AMO Prestige Advanced Cataract Extraction System Owners Manual June 1993

This manual is written to familiarize all surgical team members who will set-up and operate the AMO Prestige 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 AMO Prestige in surgery. ®

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Table of Contents Section

Contents

Page

1

Introduction

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System Components Receipt and Inspection Instructions AMO® Prestige Advanced Cataract Extraction System Components One-Step Loading System Cartridge

5 6 7 8

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

11 12 13 14 14 23

4

Equipment Operation Foot Pedal Power Pole Console Keys and Displays Remote Control Printer

25 26 28 29 30 32

5

Operating Modes Power-Up Sequence Prime Cautery Irrigate Only Phacoemulsification Irrigation/Aspiration Vitrectomy

35 36 36 39 40 41 44 47

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Memory Presets Name and Edit Name Time/Date Foot Pedal Volume

49 51 56 56 60

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Recommended Settings Cautery Phacoemulsification Irrigation/Aspiration Vitrectomy

63 64 64 65 66

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

67 68 70

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Table of Contents (Cont.) Section

Contents

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Care and Cleaning Cleaning Procedures Sterilization Procedures AMO® Prestige Advanced Cataract Extraction System

73 74 75 77

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Error Messages and Troubleshooting Most Comon User-Correctable Problems Error Messages Troubleshooting Guide Fuse Replacement Procedure

79 80 80 83 86

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Warranty and Maintenance

89

12

Specifications

91

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Index

95

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List of Illustrations Section

Figure

Description

2.1 2.2

AMO® Prestige Advanced Cataract Extraction System One-Step Loading System Cartridge

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3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12

Rear Panel Connections Command Power Pole Connection Assembling the Profinesse II Ultrasonic Handpiece Handpiece Receptacles Assembling the I/A Handpiece Loading the Cartridge Attaching I/A Tubing to the Profinesse II Ultrasonic Handpiece Connecting the Cautery Forceps AMO® VitrePure Vitrectomy Handpiece Instant Recall Printer and Print Button Paper Loading Sequence Memory Card

14 15 15 16 17 18, 19 20 21 21 22 22 23

Equipment Operation 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8

Radian Foot Pedal Foot Pedal Positions Handpiece Functions in Foot Pedal Positions Reflux Foot Pedal Operation Command Power Pole Adjustment Front Panel Keys and Displays Control Center Remote Control Keypad Sample Case Log Printout

26 26 27 27 28 29 30 32

Operating Modes

5.1

Prime Handpiece and Fill Test Chamber

37

Memory Presets

6.1 6.2 6.3 6.4

AMO® Setup Keys Used in the Name and Edit Name Modes Foot Pedal Span Selections 2-Step or 3-Step Vitrectomy Foot Pedal

50 51 57 58

Recommended Settings

7.1 7.2 7.3 7.4 7.5 7.6

Cautery Settings Phacoemulsification Settings Irrigation/Aspiration Settings Vitrectomy Settings Irrigate Only Settings Foot Pedal Settings

64 65 65 66 66 66

Care and Cleaning

9.1

Instrument Sterilization Table

76

Error Messages and Troubleshooting

10.1 10.2 10.3 10.4 10.5

Error Messages and Corrective Action Troubleshooting Fuse Specifications Back Panel Fuse Holder Command Power Pole Fuse Holder

81, 82 83 - 85 86 86 87

System Components

System Setup

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1

INTRODUCTION

About Phacoemulsification

Over twenty 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 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 Medical Optics (AMO) supports phacoemulsification with sophisticated instrumentation that optimizes the benefits of this surgical procedure.

About the ®

The AMO Prestige Advanced Cataract Extraction System represents over 4 generations of AMO phacoemulsification technology. Safety, ease-of-use, reliability and flexibility to different surgeon’s techniques are designed and manufactured into every AMO Prestige . The AMO Prestige is designed to meet UL (Underwriter’s Laboratory) and I.E.C. 601 requirements. ®

AMO Prestige

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Advanced Cataract Extraction System

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

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1•Introduction Advanced Fluidics System and Programmable Operating Parameters

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

Personal I.D. Programming

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

Functions/Modes

Seven basic modes are integrated into the AMO Prestige :

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1 - Prime 2 - Cautery 3 - Irrigate Only 4 - Phacoemulsification 5 - Irrigation/Aspiration 6 - Vitrectomy 7 - Reflux in Phacoemulsification, Irrigation/Aspiration, and Vitrectomy Modes You can select “Irrigate Only” from the Phacoemulsification Mode.

Profinesse II Ultrasonic Handpiece

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Radian Foot Pedal

The Profinesse II Ultrasonic Handpiece has been designed with a straightthrough aspiration channel for more efficient removal of nuclear fragments, to minimize clogging and to facilitate easy cleaning. The handpiece is light weight, slim, and well-balanced, making it comfortable to use and easy to manipulate. Because there are no external fluid pathways on the handpiece that can lead to interference with the irrigation and aspiration channels, the surgeon is not forced into difficult positions. TM

The operating modes (Cautery, I/A, Phaco and Vitrectomy) are controlled by the Radian Foot Pedal. This state-of-the-art foot pedal design gives you greater control through increased linearity and uniform pressure throughout the foot pedal travel, virtually eliminating foot and leg fatigue. You may also select the tactile feedback feature, varying the levels of sensory indication as you move through the foot pedal positions. The degrees of travel for each foot pedal position may be selected and saved in memory for each surgeon/ procedure.

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Reflux is activated by simply pivoting the foot pedal, giving immediate response. The foot pedal pivoting action may also be programmed to change the system modes. The foot pedal housing is waterproof to comply with I.E.C. 601 requirements. ®

AMO Prestige Panel TM

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The AMO Prestige panel is easy to read and easy to operate. You and your operating team know at a glance the exact status of the machine. The 32-character Message Center 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 located on the front of the panel for easy setup and less obstruction of the front panel. ®

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1•Introduction ®

AMO Prestige Cart TM

Operating Room teams contributed significantly to the successful design of the AMO Prestige cart. Its wide wheel base and large diameter wheels make it stable and smooth rolling. Open storage shelves, accessible from the back, give ample easy-to-access storage (i.e., foot pedal storage, cords, disposables, etc.), while the lateral and vertical adjustments on the articulating arm allow you to adjust the configuration for different surgery settings. ®

Command Power Pole TM

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The Command Power Pole allows adjustment of the bottle height through each procedural phase. Two adjustment keys on the front panel or the Control Center Remote Control are used to accurately raise and lower the bottled saline solution, while maintaining the sterility of the operating field. TM

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Control Center Remote Control

The AMO Prestige can also be operated/controlled from the Control Center Remote Control keypad. All modes except for Prime can be accessed, and all parameters may be adjusted using the remote control.

Prime Mode

A simple two-touch pre-op purge prepares the instrument for surgery. Cautery may be performed while the system primes.

Phacoemulsification Mode

The AMO Prestige gives you the choice of linear or preset panel control of the phacoemulsification power level, as well as continuous or pulsed delivery of power. It monitors the phaco time and ultrasonic power of each procedure, and at the end of each case, gives you a summary of the relative energy delivered to the eye (represented in “J” units). While in the mode, vacuum level is adjustable within a low or high vacuum range, aspiration flow rate may be selected as linear or continuous.

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phacoemulsification and the

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Irrigation/Aspiration Mode

The Irrigation/Aspiration 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.

Cautery Mode

Designed for either shrinkage of conjunctiva or bleeding control, low-heat bipolar cautery mode has variable power settings. The cautery power may be selected as panel or linear. Connections are provided for both Lemo and banana style cautery connectors.

Vitrectomy Mode

The AMO VitrePure Vitrectomy Handpiece is a guillotine-style design. Independent settings for flow rate and vacuum level during anterior vitrectomy, in addition to the variable cutting rate, give you maximum flexibility for different situations.

Instant Recall Printer

The AMO Prestige Instant Recall Printer gives you the ability to print the case log at the end of each case, summarizing use time and settings for each mode.

Memory Card

The AMO Prestige 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 AMO representative.

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1•Introduction

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SYSTEM COMPONENTS

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

• AMO® Prestige System Components TM

• AMO® Prestige Pack

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2•System Components Receipt and Inspection

When you receive your AMO Prestige 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 AMO Prestige 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 (AMO), so be sure to contact the shipper immediately. ®

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Installation and In-Service Training

Your AMO Representative will have contacted you to schedule both Installation and In-Service Training upon receipt of your new AMO Prestige . We suggest that you leave the AMO Prestige and the Command Power Pole in their original packaging and store them 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.

Components

Your AMO Prestige consists of the following components:

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• AMO Prestige Advanced Cataract Extraction System Command Power Pole Mayo Stand with Articulating Arm • Instrument Sterilization Tray • Profinesse II Ultrasonic Handpiece • Multi-Tip Irrigation/Aspiration Handpiece Set: Round Handle 0.3 mm Curved Tip 0.3 mm Straight Tip Binkhorst Tip Luer Tapered Tip Sterilization Tray O-Ring Replacement Kit • Cautery Cord with Bipolar Forceps • AMO Prestige Pack • AMO VitrePure Vitrectomy Handpiece • Radian Foot Pedal with Cord • AMO Prestige Power Cord (detachable) • Command Power Pole Cord (detachable) • Control Center Remote Control Module with Cord • Spike Mat • Dust Cover • Spare Fuses • AMO Prestige Owner’s Manual AMO Prestige Quick Reference Guide AMO Prestige Video Guide to Setup, Operation and Maintenance AMO Customer Service Rolodex Card(s) ®

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The major system components are identified in Figure 2.1.

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2•System Components

Balanced Salt Solution Power Pole

Figure 2.1

Spike Mat

AMO Prestige Advanced Cataract Extraction System ®

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Front Panel

Handle

Mayo Stand with Articulating Arm Including:

Inside Storage Area

• Cautery Forceps • Phacoemulsification Handpiece • Multi-Tip I/A Handpiece • Vitrectomy Handpiece • Remote Control

Large Diameter Wheels Foot Pedal

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2•System Components ®

AMO Prestige Pack

Each phacoemulsification procedure requires an AMO® Prestige Pack. The pack contains the following components, which are identified in Figure 2.2:

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• One-Step Loading System Cartridge containing irrigation and aspiration tubing with attached collection bag sealed TM

• Tip Wrench - for installing the Phaco Tip on the handpiece • Two Flexible Sleeve Assemblies - for I/A and Phaco Handpiece Tips • Two Test Chambers - for testing and protecting Phaco and I/A Handpiece Tips • Mayo Stand Drape - to cover the instrument tray and arm • Command Center Remote Control Sleeve - to cover the remote control TM

• Micro-MittsTM - to perform adjustments in non-sterile fields • Sterile Drape - Placed over the front panel to allow changes by surgeon while gloved, maintaining sterile field.

Figure 2.2 One-Step Loading System Cartridge

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Aspiration

Irrigation

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2•System Components Pre-Operative Sterilization

The Instrument Sterilization Table, Figure 9.1 on page 76, identifies those AMO® Prestige instruments that must be sterilized prior to each surgical case. Recommended sterilization techniques, times and temperatures are given in the table. AMO recommends that you follow the sterilization guidelines to maximize the life of your AMO® Prestige instruments. TM

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2•System Components

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SYSTEM SETUP

In this section you will find: • Safety Precautions • Symbol Definitions • Setup Sequence Power Connections Phaco Handpiece Irrigation/Aspiration Handpiece AMO® Prestige Pack Cautery 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 AMO Prestige . ®

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SAFETY PRECAUTIONS

1. The AMO Prestige uses high frequency energy which may cause interference with other medical electrical equipment. Patient monitoring electrodes should be placed as far as possible from the surgical electrodes. ®

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2. The use of cautery may interfere with cardiac implants. If in doubt, contact the patient’s cardiologist for advice. 3. Do not use the instrument with flammable anesthetics. Avoid usage of nitrous oxide and oxygen. 4. The AMO Prestige and Command Power Pole are 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. ®

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5. Do not use extension cords with your machine. 6. Do not overload your AC electrical outlet. 7. 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. 8. 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. 9. Do not try to roll the AMO Prestige cart on deep pile carpets or over objects on the floor such as cables and power cords. ®

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10. Do not place the instrument on uneven or sloped surfaces. 11. 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. 12. Do not hang more than 10 pounds (4.5 Kg) of fluid on the Command Power Pole. TM

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3•System Setup Symbol Definitions

The following symbols appear on the back of the AMO Prestige front and back panels as shown in Figure 3.1: ®

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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. Earphone Jack

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Danger: Do not use in the presence of flammable anesthetics, as there is a risk of explosion. Communications Port Remote IV Pole Cautery Vitrectomy Phaco Handpiece Receptacle

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3•System Setup Setup Sequence

The following setup sequence is recommended when learning the AMO Prestige . After you have gained more experience with the machine, the sequence may be modified to conform to specific hospital or surgical center requirements. ®

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An AMO service representative will install the AMO Prestige . At the time of installation, they will set the correct time and date, and install the printer. ®

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This setup sequence will be demonstrated to you by an AMO Representative during In-Service Training.

Power Connections

1.

Connect the AMO Prestige power cord to the back of the panel, as shown in Figure 3.1. Plug the power cord into a grounded power outlet. ®

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Model No. XXXXX - XXXXXX Serial No. XXXX - XXXXXX

Figure 3.1

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Rear Panel Connections

CAUTION: READ MANUAL BEFORE OPERATING.

CAUTION: TO REDUCE THE RISK OF SHOCK DO NOT REMOVE COVER. DO NOT USE IN THE PRESENCE OF AP DANGER: RISK OF EXPLOSION. FLAMMABLE ANESTHETICS. WARNING: FOR CONTINUED PROTECTION AGAINST FIRE HAZARD, REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE. CAUTION: RISK OF BURNS AND FIRE. DO NOT USE NEAR CONDUCTIVE MATERIALS SUCH AS METAL BED PARTS, INNERSPRING MATTRESSES, AND THE LIKE. RENEW ELECTRODE CABLES UPON EVIDENCE OF DETERIORATION. WARNING: HAZARDOUS ELECTRICAL OUTPUT. THIS EQUIPMENT IS FOR USE ONLY BY QUALIFIED PERSONNEL. DISCONNECT POWER BEFORE SERVICING.

Voltage Label

Foot Pedal

Remote Control

Power Pole

Power Connection

Headset

NOTES: The AMO Prestige is designed for multiple voltages. The voltage is preselected at the factory and can be changed only by a service technician. The voltage label on the back of the panel (near the power cord connection) indicates the factory voltage setting. If you are unsure of the power supply voltage in your area, consult your local power company. ®

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The Command Power Pole has an automatic voltage selector and will operate from 100 to 240 Vac without any adjustments. TM

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Connect the Radian Foot Pedal to the back of the AMO Prestige (see Figure 3.1). Once connected, the foot pedal can be stored in the back storage area of the cart without disconnecting. TM

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