Abbott Medical Optics SOVEREIGN Compact Operators Manual Rev A Sw V5.2

SOVEREIGN Compact OPERATOR’S MANUAL

CMP Z370385 Rev. A 0511

Trademarks

AMO, SOVEREIGN, the SOVEREIGN logo, WHITESTAR, and LAMINAR are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. SOLO is a trademark of Micro-Surgical Technology, Inc. All other trademarks and trade names are the intellectual property of their respective owners.

Compliance

In accordance with: • IEC/EN 60601-1 Abbott Medical Optics Inc. 1700 E. St. Andrew Place Santa Ana, CA, USA 92705 1-877-AMO-4-LIFE (USA) www.amo-inc.com Product of USA AMO Ireland Block B Liffey Valley Office Campus

Quarryvale, Co. Dublin, Ireland Order Placement of Surgical Products

(IOLs and Phaco Supplies) Call 1-877-AMO-4-LIFE (USA) For outside the United States, contact your local representative.

Phaco Returns or Technical Service

Call 1-877-AMO-4-LIFE (USA) All returns must be accompanied by a RGA# (Returned Goods Authorization) For outside the United States, contact your local representative. Rx Only

© 2011 Abbott Medical Optics Inc.

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Table of Contents

Introduction... 1-1 About This Manual... 1-2 About Phacoemulsification... 1-2 Intended Use... 1-2 SOVEREIGN Compact System Features... 1-2 WHITESTAR Technology... 1-2 Advanced Fluidics System... 1-3 WHITESTAR ICE Software Technology... 1-3 Phacoemulsification Ultrasonic Handpiece... 1-3 Foot Pedal... 1-3 Remote Control... 1-4 SOVEREIGN Compact System Cart... 1-4 SOVEREIGN Compact Display... 1-4 Multi-Lingual User Interface... 1-4 Prime/Tune... 1-5 Continuous Irrigation... 1-5 Programmable Operating Parameters... 1-5 MMP... 1-5 SOVEREIGN Compact Operating Modes... 1-5

System Components... 2-1 Receipt and Inspection... 2-2 SOVEREIGN Compact System Components... 2-2 SOVEREIGN Compact System Pack... 2-4

System Setup... 3-1 SAFETY PRECAUTIONS... 3-2 WARNINGS... 3-3 SYSTEM DISPOSAL... 3-5 Symbol Definitions... 3-8 Setup Sequence... 3-10 Power Connections... 3-10 Phacoemulsification Ultrasonic Handpiece... 3-11 Irrigation/Aspiration Handpiece... 3-14 Load the Tubing Manifold... 3-15 Positioning the I/A Tubing Manifold in the Pump... 3-16 Complete Setup... 3-20 Diathermy... 3-21 Vitrectomy... 3-21

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Equipment Operation... 4-1 Foot Pedal... 4-2 Foot Pedal Operation... 4-2 Reflux... 4-3 Submode Switching... 4-4 Programmable IV Pole... 4-7 IV Pole Extension... 4-7 Display Screen and Controls... 4-9 Active Submodes... 4-13 Remote Control... 4-14

Programs... 5-1 AMO DEFAULT Setup... 5-2 Startup... 5-5 Programming... 5-5 Program SETTINGS... 5-6 Program DIATHERMY... 5-8 Program PHACO... 5-10 Program PHACO SUBMODES... 5-14 Program I/A... 5-15 Program VITRECTOMY... 5-17 Program END CASE... 5-18 SAVE OPTIONS Program... 5-20 SAVE AS Program... 5-21 SAVE PROGRAM After Operation... 5-22

Operating Modes... 6-1 Setup... 6-2 Continuous Irrigation... 6-2 Select Program... 6-3 PRIME/TUNE... 6-3 Verify Irrigation/Aspiration Balance... 6-7 Diathermy... 6-7 Phacoemulsification... 6-9 Using Phaco... 6-17 Irrigation/Aspiration... 6-21 Vitrectomy... 6-24 End Case... 6-27

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Recommended Settings... 7-1 Power IV Pole Heights... 7-2 Diathermy... 7-2 Phacoemulsification... 7-3 Phaco Settings... 7-3 Irrigation/Aspiration... 7-6 Vitrectomy... 7-6 System Settings... 7-7 CASE Settings... 7-7

Check-Out... 8-1 System Check-Out... 8-2 Changing Irrigation... 8-3 Phacoemulsification Without Adequate Irrigation... 8-3 Power Failure During Surgery... 8-3 Connecting Handpieces... 8-4 Handling the Phacoemulsification Ultrasonic Handpiece... 8-4 Phaco and Vitrectomy Operation... 8-4

Care and Cleaning... 9-1 Cleaning Procedures... 9-2 Phacoemulsification Ultrasonic Handpiece... 9-2 Irrigation/Aspiration Handpiece... 9-3 Diathermy Handpiece... 9-3 Vitrectomy Handpiece... 9-3 Sterilization Procedures... 9-3 SOVEREIGN Compact System Cleaning... 9-5

Error Messages, Troubleshooting, and Diagnostics... 10-1 Most Common User-Correctable Problems... 10-2 Advisory, Warning, and Error Messages... 10-2 Diagnostics/Maintenance... 10-10 Self Test... 10-11 Foot Pedal Test... 10-12 Console and Remote Test... 10-13 Upload/Download Files... 10-13 Delete Surgeon Database... 10-14 View Logs... 10-14 View Software Versions... 10-15 Set Time & Date... 10-16 Fuse Replacement Procedure... 10-16

Warranty and Maintenance... 11-1 Warranty Statement... 11-2

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Specifications... 12-1 Physical Specifications... 12-2 Electrical Specifications... 12-3 Environmental Specifications... 12-3 Storage Conditions... 12-3 Diathermy Specifications... 12-3

Accessories and Parts Reordering... 13-1 Parts Reordering... 13-2

Index... Index-1

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1 • Introduction

INTRODUCTION

About This Manual About Phacoemulsification SOVEREIGN Compact System Features

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About This Manual

This manual includes information about optional SOVEREIGN Compact System enhancements. Your AMO representative can confirm the availability of these features for your System configuration and availability in your area.

About Phacoemulsification

Over thirty years ago, Dr. Charles Kelman conceived and developed phacoemulsification, a method of cataract removal by use of ultrasonic emulsification with aspiration of the cataractous lens through a small incision. Phacoemulsification is advantageous for both patient and surgeon: • • •

Intended Use

Greater intraoperative control. The smaller incision requires fewer or no sutures, poses less risk of infection and induced astigmatism, and gives better long-term 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. Abbott Medical Optics Inc. (AMO) supports phacoemulsification with sophisticated instrumentation that optimizes the benefits of this surgical procedure.

The SOVEREIGN Compact Cataract Extraction System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. You do not need a specified NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT.

SOVEREIGN Compact System Features

The SOVEREIGN Compact System represents over seven generations of AMO phacoemulsification technology. Designed and manufactured into every SOVEREIGN Compact System are safety, ease-of-use, and reliability. 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 with experience as phacoemulsification surgeons.

WHITESTAR Technology

Optional WHITESTAR 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 into the eye.

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Chamber Stabilization Environment (CASE) OCCLUSION MODE Phaco Optional CASE Occlusion Mode Phaco is an intelligent vacuum monitoring system available for all Phaco submodes. CASE Occlusion Mode regulates the maximum allowable vacuum following occlusion of the phaco tip. When the phaco tip becomes occluded, vacuum rises. Clearing of the occlusion while the vacuum is at a high level may lead to post occlusion surge. With CASE, the system monitors the actual vacuum levels and when the vacuum exceeds a specific threshold for a specified duration, the system automatically adjusts the maximum allowable vacuum setting to a lower predefined CASE Occluded Max Vac level. When the occlusion clears (at a lower Max Vac setting), the system automatically restores the system to the original programmed Max Vac setting. It is possible to have a different Max Vac setting for an occluded needle and an unoccluded needle. You can also use CASE Occlusion Mode Phaco to regulate ultrasound power modulation. You can program the power modulation of the phaco handpiece (continuous, pulse, burst) to automatically change when the phaco tip changes from an unoccluded condition to an occluded condition.

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 closed and isolated fluidics system provides the maximum safety and minimum biohazard risk.

WHITESTAR ICE Software Technology

WHITESTAR ICE Software Technology, optional for the SOVEREIGN Compact System, is the next generation of WHITESTAR Technology. WHITESTAR ICE delivers finely modulated, shaped pulses of energy, interrupted by extremely brief cooling periods. You can customize the ON/OFF duty cycle times; with the ON times ranging from 2 - 30 ms and the OFF times ranging from 2-30 ms. WHITESTAR ICE allows the SOVEREIGN Compact System to achieve full ultrasound cutting efficiency and excellent followability while putting less energy into the eye.

Phacoemulsification Ultrasonic Handpiece

The Phacoemulsification Ultrasonic Handpiece design has a straight-through aspiration channel for more efficient removal of nuclear fragments, to minimize clogging, and to facilitate easy cleaning. The handpiece 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. You can save the degree of travel for each foot pedal position for each surgeon/procedure.

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You can activate Reflux by a programmable switch, giving immediate response. You can program the two lateral foot pedal side switches to change between surgical submodes. 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.

Remote Control

The SOVEREIGN Compact System can be operated/controlled from the remote control keypad. Use the remote control to access all modes and to adjust all parameters, including full programming and prime capabilities. Backlighting supports low light OR conditions.

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. Use the two adjustment keys on the front control panel or the remote control 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. You can remove the pole from the cart for transport.

Programmable Power Pole Capability The SOVEREIGN Compact System comes with a programmable power pole. If the System activates the programmable power pole capability at the beginning of the customizing program sequence, you can enter the programmable power pole height settings independently for each of the Phaco MMP modes plus the settings for Diathermy, I/A, and Vitrectomy. During surgery, the programmable power pole height changes to the pre-programmed height when you switch modes. You can program the foot pedal to manually adjust the power pole height during surgery.

SOVEREIGN Compact Display

The SOVEREIGN Compact System screen display is easy to read and easy to operate. You can see 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. You can access all instrument connections from the front for easy setup and less obstruction of the front panel displays.

Multi-Lingual User Interface

The User Interface is available in multiple languages, easily selected from the opening display screens. When you select a language, all of the programming and operating screens are in the selected language, and the chosen language remains in effect until otherwise changed. CMP Z370385 Rev. A 0511

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Prime/Tune

The system incorporates a variety of prime and tune options for a various of purposes. The comprehensive Prime & Tune mode includes tubing purge and fill, phaco handpiece tune, and system vacuum check. Other choices are I/A Prime and Phaco Tune only, tune only, and irrigation free flow. Use the Irrigation free flow to set up the case without use of the footpedal. Collecting irrigation can 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 the front panel keypad. The surgeon may preselect his/her desired settings for each portion of the surgical procedure. The instrument program memory can store up to 16 different setups, or “surgeon names”, plus the AMO DEFAULT settings program. This allows different users to preset their preferences, or an individual user to preselect setups for different procedures.

MMP

Multiple submode memories are available within SOVEREIGN Compact (Multiple Modulation Presets) operating modes. The MMP allows users to preset their parameters for specific techniques such as phaco chop or viscoelastic removal.

SOVEREIGN Compact Operating Modes

The design of the SOVEREIGN Compact System provides the anterior segment/ cataract surgeon all the desired surgical capabilities. These capabilities include:

Bipolar Diathermy (DIA) Most surgeons use diathermy 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) You use the Phacoemulsification mode to break up (emulsify) the nucleus of the lens. You then aspirate the nucleus of the lens from the eye through a small incision. The continuous auto-tuning circuitry maximizes the emulsification efficiency for each lens density, even varying densities within the same lens. The System displays Phaco time 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.

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Irrigation/Aspiration (I/A) The Irrigation and Aspiration 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. You can achieve complete control with “ASPIRATION RATE” and “VACUUM”. Irrigation is gravity-fed. You can regulate the gravity-fed irrigation by adjusting the height of the balanced salt solution bottle. This mode gives you flexible control of each case with the independently adjustable vacuum level settings and flow rate settings. The adjustable volume tone indicates the vacuum level. Note:

The vacuum units can be set to either mmHg or kPa. To set the vacuum units go to System Options, Diag/Maint and select Set Vacuum Units.

Anterior Vitrectomy (VIT) You use Vitrectomy mode 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 there is vitreous loss during cataract surgery, the vitrectomy capability can be ready and available in seconds.

Occlusion Mode Phaco You use the Occlusion Mode Phaco to regulate the vacuum rise time that follows the occlusion of the phaco tip, without limiting the choice of aspiration rate through an unoccluded needle. In order to independently control the aspiration rate and the vacuum rise time, it is possible to have a different aspiration rate for an occluded needle and an unoccluded needle. You can use Occlusion Mode Phaco to regulate ultrasound power modulation. You can program the power modulation of the phaco handpiece (continuous, pulse, burst) to automatically change when the phaco tip changes from an unoccluded condition to an occluded condition.

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2 • System Components

SYSTEM COMPONENTS

Receipt and Inspection SOVEREIGN Compact System Components SOVEREIGN Compact System Pack

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Receipt and Inspection

2 • System Components

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 • IV Pole Extension (Optional) • Cart with Mayo Stand • Instrument Sterilization Trays • Phacoemulsification Ultrasonic Handpiece • OPO61 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 Operator’s Manual • SOLO I/A Handpiece, 20 Gauge, Curved Silicone Sleeve Tip • SOLO I/A Handpiece, 20 Gauge, 45° Silicone Sleeve Tip • SOLO I/A Handpiece, 20 Gauge, Straight Silicone Sleeve Tip • Spike Mat The major system components are identified in Figure 2.1 – SOVEREIGN Compact System with Optional Cart and I/V Pole.

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Figure 2.1 – SOVEREIGN Compact System with Optional Cart and I/V Pole 1

3

2

4

DIA

5 6

7 8

1. Programable IV Pole 2. Handpiece Connections 3. Display Screen 4. Mayo Stand with Articulating Arm

5. Remote Control 6. Cart 7. Closed-Toe Foot Pedal 8. Open-Toe Foot Pedal

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SOVEREIGN Compact System Pack

2 • System Components

Each phacoemulsification procedure requires a disposable OPO61 Tubing Pack or a sterilized OPO65 reusable Tubing Pack. The OPO61 Tubing Pack contains the following components, some of which are identified in Figure 2.2 – OPO61 Tubing Pack: • • • • •

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 Tips Mayo Stand Drape - to cover the instrument tray and arm

Figure 2.2 – OPO61 Tubing Pack 1 2

3

4 5 6

7

8

1. Irrigation Bottle Spike 2. Drip Chamber 3. Pump Segment 4. Aspirated Fluid to Drain Bag 5. Vent Tube

9

6. I/A Tubing Manifold 7. Drain Bag 8. Aspiration from Handpiece 9. Irrigation to Handpiece

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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. Figure 2.3 – OPO65 Tubing Pack and Tubing Assembly 1 2

3

4

5 6

7

8 1. Irrigation Bottle Spike 2. Drip Chamber 3. Pump Segment 4. Aspirated Fluid to Drain Bag 5. Vent Tube

9

6. I/A Tubing Manifold 7. Drain Bag 8. Aspiration from Handpiece 9. Irrigation to Handpiece

Pre-Operative Sterilization 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 “Sterilization Procedures” on page 9-3. 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

System Setup

SAFETY PRECAUTIONS SYSTEM DISPOSAL Symbol Definitions Setup Sequence Power Connections Phacoemulsification Ultrasonic Handpiece Irrigation/Aspiration Handpiece Load the Tubing Manifold Positioning the I/A Tubing Manifold in the Pump Complete Setup Diathermy Vitrectomy

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

SAFETY PRECAUTIONS

The SOVEREIGN Compact System is equipped with a 3-prong plug 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. 1. Do not use extension cords with your machine. 2. Do not overload your AC electrical outlet. 3. If the cord or plug is damaged, do not continue using the instrument. Electric shock or fire hazard may result. Call AMO to order a new cord. 4. The instrument has ventilation openings to allow the release of heat generated during operation. If these openings are blocked, heat buildup can cause system failures which may result in a fire hazard. 5. Do not try to roll the SOVEREIGN Compact System cart on deep pile carpets or over objects on the floor such as cables and power cords. 6. Take care not to trip over power and footpedal 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 AMO to achieve optimum performance and safety. 9. Do not exceed maximum weight of 25 pounds (11.25 Kg) on the Programmable IV Pole bottle holder. 10. To protect the patient from contaminated fluids or handpieces, use only: • sterile tubing sets • sterile irrigation fluid • sterile handpieces 11. Use caution when extending, retracting, or swiveling the Mayo stand articulating arm. Stay clear of hinged hardware. 12. Use caution when handling handpieces with sharp edges or pointed tips. 13. When using OPO65, always replace the drain bag with a clean bag between cases. 14. Wrap the excess power cord neatly around the cord wrap on the back of the I/V pole or cart. 15. Electrode cables and accessories should be regularly inspected for possible damage to the insulation. This includes the Diathermy, EVIT, and Phaco cables.

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