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Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 U.S.A.
EU Authorized Representative: Alcon Laboratories (U.K.) Ltd. Boundary Way, Hemel Hempstead Hertfordshire, HP2 7UD United Kingdom
Produced By: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A. Telephone: FAX:
949/753-1393 800/832-7827 949/753-6614
8065751606 T, CATALOG NUMBER 905-2100-006 C, TEXT ONLY
For Reference Only
© 2009-2010 Alcon, Inc.
Infiniti® Vision System Operator's Manual 8065751606
MANUAL REVISION RECORD
ECN NUMBER AND DESCRIPTION
20091225 - Initial release of operator's manual with catalog number 8065751606, and 905-2100-006 text (applies to Infiniti® Vision System consoles with software version 2.04). This manual includes the Ozil® IP feature, and the 23 gauge Infiniti® UltraVit® probe.
20091528 - Add note on text cover sheet to inspect per generic QIP manual.
20100589 - Regulatory updates for hazardous substance considerations, new safety warnings, coagulation specifications expanded, tables 1-1 to 1-5 updated by one digit. Pages affected are: i, ii, vii, 1.3, 1.4, 1.5, 1.6, 1.12, 1.15, 1.16, 1.18, 7.1-7.4.
END USER LICENSE AGREEMENT: This product contains software licensed from Microsoft Corporation. * Registered in the U.S. Patent & Trademark Office. ** Mackool is a trademark of Richard J. Mackool, M.D. SmartPhaco is a registered trademark of Micro Medical Devices, Inc. SmartPhaco is licensed from Micro Medical Devices, Inc. Cycoloy and Lexan are registered trademarks of Sabic Innovative Plastics IP ii
For Reference Only
TABLE OF CONTENTS SECTION ONE - GENERAL INFORMATION
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2 Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7 Product Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.16 Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.17 SECTION TWO - DESCRIPTION
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1 INFINITI® VISION SYSTEM CONSOLE AND ACCESSORIES Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 Footswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7 Remote Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.14 Handpieces, Tips, and Infusion Sleeves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.19 Fluidic Management System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.29 Infiniti® AquaLase® Balanced Salt Solution Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.30 Consumable Pak Configurations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.31 Infiniti® VideOverlay System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.34 INFINITI® VISION SYSTEM OPERATOR INTERFACE Front Display Panel and Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.38 Setup Screen and its Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.39 Doctor Name. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.40 Handpiece Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.40 Tip Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.41 Procedure Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.41 Cataract Grade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.41 Irrigation Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.42 Metrics Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.43 Footswitch Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.45 Custom Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.47 Setup Status Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.62 Setup Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.63 Surgery Screen and its Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.65 Main Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.65 Surgery Control Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.66 Fluidics Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.67 Surgery Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.67 Adjust Button and Information Bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.69 Surgery Controls Window with I/A Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.70 Surgery Controls Window with Vitrectomy Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.70 Surgery Controls Window with Coagulation Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.70 Surgery Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.71 Setup Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.72 8065751606
For Reference Only
Procedural Step Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.72 Stationary Step Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.72 Surgery Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.73 Ultrasound (U/S) Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.73 NeoSoniX® Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.77 OZil® Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.81 OZil® IP Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.86 AquaLase® Liquefaction Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.88 Irrigation/Aspiration Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.90 Fill Mode of Operation for Irrigation/Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.91 Coagulation (Coag) Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.92 Anterior Vitrectomy Mode of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.94 SECTION THREE - OPERATING INSTRUCTIONS
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 Power Up Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 Initial System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 Standard Phacoemulsification Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 Standard AquaLase® System Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.8 Irrigation/Aspiration Handpiece Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12 Anterior Vitrectomy Probe Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.13 Coagulation Handpiece Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.15 SECTION FOUR - CARE AND MAINTENANCE
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1 Upon Completion of the Day's Surgical Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 Care and Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4 Sterilization Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5 Fuse Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6 SECTION FIVE - TROUBLESHOOTING
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1 Problem Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4 Advisories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.8 Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.10 Faults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.10 SECTION SIX - ACCESSORIES AND PARTS
Catalog Numbers and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2 SECTION SEVEN - INDEX
Alphabetical Listing of Topics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1
For Reference Only
LIST OF FIGURES FIGURE# Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4
TITLE PAGE # ® The Infiniti Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 Icons Used With the Infiniti® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.19 Labeling on Infiniti® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.20 Coagulation Power Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.21
Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 Figure 2-6 Figure 2-7 Figure 2-8 Figure 2-9 Figure 2-10 Figure 2-11 Figure 2-12 Figure 2-13 Figure 2-14 Figure 2-15 Figure 2-16 Figure 2-17 Figure 2-18 Figure 2-19 Figure 2-20 Figure 2-21 Figure 2-22 Figure 2-23 Figure 2-24 Figure 2-25 Figure 2-26 Figure 2-27 Figure 2-28 Figure 2-29 Figure 2-30 Figure 2-31 Figure 2-32 Figure 2-33 Figure 2-34 Figure 2-35 Figure 2-36 Figure 2-37 Figure 2-38 Figure 2-39 Figure 2-40
The Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 The Front Connector Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 The Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 The Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6 The Accurus®/Legacy® and Infiniti® Footswitches . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7 Footswitch Cable Routing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.8 Diagram of Footpedal Positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9 Footswitches Used with the Infiniti® Vision System . . . . . . . . . . . . . . . . . . . . . . . . 2.11 The Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.14 The Remote Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.15 Proper Orientation of Two Halves of Remote Control . . . . . . . . . . . . . . . . . . . . . . 2.17 The Remote Control Settings Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.18 OZil® Torsional Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.19 Infiniti® NeoSoniX® Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.19 Infiniti® Ultrasonic (U/S) Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.19 TurboSonics® Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.21 AquaLase® Liquefaction Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.22 Infiniti® U/S HP with Infusion Sleeve and BSI . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.22 Ultraflow™* IT Handpiece and Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.25 Ultraflow™* IT HP with infusion sleeve, reusable I/A tip, and tip adapter . . . . . . 2.25 Ultraflow™* O-ring tool with large and small O-rings . . . . . . . . . . . . . . . . . . . . . . 2.25 Ultraflow™* SP Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.25 Infiniti® Vitrectomy Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.26 Single use bipolar brush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.28 The Infiniti® Ultrasound Fluidic Management System (FMS) . . . . . . . . . . . . . . . . 2.29 The AquaLase®/Balanced Salt Solution Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.30 VideOverlay Front Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.34 VideOverlay Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.35 Wall Outlet Adapters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.36 Standard VideOverlay Connection Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.36 High Definition VideOverlay Connection Diagram. . . . . . . . . . . . . . . . . . . . . . . . . 2.37 The Infiniti® Vision System Front Display Panel and Touch Screen . . . . . . . . . . . . 2.38 Navigating the Infiniti® Vision System User Screens . . . . . . . . . . . . . . . . . . . . . . . 2.38 Functional Areas of the Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.39 Bottle Height Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.42 Metrics Dialog Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.44 Footswitch Buttons Dialogs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.45 Footswitch Treadle Dialogs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.45 Setup Screen with Custom Drop List Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.47 Doctor Settings Dialog Screen - General Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.48
For Reference Only
FIGURE# Figure 2-41 Figure 2-42 Figure 2-43 Figure 2-44 Figure 2-45 Figure 2-46 Figure 2-47 Figure 2-47 Figure 2-48 Figure 2-50 Figure 2-51 Figure 2-52 Figure 2-53 Figure 2-54 Figure 2-55 Figure 2-56 Figure 2-57 Figure 2-58 Figure 2-59 Figure 2-60 Figure 2-61 Figure 2-62 Figure 2-63 Figure 2-64 Figure 2-65 Figure 2-66 Figure 2-67 Figure 2-68 Figure 2-69 Figure 2-70 Figure 2-71 Figure 2-72 Figure 2-73 Figure 2-74 Figure 2-75 Figure 2-76 Figure 2-77 Figure 2-78 Figure 2-79 Figure 2-80 Figure 2-81 Figure 2-82 Figure 2-83 Figure 2-84 Figure 2-85 Figure 2-86 Figure 2-87
TITLE PAGE # ® OZil Torsional Function Before Phaco. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.49 Doctor Settings Dialog Screen - Steps Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.51 Doctor Settings Dialog Screen - Defaults Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.52 Doctor Settings Dialog Screen - Advanced Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.52 Copy/Delete Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.54 Copy/Delete Dialog with Enabled and Disabled Tips . . . . . . . . . . . . . . . . . . . . . . . 2.56 System Settings Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.58 IV Pole Extender Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.59 Sound Settings Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.60 AquaLase® Occlusion Settings Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.60 About Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.61 Functional Area of the Setup Status Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.62 Functional Areas of the Setup Steps Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.63 Functional Areas of the Infiniti® Vision System Surgery Screen . . . . . . . . . . . . . . . 2.65 Surgery Control Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.66 Lower and Upper Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.69 Surgery Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.71 U/S Footpedal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.73 The Ultrasound Continuous Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.74 The Ultrasound Pulse Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.74 The Ultrasound Burst Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.75 The U/S Custom Pulse Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.76 NeoSoniX® Footpedal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.77 The NeoSoniX® Continuous Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.78 The NeoSoniX® Pulse Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.79 The NeoSoniX® Burst Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.79 The NeoSoniX® Custom Pulse Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.80 OZil® Footpedal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.81 The OZil® Continuous Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.82 The OZil® Pulse Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.83 Phaco Duty Cycle (% Time On) Not Adjustable . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.83 The OZil® Burst Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.84 The OZil® Custom Pulse Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.85 Surgery Screen with OZil® IP Enabled. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.86 OZil® IP Dialog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.86 OZil® IP Dialog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.87 The AquaLase® Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.89 AquaLase® Footpedal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.89 The Irrigation/Aspiration Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.90 Irrigation/Aspiration Footpedal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.90 The Coagulation Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.92 Coagulation Footpedal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.92 Anterior Vitrectomy Footpedal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.94 Anterior Vitrectomy Screen with Vit Probes in Drop Down List . . . . . . . . . . . . . . 2.94 Anterior Vitrectomy Surgery Screen Using 20 Gauge Infiniti® Vitrectomy Probe. . 2.95 Anterior Vitrectomy Surgery Screen Using 23 Gauge Infiniti® UltraVit® Probe . . . 2.95 Vitrectomy Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.96
For Reference Only
FIGURE# Figure 3-1 Figure 3-2 Figure 3-3 Figure 3-4
TITLE PAGE # U/S Tip/Wrench Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5 Mackool** Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5 Protective Cap Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.6 Preparing Test Chamber and Placing Handpiece in Pouch . . . . . . . . . . . . . . . . . . . . 3.6
Footswitch Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3
Figure 5-1 Figure 5-2 Figure 5-3 Figure 5-4
Advisories Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1 Warnings Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Faults Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Troubleshooting Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3
Table 1-1 Table 1-2 Table 1-3 Table 1-4 Table 1-5 Table 1-6
Information on Location of Hazardous Substances in Infiniti® Vision System . . . . . 1.4 Guidance and Manufacturer's Declaration - Electromagnetic Emissions . . . . . . . . . 1.4 Guidance and Manufacturer's Declaration - Electromagnetic Immunity . . . . . . . . . 1.5 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Infiniti® Vision System . . . . . . . . . . . . . . . 1.6 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.18 Abbreviations Used with the Infiniti® Vision System . . . . . . . . . . . . . . . . . . . . . . . 1.18
Table 2-1 Table 2-2 Table 2-3
Table of Footpedal Positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9 Programming the Footswitch Treadle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.45 Parameters in Surgery Controls Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.67
Table 5-1 Table 5-2
Problem Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4 Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.8
For Reference Only
PREFACE This operator's manual is your written guide to the Infiniti® Vision System and considers all options available to the customer; therefore, when reading this manual, ignore the options which do not apply to your specific unit. Please read the entire manual carefully before operating the instrument. Recommended settings are given only as guidelines, and are not meant to restrict the surgeon; however, before trying other settings, the surgeon and support personnel should be experienced with the system and familiar with the new settings. NOTE: If an inconsistency exists between the instructions in the operator's manual and the Directions For Use (DFU) supplied with a consumable pak or accessory, follow the DFU. Equipment 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, Cautions, and Notes in this manual. A WARNING! statement is written to protect individuals from bodily harm. A Caution statement, with the CAUTION heading centered above the text, is written to protect the instrument from damage. A NOTE: is written to bring attention to highlighted information. If you have questions, or want additional information, please contact your local Alcon representative or the Alcon Technical Services Department at: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618 (949) 753-1393 FAX (949) 753-6614 CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician.
LAST PAGE THIS SECTION For OF Reference Only
SECTION ONE GENERAL INFORMATION INTRODUCTION
Alcon’s Infiniti® Vision System is an ophthalmic surgical instrument designed to be reliable, safe, and easy to operate. The Infiniti® Vision System provides four modes for cataract lens extraction using AquaLase®, OZil® torsional, NeoSoniX®, and high performance U/S handpieces. This instrument has been developed to be user friendly, combining hardware that is easy to install and maintain along with software that increases the effectivity of the user.
The Infiniti ® Vision System is intended for use in small incision cataract lens extraction surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® or BSS®Plus irrigation solution. The system controls include a footswitch to enable the surgeon to control irrigation flow, aspiration rate, phaco power, vitrectomy cut rate, and coagulation power.
Figure 1-1 The Infiniti® Vision System
For Reference Only
The Infiniti® Vision System is designed for use in anterior segment procedures that require simultaneous cataract lens extraction, irrigation, and aspiration, as well as associated procedures such as vitrectomy and coagulation. It was developed with a dual purpose: to make it simple to operate, and to allow the surgeon tremendous versatility and control. The system is designed to allow the surgeon to customize the treatment of every patient.
Following are key features of the Infiniti® Vision System:
• Customized cataract lens removal options: - OZil® torsional handpiece with ultrasonic torsional oscillations which can be used exclusively or alternated with traditional phaco. - AquaLase® liquefaction device handpiece, technology, and accessories. - Infiniti® NeoSoniX® handpiece combining the features of a phaco handpiece with sonic oscillations. - High performance Infiniti® U/S handpiece: 40 kHz, piezoelectric, slim, lightweight, autoclavable. • Advanced fluidics with quick, smooth control of peristaltic aspiration. • Fully programmable, multi-microprocessor control. • Modularized fluidic connections achieved with the disposable Fluidic Management System (FMS). • Emulation of venturi-like fluidic performance. • Ability to drive a high performance Infiniti® vitrectomy guillotine cutter. • Bipolar coagulation capability. • Several traditional modalities of ultrasonic power control including continuous, pulsed, and “burst” application of ultrasonic power, as well as duty cycle management. • Automated IV pole, controlled via the front panel, footswitch, or remote control. • Linear footswitch control of ultrasonic power in U/S steps (sophisticated control loop offers low-end control). • Linear footswitch control of aspiration flow rate (AFR) in I/A, VIT, and lens removal modes. • Linear footswitch control of vacuum in I/A, VIT, and lens removal modes. • On-demand continuous irrigation. • Programmable, pressurized reflux via the footswitch. • Ability to set vacuum levels and aspiration flow rates to desired levels in phaco, I/A, and VIT steps. • Ability to switch between surgical steps using touch screen, remote, or footpedal. • Emission of variable tones for confirmation of system operational status. • Voice confirmation during surgical step or mode changes. • Flat screen, active matrix color LCD with touch screen display that is tiltable and rotatable. • High-tech graphical user interface. • Multi-channel wireless remote control.
For Reference Only
Many of the abbreviations used in this manual and on the Infiniti® Vision System are described in Table 1-5. Icons are identified in Figure 1-2.
Accessory equipment connected to or used with this equipment must be certified according to the respective IEC Standard (e.g., IEC 950 for data processing equipment, and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with System Standard IEC 60601-1-1. 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.
Follow local governing ordinances and recycling plans regarding disposal or recycling of device components and packaging.
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 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-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. The Pb notation, if 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.
For Reference Only
Table 1-1 Information on the Location of Hazardous Substances in the Infiniti® Vision System - The Infiniti® Vision System contains hazardous substances which could have potential effect on the environment and human health if disposed of improperly.
Hazardous Substances Contained
Printed Circuit Board Assembly
Lead, Polybrominated Biphenyls (PBB)
Other Electrical / Electronic Device
Lead, Polybrominated Biphenyls (PBB)
Lead, Polybrominated Biphenyls (PBB)
Lead, Polybrominated Biphenyls (PBB)