Alcon Research 212-1 Constellation Vision System User Manual NGVS Book 1 indb

Alcon Research Ltd. Constellation Vision System NGVS Book 1 indb

User Manual part 1

OPERATOR'S MANUALManufacturer: EU Authorized Representative:Alcon Laboratories, Inc. Alcon Laboratories (U.K.) Ltd.6201 South Freeway Boundary Way, Hemel HempsteadFort Worth, Texas 76134-2099 Hertfordshire, HP2 7UD EnglandU.S.A. Produced By:Alcon Laboratories, Inc.15800 Alton ParkwayIrvine, California 92618-3818U.S.A.Telephone: 949/753-1393 800/832-7827FAX: 949/753-66148065751025 Rev. P3, CATALOG NUMBER905-2120-001 Rev. P3.1, TEXT ONLY © 2007 Alcon, Inc.
ii 8065751025Constellation® Vision SystemConstellation® Operator's8065751025MANUAL REVISION RECORD DATE REVISION ECN NUMBER AND DESCRIPTION* Registered U.S. Patent & Trademark Office9/15/06 P17/2/07 P2 (no PECN)9/1807 P3
8065751025 iiiConstellation® Vision System TABLE OF CONTENTSTOPIC PAGE #Manual Revision Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iiForeword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viImportant Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiSECTION ONE - GENERAL INFORMATIONIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7Source Air Pressure Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7Settings Restoration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7Environmental Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8User Information - Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8Universal Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9EMC Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9FCC and IC Compliance Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12EU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12Australia and New Zealand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12Cautions and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.13Diathermy, Cautery, Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.18Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.20Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.21SECTION TWO - DESCRIPTIONIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.8Front Panel Displays And Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.12Global Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.37System State Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.41Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.58Surgical Modes And Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.65End Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.94Probes and Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.98The Constellation Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.106Consumable Pak Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.107Combined Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.107Posterior Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.108Anterior Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.108SECTION THREE - OPERATING INSTRUCTIONSIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Power Up Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1Initial System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2Constellation™ Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3Procedure Pak and Cassette Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4Posterior Segment Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5Anterior Segment Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.6Auto Gas Filler Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.8Fragmentation Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.9Viscous Fluid Control Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.10Extrusion Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12
iv 8065751025Constellation® Vision SystemFiber Optic Illuminator Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12Diathermy Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12Pneumatic Handpiece Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.13SECTION FOUR - CARE AND MAINTENANCEIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1Upon Completion Of The Day's Surgery Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2Sterilization Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3Reusable Handpiece and Accessories Cleaning and Sterilization Instruction . . . . . . . . . . . . . . . . . . . . . . . 4.4Disposal of Xenon Lamps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8SECTION FIVE - TROUBLESHOOTINGEquipment Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1System Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2Advisory Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3Information Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3SECTION SIX - ACCESSORIES AND PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1SECTION SEVEN - INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1TABLE OF CONTENTSTOPIC PAGE #
8065751025 vConstellation® Vision System FIGURE # TITLE PAGE #LIST OF ILLUSTRATIONSFigure 1-1 The Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1Figure 1-2 Icons used with the Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5Figure 1-3 Labeling used on the Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.6Figure 1-4 Diathermy Power Through 75 Ohm Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19Figure 1-5 Diathermy Power Vs. Load Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19Figure 1-6 Diathermy Output Voltage Vs. Output Control Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19Figure 2-1 The Constellation® Vision System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.2Figure 2-2 The Constellation® Vision System Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.5Figure 2-3 The Constellation® Vision System Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.7Figure 2-4 The Constellation® Vision System Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.8Figure 2-5 Remote Control Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.10Figure 2-6 Remote Control Channel Selection Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.11Figure 2-7 The Startup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.12Figure 2-8 The Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.13Figure 2-9 The Main Screen Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.14Figure 2-9a Procedure Modify Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.16Figure 2-10 The Doctor Settings Popup - General Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.19Figure 2-10a The Doctor Settings Popup - Surgery/Inf/Irr Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.20Figure 2-10b The Doctor Settings Popup - Surgery/Reflux Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.21Figure 2-10c The Doctor Settings Popup - Surgery/General Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.22Figure 2-11 Doctor Settings - Footswitch Buttons Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.23Figure 2-12 Footswitch Action Selection Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.24Figure 2-13 Doctor Settings - Footswitch Treadle Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.25Figure 2-14 Doctor Settings - Sound Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.26Figure 2-15 Doctor Settings - Laser Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.27Figure 2-16 Deleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.27Figure 2-17 System Settings - Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.28Figure 2-18 System Settings - Connections Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.29Figure 2-19 System Settings - VideoOverlay Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.30Figure 2-20 Auto Gas Fill Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.31Figure 2-21 View/Copy/Delete Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.32Figure 2-22 Sample View of a Doctor Settings Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.34Figure 2-23 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.35Figure 2-24 About Constelllation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.35Figure 2-25 Infusion Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.37Figure 2-26 F/AX Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.38Figure 2-27 Irrigation Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.39Figure 2-28 Diathermy Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.39Figure 2-29 Illuminator Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.40Figure 2-30 The Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.41Figure 2-31 The Fluidics Popup Screen(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.42Figure 2-32 The Probe Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.43Figure 2-33 The Handpiece Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.44Figure 2-34 The Accessory Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.45Figure 2-35 The Illuminator Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.46Figure 2-36 The Laser Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.47Figure 2-37 The Fluidics Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.49Figure 2-38 The Detailed Probe Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.50Figure 2-39 The Detailed Handpiece Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.51Figure 2-40 The Detailed Accessory Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.52Figure 2-41 The Detailed Illuminator Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.53
vi 8065751025Constellation® Vision SystemFigure 2-41a The Detailed Laser Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.54Figure 2-42 Video Help Popups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.55Figure 2-43 Prime & Test Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.56Figure 2-44 Consumables Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.56Figure 2-45 Timer Configuration Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.57Figure 2-46 The Surgery Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.58Figure 2-47 Vacuum Control and Settings Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.59Figure 2-48 Surgical Control Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.60Figure 2-49 Surgical Control with Dropdown List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.61Figure 2-50 Accurus® Classic Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.63Figure 2-51 Surgical Step Panel - Custom Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.63Figure 2-51a Surgical Step Panel Scroll Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.64Figure 2-52 Surgery Screen: Vitrectomy Mode-3D Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.66Figure 2-53 Surgery Screen: Vitrectomy Mode-Momentary Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.68Figure 2-54 Surgery Screen: Vitrectomy Mode-PropVac Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.69Figure 2-55 Surgery Screen: Vitrectomy Mode-VitWet Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.70Figure 2-56 Surgery Screen: Phaco Mode - Burst Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.72Figure 2-57 Surgery Screen: Phaco Mode - Custom Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.74Figure 2-58 Surgery Screen: Phaco Mode - Pulsed Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.76Figure 2-59 Surgery Screen: Phaco Mode - Continuous Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.78Figure 2-60 Surgery Screen: Fragmentation Mode - Fixed Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.79Figure 2-61 Surgery Screen: Fragmentation Mode - Linear Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.81Figure 2-62 Surgery Screen: Fragmentation Mode - Momentary Submode . . . . . . . . . . . . . . . . . . . . . . . .2.82Figure 2-63 Surgery Screen: Irrigation/Aspiration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.83Figure 2-64 Surgery Screen: Extrusion Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.85Figure 2-65 Surgery Screen: Laser Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.87Figure 2-66 Surgery Screen: Forceps Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.89Figure 2-67 Surgery Screen: Scissors Mode - MultiCut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.90Figure 2-68 Surgery Screen: Scissors Mode - Proportional . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.91Figure 2-69 Surgery Screen: VFC Mode - Extract Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.92Figure 2-70 Surgery Screen: VFC Mode - Injection Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.93 Figure 2-71 End Case Screen: Anterior Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.94Figure 2-72 End Case: Setup Form Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.95Figure 2-73 UltraVit Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.98Figure 2-74 Pneumatic Scissors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.98Figure 2-75 Fragmentation Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.99Figure 2-76 Infiniti™* Ultrasonic (U/S) Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.99Figure 2-77 TurboSonics® Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.101Figure 2-78 Infiniti™* U/S Handpiece shown with Infusion Sleeve and Bubble Suppression Insert . . .2.102Figure 2-79 Ultraflow™* IT handpiece and tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.104Figure 2-80 Ultraflow™* IT handpiece with infusion sleeve, reusable I/A tip, and threaded tip adapter 2.104Figure 2-81 Ultraflow™* O-ring tool with large and small O-rings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.104Figure 2-82 Ultraflow™* SP handpiece (handpiece shown with .3 mm 45° tip) . . . . . . . . . . . . . . . . . . .2.104Figure 2-83 Single use bipolar brush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.105Figure 2-84 The Constellation® Combined Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.106Figure 4-1. Auto Wash: Handpiece with "Y" Adapter Connected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6Figure 4-2. Auto Wash: "Y" Adapter Connected to Injector Nozzel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6Figure 4-3. Auto Wash: Unused Injectors Shown Plugged Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6 Figure 4-4. Depressurizing the Xenon Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.8Figure 5-1 System Fault Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.1Figure 5-2 System Error Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.2Figure 5-3 Advisory Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3Figure 5-4 System Information Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3
8065751025 viiConstellation® Vision System LIST OF TABLESTable 1-1 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.2Table 1-2 Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4Table 1-3 Guidance and Manufacturer's Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.10Table 1-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Constellation® Vision System . . . . . . . . . . . . . . . . . . .1.11Table 2-1. Surgical Modes And Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.66Table 6-1. Constellation® Vision System Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.1TABLE # TITLE PAGE #
viii 8065751025Constellation® Vision SystemFOREWORDThis 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 manual 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 or 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. All 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: 800-241-0677Outside U.S.A.: Contact your local Alcon representative for supplies.
8065751025 ixConstellation® Vision System IMPORTANT NOTICEEquipment improvement is an on-going process and, as such, changes may be made to the equipment after 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. Illustrations contained in this manual are for reference only.It is recommended that maintenance be performed by a qualified Alcon Field Engineer.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 ProfileThe Constellation 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 surgeon to map any function to any switch position, assuming the function is valid in a particular scenario. The display screen was designed to mount on an articulating arm to allow optimum placement of the display so the surgeon can reference it at any time. The design also incorporated items specifically for nurses and scrub techs, 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.CAUTIONU.S. Federal Law restricts this device to sale by or on the order of a physician only.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 - FusesA 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: EN 60601-1/IEC 601-1). 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.
x 8065751025Constellation® Vision SystemLAST PAGE OF THIS SECTIONComments or corrections concerning this manual should be addressed to: Alcon Technical Services Group PO BOX 19587 Irvine, CA, USA 92623All 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, or otherwise; without prior written permission from Alcon Laboratories, Inc.
8065751025 1.1Constellation® Vision System SECTION ONEGENERAL INFORMATIONIntroductionThe Constellation® Vision System is a multifunctional surgical tool 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 via either an infusion cannula or flows through a handpiece. The graphical operator interface is menu driven. The operator provides inputs using the touchscreen panel, the remote control, voice commands, and the footswitch.Figure 1-1 The Constellation® Vision System - The Constellation® Vision System is a multifunctional surgical tool is used in anterior and posterior segment ophthalmic surgeries.
1.2 8065751025Constellation® Vision SystemCONSOLEDIMENSIONS:Tabletop: Height: 160.0 cm (63.0 inches) Width: 76.2 cm (30.0 inches) Depth: 77.5 cm (30.5 inches)Base: Height: 63.5 cm (25.0 inches) Width: 53.3 cm (21.0 inches) Depth: 57.2 cm (22.5 inches)WEIGHT: Tabletop: 61.2 kg (135 pounds) Base: 72.6 kg (160 pounds)ENVIRONMENTAL LIMITATIONS: Operating Non-Operating Altitude: -125 to 2000 m -125 to 3000 m (-410 to 6562 feet) (-410 to 9843 feet) Temperature: 10° C to 35° C -10 to 55°C (50° F to 95° F) (14° F to 131° F) Relative Humidity: 10% to 95% 10% to 95% without without condensation condensationELECTRICAL REQUIREMENTS: The console accepts the following ranges or input commercial power voltages and frequencies and meets the leakage currents specified in IEC 60601-1. Protection against electrical shock is Class I. 100-120 Vac 50/60 Hz 12 A max. Fuse: T 10 A / 250 V slow blow 220-240 Vac 50/60 Hz 7.5 A max. Fuse: T 5 A / 250 V slow blowFOOTSWITCHDIMENSIONS: Height: 14.0 cm (5.50 inches) Width: 22.9 cm (9.00 inches) Depth: 43.2 cm (17.0 inches)WEIGHT: 5.4 kg (12 pounds)ENVIRONMENTAL: The footswitch construction is water tight in compliance with IEC 60601-1 and IEC 60601-2-2, subclause 44.6 aa. ELECTRICAL: The footswitch is connected to the console via electrical cable. All power and communications enter/exit the footswitch from this cable.Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS - This table is a quick reference point to identify system specifications, system requirements, and performance figures.PERFORMANCE SPECIFICATIONSPRESSURIZED INFUSION/IRRIGATION @SEA LEVEL: Range: 0 to 120 mmHg Accuracy: ±(2% of setpoint +5 mmHg) Flow Rate: 0 - 20 cc/min. for infusion (20 Ga) 0 - 60 cc/min. for irrigation Setpoint Transient: 500 ms maximumIOP CONTROLLED INFUSION: Setpoint Range: 0-120 mmHg Repeatability1: ± 2 mmHg2 Setpoint Response Time: <500 ms (20 Ga) Transient Disturbance Response Time: <500 ms3 Flow Range: 0-20 cc/min 1 BSS Dual chamber mode. 2 BSS medium, 20 gauge high flow Cannula, steady state condition at rated flow range 3 Transient condition from no flow state to 10cc/minASPIRATION/SUCTION @SEA LEVEL: Standard & Reduced Pressure Range: 0-650 mmHg Vacuum Minimal Pressure Range: 0-600 mmHg Vacuum Pressure Accuracy: ±(2% of Setpoint +5 mmHg) Flow Range: Posterior Modalities: 0-20 cc/min Anterior Modalities: 0-60 cc/min Transient Response Time (Standard Pressure Range): From– 0 to -400 mmHg @0 cc/min 10-90% Rise Time:300 msec max 90-10% Fall Time: 300 msec maxIRRIGATION/ASPIRATION @SEA LEVEL: Sub Modes: Cap Vac, I/A Max Vacuum: Standard & Reduced Pressure Range: 0 to -650 mmHg Minimal Pressure Range: 0 to -600 mmHg Vacuum Vacuum Accuracy: 2% of displayed value + 5 mmHg Flow Rate: 10 cc/min minimum + 1.5cc at 50 mmHg vacuum maxVACUUM @ SEA LEVEL: Vitrectomy: 0 to 650 mmHg Fragmentation: 0 to 650 mmHg Extrusion: 0 to 650 mmHg Extraction: 0 to 650 mmHg Irrigation/Aspiration: 0 to 650 mmHg Phacoemulsification: 0 to 650 mmHg
8065751025 1.3Constellation® Vision System PERFORMANCE SPECIFICATIONS...continuedLOW PRESSURE AIR SOURCE (LPAS) @SEA LEVEL: Pressure Range: 0 – 120 mmHg at rated flow Pressure Accuracy: ±3% of Setpoint +3 mmHg Flow Rate: 1.2 slpm minimum at 120 mmHgVITRECTOMY: Submodes: 3D, Momentary, PropVac, VitWet Cut Rate: UltraVit™ 5000 Probe: 100 to 5000 cpm UltraVit™ 2500 Probe: 100 to 2500 cpmDIATHERMY: Frequency: 1.5 Mhz ± 10%. Waveshape: Sinusoidal Output power 10 Watts maximum at 100% setting with 75 ± 10% ohm non-inductive load Power range 0 - 100% of maximum output power ILLUMINATION: Lumen Accuracy: ±30% Light Output through 20GA 0.5 NA Fiber Probe: 0-200 hrs: 50 lumens minimum at 100% setting 201-400 hrs:25 lumens minimum at 100% setting Light Output through 25GA 0.63 NA Fiber Probe: 0-200 hrs: 15 lumens minimum at 100% setting 201-400 hrs:10 lumens minimum at 100% settingFRAGMENTATION: Submodes: Linear, Fixed, Momentary Tip Stroke @ 100%: 3.1 ± 0.5 mils at 100% power Resonant Frequency: 39.0 ± 1.9 KHz Pulse Rate Range: 0 – 100 ppsSCISSORS: Submodes: Proportional, Multi-Cut Proportional Pressure: 0-50 psi @sea level Multi Cut Rate: single cut to 450 cpm PROPORTIONAL AND CONTINUOUS REFLUX @SEA LEVEL: Pressure Range: 0 to 120 mmHg Pressure Accuracy: ±(2% of Setpoint +5 mmHg)MICRO REFLUX: Pressure Range: 100 ± 15% mmHg1 Volume: 50 ± 10 µL1 1 measured with unoccluded Accurus® probe and aspiration tubingVISCOUS FLUID CONTROL: Submodes: Inject, Dual, Extract Injection Pressure: 0 to 551.6 KPascal (0 to 80 psi) 0 to 482.7 KPascal @ Reduced (0 to 70 psi) Extract Vacuum at Sea Level: 0 to 650 mmHg Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS...continuedAUTO-GAS FILLING (AGF): Maximum Gas Pressure: 10 psig Fill Purity: 99.9% gas concentration following fillAUTO-STOPCOCK: Response Time: 0.5 seconds minimum Pressure (Liquid): 0-120 mmHg Rated Flow (Liquid): 20 cc/min Pressure (LPAS): 0-120 mmHg Rated Flow (LPAS): 1.2 slpmPHACOEMULSIFICATION: Submodes: Burst, Pulsed, Continuous Tip Stroke @ 100%: 3.5 ± 0.5 mils Resonant Frequency: 34khz – 42Khz ± 10%. Pulse Rate Range: 0-100 pulses per second Burst Length: 2.5 sec – user adjustable Burst Pulse durations: 5ms to 500msANTERIOR VITRECTOMY: Submodes: Wet, Dry Cut Rate: 0 to probe maximumLASER (optional): Treatment beam: Class: IV Power: 30 mW to 2 W (maximum) Wavelength: 532 nm Aiming beam: Class: II Power: less than 1mW Wavelength: 635 nm ± 5 nmDOCTOR MEMORIES: Storage Capacity: xxx Doctors Memory Cells per Dr: xx (xx anterior, xx posterior, xx common)TIMER: Range: 0 to xx h Resolution: 1 sTONE VOLUMES @ 1 Meter: Errors/Faults/Invalid Key: 40 to 65 dB, short tones Diathermy: 40 to 65 dB, continuous tone Advisory/Timer Expire/Elev Infusion: 0 to 65 dB, short tones Frag/Phaco/Vacuum: 0 to 65 dB, continuous tone Valid Key: Factory set and not adjustable Volume Accuracy: 6 dBVOICE CONFIRMATION: 0 to 65 dBREMOTE CONTROL: Method: Infrared Channels: 4
1.4 8065751025Constellation® Vision SystemTerm or AbbreviationBSS PLUS®cmH2OcpmDetentDiathermyExtrusionF/AXFragGlobal FunctionHighlightedI/AIECISOIVLCDmmHgN/APELPINpsippsslpmU/SVFCVitDescriptionBalanced Salt Solution enriched with bicarbonate, dextrose, and glutathione.Centimeters of water.Cuts Per Minute.A discrete footpedal position at which more force is required to depress the footpedal to the next position.The production of heat in body tissues by electric current for therapeutic purposes.A mode where vacuum is available to remove fluid/matter.Fluid Air Exchange.Fragmentation.A function whose status and controls are independent of the current footpedal position and surgery mode.To center attention by video reversing the function key and changing the key color from gray to blue.Irrigation/Aspiration.International Electromechanical Commission.International Standards Organization.Intravenous.Liquid Crystal Display.Millimeter of Mercury. A unit of vacuum.Not Applicable.Patient Eye Level. A difference in height between the cassette and the patient eye level.Personal Identification Number.Pressure per Square Inch. A unit of pressure.Pulses Per Second.Standard Liters Per Minute.Ultrasound.Viscous Fluid Control.Vitrectomy. Extraction of the vitreous from the vitreous cavity.Table 1-2 Terms and Abbreviations
8065751025 1.5Constellation® Vision System Figure 1-2 ICONS USED WITH THE Constellation® Vision System - Icons identifying modes, functions, etc., that are used with the Constellation® Vision System are identified in this chart.ExtrusionForcepsFragmentationIrrigation/AspirationLaserPhacoScissorsViscousFluidControl(VFC)VitrectomyExpandWindowHelp VideoModifyPowerSaveAir PressureInputAuto Gas Filling(AGF)Alternating CurrentCoagulationConnectorConnectionIndicatorDangerous VoltageEjectEquipotentialityFootswitchForcepsFuseHot1IlluminatorLaser ConnectionLaser Emergency Stop Switch1Laser Port 1Tethered LaserNetwork ConnectionOffOn!Consult Operator's Manual, or System Error or AdvisoryOpens Operator's ManualVideo RecorderScissors ConnectorSerial In/OutStandby StateSYSTEMFAULTSystem FaultSystem InformationType BF EquipmentType B EquipmentU/S Handpiece ConnectorUSB ConnectorUse appropriate take-back system (see Environmental Considerations in this manual).Viscous Fluid Control ConnectorVGA OutVideo In/OutVitreous Cutter Connection
1.6 8065751025Constellation® Vision SystemFigure 1-3 LABELING USED ON THE CONSTELLATION® VISION SYSTEM - Labels used on the Constellation® Vision System console are identified and illustrated here.LASER 532 nm - 2W - CWDIODE LASER 635nm - 1mWCLASS 4 LASER PRODUCTIEC 60601-2-22: 1995RAYONNEMENT LASEREXPOSITION DANGEREUSEDE LÔEIL OU DE LA PEAU AURAYONNEMENT DIRECT OU DIFFUSAPPAREIL Å LASER DE CLASSE 4LASER RADIATIONAVOID EYE OR SKIN EXPOSURE TODIRECT OR SCATTERED RADIATIONCLASS 4 LASER PRODUCTLaser 532nm - 2WDIODE LASER 635nm - 1mWRISQUE D'EXPLOSION SI UTILISATIONEN PRESENCE D'ANESTHETIQUE INFLAMMABLEPOSSIBLE EXPLOSION HAZARD IF USED INTHE PRESENCE OF FLAMMABLE ANESTHETICDANGERUSE OF THIS LASER WITHOUT A SAFETY FILTERMAY RESULT IN DAMAGE TO THE OPERATOR'S EYESL'USAGE DE CE LASER SANS FILTRE MEDECINPEUT ENDOMAGER LES YEUX DE L'UTILISATEURWARNINGVisible laser radiation.Avoid eye or skin exposure todirect or scattered radiation.Class IV laser productLabels for gas containers
8065751025 1.7Constellation® Vision System 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 Air Pressure Requirements The Constellation® Vision System is designed to operate using different levels of source air pressure. The system operates automatically with pressures of 58 (4 bar) to 120 psi (8.3 bar). Between 4 bar and 5 bar, vacuum performance is reduced. Between 4 bar and 5.5 bar, VFC inject performance is reduced. Accessory equipment connected to or used with this equipment must be certified according to the respective IEC Standard (e.g., IEC 60950 for data processing equipment, and IEC 60601-1 for medical equipment). The Constellation® is shipped with English and metric air fittings compliant with EN739:1998. 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. If in doubt, consult the Technical Services department or your local Alcon representative.Settings Restoration When a loss of power occurs, the Constellation® Vision System retains its current settings and mode in memory. When power is reestablished a System Information popup window appears asking: "Do you want to restore the system's previous settings and mode?" The user can press Yes to restore the previous settings, or No to enter the default settings. Disconnecting the power cord, or turning the system off using the rear panel power switch, is considered a loss of power; using the rear panel standby switch is not.
1.8 8065751025Constellation® Vision SystemEnvironmental IssuesFollow local governing ordinances and recycling plans regarding disposal or recycling of device components.WARNINGS!Laser: There are potential hazards when inserting, steeply bending, 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 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 (N2O) and oxygen should be avoided. Some materials - for example cotton wool when saturated with oxygen - may be ignited by the high temperatures produced in 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.User Information - Environmental ConsiderationsThe equipment that you have purchased requires the use of natural resources for its production. This equipment may also contain hazardous substances which could have 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, we encourage you to use the appropriate take-back systems. Such take-back systems reuse or recycle 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.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.
8065751025 1.9Constellation® Vision System Universal PrecautionsUniversal 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 StatementIt is important to 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: Reorient 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 field service engineer for help.Table 1-2 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 Electromagnetic Environment-GuidanceRF emissionsCISPR 11Group 1 The Constellation® Vision System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissionsCISPR 11Class A Based on extensive field experience the Constellation® Vision System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.The EMC Statement provides guidance on steps to take in case of electromagnetic interference.Harmonic emissionsIEC 61000-3-2Class AVoltage fluctuations/Flicker emissionsIEC 61000-3-3Complies
1.10 8065751025Constellation® Vision SystemTable 1-3 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 Constellation® Vision System should assure that it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment-GuidanceElectrostatic discharge (ESD)IEC 61000-4-2• ±6 kV contact• ±8 kV air • ±6 kV contact• ±8 kV airFloors should be wood, concrete, or ceramic tile. Do not use around floors that are covered with synthetic material to avoid laser stoppage due to ESD.Electrical fasttransient/burstIEC 61000-4-4• ±2 kV for power supply lines• ±1 kV for input/output lines• ±2 kV for power supply lines• ±1 kV for input/output linesMains power quality should be that of a typical commercial or hospital environment. To avoid laser stoppage due to fast transients avoid powering the Constellation® Vision System on the same branch circuit with sources that can generate fast transients (inductive switching; e.g., high current motors).SurgeIEC 61000-4-5 • ±1 kV differential mode• ±2 kV common mode• ±1 kV differential mode• ±2 kV common modeMains power quality should be that of a typical commercial or hospital environment. To avoid laser stoppage due to power-line surges consider powering the Constellation® Vision System through branch circuit that has surge suppressor for protection against lightning surges (e.g., at power panel to surgical/office suite).Voltage dips, short interruptions, and voltage variations on power supply input linesIEC 61000-4-11• <5% UT (>95% dip in UT) for 0.5 cycle• 40% UT (60% dip in UT) for 5 cycles• 70% (30% dip in UT) for 25 cycles• <5% (>95% dip in UT) for 5 sec• <5% UT (>95% dip in UT) for 0.5 cycle• 40% UT (60% dip in UT) for 5 cycles• 70% (30% dip in UT) for 25 cycles• <5% (>95% dip in UT) for 5 secMains power quality should be that of a typical commercial or hospital environment. If the uses of the Constellation® Vision System require continued operation during power mains interruptions, it is recommended that the Constellation® Vision System be powered from an uninterruptible power supply or a battery.Power frequency (50/60 Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.Conducted RFIEC 61000-4-6Radiated RFIEC 61000-4-33 Vrms150 kHz to 80 MHz3 V/m80 MHz to 2.5 GHz3 Vrms3V/mPortable and mobile RF communications equipment should be used no closer to any part of the Constellation® Vision System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency to the transmitter.Recommended separation distance:d = 1.2√Pd = 1.2√P 80 MHz to 800 MHzd = 2.3√P 800 MHz to 2.5 GHzConstellation® Vision Systemwhere P is the maximum output power rating to the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strength from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with following symbol.Note: UT is the a.c. mains voltage prior to application of the test level.Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Constellation® Vision System is used exceeds the applicable RF compliance level above, the Constellation® Vision System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Constellation® Vision System.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
8065751025 1.11Constellation® Vision System Table 1-4 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 electromagnetic 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 outputpower of transmitter(W)150 kHz to 80 MHzd = 1.2√P80 MHz to 800 MHzd = 1.2√P800 MHz to 2.5 GHzd = 2.3√P0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters rates at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Note 1 - At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
1.12 8065751025Constellation® Vision SystemUSA – Federal Communications Commission (FCC) Compliance StatementThis device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference.This device must accept any interference received, including interference that may cause undesired operation.CautionChange or modifications made to this equipment not expressly approved by Alcon may void the FCC authorization to operate this equipment.FCC Radiation Exposure StatementCautionTo 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 be co-located or operating in conjunction with any other antenna or transmitter.Canada – Industry of Canada (IC) Compliance StatementThis device complies with Industry Canada Radio Standards Specification RSS-210. Operation is subject to the following two conditions: This device may not cause harmful interferenceThis device must accept 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 à la norme NMB-001 du Canada.Antenna NoticesThis 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 communication.Exposure of Humans to RF FieldsThis device complies with the RF exposure limits for humans as called out in RSS-102. 1.2.1.2.
8065751025 1.13Constellation® Vision System Europe – R&TTE Directive 99/5/ECThis device complies with the requirements of the Council Directive 99/5/EC (R&TTE).CautionThe radio equipment is intended to be used in all EU and AFTA countries. Outdoor use may be restricted to certain frequencies and/or 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.i.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.For more details on legal combinations of power levels and antennas, contact Alcon Compliance.Equipment contains radio transmitters: Wireless LAN device (WiFi)Frequency or frequency band of transmission: 2.412 – 2.462 GHzType and frequency characteristics of the modulation: CCK, DQPSK, DBPSK, OFDMThe Effective Radiated Power (ERP): 17 – 18dBm (50 – 64mW)Radio Frequency Identification (RFID) deviceFrequency or frequency band of transmission: 13.56 MHzType and frequency characteristics of the modulation: ASKThe Effective Radiated Power (ERP): -119 dBm (1260 pW)Australia and New ZealandThis device complies with the Australian/New Zealand Standard AS/NZS 4268: 2003 Radio Equipment and Systems – Short Range Devices – Limits and methods measurement, and AS/NZS 4771 (2000 + A1: 2003) Technical characteristics and test conditions for data transmission equipment operating in the 900 MHz, 2.4 GHz and 5.8 GHz bands and using spread spectrum modulation techniques.••••••
1.14 8065751025Constellation® Vision SystemCautions and WarningsPlease contact Alcon for instrument setup and in-service training.If you have any questions or require additional information, please contact your local Alcon representative or the Technical Services Department. For locations outside the USA, please contact your local authorized Alcon Service/Sales office.• Good clinical practice dictates the testing for adequate irrigation, aspiration flow, and operation as applicable for each handpiece prior to entering the eye.• Do not use the Constellation® Vision System system near flammable anesthetics.• Use only Alcon-supplied A.C. power cords. Prior to plugging the power cord into its power source, ensure that the proper voltage selection has been made. See Care and Maintenance section of this manual for instructions.• 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 instrument cart is used for moving the instrument. The cart should be pulled, not pushed, over elevator and door thresholds.WARNING!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 by hospital staff is not recommended. Unauthorized extension of the power cord could result in injury.Presurgical Setup InstructionsPresurgical setup instructions must be performed as outlined in this manual. If an error message is displayed on the front panel, refer to Troubleshooting of this Manual. If a problem persists, DO NOT PROCEED. Contact your local Alcon Surgical Service Representative.NOTE: If an inconsistency exists between the setup instructions in this manual and the Directions For Use (DFU) supplied with a consumable pak, follow the DFU.Vitreous ProbesDo not operate vitreous probes in air. This could result in performance degradation and/or potential hazard.
8065751025 1.15Constellation® Vision System Cautions and WarningsUltrasonic HandpiecesPower loss may occur if handpiece tip is not securely tightened into Fragmentation and Phaco handpieces.WARNING!Use of a Phaco handpiece at power settings greater than 80% continuously for over 4 minutes can result in ultrasonic system failure. Allow the system to cool for 8 minutes between heavy usage of this type.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.CAUTIONNever ultrasonically clean the Fragmentation and Phaco handpieces; irreparable damage will result.WARNINGS!Use of the phaco handpiece in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential corneal and/or scleral burns.Use of the Fragmentation handpiece in the absence of aspiration flow can cause excessive heating and potential scleral burns.Handpiece TipsScissors, 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 only Alcon supplied fragmentation tip wrenches; otherwise, damage to tips and/or handpiece may occur.WARNING!For phaco surgery use only Alcon-certified Turbosonics® MicroTip™ configurations (.9 mm). Alcon does not recommend the use of standard Turbosonics® tips (1.0 mm) with the Constellation® Vision System.
1.16 8065751025Constellation® Vision SystemDiathermy FunctionTo 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!• Do not use the diathermy function on patients with pacemakers or implanted defibrillatory 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 and its 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. 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.
8065751025 1.17Constellation® Vision System • The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N2O) 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.• 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.Illuminator Function Housed inside Constellation® tabletop, the illuminator provides two channels of illumination from a single xenon arc lamp. Two front panel sockets accept ACMI compatible fiber optic light guides to provide intraocular illumination. When installed, an optional illuminator is housed inside Constellation® base and provides two channels of illumination from a single xenon arc lamp. To gain access for bulb replacement or servicing, follow directions in section four of this manual. Be aware that using the illuminator at high settings will reduce the life of the bulbs.WARNING!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- If you are handling the lamp without its protective sleeve, always wear safety goggles, a face mask, gauntlets with wrist protectors and a breast protector.
1.18 8065751025Constellation® Vision SystemCautions and WarningsFootswitchNever pick up or move the footswitch by holding the cable. Damage may result.CassetteDuring initialization the drain pump is rotated to the home position; therefore, keep hands and fingers clear of cassette well during power-on initialization. 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!All fluids aspirated during surgery should be treated as biohazards. Take appropriate precautions when handling instruments and lines in contact with aspirated fluids.Drain bag volume should not exceed 500cc “Max. Capacity.” Exceeding this volume may result in a biohazardous condition.ConsumablesDo not use consumable paks 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.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.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 Pak configurations.Ensure that tubing is not occluded during any phase of operation.
8065751025 1.19Constellation® Vision System Cautions and WarningsConsumable PaksIf any item in a consumable pak 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. Paks 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 76134-2099Diathermy, Cautery, CoagulationIn 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.
1.20 8065751025Constellation® Vision SystemFigure 1-4 DIATHERMY POWER THROUGH 75 OHM LOADFigure 1-5 DIATHERMY POWER VS. LOAD IMPEDANCEFigure 1-6 DIATHERMY OUTPUT VOLTAGE VS. OUTPUT CONTROL SETTING Note: Maximum output peak-to-peak voltage is about 140V without resistive load.
8065751025 1.21Constellation® Vision System PRODUCT SERVICEFor 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 Instructions 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 one time 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 (e.g., qualified service personnel) at least twice a year. Ground resistance must be under 0.1 ohms. Leakage current must be under 500 µA.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 shipping instructions.Alcon Laboratories, Inc.Technical Services Department15800 Alton ParkwayIrvine, California 92618-3818(949) 753-1393(800) 832-7827
1.22 8065751025Constellation® Vision SystemLIMITED WARRANTYAlcon 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. 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) a result 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 particular 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.LAST PAGE OF THIS SECTION

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