AMO Sovereign System Owners and Operators Manual English V3.0 1999

This manual is written to familiarize all surgical team members who will set-up and operate the SOVEREIGN System with the components, set-up, operation and care of your system and its accessories. You should read and understand this manual completely before using the Sovereign System in surgery. TM

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Table of Contents Section

Contents

Page

1

Introduction

1-1

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System Components Receipt and Inspection Instructions SOVEREIGN System Components OPO50 Tubing Pack OPO55 Tubing Manifold OPO58 Disposable Drain Bag OM2525191 Administration Set

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

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System Setup Safety Precautions and Warnings Symbol Definitions Setup Sequence Printer/Paper Loading Memory Card/Updates

3-1 3-2 3-4 3-6 3-16 3-19

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Equipment Operation Foot Pedal Display Screen and Controls Selecting and Changing Mode and Parameters Remote Control Printer

4-1 4-2 4-4 4-7 4-9 4-10

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Programs Programs Attributes

5-1 5-5 5-10

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Operating Modes Testing Verify Irrigation/Aspiration Balance Diathermy Phacoemulsification Irrigation/Aspiration Vitrectomy End Case

6-1 6-2 6-5 6-6 6-8 6-11 6-14 6-16

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Recommended Settings Programmable Power Pole Heights Diathermy Phacoemulsification Irrigation/Aspiration Vitrectomy Attributes (Contents continued on page 3)

7-1 7-2 7-2 7-2 7-3 7-4 7-4

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Table of Contents (Cont.) Section

Contents

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Check-Out, Precautions and Warnings System Check-Out Safety Precautions and Warnings

8-1 8-2 8-4

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Care and Cleaning Cleaning Procedures Sterilization Procedures System Cleaning and Care

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Error Messages and Troubleshooting and Diagnostics Start Up and Self Test Error Messages System Operation Error Messages Troubleshooting Diagnostics Touch Strip Calibration Bezel Test Fuse Replacement Procedure

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Warranty and Maintenance

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Specifications

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Accessories and Parts Reordering

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List of Illustrations Section

Figure

Description

Page

System Components

2.1 2.2 2.3 2.4 2.5

SOVEREIGN Sovereign System OPO50 Tubing Pack OPO55 Tubing Manifold OPO58 Disposable Drain Bag OM2505191 Administration Set

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System Setup

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18 3.19

Foot Pedal Connections Assembling the Phaco Handpiece Handpiece Receptacles Assembling the I/A Handpiece OPO50 Tubing Pack Releasing the Manifold Latch and Opening the Pump Latch Loading the Tubing Manifold Closing the Manifold Latch Install Aspiration Tubing Close Pump Latch Attach Drainage Bag Attaching I/A Tubing to the Phacoemulsification Ultrasonic Handpiece Connecting the Diathermy Forceps Allergan Vitrectomy Handpieces Printer and Print Button Paper Loading Sequence Loading Ribbon Cassette Memory Card Inserting Memory Card

3-6 3-7 3-8 3-9 3-10 3-10 3-11 3-11 3-12 3-12 3-13 3-14 3-15 3-15 3-16 3-17 3-18 3-19 3-19

Equipment Operation 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8

Foot Pedal - Full Position Foot Pedal - Toe Activated Position Foot Pedal Positions Handpiece Functions in Foot Pedal Positions Foot Pedal Side Switches Display Screen and Controls Remote Control Keypad Sample Case Log Printout

4-2 4-2 4-2 4-3 4-3 4-4 4-9 4-10

Programs

5.1

Allergan Default Setup

5-2• 5-4

Operating Modes

6.1

Prime Handpiece and Fill Test Chamber

6-3

Recommended Settings

7.1 7.2 7.3 7.4 7.5

Diathermy Settings Phacoemulsification Settings Irrigation/Aspiration Settings Vitrectomy Settings Attributes

7-2 7-3 7-3 7-4 7-4

Error Messages and Troubleshooting

10.1 10.2 10.3 10.4 10.5

Start Up and Self Test Error Messages System Operation Error Messages Troubleshooting Fuse Specifications Back Panel Fuse Holder

10-2• 10-4 10-5 10-6 • 10-8 10-13 10-13

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INTRODUCTION

In this section you will find: • About Phacoemulsification • Compliance Declaration Certificate • SOVEREIGNTM System Features • SOVEREIGNTM System Operating Modes

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1•Introduction About Phacoemulsification

Over thirty years ago, Dr. Charles Kelman conceived and developed phacoemulsification, a method of cataract removal by ultrasonic fragmentation and aspiration of the cataractous lens through a small wound. Phacoemulsification is advantageous for both patient and surgeon: • greater intraoperative control. • the smaller wound requires fewer or no sutures, poses less risk of infection and induced astigmatism, and gives better long and short term predictability of vision. • patients are able to resume normal activity much sooner and with fewer restrictions than with traditional cataract extraction surgeries. Allergan, Inc. supports phacoemulsification with sophisticated instrumentation that optimizes the benefits of this surgical procedure.

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1•Introduction

DECLARATION OF CONFORMITY Application of Council Directive ... Medical Devices Directive 93/42/EEC Standards to which Conformity is Declared ... IEC 601-1 EN 60601-2-2 EN 60601-1-2 Supplier ... Allergan Address ... Irvine, CA 92612 U.S.A. Product ... SOVEREIGN System TM

I, the undersigned, hereby declare that the equipment specified above conforms to the above Directive. Place: Irvine, California

Signature:

Date:

Full Name: Position: Director, Worldwide Quality Assurance Allergan Surgical Products 0050

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1•Introduction About the SOVEREIGN TM System Features

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The SOVEREIGN System represents over 5 generations of Allergan phacoemulsification technology. Safety, ease-of-use, reliability and flexibility to different surgeon’s techniques are designed and manufactured into every Sovereign System. The SOVEREIGN System is designed to meet UL (Underwriter’s Laboratory) and I.E.C. 601 requirements. TM

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The SOVEREIGN System contains a number of features based on extensive research and clinical trials with highly-trained and noted ophthalmologists who are experienced phacoemulsification surgeons.

Advanced Fluidics System and Programmable Operating Parameters

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One of the most advanced features of the SOVEREIGN System is its fluidics system, that allows for intraocular-intraoperative control. In conjunction with this fluidics system, the SOVEREIGN System is fully programmable through the color screen displays and front panel pushbuttons. The surgeon may preselect his/her desired settings for each portion of the surgical procedure. TM

Up to 29 different setups, or “surgeon names,” plus the Allergan default settings program may be stored in the instrument program memory. This allows different users to preset their preferences, or an individual user to preselect setups for different procedures.

Phacoemulsification Ultrasonic Handpiece

The Phacoemulsification Ultrasonic Handpiece has been designed with a straight-through aspiration channel for more efficient removal of nuclear fragments, to minimize clogging and to facilitate easy cleaning. The hand piece is light weight, slim, and well-balanced, making it comfortable to use and easy to manipulate.

Foot Pedal

The operating modes (Diathermy, I/A, Phaco and Vitrectomy) are controlled by the foot pedal. This state-of-the-art foot pedal design offers two options for activation and gives greater control through increased linearity and uniform pressure throughout the foot pedal travel, virtually eliminating foot and leg fatigue. The degrees of travel for each foot pedal position may be selected and saved in memory for each surgeon/procedure. Reflux is activated by programmable circle or square side switches, giving immediate response. The foot pedal pivoting action may also be programmed to change between MMP modes. The foot pedal housing is waterproof to comply with I.E.C. 601 requirements.

SOVEREIGN TM System Panel

The SOVEREIGN System screen display is easy to read and easy to operate. ate. You will know at a glance the exact status of the machine. The LCD display tilts and rotates for optimum visibility and comfort, and gives you visual indication of modes, settings, and system status. Messages cue you through the procedure, and error messages indicate improper connections or selections. Most custom programming and mode selections are made from the same display screen, eliminating the need to scroll through multiple displays. All instrument connections are easily accessed from the front for easy setup and less obstruction of the front panel displays.

SOVEREIGN TM System Cart

Operating Room teams contributed significantly to the successful design of the SOVEREIGN System cart. Its solid wheel base and large diameter wheels make it stable and smooth rolling. An open front "hearth" storage area gives ample easy-to-access storage for the foot pedal while the lateral and vertical adjustments on the articulating arm allow you to adjust the configuration for different surgery settings.

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1•Introduction Programmable Power Pole

The integral automated and programmable power pole allows adjustment of the bottle height through each procedural phase. Two adjustment keys on the front control panel or the remote control are used to accurately raise and lower the bottled saline solution, while maintaining the sterility of the operating field.

Remote Control

The SOVEREIGN System can also be operated/controlled from the remote control keypad. All modes can be remotely accessed, and all parameters may be adjusted using the remote control, including full programming and prime capabilities.

Prime Mode

The system incorporates a variety of prime and tune options for various purposes. The comprehensive prime tune mode includes tubing purge and fill, phaco handpiece tune and vacuum check. Other choices are I/A prime only and tune only.

Printer

The SOVEREIGN System printer gives you the ability to print the case log at the end of each case, summarizing use time and settings for each mode. Individual surgeon programs may also be printed.

Memory Card

The SOVEREIGN System software is located on a memory card, which simply plugs into the rear of the machine. This memory card may be replaced to facilitate software updates as directed by your Allergan representative.

Description of SOVEREIGN TM System Operating Modes

The SOVEREIGN System has been designed to provide all the surgical capabilities desired by the anterior segment/cataract surgeon. These capabilities include:

Phacoemulsification (PHACO)

This mode is used to break up (emulsify) the nucleus of the cataractous lens, allowing it to be aspirated from the eye through a small incision. The continuous autotuning circuitry maximizes the emulsification efficiency for each lens density, even varying densities within the same lens. Phaco time is displayed in minutes and seconds. Convenient selection of linear or panel-preset phaco power, in a variety of power delivery options (pulsed, burst etc.), gives the surgeon increased precision and control.

Anterior Vitrectomy (VIT)

This mode is used to remove vitreous from the anterior chamber of the eye during a secondary IOL (intraocular lens) implant procedure, or following vitreous loss associated with trauma, or vitreous loss during primary cataract surgery. If vitreous is lost during cataract surgery, the vitrectomy capability can be ready and available in seconds.

Bipolar Diathermy (DIA)

This mode is used by most surgeons to coagulate blood vessels during the procedure and by some surgeons to "coapt" the conjunctiva at the end of the procedure. An isolated output frequency allows non-contact tissue coagulation, eliminating adhesion and traction. Also, the depth of penetration of the energy field is less than that of higher frequency units, minimizing tissue shrinkage or charring. The gentleness of the diathermy mode allows the surgeon to stop "bleeders" within the incision with only minimal scleral shrinkage, and to stop a "bleeder" from a 10-0 suture tract without melting the suture.

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1•Introduction Irrigation/Aspiration (I/A)

This mode allows for controlled aspiration of cortical material from the eye, while maintaining intraocular stability by replacing the aspirated material with irrigation solution. A peristaltic pump provides a predictable and stable aspiration rate. Complete control is achieved with footswitch-linear or nonlinear aspiration and adjustable presets for "ASPIRATION RATE" and "VACUUM". Irrigation is gravity-fed and is regulated by adjusting the height of the irrigating solution bottle. This mode gives you flexible control of each case with independently adjustable vacuum level and flow rate settings. The adjustable volume tone gives indication of the vacuum level.

Customized Surgeon Program

This capability allows programming of the machine with 29 different sets of specific surgeon parameters and preferences. Simply select the appropriate surgeon program and the Sovereign System automatically adjusts to the selected surgeon's preferences. Preset parameters are easily adjusted during a case to meet varying requirements. This capability allows rapid intraoperative access to 4 different sets of phaco mode parameters within each of the 29 customized programs. Quick activation via the graphical user interface or foot pedal side switch will instantly change the settings for aspiration rate, vacuum level, vacuum rise time, power preset, linear/non-linear and pulse/burst/continuous phaco. This increases efficiency when a surgeon uses different settings for different stages of phacoemulsification (sculpting, quadrant removal, epinuclear evacuation, etc.). Other Multiple Modulation Presets • Diathermy ... 2 Sets • I/A ... 3 Sets • Vitrectomy ... 2 Sets TM

Programmable Power Pole Capability

The SOVEREIGN System is equipped with a programmable power pole. If the programmable power pole capability is activated at the beginning of the customizing program sequence, programmable power pole height settings can be entered independently for each of the Phaco MMP modes plus settings for Diathermy, I/A and Vitrectomy. During surgery, the programmable power pole height will change to the preprogrammed height when switching modes.

Occlusion Mode Phaco

Occlusion Mode Phaco is used to regulate the vacuum rise time that is experienced following occlusion of the phaco tip, without limiting the choice of aspiration rate through an unoccluded needle. In order to independently control aspiration rate and vacuum rise time, it is necessary to have a different aspiration rate when the needle is occluded than when the needle is not occluded. TM

Occlusion Mode Phaco is also used to regulate ultrasound power modulation. The power modulation of the phaco handpiece (continuous, pulse, burst) can be programmed to automatically change when the phaco tip changes from an unoccluded condition to an occluded condition. TM

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SYSTEM COMPONENTS

In this section you will find: • Receipt and Inspection Instructions TM

• SOVEREIGN System Components TM

• SOVEREIGN System Pack

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2•System Components Receipt and Inspection

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When you receive your SOVEREIGN System inspect the exterior packaging for any signs of damage that may have occurred during shipping and record this damage on the shipping documents. If there are any signs of damage, carefully unpack the SOVEREIGN System and inspect it for damage. If any damage to the package contents has occurred, you must file a claim with the transporter. Transporters will accept claims only from the recipient (you), not the shipper Allergan, Inc., so be sure to contact the shipper immediately. TM

Installation and In-Service

Your Allergan Representative will have contacted you to schedule both Installation and In-Service Training upon receipt of your new Sovereign System. We suggest that you leave the SOVEREIGN System in its original packaging and store it in a cool, dry environment until Allergan, Inc. installation personnel arrive to assemble, install and test your equipment. Extreme heat, cold or moisture can damage any electronic equipment. TM

Components

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Your SOVEREIGN System may consist of some or all of the following components: TM

• SOVEREIGN Console • Cart with Mayo Stand, Articulating Arm and Programmable Power Pole • Instrument Sterilization Tray • Phacoemulsification Ultrasonic Handpiece • AMO® Phacofit® Multi-Tip Irrigation/Aspiration Handpiece Set: Handle Straight Tip for Silicone Sleeve 45˚ Tip for Silicone Sleeve 90˚ Tip for Metal Sleeve Straight Tip for Metal Sleeve Sterilization Tray O-Ring Replacement Kit • OPO50 Disposable Tubing Pack • OPO55 Reusable Tubing Pack • OPO58 Detachable Drainage Bag • OM2505191 Administration Set • Diathermy Cord with Bipolar Forceps • Electronic Oscillating Vitrectomy Handpiece • Guillotine Vitrectomy Handpiece (OPO39) • Foot Pedal with Cord • AMO® Power Cord (detachable) • Remote Control Module with Cord • Spike Mat • Spare Fuses • SOVEREIGN System Owner’s Manual SOVEREIGN System Quick Reference Guide Allergan Customer Service Rolodex Card(s) TM

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The major system components are identified in Figure 2.1.

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2•System Components

Programmable Power Pole

Balanced Salt Solution

Display Screen Progammable Power Pole Adjustment

Spike Mat

Figure 2.1 SOVEREIGN TM System Enter Controls TM

Handpiece Connections

Remote Control

Cart

Foot Pedal Storage Area

Mayo Stand with Articulating Arm

Footpedal

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2•System Components SOVEREIGN TM System Pack

Each phacoemulsification procedure requires a tubing pack which may consist of the disposable OPO50 Tubing Pack or the reusable tubing pack combination of the OPO55, OPO58, and the OM2505191. The OPO50 Tubing Pack contains the following components, which are identified in Figure 2.2: • Tubing manifold with irrigation and aspiration tubing • Aspiration Collection Bag - attached • Two Tip Cap Sleeves • Test Chamber - for testing and protecting Phaco Tips and I/A Handpiece Tips • Mayo Stand Drape - to cover the instrument tray and arm

Figure 2.2 OPO50 Tubing Pack

Aspirated Fluid to Drainage Bag I/A Tubing Manifold

Drainage Bag

Irrigation Bottle Spike

Drip Chamber

Aspiration from Handpiece Irrigation to Handpiece

The reusable tubing pack combination of the OPO55, OPO58, and the OM2505191 consist of the tubing manifold with irrigation and aspiration tubing the drain bag, and the administration set, respectively (see Figures 2.3, 2.4 and 2.5). Provisions will need to be made to obtain the irrigation sleeves and test chamber which will depend on the phaco tip type selected. Your Allergan Sales Representative will be able to assist you in this selection. The Mayo Stand Drape is available as part number OM271000.

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2•System Components

Figure 2.3 OPO55 Tubing Manifold

Figure 2.4 OPO58 Disposable Drain Bag

Figure 2.5

Spike

Drip Chamber

Roller Clamp

Male Luer

OM2505191 Adminstration Set

Female Luer

Pre-Operative Sterilization

The Instrument Sterilization Procedures in Section 9, identifies those SOVEREIGN System instruments that must be sterilized prior to each surgical case. Recommended sterilization techniques, times and temperatures are given in the table. Allergan recommends that you follow the sterilization guidelines to maximize the life of your SOVEREIGN System instruments. TM

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SYSTEM SETUP

In this section you will find: • Safety Precautions and Warnings • Symbol Definitions • Setup Sequence Power Connections Phaco Handpiece Irrigation/Aspiration Handpiece SOVEREIGN System Pack Diathermy Vitrectomy TM

• Printer / Paper Loading • Memory Card / Updates

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3•System Setup Before proceeding with system setup, thoroughly read the following safety precautions and familiarize yourself with the symbols found on the back of the SOVEREIGN System. TM

SAFETY PRECAUTIONS TM

1. The SOVEREIGN System is equipped with 3-prong plugs which should be plugged into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT defeat or remove the ground pin. 2. Do not use extension cords with your machine. 3. Do not overload your AC electrical outlet. 4. If the cord or plug is damaged, do not continue using the instrument. Electric shock or fire hazard may result. Call Allergan to order a new cord. 5. The instrument has ventilation openings to allow the release of heat generated during operation. If these openings are blocked, heat build-up can cause system failures which may result in a fire hazard. TM

6. Do not try to roll the SOVEREIGN System cart on deep pile carpets or over objects on the floor such as cables and power cords. 7. Do not place the instrument on uneven or sloped surfaces. 8. Do not use disposables, accessories or other surgical instruments that are not designed for this system. Use only parts recommended by Allergan to achieve optimum performance and safety. 9. Do not exceed maximum weight of 25 pounds (11.25 Kg) on the Programmable Power Pole bottle holder.

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3•System Setup TM

The SOVEREIGN System meets UL (Underwriter's Laboratory), I.E.C. (International Electromechanical Commission) 601-1 and E.M.C. (Electromagnetic Compatibility) requirements for this type of device. Page 3 contains the E.M.C. declaration for the SOVEREIGN System. TM

CAUTION FEDERAL (U.S.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

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WARNING: All personnel should read and understand the instructions in this manual before the system is used. Failure to do so may result in the improper operation of the system.

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WARNING: This unit may interfere with any cardiac pacemaker fitted to the patient, therefore qualified advice should be obtained prior to such use.

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WARNING: DO NOT attempt to use the system if it fails to perform properly as stated in this manual. WARNING: DO NOT use the system in the presence of flammable anesthetics, or other flammable gases, near flammable fluids or objects, or in the presence of oxidizing agents, as fire could result.

WARNING: The patient should not come into contact with metal parts which are earthed or have appreciable capacitance to earth. The use of an antistatic mat for this purpose is recommended. WARNING: Monitoring electrodes or other types of equipment should be placed as far from those of the SOVEREIGN System as possible. High current limiting devices are recommended for the protection of such systems. TM

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WARNING: The output power selected should be as low as possible for the intended purpose.

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WARNING: Risk of burns and fire. Do not use near conductive materials such as metal bed parts, inner spring mattresses, and the like. Renew electrode cables on evidence of deterioration.

WARNING: Although this unit complies with all EMI standards and requirements, it is possible that this unit could interfere with other types of electronic equipment. WARNING: Skin to skin contact on the patient, e.g., between the arms and the torso is not recommended. Note: The unit contains no neutral electrode. Note: The diathermy output is bipolar. Note: It is recommended that the condition of all inter-connecting and handpiece cables be checked on regular basis.

WARNING: Hazardous electrical output. This equipment is for use only by qualified personnel. WARNING: Disconnect Power Before Servicing. WARNING: Not recommended for use in condensing environment. If exposed to condensing environment, allow system to equilibrate to typical operating room conditions prior to use.

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3•System Setup Symbol Definitions

The following symbols appear on the back of the Sovereign System front and back panels: Symbol on power switch indicates Power is ON. Symbol on power switch indicates Power is OFF.

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Indicates that there are important operating and maintenance instructions included in the User's Manual. Indicates the presence of uninsulated high voltage inside the instrument. Risk of electric shock. Do not remove the instrument cover. Indicates fuse. Single phase alternating current. Patient applied part is isolated from earth ground. Patient applied part is grounded OR no direct electrical energy is involved. Foot pedal connection.

Communications Port Remote Programmable Power Pole

Diathermy Forceps Guillotine Vitrectomy Cutter Phaco Handpiece Receptacle TAC Cutter (Oscillating)

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