Millennium Owner’s Manual Rev A

Preface Table of Contents

1 1.1. 1.2. 1.3.

1.4. 2 2.1. 2.2.

2.3. 2.4.

Table of Contents...1-i Indications for Use...Preface-xi Contraindications...Preface-xi Patents...Preface-xii Trademarks...Preface-xii Power Outputs...Preface-xiii Symbol Definitions...Preface-xiv Manual Concept...Preface-xv Symbols and Notes...Preface-xvii Precautions...Preface-xviii Quick Reference...1-1 System Description...1-1 Turning on Your System...1-2 Anterior Segment Example...1-4 Setting Up Your System...1-4 Ultrasound Tuning...1-5 Using Your System in Surgery...1-6 Ultrasound Setup...1-6 Irrigation/Aspiration Set-up...1-7 Anterior Vitrectomy Set-up...1-8 Surgical Procedure Conclusion...1-9 System Components...1-11 User Interface...2-1 Basic Button Operations...2-1 User Interface Concepts...2-4 Screen Layout...2-4 Anterior Surgical Modes...2-6 Posterior Surgical Modes...2-8 User Interface Screens...2-10 System Hierarchy...2-10 Foot Controller CX9550...2-11 Basic Button Operation...2-12 Center Pedal Control...2-14 1 Region Pitch Control...2-14 Owner’s Manual Preface-i

Preface - Table of Contents

2.5.

3 3.1.

3.2. 3.3. 4 4.1. 4.2. 4.3.

Preface-ii

2 Region Pitch Control... 2-14 3 Region Pitch Control... 2-14 Single Linear Yaw Control... 2-15 Dual Linear Yaw Control... 2-15 Yaw Control of Reflux... 2-15 Yaw Control of Ultrasound Submode... 2-15 Foot Controller CX9555... 2-16 Basic Button Operation... 2-17 Center Pedal Control... 2-20 1 Region Pitch Control... 2-20 2 Region Pitch Control... 2-20 3 Region Pitch Control... 2-20 Programmable Yaw Positions... 2-21 Single Linear Yaw Control... 2-22 Dual Linear Yaw Control... 2-22 Yaw Control of Reflux... 2-22 Yaw Control of Ultrasound Submode... 2-22 . Center Footpedal Control... 2-23 Customizing Your System... 3-1 Mode Programming... 3-1 Create a New Setup... 3-1 Modify an Existing Setup... 3-3 Customizing Mode Settings... 3-5 System Status... 3-6 Customizing Foot Control Settings... 3-7 Customizing the Mode Sequence... 3-8 Customizing Audio Control... 3-10 Customizing Language Setting... 3-13 Saving Your Personal Settings... 3-14 Transferring and Deleting Personal Settings... 3-15 Advanced Operation... 4-1 Computer Unit... 4-1 Screen Drape Installation... 4-3 Base Unit... 4-4 Instrumentation Cart... 4-5

Millennium™ Microsurgical System

Preface - Table of Contents

4.4. 4.5. 4.6.

4.1. 4.7

IV Pole... 4-6 Fluid Tamponade... 4-7 Remote Control... 4-8 Venturi IAV Module... 4-11 Irrigation-Aspiration Modes... 4-11 Irrigation... 4-11 Irrigation/Aspiration... 4-12 Capsule Polish... 4-12 Viscoelastic Removal... 4-12 Reflux... 4-12 Vacuum Response... 4-13 Foot Control of Irrigation/Aspiration... 4-13 Venturi Irrigation/Aspiration Set-up And Use...4-15, 4-18 Vitrectomy Mode... 4-19 Vitrectomy Cutter Modes... 4-19 Foot Control Of Anterior Vitrectomy Mode . . . 4-19 Foot Control Of Posterior Vitrectomy Mode (with Irrigation Control Feature Off)... 4-20 Foot Control Of Posterior Vitrectomy Mode (with Irrigation Control Feature On)... 4-21 Anterior Vitrectomy Set-up And Use Anterior Venturi... 4-22 Posterior Vitrectomy Set-up and Use - Venturi (Irrigation Control Feature Off)... 4-27 Posterior Vitrectomy Set-up and Use - Venturi (Irrigation Control Feature On)... 4-29 Advanced Flow System IAV Module... 4-35 Irrigation-Aspiration Mode... 4-35 Irrigation... 4-35 Irrigation/Aspiration... 4-35 Capsule Polish... 4-36 Viscoelastic Removal... 4-36 Venting... 4-36

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4.1.

Preface-iv

Reflux... 4-36 Vacuum Response... 4-37 Foot Control of Irrigation/Aspiration... 4-37 Advanced Flow System Irrigation/Aspiration Set-up and Use... 4-38 Vitrectomy Mode... 4-42 Vitrectomy Cutter Modes... 4-42 Foot Control of Vitrectomy Mode... 4-42 Advanced Flow System Anterior Vitrectomy Set-Up and Use...4-44, 4-47 Ultrasound Module... 4-49 4-49 Ultrasound Module Description... 4-49 4-49 Ultrasound Power... 4-49 4-49 Pulse Mode Ultrasound... 4-49 4-50 Burst Mode Ultrasound... 4-50 4-51 Ultrasound Submode Sequence... 4-51 4-51 Ultrasound Tuning... 4-51 4-51 Description of Ultrasound Modes... 4-51 Dual Linear Segment Removal in 4-52 Anterior Mode... 4-52 Dual Linear Sculpt in Anterior Mode... 4-52 Segment Removal in Anterior Mode... 4-52 Sculpt in Anterior Mode... 4-52 Epinucleus Mode... 4-53 4-52 Irrigation/Aspiration in Ultrasound Modes... 4-53 4-53 Anterior Single Linear Ultrasound Mode... 4-53 Anterior Single Linear Ultrasound Mode with 4-54 Aspiration Control Feature On... 4-54 Anterior Dual Linear Ultrasound Mode with Aspiration in Yaw... 4-54 Anterior Dual Linear Ultrasound Mode with Aspiration in Yaw and Aspiration Control 4-55 Feature On... 4-55 Anterior Dual Linear Ultrasound Mode with Yaw Ultrasound... 4-55

Millennium™ Microsurgical System

Preface - Table of Contents

Fixed Ultrasound in Posterior Mode... 4-55 4-56 Dual Linear Ultrasound in Posterior Mode... 4-56 4-57 Phacoemulsification Set-Up - Venturi... 4-57 4-59 Phacoemulsification Operation - Venturi... 4-59 Phacofragmentation Set-Up 4-62 (Irrigation Control Feature Off) - Venturi... 4-62 Phacofragmentation Set-up 4-63 (Irrigation Control Feature On) - Venturi... 4-64 4-66 Phacofragmentation Operation - Venturi... 4-66 Phacoemulsification Set-Up 4-69 Advanced Flow System Module... 4-69 Phacoemulsification Operation4-71 Advanced Flow Module... 4-71 4-73 4.1. Illumination Module... 4-73 4-73 Illumination Setup and Use... 4-73 4-75 4.10. Coagulation Module... 4-75 4-76 Fixed Coagulation Set-up And Use... 4-76 4-78 Linear Coagulation Set-Up and Use... 4-78 Linear Coagulation-Linear 4-80 Vacuum Set-Up and Use 4-83 (Posterior only)... 4-80 4-83 4.12. Scissors/Air Module... 4-83 4-83 Scissors/Forceps... 4-83 4-83 Scissors/Forceps Operation... 4-83 4-84 Vertical Scissors Modes:... 4-83 4-85 Proportional Handpiece Modes:... 4-84 4-87 Scissors Set-up (without Aspiration)... 4-85 4-90 Linear Cut, Linear Vacuum Scissors Set-up . . . 4-87 4-90 Air Fluid Exchange... 4-90 4-90 Air Fluid Exchange Operation... 4-90 Air Tamponade... 4-90 4-91 Air Fluid Exchange Set-up (Irrigation Control Feature Off)... 4-91 4-93 4-96 Air Fluid Exchange Set-up 4-96 (Irrigation Control Feature On)... 4-93 4-99 Owner’s Manual Preface-v

Preface - Table of Contents

Bottle Infusion Operation...4-96 Bottle Infusion Set-up...4-96 4.13. High Speed Vitrectomy Module...4-99 Operating Modes...4-99 Aspiration for High Speed Vitrectomy...4-100 Foot Control Of Posterior Vitrectomy Mode (with Irrigation Control Feature Off)...4-100 Foot Control Of Posterior Vitrectomy Mode (with Irrigation Control Feature On)...4-100 High Speed Vitrectomy Set-up and Use - Posterior Venturi Aspiration (Irrigation Control Feature Off)...4-102 High-Speed Vitrectomy Set-up and Use - Posterior Venturi (Irrigation Control Feature On) . 4-104, 4-108 High Speed Vitrectomy Set-up...4-109 And Use - Anterior Venturi...4-109 High Speed Vitrectomy Set-Up and Use Anterior Advanced Flow System...4-114 4.14. Viscous Fluid Module...4-119 Viscous Fluid System Setup and Use...4-121 Linear Fluid Injection, Linear Vacuum Setup and Use...4-127 4.15. Laser Module...4-129 Laser Safety Information...4-130 Compliance with FDA-Required Safety Features...4-132 Additional Safety Features...4-136 Laser System Description...4-138 Operating Modes...4-139 Laser User Interface...4-139 User Notes...4-141 LIO+ Mode Set-up And Use...4-142 EndoProbe Mode Set-Up and Use...4-145 5 Cleaning and Sterilization Requirements...5-1 5.1. Computer Unit, Base Unit,

Preface-vi

Millennium™ Microsurgical System

Preface - Table of Contents

5.2. 5.3. 5.4.

5.5.

5.6.

5.7.

5.8.

5.9. 6 6.1. 6.2.

Foot Controller, and Cart... 5-1 Bipolar Coagulation Accessories... 5-2 Advanced Flow Module Transducer... 5-2 Irrigation Handpiece and Irrigation/Aspiration Handpiece... 5-4 Handpiece Cleaning Instructions... 5-4 Irrigation and I/A Handpiece Sterilization... 5-7 Phacoemulsification Handpiece and Accessories 5-8 Handpiece Cleaning Instructions... 5-8 Needle Cleaning Instructions... 5-11 Phacoemulsification Handpiece and Accessories Sterilization... 5-11 Phacofragmentation Handpiece... 5-12 Handpiece Cleaning Instructions... 5-12 Phacofragmentation Handpiece Sterilization . . . 5-14 Microscissors and High Speed Vitrectomy Handpieces... 5-15 Tip Storage:... 5-16 Vitreoretinal Instruments... 5-16 Cleaning:... 5-16 Sterilization:... 5-17 Storage:... 5-17 Special Instructions for United Kingdom Users. 5-18 Unpacking and Setting Up... 6-1 Unpacking Instructions... 6-1 Connections and Setup... 6-1 IV Pole... 6-1 Illumination Module... 6-1 Video Overlay Generator... 6-1 System Set-up without Cart or Laser Module. . . 6-2 System Set-up with Cart (without Laser Module)... 6-4 Expanded System Set-up (without Laser Module)... 6-6 Laser System Set-up with

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Preface - Table of Contents

6.3. 6.4. 7 7.1.

7.2. 7.3. 7.4. 7.5. 7.6. 7.7. 7.8. 7.9. 8 8.1.

8.2.

8.3.

IAV Venturi Module...6-9 Installing Laser Junction Box...6-12 Adding or Replacing Modules...6-18 Maintenance, Service and Warranty...7-1 Service Information...7-1 Technical Assistance...7-1 Returning Modules...7-2 Environmental Protection...7-3 Warranty Information...7-3 System Checkout...7-5 User Troubleshooting...7-6 Lamp Replacement...7-7 Fuse Replacement...7-9 Verification of Calibration...7-11 System Messages...7-12 Specifications...8-1 Environmental and Physical Specifications...8-1 Environmental Specifications...8-1 Physical Specifications...8-2 Equipment Classifications...8-2 Table of Accessories and Cables:...8-4 CX5810 High Speed Vitrectomy Handpiece...8-4 CX9550 Foot Control...8-4 Primary System Specifications...8-9 Computer Unit Specifications...8-9 Foot Controller Specifications...8-10 Remote Control Unit Specifications...8-12 IV Pole Specification...8-13 Ophthalmic Module Specifications...8-14 Air Fluid Exchange Specifications...8-14 Scissors/Forceps Specifications...8-15 Illumination Module Specifications...8-16 Viscous Fluid Module Specifications...8-16 Coagulation Module Specifications...8-17 Ultrasound Module Specifications...8-18 Ultrasound Module Specifications...8-19 Venturi Irrigation, Aspiration and Vitrectomy

Preface-viii Millennium™ Microsurgical System

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Module Specifications... 8-20 Advanced Flow System Irrigation, Aspiration and Vitrectomy Module Specifications... 8-21 Laser Module Specifications... 8-22 Compliance with FDA-Required Safety Features... 8-26 Index... Index-i

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Preface-x

Millennium™ Microsurgical System

Preface - Introduction

Indications for Use The Bausch & Lomb (hereinafter referred to as B&L) Millennium™ Microsurgical System is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar and photo coagulation, vitrectomy, viscous fluid injection/removal, and air/fluid exchange operations. Use only B&L approved disposable packs and B&L handpieces designated for use with this system. The CX5900 Laser Module is intended for use only by qualified physicians. If you are not a qualified physician, do not attempt to operate the laser system for any reason. Specific indications for laser modes are retinal photocoagulation and laser trabeculoplasty. Delivery devices available are the EndoProbe for intraocular endolaser surgery, and the Laser Indirect Ophthalmoscope Plus (LIO+) for transpupillary laser delivery for patients treated in a supine position.

Contraindications Use of accessories not designated by B&L for use with this equipment may result in serious permanent patient injury, adverse surgical outcome, or damage to the equipment, which may not be covered by warranty. See page 1-1 for precautions relevant to patients with implantable defibrillators and cardiac pacemakers. Photocoagulation is not indicated for patients without pigmentation (albino eyes). In addition, Laser Indirect Ophthalmoscope (LIO+) is not indicated for cases involving laser photocoagulation within the arcades. On the following pages you will find a summary of the precautions that should be observed when using this equipment. Each precaution shows the page number where it appears near the applicable instruction. For safety's sake, please heed these precautions.

Owner s Manual

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Preface - Introduction

Patents The B&L Millennium™ Microsurgical System is covered by the following patents: 4,757,426; 4,773,897; 5,091,656; 5,112,019; 5,157,603; 5,242,404; 5,331,951; 5,370,602; 5,388,569; 5,406,503; 5,417,246; 5,429,601; 5,455,766; 5,997,528; 6,077,272; 6,083,195; 6,086,576; 6,106,512; 6,117,126; 6,179,829; 6,251,113; additional patents pending. Other patents may also apply. The CX5900 Laser Module system is covered by one or more of the following IRIDEX Corporation patents: 5,085,492; 5,511,085; 5,372,595; 5,088,803; additional patents pending. Other patents may also apply.

Trademarks Bausch & Lomb, Millennium, Storz, ErgoTec, and SuperSorb are trademarks of Bausch & Lomb Incorporated and/or its affiliates. Other brands and product names used in this manual are trademarks of their respective owners.

Preface-xii

Millennium™ Microsurgical System

Preface - Introduction

Power Outputs The power outputs of each optional module are: COAG

U/S

SCISSORS

HIGH SPEED VITRECTOMY

AIMING LASER

LASER

KOAG

U/S

SCHERE

HOCHGESCHWINDIGKEITS VITREKTOMIE

RICHTLASER

LASER

COAG

U/S

MICROTIJERAS

VITRECTOMIA DE ALTA FRECUENCIA

RADIACIÓN DIRIGIDA

LASER

COAG

U/S

CISEAUX

VITRECTOMIE A GRANDE VITESSE

LASER DE DIRECTION

LASER

COAG

U/S

MICROFORBICI

VITRECTOMIA AD ALTA VELOCITA

LASER DIREZIONALE

LASER

COAG

U/S

SCHAAR

ULTRASNELLE VITRECTOMIE

RICHTLASER

LASER

KOAG

UL

SAX

HÖGHASTIGHETS VITREKTOMI

RIKTLASER

LASER

KOAG

UL

SAKS

HØJHASTIGHEDS VITREKTOMI

SIGTLASER

LASER

COAG

US

TESOURA

VITRECTOMIA DE ALTA VELOCIDADE

LASER DIRECCIONAL

LASER

BF

BF

BF

BF

BF

BF

7.5 W

35 W

2.8 W

2.8 W

DIODE

DPSS

100Ω/200Ω

1500Ω

10Ω

10Ω

1mW CW (max)

2 Watts CW (max)

1 MHz

28.5 kHz

5 Hz

DC

630 - 650 nm

532nm

Owner s Manual

Preface-xiii

Preface - Introduction

Symbol Definitions The following are definitions of the symbols used on this equipment and in this manual.

Laser Pulse On (Duration)

Alternating Current Direct Current Ω Ohms Laser Module Power Off

Laser Pulse Off (Interval) Emergency Laser Off

(ON)

LIO Illuminator Output

BF

(OFF)

Air

Input

T 5A 250V

Patient Floating Ground

Fuse DangerExplosion Hazard Note

Preface-xiv

Wavelength Po Maximum Power

EndoProbe Connection

Laser Module Power On (Standby/Ready)

Main Power Switch

λ

Electrical Shock Hazard

Equipotential Footswitch Ground Laser Hazard

See Instructions

Millennium™ Microsurgical System

Remote InterlockConnection

Precaution

Preface - Introduction

Manual Concept B&L designs manuals to give you the information you need when you need it, and we don't want you to have to search to find it. This manual is organized so that in the first chapter you will find enough information to quickly get up and running, and to answer general questions about the Millennium™ Microsurgical System. We have added plenty of pictures so concepts can be grasped quickly. Be sure to read Chapter 2 to become familiar with the graphical user interface and the foot controller. These are your connections to operating the system. You will find in Chapter 3 information on how to customize the system to suit your particular needs. In Chapter 4 you will find detailed information about each module function and feature, how to set up the module and its associated disposables, and how to interact with each module. Chapter 5 gives you cleaning and sterilization information. These chapters are meant to serve as a reference to questions of a more technical nature. Chapters 6 through 8 contain information that you may rarely need, such as unpacking, installing modules, system check-out, meanings of error messages, service information, and system specifications. Make sure that you read and follow all safety precautions set forth in this manual. Information presented in this manual relating to surgical procedures are suggestions only, and do not constitute any warranty of fitness or claim of responsibility, or undertaking of liability resulting from any surgical techniques practiced. The physician is ultimately responsible for determining the appropriate procedure for each patient. We hope that this manual meets your needs.

Owner s Manual

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Preface - Introduction

Preface-xvi

Millennium™ Microsurgical System

Preface - Precautions

Symbols and Notes The following are general definitions of the symbols and precautions used on this equipment and in this manual. This symbol indicates that it is necessary for the user to refer to the appropriate instruction. DANGER: “Danger” calls attention to an operating procedure, practice, or condition, which if disregarded or incorrectly performed, could result in imminent explosion hazard and risk of death or serious injury. WARNING: “Warning” calls attention to an operating procedure, practice, or condition, which if disregarded or incorrectly performed, could result in serious injury to personnel and/or patients. CAUTION: “Caution” calls attention to an operating procedure, practice, or condition, which if disregarded or incorrectly performed, could result in damage to the product and/or equipment. NOTE: “Note” calls attention to an operating procedure, practice, or condition providing essential information.

Owner s Manual

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Preface - Precautions

Precautions DANGER:EXPLOSION HAZARD. Do not use in the presence of flammable anaesthetics, disinfectants, aerosol sprays, or in an oxygen rich atmosphere... 1-2, 4-1, 6-1 WARNING: Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during intraocular surgery, due to involuntary motion by the patient. Patients being considered for intraocular procedures must be questioned to determine if they have such a device and, if so, the defibrillator manufacturer must be consulted to determine the appropriate action... 1-1 WARNING: Manufacturers of implantable defibrillators recommend that these devices be temporarily disabled when using bipolar cautery on patients with implants. The surgeon should determine if the patient has such a device and consult the manufacturer for appropriate actions... 1-11 WARNING: Manufacturers of implantable defibrillators recommend that these devices be temporarily disabled when using phacoemulsification or phacofragmentation systems on patients with these implants. This is especially important when using pulsed phaco modes of operation. Although the implanted devices are designed to reject electromagnetic interference, and Bausch & Lomb microsurgical equipment is designed to minimize such interference, a chance interaction cannot be ruled out. Patients should be questioned to determine if they have such an implant and, if so, the manufacturer should be consulted to determine the proper course of action... 1-13

Preface-xviii

Millennium™ Microsurgical System

Preface - Precautions

WARNING: The use of controls or adjustments or performance of procedure other than those specified herein may result in hazardous radiation exposure...4-130 WARNING: Before each use, the handpiece and power cord should be inspected for damage (e.g. nicks, crimps, dents, exposed wires, etc.). If the handpiece is damaged, it should be immediately removed from service. Use of damaged handpiece may result in serious permanent patient injury. 5-11 WARNING: Any support personnel present during laser treatment must wear appropriate laser protective eyewear. ... 1-16, 1-17, 4-130, 4-142, 4-145

WARNING: Use only handpieces, cables, and accessories designated by Bausch & Lomb for use with this system. . 1-12

WARNING: The use of unapproved delivery devices may cause inaccurate laser delivery which could result in serious permanent patient injury. Use only approved delivery devices. ... 1-17, 4-141

WARNING: This system should only be operated by personnel who have been trained and qualified to use this system... 1-2

WARNING: Use of an IV pole extension or other means of altering the bottle height may cause inaccurate setting displays resulting in serious permanent patient injury. . . 4-6

Owner s Manual

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