ae panel. When the system detects connection _—— of an endoilluminator probe on a port, the @ 1: 206A straight “connected” icon appears next to that port ‘on the selection list and the operator will not be able to select another probe type from the @ 2 206A Straight touchscreen for that port (the selection list will @ > w:rs004 be locked). Ifa non-RFID probe is inserted into an @ 4c 206A Straight illuminator port, the system displays . "Unrecognized! in the Setup panel and the Ilumination ‘Type Selection popup displays a list of possible selections. More Information Button D - Pressing the More Information button opens the detailed Figura 2.98 setup popup that is covered later in this The illuminator Setup Panel section, 2B 18068762291Consteliation® Vision System Basic Setup: Figure 2-39 aser Setup Panel ‘The Lasers Setup panel shown in Figure 2-39 displays setup information related to laser probes. Laser Port 1 and 2 Probe Selection - Pressing the Laser Port I or 2 button displays a list of selectable probe types: + Endo + LIO (Laser Indirect Opthalmoscope) When one of the buttons is pressed, the system also illuminates the ring on the associated laser port on the front pane], When the system detects the connection of a laser probe on & port, the connected icon EBEEHM appears next to the selection list, and the user will not be able to select another probe from the touchscreen for this port (the selection list will be locked). If anon-REID probe is inserted into a laser port, the system displays "Unrecognized" in the Setup panel. Pressing "Unrecognized displays a list of possible selections. More Information Button @ xc Jng the More Information button opens the detailed setup popup that is covered later in this section. ‘The Lasers Setup Pan Basic Setup: Status Setup Panel ESS. (a f 400 | WeiPressue os) eee | Cee ene Figure 2-40 The Status Setup panel shown in Figure 2-40 displays the inlet pressure and gives status of its current state: + Green background: inlet pressure within optimal range + Yellow background: inlet pressure acceptable but with potentially reduced performance + Orange background: inlet pressure out of range More Information Button @D - pressing the More Information button opens the popup shown in Figure 2-40 that provides additional details on the inlet pressure. - Mr A | £101 hegllb Ravine dRoemn The Status Setup Panel aoss7sz2a1 258Constelfation® Vision System Detailed Setup © ‘The Detailed Setup screens are displayed by pressing the Setup button in the Menu Bar or pressing the Mote Information button @ on any of the seven setup panels discussed previously. Figure 2-41 shows the Fluidics Detailed Setup screen. On the left side of the screen are seven selection controls that, when pressed, display the detailed information related to that control ‘The seven selections on the Detailed Setup screen are: * Fluidics + Probe + Handpiece + Accessories + Tluminators + Lasers * Priming ‘Tray Pressing a selection presents a graphical display of the step required to successfully setup that selection. The Help button at the bottom of the setup screen allows the user to access a video demonstration of the setup process (see Video Help at the end of the Detailed Setup section). ‘Connection Help - Pressing a highlighted area on the Constellation® system shown below the selection area displays a detailed view of the connections for each the following areas on the front panel: electrical/pneumatic, cassette, illuminators, and lasers. Start Prime Button - ‘The Start Prime button at the bottom of each detailed setup sereen enables the user to initiate the priming process (same function as the Start Prime button located in the menu bar of the setup screen). When the user presses this bution, the detailed setup dialog closes and the system initiates the Priming/Testing sequence and displays the Prime Test status dialog. * Push Prime - Push prime is the system default when a new cassette is inserted into the system at the beginning of a surgical case. During push prime, irrigation solution is "pushed" through both the irrigation and aspiration lines. When push prime is active, the Start Prime button appears with no icon as shown at left, + Suction Prime - Suction prime is used in the event an accessory must be te-primed after the surgical case has started. In this situation, the handpiece ‘must be inserted into a container of sterile solution, and priming is accomplished through suction (aspiration) pulling the solution from the container. When suction ptime is active, the Start Prime button appears with an icon as shown at left. 264 18065752031Constotation® Vision System 1d Setup: Fluidics, ‘The Fluidics setup panel shown in Figure 2-41 displays the steps required to properly setup the fluidics system after a cassette has been inserted, If a cassette has not been inserted, this screen will direct the user to insert the cassette. Once inserted, the type of cassette is displayed at the top of the panel along with the compatible infusion tubing (1e., stopcock type: automatic or manual) for that cassette. Note: If an anterior or posterior only cassette is inserted, the user can only select the associated mode. 1. Select Infusion/Irrigation Source - A selection from the Power 1V Pole, Gravity or Pressurized options is made here by pressing the bottle associated with the source to be used. The desired source is highlighted in yellow when selected. 2. Select Infusion Cannula - Allows the user to select one of the following infusion cannula: 20,23, 25 or 27+™ gauge. 3. (Optional) Specify Initial Fluid Level - Allows the user to set the starting level of the fluid in the container using the increment and decrement arrow buttons. ‘This ‘enables the system to accurately track the fluid Jevel (in terms of percentage) as the operation progresses and alert the operator when fluid level is low. (@ suestnlen Come eee @| Solection Controls: © pons pet Fi Lor Connection Help-——> Indicates Suction Figure 2-41 The Detailed Fluldic Setup Panel Prime is active 8085752231 255Constellation? Vision System Detailed Setuy ‘The Probe Setup panel shown in Figure 2-42 displays the available probe selections and provides visual cues to guide the operator in connecting the selected probe to the system. ‘When the system detects that the operator has plugged in an UltraVit® probe, the probe type and gauge display are automatically updated and the “connected” icon appears next to the probe graphic. ‘The system also “locks” the selection so another probe type cannot be selected. For low speed Vit probes, the "connected" icon does not appear and the selection button is not locked. ‘The Connection Guide shows the proper connections to the handpiece panel and the cassette for the selected probe, Skip Probe Prime/Test - Indicates whether the operator wants to skip priming the selected vitreous probe. When the checkbox is checked, the system will not prime or test the vitreous probe when the user requests Prime & Test, Probe Setup cisply when probe ‘connected. con shows probe ‘connectod and locked; Select Probe Tt wil not bo eplayed, cell Fy seadeor ‘econo Figure 2-42 The Detailed Probe Setup Panel 286 ‘8085752201Constotlation® Vision System Detailed Setup: Handpiece The Handpiece Setup panel shown in Figure 2-43 displays the steps required to properly connect the various handpieces to the system. 1, Select Handpiece - Provides a selection of handpieces. When the system detects. that the operator has plugged in the fragmentation, phaco, or OZif® handpiece, the handpiece type is automatically selected and the “connected” icon appears next fo the selection list. 2, Select Tip - When a handpiece is selected, the Select Tip button appears and pressing the button opens a popup that will show a variety of tips that can be selected. Once selected, the tip will appear under the selected handpiece. 3. Connection Guide - This section shows an illustration of the connector panel anc highlights the connections for the selected handpiece: res fartermetonn —— Figure 2-43 The Detailed Handplece Setup Panel eoss75e231 257Constellation Vision System Detailed Setup: Accessories ‘The Accessories setup panel shown in Figure 2-44 displays the steps required to properly connect the following accessories + Scissors * Viscous Fluid Controller + Foreeps + Auto Gas Fill + Diathermy 1, Select Optional Accessory - Provides a selection of accessories, When the system detects that the operator has connected the accessory, that accessory type is automatically selected and the “connected” icon appears next to it in the selection list. Confirm Connection - This button is present when the user has selected an accessory that is not currently detected as connected by the system. When this button is pressed, the system assumes that the currently selected accessory has been connected (even though it was unable to detect it). However, since the system did not auto-detect the connection, it will not lock the user from selecting the type of the accessory (¢.g., type of scissors). 2. Connection Guide - This section shows an illustration of the connector panel, and highlights the connections for the selected accessory. Ly) Figure 2-44 The Detailed Accessory Setup Panel 258 18065762281Constefation® Vision System Detailed Setup: lan ‘The Hlumninators setup panel shown in Figure 2-45 allows the operator to view and select illuminator port and connection options. 1. Select Illuminator Port - Displays the endoilluminator probe the operator has chosen and/or inserted in the indicated illuminator port. When the system detects that a probe is plugged into a port, the Huminator Type is automatically displayed and the “connected” icon appears next to the selection control. The system also “Jocks” the user from selecting another illuminator type. 2, Select Illuminator Type - When a port is selected in the Select Huminator Port section (1), this section displays a scrolling list of Llluminator Types that can be assigned to the selected port. This section is not visible if the system has detected that a probe is connected to the selected port (connected and locked icons displayed) “The Connection Guide shows the proper connections to the illuminator panel for the selected probe. aeaASiaight Taensuah Figure 2-45 The Detailed liluminator Setup Panel 0ss7se201 2.59Constetation® Vision System Detailed Setup Screen: Lasers ‘The Lasers Setup panel shown in Figure 2-46 allows the operator to view and select laser port and connection options for the various laser delivery devices. 1, Select Laser Port - Displays the laser delivery device the operator has chosen and/or connected to the indicated laser port, When the system detects that a device is connected to the port, the “connected” icon appears and the system “locks” the selection, Select Laser Type - Shows the Laser type the operator has chosen and/or inserted for the highlighted laser port. The following laser types are selectable: *Endo + Laser Indirect Ophthalmoscope (L10) ‘The Connection Guide shows the operator where to connect the device to the laser panel. Comecion oie Figure 2-46 The Detailed Laser Setup Panel 260 jBoss752281CConstettation® Vision System Detailed Setup Seren: Priming Tray ‘The Priming ‘Tray Setup panel shown in Figure 2-47 displays the suggested instructions for use of the priming tray according to the current connections and system configuration (ic., push prime or suetion prime) NOTE: Push prime occurs when a cassette is inserted into the system af the beginning of a surgical case. During push prime, irrigation solution is "pushed" through both the irrigation and aspiration lines. Suction prime is used in the event an accessory must be re-primed after tle surgical case has started. In this situation, the handpiece must be inserted into a container of sterile solution, and. priming is accomplished through suetion (aspiration) pulling the solution from the container. RE, push Prime Setup Screen Suction Prime Setup Screen mat) Figure 2-47 The Priming Tray Set Up Scret ‘age5752231 BetConsteifation® Vision System Detailed Setup: Help When Video Help is selected, the popup shown in Figure 2-48 is displayed offering a list of help topics. Once the topic is selected, the user can choose between Video Help and Wizard Help. Pressing the Video Help button launches a help video that plays completely through the video for the selected topic. Wizard Help plays the same video but adds textual information and stops at various points to give the user a chance to perform the required actions before continuing. The controls on the Video Help Display operate as follows: + Start - Places the video at its beginning, + Rewind - Rewinds the video one segment. * Play/Pause - This button is labeled Pause when the video is playing and Play when the video is not playing. + Forward - Forwards the video to the next segment * End - Forces the video to be forwarded to the end. * Move Left - Moves the entire video popup to the left side of the surgical panels, * Move Right - Moves the entire popup to the right side of the surgical panels, + Close - Closes the Video Help popup. ‘The controls on the Wizard Help Display operate as follows: *+ Previous - Rewinds the video one segment and pauses. + Replay - Rewinds the video one segment and play continues, * Continue - Resumes video play. + Next - Advances the Help screen to the next video segment and associated help text. * Move Left - Moves the entire video popup to the left side of the surgical panels * Move Right - Moves the entire popup to the right side of the surgical panels * Close - Closes the Video Help popup. Video Help Figure 2-48 Video Help Popups 2a ‘8065752231Constalation® Vision System Start Prime Button And Popup After the instrument connections are complete, pressing the Start Prime button displays the Prime & Test Status popup (see Figure 2-49) and begins the prime/test process for the current setup (Figure 2-49 shows possible variations as determined by the current setup and user actions). The status bar uses different colors to indicate the progress and completion status of each segment of the prime/test process. + Partial green bar - indicates that the current segment is in progress. + Complete green bar - indicates that the process related to that segment has finished with no errors. + Yellow bar - indicates that the user has cancelled the process by pressing the Stop button at the end of the bar. * Red bar - indicates that the process related to that segment ha failed with errors. When the Prime and Test is complete, the system will transition to the Surgery screen Prime & Test Status with a Probe and Handpiece connected to system. Prime & Test Status with IOP ‘compensation enabled. The Calibration segment indicates that the infusion ine is being calibrated. ‘A'Skip Calibration” button appears