INFINITI Operators Manual Rev AB April 2016

Operator's Manual EC Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 U.S.A. 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

REP

EU Authorized Representative: Alcon Laboratories (UK) Ltd. Frimley Business Park Frimley, Camberley Surrey, GU16 7SR United Kingdom

Directive 93/42/EEC

8065752899 AB CATALOG NUMBER 905-2100-010 C TEXT ONLY © 2012-2016 Novartis

a Novartis company

Infiniti* Vision System Operator's Manual 8065752899

MANUAL REVISION RECORD DATE

REVISION

ECN NUMBER AND DESCRIPTION

September 2013

X

20132112 - Initial release of operator's manual with catalog number 8065752899, and 905-2100-010 text (applies to Infiniti* Vision System consoles with software version 3.02). Changes to better define the AutoSert* Injector and its operation.

April 2014

AA

20140663 - All references to Intrepid* IOL removed from manual. Affected pages are: i, ii, 2.27, 2.93, 2.95, 2.96, 3.13, 3.14, 7.3.

Revisions A-W and revisions Y-Z not used with this manual.

April 2016

20160312 - All Alcon trademarks (™, ®) changed to an asterisk and definition of asterisk added to bottom of page ii. Warnings and Cautions added in section one. OSHA icon updated and Australian Regulatory Compliance Mark added in Figure 1-2. Weight and Phacoemulsification specifications edited. Rear panel label updated in Figure 1-3. Two small parts kits added to catalog items in section six. References to fluidics bottle changed to "bottle or bag" throughout manual. Affected pages are: i, ii, 1.7, 1.8, 1.10, 1.21, 1.22, 1.23, 2.4, 2.31, 2.45, 2.46, 2.62, 3.3, 3.8, 4.2, 5.4, 6.3.

AB

END USER LICENSE AGREEMENT: This product contains software licensed from Microsoft Corporation. * A trademark of Novartis. ** Mackool is a trademark of Richard J. Mackool, M.D. Cycoloy and Lexan are registered trademarks of Sabic Innovative Plastics IP ii

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TABLE OF CONTENTS SECTION ONE - GENERAL INFORMATION PAGE # INTRODUCTION... 1.1 GENERAL INFORMATION... 1.2 Key Features of the Infiniti* Vision System... 1.2 Abbreviation Descriptions... 1.3 Accessory Equipment... 1.3 User Information – Environmental Considerations... 1.3 Universal Precautions... 1.4 EMC Statement... 1.4 WARNINGS AND CAUTIONS... 1.7 Handpiece Care... 1.9 IV Pole and Extender... 1.11 Ultraflow* (I/A) Handpiece... 1.11 Recommended Vacuum Range for I/A Tips... 1.11 Handpiece Tips... 1.12 INTREPID* AutoSert* IOL Injector... 1.12 Infiniti* Vitrectomy Probe... 1.13 Aspiration/Vacuum Adjustments... 1.13 Presurgical Check-out Tests... 1.13 Footswitch... 1.14 High Altitudes... 1.14 Occlusion Tones... 1.14 Vacuum Tone... 1.15 Coagulation Function... 1.16 Cautery, Diathermy, Coagulation Definition...1.17 Infiniti* VideOverlay System (IVO)... 1.17 Consumable Paks... 1.18 PRODUCT SERVICE... 1.19 LIMITED WARRANTY... 1.20 SECTION TWO - DESCRIPTION PAGE # INTRODUCTION... 2.1 INFINITI* VISION SYSTEM CONSOLE AND ACCESSORIES... 2.2 CONSOLE... 2.2 Fluidics Module... 2.2 Front Display Panel and Touch Screen... 2.3 Front Connector Panel... 2.3 Footswitch Drawer... 2.4 Instrument Tray... 2.4 IV Pole with Bottle Hanger... 2.4 Accessory Drawers... 2.4 Caster Wheels... 2.4 Handles... 2.4 REAR AND SIDE PANELS... 2.5 Power Module... 2.5 Equipotential Ground Connector - For Service Personnel Use Only... 2.5 Cord Wrap... 2.5 Connectors and CD/DVD Drive... 2.5 8065752899

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Data Card Slot... 2.6 Standby Power Switch... 2.6 Audio Speaker... 2.6 FOOTSWITCH... 2.7 Plugging in the Footswitch... 2.8 Footpedal Control... 2.9 Switch Control... 2.10 REMOTE CONTROL... 2.14 Remote Control Keys and Buttons... 2.15 Remote Control Batteries... 2.17 Select Remote Control Channel... 2.18 HANDPIECES, TIPS, AND INFUSION SLEEVES... 2.19 Phaco Ultrasound Handpieces... 2.19 TurboSonics* Family of Tips... 2.21 AquaLase* Liquefaction Handpiece (optional item)... 2.23 MicroSmooth* Infusion Sleeves... 2.23 UltraFlow* Handpieces and Tips... 2.25 INTREPID* AutoSert* IOL Injector... 2.27 Infiniti* Vitrectomy Probes... 2.29 Bipolar Coagulation Handpieces... 2.30 FLUIDIC MANAGEMENT SYSTEM... 2.31 INFINITI* AQUALASE* BALANCED SALT SOLUTION BOTTLE (optional item)... 2.32 CONSUMABLE PACK CONFIGURATIONS... 2.33 Custom Pak* Surgical Procedure Pack Configurations... 2.33 Infiniti* U/S Fluidic Management System Packs... 2.34 Infiniti* AquaLase* Fluidic Management System Packs (optional item)... 2.35 INFINITI* VIDEOVERLAY SYSTEM (optional item)... 2.36 Setup For Standard IVO... 2.37 INFINITI* VISION SYSTEM OPERATOR INTERFACE... 2.40 FRONT DISPLAY PANEL AND TOUCH SCREEN... 2.40 SETUP SCREEN AND ITS FUNCTIONS... 2.41 Main Window... 2.41 Doctor Name... 2.42 Add Doctor... 2.42 Handpiece Type... 2.43 Tip Type... 2.44 Procedure Type... 2.44 Cataract Grade... 2.44 Irrigation Controls... 2.45 Metrics Display... 2.46 Footswitch Button... 2.48 Custom Button... 2.50 Custom / Doctor... 2.51 Doctor Settings / General Tab... 2.51 Doctor Settings / Steps Tab... 2.54 Doctor Settings / Defaults Tab... 2.55 Doctor Settings / Advanced Tab... 2.55 Custom / Save... 2.57 iv

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Custom / Copy/Delete... 2.57 Copy/Delete - Handpiece Tip Selections... 2.59 Custom / System... 2.61 Custom / Sound... 2.63 Custom / AQL Occlusion... 2.63 Custom / About... 2.64 Custom / Shutdown... 2.64 Setup Status Window... 2.65 Setup Steps... 2.66 Prime FMS Button... 2.66 Fill or Irrigation Fill Button... 2.67 Test Handpiece Button... 2.67 Surgery Button... 2.67 SURGERY SCREEN AND ITS FUNCTIONS... 2.68 Main Window... 2.68 Surgery Control Window... 2.69 Fluidics Controls... 2.70 Surgery Controls... 2.70 Adjust Button and Information Bar... 2.72 Surgery Controls Window with I/A Steps... 2.73 Surgery Controls Window with Vitrectomy Steps... 2.73 Surgery Controls Window with Coagulation Steps... 2.73 Surgery Menu... 2.74 Setup Button... 2.75 Procedural Step Buttons... 2.75 Stationary Step Buttons...2.75 SURGERY MODES... 2.76 Ultrasound (U/S) Mode of Operation... 2.76 Power... 2.76 Timing... 2.77 Smart Pulse... 2.78 NeoSoniX* Handpiece Mode of Operation... 2.80 Power... 2.80 Timing... 2.81 OZil* Handpiece Mode of Operation... 2.84 Power/Amplitude... 2.84 Timing... 2.85 OZil* IP Feature... 2.89 AquaLase* Liquefaction Mode of Operation (optional feature)... 2.91 PPS... 2.91 Irrigation/Aspiration Mode of Operation... 2.93 Vacuum Control... 2.94 Aspiration Control... 2.94 Fill Mode of Operation for Irrigation/Aspiration... 2.94 AutoSert* Mode of Operation... 2.95 Coagulation (Coag) Mode of Operation... 2.98 Anterior Vitrectomy Mode of Operation... 2.100

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SECTION THREE - OPERATING INSTRUCTIONS PAGE # INTRODUCTION... 3.1 POWER UP SEQUENCE... 3.1 INITIAL SYSTEM SETUP... 3.2 STANDARD PHACOEMULSIFICATION SETUP... 3.3 Prepare Contents of U/S Surgical Pak... 3.3 Prime, Vacuum, and Vent Test... 3.4 U/S Handpiece, OZil* Torsional Handpiece, or NeoSoniX* Handpiece Setup and Test... 3.5 STANDARD AQUALASE* DEVICE SYSTEM SETUP (optional feature)... 3.8 Prepare Contents of AquaLase* Surgical Pak...3.8 Prime, Vacuum, and Vent Test... 3.9 AquaLase* Handpiece Setup and Test... 3.10 IRRIGATION/ASPIRATION HANDPIECE SETUP... 3.12 INTREPID* AutoSert* IOL INJECTOR SETUP... 3.13 In Setup Screen... 3.13 In I/A, Cap Wash, or IOL Step... 3.13 ANTERIOR VITRECTOMY PROBE SETUP (using Vitrectomy Setup screen)... 3.15 ANTERIOR VITRECTOMY PROBE SETUP (without using Vitrectomy Setup screen)... 3.17 COAGULATION HANDPIECE SETUP... 3.18 SECTION FOUR - CARE AND MAINTENANCE PAGE # 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 PAGE # Introduction... 5.1 Equipment Malfunction... 5.1 Problem Conditions... 5.4 Advisories... 5.8 Warnings... 5.11 Faults... 5.11 SECTION SIX - ACCESSORIES AND PARTS PAGE # Catalog Numbers and Descriptions... 6.2 SECTION SEVEN - INDEX PAGE # Alphabetical Listing of Topics... 7.1

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LIST OF FIGURES FIGURE# Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4 Figure 1-5

TITLE PAGE # The Infiniti* Vision System... 1.1 Icons Used With Infiniti* Vision System... 1.22 Labeling On Infiniti* Vision System... 1.23 Labeling On Infiniti* Vision System Accessories... 1.24 Coagulation Power Outputs... 1.25

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 Figure 2-41 Figure 2-42

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... 2.22 AquaLase* Liquefaction Handpiece (optional item)... 2.23 Infiniti* U/S HP shown with Infusion Sleeve and Bubble Suppression Insert... 2.23 Ultraflow* I/A Handpiece and Tips... 2.26 Ultraflow* I/A Handpiece and Accessories... 2.26 O-Ring Replacement Tool... 2.26 Ultraflow* SP I/A Handpiece... 2.26 INTREPID* AutoSert* IOL Injector... 2.27 Vitrectomy Probes... 2.29 Single Use Bipolar Brush... 2.30 The Infiniti* Ultrasound Fluidic Management System (FMS)... 2.31 The AquaLase* Balanced Salt Solution Bottle (optional item)... 2.32 VideOverlay Front Panel... 2.36 VideOverlay Rear Panel... 2.37 Wall Outlet Adapters... 2.38 Standard VideOverlay Connection Diagram...2.38 High Definition VideOverlay Connection Diagram... 2.39 The Infiniti* Vision System Front Display Panel and Touch Screen... 2.40 Navigating the Infiniti* Vision System User Screens... 2.40 Functional Areas of the Setup Screen... 2.41 Drop List of Available Handpieces... 2.43 Bottle Height Measurement... 2.45 Metrics Dialog Screen... 2.47 Footswitch Buttons Dialogs... 2.48 Footswitch Treadle Dialogs... 2.48 Setup Screen with Custom Drop List Menu... 2.50 Doctor Settings Dialog Screen - General Tab... 2.51

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Figure 2-43 Figure 2-44 Figure 2-45 Figure 2-46 Figure 2-47 Figure 2-48 Figure 2-49 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 Figure 2-88 Figure 2-89 Figure 2-90 Figure 2-91 Figure 2-92 viii

OZil* Torsional Function Before Phaco... 2.52 Doctor Settings Dialog Screen - Steps Tab... 2.54 Doctor Settings Dialog Screen - Defaults Tab... 2.55 Doctor Settings Dialog Screen - Advanced Tab... 2.55 Copy/Delete Dialog... 2.57 Copy/Delete Dialog with Enabled and Disabled Tips... 2.59 System Settings Dialog... 2.61 IV Pole Extender Settings... 2.62 Sound Settings Dialog... 2.63 AquaLase* Occlusion Settings Dialog (optional feature)... 2.63 About Dialog... 2.64 Functional Area of the Setup Status Window with UltraChop and IOL Steps Enabled... 2.65 Functional Areas of the Setup Steps Window... 2.66 Functional Areas of the Infiniti* Vision System Surgery Screen... 2.68 Surgery Control Window... 2.69 Lower and Upper Limits... 2.72 Surgery Menu... 2.74 U/S Footpedal Control... 2.76 The Ultrasound Continuous Surgery Screen... 2.77 The Ultrasound Pulse Surgery Screen... 2.77 The Ultrasound Burst Surgery Screen... 2.78 The U/S Custom Pulse Surgery Screen... 2.79 NeoSoniX* Footpedal Control... 2.80 The NeoSoniX* Continuous Surgery Screen... 2.81 The NeoSoniX* Pulse Surgery Screen... 2.82 The NeoSoniX* Burst Surgery Screen... 2.82 The NeoSoniX* Custom Pulse Surgery Screen... 2.83 OZil* Footpedal Control... 2.84 The OZil* Continuous Surgery Screen... 2.85 The OZil* Pulse Surgery Screen... 2.86 Phaco Duty Cycle (% Time On) Not Adjustable... 2.86 The OZil* Burst Surgery Screen... 2.87 The OZil* Custom Pulse Surgery Screen... 2.88 Surgery Screen with OZil* IP Enabled... 2.89 OZil* IP Dialog... 2.89 OZil* IP Dialog... 2.90 The AquaLase* Surgery Screen (optional mode of operation)... 2.92 AquaLase* Footpedal Control (optional feature)... 2.92 The Irrigation/Aspiration Surgery Screen... 2.93 Irrigation/Aspiration Footpedal Control... 2.93 Intraocular Lens Injector Screen... 2.95 IOL Injector Footpedal Control... 2.95 Preloading IOL... 2.96 The Coagulation Screen... 2.98 Coagulation Footpedal Control... 2.98 Anterior Vitrectomy Footpedal Control... 2.100 Anterior Vitrectomy Screen with Vit Probes in Drop Down List... 2.100 Anterior Vitrectomy Screen Using 20 Gauge Infiniti* Vitrectomy Probe... 2.101 Anterior Vitrectomy Screen Using 23 Gauge Infiniti* UltraVit* Probe... 2.101 Vitrectomy Setup Screen... 2.102 8065752899

Figure 3-1 Figure 3-2 Figure 3-3 Figure 3-4 Figure 3-5

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 Vitrectomy Setup Screen... 3.15

Figure 4-1

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

LIST OF TABLES TABLE#

TITLE

PAGE #

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... 1.21 Abbreviations Used with the Infiniti* Vision System... 1.21

Table 2-1 Table 2-2 Table 2-3

Table of Footpedal Positions... 2.9 Programming the Footswitch Treadle... 2.49 Parameters in Surgery Controls Area... 2.71

Table 5-1 Table 5-2

Problem Conditions... 5.4 Event Codes... 5.8

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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 pack 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.

x

LAST PAGE OF THIS SECTION

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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 the OZil* torsional handpiece, NeoSoniX* handpiece, high performance U/S handpiece, and optional AquaLase* handpiece. 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 and IOL injection 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* irrigating solution. The system includes a footswitch to enable the surgeon to control irrigation flow, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

Figure 1-1 The Infiniti* Vision System

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1.1

GENERAL INFORMATION The Infiniti* Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID* AutoSert* IOL Injector is intended to deliver qualified AcrySof* intraocular lenses into the eye following cataract removal. The following system modalities additionally support the described indications: • Ultrasound with the ALCON* UltraChopper* tip achieves functionality of cataract separation. • Optional AquaLase* device achieves functionality for removal of residual cortical material and lens epithelial cells. • The AutoSert* IOL injector handpiece achieves the functionality of injection of intraocular lenses. The AutoSert* is indicated for use with AcrySof* lenses SN60WF and SN6AD1, as well as approved AcrySof* lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses. 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. - 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. - Optional AquaLase* liquefaction device handpiece, technology, and accessories. • Advanced fluidics with quick, smooth control of peristaltic aspiration. • Surgeon controlled IOL injection. • Fully programmable, multi-microprocessor control. • Modularized fluidic connections achieved with disposable Fluidic Management System (FMS). • Emulation of venturi-like fluidic performance. • Ability to drive a high performance Infiniti* system 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. • 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. 1.2

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Trademark Note A button, mode, or step labeled OZil*, NeoSoniX*, AutoSert*, or UltraChop refers to a display screen control used with an OZil* torsional handpiece, NeoSoniX* handpiece, INTREPID* AutoSert* IOL injector, or ALCON* UltraChopper* tip, respectively. Abbreviation Descriptions Many of the abbreviations used in this manual and on the Infiniti* Vision System are described in Table 1-6. Icons are identified in Figure 1-2. Accessory Equipment Accessory equipment connected to or used with this equipment must be certified according to the respective IEC Standard (e.g., IEC 60950-1 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. Pb

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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.

1.3

Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials. In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled in accordance with OSHA or your own national guidelines. EMC Statement It 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 equipment off and on), the user is encouraged to try to correct 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 1-1 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. Material Location

Table 1-2

Hazardous Substances Contained

Printed Circuit Board Assembly

Lead, Polybrominated Biphenyls (PBB)

Other Electrical / Electronic Device

Lead, Polybrominated Biphenyls (PBB)

Cable Assembly

Lead

Power Supply

Lead, Polybrominated Biphenyls (PBB)

Host PC Module

Lead, Polybrominated Biphenyls (PBB)

Liquid Crystal Display

Lead

Battery

Lead, Lithium, Zn/MnO2

IV Pole Assembly

Lead, Polybrominated Biphenyls (PBB)

Remote Control

Lead

Fluidics Assembly

Lead

Pneumatic Assembly

Lead

Guidance and Manufacturer's Declaration - Electromagnetic Emissions - The Infiniti* Vision System is intended for use in the electromagnetic environment specified below. The customer or the user of the Infiniti* Vision System should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment-Guidance

RF emissions CISPR 11

Group 1

The Infiniti* 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 emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Based on extensive field experience the Infiniti* Vision System is suitable for use in all establishments other than domestic and those directly connected to a low voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ Flicker emissions IEC 61000-3-3

Complies

The EMC Statement provides guidance on steps to take in case of electromagnetic interference.

1.4

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Table 1-3

Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The Infiniti* Vision System is intended for use in the electromagnetic environment specified below. The customer or the user of the Infiniti* Vision System should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Electrostatic discharge • ±6 kV contact (ESD) • ±8 kV air IEC 61000-4-2

Compliance Level • ±6 kV contact • ±8 kV air

Electromagnetic Environment-Guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

• ±2 kV for power supply • ±2 kV for power supply lines lines • ±1 kV for input/output • ±1 kV for input/output lines lines

Surge IEC 61000-4-5

• ±1 kV differential mode • ±1 kV differential mode Mains power quality should be that of a typical commercial • ±2 kV common mode • ±2 kV common mode or hospital environment.

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

• <5% UT (>95% dip in • <5% UT (>95% dip in UT) for 0.5 cycle UT) for 0.5 cycle • 40% UT (60% dip in UT) • 40% UT (60% dip in UT) for 5 cycles for 5 cycles • 70% UT (30% dip in UT) • 70% UT (30% dip in UT) for 25 cycles for 25 cycles • <5% UT (>95% dip in • <5% UT (>95% dip in UT) for 5 sec UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the use of the Infiniti* Vision System requires continued operation during power mains interruptions, it is recommended that the Infiniti* Vision System be powered from an uninterruptible power supply or a battery.

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

Mains power quality should be that of a typical commercial or hospital environment. To avoid pre-mature shutdown due to fast transients avoid powering the Infiniti* Vision System on the same branch circuit with sources that can generate fast transients (inductive switching; e.g., high current motors).

Portable and mobile RF communications equipment should be used no closer to any part of the Infiniti* Vision System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency to the transmitter. Recommended separation distance: Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

d = 1.2√P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3V/m

d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz where 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: Note 1: Note 2: a

b

UT is the a.c. mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 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 (equipment or system) is used exceeds the applicable RF compliance level above, the (equipment or 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 Infiniti* Vision System. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 1-4

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Infiniti* Vision System - The Infiniti* Vision System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Infiniti* Vision System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Infiniti* Vision System as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2√P d = 1.2√P d = 2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For 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.

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WARNINGS AND CAUTIONS Many of these warnings are stated elsewhere in this manual; however, for easy reference they are repeated in greater detail here. If additional information is required, please contact your local Alcon service representative, or the Technical Services Department. There are no user serviceable components inside the Infiniti* Vision System console or footswitch. Refer all service issues to your factory-trained Alcon service engineer. WARNINGS! The Infiniti* Vision System battery can only be serviced by a factory-trained Alcon service engineer. Access by untrained personnel can lead to injury. A qualified technician must perform a visual inspection of the following components every twelve months: • Warning Labels (see section one of this manual) • Power Cord • Fuses In case of a deficiency, do not use the system; call Alcon Technical Services. A qualified technician must check ground continuity for leakage current every twelve months to ensure they are within the applicable standards (for example: EN60601-1/IEC60601-1). Values must be recorded, and if they are above the applicable standards, or 50% above initial measurement, do not use the system; call Alcon Technical Services. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth (ground). For continued protection against risk of fire, only replace fuse with one that has the same type and rating. If the Infiniti* Vision System is used at the 220V - 240V range in the United States or Canada, it should be used on a center-tapped, 240V single phase circuit. Console isolation from mains is achieved through a two pole power switch. Turn OFF power switch or unplug the power cord from wall outlet to achieve isolation from mains. The pneumatic system contains a pressure vessel with the following ratings: PS = 4.1 Bar, Tmax = 35 ºC, Tmin = 10 ºC, V = 0.3L Modification of the equipment is NOT allowed without prior authorization from the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye. Ensure device moves freely in and out of incision to avoid damage at the incision site. Ensure that the tubings are not occluded during any phase of operation. Do not exceed maximum capacity of drain bag (500 ml). Excessive pressure can result from exceeding drain bag maximum capacity and potentially result in a hazardous condition for the patient. Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. 8065752899

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WARNINGS! Inadvertent pressing of Standby switch when system is active will cause unit to shut down. Ensure that the Continuous Irrigation setting is correct after discarding unsaved changes or copying Doctor Settings. Ensure that appropriate Infiniti* system parameters and system settings are selected prior to starting the procedure. Parameter and system settings include, but are not limited to, ultrasound mode, ultrasound power, vacuum, aspiration flow rate, bottle height, etc. Use of appropriate technique and settings is important to minimize fragments and turbulence. Do not remove the FMS during the surgical procedure. If the handpiece test chamber is collapsed after tuning, there is a potential of low irrigation flow through the handpiece and may result in a fluidic imbalance. This, in turn, may cause a shallowing or collapsing of the anterior chamber. Avoid setting the patient above the FMS. Operating with the patient above the FMS will result in a lower irrigation pressure than indicated on the display, and possible underventing. Keep clear of the IV pole when it is in motion to prevent skin, hair, and/or clothing from being trapped in the IV pole mechanism. The IV pole moves during power on/ off, priming, and bottle height adjustment. Keep clear of display base when raising display from stored position to prevent skin, hair, and /or clothing from being trapped at the base. 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. Tray support must be set in its stored position when moving instrument. Console might overbalance when it is pushed and its wheels are immobilized (blocked). Route the footswitch cable, power cord and any other cables connected to the Infiniti* Vision System to avoid tripping.

CAUTIONS • Do not use the Infiniti* Vision System near flammable anesthetics. • Avoid spilling BSS* irrigating solution, or moisture of any kind, around the electrical handpiece connectors. • Do not push or pull the unit by the display, the tray, or the IV pole. Handles located at the rear and sides of the unit are provided for moving the instrument. The unit should be pulled and not pushed, especially over elevator and door thresholds. • Do not place more than a 20 lb. load on tray support. • The USB connector ( ) and Infiniti* system port ( ) located on the rear panel are for use by Alcon trained personnel only. Failure to comply will void warranty. • Risk of burns and fire - do not use near conductive materials. Renew electrode cables upon evidence of deterioration. 1.8

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Handpiece Care The OZil* torsional handpiece, NeoSoniX* handpiece, high performance U/S handpiece, and optional AquaLase* handpiece are surgical instruments and must be handled with care. The handpiece tip should not touch any solid object while in operation. Immediately following surgery the handpiece must be thoroughly cleaned. Be sure handpiece connector is completely dry before connecting it to console. For cleaning and sterilization procedures, see the Directions for Use (DFU) supplied with the handpiece. WARNING!

If in the medical opinion of the physician a patient with a prion related disease undergoes a high risk procedure, the instrument should be destroyed or be processed according to local requirements.

The Infiniti* NeoSoniX* handpiece, OZil* torsional handpiece, U/S handpiece, and INTREPID* AutoSert* IOL Injector must be at room temperature just before use. Allow the handpiece to air cool for at least 15 minutes after autoclaving; never immerse the handpiece in liquid when hot. CAUTIONS Never ultrasonically clean the OZil* torsional handpiece, NeoSoniX* handpiece, U/S handpiece, or optional AquaLase* handpiece, ; irreparable damage may result. Prior to sterilization, the OZil* torsional handpiece, NeoSoniX* handpiece, U/S handpiece, and optional AquaLase* handpiece should always have the connector end cap secured and placed in the sterilization tray. This will prevent damage to the connectors and handpieces during handling, and especially during autoclaving. Do not operate OZil* torsional handpiece, NeoSoniX* handpiece, or U/S handpiece unless the tip is immersed in BSS* sterile irrigating solution or distilled water or is in surgical use. Irreparable damage to the handpiece and tip can result if run dry. Ensure that test chamber is filled with BSS* sterile irrigating solution before tuning OZil* torsional handpiece, NeoSoniX* handpiece, or U/S handpiece. Tuning a handpiece dry may result in premature tip failure and breakage. Quenching a hot handpiece in water can cause damage and will void warranty. Be sure handpiece is completely dry before connecting it to console. Damage to handpiece and console may result if plugged in when wet.

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1.9