Sovereign Compact Owners and Operators Manual V4.0 June 2004

This manual is written to familiarize all surgical team members who will set-up and operate the SOVEREIGN® COMPACT 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® COMPACT System in surgery. One or more of the following US Letters Patents apply to the SOVEREIGN® COMPACT System: Patents: 4,793,345; 5,230,614; 5,268,624; 5,342,293; 5,392,653; 5,470,312; 5,591,127, 5,700,240; 5,852,794; 6,059,765, likewise patents pending and corresponding foreign patents supplied on request.

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Table of Contents Section

Contents

Page

1

Introduction About Phacoemulsification About This Manual Declaration of Conformity Intended Use SOVEREIGN® COMPACT System Features SOVEREIGN® COMPACT Operating Modes

1-1 1-2 1-2 1-3 1-4 1-5 1-7

2

System Components Receipt and Inspection Instructions SOVEREIGN® COMPACT Components SOVEREIGN® COMPACT System OPO60 Tubing Pack OPO65 Tubing Pack

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

3

System Setup Safety Precautions and Warnings Symbol Definitions Setup Sequence

3-1 3-2 3-5 3-6

4

Equipment Operation Foot Pedal IV Pole Controls Select Language Selecting and Changing Mode Parameters Remote Control

4-1 4-2 4-5 4-6 4-7 4-8 4-10

5

Programs AMO Default Setups Start-Up Program

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

6

Operating Modes Setup Continuous Irrigation Prime/Tune Verify Irrigation/Aspiration Balance Diathermy Phacoemulsification Irrigation/Aspiration Vitrectomy End Case

6-1 6-2 6-2 6-3 6-6 6-7 6-10 6-16 6-18 6-20

7

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

7-1 7-2 7-2 7-2 7-4 7-4 7-5

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Table of Contents (Cont.) Section

Contents

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

8-1 8-2 8-4 8-7 8-9

9

Care and Cleaning Cleaning Procedures Sterilization Procedures System Cleaning and Care

9-1 9-2 9-4 9-6

10

Error Messages, Troubleshooting and Diagnostics Most Commmon User-Correctable Problems System Operation Messages Troubleshooting Diagnostics Self Test Foot Pedal Test Console & Remote Test Delete Surgeon Database View Logs View Software Versions Set System Time Fuse Replacement Procedure

10-1 10-2 10-3 10-7 10-11 10-12 10-13 10-13 10-14 10-14 10-15 10-16 10-17

11

Warranty and Maintenance

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12

Specifications

12-1

13

Accessories and Parts Reordering

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14

Index

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List of Illustrations Section

Figure

Description

Page

System Components

2.1 2.2 2.3

SOVEREIGN® COMPACT System OPO60 Tubing Pack OPO65 Tubing Pack

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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

Foot Pedal Connections Assembling the Phaco Handpiece Handpiece Receptacles SOLOTM I/A Handpiece OPO60 Tubing Pack Releasing the Manifold Latch and Opening the Pump Latch Positioning the I/A Tubing Manifold in the Pump Pump Segment Installation (part 1) Pump Segment Installation (part 2) Prepared for Priming Attach Drain Bag Installation Troubleshooting Watchouts Attaching I/A Tubing to the Phacoemulsification Ultrasonic Handpiece Connecting the Diathermy Forceps AMO Vitrectomy Handpiece

3-6 3-7 3-8 3-9 3-10 3-10 3-11 3-11 3-11 3-12 3-12 3-13 3-14 3-15 3-15

Equipment Operation 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13

Foot Pedal Foot Pedal Positions Handpiece Functions in Foot Pedal Positions Foot Pedal Reflux Top Switch Foot Pedal Side Switches Foot Pedal Position Indication Controls Select SYSTEM OPTIIONS Select LANGUAGES Select and SAVE Language Typical Phaco Operating Screen Programming Modes Remote Control Keypad

4-2 4-2 4-3 4-3 4-4 4-5 4-6 4-7 4-7 4-7 4-8 4-9 4-10

Programs

5.1 5.2 5.3 5.4 5.5

AMO Default Setups Diathermy I/A Phaco Vitrectomy

5-2 5-2 5-2 5-3 5-3

Operating Modes

6.1

Prime Handpiece and Fill Test Chamber

6-4

Recommended Settings

7.1 7.2 7.3 7.4 7.5

Diathermy Settings Phacoemulsification Settings Irrigation/Aspiration Settings Vitrectomy Settings Settings

7-2 7-3 7-4 7-4 7-5

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List of Illustrations (Cont). Section

Figure

Description

Page

Error Messages and Troubleshooting

10.1 10.2 10.3 10.4

System Operation Messages Troubleshooting Fuse Specifications Back Panel Fuse Holder

10-3•10-6 10-7•10-10 10-17 10-17

Specifications

12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 12.9

Diathermy Power Graph (10 ohm rated load) Diathermy Power Graph (50 ohm rated load) Diathermy Power Graph (100 ohm rated load) Diathermy Power Graph (200 ohm rated load) Diathermy Power Graph (500 ohm rated load) Diathermy Power Graph (1000 ohm rated load) Diathermy Power VS. Load Impedence (100% power) Diathermy Power VS. Load Impedence (50% power) Phaco Power Graph

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INTRODUCTION

In this section you will find:

• About Phacoemulsification • About This Manual • Declaration of Conformity • Intended Use • SOVEREIGN® COMPACT System Features • SOVEREIGN® COMPACT 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 emulsification and aspiration of the cataractous lens through a small incision. Phacoemulsification is advantageous for both patient and surgeon: • greater intraoperative control. • the smaller incision 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. Advanced Medical Optics, Inc. (AMO) supports phacoemulsification with sophisticated instrumentation that optimizes the benefits of this surgical procedure.

About This Manual

SOVEREIGN ® COMPACT System

This manual includes information regarding optional SOVEREIGN® COMPACT System enhancements. The availability of these features in your SOVEREIGN® COMPACT System configuration and availability in your area may be confirmed by your AMO representative.

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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 60601-1-2 EN 60601-2-2 Supplier...Advanced Medical Optics, Inc. Address ...Santa Ana, CA 92705 U.S.A. Product ...SOVEREIGN® COMPACT

I, the undersigned, hereby declare that the equipment specified above conforms to the above Directive.

Position: Director Quality Assurance Advanced Medical Optics, Inc.

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1•Introduction Intended Use

The SOVEREIGN® COMPACT Cataract Extraction System is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. This HIGH FREQUENCY (HF) SURGICAL EQUIPMENT is specified for use without a NEUTRAL ELECTRODE.

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1•Introduction SOVEREIGN® COMPACT System Features

The SOVEREIGN® COMPACT System represents over 7 generations of AMO phacoemulsification technology. Safety, ease-of-use, and reliability are designed and manufactured into every SOVEREIGN® COMPACT System. SOVEREIGN® COMPACT System meets UL (Underwriter’s Laboratory), I.E.C. (International Electrotechnical Commission) 601-1 and E.M.C.(Electromagnetic Compatibility) requirements for this type of device. The SOVEREIGN® COMPACT System contains a number of features based on extensive research and clinical trials with highly-trained and noted ophthalmologists who are experienced phacoemulsification surgeons.

WHITESTARTM Technology

Optional WHITESTARTM Technology enhancement for the SOVEREIGN® COMPACT System delivers finely modulated pulses of energy, interrupted by extremely brief cooling periods. This allows the SOVEREIGN® COMPACT System to achieve full ultrasound cutting efficiency and magnetic followability, while introducing less energy int the eye.

Advanced Fluidics System

One of the most advanced features of the SOVEREIGN® COMPACT System is its fluidics system that allows for intraoperative intraocular control. An integral part of the advanced fluidics is resident in the patented technology of the disposable and reusable tubing packs. The fluidics system is fully closed and isolated providing the maximum safety and minimum biohazard risk.

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 lightweight, 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. The degree of travel for each foot pedal position may be selected and saved in memory for each surgeon/procedure. Reflux is activated by a programmable switch, giving immediate response. The two lateral foot pedal side switches may also be programmed to change between surgical sub-modes. Surgeon control of continuous irrigation is also available through the foot pedal. The foot pedal housing is waterproof to comply with I.E.C. 601 requirements.

SOVEREIGN® COMPACT Display

The SOVEREIGN® COMPACT System screen display is easy to read and easy to operate. You will know at a glance the exact status of the machine. The LCD display gives you visual indication of modes, settings, and system status. Messages cue you through the procedure, and error messages indicate improper connections or selections. All instrument connections are easily accessed from the front for easy setup and less obstruction of the front panel displays.

Multi-Lingual User Interface

The User Interface is available in 14 languages, easily selected from the opening display screens. Once selected, all of the programming and operating screens are in the selected language, and the chosen language remains in effect until otherwise changed.

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1•Introduction SOVEREIGN® COMPACT System Cart

Operating Room teams contributed significantly to the successful design of the SOVEREIGN® COMPACT System Cart. Its solid wheel base and two locking wheels make it stable and smooth rolling. An open design minimizes weight. A manually adjustable height Mayo tray with baling ring accommodates either an autoclavable instrument tray or a solid tray. A tray for the remote control provides easy access under the sterile drape. An open bin and footpedal platform are available for storage.

Programmable Power Pole

The 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. A separate circulator up/down switch allows access at the rear of the system. The pole is easily removed from the cart for transport.

Remote Control

The SOVEREIGN® COMPACT System can 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. Backlighting supports low light OR conditions.

Prime/Tune

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 and Phaco Tune only, tune only, and irrigation free flow. Irrigation free flow can be used to set up the case without use of the footpedal. Collecting irrigation may occur prior to priming.

Continuous Irrigation

Continuous Irrigation is immediately available via dedicated keys on both the front panel and remote control. Surgeon control via footpedal programming is also available.

Programmable Operating Parameters

The SOVEREIGN® COMPACT System is programmable through the color screen displays and front panel keypad. The surgeon may preselect his/her desired settings for each portion of the surgical procedure. Up to 16 different setups, or "surgeon names," plus the AMO 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.

MMP

SOVEREIGN ® COMPACT System

Multiple sub-mode memories are available within SOVEREIGN® COMPACT (Multiple Modulation Presets) operating modes. This allows users to preset their parameters for specific techniques such as phaco chop or viscoelastic removal.

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1•Introduction SOVEREIGN® COMPACT Operating Modes

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

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.

Phacoemulsification (PHACO)

This mode is used to break up (emulsify) the nucleus of the 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.

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 "ASPIRATION RATE" and "VACUUM". Irrigation is gravity-fed and is mode 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 indicates the vacuum level.

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.

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1•Introduction Programmable Power Pole Capability

The SOVEREIGN® COMPACT 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 possible to have a different aspiration rate when the needle is occluded than when the needle is not occluded. 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.

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SYSTEM COMPONENTS

In this section you will find:

• Receipt and Inspection Instructions • SOVEREIGN® COMPACT System Components • SOVEREIGN® COMPACT System Pack

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2•System Components Receipt and Inspection

When you receive your SOVEREIGN® COMPACT 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® COMPACT System and inspect it for damage. If any damage to the package contents has occurred, you must immediately file a claim with the transporter. Transporters will accept claims only from the recipient (you), not the shipper (AMO). Your AMO Representative will have contacted you to schedule both Installation and In-Service Training upon receipt of your new SOVEREIGN® COMPACT System. We suggest that you leave the SOVEREIGN® COMPACT System in its original packaging and store it in a cool, dry environment until AMO installation personnel arrive to assemble, install and test your equipment. Extreme heat, cold or moisture can damage any electronic equipment.

SOVEREIGN COMPACT System Components ®

Your SOVEREIGN® COMPACT System may consist of some or all of the following components: • SOVEREIGN® COMPACT System Console • Programmable IV Pole • Cart with Mayo Stand • Instrument Sterilization Tray (s) • Phacoemulsification Ultrasonic Handpiece • OPO60 Disposable Tubing Pack or OPO65 Reusable Tubing Pack • Diathermy Cord with Bipolar Forceps • Electronic Oscillating Vitrectomy Handpiece • Foot Pedal with Cord • Power Cord (detachable) • Remote Control Module with Cord • SOVEREIGN® COMPACT System Owner’s Manual • SOLOTM I/A Handpiece, 20 Gauge, Curved Silicone Sleeve Tip • SOLOTM I/A Handpiece, 20 Gauge, 45˚ Silicone Sleeve Tip • SOLOTM I/A Handpiece, 20 Gauge, Straight Silicone Sleeve Tip • Spike Mat The major system components are identified in Figure 2.1.

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2•System Components

Programmable IV Pole

Figure 2.1 SOVEREIGN® COMPACT System with Optional Cart and I/V Pole

Handpiece Connections

Display Screen Mayo Stand with Articulating Arm

DIA

Remote Control Cart

Foot Pedal

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2•System Components SOVEREIGN® COMPACT System Pack

Each phacoemulsification procedure requires a disposable OPO60 Tubing Pack or a sterilized OPO65 reusable Tubing Pack. The OPO60 Tubing Pack contains the following components, some of which are identified in Figure 2.2: • Tubing manifold with irrigation and aspiration tubing • Drain Bag - attached and sealed • One Tip Cap Sleeve • Test Chamber - for testing and protecting Phaco Tips and I/A Handpiece Tip • Mayo Stand Drape - to cover the instrument tray and arm

Irrigation Bottle Spike Pump Segment

Drip Chamber

Figure 2.2 OPO60 Tubing Pack

Aspirated Fluid to Drain Bag Vent Tube I/A Tubing Manifold

Drain Bag

Aspiration from Irrigation to Handpiece Handpiece

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2•System Components The OPO65 Tubing Pack consists of a tubing manifold with irrigation and aspiration tubing. The pack is joined with a drain bag and administration set.

Pump Segment

Administration Set

Figure 2.3 OPO65 Tubing Pack and Tubing Assembly Aspirated Fluid to Drain Bag Vent Tube

I/A Tubing Manifold

Drain Bag

Aspiration from Irrigation to Handpiece Handpiece

Pre-Operative Sterilization

SOVEREIGN ® COMPACT System

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

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3

SYSTEM SETUP

In this section you will find:

• Safety Precautions and Warnings • Symbol Definitions • Setup Sequence Power Connections Phaco Handpiece Irrigation/Aspiration Handpiece SOVEREIGN® COMPACT System Pack Diathermy Vitrectomy

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