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Customer Service Manual Revision F

This document contains information that is the confidential and proprietary property of Bausch & Lomb. Any dissemination, distribution or
copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
This service manual is only intended for persons trained and authorized by Bausch + Lomb to service the Bausch
+ Lomb Stellaris Vision Enhancement System and the Bausch + Lomb Stellaris PC Vision Enhancement System.
The technician is assumed to have the knowledge required to use this manual safely and effectively. If the
technical state of the unit differs from that described in the service manual, please contact the technical service
department.

Bausch & Lomb Incorporated


3365 Tree Court Industrial Blvd.
St. Louis, Missouri 63122 U.S.A.
Attention: Technical Support Department
Phone: 1-800-338-2020 or 1-636-226-3705
FAX: 1-636-226-3070

© Bausch & Lomb Incorporated. All rights reserved.

Bausch & Lomb Incorporated, Rochester, NY 14609

USA

Manufactured by:
Bausch & Lomb Incorporated
3365 Tree Court Ind. Blvd
St. Louis, MO 63122 USA

Customer Service Manual Revision F

This document contains information that is the confidential and proprietary property of Bausch & Lomb. Any dissemination, distribution or
copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Introduction and General Information...................................................................................1-1
Precautions and Warnings ......................................................................................................2-1
Specifications .........................................................................................................................3-1
Technical Descriptions ...........................................................................................................4-1
Tools ......................................................................................................................................5-1
Installation and Deinstallation................................................................................................6-1
Preventative Maintenance ......................................................................................................7-1
Upgrades ................................................................................................................................8-1
Error Codes and Troubleshooting Guides ..............................................................................9-1
Calibration..............................................................................................................................10-1
Disassembly and Assembly ...................................................................................................11-1
Test Procedures ......................................................................................................................12-1
TruLink® Customer Support Network ..................................................................................13-1
Parts List ................................................................................................................................14-1
Technical Service Notes .........................................................................................................15-1
Glossary and Medical Terminology .......................................................................................16-1
Service Manual Revision History ..........................................................................................17-1
Addendum ..............................................................................................................................18-1
Index ......................................................................................................................................19-1

Customer Service Manual Revision F

This document contains information that is the confidential and proprietary property of Bausch & Lomb. Any dissemination, distribution or
copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Customer Service Manual Revision F

This document contains information that is the confidential and proprietary property of Bausch & Lomb. Any dissemination, distribution or
copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Chapter 1: Introduction and General Information........................................................... 1-1
1.1 Manual Concept ............................................................................................. 1-1
1.2 Indications for Use ......................................................................................... 1-1
1.3 Training .......................................................................................................... 1-1
1.4 Patents ............................................................................................................ 1-2
1.5 Trademarks .................................................................................................... 1-2
1.6 General Information ....................................................................................... 1-2
1.6.1 Conventions .......................................................................................... 1-2
1.6.2 Abbreviations ........................................................................................ 1-2
1.7 Symbols.......................................................................................................... 1-4
1.8 Hazards and Notes ......................................................................................... 1-7
1.9 Product Description ....................................................................................... 1-8
1.9.1 User Interface Computer (UIC) .......................................................... 1-10
1.9.2 Graphical User Interface (GUI) .......................................................... 1-11
1.9.3 Electromechanical Base (EMB) or System Chassis............................ 1-13
1.9.4 Ultrasound Module ............................................................................. 1-14
1.9.5 Fluidics Function ................................................................................ 1-16
1.9.6 Tray Arm ............................................................................................. 1-19
1.9.7 Compressor Module ............................................................................ 1-20
1.9.8 Posterior Illumination Module (PIM) (Posterior/Combined) ............. 1-22
1.9.9 Power Module ..................................................................................... 1-24
1.9.10 IV Pole .............................................................................................. 1-25
1.9.11 IV Pole Controller ............................................................................. 1-26
1.9.12 Foot Control ...................................................................................... 1-27
1.9.13 Foot Control Interface Board (FCIB)................................................ 1-38
1.9.14 Wireless Remote .............................................................................. 1-38
1.9.15 Multimedia Center (MMC) .............................................................. 1-40
1.9.16 TruLink® Customer Support Network ............................................. 1-40
Chapter 2: Precautions and Warnings .............................................................................. 2-1
2.1 Danger, Warning and Caution ....................................................................... 2-1
2.2 Biological Hazard Warning ........................................................................... 2-5
2.3 Battery Disposal ............................................................................................. 2-6
2.4 Module Safety Precautions ............................................................................ 2-7
2.4.1 Ultrasound ............................................................................................. 2-7
2.4.2 Bipolar (Cautery) .................................................................................. 2-7
2.4.3 Advanced Flow Module ........................................................................ 2-8
2.4.4 Posterior Illumination Module .............................................................. 2-8
Chapter 3: Specifications ................................................................................................. 3-1
3.1 Module Cross Reference Table ...................................................................... 3-1
3.2 Environmental Specifications ........................................................................ 3-2
3.3 Physical Specifications .................................................................................. 3-3
3.4 Equipment Classifications ............................................................................. 3-3
3.5 Primary System Specifications ...................................................................... 3-8
3.5.1 User Interface Computer ....................................................................... 3-8

Customer Service Manual Revision F Page 1

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copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
3.5.2 Ultrasound Module Specifications ........................................................ 3-9
3.5.3 Fluidics Module .................................................................................. 3-14
3.5.4 Viscous Fluid Control Specifications ................................................. 3-18
3.6 Fluid Air Exchange, Pressurized & Air Force Infusion Specifications........ 3-18
3.6.1 Posterior Illumination Module ............................................................ 3-18
3.7 IV Pole Specifications.................................................................................. 3-19
3.7.1 Foot Control Specifications ................................................................ 3-19
3.7.2 Remote Control Specifications ........................................................... 3-21
3.7.3 Multimedia Center (MMC) (optional accessory) Specifications ........ 3-21
3.7.4 Green Laser Specifications ................................................................. 3-22
3.8 System Labels .............................................................................................. 3-26
Chapter 4: Technical Descriptions ................................................................................... 4-1
4.1 User Interface Computer ................................................................................ 4-1
4.1.1 Screen Housing ..................................................................................... 4-1
4.1.2 Display and Touch Screen .................................................................... 4-1
4.1.3 Display Transition Board ...................................................................... 4-1
4.1.4 Main Processor Housing and PCB Mounting ....................................... 4-2
4.1.5 Main CPU Module ................................................................................ 4-2
4.1.6 Main PC Board ..................................................................................... 4-2
4.1.7 Power Control Switch PCB................................................................... 4-3
4.2 Electromechanical Base (EMB) ..................................................................... 4-3
4.2.1 Electromechanical Base Definitions (EMB) ........................................ 4-4
4.2.2 Disassembly Scheme ............................................................................ 4-4
4.2.3 Weight ................................................................................................... 4-5
4.2.4 Damage Protection Devices ................................................................. 4-5
4.2.5 General Requirements ........................................................................... 4-6
4.3 Ultrasound Module ...................................................................................... 4-16
4.3.1 Enclosure (Chassis) ............................................................................. 4-16
4.3.2 Front ‘Customer’ Panel ....................................................................... 4-17
4.3.3 Electrical Interface .............................................................................. 4-17
4.3.4 Front Panel Input/Output .................................................................... 4-20
4.3.5 Fusing .................................................................................................. 4-21
4.3.6 Electrical Safety .................................................................................. 4-21
4.3.7 Phacoemusification ............................................................................. 4-23
4.3.8 High Speed Vitrectomy (Discontinued) .............................................. 4-26
4.4 Fluidics Modules .......................................................................................... 4-27
4.4.1 Advanced Flow Module (AFM) ......................................................... 4-27
4.4.2 Vacuum Fluidics Module .................................................................... 4-38
4.4.3 Posterior Fluidics Module (PFM) ....................................................... 4-51
4.4.4 Module Shipping Configuration ......................................................... 4-60
4.5 Compressor (Anterior only) ......................................................................... 4-62
4.5.1 Power Requirement ............................................................................. 4-63
4.5.2 Physical Attributes .............................................................................. 4-63
4.5.3 Enclosure............................................................................................. 4-63

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4.5.4 Interface Requirements ....................................................................... 4-63
4.5.5 Power and Communication Interference............................................. 4-64
4.5.6 CAN Network Cable (Communication) ............................................. 4-65
4.5.7 Power Supply Interface ....................................................................... 4-65
4.5.8 Functional Requirements .................................................................... 4-65
4.6 Posterior Compressor (Posterior and Combined only) ................................ 4-68
4.6.1 Power Requirement ............................................................................. 4-69
4.6.2 Physical Attributes .............................................................................. 4-69
4.6.3 Enclosure............................................................................................. 4-69
4.6.4 Interface Requirements ....................................................................... 4-69
4.6.5 Power and Communication Interference............................................. 4-70
4.6.6 CAN Network Cable (Communication) ............................................. 4-70
4.6.7 Power Supply Interface ....................................................................... 4-70
4.6.8 Functional Requirements .................................................................... 4-71
4.7 Posterior Illumination Module (Posterior and Combined Only) .................. 4-73
4.7.1 Enclosure (Chassis) ............................................................................. 4-73
4.7.2 Front ‘Customer’ Panel ....................................................................... 4-73
4.7.3 Electrical Interface .............................................................................. 4-74
4.7.4 Front Panel Input/Output .................................................................... 4-76
4.7.5 Module Viscous Fluid Output and Fluid and Air Exchange ............... 4-76
4.7.6 Illumination ......................................................................................... 4-77
4.8 Power Module with Battery Backup ........................................................... 4-79
4.8.1 Physical Specifications ...................................................................... 4-79
4.8.2 Environmental Specifications ............................................................. 4-80
4.8.3 Power Level Specifications................................................................. 4-81
4.8.4 Connections and Switches .................................................................. 4-81
4.8.5 System Communication ...................................................................... 4-82
4.8.6 Backup Battery Specifications ............................................................ 4-83
4.8.7 Regulatory Specifications ................................................................... 4-83
4.8.8 Service Specifications ......................................................................... 4-84
4.9 Power Module without Battery Backup ....................................................... 4-84
4.9.1 Power Module Features ...................................................................... 4-84
4.9.2 Power Module Interface ...................................................................... 4-84
4.9.3 Physical Specifications Dimensions ................................................... 4-85
4.9.4 Environmental Specifications ............................................................. 4-86
4.9.5 Operating Modes ................................................................................. 4-87
4.9.6 Input Specifications ............................................................................ 4-88
4.9.7 Functional Output Specifications ........................................................ 4-90
4.9.8 Connections......................................................................................... 4-92
4.9.9 Regulatory Specifications ................................................................... 4-95
4.10 IV Pole ....................................................................................................... 4-96
4.10.1 Functional Description ...................................................................... 4-96
4.10.2 Physical Specifications ..................................................................... 4-97
4.10.3 Operating Characteristics .................................................................. 4-97

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4.10.4 Configuration .................................................................................... 4-98
4.10.5 Input/Output ...................................................................................... 4-98
4.10.6 Noise ................................................................................................. 4-98
4.10.7 Electrical and Software Specifications ............................................. 4-98
4.10.8 Service............................................................................................... 4-98
4.10.9 DRM (Device Relationship Management) requirements:................. 4-99
4.11 Foot Control ............................................................................................... 4-99
4.11.1 Functional Description ...................................................................... 4-99
4.11.2 Mechanical Specifications .............................................................. 4-101
4.12 Wireless Remote ...................................................................................... 4-102
4.13 Multimedia Center ................................................................................... 4-103
4.13.1 Electrical Inputs .............................................................................. 4-104
4.13.2 Electrical Outputs............................................................................ 4-105
4.13.3 Mechanical ...................................................................................... 4-106
4.13.4 Bottom Surface ............................................................................... 4-107
4.13.5 Video Overlay ................................................................................. 4-107
4.13.6 Motherboard .................................................................................... 4-108
4.13.7 Operating System / Hard Drive ....................................................... 4-108
4.13.8 Service Times.................................................................................. 4-108
4.13.9 Configuration .................................................................................. 4-108
4.13.10 Front Panel Labelling .................................................................... 4-108
4.13.11 Rear Panel Labelling ..................................................................... 4-108
4.14 Stellaris PC Laser System ........................................................................ 4-110
4.14.1 Treatment Laser .............................................................................. 4-110
4.14.2 Aiming Beam .................................................................................. 4-110
4.14.3 Laser delivery device connector ..................................................... 4-110
4.14.4 Laser fire tone ................................................................................. 4-110
4.14.5 Other Information ........................................................................... 4-110
Chapter 5: Tools ............................................................................................................... 5-1
5.1 Tool Recommendations ................................................................................. 5-1
Chapter 6: Installation and Deinstallation ........................................................................ 6-1
6.1 Complete System ........................................................................................... 6-1
6.1.1 Unpacking the System (Corrugated Box) ............................................. 6-1
6.1.2 Unpacking the System (Wooden Crate)................................................ 6-3
6.1.3 Installation of System ........................................................................... 6-4
6.1.4 Multimedia Center (MMC) Installation .............................................. 6-14
6.1.5 De-Installation of System ................................................................... 6-18
6.2 Individual Modules ...................................................................................... 6-20
6.2.1 Unpacking Modules ............................................................................ 6-20
6.2.2 Packing a System or Modules ............................................................. 6-20
6.3 Moving the Stellaris or Stellaris PC System to a Different Location........... 6-20
6.4 Returning Equipment to Bausch + Lomb .................................................... 6-21
Chapter 7: Preventative Maintenance .............................................................................. 7-1
7.1 Cleaning Requirements .................................................................................. 7-1

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copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
7.1.1 System Skins ......................................................................................... 7-1
7.1.2 Handpiece and Accessories ................................................................... 7-1
7.1.3 Multimedia Center (MMC) ................................................................... 7-3
7.1.4 Advanced Flow Module (AFM) Transducer ......................................... 7-4
7.2 EMB/Compressor Hydrophobic Filter Replacement (Anterior Only) ........... 7-5
7.2.1 Hydrophobic Filter Replacement Procedure ......................................... 7-5
Chapter 8: Upgrades......................................................................................................... 8-1
8.1 TFSN0057 – Stellaris Power Module Upgrade ............................................. 8-1
8.1.1 Part Details: ........................................................................................... 8-1
8.1.2 Stellaris Power Supply Upgrade Procedure: ......................................... 8-2
8.2 TFSN0058 - Plastic UIC Upgrade ................................................................. 8-4
8.2.1 Procedure – Upgrading a Metal UIC to a Plastic UIC .......................... 8-5
Chapter 9: Error Codes and Troubleshooting Guides ...................................................... 9-1
9.1 User Interface Computer (UIC/UPC)............................................................. 9-2
9.1.1 User Interface Computer (UIC) Error Codes ........................................ 9-2
9.1.2 User Interface Computer (UIC) Troubleshooting Guide ...................... 9-4
9.2 Electromechanical Base (EMB) ..................................................................... 9-9
9.2.1 EMB or System Chassis Troubleshooting Guide ................................. 9-9
9.3 Ultrasound Module (USM/USV/USL) ........................................................ 9-10
9.3.1 Ultrasound Module (USM/USV) Error Codes .................................... 9-10
9.3.2 Ultrasound Modules (USM/USV) Troubleshooting Guide................. 9-13
9.4 Fluidics Modules .......................................................................................... 9-16
9.4.1 Advanced Flow Module (AFM) (Anterior Only)................................ 9-16
9.4.2 Vacuum Fluidics Module (VFM/PFM) .............................................. 9-21
9.5 Compressor Module ..................................................................................... 9-38
9.5.1 Compressor Module Error Codes (CPA/PCM) ................................... 9-38
9.5.2 Compressor Module (CPA) Troubleshooting Guide (Anterior Only) 9-39
9.5.3 Posterior Compressor Module (PCM) Troubleshooting Guide........... 9-43
9.6 Posterior Illumination Module (PIM) (Posterior and Combined Only) ....... 9-44
9.6.1 Posterior Illumination Module (PIM) Error Codes (Posterior/Combined) 9-44
9.6.2 Posterior Illumination Module (PIM) Troubleshooting Guide
(Posterior/Combined) ................................................................................... 9-47
9.7 Power Module .............................................................................................. 9-51
9.7.1 Power Module (BPS/SPS) Error Codes .............................................. 9-51
9.7.2 Power Module with Backup Battery (BPS) Troubleshooting Guide 9-53
9.7.3 Power Module without Backup Battery (SPS) Troubleshooting Guide 9-55
9.8 IV Pole (MIV) and Controller (EIV)............................................................ 9-56
9.8.1 IV Pole Controller (EIV) Error Codes ................................................ 9-56
9.8.2 IV Pole (MIV) and Controller (EIV) Troubleshooting Guide ............. 9-57
9.9 Foot Control (WFC) and FCIB (WFR) ........................................................ 9-59
9.9.1 Foot Control (WFC) and Integrated Foot Control (IFC) Error Codes 9-59
9.9.2 Foot Control Interface Board (FCIB (WFR)) Error Codes ................. 9-64
9.9.3 Foot Control (WFC) and FCIB (WFR) Troubleshooting Guide ......... 9-65
9.10 Wireless Remote Control (REM) (Anterior Only) ..................................... 9-68

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9.10.1 Wireless Remote Control (REM) Error Codes (Anterior Only) ....... 9-68
9.10.2 Wireless Remote Control (REM) Troubleshooting Guide ................ 9-69
9.11 Multimedia Center (MMC) ........................................................................ 9-70
9.11.1 Multimedia Center (MMC) Error Codes ........................................... 9-70
9.11.2 Multimedia Center (MMC) Troubleshooting Guide ......................... 9-72
9.12 Green Laser Module (LAS, Posterior and Combined Only) ...................... 9-74
9.12.1 Green Laser Module Error Codes ..................................................... 9-74
9.12.2 Green Laser Module Troubleshooting Guide.................................... 9-75
Chapter 10: Calibration .................................................................................................. 10-1
10.0.1 Procedure .......................................................................................... 10-1
10.1 .............................................................................................................10-1
10.1.1 Calibration of Foot Control ............................................................... 10-1
Chapter 11: Disassembly and Assembly ........................................................................ 11-1
11.1 Torque Specifications ................................................................................ 11-1
11.2 Skin Disassembly and Assembly (Anterior and Posterior Combined)....... 11-3
11.2.1 Upper Cover Panel (VFM, AFM, or PFM), Front Upper
Access Panel, and Tray Opening Panel (Anterior and Posterior Combined) 11-3
11.2.2 Tray Opening Skin ............................................................................ 11-4
11.2.3 Accessories Drawer Cover Panel ...................................................... 11-4
11.2.4 Front Lower Access Panel ................................................................ 11-4
11.2.5 Rear Access Panel ............................................................................. 11-6
11.2.6 Lower Casting Skin (Original UIC) .................................................. 11-7
11.2.7 UIC Cover Skin (Plastic UIC)........................................................... 11-8
11.2.8 IV Pole Housing Skins ...................................................................... 11-9
11.2.9 Handle ............................................................................................. 11-10
11.2.10 Right and Left Main Skins ............................................................ 11-12
11.2.11 Vent Removal and Installation ...................................................... 11-14
11.3 Removing and Installing Modules ........................................................... 11-18
11.3.1 User Interface Computer (UIC) ...................................................... 11-19
11.3.2 Ultrasound Module ......................................................................... 11-24
11.3.3 Vacuum Fluidics (VFM), Advanced Flow Module (AFM) or
Posterior Fluidics Module (PFM) .............................................................. 11-26
11.3.4 Posterior Illumination Module (PIM) ............................................. 11-29
11.3.5 Compressor Module (CPA) and Posterior Compressor Module
(PCM) ........................................................................................................ 11-39
11.3.6 Power Module with Battery Backup (BPS) .................................... 11-41
11.3.7 Backup Battery................................................................................ 11-43
11.3.8 Power Module without Battery Backup (SPS) ................................ 11-44
11.3.9 Tray Assembly ................................................................................ 11-48
11.3.10 IV Pole .......................................................................................... 11-50
11.3.11 IV Pole Controller ......................................................................... 11-52
11.3.12 Foot Control .................................................................................. 11-53
11.3.13 Remote .......................................................................................... 11-56
11.4 User Interface Computer Module Disassembly ....................................... 11-57

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11.4.1 Top Work Surface Cover ............................................................... 11-57
11.4.2 Lower Casting Skin (Metal UIC) .................................................... 11-57
11.4.3 Assembling the EMB ...................................................................... 11-58
11.4.4 EMB Base Assembly ...................................................................... 11-58
11.4.5 Tray Arm ......................................................................................... 11-63
11.4.6 IV Pole (New Style) ........................................................................ 11-65
11.5 Wireless Remote (REM) Disassembly .................................................... 11-65
11.5.1 Remote Battery Cover (minimal time required) ............................. 11-65
11.5.2 Batteries (minimal time required) ................................................... 11-66
11.6 Multimedia Center (MMC) Disassembly ................................................ 11-67
Chapter 12: Test Procedures .......................................................................................... 12-1
12.1 Acceptance Criteria .................................................................................... 12-1
12.2 Responsibility ............................................................................................ 12-1
12.3 Quality Criteria .......................................................................................... 12-1
12.3.1 Minor Repair ..................................................................................... 12-1
12.3.2 Major Repair ..................................................................................... 12-1
12.3.3 Preventative Maintenance ................................................................. 12-2
Chapter 13: TruLink® Customer Support Network ...................................................... 13-1
13.1 Definitions, Acronyms, and Abbreviations................................................ 13-1
13.2 Agent Specifications .................................................................................. 13-1
13.3 Agent Monitoring....................................................................................... 13-1
13.4 Windows Logs ........................................................................................... 13-1
13.5 Agent Overview of Operation .................................................................... 13-2
13.6 DRM Models ............................................................................................. 13-3
13.6.1 Bausch & Lomb Stellaris Vision Enhancement System ................... 13-3
13.6.2 Ultrasound Handpiece ....................................................................... 13-4
13.6.3 MMC ................................................................................................. 13-4
13.7 Log File Specifications .............................................................................. 13-4
13.7.1 Data Logging Format ........................................................................ 13-4
13.7.2 DRM Data Items List ........................................................................ 13-5
13.7.3 Individual Data Items ........................................................................ 13-7
13.7.4 Device and modules Generated Warnings and Error Messages........ 13-9
13.7.5 Error and Warning Strings .............................................................. 13-11
13.7.6 Handpiece Data Items ..................................................................... 13-11
13.7.7 Configuration Data.......................................................................... 13-12
13.8 DRM Implementation Process ................................................................. 13-12
13.8.1 Vendor............................................................................................. 13-12
13.8.2 Manufacturing ................................................................................. 13-12
13.8.3 Field ................................................................................................ 13-13
13.8.4 Depot ............................................................................................... 13-13
13.9 Initiating a Remote Session ..................................................................... 13-13
Chapter 14: Parts List ..................................................................................................... 14-1
14.1 Requirements ............................................................................................. 14-1
14.2 Install New Service Parts Catalog .............................................................. 14-1

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copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Chapter 15: Technical Service Notes ............................................................................. 15-1
Chapter 16: Glossary and Medical Terminology ........................................................... 16-1
16.1 Eye Anatomy ............................................................................................. 16-1
16.2 Ophthalmology and Cataract Equipment Terms ........................................ 16-1
16.3 Fluidics Terms ........................................................................................... 16-2
16.4 Common Medical Abbreviations ............................................................. 16-55
16.5 Fundamentals of Medical Etymology ...................................................... 16-58
Chapter 17: Service Manual Revision History .............................................................. 17-1
Chapter 18: Addendum .................................................................................................. 18-1
18.1 Tools .......................................................................................................... 18-1
Chapter 19: Index ........................................................................................................... 19-1

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copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Customer Service Manual Revision F
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copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Chapter 1 - Introduction

1 Introduction and General Information

IMPORTANT:FIELD SERVICE TECHNICIANS ARE ONLY AUTHORIZED TO PERFORM FIELD


SERVICE PROCEDURES FOR WHICH THEY HAVE BEEN TRAINED BY AN APPROVED BAUSCH +
LOMB TRAINER. THIS MANUAL MAY CONTAIN DEPOT LEVEL INFORMATION. FIELD SERVICE
TECHNICIANS ARE NOT AUTHORIZED TO PERFORM DEPOT LEVEL PROCEDURES.

1.1 Manual Concept

Bausch + Lomb 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. We periodically conduct focus groups on our products, and we have used the results
of these focus groups to develop a manual, which we hope you will find useful and informative.

Although you may print this manual, it was designed to be used in its electronic format. It contains numerous cross
references and hyperlinks to allow easy navigation between sections. The hard copy format has been allowed for
by separating sections within each chapter, so individual sections can be quickly identified and located. Printing
can be performed in either 8 ½” X 11” or A4 format.

We hope that this manual meets your needs. The Global Product Support Department would appreciate any
comments you care to share with us.

1.2 Indications for Use

The Bausch + Lomb Stellaris® Vision Enhancement System is designed for use in anterior segment surgeries. It
provides capabilities for phacoemulsification, irrigation/aspiration, bipolar, vitrectomy, and air/fluid exchange
(not available in all locations) operations. Use only Bausch + Lomb approved disposable packs and Bausch +
Lomb handpieces designated for use with this system.

The Bausch + Lomb Stellaris® PC Vision Enhancement System device is intended for the emulsification and
removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior
and posterior segment surgeries. It provides capabilities for phacofragmentation (coaxial or bimanual), irrigation/
aspiration, bipolar diathermy, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The
laser modes are intended for photocoagulation and laser trabeculoplasty. Use only Bausch + Lomb™ disposable
packs and handpieces designated for use with the system.

Use of accessories not designated by Bausch + Lomb 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.

On the following pages, you will find a summary of the precautions that should be observed when using or
servicing this equipment. For safety’s sake, please heed these precautions.

1.3 Training

The Stellaris and Stellaris PC Vision Enhancement System Service Manual will be the primary source of
information used during all Stellaris and Stellaris PC Vision Enhancement System Service related training. The

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Training will include all aspects of service required to properly maintain the systems. All personnel providing
any type of service to the Stellaris or Stellaris PC Vision Enhancement Systems is required to successfully
complete the required training prior to initiating such service.

1.4 Patents

The Bausch + Lomb Stellaris Vision Enhancement System is covered by the following patents: 5,242,404;
5,331,951; 5,370,602; 5,388,569; 5,406,503; 5,429,601; 5,910,139; 5,964,746; 5,970,457; 5,991,142; 6,045,527;
6,055,458; 6,077,272; 6,081,122; 6,083,195; 6,106,512; 6,203,516; 6, 251, 11; 7,168,930 and 7,445,436; additional
Patents pending. Foreign and other patents may also apply.

The Bausch + Lomb Stellaris PC Vision Enhancement System is covered by the following patents: 5,910,139;
6,055,458; 6,081,122; 6,083,195; 6,106,512; 6,203,516; and 8,403,917; additional patents pending. Foreign and
other patents may also apply.

1.5 Trademarks

Bausch & Lomb, Bausch + Lomb, Stellaris, and TruLink are trademarks of Bausch & Lomb Incorporated.

The Bluetooth® word mark and logos are owned by the Bluetooth SIG, Inc.

Other brands and product names used are trademarks of their respective owners.

1.6 General Information

1.6.1 Conventions

Abbreviated menu
For Example: select Tools | Options...
command
In procedures and instructions, Boldface type indicates an action of the user, such as, a button
Boldface type
on the screen to press. Boldface type may also be used in general text for emphasis.

In procedures and instructions, Italicized type indicates what the user observes, such as, a
Italicized type
function on the screen. Italicized type may also be used in general text for emphasis.

Table 1.1: Text Conventions

1.6.2 Abbreviations

’ Foot
’’ Inch
A Amps
AC Alternating Current
Table 1.2: Abbreviations

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AFI Air Forced Infusion


AFM Advanced Flow Module
AFX/IP Air Fluid Exchange/Intraocular Pressure
BPCS Business Planning and Control System
CD Compact Disk
DC Direct Current
cm Centimeter
EMB Electromechanical Base
EMI Electromagnetic Interference
FCIB Foot Control Interface Board
GND Ground
GUI Graphical User Interface
HSPV High Speed Pneumatic Vitrectomy
HV High Voltage
HW Hardware
IC Integrated Circuit
IDC (connector) Insulation-Displacement Connection
I. D. Inside Diameter
IR Infrared
LB pound
lbf-ft Foot Pound
lbf-in Inch pound
LCD Liquid Crystal Display
LED Light Emitting Diode
LIO+ Laser Indirect Ophthalmoscope
mm Millimeter
MMC Multimedia Center
mmHg millimeters of Mercury
N/A Not Applicable
NC (screw) National Course
NTSC National Television System(s) Committee
O. D. Outside Diameter
phase-alternating Line, phase alternation line,
PAL
phase alternation by line
PCB Printed Circuit Board
PCM Posterior Compressor Module
PFM Posterior Fluidics Module
PIM Posterior Illumination Modules
PSI Pounds per Square Inch
SBC Single Board Computer
Table 1.2: Abbreviations

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SPS Stellaris Power Supply


SW Software
UIC User Interface Computer
U/M Unit of Measure
UPS Uninterruptible Power Supply
V Volts
VA Volt Amps
VFM Vacuum Fluidics Module
W Watts
Table 1.2: Abbreviations

1.7 Symbols

Alternating Current Authorized Rep in the EC Battery


Air Input

Battery Condition Indicator Caution Danger - Flammable


Coagulation

Direct Current
Danger - Explosion Hazard Date of Manufacture
Dispose of Properly

Electrical Shock Hazard Ethernet


Electrostatic-Sensitive Equipotential Ground
Device

Table 1.3: Symbol Definitions

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Foot Control
Frequency
Fuse High Speed Vit

Member Green Dot


Manufacturer Scheme Microscope Camera

Main Power Switch

Non Ionizing
Monitor No Latex Electromagnetic Note
Radiation

Ohms Serial Number


See Instructions
Stellaris/Stellaris PC

Type BF Applied Part


Ultrasound USB

Transport Symbol

Warning

Table 1.3: Symbol Definitions

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Always wear eye


Do Not Use
protection or face mask Do not re-sterilize Do Not Reuse
when installing or if Damaged
removing the lamp

Gamma Irradiation
Electrostatic- EtO Gas Sterilized Sterilized
Fluid/Air Exchange
sensitive device

21 CFR 801.109 (b)


Caution: Federal
(USA) law restricts
Illumination Never touch the silica No Latex this device to sale by
glass bulb of the lamp or on the order of a
with bare hands. physician

Viscous Fluid Xenon-Mercury


Xenon
Control

Table 1.4: Posterior Function Symbol Definitions

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1.8 Hazards and Notes

General definitions of the symbols and precautions used on this equipment and in this manual.

See Instructions indicates that it is necessary for the user to refer to the appropriate instruction.

CALLS ATTENTION TO AN OPERATING PROCEDURE, PRACTICE, OR CONDITION, WHICH IF


DISREGARDED OR INCORRECTLY PERFORMED, COULD RESULT IN IMMINENT DEATH OR
SERIOUS INJURY.

CALLS ATTENTION TO AN OPERATING PROCEDURE, PRACTICE, OR CONDITION, WHICH IF


DISREGARDED OR INCORRECTLY PERFORMED, COULD RESULT IN INJURY TO PERSONNEL AND/
OR PATIENTS.

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 calls attention to an operating procedure, practice, or condition providing essential information.

Tip calls attention to a helpful hint that may reduce time in completing a process.

Time shows the approximate time required to perform a process. For example, this clock shows 12:00 pm, indicating
the procedure should take about 5 minutes.

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1.9 Product Description

The Bausch + Lomb Stellaris Vision Enhancement System has a modular design
which enables it to be upgraded to take advantage of advances in technology. The
system consists of a main housing unit which contains a touch screen and the
surgical modules, and a foot control. The modules are housed in the
Electromechanical Base (EMB) chassis underneath removable skins. The
following modules make up the Stellaris/Stellaris PC:

• User Interface Computer (UIC)


• Electromechanical Base (EMB) or System Chassis
• Ultrasound module (containing Coagulation and Ultrasound (USM)), or
Ultrasound Module (containing Coagulation, Ultrasound and High
Speed Vitrectomy (USV)) or Ultrasound Module (containing
Coagulation, Ultrasound and Laser Interface (USL))
• Vacuum Fluidics (VFM) or Advanced Flow Module (AFM) (Anterior
Only)
• Posterior Fluidics Module (PFM) (Posterior/Combined Only)
• Expansion Bay (for additional surgical modules as they become available)
(Anterior Only)
• Tray Arm
• Compressor Module (CPA) (Anterior Only)
• Posterior Compressor Module (PCM) (Posterior/Combined Only)
• Posterior Illumination Module (PIM) (Posterior/Combined Only)
• Power Module with Battery Backup (BPS) or Power Supply without Battery Backup (SPS)
• IV Pole (MIV)
• IV Pole Controller (EIV)
• Green Laser Module (GLM)
• Standard Foot Control (WFC)
• Integrated Foot Control (IFC
• Foot Control Receiver (WFR)
• Wireless Remote (REM)
• Multimedia Center (MMC) (optional accessory)
• TruLink® Customer Support Network (Device Relationship Management, DRM)
• Additional surgical functions as they become available

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Stellaris Front Stellaris Rear * Optional

Stellaris PC Front Stellaris PC Rear

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Figure 1.1. Stellaris PC Front Detail.

1.9.1 User Interface Computer (UIC)

The User Interface Computer (UIC) is the interface for user control of the
Bausch + Lomb Stellaris Vision Enhancement System. The UIC contains a
main baseboard with on-board audio and video, a CPU running at 1.6 GHz, 1 or
2 gigabyte of RAM, a 40 or 80 gigabyte hard drive, a multimedia kit and two
USB ports (on the back) for inserting memory sticks, for storing and recalling
physician settings, and connecting a keyboard. The display contains an 18” or
19" LCD/CCFL or 19" LCD/LED monitor, a touch screen, an infrared remote
receiver and Graphical User Interface (GUI). The display console includes a flat
panel color display which has a tilt angle of ± 15 degrees for operation and can
be positioned to 90 degrees horizontal for shipping, an analog touch screen, and
remote receiver and decoding circuitry for wireless remote. The audio portion of the UIC provides warning
messages, alarms, and other audio indications; the volume is adjustable using the touch screen. System status
and operational conditions are reported on the display and optionally, announced to the user via voice
confirmation through the speakers. The UIC also provides an optional picture-in-picture streaming video
image from the surgical microscope through the Multimedia center (MMC). The UIC communicates to the
EMB and modules within the system through the CAN (Controller Area Network) Bus interface. The UIC
provides local service or remote service access to the system through the TruLink® Customer Support
Network which allows Bausch + Lomb Global Product Support to query the system and access diagnostic
information from all connected modules. This function may be through a direct local connection to a service
technician’s laptop computer or remotely via the Internet.

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Original UIC Rear New UIC Rear

1.9.2 Graphical User Interface (GUI)

The Graphical User Interface is a user friendly interface designed to give the user flexibility in use and
assistance in rectifying problems.

Values for variable parameters such as Vit cut rate are entered on “Spin Buttons”. Pressing
the up or down arrows above and below the button increment or decrement the value shown
on the button.

Exact values can be quickly entered by touching the value to bring up a numeric keypad (shown below). A
keyboard is also available when alphabetical characters need to be entered (shown below). The touch screen
makes these procedures easy and straightforward.

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In addition to Spin Buttons, “Slide Displays and Controls” are available. Markers show the
minimum and maximum setting, and a slider shows the current actual settings. By grabbing and
sliding the slide ring the actual value can be changed.

For features without values that simply require activation such as cassette eject, “Pushbar”
buttons are used. The Pushbar’s function is displayed on the bar. A “+” next to the
function indicates that more options are available for that function.

“Progress Bars” show a graphical representation of the progress of a procedure.

Users will be alerted to errors and warning messages via pop-up


displays. The displays will feature pictorial animations and
suggested actions to fix problems; for example a phaco handpiece
error may advise the user to check the handpiece connection and
visually show how to do that.

“More Screens” show more settings available for a selected function. More screens are available
for the following sections: A/V, Case Display, U/S, Coagulation, Vit, Footpedal, and Fluidics, and
are accessed by pressing the more button on that section of the screen.

The “Clock Menu” allows easy access up to 12 different functions.


These can be customized by the user. If an MMC is used, the video
will also be displayed in the center of this menu.

There are 2 levels of complexity for the controls that the user can
select. Level 1 shows only the most basic controls, including spin
buttons and the clock menu. Level 2 adds slide controls and
displays.

On start-up the surgeon will select their name to access their custom,
saved parameters. If desired, the surgeon can select the operating
room in which the Bausch + Lomb Stellaris Vision Enhancement System will be used, or specific case
parameters. Bausch + Lomb Stellaris Vision Enhancement System will guide the surgeon through the system
setup by highlighting the next step in the setup procedure, which includes setting up the proper fluid collection
system and connecting accessories.

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1.9.3 Electromechanical Base (EMB) or System Chassis

The chassis, known as the Electromechanical


Base (EMB) is the main unit, which contains the
connections for all handpieces, tray, drawer,
Ethernet connector and system housing. On the
rear of the main unit, near the IV Pole, are three
buttons that move the IV Pole up, down or back
to the preset height for the current mode of
operation. The chassis also contains the power
supply. It may contain a backup battery. The
chassis sits on four rotating castors.

On the bottom of the system chassis is the on/off


power switch.

The front two wheels can be locked in place by pressing down


on the wheel brake lever with your foot. Pulling up on the
wheel brake releases the lock.

The Stellaris PC requires an external filtered medical grade


air or medical grade nitrogen input with a pressure between
72.5 and 100 psig and a flow rate of 2.25 SCFM (64 LPM).
An input connector on the lower rear of the unit allows for
the Stellaris PC to be connected to an external medical
grade air source using the proper air input line supplied with
the system.

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The Stellaris PC lamps can be accessed by removing the


Lamp-replacement access door on the right side of the
system. Placing a coin or flat head screwdriver into the
slot on the door and turning it clockwise will allow the
door to be removed.

The Stellaris PC provides for a Zero Level Bottle Hanger


(BL4363) which allows the balanced salt solution drip
chamber to be level with the aspiration port.

1.9.4 Ultrasound Module

The Ultrasound Module contains all anterior segment electrical handpiece


connections, circuits, operating hardware and firmware (less mechanical pumps and
handpieces) needed for an anterior segment procedure. It is specifically designed to
provide ultrasound in continuous, burst, and modulated modes, bipolar coagulation,
and optional high speed electric vitrectomy. It also has open slots for the potential
upgrade of function capabilities as they become available.

1.9.4.1 Connections

This module contains connections for connecting system accessories

1.9.4.1.1 High-Speed Vitrectomy (Anterior Systems Only)

The top connection is for an optional electric vitrectomy cutter. This feature is no longer
available.

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1.9.4.1.2 Ultrasound (Phacoemulsification and Fragmentation)

The second connection is for ultrasound handpieces. This supports phacoemulsification and
fragmentation procedures in continuous, pulsed, and burst modes.

1.9.4.1.3 Coagulation

The third connection is for a coagulation handpiece which provides coagulation power in either
fixed or linear modes.

1.9.4.1.4 Laser Aperture (Laser Systems Only)

The top connector of a USL Module (Ultrasound with Laser) is used to connect an Endoprobe
or LIO fiber optic for green laser photocoagulation.

1.9.4.1.5 LIO Lamp Connector (Laser Systems Only)

The fourth connector down of a USL Module (Ultrasound with Laser) is used to connect the
lamp for an LIO+ headset.

1.9.4.2 Ultrasound Handpiece

1.9.4.2.1 Phacoemulsification Handpiece

The Phacoemulsification Handpiece is an electrically-powered hand-held instrument intended


for use in anterior segment ophthalmic surgery. It has three basic capabilities: generation of
ultrasonic energy for disruption of lens tissue, aspiration path for disrupted tissue from the eye,
and delivery of saline irrigation fluid to the eye for phacoemulsification.

The handpiece is powered by the Ultrasound Module and is controlled by the Foot Control and
GUI. It receives irrigation and aspiration lines from the fluidics cassette. The handpiece is not
backward-compatible with any previous Bausch + Lomb cataract systems. The handpiece has
a proprietary locking connector for the irrigation line to ensure that only the correct Bausch +
Lomb tubing can be used with the handpiece.

The handpiece contains an embedded memory device housed inside the handpiece connector.
Surgical data can be written to and read from the memory device and the data shall be retained
for at least ten years. Data such as phaco time, average phaco power, and tuning cycles will be
stored in the handpiece. The handpiece can be autoclaved without damage to the memory
device.

1.9.4.2.2 Fragmentation Handpiece

The Fragmentation Handpiece is an electrically-powered hand-held instrument intended for use


in posterior segment ophthalmic surgery. It has two basic capabilities: generation of ultrasonic

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energy for disruption of lens tissue and providing an aspiration path for disrupted tissue from
the eye.

The handpiece is powered by the Ultrasound Module and is controlled by the Foot Control and
GUI. It receives an aspiration line from the fluidics cassette. The handpiece is not backward
compatible with any previous Bausch + Lomb cataract systems.

The handpiece contains an embedded memory device housed inside the handpiece connector.
Surgical data can be written to and read from the memory device and the data shall be retained
for at least ten years. Data such as handpiece serial number, usage time, average power, and
tuning cycles will be stored in the handpiece. The handpiece can be autoclaved without damage
to the memory device.

1.9.5 Fluidics Function

Each system will have either an Advanced Flow Module or Vacuum Fluidics Module. Each fluidics
module has a connector for a pneumatic Vitrectomy cutter.

1.9.5.1 Advanced Flow Module (AFM) (Anterior


Only)

This module is designed for use with surgical procedures in the


Bausch + Lomb Stellaris Vision Enhancement System. It provides
both flow and vacuum control capability. Vacuum control is
accomplished by software based on the feedback from the
Aspiration Transducer, while the flow control is accomplished via
a peristaltic action displacing a known quantity of fluid per
solutions of the motor.

Included in the Advanced Flow Module (AFM) is the pneumatic Vitrectomy, the printed circuit
board, peristaltic pump, pinch valves and the transducer to monitor the vacuum levels. The module
is designed to function with a Bausch + Lomb specific disposable cartridge.

The module has three (3) color coded pneumatic connections located on the back of the module. The
connections are as follows:

• Pinch Valves – Red


• Vitrectomy – Blue
• Vitrectomy Exhaust – Green

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This module uses a peristaltic-based pump to provide flow from 1 cc/min to 60 cc/min, and vacuum
levels from 0 to 650 mmHg. It comes with irrigation and aspiration tubing and a 500 mL fluid
collection bag that fits in a drawer on the front of the Bausch + Lomb Stellaris Vision Enhancement
System. Irrigation on/off control is provided by an internal pinch valve. Vitrectomy operation is
standard, and supports both a Linear Cut Rate and a Fixed Cut Rate from 30 to 800cpm.

A CAN Network cable is routed from the User Interface Computer to the Advanced Flow Module
through the connector on the back of the module. A common power line is routed from the Power
Module to the Advanced Flow Module through the connector on the back of module. This power
line also goes to all the modules in the Bausch + Lomb Stellaris Vision Enhancement System.

1.9.5.2 Vacuum Fluidics Module (VFM) (Anterior


Only)

This module is designed for use with surgical procedures. The


module provides vacuum control. The vacuum is generated by a
rotary vane pump located in the Bausch + Lomb Stellaris Vision
Enhancement System Compressor Module and routed to the
Vacuum Fluidics Module. The vacuum control is accomplished by
the software via a transducer and bleed valve located inside the
Vacuum Fluidics Module.

The VFM includes the following: pneumatic Vitrectomy, a printed circuit board, pinch valves, fluid
level detection and a transducer to monitor the vacuum levels.

The module has four (4) color coded pneumatic connections located on the back of the module. The
connections are as follows:

• Vacuum – White
• Pinch Valves – Red
• Vitrectomy – Blue
• Vitrectomy Exhaust – Green

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The vacuum output range is from 0 to 600 mmHg and the module uses a rigid 300 mL collection
cassette with irrigation and aspiration tubing. Blue LEDs illuminate the cassette and any fluids
within the cassette and a vacuum check of the cassette is performed when it is inserted into the
module.

Irrigation on/off control venting is provided by a series of pinch valves. Vitrectomy operation is
standard, and supports both a Linear Cut Rate and a Fixed Cut Rate from 30 to 800 cpm.

A CAN Network cable is routed from the User Interface Computer to the Vacuum Fluidics Module
through the connector on the back of the module. A common power line is routed from the Power
Module to the Vacuum Fluidics Module through the connector on the back of module. This power
line also goes to all the modules in the Bausch + Lomb Stellaris Vision Enhancement System.

1.9.5.3 Posterior Fluidics Module (PFM) (Posterior/Combined Only)

This module is designed for use with surgical procedures. The


module provides vacuum control. The vacuum is generated by a
Venturi pump located in Posterior Fluidics Module. The vacuum
control is accomplished by the software via a transducer located
inside the Posterior Fluidics Module.

The PFM includes the following: pneumatic Vitrectomy, a printed


circuit board, pinch valves, fluid level detection, Cassette Housing
Assembly and a transducer to monitor the vacuum levels.

The module has four (4) color coded pneumatic connections located on the back of the module. The
connections are as follows:

• Vitrectomy – Blue
• Vitrectomy Exhaust – Green
• Pinch Valves – Red
• Air Input – Orange

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The air input from the Compressor Module is 65 psi. The vacuum output range is from 0 to 600
mmHg and the module uses a specific rigid 300 mL collection cassette with irrigation and aspiration
tubing. Blue LEDs illuminate the cassette and any fluids within the cassette and a vacuum check of
the cassette is performed when it is inserted into the module.

Irrigation on/off control venting is provided by a series of pinch valves. Vitrectomy operation
supports both a Linear Cut Rate and a Fixed Cut Rate from 30 to 5000 cpm. The Vitrectomy luer is
larger than the Vitrectomy luers on all previous Stellaris Fluidics modules. Therefore, the
Vitrectomy tubing sets from previous fluidics modules are not compatible with the Posterior
Fluidics Module. Sensing for the Vitrectomy probe present is accomplished via the Vitrectomy
Transducer which is connected to the exhaust side of the Vitrectomy valve.

The module features two aspiration ports, one for Fragmentation and the other for Vitrectomy. The
modules front panel incorporates two aspiration LEDs to indicate which port is active. The left
aspiration LED indicates Fragmentation Aspiration and the right aspiration LED indicates
Vitrectomy Aspiration.

A CAN Network cable is routed from the User Interface Computer to the Posterior Fluidics Module
through the connector on the back of the module. A common power line is routed from the Power
Module to the Posterior Fluidics Module through the connector on the back of module. This power
line also goes to all the modules in the Bausch + Lomb Stellaris Vision Enhancement System.

1.9.6 Tray Arm

The Tray Arm is located on the front of the EMB. It is a


retractable tray and arm which can be used to hold a surgeon’s
Mayo tray.

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1.9.7 Compressor Module

1.9.7.1 Compressor Module (CPA) (Anterior Only)

The Compressor Module is a non-user interface module within the system (not
externally visible) and provides all the system’s pneumatic requirements for
Cataract and Vitreoretinal surgery.

The Compressor Module contains a compressor pump and reservoirs for the
VFM and AFM module pinch valves, and the pneumatic vitrectomy output.
The Compressor module also contains a Rotary Vane pump to provide vacuum
for the VFM. The bottle infusion output is directly connected to a port in the
Bausch + Lomb Stellaris Vision Enhancement System outer skin.
Hydrophobic filters are located in the EMB in the vacuum line to prevent
balanced salt solution ingress into the Compressor Module.

The hardware level 1.0 module has eight (three small connectors are unused) color coded pneumatic
connections located on the back of the module. The three small unused connectors were removed in the
hardware level 1.1 module. The connections are as follows:

• Pressurized Infusion (optional) – Yellow


• Vacuum – White
• Pinch Valves – Red
• Vitrectomy – Blue
• Vitrectomy Exhaust – Green

A Pressurized Infusion LED connector is located on the back of the Compressor module.

A CAN Network cable is routed from the User Interface Computer to the Compressor Module through the
connector on the back of the module. A common power line is routed from the Power Module to the

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Compressor Module through the connector on the back of module. This power line also goes to all the
modules in the Bausch + Lomb Stellaris Vision Enhancement System.

1.9.7.2 Posterior Compressor Module (PCM) (Posterior and Combined Only)

The Compressor Module is a non-user interface


module within the system (not externally visible) and
provides all the system’s pneumatic requirements for
Cataract and Vitreoretinal surgery.

The Compressor Module contains a Printed Circuit


Board, Viscous Fluid Device (pump and valves), IOP
Pump and Valve Assembly, Accumulator Reservoir,
AFX/IP Directional Control, Line Pressure Filter,
regulators and shut off valves. The Compressor
module regulates external air to allow the PFM to
generate vacuum (Venturi). The bottle infusion output
is directly connected to a port in the Bausch + Lomb
Stellaris Vision Enhancement System outer skin.

The Posterior Compressor also has an Air


Accumulator Assembly in-line with the exhaust (green
tubing) for the High Speed Pneumatic Vitrectomy to
reduce noise caused by the High Speed Pneumatic Vitrectomy feature.

The module has eight (8) color coded pneumatic connections located on the back of the module. The
connections are as follows:

• Pressurized/Air Force Infusion – Yellow


• IOP/AFX – White
• Vacuum Circuit– Orange
• Viscous Fluid Device – Black
• Pinch Valves – Red

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• Vitrectomy – Blue
• Vitrectomy Exhaust – Green
• Input Air Pressure – Grey

A Pressurized Infusion LED connector is located on the back of the Compressor module.

A CAN Network cable is routed from the User Interface Computer to the Compressor Module
through the connector on the back of the module. A common power line is routed from the Power
Module to the Compressor Module through the connector on the back of module. This power line
also goes to all the modules in the Bausch + Lomb Stellaris Vision Enhancement System.

1.9.8 Posterior Illumination Module (PIM) (Posterior/Combined)

CAUTION: Do not use lamps in damp locations, in areas of high humidity, or if condensation is likely to have
formed - for example, immediately after moving from a cold location to a warm location.

CAUTION: Do not block air vents.

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Fiber optic illumination for intraocular viewing is


accomplished with the Stellaris PC Vision
Enhancement System. The system contains two
individually controlled light outputs, each with its own
lamp. The standard configuration is a xenon lamp in the
lower position (Lamp 1) and xenon-mercury lamp in the
upper position (Lamp 2), but can be configured with
either type of lamp in either position. The probe
connector contains a shutter mechanism to prevent
light leakage when the probe is not connected.

The light transmitted to the patient will have a spectral


content between 435 nm and 650 nm.

Each lamp provides slightly different illumination, and


the choice of which to use will be dependent on both
surgeon preference and procedure type. The xenon lamp
has a whiter light with a full spectrum. The xenon-
Mercury lamp has a greener light that has less blue light content than the xenon spectrum at the same
perceived light level.

Using the lower position, the user may select one of three color filters (green, yellow, amber) to tint the light
output to give improved visualization in certain circumstances.

Fluid/Air Exchange (F/AX) (Posterior Only)

The Fluid/Air Exchange function provides continuous air flow from a pneumatic pump located in the
compressor. The air output connector must be used in the posterior mode for Fluid/Air Exchange. Air is
filtered through a disposable filter. The Foot Control side button may be programmed to turn Fluid/Air
Exchange On or Off. The Fluid/Air Exchange mode provides the ability to install a pre-set air pressure into
the eye for Fluid/Air Exchange. It supports pressures up to 150 mmHg at flow rates up to 3.5 standard cubic
feet (99 liters) per hour. The air pressure from the pump may be adjusted from 0 to 150 mmHg in 1 mmHg
increments.

Viscous Fluid Control (VFC) (Posterior Only)

WARNING: THE VISCOUS FLUID CONTROL IS NOT INTENDED FOR ASPIRATION OF BALANCED
SALT SOLUTION.

The Stellaris PC Vision Enhancement System Viscous Fluid Control function generates the required injection
pressures and aspiration vacuums for injecting viscous fluids to and aspirating viscous fluids from the eye
during posterior segment surgery. The Viscous Fluid function will deliver up to 72.5 psig (500 kPa, 5.0 bar)
of pneumatic pressure to the disposable tube set. All other posterior system functions except fragmentation
and vitrectomy may be operated simultaneously or in conjunction with this function.

Viscous Injection (Oil)

When used in the injection mode, the system can inject up to 5 cc of 1000 to 5000 centistoke silicone oil @
24 °C in less than 6.25 minutes.

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1.9.9 Power Module

1.9.9.1 Power Module with Battery Backup

The Power Module provides electrical power to all of the


modules in the Bausch + Lomb Stellaris Vision Enhancement
System in the Electromechanical Base (EMB). The Power
module communicates with the UIC through the CAN Bus.

The Power Module consists of the following:

• An AC to DC power supply (+24v output ±1%).


• A short-term backup power supply.
• A mains power switch, mains input connector,
mains fusing.
• Input and output cable connection points.
• Wiring/cables between power module components.
• A connection point to a digital start-up switch.

The Power Module contains a backup power supply to


prevent short-term interruptions of power to the system. The
backup battery is located outside of the module in the rear and
may be removed for service.The backup battery requires at
least two (2) hours to fully charge before it will be effective
as a backup, and should be replaced every three (3) years.

Note: The BPS module can be used without a battery with GUI
version 4.x or higher.

Uninterruptible Operation of the Stellaris System

The backup battery is not considered an UPS (uninterruptible power supply) as it only sustains the software
(for 60 seconds) but is not sufficient to power surgical functions. If the user of the Bausch + Lomb Stellaris
Vision Enhancement System requires continued operation during power main interruptions, the system
should be powered from an uninterruptible power supply.

Stellaris and Stellaris PC system power modules manufactured after August 2009 do not have the memory
back-up battery function.

Note: In the event the power source is interrupted causing the system to shut down, remove handpiece from the eye
safely and pinch off irrigation clamp to stop fluid flowing into the cassette.

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1.9.9.2 Power Module without Battery Backup

The Power Module provides electrical power to all the modules of the Bausch + Lomb Stellaris Vision
Enhancement System in the Electromechanical Base (EMB). The Power module communicates with the UIC
through the CAN Bus.

The Power Module consists of the following:

• An AC to DC power supply (+24v output ±1%).


• A mains power switch, mains input connector, mains
fusing.
• Input and output cable connection points.
• Wiring/cables between power module components.
• A connection point to a digital start-up switch.

1.9.10 IV Pole

USE OF A NON-BAUSCH + LOMB IV POLE EXTENSION OR OTHER MEANS OF ALTERING THE


BOTTLE HEIGHT MAY CAUSE INACCURATE SETTING DISPLAYS RESULTING IN SERIOUS
PERMANENT PATIENT INJURY.

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Do not manually force the IV Pole up or down when the system is powered on, and do not ever use the IV Pole
as a handle.

Note: IV Pole adjustments may be made off-screen with the remote control.

The Bausch + Lomb Stellaris Vision Enhancement System automated IV Pole is an integral part of the
system chassis. It can be directly moved to the preset height, up, or down by pressing the buttons at the back
of the IV Pole itself.

The IV Pole height can be controlled from the touch screen, Foot Control, remote control, or through the
buttons on the back of the IV Pole itself. It can be pre-programmed to move to a certain height for each
ophthalmic mode.

The system will not compensate if an IV Pole extension or other means to alter the bottle height, is used. In
the lowest (stowed) position the IV Pole will be approximately 30 cm. (12 in.) high, measured from the
aspiration port to the middle of the balanced salt solution drip chamber. With a 500 ml bottle, this provides
an equivalent pressure (not Intraocular Pressure) of 22.4 mmHg. The IV Pole can extend to 140cm (55 in.),
for an equivalent pressure of 102.74 mmHg.

To change the settings for the current surgical mode, select the Fluidics More Screen, then select the Infusion
Tab to change the actual, preset and maximum IV Pole height.

Use the programming interface to set the desired IV Pole height for each surgical mode.

The maximum IV pole height is the highest setting the IV Pole will be allowed to reach, usually determined
by the ceiling height and set at time of system installation (through the Programming > System Setup > Rooms
> Max IV Pole Height option).

1.9.11 IV Pole Controller

The IV Pole Controller contains the circuitry to control the IV Pole function and provides
power to the IV pole motor, home switch, and manual switches as well as the CAN Bus
for communications.

The IV Pole Controller is located inside the EMB at the rear of the unit and is attached to
the Base Assembly.

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1.9.12 Foot Control

The Foot Control provides the main interface between


the user and the microsurgical system for controlling
most functions. It can be used in a wired or wireless
mode.

The surgeon can control most of the available


functions from the foot control and pedals. The Foot
Control can be connected through a physical cable, or
through a wireless Bluetooth connection. It contains
an internal, rechargeable battery.

Original Foot Control (100027047) New Foot Control (100027076)

The Foot Control can be stored on the back of the EMB on the bottom hook, as shown below. The top hooks
are used for storing the AC power cord.

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1.9.12.1 Foot Control Operation

The Foot Control has four buttons and a center pedal which has two axes of movement, so the center
pedal can control two functions simultaneously.

The center pedal operates with both the pitch (up and down) and yaw (side to side) travel. The yaw
movement simulates the side switches used on some systems, and can be set and programmable for
left-foot or right-foot users.

Reflux (if selected) is always activated by inward yaw displacement.

The center pedal may be programmed to operate two linear functions simultaneously (dual linear
control). The control of linear functions is proportional to the amount of foot pedal travel. In single
linear mode, pitch controls the linear functions selected, and yaw movement provides on/off control
in both directions. In dual linear mode, one linear function is controlled by pitch travel, and the other
linear function is controlled by yaw travel.

The first time a Foot Control is used, it must be connected via the power cable to set the
configuration. The power cable connects to the back of the Foot Control, as shown below.

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Once this is set, the Foot Control will only communicate wirelessly with that specific system. To
begin wireless operation, make sure the Bausch + Lomb Stellaris Vision Enhancement System is
on, then press and hold any foot control button for up to 10 seconds, until communication is
established.

The ready light will flash until communication is established between the Foot Control and the
Bausch + Lomb Stellaris Vision Enhancement System. It will be solid green when communication
has been established. If the Foot Control is out of range of the receiver for more than 10 minutes, it
will turn off. Pressing any button on the Foot Control for up to 10 seconds will re-establish
communication. When not in use, the Foot Control can be stored on the back of the Bausch + Lomb
Stellaris Vision Enhancement System.

In some operating configurations the surgeon can change modes using the foot control.

1.9.12.2 Power Considerations

The battery, when fully charged, will last approximately 12 hours. You may rely on a single battery,
or opt to purchase a second (BL4390) and keep one charging in the battery charger while the other
is being used.

There are two LEDs on the front of the Foot Control housing. The LED on the right indicates that
the wireless connection on the Foot Control is active. The LED on the left indicates battery status.

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The battery light indications are described in the table below.

Indicator Meaning
Green More than one hour of battery time remains
Yellow The battery is charging.

Red Less than one hour of battery life remains.

Table 1.5: Battery Light Indications.

1.9.12.3 Battery Charging Options

IMPORTANT: All U.S. personnel must comply with the U.S. Department of Transportation
(DOT) regulations regarding the shipment of Lithium batteries or equipment containing
Lithium batteries. Personnel in countries other than the United States must comply with their
local or regional regulations regarding the shipment of Lithium batteries or equipment
containing these batteries.

The Foot Control battery should be charged whenever the system is not in use. Any one of three
methods can be used to charge the battery.

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• BPS Power Module (Discontinued)


If the Bausch + Lomb Stellaris Vision Enhancement System is plugged in to an electrical
source and the main power switch at the bottom rear of the system is on, the Foot Control can
be connected via a cable to the connector on the bottom rear of the machine, and the battery
will charge as long as the unit is fully powered up.
• SPS Power Module
If the Bausch + Lomb Stellaris Vision Enhancement System is plugged in to an electrical
source and the main power switch at the bottom rear of the system is on, the Foot Control can
be connected via a cable to the connector on the bottom rear of the machine, and the battery
will charge.
• The Foot Control can be directly connected to the wall charger. Plug the cable from the wall
charger into the back of the foot control, into the same receptacle used for the wired connection
to the Bausch + Lomb Stellaris Vision Enhancement System.
• With an optional extra battery and battery charging cradle, you can connect the wall charger
cable to the battery charging cradle. The lights on the cradle will indicate when the battery is
fully charged. Once the battery is fully charged, you can take it out of the cradle and replace the
battery in the Foot Control.

When the Foot Control is connected to the wall charger or in the battery charging cradle it will not communicate
with the system and cannot be used in surgery.

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1.9.12.4 Foot Control Connection Status

The status of the Foot Control operation is represented by icons displayed at the lower portion of the
screen above the foot pedal activation status indicator. Wired connectivity is represented with a cable
icon and the wireless connectivity is indicated with a signal strength meter icon. See table below.

Display
Foot Control Setup Status Action
Type

Wired or Wireless System detecting wired Foot Control No action required

Check foot controller


cable connection. If
Wireless System Setup
is on “enabled,”
wireless connection
System NOT detecting wired will be activated
connection. momentarily when
Wired (Wireless disabled)
Possible cause: system detects loss
Foot controller cable not connected of
wired connection. The
wireless signal
strength icon will be
displayed indicating
system is now in
wireless operation.
1. Initiate wireless foot
controller connectivity
System NOT detecting wireless by pressing one of the
connection signal foot control buttons
Possible cause: momentarily, the left
Wireless 1. Foot Controller wireless function LED will light up.
has not been activated. 2. Check battery if foot
2. Wireless connectivity not controller wireless
functioning due to battery issue. function not
established after
Step 1.
Table 1.6: Foot Control Wireless Connection Status.

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Display
Foot Control Setup Status Action
Type

System detecting Excellent signal


Wireless No action required.
strength

Wireless System detecting Good signal strength No action required.

System detecting Moderate signal


Wireless No action required.
strength

Wireless System detecting Low signal strength No action required.

Table 1.6: Foot Control Wireless Connection Status.

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Display
Foot Control Setup Status Action
Type

Connect foot controller


System lost wireless connection signal backup cable to
during procedure. System will resume operation.
automatically configure to wired Note: System will
operation. remain in wired
Wireless (System disabled
The icon remains until connected with configuration the next
wireless setup)
foot controller cable or manually re- time system is
configures system to wireless powered up. To
configuration. configure system to
wireless operation, see
Operator Manual.

Table 1.6: Foot Control Wireless Connection Status.

Depending on the software level of the system, you may see the icons shown in the table below.

Foot Control
Display Type Status Action
Setup

Wired System detecting wired


No action required
(wireless disabled) Foot Control

Check Foot Control cable


connection.
If Wireless System Setup
is on “enabled,” wireless
System NOTE detecting
connection will be
wired connection.
Wired activated momentarily
Possible cause:
(wireless disabled) when system detects loss
Foot Control cable not
of wired connection. The
connected
wireless signal strength
icon will be displayed
indicating system is now
in wireless operation.

Table 1.7: Foot Control Wireless Connection Status.

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Foot Control
Display Type Status Action
Setup

System NOT detecting 1. Initiate wireless Foot


wireless connection Control connectivity by
signal. pressing one of the foot
Possible cause: control buttons
1. Foot Control wireless momentarily, the left
Wireless
function has not been LED will light up.
activated. 2. Check battery if Foot
2. Wireless connectivity Control wireless function
note functioning due to is not established after
battery issue. Step 1.

System detecting
Wireless No action required
Excellent signal strength

System detecting Good


Wireless No action required
signal strength

System detecting
Wireless No action required
Moderate signal strength

System detecting Low


Wireless No action required
signal strength

Table 1.7: Foot Control Wireless Connection Status.

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Foot Control
Display Type Status Action
Setup

Connect Foot Control


System lost wireless
backup cable to resume
connection signal during
operation.
procedure. System will
automatically configure
Wireless (System Note: System will remain
to wired operation. The
disabled wireless in wired configuration the
icon remains until
setup) next time system is
connected with Foot
powered up. To configure
Control cable to manually
system to wireless
re-configured system to
operation, see Operator
wireless configuration.
Manual.

Table 1.7: Foot Control Wireless Connection Status.

System will remain in wired configuration the next time it is powered up. To configure the system for wireless
operation, see System Setup Instructions.

Irrigation will be turned ON and other functions will be disabled when the system does not detect foot control
connectivity in surgical mode. Irrigation can be turned OFF from the touch screen.

1.9.12.5 Primary (Integrated) Foot Control

In 2014, Bausch + Lomb introduced the Primary (Integrated) Foot Control for use with the Bausch + Lomb Stellaris
Vision Enhancement Systems.

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Figure 1.2. Top of Primary (Integrated) Foot Control.


1. Left Toe Button. 2. Foot Pedal. 3. Right Toe Button. 4. Wireless Indicator. 5. Battery Indicator.
6. Right Heel Button. 7. Laser Button Cover. 8. Left Heel Button.

Figure 1.3. Back of Primary (Integrated) Foot Control.


1. Pedal Pitch Tension Adjustment Knob. 2. Backup Power Cord Connection.

It requires use of version 4.0 (or higher) GUI software on the UIC/UPC.

The Primary (Integrated) Foot Control contains a laser firing switch and door.

The Standard foot Control is similar to the Primary (Integrated) Foot Control, but without the laser firing switch and
door. The foot control charger and battery are interchangeable.

Figure 1.4. Primary (Integrated) Foot Control and Standard Foot Control.

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1.9.13 Foot Control Interface Board (FCIB)

The FCIB contains the Bluetooth module for wireless communication between the Foot Control Module and the
Bausch + Lomb Stellaris Vision Enhancement System. It communications with the UIC through the CAN BUS.

Old FCIB (100027048) New FCIB (100027077)

1.9.14 Wireless Remote

The Remote Control is not waterproof and cannot be sterilized. The remote control must be placed in a sterile
drape Bausch + Lomb prior to use in the sterile field.

Rechargeable batteries should not be used in the Remote.

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The Remote transmits an infrared signal to the UIC,


which then activates the appropriate touch screen
command. The Remote is designed to work from the
Mayo Tray up to 90 degrees to the right or left of the
IR receiver, which is located at the bottom of the
touch screen. The commands which may be given
from the Remote and its button locations are shown
in the figure below. The buttons are color coded to
correspond with the GUI and use international
symbols or icons to represent the button function.

The Remote uses two (2) standard AA Alkaline


batteries. When the batteries are first inserted into the
Remote a three second lamp (LED) test is performed,
after three seconds all LEDs will extinguish. The
minimum fresh battery life while the Remote is in the
stand-by or sleep mode is 6 months; however this
should be considerably longer, dependent upon use.

The Remote features a Low Battery LED (amber)


which will illuminate when the voltage of the batteries reaches 2.2v. The Remote will continue to work until
the battery voltage reaches 1.8 V. A Transmission LED (green) will flash when the Remote is transmitting a
signal to the IR receiver.

The Remote features mechanical reverse battery protection to prevent accidental damage. The positive
contact inside the Remote is recessed and will not touch the negative side of the battery should a battery be
reversed. The printed circuit board (PCB) also contains electrical reverse battery protection.

The Remote also has a backlit keypad which illuminates for a period of five (5) seconds, when a key is
pressed.

The Remote is not waterproof, but is splash and spill resistant. The battery compartment is not sealed against
potential fluid ingress.

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1.9.15 Multimedia Center (MMC)

The MMC is an optional accessory that


provides streaming video and microscope
overlay capability. The MMC supports
NTSC and PAL format composite video and
S-video, or a Firewire digital connection.
Plug your microscope camera into the MMC,
and the output can be sent to either a video
monitor or to a VCR for archiving. Data is
transferred from the MMC to the Bausch +
Lomb Stellaris Vision Enhancement System
through an Ethernet cable that runs from the
back of the MMC system to the Ethernet port
on the bottom of the Bausch + Lomb
Stellaris Vision Enhancement System.
Whenever the MMC is on and connected,
and the Bausch + Lomb Stellaris Vision
Enhancement System is in surgical mode,
the current video image will appear on
screen in the center of the Clock Menu. Select the video itself to toggle between small and large display sizes,
or select the edge of the video to display an animation showing the effect of the handpiece on the eye for the
current surgical phase. The MMC also has an Ethernet port on the back that allows you to connect it to your
facility’s network connection for TruLink® Customer Support Network.

1.9.16 TruLink® Customer Support Network

TruLink®Customer Support Network, the DRM feature, provides optimum system reliability by supporting
remote diagnostics and performance analysis. System performance data, but no patient data, is collected by
the Bausch + Lomb Stellaris Vision Enhancement System throughout the surgical day. Upon system shut
down, that information can be sent to Bausch + Lomb secure servers through an encrypted, point to point
connection. This allows Bausch + Lomb to analyze system performance, and proactively service the system.

The Ethernet cable that is used to transfer the data can be permanently connected to the Bausch + Lomb
Stellaris Vision Enhancement System, or it can be connected at the end of each surgical day just before
shutting down, and then disconnected to move or store the Bausch + Lomb Stellaris Vision Enhancement
System.

TruLink® Customer Support Network features include the following:

• Pre-emptive System Maintenance


• Reduce system down time
• Enhanced Service and Application support
• Improved Inventory Management

The TruLink® Customer Support Network agent will reside on the UIC. If an MMC is present the MMC will
be accessed through the UIC. The agent will start only in service mode and when the user explicitly starts it.
In most cases, this will be done at shutdown at the end of the day. Data will be collected from the Windows

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log file and the Bausch + Lomb Stellaris Vision Enhancement System log file. DRM will also offer the ability
for remote desktop management.

An Ethernet cable will connect the customer’s Bausch + Lomb Stellaris Vision Enhancement System to the
facility’s network through a firewall to the internet. The agent will be pointed to the enterprise server located
in Rochester, New York. Data will be transferred through a secured connection. No patient data will be
transferred.

The information can be used for custom reports for sales and marketing and for scheduling preventive
maintenance. Updates can be performed without a field service call being made.

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Chapter 2 - Precautions and Warnings

2 Precautions and Warnings

This manual contains several notes, cautions, and warnings. All notes, cautions, and warnings must be read,
understood and followed. Failure to comply with all notes, cautions, and warnings may result in serious personal
injury and/or equipment damage and may void any equipment warranty.

2.1 Danger, Warning and Caution

EXPLOSION HAZARD. DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS,


DISINFECTANTS, AEROSOL SPRAYS, OR IN AN OXYGEN RICH ATMOSPHERE.

DO NOT USE THE BIPOLAR OR CAUTERY MODULE IN THE PRESENCE OF FLAMMABLE


ANESTHETICS.

DO NOT CONDUCT SURGERY OR ANY PATIENT PROCEDURES WHILE REMOTE ACCESS IS


ACTIVATED. SERIOUS PATIENT INJURY MAY OCCUR.

IMPLANTABLE DEFIBRILLATORS PRESENT A RISK OF INJURY IF TRIGGERED BY A FIBRILLATORY


EVENT DURING ULTRASOUND HANDPIECE TESTING. SERVICE PERSONNEL PLANNING TO TEST
ULTRASOUND HANDPIECES 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.

MANUFACTURERS OF IMPLANTABLE DEFIBRILLATORS RECOMMEND THAT THESE DEVICES BE


TEMPORARILY DISABLED WHEN USING BIPOLAR CAUTERY EQUIPMENT. THE SERVICE PERSON
SHOULD CONSULT THE MANUFACTURER FOR APPROPRIATE ACTIONS.

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 MICRO-SURGICAL
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.

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DO NOT ADD OR REMOVE ANY MODULES WITH THE SYSTEM PLUGGED IN. DOING SO CREATES
ELECTRIC SHOCK HAZARD.

USE ONLY HANDPIECES, CABLES, AND ACCESSORIES DESIGNATED BY BAUSCH + LOMB FOR USE
WITH THIS SYSTEM.

THIS SYSTEM SHOULD ONLY BE OPERATED BY PERSONNEL WHO HAVE BEEN TRAINED AND
QUALIFIED TO USE THIS SYSTEM.

USE OF AN IV POLE EXTENSION OR OTHER MEANS OF ALTERING THE BOTTLE HEIGHT MAY
CAUSE INACCURATE SETTING DISPLAYS.

KEEP HANDS AND FINGERS CLEAR OF THE DRAWER WHEN CLOSING OR OPENING THE DRAWER.

A LOOSE NEEDLE MAY LEAD TO IMPROPER TUNING.

USE ONLY BIPOLAR HANDPIECES AND CABLES DESIGNATED BY BAUSCH + LOMB FOR USE WITH
THIS SYSTEM.

REFLUX IS NOT AVAILABLE IN THE LINEAR CUT-LINEAR VACUUM MODE.

THE VISCOUS FLUID MODULE IS NOT INTENDED FOR ASPIRATION OF BALANCED SALT SOLUTION.

INSPECT MOVEABLE FILTER PERIODICALLY BEFORE USE TO ASSURE THERE ARE NO SCRATCHES
OR OTHER DAMAGE, AND THAT IT IS OPERATING PROPERLY.

CARELESS HANDLING OF THE FIBEROPTIC CABLE, SUCH AS IMPROPERLY INSERTING OR


SECURING THE CONNECTOR, OR SHARPLY BENDING THE CABLE, MAY CAUSE DAMAGE TO THE
CABLE AND/OR THE DELIVERY SYSTEM WHICH COULD RESULT IN SERIOUS PERMANENT PATIENT
OR USER INJURY.

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Chapter 2 - Precautions and Warnings

DISCONNECT AC POWER BEFORE CLEANING THE SKIN.

THE COAGULATION ACCESSORIES SHOULD NOT BE STERILIZED USING A COLD SOAKING


SOLUTION.

ALLOW 20 MINUTES FOR THE HANDPIECE TO COOL AFTER STERILIZATION BEFORE IT IS USED.

ALL EXTERNAL WIRING MUST BE IN ACCORDANCE WITH LOCAL ELECTRICAL CODE


REQUIREMENTS AND NEC CLASS II SIGNALING SYSTEM TWISTED WIRE WITH OUTER SHIELD. THE
WIRE LENGTH MUST NOT EXCEED 20 METERS (60 FEET). THE WIRE GAGE MUST BE 26 AWG TO 12
AWG GAGE, WITH ENDS STRIPPED FROM 9 MM TO 10 MM (3/8 INCH). AT NO POINT SHOULD THE
WIRE BE UNTWISTED MORE THAN 5 CM (2 INCHES).

ALWAYS FOLLOW LOCAL GOVERNING ORDINANCES AND RECYCLING PLANS REGARDING


DISPOSAL OR RECYCLING OF DEVICE COMPONENTS.

ELECTROMAGNETIC INTERACTION BETWEEN THE PHACOEMULSIFICATION OR


PHACOFRAGMENTATION HANDPIECES AND AN IMPLANTED CARDIAC PACEMAKER IS UNLIKELY,
BUT CANNOT BE RULED OUT. PATIENTS SHOULD BE QUESTIONED TO DETERMINE IF THEY HAVE
SUCH AN IMPLANT AND, IF SO, THE MANUFACTURER OF THE IMPLANT SHOULD BE CONSULTED
TO DETERMINE THE PROPER COURSE OF ACTION.

IT IS NOT SAFE TO TRANSPORT THE STELLARIS WITH THE IV POLE AND TRAY EXTENDED ON
INCLINES OF MORE THAN 5 DEGREES.

ALWAYS TURN OFF THE POWER SUPPLY BEFORE ATTEMPTING TO REPLACE THE LAMPS TO
AVOID DANGER OF BURNS, ELECTRIC SHOCK AND EYE DAMAGE FROM ARC LIGHT.

THE LIGHT EMITTED FROM THIS INSTRUMENT IS POTENTIALLY HAZARDOUS. AVOID


CONCENTRATING THE ILLUMINATION OUTPUT ON A SMALL AREA OF THE RETINA FOR
PROLONGED PERIODS OF TIME DUE TO THE POTENTIAL FOR PHOTORETINITIS AND SERIOUS
PERMANENT PATIENT INJURY. SET THE ILLUMINATION LEVEL TO THE MINIMUM NEEDED TO
PERFORM THE SURGICAL PROCEDURE.

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Chapter 2 - Precautions and Warnings

WEAR EYE PROTECTION WHEN INSTALLING OR REMOVING LAMPS.

DO NOT TOUCH THE GLASS OF THE LAMPS. HOLD THE LAMP ONLY BY THE OUTER METAL
HOUSING.

DO NOT DROP, SCRATCH, OR APPLY FORCE TO LAMP, AS THE HIGH PRESSURE INSIDE MAY CAUSE
THE LAMP TO RUPTURE.

RISK OF ARC EXPOSURE WHILE LAMP ON IF LAMP DOOR IS NOT PROPERLY SECURED.

Never turn the power switch off or disconnect the power without proper system shutdown. Equipment damage
can occur.

Never place an irrigation bottle or any other containers of liquid on the computer unit.

Do not manually force the IV Pole up or down when the system is powered on, and do not ever use the IV Pole
as a handle.

The Remote Controls are not waterproof and are not sterilizable. The Remote Controls must be placed in a
sterile cover prior to use in the sterile field.

Do not touch the handpiece needle at any time while ultrasound power is operating.

To preserve the cabinet finish, avoid the use of abrasive cleaners. If possible, clean spots before they dry.

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Chapter 2 - Precautions and Warnings

Use only warm (30 oC to 40 oC / 85 oF to 105 oF) distilled or deionized water to flush the handpiece.

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.

All connections must be made with power turned off.

Do not put fluid or fluid containers on top of the unit. The unit is designed to allow for adjustments to the
position of the display screen. Fluid spilled when the display is repositioned could leak into circuitry and
damage the unit.

Touch the touch screen with fingers only. Use of any other object will cause permanent damage to the screen.

Do not use lamps in damp locations, in areas of high humidity, or if condensation is likely to have formed - for
example, immediately after moving from a cold location to a warm location.

Do not block Illumination air vents.

This product, like all micro-circuitry products, uses semiconductors that can be damaged by electrostatic
discharge (ESD). When handling, care must be taken to that these devices are not damaged.

2.2 Biological Hazard Warning

Accessories such as disposable packs, handpieces, and tubing will be contaminated with human tissue fragments
and bodily fluids during the surgical process. These should be handled and disposed of in accordance with current
hospital procedures.

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Chapter 2 - Precautions and Warnings

The cart, irrigation/aspiration modules and foot control may, in use, become contaminated with fluids from the
operating field and should also be treated as bio-hazardous waste.

All major components of the system should be disposed of in accordance with techniques for disposal of standard
electronic components and equipment.

2.3 Battery Disposal

Batteries such as the one used in the Foot Control must be disposed of properly.

This symbol on the battery indicates that the product must be disposed of separately and safely. Therefore, it is
your responsibility to dispose of this waste equipment by handing it over to a designated collection point or
organization that specializes in the recycling of waste electrical and electronic equipment. The separate collection
and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that
it is recycled in a manner that protects human health and the environment. For more information about where you
can drop off your waste equipment for recycling, please contact your local recycling office or electronic waste
hauler.

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Chapter 2 - Precautions and Warnings

IMPORTANT: All U.S. personnel must comply with the U.S. Department of Transportation
(DOT) regulations regarding the shipment of Lithium batteries or equipment containing
Lithium batteries. Personnel in countries other than the United States must comply with their
local or regional regulations regarding the shipment of Lithium batteries or equipment
containing these batteries.

2.4 Module Safety Precautions

The Bausch + Lomb Stellaris Vision Enhancement System includes functions that use high frequency signals for
treatment, including bipolar coagulation and pulsed phaco. As with all systems using high frequency signals,
interference may occur between the bipolar function or the pulsed phaco function and other equipment.

2.4.1 Ultrasound

• Do not apply power to the U/S handpiece unless the tip is immersed in water or balanced salt solution,
in the test chamber, or in surgical use.
• Do not use any tools or devices on the ultrasound handpiece other than tip wrenches supplied for the
U/S tips. The U/S handpiece could be damaged or metal fragments could enter the eye, causing
serious injury.
• All accessories should be regularly inspected for damage.

2.4.2 Bipolar (Cautery)

• Interference produced by the operation of the high frequency surgical equipment may adversely
influence the operation of other electronic equipment.
• The output power selected should be as low as possible for the intended purpose.
• All accessories should be regularly inspected for damage

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Chapter 2 - Precautions and Warnings

2.4.3 Advanced Flow Module

• Do not place fingers near the cartridge drawer when it is moving; doing so may result in physical
injury.

2.4.4 Posterior Illumination Module

• UV Glasses or Goggles (Edmund Optics NT55-162) must be worn during repair or testing, if the
module is going to be powered ON outside of the system.
• High Voltage (30,000V) is present when the igniter is active.
• The Bulb Assembly housing will be hot after operating. Allow the Bulb Assembly housing to cool
down before module is removed from the system.
• Be careful not to break the bulbs, broken glass from the bulbs can cause personal injury. The xenon
and mercury gases can be very harmful if contact is made.

2.4.5 Green Laser Module


• All personnel must wear adequate eye protection if they work within 4 meters of the delivery end of
the laser system while it is in ready or treat state. The NHZ for the EndoProbe as calculated per ANSI
Z136.1-2007 is 4 meters using a beam divergence half angle of 4.5 degrees, an average aversion
reflex time of 0.25 seconds, and assuming that a (worst case) 2 watt accidental boresight exposure.

• All ancillary personnel who can be exposed to a laser beam directed out of the Laser Indirect
Ophthalmoscope (LIO) must wear eye protection. The NHZ for the LIO as calculated per ANSI
Z136.1-2000 is 20 meters using an aversion reflex time of 0.25 seconds, and assuming that a (worst
case) 2 watt accidental boresight exposure.

• To adequately protect the eyes of ancillary personnel within the Nominal Hazard Zone (NHZ) from
both accidental intrabeam (boresight) viewing or long-term viewing of diffuse reflections of the
treatment beam, all personnel must wear Laser Protective Eyewear which offer a minimum OD
protection of 3.5 (EN 207 L5) or greater at the laser wavelength of 532 nm. Appropriate laser safety
eye wear is permanently identified with the protection wavelength and OD.

• Laser beams reflected from specular surfaces can harm the eyes of the physician, the patient, or
others. Any mirror or metal object which reflects the laser beam can constitute a reflection hazard.
Make sure to remove all reflection hazards near the laser, and use nonreflecting instruments whenever
possible. Be careful not to direct the laser beam at unintended objects.

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Chapter 3 - Specifications

3 Specifications

3.1 Module Cross Reference Table

Module Name S/N Prefix B+L Part Number Assembly Number


Advanced Flow Module AFM BL2120 101028118

Compressor Module Deluxe CPA BL2380 101028116

Foot Control WFC BL2390/BL2392 100027047/100027076

Integrated Laser Foot Control IFC BL2295 100027094

Foot Control Receiver (FCIB) WFR BL2391 100027048/100027077

IV Pole MIV BL2340 100027044

IV Pole Controller EIV BL2341 100027045

IV Pole Controller II EIV BL2342 100027082

Laser Head and Controller,


GLM BL2271 100027091
Stellaris PC
Multimedia Center MMC BL2300 101028109

Posterior Compressor Module PCM BL2282 101028128

Posterior Fluidics Module PFM BL2213 101028127

Posterior Illumination Module PIM BL2270 101028125

Power Module BPS/SPS BL2350/BL2351 100027065/100027075

Wireless Remote REM BL2111 101028117

Ultrasound Module USM BL2330 101028119

Ultrasound Module with HSV USV BL2331 101028111

Ultrasound Module with Laser -


USL BL2273 101028168
Stellaris PC
User Interface Computer (Metal) UIC BL2360/BL2361 101027058/102032444

User Interface Computer (Plastic) UIC BL2361 101027078

User Interface Computer (Posterior) UPC BL2362 100027079

Vacuum Fluidics Module VFM BL2310 101028112

Table 3.1: Bausch + Lomb Stellaris Vision Enhancement System Module Serial Number Cross Reference
Table

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Chapter 3 - Specifications

3.2 Environmental Specifications

Cable or Accessory Length


BL3170 Ultrasound Phaco Handpiece 84”

BL3270 Fragmentation Handpiece 84”

CX5810 High Speed Vitrectomy Handpiece 94”

BL4531US Power Cable US 180”

BL4531UK Power Cable Great Britain 180”

BL4351EUR Power Cable General Europe 180”

BL4351ITL Power Cable Italy 180”

BL4351CHI Power Cable China 98”

BL4351SWI Power Cable Switzerland 180”

BL4394 Foot Control Backup Cable 144”

S2050B Autoclavable Bipolar Cord 144”

CX9400 Bipolar Cord 144”

CX9430 Bipolar Cord with Lemo 144”

CX9404 Bipolar Cord 144”

Table 3.2: Bausch + Lomb Stellaris Vision Enhancement System Cable Length Table.

Parameter Specifications
Detachable international power cord
Universal Input (100-240 VAC, 50/60 Hz, 1000 VA)
Electrical Input Equipotential grounding stud
Fuse Set BL4352—includes (2)T 10AL, 250V
slow-blow (5 mm X 20 mm) fuses

Ambient Operating Temperature:


10° to 40° Celsius (50° to 104° Fahrenheit)
Temperature
Ambient Storage/Transport Temperature:
-20° to 60° Celsius (-4° to 140° Fahrenheit)

Operating Humidity:
30% to 70% Relative
Humidity
Storage/Transport Humidity:
10% to 98% Non-Condensing

Altitude Operates as rated up to 3,000 feet above sea level

Shock/Vibration Passes ISTA 3A and 3H

Table 3.3: Environmental Specifications

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Chapter 3 - Specifications

3.3 Physical Specifications

Parameter Specifications
122 cm (H) X 45.7 cm (W) X 45.7 cm (D)
Bausch + Lomb Stellaris Vision 48 in. (H) X 18 in. (W) X 18 in. (D)
Enhancement System 162.5 cm (64 in.) from floor to top of IV Pole
(excluding IV Pole and handle) Weight: 230 pounds (114 kg)
Recommended tray capacity: 12 pounds (5.4 kg)

Table 3.4: Physical Specifications.

3.4 Equipment Classifications

Type of Protection Against Electrical Shock Class I

Degree of Protection Against Electrical Shock Type BF

Degree of Protection Against Water Ingress Ordinary

Mode of Operation Continuous

Electromagnetic Compatibility (EMC) Class A

Table 3.5: Equipment Classification.

Recommended separation distances


between portable and mobile RF communications equipment
and the Bausch + Lomb Stellaris Vision Enhancement System
The Stellaris Vision Enhancement System is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Stellaris Vision Enhancement System as recommended below, according to the maximum output
power of the communications equipment.

Rated Separation distance according to frequency of transmitter – meters (m)


maximum
output power of 150 kHz to 80 MHz to 800 MHz to 2.5 GHz
transmitter 80 MHz 800 MHz
(W) d= 1.2 P d= 1.2 P d = 2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

Table 3.6: Recommended Separation Distance.

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Chapter 3 - Specifications

Recommended separation distances


between portable and mobile RF communications equipment
and the Bausch + Lomb Stellaris Vision Enhancement System
10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Table 3.6: Recommended Separation Distance.

Guidance and Manufacturer’s declaration – electromagnetic emissions


The Stellaris Vision Enhancement System is intended for use in the electromagnetic environment specified below.
The customer or the user should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

The Bausch + Lomb Stellaris Vision Enhancement System must emit


RF emissions
Group 2 electromagnetic energy in order to perform its intended function. Nearby
CISPR 11
electronic equipment may be affected

RF emissions
Class A
CISPR 11

Harmonic
Emissions Class A The Bausch + Lomb Stellaris Vision Enhancement System is suitable for
IEC61000-3-2 use in all establishments other than domestic establishments and those
directly connected to the public low-voltage power supply network that
Voltage supplies buildings used for domestic purposes
fluctuations /
flicker Complies
emissions
IEC 611000-3-3

Table 3.7: Guidance and Manufacturer’s declaration – electromagnetic emissions

Guidance and Manufacturer’s declaration – electromagnetic immunity


The Stellaris Vision Enhancement System is intended for use in the electromagnetic environment specified
below. The customer or the user should assure that it is used in such an environment.

Table 3.8: Guidance and Manufacturer’s declaration – electromagnetic immunity

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Chapter 3 - Specifications

Guidance and Manufacturer’s declaration – electromagnetic immunity


IEC 60601
Emissions test Compliance level Electromagnetic environment – guidance
test level

± 6 kV ± 6 kV contact
Electrostatic Floors should be wood, concrete or ceramic tile. If
contact
discharge (ESD) floors are covered with synthetic material, the
IEC 61000-4-2 relative humidity should be at least 30%.
± 8 kV air ± 8 kV air

± 2 kV for
power supply ± 2 kV for power
Electrical fast
lines supply lines Mains power quality should be that of a typical
transient / burst
± 1kV for ± 1kV for input / commercial or hospital environment.
IEC61000-4-4
input / output output lines
lines

±1kV
differential ±1kV differential
Surge mode mode Mains power quality should be that of a typical
IEC 61000-4-5 ±2 kV ±2 kV common commercial or hospital environment.
common mode
mode

5% UT (95%
dip in UT) for
0,5 cycle
40% UT 5% UT (95% dip in
Voltage dips, (60% dip in UT) for 0,5 cycle Mains power quality should be that of a typical
short UT) for 5 40% UT (60% dip in commercial or hospital environment. If the user of
interruptions and UT) for 5 cycles the Stellaris Vision Enhancement System requires
cycles
voltage 70% UT (30% dip in continued operation during power mains
70% UT
variations on interruptions, it is recommended that the Stellaris
(30% dip in UT) for 25 cycles
power supply Vision Enhancement System be powered from an
UT) for 25 <5% UT (>95% dip
input lines uninterruptible power supply or battery.
IEC 61000-4-11 cycles in UT) for 5 sec
<5% UT
(>95% dip in
UT) for 5 sec

Note: UT is the a.c. mains voltage prior to the application of the test level.

Power frequency
Power frequency magnetic fields should be at
(50/60 hz)
3 A/m 3 A/m levels characteristic of a typical location in a typical
Magnetic field
commercial or hospital environment
IEC 61000-4-8

Immunity Test IEC 60601 Compliance Electromagnetic environment - guidance

Table 3.8: Guidance and Manufacturer’s declaration – electromagnetic immunity

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Chapter 3 - Specifications

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Chapter 3 - Specifications

Guidance and Manufacturer’s declaration – electromagnetic immunity

Conducted RF 3 Vrms Portable and mobile RF


IEC 61000-4-6 150 kHz to 80 3V communications equipment
MHz should be used no closer to
any part of the Bausch +
Lomb Stellaris Vision
Enhancement System,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

Recommended Separation
distance:

d = 1.2 P (Conducted)

d = 1.2 P 80 Mhz to 800


MHz (Radiated)

d = 2.3 P 800 Mhz to 2,5


GHz (Radiated)

Where P is the maximum


output power rating of the
3 V/m
transmitter in watts (W)
Radiated RF IEC 61000-4-3 80 mHz to 2.5 3 V/m according to the transmitter
GHx manufacturer and d is the
recommended separation
distance in meters (m).

Field strengths from fixed


RF transmitters, as
determined by an
electromagnetic site
surveya, should be less than
the compliance level in each
frequency
range.b

Interference may occur in


the vicinity
of equipment marked with
the
following symbol:

Table 3.9: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.

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Chapter 3 - Specifications

Guidance and Manufacturer’s declaration – electromagnetic immunity

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Bausch + Lomb Stellaris Vision
Enhancement System is used exceeds the applicable RF compliance level above, the Bausch + Lomb Stellaris
Vision Enhancement System should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Bausch + Lomb Stellaris Vision
Enhancement System.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 3.9: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.

3.5 Primary System Specifications

3.5.1 User Interface Computer

Parameter Specification
Technology: Flat Panel, Liquid crystal display (TFT LCD) full
color
Size: 18.1" or 19” diagonal
Pixels: 1280 X 1024
Display
Physical Adjustment:
Tilt: +15° up and -10° down
Display Assembly Swivel: 90° left and 90° right
Brightness: Controlled via touch screen.

Technology: Resistive Analog


Size: Approximately 18.1" or 19” diagonal active area
Touch Screen Environmental:
Chemical resistant to cleaning solutions
Drip proof bezel

Baseboard Technology: IBM Compatible, Pentium compatible or better

Hard Drive or Solid State Drive


Computer Assembly Computer Two Audio Speakers
hardware Two USB ports
Ethernet port

Table 3.10: User Interface Computer Specifications

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Chapter 3 - Specifications

3.5.2 Ultrasound Module Specifications

3.5.2.1 High Speed Vitrectomy (Electric) Function Specifications

Parameter Specification

Single floating BF Connection


Output Power: 2.8 Watts @ approx. 10 ohms
Frequency: DC

Linear Cut Rate Mode Range: 600 to 1500 cuts per minute
Vitrectomy
Operating Parameters Control: Linear control of cut rate via the Foot Control

Fixed Cut Rate Mode Range 600 to 1500 cuts per minute
Vitrectomy
Operating Parameters Control: On/Off control of cut rate via the Footpedal

Table 3.11: High Speed Vitrectomy Function Specification

3.5.2.2 Ultrasound Function Specifications

Parameter Specification
Ultrasound Time: System records and displays ultrasound time in 0.01
second increments
Tuning: System provides one step tuning. Self adjusts to resonant
Special Features
frequency of handpiece
Probe Present: System provides a probe present detection system
Wave form ultrasound available

Connection Type: Floating BF Connection

Continuous ultrasound
Pulsed ultrasound
Fixed pulse ultrasound
Single burst ultrasound
Multiple burst ultrasound
Modes of Operation
Dual Linear Ultrasound
Linear Power, Linear Pulse ultrasound
Linear Power, Linear Duty Cycle ultrasound
Dual Linear Multiple Burst ultrasound
Variable Power Multiple Burst ultrasound
Variable Power Linear Burst ultrasound

Table 3.12: Ultrasound Function Specifications

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Chapter 3 - Specifications

Operating Parameter Specification


Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Continuous Ultrasound Mode Range: 0% to 100% power in 1% increments
Wave for Ultrasound: Disabled/Enabled (throughout)
Control: Linear power control via the footpedal

Maximum Power: 35 Watts @ approx. 900 ohms


Frequency: 28.5 kHz nominal
Pulsed Ultrasound Mode
Range: 1 to 250 pulses per second
Duty Cycle: 5 to 95% in 1% increments

Maximum Power: 35 Watts @ approx. 900 ohms


Frequency: 28.5 kHz nominal
Single Burst Ultrasound Mode
Range: 80 to 600 msec. burst width
Control: Single burst at end of pitch or yaw travel

Maximum Power: 35 Watts @ approx. 900 ohms


Frequency: 28.5 kHz nominal
Duration: 2 to 600 msec
Fixed Pulse Ultrasound Mode
Interval: 2 to 600 msec
Control: Linear power control via the footpedal. Burst duration and interval
as selected

Maximum Power: 35 Watts @ approx. 900 ohms


Frequency: 28.5 kHz nominal
Range: 2 to 600 msec. burst width
Duty Cycle: 50 to 99% in 1% increments
Multiple Burst Ultrasound Mode
Control: 1 burst at minimum duty cycle at start of linear control region.
Interval decreases until maximum duty cycle is commanded at end of linear
control region. Actual Duty Cycle Range is limited by the Burst Width
Setting.

Table 3.13: Ultrasound Operating Parameters

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Chapter 3 - Specifications

3.5.2.3 Dual Linear Ultrasound Specifications

Operating Parameter Specification

Linear Power Linear Pulse


Min Power, Max Power, Min PPS, Max PPS, Fixed Duty Cycle
Power can be on pitch or yaw (PPS on opposite)

Linear Power Linear Duty Cycle


Min Power, Max Power, Min DC, Max DC, Fixed Pulse Rate
Power can be on pitch or yaw (DC on opposite)

Dual Linear Multiple Burst


Dual Linear Ultrasound Modes Fixed Power, Min DC, Max DC, Min Duration, Max Duration
DC can be on pitch or yaw (Duration on opposite)

Variable Power Multiple Burst


Min Power, Max Power, Min DC, Max DC, Fixed Duration
Power can be on pitch or yaw (DC on opposite)

Variable Power Linear Burst


Min Power, Max Power, Min Duration, Max Duration, Fixed DC
Power can be on pitch or yaw (Duration on opposite)

Table 3.14: Dual Linear Ultrasound Specifications.

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Chapter 3 - Specifications

3.5.2.4 Bipolar (Coagulation) Specifications

Parameter Specification
Single, Floating BF Connection
Connector
Coaxial connector
Coagulation Connections United States - Banana Jack Cord, Banana Jack to Coaxial
Cords adapter
International - Reusable Coaxial Cord

Modes of Operation Linear Mode, Fixed Mode

Output Range: 7.5 Watts Nominal @ 100 ohms


Frequency: 1 MHz nominal
Maximum Peak Open Circuit Voltage = 120V
Linear Mode
Range: Programmable from 0% to 100% in 1% increments
Control: Linear control of coagulation power via
Operating Parameters the footpedal

Output Range: 7.5 Watts Nominal @ 100 ohms


Frequency: 1 MHz nominal
Fixed Control Maximum Peak Open Circuit Voltage = 120V
Range: Programmable from 0% to 100% in 1% increments
Control: On/Off control via the footpedal

Table 3.15: Bipolar (Coagulation) Specifications

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Chapter 3 - Specifications

Settings
100%
Power Out Load Setting
75% Load
50%

25%
Bipolar Power vs. Load
Power (watts)

100 200 300 400 500 600 700 800 900 1000
Load (ohms)

Maximum Possible Peak Coagulation Output Voltage at all Output Control Settings and Both Modes

Linear and Fixed Control

Peak Output (V)

Output Control Setting (%)

Figure 3.1. Coagulation Power Output

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Chapter 3 - Specifications

3.5.3 Fluidics Module

3.5.3.1 Advanced Flow Module Specifications

Parameter Specification
General Programmable vacuum response

Flow Mode
Fixed flow fixed vacuum limit
Fixed flow linear vacuum limit
Linear flow fixed vacuum limit
Modes of Operation
Linear Flow Linear Vacuum Limit
Vacuum Mode
Fixed vacuum
Linear vacuum

Flow
Aspiration I/A Mode: 0 ml/min to 60 ml/min
U/S Mode: 5 ml/min to 60 ml/min
Vit Mode: 0 ml/min to 60 ml/min
Flow Mode Operating Parameters Vacuum Limit
I/A mode: 0 mmHg to 650 mmHg
U/S: 10 mmHg to 650 mmHg
Vitrectomy: 0 mmHg to 650 mmHg
Vacuum Control: 1 mmHg increments

I/A: 0 - 600 mmHg


Vacuum Mode Operating Parameters U/S: 10 - 600 mmHg
Vit: 0 - 600 mmHg

Gravity feed from I/V bottle with On/Off


Irrigation
control provided in cassette

Table 3.16: Advanced Flow Module Specifications

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Parameter Specification
Control Activated via foot control

Reflux volume depend on operation mode


Safety
only

Modes Single, repeat or continuous


Reflux

Note: Active reflux volumes will be software controlled via reversal of Advanced Flow
Pump
Range: 30 to 800 cuts per minute in 1 cut
per minute increments
Linear Cut Rate Mode Operating Parameters
Control: Linear control of cut rate via the
footpedal
Vitrectomy
Range: 30 to 800 cuts per minute in 1 cut
per minute increments
Fixed Cut Rate Mode Operating Parameters
Control: On/Off control of cut via the
footpedal

Table 3.16: Advanced Flow Module Specifications

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3.5.3.2 Vacuum Fluidics Module Specifications

Parameter Specification
Provides Cassette Full, Near-Full and Continuous Fluid Level Sensing
General
Programmable Rise time curves

Linear control of vacuum


Modes of Operation Fixed, On/Off control of vacuum
Aspiration Dual Linear Modes: Pitch or Yaw

I/A mode: 0 mmHg to 600 mmHg


Phaco: 10 mmHg to 600 mmHg
Operating Parameters
Vitrectomy: 0 mmHg to 600 mmHg
Vacuum Control: 1 mmHg increments

Gravity feed from I/V bottle with pinch valve On/Off control via
Irrigation
footpedal

Gravity feed from I/V bottle


Reflux Control Modes: Continuous, Momentary
Activated via the foot control

Linear Cut Rate


Range: 0 to 800 cuts per minute in 1 cut per minute increments
Mode Operating
Control: Linear control of cut rate via the footpedal
Vitrectomy Parameters

Fixed Cut Rate Mode Range: 0 to 800 cuts per minute in 1 cut per minute increments
Operating Parameters Control: On/Off control of cut via the footpedal

The compressor module will provide a minimum of 600 mmHg up to 3,000 feet above sea level. A derating of
25 mmHg per 1000 ft will be used for operation above 3,000 ft.

Table 3.17: Vacuum Fluidics Module Specifications

3.5.3.3 Posterior Fluidics Module Specifications

Parameter Specification
Provides Cassette Full, Near-Full and Continuous Fluid Level Sensing
General
Programmable vacuum response curves

Linear control of vacuum


Modes of
Fixed, On/Off control of vacuum
Operation
Dual Linear Modes: Pitch or Yaw
Aspiration
I/A mode: 0 mmHg to 600 mmHg
Phaco: 10 mmHg to 600 mmHg
Operating
Vitrectomy: 0 mmHg to 600 mmHg
Parameters
Extrude: 0 mmHg to 600 mmHg
Vacuum Control: 1 mmHg increments

Gravity feed from I/V bottle with pinch valve On/Off control via Foot
Irrigation
Control

Table 3.18: Posterior Fluidics Module Specifications.

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Parameter Specification
Gravity feed from I/V bottle
Reflux Control Modes: Continuous, Pulsed
Activated via the Foot Control

Linear Cut Rate


Mode Range: 30 to 5000 cuts per minute in 1 cut per minute increments
Operating Control: Linear control of cut rate via the Foot Control
Parameters
Vitrectomy
Fixed Cut Rate
Range: 30 to 5000 cuts per minute in 1 cut per minute increments
Mode
Cut rate is derated no more than 20% above 3000 feet (915 meters) altitude.
Operating
Control: On/Off control of cut via the footpedal
Parameters

The system will provide a minimum of 600 mmHg up to 3,000 feet above sea level. A derating of 25 mmHG per
1000 ft. will be used for operation above 3,000 ft. The vacuum rise time, with an empty cassette, shall not increase
more than 25% above 1.6 seconds per 1000 feet (305 m) of altitude up to 3000 feet (915 m).

Table 3.18: Posterior Fluidics Module Specifications.

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3.5.4 Viscous Fluid Control Specifications

Parameter Specification
Injection Mode Pressure: 70 psi (482.6kPa, 4.8 bar)

Extraction Mode Vacuum: Between 5 to 600 mmHg in 10 mmHg increments

Table 3.19: Viscous Fluid Control Specifications.

3.6 Fluid Air Exchange, Pressurized & Air Force Infusion Specifications

Parameter Specification
Output 0.1 micron hydrophobic filtered air

Pressure 150 mmHg or 203 cm H2O maximum air pressure

Flow Rate Up to 4.8 standard cubic feet per hour (2.25 L/min)

Safety System includes pneumatic shut-off valve in case of power loss

Table 3.20: Fluid Air Exchange, Pressurized Infusion and Air Force Infusion Specifications.

3.6.1 Posterior Illumination Module

Parameter Specification
Modes of Operation Independent Illumination and control of either port

Lamp Type Xenon and Xenon-Mercury

Light output from a single port is minimum 25 lumens using standard


Output
20g probe

Both ports incorporate permanent filtration to reduce ultraviolet, violet,


Safety Filter
deep red and infrared light

Control 0-100% control range, 1% resolution

None, Green, Yellow, Amber


Color Filtration
(only available on Port 1 when a xenon lamp is installed)

Table 3.21: Posterior Illumination Module Specifications.

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Chapter 3 - Specifications

3.7 IV Pole Specifications

Parameter Specification
Automated
General
Provides two (2) bottle hooks

Capable of lifting two 500 ml glass bottles of balanced salt


Capacity
solution

Range of 110 cm (43.3 in.)


Travel
(30 cm. to 140 cm., 13.8 in. to 55 in. from aspiration port)

Operation Parameters Speed 10.6 cm/sec. (4 in./sec.)

Controlled via touch screen entry, remote control,


Control foot control, or directly via buttons on the back of the
system

Positioning Relative from home sensed position

Table 3.22: IV Pole Specifications

3.7.1 Foot Control Specifications

Parameter Specification
External components and housing are corrosion resistant
Watertight housing
Wireless control (10m standard range)
Corded, low voltage connection to system
General Non-skid base
4 gray colored function switches
Wall Charger
3.6v battery (lithium)
Optional battery charging cradle

12.22 cm, 4.8125 in.(H)


27.6 cm, 10.875 in. (W)
Physical
32.4 cm, 12.75 in. (L)
Weight 2.7 kg, 6 lbs.

Center pedal: pitch Linear on/off

Left On/Off (simulated)


Right On/Off (simulated)
Center pedal: yaw
Left Linear
Right Linear

Increase/decrease
Function switches On/Off
Function

Table 3.23: Foot Control Specifications

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Parameter Specification
Motion: Pitch (up/down)
Automatic return to up position
Center pedal: Pitch
Detent: (2) programmable as to position, may be enabled or disabled
Control: Provides primary linear function or on/off

Motion: Yaw (Left/Right)


Automatic return to center
Detent: (1) center detent,
Center Pedal: Yaw
Non-programmable control: Provides secondary linear function in primary yaw
direction and on/off control in secondary yaw direction, may be physically set for
greater linear movement

Motion: Momentary Push-button


Function switches Control: Provides programmable increment/decrement or on/off control of assigned
function

Table 3.23: Foot Control Specifications

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3.7.2 Remote Control Specifications

Parameter Specification
Wireless pointing device providing line of sight operation using an IR
transmitter

Provides operation up to 15 feet from display console

Powered from standard AA battery(s)


General
Low battery indicator

Transmit indicator

Splash-proof

Illuminated keys

Vacuum Level Increase/Decrease


Aspiration (ASP)
Air Consumption Increase/Decrease

Up
IV Pole
Down

Next Phase
Phase
Previous
Phase
Increment
Ultrasound Power (U/S),
Decrement
Vitrectomy, Coagulation
(shared button)

Tab Future Use

Enter Future Use

Parameter increment/decrement Future Use

Table 3.24: Remote Control Specifications

3.7.3 Multimedia Center (MMC) (optional accessory) Specifications

Parameter Specifications
Detachable international power cord
Universal Input (100-240 VAC, 50/60 Hz)
Electrical Input
75 VA rating
Fuse: Type GDC T1.0 A, 250V

Composite Video Cable RCA, male/male, 6 feet

S-Video Cable S-Video, male/male, 6 feet

Firewire Cable IEEE-1394 6P/4P 30 ANG, 6 feet

Table 3.25: Multimedia Center Specifications.

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Parameter Specifications
Ethernet Cable RJ-45, 350 MHz, 50 feet

Table 3.25: Multimedia Center Specifications.

3.7.4 Green Laser Specifications

Parameter Specification
Connector Single, Floating BF
Connector
Connection
Laser Connections Ground < 200 A 115V 60 Hz
Leakage < 300 A 230V 60 Hz
Current < 500 A 250V 60 Hz

Low Power 150 W

Electrical Power Consumption Standby 250 W

Treat 300 W

Room Interlock, Key Switch, Laser Turn-


On and emission Indicator, Emergency
Safety Interlocks
Off, Microscope Eye Safety Filter
Interlock

Internal whisper fans, operating on


Cooling
demand

Operating 100 C to 350 C (500 F to 950F)


Temperature Range
Storage: -200 C to 600 C (-40 F to 1400 F)

Operating: 30% - 70%, non-condensing


Relative Humidity
Storage: 10% - 98%

Passes IEC601-1, MIL-STD-810D, and


Shock/Vibration
ISTA Procedure 2A

LIO Mode, EndoProbe Mode, Continuous


Surgical Submodes
Endo Mode

Disabled, Stabilization, Reduced cooling,


Laser Operating Modes
Standby, Treatment, Deliver Pulse

Table 3.26: Green Laser Specifications.

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Features Description
Fixed 532nm +/- 3 nm
Treatment Laser
Treatment Laser: Diode-pumped, frequency-doubled, solid-state laser

Industry standard SMA 905 connection with delivery device detection via a
resistor in the delivery device connector
Connection located above the sterile field
Laser delivery device connector
Connector back lit to make it visible in a darkened room
Back light will be on when in a Laser Mode or when the key is turned on, and
will blink to indicate no or incorrect delivery device is connected

single shot 10 ms to 3000 ms


Endo Single Shot mode
50 to 2000 mW

Duration 10 to 3000 ms
Endo Pulsed mode Interval 10 to 3000 ms
50 to 2000 mW

Continuous mode for up to 1 minute of firing


Endo Continuous (paint ode)
50 to 500 mW

single shot 10 ms to 3000 ms


LIO single shot
50 to 1000 mW

Duration 10 to 3000 ms
LIO pulsed mode Interval 10 to 3000 ms
50 to 1000 mW

635 nm +/- Red diode laser adjustable from 0 to 0.8 mW


Aiming beam
Coincidental with treatment laser to ensure accurate targeting

Standby Mode - aiming Beam On/Off


Aiming beam modes Ready Mode - Aiming Beam On
Treatment Mode - Continuous On or On/Off during pulse treatment

Laser fire tone 2k Hz, 45 to 65 dBA adjustable

Laser firing button integrated into Bausch + Lomb Stellaris Vision


Enhancement System Primary (Integrated) Foot Control, with wired and
wireless modes of operation
All system functionality accessible from the integrated Primary (Integrated)
Foot Control
Primary (Integrated) Foot Control
Laser firing button is located under a flip up door
General purpose toe and heel buttons can be assigned laser functions
Laser power up, power down, standby / ready toggle, single/toggle, in addition
to standard functions
IPX6 rating (water and dust proof)

Table 3.27: Green Laser Features.

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Features Description
Dedicated Secondary (LIO) Foot control (wired) for laser functions only
Designed to be easily moved when using an LIO headset, but remain in place
and be stable when firing the laser
Can be used in all Laser Modes (Endo and LIO)
Secondary (LIO) Foot Control Laser power adjustment via side button, which can be programmed for Standby/
Ready toggle or Single/Repeat toggle. Default setting is for buttons to adjust
laser power - right is increase, left is decrease. Side buttons can be disabled via
the GUI.
IPX rating (water and dust proof)

Laser control, Aspiration control, Infusion control, Illumination control, all


GUI integration accessible in Endo and Continuous Submodes
Illumination is not available while in LIO mode

Preset increment and decrement values for up and down button (power duration
Laser Setting
and interval) or the ability to enter an exact setting

Laser default settings power, interval and duration by mode can be stored by the
User presets user in Bausch + Lomb Stellaris PC Vision Enhancement System surgeon
preference file

Active Laser Mode (Endo, LIO)


Active laser state (Laser Standby or Ready mode)
Audio feedback Current laser settings
Laser setting changes via either Primary (Integrated) Foot Control
Language of voice selectable

System interlock interface to a 2 position microscope filter


Connector available to adapt existing 2 position filters to system
Adapter available for backwards compatibility to Millennium 2 position filters
Movable filter interface (BL3242)
• B+L part number CX5996 IRIDEX 30494 WILD
• B+L part number CX5595 IRIDEX 30493 ZEISS
Key included with each system to be used when a fixed filter is in use

System room interlock


Room Interlock Smart key included when used in a room without a room interlock connection
Connector available to adapt existing room interlock

System interface to control a room laser safety light


Room safety light Light will be commanded on when laser key is on
Connector available to adapt existing safety interlock

Conveniently located on front of system for easy access


Two laser keys supplied
Laser Key Key on initiates system warm-up
Key On illuminates EndoProbe connection back lights (blinks until probe is
connected)

Table 3.27: Green Laser Features.

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Features Description
Conveniently located on front of system
Back lit to be clearly visible in a darkened room
Off when the laser key is off
Emergency stop button
On when the laser key is on
Blinking if the emergency stop function is active. Cycling the laser key will
clear emergency stop)

LIO lamp power connector conveniently located on front of system


Connector back lit to be clearly visible in a darkened room
LIO
System will automatically detect if an LIO device is connected
LIO power output for a 6.3 V 10 W bulb

Full line of EndoProbes in 20, 23, 25 gauge


EndoProbes Proprietary illuminating prove connects directly with Bausch + Lomb Stellaris
PC Vision Enhancement System illumination module

Microscope safety filter > 3.0 OD at 532 required

Eye protection 1 set of user goggles supplied > 3.5 OD at 532 NM

LIO Head Set Compatible with CX5970 LIO

Industry standard SMA 905 connection with LIO device detection resister
fiber >= 150 micron
System LIO compatibility 532 nm 50 to 1000 mW
requirements Laser light input 100 micron spot size with a NA of 0.08
RCA Style Illumination power connector
Illumination Power output 6.3V 10W user variable

Table 3.27: Green Laser Features.

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Chapter 3 - Specifications

3.8 System Labels

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Chapter 4 - Technical Descriptions

4 Technical Descriptions

4.1 User Interface Computer

Both the Anterior and the Posterior/Combined User Interface Computers are equivalent internally. Only the
external skins are different.

4.1.1 Screen Housing

The screen housing contains a color LCD (display), a touch screen, infrared receiver for external remote
control input, user accessible USB ports for memory devise insertion and optional keyboard connection
(located on back of housing).

The IR window is located in the bottom front of the screen housing. The receiver is angled providing visibility
of the IR remote control when handled by the user at a distance from the screen and when positioned on the
surgical tray.

The screen articulation pivot provides rotation about the vertical axis 90° ± 5° to either side of the nominal
front of the EMB. The display hinge provides articulation 15° ± 2° fore/aft with respect to vertical in normal
operation. For shipment only, a latching mechanism must be released to allow the screen to fold back 90° ± 5°.

4.1.2 Display and Touch Screen

The size of the display is 18.1” or 19” measured diagonally. It is connected to the main PCB via low-voltage
differential signaling (LVDS) to minimize radiated EMI. The display brightness (backlight) is software
controlled and variable between 20% and 100% of the maximum brightness via interaction with the
touchscreen. The backlight may be turned on an off under software control. The display with touchscreen
provides 90 degree horizontal X 90 vertical degree viewing cone. The display also provides a minimum 1280
X 1024 pixels in a horizontal (landscape) orientation. The display is capable of a minimum of 18-bit color
depth.

The touchscreen is mounted in the screen housing in front of the display and is electrically connected to the
Display Transition Board in the screen housing. The touchscreen interface emulates a normal computer
mouse. The control and encoding of the touchscreen interaction is via a chip set supplied or recommended by
the touchscreen manufacturer. The chip set interfaces with the Bausch + Lomb Stellaris Vision Enhancement
System software via drivers supplied or recommended by the touchscreen manufacturer and compatible with
the operating system software used on the UIC CPU module. The touchscreen provides a minimum of 80%
transmissivity for the display and incorporates an anti-glare surface treatment. The touchscreen controller
encodes a minimum of 256 X 256 points.

4.1.3 Display Transition Board

The transition board is located behind the display. The transition board accommodates power to and control
of the display backlight inverter, touchscreen controller/encoder, non-user accessible USB port the wireless
microphone receiver, IR remote control decoder and touchscreen controller. The transition board provides a

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Chapter 4 - Technical Descriptions

dual USB interface pass-through for connection of an external USB memory stick and/or external USB
keyboard. USB interconnections use components which support USB 2.0 standards.

4.1.4 Main Processor Housing and PCB Mounting

The processor housing is affixed to the top of the EMB chassis and does not rotate with respect to the chassis.
It contains the mechanism providing rotation in both horizontal and vertical dimensions. Necessary power and
input/out cabling between the processor PCB assembly and the display and associated inputs/outputs are
contained within the hinge with adequate bend relief for the 105-degree excursion of the display with respect
to the plane of the top of the EMB. Audio speakers are also contained within the housing. Audio power
amplifier to drive UIC speakers is connected to audio line outputs from the UIC CPU module. The main
processor housing also provides mounting for the power/stand-by switch and illumination on the front surface
of the housing. The processor main housing also provides mounting for a standard 2.5” notebook hard drive.
The general configuration of the PCB is an octagon with a 4.2” face length. The power and communication
cables exit from the right front of the computer enclosure.

4.1.5 Main CPU Module

The CPU board incorporates all video, audio and memory functions for the UIC. The CPU supports interfaces
for non-volatile memory and external PCI input/output. The clock frequency for the CPU is 1.6 GHz and the
CPU has 1 or 2 GB of RAM.

4.1.6 Main PC Board

The main PC Board contains the connectors and mounting hardware for the UIC CPU module, non-volatile
memory, system input/output (I/O) connectors, and support circuitry for the interface functions of the UIC.
Non-volatile system software storage is provided by an internal 40 or 80 GB notebook hard drive. The main
PCB uses the CPU module’s PCI interface bus for all system-specific I/O except as defined elsewhere in this
document. The main PCB provides buffered and/or isolated connections for the following CPU module I/O
interface: Ethernet connection to the external Multimedia Center (MMC) or for local/remote service/
diagnostic use through the outer skin. The Ethernet interface is electrically isolated to required standards for
patient-contact equipment. The Ethernet interface is a standard RJ-45 jack and is located in the AC Power
Entry Panel at the bottom of the EMB for connection to external 10baseT or 100baseT cabling.

Control Area Network (CAN) bus interface is used for communications among surgical and functional
modules of the system. Power pins A1 and A2 supply +24V to the UIC and power pins A3 and A4 provide
power return (ground) to the UIC. Signal Pins 1 and 3 are connected to CAN bus signal CANH and signal
pins 2 and 4 are connected to CAN bus signal CANL. Signal pin 5 is not connected. It connects to the system
communication cable from the main PCB to other surgical modules and to the IR remote control decoder. The
CAN-to PCI interface uses the design of the Softing CAN-AC1-PCI interface.

The LVDS interface incorporates EMI control circuitry adequate to meet stated requirements. The LVDS
interface has a shielded cable with a mechanical strain relief device to maintain connection integrity.

DC power is +24V with local down-regulation to voltages required for various functions. The DC power
interface is combined with the system CAN bus connector. CAN bus communications from the Power
Module will indicate whether power is currently being supplied from mains input or from the backup battery.
The battery backup for SOM CPU module will power the calendar/clock/BIOS configuration chip for a
minimum of five years under power-off conditions.

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4.1.7 Power Control Switch PCB

The power control switch PCB provides the power/stand-by control function to the Power Module. It contains
a momentary push button switch to signal transition between power and stand-by states to the Power Module.
The switch incorporates an integral actuator operated by the decorative switch button incorporated into the
front of the decorative skin. The PCB also contains four (4) green LEDs to illuminate the decorative switch
button. Control circuitry in the Power Module drives the LEDs in two distinguishable brightness states to
differentiate between operating and stand-by modes. The connector is a five (5) pin 2 mm centers latching
connector has the following signals: Pin1: Power/stand-by switch, shorts to ground when pressed, external
pull-up, Pin 2: Signal ground, Pin 3: No connection, Pin 4: Operating mode LED drive, low to illuminate
LEDs at operating mode brightness, Pin 5: +12VDC. The power control switch PCB is mounted to the front
face of the computer housing/chassis and retained using four (4) M4 threaded fasteners.

4.2 Electromechanical Base (EMB)

The EMB acts as the central frame including the outer skin through which all system modules attach or receive
power. The EMB also serves as the attachment point for all external electrical cords and fluid lines. The EMB is
of a physical size and appearance that incorporates aesthetic and ergonomic design concepts that is comfortable
for a wide variety of operators to use.

The EMB will consist of the following items:

1. An outer skin that attaches to an internal chassis and provides attachment points to external components
and access to internal modular elements.

2. Bumpers to protect the unit from damage.

3. Handle to enable movement and adjustment of position.

4. A rolling base that can be locked into place and attaches to the chassis.

5. A swivel and tilt mechanism for the attached user interface screen.

6. The housing for the user interface screen and computer.

7. The cabling assembly that supplies power, air, and communication throughout the system.

8. Backlighting of surgical connections.

9. A method of ensuring that fluids cannot directly enter internal portions of the EMB.

10. A method of ensuring that fluids cannot directly enter through electrical connections to the EMB.

11. A method of stowing the foot control and cable on the system.

12. An attachment slot for the IV pole and control board.

13. A method of stowing the power cord on the system.

14. The surgical tray, tray arm, and lift mechanism.

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15. Design for manufacturing and assembly (DFMA) techniques to select common fasteners and connectors
throughout the EMB assembly, minimize the number of parts and fasteners, employ locking features and snap
fit where applicable, and utilize locating features to simplify the assembly of parts and modules.

4.2.1 Electromechanical Base Definitions (EMB)

The Electromechanical Base (EMB) when fully assembled is defined as containing the following elements:

• Chassis
• Internal Frame and Component Mounting System.
• Base
• Wheels
• Wheel Locking System
• Outer Skins (May or may not include noise-dampening foam)
• IV Pole position switch
• IV Pole position switch located at the top rear of the EMB and protruding through the rear outer
skin.
• Power Input Panel
• Power input panel connections located at the bottom rear of the EMB
• Power input panel connections include the following:
• Main system power switch
• External AC plug connection
• (2) Power input fuses
• Ethernet connection
• Equipotential stud.
• Foot Control back-up cable connector.
• Microscope Filter Interlock connector (SPC Laser System Only)
• Room Interlock connector (SPC Laser System Only)
• Secondary (LIO) Foot Control connector (SPC Laser System Only)
• Foot Control Stowage
• Hanger on the back of the EMB to hang the foot control for stowage when not in use.
• External pneumatic connection for pressurized infusion.
• Handle
• IV Pole Attachment
• Opening for the IV Pole to extend through the outer skin
• Module to Module Electrical and Communications Cabling
• Pneumatic Tube Sets
• Surgical Tray with Tray Arm
• Accessory Drawer

4.2.2 Disassembly Scheme

The following modules shall be capable of being removed from the EMB (For reference, a Bausch + Lomb
Stellaris Vision Enhancement System Anterior System will only be configured with one Fluidics module):

• User Interface Computer (UIC)


• Ultrasound Module [USM / USV (Anterior Only) / USL (Posterior and Combined Only)]
• Vacuum Fluidics Module (VFM) (Anterior Only)
• Advanced Flow Module (AFM) (Anterior Only)

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• Posterior Fluidics Module (PFM) (Posterior and Combined Only)


• Posterior Illumination Module (PIM) (Posterior and Combined Only)
• Compressor Module (CPA) (Anterior Only)
• Posterior Compressor Module (PCM) (Posterior and Combined Only)
• Power Supply Module (BPS or SPS)
• Power Supply Battery (Select Anterior Systems Only)
• IV Pole and IV Pole Controller (MIV and EIV)
• Foot Control Interface Board Module (FCIB)
• Laser Module and PCB Control Assembly (GLM) (Posterior and Combined Only)

Disassembly of the EMB and module removal and installation shall be accomplished with a standard service
tool kit. Reference Section 8.1 of the Bausch + Lomb Stellaris Vision Enhancement System General
Technical Specification (118-006-023) for a list of items in the standard service tool kit.

4.2.3 Weight

The estimated weights of the main internal Bausch + Lomb Stellaris Vision Enhancement System modules
are listed for reference only. Refer to the module technical specifications for module weight requirements.

• Power Module (BPS) - 15 lbs.


• Power Module (SPS) - 12 lbs.
• Compressor Module - 45 lbs. (1.0 HW) and 30 lbs. (1.1 HW)
• Compressor Module (Noise Abated) - 44 lbs.
• Posterior Compressor Module - 21 lbs.
• Expansion Module - 10 lbs.
• Ultrasound Module - 10 lbs.
• Vacuum Fluidics Module - 15 lbs.
• Advanced Flow Fluidics Module - 15 lbs.
• Posterior Fluidics Module - 10 lbs.
• Posterior Illumination Module - 9 lbs.
• User Interface Computer (Metal) - 25 lbs.
• User Interface Computer (Plastic) - 20 lbs.
• IV Pole system - 17 lbs.
• Surgical tray and tray arm - 8 lbs.

Quick disconnect fastening mechanisms and fasteners as defined by the DFMA guidelines are preferred to
minimize the number and type of screws and bolts needed. Latches are permissible as long as a positive lock
is provided. The modular nature of the system is not obvious to the end user. Electrical and communication
connections are to be grouped and secured to the EMB chassis. Pressure and vacuum connections are to be
grouped and secured to the EMB chassis.

4.2.4 Damage Protection Devices

Protection devices (Bumpers, rub strips, etc.) are included on the EMB.

For reference, the protection devices may be integrated into the industrial design and may be rigid or
cushioned. Damage protection devices are placed on the widest points on each side of the EMB.

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4.2.4.1 Safety and Water Ingress Protection

EMB shall meet IEC 60529 Edition 2.1 2001 - 2002. IP rating shall be IP21C. EMB shall meet EN
60601-2-2:2001 Section 44.3 for water ingress protection of an enclosure for high frequency surgical
equipment.

4.2.4.2 Shipping Configurations

The EMB is designed to support shipment in either a horizontal or vertical configuration. For
reference only, the Bausch +Lomb Stellaris Vision Enhancement System and the Bausch + Lomb
Stellaris PC Vision Enhancement System shall be transportable for sales demonstrations.

4.2.4.3 Shock, Vibration, and Transportation

Refer to Section 6.4 of Bausch + Lomb Stellaris Vision Enhancement System General Technical
Specification (118006023) for shock, vibration, and transportation requirements.

4.2.4.4 Flammability

The EMB serves as the enclosure of the Bausch + Lomb Stellaris Vision Enhancement System and
the Bausch + Lomb Stellaris PC Vision Enhancement System. All parts that make up the enclosure
(chassis, base, and skins) shall have a minimum flammability rating of UL 94-V2.

4.2.5 General Requirements

The Bausch + Lomb Stellaris Vision Enhancement System and the Bausch + Lomb Stellaris PC Vision
Enhancement System shall be fully functional when the outer skins have been removed.

The maximum foot print of the EMB is 20 inches wide by 20 inches deep excluding the display and the
protrusion of the castors from the base. The overall height of the Bausch + Lomb Stellaris Vision
Enhancement System and the Bausch + Lomb Stellaris PC Vision Enhancement System, from the floor to the
top system work surface, is no more than 50 inches and no less than 42 inches. The height of the aspiration
port on the vacuum Fluidics module cassette is 38.5 inches from the floor. The Bausch + Lomb Stellaris
Vision Enhancement System when assembled with tray and display extended is stable when subjected to
standard 10 degree tip testing. (Reference: EN 60601-1, Section 4, Clause 24, “Stability in Normal Use
Test”.) The Bausch + Lomb Stellaris PC Vision Enhancement System, fitted with a Plastic UIC and SPS
Power Module, when assembled with tray and display extended is stable when subjected to standard 5 degree
tip testing. (Reference: EN 60601-1, Section 4, Clause 24, “Stability in Normal Use Test”.)

A symbol or recessed area for labelling of connector functions shall be located adjacent to the following
connectors on the EMB outer skins:

• Electronic high speed Vitrectomy connector


• Bi-polar connector
• Ultrasound/phaco connector
• Pneumatic Vitrectomy connector on the vacuum Fluidics module
• Pneumatic Vitrectomy connector on the advanced flow Fluidics module
• Pressurized infusion pneumatic connector
• Two expansion connectors

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All user connections will not be attached to the outer skin.

ASTM Standard D3359-02, Standard Test Methods for Measuring Adhesion by Tape Test, shall be applied
to all painted parts.

4.2.5.1 Wheels

There are four wheels attached to the system base. The wheels swivel 360°. The wheel diameter shall
be 3.5 inch to 4.5 inch. The wheel width shall be 3 inch to 3.5 inch. The swivel action of the wheels
may protrude beyond the dimensions of the bumpers. The front two wheels are capable of being
locked by a user’s foot. The wheel tread is made of an elastomeric material.

4.2.5.2 Frame and Component Mounting System

4.2.5.2.1 Frame

The Bausch + Lomb Stellaris Vision Enhancement System and the Bausch + Lomb Stellaris PC
Vision Enhancement System have an internal frame surrounded by an outer skin. The frame attaches
to the base and a component mounting system is incorporated into the frame. The component
mounting system allows modular elements to be positioned and secured within the frame. The
underside of the system shall be no more than 5 inches off the floor when attached to the wheels.
The EMB/chassis is capable of supporting the modules at the weight described above applied at the
module center of gravity with a structural safety factor of 2.0 with the system at rest. The EMB/
chassis shall support 50 lbs. applied vertically and uniformly to the secondary work surface on a
fully assembled system with the system at rest. The frame shall be resistant to corrosion or made
from material that can be treated to resist corrosion. The frame supplies attachment points for the
base, outer skin, UIC module, surgical tray arm, subsystem modules, foot control interface board
(FCIB), IV Pole Controller, and handle.

4.2.5.2.2 Component Mounting System

Note: The approximate dimensions for the main internal Bausch + Lomb Stellaris Vision Enhancement System
and the Bausch + Lomb Stellaris PC Vision Enhancement System modules are listed for reference only. Refer to
the module technical specifications for specific requirements.

The component mounting system in the frame shall accommodate the following modular elements:

• Power Supply Module - Dimensions: 14” High X 11” Wide X 5” Deep


• Battery (BPS Model Only) - Dimensions: 4.6” High X 2.7” Wide X 2.12” Deep and is
mounted to the Power Supply Module
• Compressor Module - Dimensions: 19” High X 12” Wide X 6” Deep
• Posterior Compressor - Dimensions: 17.75" High X 12" Wide “ 6.25" Deep
• Expansion Module Bay - Dimensions: 9” High X 3” Wide (front) X 10.5” Deep
• Ultrasound Module - Dimensions: 9” High X 3” Wide (front) X 10.5” Deep
• Vacuum Fluidics Module - Dimensions: 9” High X 6” Wide (front) X 12” Deep
• Posterior Fluidics Module - Dimensions: 9" High X 6" Wide (front) X 12" Deep (Same as
VFM)

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• Cassette - Vacuum Fluidics Module - Dimensions: 4” High X 1.5” Wide X 6” Deep


• Advanced Flow Fluidics Module - Dimensions: 9” High X 6” Wide (front) X 12” Deep
• Advanced Flow cartridge shall be the same size as the current Millennium Advanced Flow
System cartridge
• Posterior Illumination Module - Dimensions: 10.5" High X 2.14" Wide X 8.9" Deep
• IV Pole - dimensions: 3” X 3” footprint
• IV Pole height not to extend past secondary work surface by more than 12 inches when
pole is in the retracted position
• IV Pole Controller - Dimensions: 6” High X 5.0” Wide X 3.0” Deep
• The IV Pole Controller will be mounted to the frame near the IV Pole motor
• Foot Control Interface Board (FCIB) - Dimensions: 35 mm High X 60 mm Wide X 100 mm
Deep
The antenna for the FCIB is mounted so it points towards the front of the EMB without any
metal framework between the antenna and the plastic outer skin.

The lower half of the EMB below the tray contains the Power Supply module, Power Supply
Battery where applicable, Compressor module, IV Pole motor mount, IV Pole Controller, and
the FCIB. The module section above the tray will contain the Ultrasound module, either the
Vacuum Fluidics module, the Advanced Flow Fluidics module, or the Posterior Fluidics
module, and the Expansion bay for Anterior systems or the Posterior Illumination module for
Posterior and Combined systems. The component mounting system shall incorporate alignment
features for each module to assist insertion and removal with captive type fasteners where
permissible.

4.2.5.3 Outer Skin and Attachments

4.2.5.3.1 Outer Skin

The outer skin is attached to the frame excluding the UIC/display skins. All access door or
panels are discreet and blend into separation or design lines of the EMB. The outer skin
coloration including outer labelling or symbols will not be damaged through cleaning with IPA,
soap and water, or exposure to balanced salt solution. All seams and openings are designed to
prevent fluid intrusion without interfering with the ability to remove the skins. Exhaust
cooling vents are located on the back side of the EMB and should direct the air towards the
floor. There is one accessory drawer on the system. There is no accessory drawer on systems
that contain a Laser.

4.2.5.3.2 Vacuum Fluidics Module Decorative Skin

The Vacuum Fluidics Module decorative skin is an integral part of the outer skin and mates with
the Vacuum Fluidics Module. The Vacuum Fluidics Module decorative skin has cut-outs to
accommodate the size of the cassette and Vitrectomy cutter port. The location of the Fluidics
cut-out is in the front of the system. The pneumatic Vitrectomy cutter port will extend through
the outer skin. The pneumatic Vitrectomy cutter port will remain attached to the Fluidics module
when the outer skin front panel is removed.

4.2.5.3.3 Advanced Flow Fluidics Module Skin

The Advanced Flow Module front panel is an integral part of the outer skin and mates with the
Advanced Flow Module. The Advanced Flow Module decorative skin has cut-outs to

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Chapter 4 - Technical Descriptions

accommodate the size of the current AFS cartridge and Vitrectomy cutter port. For cartridge
dimensions, reference Millennium AFS cartridge.

The location of the AFM cutout is in the front of the system. The pneumatic Vitrectomy cutter
port is part of the main Advanced Flow Module, which extends through the outer skin. The
pneumatic Vitrectomy cutter port will remain attached to the Advanced Flow Module when the
outer skin front panel is removed.

4.2.5.3.4 Ultrasound Module Skin

The external hand piece connections to the anterior and expansion modules are through cut-outs
in the outer skin. The connectors are not attached to the outer skin. The ultrasound module
connectors are fully functional with the outer skins removed. The outer skin provides room for
a total of five individual connectors for the ultrasound module. The connectors are as follows:

Anterior System
• Coagulation (Bipolar) connector, if configured
This is an optional upgrade. The connector position will be filled with a knock out if not
included with the system.

• Ultrasound (Phaco) connector

• High Speed Vitrectomy connector, if configured


This is an optional upgrade. The connector position will be filled with a knock out if not
included with the system.

Posterior System

• Coagulation (Bipolar) connector, if configured


This is an optional upgrade. The connector position will be filled with a knock out if not
included with the system.
• Ultrasound (Phaco) connector
• Illumination 1
• Illumination 2
• Air Fluid Exchange (AFX)

• Viscous Fluid Injection (VFI)


This is an optional upgrade. The connector position will be filled with a knock out if not
included with the system.

• Laser SMA connector for EndoProbe or LIO laser fiber optic


This is part of the optional Laser upgrade. The connector position will be filled with a knock
out if not included with the system.

·RCA connector for LIO lamp voltage


This is part of the optional Laser upgrade. The connector position will be filled with a knock out
if not included with the system.

The ultrasound module also contains two dummy plugs or knockouts for future hand piece
expansion. The ultrasound module connector cutouts be between 33 and 44 inches above the
ground. Each connector cut-out on the ultrasound module panel are sized according to the

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Chapter 4 - Technical Descriptions

specified connectors in the ultrasound module. Connector center to center spacing shall be a
minimum of 1.25 inches. The location of all cut-outs are on the front of the system.

4.2.5.3.5 Stand By Start Button

The standby start button protrudes through the outer skins of the EMB. The standby start button
shall be a minimum of 36 inches above the ground.

4.2.5.3.6 Power Input

The main AC power input resides on a panel above the Base Assembly at the rear of the EMB.
The main AC power input shall include a feature to prevent accidental disconnection of the
power cord. The connection shall be located no higher than 12 inches above the ground. The
main system power switch will be located on the rear of the EMB within 6 inches from the
main AC power input.

The skin contains two (2) hooks to wrap a 15 foot 16 AWG power cord around on the back of
the system. An equipotential grounding stud is provided for customer use.

4.2.5.3.7 Ethernet Connection

The Ethernet port is located on the AC power input panel on the Base Assembly.

The vertical height of the port shall be no higher than 12 inches above the ground.

4.2.5.3.8 Foot Control Provisions

The connector between the foot control back up cable and the system is located on the rear of
the EMB base. A cable connects the foot control connector in the base assembly to the foot
control interface board (FCIB) for systems with older power supplies. The Foot Control can be
stowed on the back of the system when not in use. Stowage of the Foot Control shall be no
higher than 25 inches above the floor. The lower edge of the Foot Control does not protrude
below the lowest portion of the base.

4.2.5.3.9 Handle

The EMB contains one handle to enable movement of the system. The handle shall be placed
no lower than 32.5 inches above the ground or higher than 42 inches above the ground. The
Handle provides direct force transmission to the frame for pushing or pulling. The Handle is
capable of supporting a 200 lb. vertical or horizontal load (positive and negative) with a factor
of safety of 1.5.

4.2.5.3.10 UIC Display Articulation

The EMB will not prevent the UIC display from its range of articulation, forward and
backward about the display hinge. Also, the EMB will not prevent the UIC display from its
full range of swivel, side to side about the axis in the UIC.

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4.2.5.3.11 IV Pole Attachment

The IV pole attaches to the rear of the EMB frame. The IV Pole controller board enclosure
attaches to the EMB chassis and is not attached to the main IV Pole assembly. The EMB
provides a mechanical guide to allow connection of the IV Pole into the correct position.

4.2.5.3.12 Accessory Drawer

The accessory drawer is large enough to contain an emergency Vitrectomy pack (Refer to
Millennium Pack DP4400VP) and the wireless remote. Bausch + Lomb Stellaris Vision
Enhancement Systems with the optional Green Laser Module will not have an Accessory
Drawer.

The height of the accessory drawer above ground shall be at least 24 inches.

4.2.5.3.13 Pressurized Infusion (optional)

The pneumatic fitting for the pressurized infusion function is a standard female luer lock. The
pneumatic fitting is located within 5 inches from the IV Pole at the top rear of the EMB. A
lighted indication ring fits around the pneumatic pressurized infusion fitting. The ring will be
illuminated when the pressurized infusion surgical function is selected. The pressurized
infusion female luer lock shall be recessed or protected with a collar.

4.2.5.3.14 Electrical Cable and Pneumatic Tubing Routing

There is a primary cable harness throughout the Bausch + Lomb Stellaris Vision Enhancement
System and the Bausch + Lomb Stellaris PC Vision Enhancement System, with individual
branches as required for Power, Communication, Pressure, and Vacuum. The electrical cable
harness is attached to the system frame. Refer to the diagram below for the general cable routing
scheme.

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Chapter 4 - Technical Descriptions

Figure 4.1. Power and Pneumatic Distribution (Anterior with BPS Power Module).

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Figure 4.2. Power and Pneumatic Distribution (Anterior with SPS Power Module).

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Figure 4.3. Power and Pneumatic Distribution (Posterior) (Laser Module Not Shown)

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Figure 4.4. Green Laser Module Electrical Block Diagram

4.2.5.3.15 Power

Power into the system is routed from the power access area at the rear of the EMB directly to
the Power module via the AC mains. Individual signal connection is routed from the Power
Module to the stand by start-up switch. System power is routed per the block diagram above.

4.2.5.3.16 CAN Network Cable (Communication)

System communications shall be routed per the Block Diagram shown.

4.2.5.3.17 Pressure, Vacuum, Vitrectomy Exhaust, and Pressurized Infusion


Lines

Individual pressure, vacuum, air exchange, and Vitrectomy exhaust lines are routed from the
Compressor Module (CPA/PCM) per the block diagram shown above.

The Vitrectomy Pressure line is ¼ inch outer diameter X 1/8 inch inner diameter (Anterior) and
0.159 inch inner diameter (Posterior) and capable of handling 150 PSIG minimum. The
Vitrectomy Pressure tubing color is Blue.

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The Vitrectomy Exhaust line is 1/8 inch inner diameter (Anterior) and 0.159 inch diameter
(Posterior) and capable of handling 75 PSIG minimum. The Vitrectomy Exhaust tubing color is
Green.

The Pinch Valve/ Pressure lines are 1/8 inch inner diameter (Anterior) and 0.159 inch diameter
(Posterior) and capable of handling 150 PSIG minimum. Pinch Valve/ Pressure tubing color is
Red.

Vacuum lines are ¼ inch outer diameter X 0.170 inch inner diameter and capable of handling
700 mmHg minimum. The Vacuum line tubing color is White. (Anterior Systems Only)

Intraocular Pressure lines are ¼ inch outer diameter X 0.159 inch inner diameter and working
pressure at 75°F is 135 PSIG and has a vacuum rating of 700 mmHg. The Intraocular Pressure
line tubing color is White. (Posterior and Combined Systems Only)

The Air Input lines are ¼ inch outer diameter X 0.159 inch inner diameter and working pressure
at 75°F is 135 PSIG. The Air Input line tubing color is Orange. (Posterior and Combined
Systems Only)

The Air Fluid Exchange lines are ¼ inch outer diameter X 0.159 inch inner diameter working
pressure at 75°F is 135 PSIG. The Air Fluid Exchange tubing color is Black. (Posterior and
Combined Systems Only)

The System Pressure lines are ¼ inch outer diameter X 0.159 inch inner diameter and the
working pressure at 75°F is 135 PSIG. The System Pressure tubing color is Grey. (Posterior and
Combined Systems Only)

The Pressurized Infusion Pressure line is ¼ inch in outer diameter X 0.159 inch inner diameter
and capable of handling 75 PSIG minimum. The Pressurized Infusion Pressure line tubing color
is Yellow. The Pressurized Infusion Pressure line is routed from the Compressor Module to the
pneumatic pressurized infusion fitting on the top rear of the EMB for the purposes of
pressurized infusion (optional).

4.2.5.4 Surgical Tray

4.2.5.4.1 Positioning - Vertical Height

The height of the surgical tray is adjustable between a lower position of 32 inches above the
floor to an upper position 39 inches above the floor when fully extended. The tray/arm assembly
has a mechanism capable of initiating the height adjustment of the tray by hand. Tray height
adjustment mechanism is achievable with one hand. Movement of the tray vertically requires a
force of no more than 2.5 lb. when the mechanism is activated without any external load applied
to the top tray surface.

4.2.5.4.2 Positioning - Forward and back

The arm is capable of extending the front edge of the tray to between 27 and 29 inches from the
front of the EMB when the tray is fully extended and in its lowest vertical position. When fully
retracted, the tray and tray arm is enclosed in a recess within the EMB for transportation with
only the waste bag loop/handle protruding from the front of the EMB. The arm is capable of

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Chapter 4 - Technical Descriptions

fitting under the tray when in the retracted position. Movement of the tray horizontally requires
a force of no more than 4.5 lbs. without any external load applied to the tray surface.

4.2.5.4.3 Positioning - Side to side

When the tray arm assembly is fully extended from the EMB, it rotates a minimum of 45° to
each side about a pivot point at the base of the tray arm assembly. The rotation of the tray/arm
assembly from side to side requires a force of no more than 4.5 lbs. and no less than 2 lbs.
without any external load applied to the tray surface. The tray is capable of rotating 360°
about the end of the tray arm assembly when fully extended.

4.2.5.4.4 Physical Constraints

The surgical tray shall have a total area of between 100 and 130 square inches. The surgical tray
is removable so that it can be sterilized in an autoclave. The surgical tray is constructed from
medical grade stainless steel. The tray material is capable of maintaining its finish when cleaned
with IPA, soap and water, or in an autoclave. The surgical tray incorporates a lip around the
work surface area that is at least 0.20 inches high. The surgical tray shall accommodate a
minimum of 5 surgical instruments assumed to be 0.75” diameter and 8” long with attached
tubes. The surgical tray does not contain a recess for the remote control. The surgical tray
incorporates an adjustable waste bag loop or handle. The waste bag loop or handle shall be a
minimum of 7.5 inches wide and be capable of extending at least 8 inches, but no more than 10
inches from the front of the tray. The surgical tray arm is capable of supporting a minimum of
15 lbs. with no more than 0.75 inches deflection of the tray/arm assembly at full extension.
The surgical tray arm shall be made from or covered with non-corroding material capable of
being cleaned with IPA or soap and water.

4.2.5.4.5 Labelling

System labelling is located on the rear of the EMB. The rear side of the EMB includes a recessed
area and smooth area 2 1/16 inches wide by 5 1/16 inches tall for a label. Reference Section 10.3
of the General Technical Specification (118-006-23) for EMB/chassis labelling.

4.3 Ultrasound Module

The Ultrasound Module contains all anterior segment connections, circuits, and operating hardware and
firmware (less mechanical pumps and handpieces) needed for an anterior segment procedure. It is specifically
intended to enable ultrasound in continuous, burst, and modulated modes, bi-manual phacoemulsification,
bipolar coagulation, and high speed electric vitrectomy capability (discontinued). It is also intended to have
a total of two open slots for the potential upgrade of the anterior function capabilities as the system expands.

4.3.1 Enclosure (Chassis)

The module enclosure is constructed of 0.063” anodized aluminum sheet metal.

The module enclosure provides provisions for guarding against electromagnetic emissions. The enclosure
will include a fan capable of providing 24 CFM.

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The module has one locking electrical connector for power and I/O connections not visible to the user at the
back. The side cover is provided for accessing the circuit board.

4.3.2 Front ‘Customer’ Panel

Only the handpiece connectors will be visible to the user.

4.3.2.1 Connectors

The High Speed Vitrectomy (HSV) connector (discontinued) is RECPT 5POS ODU-MINI SNAP
or equivalent. The Coagulator connector is CONNECTOR BIPOLAR ERBE or equivalent. The
phacoemulsification connector is a LEMO P/N ECG.2B.708.CJL or equivalent. The dummy plug 1
accommodates CONN RECP 4POLE HV REAR MT C1 connector or equivalent. The dummy plug
2 accommodates CONNECTOR - FISCHER connector or equivalent.

4.3.2.2 Connector Illumination

All front panel connectors will be independently illuminated. A lighted indication ring fits around
each Ultrasound Module cutout. The ring shall be illuminated by LEDs. The connector illumination
is controlled by the software. The connector illumination blinks at rate specified in general technical
specification. The LED configuration, color, and intensity is per the specification in the general
technical specification.

4.3.2.3 Connector Configuration

The Coagulator and Phacoemulsification connectors shall be on all Ultrasound modules. The HSV
connector (discontinued) is capable of being hidden via dummy plug. There are two dummy plugs
for future expansion. There is one dummy plug that is used for the HSV or Green Laser, Dummy
Plug 1/Laser LIO, and Dummy Plug 2 connectors. The top connector and fourth connector down are
used on the Ultrasound Laser Module (USL) for the endoprobe/LIO+ and LIO+ illumination
respectively.

4.3.3 Electrical Interface

4.3.3.1 Processor

The Main PCB utilizes a Freescale MCF5282 Coldfire microprocessor as its main processor.

4.3.3.2 Processor Inputs

Discrete Pins Coagulation Activity Monitor

Electric Vitrectomy Speed Sense Phaco Overcurrent

Phaco Phase Feedback QSPI Interface

Phaco Voltage Feedback Phaco Current Feedback

Phaco Phase Feedback Phaco Boost Feedback

Table 4.1: Processor Inputs.

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4.3.3.3 Processor Outputs

Discrete Pins Watch Dog Toggle

Phaco Pulse Timer Phaco Enable

Vitrectomy Brake Vitrectomy Emergency Brake

Coagulator On Phaco Frequency Data

Phaco Frequency Clock Phaco Frequency Latch

Bipolar Activity Reset EPLD Parallel Interface

QSPI Interface Phaco Boost Command

Phaco Drive Command Electric Vitrectomy

Drive Commands

Table 4.2: Processor Outputs.

Name Address Description


D7 = Not
Used D6 =
Not Used D5
= Not Used
Control0 0x00 D4 = Not
Used D3 =
Not Used
D2 = PHACO CLEAR SHUTDOWN
(W)
D1 = CLEAR FAN MONITOR (W)
D0
D7 =
= FAN CONTROL (W)
Not Used
D6 = BIPOLAR OVERVOLT
MONITOR (R)
D5 = HSV HANDPIECE PRESENT (R)
Control1 0x01 D4 = PHACO SHUTDOWN (R)
D3 = PHACO PROBE PRESENT (R)
D2 = FAN MONITOR (R)
D1 = DUMMY PLUG 2 STATUS (R)
D0 = DUMMY PLUG 1 STATUS (R)

D7 = Not
Used D6 =
Not Used D5
= Not Used
Control2 0x02 D4 = DUMMY PLUG 2 LED (W)
D3 = DUMMY PLUG 1 LED (W)
D2 = HSV LED (W)
D1 = BIPOLAR LED (W)
D0 = PHACO LED (W)

Table 4.3: Processor Outputs.

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Name Address Description


Bipolar 0x03 BIPOLAR REGISTER (R/W)

Table 4.3: Processor Outputs.

4.3.3.4 Processor Bidirectional Input/Output

CAN Tx

CAN Rx

Phaco handpiece Clock

Phaco Handpiece Data

Board Input/Output

4.3.3.5 Power

The Main PCB is powered by a single 24VDC rail. The maximum continuous current draw is 5
Amps.

4.3.3.6 Network

The Main PCB communicates to other modules within the Bausch + Lomb Stellaris Vision
Enhancement System and the Bausch + Lomb Stellaris PC Vision Enhancement System via a CAN
(Controller Area Network) bus as defined in the System Architecture Specification.

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4.3.4 Front Panel Input/Output

4.3.4.1 Illuminated Panel Connector

Pin Function
1 LED Power (signal name ‘VCC’)
2 Laser Delivery, or Dummy Plug 3 LED Control (signal name ‘HSV
3 LED0’)
Phacoemulsification LED Control (signal name ‘HSV LED0’)
4 Coagulator LED Control (signal name ‘BIPOLAR LED0’)
5 Laser Indirect Ophthalmoscope (LIO) or Dummy Plug 1 LED Control
(signal name ‘Dummy Plug 1 LED0’)
6 Dummy Plug 2 LED Control (signal ‘Dummy Plug 2 LED0’)
7 Ground

4.3.4.2 High Speed Vitrectomy Connector

Pin Function
1 Motor Power
2 Hall Sensor Output - Open Collector

3 Hall Sensor Power and HP Detect - 1.6 mA min Quiescent Current

4 Ground

4.3.4.3 Coagulator Connector

Pin Function
1 Coagulator Out
2 Coagulator Return

4.3.4.4 Phacoemulsification Connector

Pin Function
1 Power, +5 VDC provided by Ultrasound Module for memory IC in handpiece.
2 Ground, 0 VDC provided by Ultrasound Module for memory IC in handpiece

Handpiece Probe Present, Connected internally in handpiece connector to Ground signal for
3 Ultrasound Module to detect handpiece.

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Pin Function
4 Phaco Return, Drive voltage return for piezo crystals
5 Clock, Provided by Ultrasound Module for memory IC in handpiece

6 Data, Bidirectional data transferred between Ultrasound Module and memory IC in handpiece

7 Not Used

8 Not Used

9 Phaco Out, Drive voltage out for piezo crystals

4.3.5 Fusing

All fusing on SELV power lines are be self-resetting. The 24VDC power rail has a 7 amp fuse. The High
Speed Vitrectomy motor output has a 0.5 amp fuse.

4.3.6 Electrical Safety

The Phacoemulsification, Coagulation, and High Speed Vitrectomy outputs will be EN 60101-1 class BF
floating circuits. The Phacoemulsification, Coagulation, and High Speed Vitrectomy outputs comply with EN
60601-1 section 19 for patient leakage. The Phacoemulsification, Coagulation, and High Speed Vitrectomy
outputs comply with EN 60601-1 section 20 for dielectric (Hi-Pot Test). The layout, cabling, and connectors
comply with EN 60601-1 section 57.10 for creepage and clearance. The electrical connections provide full
patient isolation.

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Figure 4.5 Stellaris and Stellaris PC Isolation Block Diagram

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Figure 4.4 Stellaris and Stellaris PC Isolation Table

4.3.7 Phacoemusification

The module phaco output/connector is not backwards compatible with the Millennium CX7000, Premiere, or
Protégé handpieces. Maximum electrical phaco power out will be at least 35W + 10% for loads between 600
to 4000 ohms across pins 4 and 9 of the connector. The phaco output maximum current will be at least 253
milliamps across pins 4 and 9 of the connector into a 600 ohm load. The phaco output maximum voltage will
be less than 240 VAC across pins 4 and 9 of the connector. The phaco over current condition results in a
hardware lockout of the phaco drive output. The phaco handpiece circuit is able to read/write data via serial
interface over pins 1, 5, 6, and 2 of the connector to memory device (Example Atmel AT24C01A or
Microchip 24LC01B) in phaco handpiece. The circuit is isolated. The memory device size is one block of 128
X 8-bit memory. The data includes model, unique serial number, and number of tuning cycles, failure
codes, accumulated phaco time, average phaco power, and factory tuning parameters. The failure code,
tuning parameters, and tuning cycle marker will be stored for the 10 most recent failures.

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Size
Name Description Read Write Address
(Bytes)
Serial Number Handpiece S/N 4 Handpiece Present Factory 0x00
Module Prefix ASCII Characters 5 Handpiece Present Factory 0x04

Module Number Binary 1 Handpiece Present Factory 0x09

Module Version Major/Minor 2 Handpiece Present Factory 0x0a

Impedance Binary 2 Handpiece Present Factory 0x0c

Phase Binary 2 Handpiece Present Factory 0x0e

Frequency Binary 2 Handpiece Present Factory 0x10

Accumulated Tuning Cycles Binary 2 Handpiece Present After Tuning* 0x12

Accumulated Phaco Time Binary (msec) 4 Handpiece Present Mode Change* 0x14

Average Phaco Power Binary 1 Handpiece Present Mode Change* 0x18

Failure Code Buffer Index Head & Tail of Error Block 1 Error Event Error Event* 0x19

Tuning Cycle Marker Binary (2 bytes / error) 20 Factory/DRM Error Event* 0x1A

Failure Code Binary (1 byte / error) 10 Factory/DRM Error Event* 0x2E

Impedance Binary (2 bytes / error) 20 Factory/DRM Error Event* 0x38

Frequency Binary (2 bytes / error) 20 Factory/DRM Error Event* 0x4C

Phase Binary (2 bytes / error) 20 Factory/DRM Error Event* 0x60

Spare Not used set to 0 10 N/A N/A 0x74

Check sum Check sum 1 On each write 0x7f

Table 4.5: Data Memory Map. * Set to Zero at Factory.

The phaco circuit detects a short across pins 2 and 3 of the connector, and provides a probe present indication.
The phaco drive frequency output range is 28,500 Hz ± 1500 Hz across pins 4 and 9 of the connector. For
reference the phaco handpiece frequency range is 28,500 Hz ± 500 Hz across pins 4 and 9 of the connector.

4.3.7.1 Module Phaco Output Control

Output power accuracy (RMS over a minimum 50 millisecond sample) is ± 10% or 0.5 watts,
whichever is larger. Output power ripple (RMS over a minimum 50 millisecond sample) is ± 10%
or 0.5 watts, whichever is larger, over 30 second duration. Rise Time capability from 10% to 90%
in continuous mode is less than 100 milliseconds. Settling Time is less than 2 seconds of total phaco
on time.

Overshoot (RMS over a minimum 25 millisecond sample) is less than 15% or 2.0 watts, whichever
is larger. The phaco phase feedback maintains the same output level from the end of one pulse until
the beginning on the next pulse. The output will not adjust during the phaco pulse off time. The pulse

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rate range shall be from 1 PPS to a minimum of 120 PPS. The minimum pulse on time shall be no
greater than 4 milliseconds. The minimum pulse off time shall be no greater than 2 milliseconds. The
duty cycle range ranges from 10% to 90% with a tolerance of ± 1% over full scale and limited by the
pulse rate, minimum pulse on time, and minimum pulse off time.

4.3.7.2 Coagulation

The bipolar output (Volt-Amps) are per the following table. The output power will not increase with
the decrease of the control setting per EN60601-2-2 section 50.1b.

Load
10% 25% 75% 100%
(ohms)
10 ± 1% 0.25 VA ± 10% 0.62 VA ± 10% 1.24 VA ± 10% 2.48 VA ± 10%
50 ± 1% 0.67 VA ± 10% 1.67 VA ± 10% 3.34 VA ± 10% 6.67 VA ± 10%

100 ± 1% 0.75 VA ± 10% 1.88 VA ± 10% 3.75 VA ± 10% 7.51 VA ± 10%

200 ± 1% 0.67 VA ± 10% 1.67 VA ± 10% 3.34 VA ± 10% 6.67 VA ± 10%

500 ± 1% 0.42 VA ± 10% 1.04 VA ± 10% 2.09 VA ± 10% 4.17 VA ± 10%

1000 ± 1% 0.25 VA ± 10% 0.62 VA ± 10% 1.24 VA ± 10% 2.48 VA ± 10%

Table 4.6: GUI Power Settings.

The bipolar output diagram is calculated with following equation.

Note that the values determined from the equation need to be within ± 20% of actual output per
EN60601-2-2 section 50.2.

The output nominal operating voltage at 100 ohm load is 32 VAC RMS or 46 V peak. The output
nominal open circuit voltage is 120 V peak.

4.3.7.3 Coagulator Timer

The timer generates an output for the power driver with two non-overlapping 180 degree out of
phase 1 MHz square waves. The timer generates a control signal with an on time that varies from 0
to 100 microseconds in 1 microsecond intervals. The timer duty cycle can be changed at any time
during output period. The timer hardware will disallow a control setting above 100%. The timer
frequency is 1 MHz ± 5%. The timer power adjust resolution is 1 count per cycle, 100 counts.

The coagulator activity monitor checks the coagulator output drive for the presence of pulses. It will
indicate any activity since the last read cycle.

The coagulator power supply voltage monitor l detects an over voltage of 10%, which will produce
a hardware lockout of the coagulator driver and provide a status bit to the computer. The coagulation

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function complies with electromagnetic compatibility per EN60601-2-2 section 36. The components
shall not overheat per EN60601-2-2 section 42.3. The output should withstand short per EN60601-
2-2 section 52.101. The output will have capacitance to block DC currents per EN60601-2-2 section
59.105.

4.3.8 High Speed Vitrectomy (Discontinued)

The High Speed vitrectomy module cut rate range is between 600 CPM to 1500 CPM with 8% accuracy. The
maximum output voltage is +16.5 ± 0.5 VDC.

The minimum motor output voltage is 13 VDC. Reference: The output is equal to the nominal projected back
EMF for the handpiece motor, plus 90% of the voltage drop across the winding resistance. The motor output
voltage is capable of delivering at least 250 mA of current at +16.5 ± 0.5 VDC. The module detects the
presence of the High Speed Vitrectomy handpiece. The module powers the hall sensor in the High Speed
Vitrectomy handpiece. The module detects the hall sensor output state in the High Speed Vitrectomy
handpiece.

4.3.8.1 Braking

Braking conditions are defined as the first transition from low to high on the Hall sensor input from
the High Speed Vitrectomy handpiece after the module receives a stop command from the footpedal.
The handpiece stops within 500 milliseconds of the occurrence of the braking conditions. The
braking circuit shorts the handpiece motor windings within 2 milliseconds of the occurrence of the
braking conditions. Although the module always stops the handpiece with the tip open, the Hall
sensor input will not necessarily be high when the handpiece is in a stopped state. The module detects
the presence or absence of a handpiece and report an error when a cut rate is commanded and no
handpiece is present. The module software monitors the handpiece cut rate as feedback from the
handpiece and report an error when the measured cut rate differs from the target cut rate by more
than 50% for more than 5 seconds. This condition is an indication of motor failure or Hall sensor
failure.

4.3.8.2 Low Power State

The Phacoemulsification output is off when in low power state. The Coagulation output is off when
in low power state. The High Speed Vitrectomy output is off when in low power state. The connector
illumination is off in low power state.

4.3.8.3 Labelling

Ultrasound Module labelling provided contains a bar code, assembly, serial number, and appropriate
regulatory markings.

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Figure 4.6. Ultrasound Electrical Block Diagram

4.4 Fluidics Modules

4.4.1 Advanced Flow Module (AFM)

This module is designed for use with anterior surgical procedures in the Bausch + Lomb Stellaris Vision
Enhancement System only. The module is capable of providing both flow and vacuum control capability.
Vacuum control is done by the software via a transducer while the flow control will be via a peristaltic action.

The AFM provides the electronics, pneumatic actuators, and mechanisms necessary to rotate the peristaltic
pump at variable speeds, monitor aspiration vacuum level, engage a disposable Bausch + Lomb peristaltic
pump cartridge, control irrigation flow, drive a Bausch + Lomb pneumatic vitrectomy cutter, and
communicate with the Bausch + Lomb Stellaris Vision Enhancement System. The AFM communicates with
the other Bausch + Lomb Stellaris Vision Enhancement System Modules via CAN bus.

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The AFM is located in the upper shelf of the EMB and is mounted to the EMB chassis using an upper and
lower mounting tab. The AFM enclosure is constructed of corrosion resistance sheet medal and also provides
EMI protection for the module. The rear of the module contains the following electrical and pneumatic one-
touch connections:

• A CAN/Power connector
• Red color coded one-touch fitting for Pinch Valves
• Blue color coded one-touch fitting for Vitrectomy Input
• Green color coded one-touch fitting for Vitrectomy Exhaust

The input air pressure tubing for the vitrectomy is ¼" O.D. X 1/8" I.D. and color coded Blue.

The air exhaust tubing for the vitrectomy is ¼" O.D. X 1/8" I.D. and color coded Green.

The exhaust tubing routes the exhaust from the internal vitrectomy valve through a connector located on the
back of the AFM.

The front of the module cartridge opening is designed to mate with the contour of the EMB exterior skins.
The AFM front panel includes a 360º green (450nm) backlit, male locking luer fitting for interfacing with the
Bausch + Lomb Vitrectomy Probe. The front cover has two parts:

• Stationary upper portion (contains a peristaltic backing plate)


• The upper plate shall not deflect by more than 0.02 inches under load of the roller head, when the
cartridge is in the drawer.
• Movable lower portion (drawer)
• The drawer shall accommodate a Bausch + Lomb Advanced Flow Cartridge.

Drawer opening and closure is be controlled by electro-pneumatic means and controlled via the CAN bus.
When commanded to close, the time required from the initial drawer motion until the pump head contacts the
backing plate shall be 2.5 to 6.0 seconds. The drawer shall close at the same rate after loss of power. Upon
drawer closure, the patient vacuum transducer is be used to detect the presence of a cartridge. The module
will assume that a cartridge is present if the pressure increase meets the minimum acceptable high pressure
point within a 99.7% confidence interval.

The drawer is designed to maintain sufficient mechanical alignment between the cartridge and the motor
mount, such that the peristaltic tubing on the cartridge will engage the peristaltic roller head and the pinch
valve plungers will clear the cartridge.

The drawer is designed to meet the pertinent safety requirements of IEC 60601-1.

4.4.1.1 Aspiration Drive

The aspiration drive mechanism consists of a rotating pump head with four rollers and mating
backing plate, integral to the upper portion of the front cover.

The drive is capable of rotating the pump head up to 500 rpm in both the clockwise and counter
clockwise directions.

For reference only, the following pump head motor speed requirements assume a 14:1 gear ratio and
the requirements of the Surgical Functions section:

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Mode Forward Speed (RPM) Reverse Speed (RPM)


Flow Mode 5280 ± 5 -10 ± 10
Reflux 0±5 -7000 ± 5

Vacuum Mode 7000 ± 5 -1000 ± 5

Table 4.7: Aspiration Drive Speeds.

The pump motor rotation rate has a rise time of less than 100ms from motor activation to initially
passing 90% of the intended final value under typical running conditions.

The drive system consists of a DC motor with integral tachometer and a motor control circuit. The
drive system uses a 12V DC motor rated at 5000 RPM. The motor is able to be overdriven
indefinitely to produce 7500 RPM.

For reference only, in actual use, the motor would be overdriven approximately 10% of the time.

The motor is coupled to the cartridge through a 14:1 gear ratio. For reference only, 113 RPM = 1 ml/
min with a gear ratio of 14:1.

The motor speed control is sufficient to maintain the pump head speed within 50 RPM of the target
value in flow mode.

The pump motor/tachometer component has the following nominal specifications:

4.4.1.2 Pinch Valves

Supply Voltage 12 VDC

Max power Output 6.8 W

No-load max RPM tolerance (not including overdrive) ± 12%

Voltage Gradient 1mV/RMP ± 2%

Table 4.8: Pump motor specifications.

Two pinch valves are required for irrigation control and fluid vent or passive and continuous reflux
control. Each pinch valve consists of a pneumatic cylinder that drives a “blade” into the pinch ports
in the cartridge and depresses the tubing, which prevents flow through a particular cartridge path.

The tip is designed to seal the tubing against the inside front face of the drawer and to minimize the
amount of fluid that is displaced. The tip is designed with no sharp corners or edges.

The Vent Pinch Valve cylinder shall deliver a minimum pinch force of 0.84 pounds (including a
safety margin of 0.5 pounds) at maximum displacement.

The Irrigation Pinch Valve cylinder shall deliver a minimum pinch force of 1.05 pounds (including
a safety margin of 0.5 pounds) at maximum displacement.

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To prevent damage to the tubing, no pinch valve shall provide a force in excess of 10 pounds.

Each cylinder shall provide sufficient force to maintain occlusion of the tubing in the presence of the
maximum allowed vacuum and irrigating solution head pressure within the cartridge.

4.4.1.3 Main Board

The Main PCB utilizes a Freescale MCF5282 Coldfire microprocessor as its main processor.

4.4.1.4 Input/Output

The Main PCB communicates to other modules within the system via a CAN (Controller Area
Network) bus as defined in the System Architecture Specification.

4.4.1.5 Fusing

• All fusing on SELV power lines are self-resetting.


• The 24VDC power rail is designed to have a 6A fuse (holding current).

4.4.1.6 Surgical Functions

4.4.1.6.1 Initialization

For reference only sequence of events for use shall be:

Event Results
Module Enabled Module is enabled on the network.
User opens drawer via button
on touchscreen Drawer opens

User inserts cartridge

Cartridge present sensor detects cartridge and


cartridge calibration begins.

User closes drawer via button If user has not inserted a cartridge,
on touchscreen no calibration occurs.
System calibrates the pressure
transducer Audio feedback: cartridge calibration complete

Customer commands system to


prime Audio feedback: Cartridge prime is complete.

Table 4.9: Sequence of Surgical Functions during initialization.

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4.4.1.6.2 Priming

Following cartridge calibration, the cartridge requires priming to remove air from the irrigation
and aspiration paths, including any attached handpiece(s) and accessories. Priming is initiated
by the user through the user interface. During priming, the system will cycle the irrigation pinch
valve and draw a vacuum within the cartridge of at least 380 mm Hg. For reference, drawing
this vacuum removes any residual "set" in the diaphragm and is a redundant check of cartridge
performance.

The priming operation removes a sufficient quantity of air such that the system meets the
following specs detailed in the Aspiration Parameters section.

•Rise time
•Post occlusion surge
•Venting and decay time requirements

The combined volumes of any air bubbles in the aspiration tubing shall not exceed 1" in length.
For reference, this volume is approximately equivalent to 33% of the anterior chamber volume
using 0.063" ID tubing. The combined volumes of any air bubbles in the irrigation tubing shall
not exceed 0.25" in length.

From selection of a cartridge priming or ultrasound handpiece tuning button on the touchscreen,
priming takes 40 seconds or less. For reference, this is based on competitive characterization
testing. Priming will successfully complete with the handpiece either held vertically with tip up
or laid horizontally on the mayo tray and priming will successfully complete when either run
individually or simultaneously with ultrasound handpiece tuning.

4.4.1.6.3 Irrigation Parameters

For reference, irrigation flow rate is controlled independently of the AFM by a gravity fed or
pressurized IV bottle or bag capable of maintaining a positive intraocular pressure. At 140 cm
above the cartridge aspiration port, the irrigation rate from the bottle through the tube set and
out the handpiece connector is at least 60 ml/min.

Irrigation on/off control (via the Irrigation Pinch Valve) is provided in all modes of use. When
power is removed from the module, the system will default to irrigation on. When engaged, the
Irrigation Pinch Valve restricts the cartridge tubing to a flow rate of 0.3 ml/min or less.

With the cartridge inserted in a module drawer, the irrigation system fluidic resistance does not
exceed 105 mmHg/(ml/s) as measured at the irrigation tube handpiece connection.

4.4.1.6.4 Aspiration Parameters

The aspiration flow rate is controllable from 1 to 60 ml/min. The flow is adjustable in 1 ml/min
increments. At aspiration rates from 1 to 30 ml/min, the accuracy shall be ± 5 ml/min. At
aspiration rates from >30 to 60 ml/min, the accuracy shall be ± 8 ml/min.

The cartridge flow rate is defined as the flow rate which occurs without a vacuum load. A no-
vacuum load condition is one where the aspiration port vacuum is 50 mmHg or less.

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The commanded aspiration vacuum limit range is 0 to 650 mmHg. The vacuum limit shall be
accurate to ± 5% of the set point. From a steady state flow using a vacuum response setting of
5, the system shall prevent overshoot of the vacuum limit greater than 5% of the set point, or
10 mm Hg whichever is greater.

At vacuum response settings of 3 or 4, the system shall prevent overshoot of the vacuum limit
greater than 5% of the set point, or 10 mm Hg whichever is greater at vacuum limits of 450
mmHg and above. At vacuum response settings of 1 or 2, the overshoot specification is 9%. To
prevent overshoot, the drive system may ramp down the aspiration rate when within 25% of
the vacuum limit. When at the vacuum limit, the aspiration pump shall be stopped.

For reference only, the vacuum limit specification is based upon a measured overshoot of a
competitive system of 17 mmHg at 500 mmHg set point (3.3% rounded to 4%) plus the allowed
transducer accuracy tolerance of 10 mmHg or 5% of the reading.

When fully occluded, the fluidics system will maintain the commanded vacuum limit, as
measured by the vacuum transducer, with 95% confidence, to within ± 10 mmHg for vacuum
limits from 50 to 200 mmHg, and ± 5% for vacuum limits greater than 200 mmHg.

This vacuum accuracy requirement shall be achievable after the system has been calibrated and
primed and has sat idle for 20 minutes.

For reference, when at or over the vacuum limit, the system will provide a visual and audible
occlusion warning indication.

After the system vacuum falls below the vacuum limit and to 20 mmHg below the vacuum limit,
aspiration may be ramped up to the steady state conditions. If the system senses a decrease in
vacuum of greater than 60 mmHg/sec, the system will perform an air vent.

Any pulsation that the system may generate will not exceed 3 mmHg peak to peak as measured
at the distal end of the aspiration port of the I/A tubing while the pump is operating at the
maximum vacuum of 600 ml/min and a minimum vacuum of 5 mmHg.

The Post-Occlusion Surge pressure drop in a modified test chamber with a phaco handpiece and
a standard needle shall be no more than 10% below the steady state pressure following the
occlusion break. The Post-Occlusion Surge shall end less than 2 seconds after the occlusion
break after the vacuum limit of 600 mmHg is achieved with a 0.3 mm I/A handpiece.

4.4.1.6.5 Air Venting

Air vent mode reduces the aspiration tube vacuum from 550 mmHg to less than 5 mm Hg within
0.5 seconds. Air venting will vent the aspiration path to atmospheric pressure by way of the bag
port by dropping the peristaltic head.

4.4.1.6.6 Fluid Venting

Fluid venting is the default vent mode. Fluid venting will vent the aspiration path to the
irrigation path. Fluid vent mode reduces the aspiration tube vacuum from 550 mmHg to less than
5 mmHg in less than 0.5 seconds with an IV bottle height of 40 cm.

The aspiration system must be at a pressure greater than atmosphere in 1 second.

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The fluid vent pinch valve shall leak less than 1.0 ml/min when at 500 mmHg on the aspiration
side of the pinch valve, at maximum bottle height of 140 cm.

Fluid venting is by the hybrid vent method. For reference, hybrid venting consists of a
combination of air and fluid venting that reduces the compliant influence on chamber stability
and achieves bottle pressure more quickly. Hybrid venting from 500 mmHg will not result in a
vacuum in a filled test chamber after attaching an unprimed I/A handpiece.

For reference, the hybrid venting scheme may be based on the following table:

Foot Fluid
Time Motor
# Time Pedal Motor Irr Pinch Vent Notes
(s) Air Vent
Position Pinch
0 0 0 2 or 3 On, Normal Open Closed Closed
1 0.25 0.25 0 or 1 Stop Open Closed Open Air Vent

Fluid
2 0.75 0.50 0 or 1 Stop Open Open Open Vent

3 1.00 0.25 0 or 1 Stop Open Closed Closed

Closed if foot position 0.


4 > 1.00 - 0 or 1 Stop Open if foot position 1. Closed Closed

Table 4.10: Hybrid Venting Scheme.

Reflux type will be controlled by the settings file and only the selected reflux type will be
available during surgery. For reference, reflux will be provided in I/A, ultrasound, and
vitrectomy modes.

The AFM offers irrigation-fed continuous reflux. For reference only, irrigation shall not flow
from the irrigation sleeve during continuous reflux.

The AFM shall offer single and repeat reflux. For reference only, measurements of reflux are to
be made at the tip of the phaco needle.

1. A single reflux volume shall be between 0.1 to 0.2 ml.

2. The primed reflux pressure shall be 230 to 380 mmHg.

3. The maximum allowable reflux volume (measured across multiple refluxes) from motor
reversal without additional aspiration is 3.25 ml.

4.4.1.6.7 Vacuum Control

The patient vacuum is controlled via a non-patient-contact vacuum transducer.

The vacuum output allows fixed or linear control of vacuum. The Vacuum Accuracy is ± 5% of
the set point. The AFM has a vacuum level range between 0 and 650 mmHg.

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The Vacuum Rise-time measured from 10% to 90% of the maximum vacuum level will be at
most 1.5 seconds. The system will allow for programmable rise times.

4.4.1.6.8 Vitrectomy

The AFM provides an internal pneumatic Vitrectomy valve for driving the Bausch + Lomb
102005795 Vitrectomy Probe Assembly. The pneumatic Vitrectomy valve is mounted so that it
is mechanically isolated from transmitting vibrations. An external male locking luer fitting is
provided on the front face of the module for interfacing with the Bausch + Lomb 102005795
Vitrectomy Probe Assembly. The air pressure of 40 psig ± 5% and flow of 0.2 SCFM ± 5%
required to drive the pneumatic vitrectomy cutter is provided by the Bausch + Lomb Stellaris
Vision Enhancement System compressor module. The air supply will drive the cutter at rates of
30 to 800 cuts per minute.

For reference only, to drive the vitrectomy probe assembly at all cut rates up to 800 cuts per
minute, the minimum differential pressure shall be 28 psig; the maximum shall be 38 psig. The
maximum residual pressure must be at most 5 psig.

A precision pressure transducer (Setra 2101050PG 2 D45C1GB1) is connected on the output


line of the vitrectomy valve to monitor the differential and residual pressures.

4.4.1.7 Error Recovery

Upon drawer closure, the module will test for tachometer feedback. If there is incorrect or no
feedback, the module will not detect a cartridge, the module will indicate the error condition on
the network.

Upon failure to calibrate a cartridge, the system will open the cartridge drawer and the module
will indicate the error condition on the network.

Upon failure to prime a cartridge, the system returns to its pre-prime state, allowing the user to
again command priming and the module will indicate the error condition on the network.

4.4.1.8 Vacuum Transducer Functional Description

For referenced only, the purpose of the vacuum transducer is to measure the vacuum within the
aspiration path of the cartridge. The vacuum transducer is a capacitive pressure sensor. As the
peristaltic pump draws fluid through the chamber, the disposable disk or diaphragm is deformed
by the differential pressure across it, changing the distance between the transducer head and the
disposable disk, which changes the capacitance of the structure formed by the disk and head.
The disk deflects by approximately 0.006 inches between 0 and 550 mmHg applied vacuum. A
typical capacitance will be 5 to 8 pF. The outer zone capacitance changes very little, while the
inner zone capacitance changes by approximately 1.5 pF from 0 to 550 mmHg of vacuum within
the cartridge chamber. A run-time calibration will handle the cartridge-to-cartridge variation.

For reference only, capacitive variations are very small, the transducer is susceptible to EMI,
and has been enclosed in the housing for shielding. Due to stray capacitance sensitivity, the
system will have electrical shielding for connections to the sensor board and around the sensor
board.

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For reference only, the transducer interface circuit measures the difference in charge time of the
inner and outer zone capacitors divided by the sum of the charge time of the inner and outer zone
capacitors. The capacitances are formed by the transducer head surfaces and the disposable disk.
The circuit works by alternatively and discharging the two capacitors through fixed resistances.
The charge time of one capacitor determines the pulse width of the positive portion of a square
wave. The other capacitor determines the negative pulse width. The duty cycle represents the
difference in charge time of the inner and outer zones capacitors divided by the sum of the
charge time of the inner and outer zones capacitors, and is measured by filtering the square wave
to provide its average voltage. The square wave frequency will typically be on the order of 35
to 50 kHz.

4.4.1.9 Transducer Calibration

For reference only, the cartridge housing assembly is placed in a peristaltic pump interface
assembly and shall critical measurements for Bausch + Lomb Stellaris Vision Enhancement
System equal to those in Millennium.

When the drawer is closed, the housing assembly is captured between the spring button and the
fixed transducer sensor. The fixed transducer sensor consists of an inner circular metal flat
surface and a concentric outer annular metal flat surface. When the cartridge is engaged, the
disposable disk must be positioned accurately with respect to the transducer head, as controlled
by the component parts, for proper operation. The transducer sensor is attached to a cylindrical
stainless steel shield tube, which is attached to the housing containing the interface circuit.

In the drawer closed position, a force of 20-27 lbs. shall be generated by the spring button to
the back face of the cartridge in a location centered on the transducer. With the drawer force
holding the metal diaphragm of the cartridge assembly against the metal surface of the
transducer sensor, air pressure is applied through the transducer sensor into the space between
the metal diaphragm and the outer face of the transducer sensor.

The circular metal surface of the transducer housing seals against the diaphragm such that the
pressure difference between the diaphragm and the peristaltic module's internal pressure
transducer is less than 2 mmHg while pressure is applied to the diaphragm.

Calibration pressures are achieved by setting pneumatic valves per the following table:

Calibration Point Design Nominal (mmHg) Tolerance (mmHg)


1 (Low) 0 ±2
2 (Mid) 160 +140/-60

3 (High) 450 + 150/-100

Table 4.11: Calibration Pressures.

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The system requires that there be adequate pressure differences between the high and low
calibration pressures:

Calibration Point Design Nominal (mmHg) Tolerance (mmHg)


High-Mid 290 > 150
Mid-Low 160 > 100

Table 4.12: Required Pressure Differences.

Each calibration point shall result in a nominal voltage output from the transducer between -12
and +12 VDC.

• The voltage at the low calibration point shall be greater than -12 VDC.
• The voltage at the mid calibration point shall be greater than that of the low calibration point.
• The voltage at the high calibration point shall be greater than that of the mid calibration point
and less than 12 VDC.

4.4.1.10 Drift & Offset

After calibration and prime, the vacuum level indicated by the transducer shall not be greater
than 15 mmHg when the system is in an idle, uninterrupted state for 20 minutes.

4.4.1.11 Electrical Connectors

All electrical connectors are a positive latching type so that there will be no accidental
disconnections or disconnections that occur during ship testing and vibration testing.

4.4.1.12 Labelling

AFM labelling contains a bar code, assembly, serial number, and appropriate regulatory
markings. A warning label, meeting the requirements of IEC 60601-1, shall be placed near the
rotating drive mechanism. For reference, this label is to address drive head and drawer closure
pinch points.

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Figure 4.7. AFM Pneumatics Diagram.

Figure 4.8. AFM Electrical Block Diagram

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4.4.2 Vacuum Fluidics Module

The Vacuum Fluidics Module is capable of provides vacuum control. The vacuum is generated by a rotary
vane pump located in the Bausch + Lomb Stellaris Vision Enhancement System Compressor Module and
routed to the module. The vacuum control will be done by the software via a transducer and bleed valve
located inside the fluidics module.

The fluidics module provides the electronics, pneumatic actuators, and mechanisms necessary to interface and
control the fluidics of the Bausch + Lomb Stellaris Vision Enhancement System cassette. Also, the fluidics
module has the capability to monitor the fluid level. The module also provides a pneumatic pressure control
and interface (locking female luer connector) for the pneumatic Vitrectomy cutter. The module has a LED
light source to illuminate the cassette and any fluids within the cartridge. The module will communicate with
the Bausch + Lomb Stellaris Vision Enhancement System compressor module and communications module
via a CAN Bus.

4.4.2.1 Enclosure

The Fluidics module enclosure is located at the front of the EMB for easy access and will not be
within the sterile field. The enclosure is constructed of sheet metal. The enclosure is mounted to the
EMB chassis using an upper and lower mounting tab. The enclosure includes provisions for guarding
against electromagnetic emissions. The fluidics module has the following connections interior to the
EMB (not visible to the user - see diagram in Figure 4.7. on page 4-49) and located at the back of the
module:

• One locking electrical connector for power and I/O. The connector used is an FCT Group
FM9W4P5 plus four FMP009P104 high-power pins with F1080 metal brackets with snap-in
rivets and M3 cinch nuts.

• One pneumatic quick connect for pneumatic system functions (40 psig - 30 psig). The connector
used is ¼" SMC one touch pneumatic bulkhead connector. The connector is color coded red.
The tubing for system functions are 85 durometer, Red ¼" OD X 1/8" ID polyurethane tubing.

• One pneumatic quick connect for vacuum function (0-600 mmHg). The connector used is ¼"
SMC one touch pneumatic bulkhead connector. The connector is color coded white. The tubing
for vacuum functions is 85 durometer, Clear ¼" OD X 0.170" ID polyurethane tubing.

• One pneumatic quick connect for Vitrectomy valve input pressure (40 psig ± 5%, 0.2 SCFM).
The connector is ¼" SMC one touch pneumatic bulkhead connector. The connector is color
coded blue. The tubing for Vitrectomy valve input is 85 durometer, Blue ¼" OD X 1/8" ID
polyurethane tubing.

• One pneumatic quick connect for Vitrectomy valve exhaust (0-36 psig). The connector used is
¼" SMC one touch pneumatic bulkhead connector. The connector is color coded green. The
tubing for Vitrectomy valve exhaust is 85 durometer, Green ¼" OD X 1/8" ID polyurethane
tubing.

The maximum internal temperature shall not exceed 50° C under normal operating conditions. The
fluidics module enclosure shall not exceed 9" High X 6" Wide X 10" deep. (Note: Height and width
dimensions define the front panel).

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The overall weight of the module, without accessories, shall not exceed 15 lbs.

4.4.2.2 Front 'Customer' Panel

The front of the module cassette opening matches the contour of the EMB. The fluidics module front
panel includes a green backlit, male locking luer fitting. It is provided on the module for interfacing
with the Bausch + Lomb 102005795 Vitrectomy Probe Assembly.

The front panel includes a 1.53" X 4.03" opening for the Bausch + Lomb Stellaris Vision
Enhancement System Vacuum Cassette (4" X 1.5" X 6"). The cartridge interface includes a blue
(470nm) light source so that the opening for the disposable cartridge is illuminated. When a cartridge
is in the fluidics module the cartridge and any contents will be illuminated and visible from 6 ft. in
a dark room. The cartridge interface includes a gasket around the outside of the opening to
interface with the EMB.

4.4.2.3 Main Board

4.4.2.3.1 Input/Output

Power

The Main PCB is powered by a single 24VDC rail.

Network

The Main PCB communicates to other modules within the Bausch + Lomb Stellaris Vision
Enhancement System via a CAN (Controller Area Network) bus as defined in the System
Architecture Specification.

Fusing

All fusing on SELV power lines are self-resetting. The 24VDC power rail has a 3.5A fuse
(holding current).

Processor

The Main PCB utilizes a Freescale MCF5282 Coldfire microprocessor as its main processor.

4.4.2.4 Environmental Specifications

4.4.2.4.1 Temperature and Humidity

The module shall operate in humidity as specified in the General Tech Spec 118-006-023. The
module shall be capable of being stored in a humidity range as specified in the General Tech
Spec 118-006-023 The module shall operate within a temperature range as specified in the
General Tech Spec 118-006-023. The module shall be capable of being stored at a temperature
range as specified in the General Tech Spec 118-006-023.

Altitude

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The module shall be capable of operating up to an altitude of 3000 feet without any performance
degradation. 3000 feet above sea level (a derating of 25 mmHg per 1000 feet will be used for
operation above 3000 feet up to 8000 feet). Any vacuum performance requirements will be
noted in Compressor Module Tech Spec 11800627. The Vitrectomy system will meet all
requirements to an altitude of 3000 feet. Above 3000 feet, the Vitrectomy system will meet all
requirements to an altitude of 8000 feet to within ± 20% of the required pressure. The
Vitrectomy system shall have no performance requirements above 8000 feet.

Shock and Vibration

The module shall meet the requirements as specified in the General Tech Spec 118-006-023.

Noise

The vacuum fluidics module acoustical noise shall comply with the requirement of the Anterior
System (118-006-023, NEXT GENERATION MICROSURGICAL SYSTEM General
Technical Specification).

4.4.2.5 Surgical Functions

4.4.2.5.1 Initialization

For reference only sequence of events for use shall be:

Event Results Notes


Module enabled Module is enabled on the network
User loads cartridge into module Cartridge is detected.

Cartridge present sensor detects Cartridge capture mechanism


cartridge engages and restrains cartridge.

If fluid level is less than 250 mls If fluid level is 250 or greater an
Module checks fluid level in cassette allow vacuum check error message should be generated.

Module checks cartridge seal Cartridge vacuum seal test is


integrity with a vacuum of 450 initiated. Audio feedback: Cartridge If reaches a vacuum of > 450 mmHg
mmHg vacuum check is complete allow priming.

See Anterior System Priming for


Customer commands system to Audio feedback: Cartridge prime is detail description of cassette
prime initiated priming routine
Audio feedback: Cartridge prime is
Cartridge ready for surgery complete.

Table 4.13: Initialization of Surgical Functions.

4.4.2.5.2 Cassette Present Sensor

The module has a cassette present sensor. The cassette present sensor is designed so that there
is no direct contact with the Bausch + Lomb Stellaris Vision Enhancement System cassette.

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Note: This should eliminate the potential for balanced salt solution contacting the sensor actuator. The cassette
present sensor actuator is aligned with the end of the cassette eject plunger.

The cassette present sensor is actuated by the inside end of the cassette eject plunger when a
Bausch + Lomb Stellaris Vision Enhancement System cassette is inserted into the module. The
cassette present sensor shall not require more than 1.0 lbs. of force to indicate the presence of a
cassette.

4.4.2.5.3 Cassette Capture Mechanism

The module incorporates a mechanism for capturing and engaging the vacuum port of the
cartridge. This mechanism also incorporates a means to seal and prevent a vacuum leak
between the capture block port and the cartridge port. A vacuum leak between the capture block
port and the cartridge port must be less than 10 sccm at a vacuum of 600 mmHg. The cassette
capture mechanism shall exert a total normal force of 6 - 11 lbs. Any lateral forces applied on
the cassette by the capture mechanism shall not exceed 2 lbs.

4.4.2.5.4 Cassette Ejection Mechanism

The module incorporates a mechanism for ejecting the cartridge. The ejection mechanism is
capable of ejecting a full cassette a minimum of 0.25" and a maximum of 1.0". An empty
cartridge must not be ejected less than 0.25" or more than 2.0". Any lateral forces applied on the
walls of the cartridge, by the ejection mechanism, shall not exceed 2 lbs.

4.4.2.5.5 Pinch Valves

The module contains 5 pinch valves - main aspiration pinch, aspiration pinch #1, aspiration
pinch #2, fluid vent/passive reflux pinch and irrigation pinch. The aspiration pinch #2 allows
for an additional aspiration pinch valve for use with a future posterior cassette that has 2
aspiration lines. The pinch valves are actuated pneumatically and are part of the cylinder
manifold. The pinch valves shall exert a minimum force of 4 lbs. and a maximum force of 8
lbs. The pinch contact area is designed to displace a minimal amount of fluid without
damaging the tubing. The pinch valve cylinder shaft is designed to prevent rotation of the
contact end to insure proper alignment with the tubing. For reference, refer to the Cartridge
Technical Specification (118006043) for pinch valve leak rate specifications.

4.4.2.5.6 Cartridge Fluid Level Sensor

The module has a sensor to provide an indication of the amount and level of the fluid collected
within the cartridge. The sensor provides an indication of fluid collected within ± 15ml. The
sensor also insures that the fluid level never rises to a level greater than 300 ml. For reference
the fluid level of 300 mls, within the cassette, will not allow fluid to be aspirated into the module
vacuum circuit.

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4.4.2.5.7 Cassette Initialization

The cassette will not require calibration. The table below shows the various valve states for
operation of the cassette fluidics.

During Steady state Fluid


Low Power
No cartridge Vacuum aspiration Venting/
State
Valve check or priming Reflux
Valve State
Valve State
Valve State Valve State Valve State
Main Aspiration Pinch Opened/
Valve Opened Closed Opened Closed* Open
Closed/
Fluid Vent Pinch Valve Opened Closed Closed Opened* Open

Irrigation Pinch Valve Opened Opened Opened Opened Opened

Cassette capture valve Opened Closed Closed Closed Closed

Table 4.14: Cassette Initialization.

* Denotes hybrid fluid venting scheme may be employed. Bold indicates first 100 msec.

There is a vacuum check at 450 mmHg upon each insertion of the cassette into the fluidics
module. The system will run the vacuum check for a maximum of 5 seconds.

4.4.2.5.8 Anterior System Priming

After the vacuum check the cartridge must be primed. Priming is initiated by the user through
the user interface. For reference all HP connections must be completed and the test chamber
placed over the irrigation sleeve. Also, the IV bottle must be spiked before the priming routine
is initiated. Once the priming routine is initiated the IV pole is raised to 100 cm. Once the bottle
is at 100cm, the irrigation pinch valve and aspiration pinch valve will open allowing fluid to
freely flow from the bottle to the cassette. Then the system slowly (i.e. in approx. 3 seconds)
generates a vacuum of 300 mmHg. After 20 seconds, if the phaco tuning function is selected
then it initiates the tuning routine (approx. 4 seconds). Once the tuning routine is completed wait
5 seconds then close the irrigation pinch valve. Once the irrigation pinch valve is closed increase
the vacuum within the cartridge - from 300 mmHg -- and aspiration system, including HP with
test chamber, to 500 mmHg using the vacuum pump for 5 seconds. For reference, this removes
any air bubbles within the aspiration system and is a check of the cartridge tubing connections
and HP connections for leaks. After the 500 mmHg vacuum has run for 5 seconds perform a
fluid vent. Once the fluid vent is completed continue to run the vacuum at 300 mmHg for 5
seconds. For reference, the intent of the priming operation is to fill the aspiration and irrigation
circuit with fluid and remove any air that may prevent the system from meeting the rise time,
surge and venting requirements. The combined volumes of any air bubbles in the aspiration
tubing shall not exceed 0.5" in length. For reference, the allowable aspiration system air
volume is equivalent to 17% of the anterior chamber volume using 0.063" ID tubing. The
combined volumes of any air bubbles in the irrigation tubing shall not exceed 0.25" in length.
(Ref - Irrigation tubing diameter 0.120"). The priming portion of the setup, defined as the time
from

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selection of the prime or handpiece calibration function, is less than or equal to 40 seconds. This
assumes that the irrigation line, aspiration line, HP and test chamber have been properly
connected. The handpiece orientation during priming is vertical with tip up ± 15º or horizontal
± 15º lying on the Bausch + Lomb Stellaris Vision Enhancement System surgical tray.

4.4.2.5.9 Irrigation Parameters

The irrigation flow is provided by a gravity fed or pressurized IV bottle or bag and capable of
maintaining a positive intraocular pressure.

The fluidics module will provide on/off control of irrigation by pinching the irrigation line that
is connected to the HP. The irrigation flow is unaffected by the open fluidics module pinch
actuator. Irrigation on/off control is provided in all modes of use. When power is removed from
the system, the irrigation pinch valve defaults to irrigation on (i.e. open). When the irrigation
pinch valve is in the off position (i.e. closed), it shall prevent irrigation leak rates in excess of 1
ml/ min at 140 cm bottle height.

4.4.2.5.10 Anterior Aspiration Parameters

Aspiration control is provided by the main pinch and aspiration pinch #1.

Flow Rate Accuracy- The system aspirates at rates from 1 to 10 ml/min with an accuracy of ±
2 ml/min, 10 to 30 ml/min with an accuracy of ± 3 ml/min, 30 to 60 ml/min with an accuracy
of ± 10%. The cartridge flow rate is defined as the flow rate, which occurs without a vacuum
load. A no-vacuum load condition is one where the aspiration port vacuum is 25 mmHg or less.
VERIFY WITH CCRs.

Vacuum Limit - The commanded aspiration vacuum limit range is 0 to 600 mm Hg.

Vacuum Limit Accuracy - ± 5% of set point.

Programmable vacuum response - The system allows for programmable vacuum limit
response settings 1 - 5. These response settings controls the rate the system approaches the
vacuum limit. The response setting is user selectable via the system GUI and defined by the
system software specification.

Rise Time - The default (uncompensated) vacuum response setting is 3.

Overshoot - The system shall not overshoot the vacuum limit set point by more than 5% or 8
mmHg.

Pulsations - Any pulsation that the system may generate shall not exceed 3 mmHg peak to peak
as measured at the distal end of the aspiration port of the I/A tubing while the pump is operating
at the maximum vacuum of 600 ml/min or a minimum vacuum of 5 mmHg.

Post-Occlusion Surge Magnitude - The pressure drop below the steady state pressure drop in a
modified test chamber with a phaco handpiece and a standard needle shall not drop > 10%.

Post-Occlusion Surge Duration - The vacuum level in a modified test chamber with a phaco
handpiece and a standard needle will return to the steady state pressure level within 2 seconds
of the occlusion break after the vacuum limit of 600 mmHg is achieved with a 0.3 mm I/A HP

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P/N Verify. When in flow mode and within 1% of the set vacuum limit, the system provides a
visual and audible occlusion warning indication. When in flow mode the vacuum overshoot will
not exceed the set vacuum limit by more than 7%.

4.4.2.5.11 Vacuum

Vacuum is provided by a three phase variable speed pump. The vacuum is measured by the
vacuum sensor and the control circuit adjusts the pump speed to provide the correct value. The
pump cannot run at a speed low enough to provide 50 mmHg. At low vacuum settings the servo
valve opens, allowing air in, causing the pump to run faster to provide the set vacuum. At higher
settings the servo valve is closed. The system can aspirate 0 to 600 mmHg.

4.4.2.5.12 Vacuum Source

The vacuum source is provided by the compressor module. The vacuum is also be controlled in
the fluidics module via vacuum transducer. Also, a proportional valve is located within the
fluidics module to assist in making fine adjustments by bleeding off excess vacuum. The
vacuum output is capable of fixed or linear control of vacuum.

Vacuum Accuracy - ± 5% of set point or ± 5 mmHg whichever is greater. Steady state Vacuum
- ± 3% of set point or ± 3 mmHg whichever is greater.

Vacuum overshoot - Not to exceed the set point by more than 5% or ± 5 mmHg whichever is
greater.

Vacuum Range - The module accommodates vacuum levels between 0 and 600 mmHg at sea
level and up to 3000 ft.

Vacuum Rise Time - The minimum rise time, with an empty Bausch + Lomb Stellaris Vision
Enhancement System cassette, will be less than or equal to 1.3 ± 0.2 seconds over the entire

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aspiration range with a 300 ml Bausch + Lomb Stellaris Vision Enhancement System cassette.
Reference: At sea level up to 3000', from 10% to 90% of the rise time curve. The vacuum control
system accommodates programmable rise times.

4.4.2.5.13 Air Venting

Air venting will reduce the aspiration line vacuum from 600 mm Hg to less than - 5 mmHg. Air
venting will occur within 0.450 seconds or less, from the time the foot pedal is released.
Reference: At vacuum level, from 90% to 10% of the fall time curve. Air venting will vent the
vacuum circuit to atmospheric pressure by way of the cassette vacuum port through the
proportional valve. Also, the system will vent through the vacuum pump.

4.4.2.5.14 Fluid Venting

Fluid venting is the default vent mode. Fluid venting will vent the aspiration path to the
irrigation path. Fluid venting brings the distal end of the aspiration line to the bottle pressure ±
10%. Reference: At vacuum level, from 90% to 10% of the fall time curve. Fluid venting will
occur in 0.5 seconds or less, from the time the foot pedal is released, or less with a minimum
bottle height of 40 cm H2O. To allow faster fluid venting, the aspiration system may perform an
air vent before a fluid vent. The fluid and air vent will not occur at the same time. For reference,
performing both vents simultaneously may starve the irrigation supply by directing it into the
cartridge.

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4.4.2.5.15 Cassette

Cassettes are assembled with tubing attached. There is a tube for PHACO aspiration and one for
VIT aspiration. When PHACO is selected the VIT tubing is pinched. When VIT is selected the
PHACO tubing is pinched. Reflux is accomplished using the pressure of the fluid in the IV
bottle. When the FOOTPEDAL is pushed in the reflux position the irrigation tubing is pinched,
aspiration pinch is activated, PHACO aspiration pinch is released and reflux pinch is
momentarily released. This applies reverse pressure to the needle, dislodging any clogging
particles.

4.4.2.5.16 Reflux

Aspiration reflux connects (i.e. short) the irrigation path to the aspiration path to allow irrigation
fluid to flow from the irrigation line to the aspiration circuit. Aspiration pinch will remain closed
and the fluid vent pinch and irrigation pinch will open to allow the fluid from the bottle to flow
into the aspiration line and towards the distal end to the aspiration line. The fluid reflux function
- cylinder - must disengage the vent/reflux line within 150 msecs.

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4.4.2.5.17 Vitrectomy

The aspiration module provides and internal pneumatic Vitrectomy valve for driving the Bausch
+ Lomb Vitrectomy Probe Assembly. The pneumatic Vitrectomy valve is mounted such that it
is mechanically isolated from transmitting vibrations. An external male locking luer fitting is
provided on the front face of the module for interfacing with the Bausch + Lomb Vitrectomy
Probe Assembly.

The air pressure of 40 psig ± 5% required to drive the pneumatic Vitrectomy cutter is provided
by the Bausch + Lomb Stellaris Vision Enhancement System Compressor module. The air
supply is sufficient enough to drive the cutter at rates of 30 to 800 cuts per minute.
REFERENCE: To drive the Vitrectomy probe assembly, at all cut rates up to 800 cuts per
minute, the minimum differential pressure shall be 28 PSIG, but 45 psig. The maximum residual
pressure must be 5 psig. The air flow of 0.2 Standard Cubic feet per minute [SCFM] ± 5%
required to drive the pneumatic Vitrectomy cutter will be provided by the Bausch + Lomb
Stellaris Vision Enhancement System Compressor module. The air supply is sufficient enough
to drive the cutter at rates of 30 to 800 cuts per minute. The input air pressure connector for the
Vitrectomy is located on the back of the module. The input air pressure tubing for the
Vitrectomy is ¼" O.D. X 1/8" I.D. and color coded Blue. The blue pressure tubing will route the
air pressure from the internal Vitrectomy valve to the blue connector located at the rear of the
module. The air exhaust tubing for the Vitrectomy is ¼” O.D. X 1/8" I.D. and color coded
Green. The exhaust tubing routes the exhaust from the internal Vitrectomy valve to a green color
connector located at the rear of the module. The air pressure tubing from the Vitrectomy valve
to the front Male luer lock connector is 1/8' O.D. X 1/16" I.D. and color coded blue.

The air pressure tubing from the Vitrectomy valve to the front Male luer lock connector is 6" in
length.

A pressure transducer mounted to the PCB is connected via a tee fitting to the output line of the
Vitrectomy valve to monitor the Vitrectomy output pressure. The accuracy of the Vitrectomy
pressure transducer should be < ± 1 psig. When the Vitrectomy test is selected the peak output
pressure should be read via the transducer and verified that the pressure is 22 psig when running
at the maximum cut rate of 800 cpm.

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4.4.2.5.18 Vacuum Transducer

The module contains a transducer for measuring the vacuum within the cartridge and internal
vacuum line. The transducer is in contact with the air within the vacuum system. The transducer
is able to withstand contact with balanced salt solution and/or water. The transducer shall
measure in the range of 0 to -14.7psig. Accuracy = ± 0.25% FS or better. The transducer has a
repeatability of ± 0.2% typical (0.5% max.) FS or better. The maximum measurable resolution
needs to be ± 0.5 mmHg or better. The linearity is 0.01% typical (0.05% max.) FS or better. The
transducer has a minimum response time of 10.0 ms or better.

4.4.2.5.19 Cassette Fluid Level Detection

There are 30 red LEDs in a row illuminate a pair of prisms molded into the side of the cassette.
The light from the LEDs reflect on the two prisms and are detected by an image sensor. The
image sensor is a 832 pixel linear array. When the cassette is empty the sensor is illuminated
evenly. As the fluid level in the cassette rises some of the light is dispersed into the fluid. The
sensor sees dim light below the fluid level and bright light above. The output of the sensor is
processed by the circuit board and sent to the system computer. The level of fluid is displayed
on the system display. When the fluid reaches a "full" point, aspiration stops, preventing over
filling the cassette. The system then will not allow the full cassette to be reinserted. Only an
empty cassette or one that has been emptied will be accepted.

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Figure 4.9. VFM Pneumatics Diagram.

4.4.2.6 Error Recovery

Upon a cassette failing the cassette check. The system returns to its pre check state and will eject the
cassette, allowing the user to again to insert the cassette. The module reports the error condition to
the network and recommends that the user attempt to carefully re-insert the cassette after verifying
that the cassette is in good condition.

Upon a cassette failing the second cassette check the module reports the error condition to the
network and recommends that the user check all fittings and connections or attempt to insert a new
cassette.

Upon a cassette failing the vacuum check the system returns to its pre vacuum check state and will
eject the cassette, allowing the user to again to insert the cassette. The module reports the error
condition to the network and recommend that the user attempt to re-insert the cassette after verifying
that the cassette has been properly connected and is in good condition. A vacuum check will be
performed once cassette is re-inserted.

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Upon a cassette failing the vacuum check the module reports the error condition to the network and
recommends that the user attempt to insert a new cassette.

Upon failure to prime the aspiration system, the system returns to its' pre-primed state, allowing the
user to again command priming. The module reports the error condition to the network and the user.
The user will be instructed to check all connections before attempting to reprime the system.

Upon a cassette failing the aspiration system prime the system reports the error condition to the
network and recommends that the user check all fittings and connections or attempt to insert a new
cassette.

Upon failing to reprime a cassette, the system returns to its' pre-prime state, allowing the user to
again command priming. The module reports the error condition to the network and recommends
that the user attempt a cartridge vacuum check.

Upon a cassette failing the reprime the system reports the error condition to the network and
recommend that the user check all fittings and connections or attempt to insert a new cassette.

4.4.2.7 Manufacturing

The fluidics module will be evaluated for DFMA. All tubing is color-coded and when possible the
color code matches so that the color is the same as past pneumatic functions. The design should strive
to use 1 or 2 common fasteners. The design has positive latching type connectors. The design should
not use the same size connector (i.e. the fluidics module internal connectors should have a different
# of pins to avoid assembly errors). In a case of 2 connectors having to be the same configuration
then the cable length should be such that it is impossible to connect the wrong component into the
wrong connector.

4.4.2.8 Module Shipping Configuration

4.4.2.8.1 Labelling

The module label contains a bar code, assembly, serial number, and appropriate regulatory
markings.

4.4.2.8.2 Reliability

The reliability of the all of the pinch cylinders (i.e. Cylinder manifold) will be such that they can
be actuated 240,000 times without a sticking failure. Reference: cycles are based on 50
actuations X 4 days X 8 hrs. X 50 wks. X 3 yrs. The vacuum detection device (i.e.
Transducer) shall have no balanced salt solution related failures within 4,800 hrs. of operation.
The vacuum detection device (i.e. Transducer) shall not require calibration within 4,800 hrs.
of operation. The fluid level detection device shall have no read failures within 4,800 hrs. of
operation. The fluid level and cassette illumination shall not fail within 9,600 hrs. of operation.
For reference 4 days X 8 hrs. X 50 wks. X 6 yrs. All electrical connectors will be a positive
latching type such that there will be no accidental disconnections or disconnections that occur
during ship testing and vibration testing.

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4.4.2.8.3 Warnings

Fluid level in cassette is 240 mls. Please consider emptying cassette.

Fluid level in cassette is 280 mls. Please consider emptying cassette.

Fluid level in cassette is 280 mls, 100% of maximum capacity has been reached. The cassette
must be emptied before proceeding.

If inserted full (280ml - 300ml) -- Fluid level in cassette is at or near 100% of maximum
capacity. The cassette must be emptied before proceeding. Please refer to owner’s manual if
problems occur.

4.4.3 Posterior Fluidics Module (PFM)

The Posterior Fluidics Module is capable of providing vacuum control. The vacuum is generated by a Venturi
assembly located in the Bausch + Lomb Stellaris PC Vision Enhancement System Posterior Fluidics Module.
The vacuum control will be done by the software via a transducer inside the fluidics module.

The Posterior Fluidics Module provides the electronics, pneumatic actuators, and mechanisms necessary to
interface and control the fluidics of the Bausch + Lomb Stellaris PC Vision Enhancement System cassette.
Also, the posterior fluidics module has the capability to monitor the fluid level. The module also provides a
pneumatic pressure control and interface (locking male luer connector) for the pneumatic Vitrectomy cutter.
The module has a blue LED light source to illuminate the cassette and any fluids within the cassette. The
Cassette Illumination PCB is mounted on the left side of the pinch manifold and is easily accessible for
servicing. The module will communicate with the Bausch + Lomb Stellaris PC Vision Enhancement System
compressor module and communications is via a CAN Bus.

4.4.3.1 Enclosure

The Posterior Fluidics Module enclosure is located at the front of the EMB for easy access and will
not be within the sterile field. The enclosure is constructed of sheet metal. The enclosure is mounted
to the EMB chassis using an upper and lower mounting tab. The enclosure includes provisions for
guarding against electromagnetic emissions. The Posterior Fluidics Module has the following
connections interior to the EMB (not visible to the user – Figure 4.7. on page 4-49) and located at
the back of the module:

• One locking electrical connector for power and I/O. The connector used is an FCT Group
FM9W4P5 plus four FMP009P104 high-power pins with F1080 metal brackets with snap-in
rivets and M3 cinch nuts.

• One pneumatic quick connect for pneumatic system functions (40 psig - 30 psig). The connector
used is a ¼" SMC one touch pneumatic bulkhead connector. The connector(s) is color coded
red. The tubing for the system functions are 85 durometer, Red ¼" OD X 0.159" ID
polyurethane tubing.

• One pneumatic quick connect for vacuum function (68 psig ±2 psig). The connector used is a ¼"
SMC one touch pneumatic bulkhead connector. The connector(s) is color coded orange. The
tubing for the vacuum functions is 85 durometer, Clear ¼" OD X 0.159" ID polyurethane
tubing.

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• One pneumatic quick connect for Vitrectomy valve input pressure (40 psig ± 5%, 0.2 SCFM).
The connector is a ¼" SMC one touch pneumatic bulkhead connector. The connector(s) should
is color coded blue. The tubing for the Vitrectomy valve input is 85 durometer, Blue ¼" OD X
0.159” ID polyurethane tubing.

• One pneumatic quick connect for Vitrectomy valve exhaust (0-36 psig). The connector used is a
¼" SMC one touch pneumatic bulkhead connector. The connector(s) are color coded Green.
The tubing for the Vitrectomy valve exhaust is 85 durometer, Green ¼" OD X 0.159” ID
polyurethane tubing.

The maximum internal temperature shall not exceed 50 ºC under normal operating conditions. The
posterior fluidics module enclosure shall not exceed 9" High X 6" Wide X 10" deep. (Note: Height
and width dimensions define the front panel). The overall weight of the module, without accessories,
shall not exceed 15 lbs.

4.4.3.2 Front 'Customer' Panel

The front of the module cassette opening matches the contour of the EMB. The Posterior Fluidics
Module front panel includes a green backlit, male locking luer fitting. It is provided on the module
for interfacing with the Bausch + Lomb Vitrectomy Probe Assembly. The front panel includes a
1.53" X 4.03" opening for the Bausch + Lomb Stellaris PC Vision Enhancement System Vacuum
Cassette (4" X 1.5" X 6"). The cassette interface includes a blue (470nm) light source so that the
opening for the disposable cassette is illuminated. When a cassette is in the Posterior Fluidics
Module the cassette and any contents will be illuminated and visible from 6 ft in a dark room. The
cassette interface includes a gasket around the outside of the opening to interface with the EMB.
The Cassette Illumination PCB is mounted on the left side of the pinch manifold and is easily
accessible for servicing.

4.4.3.3 Main Board

Input/Output

Power

The Main PCB is powered by a single 24VDC rail.

Network

The Main PCB communicates to other modules within the Bausch + Lomb Stellaris PC Vision
Enhancement System via a CAN (Controller Area Network) bus as defined in the System
Architecture Specification.

Fusing

All fusing on SELV power lines are self-resetting. The 24VDC power rail has a 3.5A fuse
(holding current).

Processor

The Main PCB utilizes a Freescale MCF5282 Coldfire microprocessor as its main processor.

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4.4.3.4 Environmental Specifications

4.4.3.4.1 Temperature and Humidity

The system shall operate in a humidity of at least 30 to 70% (relative). The system shall be
capable of being stored in a humidity range of 10 - 98% (non-condensing). The system shall be
designed and constructed to meet the requirements of IEC 60601-2-2:2009, Section 201.11 -
“Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection
and compatibility.

Altitude

The module shall be capable of operating up to an altitude of 3000 feet without any performance
degradation. The Vitrectomy system shall be capable of operating up to an altitude of 3000 feet
without any performance degradation.

Shock and Vibration

The system and modules designed and tested for compliance to NAVMAT-P9492 & MIL-STD-
810F for shock and random vibration.

Noise

The system noise shall be less than or equal to 45 dbA above ambient noise at one meter distance
from front, sides, and back of system. The noise emission of the high speed pneumatic
Vitrectomy (HSPV) cutter shall not exceed 20 dBA over 10-20 kHz audible range at a distance
of 2 feet from cutter. The compressor module shall be isolated for vibrations generated within
the module and to minimize acoustic noise. The system shall detect and report remote control
IR timeout and noise conditions on the remote control inputs and not report button activations.

4.4.3.5 Surgical Functions

4.4.3.5.1 Initialization

For reference only sequence of events for use shall be:

Event Results Notes


Module is enabled on the
Module enabled network
User loads cassette into module Cassette is detected.

Cassette capture
Cassette present sensor detects mechanism engages and
cassette restrains cassette.

If fluid level is less than


Module checks fluid level in 250 mls allow vacuum If fluid level is = 250 mls an error
cassette check message should be generated.

Table 4.15: Initialization of Surgical Functions.

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Event Results Notes


Cassette vacuum seal test
is initiated. Audio
Module checks cassette seal feedback: Cassette
integrity with a vacuum of 450 vacuum check is If reaches a vacuum > 450 mmHg
mmHg complete allow priming.
See Anterior System Priming for
Customer commands system to Audio feedback: Cassette detailed description of cassette
prime prime is initiated priming routine

Audio feedback: Cassette


Cassette ready for surgery prime is complete.

Table 4.15: Initialization of Surgical Functions.

4.4.3.5.2 Cassette Identification

The Stellaris PC is designed with a cassette identification feature that can recognize which type
of cassette is inserted into the Posterior Fluidics Module. A system error message will display
when the wrong cassette type is inserted.

The Stellaris Posterior and Posterior Combined Cassettes have a prism molded into the top of
the cassette which is detected by the Posterior Fluidics Module camera. The Posterior Combined
Cassette prism is larger than the Posterior Cassette prism. The camera inside the Posterior Fluids
Module detects this difference and can then identify which cassette has been inserted.

The Anterior Cassette does not have this feature and therefore will be recognized as an Anterior
Cassette by the Stellaris PC.

4.4.3.5.3 Cassette Present Sensor

The module has a cassette present sensor. The cassette present sensor is designed so that there
is no direct contact with the Bausch + Lomb Stellaris PC Vision Enhancement System cassette.

Note: This should eliminate the potential for balanced salt solution contacting the sensor actuator. The cassette
present sensor actuator is aligned with the end of the cassette eject plunger.

The cassette present sensor is actuated by the inside end of the cassette eject plunger when a
Bausch + Lomb Stellaris PC Vision Enhancement System cassette is inserted into the module.

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The cassette present sensor shall not require more than 1.0 lbs. of force to indicate the
presence of a cassette.

4.4.3.5.4 Cassette Capture Mechanism

The module incorporates a mechanism for capturing and engaging the vacuum port of the
cassette. This mechanism also incorporates a means to seal and prevent a vacuum leak between
the capture block port and the cassette port. A vacuum leak between the capture block port and
the cassette port must be less than 10 sccm at a vacuum of 600 mmHg. The cassette capture
mechanism shall exert a total normal force of 6 - 11 lbs. Any lateral forces applied on the
cassette by the capture mechanism shall not exceed 2 lbs.

4.4.3.5.5 Cassette Ejection Mechanism

The module incorporates a mechanism for ejecting the cassette. The ejection mechanism is
capable of ejecting a full cassette a minimum of 0.25" and a maximum of 1.0". An empty
cassette must not be ejected less than 0.25" or more than 2.0". Any lateral forces applied on the
walls of the cassette, by the ejection mechanism, shall not exceed 2 lbs. The aspiration cassette
ejection shall be allowable only via touch screen command. The system shall prevent cassette
ejection when any surgical function is active.

4.4.3.5.6 Pinch Valves

The module contains 7 pinch valves - main aspiration pinch, aspiration pinch #1, aspiration
pinch #2, fluid vent cassette capture, reflux and irrigation pinch. The aspiration pinch #2 allows
for an additional aspiration pinch valve for use with a posterior cassette with 2 aspiration lines.
The pinch valves are actuated pneumatically and should be part of the cylinder manifold.

The pinch valves shall exert a minimum force of 4 lbs. and a maximum force of 8 lbs. The
pinch contact area is designed to displace a minimal amount of fluid without damaging the
tubing. The pinch valve cylinder shaft is designed to prevent rotation of the contact end to
insure proper alignment with the tubing.

4.4.3.5.7 Cassette Fluid Level Sensor

The module has a sensor to provide an indication of the amount and level of the fluid collected
within the cassette. The sensor provides an indication of fluid collected within ± 15ml. The
sensor also insures that the fluid level never rises to a level greater than 300 ml. For reference
the fluid level of 300 mls, within the cassette, will not allow fluid to be aspirated into the module
vacuum circuit. The cassette fluid level sensor is also used to detect which cassette Anterior,
Posterior or Combined is being used.

4.4.3.5.8 Posterior System Priming

After the vacuum check the cassette must be primed. Priming is initiated by the user through the
user interface. Also, the IV bottle must be spiked before the priming routine is initiated.

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4.4.3.5.9 Irrigation Parameters

The irrigation flow is provided by a gravity fed or pressurized IV bottle or bag and capable of
maintaining a positive intraocular pressure. The fluidics module will provide on/off control of
irrigation by pinching the irrigation line that is connected to the handpiece. The irrigation flow
is unaffected by the open fluidics module pinch actuator. The system shall provide options to
allow irrigation on / off in foot pedal region one for posterior modes. When power is removed
from the system, the irrigation pinch valve defaults to irrigation on (i.e. open). When the
irrigation pinch valve is in the off position (i.e. closed), it shall prevent irrigation leak rates in
excess of 1 ml/min at 140 cm bottle height.

4.4.3.5.10 Aspiration Parameters

Aspiration control is provided by the main pinch and aspiration pinch #1 & 2. Flow Rate
Accuracy - The system aspirates at rates from 1 to 10 ml/min with an accuracy of ± 2 ml/min,
10 to 30 ml/min with an accuracy of ± 3 ml/min, 30 to 60 ml/min with an accuracy of ± 10%.
The cassette flow rate is defined as the flow rate, which occurs without a vacuum load. A no-
vacuum load condition is one where the aspiration port vacuum is 25 mmHg or less. Vacuum
Limit - The commanded aspiration vacuum limit range is 0 to 600 mmHg Vacuum Limit
Accuracy and ± 5% of the set point.

Programmable vacuum response - The system allows for programmable vacuum limit response
settings 1 - 5. These response settings controls the rate the system approaches the vacuum limit.
The response setting is user selectable via the system GUI and defined by the system software
specification.

Rise Time - The default (uncompensated) vacuum response setting is 3.

Overshoot - The system shall not overshoot the vacuum limit set point by more than 5%.

Pulsations - Any pulsation that the system may generate shall not exceed 3 mmHg peak to peak
as measured at the distal end of the aspiration port of the I/A tubing while the pump is operating
at the maximum vacuum of 600 ml/min or a minimum vacuum of 5 mmHg.

Post-Occlusion Surge Magnitude - The pressure drop below the steady state pressure drop in a
modified test chamber with a phaco handpiece and a standard needle shall not drop > 10%.

Post-Occlusion Surge Duration - The vacuum level in a modified test chamber with a phaco
handpiece and a standard needle will return to the steady state pressure level within 2 seconds
of the occlusion break after the vacuum limit of 600 mmHg is achieved with a 0.3 mm I/A HP
P/N Verify. When in flow mode and within 1% of the set vacuum limit, the system provides a
visual and audible occlusion warning indication. When in flow mode the vacuum overshoot will
not exceed the set vacuum limit by more than 7%.

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4.4.3.5.11 Vacuum Source

Figure 4.10. Stellaris PC Fluidics Theory

The vacuum source is provided by the legacy-type (Protegé) Venturi assembly in the Posterior
Fluidics Module. The vacuum is controlled in the Posterior Fluidics Module via a vacuum
transducer. A servo valve is also located within the Posterior Fluidics Module which adjusts the
air pressure to produce the desired vacuum. The vacuum output is capable of fixed or linear
control of vacuum.

Vacuum Accuracy – The system shall be able to create a vacuum of ± 5% or ± 10 mmHg.

Vacuum overshoot – Will not exceed the set point by more than 5%.

Vacuum Range – The module accommodates vacuum levels between 0 and 600 mmHg up to
3000 ft. above sea level.

Vacuum Rise Time – The vacuum control system rise time shall be adjustable. The system shall
support 5 vacuum rise times.

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For operations at altitudes exceeding 3000 feet, the maximum vacuum performance shall be
derated 19.4 mmHg per 1000 feet.

Reference: At sea level up to 3000 feet, from 10% to 90% of the rise time curve. The vacuum
control system accommodates programmable rise times.

4.4.3.5.12 Air Venting

Air venting shall be the default vent mode for posterior techniques. The system shall provide air
venting via the cassette. Air venting will reduce the aspiration line vacuum from 600 mmHg to
less than - 5 mmHg. Air venting will occur within 0.450 seconds or less, from the time the foot
pedal is released.

Reference: At vacuum level, from 90% to 10% of the fall time curve. Air venting will vent the
vacuum circuit to atmospheric pressure by way of the cassette vacuum port through the
proportional valve. The system will also vent through the vacuum pump.

4.4.3.5.13 Fluid Venting

The system provides fluid venting via the cassette. Fluid venting is the default vent mode. Fluid
venting will vent the aspiration path to the irrigation path. Fluid venting brings the distal end of
the aspiration line to the bottle pressure ± 10%. Reference: At vacuum level, from 90% to 10%
of the fall time curve. Fluid venting will occur in 0.5 seconds or less, from the time the foot pedal
is released, or less with a minimum bottle height of 40 cm H 2O. To allow faster fluid venting,
the aspiration system may perform an air vent before a fluid vent. The fluid and air vent will not
occur at the same time. For reference, performing both vents simultaneously may starve the
irrigation supply by directing it into the cassette.

4.4.3.5.14 Reflux

The system shall provide fluid reflux capability via the cassette. The system shall support two
types of reflux, active and passive reflux. Aspiration (passive) reflux connects (i.e. short) the
irrigation path to the aspiration path to allow irrigation fluid to flow from the irrigation line to
the aspiration circuit. Aspiration pinch will remain closed and the fluid vent pinch and irrigation
pinch will open to allow the fluid from the bottle to flow into the aspiration line and towards the
distal end to the aspiration line. The fluid reflux function - cylinder - must disengage the vent/
reflux line within 150 msecs. Pulsed (active) reflux is activated when a reflux plunger pulses a
bulb on the top of the cassette which forces fluid into the aspiration lines. A seventh valve has
been added to the pinch valve assembly to activate the reflux plunger.

4.4.3.5.15 Vitrectomy

The aspiration module provides an internal High Speed Pneumatic Vitrectomy (HSPV) valve
for driving the Bausch + Lomb Vitrectomy Probe Assembly. This valve is the Bausch + Lomb
valve assembly or equivalent. The pneumatic Vitrectomy valve is foam mounted so that it is
mechanically isolated from transmitting vibrations. A larger external custom male locking luer
fitting is provided on the front face of the module for interfacing with the Bausch + Lomb
Vitrectomy Probe Assembly.

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The air pressure of 42 psig ± 0.5 psig required to drive the pneumatic Vitrectomy cutter is
provided by an external air source. The air supply is sufficient enough to drive the cutter at rates
of 30 to 5000 cuts per minute.

The input air pressure connector for the Vitrectomy is located on the back of the module. The
input air pressure tubing for the Vitrectomy is ¼" O.D. X 0.159" I.D. and color coded Blue. The
blue pressure tubing will route the air pressure from the internal Vitrectomy valve to the blue
connector located at the rear of the module. The air exhaust tubing for the Vitrectomy is ¼"
O.D. X 0.159" I.D. and color coded Green. The exhaust tubing routes the exhaust from the
internal Vitrectomy valve to a green color connector located at the rear of the module. Probe
sensing is accomplished using the exhaust side (green tubing) of the Vitrectomy valve.

The air pressure tubing from the Vitrectomy valve to the front Male luer lock connector is 1/8'
O.D. X 1/16" I.D. and color coded blue.

4.4.3.5.16 Vacuum Transducer

The module contains a transducer for measuring the vacuum within the cassette and internal
vacuum line. The transducer is in contact with the air within the vacuum system. The transducer
is able to withstand contact with balanced saline solution and/or water. The transducer shall
measure in the range of 0 to -14.7 psig. Accuracy = ± 0.25% full scale or better. The transducer
has a repeatability of ± 0.2% typical (0.5% max.) full scale or better. The maximum measurable
resolution needs to be ± 0.5 mmHg or better. The linearity is 0.01% typical (.05% max.) full
scale or better. The transducer has a minimum response time of 10.0 ms or better.

4.4.3.6 Error Recovery

The system shall not allow priming if a cassette fails the vacuum check.

Upon a cassette failing the cassette check. The system returns to its pre check state and will eject the
cassette, allowing the user to insert the cassette again. The module reports the error condition to the
network and recommends that the user attempt to carefully re-insert the cassette after verifying that
the cassette is in good condition.

Upon a cassette failing the second cassette check, the module reports the error condition to the
network and recommends that the user check all fittings and connections or attempt to insert a new
cassette.

Upon a cassette failing the vacuum check the system returns to its pre vacuum check state and will
eject the cassette, allowing the user to insert the cassette again. The module reports the error
condition to the network and recommends that the user attempt to re-insert the cassette after
verifying that the cassette has been properly connected and is in good condition. A vacuum check
will be performed once a cassette is re-inserted.

Upon a cassette failing the vacuum check the module reports the error condition to the network and
recommends that the user attempt to insert a new cassette.

The system shall support priming of both aspiration lines.

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Upon failure to prime the aspiration system, the system returns to its pre-primed state, allowing the
user to again command priming. The module reports the error condition to the network and the user.
The user will be instructed to check all connections before attempting to re-prime the system.

Upon a cassette failing the aspiration system prime, the system reports the error condition to the
network and recommends that the user check all fittings and connections or attempt to insert a new
cassette.

Upon failing to re-prime a cassette, the system returns to its pre-prime state, allowing the user to
again command priming. The module reports the error condition to the network and recommends
that the user attempt a cassette vacuum check.

Upon a cassette failing the re-prime, the system reports the error condition to the network and
recommends that the user check all fittings and connections or attempt to insert a new cassette.

4.4.3.7 Assembly

All tubing is color coded and when possible the color code matches so that the color is the same as
past pneumatic functions.

The design should strive to use 1 or 2 common fasteners. The design has positive latching type
connectors. The design should not use the same size connector (i.e. the Posterior Fluidics Module
internal connectors should have a different number of pins to avoid assembly errors). In a case of
two (2) connectors having to be the same configuration then the cable length should be such that it
is impossible to connect the wrong component into the wrong connector.

4.4.4 Module Shipping Configuration

4.4.4.1 Labelling

The module label contains a bar code, assembly and serial numbers, and appropriate regulatory
markings.

4.4.4.2 Warnings

Fluid level in the cassette is 240 ml. Please consider emptying cassette.

Fluid level in the cassette is 280 ml. Please consider emptying cassette.

Fluid level in the cassette is 280ml, 100% of maximum capacity has been reached. The cassette must
be emptied before proceeding.

If inserted full (280 ml - 300 ml) - Fluid level in cassette is at or near 100% of maximum capacity.
The cassette must be emptied before proceeding. Please refer to the Operator’s Manual if problems
occur.

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Figure 4.11. PFM Pneumatics Diagram.

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Figure 4.12. PFM Electrical Block Diagram

4.5 Compressor (Anterior only)

The Compressor module is a non-user interface module within the system (not externally visible) and provides all
the system’s pneumatic requirements for Cataract and Vitreoretinal surgeries, and also for the active pressurized
infusion control.

The Compressor module provides a pressure source for fluidics module pinch valves, the fluidics module
pneumatic vitrectomy output, the pressurized infusion, and the viscous fluid injection output. The bottle infusion
output is directly connected to a port in the Bausch + Lomb Stellaris Vision Enhancement System skin. The
Compressor module has the following features:

• Sliding vane pump for aspiration function in the vacuum based fluidics modules.
• Compressor for pinch valves, the fluidics module pneumatic vitrectomy output.
• Compressed air for pressurized infusion.
• Dual pump for viscous fluid injection/aspiration.

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A CAN Network cable is routed from the User Interface Computer / Screen to the Compressor module. A common
power line is routed from the Power Module to the Compressor module, Expansion Module, Ultrasound Module,
Fluidics Module, User Interface Computer / Screen, IV Pole and Foot Control but may be divided for functions
within each module.

4.5.1 Power Requirement

The power for the compressor and vacuum module is provided by the power module. The power requirement
is 24 VDC, the maximum current shall be less than or equal to 20 amps and the maximum of power
consumption is 480 W.

4.5.2 Physical Attributes

The compressor and vacuum module are placed as low as possible in the EMB for add stability in tip testing
and to aid in sound mitigation.

4.5.2.1 Size

Maximum 12” (W) X 19” (H) X 6.16” (D)

4.5.2.2 Weight

Approximately 45 lbs.

4.5.3 Enclosure

The enclosure is metal with provisions for guarding against electromagnetic emissions.

4.5.3.1 Airflow requirements

Airflow rate is sufficient to keep module internal temperature below 40ºC (104ºF) and surface
temperature below 48ºC (120ºF).

4.5.3.2 Filter, Autodrain Filter and Pressure Relief Valve

The Compressor module has a filter to remove particulate from the input air down to the 5 micron
size. The auto-drain filter (10 micron) will assist in capturing and removing moisture and drain
toward the bottom. 40 psig ASME pressure relief valves are provided to control pressure of the main
compressor.

4.5.4 Interface Requirements

4.5.4.1 Pneumatic Output Connection (Interface)

Connections may be grouped as a single attachment or may be individualized but grouped on the
same side of the module with adequate space for finger attachment (approximately 1 inch edge to

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edge spacing). There are total of eight air connections, CAN network cable, auto drain and one power
line in the Compressor module as follows:

• A vacuum connection for operation of the fluidics module in vacuum mode. Vacuum line size is:
¼” OD and 0.159” ID, the material is to be: Polyurethane (clear). The connector used is ¼”
SMC one touch pneumatic bulkhead connector. The connector is color coded white.

• A pressure connection for operation of the pinch valve in the fluidics module. Line size is: ¼” OD
and 0.159” ID, the material is to be: Polyurethane (Red). The connector used is ¼” SMC one
touch pneumatic bulkhead connector. The connector is color coded red.

• A pressure connection for operation of the pneumatic vitrectomy cutter (Reference: 37 psig to 45
psig, 0.2 SCFM). Line size is to as follows: ¼” OD and 0.159” ID, the material is to be:
Polyurethane (Blue). The connector used is ¼” SMC one touch pneumatic bulkhead connector.
The connector should be color coded blue.

• A pneumatic exhaust connection that vents the vitrectomy cutter exhaust air into the module for
sound dampening and a more quiet operation. Pneumatic exhaust line size is to be: ¼” OD and
0.159” ID, the material is to be: Polyurethane (Green). The connector used is ¼” SMC one
touch pneumatic bulkhead connector. The connector is color coded green.

• An air exchange connection for balanced salt solution bottle pressurization. Air exchange line
size shall be: ¼” OD and 0.159” ID, material is to be: Polyurethane (Yellow). The connector
used is ¼” SMC one touch pneumatic bulkhead connector. The connector is color coded
yellow.

• Two separate fluid exchange connections for fluid injection/aspiration. Fluid exchange line size
shall be: 1/8” OD and 1/16” ID, the material is to be: Polyurethane (Red for pressure and Clear
for vacuum). The connectors used are 1/8” SMC one touch pneumatic bulkhead connectors.
The connectors are color coded, red for pressure and white for vacuum.

• A pressure connection for pressurized infusion. Air exchange line size shall be: 1/8” OD and
1/16” ID, the material is to be: Polyurethane (Yellow). The connector to be used is 1/8” SMC
one touch pneumatic bulkhead connector. The connector should be color coded yellow.

Leakage rate on the pinch valve pressure line may not be greater than 64 STD cc/min for the system,
and 7 STD cc/min is allocated to the Compressor module and 57 STD cc/min is allocated to fluidics
module (vacuum or flow) when system is active but not in use.

Leakage rate on the vacuum system may not be greater than 30 cc/sec at 600 mmHg when system is
active but not in use. There is no leakage rate restriction on the vitrectomy valve exhaust line.

4.5.5 Power and Communication Interference

One locking electrical connector for power and I/O. The connector used is an FCT Group FH9W4P5 plus four
FMP009P104 high-power pins with F1080 metal brackets with snap-in rivets and M3 threaded spacer (FCT
Part No. FH9W4P5-1161).

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4.5.6 CAN Network Cable (Communication)

A CAN Network cable is routed from the User Interface Computer / Screen to Compressor module.

4.5.7 Power Supply Interface

A common power line is routed from the Power Module to the Compressor module. The Compressor module
provides power to the illumination light of the balanced salt solution bottle pressurization port in the EMB.

4.5.7.1 Mounting Method

The Compressor module is mounted in the EMB using the mounting system provided by the EMB.
The Compressor module is isolated for vibrations and noise generated within the module. The
mounting system shall satisfy the shock and vibration requirements stated in Section 6.4 of Next
Generation Microsurgical System-General Technical Specification (118-006-023).

4.5.7.2 Noise

The Compressor module acoustical noise shall comply with the requirement of Section 6.5 of the
NEXT GENERATION MICROSURGICAL SYSTEM General Technical Specification (118-006-
023).

4.5.7.3 Reliability

The module MTBF (Mean Time between Failure) is 1,300 surgery hours.

4.5.7.4 Others

Reference to Section 6 General Requirements of Next Generation Microsurgical System-General


Technical Specification (118-006-023).

4.5.8 Functional Requirements

4.5.8.1 Accumulator

The compressor provides compressed air to charge the air reservoir in less than 15 seconds. The
reservoir volume shall be 24 in3. The pneumatic cylinders will be filled by a compressor and
accumulator system. The purpose of the accumulator system is to reduce the on-time of the
compressor. When the module is active but not in use, a fully charged accumulator system will not
decay and require recharging in less than 5 minutes. The compressor will run to boost the head to
40psi or the maximum popup pressure whenever it drops to 28 psig.

For reference only, the compressed air to activate the irrigation pinch valve on and off which is
located in the Fluidics module shall be provided by Compressor module.

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4.5.8.2 Vitrectomy

The Compressor module meets all requirements for vitrectomy operation up to an altitude of 3000
feet. Above 3000 feet, the Compressor module meets all requirements for vitrectomy operation up
to an altitude of 8000 feet to within ± 20% of the nominal cuts per minute. The Compressor module
is not designed to function above 8000 feet. The Compressor module provides air pressure of 37
psig to 45 psig to drive the pneumatic vitrectomy cutter. The Compressor module provides air flow
of 0.2 Standard Cubic feet per minute [SCFM] ± 5% required to drive the pneumatic vitrectomy
cutter.

4.5.8.3 Vacuum Pump

The Compressor module provides sufficient aspiration ability in “venturi” mode to drive a single
aspiration port in the vacuum based fluidics module. The method of generating the required vacuum
is through a sliding vane pump. The pump will be driven via an internal DC motor powered by the
power supply module. A vacuum reservoir is added to the aspiration line as required by the fluidics
module.

The sliding vane pump in the Compressor module will provide a minimum of 600 mmHg maximum
vacuum in a sealed cartridge up to 3000 feet above sea level. (A derating of 19.4 mmHg per 1000
feet will be used for operation above 3000 ft).

Stable vacuum source: The variation of steady state vacuum is less than 3% of the commanded level.

4.5.8.4 Vacuum Rise Time

The sliding vane pump is able to provide the system with an aspiration rise time (10% - 90% of
maximum) less than or equal to 1.3 ± 0.2 second over the entire aspiration range (0 - 600 mmHg ±
30 mmHg) at a closed volume of 300 ml at sea level.

4.5.8.5 Pressurized Infusion

A compressed air line from the main compressor is reduced to a pressure of 370 ± 100 mmHg to
provide necessary air pressure for pressurized bottle infusion and pressurized infusion function. The
compressed air line charges to a pressure reservoir to provide infusion pressure between 0 to 100
mmHg up to 3000 feet above sea level for the pressurized infusion. The pressurized infusion is able
to provide a pressure limit range from 5 mmHg to 100 mmHg in 1 mmHg interval.

The steady state pressure limit accuracy is ± 5 mmHg. The ripple pressure is no more than 5 mm Hg.
Pressure Rise Time (10% - 90% of maximum) less than or equal to 6 second over the entire pressure
range (5 - 100 mmHg ± 5 mmHg) at sea level with a volume of 410 ml.

4.5.8.6 Labelling

The Compressor module labelling provided shall contain a bar code, assembly, serial number, and appropriate
regulatory markings.

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Figure 4.13. Original Compressor Pneumatic Diagram.

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Figure 4.14. Compressor (Optimized for Noise Abatement) Pneumatic Diagram.

4.6 Posterior Compressor (Posterior and Combined only)

The Posterior Compressor Module is a non-user interface module buried within the system (not externally visible)
and intended to provide all the system’s pneumatic requirements.

The Posterior Compressor Module contains a Printed Circuit Board, Viscous Fluid Device (pump and valves), IOP
Pump and Valve Assembly, Accumulator Reservoir, AFX/IP Directional Control, Line Pressure Filter, regulators
and shut off valves. The Posterior Compressor module uses an external medical grade air source to supply air
needed for the PFM to generate vacuum (Venturi). The bottle infusion output is directly connected to a port in the
Bausch + Lomb Stellaris Vision Enhancement System outer skin.

Posterior Compressor module has the following features:

• External air connection for aspiration function in the vacuum based posterior - combined fluidics.
• Provides regulated pressure for pinch valves, the pneumatic vitrectomy output.
• IOP pump for pressurized infusion.

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• Dual pump for viscous fluid injection/aspiration.


• A Pressurized Infusion LED connector is located on the back of the Posterior Compressor Module.

A CAN Network cable is routed from the User Interface Computer to the Posterior Compressor Module through
the connector on the back of the module. A common power line is routed from the Power Module to the Posterior
Compressor Module through the connector on the back of module. This power line also goes to all the modules in
the Bausch + Lomb Stellaris PC Vision Enhancement System.

4.6.1 Power Requirement

The power for the Posterior Compressor and Vacuum module is provided by the Power Module. The power
requirement is 24 VDC.

4.6.2 Physical Attributes

The Posterior Compressor and Vacuum Modules are placed as low as possible in the EMB for added stability
in tip testing and to aid in sound mitigation.

4.6.2.1 Size

12” (W) X 17.75” (H) X 6.25” (D)

4.6.2.2 Weight

Approximately 23 lbs.

4.6.3 Enclosure

The enclosure is metal with provisions for guarding against electromagnetic emissions.

4.6.3.1 Filter (Autodrain Filter)

The Posterior Compressor Module has an auto-drain filter to remove particulate from the input air
down to the 5 micron size. The auto-drain filter (5 micron) will assist in capturing and removing
moisture and drain toward the bottom of the system.

4.6.4 Interface Requirements

4.6.4.1 Pneumatic Output Connection (Interface)

Connections are grouped on the same side of the module with adequate space for finger attachment
(approximately 1 inch edge to edge spacing). There are a total of eight pneumatic connections, CAN
network cable and IOP illumination.

• A pressure connection for operation of the Fluidics Module vacuum. Vacuum line size is: ¼” OD
and 0.159” ID, the material is to be: Polyurethane (Orange). The connector used is a ¼” SMC
one touch pneumatic bulkhead connector. The connector is color coded orange.

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• A pressure connection for operation of the pinch valve in the Fluids Module. Line size is: ¼” OD
and 0.159” ID, the material is to be: Polyurethane (Red). The connector used is a ¼” SMC one
touch pneumatic bulkhead connector. The connector is color coded red.

• A pressure connection for operation of the pneumatic vitrectomy cutter. At full speed operation
the HSPV shall consume no more than 0.2 SCFM supply air at 42.5 PSI. Line size is as
follows: ¼” OD and 0.159” ID, the material is to be: Polyurethane (Blue). The connector used
is ¼” SMC one touch pneumatic bulkhead connector. The connector should be color coded
blue.

• A pneumatic exhaust connection that vents the vitrectomy cutter exhaust air into the module for
sound dampening and a more quiet operation. Pneumatic exhaust line size is to be: ¼” OD and
0.159” ID, the material is to be: Polyurethane (Green).

• An air connection for balanced saline solution bottle pressurization. Air exchange line size shall
be: ¼” OD and 0.159” ID, material is to be: Polyurethane (Yellow). The connector used is a ¼”
SMC one touch pneumatic bulkhead connector. The connector is color coded yellow.

• A fluid exchange connection for fluid injection/aspiration (VFX). The fluid exchange line size
shall be: 1/8” OD and 1/16” ID, the material is to be: Polyurethane (Black). The connectors
used are 1/8” SMC one touch pneumatic bulkhead connectors. The connector color code is
black.

• A pressure connection for air fluid exchange line size shall be: 1/8” OD and 1/16” ID, the
material is to be: Polyurethane (White). The connector to be used is a 1/8” SMC one touch
pneumatic bulkhead connector. The connector should be color coded white.

There is no leakage rate restriction on the vitrectomy valve exhaust line.

4.6.5 Power and Communication Interference

One locking electrical connector for power and I/O. The connector used is an FCT Group FH9W4P5 plus four
FMP009P104 high-power pins with F1080 metal brackets with snap-in rivets and M3 threaded spacer (FCT
Part No. FH9W4P5-1161).

4.6.6 CAN Network Cable (Communication)

A CAN Network cable is routed from the User Interface Computer/Screen to the Posterior Compressor
Module.

4.6.7 Power Supply Interface

A common power line is routed from the Power Module to all the modules. The Posterior Compressor Module
provides power to the illumination light of the balanced saline solution bottle pressurization port in the EMB.

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4.6.7.1 Mounting Method

The Posterior Compressor Module is mounted in the EMB using the mounting system provided by
the EMB. The Posterior Compressor Module is isolated for vibrations and noise generated within
the module. The mounting system shall satisfy the shock and vibration requirements for compliance
to NAVMAT-P9492 & MIL-STD-810F for shock and random vibration.

4.6.7.2 Noise

The system noise shall be less than or equal to 45 dbA above ambient noise at one meter distance
from front, sides, and back of system. The Posterior Compressor Module shall be isolated from
vibrations generated within the module and to minimize acoustic noise.

4.6.8 Functional Requirements

4.6.8.1 Vitrectomy

The Posterior Compressor Module meets all requirements for vitrectomy operation up to an altitude
of 3000 feet. The Posterior Compressor Module provides air pressure of 42 psig ± 0.5 psig to drive
the pneumatic vitrectomy cutter (Bausch + Lomb Vitrectomy Probe Assembly). The Posterior
Compressor module shall provide air flow of 0.2 Standard Cubic feet per minute [SCFM] ± 5%
required to drive the pneumatic vitrectomy cutter.

4.6.8.2 Vacuum

The Posterior Compressor Module provides sufficient aspiration ability in the Venturi mode to drive
a single aspiration port in the vacuum based fluidics module. The method of generating the required
vacuum is through an external air medical grade source.

The Posterior Compressor Module will provide a minimum of 600 mmHg maximum vacuum in a
sealed cartridge up to 3000 feet above sea level. (A derating of 19.4 mmHg per 1000 feet will be
used for operation above 3000 ft).

4.6.8.3 Pressurized Infusion

A compressed air line provides the necessary air pressure for pressurized bottle infusion and
pressurized infusion function. The compressed air line charges a pressure reservoir to provide
infusion pressure between 0 to 150 mmHg up to 3000 feet above sea level for the pressurized
infusion.

The pressurized infusion is able to provide a pressure limit range from 5 mmHg to 150 mmHg in 1
mmHg interval. The steady state pressure limit accuracy is ± 5 mmHg. The ripple pressure is no
more than 5 mmHg.

4.6.8.4 Labelling

The Posterior Compressor Module labelling provided shall contain a bar code, assembly, serial
number, and appropriate regulatory markings.

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Figure 4.15. Posterior Compressor Pneumatic Diagram

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Figure 4.16. Posterior Compressor Model Electrical Block Diagram

4.7 Posterior Illumination Module (Posterior and Combined Only)

4.7.1 Enclosure (Chassis)

The module enclosure provides mechanical support, physical protection and control of airflow.

4.7.2 Front ‘Customer’ Panel

4.7.2.1 Connectors

The front panel has four connectors:

• The first (top) port is for Viscous Fluid Injection and Aspiration.
• The second port is for air forced infusion and Fluid/Air Exchange.
• The third port is for illumination lamp 2.
• The fourth port (bottom) is for illumination lamp 1.

4.7.2.2 Connector Illumination

The connectors are illuminated by a ring of LEDs controlled by the PIM firmware.

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4.7.3 Electrical Interface

4.7.3.1 Processor

The PIM Main PCB uses a Freescale MCF5282 Coldfire microprocessor.

4.7.3.2 Selected Processor Interface Signals

Port Signal
PC0 LED_AFX_ON
PC1 LED_VFI_ON

PC2 LED_LAMP1_ON

PC3 LED_LAMP2_ON

PC6 ATT_HOME1

PC7 ATT_HOME2

PD0 FILTER_MOTOR_EN_N

PD1 FILTER_MOTOR_DIR

PD2 FILTER_MOTOR_BRAKE_N

PD3 ATT_STEP_MOTOR1_1_CUR_CNTRL

PD4 ATT_STEP_MOTOR1_DIR

PD5 ATT_STEP_MOTOR2_DIR

PD6 ATT_STEP_MOTOR1_2_MS1

PD7 ATT_STEP_MOTOR1_2_MS2

PEL0 LAMP1_ON_N

PEL1 LAMP1_CURRENT_SEL

PEL2 LAMP1_CLOCK

PEL3 LAMP1_DATA

PEL4 LAMP2_ON_N

PEL5 LAMP2_CURRENT_SEL

PEL6 LAMP2_CLOCK

PEL7 LAMP2_DATA

PEH0 FAN1_ON

PEH1 FAN1_FAULT_N

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Port Signal
PEH2 FAN2_ON
PEH3 FAN2_FAULT_N

PEH4 FAN2_ON

PEH5 FAN2_FAULT_N

PEH6 LED_ON_N

PEH7 ATT_STEP_MOTOR1_2_SLEEP_N

PNQ1 FILTER_NONE

PNQ2 FILTER_A

PNQ3 FILTER_B

PNQ4 FILTER_C

PNQ5 LAMP1_STRIKE_IND_N

PNQ6 LAMP2_STRIKE_IND_N

AN1 BAL_TEMPERATURE

AN2 +24V_DIV

AN3 PCB_TEMPERATURE

AN52 LAMP1_VOLTAGE

AN53 LAMP1_CURRENT

AN55 LAMP2_VOLTAGE

AN56 LAMP2_CURRENT

GPTA0 ATT_STEP_MOTOR1_STEP

GPTA1 FAN1_ROTATING

GPTA2 FAN2_ROTATING

GPTB0 ATT_STEP_MOTOR2_STEP

GPTB1/3 FAN3_ROTATING

4.7.3.3 Power

The Illumination Module is powered by 24 VDC. The Lamp Ballasts receive their power separately.

4.7.3.4 Network

The module communicates to other modules within the Stellaris PC via a CAN bus.

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4.7.4 Front Panel Input/Output

4.7.4.1 Illuminated Panel Connector

Pin Signal
1 24V
2 AFX

3 VFI

4 PROBE 1

5 PROBE 2

6 GND

Table 4.16:

4.7.4.2 Viscous Fluid Connector

The Viscous Fluid Connector is Bausch + Lomb P/N 102004876 (FEMALE LUER TO
BULKHEAD ASSY) or equivalent.

4.7.4.3 F/AX and AFI Connector

The Fluid Air Exchange and Air Forced Infusion Connector is Bausch + Lomb P/N 007009058
(FEMALE LUER TO BULKHEAD,#A1470) or equivalent.

4.7.4.4 Lamp 1, Lamp 2 Connectors

Proprietary NGPC Illumination probe connectors with automatic shutter mechanisms.

4.7.5 Module Viscous Fluid Output and Fluid and Air Exchange

The Illumination module does not control either of these functions but is merely a pass-through for tubing.
See below for functional descriptions.

4.7.5.1 Fluid/Air Exchange Operation

The Fluid/Air Exchange mode is a posterior feature which provides the surgeon with the ability to
instill a preset air pressure into the eye for Fluid/Air Exchange. It supports pressures up to 150
mmHg at flow rates up to 3.5 standard cubic feet (99 liters) per hour. The air pressure from the pump
may be adjusted from 0 to 150 mmHg in 1 mmHg increments.

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4.7.5.2 Viscous Fluid Control (VFC) (Posterior Only)

WARNING: THE VISCOUS FLUID CONTROL IS NOT INTENDED FOR ASPIRATION OF BALANCED
SALT SOLUTION.

WARNING: SUBRETINAL CANNULAS ARE NOT INTENDED FOR ASPIRATION OF VISCOUS FLUID OR
BALANCED SALT SOLUTION.

The Stellaris PC Vision Enhancement System’s Viscous Fluid Control function generates the
required injection pressures and aspiration vacuums for injecting viscous fluids to and aspirating
viscous fluids from the eye during posterior segment surgery. The Viscous Fluid function will
deliver up to 72.5 psig (500 kPa, 5.0 bar) of pneumatic pressure to the disposable tube set. All other
posterior system functions except fragmentation and vitrectomy may be operated simultaneously or
in conjunction with this function.

4.7.5.3 Viscous Injection (Oil)

When used in the injection mode, the system can inject up to 5 cc of 1000 to 5000 centistoke silicone
oil @ 24 °C in less than 6.25 minutes.

4.7.6 Illumination

The primary function of the Illumination Module is to provide a light source useful for illuminating the
posterior segment of the eye.

The module has mounting features for two lamps, both of which must be installed for operation of either lamp.

Each lamp may be a xenon type or a xenon-mercury type. Both lamps are short-arc lamps. They require a high
voltage pulse (15 – 30 kV) to ignite. But after ignition they run from low voltage DC. The igniter modules
(mounted inside the PIM) generate the high ignition voltage pulse while the ballast units (mounted below the
PIM) generate and control the DC drive for the lamps. The lamps do not have a filament to burn out but as
they age become dimmer and more difficult to start. A memory module on each lamp housing stores life usage
data so that the lamp can be removed from use before it normally fails.

Both channels feature a mechanical attenuator which may be adjusted to any setting from 0% to 100% in 1%
increments. Each attenuator is individually operated by a step motor through a gear train. An optical sensor
is used to sense the home position. The attenuator is assembled from a pair of finely slotted plates which are
rotated over approximately 45º to control the light level. A firmware-based alignment procedure is used to
compensate for tolerances in the attenuator assembly and should be repeated if the attenuator parts are
removed and replaced (even if same parts are put back) or if the PIM Main PCB is replaced (the PIM Main
PCB stores values associated with the alignment). Failure to perform this alignment may result in errors in
output value (for example, maximum output may not occur at the 100% setting). The attenuator can be moved
by hand without damaging the mechanism; however care must be taken not to damage the fine slats of the
attenuator plates. Damage to these plates may cause patterns (such as rings) in the light output and may make
it impossible to successfully align the attenuator.

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Each probe connection point has a shutter mechanism built-in. The shutter is a comprised of a spring-loaded
part which moves out of the way as the connector is inserted.

The lower channel (Lamp 1) features three selectable filters: amber, green tint and yellow tint. These filters
are only available when a xenon lamp is installed in the Lamp 1 location. Hall-based sensors are used to detect
magnets in the filter holders. A small geared DC motor drives the filter camshaft through a belt. This motor
runs in one direction only, such that some filters are cycled in the following order: no filter, amber, green,
yellow. The mechanism can be moved by hand but only in one direction. In the other direction the cams will
block motion.

Each lamp housing contains a memory device which is used to communicate the lamp type to the module and
is used to store usage information about the lamp.

Figure 4.17. Posterior Illumination Module Electrical Block Diagram

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4.8 Power Module with Battery Backup

The Power Supply Module provides electrical power to all parts of the Bausch + Lomb Stellaris Vision
Enhancement System integral to the Electromechanical Base (EMB). The Power Supply Module will prevent
short- term interruptions of power to the Bausch + Lomb Stellaris Vision Enhancement System.

The Power Module will consist of the following items:

1. An AC to DC power supply.

2. A short-term backup battery.

3. A mains power switch, mains input connector, mains fusing. These will be external to the Power Supply
Module, as they must be user-accessible.

4. Input and output cable connection points.

5. Wiring/cables between power module components.

6. A connection point to a digital start-up switch, which will be part of the User-Interface Computer (UIC)
assembly.

4.8.1 Physical Specifications

Maximum Nominal Case Height: 13.6 inches

Maximum Nominal Case Width: 11 inches

Maximum Nominal Case Depth: 5 inches

Mounting is shown below:

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Figure 4.18. Power Module Mounting Layout.

The battery is external to the main power supply and fits within a volume of approximately 25 cubic inches
in a form factor which is accommodated by the interior volume of the Bausch + Lomb Stellaris Vision
Enhancement System chassis (Reference diagram above). The power supply and backup battery are
separately removable from the EMB when necessary.

4.8.1.1 Weight

The Power Module weighs about 15 pounds (6.8 kg).

4.8.2 Environmental Specifications

4.8.2.1 Temperature Regulation

The Power Module requires no more than 75 CFM airflow during operation to maintain an external
surface temperature less than 48 °C. The Power Module cooling fan speed is controllable via
software.

4.8.2.1.1 Temperature

The Power Module operates within a minimum range of 10° to 40 °C. The Power Module is
capable of storage within a minimum range of -20° to 60 °C.

4.8.2.1.2 Humidity

The Power Module operates within a minimum range of 30% to 70% (relative). The Power
Module is capable of storage within a minimum range of 10% to 98% (non-condensing).

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4.8.2.1.3 Shock and Vibration

The Power Module shall withstand shock and vibration as defined by the specifications listed
in the External Reference Documents.

4.8.3 Power Level Specifications

4.8.3.1 Input

The Power Module operates on voltages from 90-264 VAC. The Power Module operates on
frequencies from 47-63 Hz. The steady-state input current shall be no greater than 6 A at 240 VAC.
The inrush current shall be no greater than 40 A for a half-cycle at 240 VAC. The power-up time
shall be no greater than 100 ms. AC Input fuses are 10 A slow-blow style fuses. AC Input fuses shall
be user-replaceable or self-resetting. For reference, the backup battery is not a power conditioner.

4.8.3.2 Output

The Power Module has a single output of 24 VDC +3/-0%. The power-up overshoot is less than 10%
for less than 100 ms. Output voltage ripple will not exceed 250 mV peak to peak. The Power Module
has a minimum output current capacity of 41 A total steady-state current. In the case of over-current,
the Power Module is limited to a maximum of 130% of the rated output current. The output voltage
may be out of regulation. In the case of over-voltage, the Power Module is clamped to a maximum
of 135% of the rated output voltage. The minimum load shall be at most 10% capacity. The Power
Module shall be reverse voltage protected to at least 100% of the rated output current. The Power
Module will recover from step loads of 25% of the rated output current to within 1% tolerance within
2 ms.

4.8.4 Connections and Switches

4.8.4.1 AC Mains

The Power Module connects to AC mains via an IEC 60320-1/C14 standard input plug. The Power
Module has a mains power switch at the AC input. The Power Module is capable of sensing the state
of the mains power switch while the Power Module is in a powered up state. For reference, the AC
Input is connected similarly to the following:

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Figure 4.19. AC Main Electrical Diagram.

4.8.4.2 DC Output

The Power Module DC output connects to the other Bausch + Lomb Stellaris Vision Enhancement
System modules and powered components integral to the EMB via a single connection point as
defined through the EMB technical specification, #118006026.

The Power Module has a connection to a digital-level "soft-switch" which performs as follows:

The switch is a momentary switch. With power to the system switched off, closing the switch
commands the Power Module to switch on power supplied to the system. With power to the system
switched on, holding the switch closed for a given amount of time shuts down power to the system.
A CAN bus command is sent to the User-Interface Computer (UIC) as this shut-down takes place
whether or not the UIC responds. The default amount of time is 3 seconds.

The amount of time is programmable by the UIC.

The Power Supply supplies a 12 VDC rail to power LEDs to light up the soft-switch. The switch will
light up green with the mains power switch on and no DC power supplied to the system. The switch
will light up a dimmer green with the mains power switch on and DC power supplied to the system.
The Power Supply supplies a signal-level open collector output to enable this change.

4.8.5 System Communication

The Power Module at a minimum is capable of communicating the following via the CAN bus interface:

• Power Supply operating status and output level.


• Backup Battery level.
• Critical temperatures of the Power Supply and Battery.

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• Digital soft-switch status.

The Power Module is capable of switching off the power supplied to the system following a received CAN
bus command.

4.8.6 Backup Battery Specifications

4.8.6.1 Battery

A NiMH battery is to be used. The battery is to be reverse voltage protected. The battery is thermally
protected against charging fault.

4.8.6.2 Timing

The backup battery provides 100 W of power at 24 VDC for no less than 1 minute in the event of
loss of AC mains power. The Power Module has a backup hardware timer nominally set to 90
seconds. The backup battery charges in a maximum time of 4 hours from a fully discharged state.
The Power Module reports an error if the Power Supply is unable to charge the battery. The backup
battery holds enough charge to perform per specification with power off for a minimum of 7 days.
The backup circuitry communicates switchover to backup power over the CAN bus. The backup
circuitry affects a switch to battery-power in a maximum of 50 milliseconds. The Power Module
sends a CAN bus command to all other modules to enter a lower-power state and reply when
completed. If module load is not dropped to low-power state and communicated back to the PSM
within 50 milliseconds, the Power Module shuts-down without switching to the backup battery. The
Power Module output will not deviate from regulation for longer than 2 ms during change-over to
battery backup output.

4.8.6.3 Charging

Provided the battery voltage is 3.2 V or greater, the backup battery charges the battery with the mains
power switch switched on, regardless of system power state. The charging algorithm is specific to
the battery and controlled via the Power Supply Module Software.

4.8.7 Regulatory Specifications

4.8.7.1 General Safety

As part of the Bausch + Lomb Stellaris Vision Enhancement System, the Power Module shall
comply with the general safety standards as listed in the External Reference Documents.

4.8.7.2 Electromagnetic Compatibility (EMC)

As part of the Bausch + Lomb Stellaris Vision Enhancement System, the Power Module shall
comply with the EMC standards as listed in the External Reference Documents.

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4.8.7.3 Materials

The Power Module shall comply with the WEEE/RoHS initiative where possible and practical for
those components under direct control of the direct vendors of Power Module components.

4.8.8 Service Specifications

4.8.8.1 Field Service

Power Supply Module components (power supply, battery, etc.) are replaceable in 30 minutes or
less with EMB skins previously removed.

4.8.8.2 Battery service

The backup battery is separately serviceable from the power supply. The Power Module counts the
number of backup battery usages. Battery life shall be no less than 3 years, as defined by 10 full
battery discharges per year, separated by daily cycles of power off and trickle charging.

4.9 Power Module without Battery Backup

The Power Supply Module provides electrical power to all parts of the Bausch + Lomb Stellaris Vision
Enhancement System integral to the Electromechanical Base (EMB).

4.9.1 Power Module Features

• An AC to DC power supply, incorporating a Power Factor Corrected input stage


• Input and output cable connection points
• Wiring/cables between power module components
• A connection point to a digital start-up switch, which will be part of the User-Interface Computer
(UIC) assembly
• An auxiliary 9.0 VDC, 1 amp minimum output for use for foot control battery charging.

4.9.2 Power Module Interface

• The EMB at the mechanical mounting interface


• The EMB power entry module, which will have the mains power switch, input connector and
customer accessible fusing
• The rest of the electrical modules via the CAN Bus communication bus and the 24 VDC power bus
• The UIC front panel soft start power on button via a cable
• The foot control connector will interface to the power supply module
• The FCIB will interface to the power supply module

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4.9.3 Physical Specifications Dimensions

These represent dimensional not to exceed constraints, but only mounting holes & cable locations must
remain the same.

Maximum Nominal Case Height: 14.4 inches

Maximum Nominal Case Width: 12.2 inches

Maximum Nominal Case Depth: 5.4 inches

Mounting and general layout shall be as shown below:

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Figure 4.20. Mounting and General Layout for Power Supply without Battery Backup.

4.9.3.1 Weight

The Power Module weighs approximately 15 pounds.

4.9.3.2 Airflow Requirements

The Power Module shall require no more than 90 CFM airflow during operation to maintain an
external surface temperature less than 48 °C.

The Power Module shall supply an air flow of at least 30 CFM into the system during normal mode
operation.

4.9.4 Environmental Specifications

4.9.4.1 Temperature

The Power Module shall meet all specifications of the Functional Output Specifications, over a
temperature range of 10° to 40 °C.

The Power Module shall be capable of storage within a minimum range of -20° to 60 °C.

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4.9.4.2 Humidity

The Power Module shall meet all the requirements of the Functional Output Specification, over a
humidity range of 30% to 70% (relative).

The Power Module shall be capable of storage within a minimum range of 10% to 98% (non-
condensing) where the dew point does not exceed 34 °C.

4.9.4.3 Barometric Pressure

The Power Module shall meet all specifications of the Functional Output Specifications, over a
barometric pressure range of 24.9 InHg to 30.45 InHg.

For Reference: this corresponds to 5000 feet above sea level to 500 feet below sea level.

4.9.4.4 Shock and Vibration

The Power Module shall meet all specifications of the Functional Output Specifications, after
withstanding shock and vibration as defined by the specifications listed in the General Technical
Specification. This requirement applies to both the module and the complete system.

4.9.4.5 Cooling Requirements

The temperature of all components in the supply shall be within their rated operating specification
when the supply is running at any power between 5% and 100% of its rated capacity at the maximum
temperature of 40 °C, the minimum humidity level of 30% and the minimum barometric pressure of
24.90 InHg.

4.9.4.6 Housing Requirements

The housing shall not have any openings that allow a M3 or larger screw to completely enter the
power supply.

If a M3 or larger screw should fall on the AC terminal block, the terminal block shall prevent the
screw from shorting to an adjacent terminal.

4.9.5 Operating Modes

4.9.5.1 General

There shall be three primary operating states for the outputs defined in section 4.7.7, depending on
the states from inputs defined in section 4.7.6. These are detailed in the sections below.

4.9.5.2 Off Mode

Mode Entry Trigger

• AC mains not present

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• All rails shall be disabled


• Signal input / output lines shall be high impedance (disabled)

4.9.5.3 Normal Power Mode

Mode Entry Trigger

• Standby mode and rising edge on soft start input after at least 0.1 second of being held low.

Enabled Rails

• +24 VDC
• +9.0 VDC
• Switched output to foot control enabled only when foot control detected

Front Panel LED output collector held low

4.9.5.4 Standby Mode

Mode Entry Trigger

Default power up state (AC Mains switched on).

Normal mode and a programmable low state period of between 1 second and 5 seconds on soft
start input pin.

• Time to transition from normal to standby mode entry time shall be longer if the CAN Bus
heartbeat is present than if the CAN Bus heart beat is not present.

Normal mode and shutdown command from the CAN Bus.

Enabled Rails

• +9.0 VDC

Switched output to foot control enabled only when foot control detected

• Front Panel LED output collector high impedance

Disabled Rails

• +24 VDC

4.9.6 Input Specifications

4.9.6.1 General

The power supply shall have four inputs.

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4.9.6.2 AC Power Input (In Normal and Standby modes)

The Power Module shall function correctly at mains input voltages between 90 and 264 VAC.

The Power Module shall function correctly at mains input frequencies between 47 and 63 Hz.

The Power Supply Module shall meet the requirements of EN61000-3-2 EMC Limits for Harmonic
Current Emissions.

The steady-state input current shall be no greater than 6 A at 264 VAC at maximum current capacity
in normal operating mode.

Reference: This requirement provides approximately 1464 watts input to support 1000 watts
output.

The steady state input current shall be no greater than 15 A at 90 VAC at maximum current capacity
in normal operating mode.

Reference: This requirement provides approximately 1350 watts input to support 1000 watts
output.

The inrush current shall be no greater than 40 A peak for 3 cycles at 240 VAC. Any inrush current
limiting circuitry shall be synchronized to the AC line frequency.

Higher amplitude transient spikes within 200 microsecond of initial current inrush do not violate
this requirement.

The inrush current shall be no greater than 20A for 3-cycles at 115 VAC. Any inrush current limiting
circuitry shall be synchronized to the AC line frequency.

Larger transient spikes within 200 microsecond of initial current inrush do not violate this
requirement.

The power-up time shall be no greater than 800 milliseconds, at all permissible mains voltage and
frequency conditions at full load on the +24 VDC output.

The power supply shall work properly (including inrush current limiting) for AC off periods less
than 20 milliseconds over the entire input voltage range.

4.9.6.3 CAN Bus data Input

The power supply shall be capable of communicating on the CAN Bus when required, with the
following messages that influence the functional outputs.

Input Message: Shut Down command from GUI, with a delay time period specified within the
CAN Bus command in tenths of a second.

Input Message: CAN Bus heartbeat.

Input Message: Power Off Button Hold Down Time: Time period required to hold down the soft
start button to turn the machine off, in tenths of a second.

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Input Message: Node reporting in that it has entered low power mode (remains for legacy
systems but not used).

Input Message: GUI informing power supply during set up of number of nodes to expect low
power mode messages from prior to transitioning to low power mode (remains for legacy
systems but not used).

The power supply microprocessor shall manage other internal housekeeping functions that do not
materially influence the functional outputs as required in the Power Supply Module Software
Detailed Design Specification.

4.9.6.4 Front Panel soft start control input

The Power Module shall have an input pin driving an operating state change by a momentary input.

The input state shall be normally high impedance.

The input shall be capable of being pulled low by a load to within 0.5 volts of ground by a load across
the pin and ground of no less than 100 .

Detection of the state of this input for the purposes of mode selection shall be internally debounced
for a period of between 20 and 50 milliseconds.

This state change shall toggle the power supply between Normal Mode and Standby Mode as
outlined in the mode section.

4.9.6.5 Foot Control Present input

The Power Module shall have an input pin indicating the presence of a foot control on the foot
control cable for the purposes of switching the 9.0 VDC rail on at the output pin.

The input shall be capable of being pulled to within 0.5 volts of ground by a current sink of no more
than 2 mA.

4.9.7 Functional Output Specifications

4.9.7.1 General

The power module shall have two power level output nodes, a signal level output node and a
communications node.

4.9.7.2 24 VDC Primary Power Source

The Power Module shall have a primary 24 VDC rail.

The 24 VDC rail shall be present on the output connection only in Normal operating mode.

The 24 VDC rail shall have a minimum output current capacity of 41A total steady-state current
when powered from the AC power line in normal operating mode.

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Load Regulation: The 24 VDC rail shall stay within the range of +3% and -1% of the nominal
voltage under current loads between 10% and 100% of rated current.

The 24 VDC rail shall have no more than 250 mV peak to peak voltage ripple bandwidth limited to
20 MHz under current loads between 10% and 100% of rated current.

The 24 VDC rail power-up overshoot shall be less than 10% for less than 100 ms.

The 24 VDC rail shall drop to less than 5 volts within 30 seconds of initial 2.4 volt decrease in output
at power down.

In the case of over-current, the 24 VDC rail shall be limited to a maximum of 125% of the rated
output current. The output voltage may be out of regulation in this condition.

In the case of over-voltage, the 24 VDC rail shall have an over-voltage shutdown during out of
regulation faults if the rail exceeds 32 volts.

The 24 VDC rail shall recover from step loads of 25% of the rated output current to within 1%
tolerance within 2 ms.

4.9.7.3 9.0 VDC Power Rail

The Power Module shall have a 9.0 VDC output to power the foot control and front panel LEDs
when the system is in standby or normal mode.

The 9.0 VDC foot control power shall only be present when the foot control present pins are shorted.

The 9.0 VDC rail shall have a minimum output current capacity of 1A total steady-state current
capacity when powered from the AC power line.

The 9.0 VDC rail shall stay within the range of +3% and -3% of the nominal under current loads
between 10% and 100% of rated current.

The 9.0 VDC rail shall have no more than 150 mV peak to peak voltage ripple bandwidth limited to
20 MHz under current loads between 10% and 100% of rated current.

The 9.0 VDC rail power-up overshoot shall be less than 10% for less than 100ms.

In the case of over-current, the 9.0 VDC rail shall be limited to less than the RMS value for 125%
of the rated output current. The output voltage may be out of regulation above rated current.

4.9.7.4 Front Panel Soft Start Control LED Bright / Dim Output

There shall be an open collector or open drain output to control the bright / dim state condition for
the front panel.

The output shall provide a minimum 0.5 mA current sink to ground in normal mode.

The output shall be high impedance in standby mode.

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4.9.7.5 Foot Control Present Output

There shall be an output, with no internal or onboard pull-up resistance, capable of meeting the
following requirements.

The output shall sink 0.4mA to less than or equal to 1.0 VDC when the foot control present input is
shorted to ground. This will generate a logic level zero at the FCIB microprocessor input. This is
effectively equal to an input impedance of no more than 2500 .

The output shall be no less than 2.5 VDC when sinking 0.08 mA when the foot control present input
is open to ground. This will generate a logic level one at the FCIB microprocessor input. This is
effectively equal to an input impedance of at least 32K .

4.9.7.6 Foot Control Data Transmission pass-through

The power supply shall pass foot control data signals from input to output without functionally
degrading them.

4.9.7.7 CAN Bus data output

The power supply shall be capable of communicating on the CAN Bus when required, with the
following messages:

Output Message: Shut Down commanded by Front Panel Button, to be sent prior to shutting down
the 24 V output.

Output Message: Module revision and serial number.

4.9.8 Connections

4.9.8.1 Backward Compatibility

The location and size of connectors shall be compatible with the connectors and length of cables
currently used with the power supply.

Connectors and labels shall be as shown below:

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Figure 4.21. Connections.

4.9.8.2 AC IN (AC MAINS) Input

The AC Mains Input connection shall be a 3 position terminal block, rated at 300 V, 20A.

Pin assignments shall be as follows:

Pin 1: Line (Power Input)

Pin 2: Neutral (Power Input)

Pin 3: Earth Ground (Common)

A label identifying each of the pin assignments shall be visible on the outside of the unit.

4.9.8.3 24 VDC Output

The Power Module DC output shall connect to the other Stellaris modules and powered components
integral to the EMB via a single connection point as defined through the EMB technical
specification.

The +24 VDC output connections shall allow a #10 spade terminal to be securely fastened.

Pin Assignments shall be:

Pin 1: 24 V (Power Output)

Pin 2: 24 V Return (Power Output)

A label identifying each of the pin assignments shall be visible on the outside of the unit.

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4.9.8.4 System Communication / Can Connector (input / output)

The communication connection shall be a three pin Hirose RP34-8R-3PDL receptacle.

Pin Assignments shall be:

Pin 1: CAN Bus High (Bidirectional signal level)

Pin 2: Not Connected

Pin 3: CAN Bus Low (Bidirectional signal level)

4.9.8.5 Front Panel Button Connection (input / output)

The front panel connection shall be a 5 pin Molex type 15912055 connection. This connection
provides both output connection for the 9.0 VDC LED power to the switch PCB, and the input
connection for the soft start power on / off control.

Pin assignments shall be:

Pin 1: Soft Start Switch Contact (normally open, shorts to ground, pulled up inside power supply
by no more than 5 mA) (signal input)

Pin 2: GND (Common)

Pin 3: Not Connected for unique connector Poke Yoke

Pin 4: LED Bright / Dim State (Signal Output)

Pin 5: +9.0 VDC Supply (Power Output)

4.9.8.6 Foot Control Connection (input / output)

The foot control cable connection shall be a latching female DB9 connector.

Pin assignments shall be:

Pin 1: 9.0 Volts switched (power output)

Pin 2: RXD pass through data transmission line

Pin 3: TXD pass through data transmission line

Pin 4: Foot control present input pin

Pin 5: Ground

Pin 6: Ground

Pin 7: Not Connected

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Pin 8: Not Connected

Pin 9: Not Connected

The shielding on the connector shall be grounded to chassis

4.9.8.7 FCIB Connection (input / output)

The FCIB connection shall be a latching male DB9 connector.

Pin assignments shall be:

Pin 1: Not connected

Pin 2: RXD pass through data transmission line

Pin 3: TXD pass through data transmission line

Pin 4: Foot control present output pin

Pin 5: Ground

Pin 6: Ground

Pin 7: Not Connected

Pin 8: Not Connected

Pin 9: Not Connected

The shielding on the connector shall be grounded to chassis.

4.9.9 Regulatory Specifications

4.9.9.1 General Safety

As part of the Bausch + Lomb Stellaris Vision Enhancement System, the Power Module shall
comply with the general safety standards as listed in the Technical Specification’s External
Reference Documents.

4.9.9.2 Electromagnetic Compatibility (EMC)

As part of the Bausch + Lomb Stellaris Vision Enhancement System, the Power Module shall
comply with the EMC standards as listed in the Technical Specification’s External Reference
Documents.

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4.9.9.3 Materials

The Power Module shall comply with the RoHS initiative where possible and practical for those
components under direct control of the direct vendors of Power Module components.

All components shall be lead free.

PCB assembly process does not have to be certified lead free.

4.9.9.4 Service Specifications

Field Service

The Power Supply Module shall be replaceable in 30 minutes or less with EMB skins previously
removed.

4.10 IV Pole

4.10.1 Functional Description

The Bausch + Lomb Stellaris Vision Enhancement System IV Pole System provides a means for vertical
positioning of a maximum of 1000 ml of balanced salt solution. The mechanism is integral to the EMB, yet
the controller and pole assembly can be removed. Access for service is provided.

The IV Pole System consists of the following items:

1. A controller, providing power to the pole.

2. Input and output quick connect cable connection points to the controller.

3. Retractable IV pole, fluid-resistant housing attachable to the EMB, pole height electronically
adjustable so that the center of the viewing chamber on the drip chamber goes to a height of 140cm
measured from the aspiration port of the fluidics system cassette and is at least as quiet as the
Millennium IV pole during operation.

4. The user can program in (on the system-level GUI) the maximum ceiling height so that the pole
will not go through the ceiling in a shorter facility.

5. The IV pole maintains its position if power is interrupted.

6. The IV pole allows for manual retraction in an unpowered state with a force no greater than 13
pounds, per MIL-STD-1472F section 5.9.11.4.2 and Figure 23 therein.

7. The EMB provides 3 buttons wired to the IV pole board that will permit the user to select if they
want the pole to travel to the ‘return to preset’ position, and up/down control.

8. Pole extension provides connection for two 500 ml balanced salt solution containers.

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9. Pole is designed so that the user is deterred from using the extension above machine as handle,
and such that the bottles are visible from the front of the EMB when the drip chamber is at 40 cm
from the aspiration port, easily reachable from the front of the EMB.

10. The Bottle hanger design minimizes interference between hanging bottles and the EMB or
display throughout the range of motion of the IV pole and hangers.

11. All parts service accessible, the controller is separated from the pole, likewise the pole can be
removed from the system.

4.10.2 Physical Specifications

4.10.2.1 Pole and Supporting Structure Dimensions:

Maximum height fully extended, as installed in the EMB, from the floor: 8’11”.

Maximum Width: 4 inches to properly mount in EMB.

Retracted length: Exposed portion outside of EMB shall be no more than 12” long when fully
retracted.

Dual bottle hangers, length and position such that they prevent the possibility of the bottles hitting
EMB body or screen in any position, yet fluid level in bottles is visible from front of EMB at
>40cm minimum height for a person seated in front of the machine, and bottles can be easily
reloaded.

4.10.2.2 Controller Box Dimensions:

Maximum height: 6.75 inches to permit proper mounting in EMB

Maximum width: 5 inches

Maximum depth: 3 inches.

Pole segments meet system EMI requirements.

A seal is present on the IV pole assembly to prevent water ingress through the interface between the
IV pole and the EMB, and seals are also present between the translating and fixed pole elements to
prevent water ingress through the interface between the IV pole elements. Seals at pole elements
and at EMB/pole interface comply with water ingress requirements, but are tested with balanced
salt solution instead of water.

Use of ColdFire processor as in all Bausch + Lomb Stellaris Vision Enhancement System modules.

4.10.3 Operating Characteristics

Load capacity: 1.6kg (3.6 lbs.) (Ref only: Equivalent to two (2) 500 ml bottles)

Stroke length: minimum such that the center of the viewing chamber of the drip chamber connected to the
balanced salt solution bottle shall go from at least 40 cm to a required height of 140 cm above aspiration port

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Meets or exceeds speed >10.6 cm/sec, <12.0 cm/sec

1 cm position resolution.

2 cm position repeatability.

The Home sensor determines when pole has reached bottom position of travel, and reset software counter to
‘home’.

Button controls for pole up, pole down and return to preset; buttons are part of EMB design; electrical control
via controller circuitry.

4.10.4 Configuration

The IV Pole and Controller shall fit into the Bausch + Lomb Stellaris Vision Enhancement System EMB/
Chassis, Specification #: 118-006-026.

4.10.5 Input/Output

There is a cable that goes from the stepper motor to the controller, a cable that goes from the controller to the
3 switches and a cable that goes from the home switch to the controller.

The Controller provides inputs for +24V at less than 5 amps, power return, plus a twisted pair for CAN bus
communication. No pneumatic inputs required.

4.10.6 Noise

The operating IV Pole System noise quality when installed in the System shall be the same or less than that
of the Millennium system with IV pole engaged, at one meter distance.

4.10.7 Electrical and Software Specifications

4.10.7.1 Design Specifications:

See 118006013 IV Pole Controller Software Requirements Specification also the GUI will provide
for the ability to program in a safe ceiling height for a given facility so that the pole may not go
through the ceiling.

4.10.7.2 Electromagnetic Compatibility

As part of the Bausch + Lomb Stellaris Vision Enhancement System, the IV Pole System shall
comply with the EMC standards as listed in the General Technical Specification.

4.10.8 Service

The IV Pole, IV Pole skins, and Controller are removable from the EMB.

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Motor, pole, home sensor, and controller shall be field replaceable.

4.10.9 DRM (Device Relationship Management) requirements:

The IV Pole Controller Board provides the means to monitor the incoming supply voltage, home switch,
current applied to motor and the CAN bus communication at the controller board.

4.11 Foot Control

The Foot Control is an independent peripheral within the Bausch + Lomb Stellaris Vision Enhancement System
that provides the main interface between the user and the microsurgical system for controlling most functions.

The Foot Control system consists of the following: Foot Control, Foot Control Interface Board (FCIB), backup
Foot Control power cable, rechargeable battery, wall charger, and rechargeable battery charging cradle.

The main features of the Foot Control include the following: dual linear foot pedal assembly, which controls pitch
and yaw functions, four user programmable button switches and wireless communication through a Bluetooth
module.

4.11.1 Functional Description

The Foot Control communicates bi-directional data to the system through the FCIB via the user detachable
back-up power cable when the back-up power cable (12 ft., 3.7m) is connected to the Foot Control. Once the
power cable has been connected to the Bausch + Lomb Stellaris Vision Enhancement System and a
handshake has occurred between the Bausch + Lomb Stellaris Vision Enhancement System and the Foot
Control, then the Foot Control (with power cable removed) communicates bi-directional data to the system
through the FCIB via a Bluetooth wireless connection between the Foot Control and the FCIB. The FCIB
module in the system will only communicate wirelessly with the Foot Control to which it was configured. If
a new Foot Control is connected to a system through the back-up power cable, the configuration process will
begin automatically when the Bluetooth module in the FCIB recognizes a new Foot Control serial number.
The FCIB communicates with the other modules in the Bausch + Lomb Stellaris Vision Enhancement
System through a CAN (Controlled Area Network) Bus and is powered by a single 24 VDC rail with
maximum current of 0.5 Amps.

To begin wireless operation, when the system is turned on and the Foot Control is off, the user has to press
and hold any Foot Control button for 10 seconds. The Foot Control will power off after 10 minutes if the
receiver signal from the FCIB is not available because the system is powered off or out of range. The FCIB
will automatically search for and begin communicating with the Foot Control upon system start up or after
momentary loss of power.

The Foot Control is powered by an internal rechargeable battery pack (Lithium Ion) when operating in
wireless mode. The battery will maintain power for 12 hours after 300 charging cycles. The battery will
recharge in 6 hours or less. The battery status including available battery capacity, charging cycles, and serial
number shall be reported to the user through the graphical user interface (GUI). The rate of battery
degradation is 0.04% per charging cycle. The battery pack contains short circuit protection. The Foot Control
cannot function without the internal rechargeable battery when connected to the system via the backup power
cable. The replacement of the internal battery does not require a tool to open the cover to access the battery
pack.

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IMPORTANT: All U.S. personnel must comply with the U.S. Department of Transportation
(DOT) regulations regarding the shipment of Lithium batteries or equipment containing
Lithium batteries. Personnel in countries other than the United States must comply with their
local or regional regulations regarding the shipment of Lithium batteries or equipment
containing these batteries.

A wall charger (medical grade) charges the internal foot control battery when connected to the foot control
via a charging cable connected to the same connector used for the backup power cable. The wall charger
charges a single back up battery when connected to a battery charging cradle. The wall charger operates on
voltages from 90-264 VAC. and on frequencies from 47-63 Hz. The Foot Control will power on for 10
minutes after being disconnected from the wall charger. The wall charger provides global input power adapter
for Europe, US, Asia-Pacific, and Japan. The Foot Control will not operate the system when connected to the
wall charger.

A charging cradle holds the battery pack and is connected to the wall charger for charging the battery outside
the Bausch + Lomb Stellaris Vision Enhancement System. The charging cradle contains two (2) LEDs for
reporting the battery charging status. A two color LED indicates the charging status, yellow for charging in
progress and green for charging complete. The second green LED indicates the operating mode (On or Off).

The backup cable can be used to charge the internal battery when connected to the EMB and the system is
powered up for older power supplies. The backup cable should be stored in a drawer on the EMB. There are
no RF transmissions when the backup cable is connected. The user is able to operate the Foot Control with
the backup cable connected when the system is turned on without pressing a Foot Control button or
acknowledging any message from the graphical user interface (GUI). The user is able to connect or disconnect
the backup cable while the Foot Control is powered on (Hot Swap), but the system will require that the user
stop pressing all Foot Control buttons and the pedal before resuming operation for no more than 10 seconds.

The Foot Control handle is integrated into the Foot Control housing. The clearance between the Foot Control
handle and the pedal assembly at the home position is 1.5 inch diameter ± 0.100”. (Ref. the Human Factors
Handbook for the size of the 95th percentile man’s hand).

The Foot Control is designed to be stored on a hanger or hook on the back of the Electromechanical base
(EMB) via the handle when not in use.

The Foot Control functions are disabled when the Foot Control exceeds an angle of 60° ± 15° from its normal
operating position on the floor per EN60601-1, 56.11c.

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The Foot Control has an IPX8 watertight rating per IEC 60529.

The Foot Control position remains stable and does not move when it is in use during a surgical procedure; a
minimum lateral force of 5 lbs. applied to the Foot Control in any direction is required to move the Foot
Control.

The Foot Control has been designed so that an object with a maximum diameter of 1/2 inch cannot impede
the pedal motion (pitch and yaw) from returning to its center or starting position.

The Foot Control has two (2) user visible LEDS with the following functions:

The LEDs are off, when the Foot Control is off and not charging, one (1) LED (Green) for ready (on-line)
status and one (1) LED (tricolor; red-yellow-green) for battery capacity status. The ready (on-line) LED is on
when the Foot Control is communicating with the FCIB in wired or wireless mode.

The battery capacity status LED will be Green when the battery capacity is more than 0.10 Amp hours
(equivalent to more than 1 hour of surgical time), yellow when charging is in progress, green when the
charging cycle is complete, and red and blinking when the battery capacity is 0.1 Amp-hours or less
(equivalent to 1 hour or less of surgical time).

The Foot Control will only contain safety extra-low voltage circuitry per EN60601-1, Sec. 2.4.3.

Foot Control usage requirements are as follows: 10,000 operations per year based on 50 weeks per year 5 days
per week and 40 operations per day, a maximum 5 button switch activations per button switch per operation,
a maximum 40 pitch detent activations per operation, a maximum 10 full range of pitch pedal motion per
operation, a maximum 5 half range of pitch pedal motion per operation, and a maximum 10 full range of yaw
pedal motion per operation.

The Foot Control, FCIB, and wall charger shall have a product life of and be supported by the manufacturer
for 10 years from the date of manufacture.

4.11.2 Mechanical Specifications

4.11.2.1 Pitch Pedal Assembly

The pitch travel is 15º ± 1.0º. Initial elevation of pedal is between 15º and 20º from horizontal. The
torque for pitch pedal motion is adjustable by the user through the user interface. The maximum
torque range of fully depressed pedal is 40. The minimum torque range of initial pedal motion is 10.
The pitch detents fire a momentary peak change in pitch torque when passing into and out of region.
The peak change in pitch detent is between 3 and 6.

The Pitch Pedal Assembly has a spring return to pitch home position.

4.11.2.2 Yaw Pedal Assembly

The Pedal position can be adjusted by the user to a left, center, or right starting position. The
Center position is nominal 0º ± 1º. The Left position is 5º ± 1º from nominal center position. The
Right position is 5º ± 1º from nominal center position. The Full range of yaw travel is 20º ± 2º.
The Yaw Actuation Torque range is from 2 lbf-in (0.23 Nm) initial to 6 lbf-in (0.68 Nm) final.
The Yaw Pedal Assembly has a spring return to yaw home position.

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Figure 4.22. Foot Control Electrical Block Diagram

4.12 Wireless Remote

The Bausch + Lomb Stellaris Vision Enhancement System remote control transmitter allows a user to adjust
selected instrument operating parameters via an infrared remote control handpiece similar to television and VCR
remote controls. The remote control mimics the GUI and is intuitive to the user.

The remote control is self-contained, back-lit, and the entire unit is capable of operating while fitted into a sterile
bag sleeve when on tray or hand held. The unit is designed to be comfortable and buttons easily activated while
holding with one hand with or without surgical gloves. The remote is powered by standard alkaline batteries and
provides a low battery indicator. Because of the possibility of unintended activation of the Bausch + Lomb
Stellaris Vision Enhancement System by other commercial remote controls (e.g. TV, VCR, stereo) which may be
present in the operating room, a custom-programmed microcontroller is used to implement the remote control
transmitter.

The remote control transmitter encodes user input from buttons and transmits this input to the Bausch + Lomb
Stellaris Vision Enhancement System via modulated infrared (IR) transmission. The primary electronic
components are a single-chip microcontroller, buttons, infrared light-emitting diodes (IRLEDs), backlight,
transmission indicator, low battery indicator, and proprietary software which implements protection against false
triggering by other consumer IR remote controls. The remote will function in operating rooms in the presence of
incandescent, line-frequency ballast fluorescent and electronic (high-frequency/energy-efficient) ballast
fluorescent ambient illumination. The remote control works with the IR receiver circuit in Bausch + Lomb
Stellaris Vision Enhancement System that contains circuitry to demodulate IR, and transmit button data to the
CPU.

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Figure 4.23. Wireless Remote Electrical Block Diagram.

4.13 Multimedia Center

The Bausch + Lomb Stellaris Vision Enhancement System Multimedia Center (MMC) is a small compact video
overlay system that provides a streaming video source of information sent to the MMC by the Bausch + Lomb
Stellaris Vision Enhancement System console. This video consists of the microscope video input signal mixed
with the GUI. It achieves this by generating a Microscope Overlay in the microscope viewing optics from the
information sent to the MMC via the Bausch + Lomb Stellaris Vision Enhancement System console. This can be
hooked up to any standard monitor in formats NTSC and PAL (I,B,G,H,D and N) via the Composite Video, S-
Video or the Digital Video Input jacks located on the rear of the unit.

The MMC system runs on a version of the Microsoft Windows XP Operating System using a Hard Drive that has
a capacity of at least 40 gigabytes. The MMC also provides a bridge for the internet connection for remote service
and diagnostics functions of the Bausch + Lomb Stellaris Vision Enhancement System console.

The Bausch + Lomb Stellaris Vision Enhancement System Multimedia Center (MMC) provides the following
functions for the system:

• Provides a streaming video source to the system console for display on the GUI.
• Generate a Video Overlay display output from information sent to the MMC by the system console.
The video overlay display consists of the microscope video input signal mixed with computer
generated graphics.
• Provide a bridge for the internet connection for the remote service and diagnostics function of the
system console.

Refer to the Bausch + Lomb Stellaris Vision Enhancement System Multimedia Center Software Requirements

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Specification (118-006-016) and the Multimedia Center Software Human Factors Specification (118-006-024) for
the software functionality and the output display formats.

Refer to the Bausch + Lomb Stellaris Vision Enhancement System Device Relationship Management Technical
Specification (118-006-063) and the Bausch + Lomb Stellaris Vision Enhancement System Device Relationship
Management Software Requirements Specification (118-006-052) for the remote service data to be made available
through the DRM software system.

4.13.1 Electrical Inputs

4.13.1.1 On/Stand-by Control

The Multimedia Center power is controlled by a front panel momentary push on / stand-by switch.

4.13.1.2 Power Supply

The Multimedia Center is powered by a detachable IEC-320 AC power cord. The AC power cord
connects through the rear panel of the chassis. The medical grade power supply supports U.S.,
European, and Japanese line voltage inputs. The embedded computer provides for an operating
system shutdown of the unit when the front panel power/stand-by button is pressed to shut down
the system.

4.13.1.3 Data Communications Link 1

The data communications link to the Bausch + Lomb Stellaris Vision Enhancement System console
is via a wired Ethernet connection. The input connector is a female RJ-45 connector and connects
through the rear panel of the chassis. Internal to the system, this link supports dynamic polarity
assignment to allow a point-to-point Ethernet connection with a standard Ethernet cable and no hub
or router or a crossover Ethernet cable.

4.13.1.4 Data Communications Link 2

The data communications link to the facility internet access is via a wired Ethernet connection. The
input connector is a female RJ-45 connector and connects through the rear panel of the chassis. This
data communications link may be used for local desktop sharing with a field service technician’s
computer and either a standard or a crossover Ethernet cable with support for dynamic polarity
assignment.

4.13.1.5 Composite Video Input

The composite video input connection is an RCA phono female connector and connects through the
rear panel of the chassis. An RCA plug to BNC jack adapter is provided to accommodate those
installations requiring a BNC connector.

4.13.1.6 S-Video Input

The S-Video input connection is a female 4-pin mini din connector and connects through the rear
panel of the chassis.

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4.13.1.7 Digital Video Input

The Digital Video input connection is a standard size female IEEE 1394 connector and connects
through the rear panel of the chassis.

4.13.1.8 Monitor, Mouse, and Keyboard

A monitor (DVI), mouse (PS/2), and keyboard (PS/2) connector are accessible from the rear of the
unit for use in production or field service.

4.13.1.9 USB Connection

A minimum of two female USB 2.0 (Universal Serial Bus) connectors shall be provided to support
local software installation and future system enhancements. The USB connectors shall connect
through the rear panel of the chassis.

4.13.2 Electrical Outputs

4.13.2.1 Front Panel LED Indicators

4.13.2.1.1 Power Indicator

A front panel LED indicator that power is applied is provided on the Multimedia Center. This
LED is integrated with the On/Stand-by switch and is bright blue when in the ‘Stand-by’ state
and dim blue when in the ‘On’ state.

4.13.2.1.2 Computer Ready Indicator

A front panel LED indicator that the computer has loaded the operating system and applications
shall be provided on the Multimedia Center. The LED shall be blue.

4.13.2.1.3 Console Communications Indicator

A set of front panel LED indicators (one for carrier present, one for hardware activity, one for
application send and one for application receive) that communications activity with the Bausch
+ Lomb Stellaris Vision Enhancement System console is occurring are provided on the
Multimedia Center. The carrier detect LED is green (100 Mbps) or orange (1000 Mbps), the
hardware data activity LED is amber, and the application data activity LEDs are blue.

4.13.2.1.4 Internet Communications Indicator

A set of front panel LED indicators (one for carrier present and one for hardware activity) that
communications activity with the Internet is occurring shall be provided on the Multimedia
Center. The carrier detect LED shall be green (100 Mbps) or orange (1000 Mbps) and the data
activity LEDs shall be amber.

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4.13.2.1.5 Video Source Indicators

A set of three front panel LED indicators (one for Video, one for S-Video, and one for Digital
Video) to identify the active input source are provided on the Multimedia Center. The LEDs are
blue.

4.13.2.1.6 Composite Video Output

The composite video output connection is an RCA phono female connector and connects
through the rear panel of the chassis. An RCA jack to BNC plug adapter is provided to
accommodate those installations requiring a BNC connector.

4.13.2.1.7 S-Video Output

The S-Video output connection is a female 4-pin mini din connector and connects through the
rear panel of the chassis.

4.13.2.1.8 Digital Video Output

The Digital Video output connection is a standard size female IEEE 1394 connector and
connects through the rear panel of the chassis.

4.13.2.1.9 Microscope Overlay Display Output

The microscope overlay display connector contains VGA video signals. This connector
connects through the rear panel of the chassis. The microscope overlay display connector is a
standard VGA female connector.

4.13.3 Mechanical

4.13.3.1 Size

The Multimedia Center shall be housed in a chassis that is not greater than 15 cm. H X 42 cm. W X
32 cm. D., including any feet.

4.13.3.2 Weight

The Multimedia Center weight is approximately 30 pounds (15 kg).

4.13.3.3 Cooling

The Multimedia Center shall contain chassis fans as necessary to meet the Bausch + Lomb Stellaris
Vision Enhancement System environmental specifications.

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4.13.4 Bottom Surface

The Multimedia center bottom surface is slip resistant. The slip resistance is sufficient to allow connection
of the keyboard and mouse (service only connections) without holding the unit.

4.13.4.1 Rack Mount

The Multimedia center is compatible with an optional 19” rack mount kit.

4.13.4.2 Color Scheme

The color scheme is compatible with the scheme of the Bausch + Lomb Stellaris Vision
Enhancement System console.

4.13.4.3 Front Bezel

The front bezel may be custom molded, machined, or formed. The remainder of the chassis is formed
or machined sheet metal. If non-metallic, the front bezel must be backed by a sheet metal panel so
that the molded bezel does not provide the safety barrier required by EN60601-1.

4.13.5 Video Overlay

4.13.5.1 Video Formats

The video overlay accepts and processes video in NTSC (National Television Systems Committee)
and PAL (Phase Alternating Line) format in Composite Video, S-Video, and IEEE-1394 Digital
Video formats. The generator automatically recognizes the input format supplied and provides
output in the same format. The Digital Video format is generated for all video input formats.
Supported PAL formats shall include I, B, G, H, D, and N. Note for reference that commercially
available video chipsets and PAL video equipment support all these PAL formats and are not
available specifically for each format. Note for reference that the PAL-M format and any SECAM
formats are not supported.

4.13.5.2 No Video Input Detected

When no recognized video input is detected, the video output defaults to NTSC Composite Video,
NTSC S-Video, and Digital Video outputs with a blue background image. All video overlay fields
are displayed normally.

4.13.5.3 Power-Off Pass-Through

When the unit is powered down (stand-by mode) or unplugged, the video input, the S-Video input,
and the digital video inputs all pass the input signals through to the corresponding output connectors.

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4.13.6 Motherboard

The main processor for the MMC shall be a Pentium M, Celeron M, or Pentium III or higher processor. The
motherboard BIOS is configured (Defaults set in FLASH) such that the operating system and application
function with the battery removed. The CPU shall operate at a minimum clock frequency of 1.6 GHz. There
shall be a minimum of 512 megabytes of RAM. The Ethernet port for connection to the system console and
motherboard BIOS is configured to allow for Wake On LAN functionality.

4.13.7 Operating System / Hard Drive

The system runs under a version of the Microsoft Windows(tm) XP or XP Embedded operating system. Non-
volatile system software storage is provided by a hard drive, with a capacity of at least 40 gigabytes.

The hard drive is partitioned approximately equally into a C:\ drive and a D:\ drive. The C:\ drive contains the
operating system and any virus scanning software required. The D:\ drive contains the MMC application
software and the Axeda agent software (if required).

4.13.8 Service Times

It is expected that the time required to replace a Multimedia Center in the field is 30 minutes or less.

4.13.9 Configuration

The Multimedia Center and all accessories are packaged in a single shipping carton. The accessory items and
their approximate lengths are as follows:

• S-Video Cable - length between 1.5 and 3 meters


• Composite video cable - length between 1.5 and 3 meters
• Digital (IEEE-1394) video cable - length between 1.5 and 3 meters
• RCA / BNC Adapters (Set of two)
• Power adapter cable - length between 2 and 3 meters
• Ethernet data cable (to connect the MMC to the system Console), with a length between 12 and 15
meters
• Ethernet data cable (to connect the MMC to the facility internet), with a length between 12 and 15
meters

4.13.10 Front Panel Labelling

The chassis front panel includes the Bausch + Lomb logo and the Bausch + Lomb Stellaris Vision
Enhancement System logo. The international push button ON/Stand-by symbol is used to indicate the power
on/stand-by push button.

4.13.11 Rear Panel Labelling

The rear panel is permanently marked with graphic artwork. The ink resists water and isopropyl alcohol
cleaning. The chassis rear panel indicates the following connections with icons identified in the owner’s

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manual: Triangle exclamation mark to reference Owner’s Manual, POWER-IN, VIDEO IN, VIDEO OUT,
S-VIDEO IN, S-VIDEO OUT, DIGITAL VIDEO IN, DIGITAL VIDEO OUT, CONSOLE ETHERNET,
FACILITY INTERNET, USB.

Figure 4.24. MMC TV Monitor (Video Overlay Presentation).

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4.14 Stellaris PC Laser System

4.14.1 Treatment Laser

• Diode-pumped, frequency-doubled, solid-state laser


• Continuous Wave
• Class 4 Laser
• 532nm +/-3nm Green-Yellow

4.14.2 Aiming Beam

• Class 2 Laser
• 635nm +/-5nm Red diode laser

4.14.3 Laser delivery device connector

• Industry standard SMA 905 connection with delivery device detection via a resistor in the delivery device
connector.

4.14.4 Laser fire tone

• 2k Hz, 45 to 65 dBA adjustable

4.14.5 Other Information

If the laser module fires; then it always is within +/- 20% of set power. Two photocells monitor power and safeguards
are built in to make sure it works properly. However, there are three mirrors or lens past the photocell area that can
affect output, even though the laser is working fine up to the point of the photocells. There is also a fiber optic patch
cable that delivers the aiming and treatment beams from the Laser Head/Optics Deck, through the Anterior Module to
the laser SMA connector that can also affect output.

The aiming beam is coaxial with the treatment laser beam to insure accurate targeting.

The laser will not fire without the fiber optic cable attached.

There is a resistor in the fiber optic cable connector that tells the unit whether an EndoProbe is attached or whether an
LIO (Laser Indirect Ophthalmoscope) is attached.

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Chapter 5 - Tools

5 Tools

5.1 Tool Recommendations

The recommendations below are current as of 2016 April 13.

BPS/SPS
USM/
Depot

MMC
VFM

AFM

REM
EMB

WFC

WFR
PCM
Field

PFM

PIM
USV

MIV
UIC

CPA
Description

Adapter, 1/4" Hexagonal


to 3/8" Square (Figure X X X
18.1)
Adapter, 1/4" Square
to 1/4" Hexagonal X X X
(Figure 18.2)

Alcohol, Isopropyl X X X X X X X X X X X X X X X X X

Bit, Cross Tip, #1, 1/4”


X X X X X X X X X X
drive (Figure 18.3)

Bit, Cross Tip, #2, 1/4”


X X X X X X X X X X
drive (Figure 18.3)

Bit, Cross Tip, #3, 1/4”


X X X X X
drive (Figure 18.3)

Bit, Flat Blade, 1/4” X X X

Bit, Hexagonal, 1/16, 1/4”


X X X
drive(Figure 18.4)

Bit, Hexagonal, 0.94, 1/4”


X X X
drive (Figure 18.4)

Bit, Hexagonal, 2 mm, 1/


X X X X
4” drive (Figure 18.4)

Bit, Hexagonal, 2.5 mm,


X X X X
1/4” drive(Figure 18.4)

Bit, Hexagonal, 3 mm,


X X X
1/4” drive (Figure 18.4)

Bit, Hexagonal, 4 mm,


X X X
1/4” drive (Figure 18.4)

Bit, Hexagonal, 5 mm,


X X X
1/4” drive (Figure 18.4)

Bit, Hexagonal, 3/32",


X X X
1/4” drive (Figure 18.4)

Table 5.1: Tool Recommendations.

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Chapter 5 - Tools

BPS/SPS
USM/
Depot

MMC
VFM

AFM

WFC

WFR
EMB

REM
PCM
Field

PFM

PIM
USV

MIV
UIC

CPA
Description

Bit, Hexagonal, 1/8", 1/4”


X X X X
drive (Figure 18.4)
Bit, Hexagonal, 3/8", 1/4”
X X X
drive (Figure 18.4)

Cutter, Wire (Figure 18.5) X X X

Flashlight, Small (Figure


X X X X X X X X X X X X X
18.7)

Handle, Bit Driver, Offset,


X X X X X X X X X
Ratcheting (Figure 18.9)

Pliers, Needle Nose


X X X X X X X X
(Figure 18.10)

Ratchet, 1/4" Drive


X X X X X X X X X X
(Figure 18.11)

Ratchet, 3/8" Drive


X X X
(Figure 18.11)

Screwdriver, Cross Tip,


X X X X X X
# 1 (Figure 18.17)

Screwdriver, Cross Tip,


X X X
# 2 (Figure 18.17)

Screwdriver, Flat Tip, 1/4"


X X X X X
(Figure 18.18)

Screwdriver, Phillips,
X X X X X X X X X X X X X X X X
stubby (Figure 18.19)

Socket, Deep, 7/16”, 1/4”


X X X X
drive (Figure 18.20)

Socket, Hexagonal Head,


X X X
7/16”, 1/4” drive

Socket, 7/16", 1/4” drive


X X X
(Figure 18.21)

Socket, 1/2”, 3/8” drive


X X X X X X X
(Figure 18.21)

Socket, 10 mm, 1/4” drive


X X X
(Figure 18.21)

Solder, (039005133) X X X X X X X X X X X X X X

Torque Driver(s) (Figure


X X X X X X X X X X X X X
18.25)

Table 5.1: Tool Recommendations.

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Chapter 5 - Tools

BPS/SPS
Depot

USM/

MMC
EMB

VFM

AFM

REM

WFC

WFR
PCM
Field

PFM

PIM
USV

MIV
UIC

CPA
Description

Towels, Shop (Cleaning) X X X X X X X X X X X X X X X X


Wrench, Combination, 10
X X X
mm (Figure 18.27)

Wrench, Combination,
X X X X X X X
5/16" (Figure 18.27)

Wrench, Hexagonal,
X X X
3 mm (Figure 18.28)

Wrench, Hexagonal,
X X X
5 mm (Figure 18.28)

Wrench, Hexagonal, 3/32”


X X X X
(Figure 18.28)

Table 5.1: Tool Recommendations.

See Table 5-1 for torque specifications used in the Bausch + Lomb Stellaris Vision Enhancement System.

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Chapter 5 - Tools

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Chapter 6 - Installation and Deinstallation

6 Installation and Deinstallation

This chapter provides information for unpacking and setting up the Bausch + Lomb Stellaris PC, making
necessary connections, and instructions for adding new modules.

6.1 Complete System

6.1.1 Unpacking the System (Corrugated Box)

Note: Before unpacking, inspect all packages for damage. Report any damage from shipping to the carrier. Before
discarding packaging material, assure all parts are accounted for. Smaller parts may be attached to packing
materials.

Standard components shipped with the system include:

• System Main Console


• Foot Control with Battery
• Foot Control Wall Charger
• Extra Foot Control Battery
• Foot Control Backup cable
• Operator’s Manual (CD)
• Quick Reference Guide
• System Power Cord
• Mayo Tray
• Foot Control Battery Charging Cradle
• Air Hose (Posterior and Combined Only)
• Zero Level Bottle Hanger (Posterior and Combined Only)

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6.1.1.1 Cut pallet strapping and remove from pallet.

6.1.1.2 Remove corner protectors (not shown above).

6.1.1.3 Remove the top lid.

6.1.1.4 Remove all accessory boxes from within the main package. Boxes may include but not be
limited to: wireless remote control, foot control, user’s manual, foot control battery charger.

6.1.1.5 Remove all corrugated partitions from the inside of the package.

6.1.1.6 Remove the white foam pad from the end of the package that touches the castors.

6.1.1.7 Remove outer corrugated sleeve that surrounds the product by pulling it upward.

6.1.1.8 Slide the foam encased system and the bottom corrugated tray that it sits in, so that the
castor wheels hang over the edge of the pallet by approximately 5 inches.

6.1.1.9 Cut the two (2) corners of the bottom corrugated tray that is closest to the castor wheels.

6.1.1.10 Ensure that the wheel lock is engaged by engaging the locking pedal.

THE FOLLOWING IS A TWO PERSON OPERATION.

6.1.1.11 Tip the foam encased system upward so that it rests on its castor wheels.

DO NOT USE THE IV POLE AS A GRAB POINT.

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6.1.1.12 After placing the system onto its castor wheels, cut the straps around the white foam
structure.

6.1.1.13 Remove the white foam structure in two pieces.

6.1.1.14 Remove the plastic bag that covers the system.

6.1.1.15 Remove the hand held remote control unit from the drawer located under the Mayo tray.

6.1.1.16 Properly discard all packaging materials.

6.1.2 Unpacking the System (Wooden Crate)

6.1.2.1 Unlatch the door and open the wooden crate.

6.1.2.2 Unlatch and lower the ramp.

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Chapter 6 - Installation and Deinstallation

6.1.2.3 Remove the foam insert (half) that is on the system facing the door.

6.1.2.4 Pull up on the wheel lock lever to disengage the brake on the bottom front of the Stellaris.
Leave the other foam half in the wooden case.

6.1.2.5 Roll the Stellaris down the ramp.

6.1.2.6 Remove the plastic covering from the Stellaris System, the stretch film securing the Mayo
Tray and the plastic bag covering the display once the display is raised into the upright position.

6.1.2.7 Cut the cable tie securing the power cord on the back of the unit.

6.1.2.8 Remove the Foot Control box, Accessories box, IV Pole Hanger box, any additional
accessories and any packing material that may prevent the removal of the boxes from the top shelf of
the case.

6.1.2.9 Remove the fright bill from the case with return shipping labels. Place all previously
removed packing material back in the wooden case.

6.1.2.10 Raise the wooden ramp and latch it in place.

6.1.2.11 Close and latch the case door.

6.1.2.12 If the case is going to be picked up by the designated shipping company, then notify the
shipping company using the information on the freight bill, place return shipping labels on the outside of
the case door and leave the case for the shipper to pick up.

6.1.3 Installation of System

EXPLOSION HAZARD. DO NOT USE IN THE PRESENCE OF FLAMMABLE ANAESTHETICS,


DISINFECTANTS, AEROSOL SPRAYS, OR IN AN OXYGEN RICH ATMOSPHERE.

ALL EXTERNAL WIRING MUST BE IN ACCORDANCE WITH LOCAL ELECTRICAL CODE


REQUIREMENTS AND NEC CLASS II SIGNALLING SYSTEM TWISTED WIRE WITH OUTER SHIELD.
THE WIRE LENGTH MUST NOT EXCEED 20 METERS (60 FEET). THE WIRE GAGE MUST BE 26 AWG TO
12 AWG GAGE, WITH ENDS STRIPPED FROM 9 MM TO 10 MM (3/8 INCH). AT NO POINT SHOULD THE
WIRE BE UNTWISTED MORE THAN 5 CM (2 INCHES).

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Chapter 6 - Installation and Deinstallation

IT IS NOT SAFE TO TRANSPORT THE STELLARIS WITH THE IV POLE AND TRAY EXTENDED ON
INCLINES OF MORE THAN 5 DEGREES.

6.1.3.1 Display Setup (Metal UIC)

6.1.3.1.1 The UIC display is folded down for shipping. Remove the hinge cover from the left side
of the display, and press the button underneath the cover.

6.1.3.1.2 While pressing the button in, lift up on the top of the display and raise it until it snaps into
the vertical position, then release the button and replace the hinge cover.

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Chapter 6 - Installation and Deinstallation

6.1.3.1.3 Remove the UIC Pad and loosen the captive Shipping Screw that sites in the back of the
unit to allow the UIC to rotate freely from side to side.

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6.1.3.2 Display Setup (Plastic UIC)

Note: A new screen hinge mechanism was implemented starting with system serial number SYS01280.

• The mechanism to lock and un-lock the screen for repositioning has been changed from a release
button inside the left hinge cap of the UIC to two (2) pull levers underneath the display screen.
• The screen is not locked in the horizontal position and can be moved freely (like a laptop screen)
to the vertical upright position.
• In the vertical position the levers will spring-lock the screen with a 10 degree forward and a 15
degree backward range of freedom, allowing some customization of the viewing angle. Verify
the levers are locked.

Note: Refer to Figures 1 - 3 below.

Note: The display is not locked when it is folded down in the horizontal position.

6.1.3.2.1 Lift the display into the upright (vertical) position. The display should tilt back and forth
15° in either direction. The screen is now locked in the upright position.

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Chapter 6 - Installation and Deinstallation

6.1.3.2.2 To lower the display screen, locate the two shipping locks on the bottom of the UIC
Assembly.

6.1.3.2.3 Pull each lock down and rotate 90º.

6.1.3.2.4 Lay the display down in the horizontal position.

6.1.3.2.5 Rotate the shipping locks until the locks retract into their original position.

Figure 6.1. Figures 1, 2 and 3.

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6.1.3.3 Initial Setup and Power On

All of these connections must be made before power to the system is turned on.

Note: The Bausch + Lomb Stellaris PC requires filtered medical grade air or medical grade nitrogen, at 72.5 to 100
psig (500 kPa to 690 kPa or 5.0 to 6.9 bar) and a flow rate of 2.25 SCFM (63.7 SLPM).

6.1.3.3.1 Connect the external air hose to the rear of the system as shown, and then to an appropriate
air source (Stellaris PC Only).

6.1.3.3.2 Connect the power cable at the bottom rear of the system.

6.1.3.3.3 At the user’s discretion, use the optional cable clip to secure the power cord to the system.
Remove the screw, place the cable through the clip, and then reinstall the clip.

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Chapter 6 - Installation and Deinstallation

6.1.3.3.4 Connect the main power cable to a medical grade wall outlet.

6.1.3.3.5 Remove the protective cap from the Ethernet receptacle at the lower rear of the Bausch +
Lomb Stellaris PC then connect the Ethernet cable to the port, and the other end to the facility
network port. If you have the optional MMC system, this cable may be connected to the MMC, and
the MMC in turn connected to the facility network port. If the customer does not want their system
data archived, this step can be skipped.

6.1.3.3.6 Turn on the switch at the bottom rear of the EMB.

Do not turn this switch off until the system has been properly powered down.

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Chapter 6 - Installation and Deinstallation

6.1.3.3.7 Press the power button on the front of the system, and wait for the screen to come on and
the animation to finish. The front power switch is brighter when the system is off, and dims when
you turn the system on.

Note: The Bausch + Lomb Stellaris PC performs a self-check each time the power is turned on. The system
automatically checks its configurations for any changes since the last time it was turned on. If there was any change
in the system since it was last configured, it may take up to five seconds to complete the start-up routine.

6.1.3.4 Foot Control Setup

Note: The Foot Control can use either wired or wireless communication. The first time the Bausch + Lomb Stellaris
PC is used, the Foot Control cable must be connected in order to establish communication between the Foot Control
and the Bausch + Lomb Stellaris PC system.

6.1.3.4.1 System Setup Instructions – Wired or Wireless Operations.

Note: The out of factory Wireless System Setup is “Disabled”. Software upgrade will reset the Wireless System
Setup to “Disabled”.

The Stellaris software Version 3.6 or higher and the Stellaris PC allow the user to configure the
system for wired or wireless operations with the following steps:

Step 1: Select Programming from Setup or “Select Surgeon” screens.

Step 2: Select System Setup from the programming screen. (Figure 6.2, circle)

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Chapter 6 - Installation and Deinstallation

Figure 6.2. Programming Screen.

Step 3: Select “Foot Control” tab from the System Setup screen. (Figure 6.3, circle).

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Chapter 6 - Installation and Deinstallation

Figure 6.3. System Configuration Screen.

Step 4. Select Wireless “Enabled” or “Disabled” to configure foot control connection (Figure 8,
arrow).

Note: The system setup is for enabling wireless functionality, it does not affect the wired functionality. The wired
option is always available and active when connected.

6.1.3.4.2 To use the Foot Control, verify that the Foot Control battery is charged.

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Chapter 6 - Installation and Deinstallation

6.1.3.4.3 Hold down any button on the Foot Control until the green ready light comes on, indicating
that communication has been established.

6.1.4 Multimedia Center (MMC) Installation

If the Bausch + Lomb Stellaris PC has the optional Multimedia Center (MMC) Video Overlay Generator, all
setup, connections, and operating instructions are provided in the manual for that system. See the Bausch +
Lomb Stellaris PC Multimedia Center (MMC) Video Overlay Generator System manual for all setup,
connections, and operating instructions.

Note: The MMC is NOT intended for diagnostic purposes.

THE MMC IS NOT TO BE PLACED INSIDE THE PATIENT ENVIRONMENT.

Allow the MMC to stabilize to room temperature before energizing.

Do not place the Video Overlay on devices that radiate heat.

The Video Overlay Generator may be damaged if fluids are spilled on the outer enclosure.

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DO NOT PLUG THE MMC INTO MULTIPLE PORTABLE SOCKET OUTLETS OR EXTENSION CORDS.

THE VCR AND/OR MONITOR CONNECTED TO THE VIDEO OVERLAY GENERATOR MUST BE
MEDICAL GRADE OR PLUGGED INTO A MEDICAL GRADE ISOLATION TRANSFORMER.

Connecting the Video Overlay data communication cable to equipment other than the Bausch + Lomb Stellaris
PC may cause damage to both systems.

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Chapter 6 - Installation and Deinstallation

MMC TV Monitor (Video Overlay Presentation).

6.1.4.1 Assure all equipment is turned off before making any connections. Position the MMC and
Power Supply on a flat surface near the video monitor and/or recorder to be used.

6.1.4.2 Ensure that the AC power source selection switch on the MMC Power Supply is set
appropriately (115 VAC or 230 VAC). Connect the detachable power cord to the MMC Power Supply
and plug it in to the AC power source.

6.1.4.3 Attach the DC power connector from the MMC Power Supply to the Video Overlay
Generator DC power receptacle. Assure the power indicator on the Video Overlay Generator front panel
is not lit. If it is, turn off the Video Overlay Generator by pressing the power on/off switch.

6.1.4.4 Connect the video input cable from the surgical microscope camera to the VIDEO IN
connector (use the included RCA Plug to BNC Jack adapter if necessary) or S-VIDEO IN connector of
the Video Overlay Generator.

6.1.4.5 Using the video output cable provided with the MMC, connect the VIDEO OUT or S-
VIDEO OUT from the Video Overlay Generator to the user supplied video monitor. If desired, the video
cassette recorder (per manufacturer’s instructions for that equipment) may be connected between the

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Video Overlay Generator and monitor using user supplied cables. Use the included RCA Jack to BNC
Plug adapter if necessary.

Note: The VIDEO OUT output must be used if the input video signal is connected via the VIDEO IN connector.
The S-VIDEO OUT output must be used if the input video signal is connected via the S-VIDEO IN connector.

6.1.4.6 Attach the round connector of the data communications cable to the proper receptacle on
the back of the Bausch + Lomb Stellaris PC Computer Unit. Attach the other end of the data
communications cable to the IN connector of the Video Overlay Generator.

6.1.4.7 Turn on the microscope camera and the video recorder and/or monitor.

6.1.4.8 Verify that the image captured by the surgical microscope camera is displayed on the video
monitor. With the Video Overlay Generator power off, the Video Overlay System is operating in a video
bypass mode; thus the video input is directly connected to the video output.

6.1.4.9 Turn on the Video Overlay Generator by pressing the power on/off switch. The power
indicator on the Video Overlay Generator front panel should light.

Make sure the MMC is stabilized to room temperature before energizing.

6.1.4.10 After several seconds, verify that the “Bausch + Lomb STELLARIS” logo appears in the
lower right corner of the video image on the monitor.

6.1.4.11 Turn on the Bausch + Lomb Stellaris PC as directed in Initial Setup and Power On. The
Bausch + Lomb Stellaris PC mode and settings information will not be displayed until a surgical mode
is entered.

6.1.4.12 Verify that the Bausch + Lomb Stellaris PC’s mode and setting information is overlaying
the video image from the microscope camera on the video monitor.

6.1.4.13 Video Capture Installation

6.1.4.14 The MMC has FireWire output capability, which can be used to send video to a personal
computer for video capture. To take advantage of this capability, you must connect the two units and
install the video capture software, as described below.

6.1.4.15 Connect a FireWire cable from the output jack on the back of the MMC unit to the FireWire
port on your personal computer.

6.1.4.16 Turn on the computer, open a web browser, and navigate to \\192.168.1.4\MMC_Client.

6.1.4.17 Copy MMC_Client.exe to c:\temp

6.1.4.18 Run MMC_Client.exe

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Chapter 6 - Installation and Deinstallation

6.1.5 De-Installation of System

Never turn the power switch off or disconnect the power without proper system shutdown. Equipment damage
can occur.

6.1.5.1 Shutting Down the System

6.1.5.1.1 If necessary, exit the surgical software by selecting End on the Clock Menu.

6.1.5.1.2 Select Yes at the Exit Surgery pop-up window.

6.1.5.1.3 Select Shut Down System on the lower right corner of the screen.

6.1.5.1.4 Make sure the TruLink® Customer Support Network cable is connected to the facility
network port, then select Yes to report system data to the TruLink® Customer Support Network. If
the customer does not want their system data archived, this step can be skipped.

6.1.5.1.5 When the System Shutdown Pop-up window appears, select Yes.

6.1.5.1.6 Press the green illuminated power switch on the front of the UIC to turn off the system
power.

6.1.5.1.7 Turn off the main power switch located underneath the EMB between the rear castors.

6.1.5.1.8 Disconnect the Ethernet cable from the port at the bottom of the Bausch + Lomb Stellaris
PC, and the other end from the facility network port. If you have the optional MMC system,
disconnect the cable from the MMC, and then the other end of the cable from the facility network
port.

6.1.5.1.9 Disconnect the power cord from the wall outlet.

6.1.5.1.10 If returning system to Bausch + Lomb follow the procedures for Packing of System and
Returning Equipment to Bausch + Lomb.

6.1.5.2 Multimedia Center (MMC) Deinstallation

6.1.5.2.1 Exit the surgical screen and properly shutdown the Bausch + Lomb Stellaris PC. Turn off
the Bausch + Lomb Stellaris PC.

Note: Assure all equipment is turned off before disconnecting any cables.

6.1.5.2.2 Turn off the Video Overlay Generator by pressing the power on/off switch.

6.1.5.2.3 Turn off the microscope camera and the video recorder and/or monitor.

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6.1.5.2.4 Disconnect the data communications cable from the IN connector of the Video Overlay
Generator.

6.1.5.2.5 Disconnect the round connector of the data communications cable from the receptacle
identified with the number ‘3IV’ on the back of the Bausch + Lomb Stellaris PC.

6.1.5.2.6 Disconnect the video output cable provided with the MMC from between the VIDEO OUT
or S-VIDEO OUT of the Video Overlay Generator and the user supplied video monitor. If
connected, the video cassette recorder (per manufacturer’s instructions for that equipment) must be
disconnected from between the Video Overlay Generator and monitor (user supplied cables). If
used, disconnect the included RCA Jack to BNC Plug adapter.

6.1.5.2.7 Disconnect the video input cable from between the surgical microscope camera and the
VIDEO IN connector (use the included RCA Plug to BNC Jack adapter if necessary) or S--VIDEO
IN connector of the Video Overlay Generator.

6.1.5.2.8 Assure the power indicator on the Video Overlay Generator front panel is not lit. If it is,
turn off the Video Overlay Generator by pressing the power on/off switch. Disconnect the DC power
connector from the MMC Power Supply and the Video Overlay Generator DC power receptacle.

6.1.5.2.9 Disconnect the detachable power cord from the MMC Power Supply and unplug it from
the AC power source.

If unit is being shipped back to Bausch + Lomb, pack the MMC into its shipping container with the
appropriate packing materials. Follow the procedures for Returning Equipment to Bausch + Lomb.

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Chapter 6 - Installation and Deinstallation

6.2 Individual Modules

6.2.1 Unpacking Modules

6.2.1.1 Using a small box cutter or scissors, carefully cut the tape securing the box flaps. Be careful
to avoid personal injury or damaging the product.

6.2.1.2 Open the box flaps and remove the module with packing material from the box. Retain the
box.

6.2.1.3 Remove the right and left pieces of foam, if applicable from around the module. Retain
right and left foam.

6.2.1.4 Remove the module from the anti-static bag. Retain the bag.

6.2.2 Packing a System or Modules

6.2.2.1 Package returning module using the bag, foam pieces and box from the above steps.

IMPORTANT: All U.S. personnel must comply with the U.S. Department of Transportation
(DOT) regulations regarding the shipment of Lithium batteries or equipment containing
Lithium batteries. Personnel in countries other than the United States must comply with their
local or regional regulations regarding the shipment of Lithium batteries or equipment
containing these batteries.

6.3 Moving the Stellaris or Stellaris PC System to a Different Location

The Bausch + Lomb Stellaris Vision Enhancement System and the Bausch + Lomb Stellaris PC Vision
Enhancement System are designed to provide mobility within the environment of the operating room.

Care must be taken as to avoid sloped floors having an angle of greater than 5º during use. Before transporting the
unit from room to room or for any more extensive moving, follow these basic safety instructions:

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Chapter 6 - Installation and Deinstallation

1. Power the system down normally by selecting Shut Down from the End of Case screen or pressing and
holding the front button for at least 8 seconds, ensuring the IV pole is fully retracted.

2. Remove any objects from mat on top of system.

3. Store the tray all the way in the system’s tray receptacle.

4. Fully close the front drawer.

5. Roll the power cord in its proper storage hooks on the rear end of the system.

6. Place the Foot Control on its dedicated hook, on the rear end of system.

7. Remove any bottles and tube sets from the system’s IV Pole hanger and store them separately from the
system.

8. Make sure no objects such as an air hose, electrical cord, video cables, etc... lay in the moving path.

9. Disengage the front brake lever.

10. Always manoeuvre the unit using the handle bar designed for this purpose.

The system is now ready to be moved to a new location.

Note: Do not store anything on top of the system, and do not pull the system by the IV pole.

6.4 Returning Equipment to Bausch + Lomb

To return a Bausch + Lomb Stellaris PC and /or Bausch + Lomb Stellaris PC modules to Bausch + Lomb for
service, a return authorization number must be obtained from the Technical Support Department prior to
returning any unit for repair or calibration. The following information must accompany all returned units:

• The customer account number


• The customer name, address, and telephone number
• The name of function, handpiece, etc. that needs service
• The model number (REF #) and serial number (SN#) of the component which is located on the back panel
and also on the front of ophthalmic modules but concealed by the bezel, or engraved on side of
handpieces
• The date of purchase
• A description of the problem or service desired. List all observable symptoms and characteristics, and
details of occurrence. Was patient involved at time of occurrence?
• The return authorization number assigned by our Technical Support specialist.
• Contact name and phone number if additional information is required.

Ship or otherwise return the part, transportation and insurance prepaid, to your local Bausch + Lomb International
Facility unless otherwise instructed. Consult the Bausch + Lomb Stellaris PC Operator’s Manual for a complete
list of Bausch + Lomb International Facilities by country.

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Chapter 6 - Installation and Deinstallation

For accessories and disposable hand pieces, contact your local Bausch + Lomb representative to determine
applicable return policies for your local market.

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Chapter 7 - Preventative Maintenance

7 Preventative Maintenance

To perform preventative maintenance, all Bausch + Lomb certified individuals should utilize procedure SP-ST-0025
Stellaris and Stellaris PC Field Service preventative Maintenance Procedure and perform all steps on all modules.
After completing all steps, a full functional checkout must be completed using procedure SP-ST-0002 Stellaris and
Stellaris PC Field Service Test Procedure.

Note: Scheduled preventative maintenance is required once per year to ensure that the Bausch + Lomb Stellaris
Vision Enhancement System meets its optimum performance, reliability and safety standards as set by the
manufacturer.

7.1 Cleaning Requirements

7.1.1 System Skins

DISCONNECT AC POWER BEFORE CLEANING THE SKINS.

To preserve the skin finish, avoid the use of abrasive cleaners. If possible, clean spots before they dry.

Bausch + Lomb tested the following products, and found that they can be used on all external surfaces of the
Bausch + Lomb Stellaris Vision Enhancement System. Use of any substance not listed is at the user’s
responsibility.

• Isopropyl Alcohol (70%)


• Mild Soap and Water

Wipe the area to be cleaned using a soft cloth moistened with cleaning solution. Avoid applying any cleaner
directly to the display (apply to cloth sparingly). Avoid excessive quantities of cleaning solution around the
ports. Remove all traces of the cleaning solution with a cloth dampened with clean water. The surfaces should
then be dried with a lint-free cloth.

7.1.2 Handpiece and Accessories

Note: Specific instructions for cleaning included with any handpiece or accessory take precedence over these
instructions.

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Chapter 7 - Preventative Maintenance

7.1.2.1 Bipolar Handpiece and Accessories

The bipolar coagulation forceps, eraser, and reusable cord should be inspected before each use for
signs of misalignment, pitting, contamination (blood, tissue, etc.), or other damage. If the forceps are
dropped and seriously misaligned, or if deep pits or scores appear on the tips after long use, the
forceps may be returned to Bausch + Lomb for repair, refinishing, or repotting of the insulating base.

Wipe the forceps using a soft cloth moistened with a mild soap water solution. Avoid excessive
quantities of solution around the electrical connector. Remove all traces of the solution with a cloth
dampened with clean water. The surfaces should then be dried with a lint-free cloth.

7.1.2.2 Phacoemulsification Handpiece and Accessories

Note: Refer to A-110017293 (Instructions for Cleaning, Sterilization and Preparation for Use) in Documentum for
complete care instructions.

The phacoemulsification handpiece, reusable accessories, and cord should be inspected before each
use for signs of contamination, or other damage. If the handpiece, its cord, or any reusable accessory
show signs of damage or cracked insulation, it should not be used.

Remove the silicone irrigation sleeve and the needle. Remove any tubing from the rear of the
handpiece. Wipe the handpiece using a soft cloth moistened with a mild soap water solution. Avoid
excessive quantities of solution around the electrical connector. Remove all traces of the solution
with a cloth dampened with clean water. The surfaces should then be dried with a lint-free cloth.

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Chapter 7 - Preventative Maintenance

7.1.2.3 Fragmentation Handpiece and Accessories

Note: Refer to A-110017293 (Instructions for Cleaning, Sterilization and Preparation for Use) in Documentum for
complete care instructions.

The fragmentation handpiece, reusable accessories, and cord should be inspected before each use for
signs of contamination, or other damage. If the handpiece, its cord, or any reusable accessory show
signs of damage or cracked insulation, it should not be used.

Remove the silicone irrigation sleeve and the needle. Remove any tubing from the rear of the
handpiece. Wipe the handpiece using a soft cloth moistened with a mild soap water solution. Avoid
excessive quantities of solution around the electrical connector. Remove all traces of the solution
with a cloth dampened with clean water. The surfaces should then be dried with a lint-free cloth.

7.1.2.4 High Speed Vitrectomy Handpiece

The handpiece, disposable tips, and reusable cord should be inspected before each use for signs of
misalignment, pitting, contamination, or other damage. Wipe the handpiece using a soft cloth
moistened with a mild soap water solution. Avoid excessive quantities of solution around the
electrical connector. Remove all traces of the solution with a cloth dampened with clean water. The
surfaces should then be dried with a lint-free cloth. If deep pits or scores appear on the tips after long
use, they should be discarded. If the handle or cord shows signs of damage or cracked insulation, it
should not be used.

7.1.3 Multimedia Center (MMC)

To preserve the housing finish, avoid the use of abrasive cleaners. If possible, clean spots before they dry.

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Chapter 7 - Preventative Maintenance

DISCONNECT AC POWER BEFORE CLEANING THE HOUSING.

The following cleaning solutions are recommended for use in cleaning the Multimedia Center.

• Isopropyl Alcohol (70%)


• Mild Soap and Water

Wipe the area to be cleaned using a soft cloth moistened with cleaning solution. Avoid excessive quantities
of cleaning solution around the open vents on the Multimedia Center outer chassis. Remove all traces of the
cleaning solution with a cloth dampened with clean water. The surfaces should then be dried with a lint--free
cloth.

A periodic visual inspection of the system components should be performed to inspect for damaged cables or
connectors.

Store the MMC in a dry and clean area and avoid extreme temperatures.

There are no requirements for periodic calibration or adjustments.

7.1.4 Advanced Flow Module (AFM) Transducer

Inspect the Transducer Assembly and verify that there is no foreign material on the transducer PCB. If so,
clean it with a lint free cloth and Isopropyl Alcohol. Use the following steps to properly clean the surface of
the transducer.

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Chapter 7 - Preventative Maintenance

7.1.4.1 The Bausch + Lomb Stellaris Vision Enhancement System must be in an Advanced Flow System
operating mode.

7.1.4.2 Open the drawer by pressing the Open Drawer button.

7.1.4.3 Use an absorbent sponge moistened with isopropyl alcohol to remove contaminant or saline from
the transducer.

Note: Transducer must be thoroughly dry before operating module.

7.2 EMB/Compressor Hydrophobic Filter Replacement (Anterior Only)

Examine the hydrophobic filters for evidence of balanced salt solution and if present, use the following steps to
replace the filters.

7.2.1 Hydrophobic Filter Replacement Procedure

7.2.1.1 Remove the Rear Access Panel.

7.2.1.2 Locate the hydrophobic filter assembly in the bottom left corner of the EMB.

7.2.1.3 Disconnect from the tube assembly and replace.

7.2.1.4 Install the Rear Access Panel.

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Chapter 7 - Preventative Maintenance

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Chapter 8 - Technical Descriptions

8 Upgrades

The following document provides instructions for performing the described upgrade.

• SP-ST-0014 Stellaris and Stellaris PC Software Upgrade Procedure (GUI on UIC / UPC)

8.1 TFSN0057 – Stellaris Power Module Upgrade

A new Power Module has been released for use with the Stellaris. The new Power Module will have a prefix of
“SPS” and can be retrofitted into older systems.

Note: The new power supply no longer includes a backup battery but can charge the foot control without booting
up the system. More details included in Stellaris update training.

New Part Numbers

Part Number Description


BL2351 Power Supply II module
101028144 Power Supply II module

031006022 Power Supply

102002445A Control PCB

102002440A Power PCB

102004884 FCIB Patch Cable

015000624 Transportation Label

015000483 Caution Label

Table 8.1: New Part Numbers.

8.1.1 Part Details:

031006022 - Power Module

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Chapter 8 - Technical Descriptions

• Supplies the 24 volts for the system.

102002445A - Power PCB

• The board interfaces with the Power Module & system to receive and deliver all the CAN messages.
• Supplies voltage to charge the foot control.
102002440A - Control PCB

• Contains the microcontroller for all message processing.

8.1.2 Stellaris Power Supply Upgrade Procedure:

8.1.2.1 Once the old Power Module is removed, the AC Sense Cable should be wrapped and cable
tied together as shown in the Figures below.

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Chapter 8 - Technical Descriptions

8.1.2.2 Disconnect the Internal Foot Control Back Up Cable from the FCIB. Then connect the
FCIB Patch Cable to the FCIB. Both of these cables will be connected to the new Power Module once it
is installed.

8.1.2.3 Install the new Power Module, connecting AC power to the Power Module and making all
the electrical connections as outlined in Table 1 to the new Power Module.

New Power
Module Connects to Function
Connection
J12 CAN Bus System communications
Power entry module for Foot Control (internal Foot
J7 Control backup cable disconnected in Step 2) Hard wire connection for the Foot Control

J3 Front on/ off switch Turns power supply on when front switch is pushed

J6 FCIB (FCIB patch cable connected in Step 2) Hard wire from foot pedal

J4 Power Module Already connected

J5 Power Module Already connected

J1 AC power Stand by power

Table 8.2: Electrical Connections.

8.1.2.4 Reassemble the system including the skins.

8.1.2.5 Install the caution and transportation labels on the rear skin as shown in the figure below.

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Chapter 8 - Technical Descriptions

8.2 TFSN0058 - Plastic UIC Upgrade

The Stellaris User Interface Computer (UIC) has been redesigned to be made of structural foam. The redesign
increases serviceability by allowing for easier disassembly (covered in training). The new UIC is denoted by the
version of remote receiver hardware. Hardware 1.2 represents the new plastic UIC with the new touch screen.

Retrofitting older systems that have the older version of UIC require addition parts as listed in Table 8.3.

Part Number Description


BL2361 UIC Module
100027078 UIC Module

102032426 Main CAN Bus Cable

025003036 Ferrite

102004899 Power Switch Cable

102004906 IV Pole Switch Cable

100027082 New IV Pole Controller

102032426 IV Pole Support

102032425 Top Shelf

107040257 IOP Bracket

021021450 Screw for IV Pole Support

107040449 ** Lower Casting Skin (top skin)

Table 8.3: New Parts.

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Chapter 8 - Technical Descriptions

Part Number Description


102002425C ** Transition PCB
102002424B ** Baseboard PCB

Table 8.3: New Parts.

** Denotes that these parts are not needed for retrofitting.

8.2.1 Procedure – Upgrading a Metal UIC to a Plastic UIC

8.2.1.1 Remove the IV Pole Controller (if not 100027082 which is shown on the serial number
label), the cable for the front switch (connected to the power supply), and the cable for the IV Pole
buttons on the back of the unit.

8.2.1.2 Check the main CAN bus cable and ensure it has the 90º connector as defined in
TFSN0054. If it has the older version (45º connector), remove it from the system.

8.2.1.3 Remove the old Top Shelf from the system (including the crown and IOP bracket with
yellow tubing).

8.2.1.4 Remove the IOP printed circuit board and connector to be mounted to the new bracket
(refer to TFSN0044).

8.2.1.5 Install the new plastic shelf.

8.2.1.6 Install the new IV Pole Support and IOP Bracket.

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Chapter 8 - Technical Descriptions

8.2.1.7 Re-Install the IOP tubing, connector and PCB.

8.2.1.8 Install the new CAN Bus cable if needed.

8.2.1.9 Install the ferrite bead on to the CAN Bus cable (cable tie the bead to the cable to ensure it
does not come off).

8.2.1.10 Install the new IV Pole Controller.

8.2.1.11 Install the new UIC.

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Chapter 8 - Technical Descriptions

8.2.1.12 Install the new power switch cable. Connect the ground wire to the screw holding the AFM
or VFM. Connect the other end of the ground wire to the screw on the Power Module.

8.2.1.13 Install the new IV Pole switch cable. Connect the ground cable to the IV Pole Controller.

8.2.1.14 Reinstall any remaining parts and skins.

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Chapter 8 - Technical Descriptions

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Chapter 9 - Error Codes and Troubleshooting Guides

9 Error Codes and Troubleshooting Guides

All error messages displayed by the user interface are uniform in their appearance. However, the box will have a
red border if a safety related condition is present. When an error occurs, the system will sound the error tone and
display a pop-up window with the error displayed. The pop-up window will provide the user with a choice of
options for proceeding from the error. Nothing else may be done while a pop-up window is displayed.

Error Code Prefix Module


UIC User Interface Computer (UIC) Error Codes

USM Ultrasound Module (USM/USV) Error Codes

Advanced Flow Module (AFM) Error Codes (Anterior


AFM
Only)

Vacuum Fluidics Module (VFM) (Anterior Only) and


VFM Posterior Fluidics Module (PFM) (Posterior and
Combined Only) Error Codes

Compressor Module (CPA) (Anterior Only) and


CPX Posterior Compressor Module (PCM) (Posterior and
Combined Only) Error Codes

BPS Power Module (BPS/SPS) Error Codes

EIV IV Pole Controller (EIV) Error Codes

LM Light Module (PIM) Error Codes

Foot Control (WFC) and Integrated Foot Control (IFC)


WFC
Error Codes

Foot Control Interface Board (FCIB (WFR)) Error


WFR
Codes

Wireless Remote Control (REM) Error Codes


RCR
(Anterior Only)

MMC Multimedia Center (MMC) Error Codes


Green Laser Module (LAS, Posterior and Combined
LAS
Only)

Table 9.1: Error Codes and Associated Modules

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Chapter 9 - Error Codes and Troubleshooting Guides

9.1 User Interface Computer (UIC/UPC)

9.1.1 User Interface Computer (UIC) Error Codes

Error Code Description Corrective Action


IV Pole height range is (0)-(1) cm. Note: (0) is IV Pole
Min Value and (1) is IV Pole Max Value.
(Anterior 3.14 software and below.)
Go to Infusion More screen or
IV pole height range is X to Y cm.
programming function to reset max
(PC 1.20 software and below.)
UIC01 IV Pole Height. Close this message
to complete this action or use the
The IV Pole height has been limited to the maximum
action button on this message.
ceiling height. The IV Pole height range is {X}-{Y} {cm
| mmHg}. (
4.x software)

IV pole valid range is (0)-(1) cm.


IV Pole height range is (0)-(1) cm. Note: (0) is IV Pole
Go to IV pole more screen or
UIC02 Min Value and (1) is IV Pole Max Value.
programming function to reset
(Anterior 3.14 software and below.)
ceiling limit.
Phase/Mode change not allowed while surgical functions Phase/Mode change not allowed
UIC03
are in use. while surgical functions are in use.

Power down the system by selecting


the ‘End’ icon, confirming any
prompts, and then selecting the
‘Shutdown System’ button on the
Initialization of surgical system failed. Surgical mode End screen.
UIC04
not available. Following system shut down, restart
the system. Close this message and
then complete this action or use the
‘Shut Down System’ button on this
message.

The system database is corrupt. Surgical mode is not


available. The system will shut down after confirmation Contact Technical Support and/or
UIC05
of this message. (Not for Anterior 3.14 software and replace the Hard Drive or UIC.
below.)

Cassette type does not match procedure type. Do you Press Yes for a {anterior, posterior,
UIC06 want to change to the matching procedure type? combined} procedure or Press No to
(All PC & 4.x software) eject the cassette.

Cassette type does not match procedure type.


UIC07 Please insert a posterior cassette.
(All PC & 4.x software)

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Chapter 9 - Error Codes and Troubleshooting Guides

Please plug in a {Phaco, Frag}


Incorrect ultrasound handpiece connected.
UIC08 handpiece, or try a different
(All PC & 4.x software)
ultrasound handpiece.

Please wait for Priming/Tuning/


Priming/Tuning/Vitrectomy cutter testing is in progress.
UIC09 Vitrectomy cutter testing to
(All PC & 4.x software)
complete.

Surgeon File Is Not Usable due to loss of database Reload surgeon file or replace Hard
UIC13
integrity. Try a system default setting file. Drive.

Posterior and Combined Techniques Only: The IV Pole


UIC14 and AFI are both engaged. Please confirm that the AFI None
bottle is at patient eye level.

A laser endoprobe is not connected. Notes: upon entry


UIC15 into Endo and a fiber is connected that is not endoprobe. Connect an EndoProbe.
(Laser only – 4.x software)

A Laser Indirect Ophthalmoscope (LIO) is not


UIC16 Connect an LIO.
connected. (Laser only – 4.x software)

A laser module is not installed; laser functions will not


UIC17 None
be available. (Laser only – 4.x software)
Change the laser Foot Control to
The laser foot control is programmed for primary
secondary (LIO) via the info screen.
UIC18 (integrated) but the primary (integrated) foot control is
Connect the Primary (Integrated)
not found. (4.x software)
Foot Control.

Connect the secondary (LIO) Foot


The laser foot control is programmed for secondary Control.
UIC19 (LIO) but the secondary (LIO) foot control is not Change the laser Foot Control to
connected. (4.x software) primary (integrated) via the info
screen.

Power down the system by selecting


the ‘End’ icon, confirming any
prompts, and then selecting the
‘Shutdown System’ button on the
End screen.
A loss of audio feedback processing has been detected.
Following system shut down, restart
UIC20 System may not be providing audio feedback. (4.x
the system. Close this message and
software)
then complete this action or use the
‘Shut Down System’ button on this
message.
Contact Technical Support or
replace the UIC module.

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Chapter 9 - Error Codes and Troubleshooting Guides

The system requires restarting due to an internal error,


Please perform the following:
1. Select “Shutdown” to initiate system shutdown.
2. If system does not shut down in 30 seconds, power off Contact Technical Support, if the
UIC21
the system by pressing and holding the power button at problem persists.
the front panel.
3. Restart system after 1 minute.
(4.x software)

9.1.2 User Interface Computer (UIC) Troubleshooting Guide

Symptom Probable Cause Corrective Action

Power on the unit and allow unit to


boot up. Verify that the main power
Unit is powered off.
switch and standby switch is in the
ON position.

Main video cables have become Re-seat or plug in the main video
loose or disconnected. cables.

Power\CAN cable is loose or un- Re-seat or plug in the power cord and
attached from the UIC. re-boot the UIC.
Screen is blank
Internal cables (two video cables
or the backlight cable) between the
Re-seat internal flat panel cable.
Transition Board and the display
have come loose or dislodged.

Back lights on the LCD may have


Replace the LCD display.
burned out.

Possible Baseboard failure of Send module to nearest Depot for


video port. Baseboard replacement.

Discolored Display or rolling Internal Power\USB cable is Connect or replace Power\USB


video. disconnected or faulty. cable.

Table 9.2: User Interface Computer (UIC) Troubleshooting Guide.

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Chapter 9 - Error Codes and Troubleshooting Guides

Wide Dark bar across display Part of backlight is burned out. Replace the display.

Power cord is loose or un-attached Re-seat or plug in power cord and re-
from unit. boot unit.

Standby Switch cable is


Replace Standby Switch cable.
disconnected or broken.

Standby Switch PCB is damaged. Replace Standby Switch PCB.

The power cord has been stepped


Unit will not power on on at the bottom of the EMB and Replace the Main Power Input
cracked the Main Power Input assembly.
assembly.

Make sure unit is plugged into a


Incompatible power source.
compatible power source.

A power/communication Check power/communication cable


connector may have become connections to all modules. Verify all
disconnected from a module. cables are connected.

Blown fuse(s) in the power


Replace necessary fuses.
module.

Fan connector is loose or Return to Depot to Re-seat or re-


disconnected from PCB. connect the Fan to the PCB.
Fan not working

Fan motor may be defective Replace Fan.

Hard Drive may be defective. Replace Hard Drive.

Operating System may be


Windows XP Operating System Replace or Reimage Hard Drive.
corrupted.
will not boot

Hard Drive IDE or SATA cable is


Re-seat and/or plug Hard Drive IDE
loose or disconnected from
or SATA cable into the Baseboard.
Baseboard.

Table 9.2: User Interface Computer (UIC) Troubleshooting Guide.

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Chapter 9 - Error Codes and Troubleshooting Guides

Baseboard or SOM may be Send to the nearest Depot for


defective. Baseboard or SOM replacement.

Locks up during BIOS


Possible Hard Drive failure. Replace Hard Drive.
initialization

SDRAM memory module failure. Replace the DIMM.

Touch Screen flex cable or


Re-seat and/or re-plug in the Touch
Power\USB cable has become
Screen flex cable or Power\USB
loose or dislodged from its
cable.
connector.

Touch Screen is not functioning


Replace the Touch Screen.
properly.
Touch Screen is not working
Touch Screen has been damaged. Replace the Touch Screen.

The Transition PCB is not


Replace the Transition PCB.
functioning properly.

The Touch Screen driver in the


Windows XP Operating System Replace or Reimage Hard Drive.
has been corrupted.

The Touch Screen is out of Performed a calibration of the Touch


calibration. Screen.
Touch Screen is activating a
different area than the area that
was touched or Touch Screen A new Touch Screen that has never
needs calibrated. been calibrated will act as if the
Touch Screen is new and needs
Touch Screen is upside down and
calibration.
backwards. Calibrate the Touch
Screen and it will work normally.

Remote Control batteries power Install fresh AA batteries into


may be low. remote.

IR Remote Receiver PCB Replace the IR Remote Receiver


assembly is malfunctioning. PCB assembly.
IR Remote Receiver not
functioning IR Remote Receiver cable has Re-seat and/or re-plug in the IR
become loose or dislodged. cable.

The Transition PCB is not


Replace the Transition PCB.
functioning properly.

Table 9.2: User Interface Computer (UIC) Troubleshooting Guide.

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Windows XP did not boot Power down the system and then
properly. restart the system.

Integrated sound on the Baseboard Send to the nearest Depot for


has failed. Baseboard replacement.
No sound
Windows XP sound driver has
Replace or Reimage Hard Drive.
become corrupted.

Speaker cables have become


disconnected or speakers have Reconnect or replace speakers.
failed.

The Windows XP operating


Replace or Reimage Hard Drive.
system has become corrupted.

Possible RAM error on the Send to the nearest Depot for RAM
Baseboard. replacement.
System locks up during use
Hard Drive may be bad causing
Replace or Reimage Hard Drive.
the Baseboard to freeze up.

PCI\CAN Bus Interface failure on


Replace the Baseboard.
the Baseboard.

Possible software error due to


Windows XP error message Replace or Reimage Hard Drive.
installation failure.

Files may not be compatible with Use files that are compatible with the
UIC software version. UIC software version.

Power\USB cable is disconnected Connect or replace Power\USB


or has failed. cable.
Cannot load files from a
memory stick.
Display Transition Board failure. Replace Display Transition Board.

Baseboard has failed. Replace Baseboard.

Table 9.2: User Interface Computer (UIC) Troubleshooting Guide.

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Chapter 9 - Error Codes and Troubleshooting Guides

External Ethernet cable is not Connect or replace external Ethernet


plugged in or is damaged. cable.

MMC is not turned on. Turn MMC on.

UIC will not communicate with Internal Ethernet cable is Connect or replace internal Ethernet
the MMC. disconnected or has failed. cable.

Baseboard has failed. Replace Baseboard.

Windows XP driver has become


Replace or Reimage Hard Drive.
corrupted.

CAN Bus cable has come loose or Re-seat or re-connect the CAN Bus
disconnected. cable.

CAN bus interface on the Send to the nearest Depot for


Baseboard failed. Baseboard replacement.

UIC Module will not Possible other module is loading Disconnect modules one at a time
communicate with the system down communications with the until failure is corrected. Replace
modules. UIC. corresponding module.

Power down the system and then


Configuration error
restart the system.

Replace module or send to the


Module Baseboard has failed. nearest Depot for Baseboard
replacement.

Table 9.2: User Interface Computer (UIC) Troubleshooting Guide.

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Chapter 9 - Error Codes and Troubleshooting Guides

9.2 Electromechanical Base (EMB)

9.2.1 EMB or System Chassis Troubleshooting Guide

Symptom Probable Cause Corrective Action


Base Assembly:
Brake Mechanism is engaged. Disengage Brake Mechanism.

BSS ingress into Castor Replace Castor.


Castor will not move
Castor damaged. Replace Castor.
Debris lodged under Castor
Clear debris from under Castor Cover.
Cover.

Brake Mechanism will not Brake Mechanism damaged. Replace Brake Mechanism.
engage or Castors move with Wheel may have been incorrectly Remove wheel and install wheel
brake engaged. installed if removed. correctly.

Tray Assembly:
Tighten the Clevis screws or slide
Mayo Tray Arm is falling off. Clevis or slide is loose or screws.
damaged.
Replace the TADA.

Tray Arm will not slide in or


There may be debris or BSS in Remove debris or BSS from Tray Arm
out of EMB or movement is not
the slide for the Tray Arm. slide.
smooth.

Bag Holder will not slide into


Bag Holder is bent or damaged. Replace Bag Holder.
Tray assembly.

Bag Holder is falling off. Holder Stops have fallen off. Replace Tray Arm Assembly.

Too many things are in drawer. Take some items out of the drawer.
Accessories Drawer will not Replace drawer latch. May not be able
stay closed. Drawer latch is broken. to fix in the field. If not, send unit to
depot for repair.

Table 9.3: EMB or System Chassis Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

9.3 Ultrasound Module (USM/USV/USL)

9.3.1 Ultrasound Module (USM/USV) Error Codes

Error
Description Corrective Action
Code
Ultrasound Module will not
The ultrasound module was not detected in the system. communicate.
USM01 Surgical mode is not available. Reboot system.
Ultrasound and coagulation are not available. Daughter Board may have failed.
Replace module.

The ultrasound module software version is not compatible


with the system software version. Surgical mode is not A compatible software version must
USM02
available. be downloaded.
Ultrasound and coagulation are not available.

Ultrasound Module will not


The ultrasound module has failed to respond to a settings
communicate.
USM03 command. The module settings have been re-sent to the
Reboot system.
module.
Reload software or replace module.

Ultrasound Module will not


The ultrasound module has reset. The module settings have communicate.
USM04
been re-sent to the module. Reboot system.
Reload software or replace module.

Please plug in the {Phaco, Frag}


handpiece. The ultrasound
connector indicator light is flashing.
USM05 The ultrasound handpiece is not connected or detected.
If the handpiece is not detected,
unplug the handpiece and try
another {Phaco, Frag} handpiece.

Select ‘Setup’, then select ‘Prime /


Tune’ or ‘Tune Only’ button. Close
USM06 The ultrasound handpiece has not been tuned. this message and then complete this
action or select the ‘Prime / Tune’
button on this message.

The ultrasound handpiece tuning is in progress. Please wait for the ultrasound
USM07
(Anterior 3.14 software and below.) handpiece tuning to complete.

Table 9.4: Ultrasound Module (USM/USV) Error Codes

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Ensure ultrasound needle is


properly tightened, the handpiece is
sufficiently cooled, and the
connector is dry. Select the ‘Prime /
Tune’ or ‘Tune Only’ button again
to repeat the handpiece tuning
process. Close this message and
then complete this action or use the
‘Prime and Tune’ button on this
USM08 The ultrasound handpiece has failed the tuning process.
message.
Unplug the handpiece and try
another ultrasound handpiece.
Select the ‘Prime/ Tune’ or ‘Tune
Only’ button again to repeat the
handpiece tuning process. Close this
message and then complete this
action or use the ‘Prime and Tune’
button on this message.

Unplug the handpiece and try


another ultrasound handpiece.
Select the ‘Prime/ Tune’ or ‘Tune
The ultrasound handpiece may have failed or may be Only’ button again to repeat the
USM09
failing. handpiece tuning process. Close this
message and then complete this
action or use the ‘Prime and Tune’
button on this message.

Unplug the bipolar handpiece and


Coagulation circuit may have failed, potential coagulation
USM10 cord and try another bipolar
output overvoltage condition.
handpiece and cord.

Unplug the bipolar handpiece and


Coagulation circuit may have failed, potential
USM11 cord and try another bipolar
uncommanded or incorrect coagulation output.
handpiece and cord.

If the handpiece is not detected,


Incorrect ultrasound handpiece connected. (Anterior 3.14
USM12 unplug the handpiece and try
and below.)
another ultrasound handpiece.

Plug in the electric vitrectomy


handpiece. The electric vitrectomy
The electric vitrectomy handpiece is not plugged in to the connector light is flashing. If the
USM13
system. (Anterior 3.14 and below.) handpiece is not detected, unplug
the handpiece and try another
electric vitrectomy handpiece.

Table 9.4: Ultrasound Module (USM/USV) Error Codes

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Confirm proper operation of the


electric vitrectomy handpiece in a
The electric vitrectomy handpiece may have failed. beaker of balanced salt solution.
USM14
(Anterior 3.14 and below.) Unplug the handpiece and try
another electric vitrectomy
handpiece.

Ensure ultrasound needle is


properly tightened, the handpiece is
sufficiently cooled, and the
connector is dry. Select the ‘Prime /
Tune’ or ‘Tune Only’ button again
to repeat the handpiece tuning
process. Close this message and
then complete this action or use the
Unable to read ultrasound handpiece data. Attempt to tune ‘Prime and Tune’ button on this
USM15
the handpiece to confirm proper operation. message.
Unplug the handpiece and try
another ultrasound handpiece.
Select the ‘Prime/ Tune’ or ‘Tune
Only’ button again to repeat the
handpiece tuning process. Close this
message and then complete this
action or use the ‘Prime and Tune’
button on this message.

Power down the system by selecting


the ‘End’ icon, confirming any
prompts, and then selecting the
‘Shutdown System’ button on the
End screen.
The ultrasound module fan has failed. The ultrasound
USM16 Following system shut down, restart
handpiece cannot be tuned or operated. (4.x software)
the system. Close this message and
then complete this action or use the
‘Shut Down System’ button on this
message.
Replace fan or module.

Table 9.4: Ultrasound Module (USM/USV) Error Codes

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9.3.2 Ultrasound Modules (USM/USV) Troubleshooting Guide

Symptom Probable Cause Corrective Action

Try a new Bausch + Lomb Adapter. If


Defective Coagulation Adapter
bad, replace Adapter.

Broken or damaged Coagulation Try a new Bausch + Lomb Coagulation


cable. cable. If bad, replace Coagulation cable.

Coagulation connector is Examine connector for cracked, broken


damaged, broken or corroded or damaged connector. If damaged,
with BSS replace connector.

Connect a known-good Bausch + Lomb


Faulty Coagulation handpiece or Coagulation handpiece to its appropriate
non-Bausch & Lomb handpiece. Bausch + Lomb cable. Replace
handpiece

Check coagulation power level on


Coagulation power set too low. STELLARIS display; verify it is not set
too low.

Verify coagulation has been selected


No or low Coagulation output Not in coagulation mode. from clock menu. Verify that the
coagulation connector LEDs are ON.

Foot Control programmed for Verify coagulation mode is correct


Linear Coagulation instead of (Linear coagulation is controlled by foot
Fixed Coagulation. pedal pitch).

Verify other system tones or commands


can be heard (speakers working) .If so,
verify tone is heard when Coagulation
Programmed Foot Control button
button is depressed on foot pedal. If not
is broken.
programmed Foot Controller button
(Coagulation) may be broken, replace /
repair Foot Control.

Reboot, attach Foot Control external


Foot Control lost communication.
cord or replace Foot Control.

Check Coagulation output with an


Output from PCB too low. Electrical Surgical Analyzer (Depot
Only). Adjust output if necessary.

Printed Circuit Board failed. Replace Main PCB.

Table 9.5: Ultrasound Modules (USM/USV) Troubleshooting Guide

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See Foot Control does not have full


Foot Control does not have
No or low Coagulation output linear Pitch travel in Foot Control
full linear Pitch travel.
Troubleshooting Guide.

Over-voltage Error
Printed Circuit Board failed. Replace Main PCB
(Coagulation)

Needle is loose. Tighten the needle.

Try a known good Bausch + Lomb


ultrasound handpiece to determine
Possible bad handpiece.
whether it is the module itself or the
handpiece that is failing during tuning.

Check cables between Main PCB and


Daughter, replace cable if faulty.
No sine wave or boost signal

Ultrasound hand piece will not Replace Main PCB.


tune, but handpiece is present. Signals coming from the Main
PCB going into the Daughter
Replace Daughter PCB.
Board are normal, but handpiece
will not tune.

Daughter PCB may have failed. Replace Daughter PCB.


Fan has failed. Unit will display Verify fan cable is properly connected.
fan failure error. Replace fan.

Look for pushed pins, spinning


Ultrasound connector damaged or
connector or signs of BSS. Clean or
corroded with BSS.
replace ultrasound connector or module.

Memory device inside handpiece


Memory Device Failure has failed. DRM is logging bad Replace handpiece.
data from handpiece.

Over Current Error Handpiece may have failed. Replace handpiece.


(Ultrasound)
Main PCB Failed Replace PCB or module.

Table 9.5: Ultrasound Modules (USM/USV) Troubleshooting Guide

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Try a known good Bausch + Lomb


ultrasound handpiece to determine
Possible bad handpiece. whether it is the module itself or the
handpiece that is failing during
calibration.

Look for pushed pins, spinning


Ultrasound connector damaged or
connector or signs of BSS. Clean or
corroded with BSS.
No, Low, or Intermittent replace ultrasound connector or module.
ultrasound output.
Failed PCB. Daughter Board may Replace PCB or module. Replace
be bad. Daughter Board.

Fan has failed. Unit will display Verify fan cable is properly connected.
fan failure error. Replace fan.

See Foot Control does not have full


Foot Control does not have
linear Pitch travel in Foot Control
full linear Pitch travel.
Troubleshooting Guide.

Try a known good ultrasound handpiece


to determine whether it is the module
Possible bad handpiece.
itself or the handpiece that is failing
during calibration.

Output cable harness


Reconnect cable harness.
disconnected from PCB.

Look for pushed pins, spinning


Ultrasound connector damaged or
connector or signs of BSS. Clean or
corroded with BSS.
Ultrasound handpiece not replace ultrasound connector or module.
present
Daughter board may have failed.
Check Probe Present (pin 10 of
J10).
Verify +5v ISO is present (pin 1
on J11).
Replace Daughter PCB or module.
Check for data (pin 3 on J11)
when handpiece is connected to
module.
Note: Pin 2 of J11 is ISO Ground
for +5v ISO voltage check.

Replace tip with a new Bausch + Lomb


Tip is bent or damaged.
tip.

High Speed Vitrectomy Verify that the problem is not in the


handpiece will not actuate Possible bad handpiece. handpiece by using a known-good High
Speed Vitrectomy Handpiece

Main PCB Failed Replace Main PCB or module.

Table 9.5: Ultrasound Modules (USM/USV) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Check cut rate on display. Verify proper


Vitrectomy cut rate is too low.
cut rate is set.

Possible bad handpiece, if Replace handpiece with known Bausch


High Speed Vitrectomy
handpiece is slow. + Lomb good handpiece.
Handpiece actuation is too fast
or slow. Replace tip with a new Bausch + Lomb
Tip is bent or damaged.
tip.

PCB is causing handpiece to


Replace Main PCB.
actuate too fast.

Try a known good HSV handpiece to


determine whether it is the module itself
Possible bad handpiece.
or the handpiece that is failing during
calibration.
High Speed Vitrectomy
Output cable harness
handpiece is not present Reconnect cable harness.
disconnected from PCB.

Check Probe Present signal (pin 3


of J12). Replace Main PCB or module.
PCB may have failed.

Module may have become With the system shutdown, reattach


disconnected from CAN Bus. CAN Bus cable.
Ultrasound Module will not
communicate. Configuration error Reboot unit.

Main PCB has failed. Replace module or Main PCB.

Table 9.5: Ultrasound Modules (USM/USV) Troubleshooting Guide

9.4 Fluidics Modules

9.4.1 Advanced Flow Module (AFM) (Anterior Only)

9.4.1.1 Advanced Flow Module (AFM) Error Codes (Anterior Only)

Error
Description Corrective Action
Code
Advanced Flow Module will not
The flow fluidics module was not detected in the
AFM01 communicate. Check or reload software or
system. Surgical Mode is not available.
replace module.

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The flow fluidics module software version is not


A compatible software version must be
AFM02 compatible with the system software version. Surgical
downloaded.
mode is not available.

The flow fluidics module has failed to respond to a Confirm correct irrigation, aspiration, and
AFM03 settings command. The module settings have been re- Vitrectomy function. Reboot system or
sent to the module. reload software.

Confirm correct irrigation, aspiration, and


The flow fluidics module has reset. The module
AFM04 Vitrectomy function. Reboot system or
settings have been re-sent to the module.
reload software.

The flow fluidics module does not have valid factory Module may need a calibration. Replace
AFM05
calibration data. Surgical mode is not available. module if necessary.

Open the flow fluidics module drawer, re-


insert the cartridge, and close the drawer
AFM06 The fluidics pump motor may have failed. again. Try to observe if the pump head
moves as the drawer closes. Replace
module if necessary.

Select ‘Setup’, select Open Drawer’, re-


The flow fluidics module cartridge vacuum sensor test
insert the flow fluidics cartridge, and select
AFM07 has not been attempted.
‘Close Drawer’ for the cartridge vacuum
(Anterior 3.14 software and below.)
sensor test. Replace module if necessary.

The cartridge vacuum sensor test is in progress. Please wait for the flow fluidics module
AFM08 (Anterior 3.14 and below says “flow fluidics cartridge vacuum sensor check to
cartridge…”) complete.

Select ‘Setup’, select Open Drawer’, re-


insert the flow fluidics cartridge, and select
‘Close Drawer’ for the cartridge vacuum
The cartridge vacuum sensor test has failed. sensor test.
AFM09 (Anterior 3.14 and below says “flow fluidics Make sure that the flow fluidics
cartridge…”) module and cartridge vacuum sensor
surfaces are clean and dry.
Replace the flow fluidics cartridge or
module if necessary.

Select ‘Setup’, select Open Drawer’, and


make sure that the flow fluidics module
The vacuum sensor has failed. and cartridge vacuum sensor surfaces are
AFM10 (Anterior 3.14 and below says “flow fluidics clean and dry. Select ‘Close Drawer’ to
cartridge…”) retry the cartridge vacuum sensor test.
Replace the flow fluidics cartridge or
module if necessary.

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Chapter 9 - Error Codes and Troubleshooting Guides

Wait for priming to complete or Select


System priming has not been completed.
‘Setup’, and select ‘Prime and Tune’ or
AFM11 (Anterior 3.14 and below says “not been
‘Prime Only’ to complete the system
attempted”)
priming.

System priming is in progress. Please wait for the system priming to


AFM12
(Anterior 3.14 software and below.) complete.

Check irrigation and aspiration tubing


connections for leaks. Check that the test
chamber is forming a tight seal around the
handpiece. Try priming the system again.
AFM13 System priming has failed.
Select ‘Open Drawer’, load a new pack,
and try priming the system again.
Replace the flow fluidics cartridge or
module if necessary.

Check that the Vitrectomy cutter tubing is


The vitrectomy cutter output pressure is low. connected tightly to the system.
Vitrectomy cutter may not be cutting. Confirm correct Vitrectomy function. Try
AFM14
(Anterior 3.14 and below says “flow fluidics a new cutter.
cartridge…”) Check Vitrectomy pressure.
Replace Compressor or AFM if necessary.

Please insert the cartridge. Confirm correct Vitrectomy function.


AFM15 (Anterior 3.14 and below says “flow fluidics Check Vitrectomy pressure.
cartridge.”) Replace Compressor or AFM if necessary.

Insert the flow fluidics cartridge and press


AFM16 Please insert the flow fluidics cartridge.
the Close Drawer button.

To activate reflux, release the foot pedal to


Reflux is not available – Reflux cannot be activated
a non-aspirating position and activate the
AFM17 when aspiration is active.
inward-yaw reflux command or the button
(4.x software)
programmed for reflux.

Reflux is not available – too many reflux pulses


Press the foot pedal to activate a short
have been activated, aspiration must be commanded
AFM18 period of aspiration before re-activating
again to reset the reflux function.
reflux.
(4.x software)

Release the foot pedal to home position


Aspiration is not available – the foot pedal started in
and ensure the Primary (Integrated) Foot
the inward yaw position when pressed to activate
Control button programmed for reflux is
AFM19 aspiration or the foot control button programmed for
not activated. Press the foot pedal into the
reflux is activated.
aspiration region again to obtain
(4.x software)
aspiration.

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Chapter 9 - Error Codes and Troubleshooting Guides

9.4.1.2 Advanced Flow Module (AFM) Module Troubleshooting Guide


(Anterior Only)

Symptom Probable Cause Corrective Action


Reseat the Peristaltic Cartridge
The cartridge is not fully seated and verify that the cartridge is
in the drawer. fully inserted into the drawer and
the drawer closes properly.

Replace the cartridge with new


A cartridge failure.
cartridge.
Check the front of the
Transducer Assembly for any Remove any foreign material.
foreign material.

Adjust the flow control valve to


Calibration pressure is less than
obtain a pressure reading
450 mmHg ± 10 mmHg.
between 440 and 460 mmHg.
Cartridge will not calibrate
Check all tubing inside the
module and verify that no tubing
is loose or disconnected, which
Loose tubing inside module.
would cause air leaks and
calibration failure. Connect or
tighten tubing if necessary.

The Transducer Box cable is Reconnect the Transducer Box


unseated or disconnected. cable.

Send to the nearest Depot for


The drawer is out of alignment.
Drawer Alignment.

Check the module for Extension Install Extension Spring


Spring Upgrade (Hardware 1.1) Upgrade

Loose tubing on the handpiece. Tighten or replace the tubing.

Verify the IV bottle clamp is


Low or no irrigation from IV
open and irrigation is flowing
bottle.
during priming.
Cartridge will not prime
Check the screw on the Rotor.
The rotor is loose.
Tighten screw if necessary.

Check the module for Extension Install Extension Spring


Spring Upgrade (Hardware 1.1) Upgrade

Table 9.6: Advanced Fluidics Module Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Symptom Probable Cause Corrective Action


With the power off, manually
The Vertical or Horizontal Slide
pull the drawer open to verify
has failed.
smooth operation of the slide.
Drawer will not open
Verify that the tubing going into
Low air pressure into vertical
the slide has not become
slide.
disconnected.

The cartridge is not fully or


Fully seat the cartridge.
properly seated in the drawer.

Check for obstruction in the Remove any obstruction in


Drawer will not close drawer path. drawer path.

With the power off, manually


The Vertical or Horizontal Slide
pull the drawer open to verify
has failed.
smooth operation of the slide.

The Vitrectomy wiring harness


Properly connect the Vitrectomy
may have become disconnected
wiring harness.
from the valve or PCB.

The Vitrectomy wiring harness Replace the Vitrectomy wiring


may have an open wire. harness.
No Vitrectomy Output
The Vitrectomy valve may be
Replace the Vitrectomy valve.
stuck.

The Blue tubing going into or


out of the Vitrectomy valve is Reconnect the Blue tubing.
disconnected.

The Vitrectomy wiring harness Replace the Vitrectomy wiring


Intermittent Vitrectomy may have an open wire. harness.
Operation The Vitrectomy valve may have
Replace the Vitrectomy valve.
been stuck.

The Vitrectomy cable assembly Connect the Vitrectomy cable


is disconnected or connector assembly or replace broken or
No Vitrectomy Illumination may be broken or damaged. damaged cable assembly.

The LED PCB is bad. Replace the LED PCB.


The Module may have become With the system shutdown,
separated from CAN Bus. reattach the CAN Bus cable.
Advanced Flow Module will
not communicate. A configuration error. Reboot the unit.

The module PCB has failed. Replace the module or PCB.

Table 9.6: Advanced Fluidics Module Troubleshooting Guide

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9.4.2 Vacuum Fluidics Module (VFM/PFM)

9.4.2.1 Fluidics Module Error Codes (VFM/PFM)

Error
Description Corrective Action
Code
The vacuum fluidics module was not detected in the
Vacuum Fluidics Module will not
system. Surgical mode is not available.
VFM01 communicate. Reboot system.
(Anterior 3.14 and below says “Vacuum Fluidics
Reload software or replace module.
module not available.”)

The vacuum fluidics module software version is not


compatible with the system software version. Surgical
A compatible software version must
VFM02 mode is not available.
be downloaded.
(Anterior 3.14 and below says “Vacuum Fluidics
module not available.”)

The vacuum fluidics module has failed to respond to a


Reboot system.
VFM03 settings command. The module settings have been re-sent
Reload software or replace module.
to the module.

The vacuum fluidics module has reset. The module Reboot system.
VFM04
settings have been re-sent to the module. Reload software or replace module.
The vacuum fluidics module does not have valid factory
calibration data. Surgical mode is not available. ( Possible faulty Vacuum Transducer.
VFM05
Anterior 3.14 and below says “Vacuum Fluidics Replace transducer or module.
module not available.”)
Select ‘Setup’, select ‘Eject
The vacuum fluidics module cassette vacuum check has
Cassette’, and then re-insert the
VFM06 not been attempted.
vacuum fluidics cassette for the
(Anterior 3.14 software and below.)
cassette vacuum check.

The cassette vacuum check is in progress.


Please wait for the cassette vacuum
VFM07 (Anterior 3.14 and below says “The vacuum fluidics
check to complete.
module cassette vacuum check is in progress.”)

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Chapter 9 - Error Codes and Troubleshooting Guides

Eject the cassette using the ‘Eject


Cassette’ icon button in the status
display and then re-insert the
cassette to retry the cassette vacuum
check. Close this message and then
complete this action or use the ‘Eject
The cassette vacuum check has failed.
Cassette’ button on this message.
VFM08 (Anterior 3.14 and below says “The vacuum fluidics
Eject the cassette using the ‘Eject
module cassette vacuum check has failed.”)
Cassette’ icon button in the status
display and then replace the cassette
with a new cassette. Close this
message and then complete this
action or use the ‘Eject Cassette’
button on this message.

Select the ‘Setup’ icon, then select


the ‘Prime’ or ‘Prime and Tune’
System priming has not been completed. button to complete the system
VFM09 (Anterior 3.14 and below says “System priming has priming. Close this message and
not been attempted.”) then complete this action or use the
‘Prime’ or ‘Prime and Tune’ button
on this message.

System priming is in progress. Please wait for the system priming to


VFM10
(Anterior 3.14 and below; also PC 1.20 and below.) complete.

Check irrigation and aspiration


tubing connections for leaks. Check
that the test chamber is forming a
tight seal around the handpiece.
Select the ‘Setup’ icon, then select
the ‘Prime’ or ‘Prime and Tune’
button to complete the system
priming. Close this message and
then complete this action or use the
VFM11 System priming has failed.
‘Prime’ or ‘Prime and Tune’ button
on this message.
Eject the cassette the cassette using
the ‘Eject Cassette’ icon button in
the status display and then load a
new pack. Close this message and
then complete this action or use the
‘Eject Cassette’ button on this
message.

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Chapter 9 - Error Codes and Troubleshooting Guides

The internal air pressure supply to the Vacuum Fluidics


Module is low. The irrigation and aspiration pinch valves Check appropriate tubing and air
may not be functioning properly. pressures.
VFM12
Internal tubing may be kinked. Replace VFM or Compressor
Rotary Vane Pump may not be working properly. module.
(Below Anterior 3.14 software)

P/C Domains: At the soonest


convenient time, empty the cassette.
To empty the cassette: 1. Clamp the
infusion line. 2. Select the eject
cassette icon. 3. Empty the cassette.
4. Re-insert the cassette. 5. Open the
infusion clamp. Refer to operator’s
manual for detailed instructions to
detach tubing manifold from the
The vacuum fluidics module cassette is nearly full. cassette.
(Anterior 3.14 and below.) Anterior Domain: At the soonest
convenient time, empty the cassette.
The cassette has just become nearly full. To empty the cassette: 1. Clamp the
VFM13 irrigation line. 2. Replace the test
(PC 1.20 and below.)
chamber on the handpiece. 3. Select
The cassette is nearly full. the eject cassette icon. 4. Empty the
(4.x software) cassette. 5. Re-insert the cassette. 6.
Open the irrigation clamp 7. Remove
the test chamber from the handpiece.
Eject the cassette the cassette using
the ‘Eject Cassette’ icon button in
the status display and then load a
new pack. Close this message and
then complete this action or use the
‘Eject Cassette’ button on this
message.

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Chapter 9 - Error Codes and Troubleshooting Guides

P/C Domains: Empty the cassette.


To empty the cassette: 1. Clamp the
infusion line. 2. Select the eject
cassette icon. 3. Empty the cassette.
4. Re-insert the cassette. 5. Open the
infusion clamp. Refer to operator’s
manual for detailed instructions to
detach tubing manifold from the
cassette.
Anterior Domain: Empty the
cassette. To empty the cassette: 1.
The cassette is full. Clamp the irrigation line. 2. Replace
VFM14 (Anterior 3.14 and below says “The vacuum fluidics the test chamber on the handpiece. 3.
cassette is full.”) Select the eject cassette icon. 4.
Empty the cassette. 5. Re-insert the
cassette. 6. Open the irrigation
clamp 7. Remove the test chamber
from the handpiece.
Eject the cassette the cassette using
the ‘Eject Cassette’ icon button in
the status display and then load a
new pack. Close this message and
then complete this action or use the
‘Eject Cassette’ button on this
message.

Check that the vitrectomy cutter


tubing is connected tightly. Select
the ‘Setup’ icon, then select the ‘Vit
Test’ button. Close this message and
The vitrectomy cutter output pressure is low. Vitrectomy then complete this action or select
cutter may not be cutting. the ‘Vit Test’ button on this
VFM15 (Anterior 3.14 and below says “The vacuum fluidics message.
module vitrectomy cutter output pressure is low. Replace the vitrectomy cutter. Select
Vitrectomy cutter may not be cutting.”) the ‘Setup’ icon and then select the
‘Vit Test’ button. Close this message
and then complete this action or
select the ‘Vit Test’ button on this
message.

The Vacuum Fluidics Module vitrectomy cutter output


Contact Technical Support and/or
VFM16 pressure is high. The vitrectomy cutter may not be
replace the module.
cutting.

Please insert the cassette.


VFM17 (Anterior 3.14 and below says “Please insert the Insert the vacuum fluidics cassette.
vacuum fluidics cassette.”)

Unrecognized cassette. Please re-insert the cassette or try a


VFM18
(All PC versions and 4.x software) different cassette.

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Chapter 9 - Error Codes and Troubleshooting Guides

Eject the cassette using the ‘Eject


Cassette’ icon button in the status
A Vacuum Fault has occurred. display and then load a new pack.
VFM19
(All PC versions and 4.x software) Close this message and then
complete this action or use the ‘Eject
Cassette’ button on this message.

To activate reflux, release the foot


Reflux is not available – Reflux cannot be activated when pedal to a non-aspirating position
VFM20 aspiration is active. and activate the inward yaw reflux
(4.x software) command or the button programmed
for reflux.

Reflux is not available – too many reflux pulses have


Press the foot pedal to activate a
been activated, aspiration must be commanded again to
VFM21 short period of aspiration before re-
reset the reflux function.
activating reflux.
(4.x software)
Release the foot pedal to home
position and ensure the Primary
Aspiration is not available – the foot pedal started in the
(Integrated) Foot Control button
inward yaw position when pressed to activate aspiration
VFM22 programmed for reflux is not
or the foot control button programmed for reflux is
activated. Press the foot pedal into
activated. (4.x software)
the aspiration region again to obtain
aspiration.

Set Manual mode infusion to ON.


Aspiration is not available – in Manual infusion mode, Close this message and then
VFM23 infusion is set to OFF. complete this action or use the
(4.x software) ‘Infusion On’ button on this
message.

Clean and dry the fluid level


detection lens inside the cassette
The cassette was not captured – the fluid level sensor
capture slot on the right side (red
VFM24 could not be read.
blinking light) as recommended in
(4.x software)
the Operator’s Manual, and insert
the cassette again.

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Chapter 9 - Error Codes and Troubleshooting Guides

Without ejecting the cassette, gently


push it back into the module. This
message will clear automatically
once the fluid level sensor can be
read successfully.
Clean and dry the fluid level
detection lens inside the cassette
capture slot on the right side (red
blinking light) as recommended in
VFM26 The fluid level sensor could not be read.
the Operator’s Manual, and insert
the cassette again.
Eject the cassette using the ‘Eject
Cassette’ icon button in the status
display and then replace the cassette
with a new cassette. Close this
message and then complete this
action or use the ‘Eject Cassette’
button on this message.

9.4.2.2 Vacuum Fluidics Module (VFM) Troubleshooting Guide

Symptom Probable Cause Corrective Action


Remove module, remove left side and
Aspiration sensor may have connect extenders. Release clear tubing
failed. from capture block. Connect DPM-III
to clear tubing. Insert cassette, set
Servo valve may have failed. aspiration to 100 mmHg. Initiate
Aspiration is too high aspiration. Check DPM for vacuum
Circuit board may have failed. level. If the vacuum level equals the set
point, replace the sensor. If the vacuum
Compressor module may have level is high, replace the servo valve. If
failed. level is still too high replace circuit
board.

Table 9.7: Vacuum Fluidics Module (VFM) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Reseat or reconnect

Replace Hydrophobic Filter.


Vacuum line (clear) may be
Remove module, remove left side and
disconnected or leaking.
connect extenders. Release clear tubing
from capture block. Connect DPM-III
Hydrophobic Filter may be full of
to clear tubing. Insert cassette, set
liquid.
aspiration to 100 mmHg. Initiate
aspiration. Check DPM for vacuum
Cassette may be leaking.
level.
Aspiration sensor may have
If the vacuum level equals the set
Aspiration is too low failed.
point, replace the cassette. If the
vacuum level is low, plug the “E” port
Servo valve may have failed.
with finger. If the vacuum level equals
the set point replace the servo valve. If
Foot Control may not be making
the vacuum level is low replace the
full travel.
pressure sensor.
Compressor module may have
Foot Control does not have
failed.
full linear Pitch travel.

Check Compressor operation in


Service Software.

Cassette may not be primed. Prime Cassette.

Replace Rotary Vane pump in


Rotary Vane pump failure.
Compressor Module.

No Aspiration
Foot Control will not work with
system.
Foot Pedal not responding.
Foot Control does not have
full linear Pitch travel.

Table 9.7: Vacuum Fluidics Module (VFM) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Remove module, remove left side and


Capture switch may have failed. connect extenders. Insert cassette, see
if switch is actuated. If switch is
Six Station Valve assembly may actuated, are the LEDs on the valve
have failed. assembly on? If LEDs are on, connect
DPM to the red extension tubing T.
Pinch Manifold may have failed. The DPM should read 40 psig. If less
than 40 psig, the problem is in the
Cassette won’t capture Compressor module may have compressor module. If the LEDs on the
failed. valve assembly are not on, replace the
circuit board or Six Station Valve.
Circuit board may have failed. Check Cassette Capture valve
actuation in the Service Software, if
faulty; replace Pinch Manifold.

CCD Camera failed.


Replace CCD Camera.

Connector may disconnect from Verify connector is connected.


Cassette Illumination LED PCB or Main PCB.

LED on PCB is bad. Replace LED PCB.

Cassette Capture Switch may be


out of position causing the Properly align Cassette Capture
No Fluid Level Detection
cassette prism to not align with Switch.
the CCD Camera.

Customer may be using a used


cassette and water droplets inside
may be throwing off level Use a dry or new cassette.
Fluid Level Detection too high detection.
Replace damaged cassette.
Cassette detection prism may be
damaged.

Using a lint-free cloth and Isopropyl


Detection window on CCD
Alcohol clean the CCD Camera
Camera is dirty.
window inside the VFM cassette
Fluid Level Detection too low
holder.
Cassette detection prism may be
damaged.
Replace damaged cassette.

Table 9.7: Vacuum Fluidics Module (VFM) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Reconnect blue tubing to Vitrectomy


Valve or coming out of Vitrectomy
Blue tubing going into Valve going to luer on the front of the
Vitrectomy Valve may be loose module.
or disconnected.
Remove module, remove left side and
Blue tubing out of Vitrectomy connect extenders. Initiate VIT. Is the
Valve or going into luer may be LED in the valve flashing? If not
disconnected. replace the circuit board. If flashing,
No VIT output
connect DPM to the blue extension
Vitrectomy Valve stuck closed. tubing T. The DPM should read 40
psig. If less than 40 psig, the problem is
Circuit board may have failed. in the compressor module. If the DPM
reads 40 psig and the LED is flashing,
Compressor module may have replace the valve. If the symptom is
failed. that the VIT had no output but is OK
during service test, replace the valve as
PM.

Connector is disconnected from Verify connector is connected.


Vitrectomy connector or PCB.
Verify that the connector is not
No Vitrectomy Illumination
Connector may be damaged. damaged.

LED PCB is bad. Replace LED PCB.

Remove module, remove left side and


connect extenders. Examine cassette
Cassette tubing may be out of for misplaced tubing, kinked tubing.
place or kinked. Replace cassette. Insert cassette,
observe pinchers, does irrigation
Six Station Valve assembly may pincher descend to pinch tubing on
have failed. cassette? If not, is the LED for
irrigation pinch on the valve assembly
Irrigation pinch does not
Compressor module may have ON? If LED is on, remove the brown
function
failed. tubing from the capture block; connect
DPM to the brown tubing. The DPM
Pinch manifold valve (irrigation) should read 40 psig. If less than 40
may be stuck. psig, the problem is in the compressor
module. If there is 40 psig the pinch
Circuit board may have failed. block has failed (pincher is stuck). If
the LED is not on, replace the circuit
board.

Table 9.7: Vacuum Fluidics Module (VFM) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Cassette tubing may be kinked. Reflux pressure is controlled by the


height of the BSS bottle. Remove
BSS bottle may not be high module, remove left side and connect
enough. extenders. Insert cassette, open bottle
valve. Initiate reflux. BSS should flow
Pinch block may have failed. from the aspiration tubing. Does the
Low or no reflux
Valve assembly may have failed. valve assembly (yellow tubing) LED
go off? If the LED goes off and the
Circuit board may have failed. pincher does not retract replace the
pinch block assembly. If the LED does
Verify that customer is not using not go off replace the circuit board.
restrictive flow tubing. Verify use of proper B+L tubing.

Cassette may have a leak or Reconnect cassette tubing.


tubing is not connected.
Reconnect Vacuum line (clear).
Vacuum line (clear) disconnected
from Compressor. Remove module, remove left side and
connect extenders. Insert a new
Capture block may be stuck or cassette. Observe pinchers for correct
broken. operation. If pinchers are not correct,
watch LEDs on the valve assembly. If
Cassette will not pass vacuum Pinch block may have failed. the LEDs are correct replace the pinch
check block. If the LEDs are not ON, replace
Circuit board may have failed. the circuit board.

Six Station Valve may have If Six Station Valve has failed, replace
failed. Six Station Valve.

Servo Valve may have failed If Servo Valve has failed, replace
Servo Valve.
Hydrophobic Filters are full of
liquid. Replace Hydrophobic Filters.

Module may have become With the system shutdown, reattach


separated from CAN Bus. CAN Bus cable.
Vacuum Fluidics Module will
Power down the system and then
not communicate. Configuration error
restart the system.

Module PCB has failed. Replace module or PCB.

Table 9.7: Vacuum Fluidics Module (VFM) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

9.4.2.3 Posterior Fluidics Module (PFM) Troubleshooting Guide (Posterior


and Combined Only)

Symptom Probable Cause Corrective Action


Check the vacuum using a DPM
Pressure Meter and a cassette with
Replace the Transducer.
tubing. The transducer may need
to be replaced.
Aspiration is too high.
The main Fluidics PCB may have
Replace the Main PCB.
failed.

The Servo Valve may not be


Replace the Servo Valve.
working properly.

The orange tubing may be


Reconnect the Orange Tubing.
disconnected or leaking.

The cassette may be leaking Replace the Cassette.

The tubing or tubing connector


going to the cassette may be Replace the Tubing.
broken causing low aspiration.

Verify that the input pressure


Replace the air tank or check the
going into the system is not low
external air pressure.
(72.5 - 100 PSI).

Check the vacuum using a DPM


Aspiration is too low. Pressure Meter and a cassette with
Replace the Transducer.
tubing. The transducer may be out
of specification.

The servo Valve may not be


Replace the Servo Valve.
working properly.

Check the Compressor vacuum


The vacuum control regulator in control regulator setting (65 psig)
the Compressor Module has failed. using the Service Software (CAN
Tool).

The Foot Control is not making The Foot Control may need to be
full travel. recalibrated.

Table 9.8: Posterior Fluidics Module Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Symptom Probable Cause Corrective Action


The Cassette is not primed. Prime the cassette.
Check for crystallized balanced
salt solution in the Venturi Replace the Venturi Assembly.
assembly.

The Servo Valve may not be


working properly due to balanced Replace the Servo Valve.
salt solution ingress.

Connect the Foot Control to


The Foot Control is not
backup cable or replace the Foot
responding.
No Aspiration Control.

The Servo valve connection is


Replace the Servo Valve.
faulty.

Check the Compressor vacuum


The vacuum control regulator in control regulator setting (65 psig)
the Compressor Module has failed. using the Service Software (CAN
Tool).

Verify that the input pressure


Replace the air tank or check the
going into the system is not low
external air pressure.
(72.5 - 100 PSI).

Check for balanced salt solution Replace the Aspiration Transducer


ingress. or the Main Fluidics PCB.
Aspiration Surge
Verify proper cassette is being Discard the damaged or non B+L
used. cassette.

Table 9.8: Posterior Fluidics Module Troubleshooting Guide

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Symptom Probable Cause Corrective Action


Replace the Cylinder Manifold if
Check alignment of the Aspiration
the Aspiration Pincher is
Pincher.
misaligned.

Replace the Cylinder Manifold if


Verify that the Aspiration Pincher
the Aspiration Pincher won’t
is UP when cassette is ejected.
retract.

Verify that the Cassette Capture Replace the Cassette Capture


Block is retracting. Block if it won’t retract.

Verify that the Reflux Plunger is Replace the Reflux Plunger if it


retracting. won’t retract.
Cassette will not eject or capture
Replace the valve wiring harness,
The 7-Station Valve has failed. 7-Station Valve or Main Fluidics
PCB.

The Digital Limit Switch has


Replace the Digital Limit Switch.
failed.
Check the pressure from the
The pressure from the Compressor
Compressor regulator, adjust or
is low.
replace the regulator if necessary.

The Main Fluidics PCB may have


Replace the Main Fluidics PCB.
failed.

The Cassette Capture Switch may


be out of position causing the Properly align the Cassette
cassette prism to not align with the Capture Switch.
CCD Camera.

Water droplets inside the cassette


may be throwing off the level
Use a dry or new cassette.
detection.

No Fluid Level Detection Replace the damaged cassette.


The cassette detection prism may
be damaged.

Using a lint-free cloth and


The detection window for the CCD Isopropyl Alcohol, clean the
Camera is dirty. camera window inside the PFM
Cassette Holder.

The CCD Camera may be


Replace the CCD camera.
damaged.

Table 9.8: Posterior Fluidics Module Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Symptom Probable Cause Corrective Action


The cassette Capture Switch may
be out of position causing the Properly align the Cassette
cassette prism to not align with the Capture Switch.
CCD Camera.

Water droplets inside the cassette


may be throwing off the level
Use a dry or new cassette.
detection.
Replace the damaged cassette.
No Cassette Identification Cassette detection prism may be
damaged.

Using a lint-free cloth and


The detection window for the CCD Isopropyl Alcohol, clean the
Camera is dirty. camera window inside the PFM
Cassette Holder.

The CCD Camera may be


Replace the CCD camera.
damaged.

The cassette may have a leak or Change the cassette or reconnect


tubing is not connected. tubing.

The orange tubing is loose going


into module or in the Compressor Reconnect the orange tubing.
module.
Cassette will not pass vacuum
check The Pinch valve may have failed. Replace the Pinch Valve Manifold.

Check the wiring harness or


The 7-Station Valve has failed.
replace the 7-Station Valve.

The Servo Valve may have failed. Replace the Servo Valve.

the Main Fluidics PCB has failed. Replace the Main Fluidics PCB.

Table 9.8: Posterior Fluidics Module Troubleshooting Guide

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Symptom Probable Cause Corrective Action


The Reflux insert on the top of the
Discard the cassette and replace
cassette could be punctured or
with a new one.
torn.

For continuous reflux -Saline


Adjust the saline bottle height.
bottle may not be high enough.

Actuate Reflux and verify that the


Aspiration Pinch Block and the
Replace the Cylinder Manifold.
Reflux Plunger are extending and
releasing properly.

Check for air leaks from the


Secure the tubing or replace the
Reflux tubing of the 7-Station
one-touch fitting.
Low or No Reflux Valve.

Verify that the 7-Station Valve is


switching to allow air flow through Replace the 7-Station Valve.
the tubing to the Reflux valve.

Verify that red LED on 7-Station


Valve is ON when Reflux valve is
DOWN. If not, cable to wiring Replace or repair the wiring.
harness of 7-Station Valve may be
OPEN.

Verify that the reflux bulb on the


cassette is not damaged, Replace the Cassette Manifold.
misaligned or missing.

Actuate Reflux and verify that the


Pinch valves and the Reflux If not, replace the Cylinder
Plunger are extending and Manifold.
releasing properly.

Verify that the Reflux Solenoid is


switching to allow air flow through If not, replace 7-Station valve
the tubing going to the Reflux assembly.
Plunger.
“Pulsed Reflux”
Low or No Reflux Verify that the red LED on Reflux
Solenoid is ON when Reflux valve
is DOWN. If not, cable to wiring Replace or repair wiring.
harness of 7-Station Valve (Reflux
Solenoid) may be OPEN.

The bulb or tubing on the top of


the cassette could be punctured or Discard the cassette and replace
torn. The Cassette will leak water with a new one.
if tubing is damaged.

Table 9.8: Posterior Fluidics Module Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Symptom Probable Cause Corrective Action


The blue tubing going into the
Vitrectomy Valve may be
disconnected.
Reconnect the blue tubing.
The blue tubing from Vit. Valve
going into the luer may be
disconnected.

Turn the Vitrectomy Valve ON


and verify that the Vitrectomy
No Vitrectomy Output Valve is generating a pulse of air. Replace or repair the wiring.
If not, check for OPEN in cable
harness.

Check tubing for kinks inside the


No Vitrectomy pressure from the Compressor module.
Compressor. Check or replace regulator inside
the Compressor module.

The FET on the Main Fluidics


Replace the Main Fluidics PCB.
PCB has failed.

Verify the continuity of the cable


harness. A break (open) in the wire
Replace or repair the broken wire.
can cause intermittent function of
the Vitrectomy Valve.
Intermittent Vitrectomy
Operation The valve may have a damaged
Replace the valve.
coil.

The valve may have a damaged


Replace the valve.
poppet or return spring.

The connector is disconnected


Reconnect the connector to the
from the Vitrectomy connector or
No Vitrectomy Illumination LED PCB.
the LED PCB.

The LED is bad. Replace the LED PCB.

If a loud rush of air is heard when


activating the vacuum then the Tighten or replace Venturi
Venturi muffler may be loose or muffler.
Leaking Air Symptoms missing.

An External or Internal tubing may Tighten or replace the pressure


be leaking. tubing.

Table 9.8: Posterior Fluidics Module Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Symptom Probable Cause Corrective Action


This module may have become
Reattach the CAN Bus Cable.
separated from the CAN Bus.

Power down the system and then


A Configuration Error
restart the system.

Module will not communicate Replace Main Fluidics PCB in the


The Main Fluidics PCB in module
module or send the module to the
has failed.
nearest Depot.

Verify that the module has the


proper FIRMWARE for the type Reload the firmware if necessary.
of module.

The connector may be


disconnected from the LED PCB Connect the connector to the PCB.
Cassette Illumination
or the Main Fluidics PCB. Replace the LED PCB.
The LED on the LED PCB is bad.

The connector may be


disconnected from the LED PCB Connect the connector to the PCB.
or the Main Fluidics PCB. Replace the LED PCB.
The LED on the LED PCB is bad.
Aspiration LED(s) are not
illuminated Verify that a proper cassette is Must use a posterior or posterior
being used. combined cassette.

Verify the wires for the LED


Replace or repair the wiring.
connector are not open.

Table 9.8: Posterior Fluidics Module Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

9.5 Compressor Module

9.5.1 Compressor Module Error Codes (CPA/PCM)

Error
Description Corrective Action
Code
The compressor module was not
Compressor Module will not communicate. Disconnect
CPX01 detected in the system. Surgical mode is
all external tubing and reboot the system.
not available.

The compressor module software


version is not compatible with the
CPX02 A compatible software version must be downloaded.
system software version. Surgical mode
is not available.
The compressor module has failed to
Compressor Module will not communicate. Reboot the
respond to a settings command. The
CPX03 system.
module settings have been re-sent to the
Reload the software in the CAN Tool.
module.

The compressor module has reset. The


Compressor Module will not communicate.
CPX04 module settings have been re-sent to the
Reboot the system.
module.

Check that the air line hose is connected tightly to the


system.
The air pressure output is lower than
CPX05 Check that there are no leaks in the air line.
commanded.
Check that no air functions, such as, IOP is ON without
being connected (open).

The air pressure output is higher than Check that the air or fluid infusion pressure setting is
CPX06
commanded. suitable for use in surgery.

Confirm correct operation of the irrigation and


aspiration functions.
The internal air pressure system cannot
CPX07 Confirm correct Vitrectomy function.
reach the full pressure expected.
Red tubing loose. Remove and re-insert or replace red
tubing.

CPX08 The internal vacuum pump has failed. Confirm correct operation of the aspiration function.
PC System Only:
The internal vitrectomy air pressure is
CPX09 Increase input pressure to nominal pressure of 85 psi
low.
(5.9 bars).

PC System Only:
CPX10 Viscous fluid injection pressure is low. Check that the VFI tubing is connected tightly to the
system and to the other pack systems.

CPX11 Viscous fluid injection pressure is high. Internal module problem. Replace module.

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Chapter 9 - Error Codes and Troubleshooting Guides

PC System Only:
CPX12 Viscous fluid extraction vacuum is low. Check that the VFI tubing is connected tightly to the
system and to the other pack systems.

CPX13 Viscous fluid extraction vacuum is high. Internal module problem. Replace module.

PC System Only:
CPX14 External supply pressure is low. Increase input pressure to nominal pressure of 85 psi
(5.9 bars).

The internal air pressure supply to the


vacuum fluidics module is low. PC System Only:
The vacuum fluidics module may not Increase input pressure to nominal pressure of 85 psi
CPX15
function properly. (5.9 bars).
The irrigation and aspiration pinch Check all external and internal tubing for leaks.
valves may not be functioning properly.

The vitrectomy cutter input pressure is


CPX19 high. The vitrectomy cutter function is Internal module problem. Replace module.
not available.

The vacuum fluidics module may not function properly.


The internal air pressure supply to the The irrigation and aspiration pinch valves may not be
CPX20
vacuum fluidics module is high. functioning properly.
Check all external and internal tubing for leaks.

The internal air pressure system pressure


CPX22 Internal module problem. Replace module.
is higher than expected.

PC System Only:
CPX23 External supply pressure is high.
Decrease input pressure to 85 psi (5.9 bars).

9.5.2 Compressor Module (CPA) Troubleshooting Guide (Anterior Only)

Symptom Probable Cause Corrective Action


Table 9.9: Compressor Module (Anterior Only) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Rotary Pump Damaged. Replace Rotary Pump.

Clear Tubing Is Not Seated Remove & Reinsert / Replace


Properly. Clear Tubing.

Rotary Pump Control Wiring With The System Shutdown,


Harness May Have Become Properly Connect The Rotary
Disconnected From The PCB. Pump Control Wiring Harness.
Low Vacuum Output.
Rotary Pump flooded with BSS. Replace Rotary Pump.

Check to see if the hardware is


1.0 or 1.1. If hardware is 1.0
Vacuum Pump will not make
replace module with 1.1
proper vacuum at or below 50
hardware version.
mmHg.
Replace Rotary Pump.

Rotary Pump Damaged. Replace Rotary Pump.

Clear Tubing Disconnected. Reinsert / Replace Clear Tubing.


Rotary Pump Flooded With
Replace Rotary Pump.
BSS.

Hydrophobic Filter(s) blocked Replace Hydrophobic Filter(s)


No Vacuum Output.
Rotary Pump Power / Control With The System Shutdown,
Wiring Harness May Have Properly Connect The Rotary
Become Disconnected From The Pump Power / Control Wiring
PCB. Harnesses.

Rotary Pump Power / Control


Wiring Harnesses May Have An Replace Rotary Pump.
Open Wire.

Relief Valve Not Seating


Replace Relief Valve.
Properly / Stuck Open.

Remove & Reinsert / Replace


Red Tubing Loose.
Red Tubing.

Pinch Valve Controls Will Not Compressor Damaged. Replace Compressor.


Function Properly.
Compressor Wiring Harness With The System Shutdown,
May Have Become Properly Connect The
Disconnected From The PCB. Compressor Wiring Harness.

Compressor Wiring Harness


Replace Compressor.
May Have An Open Wire.

Regulator output too high. Adjust Regulator to 370 mmHg.


High IOP Pressure Recalibrate Transducer or
Transducer out of calibration
replace PCB.

Table 9.9: Compressor Module (Anterior Only) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Yellow Tubing not seated Remove & Reinsert / Replace


Properly. Yellow Tubing.

Relief Valve Not Seating


Replace Relief Valve.
Properly.

Transducer Has Lost Calibration Recalibrate IOP or Replace


or out of calibration. PCB.
Low IOP Pressure. Adjust Regulator to 370 mmHg
IOP Regulator output too low.
+/- 50 mmHg.

Compressor Damaged. Replace Compressor.

IOP Dampener Is Leaking. Replace IOP Dampener.

3-Valve Manifold is Leaking. Replace 3-Valve Manifold.

Regulator setting drifting down Re-adjust Regulator

Reinsert / Replace Yellow


Yellow Tubing Disconnected.
Tubing.

Relief Valve Is Stuck Open. Replace Relief Valve.


3-Valve Manifold Wiring With The System Shutdown,
Harness may have become Properly Connect The 3-Valve
disconnected from the PCB. Manifold Wiring Harness.
No IOP Pressure.
Compressor Damaged. Replace Compressor.

Compressor Wiring Harness


Replace Compressor.
may have an open wire.

Compressor Wiring Harness With The System Shutdown,


may have become disconnected Properly Connect The
from the PCB. Compressor Wiring Harness.

Verify connector is connected


Connector is disconnected from
No IOP Connector and no damaged.
Compressor or connector is
Illumination
damaged. LED PCB is bad.
Replace LED PCB.

Relief Valve Is Stuck Open. Replace Relief Valve.

Blue Tubing Disconnected. Reinsert / Replace Blue Tubing.

Compressor Damaged. Replace Compressor.

No Vitrectomy Output. Compressor Wiring Harness


With The System Shutdown,
May Have Become
Properly Connect The
Disconnected From The Valve
Compressor Wiring Harness.
Or The PCB.

Compressor Wiring Harness


Replace Compressor.
May Have An Open Wire.

Table 9.9: Compressor Module (Anterior Only) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Wiring Harness may have an


Replace wiring harness.
open wire.

Compressor Damaged. Replace Compressor.


Vitrectomy Valve may have
Intermittent Vitrectomy Replace Vitrectomy Valve.
been stuck.
Operation.
Blue Tubing Not Seated Remove & Reinsert / Replace
Properly or kinked. Blue tubing.

Vitrectomy exhaust block due to


Replace Green tubing
kinked Green tubing.

Module may have become With the system shutdown,


separated from CAN Bus. reattach CAN Bus cable.
Compressor Module will not
communicate. Configuration error Reboot unit.

Module PCB has failed. Replace module or PCB.

Table 9.9: Compressor Module (Anterior Only) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

9.5.3 Posterior Compressor Module (PCM) Troubleshooting Guide

Symptom Probable Cause Corrective Action


The Orange tubing is loose or Remove & re-insert / replace the
leaking. Orange tubing.

Verify that the external air


The input pressure from the source is 72.5 to 100 PSI. Adjust
external source is too low. the external air source if
necessary.
Low System Vacuum Output
The Vacuum Circuit Shut-Off Replace the Vacuum Circuit
Valve is leaking. Shut-Off Valve.

The Vacuum Circuit Regulator


is set too low. Check the Set the Vacuum Circuit
pressure in the Service Software Regulator to 68 PSI ± 2 PSI.
(CAN Tool).

The Vacuum Circuit Shut-Off Replace the Vacuum Circuit


Valve is not turning on. Shut-Off Valve.
No System Vacuum Output The Vacuum Circuit Regulator
Set the Vacuum Circuit
is installed incorrectly or not
Regulator to 68 PSI ± 2 PSI.
adjusted.

Remove & re-insert / replace the


The Red tubing is loose.
Red tubing.

The Pressure (pinch) Regulator Set the Pressure (pinch)


Pinch Valve Controls will not is set too low. Regulator to 42 PSI ± 5 PSI
Function Properly
Verify that the external air
The input pressure from the source is 72.5 to 100 PSI. Adjust
external source is too low. the external air source if
necessary.

The HSPV Circuit Shut-Off Replace the HSPV Shut-Off


Valve is not turning on. Valve.
No Vitrectomy Output
The HSPV Regulator is installed Set the HSPV Regulator to 68
incorrectly or not adjusted. PSI ± 2 PSI.

Table 9.10: Posterior Compressor Module (PCM) Troubleshooting Guide (Posterior and Combined Only)

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Chapter 9 - Error Codes and Troubleshooting Guides

Symptom Probable Cause Corrective Action


The Blue Tubing is loose or Remove & re-insert / replace the
leaking. Blue tubing.

The HSPV Regulator is set too


Set Vacuum Circuit Regulator to
low. Check the pressure in the
42 PSI ± 0.5 PSI.
Service Software (CAN Tool).
Intermittent Vitrectomy
Operation Verify that the external air
The input pressure from the source is 72.5 to 100 PSI. Adjust
external source is too low. the external air source if
necessary.

The HSPV Shut-Off Valve is Replace the HSPV Shut-Off


leaking. Valve.

The Module may have become With the system shut down,
Compressor Module will not separated from the CAN Bus. reattach CAN Bus cable.
communicate A configuration error. Reboot The Module PCB has failed.
unit. Replace the PCB.

Table 9.10: Posterior Compressor Module (PCM) Troubleshooting Guide (Posterior and Combined Only)

9.6 Posterior Illumination Module (PIM) (Posterior and Combined Only)

9.6.1 Posterior Illumination Module (PIM) Error Codes (Posterior/Combined)

Error Code Description Corrective Action


The light module was not detected in the system. Surgical
LM01 mode is not available. Illumination and viscous fluid Reboot system or replace module.
control are not available.

The light module software version is not compatible with


the system software version. Surgical mode is not A compatible software version must
LM02
available. Illumination and viscous fluid control are not be downloaded.
available.

The light module has failed to respond to a settings


LM03 command. The module settings have been re-sent to the Reboot system or replace module.
module.

The light module has reset. The module settings have


LM04 Reboot system or replace module.
been re-sent to the module.

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Chapter 9 - Error Codes and Troubleshooting Guides

PC System Only:
Use the lower illumination source.
LM05 The upper illuminator bulb is near end of life. Replace the upper illuminator bulb
at your earliest convenience
(requires system shutdown).

PC System Only:
Use the upper illumination source.
LM06 The lower illuminator bulb is near end of life. Replace the lower illuminator bulb
at your earliest convenience
(requires system shutdown).

The illuminator temperature is too high. The illuminators Contact Technical Support and/ or
LM07
have been turned off. replace the Illumination module.

Wait for the system to reach room


The illuminator temperature is too low. temperature, and then try again.
LM08
(This code is not in 4.x software Error Codes table.) Contact Technical Support and/ or
replace the Illumination module.

PC System Only:
Use the lower illumination source.
LM09 The upper illuminator bulb has failed. Replace the upper illuminator bulb
at your earliest convenience
(requires system shutdown).

PC System Only:
Use the upper illumination source.
LM10 The lower illuminator bulb has failed. Replace the lower illuminator bulb
at your earliest convenience
(requires system shutdown).

Contact Technical Support and/ or


LM11 The illuminator filter control has failed.
replace the Illumination module.

Contact Technical Support and/ or


LM12 The upper illuminator brightness control has failed.
replace the Illumination module.

Contact Technical Support and/ or


LM13 The lower illuminator brightness control has failed.
replace the Illumination module.

PC System Only:
Use the lower illumination source.
Replace the upper illuminator bulb
The upper illuminator bulb type is not valid.
LM14 at your earliest convenience
(Software below 4.x does not specify “upper” bulb.)
(requires system shutdown).
Contact Technical Support and/ or
replace the Illumination module.

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Chapter 9 - Error Codes and Troubleshooting Guides

PC System Only:
Use the upper illumination source.
Replace the lower illuminator bulb
The lower illuminator bulb type is not valid. (4.x
LM15 at your earliest convenience
software)
(requires system shutdown).
Contact Technical Support and/ or
replace the Illumination module.

The upper illuminator fan has failed. Illuminator use may


be limited if overheating occurs. (below 4.x software)
Contact Technical Support and/ or
LM16 The upper illuminator fan has failed. Illuminators will be
replace the Illumination module.
turned off in 5 minutes if the fan failure persists. (4.x
software)

The lower illuminator fan has failed. Illuminator use may


be limited if overheating occurs. (below 4.x software)
Contact Technical Support and/ or
LM17 The lower illuminator fan has failed. Illuminators will be
replace the Illumination module.
turned off in 5 minutes if the fan failure persists. (4.x
software)

The upper illuminator has a bulb ballast error and cannot Contact Technical Support and/ or
LM18
be used. It will be turned off in 30 seconds. replace the ballast.

The lower illuminator has a bulb ballast error and cannot Contact Technical Support and/ or
LM19
be used. It will be turned off in 30 seconds. replace the ballast.

PC System Only:
Use the lower illumination source.
LM20 The upper illuminator bulb voltage is high. Replace the upper illuminator bulb
at your earliest convenience
(requires system shutdown).

PC System Only:
Use the upper illumination source.
LM21 The lower illuminator bulb voltage is high. Replace the lower illuminator bulb
at your earliest convenience
(requires system shutdown).

The illuminator ballast fan has failed. The illuminators Contact Technical Support and/ or
LM23
will be turned off in 30 seconds. replace the ballast fan.

PC System Only:
Use the lower illumination source.
The upper illuminator bulb is at end of life. Lamp will be
LM24 Replace the upper illuminator bulb
disabled when turned off.
at your earliest convenience
(requires system shutdown).

PC System Only:
Use the lower illumination source.
The lower illuminator bulb is at end of life. Lamp will be
LM25 Replace the upper illuminator bulb
disabled when turned off.
at your earliest convenience
(requires system shutdown).

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Chapter 9 - Error Codes and Troubleshooting Guides

The illuminator temperature is too high. The illuminators Contact Technical Support and/ or
LM26
will be turned off in 2.5 minutes if the fan failure persists. replace the Illumination module.

Note that the level of light output being requested should


be used with awareness of exposure time and proximity
to the retina.
Limiting exposure to less than a guideline value of 10 J/
LM27 &
cm2 helps maintain the retinal tissue. At the requested None
LM28
setting, this dose level may be exceeded in less than 30
minutes with the Bausch + Lomb focal light probe
positioned 15mm from the retina.
Do you want to continue?

The time to reach the exposure guidelines will vary with:


1) Filter selection - Value reached within the 30 minutes
with the following settings:
a) White - 60%
LM27 & b) Green - 68%
LM28 c) Yellow - 88% None
(continued) d) Amber - 100%
2) Distance from the retina
3) Light dispersing probes
Consult the User Manual for additional information.
Do you want to continue?

9.6.2 Posterior Illumination Module (PIM) Troubleshooting Guide (Posterior/


Combined)

The two illumination channels provide an opportunity to swap components for troubleshooting purposes if
convenient. For example, if one of the lamps will not light, swapping lamp assemblies can reveal whether the
problem is with the lamp or not. Similarly, the ballasts can be swapped to check for a bad ballast and the
igniters (inside the PIM) can be swapped to check for a bad igniter.

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Chapter 9 - Error Codes and Troubleshooting Guides

Note that if the memory cannot be read on a lamp (due to a problem on the lamp or module) that the firmware
will not operate either lamp as both must be physically present for proper airflow. Ability to read the lamp
memory is used to determine that a lamp is present.

Symptom Probable Cause Corrective Action


A damaged memory device in
Replace lamp.
lamp housing.

A damaged memory connector Replace the lamp memory interface


in the PIM. board.
Lamp not recognized even A misplaced cable or component
though physically installed interfering with the lamp Identify and correct the interfering
mounting, preventing proper part.
engagement of memory contact.

The lamp is not mounted


Reinstall the lamp assembly.
properly.

The lamp has exceeded its limits


Replace the lamp assembly.
of hours or operating voltage.

Cables from the ballast are loose Reconnect the connectors at the
Lamp will not light, with error or disconnected. ballast and at the rear of the PIM.
message
The igniter has failed. Replace the igniter.

The ballast has failed. Replace the ballast.

The PIM Main board has failed. Replace the PIM Main board.

A lamp failure Replace the lamp assembly

The shutter mechanism is Repair or replace this shutter


damaged. mechanism.

Remove any objects from the light


Low or no illumination, The light path is blocked.
path.
without error messages
The external light pipe is
Replace the light pipe.
damaged.

The optics are out of alignment. Realign the optics (Depot Only).

The illumination optics are dirty. Spray air over optics to remove dust.
The filter motor cable assembly Connect or replace the filter cable
has failed or is disconnected. assembly.

The filter motor belt is slipping


Filter will not change
or has come off of the motor Replace the belt (Depot Only).
gear.

The PIM Main Board has failed. Replace the PIM Main PCB.

Table 9.11: Posterior Illumination Module (PIM) Troubleshooting Guide

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Symptom Probable Cause Corrective Action


One of the filters stuck in path. A mechanical bind is in the filter Inspect the filter mechanism and
May give a filter error. mechanism. replace components as necessary.

Remove debris from gear mesh or


A stuck attenuator mechanism.
replace broken parts.

Attenuator fault Make sure the home flag can


The attenuator home sensor physically block the sensor. Clean
failed. any debris from the home sensor gap
or replace the home sensor.

Verify the air source is


Turn on the air source and/or adjust
connected and adjusted to the
the air source to the proper pressure.
correct pressure.

The tubing is disconnected from


the output connector or the Reconnect or replace the tubing.
tubing has become kinked.

The cable assembly for the AFX


Directional Control Valve in the Reconnect or replace the cable
AFX/IP has no output Compressor has failed or is assembly in Compressor.
disconnected.

The IOP pump in the Replace the IOP pump in the


Compressor module has failed. Compressor Module.

The IOP Valve Assembly in the Replace valve assembly in the


Compressor has failed. Compressor Module.

The AFX/IP Directional Valve


Replace valve assembly in the
in the Compressor module has
Compressor Module.
failed.

Verify the external air source is Turn on the external air source and/or
connected and adjusted to the adjust the air source to the proper
correct pressure. pressure.

AFX/IP output is low The tubing inside the PIM or


Reconnect the tubing.
Compressor module is loose.

The IOP pump in the Replace the IOP pump in the


Compressor module has failed. Compressor module.

The tubing inside the PIM or


Reconnect the tubing or replace the
AFX/IP output is erratic or Compressor module is loose or
fitting.
larger than normal output the fitting is leaking.
pressure variation from a set The AFX/IP Valve assembly in
point. the Compressor module does not Replace the valve assembly.
fully shut.

Table 9.11: Posterior Illumination Module (PIM) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

Symptom Probable Cause Corrective Action


Verify the air source is
Turn on the air source and/or adjust
connected and adjusted to the
the air source to the proper pressure.
correct pressure.

The tubing is disconnected from


the output connector or the Reconnect or replace the tubing.
VFX has no output tubing has become kinked.

The cable assembly for the VFX


Reconnect or replace the cable
Valve in the Compressor module
assembly in Compressor module.
has failed or is disconnected.

The VFX Valve in the Replace the valve assembly in the


Compressor Module has failed. Compressor Module.

Verify that the external air Turn on the external air source and/or
source is connected and adjusted adjust the air source to the proper
to the correct pressure. pressure.

The tubing inside the PIM or


Reconnect the tubing.
VFX has low output Compressor module is loose.

The VFX Valve in the Replace valve assembly in


Compressor Module has failed. Compressor.

The VFX pump in the Replace the VFX pump in the


Compressor module has failed. Compressor module.

The tubing inside the PIM or


Reconnect the tubing or replace the
Compressor module is loose or
VFX output is erratic or larger fitting.
the fitting is leaking.
than normal output pressure
variation from a set point. The VFX Valve assembly in the
Compressor module does not Replace the valve assembly.
fully shut.

The connector to the LED PCB Reconnect the LED cable assembly
Connector LED will not may be disconnected. to the LED PCB.
illuminate.
The LED PCB may have failed. Replace the LED PCB.
The module may have become With the system shutdown, re-attach
Posterior Illumination Module separated from the CAN Bus. CAN Bus cable.
will not communicate Configuration error. Reboot the The module PCB has failed. Replace
unit. the PCB.

Table 9.11: Posterior Illumination Module (PIM) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

9.7 Power Module

9.7.1 Power Module (BPS/SPS) Error Codes

Error
Description Corrective Action
Code
The power module battery has exceeded the recommended
Replace the power module battery
BPS01 number of charge cycles. Battery back-up of the system
at your earliest convenience.
may not be available.

Power Module will not


The power supply was not detected in the system. Surgical communicate. Check software
BPS02
mode is not available. version in System Configuration.
Reboot system.

The power supply software version is not compatible with A compatible software version must
BPS03
this software version. Surgical mode is not available. be downloaded.
The power supply has failed to respond to a settings Power Module will not
BPS04 command. The module settings have been re-sent to the communicate.
module. Reboot system.
Power Module will not
The power supply has reset. The module settings have been
BPS05 communicate.
re-sent to the module.
Reboot system.

The power module back-up battery temperature is higher Confirm that the bottom and lower
BPS06 than expected. rear areas of the system are not
(Anterior 3.14 software and below) blocked from free air flow.

Confirm that the bottom and lower


BPS07 The power module temperature is higher than expected. rear areas of the system are not
blocked from free air flow.

Confirm that the bottom and lower


The power module is at an over temperature condition.
BPS08 rear areas of the system are not
System shutdown is imminent.
blocked from free air flow.

Confirm proper system operation.


The power module output is low. System functions may not
BPS09 System may not be available if
be available.
needed functions cannot be verified.

Unplug system from mains AC,


The power module battery is failing to charge properly. wait 10 minutes and reconnect
BPS10 Battery back-up of the system may not be available. system to mains AC.
(Anterior 3.14 software and below) Replace the power module battery
at your earliest convenience.

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Chapter 9 - Error Codes and Troubleshooting Guides

Main power input has been lost. System is running on back


up battery power. Surgical functions are inhibited. System Confirm that the unit is still plugged
BPS11
will shut down shortly if main power input is not restored. in.
(Anterior 3.14 software and below)

Shut down the system and turn the


main power switch off for at least
A back-up battery was detected in the power supply. This
one minute then turn the main
feature is no longer supported. Surgical mode is not
BPS12 switch back on and boot the system.
available.
If problem persists replace the
(4.x software)
Power Module with the SPS Power
Module.

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Chapter 9 - Error Codes and Troubleshooting Guides

9.7.2 Power Module with Backup Battery (BPS) Troubleshooting Guide

Symptom Probable Cause Corrective Action


The power cord has become
disconnected from the power Reconnect the power cord.
entry receptacle.
The power entry receptacle is Replace the power entry
damaged. receptacle.

A blown fuse may be indicated


by any of the following
conditions:
With the system off, using a
known good outlet, no power is
sent to the system when you the
main power switch is turned on.
(i.e. the stand-by power switch is
not lit up, no faint fan noise from
the lower rear of the system,
Blown fuse or fuses. etc.).
With the system on, it switches
to low-power mode and the
Does not power the system
backup battery turns on with no
discernible cause (i.e. the cord is
still plugged in; the rest of the
operating suite still has power,
etc.)
Replace the fuse or fuses.
Use the AC Input Fuse
Replacement procedure.

The Power Supply + 24V is low


Replace the Power Supply.
or not present.

Verify that the cable assembly


between the Main Power Switch Reconnect or replace the cable
is connected and is not damaged assembly if needed.
or broken.

Verify that none of the solder


Remove any shorts on Stand-by
joints on the back of the Stand-
Switch PCB, located on the UIC.
by Switch (UIC) are shorted.

Table 9.12: Power Module with Backup Battery Troubleshooting Guide

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Symptom Probable Cause Corrective Action


With the system shut down,
The module may have become
reattach the CAN Bus cable,
disconnected from the CAN Bus.
then restart the unit.
Power Module will not
communicate Power down the system and then
A configuration error.
restart the system.

The module PCB has failed. Replace the module.

Reset the Power Supply (Shut


Backup Battery is failing down the system, shut off the
A charging failure
to charge properly Main Power Switch and unplug
the system for 10 minutes.)

Table 9.12: Power Module with Backup Battery Troubleshooting Guide

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9.7.3 Power Module without Backup Battery (SPS) Troubleshooting Guide

Symptom Probable Cause Corrective Action


The power cord has become
disconnected from the power Reconnect the power cord.
entry receptacle.

The power entry receptacle is Replace the power entry


damaged. receptacle.

A blown fuse may be indicated


by any of the following
conditions:
With the system off, using a
known good outlet, no power is
sent to the system when you the
main power switch is turned on.
(i.e. the stand-by power switch is
not lit up, no faint fan noise from
the lower rear of the system,
Blown fuse or fuses. etc.).
With the system on, it switches
to low-power mode and the
Does not power the system
backup battery turns on with no
discernible cause (i.e. the cord is
still plugged in; the rest of the
operating suite still has power,
etc.)
Replace the fuse or fuses.
Use the AC Input Fuse
Replacement procedure.

The power Supply +24V is low


Replace the Power Supply.
or not present.

Verify that the cable assembly


between the Main Power Switch Reconnect or replace the Cable
is connected and is not damaged Assembly if needed.
or broken.

Verify that none of the solder


Remove any shorts on Stand-by
joints on the back of the Stand-
Switch PCB, located on the UIC.
by Switch (UIC) are shorted.

Table 9.13: Power Module without Backup Battery Troubleshooting Guide

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Symptom Probable Cause Corrective Action


With the system shut down,
The module may have become
reattach the CAN Bus cable,
disconnected from the CAN Bus.
then restart the unit.
Power Module will not
communicate Power down the system and then
A configuration error.
restart the system.

The module PCB has failed. Replace the Module.

Table 9.13: Power Module without Backup Battery Troubleshooting Guide

9.8 IV Pole (MIV) and Controller (EIV)

9.8.1 IV Pole Controller (EIV) Error Codes

Error
Description Corrective Action
Code
The IV Pole controller was not detected in the system.
IV Pole will not communicate.
EIV01 Surgical mode is not available. The motorized IV pole
Reboot system or replace EIV.
function is not available.

The IV Pole controller software version is not


compatible with the system software version. Surgical A compatible software version must be
EIV02
mode is not available. The motorized IV pole function downloaded.
is not available.

The IV Pole controller has failed to respond to a


IV Pole will not communicate.
EIV03 settings command. The module settings have been re-
Reboot system or replace EIV.
sent to the module.

The IV Pole controller has reset. The module settings IV Pole will not communicate.
EIV04
have been re-sent to the module. Reboot system or replace EIV.

Command the IV Pole to the minimum


bottle height position using the down
arrow or the numeric keypad for the IV
EIV05 The IV Pole position cannot be determined. Pole bottle height setting on the surgical
screen. Close this message and then
complete this action or use the ‘Lower IV
Pole’ button on this message.

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Command the IV Pole to the minimum


bottle height position using the down
arrow or the numeric keypad for the IV
The IV Pole is not detecting the home position switch
EIV07 Pole bottle height setting on the surgical
or the IV Pole motor may have failed.
screen. Close this message and then
complete this action or use the ‘Lower IV
Pole’ button on this message.

Ensure that the IV Pole back panel buttons


The IV Pole panel button sensors have failed or the
are not activated. Confirm proper
EIV08 buttons have been activated continuously since being
operation of the IV Pole back panel
powered on.
buttons.

9.8.2 IV Pole (MIV) and Controller (EIV) Troubleshooting Guide

Symptom Probable Cause Corrective Action


BSS or corrosion in the Guide
Clean or replace Guide tube.
Tube.

BSS or corrosion in the Guide


IV Pole grinding Tube preventing the Drive Nut Replace the Guide Tube and Drive Nut.
from moving freely.

BSS or corrosion on Drive Screw. Clean or replace Drive Screw.

Lift Tube may be bent. Replace the Lift Tube.


Pole grinds while going up or
down
BSS in the Lift Tube. Clean or replace the Lift Tube.

Table 9.14: Pole (MIV) and Controller (EIV) Troubleshooting Guide

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Lift Tube may be bent. Replace the Lift Tube.

Adjustable Clamps holding the


Drive Screw to the Motor may be Tighten Clamps.
loose.
Pole vibrates when going up or
down Shaft Seal, Support Cylinder, or Replace Support Cylinder and Inner
Rod Wiper may be damaged. Seals.

The Drive Screw Support may be


Replace Push Nut.
loose, due to missing Push Nut.

IV Pole motor cable disconnected


Reconnect Motor cable or replace motor
from IV Pole Controller box or
assembly.
cable is faulty.

BSS on the Motor. Replace the Motor.

Home switch may be broken. Replace Home Switch.

Home Switch may be


Reconnect Home Switch to IV Pole
disconnected from IV Pole
Pole will not go up or down Controller box or replace cable.
Controller box or cable is faulty.

BSS damage to Home Switch. Replace Home Switch.

Verify TP voltage,+24 VDC ± 0.7v.

IV Pole Controller PCB may be Verify TP voltage, +5 VDC +5v +0.30/-


damaged. 0.15v.

Replace Controller PCB.

With the system shutdown, reattach


Module may have become CAN Bus cable.
separated from CAN Bus. Do not connect or disconnect CAN Bus
with power applied to unit.

Power down the system and then restart


Configuration error
the system.
IV Pole will not communicate.
Connected CAN cable to IV Pole
CAN cable is disconnected.
Controller.

CAN cable is broken or not


working Replace CAN cable.

IV Pole Controller PCB has


Replace module or PCB.
failed.

Table 9.14: Pole (MIV) and Controller (EIV) Troubleshooting Guide

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Chapter 9 - Error Codes and Troubleshooting Guides

9.9 Foot Control (WFC) and FCIB (WFR)

9.9.1 Foot Control (WFC) and Integrated Foot Control (IFC) Error Codes

IMPORTANT: All U.S. personnel must comply with the U.S. Department of Transportation
(DOT) regulations regarding the shipment of Lithium batteries or equipment containing
Lithium batteries. Personnel in countries other than the United States must comply with their
local or regional regulations regarding the shipment of Lithium batteries or equipment
containing these batteries.

Error
Description Corrective Action
Code
If the battery does not provide
power for the full day, replace the
battery. Use the Primary Foot
Control cable to connect the
The foot control battery has exceeded 300 charge cycles. The Primary Foot Control to the
WFC01 foot control battery may not provide power for the entire system.
day. Replace the Primary Foot Control
with another Primary Foot Control.
Use the wired cable connection to
initially pair the new Primary Foot
Control with the system.

Replace the Primary Foot Control


with another Primary Foot Control.
The foot control does not have valid factory calibration data.
WFC02 Use the wired cable connection to
Surgical mode is not available.
initially pair the new Primary Foot
Control with the system.

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Change the Primary Foot Control


home position switch selector
located underneath the pedal to the
center position or left-side biased
for right-footed operation or to the
center position or right-side biased
for left footed operation.
The foot control is programmed for right footed operation,
WFC03 Confirm the correct surgeons’
but is set up for left footed operation.
settings file is loaded. If incorrect,
return to the Setup Select Surgeon
screen to select the correct settings
file. Close this message and then
complete this action or select the
‘Select Surgeon’ button on this
message.

Change the Primary Foot Control


home position switch selector
located underneath the pedal to the
center position or left-side biased
for right-footed operation or to the
center position or right-side biased
for left footed operation.
The foot control is programmed for left footed operation, but
WFC04 Confirm the correct surgeons’
is set up for right footed operation.
settings file is loaded. If incorrect,
return to the Setup Select Surgeon
screen to select the correct settings
file. Close this message and then
complete this action or select the
‘Select Surgeon’ button on this
message.

Reposition the Primary Foot


Control and ensure that the center
pedal and buttons are not activated.
The foot control center pedal or button sensors have failed or
Replace the Primary Foot Control
WFC05 the foot control has been activated continuously since being
with another Primary Foot Control.
powered on.
Use the wired cable connection to
initially pair the new Primary Foot
Control with the system.

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Initiate wireless Primary Foot


Control connectivity by pressing
one of the Primary Foot Control
buttons momentarily, the left LED
will light up. Use the Primary Foot
Control cable to connect the
System not detecting the Foot Control.
WFC08 Primary Foot Control to the
(4.x software says “wireless” Foot Control.)
system.
Replace the Primary Foot Control
with another Primary Foot Control.
Use the wired cable connection to
initially pair the new Primary Foot
Control with the system.

Replace the Primary Foot Control


with another Primary Foot Control.
Use the wired cable connection to
The foot control software version is not compatible with the initially pair the new Primary
WFC09
system software version. Surgical mode is not available. (Integrated) Foot Control with the
system.
A compatible software version
must be installed.

Please wait while the Primary Foot


WFC10 Foot control detected on wired cable connection.
Control configuration completes.

Disconnect the Primary Foot


Foot control configuration on wired cable connection has
WFC11 Control cable and operate the
completed successfully.
Primary Foot Control wirelessly.

Replace the Primary Foot Control


with another Primary Foot Control.
Foot control configuration on the wired cable connection has
WFC12 Use the wired cable connection to
failed.
initially pair the new Primary Foot
Control with the system.

Use the Primary Foot Control


cable to connect the Primary Foot
WFC13 The foot control battery charge level is low. Control to the system. If the
battery does not provide power for
the full day, replace the battery.

Use the Primary Foot Control


The Foot Control battery is nearly discharged. cable to connect the Primary Foot
WFC14 (4.x software says “…and may be insufficient to complete Control to the system. If the
the case.”) battery does not provide power for
the full day, replace the battery.

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Disconnect the Foot Control cable,


Reconnect the cable and try again.
The wireless foot control signal quality is poor. Replace the Foot Control with
WFC15
(Anterior 3.14 software and below.) another Foot Control using the
wired cable connection to the
system.

Replace the Primary Foot Control


The Foot Control spring has failed; the Foot Control center with another Primary Foot Control.
WFC16 pedal has been disabled. Use the wired cable connection to
(4.x software says…center pedal is disabled.) initially pair the new Primary Foot
Control with the system.

Immediately replace the battery to


ensure Primary Foot Control
functionality. Replace the Primary
The Foot Control battery has exceeded 300 charge cycles
Foot Control with another Primary
WFC17 and the battery is nearly discharged. The Foot Control may
Foot Control. Use the wired cable
stop functioning unless the battery is replaced immediately.
connection to initially pair the new
Primary Foot Control with the
system.

Use the Primary Foot Control


cable to connect the Primary Foot
Control to the system. Replace the
System not detecting the Foot Control. Primary Foot Control with another
WFC18
(4.x software says…wired foot control.) Primary Foot Control. Use the
wired cable connection to initially
pair the new Primary Foot Control
with the system.

WFC19 The system has lost communications with the Foot Control, Go to the programming function to
wireless disabled. re-enable wireless communication.
(4.x software says...wireless function is disabled.) Close this message and then
complete this action or use the ‘Re-
enable Wireless’ button on this
message. Connect the Primary Foot
Control cable to continue surgery.

WFC20 The system has lost communications with the Foot Control. Check the Primary Foot Control
(4.x software says…wired foot control.) cable connection. Replace the
Primary Foot Control with another
Primary Foot Control. Use the
wired cable connection to initially
pair the new Primary Foot Control
with the system.

WFC21 The foot control battery charge level is less than needed for a Charge the Primary Foot Control
full surgical day. (4.x software) battery before next use.

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Suggested
Suggested Action Text
Action ID
SG04 Call your product service representative if this problem persists.

SG33 Use the wired cable connection to the system.

Replace the foot controller with another foot controller using the wired
SG34
cable connection to the system.

Initiate wireless foot control connectivity by pressing one of the foot


SG40
control buttons momentarily, the left LED will light up.

SG41 Please wait while the foot controller configuration completes.

You may disconnect the foot controller cable and operate the foot controller
SG42
wirelessly.

SG43 Disconnect the foot control cable. Reconnect the cable and try again.

SG83 Check the cable connection.

SG84 Connect the foot controller cable to continue use.

SG85 See User Manual for re-enabling wireless communication.

Table 9.15: System Suggested Actions Related to Foot Control Connectivity

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9.9.2 Foot Control Interface Board (FCIB (WFR)) Error Codes

Error
Description Corrective Action
Code
Reboot system.
The foot control receiver was not detected in the system.
WFR01 Reload software.
Surgical mode is not available.
Replace FCIB.

The foot control receiver software version is not


A compatible software version must
WFR02 compatible with the system software version. Surgical
be downloaded.
mode is not available.

The foot control receiver has failed to respond to a Reboot system.


WFR03 settings command. The module settings have been re- Reload software.
sent to the module. Replace FCIB.

Reboot system.
The foot control receiver has reset. The module settings
WFR04 Reload software.
have been re-sent to the module.
Replace FCIB.

Table 9.16: Foot Control Interface Board (FCIB (WFR)) Error Codes

9.9.2.1 Internal Application Messages

The system requires restarting due to an internal error, please perform the following:

1. Select Close to initiate system shutdown.


2. If system does not shut down after 30 seconds, power off the system by pressing and holding the power button on
the front panel.
3. Restart system after one minute.

Contact Technical Support, if the problem persists.

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9.9.3 Foot Control (WFC) and FCIB (WFR) Troubleshooting Guide

Symptom Probable Cause Corrective Action

Connect the Foot Control cable to


Foot Control has not completed
Foot Control and STELLARIS
the handshake with STELLARIS
and complete the handshake for
for Bluetooth communication.
Bluetooth communication.

The communication has timed Push one of the buttons to restart.


out.

Try a known good Foot Control.

Foot Control is not recognized by


Foot Control will not work with the system. Backup cable may be damaged
system.
Connector pins may be bent.

FCIB is not working.


Replace the FCIB.

Foot Control wireless is Disabled. Enable the wireless function.

Recalibrate Foot Control.


Possible WFC05
Replace Foot Control.

Check if mode switch is in the Switch mode switch to right or


center position. left and back to center to see if
error goes away.

WFC03 or WFC04 Error Code


Upgrade software to 1.32 if
Check software version. applicable and calibrate Foot
Control.

Foot Control is too sensitive or Foot Control pitch is stuck in Check and adjust pitch counts
irrigation will not stop. region1. and recalibrate Foot Control.

Table 9.17: Foot Control (WFC) and FCIB (WFR) Troubleshooting Guide.

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Charge battery for at least 5


Battery may need to be charged.
hours.

Check to see if battery is present;


Battery may be missing.
if not install a battery.
Foot Control battery low/ dead
error appears on screen. Battery may be over the 350
Replace battery.
charging cycles for its lifetime.

Battery may be defective. Replace battery.


Battery contact is broken or
Replace bottom plate
misaligned

There may be debris under the Remove any debris from under
Center Pedal. the Center Pedal.
Foot Control does not have
full linear Pitch travel. Foot Control is out of calibration. Calibrate Foot Control.

Pitch Potentiometer is out of


Recalibrate Pitch Potentiometer.
range.

Cable connector may be Replace Foot Control cable.


Cannot connect the Foot damaged.
Control cable to STELLARIS
or Foot Control. Receptacle (or pins) on the
system or foot control may be Replace the receptacle
damaged

Spring could be broken Replace the spring


Foot Control will not find home
position The calibration data maybe
Recalibrate the foot control
corrupt

Rubber Foot on bottom of Foot Foot may have been damaged by


Replace rubber foot.
Control is damaged or missing. prolonged use or abuse.

Rubber button cover of Foot Foot may have been damaged by


Replace rubber button cover.
Control is damaged or missing. prolonged use or abuse.

Foot Control Center Pedal is


cracked or broken off. Foot pedal may have been Install Pedal Kit with metal disc.
damaged by prolonged use or
abuse.
Cracks in Housing.
Replace Foot Control.

Table 9.17: Foot Control (WFC) and FCIB (WFR) Troubleshooting Guide.

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Wireless communication may Attach Foot Control cable.


have failed.

With the system shutdown,


Foot Control or FCIB will not Can Bus cable is disconnected
reattach CAN Bus cable to the
communicate with system. from the FCIB.
FCIB.

Replace Bluetooth module or


PCB is not working properly.
PCB.

The foot control has timed out. Push a button to start again.

Center pedal has fallen down with


The large spring has broken. Replace spring.
no tension

Verify with service software that


you are receiving counts and
activating the home switch
The potentiometers have failed or
- open bottom and do a physical
No pitch/ yaw function the cables are disconnected or
inspection
broken.
- NOTE: if the potentiometer is
replaced, calibration must be
performed

Switch is broken. Replace the switch.

No switch functions The wire or cable is disconnected. Reconnect or replace.

The cover is broken or jammed. Replace or fix.

Table 9.17: Foot Control (WFC) and FCIB (WFR) Troubleshooting Guide.

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9.10 Wireless Remote Control (REM) (Anterior Only)

9.10.1 Wireless Remote Control (REM) Error Codes (Anterior Only)

Error
Description Corrective Action
Code
The remote control receiver was not detected in the
Reboot system.
system. Surgical mode is not available.
RCR01 Contact Technical Support and/or
Remote control and display backlight control functions are
replace the UIC module.
not available.

The remote control receiver software version is not


compatible with the system software version. Surgical A compatible software version must
RCR02
mode is not available. be downloaded.
Remote Control is not available.

The remote control receiver has failed to respond to a Reboot system.


RCR03 settings command. The module settings have been re-sent Contact Technical Support and/or
to the module. replace the UIC module.

Reboot system.
The remote control receiver has reset. The module settings
RCR04 Contact Technical Support and/or
have been re-sent to the module.
replace the UIC module.
Turn off or dim room lights. Certain
types of room lighting may cause
Possible interference with remote control receivers.
RCR05 this type of interference.
Remote control function may not be available.
Contact Technical Support and/or
replace the UIC module.

The remote control battery level is low. Remote control Replace the remote control battery at
RCR06
function may not be available shortly. your earliest convenience.

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9.10.2 Wireless Remote Control (REM) Troubleshooting Guide

Symptom Probable Cause Corrective Action


Replace both batteries with fresh
product, or install batteries. Check for
“transmit” (green) and/or “low battery”
(amber) indicators. Observe correct
battery polarity as indicated within
housing.
The Battery cells are exhausted,
not present or reversed.

Note: When installing new batteries, the


keypad backlight, “transmit” indicator
and “low battery” indicator will be
Will not change mode(s) and/ illuminated for three seconds after the
or values. batteries are installed.

Review Bausch + Lomb Stellaris Vision


Use not within specified zone of Enhancement System Owner’s Manual
coverage. concerning guidelines for operation of
IR Remote.

The transmitter/receiver path is


obstructed. Review Bausch + Lomb Stellaris Vision
Enhancement System Owner’s Manual
concerning guidelines for operation of
Note: The Anterior IR Remote is IR Remote.
a line of sight device.

Verify “transmit” (green) symbol


illuminates upon pressing button and
“low battery” (amber) warning does not
appear. If indicated replace both
batteries with fresh product.
Operation seemingly The battery cells are nearing end
intermittent. of useful life.
Note: When installing new batteries, the
keypad backlight, “transmit” indicator
and “low battery” indicator will be
illuminated for three seconds after the
batteries are installed.

Table 9.18: Wireless Remote Troubleshooting

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Symptom Probable Cause Corrective Action


Replace both batteries with fresh product
prior to next surgical procedure.

“Low battery” warning The battery cells are nearing end


illuminates. of useful life. Note: When installing new batteries, the
keypad backlight, “transmit” indicator
and “low battery” indicator will be
illuminated for three seconds after the
batteries are installed.

Remote Receiver is not There is a possible Receiver


Power down the system and then reboot.
detected in the system. Board failure.

Replace the board.


Remote Receiver is not There is a possible Receiver Replace the cable between the Display
detected in the system. Cable assembly failure. Transition Board and the UIC Main
Board.

Remote Receiver has reset. Unknown transient error. Power down the system and then reboot.
Power down the system and then reboot.
Replace the remote Receiver board.
Remote Receiver does not There is a possible Receiver
Replace the cable between the Display
respond to a remote command. Board failure.
Transition Board and the UIC main
board.

Table 9.18: Wireless Remote Troubleshooting

9.11 Multimedia Center (MMC)

9.11.1 Multimedia Center (MMC) Error Codes

Error
Description Corrective Action
Code
Please ensure that the multimedia center is
plugged in and powered on.
MMC01 The multimedia center was not detected. Check that the multimedia center data cable is
plugged in to both the system and the
multimedia center.

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The multimedia center software version is not


A compatible software version must be
MMC02 compatible with the system software version.
downloaded.
The video overlay function is not available.

The multimedia center has failed to respond to a UIC will not communicate with the MMC.
MMC03 settings command. The settings have been re- Shutdown the Stellaris and MMC then reboot
sent. both systems starting with the MMC.

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9.11.2 Multimedia Center (MMC) Troubleshooting Guide

Symptom Probable Cause Corrective Action


The monitor needs to be Check the video monitor for overscan or
Video display not centered on
adjusted. underscan adjustments.
screen or edge off screen.
Needs Overscan Adjustment. Adjust overscan through the GUI.

Too much margin on display. Needs Overscan adjustment. Adjust overscan through the GUI.
The connection of video source
(i.e. TV or monitor) is not Check all outer video connections.
secure.

The wrong input source is Select the correct input source for the
selected on monitor. monitor.

The corresponding internal Re-seat or plug in the corresponding


No video. video cable may be loose. video cable.

Try a known good TV or alternate


monitor.
Bad TV or alternate video Bypass the MMC by connecting the
source. camera directly into the monitor and
check for video. If video is now present
on the monitor then replace the MMC.

The camera power may be off. Verify that the camera power is on.

The camera may not be plugged Verify that the camera is plugged into
into the MMC. the MMC.

The camera may not be plugged Plug the camera into the Video IN or S-
into the Video IN or S-Video IN. Video IN.
No camera video
Incorrect video input connection Verify that the correct video input
on VCR and monitor. connection to VCR or monitor.

Bypass MMC by connecting camera


The MMC is not working directly into monitor and check for
properly. video. If video is now present on monitor
then replace the MMC.

The video cables and


Check all video cables and connections.
Intermittent or flickering connections may be loose.
video. The monitor may not be set to Verify that the monitor is in correct
the correct format. format: NTSC or PAL.

The camera power may be off. Verify that camera power is on.
Rolling video The monitor may not be set to Verify that the monitor is in the correct
the correct format. format: NTSC or PAL.

Table 9.19: Multimedia Center Troubleshooting Guide

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Incompatible camera. Plug in a supported camera to the MMC.

Windows XP did not fully boot


Re-boot the MMC.
up.
Video is not streaming The network cable may have Re-seat and/or plug the network cable
come loose or is unplugged. back in.

The software program that runs


Enable the software program.
streaming video is disabled.

Set up the MMC for proper Firewire


Video is not streaming through Improper IP address
communication.
Firewire. configuration.
(Refer to SB-ST-0009)

The power cord is loose or un- Re-seat or plug in the power cord and re-
attached from unit. boot the unit.

Make sure the unit is plugged into a


Unit will not power on Incompatible power source.
compatible power source.

Fuses on the internal Power are


Replace the fuses.
Supply blown.

The network cable may have Re-seat and or plug network cable back
come loose or is unplugged. in.

Possible network outage if using


Check that the customer network is
the customer network
working properly.
connection.
Will not communicate with the
The UIC and MMC do not have
UIC. Install the correct MMC software.
compatible software installed.

The configuration is set Re-configure the MMC settings for the


incorrectly on the MMC. network communication.

Configuration is set incorrectly Re-configure the UIC settings for the


on the UIC. network communication.

Table 9.19: Multimedia Center Troubleshooting Guide

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The Front Panel cable has


Replace the MMC.
become loose or unplugged.

The unit did not boot up or is


Power on the unit and/or reboot the unit.
powered off.

The Hard Drive may be


Replace the MMC.
defective.
No Blue LED activity on the
Front Panel or No Overlay The Operating System may be
Replace the MMC.
corrupted.

The network cable may be


Plug in or replace the network cable.
unplugged or damaged.

Bausch + Lomb Stellaris Vision


Enhancement System is not in a Enter a surgical mode.
surgical mode.

Table 9.19: Multimedia Center Troubleshooting Guide

9.12 Green Laser Module (LAS, Posterior and Combined Only)

9.12.1 Green Laser Module Error Codes

Error
Description Corrective Action
Code
The laser module was not detected in the Contact Technical Support and/or replace the
LAS01
system. Surgical mode is not available. Green Laser Module.

The laser module software version is not


A compatible software version must be
LAS02 compatible with the system software version.
downloaded.
Surgical mode is not available.

The laser module has failed to respond to a Reboot system.


LAS03 settings command. The module settings have Contact Technical Support and/or replace the
been re-sent to the module. Green Laser Module.

Reboot system.
The laser module has reset. The module
LAS04 Contact Technical Support and/or replace the
settings have been re-sent to the module.
Green Laser Module.

The laser module emergency stop has been Cycle the laser key switch to deactivate
LAS05
pressed. emergency stop.

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Cycle the laser key off and then on.


A laser module malfunction has occurred,
LAS06 Contact Technical Support and/or replace the
malfunction code XX (where XX is the code).
Green Laser Module.

Ensure that the eye safety filter is installed


LAS07 (Endo mode) and operating room personnel None
have proper eye protection.

Laser treatment mode is unavailable – see the


LAS08 None
laser status.

Select the laser mode button to enter ready


LAS09 Laser not in treatment mode.
mode.

Cycle the laser key off and then on.


Laser has failed to deliver the commanded
LAS10 Contact Technical Support and/or replace the
power.
Green Laser Module.

9.12.2 Green Laser Module Troubleshooting Guide

Symptom Probable Cause Corrective Action


Laser fires but there is
no treatment result /
no laser burn
or
Possible broken/
Laser fires but the Try a different delivery device. If there is the same outcome
defective fiber on
surgeon has to use a with a different delivery device, proceed to Possible Cause 2.
delivery device
much higher power
setting than normal in
order to get the same
treatment result

Table 9.20: Green Laser Module Troubleshooting Guide.

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Symptom Probable Cause Corrective Action


Check throughput of (orange colored) fiber optic patch cable
by using the following steps:
Connect your EndoProbe to the customer SMA connector
(Laser Aperture) on the Anterior module front panel, and use
Aiming Beam Test (sections 3.13.5 and 3.13.6.2 through
3.13.6.8 of S.O.P SP-ST-0002 Stellaris & Stellaris PC Field
Service Test Procedure) with Handheld Laser Power Meter:
Edmund Optics, Stock Number 54-018, or equivalent.
Then disconnect the (orange colored) fiber optic patch cable
from Laser Head/Optics Deck and connect the same
EndoProbe directly to the SMA connector on the Laser
Head/Optics Deck. (A second EndoProbe will need to be
connected to the SMA connector (Laser Aperture) on the
front of the Anterior Module in order to make contact with
the ‘Spring Pins’ of the probe sensing circuit to enable the
laser.) Check, using Aiming Beam Test (sections 3.13.5 and
3.13.6.2 through 3.13.6.8 of S.O.P SP-ST-0002 Stellaris &
Laser fires but there is Stellaris PC Field Service Test Procedure) with Handheld
no treatment result / Laser Power Meter: Edmund Optics, Stock Number 54-018,
no laser burn Possible broken, or equivalent.
or defective, or damaged
Laser fires but the (orange colored) fiber
surgeon has to use a optic patch cable (Laser
It is typical to get approximately a 10% higher reading when
much higher power Head/Optics Deck to
taken from the SMA connector on the Laser Head/Optics
setting than normal in Anterior module)
Deck than the reading taken from the SMA connector
order to get the same
(Laser Aperture) on the front of the Anterior Module. This
treatment result
is due to normal loss through the fiber and connections of a
‘good’, properly functioning, (orange colored) fiber optic
patch cable.

If there is a great amount of difference between the reading


taken from the two locations, then replace (orange colored)
fiber optic patch cable, ‘Anterior Module to Laser Head/
Optics Deck’ (124003142), or replace the entire Anterior
module (USL). If the throughput of (orange colored) fiber
optic patch cable is fine; proceed to Possible Cause 3.

It has been found that the use of probes from other


companies (non-B+L probes) can cause damage to the
optical interface of the (orange colored) fiber optic patch
cable within the SMA connector at the Anterior module
(USL) front connector panel.

Table 9.20: Green Laser Module Troubleshooting Guide.

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Symptom Probable Cause Corrective Action


Laser fires but there is If the laser fires and the EndoProbe and the (orange colored)
no treatment result / fiber optic patch cable (Anterior module to Laser Head/
no laser burn Optics Deck) are eliminated as possible causes, then the
or
Possible defective laser probable cause is a defective ‘Laser Module & PCB Control
Laser fires but the
module & associated Assembly’.
surgeon has to use a
circuitry
much higher power
setting than normal in
order to get the same Laser Module and PCB Control Assembly must be
treatment result maintained as serialized module - a matched set.

Make sure that, while in the ‘Standby’ mode, the aiming


User error beam is turned ‘on’ and check aiming beam adjustment
setting. If settings are fine, proceed to Possible Cause 2.
No Red Aiming Beam
Possible broken/
Try a different delivery device. If there is the same outcome
defective fiber on
with a different delivery device, proceed to Possible Cause 3.
delivery device

Table 9.20: Green Laser Module Troubleshooting Guide.

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Symptom Probable Cause Corrective Action


Check throughput of (orange colored) fiber optic patch cable
by using the following steps:
Connect your EndoProbe to the customer SMA connector
(Laser Aperture) on the Anterior module front panel, and use
Aiming Beam Test (sections 3.13.5 and 3.13.6.2 through
3.13.6.8 of S.O.P SP-ST-0002 Stellaris & Stellaris PC Field
Service Test Procedure) with Handheld Laser Power Meter:
Edmund Optics, Stock Number 54-018, or equivalent.
Then disconnect the (orange colored) fiber optic patch cable
from Laser Head/Optics Deck and connect the same
EndoProbe directly to the SMA connector on the Laser
Head/Optics Deck. (A second EndoProbe will need to be
connected to the SMA connector (Laser Aperture) on the
front of the Anterior Module in order to make contact with
the ‘Spring Pins’ of the probe sensing circuit to enable the
laser.) Check, using Aiming Beam Test (sections 3.13.5 and
3.13.6.2 through 3.13.6.8 of S.O.P SP-ST-0002 Stellaris &
Stellaris PC Field Service Test Procedure) with Handheld
Laser Power Meter: Edmund Optics, Stock Number 54-018,
Possible broken/ or equivalent.
defective (orange
colored) fiber optic
No Red Aiming Beam
patch cable (Anterior
It is typical to get approximately a 10% higher reading when
module to Laser Head/
taken from the SMA connector on the Laser Head/Optics
Optics Deck)
Deck than the reading taken from the SMA connector
(Laser Aperture) on the front of the Anterior Module. This
is due to normal loss through the fiber and connections of a
‘good’, properly functioning, (orange colored) fiber optic
patch cable.
If there is a great amount of difference between the reading
taken from the two locations, then replace (orange colored)
fiber optic patch cable, ‘Anterior Module to Laser Head/
Optics Deck’?or replace the entire Anterior module (USL).
If the throughput of (orange colored) fiber optic patch cable
is fine; proceed to Possible Cause 4.

It has been found that the use of probes from other


companies (non-B+L probes) can cause damage to the
optical interface of the (orange colored) fiber optic patch
cable within the SMA connector at the Anterior module
(USL) front connector panel.

Table 9.20: Green Laser Module Troubleshooting Guide.

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Symptom Probable Cause Corrective Action


If the EndoProbe and the (orange colored) fiber optic patch
cable (Anterior module to Laser Head/Optics Deck) are
eliminated as possible causes, then the probable cause is a
Possible defective laser defective ‘Laser Module & PCB Control Assembly’.
No Red Aiming Beam module & associated
circuitry

Laser Module and PCB Control Assembly must be


maintained as serialized module - a matched set.

Check to make sure that the laser is in the ‘Ready’ mode on


the screen before attempting to fire. Check to make sure a
Possible user error delivery device is attached to the SMA connector (Laser
Aperture). Check for any related messages on the screen.
Take action based on the message.

If there is a delivery device, Endoprobe or LIO+, attached to


the Laser Aperture and a message is generated ‘UIC15 - A
laser endoprobe is not connected’ or ‘UIC16 - A Laser
Indirect Ophthalmoscope (LIO) is not connected’, first make
Possible faulty Laser
sure that correct laser sub mode is selected for the delivery
Aperture ‘Spring Pins’
device attached (‘Endo’ or ‘LIO’). If correct mode is selected
(delivery device sensor
for the delivery device, try a another of the same type of
Laser Won't Fire pins) on Anterior
delivery device. If you still get the ‘UIC15’ or ‘UIC16’
module
message, then check the Laser Aperture ‘Spring Pins’
(delivery device sensor pins). If one, or both, of the pins have
receded or have pushed back into the panel, then replace the
‘Connector Panel Assembly’
Check for audible tone or beeps when attempting to fire. If
there are no audible tone or beeps, and the laser will not fire
when using a Primary (Integrated) Foot Control, then close
Possible faulty foot
the safety cover, reopen it and then try again. (This condition
controller.
can be caused by booting up the Stellaris PC while the laser
switch ‘Safety Cover’ is open). If this is not the cause, then
try a different foot control.

Replace ‘Laser Module & PCB Control Assembly’.


Low Power Laser Component realignment
Output or replacement needed in
(as indicated by a Laser Head/Optics
message on the screen) Deck. Laser Module and PCB Control Assembly must be
maintained as serialized module - a matched set.

Table 9.20: Green Laser Module Troubleshooting Guide.

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Symptom Probable Cause Corrective Action


Possible defective
EndoProbe
Low Power Is customer reusing
Replace EndoProbe
EndoProbe EndoProbes?... They are
guaranteed for only
single use.

Possible problem with


Low Power LIO+ Check fiber throughput. Return for repair.
LIO+ fiber optic cable
Broken adjustment Defective knob or LIO+
Return for replacement knob and realignment
knob on LIO+ was dropped, etc.

Can't get visual image Alignment of LIO


Alignment of LIO binoculars is off
in LIO to fuse binoculars is off
Cosmetic Seems to be working...should it be returned? Yes, the shock
Laser or LIO was
damage....Laser or could have loosened something that is working OK now but
dropped.
LIO was dropped may degrade...Return for checkout.

Illumination connector Ensure that the illumination connector is connected to the


not connected. correct port on the Anterior module.

Burned out lamp or


Check the lamp and replace if necessary.
missing lamp.

On the Stellaris PC screen, make sure the LIO Lamp control


User error.
is turned on and check LIO Lamp adjustment setting.

A Special Function
Ensure that the Special Function controls on the LIO are not
control on LIO+ is
between detents.
No illumination light between detents.
from LIO+ Defective electrical
Return LIO+ for service.
cable of LIO+.

Disconnected cable of
Connect cable to wiring harness connector.
Anterior module

Defective cable of
Replace the ‘Connector Panel Assembly’
Anterior module.

Defective ‘Laser Module Replace ‘Laser Module & PCB Control Assembly’.
& PCB Control Laser Module and PCB Control Assembly must be
Assembly maintained as serialized module - a matched set.

Table 9.20: Green Laser Module Troubleshooting Guide.

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Chapter 10 - Calibration

10 Calibration

This chapter provides instructions for performing calibrations to certain modules within the Bausch + Lomb Stellaris
Vision Enhancement System.

All calibrations require Bausch + Lomb Service Software, which is unavailable for customer use.

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Chapter 10 - Calibration

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Chapter 11 - Disassembly and Assembly

11 Disassembly and Assembly

This chapter provides instructions for disassembly and assembly of the Bausch + Lomb Stellaris Vision Enhancement
System.

PRIOR TO REMOVING THE SKINS AND MODULES FROM THE EMB: SHUTDOWN ALL MODULE
OPERATIONS, TURN OFF AC POWER, AND DISCONNECT THE AC POWER CORD. DISCONNECT ANY
PERIPHERAL DEVICES ASSOCIATED WITH THE MODULE TO BE REMOVED. FAILURE TO COMPLY
WITH THIS WARNING MAY RESULT IN PHYSICAL INJURY TO PERSONNEL AS WELL AS EQUIPMENT
DAMAGE.

This product, like all micro-circuitry products, uses semiconductors that can be damaged by electrostatic
discharge (ESD). When handling, care must be taken so that these devices are not damaged. Damage due to
inappropriate handling is not covered by the warranty.

The following precautions must be taken:

• Do not open the protective conductive packaging until you have read the following, and are at an approved
anti-static work station.
• Use a conductive wrist strap attached to a good earth ground.
• If repairing a PCB, use a soldering iron or soldering station that is marked as ESD-safe.
• Always discharge yourself by touching a grounded bare metal surface or approved anti-static mat before
picking up an ESD sensitive electronic component.
• Field personnel should use an anti-static mat to cover your work surface.

11.1 Torque Specifications

Note: For unit conversions, which may be required while using this procedure, please refer to Unit Conversions.

Unless otherwise indicated, the following torque specifications are applicable.

Screw Size Torque Specification

M2 screw 4 ± 1.0 lbf-in (0.45 ± 0.11 Nm)


M2.5 screw 8 ± 2.0 lbf-in (0.90 ± 0.23 Nm)
M3 screw 10 ± 2.5 lbf-in (1.13 ± 0.28 Nm)
M4 screw 13 ± 3.25 lbf-in (1.47 ± 0.37 Nm)

Table 11.1: Screw Size and Torque Specification.

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Screw Size Torque Specification


M6 screw 40 ± 10 lbf-in (4.52 ± 1.13 Nm)
6-32 screw 9 ± 0.5 lbf-in (1.02 ± 0.06 Nm)
Table 11.1: Screw Size and Torque Specification.

The following is a list of the specific torque requirements used in the Bausch + Lomb Stellaris Vision
Enhancement System. An individual tool for each torque is not required if an adjustable tool is capable of covering
the range of torques listed in the table below.

Unless otherwise specified, torque specifications are value ± 25%.

Torque Specification Torque Specification

14 ± 0.9 oz.-in (9.89 ± 0.64 Ncm) 8 ± 2 lbf-in (0.90 ± 0.23 Nm)


2 ± 0.2 lbf-in (0.23 ± 0.02 Nm) 9 ± 0.5 lbf-in (1.02 ± 0.06 Nm)

3 ± 0.2 lbf-in (0.34 ± 0.02 Nm) 9 ± 1 lbf-in (1.02 ± 0.11 Nm)

3 ± 0.5 lbf-in (0.34 ± 0.06 Nm) 10 ± 1 lbf-in (1.13 ± 0.11 Nm)


3 ± 0.75 lbf-in (0.34 ± 0.08 Nm) 10 ± 2.5 lbf-in (1.13 ± 0.28 Nm)

4 ± 0.5 lbf-in (0.45 ± 0.06 Nm) 13 ± 3.25 lbf-in (1.47 ± 0.37 Nm)

4 ± 1 lbf-in (0.45 ± 0.11 Nm) 20 ± 5 lbf-in (2.26 ± 0.56 Nm)

6 ± 0.6 lbf-in (0.68 ± 0.07 Nm) 24 ± 6 lbf-in (2.71 ± 0.68 Nm)

6 ± 1.5 lbf-in (0.68 ± 0.17 Nm) 40 ± 10 in-lbf (4.52 ± 1.13 Nm)

Table 11.2: Additional Torque specifications.

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Chapter 11 - Disassembly and Assembly

11.2 Skin Disassembly and Assembly (Anterior and Posterior


Combined)

11.2.1 Upper Cover Panel (VFM, AFM, or PFM), Front Upper


Access Panel, and Tray Opening Panel (Anterior and Posterior
Combined)

11.2.1.1 Remove the (1) Upper Cover Panel (VFM, AFM, or PFM) skin by pulling the skin off the
front of the chassis. Retain the skin.

11.2.1.2 Remove the four (4) M4 X 12 mm screws and the four (4) M4 Flat Washers that secure the
(2) Front Upper Access Panel to the system. Retain the screws, washers, and skin.

11.2.1.3 Remove the Front Upper Access Panel from the system. Retain the skin.

11.2.1.4 Install Front Upper Access Panel over the VFM, AFM or PFM, the Ultrasound module and
if applicable, the Posterior Illumination Module then install the four (4) M4 X 12 mm screws and the four

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(4) M4 Flat Washers into the Front Upper Access Panel to secure the panel to the system. Torque to 13
± 3 lbf-in (1.47 ± 0.34 Nm).

11.2.1.5 Install the Upper Cover Panel (VFM, AFM, PFM) by pressing the skin onto the front of the
system over the Front Upper Access Panel.

11.2.2 Tray Opening Skin

11.2.2.1 Remove the (3) Tray Opening Cover Panel skin by pulling the skin off the front of the
system. Retain the skin.

11.2.2.2 To reassemble, push the Tray Opening Cover Panel onto the system until it snaps into place.

11.2.3 Accessories Drawer Cover Panel

11.2.3.1 Push on the Accessories Drawer to open the drawer and then pull the Accessories Tray
forward.

11.2.3.2 Remove the two (2) M4 X 10 mm Phillips Screws and the two (2) Flat Washers from inside
the drawer and then remove the (4) Accessory Drawer Cover Panel. Retain the screws and cover.

Note: The brushed aluminum cover skin has a slight tapered contour to it to match the contour of the Lower Front
Panel Skin. Assure the skin is oriented correctly before installing it onto the drawer.

11.2.3.3 To reassemble, place the Accessory Drawer Cover Panel onto the front of the drawer and
install the two (2) M4 X 10 mm Phillips Screws into the inside of the drawer. Torque to 13 ± 3 lbf-in
(1.47 ± 0.34 Nm).

11.2.3.4 Push in on the drawer until it latches.

11.2.4 Front Lower Access Panel

11.2.4.1 Remove the Tray Opening Cover Panel and the Upper Cover Panel (VFM, AFM or PFM).

11.2.4.2 Remove the Accessory Drawer Cover Panel from the system.

11.2.4.3 Remove the two (2) M4 X 12 mm screws and the two (2) M4 Flat Washers which secure
the Front Lower Access Panel to the system. Retain the screws and washers.

11.2.4.4 Lift up on the (5) Front Lower Access Panel and remove the skin from the chassis. Retain
panel skin.

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Note: Observe the clip on the back of the Lower Front Access Panel skin. This clip holds the right and left side skins
together at the bottom of the Bausch + Lomb Stellaris Vision Enhancement System.

11.2.4.5 Install the Front Lower Access Panel onto the chassis, making sure the clip on the lower
back of panel retains the side skins.

11.2.4.6 Install the two (2) M4 X 12 mm Screws and the two (2) M4 Flat Washers to secure the Front
Lower Access Panel to the system. Torque to 13 ± 3 lbf-in (1.47 ± 0.34 Nm).

11.2.4.7 Install the Tray Opening Cover Panel and the Upper Cover Panel (VFM, AFM or PFM).

11.2.4.8 Install the Accessory Drawer Cover Panel to the system.

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11.2.5 Rear Access Panel

For Rear Access Panel part numbers refer to the table below.

11.2.5.1 Locate the two (2) Power Cord Hooks and the Foot Control Hook on the (6) Rear Access
Panel of the unit.

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11.2.5.2 Pull the Hook Plugs out of the center of all three (3) hooks to reveal the screws underneath.
Retain the plugs.

11.2.5.3 Remove the two (2) M4 X 60 mm Socket Head Screws and the two (2) M4 Lock Washers
out of each of the three (3) hooks (6 screws and washers total). Retain the screws and washers.

11.2.5.4 The Rear Access Panel should come off of the unit at the same time. The Hook screws
secure the Rear Access Panel to the chassis. Retain rear panel.

11.2.5.5 To reassemble, place the Rear Access Panel onto the back of the system. For the Posterior
Combined System align the hole in the Rear Access Panel with the pneumatic input on the lower left
corner of the EMB (when viewed from the rear).

Note: Inside of the hooks are alignment ribs to guide the Rear Panel in place. Assure the Rear Panel properly fits
into place before installing the screws.

11.2.5.6 Install the two (2) M4 X 60 mm Socket Head Screws and the two (2) M4 Lock Washers
into of each of the three (3) hooks (6 screws and washers total) and install the hooks on the Rear Access
Panel. Torque to 6 ± 1.5 lbf-in (0.68 ± 0.17 Nm).

11.2.5.7 Push the Hook Plugs into the center of all three (3) hooks to conceal the screws underneath.

11.2.6 Lower Casting Skin (Original UIC)

11.2.6.1 Remove the UIC Top Work Surface Cover.

11.2.6.2 Puncture or peel off the two (2) 6” strips of Tape covering the screw holes on the Lower
Casting Skin. It is not necessary to remove the 4” piece of tape in the middle of the skin.

Note: It is acceptable to have two (2) layers of tape on the Lower Casting Skin. Do not exceed two (2) layers.

11.2.6.3 Remove the four (4) M4 X 16 mm Phillips Screws that secure the Lower Casting Skin to
the UIC Upper Assembly. Retain the screws and skin

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Chapter 11 - Disassembly and Assembly

11.2.6.4 To reassemble, install the Lower Casting Skin onto the top of the UIC, then install the four
(4) M4 X 16 mm Phillips Screws to secure the Lower Casting Skin to the Upper UIC Assembly. Torque
to 13 ± 3.25 lbf-in (1.47 ± 0.37 Nm).

11.2.6.5 Remove any adhesive residue from the Lower Casting Skin with Isopropyl Alcohol. Place
one (1) 6” piece of tape over the right set of screw holes and one (1) 6” piece of tape over the left set of
screw holes and then, if removed, place one (1) 4” piece of tape over the middle set of screw holes in the
Lower Casting Skin, as shown below

11.2.6.6 Install the UIC Top Work Surface Cover onto the top of the Lower Casting Skin. Ensure
the cover fits completely into the groove on the Lower Casting Skin.

11.2.7 UIC Cover Skin (Plastic UIC)

11.2.7.1 Remove the UIC Top Work Surface Cover. Retain the cover.

11.2.7.2 To remove the UIC Cover Skin, the tabs must be unlatched. Carefully pull on the left side
tab out then the right side tab should be unlatched and lastly the rear tab.

Caution: The UIC Cover Skin is fragile and prone to breakage.

11.2.7.3 Once the tabs are free, lift and pivot the rear of the skin to free it from under the display skin.

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Chapter 11 - Disassembly and Assembly

Figure 11.1. UIC Cover Skin Removal

11.2.8 IV Pole Housing Skins

11.2.8.1 Slide the IV Pole Seal up to allow access to the IV Pole Skin - Cap screws.

Note: The Rear Access Panel covers the outer bottom screws of the IV Pole Skin - Cap. Rear Access Panel must be
removed before the IV Pole skins can be removed.

11.2.8.2 Remove the two (2) M3 X 8 mm Phillips Screws and the two (2) M3 Washers from the top
of the (7) IV Pole Skin - Cap, remove the two (2) M3 X 12 mm Phillips Screws and the two (2) M3
Washers from the middle of the IV Pole Skin - Cap and then remove the two (2) M4 X 10 mm Phillips
Screws and the two (2) M4 Flat Washers from the bottom of the IV Pole Skin - Cap. Remove the IV Pole
Skin Cap. Retain the skin, screws and washers.

11.2.8.3 Remove the two (2) M4 X 10 mm Phillips Screws from inside the (7) IV Pole Skin
Housing. Remove the IV Pole Skin Housing and IV Pole Housing Gasket. Retain the skin and screws.

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Chapter 11 - Disassembly and Assembly

11.2.8.4 To reassemble, place the IV Pole Skin Housing and the IV Pole Housing Gasket onto the
IV Pole and align the notch in the skin over the Rear Skin Gasket and install the two (2) M4 X 10 mm
Phillips Screws into the IV Pole Skin Housing. Torque to 13 ± 3 lbf-in (1.47 ± 0.34 Nm).

11.2.8.5 Place the IV Pole Skin - Cap onto the IV Pole and install the two (2) M3 X 0.5 X 8 mm
Phillips Screws and the two (2) M3 Washers into the top of the IV Pole Skin - Cap. Torque to 6 ± 1.5
lbf-in (0.68 ± 0.17 Nm). Install the two (2) M3 X 12 mm Phillips Screws and the two (2) M2 Washers
into the middle of the IV Pole Skin - Cap. Torque to 6 ± 1.5 lbf-in (0.68 ± 0.17 Nm). Install the two (2)
M4 X 12 mm Phillips Screws and the two (2) M4 Flat Washers into the bottom of the IV Pole Skin - Cap.
Torque to 13 ± 3 lbf-in (1.47 ± 0.34 Nm).

11.2.8.6 Slide the IV Pole Seal fully onto the IV Pole Housing Skin.

11.2.9 Handle

11.2.9.1 Remove the two (2) M3 X 8 mm Phillips Screws and the two (2) M3 Washers in the (8)
Handle Cover Bottom underneath the (8) Handle, securing the Handle Cover Bottom and Handle Cover
Top together.

11.2.9.2 For older Anterior Systems, remove the two (2) M6 X 20 mm Socket Head Screws or for
newer Anterior and Posterior Combined Systems, remove the two (2) M6 X 18 mm Flat Head Hex
Screws (one in the top and one in the bottom) securing the (8) Right Handle and the (8) Left Handle
together.

11.2.9.3 Rotate the left handle until the dowel pin on the end of the handle moves out of the notch
which locks it in place and then pull handle up and out. Rotate the right handle the same as the left and
then pull the handle up and out of the chassis.

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Chapter 11 - Disassembly and Assembly

11.2.9.4 To reassemble, place the Handles into the unit one at a time being sure to align the pin with
the key inside the unit chassis and rotate the handle down until the handle locks into position.

Note: Apply Loctite 242 (blue) to the two (2) M6 X 20 mm or the two (2) M6 X 18 mm screws before installing them.

11.2.9.5 Install the two (2) M6 X 20 mm or the two (2) M6 X 18 mm socket head screws (one in the
top and one in the bottom) to secure the Right Handle and the Left Handle together. Torque to 40 ± 10
lbf-in. (4.52 ± 1.13 Nm).

11.2.9.6 Install the two (2) M3 X 8 mm Phillips Screw and the two (2) M3 Washers in the Handle
Cover Bottom underneath the Handle to secure the Handle Cover Bottom and Handle Cover Top
together. Torque to 6 ± 1.5 lbf-in (0.68 ± 0.17 Nm).

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Chapter 11 - Disassembly and Assembly

11.2.10 Right and Left Main Skins

11.2.10.1 Remove the Vacuum Cover Panel and Upper Front Panel, Tray Opening Skin, Accessories
Drawer Cover Panel, Front Lower Access Panel, Rear Access Panel, IV Pole Housing Skins and the
Handle from the system.

11.2.10.2 Remove the four (4) M3 X 8 mm Phillips Screws and M3 Flat Washers on the top of the
EMB, which attaches the (11) Right Main Skin and Left Main Skin to the UIC Crown (metal UIC) or the
plastic UIC. Retain the screws and washers.

11.2.10.3 Remove the six (6) M4 X 18 mm Phillips Screws and the six (6) M4 Flat Washers from the
front of the Right Main Skin and Left Main Skin. Retain the screws and washers.

11.2.10.4 Remove the four (4) M4 X 18 mm Phillips Screws and the four (4) M4 Flat Washers from
the rear of the Right Main Skin and Left Main Skin. Retain the screws and washers.

11.2.10.5 Pull the (9A) Right Front Bumper, (9A) Left Front Bumper, (9B) Right Rear Bumper, and
(9B) Left Rear Bumper off of the lower corners of the Right Main Skin and Left Main Skin. Retain the
bumpers.

11.2.10.6 Remove the four (4) M4 X 12 mm Phillips Screws and the four (4) M4 Flat Washers from
the lower corners of the Right Main Skin and Left Main Skin.

11.2.10.7 Remove the Left Main Skin, Rear Skin Gasket and then the Right Main Skin. At the bottom
of the Left and Right Main Skins, carefully flex the skins outward while pulling them off the system.
Retain the skins and gasket.

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Chapter 11 - Disassembly and Assembly

Note: The Right Main Skin will have to be fitted over the pressurized infusion fitting before installing the Right
Main Skin fully onto the system.

11.2.10.8 To reassemble, install the Right Main Skin onto the chassis, carefully flexing the skins
outward while fitting them onto the system.

11.2.10.9 Install the Rear Skin Gasket onto the Right Skin.

11.2.10.10 Install the Left Main Skin onto the chassis and properly mate the Left Main Skin into Rear
Skin Gasket.

11.2.10.11 Install the four (4) M4 X 12 mm Phillips Screws and the four (4) M4 Flat Washers into the
lower corners of the skins to secure the skins onto the system. Torque to 13 ± 3 lbf-in (1.47 ± 0.34
Nm).

11.2.10.12 Install the four (4) M3 X 8 mm Phillips Screws and Washers into the Right Main and Left
Main Skins at the top of the EMB to secure the Right Main Skin and Left Main Skin to the UIC Crown
(metal UIC) or the plastic UIC. Torque to 6 ± 1.5 lbf-in (0.68 ± 0.17 Nm).

11.2.10.13 Install the six (6) M4 X 18 mm Phillips Screws and the six (6) M4 Flat Washers into the
front of the Right Main Skin and Left Main Skin. Torque to 13 ± 3 lbf-in (1.47 ± 0.34 Nm).

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Chapter 11 - Disassembly and Assembly

11.2.10.14 Install the four (4) M4 X 18 mm Phillips Screws and four (4) M4 Flat Washers into the rear
of the Right Main Skin and Left Main Skin. Torque to 13 ± 3 lbf-in (1.47 ± 0.34 Nm).

11.2.10.15 Install the Handle, IV Pole Housing Skins, Rear Access Panel, Front Lower Access Panel,
Accessories Drawer Cover Panel, Tray Opening Skin, Upper Front Panel, and Vacuum Cover Panel.

11.2.10.16 Press the Right Front Bumper, Left Front Bumper, Right Rear Bumper and Left Rear
Bumper onto the lower corners of the Right and Left skins

11.2.11 Vent Removal and Installation

11.2.11.1 Vent Panel (Original)

11.2.11.1.1 Place a #1 flat blade screwdriver in the notch at the bottom of the Vent

Panel. 11.2.11.1.2 Carefully pry up on the panel until the bottom of the panel becomes

loose.

11.2.11.1.3 Grab the panel and carefully pull it out of the notch at the top of the panel (some slight
twisting of the panel may be necessary). Retain the panel.

11.2.11.1.4 To reassemble, place the top tab of the vent panel into the notch in the main skin and
then press the panel into place until the bottom tab of the panel snaps into place.

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Chapter 11 - Disassembly and Assembly

11.2.11.2 Vent Panel (Current)

Figure 11.2. New Vent Panel - Front View and Rear View.

11.2.11.2.1 Carefully place a #1 flat blade screwdriver into one of the vent slots in the panel (Right
or Left Vent Cover) and push up from the bottom of the panel.

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Chapter 11 - Disassembly and Assembly

11.2.11.2.2 Twist the panel to release the tabs on the inside of the panel.

11.2.11.2.3 Pull out on the panel until it comes free of the main skin. Retain the panel.

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Chapter 11 - Disassembly and Assembly

11.2.11.2.4 To reassemble, insert the top tab of the vent panel into the notch in the main skin.

11.2.11.2.5 Push in on the side tabs with the screwdriver to snap side tabs into place.

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Chapter 11 - Disassembly and Assembly

11.2.11.2.6 Use finger to pull middle of panel out and then push the bottom tab into place.

11.3 Removing and Installing Modules

PRIOR TO REMOVING THE SKINS AND MODULES FROM THE EMB: SHUTDOWN ALL MODULE
OPERATION, TURN OFF AC POWER, AND DISCONNECT AC POWER CORD. DISCONNECT ANY

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Chapter 11 - Disassembly and Assembly

PERIPHERAL DEVICES ASSOCIATED WITH THE MODULE TO BE REMOVED. FAILURE TO COMPLY


WITH THIS WARNING MAY RESULT IN PHYSICAL INJURY TO PERSONNEL AS WELL AS EQUIPMENT
DAMAGE.

11.3.1 User Interface Computer (UIC)

11.3.1.1 Remove the Vacuum Cover, Upper Front Access and for Metal UICs, remove the UIC Pad.
Retain the screws, washers, and skin.

11.3.1.2 For Metal UICs, puncture the two (2) 6” outer strips of Tape covering the screw holes in
the Lower Casting Skin.

Note: It is not necessary to remove the middle piece of tape.

11.3.1.3 For Metal UICs, remove the four (4) M4 X 16 mm Phillips Screws, securing the Lower
Casting Skin to the Upper UIC Casting. Retain the screws and skin.

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Chapter 11 - Disassembly and Assembly

11.3.1.4 For Plastic UICs/UPCs, remove the UIC Cover Skin by releasing the three (3) tabs on the
right, left and rear of the skin. Pivot the skin up to remove the skin from the UIC. Retain the skin.

11.3.1.5 For Metal UICs, remove the two (2) M4 X 16 mm Phillips Screws which secure the back
of the UIC to the Crown. Retain the screws.

11.3.1.6 For Plastic UICs/UPCs, remove the four (4) M3 X 8 mm Phillips Screws and the four (4)
Flat Washers from the top of the Right and Left Main Skins.

11.3.1.7 Remove the two (2) M4 X 12 mm Phillips Screws and if applicable, the two (2) M4
Washers in the front of the UIC, underneath the LCD, which secure the UIC to the EMB shelf. Retain
the screws and washers.

11.3.1.8 Remove the M4 X 12 mm Phillips Screw and the M4 Flat Washer from the UIC ground
strap, which is secured to the front of the EMB or for Plastic UICs/UPCs, the top screw hole of the
Fluidics Module. Retain the screw and washer.

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Chapter 11 - Disassembly and Assembly

11.3.1.9 Disconnect the Stand-by Switch cable, Ethernet cable, and CAN/Power cable from the
UIC. For Plastic UICs/UPCs, remove the M4 X 12 mm Phillips Screw and the M4 Flat Washer from the
top screw hole of the Ultrasound Module which secures the ground strap of the Stand-by Switch cable.
Retain the screw and washer.

Note: The CAN/Power Cable has a slide latch. Slide the latch to the left to disengage latch and slide it to the right
to engage the latch.

11.3.1.10 Pull the UIC forward to slide the module out of the EMB.

Do not sit the UIC down on any surface until the display assembly has been tilted back at least 30 degrees. The
UIC is top heavy and may tip over if display is not tilted back.

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Chapter 11 - Disassembly and Assembly

Note: The current EMB cable has a 90º connector for the UIC versus the 45º version on the original cable. The
current connector is compatible with the metal and plastic UIC. The original cable is only compatible with the metal
chassis UIC and not compatible with the plastic chassis UIC.

11.3.1.11 Carefully set the UIC aside.

11.3.1.12 To reassemble, place the UIC into the EMB and slide the UIC fully into the EMB.

Note: The CAN/Power Cable has a slide latch. Slide the latch to the left to disengage latch and slide it to the right
to engage the latch.

11.3.1.13 Connect the Stand-by Switch cable, Ethernet cable, and CAN/Power cable to the UIC. For
Plastic UICs, install the M4 X 12 mm Phillips Screw and the M4 Flat Washer into the top screw hole of
the Ultrasound Module which secures the ground strap of the Stand-by Switch cable. Retain the screw
and washer.

11.3.1.14 Install the M4 X 12 mm Phillips Screw through the UIC ground strap and secure the strap
to the front of the EMB. For Plastic UICs/UPCs, install the M4 X 12 mm Phillips Screw and the M4
Flat Washer into the UIC ground strap, and secure the strap to the top screw hole of the Fluidics Module.
Torque to 13 ± 3 lbf-in. (1.47 ± 0.34 Nm).

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Chapter 11 - Disassembly and Assembly

11.3.1.15 Install the two (2) M4 X 12 mm Phillips Screws and the two (2) M4 Washers in the front
of the UIC underneath the LCD to secure the UIC to the EMB. Torque to 13 ± 3.25 lbf-in (1.47 ± 0.37
Nm).

11.3.1.16 For Metal UICs, install the (2) M4 X 16 mm Phillips Screws to secure the back of the UIC
to the EMB. Torque to 13 ± 3.25 lbf-in (1.47 ± 0.37 Nm).

11.3.1.17 For Plastic UICs/UPCs, install the four (4) M3 X 8mm Phillips Screws and the four (4) Flat
Washers into the top of the Right and Left Main Skins.

11.3.1.18 For Metal UICs, install the Lower Casting Skin onto the UIC and then install four (4) M4
X 16 mm Phillips Screws, which secure the skin. Torque to 13 ± 3.25 lbf-in (1.47 ± 0.37 Nm).

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Chapter 11 - Disassembly and Assembly

11.3.1.19 For Plastic UICs/UPCs, install the UIC Cover Skin by pivoting the tab up into the hinge
cover skin behind the UIC and then press down on the UIC Cover Skin to snap the three (3) tabs on the
right, left and rear of the skin into place.

11.3.1.20 For Metal UICs, remove any adhesive residue from the bottom remaining layer of tape with
Isopropyl Alcohol. Place one (1) 6” piece of Tape over the right set of screw holes and one (1) 6” piece
of Tape over the left set of screw holes in the Lower Casting Skin.

Note: Do not remove the protective backing from the top side of the tape (Metal UICs only).

Note: A maximum of two (2) layers of tape may be applied to the Lower Casting Skin (Metal UICs only).

11.3.1.21 Install the UIC Pad, Upper Front Access Panel and the Vacuum Cover Panel skin.

11.3.2 Ultrasound Module

11.3.2.1 Remove the Vacuum Cover Panel skin, Upper Front Access Panel and the Rear Access
Panel. Retain the skins and screws.

11.3.2.2 Loosen the two (2) thumbscrews or remove the two (2) M4 X 12 mm Phillips Screws and
two (2) M4 flat washers which secure the Ultrasound module to the EMB. If applicable remove the
shielding wire (coming from the UIC Power Button cable) from the top M4 X 12 mm Phillips screw and

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Chapter 11 - Disassembly and Assembly

the M4 flat washer in the front of the module, and also remove the Phillips screw, washer and shielding
wire (coming from the IV Pole Manual Switches cable) on the rear of the module. If necessary, slide the
module forward slightly to gain access to the CAN/Power cable in the back of the module.

11.3.2.3 Disconnect the CAN/Power cable from the back of the module.

11.3.2.4 Slide the module out of the EMB.

11.3.2.5 To reassemble, place the module into the appropriate slot in the EMB and slide it
backwards (leave room to connect the electrical connection).

11.3.2.6 Connect the CAN/Power cable into the back of the module.

11.3.2.7 Secure the module to the EMB by tightening the thumbscrews or install the two (2) M4 X
12 mm Phillips Screws and two (2) flat washers of the module into the EMB. If applicable, install the
shielding wire (coming from the UIC Power Button cable) under the top M4 X 12 mm Phillips screw and
the M4 flat washer in the front of the module and also install the Phillips screw, washer and shielding
wire (coming from the IV Pole Manual Switches cable) onto the rear of the module. Torque to 13 ± 3.25
lbf-in (1.47 ± 0.37 Nm).

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Chapter 11 - Disassembly and Assembly

11.3.2.8 Install the Upper Front Access Panel, Vacuum Panel Cover skin and the Rear Access Panel.

11.3.3 Vacuum Fluidics (VFM), Advanced Flow Module (AFM) or


Posterior Fluidics Module (PFM)

11.3.3.1 Remove the Vacuum Cover Panel or AFM Cover Panel skin, Upper Front Access Panel and
the Rear Access Panel. Retain the skins and screws.

11.3.3.2 Disconnect the blue, white, red, orange (PFM only) and green tubing from the appropriate
color fitting. Refer to the table below.

Note: The AFM does not have the Vacuum (white cap) connector. The AFM and VFM do not have an Orange (Air
Input) connection.

Tubing Color/Function
Fitting Cap Color

Blue – Vitrectomy Blue Fitting Cap


Advanced
Fluidics Module Green – Vitrectomy Exhaust Green Fitting Cap
(AFM)
Red – Pressure/Pinch Valves Red Fitting Cap

Table 11.3: Tubing and Associated Cap Colors.

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Chapter 11 - Disassembly and Assembly

Tubing Color/Function
Fitting Cap Color

Blue – Vitrectomy Blue Fitting Cap


Green – Vitrectomy Exhaust Green Fitting Cap
Vacuum Fluidics
Module (VFM) Red – Pressure/Pinch Valves Red Fitting Cap

White - Vacuum White Fitting Cap

Blue – Vitrectomy Blue Fitting Cap

Posterior Fluidics Green – Vitrectomy Exhaust Green Fitting Cap


Module (PFM) Red – Pressure/Pinch Valves Red Fitting Cap
Orange – Air Input No Cap – Fitting color is orange

Table 11.3: Tubing and Associated Cap Colors.

11.3.3.3 Disconnect the CAN/Power cable from the back of the module.

11.3.3.4 Loosen the two (2) thumbscrews or remove the two (2) M4 X 12 mm Phillips Screws and
two (2) M4 flat washers which secure the module to the EMB and slide the module out of the EMB. If
applicable, remove the shielding wire (coming from the UIC) from the top M4 X 12 mm Phillips screw
and the M4 flat washer in the front of the fluidics module.

AFM Pneumatic Connections VFM Pneumatic connections


Figure 11.3. Fluidics Module connections

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Chapter 11 - Disassembly and Assembly

PFM Pneumatic Connections


Figure 11.3. Fluidics Module connections

11.3.3.5 To reassemble, place the module into the appropriate slot in the EMB and slide it backwards
(leave room to connect the tubing and electrical connector).

11.3.3.6 Connect the CAN/Power cable into the back of the module.

11.3.3.7 Connect the blue, white (VFM only), red, orange (PFM only) and green tubing to the
appropriate color fitting. Refer to Figure 11.3 for tubing location and Table 11.3.

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Chapter 11 - Disassembly and Assembly

11.3.3.8 Tighten the two (2) thumbscrews or install the two (2) M4 X 12 mm Phillips Screws and
the two (2) M4 flat washers which secure the module to the EMB. If applicable, install the shielding wire
(coming from the UIC) under the top M4 X 12 mm Phillips screw and the M4 flat washer in front of the
fluidics module. Torque to 13 ± 3.25 lbf-in (1.47 ± 0.37 Nm).

11.3.3.9 Install the Upper Front Access Panel, Vacuum Panel Cover or AFM Cover Panel skin and
the Rear Access Panel.

11.3.4 Posterior Illumination Module (PIM)

WARNING: ALWAYS TURN OFF THE POWER SUPPLY BEFORE ATTEMPTING TO REPLACE THE
LAMPS TO AVOID DANGER OF BURNS, ELECTRIC SHOCK AND EYE DAMAGE FROM ARC LIGHT.

WARNING: WEAR EYE PROTECTION WHEN INSTALLING OR REMOVING LAMPS.

WARNING: DO NOT TOUCH THE GLASS OF THE LAMPS OR THE CIRCUIT BOARD. HOLD THE LAMP
ONLY BY THE OUTER METAL HOUSING.

WARNING: DO NOT DROP, SCRATCH, OR APPLY FORCE TO LAMP, AS THE HIGH PRESSURE INSIDE
MAY CAUSE THE LAMP TO RUPTURE.

Note: The Stellaris® PC Vision Enhancement System will not work unless both lamps are fitted in place. If you
remove a lamp you must replace it with another lamp or the system will not function.

11.3.4.1 Lamp Replacement Information.

11.3.4.1.1 TURN OFF THE SYSTEM. Wait 20 minutes for the system to cool before attempting
lamp replacement.

11.3.4.1.2 Open the lamp-replacement access door on the side of the unit by placing a coin or flat
head screwdriver into the slot and turning it clockwise. The dot should be on the right, and the door
should then lift off.

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Chapter 11 - Disassembly and Assembly

Figure 11.4. System side with lamp access door open.

11.3.4.1.3 Identify the lamp that requires replacement: lower lamp = Lamp #1; upper lamp =
Lamp #2.

11.3.4.1.4 Undo the two lamp fasteners by turning the two thumbscrews counter-clockwise.

11.3.4.1.5 Carefully pull the lamp housing from the unit and dispose of according to applicable
regulations.

Note: A spent lamp that contains mercury must be recycled by an approved recycling collection facility, in
accordance with applicable domestic and international environmental laws and directives.

11.3.4.1.6 If the bulb is shattered and glass fragments are found, contact B+L service to remove
them to prevent damage to the unit.

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Chapter 11 - Disassembly and Assembly

Figure 11.5. Side of the unit with lamps removed, with lamp location and orientation shown.

11.3.4.1.7 DON’T TOUCH THE LENS, LAMP CONNECTORS OR OTHER PARTS INSIDE
THE SYSTEM.

11.3.4.1.8 Open the packaging for the replacement lamp holding only the metal housing BEING
CAREFUL NOT TO TOUCH ANY PART OF THE GLASS BULB OR CIRCUIT BOARD.

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Chapter 11 - Disassembly and Assembly

Figure 11.6. Lamp Housing Exterior.

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Chapter 11 - Disassembly and Assembly

Figure 11.7. Lamp Housing Interior.

11.3.4.1.9 Align the replacement lamp housing with the hole, taking care to align the connectors
on the top-right and bottom-left corners.

11.3.4.1.10 Push the replacement lamp housing firmly into place.

Note: Make sure to alternately apply an equal number of turns to each thumbscrew while installing the lamp
assemblies into the module.

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Chapter 11 - Disassembly and Assembly

11.3.4.1.11 Screw the two lamp fasteners clockwise until tight (thumbscrews).

WARNING: RISK OF ARC EXPOSURE.

11.3.4.1.12 Replace the door before applying power to the System. Make sure the dot is pointing
down, indicating that the door is locked.

11.3.4.1.13 Turn on the system.

11.3.4.1.14 Check that the new lamp is recognized.

Note: Make sure to dispose of the old lamp properly. Lamps are filled with high pressure xenon gas or xenon and
mercury gases. When disposing of the used lamp, take appropriate measures in compliance with applicable
regulations regarding waste disposal, or entrust disposal to a licensed industrial waste disposal company. Be sure
to comply with the regulations in your country, state, region or province to ensure the used lamp is disposed of
legally and correctly.

11.3.4.2 Posterior Illumination Module (PIM)

11.3.4.2.1 Remove the Upper Cover Panel, Front Upper Access Panel, and the right side Vent
Panel (patient view). Retain skins and vent panel.

11.3.4.2.2 Loosen the two thumbscrews under the right side Vent Panel (patient view) to remove
the Air Duct. Retain the air duct.

11.3.4.2.3 Remove the Access Door from the right side of the system using a flat tip screwdriver
or a coin. Retain the door.

11.3.4.2.4 Loosen the thumbscrews to remove the two (2) bulb assemblies (Xenon - Xenon or
Xenon - Mercury) from the right side of the system. Retain the bulb assemblies.

11.3.4.2.5 Remove the two (2) M4 X 12 mm Phillips Screws and two (2) M4 Flat Washers which
secures the module to the EMB. Retain the screws and washers.

11.3.4.2.6 Disconnect the ¼” Black tubing from the top one-touch elbow fitting (black color cap)
and the ¼” White tubing from the bottom one-touch elbow fitting (white color cap) on the back of
the module.

11.3.4.2.7 Unlatch the (1) Posterior Ballast Power Out Cable connector at the top rear of the
module by sliding the latch up and then disconnecting the connector from the module.

11.3.4.2.8 Remove the Posterior Fluidics Module in order to gain access to the bottom connectors
of the Posterior Illumination Module.

11.3.4.2.9 Using a screwdriver unlatch the (2) Posterior Ballast Ctrl-Stat Cable connector at the
bottom of the module (left connector) (rear view) by sliding the latch up and then disconnecting the
connector from the module.

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Chapter 11 - Disassembly and Assembly

11.3.4.2.10 Using a screwdriver unlatch the (3) CAN/Power connector at the bottom of the module
(right connector) by sliding the latch up and then disconnecting the connector from the module.

11.3.4.2.11 Remove the Posterior Illumination Module from the EMB.

11.3.4.2.12 To reinstall the Posterior Illumination Module, place the module into the EMB.

11.3.4.2.13 Connect the CAN/Power connector to the bottom right (rear view) module connector
and then slide the latch down to secure the connector.

11.3.4.2.14 Connect the other Posterior Ballast Ctrl-Stat Cable connector to the bottom left (rear
view) module connector and then slide the latch down to secure the connector.

11.3.4.2.15 The Posterior Fluidics Module can now be installed into the EMB.

11.3.4.2.16 Connect the Posterior Ballast Power Out Cable connector at the top rear of the module
using a flat screwdriver to help fully install the connector onto the module. Slide the latch down to
secure the connector.

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Chapter 11 - Disassembly and Assembly

11.3.4.2.17 If necessary, slide the module fully into the EMB. Connect the ¼” White tubing into
the bottom one-touch elbow fitting (white color cap) and ¼” Black tubing into the top one-touch
elbow fitting (black color cap) on the back of the module.

11.3.4.2.18 Install the two (2) M4 X 12 mm Phillips Screws and two (2) M4 flat washers to secure
the module to the EMB. Torque to 13 ± 3.25 lbf-in (1.46 ± 0.37 Nm).

11.3.4.2.19 Install the bulb assemblies one at a time onto the side of the module and tighten the
thumbscrews to secure the bulb assemblies onto the right side of the system. Make sure to alternately
apply an equal number of turns to each thumbscrew while installing the lamp assemblies into the
module.

11.3.4.2.20 Install the Access Door onto the right side of the system using a flat tip screwdriver or
a coin.

11.3.4.2.21 Install the Air Duct onto the back of the EMB and tighten the two thumbscrews to
secure the Air Duct.

11.3.4.2.22 Install the right side Vent Panel (patient view), Front Upper Access Panel and the
Upper Cover Panel.

11.3.4.3 Ballast

11.3.4.3.1 Remove all the skins from the system using the Skin Disassembly procedure.

11.3.4.3.2 Remove the two (2) M4 X 10 mm Phillips Screws from the Ballast Fixing Bracket
securing the Ballast in the EMB. Retain the screws and bracket.

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Chapter 11 - Disassembly and Assembly

11.3.4.3.3 Disconnect the electrical power connectors in front of each Ballast PCB of both
Ballasts.

Note: The tie wrap securing the electrical harnesses and tubing may need to be removed to provide enough play to
remove the ballasts.

Note: Pull only on the metal enclosure of the ballast board and not on the board itself.

11.3.4.3.4 Using needle nose pliers carefully pull the right or left Ballast out of the Ballast
Carriage Assembly until the connectors for the Posterior Ballast Power Out Cable and the Posterior
Ballast Ctrl-Stat Cable on the Ballast PCB can be disconnected and then disconnect the cable
connectors from the Ballast PCB. Move any electrical wiring aside that may be preventing the ballast
from coming out of the EMB.

11.3.4.3.5 Pull the Ballast completely out of the EMB. Repeat the same steps for the other Ballast.

11.3.4.3.6 To reassemble, connect the Posterior Ballast Power Out Cable and the Posterior Ballast
Ctrl-Stat Cable connectors onto the Ballast PCB and then place the Ballast into the Ballast Carriage
Assembly. Fully seat the Ballast inside the Ballast Carriage Assembly.

11.3.4.3.7 Connect the electrical power connectors into the front of each Ballast PCB which were
removed earlier.

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Chapter 11 - Disassembly and Assembly

11.3.4.3.8 Neatly place the wiring in front of the Ballasts into the pocket around the Ballasts.
Replace the tie wrap in the back of the EMB securing the wiring and tubing if it was removed.

11.3.4.3.9 Install the Ballast Fixing Bracket using the two (2) M4 X 10 mm Phillips Screws to
secure the Ballasts in the EMB.

11.3.4.3.10 Reinstall the skins using the Skin Assembly Procedure.

11.3.4.4 Fan (Ballast Carriage Assembly)

11.3.4.4.1 Disconnect the Fan Assembly Cable connector from the Ballast Ctrl-Stat Cable
connector.

11.3.4.4.2 Remove the four (4) M3 Nuts and M3 Washers that secure the Fan Assembly to the
Ballast Carriage Assembly standoffs. Remove the Fan Assembly.

11.3.4.4.3 To reassemble, place the Fan Assembly onto the four (4) standoffs on the back of the
Ballast Carriage Assembly and install the four (4) M3 Nuts and M3 Washers to secure the Fan.

11.3.4.4.4 Connect the Fan Assembly Cable connector to the Ballast Ctrl-Stat Cable connector.

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Chapter 11 - Disassembly and Assembly

11.3.5 Compressor Module (CPA) and Posterior Compressor Module


(PCM)

11.3.5.1 Remove the Vacuum Cover Panel or AFM Cover Panel (See page 11-3), Upper Front
Access Panel (See page 11-3), Tray Opening Skin, Accessories Drawer Cover Panel, Front Lower
Access Panel, Rear Access Panel, Lower Casting Skin (Original UIC) or UIC Cover Skin (Plastic UIC),
IV Pole Housing Skins, Handle and Right and Left Main Skins. Retain skins and screws.

11.3.5.2 Remove the Castor Lock Pedal Assembly if applicable. Retain the screws and pedal
assembly.

11.3.5.3 Disconnect the Yellow, Blue, White, Red (Orange, Grey and Black are for the PCM only)
and Green tubing from the back of the Compressor Module. Refer to table below.

Tubing Color/Function Fitting Cap Color

Blue – Vitrectomy Blue Fitting Cap


Green – Vitrectomy Exhaust Green Fitting Cap
Compress
or Module Red – Pressure/Pinch valves Red Fitting Cap
(CPA)
White - Vacuum White Fitting Cap

Yellow – Pressurized Infusion Yellow Fitting Cap

Blue – Vitrectomy Blue Fitting Cap

Green – Vitrectomy Exhaust Green Fitting Cap

Red – Pressure/Pinch Valves Red Fitting Cap


Posterior
Compress White - Vacuum White Fitting Cap
or Module Orange – Air Input (PFM) No Cap – Fitting color is orange
(PCM)
Yellow – Pressurized Infusion Yellow Fitting Cap

Black – Viscous Fluid Black Fitting Cap

Grey – System Air Pressure Grey Fitting Cap

Table 11.4: Tubing and Associated Cap Colors.

Note: Observe the color caps on the one-touch fittings and connect the tubing to the appropriate fitting. Do Not
remove the caps.

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Chapter 11 - Disassembly and Assembly

Compressor Pneumatic Connections Posterior Compressor Pneumatic Connections

11.3.5.4 Remove the CAN Bus / Power Cable from the Compressor module.

11.3.5.5 Loosen the four (4) captive thumbscrews which secure the Compressor to the EMB chassis.
If applicable, remove the ground wire and screw from the upper left hand corner of the Compressor cover

11.3.5.6 Carefully, slide the Compressor module forward and pull out of EMB chassis.

THE COMPRESSOR MODULE (CPA) IS VERY HEAVY (30-40 LBS). PLEASE USE CAUTION WHEN
REMOVING THE COMPRESSOR MODULE TO AVOID PERSONAL INJURY.

11.3.5.7 To reassemble, set the Compressor module onto the EMB base and slide the module into
the EMB chassis.

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Chapter 11 - Disassembly and Assembly

11.3.5.8 Tighten the four (4) captive thumbscrews of the Compressor module which secure the
module to the EMB base. If applicable, install the ground wire and screw to the upper left hand corner of
the Compressor cover.

11.3.5.9 Reconnect the CAN Bus/Power Cable from the Compressor module.

11.3.5.10 Connect the yellow, blue, white, red (Orange, Grey and Black are for the PCM only) and
green tubing to the back of the Compressor Module. Refer to Tubing and Associated Cap Colors. for
tubing location. If any fitting caps are missing refer to Tubing and Corresponding Cap Colors on page 11-
39 for tubing location.

11.3.5.11 Install the castor Lock Pedal Assembly, if removed in previous step.

11.3.5.12 Install the Right and Left Main Skins, Handle, IV Pole Housing Skins, Rear Access Panel,
Lower Casting Skin (Original UIC) or UIC Cover Skin (Plastic UIC), Front Lower Access Panel,
Accessories Drawer Cover Panel, Tray Opening Skin, Upper Front Access Panel and the skin and
Vacuum Cover Panel or AFM Cover Panel (See page 11-3) onto the chassis.

11.3.6 Power Module with Battery Backup (BPS)

DANGER: WHEN PHYSICALLY REMOVING AND INSTALLING THE POWER SUPPLY, ENSURE THE
SYSTEM IS OFF AND THE POWER PLUG IS DISCONNECTED FROM THE AC MAINS.

CAUTION: All power supplies contain various capacitors inside of them that retain power even after the power
supply has all power turned off. Never open up or insert any metal objects into the vents of the power supply as
you can risk electrical shock.

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Chapter 11 - Disassembly and Assembly

11.3.6.1 Remove the Vacuum Cover Panel, Upper Front Access Panel and Tray Opening Skin,
Accessories Drawer Cover Panel, Front Lower Access Panel, Rear Access Panel, Lower Casting Skin
(Original UIC) or UIC Cover Skin (Plastic UIC), IV Pole Housing Skins, Handle and Right and Left
Main Skins. Retain skins and screws.

11.3.6.2 Remove the castor Lock Pedal Assembly, if applicable. Retain the screws, connector
links, brake drive brackets, and pedal.

11.3.6.3 Remove the Compressor module.

11.3.6.4 Loosen the four (4) thumbscrews securing the Power Module to the EMB.

Note: Take care not to drop screws into the Power Module.

11.3.6.5 Disconnect the +24V wiring harness by removing the two (2) Phillips Screws.

Note: Take care not to drop screws into the Power Module.

11.3.6.6 Using a stubby Phillips Screwdriver, remove the Line (black), Neutral (white), and Earth
(green and yellow) wiring harness from the Power Module.

11.3.6.7 Disconnect the CAN/Bus, backup battery, AC Sense and stand-by switch connectors from
the Power Module.

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Chapter 11 - Disassembly and Assembly

11.3.6.8 Pull the module forward and then up and out of the EMB.

11.3.6.9 Insert the Power module into the bottom of the EMB chassis.

11.3.6.10 To reassemble, connect the CAN/Bus, backup battery, AC Sense and stand-by switch
connectors to the Power Module.

Note: Take care not to drop screws into the Power Module.

11.3.6.11 Using a stubby Phillips Screwdriver, secure the Line (black), Neutral (white), and Earth
(green and yellow) wiring harness to the Power Module.

Note: Take care not to drop screws into the Power Module.

11.3.6.12 Connect the +24V wiring harness to the Power Module, using the two (2) Phillips Screws.

11.3.6.13 Install the four (4) thumbscrews securing the Power Module to the EMB.

11.3.6.14 Reinstall the Compressor module.

11.3.6.15 Install the castor Lock Pedal Assembly.

11.3.6.16 Install the Right and Left Main Skins, Handle, IV Pole Housing Skins, Rear Access Panel,
Lower Casting Skin (Original UIC) or UIC Cover Skin (Plastic UIC), Front Lower Access Panel,
Accessories Drawer Cover Panel, Tray Opening Skin, Upper Front Vacuum Panel (See page 11-3) and
the skin and Vacuum Cover Panel (See page 11-3) onto the chassis.

11.3.7 Backup Battery

11.3.7.1 Remove the Rear Access Panel (See page 11-6) from the system. Retain the screws and
rear panel.

11.3.7.2 Remove the Backup Battery connector (J3) from the Power Module.

11.3.7.3 Loosen the captive thumbscrew and remove the bracket from the battery holder. Retain the
bracket.

11.3.7.4 Remove the Backup Battery from the holder on the back of the Power Module and replace
battery if necessary.

11.3.7.5 To reassemble, place the Backup Battery into the Backup Battery holder on the back of the
Power module.

11.3.7.6 Attach the bracket onto the Backup Battery holder and tighten the thumbscrew.

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Chapter 11 - Disassembly and Assembly

11.3.7.7 Install the Rear Access Panel onto the system.

11.3.8 Power Module without Battery Backup (SPS)

DANGER: WHEN PHYSICALLY REMOVING AND INSTALLING THE POWER SUPPLY, ENSURE THE
SYSTEM IS OFF AND THE POWER PLUG IS DISCONNECTED FROM THE AC MAINS.

CAUTION: All power supplies contain various capacitors inside of them that retain power even after the power
supply has all power turned off. Never open up or insert any metal objects into the vents of the power supply as
you can risk electrical shock.

11.3.8.1 Remove the Vacuum Cover Panel, Upper Front Access Panel and Tray Opening Skin,
Accessories Drawer Cover Panel, Lower Front Access Panel, Rear Access Panel, Lower Casting Skin
(Original UIC) or UIC Cover Skin (Plastic UIC), IV Pole Housing Skins, Handle and Right and Left
Main Skins. Retain skins and screws.

11.3.8.2 Remove the castor Lock Pedal Assembly, if applicable. Retain the screws, connector links,
brake drive brackets, and pedal.

11.3.8.3 Remove the Compressor Module or the Posterior Compressor Module.

11.3.8.4 Loosen and remove the four (4) captive thumbscrews securing the Power Module to the
EMB. If applicable, remove the ground wire and screw from the upper left hand corner of the Compressor
cover.

CAUTION: Do not drop any of the hardware into the Power Supply.

11.3.8.5 Remove the M5 Phillips screws and washers to disconnect the +24Vdc to IV Pole
Controller connection (thin red & black wires) and remove the M5 Phillips screws from the CAN Power
connection (thick red & black wires) as shown. Retain screws and washers.

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Chapter 11 - Disassembly and Assembly

11.3.8.6 Disconnect the Line, Neutral & Ground wires from the AC Power Input Module as shown.
Retain the screws.

Note: The Power Supply to FCIB cable and the FCIB Patch cable are secured with a slide latch mechanism.

11.3.8.7 Disconnect the CAN Bus connector (J12), the Power Supply to FCIB cable (J7), the UIC
Main Power Switch cable (J3), and the FCIB Patch cable (J6).

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Chapter 11 - Disassembly and Assembly

11.3.8.8 Remove the M4 X 8 mm Phillips screw on the rear of the Stellaris Power Supply, which
secures the shielding wire for the UIC Main Power Switch cable to the Stellaris Power Supply chassis.
Retain the screw.

11.3.8.9 Remove the Stellaris Power Supply from the EMB.

11.3.8.10 To reassemble, place the Stellaris Power Supply into the EMB.

Note: The Power Supply to FCIB cable and the FCIB Patch cable are secured with a slide latch mechanism.

11.3.8.11 Connect the FCIB Patch cable to J6, the UIC Main Power Switch cable to J3, the Power
Supply to FCIB cable to J7, and the CAN Bus connector to J12 of the Stellaris Power Supply.

11.3.8.12 Install the M4 X 8mm screw on the rear of the Stellaris Power Supply to secure the
shielding wire for the UIC Main Power Switch cable to the Stellaris Power Supply chassis. Torque to 13
± 3.25 lbf-in (1.46 ± 0.37 Nm).

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Chapter 11 - Disassembly and Assembly

11.3.8.13 Connect the Line, Neutral & Ground wires from the AC Power Input Module as shown.
Torque to 13 ± 3.25 lbf-in (1.46 ± 0.37 Nm).

CAUTION: Do not drop any of the hardware into the Power Supply.

11.3.8.14 Connect the +24Vdc to IV Pole Controller connection (thin red & black wires) with M5
Phillips screws and washers and the CAN Power connection (thick red & black wires) with M5 Phillips
screws as shown. Torque to 24 lbf-in. (2.7 Nm).

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Chapter 11 - Disassembly and Assembly

11.3.8.15 Install and tighten the four (4) captive thumbscrews securing the Power Module to the
EMB. Torque to 13 ± 3.25 lbf-in (1.46 ± 0.37 Nm).

11.3.8.16 Install the Compressor Module or the Posterior Compressor Module. Torque to 24 lbf-in.
(2.7 Nm).

11.3.8.17 Install the castor Lock Pedal Assembly. Torque to 13 ± 3.25 lbf-in (1.46 ± 0.37 Nm).

11.3.8.18 Install the Right and Left Main Skins, Handle, IV Pole Housing Skins, Rear Access Panel,
Lower Casting Skin (Original UIC) or UIC Cover Skin (Plastic UIC), Lower Front Access Panel,
Accessories Drawer Cover Panel, Tray Opening Skin, Upper Front Vacuum Panel (See page 11-3) and
the skin and Vacuum Cover Panel (See page 11-3) onto the chassis. Refer to Skin Disassembly and
Assembly for torque specifications.

11.3.9 Tray Assembly

Note: There are three generations of the Tray Arm Assembly. The first generation Tray Arm Assembly has
a metal Tray Bracket, and the second generation Tray Arm Assembly has a structural foam Tray Bracket.
The third generation Tray Arm Assembly is made of magnesium and must have the Service Clevis to be
interchangeable with the older shelf rail assembly. Refer to TSFN0031 and SN-FD-0011.

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Chapter 11 - Disassembly and Assembly

11.3.9.1 If applicable, remove the 6 mm set screw from the Tray Arm Clevis. Retain the screw.

11.3.9.2 Remove the M8 X 10 mm Shoulder screw from the Tray Arm Clevis. Retain the shoulder
screw.

11.3.9.3 Remove the Tray Assembly.

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Chapter 11 - Disassembly and Assembly

11.3.9.4 To reassemble, pull the Clevis out until it is fully extended and then place the Tray
Assembly back into the Tray Arm Clevis. If replacing a first or second generation tray assembly with
the third generation tray assembly, it is necessary to remove the old Clevis and install the Service
Clevis.

11.3.9.5 Apply a small amount of Loctite 242 onto the threads of the Shoulder screw and reinstall
the Shoulder screw into the Tray Arm Clevis. Torque to 40 ± 10 lbf-in. (4.52 ± 1.13 Nm).

11.3.9.6 If applicable, apply a small amount of Loctite 242 to the threads of the 6 mm set screw and
reinstall into the Tray Arm Clevis.

11.3.10 IV Pole

11.3.10.1 Remove the Rear Access Panel from the system. Retain the screws and rear panel.

11.3.10.2 Remove the Bottle Hanger from the top of the IV Pole. Retain the bottle hanger.

11.3.10.3 Pull up on the rubber IV Pole Seal on the top of the IV Pole skins and remove it from the
IV Pole. Retain the seal.

11.3.10.4 Remove the IV Pole Skin - Cap (See page 11-9) that covers the Manual IV Pole Switches.
Retain the screws and skin.

11.3.10.5 Remove the four (4) M4 X 12 mm Phillips screws from the IV Pole Mounting Bracket
which holds the Manual IV Pole Switches PCB to the EMB. Retain the screws.

11.3.10.6 Disconnect the IV Pole Manual Switches cable assembly going to J1 on the Manual IV Pole
Switches PCB. Retain the bracket and PCB.

11.3.10.7 Remove the Home Switch connector from the Home Switch.

11.3.10.8 Disconnect the Motor connector from the IV Pole Controller.

11.3.10.9 Loosen the two (2) captive screws (if applicable) or remove the two (2) M4 x 18mm Phillips
Screws and the two (2) M4 x 9mm Flat Washers from the IV Pole Motor Mounting Plate. Retain the
screws and washers.

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Chapter 11 - Disassembly and Assembly

11.3.10.10 Remove the two (2) M4 X 12 mm Phillips Screws from the IV Pole Retainer Bracket.
Remove the two (2) M4 X 12 mm Phillips Screws on the two (2) Power Cord Hook Mounting Brackets
securing the IV Pole to the EMB.

11.3.10.11 Remove the two (2) M4 Nuts from the Foot Control Hook Mounting Bracket, securing the
IV Pole to the EMB. If applicable, remove the weights from the IV Pole.

Note: The Handle on the Rear of the unit can be disassembled to allow easier extraction of the IV Pole; however it
is not necessary to remove the handle to remove the IV Pole.

11.3.10.12 Lift up on the IV Pole and separate the IV Pole from the EMB. Then pull the IV Pole
Assembly down through the Handle.

11.3.10.13 To reassemble, place the IV Pole Assembly Motor through the Handle and into the EMB
Base Assembly. Seat the IV Pole Assembly completely into the EMB.

11.3.10.14 Install the two (2) M4 X 12 mm Phillips Screws into the IV Pole Retainer Bracket. Install
the two (2) M4 X 12 mm Phillips Screws on the two (2) Power Cord Hook Mounting Brackets to secure
the IV Pole to the EMB.

11.3.10.15 Install the two (2) M4 Nuts onto the Foot Control Hook Mounting Bracket to secure the IV
Pole to the EMB.

11.3.10.16 Tighten the two (2) captive screws (if applicable) or install the two (2) M4 x 18mm Phillips
Screws and the two (2) M4 x 9mm Flat Washers into the IV Pole Motor Mounting Plate. Torque to 13
lb.-fin (1.47 Nm).

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11.3.10.17 Connect the Motor connector to the IV Pole Controller.

11.3.10.18 Connect the Home Switch connector to the Home Switch.

11.3.10.19 Connect the IV Pole Manual Switches cable assembly to J1 on the Manual IV Pole Switches
PCB. If applicable, install the left and right weights to the IV Pole and secure with a tie wrap.

11.3.10.20 Install the four (4) M4 X 12 mm Phillips screws into the IV Pole Mounting Bracket, which
holds the Manual IV Pole Switches PCB to the EMB.

11.3.10.21 Install the IV Pole Skin - Cap (See page 11-9) that covers the Manual IV Pole switches.

11.3.10.22 Place the rubber IV Pole Seal on top of the IV Pole skins and fully seat it onto the IV Pole
skin.

11.3.10.23 Install the Bottle Hanger onto the top of the IV Pole.

11.3.10.24 Install the Rear Access Panel (See page 11-6) onto the system.

11.3.11 IV Pole Controller

11.3.11.1 Remove the Rear Access Panel. Retain skins and screws.

11.3.11.2 Disconnect the CAN Bus cable, IV Pole Preset Switches, +24V Power Cable, Home Switch
Connector, and IV Pole Motor Connector from the IV Pole Controller.

11.3.11.3 Remove the M4 X 10 mm Phillips Screw and the Flat washer from the Nylon Hose Clamp
on top of the IV Pole Controller, which secures the CAN Bus cable, IV Pole Preset Switches and

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Chapter 11 - Disassembly and Assembly

shielding wire, +24V Power Cable, Home Switch Connector, and IV Pole Motor Connector to the IV
Pole Controller. Refer to figure “IV Pole Service Loop and Clamp.” on page 11-53.

Figure 11.8. IV Pole Service Loop and Clamp.

11.3.11.4 Loosen the captive screw which secures the IV Pole Controller to the EMB base.

11.3.11.5 Slide the IV Pole Controller out of the EMB until the notch in the IV Pole Controller
enclosure clears the alignment pin in the EMB Base Assembly.

11.3.11.6 To reassemble, slide the notched side of the IV Pole Controller fully against the alignment
pin on the EMB Base Assembly.

11.3.11.7 Install the captive screw into the threaded insert in the EMB Base Assembly.

11.3.11.8 Install the M4 X 10 mm Phillips Screw and the Flat Washer and the shielding wire for the
IV Pole Manual Switches onto the Nylon Hose Clamp and secure the clamp onto the top of the IV Pole
Controller. Torque to 9 ± 3 lbf-in. (1.02 ± 0.34 Nm). Ensure adequate “service loop” for the three cables
on the connections. Refer to Figure 11.8. IV Pole Service Loop and Clamp. on page 11-53.

11.3.11.9 Connect the CAN Bus cable, IV Pole Preset Switches, +24V Power Cable, Home Switch
Connector, and IV Pole Motor Connector to the IV Pole Controller.

11.3.11.10 Install the Rear Access Panel.

11.3.12 Foot Control

The Foot Control can use either wired or wireless communication. The first time the Bausch + Lomb Stellaris
Vision Enhancement System is used, the Foot Control cable must be connected in order to establish
communication between the Foot Control and the Bausch + Lomb Stellaris Vision Enhancement System.

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Chapter 11 - Disassembly and Assembly

To use the Foot Control, ensure the Foot Control battery is charged, and then hold down any button on the
Foot Control until the green ready light comes on, indicating that communication has been established.

Note: This device contains items which may be classified as waste electrical or electronic equipment. Please dispose
of the equipment according to local requirements.

IMPORTANT: All U.S. personnel must comply with the U.S. Department of Transportation
(DOT) regulations regarding the shipment of Lithium batteries or equipment containing
Lithium batteries. Personnel in countries other than the United States must comply with their
local or regional regulations regarding the shipment of Lithium batteries or equipment
containing these batteries.

11.3.12.1 Foot Control Battery

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Chapter 11 - Disassembly and Assembly

11.3.12.1.1 Turn the Foot Control over and then slide the latch(es) on the battery door to unlock
the door.

11.3.12.1.2 Open the battery door and remove the battery.

11.3.12.1.3 Insert a battery into the Foot Control battery compartment, observing proper
orientation.

11.3.12.1.4 Close the battery compartment door and slide the latch(es) to lock the door.

11.3.12.2 Foot Control Receiver (FCIB)

11.3.12.2.1 Remove the Rear Access Panel, the IV Pole Housing Skins and the IV Pole.

11.3.12.2.2 Loosen the captive thumbscrew on the FCIB.

11.3.12.2.3 Disconnect the CAN Bus cable.

11.3.12.2.4 Disconnect the FCIB to Foot Control cable from the FCIB (older Anterior Systems
Only) or disconnect the FCIB Patch cable from the FCIB.

11.3.12.2.5 If applicable, disconnect the FCIB Antenna from the Bluetooth Antenna Bracket.

11.3.12.2.6 If applicable, cut the two (2) cable ties securing the antenna cable in place.

11.3.12.2.7 Pull the FCIB out of the EMB (older Anterior Systems Only) or the FCIB Mounting
Bracket (systems with plastic EMB).

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Chapter 11 - Disassembly and Assembly

11.3.12.2.8 To reinstall, place the FCIB fully into the EMB or FCIB Mounting Bracket, making
sure to insert the alignment pin on the module into the hole in the EMB or FCIB Mounting Bracket
and tighten the Phillips thumbscrew to secure the FCIB.

11.3.12.2.9 Reconnect the Foot Control Cable or FCIB Patch cable to the FCIB.

11.3.12.2.10 Reconnect the CAN Bus Cable to the FCIB.

11.3.12.2.11 If applicable, reconnect the antenna to the Bluetooth Antenna Bracket and the FCIB
Antenna Cable. Torque to 9 ± 2.25 lbf-in. (1.02 ± 0.25 Nm).

11.3.12.2.12 If applicable, replace the two (2) cable ties securing the antenna cable in place.

11.3.12.2.13 Install the IV Pole Housing Skins, the Rear Access Panel and the IV Pole.

11.3.13 Remote

The Remote is a non-serviceable item. For remote replacement contact Bausch + Lomb Technical Support.

11.3.13.1 Remote battery cover and batteries

11.3.13.1.1 Press in on the tab of the Remote Battery Cover and pull up on the cover to remove the
cover from remote housing. Retain the cover.

11.3.13.1.2 If present, remove both old batteries. Properly discard old batteries in accordance
with applicable regional regulations.

11.3.13.1.3 Install fresh AA batteries into the remote, observing proper polarity.

11.3.13.1.4 Insert beveled end of cover into remote housing first then lower the rest of the cover
onto the housing until the cover tab snaps into place.

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Chapter 11 - Disassembly and Assembly

11.4 User Interface Computer Module Disassembly

11.4.1 Top Work Surface Cover

11.4.1.1 Locate the notch in the back of the Lower Casting Skin (Metal UIC) or the UIC Cover Skin
(Plastic UIC). Place a finger into the notch under the UIC Top Work Surface Cover and lift the cover out
of the groove in the Lower Casting Skin or the UIC Cover Skin. Retain the cover.

11.4.1.2 To reassemble, place the UIC Top Work Surface Cover into the circular groove in the top
of the Lower Casting Skin or the UIC Cover Skin.

11.4.2 Lower Casting Skin (Metal UIC)

Refer to “Lower Casting Skin (Original UIC)” on page 11-7.

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Chapter 11 - Disassembly and Assembly

11.4.3 Assembling the EMB

11.4.3.1 Install all the modules by performing the Removing and Installing Modules.

11.4.3.2 Install all the skins by performing the Skin Disassembly and Assembly (Anterior and
Posterior Combined).

11.4.4 EMB Base Assembly

11.4.4.1 Castor Lock Pedal Assembly

Time: Approximate time for replacement -15 minutes

11.4.4.1.1 Remove the four (4) M4 X 12 mm Phillips Screws (two (2) on each side) from the
Brake Pedal Assembly. Retain the screws.

11.4.4.1.2 Remove the Pedal/Brake Connector Link Assembly.

11.4.4.1.3 If removing the Compressor from the EMB then remove the two (2) Hex Brake Drivers
(one on each side) from the Base Assembly.

11.4.4.1.4 To reassemble, insert the two (2) Hex Brake Drivers (if removed earlier) into the Base
Assembly.

11.4.4.1.5 Install the Brake Pedal Assembly onto the Hex Brake Drivers using four (4) M4 X 12
mm Phillips Screws (two (2) on each side). Torque to 13 ± 3.25 lbf-in. (1.47 ± 0.37 Nm).

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Chapter 11 - Disassembly and Assembly

11.4.4.2 Castor

Time: Approximate time for replacement -1.5 hours

Note: There are two (2) types of castors on the Bausch + Lomb Stellaris Vision Enhancement System. The front
castors are locking and the rear castors are non-locking.

11.4.4.2.1 Remove the Vacuum Cover Panel, Upper Front Access Panel, Tray Opening Skin,
Accessories Drawer Cover Panel, Front Lower Access Panel, Rear Access Panel, Lower Casting
Skin (Original UIC) or UIC Cover Skin (Plastic UIC), IV Pole Housing Skins, Handle, Right and
Left Main Skins, Compressor, and Power Module from the system.

WARNING: DO NOT GRAB THE IV POLE WHEN LAYING THE BAUSCH + LOMB STELLARIS VISION
ENHANCEMENT SYSTEM ON ITS SIDE.

11.4.4.2.2 Grab the EMB (metal or plastic cage structure), do not grab the IV Pole and lay the
Bausch + Lomb Stellaris Vision Enhancement System on its side depending on which wheel is
being removed.

11.4.4.2.3 Remove the M6 X 12 mm Socket Hex screw and the M6 Lock Washer for the front
castor or the M6 X 12 mm Socket Hex screw and M6 Lock Washer for the rear castor, located on
the corner of the Base Assembly, which secures the castor to the EMB. Retain the screw.

11.4.4.2.4 Pull the castor with castor cover out of the Base Assembly.

Note: There are three generations of castor covers.

Figure 11.9. 1st Generation Castor Cover, 2nd Generation Castor Cover, 3rd Generation Castor Cover.

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Chapter 11 - Disassembly and Assembly

11.4.4.2.5 For 1st Generation castor covers, remove the two (2) M4 X 10 mm Phillips Screws on
the back of the castor covers and remove the covers. Retain the screws, washer and cover.

11.4.4.2.6 For 2nd Generation castor covers, pull the cover off of the castor.

11.4.4.2.7 For 3rd Generation castor covers, remove the 6-19x3/8 Phillips screw on the back of
the castor cover. Retain the screws.

11.4.4.2.8 To reassemble for 1st Generation covers, insert the castor into the castor cover and
install the two (2) M4 X 10 mm set screws on the back of the castor covers apply Loctite (blue).
Torque to 6 ± 1.5 lbf-in. (0.68 ± 0.17 Nm).

11.4.4.2.9 To reassemble for 2nd Generation covers, insert the castor into the castor cover and
snap the cover onto the castor.

11.4.4.2.10 To reassemble for 3rd Generation covers, insert the castor into the castor cover
and install the 6-19x3/8 Phillips screw into the castor cover.

Note: Make sure locking castors are installed at front of base plate. Locking castors have internal hex
inside hole of stem. Arrows on top of stem must point towards front of Base. Align the threaded holes in
the castors with the holes on both sides of the Base Plate, and install screws. After assembly, verify wheels
rotate and castors swivel easily.

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Chapter 11 - Disassembly and Assembly

11.4.4.2.11 Place the castor into the Base Assembly and align the screw hole in the castor with the
screw hole in the Base Assembly. See note above for front locking castors.

11.4.4.2.12 Install the M6 X 10 mm Socket Hex screw and M6 Lock Washer for the front castor
or the M6 X 20 mm Socket Hex screw and M6 Lock Washer for the rear castor into the corner of the
Base Assembly to secure the castor to the EMB. Torque to 40 ± 10 lbf-in. (4.52 ± 1.13 Nm).

DO NOT GRAB THE IV POLE WHEN STANDING THE BAUSCH + LOMB STELLARIS VISION
ENHANCEMENT SYSTEM ON ITS CASTORS.

11.4.4.2.13 Grab the EMB (metal or plastic cage structure), do not grab the IV Pole, and stand the
Bausch + Lomb Stellaris Vision Enhancement System on its castors.

11.4.4.2.14 Install the Power Module and Compressor into the system, and then install the Vacuum
Cover Panel, Upper Front Access Panel, Tray Opening Skin, Accessories Drawer Cover Panel, Front
Lower Access Panel, Rear Access Panel, Lower Casting Skin (Original UIC) or UIC Cover Skin
(Plastic UIC), IV Pole Housing Skins, Handle and Right and Left Main Skins onto the system.

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Chapter 11 - Disassembly and Assembly

11.4.4.3 AC Input Fuse Replacement

The Stellaris Vision Enhancement System has two (2) user-replaceable fuses. If an over-current
condition should occur which opens the fuses, they should be replaced with fuses of the same value
as the original fuses. A blown fuse may be indicated by either of the following conditions:

• With the system off, using a known good outlet, no power is sent to the system when you flip the
main power switch to “on”. (i.e. the stand-by power switch is not lit up, no faint fan noise from
the lower rear of the system, etc.).

• With the system on, it switches to low-power mode and the backup battery turns on with no
discernible cause (i.e. the cord is still plugged in; the rest of the operating suite still has power,
etc.)

Note: A blown fuse is usually noticeable after removal from the system by obvious discoloration within the fuse and/
or an obviously broken fuse-wire within the fuse.

Note: If damage is apparent to either fuse, both should be replaced to ensure proper operation.

11.4.4.3.1 Remove the power cord from the Bausch + Lomb Stellaris Vision Enhancement
System.

11.4.4.3.2 If the presence of the power cord will physically prevent the removal of the fuse
drawer, remove the M3 X 12 mm Phillips Screw from the Hose Clamp and Disconnect the
power cord.

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Chapter 11 - Disassembly and Assembly

11.4.4.3.3 Using a flat-blade screwdriver, carefully remove the fuse drawer. Replace the fuses.
Refer to fuse replacement figure below.

11.4.4.3.4 Snap the fuse drawer back into place.

11.4.4.3.5 If necessary, replace the cord by installing the M3 X 12 mm Phillips Screw. Torque
to 6 ± 1.5 lbf-in. (0.68 ± 0.17 Nm). The system should be ready to run again.

11.4.5 Tray Arm


11.4.5.1 Tray Arm Assembly

There is no disassembly or assembly for the Tray Arm. The entire Tray Arm must be replaced if it
is not working or damaged.

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Chapter 11 - Disassembly and Assembly

11.4.5.2 Accessory Drawer

Note: There is no Accessory Drawer on a system with a Laser module installed

11.4.5.2.1 Push on the Accessory Drawer to open the drawer and then pull the
drawer forward.

11.4.5.2.2 Locate the four (4) 6-32 X 5/16” screws (2 on each side of slide) and the
four (4) Acorn Nuts, which secure the drawer to the Slide.

11.4.5.2.3 Remove the four (4) 6-32 X 5/16” screws and the four (4) Acorn Nuts
from the drawer. Remove the drawer from the slides. Retain the screws and nuts.

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Chapter 11 - Disassembly and Assembly

11.4.5.2.4 To reassemble, place the drawer into the slides and install the four (4) 6-
32 X 5/16 screws through the slides and into the drawer and then install the four (4)
Acorn Nuts onto the end of the screws inside the drawer. Torque to 9 ± 2.3 lbf-in
(1.02 ± 0.26 Nm).

11.4.5.2.5 Push in on the Accessory Drawer until it latches.

11.4.6 IV Pole

11.4.6.1 Bottle Hanger

11.4.6.1.1 Pull Bottle Hanger Assembly off of the IV Pole Assembly.

11.5 Wireless Remote (REM) Disassembly

Note: Do not disassemble the Remote housing; doing so will destroy the Remote. The Remote is a non-serviceable
item except as noted below. For replacement of remote contact Bausch + Lomb Technical Support.

11.5.1 Remote Battery Cover (minimal time required)


11.5.1.1 Press in on the tab of the Remote Battery Cover and pull up on the cover to
remove the cover from remote housing. Retain the cover.

11.5.1.2 Insert beveled end of cover into remote housing first then lower the rest of the
cover into the housing until the cover snaps into place.

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Chapter 11 - Disassembly and Assembly

11.5.2 Batteries (minimal time required)

11.5.2.1 Remove battery cover. Retain the cover.

11.5.2.2 Remove both batteries. Properly discard old batteries in accordance with
applicable regional regulations.

11.5.2.3 Install fresh AA batteries into the remote, observing proper polarity.

11.5.2.4 Attach battery cover.

Note: There have been complaints of the Remote Control locking up under certain conditions. One such condition
can occur when installing the batteries into the Remote Control. If any of the buttons are accidentally being pressed
on the Remote Control while installing the batteries and the self-test (approximately 2 or 3 seconds) completes while
the button is still being pressed, a lock-up will occur. Also, if any button is being pressed while the backlighting
period is ending, this condition might sometimes cause the Remote Control to lock up.

There have been changes made to the Remote Control firmware to address the lock-up problem. The new Remote
Control will function with all Stellaris software revisions.

The Remote Controls with the new firmware begin with serial number REM00808. The new firmware version is 4.
However, firmware version is not indicated on the labels on the remote control.

Please Note: If a lock-up condition occurs on a Remote Control with a serial number earlier than REM00808 and
a new Remote Control is not readily available, an interim solution is to remove the batteries, wait 60 seconds (to
allow the internal capacitance in the Remote Control circuitry to discharge), and then re-insert the batteries, being
careful not to duplicate one of the above conditions.”

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Chapter 11 - Disassembly and Assembly

11.6 Multimedia Center (MMC) Disassembly

DO NOT REMOVE THE COVER FROM THE MULTIMEDIA CENTER. THIS MODULE CONTAINS NO
SERVICEABLE PARTS.

Note: The Multimedia Center is manufactured for Bausch + Lomb by Dalsa Coreco. There are no field replaceable
parts inside the module. All failing MMC units should be shipped to Bausch + Lomb St. Louis Depot for evaluation.

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Chapter 11 - Disassembly and Assembly

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Chapter 11 - Disassembly and Assembly

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Chapter 12 - Test Procedures

12 Test Procedures

This chapter provides information regarding the testing of the Bausch + Lomb Stellaris Vision Enhancement
System.

12.1 Acceptance Criteria

The Unit under Test (UuT) will be accepted as meeting specifications when it meets all applicable steps 100% as
indicated by a check in the Pass column of the checklist. If the UuT fails during testing, it must be repaired and
retested to ensure that it will pass the required tests. Upon completion of any additional repairs, the UuT will be
completely re-tested until it passes all applicable steps 100%.

12.2 Responsibility

The Product Service Technicians are responsible for performing the tasks described in this procedure and will
determine which sections of this procedure will be applicable based on the maintenance performed.

12.3 Quality Criteria

All testing in the Test Procedure section of this manual meets or exceeds the standards established in the Quality
SCAT for this equipment.

The level of testing should be determined by the level of repair or service done on the system. Different levels
have been established to balance the amount of time needed to test the equipment versus the level of repair done.
The procedure and the service report will reflect the difference in the testing to ensure that all systems are tested
to the same level.

12.3.1 Minor Repair

The replacement or repair of systems, parts or sub-components that should take a reasonably short amount of
time to complete, does not adversely affect original form, fit, or functionality specifications, and may include,
but not be limited to cosmetic improvements such as cleaning and polishing.

Examples include:

• Replacing a bottle hanger


• Replacing or cosmetically improving the front skins
• Replacing a mayo tray

After completing a minor repair, only certain system tests are required.

12.3.2 Major Repair

The replacement or repair of critical systems, software, parts, and/or sub-components that affect original
form, fit, or overall system functionality specifications.

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Chapter 12 - Test Procedures

Examples include:

• Replacing a module
• Any activity that compromises the balanced salt solution seal
• Any software upgrade

After completing a major repair, perform the proper system tests to ensure the system is in proper working
order.

12.3.3 Preventative Maintenance

For a preventative maintenance call, use the Preventative Maintenance section of this document, and perform
all steps on all modules. After completing all steps, perform the proper system tests to ensure the system is in
proper working order.

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Chapter 13 - TruLink®

13 TruLink® Customer Support Network

TruLink® Customer Support Network, the DRM (Device Relationship Management) feature provides optimum
system reliability by supporting remote diagnostics and performance analysis. System performance data, but no
patient data, is collected by the Bausch + Lomb Stellaris Vision Enhancement System throughout the surgical
day. Upon system shut down, that information can be sent to Bausch + Lomb secure servers through an encrypted,
point to point connection. This allows Bausch + Lomb to analyze system performance, and proactively service the
system. Surgeon preference files can also be transmitted, to provide a secure off-site backup.

13.1 Definitions, Acronyms, and Abbreviations

• B&L - Bausch + Lomb


• UIC - User Interface Computer
• MMC - Multimedia Center
• Agent - The gateway Agent located on the UIC
• Enterprise - Axeda DRM Enterprise Server
• DRM -Device Relationship Management
• Remote Desktop - The ability to operate and interact with the system using another computer

13.2 Agent Specifications

• The Agent will start when the UIC system is powered down
• The Agent may be started manually in service mode only
• The Agent will reside on the UIC
• The UIC and MMC will produce log files in a format defined by B+L, and approved by Axeda
• The Agent/Server will provide feedback that tasks are complete to the UIC to allow safe shutdown

13.3 Agent Monitoring

• The gateway agent resides on the UIC. It monitors the following:


• DRMLogFile.log
• Windows application logs on the UIC and MMC if present.
• Windows security logs on the UIC and MMC if present.
• Windows system logs on the UIC and MMC if present.

13.4 Windows Logs

• The following Windows event logs shall be logged to the DRM Enterprise
• Application Log: Warnings and Errors
• Security Log: Failures and Success
• System Log: Warnings and Errors

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Chapter 13 - TruLink®

13.5 Agent Overview of Operation

The agent runs at shutdown. The user receives a prompt to download the log file. If the user elects to download
the DRMLogFile is parsed and the data items transferred to the enterprise server. It’s also possible to enable the
agent in the service software. The agent cannot run during a surgery as that would present a safety concern.
Remote desktop ability is also provided by the agent but is only available if an MMC is part of the system. DRM
provides the ability to monitor system parameters for scheduling preventive maintenance, diagnosing problems
remotely, and generating reports. The reports may be valuable to sales and marketing in determining how
customers are using the equipment. Doctor setting files can be uploaded and downloaded giving users added
flexibility when using multiple systems at different locations. Upgrades to the gateway agent are possible via
remote connection to the Stellaris system.

The agent also has the ability to generate alarms. When an alarm is received the enterprise server is queried for
related information and a determination is made as to the next course of action. Contact may be made with the
customer. A request can be made to send more recent data or to have the customer initiate a remote desktop
session. If needed a replacement module is shipped and a field service rep is dispatched.

Figure 13.1. Basic Configuration Diagram.

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Figure 13.2. Configuration Diagram with MMC.

13.6 DRM Models

Models are the devices that are monitored by DRM. The serial number of the Bausch + Lomb Stellaris Vision
Enhancement System will be used to track the system in the enterprise. The models have their own individual
serial numbers. There are three (3) types of models:

1. Stellaris

2. Ultrasound Handpieces

3. MMC

13.6.1 Bausch + Lomb Stellaris Vision Enhancement System

Within the Bausch + Lomb Stellaris Vision Enhancement System there will be individual modules; such as
the footpedal, IV Pole etc. The modules also have their own serial and model numbers that can be found in
the configuration event log.

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13.6.2 Ultrasound Handpiece

In the case of the ultrasound handpieces, it is possible to not only find out what handpieces are associated with
a given Stellaris unit, but also to find out what Stellaris units a handpiece has been associated with previously.
Handpieces have a predictable lifespan. The DRM allows the life of a handpiece to be tracked thus allowing
replacement before a unit completely fails.

The serial number, hardware and firmware revision levels are available in the configuration log.

The following line is an example of a Stellaris Ultrasound Handpiece configuration event:

EXAMPLE:yyyy,mm,dd,hh,mm,ss, CFG, 9163, PHACOHP, Present, moduleSN, 0, 0, 0, 0

13.6.3 MMC

The MMC is an optional unit. If an MMC is present the UIC will find it in the CFG event log file. The UIC
uses a fixed IP address to monitor the MMC. If a system does not have an MMC, the UIC will connect directly
to the facility network via an Ethernet cable. The UIC will connect to the MMC if present and the MMC will
connect to the facility’s network. The following shows how the system is configured with and without an
MMC:

13.7 Log File Specifications

The location of the UIC log file is located at D:\axeda\logs.

The file name is called DRMLogFile.log

The file is renamed to DRMLogFilemmddyyyyhhmmss.log after the parsing by the Agent e.g.,
DRMLogFile04012006103001.log

A flag is set in d:\axeda\dataflag.dat file after the log file data is successfully transferred to the Enterprise.

The initial value of LogFileDataFinish is 0 and is set to 1 after successful data transmission in order to inform B+L
software. Successful= complete, and useful /not corrupted. When the transmission is complete and the
acknowledgement has been received, the B+L software is responsible to reset back to 0. If an internet connection
is not available within 180 seconds, the Bausch + Lomb Stellaris Vision Enhancement System software will
notify the user with a corrective action message. In case that the transfer takes more than 180 seconds, an option
is displayed by the Bausch + Lomb Stellaris Vision Enhancement System software offering the user the option at
allow additional time.

13.7.1 Data Logging Format

13.7.1.1 Log File

The first line of the Stellaris log file shall contain the revision level of the log file. The format
is as follows: Version X.Y where X is the major number and Y the minor number.

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13.7.1.2 Format

Year, month, day, hour, minute, second, Type, {Data Items}

13.7.1.3 Event Types

Code Event Notes


PWR Power up / Power Down
CFG Configuration Data Module S/N, Software Version
SNAP Snapshot Data Module Specific Embedded Data (IV Pole Total Travel, …
START Case Start
SETUP Setup Complete
WARN Warning / Error Message
DONE Case Complete
OPTIONS Option data Details the installed options on the system

13.7.1.4 Bausch + Lomb Stellaris Vision Enhancement System

This system tracks all modules installed in the system, including their serial number and hardware
and software version numbers. Each handpiece is tracked as a separate module. The system also logs
information on error messages coming from the system level (operational system), modules, and
security threats.

13.7.1.5 Handpieces

Each handpiece is tracked as an individual device. This means that each handpiece can be analyzed
separately from the system, since during normal use they will be connected to different units, even
during the same week. Aging information is available for each handpiece as well as manufacturing
date and date of first usage.

13.7.2 DRM Data Items List

An individual module may be taken out of one system and put into another system. Since the serial number of the module does
not change, data will follow the module from system to system. Therefore, a module may appear with multiple System S/N over
time (but never in two system serial numbers at the same time.)

Data ID - Data Item Name Description Contents parsed out from String

Date, Time, SNAP, {System S/N},{Module


AFS_SN AFS - AFM (Peristaltic )
S/N},{AFS_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
ANTERIOR_SN ANTERIOR - ( Ultrasound )
S/N},{ANTERIOR_SN}, {Data Value}

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Date, Time, SNAP, {System S/N},{Module


COMPRESSOR_SN COMPRESSOR
S/N},{COMPRESSOR_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
FLUIDICS_SN FLUIDICS - VFM ( Rotary Vane )
S/N},{FLUIDICS_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
FOOTBATT_SN FOOTBATT
S/N},{FOOTBATT_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
FOOTCAN_SN FOOTCAN (FCIB)
S/N},{FOOTCAN_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
FOOTCTRL_SN FOOTCTRL
S/N},{FOOTCTRL_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
FOOTRX (System)_SN FOOTRX (System)
S/N},{FOOTRX (System)_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
FOOTTX (foot controller)_SN FOOTTX (foot controller) S/N},{FOOTTX (foot controller)_SN}, {Data
Value}
Date, Time, SNAP, {System S/N},{Module
FRAGMHP_SN FRAGMHP
S/N},{FRAGMHP_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
GLM_SN Green Laser Module Serial number
S/N},{GLM_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
IVPOLE_SN IVPOLE
S/N},{IVPOLE_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
LAMP1_TYPE_SN Lamp 1 serial number & type
S/N},{LAMP1_TYPE_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
LAMP2_TYPE_SN Lamp 2 serial number & type
S/N},{LAMP2_TYPE_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
MMC_SN MMC
S/N},{MMC_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
PFM_SN POSTERIOR - VFM
S/N},{PFM_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
PHACOHP_SN PHACOHP
S/N},{PHACOHP_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
POSTERIOR COMPRESOR Serial
POSTCOMPRESSOR_SN S/N},{POSTCOMPRESSOR_SN}, {Data
& Type
Value}
POSTERIOR MODULE SERIALS
Date, Time, SNAP, {System S/N},{Module
POSTERIOR_SN AND VERSION ( Illumination
S/N},{POSTERIOR_SN}, {Data Value}
Module)
Date, Time, SNAP, {System S/N},{Module
POWER_SN POWER
S/N},{POWER_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
REMOTE_SN REMOTE
S/N},{REMOTE_SN}, {Data Value}
Date, Time, SNAP, {System S/N},{Module
UIC_SN UIC
S/N},{UIC_SN}, {Data Value}

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LOG_FILE_SETUP String of SETUP events

13.7.3 Individual Data Items


Data ID Description

Foot Control
FC_BATTCNT Foot control number of charging cycles

Fluidics Module(s)
VFM_IRRCNT
AFM_IRRCNT
PFM_IRRCNT Total irrigation activations
VFM_VENTCNT
AFM_VENTCNT
PFM_VENTCNT Total fluid vent activations
VFM_ASPTIME
AFM_ASPTIME
PFM_ASPTIME Total aspiration on time (in .1 sec)
VFM_VITCNT
AFM_VITCNT
PFM_VITCNT Total Vitrectomy activations
VFM_CAPTCNT
AFM_CAPTCNT
PFM_CAPTCNT Total cassette / cartridge captures
VFM_ASPCNT
AFM_ASPCNT VFM/PFM - Vacuum total main aspiration activations
PFM_ASPCNT AFM total air vents activations
VFM_ASP1CNT VFM/PFM - Vacuum total asp 1 activations
PFM_ASP1CNT AFM not used
VFM_ASP2CNT VFM/PFM - Vacuum total asp 2 activations
PFM_ASP2CNT AFM Not used
VFM_ONTIME
AFM_ONTIME
PFM_ONTIME Total on time of module in 1m res
PFM – Total activations of reflux pinch
PFM_RFXCNT VFM/AFM – not used

Ultrasound Handpiece – Phaco


HP_TUNECNT Accumulated Phaco Tuning Cycles
HP_ONTIME Accumulated Phaco Ultrasound Time
HP_AVGPWR Average Phaco Ultrasound Power (0-100%)

Ultrasound Handpiece - Frag


FRAGHP_TUNECNT Accumulated Tuning Cycles
FRAGHP_ONTIME Accumulated Fragmentation Time
FRAGHP_AVGPWR Average Fragmentation Power (0-100%)

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Data ID Description

Anterior Module
See Handpiece

IV Pole Controller
IV_TRAVEL IV Pole total travel (cm)
IV_HOMECNT IV Pole home switch activations

Remote Control Receiver


RMT_BACKTIME Display backlight time

Compressor Module
CMP_VANECNT Rotary vane pump on/off cycles (Vacuum)
CMP_VANETIME Rotary vane pump run time (.1 Sec)
CMP_ACCCNT Accumulator pump on/off cycles (Main Compressor)
CMP_ACCTIME Accumulator pump run time (.1 Sec)
CMP_VFICCNT
PCMP_VFICNT VFI pump on/off cycles
CMP_INFCNT
PCMP_INFCNT Total bottle infusion valve activations
CMP_VFITIME
PCMP_VFITIME VFI pump run time (.1 Sec)
PCMP_BICMPTIME On time of bottle infusion compressor (.1 sec)
PCMP_VITREGTIME On time of Vit Regulator (0.1 sec)
PCMP_BICMPCNT Total bottle infusion compressor cycles
PCMP_VITREGCNT Total on/off cycles of the vit regulator
PCMP_VFIVALCNT Total number of VFI Valve activations
PCMP_VENREGCNT Total number of venturi regulator valve on/off cycles
PCMP_VENREGTIME Venturi regulator on time (0.1 sec)
PCMP_BIVALCNT Number of activations of bottle selection valve
PCMP_AFXCNT Number of activations of AFX selection valve

Posterior Module (Module specific)


POST_LT1BALTIME Light Source 1 ballast on time in seconds
POST_LT2BALTIME Light Source 2 ballast on time in seconds
POST_LT1MOVEMENT Light Source 1 total level system movement (in % of 1 full range)
POST_LT2MOVEMENT Light Source 2 total level system movement (in % of 1 full range)
POST_LT1FILTMOVE Light Source 1 total filter system movement
POST_LT1ONCMDCNT Light Source 1 total on commands
POST_LT1FAILCNT Light Source 1 total failed start attempts
POST_LT2ONCMDCNT Light Source 2 total on commands
POST_LT2FAILCNT Light Source 2 total failed start attempts
POST_LT1PULCNT Total start pulses lamp 1
POST_LT2PULCNT Total start pulses lamp 2

Posterior Module (Lamp specific)


POST_LT1EOLTIME Lamp1 End of life in minutes
POST_LT2EOLTIME Lamp2 End of life in minutes
POST_LT1NEAREOLTIME Lamp1 near end of life in minutes
POST_LT2NEAREOLTIME Lamp2 near end of life in minutes
POST_LT1SAFEVOL Lamp1 Max safe operating voltage in MV
POST_LT2SAFEVOL Lamp2 max safe operating voltage in MV
POST_LT1EOLMV Lamp1 end of life in MV
POST_LT2EOLMV Lamp2 end of life in MV
POST_LT1SELTYPE Lamp1 current selection type
POST_LT2SELTYPE Lamp2 current selection type
POST_LT1ONTIME Lamp1 on time in minutes
POST_LT2ONTIME Lamp2 on time in minutes
POST_LT1STARTCNT Lamp1 Total start attempts
POST_LT2STARTCNT Lamp2 Total start attempts
POST_LT1STRIKEPULCNT Lamp1 Total Strike attempts
POST_LT2STRIKEPULCNT Lamp2 Total Strike attempts

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Data ID Description
POST_LT1VAR Lamp1 type variant
POST_LT2VAR Lamp2 type variant
POST_LT1GOOD Lamp1 not good to use
POST_LT2GOOD Lamp2 not good to use
POST_LT1MAXFS Lamp1 max allowed fail to start
POST_LT2MAXFS Lamp2 max allowed fail to start
POST_LT1MOVESCNT Lamp1 number of lamp moves
POST_LT2MOVESCNT Lamp2 number of lamp moves
POST_LT1BADSTCNT Lamp1 total bad starts count
POST_LT2BADSTCNT Lamp2 total bad starts count

Green Laser Module


GLM_LSRONTIME Treatment Laser Ontime
GLM_AIMGLSRONTIME Aiming Laser Ontime
GLM_LSRPULCNT Treatment Laser Pulse Count, cumulative
13.7.4 Device and modules Generated Warnings and Error Messages

13.7.4.1 WARN Events

All Warnings and Error messages String generated by Device and Modules

Error ID Description
From this string Events, Warnings, errors and alarms
Shall be generated.
Date, Time, WARN, {System S/N}, {Facility Name},
{Surgeon Name}, {Room Name}, {Case Number},
{Technique}, {Mode}, {Mode Type}, {Needle},
LOG_FILE_WARN {Grade}, {Pathology}, {Msg ID}

Vacuum Fluidics Module


Error ID Text Message
The vacuum fluidics module has failed to respond to a settings command. The
VFM03
module settings have been re-sent to the module.
The vacuum fluidics module has reset. The module settings have been re-sent to the
VFM04
module.
The vacuum fluidics module does not have valid factory calibration data. Surgical
VFM05
mode with the vacuum fluidics module is not available.

VFM08 The vacuum fluidics module cassette vacuum check has failed.

VFM11 System priming has failed.

VFM13 The vacuum fluidics module cassette is nearly full.

VFM14 The vacuum fluidics cassette is full.

VFM17 Please insert the vacuum fluidics cassette.

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Flow Fluidics Module


Error ID Text Message
The flow fluidics module has failed to respond to a settings command. The module
AFM03
settings have been re-sent to the module.
The flow fluidics module has reset. The module settings have been re-sent to the
AFM04
module.

Foot Control
Error ID Text Message

The foot control battery has exceeded 350 charge cycles. The foot control battery may
WFC01
not provide power for the entire day.

WFC07 The foot controller position sensor has failed.

The foot control receiver software version is not compatible with this software
WFR02
version. Surgical mode is not available.
The foot control receiver has failed to respond to a settings command. The module
WFR03
settings have been re-sent to the module.
The foot control receiver has reset. The module settings have been re-sent to the
WFR04
module.

Compressor
Error ID Text Message
The compressor module has failed to respond to a settings command. The module
CPX03
settings have been re-sent to the module.
The compressor module has reset. The module settings have been re-sent to the
CPX04
module.
CPX05 The air pressure output is lower than commanded.
CPX06 The air pressure output is higher than commanded.

Ultrasound
Error ID Text Message
The ultrasound module has reset. The module settings have been re-sent to the
USM04 module.

USM08 The ultrasound handpiece has failed the tuning process.

USM09 The ultrasound handpiece may have failed or may be failing.

Coagulation circuit may have failed, potential coagulation output overvoltage


USM10
condition.

Coagulation circuit may have failed, potential uncommanded or incorrect coagulation


USM11
output

Unable to read ultrasound handpiece data. Attempt to tune the handpiece to confirm
USM15
proper operation.

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13.7.5 Error and Warning Strings

Application Log: Warnings and Errors


String reported by system
UIC_EVTAPP_ERROR i.e: [317] Application Error at: 01/15/2006 22:02:45
String reported by system
UIC_EVTAPP_WARNING i.e.: [309] Userenv Warning at: 01/15/2006 21:35:47

Security Log: Failures and Success / Only Failures


String Warning on Security. - System related.
i.e.: [211478] Security Audit Success at: 07/31/2006
UIC_EVENTLOGS_SECURITY 12:04:56

System Log: Warnings and Errors


Windows Err String
UIC_EVTSYS_ERROR i.e.: [35911] EventLog Error at: 07/31/2006 12:03:39
Windows Err String
UIC_EVTSYS_WARNING i.e.: [35850] LSASRV Warning at: 07/31/2006 07:06:42

MMC Warnings and errors


MMC_EVTAPP_ERROR String reporting Error on MMC - System related
MMC_EVTAPP_WARNING String

MMC_EVTSYS_ERROR String

MMC_EVTSYS_WARNING String

13.7.6 Handpiece Data Items

Data ID Description
HP_TUNECNT Accumulated Tuning Cycles./ Counter
HP_ONTIME Accumulated Phaco Time

HP_AVGPWR Average Phaco Power (0-100%)

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13.7.7 Configuration Data

13.7.7.1 Configuration Events II

PHACOHP_SN PHACOHP Serial Number

Serial number of Stellaris System to which it is


NGX_System_S/N connected at the Timestamp the hand piece

Date of Manufacture, Registration Date, Where System


HP_MANU_DATE S/N Contains: “MANUHP”

Date of First Usage by customer, Second Finding at


HP_FIRST_USE_DATE different System than “MANUHPxxx”

13.7.7.2 Warning Events

Warning strings having “USM” in Msg ID field


Format:
Date, Time, WARN, {System S/N}, {Facility Name},
{Surgeon Name}, {Room Name}, {Case Number},
{Technique}, {Mode}, {Mode Type}, {Needle},
US_HP_WARN {Grade}, {Pathology}, {Msg ID}

13.8 DRM Implementation Process

13.8.1 Vendor

The serial number of the UIC will also be the computer name. The serial number of the MMC will also be the
computer name. Both will be configured by the vendor who builds them. A functional test will be performed
on the Ethernet port but the units will not be connected to the internet at this time.

13.8.2 Manufacturing

After the system is assembled the manufacturing group will run the DRM deployment utility. The system
network name will be configured to be the system serial number. The system will be connected to the Bausch
+ Lomb enterprise server for the first time at this point. Once the DRM agent has successfully registered the
system it will send an email with the serial number of the system and all associated module serial numbers.
The system will then be set to “standby” indicating it is awaiting field installation.

The enterprise captures the date of first connection to the gateway at the manufacturing site. Each new
ultrasound handpiece is registered as a new device and is set to a standby status on the enterprise server. The
enterprise then sends an email to verify successful registration of the new handpiece.

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13.8.3 Field

If a DRM connection is available, the Bausch + Lomb Stellaris Vision Enhancement System will be
configured to access the enterprise server through the Ethernet network. The MMC will be configured if
present and data will be sent to the enterprise to verify that the MMC associates with the UIC.

In facilities without a network connection the UIC will be configured to use a DHCP connection in the event
that a connection becomes available. If an MMC is present then the MMC is configured to use DHCP and the
UIC is configured to communicate with the MMC.

13.8.4 Depot

Total age/usage data may need to be reset if certain components are replaced. Model and serial number
changes may be necessary at times also.

13.9 Initiating a Remote Session

13.9.1 The technician will enter their "log on" User Name and Password

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13.9.2 Change the password if prompted. The old password must be entered as well as the new password.
Then select Submit.

13.9.3 The screen will display this prompt when password has been successfully changed.

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13.9.4 Select Device Serial Number under the Search for Device pull-down menu.

13.9.5 Enter the system serial number of the Stellaris.

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13.9.6 Verify the cog icon on the left is yellow and then select the system serial number hyperlink.

13.9.7 While holding down the Ctrl key (if a pop-up blocker is enabled), select the UIC-Access Remote
hyperlink.

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13.9.8 Enter a reason for the remote session such as "depot or field test" and then select Start Session.

13.9.9 At the Warning - Security window, select Run.

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13.9.10 Allow time for the Stellaris system to connect with the Enterprise server in Rochester. The Status
should briefly state "Waiting for device to contact Enterprise..."

13.9.11 When the system is connected, the Status will state "Remote connection ready..." and under Ports: the
Available: line should read 5900.

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13.9.12 Select the Download Viewer hyperlink.

13.9.13 When prompted Do you want to run or save this file?, select Run.

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13.9.14 When prompted Are you sure you want to run this software?, select Run.

13.9.15 At the Axeda Access Viewer window, verify that the Axeda Service radio button is enabled and then
enter the Service password.

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13.9.16 Wait until the initial screen loads

13.9.17 When the remote session is successful, the screen the Stellaris is currently displaying will appear.
Using the mouse from the remote computer, select Programming.

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13.9.18 Move the yellow box to the bottom of the screen and then select System Configuration,

13.9.19 Verify that all the Serial Numbers, Hardware and Software version are correct and then press the
Print Screen button on the keyboard of the remote computer.

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13.9.20 Press Ctrl and Esc together to bring up the taskbar at the bottom of the screen. Select Start -
Programs - Microsoft Word.

13.9.21 Paste the print screen from the clipboard into Microsoft Word.

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13.9.22 Resize the image height to 6” and center the image in the middle of the page. Select File - Page Setup.

13.9.23 Under Page Setup, select Landscape, set the borders to 1" and then select OK.

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13.9.24 The image should now be properly formatted. Print the screenshot to the nearest available printer.

13.9.25 Select the Close Connection icon on the toolbar at the top of the screen.

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13.9.26 Select Yes to terminate the connection.

13.9.27 Select Log Out in the top right-hand corner of the screen.

13.9.28 Exit the browser at the Log Out screen.

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Chapter 13 - TruLink®

13.9.29 If the session has not been closed out, under Remote Access Application window, select Close Session
on the upper right-hand corner of the screen.

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Chapter 13 - TruLink®

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Chapter 14 - Parts

14 Parts List

The Bausch + Lomb Cataract System Illustrated Parts List is for anyone that has the need to identify parts associated
with the Bausch + Lomb Stellaris Vision Enhancement System. It has been designed to be very user-friendly in
allowing for the quickest access to the information desired.

14.1 Requirements

You must have MS Access installed on your system, preferably MS Access V10 or newer.

14.2 Install New Service Parts Catalog

14.2.1 You will receive an email to download the Service Parts Catalog (SPC) from TrueShare similar to the
one below.

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Chapter 14 - Parts

14.2.2 Before Clicking the download link, verify You have created a folder in the C:\ with a name of “Service
Parts Catalog”.

14.2.3 Click the link in the email “Click here to download files”.

14.2.4 Check the box to select the Service Parts Catalog zip file.

14.2.5 Click the Download button.

14.2.6 The File Download window will display:

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Chapter 14 - Parts

14.2.7 Click the Save button.

14.2.8 Locate and select the “Service Parts Catalog” folder on Your C:\ drive. If you have not created a
“Service Parts Catalog” folder, please create the folder now.

14.2.9 Click the SAVE button to save the download zip file in the “Service Parts Catalog” folder.

14.2.10 Open the Service Parts Catalog zip file, if you have WinZip installed, double click the Zip file to open
the file.

14.2.11 There will be three files in the zip file.

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Chapter 14 - Parts

14.2.12 Unzip / Extract all three files into the “Service Parts Catalog” folder.

14.2.13 The Service Parts Catalog folder should now show these four files:

14.2.14 Create another folder in the ‘Service Parts Catalog’ folder named ‘Pictures’

• Steps: right click in the ‘Service parts Catalog’ folder


• Click New
• Click folder
• Type new Folder name as ‘Pictures’

14.2.15 Copy the “Parts Catalog – Shortcut” file to your Desktop

14.2.16 Next step: You should have received an email from Dennis Boyer with a subject of: “Service Parts
Catalog – Parts Graphical Images” looking similar to the email below:

14.2.17 Click the link “Click here to download files”

This will download the file with the images of the parts for the parts in the Service Parts Catalog.

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Chapter 14 - Parts

14.2.18 Check the box to select the Pictures.zip zip file

14.2.19 Click the Download button

14.2.20 Depending on the speed of your internet connection, this download may run for a while. This file
contains the images for the parts in the Service Parts Catalog. Please do not stop it to ensure the entire file
gets downloaded.

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Chapter 14 - Parts

14.2.21 Click the SAVE button.

14.2.22 Navigate to C:/ Service Parts Catalog /Pictures folder and click the SAVE button shown below:

14.2.23 Progress will be shown as the zip file is copied to the “Pictures” folder:

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Chapter 14 - Parts

14.2.24 When it is complete the above window will automatically close.

14.2.25 Navigate to the “C:/Service parts Catalog/Pictures” folder and verify the Pictures.zip file is there.

14.2.26 Next steps: Unzip the images in the Pictures.zip file.

• Steps: Double click the Pictures.zip file to open the zip file
• Extract all the images to the Pictures folder:

• Click the Extract button

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Chapter 14 - Parts

• All the image .jpg files will now show up in the ‘Pictures’ folder

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Chapter 14 - Parts

14.3 Service Parts Catalog Operation

14.3.1 Click the Parts Catalog – Shortcut Icon on the desktop to launch the Service Parts Catalog.

14.3.2 The User Login Screen below should display.

14.3.3 Select the Group = Field Service Group, if this group is not displayed click the drop down arrow and
select it from the list.

14.3.4 Enter the password provided.

14.3.5 Click the ‘Login’ button

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Chapter 14 - Parts

14.3.6 The “Main Menu” should display

14.3.7 Click the Start Parts Catalog button on the Main Menu.

14.3.8 The “Service Parts Catalog” Opening Screen will display:

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Chapter 14 - Parts

14.3.9 System will default to <All Systems>, and Module will default to <All Modules>.

14.3.10 Click the Show Selection and a display for All System, All Modules is shown.

14.3.11 Click the Close button to return Parts Catalog Selection Menu.

14.3.12 Click the dropdown arrow in the System box and you will see:

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Chapter 14 - Parts

14.3.13 The selection allows to select either the Stellaris System or the Stellaris/PC System Select Stellaris.

14.3.14 The Image of the Stellaris System is displayed and the Modules for the Stellaris.

14.3.15 Select Stellaris/PC

14.3.16 The Image of the Stellaris/PC System is displayed and the Modules for the Stellaris/PC.

14.3.17 Select Stellaris/PC, Module - <All Modules>

14.3.18 Click the Show Selection button to display all parts for all modules for the Stellaris/PC.

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Chapter 14 - Parts

14.3.19 Click any part number and if an image exists for the part it will be displayed similar to the example
below.

14.3.20 Close the image by clicking the X in the upper right corner.

14.3.21 Click the Close button to return to Parts Catalog Selection Menu

14.3.22 Select a single module and Click the Show Selection button.

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Chapter 14 - Parts

14.3.23 With the selection in the example above, the Parts are listed for the GLM Module:

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Chapter 14 - Parts

14.4 Service Parts Catalog – Advanced Search Capability

14.4.1 There are Search capabilities at the Part Number and the Part Description levels.

14.4.2 The control character for the Search feature is the asterisk (*) - (shift 8)

14.4.3 Example 1: Key in *107* in the Part Number box. Click Show Selection.

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Chapter 14 - Parts

14.4.4 Result: Will produce a listing of all parts that meet the criteria of have the character string of “107” any
place in the Part Number.

14.4.5 Example 2: Search Criteria - *107Click Show Selection

14.4.6 This will produce a listing of all parts that meet the criteria of having the character string of “107” at
the end of the Part Number.

14.4.7 Example 3: Search Criteria – 107* Click Show Selection

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Chapter 14 - Parts

14.4.8 Results: Will produce a listing of all parts that meet the criteria of having the character string of “107”
at the start of the Part Number.

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Chapter 14 - Parts

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Chapter 15 - Technical Service Notes

15 Technical Service Notes

This is a list of Technical Service Notes (TSNs) that provides information pertaining to the equipment used in testing
the Bausch + Lomb Stellaris Vision Enhancement System.

15.1 TSN 1041 Fluke 85 III Digital Multimeter (or equivalent)

15.2 TSN 1042 Fluke DPM 3 Universal Biometer (or equivalent)

15.3 TSN 1055 Digital Stopwatch (Timer)

15.4 TSN 1090 Roll up Keyboard (or equivalent)

15.5 TSN 1095 Stellaris Extension Cable

15.6 TSN 1108 Extech Multiscope (or equivalent)

15.7 SN-FD-0023 Extension Tube Test Sets

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Chapter 15 - Technical Service Notes

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Chapter 16 - Glossary

Capsule Polish- This feature is selected when the


16 Glossary and Medical surgeon requires a preset low aspiration in order to
Terminology polish the posterior
phacoemulsification or ECCE.
capsule after

Elevated Infusion - Refers to temporary use of


Cataract Surgery Presentation
higher than normal infusion pressure during
posterior surgery. In Bausch + Lomb Stellaris
16.1 Eye Anatomy Vision Enhancement System and Bausch + Lomb
Stellaris PC Vision Enhancement System, elevated
infusion is defined as pressure above 60 mm Hg for
air infusion or above 100 cm H2O for fluid infusion.

Extrude-A surgical mode that aspirates fluid out of


the eye. Selecting the Extrude mode activates
vacuum from the left aspiration line to be used
during the procedure.

Fluid-Air Exchange- F/AX. A surgical procedure


to replace fluid in the eye with atmospheric air. The
process involves injecting air with a specific
pressure and an extrusion cannula to evacuate the
fluid.

Figure 16.1. Anatomy of the Eye. Gravity Infusion- Infusion derived from pressure
created by hanging the fluid bottle at a certain height
above the patient’s eye level.
16.2 Ophthalmology and
Cataract Equipment Terms Infusion- Similar to irrigation, particularly referring
to fluid use for posterior segment surgery. In
addition to fluid, atmospheric air infusion can also
AFI- Air Forced Infusion. Refers to the use of
be used in posterior surgery.
pressurized air to create the necessary pressure for
infusion of fluid into the eye. The Stellaris PC
Irrigation- provides an infusion of balanced salt
Vision Enhancement System AFI requires the use of
solution into the eye to replace fluid that may be lost
the bottle spike with metal tube to supply air
at the incision site. Thus, irrigation helps to maintain
pressure and venting.
the anterior chamber and prevent collapse. This
function is used during the capsulatomy. Refers to
Bipolar Coagulation- This function enables the
flow of fluid use in the surgery. Irrigation flows out
surgeon to cauterize surface bleeding, which can
of surgical handpieces into the eye through tubing to
occur at the incision site. The cautery action is the
maintain intraocular pressure.
result of an electrical current passing through
bipolar forceps or an eraser tip which produces heat
Irrigation/Aspiration- An Irrigation/Aspiration
at the tip capable of cauterizing the bleeding vessels
handpiece gently aspirates residual cortex from the
on the conjunctiva. Bipolar coagulation can also be
anterior chamber after phacoemulsification or
used at the end of the procedure to reattach the
ECCE is completed. This function is used during
conjunctival flap.
cortical clean-up.
Burst Mode Ultrasound- An intermittent ultrasound
Patient Eye Level- The vertical distance from the
modulation with ultrasound duration and rest-time
patient eye level to the aspiration ports of the
controlled linearly with the Foot Control.
Stellaris PC
Ultrasound power is fixed.

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Chapter 16 - Glossary

Vision Enhancement System. The Stellaris PC occur during the course of cataract surgery, the
system has a feature to adjust patent eye level offset surgeon uses a Vitrectomy cutter to cut and aspirate
if the patient eye level is not at the same level as the the vitreous, together with a coaxial infusion line
aspiration port. The offset range is -15cm to +15cm. that provides irrigation to maintain the anterior
chamber fluid balance.
Pressurized Infusion Control- This function
controls the pressurization of the IV bottle for Xenon lamp- A type of lamp used in the Stellaris
intraocular control. The Pressurized Infusion PC Vision Enhancement System to provide
Control mode provides the surgeon with the ability endoillumination. It contains pure xenon gas and
to maintain the anterior chamber throughout anterior emits whiter light with a full spectrum.
segment surgery.
Xenon-Mercury lamp- A type of lamp used in
Intraocular Lens- (IOL) Artificial lens that a Stellaris PC Vision Enhancement System to provide
cataract surgeon places in a patient's eye after endoillumination. It contains xenon gas and small
removing the eye's natural lens. Like a contact lens, amounts of mercury metal, and emits greener light.
it has a built-in refractive power tailored specifically
to the patient's visual condition. 16.3 Fluidics Terms
Phacoemulsification- Also called "phako," this in-
office cataract surgery procedure involves using a Flow- The movement of fluid through an
device with a vibrating, ultrasonic tip to break up the ophthalmic device.
cataract, then suctioning the pieces out with a tiny
needle. This feature is selected if the surgeon Normally when a surgeon refers to flow, they are
chooses to emulsify the lens nucleus with ultrasonic referring to the fluid that leaves the eye through the
power through a small incision. The phaco phacoemulsification or Irrigation/Aspiration (I/A)
handpiece is used to emulsify the lens and aspirate tip. Flow can also refer to the fluid that enters the eye
the emulsified lens particles. This generally from the balanced salt solution bottle, or the fluid
accomplished using either linear phaco or fixed that leaves the eye from incisional leakage.
phaco; however pulsed phaco may be employed.
Flow is measured by calculating the volume of fluid
Pulse Mode Ultrasound- An intermittent ultrasound that moves past a given point per unit of time. This
pulse modulation with fixed rate. Ultrasound power quantity of time is known as the flow rate, and is
is linearly controlled with the Foot Control. measured in cubic centimeters per minute (cc/min).

Reflux- The reflux feature applies a momentary In eye surgery there are two flow rates to be
pressure through the aspiration line to clear considered, the irrigation flow rate and the
aspiration port of lodged material. Reflux may be aspiration flow rate.
applied in all anterior aspiration modes.

Vacuum Response- Speed with which system


generates commanded vacuum level. Stellaris PC
Vision Enhancement System has a vacuum response
range of 1 to 5 (1= fastest).

Viscous fluid- Refers to high viscosity fluids.


Normally refers to silicone oil use in posterior
segment surgery.

Vitrectomy- This function is used to cut away


vitreous that has entered the anterior chamber as the
result of a tear in the posterior capsule. Should this

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Chapter 16 - Glossary

Irrigation flow- is that fluid which is displaced level and decreases as elevation increases. At sea
from the balanced salt solution bottle, through level, atmospheric pressure is approximately 760
administration spike set, through the irrigation mmHg.
line of the I/A tubing, through the handpiece,
and into the eye. pressure differential- The difference in pressure
between two identified points. In ophthalmic
Aspiration flow- is that which exits the eye surgery, the pressure within the anterior chamber is
through the aspiration port of the handpiece, determined by the height of the balanced salt
through the aspiration tubing, and into the solution bottle. The pressure within the rigid
collection cassette. collection cassette is determined by the vacuum
level created by the pump system.
When discussing flow, it is important to clarify
whether a surgeon is talking about irrigation flow or Vacuum- A pressure measured relative to
aspiration flow. Typically, when a surgeon refer to atmospheric pressure, specifically, a pressure less
"flow" or "flow rate", they are referring to aspiration than atmospheric pressure. When the pressure is
flow and not irrigation flow. decreased below atmospheric pressure, the resulting
condition is known as vacuum. For example a
Surgeons will often refer to the "followability" of vacuum setting of 100 mmHg on the Stellaris®,
the system. (ASP=100 mmHg), corresponds to 100 mmHg
below atmospheric pressure.
Followability- is the ease in which material is pulled
or drawn to the phaco or I/A tip. Followability is • Note: In reference to "vacuum" on a pump
dependent upon flow rate. system, even though that number on the
phaco system is at 100 mmHg, it really
represents 100 mmHg below atmospheric
pressure
• The term aspiration has probably caused
more confusion to ophthalmic surgery than
any other term. Ophthalmic surgeons
typically refer to aspiration as the
removal of fluid and nuclear material from
the anterior chamber through the phaco or
I/A tip. The term aspiration is often
confused with vacuum.
• Aspiration - The term aspiration indicates
the vacuum level measured in mmHg
Typical aspiration flow rates are from 10 to 30 cc/
maintained within the rigid collection
min during the phaco procedure.
cassette. Increasing aspiration in the
Stellaris systems increases the vacuum
Aspiration - Removal of fluid and nuclear material
level maintained within the collection
from the anterior chamber through the phaco or I/A
cassette. The increased vacuum level in
tip.
the collection cassette will increase both
holding power and the aspiration flow rate
Pressure- is defined as force per unit area. In
(followability).
ophthalmic surgical applications, pressure is
commonly measured in millimeters of mercury
Aspiration flow rate - The rate at which fluid
(mmHg).
departs from the eye through the aspiration port of
the handpiece, the aspiration tubing line, and finally
Atmospheric Pressure- is the pressure exerted in all
into the collection cassette. Aspiration flow rate is
directions at any given point by the weight of the
measured in cc/min.
atmosphere. Atmospheric pressure is greatest at sea

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Chapter 16 - Glossary

Atmospheric pressure - The pressure that is exerted through the irrigation line of the I/A tubing, through
in all directions by the weight of the atmosphere. At the handpiece, and into the eye. .
sea level, atmospheric pressure is approximately
760 mmHg.

Compliance - Refers to the elastic properties of


aspiration tubing. High compliance means that the
aspiration tubing will constrict more readily under
increased vacuum. Peristaltic pumps require a
certain amount of compliant tubing to enable the
pump rollers to squeeze the fluid through the tubing.

Discrete Fluid Quanta - That volume of fluid


contained between the two pinched rollers in a
peristaltic pump.
Incisional leakage - The leakage of fluid out of the
Flow - The movement of fluid. primary and/or secondary phaco incision.

Flow rate - In this booklet, refers to the rate at which Occlusion - The state in which material entirely
a fluid moves past any given point. Measured in cc/ blocks the opening of the phaco tip or I/A handpiece
minute. that results in the stoppage of balanced salt solution
flow. The result in a peristaltic system is for vacuum
Fluidics - The technology concerned with the use of to build at the tip. In vacuum control systems,
fluid flow to accomplish a function. The occlusion will cause the extension of vacuum from
understanding of how forces move fluids. the rigid cassette system to the point occlusion.

Followability - The ability of a phaco system's Peristalsis - The mechanical wave-like contractions
fluidics to bring material to the phaco tip. Factors of a tubular structure which causes fluid to be
that influence followability are aspiration flow rate, displaced. The peristaltic pump uses a similar action
vacuum, bottle height, and other forces generated at to create fluid movement.
the phaco tip.
Post occlusion surge - A momentary decrease in
pressure at the phaco tip after an occlusion has been
cleared through the tip. This can cause shallowing of
the anterior chamber.

Head pressure - That pressure exerted on the


anterior chamber of the eye due to the height
between the balanced salt solution bottle and the
eye.

Irrigation flow - The rate at which the balanced salt


Pressure - Force per unit area. In ophthalmic
solution fluid is displaced from the balanced salt
surgery this is expressed in mmHg.
solution bottle, through the administration spike set,

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Chapter 16 - Glossary

Pressure differential - The difference in pressure a pump head/rotor, and discharged into a collection
between two identified points. bag. This system is a flow controlled system.

Pressure pulsations - Small movements that appear


in the anterior chamber due to the action of the
pump. In a peristaltic pump, pulsations result
because of the repeated pinching of the tubing
within the rotating pump head.

Pump speed - The speed in which the pump


operates. In the case of a peristaltic pump, the speed
at which the pump head rotates. In a diaphragmatic
pump, the speed at which the crankshaft turns. In a
rotary vane pump, the speed at which the vanes
rotate.

Rise Time - The time needed to reach the maximum


vacuum setting. Peristaltic pumps are typically The rotary vane pump system controls aspiration
slower in building vacuum as they are dependent on flow rate in a manner very similar to that of the
the speed of pump rotation, occlusion, and tubing diaphragmatic pump and venturi systems. The
compliance. aspiration flow rate in all three systems is controlled
by the pressure differential maintained between the
Trampolining - The bouncing of the posterior rigid collection cassette and the anterior chamber.
capsule or iris that occurs due to post occlusion The difference between the three systems is how air
surge, or pulsations due to the action of a peristaltic is evacuated and vacuum created within the rigid
pump. collection cassette.

Vacuum - A condition that occurs when pressure is The rotary vane pump consists of a series of flat
decreased below atmospheric pressure. sliding vanes, which are attached to a rotor . The
rotor is mounted eccentrically within a cylindrical
Venting - There are two types of venting. The first case. The cylindrical case contains separate inlet and
is venting that must occur when a surgeon has outlet ports. As the rotor spins, the vanes are flung
occlusion and needs to release that material he has outward by centrifugal force. The vanes, rotor, and
engaged. The second type of venting is in reference inside wall of the cylindrical case define a series of
to maintaining a vacuum limit. When a peristaltic compression chambers. As the rotor spins, each
pump reaches its set vacuum limit, any vacuum in chamber passes the entry port and traps a quantity of
excess of the preset limit is typically vented to air inside. This quantity of air is compressed by the
atmosphere or to a fluid based venting system. shrinking chambers as the vanes are pushed into the
rotor by the sides of the case. When the compressed
Peristaltic Pump -The peristaltic pump based chamber passes the outlet port, the compressed air is
aspiration system consists of an aspiration tubing set exhausted or vented to atmosphere. The evacuation
which is connected to a handpiece, threaded through of air from the rigid collection cassette, creates a
vacuum (negative pressure) within the cassette. The
pressure differential maintained between the rigid
collection cassette and the anterior chamber is
responsible for creating aspiration flow.

Venturi -The venturi pump, a vacuum control


aspiration system consists of an aspiration tubing set
that is connected to the phaco or I/A handpiece on
one end, and the rigid collection cassette on the other

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Chapter 16 - Glossary

end. The collection cassette is also connected to the decreasing aqueous fluid production (secretion) by
low-pressure output side of a compressed gas driven diary body. See also CARBONIC ANHYDRASE
venturi. INHIBITOR (16-12), DIAMOX (16-20).

acetylcholine (AS-lh-teel-KOH-leen or uh-SEE-


tU-KOH-leen). Chemical. Naturally occurring in
the body; transmits impulses across nerve junctions
throughout the nervous system When administered
into the eye during surgery, acts as a cholinergic
stimulator, inducing pupillary constriction (miosis).

AC IOL (anterior chamber intraocular lens).


Optical device. Plastic lens that may be surgically
implanted into the anterior chamber (in front of the
iris) to replace the natural lens of the eye after
A-Constant. The lens constant used in the SRK (see cataract extraction. Examples: Azar, Choyce,
page 16-48) regression formulas (determined by the Copeland, Hessberg, Kelman, Relchert, Stableflex.
type of lens and where it is to be implanted) that is See also POSTERIOR CHAMBER
utilized to calculate the lOL power. INTRAOCULAR LENS (16-40).

abduction. Function. Movement of an eye outward acuity, visual acuity. Measurement. Measure of
(away from nose) from the straight-ahead position. eye’s ability to distinguish object details and shape.
Assessed by the smallest identifiable object that can
abductor muscles. Anatomy. Muscles that move be seen at a specified distance (usually 20 ft or 16
eyeball outward (away from nose) from the straight- in).
ahead position. Primary abductor lathe lateral
rectus. acute. Sudden, rapid onset, usually with notable
symptoms. See also CHRONIC (16-14).
aberration. Optics. Blurred or distorted image
quality that results from inherent physical properties acute angle closure glaucoma (AACG), angle
(shape, curvature, density) of an optical device (lens closure glaucoma. Pathologic condition. Sudden
or prism). rise in intraocular pressure; occurs in patients with
narrow anterior chanter angles. Aqueous fluid
abrade. To scrape or rub away a surface; chafe. See behind the iris cannot pass through the pupil and
also ABRASION (16-6). pushes the iris forward, preventing aqueous
drainage through the angle (pupillary block
abrasion, corneal abrasion. Injury. Scraped area of mechanism). See also GLAUCOMA (16-23).
corneal surface, accompanied by loss of superficial
tissue (epithelium). adduction. Function. Movement of an eye inward
(toward nose) from the straight ahead position.
accommodation (uh-KAH-muh-DAY-shun).
Function. Increase in optical power by the eye to adductor muscles. Anatomy. Rotate eyeball inward
maintain a clear image (focus) as objects m moved (toward nose) from the straight-ahead position.
closer. Occurs through a process of ciliary muscle Primary adductor is the medial rectus.
contraction and zonular relaxation, causing the
elastic-like lens to “round up” and increase its adnexa ocull (ad-NEX-uh AH-kyoo-ly).
optical power. See also PRESBYOPIA (16-41). appendages of the eye, ocular adnexa. Anatomy.
Structures surrounding eyeball; Includes eyelids,
Acetazolamide (uh-see-tuh-ZOH-luh-myd). Drug. eyebrows, tear drainage system, orbital walls, and
Oral medication that lowers intraocular pressure by orbital contents.

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Chapter 16 - Glossary

adrenergic blocking drug (ad-ron-UR-jik). amblyopia (am-blee-OH-pee-uh), lazy eye.


sympatholytic drug. Drug. Used in control of Functional defect. Decreased vision in one or both
glaucoma. Blocks action of sympathetic nerves by eyes without detectable anatomic damage in eye or
inactivating epinephrine in nerve impulse visual pathways. Uncorrectable by optical means
transmission; sometimes causes pupilary (e.g.. eyeglasses).
constriction. See also TIMOLOL MALEATE (16-
51). ametropia (am-uh-TROH-pee-uh). Refractive
error. Any optical error that can be corrected by
adrenergic stimulating drug, sympathomimetic eyeglasses or contact lenses. See also
drug. Drug. Mimics action of the sympathetic ASTIGMATISM (16-9), HYPEROPIA (16-26),
nervous system; used to control glaucoma MYOPIA(16-34).
(mechanically opens the anterior chamber angle to
increase aqueous fluid outflow, and decreases aminoglycoside, (am-EE-no-gli-KO-syd). Drug.
aqueous secretion from the ciliary epithelium), to Any of a group of antibacterial antibiotics derived
dilate the pupil without affecting accommodation, from various species of streptomyces, which
and to whiten the eye by constricting dilated interfere with the function of bacterial ribosomes.
conjunctival blood vessels. See also This group of antibiotics is generally associated with
EPINEPHRINE (16-21), NEOSYNEPHRINE (16- a very broad spectrum of activity with superior gram
35). negative activity and bactericidal in nature.

adverse reaction. Reaction to therapy that is amplitude. The relative height of a waveform, as
unwanted and/or potentially detrimental to the host displayed on a screen. These spikes represent
or patient. location of various objects and tissue within the
body.
AFI. Air Forced Infusion. Refers to the use of
pressurized air to create the necessary pressure for Amsler grid (AM-slur). Test card. Graph-paper-
infusion of fluid into the eye. The Stellaris PC like grid used In detecting central vision field
Vision Enhancement System AFI requires the use of distortions or defects, e.g., in macular degeneration.
the bottle spike with metal tube to supply air
pressure and venting. anaphylaxis (an-uh-fuh-LAK-suhs). Pathologic
condition. Extreme allergic reaction to an antigen
”against-the-rule” astigmatism. Refractive error. (foreign substance), resulting from sensitization
Optical power that is greater (norm plus power) in following prior contact with the substance.
the horizontal meridian of an eye than In the vertical Potentially fatal.
meridian. See also “WITH-THE-RULE”
ASTIGMATISM (16-54). anesthesia. State or condition. Total or partial loss
of feeling, usually from disease or anesthetic drugs
age-related macular degeneration (ARUD) used for decreasing sensitivity to pain.
(MAK-yoo-lur). senile macular degeneration.
Pathologic condition. One of the most common general. Affects entire body, accompanied by
causes of decreased vision after age 60. Usually loss of consciousness.
evident as a loss of pigment from pigment
epithelium and deposits of yellowish material In the local. Affects a part of the body without loss of
sub-pigment epithelial layer in the central retinal consciousness
zone. Abnormal new blood vessels may grow under
the retina and leak fluid and blood. regional. Local anesthetic affecting an area of
the body, e.g., an arm.
alpha adrenergic. Drug. Compound that enhances
the action of the sympathetic nervous system. topical. Surface anesthesia, as by an eye drop.

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Chapter 16 - Glossary

anesthetic. Drug. Medication that removes an ora serrata to a ring-like insertion on the back of the
sensation, including pain, e.g., proparacaine. lens. Separates jelly-like vitreous from the watery
aqueous in the posterior chamber. See also
angiography (an-jee-AH-gruh-fee). Test. Any VITREOUS FACE (16-54).
technique used clinically to visualize and record
location and size of blood vessels, e.g.. with x-ray anterior sclerectomy (skler-EK-tuh-mee). Surgical
opaque dyes or fluorescein. See also procedure. Removal of small tongue-shaped section
FLUORESCEIN ANGIOGRAPHY (16-23). from the front-most portion of sclera, to form
alternate exit site for aqueous drainage. Treatment
angle closure glaucoma (ACO) (glaw-KOH- for glaucoma.
muh), acute angle closure glaucoma, closed angle
glaucoma. Pathologic condition. Sudden rise in anterior segment. Anatomy. Front third of eyeball;
intraocular pressure; occurs in patients with narrow includes structures located between the front surface
anterior chamber angles. Aqueous fluid behind iris of cornea and the vitreous.
cannot pass through pupil and pushes iris forward,
preventing aqueous drainage through the angle anterior synechia (sln-EE-kee-uh). Pathologic
(pupillary block mechanism). See also condition. Adhesions binding front of iris to
GLAUCOMA (16-23). innermost comeal surface. See also SYNECHIAE
(16-50).
anterior. Location. Located on or near the front of
an organ or of the body. See also POSTERIOR (16- anterior uveitis (yoo-vee-I-tis), Iridocyclitis.
40). Pathologic condition. Acute inflammation of the
anterior chamber, ciliary body; causes pain, tearing,
anterior chamber (AC). Anatomy. Fluid-filled blurred vision, constricted pupil, and a red
space inside the eye between the iris and the (congested) eye without purulent discharge. See also
innermost corneal surface (endothelium). POSTERIOR UVEITIS (16-40).

anterior chamber angle, angle, angle of the anterior vitrectomy. Surgical procedure. Removal
anterior chamber. Anatomy. Junction of the front of the front portion of vitreous tissue. Used for
surface of the Iris and the back surface of the cornea, preventing or treating vitreous loss during cataract
where aqueous fluid filters out of the eye. Nearby or corneal surgery, or to remove misplaced vitreous
structures Include Schlemm’s canal, scleral spur, in conditions such as aphakia pupillary block
trabecular meshwork, Schwalbe’s membrane and its glaucoma.
processes.
antibiotic (AN-ty-by-OT-ik). Drug. A chemical
anterior chamber intraocular lens (AC IOL). substance which has the capacity to inhibit the
Optical device. Plastic lens that may be surgically growth of microorganisms (bacteriostatic) or kill
implanted into the anterior chamber (in front of the microorganisms (bactericidal).
iris) to replace the natural lens of the eye after
cataract extraction. Examples: Azar, Choyce, antibody. Immune system protein
Copeland, Hessberg, Kehuan, Relchert. Stableflex. (Immunoglobulin) that has been produced in
See also POSTERIOR CHAMBER response to a specific foreign antigen (foreign
INTRAOCULAR LENS (16-40). substance) and is then available to neutralize,
inhibit, or destroy that antigen.
anterior chamber tap, keratocentesis,
paracentesis. Surgical procedure. Corneal puncture anticholinesterase (AN-tee-koh-Iin-ES-tur-ayz).
with removal of some aqueous fluid, for analysis or Drug. Eye drop that causes contraction of iris
to lower eye pressure temporarily. sphincter, resulting in pupil constriction (miosis)
and ciliary muscle contraction, which increases
anterior hyaloid membrane (AHM) (HY-uh-loyd). accommodation. Mimics action of parasympathetic
Anatomy. Front layer of vitreous; extends from the nerves by inactivating cholinesterase, allowing

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Chapter 16 - Glossary

prolonged activity of acetylcholine. See also intraocular pressure. See also ANTERIOR
CHOLINERGIC STIMULATING DRUG (16-14). CHAMBER (16-8), POSTERIOR CHAMBER (16-
40).
aphakic (ay-FAY-kee-uh). Anatomic defect.
Absence of crystalline lens of the eye, usually after arcus senifis, gerontoxon. Degenerative change.
cataract extraction See also PSEUDOPHAKIA (16- Ring-shaped white deposit of fat near peripheral
41). edge of cornea (limbus). Found typically in patients
older than age 60; also occurs in young patients with
aphakic correction (ay-FAY-kik). Optical device. abnormally high blood fat levels (arcus juvenilis).
Contact lens or eyeglass that replaces optical power
lost after cataract extraction or lens loss from any Argon laser. Surgical Instrument. Argon-gas-filled
cause. device that emits laser light beam; used to place
minute burns for selectively destroying bits of iris,
aphakic pupillary block, aphakic pupillary block retina, abnormal blood vessel tissue
glaucoma. Pathological condition. Type of angle- (neovascularization), tumors, etc. See also LASER
closure glaucoma that occurs at some time after IRIDOTOMY (16-31), YAG LASER (16-55).
removal of the crystalline lens. Created by
adhesions of the pupillary margin to the vitreous or artificial tears. Drug. Any eye drop that
to an intraocular lens. See also PUPILLARY approximates the consistency (viscosity and
BLOCK (16-42). tonicity) of normal tears, such as weak
methylcellulose solution. Used for alleviating dry
aphakic spectacles, cataract glasses. Optical eye symptoms.
device. Thick, plus-powered eyeglasses used to
replace optical power lost with lens removal after A-Scan. Instrument. Type of ultrasound, radar-like
cataract extraction, when no intraocular lens has device that emits very high frequency waves that are
been inserted. reflected by the ocular structures and converted into
electrical impulses; can be displayed on a screen as
appendages of the eye, adnexa ocull, ocular a series of echo spikes. Used for differentiating
adnexa. Anatomy. Structures surrounding the normal and abnormal eye tissue or for measuring
eyeball; includes eyelids, eyebrows, tear drainage length of eyeball (axial length). See also B-SCAN
system, orbital walls, and orbital contents. (16-11), ECHOGRAPHY (16-21).

applanation tonometer (tuh-NAHM-Ih-tur). aseptic (ay-SEP-tik). Sterile; free from pathogenic


Instrument. Device used for measuring intraocular organisms.
pressure: measures force required to flatten a small
area of central cornea. Usually attaches to slit lamp. aspirate. 1. (ASS-pur-ayt). Surgical procedure.
Examples: Draeger tonometer, Goldmann Withdrawing of fluid by suction, usually into a
tonometer. needle, as from a body cavity. 2. (ASS-pur-it).
Fluid that has been aspirated.
applanation tonometry, tension by applanation.
Measurement. Determination of intraocular pressure aspiration-irrigation system. Instrument. Device
by measuring the force required to flatten a small that permits simultaneous removal of fluid and/or
area of central cornea. See also INDENTATION tissue from the eye and replacement with fluid or
TONOMETRY (16-27), PNEUMOTONOMETER gas.
(16-40).
astigmatism (uh-STIG-muh-tlzm). Refractive
aqueous (AY-kwee-us), aqueous humor. Anatomy. error. Optical defect in which refractive power is
Clear, watery fluid that fills the space between the not uniform in all meridians. Light rays entering the
back corneal surface and the front vitreous surface, eye are bent unequally by different meridians.
bathing the lens. Produced by the ciliary processes; preventing formation of a sharp point focus on the
nourishes cornea, iris, and lens and maintains retina. Instead, light rays form two focal lines.

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Chapter 16 - Glossary

Corrected by a cylindrical (toric) eyeglass or contact balanced salt solution. Drug. Sodium, potassium,
lens. calcium, and magnesium chloride In physiological
concentration; used during eye surgery to rinse or
atopic conjunctivitis (ay-TAH-pic kun-junk-tih- replace Intraocular fluids.
VY-tis). Pathologic condition. Allergic reaction of
membrane covering white of eye and inner eyelids band keratopathy (kehr-uh-TOP-uh-thee).
(conjunctiva) to pollens; usually with hay fever. Pathologic condition. Horizontal band of calcium
Characterized by tearing, swelling, and watery deposits in superficial layers of cornea: associated
discharge containing eosinophils. with chronic uveitis and other chronic ocular
disease.
atrophy (AT-roh-fee). Anatomic detect. Wasting
away, or loss of function, of cells, tissue, or an basement membrane. Anatomy. Thin membranous
organ. layer of connective tissue found at the base of every
type of epithelial cell; helps hold the cells in place.
automated perimeter. Instrument. Device that
utilizes a computerized program to map the field of benign (buh-NINE). Description. Does not threaten
vision. Examples: Dicon, Humphreys Analyzer. See health of life. Refers to a lesion or tumor that is non-
also PERIMETRY (16-38). cancerous (non-malignant).

automated refractor, auto refractor. Instrument. benzalkonium chloride. Chemical. Preservative


Electra-mechanical or computerized device used for commonly used in ophthalmic solutions. Causes
determining an eye’s refractive error. allergic reaction in some patients. See also Zephiran
(See page 16-55).
axial length. Anatomy. Length of eyeball from
center of cornea (anterior pole) to back of sclera beta adrenergic. Drug. Compound that enhances
(posterior pole), normally about 24 mm. See also A- the action of the sympathetic nervous system, e.g.,
SCAN (16-9). isoproterenol.

bacteremia (bak-tur-EE-mee-uh). Pathologic beta blocker. Drug. Compound that blocks the
condition. Bacteria In the blood stream. action of the sympathetic nervous system, e.g.,
timolol.
bacterial conjunctivitis (kun-junk-tlh-VY-tls).
Pathologic condition. Infection of the membrane biconvex lens (by-KAHN-veks). Optical device.
covering the white of eye and Inner eyelids Plus-powered lens that is thicker in the center and
(conjunctiva); characterized by muco-pus discharge, thinner at the edges, with outward curvature of both
redness, and a gritty feeling. Large numbers of surfaces.
polymorphonuclear cells are found in conjunctival
discharge and scrapings. bifocals. Optical device. Eyeglasses incorporating
two different powers in each lens, usually for near
bactericidal (bak-TER-i-SY-dal). Drug. and distance corrections.
Destructive to bacteria.
bilateral. Affecting or occurring on both sides.
bacteriostatic (bak-TER-EE-o-STAT-ik). Drug.
Inhabiting the growth of multiplication of bacteria. Binkhorst equation. Measurement. One of several
formulas used prior to cataract surgery for
“bag”, capsular bag. Anatomy. Lens capsule, calculating the proper power for an intraocular lens.
during and after removal of a cataract; usually A theoretical formula based on theories of optics and
consists of intact posterior lens capsule and the how they perform in the eye. Uses ACD as the lens
residual flap of the anterior lens capsule. constant.

binocular. Referring to or affecting both eyes.

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Chapter 16 - Glossary

binocularity. Function. Ability to use both eyes and orbital structures and converted into electrical
together. pulses, which are displayed as bright spots on a
black background. Provides a cross-sectional view
biometry (ocular). Test Measurement of distances of tissues (in contrast to A-scan). See also A-SCAN
between various ocular structures (e.g., axial (16-9), ECHOGRAPHY (16-21), ULTRA-
length), usually using A-Scan and B-Scan SONOGRAPHY (16-52).
ultrasound instruments.
bulbar. Refers to, or related to, the eyeball; also, any
bipolar cautery (by-POH-lur). bipolar coagulator. globular or spherical expansion of a tubelike
Surgical Instrument. Device designed to apply a tiny structure, such as the medulla oblongata of the brain
electric current to stop bleeding within a wet field. stem.

bleb, filtering bleb. Surgical procedure. Bubble-like bulbar conjunctiva. Anatomy. Portion of
blister of conjunctiva overlying tunnel that leads to conjunctiva (membrane covering eye) that cover.
Inside of the eye; formed by surgical drainage external eyeball (except cornea), In contrast to
irocedure. Used in the treatment of open angle palpebral conjunctiva, which lines the lids.
glaucoma.
bullous keratopathy (kehr-uh-TAHP-uh-thee).
blepharitis (blef-uh-RY-tus). Pathological Pathologic condition. Degenerative process
condition. Inflammation of the eyelids, usually with characterized by small blister-like pockets that form
redness, swelling, and itching. in the swollen corneal epithelial layer; markedly
reduces vision. See also FUCH’S DYSTROPHY
blepharo- (BLEF-uh-roh). Prefix; refers to eyelids. (16-23).

blepharoplasty (BLEF-uh-roh-plas-tee). Surgical buphthalmos (boof-THAL-mus). Pathologic


procedure. Any plastic surgery of the eyelids, e.g., condition. Abnormally large eyeball, caused by
removal of excessive lid skin or subcutaneous fat. congenital glaucoma or glaucoma occurring in a
young, stretchable eye.
blepharotomy (blef-uh-RAHT-uh-mee). Surgical
procedure. Incision into an eyelid. Burst Mode Ultrasound. An intermittent ultrasound
modulation with ultrasound duration and rest-time
blind spot, scotoma. Functional detect. Non-seeing controlled linearly with the Foot Control.
area within visual field that may occur with damage Ultrasound power is fixed.
to visual pathways or to retina. A physiological
blind spot (“the blind spot” or “blind spot of caliper. Instrument Device used to measure and
Mariotte”) exists in all eyes normally and marks the mark distances between structures.
site where the optic nerve enters the eye. Types
listed under SCOTOMA(16-45). Canal of Schlemm. Anatomy. Circular channel deep
in cornea-scleral junction (limbus); collects aqueous
Bowman’s membrane. Anatomy. One of the five fluid from anterior chamber of the eye and delivers
corneal layers; located just under the epithelium and it into the blood stream.
above the corneal stroma.
canaliculi (kan-uh-UK-yoo-lie). Plural of
bridle suture. Surgical aid. Loop of thread placed CANALICULUS (16-11).
under a muscle (usually superior rectus) to help
steady eyeball; often used in cataract surgery. canalicul (kan-uh-UK-yoo-lus). Anatomy. Tiny
channel in each eyelid (upper and lower) that carries
B-Scan. Instrument. Ultrasound device used for tear. from the conjunctiva to the tear sac through the
evaluating structures that cannot be seen directly. common canaliculus, which in turn drains into the
High frequency waves are reflected by eye tissues nose. See also PUNCTUM (16-42).

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Chapter 16 - Glossary

candle power. Measurement. Unit of luminous capsule, lens capsule. Anatomy. Elastic bag
intensity. enveloping the eye’s crystalline lens; helps control
shape of lens for accommodation.
cannula (KAN-yoo-luh). Surgical Instrument.
Small tube-Ike device for injecting or extracting capsulectomy. Surgical procedure. Removal of lens
fluids or air. capsule material. (Anterior capsulectomy is a
routine part of extracapsular cataract extraction).
canthal resection. Surgical procedure. Removal of See also CAPSULE (16-12).
a section of inner or outer canthus (e.g., during
excision of an eyelid tumor). capsulorhexis (cap-suh-loh-REK-sis). Surgical
procedure. The tearing or cutting of the anterior
cantholysis (kan-thoh-LY-sis). Surgical capsule to enable removal of opaque lens material
procedure. Loosening the attachment of the junction during extracapsular cataract extraction.
of the upper and lower eyelids to the tendon or bone,
usually as part of eyelid plastic surgery. capsulotomy (kap-sul-AH-tuh-mee). Surgical
procedures. Incision in lens capsule; used for
canthoplasty (KAN-thoh-plas-tee). Surgical extracapsular cataract extraction or (after previous
procedure. Reconstruction of the medial (inner) or cataract surgery) to open an opacified posterior
lateral (outer) canthus (where upper and lower capsule. See CAPSULE (16-12).
eyelids join).
carbonic anhydrase inhibitor (kahr-BAHN-ik an-
canthotomy (kan-THOT-uh-mee). lateral HY-drays). Drug. Systemically administered drug
canthotomy. Surgical procedures. Horizontal that lowers intraocular pressure by decreasing
incision at the junction of the upper and lower aqueous secretion. Used in the treatment of
eyelids (canthi) to temporarily enlarge lid glaucoma. See also ACETYLZOLAMIDE (16-6),
separation, or as part of reconstructive lid plastic DIAMOX (16-20), METHAZOLAMIDE,
surgery. NEPTAZANE.

C-S can. Corneal Scan. Measures the thickness of cataract. Pathologic condition. Opacity or
the cornea. cloudiness of the crystalline lens; may prevent a
clear image from forming on the retina. Lens may
canthus (KAN-thus). Anatomy. Angle formed by require surgical removal visual loss becomes
the inner or outer junction of the upper and lower significant, with lost optical power replaced with a
eyelids. contact lens, aphakic spectacle or intraocular lens.
May be congenital or caused by trauma, disease, or
• inner (or) medial canthus. Angle on side near age.
the nose.
• outer (or) lateral canthus. Angle on side away brunescent. Brown in appearance (rather than
from the nose. gray or white). Occurs in elderly patients as an
advanced stage of nuclear sclerosis.
capsular bag, “bag”. Anatomy. Lens capsule,
during and after removal of a cataract; usually cortical; cortical spokes. Radially arranged
consists of intact posterior lens capsule and the opacities in the lens cortex following lens fiber
residual flap of the anterior lens capsule. swelling and fragmentation. One type of
cataract formation.
capsular-fixation. Method. One of the ways a
plastic intraocular lens is held in place. cupuliform (kuh-PUH-lih-form). See
Accomplished by Insertion of a posterior chamber POSTERIOR SUBCAPSULAR (16-40).
IOL totally within the capsular bag.
hypermature, Morgagnian. Totally opaque
lens that has begun to shrink and liquefy, so that
the remaining hard nucleus floats about in the

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Chapter 16 - Glossary

lens capsule. Degraded lens protein molecules cataract extraction, when no intraocular lens has
may leak into the aqueous through the lens been inserted.
capsule.
catecholamines (kat-uh-KOH-Iuh-meenz).
Immature. Cloudy lens that has some clear Chemical. Group of natural substances in the body
zones remaining. Vision loss depends on extent (epinephrine, norepinephrine, dopamine, and N-
of clouding. methylepinephrlne) that stimulate the sympathetic
nerves.
Intumescent (in-too-MEH-sent). Lens that has
swollen and enlarged in the process of “cell and flare”. Clinical sign. Accumulation of
becoming cloudy. May lead to secondary acute white blood cells and increased protein in aqueous,
angle closure glaucoma. visible on slit-lamp examination of anterior
chamber. Associated with inflammation of iris and/
lamellar (luh-MEL-ur). zonular. Concentric or ciliary body.
thin layers (lamellae) of opacities surrounded
by zones of clear lens. Vision may be good. cellophane retinopathy (ret-ih-NAH-puh-thee).
cellophane maculopathy, epiretinal membrane,
mature. Opaque lens having no clear zones epiretinal proliferation, macular pucker.
remaining, but not yet shrunken. Causes Pathologic condition. Retinal wrinkling in macular
marked vision decrease. Used to be called area caused by contraction of transparent membrane
“ripe”. lying on retinal surface; distorts vision.

Morgagnian. See HYPERMATURE cellulitis (sel-yoo-LY-tis). Pathologic condition.


CATARACT (16-12). infection or inflammation of tissues.

nuclear sclerosis. Type of early cataract orbital. Infection of orbital contents, often
characterized by increasing hardness or density caused by streptococci or staphylococci;
at the center of the lens. Occurs as a produces swelling and redness of eyelids,
consequence of aging and usually results In bulging eye (proptosis), irritation of eye
refractive change toward increasing myopia. movement, and swelling of orbital tissues.
Usually spreads from infected ethmoid.
posterior subcapsular. Located within the rear sphenoid, maxillary, or frontal sinuses into the
surface of the lens. Occurs in elderly patients as bony cavity (orbit) containing the eyeball.
one type of “senile cataract”; may occur at any
age after chronic intraocular inflammations or preseptal. Swelling or infection of eyelid tissue
after prolonged use of steroid drugs. in front of the orbital septum. Does not affect
eyeball itself.
cataract extraction (cat. ext.). Surgical procedure.
Removal of cloudy lens from the eye. central scotoma (skuh-TOH-muh). Function
detect. Loss of central 5o of visual field, which can
extracapsular. Method of lens removal that markedly decrease visual acuity.
leaves the rear lens capsule intact.
central visual acuity. Function. Vision from the
intracapsular. Complete removal of the cloudy fovea and macular area. An eye’s best possible
lens, including its surrounding capsule, usually vision.
by cryo-extraction.
centrocecal scotoma (sen-troh-SEE-kul skuh-
cataract glasses, aphakic spectacles. Optical TOH-muh). Functional detect. Non-seeing area
device. Thick, plus-powered eyeglasses used to (scotoma) that encompasses central vision and
replace optical power lost with lens removal after includes both the fixation point and the physiologic

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Chapter 16 - Glossary

blind spot. Characteristic of toxic damage to the choroid (KOR-oyd). Anatomy. Layer of major
optic nerve. blood vessels (vascular layer) of eye lying between
the retina and sclera: furnishes nourishment to outer
cerclage (sur-CLAHJ). Surgical procedure. layers of the retina. Forms part of the uvea, along
Operation for retinal detachment; an encircling band with the ciliary body and iris.
of elastic rubber, suture material, or piece of fascia
lata muscle is anchored around the sclera near the choroidal detachment (kor-OY-dul). Pathologic
equator of the eyeball. condition. Separation of blood vessel layer (choroid)
from sclera; caused by fluid leakage from choroidal
chalazion (kuh-LAY-zee-un), Internal blood vessels. Sometimes follows eye injury or eye
hordeolum. Pathologic condition. Inflammatory surgery. Usually related to excessively low
lump in a Meibomian gland (of the eyelid). Usually intraocular pressure.
self-limited, but surgical removal sometimes
necessary. choroidal hemorrhage, expulsive hemorrhage.
Pathologic condition. Expansion and rupture of
chemosis (kee-MOH-sls). Pathologic condition. some choroidal blood vessels from sudden decrease
Swelling of conjunctiva. in intraocular pressure. Can occur in an intact eye,
but is usually a complication of intraocular surgery;
Chlamydia trachomatis (kluh-MID-ee-uh truh- can result in pushing out of ocular contents through
KOH-muh-tus). Microorganism. Infectious agent, the surgical wound.
somewhat larger than bacteria, that causes
trachoma, eye disease that is leading cause of chronic (krahn-Ic). Of long duration, or frequent
blindness in the world. recurrence over a long time; often by a slow
progressive course of indefinite duration. See also
cholinergic blocking drug (koh-lin-UR-jik), ACUTE (16-6).
parasympatholytic drug. Drug. Blocks
parasympathetic nerves by inhibiting action of chronic angle closure glaucoma (glaw-KOH-
acetylcholine in nerve transmission; causes enlarged muh). Pathologic condition. Form of narrow angle
pupils (mydriasis) and ciliary muscle paralysis glaucoma in which repeated attacks of angle
(cycloplegia), resulting in loss of focusing ability on obstruction occur over a period of months to years
near objects (accommodation). Used for cycloplegic and eventually block the normal aqueous drainage
refraction and for treating uveitis. See also channels permanently.
CYCLOPLEGIC (16-19), MYDRIACYL (16-34).
chronic conjunctivitis (kon-junk-tih-VY-tis).
cholinergic stimulating drug, Persistent or intermittent inflammation of
parasympathomimetic drug. Drug. Mimics actions membrane covering white of eye and inner eyelids
of parasympathetic nerves by simulating (conjunctiva), accompanied by redness and slight
acetylcholine chemically or by inactivating mucous discharge; characterized by foreign-body
cholinesterase; causes small pupils (miosis), sensation, lid heaviness, light sensitivity, burning,
increased aqueous outflow, dilation of blood swelling, and irritation.
vessels, and increased accommodation. Used to treat
glaucoma and accommodative esotropia. See also chronic open angle glaucoma (COAG) (glaw-
ANTICHOLINESTERASE (16-8), KOH-muh), open angle glaucoma, primary open
PILOCARPINE (16-39). angle glaucoma. Pathologic condition. Most
common type of glaucoma, usually in both eyes.
cholinesterase (koh-lin-ES-tur-ayz). Chemical. Associated with increased intraocular pressure.
Normally-occurring body enzyme that breaks down Characteristic visual field loss and optic nerve
acetyicholine at nerve junctions, thus preventing damage caused by gradual blockage of aqueous
accumulation. outflow from the eye despite an apparently open
anterior chamber angle. If untreated, results in
gradual, painless, irersible loss of vision.

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Chapter 16 - Glossary

ciliary body. Anatomy. Circumferential tissue inside conjunctival blood vessels in repeated doses is toxic
eye composed of cilrary muscle (involved in lens to corneal epithelium.
accommodation and control of intraocular pressure)
and 70 cilraray processes that produce aqueous. comet scotoma (skuh-TOH-muh), arcuate
scotoma, Bjerrum scotoma, scimitar scotoma.
ciliary flush, ciliary hyperemia, ciliary injection. Functional defect. Arc-shaped blind area in visual
clinical sign. External eye redness caused by field; caused by damage to retinal nerve fiber
congestion of blood vessels surrounding the corna- bundles. Common in patients with glaucoma. See
scleral junction (limbus). Assoc. with corneal SCOTOMA (16-45).
inflammation, iritis, or acute angle closure
glaucoma. common canaliculus (kan-uh-UK-yoo-lus).
Anatomy. Tiny channel under the skin between
ciliary hyperemia (hy-pur-EE-mee-uh). See eyelids and nose; carries tears from upper and lower
CILIARY FLUSH (16-15). canaliculi in lids into tear sac, which in turn drains
into the nose.
ciliary muscle. Anatomy. Smooth muscle portion of
ciliary body; responsible for relaxation of zonules, complete blood count (CBC). Laboratory test.
allowing the crystalline lens to focus for near Valuable routine set of blood tests performed as part
(accommodate). of a diagnostic evaluation of a patient. Usually
consists of white and red blood cell count,
ciliary processes. Anatomy. Innermost, epithelial differential count, hemoglobin, hematocrit.
portion of ciliary body that secretes aqueous fluid
and serves as attachment site of suspensory concave lens, diverging lens, minus lens. Optical
ligaments of lens (zonules). device. Lens that is thicker at edges than in center;
increases divergence (spreads out) incoming light
ciliary sulcus (SUHL-kus). Anatomy. Groove in the rays. Used for correcting nearsightedness (myopia).
posterior chamber between the ciliary body and the
iris root. Sometimes utilized to help position an concomitant drug. In combination with.
intraocular lens.
cone. 1. Anatomy. Light-sensitive retinal receptor
closed-angle glaucoma (glaw-KOH-muh). angle ceil that provides sharp visual acuity and color
closure glaucoma, acute angle closure glaucoma. discrimination. Highly concentrated in the macula.
Pathologic condition. Sudden rise in intraocular 2. Pathologic condition. Conical-shaped portion of
pressure; occurs in patients with narrow anterior cornea, central or eccentric, that disturbs the normal
chamber angles. Aqueous present behind iris cannot image-forming properties, e.g., in keratoconus.
pass through pupil and pushes iris forward,
preventing aqueous drainage the angle (pupillary congenital glaucoma (glaw-KOH-muh), infantile
block mechanism). See also CHRONIC OPEN glaucoma. Congenital detect. High intraocular
ANGLE GLAUCOMA (16-14). pressures accompanied by hazy corneas and large
eyes (buphthalmos) in newborn or within first 6
CME. Abbiation for CYSTOID MACULAR months. Developmental abnormalities In the
EDEMA (16-19). anterior chamber angel obstruct normal intraocular
fluid drainage mechanism. Characteristic symptoms
CNS (central nervous system). Anatomy. Brain are tearing, light sensitivity (photophobia) and
and spinal cord. uncontrollable blinking (blepharospasm). Requires
early surgical correction. See also
cocaine. Drug. Used as surface anesthetic, such as TRABECULECTOMY AB EXTERNO (16-51).
eye drops to anesthetize cornea and inner eyelids.
Stimulates sympathetic nervous system, also causes conj. Slang for CONJUNCTIVA (16-16).
mild pupillary dilation and constriction of

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Chapter 16 - Glossary

conjunctiva (kahn-junk-TY-vuh). Anatomy. Thin, allergic. Hypersensitive to foreign substances.


transparent mucous membrane lining inner surfaces
of eyelids and covering outer surface of eyeball, atopic. Allergic reaction to pollens, usually
excluding cornea. accompanying hay fever.

bulbar. Portion that covers the external eyeball bacterial. Infection of conjunctiva,
(except the cornea). characterized by muco-pus discharge, redness,
and a gritty feeling; large numbers of
palpebral. Portion that lines the inside of the polymorphonuclear cells are found In
eyelids. conjunctival discharge and scrapings.

conjunctival flap (kahn-junk-TY-vul). Surgical chronic. Persistent or intermittent.


procedure. Section of conjunctiva that has been
dissected on two or three sides and resutured; used contact. Caused by allergy or by irritation from
to expose the sclera below, protect a wound, cover a eye medications.
comeal defect, or cover a filtration site for aqueous
humor, producing a filtering bleb. See also follicular. Characterized by hundreds of
SCLERAL FLAP (16-45), FORNIX-BASED FLAP follicles composed of lymphoid tissue on
(16-23), LIMBAL-BASED FLAP (16-32). under-surfaces of lids.

conjunctival hyperemia (hy-pur-EE-mee-uh). See Parinaud’s oculo-glandular. Rare type,


CONJUNCTIVAL INJECTION (16-16). characterized by conjunctival lesions
surrounded by follicles, with fever and malaise;
conjunctival injection, conjunctival hyperemia. usually affects only one eye.
Clinical sign. Eye redness caused by congestion of
blood vessels in membrane covering white of eye vernal. Allergic reaction (itching, excess
and inner eyelids (conjunctiva); most prominent mucous) affecting children; recurs in warm
near the fornix and decreasing toward the corneo- summer months. Numerous small lumps
scleral junction (limbus). As associated with all (papillae) form on the palpebral conjunctiva.
types of conjunctivitis.
conjuncto.dacryocystorhinostomy (kun-junk-TY-
conjunctival sac, cul-de-sac, fornix. Anatomy. voh DAK-ree-oh-SIS-toh-ry-NOS-toh-mee).
Loose pocket of conjunctiva, between the upper Surgical procedure. Method of constructing a new
eyelid and eyeball or lower eyelid and eyeball, that tear drainage channel from the lacrimal sac to the
permits the eyeball to rotate freely. nose, through the conjunctiva.

conjunctival scraping. Surgical procedure. contact lens. Optical devce. Small plastic disc with
Specimen obtained by scraping the conjunctiva at optical correction, worn on the cornea or sclera as
site of a lesion (or position of maximum disease substitute for eyeglasses. Sometimes worn as a
involvement) with a platinum spatula. Used for protective bandage lens for an eye with corneal
identifying cell types by means of smears, stains, disease.
and cultures. See also GRAM STAIN (16-25).
contraindicate. Any condition which renders a
conjunctivitis (kun-junk-tlh-VY-tis), “pink eye”. particular line of treatment improper or undesirable.
Pathologic condition. Inflammation of conjunctiva
(mucous membrane that covers the white of eye and contrast. Ability to detect detail having subtle
inner surfaces of eyelids). Characterized by variations and gradations between test target and
discharge, grittiness, redness, and swelling. background.
Contagious; usually viral in origin
contrast sensitivity. Function. Ability to detect
acute. Having a sudden onset. detail having subtle gradations In grayness between

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Chapter 16 - Glossary

test target and background. Tested with specially curving (convex) front surface and an inward-
designed targets or cards, e.g., AO contrast curving (concave) back surface.
sensitivity system, Arden plates, Nicolet system,
Pelli-Robson charts, Vistech system. cornea (KOR-nee-uh). Anatomy. Transparent front
segment of the eye that covers the his, pupil and
contusion. Injury Bruise. Blunt injury that does not anterior chamber, and provides most (67%) of an
break the surface of the skin or the eye. converge. 1. eye’s optical power. See also BOWMAN’S
Optics. Refers to the coming together of light rays MEMBRANE (16-11), DESCEMET’S
toward a focus. 2. Function. To simultaneously MEMBRANE (16-19), SCLERA (16-45),
move both eyes inward (toward each other), usually STROMA (16-48), ENDOTHELIEUM (16-21).
in an effort to maintain single binocular vision as an
object approaches. corneal abrasion (KOR-nee-ul), abrasion. Injury.
Scraped area of corneal surface, accompanied by a
convergence. Function. Simultaneous inward loss of superficial tissue (epithelium).
movement of both eyes (toward each other), usually
in an effort to maintain single binocular vision as corneal astigmatism (uh-STIG-muh-tizm).
object approaches. Refractive error. Variation In curvature of cornea,
causing imperfect focusing of light rays on retina.
accommodative. Occurs in response to an May be corrected with glasses or some contact
increase in optical power for focusing lenses.
(accommodation) by the eyes’ lenses as an
object moves closer. corneal “button”. Anatomy. Disc of cornea, usually
5-10 mm In diameter, removed from donor and
fusional. Amount of convergence the eyes can recipient eyes for corneal transplant surgery.
undergo while maintaining single vision.
Measured with graduate base-out prisms. corneal dystrophy (DIS-truh-fee). Pathologic
condition. Hereditary abnormally; may develop
proximal. Portion of total amount of available later In life and result in cloudiness of the cornea and
convergence; brought about merely by reduced vision. Many types. See also FUCH’S
awareness of an object’s nearness. DYSTROPHY (16-23).

relative. Amount of base-out prism a person can corneal ectasia, keratectasia. Pathologic condition.
overcome while maintaining clear binocular Abnormal bulging forward of thinned cornea, such
single vision. as occurs with keratoconus.

tonic. Portion (or full range of convergence) corneal edema, steamy cornea. Clinical sign. Hazy,
that occurs merely by the change from the swollen cornea.
sleeping to the awake state.
corneal erosion, recurrent corneal erosion.
voluntary. Amount both eyes can voluntarily Pathologic condition. Episodic, periodic loss of the
converge. outer layer of cornea (epithelium) due to its failure
to adhere properly to Bowman’s membrane. May
converging lens. See CONVEX LENS (16-17). follow minor scratch-type injury.

convex lens, converging lens, plus lens. Optical corneal graft. See CORNEAL TRANSPLANT (16-
device. Lens, thicker in center than at edges. that 18).
adds optical power to incoming light rays. Used for
correcting farsightedness (hyperopia). corneal hydrops (HY-drahps), hydrops.
Pathologic condition. Sudden, abnormal fluid
convexo-concave lens (kahn-VEKS-oh). meniscus accumulation within corneal tissue, resulting in
lens. Optical device. Lens that has an outward- clouded vision; seen in keratoconus.

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Chapter 16 - Glossary

corneal lens. Optical device. Hard or soft contact infection to infants’ eyes. See also OPHTHALMIA
lens that floats on tear film over the cornea, NEONATORUM (16-36).
providing refractive correction, or surface
protection for a damaged cornea. crocodile tears. Functional defect. Tears and
excessive saliva produced while eating. Occurs after
corneal melt, keratolysis. Pathologic condition. paralysis of 7th (facial) cranial nerve, when nerve
Superficial corneal layers that “melt” away. May be fibers of the salivary glands regenerate abnormally
associated with severe inflammatory disease of the and grow into the lacrimal gland.
sclera or peripheral cornea, dry eyes (keratitis sicca),
or rheumatoid arthritis. cross-eyes, convergent deviation, esotropia,
Internal strabismus. Functional defect.
corneal transplant, corneal graft, keratoplasty. Misalignment of eyes in which one eye deviates
Surgical procedure. Replacement of scarred or inward (toward nose) while other eye fixates
diseased cornea with clear corneal tissue from a normally. Deviation is present even when both eyes
donor. See also CORNEAL “BUTTON” (16-17), are uncovered.
LAMELLAR KERATOPLASTY (16-30),
PENETRATING KERATOPLASTY (16-38). crystalline ions, lens. Anatomy. Natural lens of the
eye; transparent, biconvex intraocular tissue that
corneal ulcer, ulcer. Pathologic condition. Area of hews bring rays of light to focus on the retina.
epithelial tissue loss from the corneal surface; Suspended by fine ligaments (zonules) attached
associated with inflammatory cells in the cornea and between ciliary processes.
anterior chamber. Usually caused by bacterial,
fungal, or viral infection. cul-de-sac, conjunctival sac, fornix. Anatomy.
Loose pocket of conjunctiva, between upper eyelid
cornea-scleral junction, limbus. Anatomy. and eyeball or lower eyelid and eyeball, that permits
Transitional zone where the cornea joins the sclera eyeball to rotate freely.
and the bulbar conjunctiva attaches to the eyeball.
About 1-2 mm wide. cup, optic cup. I. Anatomy. White depression in
center of optic disc; usually occupies about one-
cortex, lens cortex. Anatomy. Jelly-rice portion of third or less of total disc diameter. 2. Embryology.
the crystalline lens, composed of millions of thin Early stage in developing eye; an outpouching from
lens fibers that forms its main “body”. Located the primitive brain.
between denser inner nucleus and elastic outer
capsule. cupped disc, disc cupping. Pathologic condition.
Enlarged and deepened optic cup, e.g., In glaucoma.
corticosteroid (kor-tik-oh-STEER-oyd), steroid. See also CUP.
Drug. Medication used to treat inflammatory and
allergic diseases. With long-term use, serious side cup-to-disc ratio. Measurement. Numerical
effects are possible, e.g.. cataracts and glaucoma. expression indicating percentage of disc occupied
See also PREDNISONE (16-41), by cup portion. Used for helping evaluate
PREDNISOLONE (16-41). progression of glaucoma.

counts fingers (CF). Test measurement Ability to curvature hyperopia (hy-pur-OH-pee-uh).


count number of fingers presented, usually at a Refractive error. Optically underpowered eye
distance of 1 or 2 ft. Used with profound vision loss caused by flatter-than-normal corneal curvature or
(acuity less than 20/400). lens. See HYPEROPIA (16-26).

Credes prophylaxis (kreh-DAYS). Routine curvature myopia (my-OH-pee-uh). Refractive


administration of 1% sliver nitrate solution eye drop error. Optically overpowered eye caused by
to newborn to prevent spread of maternal curvature of cornea or lens that is too step for actual
gonorrhea

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Chapter 16 - Glossary

eyeball length. The cornea or lens is focusing light dacryoadenitis (DAK-ree-oh-ad-ih-NY-tis).


in front of the retina. See. MYOPIA (16-34). Pathologic condition. Inflammation of the lacrimal
gland, often chronic and caused by a granulomatous
cyclitis (si-KLI-tis). Pathologic condition. disease; acute form occurs with mumps and
Inflammation of the ciliary body. infectious mononucleosis.

cyclodialysis (sy-kloh-dy-AL-ih-sis). Pathologic dacryocystectomy (DAK-ree-oh-sis-TEK-toh-


change, surgical procedure. Separation of ciliary mee). Surgical procedure. Removal of the tear sac;
body from sclera. May result from surgery to control usually because of obstruction or tumor.
glaucoma (to establish a channel between anterior
chamber and suprachoroidal space) or after blunt dacryocystitis (DAK-ree-oh-sis-NY-tis).
trauma to the eye. Pathologic condition. Inflammation of the tear sac;
associated with faulty tear drainage.
cycloplegia (sy-kloh-PLEE-juh). Functional
disease. Paralysis of ciliary muscle, giving rise to dacryocystorhinostomy (DCR) (DAK-ree-oh-sis-
paralysis of accommodation. toh-ry-NOHS-toh-mee). Surgical procedure.
Construction of new tear drainage channel from
cycloplegic (sy-kloh-PLEE-jik). Drug. Eye drop lacrimal sac into nose.
that temporarily blocks parasympathetic nervous
system, relaxing diary muscle (to paralyze decibel. A unit for expressing the relative intensity
accommodation) and iris sphincter (to enlarge of sound.
pupil). Used for cycloplegic refraction and treating
iritis. See MYDRIACYL (16-34). dehiscence (dee-HISS-untz). Pathologic condition.
Coming apart or breaking open of tissue, as a wound
cylinder. Lens that has different refractive powers in that has been previously repaired.
each meridian no refractive power in one meridian
and a maximal retracting power in meridian dermatoconjunctivitis (DUR-muh-toh-kun-junk-
perpendicular to this. tuh-VY-tas). Pathologic condition. Inflammation
of skin near eyelid margins and of membrane
cyst. Anatomy. Thin-walled sac, usually containing a covering white of eye and inner lids (conjunctiva).
liquid or a semi-solid. May be normal or abnormal.
Descemet’s membrane (DES-uh-mayz). Anatomy.
cystoid macular edema (CUE) (SIS-toyd MAK- Thin, elastic layer deep In the cornea, formed by the
yoo-lur). Pathologic condition Retinal swelling and endothelium and composed of collagen and elastic
cyst formation in macular area; usually results in fibrils.
temporary decrease in vision, though may be
permanent. Frequently occurs to some extent after desired refractive error. The value an
cataract surgery; specific cause is unknown. ophthalmologist chooses to allow patients the
optimum visual acuity at specific working distances.
cystotome (SIS-tuh-tohm). Surgical instrument.
Used for opening front capsule of the lens during diabetic retinopathy (ret-in-AHP-uh-thee).
extracapsular cataract extraction. Pathologic condition. Spectrum of retinal changes
accompanying long-standing diabetes mellitus.
D (diopter). Unit of measurement. Measurement of Background retinopathy (non-proliferative) is the
degree that light converges or diverges; also of lens early stage; may advance to proliferative
refractive power. Equal to the reciprocal of focal retinopathy, which consists of growth of abnormal
length of a lens (in meters), e.g., a 2 diopter lens new blood vessels (neovasculauization) and
brings parallel rays of light to a focus at 1/2 meter. accompanying fibrous tissue.

dacryo- (DAK-ree-oh). Prefix; relating to tears. Diagnostic A. Teat. A-Scans that are used for
diagnostic purposes as opposed to A-Scans that are

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Chapter 16 - Glossary

used for measuring the axial length. The original paradoxic. Unexpected spacial localization of
form of ultrasound in ophthalmology. images relative to actual position of eyes.
Usually found after strabismus surgery.
Diamox (DY-a-mox). Drug. Acetazolamide. Potent
carbonic anhydrase inhibitor for treating various pathologic. Caused by misalignment of one
glaucomatous conditions. eye. Temporary in children; permanent in
adults. physiologic. Normal phenomenon;
dilate (DY-layt). Function, procedure. To widen an affects objects not directly fixated by both eyes,
opening, such as the pupil or lacrimal punctum. resulting in doubling of distant objects when
near object is viewed, and vice versa.
dilated pupil. Anatomic change. Enlarged pupil,
resulting from contraction of dilator muscle or uncrossed, homonymous. image from right eye
relaxation of iris sphincter. Normally occurs in dim is seen on right of left eyes image. Typically
illumination. May be caused by certain drugs associated with an in-turning eye (esotropia).
(mydriatics) or blunt trauma.
direct ophthalmoscope (ahf-THAL-muh-skohp),
dilator muscle (DY-lay-tur), dilator pupillae, iris direct scope. Instrument. Hand held device for
dilator, pupil dilator. Anatomy. Smooth muscle of examining interior of eye, esp. fundus. Provides a
iris that extends radially from center, like wheel magnified (15X) upright image of the retina, with a
spokes, from the papillary margin to iris periphery small (8o) field of view. See also INDIRECT
margin to iris periphery. Enervated by sympathetic OPHTHALMOSCOPE (16-27).
nerve fibers. Contracting muscle enlarges pupillary
opening. discission (dlh-SIH-zhun). Surgical procedure. 1.
Puncturing or cutting opaque pupillary membrane or
diopter (D) (dy-AHP-tur). Unit of measurement. posterior lens capsule remnant to recreate a clear
Measurement of degree to which light converges or optical opening. 2. Puncturing cataractous lens,
diverges; also of lens refractive power. Equal to the allowing it to mix with aqueous, with resulting
reciprocal of the focal length of a lens (in meters), absorption of lens material.
e.g., a 2-diopter lens brings parallel rays of light to a
focus at 1/2 m. dislocated lens, subluxation. Pathologic condition.
Partial or complete displacement of crystalline lens
dipivefrin hydrochloride (dy-PIV-ll-rln hy-droh- from Its normal position; caused by broken or absent
KLOR-lde). Drug. Prodrug. Sympathetic eye drop zonules.
that converts to epinephrine inside the eye,
decreasing aqueous secretion and increasing distance vision. Measurement. Visual acuity
aqueous outflow. Used in treatment of glaucoma. measured with target at 20 feet, the optical
See also PROPINE (16-41). equivalent of “infinite distance”. See also NEAR
VISION (16-34).
diplopia, double vision. Functional detect.
Perception of two images from a single object; diuresis. Clinical sign. Increased urination.
images may be horizontal, vertical or diagonal.
diuretic. Drug. Substance that increases the amount
crossed, heteronymous. Image seen by right of urine excreted.
eye is spatially located to the left of the left
eye’s image. Associated with an outward eye divergent strabismus (struh-BIZ-mus), exotropia,
deviation (exotropia). external strabismus, wall-eyed. Functional defect.
Misalignment of eyes In which one eye deviates
monocular. Multiple images seen with one eye. outward (away from nose) while other eye fixates
Commonly caused by early cataract or irregular normally.
comes.

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Chapter 16 - Glossary

dominant eye. Function. 1. Preferred eye for emesis (EM.uh-sus). Clinic sign. Vomiting.
sighting. 2. That eye that leads and controls the other
during binocular eye movements. Usually on same emmetropia (em-uh-TROH-pee-uh). Optics.
side of body as dominant hand. Refractive condition in which no refractive error is
present when accommodation Ii at rest. Distant
double vision, diplopia. Functional defect. images are focused sharply on the retina without the
Perception of two images from a single object; may need for accommodation or corrective lenses.
be horizontal, vertical, or diagonal. Types listed
under DIPLOPIA (16-20). endogenous (en-DAH-jun-us). Originating from
with the body. See also EXOGENOUS (16-22).
drusen (DROO-zln). Anatomic defect. Tiny white
hyaline deposits lying beneath the retinal pigment endophthalmitis (en-dahf-thal-MY-tus). Pathologic
epithelium. Commonly found after age 60. condition. Inflammation of tissues inside the
eyeball. Usually refers to purulent intraocular
dry eye syndrome, keratitis sicca, infection.
keratoconjunctivitis sicca. Pathologic condition.
Corneal and conjunctival dryness due to deficient endothelial (en-doh-THEE-lee-uhl). Relating to or
tear production, predominantly in menopausal and produced from the endothelium.
post-menopausal women. Can cause foreign body
sensation, burning eyes, filamentary keratitis, and endothelium (en-doh-THEE-lee-um). Anatomy.
erosion of conjunctival and corneal epithelium. Tissue layer lining innermost surfaces, e.g., of blood
vessels; also lines undersurface of the cornea, where
duction (DUK-shun). Function. Movement of one it regulates corneal water content (hydration).
eye only.
Enucleation (en-oo-klee-AY-shun). Surgical
dyslexia (dis-LEK-see-uh). Functional detect. procedure. Removal of eyeball, leaving eye muscles
Specific reading disability associated with problems and remaining orbital contents intact. See also
in interpreting written symbols. Not related to visual EVISCERATION (16-22).
acuity or intelligence, which are usually normal.
epikeratophakia (EKF) (eh-pee-ker-ih-toh-FAY-
dysplasia (dis-PLAY-zhuh). Pathologic condition. kee-uh). Surgical procedure. Removal of corneal
Abnormal development or growth of cells, tissues, epithelium and replacement with a lathe cut corneal
or organs. button. Used to correct extreme refractive errors.

echography. See ultrasound. epilation (eh-pih-LAY-shun). Surgical procedure.


Removal of hair or lashes; Sometimes done by
edema. Clinical sign. Swelling of tissue from fluid electrolysis.
accumulation.
epinephrine (ep-ih-NEF-rin). Chemical. Found
Elevated Infusion. Refers to temporary use of normally in body; stimulates sympathetic nervous
higher than normal infusion pressure during system. Used in treatment of glaucoma. As an eye
posterior surgery. In Stellaris PC Vision drop, causes mid pupillary enlargement (mydriasis),
Enhancement System, elevated infusion is defined blood vessel constriction, and increased aqueous
as pressure above 60 mm Hg for air infusion or outflow, side effects include stinging, allergic
above 100 cm H2O for fluid infusion. reactions, poor corneal penetration, black
conjunctival pigmentation, and macular edema in
Elschnig pearls (EL-shnig). Anatomic detect. aphakes. See also CATECHOLAMINES (16-13).
Cystic growth of lens epithelial remnants following
an extracapsular cataract extraction. Cysts look like Episclera (ep-ee-SKLER-uh). Anatomy. Outermost
single or clumped soap bubbles. layer of sclera, composed of loose, fibrous, elastic
tissue; attaches to Tenon’s capsule.

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Chapter 16 - Glossary

epistaxis (eh-pihs-TAX-sus). Medical term. exotropia (XT) (eks-oh-TROH-pee-uh), divergent


Nosebleed. strabismus, external strabismus, wall-eyed.
Functional defect. Misalignment of eyes in which
epithelium (ep-lh-THEE-Iee-um). Anatomy. one eye deviates outward (away from nose) while
Membranous layer of cells covering the internal and the other fixates normally. See also EXOPHORIA
external surfaces of the body and its organs. In the (16-22).
eye, the epithelium covers the cornea. conjunctiva,
and eyelids. expulsive hemorrhage, choroidal hemorrhage.
Pathologic condition. Expansion and rupture of
erythema (eh-rlh-THEE-muh). Clinical sign. some choroidal blood vessels from sudden decrease
Abnormal skin redness produced by congestion of in intraocular pressure. Can occur in an intact eye,
capillaries under the skin; occurs in patches of but is usually a complication of intraocular surgery;
variable size and shape. can result in pushing out of ocular contents through
the surgical wound.
esotropia (ET) (ee-soh-TROH-pee-uh), convergent
deviation, cross-eyes, Internal strabismus. extended wear lens. Optical device. Soft,
Functional defect. Misalignment of eyes in which hydrophilic contact lens designed to be worn
one eye deviates inward (toward nose) while the constantly for longer periods than daily-wear lenses
other eye fixates normally. Present even when both before being removed for cleaning and sterilization.
eyes are uncovered.
external disease. Pathologic condition. Any disease
etiology. Medical term. Cause(s) of a disease or affecting the cornea, sclera, conjunctiva or eyelids.
abnormal condition.
external hordeolum (hor-dee-OH-lum),
evisceration (eh-vis-ur-AY-shun). Surgical hordeolum, stye. Pathologic condition. Acute
procedure. Removal of an eyeballs contents, leaving pustular infection of the oil glands of Zeis, located in
scleral shell and sometimes the cornea intact. eyelash follicles at the eyelid margins. See also
Usually performed to reduce pain in a blind eye. See INTERNAL HORDEOLUM (16-28).
also ENUCLEATION (16-21).
extraocular muscles (EOM) (eks-truh-AHK-yoo-
exacerbation Medical term. Flare-up or worsening lur), extrinsic muscles. Anatomy. Six muscles that
of previous existing disease or condition. move the eyeball (lateral rectus, medial rectus.
superior oblique, inferior oblique, superior rectus,
excise. Surgical technique. To remove tissue. See inferior rectus); located on outside of eyeball within
also INCISE (16-27). orbit.

excision. Surgical procedure. Cutting out; removal Extrude. A surgical mode that aspirates fluid out of
or resection. the eye. Selecting the Extrude mode activates
vacuum from the left aspiration line to be used
exogenous (eks-AHG-uh-nus). Originating from a during the procedure.
source outside of the body. See also
ENDOGENOUS (16-21). exudate (EKS-yoo-dayt). Pathologic awn. Blood
cell-free fluid that leaks from blood vessels into the
exophoria (eks-uh-FOR-ee-uh). Function. surrounding tissue or spaces. See also
Tendency toward deviation of one eye outward INFILTRATE (16-28).
(away from nose) when cover is placed over that
eye. Eye straightens to align with uninvolved eye farsightedness, hypermetropia, hyperopia.
when cover is removed. See also EXOTROPIA (16- Refractive error. Condition in which eye is
22). underpowered, so that light rays coming from a
distant object strike the retina before coming to
sharp focus; true focus is said to be “behind the

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Chapter 16 - Glossary

retina”. Corrected with additional optical power, any eye problems affecting them. Fluorescein dye is
supplied by a plus lens (spectacle or contact) or by injected into an arm vein, then rapid, sequential
excessive use of the eyes own focusing ability photographs are taken of the eye as the dye
(accommodation). circulates.

F.D.A. Federal Regulatory Agency. United States forceps. Surgical instrument. Used for grasping
Food and Drug Administration, division of the tissues or sutures.
Department of Health and Human Services
responsible for approving all medical devices, drugs foreign body sensation (FBS). Symptom. Feeling of
and applications, as well as regulating various grittiness or having something in the eye; frequently
industry activities. caused by a foreign body. Other possibilities include
corneal abrasion, corneal ulcer, in-turned eyelash, or
fibrosis Abnormal condition. Formation of fibrous acute conjunctivitis.
connective tissue where it normally does not exist.
Often occurs after injury or degeneration. fornix (FOR-niks), conjunctival sac, cul-de-sac.
Anatomy. Loose pocket of conjunctiva, between
field of vision, visual field. Extent of space visible upper eyelid and eyeball and lower eyelid and
to an eye that is fixating straight ahead. Measured in eyeball, that permits eyeball to rotate freely.
degrees from fixation.
fornix-based flap. Surgical procedure. Type of
filtering procedure. Surgical procedure. Creation of conjunctival flap; method of gaining access to
a drainage channel from anterior chamber to eyeball by cutting the conjunctiva at the cornea-
external surface of eye under conjunctiva, allowing scleral junction (limbus) and peeling up a flap
aqueous to seep into a filtering bleb from which it is toward the fornix. Used to cover a limbal incision
slowly absorbed; for controlling intraocular pressure site into the eye. See also LIMBAL-BASED FLAP
in glaucoma. (16-32).

fixate. Function. To move an eye so that a viewed fovea (FOH-vee-uh), fovea centralis. Anatomy.
object is imaged on the fovea. Central pit in the macula that produces sharpest
vision; contains high concentration of cones and no
flap (skin). Surgical procedure. Tongue-shaped retinal blood vessels.
section of skin that has been cut to keep its blood
supply intact; often used to cover or fit a skin defect fuchs’ dystrophy (DIS-truh-fee). Pathologic
such as after removal of a tumor or scar. condition. Progressive corneal disorder
characterized by hyaline endothelial outgrowths on
floaters, vitreous floaters. Anatomic defect. Descemet’s membrane, waterlogged cornea,
Particles that float in vitreous and cast shadows on epithelial blisters, reduced vision, and pain. See also
the retina; seen by patient as spots, cobwebs, BULLOUS KERATOPATHY (16-11), GUTTATA
spiders, etc. Occurs normally with aging or with (16-25).
vitreous detachments, retinal tears, or inflammation.
fundus. Anatomy. Interior surface of eyeball,
Fluid-Air Exchange. F/AX. A surgical procedure to including retina, optic disc, macula, and posterior
replace fluid in the eye with atmospheric air. The pole. Can be seen with ophthalmoscope.
process involves injecting air with a specific
pressure and an extrusion cannula to evacuate the glaucoma (glaw-KOH-muh). Pathologic condition.
fluid. Group of diseases characterized by increased
intraocular pressure resulting in damage to the optic
fluorescein angiography (FLOR-ub-seen an-jee- nerve and retinal nerve fibers; documented by
AHG-ruh-fee), Intravenous fluorescein typical visual field defects and increased size of
angiography. Test. Used for evaluating potency of optic cup. A common cause of preventable vision
retinal, choroidal, and iris blood vessels, as well as loss.

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Chapter 16 - Glossary

absolute. End-stage of glaucoma; pressure shallow anterior chamber and forward


remains elevated and vision is completely lost. displacement of iris and lens.

acute angle closure (AACG), angle closure. narrow angle. Associated with anatomically
Sudden rise in intraocular pressure; occurs in narrow width of angle opening.
patients who have narrow anterior chamber
angles. Aqueous fluid behind the iris cannot neovascular, hemorrhagic. Severe, difficult to
pass through the pupil and pushes the iris control; leads to a painful eye with high
forward, preventing aqueous drainage through pressure, corneal swelling and “cell and flare”
the angle (pupillary block mechanism). in the anterior chamber. Associated with severe
diabetic retinopathy and other problems that
chronic angle closure. Form of narrow angle cause blockage of the retinal blood vessels.
glaucoma; repeated attacks of angle obstruction open angle. See CHRONIC OPEN ANGLE
occur over period of months to years, GLAUCOMA (16-14).
eventually block normal aqueous drainage
channels permanently. phacolytic lens induced. Caused by mechanical
blockage of eye’s drainage channels (trabecular
chronic open angle (COAG), open angle, meshwork) by cells carrying lens protein.
primary open angle. Most common type 85%; Associated with advanced (hyper-mature)
gradual blocking of aqueous outflow from the cataracts or lens trauma.
eye despite an apparently open anterior
chamber angle. If untreated, results in gradual, pigmentary dispersion. Type of open angle
painless, irersible loss of vision. glaucoma caused by pigment granules
gradually breaking free from the iris and ciliary
congenital, infantile. High intraocular pressure epithelium and deposited on back corneal
accompanied by hazy corneas and large eyes surface, lens, zonules, and pores of trabecular
(buphthalmos) in newborn resulting from meshwork.
developmental abnormalities in the anterior
chamber angle that obstruct the normal primary open angle. See CHRONIC OPEN
intraocular fluid drainage mechanism. ANGLE GLAUCOMA (16-14).

Gravity Infusion. Infusion derived from secondary. Results from a known cause, such
pressure created by hanging the fluid bottle at a as I\inflammation, degeneration, trauma, or
certain height above the patient’s eye level. tumor growths within the eye.

hemorrhagic. See NEOVASCULAR glaucoma meds. Medications used for controlling


GLAUCOMA (16-24). intraocular pressure. Includes
parasympathomimetics (e.g., Eppy) to widen
hemolytic (hee-moh-LIT-ik). Secondary anterior chamber angle & decrease fluid production,
glaucoma produced by bleeding into the eye. carbonic anhydrase inhibitors (e.g., Diamox) to
Infantile. See CONGENITAL GLAUCOMA decrease aqueous fluid production, hyperosmotic
(16-15). agents (e.g., mannitol) to pull water out of the eye
and into the blood plasma.
lens induced. See PHACOLYTIC
GLAUCOMA (16-24). glaucoma suspect, ocular hypertensive. Patient
with intraocular pressure elevated above 21 mm of
malignant. Complication following surgery for mercury, with no obvious optic nerve damage or
acute angle closure glaucoma, possibly caused visual field defects. May or may not develop
by aqueous trapped behind the vitreous. glaucoma with time.
Increase in pressure is accompanied by a

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Chapter 16 - Glossary

globe, eyeball. Anatomy. Spherical sense organ that Usually Constructed of poly(methylmethacrylate)
receives right and transmits visual information to the (PMMA).
central nervous system. Composed of three major
layers (cornea-sclera, uvea, retina) that enclose the hard exudates (EKS-lh-daytz). Pathologic
aqueous, lens, and vitreous. condition. Fat-like deposits in the retina caused by
excessive vascular leakage and by chronic, partial
goniolens (GOH-nee-oh-lenz), gonioscope. Optical blockage of small retinal veins.
device. Specialized contact lens used for
examination of anterior chamber angle structures. Healon (HEE-lon). Drug. Trade name for sodium
hyaluronate, a thick, elastic gel; used during
Goniosol (GOH-nee-oh-sol). Drug. Trade name of intraocular surgery to help stabilize structures in
methyl cellulose, used as a fluid bridge between the their normal positions and protectively coat them.
cornea and a goniolens or other examination contact See also VISCOSURGERY (16-53).
lens.
hemorrhage (HEHM-rij). Clinical sign. Bleeding.
gram-negative bacteria. Microorganism. Bacteria
(such as Pseudomonas) that stain red when Gram’s hemorrhage (expulsive or choroidal). Pathologic
stain is applied. condition. Sudden decrease in intraocular pressure
that causes expansion and rupture of some choroidal
gram-positive bacteria. Microorganism. Bacteria blood vessels. Usually a complication of Intraocular
(such as Streptococcus) that stain dark blue when surgery, but can occur in an intact eye. Can result in
Gram’s stain is applied. the pushing out of ocular contents through surgical
wound.
Gram’s stain, Gram stain. Test Chemical solution
applied to corneal and conjunctival tissue samples to hemostasis (hee-moh-STAY-sis). Function.
detect and differentiate bacteria; stains red for Condition in which bleeding has been stopped.
negative, blue for positive. Widely used in all
medical disciplines. high hyperopia (hy-pur-OH-pee-uh). Refractive
error. Farsightedness measuring 8 diopters or more.
gray line, intra-marginal sulcus. Anatomy. Line
that divides eyelid margins Into outer and inner homeostasis. Function. Maintenance of a stable
halves, separating eyelid skin from conjunctival environment within the body, such as for keeping
mucous membrane. Eyelashes are positioned in temperature and chemical composition within a
front of the line, tarsal gland ducts behind. narrow range for optimal biological functioning.

guttata (goo-TAH-tuh). Pathologic condition. Honan balloon, Honan cuff. Instrument Balloon-
Small, whitish, hyaline deposits on Descemet’s like device with an attached pressure gauge; may be
membrane on the inner surface of the cornea. See used before surgery to press on the eye and thereby
also FUCHS’ DYSTROPHY (16-23). induce reduction of intraocular pressure in a
controlled way.
halo. Symptom. Hazy ring around bight lights seen
by some patients with refractive error or optical hook. Surgical instrument Curved tool, usually with
defects (e.g., cataracts or corneal swelling). a sharp point; used for holding, fitting, or pulling on
tissue.
haptic (HAP-tic). 1. Loop or foot of an intraocular
lens implant that support the lens. 2. Non-optical, hordeolum (hor-dee-OH-lum), external
supportive zone of a lenticular spectacle lens or hordeolum, stye. Pathologic condition. Acute
contact lens. pustular infection of the oil glands of Zeis, located in
eyelash follicles at eyelid margins. See also
hard contact lens (HCL). Optical device. Rigid INTERNAL HORDEOLUM (16-28).
plastic lens that floats on the corneal tear film.

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Chapter 16 - Glossary

hordeolum (internal). Pathologic condition. Acute high. Measures 6 diopters or more.


pustular infection in a meibomian gland (of the
eyelid), if chronic, it is called a chalazion. See also index. Caused by decrease in index of
HORDEOLUM (16-26). refraction of the eye’s lens. Usually associated
with diabetes or aging.
hydrophilic (hy-droh-FIL-lk). Material that
combines with, or attracts, water. latent. Portion of total hyperopia that cannot be
overcome, or the difference between the
hydrophilic lens, hydrogel lens. Optical device. manifest and total hyperopia. Not apparent to
Soft contact lens that absorbs and binds with water. the lndividual because they compensates by
Made from various plastic polymers. Examples: AO accommodation.
soft, Aquaflex, American Hydron, Cibasoft, Gel
Flex, Hydrocurve, Hydromarc, Permalens, Plano T, manifest, faculative. Amount of hyperopia
SaufIon, Silisoft, Sof Form, Soflens, Softcon, indicated by the strongest convex spectacle or
Tresoff. contact lens a patient will accept while retaining
his best visual acuity.
hydroxyamphetamine (hy-drahk-see-am-FET-uh-
meen). Drug. Eye drop that stimulates sympathetic refractive. See CURVATURE HYPEROPIA
nerves, causing mild pupillary dilation. Used as aid (16-18).
in diagnosis of Horner’s syndrome.
total. Entire amount of hyperopia (latent and
hyper. Prefix; above, higher, or excessive. manifest).

hyperemia (hy-pur-EE-mee-uh). Clinic sign. hyphema (hy-FEE-muh). Clinical sign. Blood in the
Increased blood flow; usually refers to eye redness anterior chanter, such as following blunt trauma to
caused by congestion of conjunctival blood vessels. the eyeball.
See also INJECTION (16-28).
hypo. Prefix; below, lower, deficient.
hyperopia (hy-pur-OH-pee-uh), farsightedness,
hypermetropia. Refractive error. Condition In hypopyon (hy-POH-pee-un). Pathologic condition.
which an eye is underpowered. Thus light rays Accumulation of pus in the anterior chanter.
coming from a distant object strike the retina before
coming to sharp focus; true focus is said to be hypotony (hy-PAHT-uh-nee). Functional defect.
“behind the retina”. Corrected with additional Low intraocular pressure often related to chronic
optical power, which may be supplied by a plus lens intraocular inflammation (uveitis), wound leaks
(spectacle or contact) or by excessive use of the after eye surgery, or presence of a retinal
eye’s own focusing ability (accommodation). detachment. Prolonged low pressure can lead to
irregular choroidal and retinal pigment epithelium
absolute. Cannot be neutralized completely by folding, engorged retinal vessels, and swollen optic
accommodation. disc.

axial. Caused by abnormal shortness of the iatrogenic (ee-at-roh-JEN-ik). Condition. Refers to


anteroposteral diameter of the eye. an adverse condition inadvertently caused by a
physician, resulting from a treatment or diagnostic
curvature, refractive. Caused by abnormally procedure.
low optical power of the eye.
ICCE (itracapsular cataract extraction). Surgical
facultative. That which can be entirely procedure. Removal of a cloudy lens (cataract),
corrected by accommodation. including surrounding capsule, usually by cryo-
extraction.

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Chapter 16 - Glossary

immature cataract. Pathologic condition. Cloudy view of the eyes interior (retina and fundus) with an
lens that still has some clear zones remaining. inverted image; consists of a bright light source
Vision loss depends on extent of clouding. worn on the examiner’s head and a hand-held high-
plus lens. Binocular model allows stereoscopic
immersion method. Test. A means of measuring the depth perception of the retina. See also DIRECT
axial length by suspending the probe in a water bath OPHTHALMOSCOPE (16-20).
on top of the eye.
infantile glaucoma (glaw-KOH-muh), congenital
immune cataract. Pathologic condition. Cloudy glaucoma. Congenital detect. High intraocular
lens that still has some clear zones remaining. pressure accompanied by hazy corneas and large
Vision loss depends on extent of clouding. See also eyes (buphthalmos) in newborn, resulting from
CATARACT (16-12). developmental abnormalities in the anterior
chamber angle that obstruct the normal intraocular
immune response. Function. Body’s response by fluid drainage mechanism. Characteristic symptoms
cellular and chemical means to protect itself from are tearing, light sensitivity (photophobia) and
foreign proteins, microorganisms, parasites, or uncontrolled blinking (blepharospasm). Requires
poisons. early surgical correction. See also
TRABECULECTOMY AB EXTERNO (16-51).
immune system. Body’s elaborate defense system
against Injury from foreign proteins, infarct. Pathologic condition. Death of tissue, by
microorganisms, parasites, or poisons. insufficient blood supply.

immunocompromised, immunosuppressed. infection. Pathologic condition. Invasion of


Immune system that has been weakened or disease-producing microorganisms, resulting in
impaired, as by illness or drugs (ether intentionally localized cell injury, toxin secretion, or antigen-
or unintentionally), so as to help prevent organ antibody reaction.
transplant rejection.
inferior. Location. Located on or near the lower part
incise (in-SIZE). Surgical technique. To cut into, of an organism or of the body. See also SUPERIOR
without removal. See also EXCISE (16-22). (16-49).

incision (in-SIH-zhun). Surgical procedure. Cut inferior oblique (IO) (oh-BLEEK or oh-BLIKE).
into. See also EXCISION (16-22). Anatomy. Muscle attached to bottom of eyeball on
the outside; innervated by 3rd (oculomotor) cranial
indentation tonometry (tuh-NAHM-ih-tree). nerve. Primarily responsible for tilting eye outward
Instrument. Device that measures intraocular (extorsion), especially on outward movement
pressure by measuring amount the cornea is (abduction), and for elevation, especially on inward
indented by a fixed weight. Somewhat less accurate movement (adduction), and works with the lateral
than applanation tonometer. See also SCHIOTZ rectus for outward eye movement (abduction).
TONOMETER (16-44).
inferior punctum, lower punctum. Anatomy. The
indentation tonometer (tuh-NAHM-ih-tur). Test. opening in the papilla (elevation on lower eyelid
Measurement of intraocular pressure (in millimeters margin near nose). Marks entrance site of the tear
of mercury) by indenting the cornea with a known drainage (lacrimal) system into the nose.
weight.
inferior rectus (IR). Anatomy. Extraocular muscle
indication. A sign or circumstance that points to or attached to bottom of eyeball on the outside;
shows the cause, treatment, etc of a disease. primarily responsible for moving the eye downward
(depression), especially when it is turned outward;
indirect ophthalmoscope (ahf-THAL-muh-skohp). also rotates the eye outward (extorsion), especially
Instrument. Device that provides a wide field of on inward gaze (abduction); arid works with the

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Chapter 16 - Glossary

medial rectus for inward eye movement (adduction). intramuscular (IM). Situated or occurring within,
Innervated by the lid (oculomotor) cranial nerve. or administered into, a muscle.

infiltrate. Pathologic sen. Abnormal accumulation intraocular (in-truh-AHK-yoo-lur). Anatomy.


of cells and fluid into tissue where they are not Inside the eye.
normally found (such as by tumor cells). See also
EXUDATE (16-22). intraocular lens. See IOL (16-28).

inflammation, inflammatory response. Pathologic intraocular muscles. See INTRINSIC OCULAR


condition. Body’s localized protective response to MUSCLES (16-28).
injury, infection or irritation by enclosing involved
area; characterized by pain, heat, redness and intraocular pressure (lOP), tension.
swelling.
1. Function. Fluid pressure inside the eye.
infusion. Similar to irrigation, particularly referring
to fluid use for posterior segment surgery. In 2. Measurement. Assessment of pressure inside
addition to fluid, atmospheric air infusion can also the eye using a tonometer. See also
be used in posterior surgery. GLAUCOMA (16-23).

injection. Clinical sign. Tissue redness and swelling intravenous (IV) (in-truh-VEEN-us). Anatomic
from dilated blood vessels; caused by infection or location. Situated or occurring within, or
inflammation. See also HYPEREMIA (16-26). administered into, a vein.

inner canthus (KAN-thus), medical canthus. intravenous fluorescein angiography (IVFA)


Anatomy. Angle formed by inner (near nose) (FLOR-uh-seen an-jee-AHG-ruh-fee), fluorescein
junction of upper and lower eyelids. angiography. Test. For evaluating patency of
retinal, choroidal, and iris blood vessels, as well as
internal hordeolum (hor-dee-OH-lum). Pathologic any eye problems affecting them. Fluorescein dye is
condition. Acute pustular infection in a meibomian injected into an arm vein, then rapid, sequential
gland (of the eyelid). If chronic, it is called photographs are taken of the eye as the dye
chalazion. See also EXTERNAL HORDEOLUM circulates. See also ANGIOGRAPHY (16-8).
(16-22).
intravitreal. Technique. Injection of drugs, gas or air
“in-the-bag” Surgical procedure. Slang for an into vitreous cavity.
intraocular lens that is placed in, and supported by,
the capsular bag after an extracapsular cataract intrinsic ocular muscles, intraocular muscles.
extraction. Anatomy. Muscles Iiilator muscles.

“in-the-sulcus” (SUHL-kus). Slang for an IO. Abbiation for INFERIOR OBLIQUE (16-27).
intraocular lens that is placed in the posterior
chamber with its haptics positioned in the ciliary IOL (Intraocular lens), implant, pseudophakos.
sulcus. Optical device. Plastic lens that may be surgically
implanted to replace the natural lens of eye
intracameral. Location. Situated or occurring (examples: Binkhorst, Choyce, Copeland,
within, or administered into, a hollow organ or Fyoderov, Kelman, Kratz, Shearing, Sheets,
chamber, e.g., the anterior chamber or vitreous. Sinskey, Simcoe, Tennant, Worst).

intracapsular cataract extraction (ICCE) (KAT- lOP. Abbiation for INTRAOCULAR PRESSURE
uh-rakt). Surgical procedure. Removal of cloudy (16-28).
lens (cataract), including surrounding capsule,
usually by cryo-extraction. IR. Abbiation for INFERIOR RECTUS (16-27).

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Chapter 16 - Glossary

iridocyclitis (ir-id-oh-sy-KLY-tis). anterior uveitis. pupillary margin. Receives innervation from


Pathologic condition. Acute inflammation of the parasympathetic nerves to contract pupil size
iris, ciliary body, and anterior chanter, causing pain, (miosis) in response to bright light.
tearing, blurred vision, constricted pupil, and a
congested eye without purulent discharge. See also iritis (i-RI-tis). Pathologic condition. Inflammation
IRITIS (16-29), POSTERIOR UVEITIS (16-40). of the iris. Can cause pain, tearing, blurred vision,
small pupil (miosis), and a red congested eye. See
iridectomy (ir-ih-DEK-tuh-mee). Surgical also UVETIS (16-53).
procedure. Cutting out of a portion of iris tissue. See
also IRIDOTOMY (16-29). irrigation. Refers to flow of fluid use in the surgery.
Irrigation flows out of surgical handpieces into the
basal. Removal of iris tissue at the far periphery eye through tubing to maintain intraocular pressure.
(near the iris root).
ischemia (lh-SKEE-mee-uh). Pathologic condition.
peripheral. Removal of iris tissue at the Inadequate blood supply to a body part cased by
periphery. partial blockage of a blood vessel, Ii not ersed,
surrounding tissue dies from lack of nutrients. See
sector. Removal of a wedge-shaped section of also INFARCT (16-27).
iris that extends from the pupil margin to the iris
root, leaving a keyhole-shaped pupil. iseikonia. Visual images on both retinas are equal in
size.
irides (IR-ih-deez). Plural of IRIS (16-29).
isometropia. Equality in the retraction of both eyes.
iridotomy (ir-ih-DAHT-uh-mee). Surgical
procedure. Puncture-like opening made through the IV (Intravenous). Anatomic locition. Situated or
iris without removal of any iris tissue. Allows occurring within, or administered Into, a vein.
aqueous to drain freely from the posterior chamber
to the anterior chamber. See also LASER IVFA. Abbiation for INTRAVENOUS
IRIDOTOMY (16-31). FLUORESCEIN ANGIOGRAPHY (16-28).

Iris. Anatomy. Pigmented tissue lying behind the Jaeger test (YAY-gur or JAY-gur). Test.
cornea that (1) gives color to the eye (e.g., blue eyes) Assessment or near visual acuity using numbers and
and (2) controls the amount of light entering the eye symbols in a graded series of type sizes.
by varying size of the black pupillary opening. Most
forward extension of the middle (uveal) layer of the K. Measurement Abbiation for curvature. Corneal
eye; separates the anterior chamber from the surface direction having the flattest curvature or
posterior chamber. least amount of optical power measured with a
keratometer. Important in contact lens fitting. See
iris dilator, dilator muscle, dilator pupillae, pupil also K-READINGS (16-30).
dilator (DY-lay-tur). Anatomy. Smooth muscle of
Iris that extends radially from center, like wheel keratitis (KEHR-uh-TY-tis). Pathologic condition.
spokes, from pupillary margin to iris periphery; Corneal inflammation characterized by loss of luster
contracts to enlarge pupillary opening. Innervated and transparency, and cellular infiltration.
by sympathetic nerve fibers.
kerato- (KEHR-uh-toh). Prefix; pertaining to the
iris root. Anatomy. Junction of iris and ciliary body; cornea.
located just under the limbus.
keratoconjunctivitis (KEHR-uh-to-kun-junk-tih-
iris sphincter (SPINK-tur), sphincter pupillae. VY-tis). Pathologic condition. Inflammation
Anatomy. Circle of iris muscle that surrounds the involving both cornea and conjunctiva.

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Chapter 16 - Glossary

keratoconus (KEHR-uh-to-KOH-nus). Pathologic K-readings, keratometry readings. Measurement.


condition. Hereditary, degenerative corneal disease Corneal curvature measurements obtained with a
characterized by generalized thinning and cone- keratometer. Unequal measurements indicate
shaped protrusion of central cornea. Usually affects astigmatism.
vision of both eyes and occurs during 2nd decade of
life. lacrimal apparatus (LAK-rib-mul), tear drainage
system. Anatomy. Orbital structures responsible for
keratome (KEHR-uh-tohrn). Instrument. Any knife tear production and drainage. Tears are produced in
designed to make a corneal incision; usually has a the lacrimal gland (above eyeball), flow across eye
triangular blade. surface, then drain into upper and lower puncta
(openings in inner eyelid margins), through upper
keratometer (KEHR-uh-TAI-IM-ih-tur). and lower canaliculi to common canaliculus, into
Instrument. Device for measuring corneal curvature the tear sac, then, by the nasolacrimal duct, down
(K-readings) and for detecting and measuring into the nose.
astigmatism.
lacrimal canaliculi (kan-uh-UK-yoo-ly). Anatomy.
keratometer constant. The value used by Upper and lower canaliculi; part of the tear drainage
keratometer manufacturers to determine the system. Connect puncta in inner eyelid margins to
refractive index of the cornea. It changes mail channels within the upper and lower eyelids.
millimeters of curvature to diopters of power and
vice versa. lacrimal duct, nasolacrimal duct, tear duct.
Anatomy. Tear drainage channel that extends from
keratometer readings, K-readings. Measurement. the lacrimal sac to an opening in the mucous
Corneal curvature measurements obtained with a membrane of the nose.
keratometer. Unequal meridians indicate
astigmatism. lacrimal gland. Anatomy. Almond-shaped structure
that produces tears. Located at the upper outer
keratopathy (kehr-ut-TAHP-uh-thee). Pathologic region of the orbit, above the eyeball.
condition. Any corneal abnormally.
lacrimal probe. Instrument. The rod used for
keratophakia (kehr-uh-toh-FAY-kee-uh). Surgical clearing obstructions in the tear drainage system.
procedure. Removal of part of the surface of the
cornea and its replacement with a preserved lathe cut lacrimal sac, tear sac. Anatomy. Bag-like tear
corneal button. Used for correcting refractive errors. collecting structure under the skin near the bridge of
the nose. Tears enter from the common canaliculus
keratoplasty (KEHR-ut-toh-plas-tee), corneal and leave through the lacrimal duct in the nose.
graft, corneal transplant. Surgical procedure.
Replacement (transplantation) of scarred or diseased lacrimal system. System for production and
cornea with clear corneal tissue from a donor. drainage of tears; includes lacrimal glands, puncta,
canaliculi, lacrimal sac, and nasolacrimal duct.
lamellar. Replacement of superficial layers of
the cornea. lacrimation (lak-rlh-MAY-shun). Function. Tear
production, crying.
penetrating. Replacement of the full thickness
of the cornea. lamellar keratoplasty (LKP) (KEHR-uh-toh-plas-
tee), lamellar graft, partial-thickness graft.
keratotomy (KEHR-uh-TAH-tuh-mee). Surgical Surgical procedure. Removal of outer corneal layers
procedure. Incision of the cornea. Obsolete (lamellae) and replacement with normal corneal
procedure for limiting the spread of an ulcer. tissue from a donor. See also CORNEAL
TRANSPLANT (16-18), PENETRATING
KERATOPLASTY (16-38).

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Chapter 16 - Glossary

laser. Instrument. Acronym: Light Amplification by lathe-cut lens. Optics. Contact lens produced by the
Stimulated Emission of Radiation; used to lathe method of cuffing and grinding.
purposely burn tissues of the eye for various clinical
purposes. See also ARGON LASER (16-9), YAG lazy eye, amblyopia. Functional defect. Decreased
LASER (16-55). vision in one or both eyes without detectable
anatomic damage in the eye or visual pathways.
laser genioplasty, geniophotocoagulation. Surgical Uncorrectable by optical means (e.g., glasses).
procedure. Application of a laser light beam to the Types: see AMBLYOPIA (16-7).
anterior chamber angle; used for controlling eye
pressure in open angle glaucoma and neovascular legal blindness. Functional defect. Best-corrected
glaucoma. visual acuity of 20/200 or less, or visual field
reduced to 20º or less, in the better seeing eye.
laser iridotomy (ir-ih-DAHT-uh-mee). Surgical
procedure. Application of a laser light beam to lens. 1. Anatomy. Natural, crystalline lens of eye;
selectively burn a hole through the iris near its base; transparent, biconvex intraocular tissue that helps
used to control eye pressure in angle-closure bring rays of light to focus on the retina. Suspended
glaucoma. by fine ligaments (zonules) attached between ciliary
processes. 2. Optics. Any piece of glass or other
laser sculpting (or) sculpturing. Surgical transparent material with ability to blend light rays
procedure. Use of a computer-controlled excimer predictably. See also REFRACTION (16-42).
laser to remove a thin layer from the cornea, thus
changing its shape and optical power. See also lens capsule, capsule. Anatomy. Elastic bag
REFRACTIVE SURGERY (16-43). enveloping the eye’s crystalline lens; helps control
shape of lens for accommodation.
laser trabeculoplasty (LTP) (truh-BEK-yoo-loh-
plas-tee). Surgical procedure. Application of a laser lens cortex, cortex. Anatomy. Jelly-like portion of
beam to selectively burn the trabecular meshwork crystalline lens, composed of millions of thin lens
area, to lower intraocular pressure; used to treat fibers that forms the main “body”. Located between
open angle glaucoma. denser inner nucleus and elastic outer capsule.

laser treatment. Surgical procedure. Application of lensectomy. Surgical procedure. Removal of a lens.
laser beams (argon, Krypton, ruby, YAG, etc.) to See also ICCE (16-26).
bum selected areas of the eye. Used in the retina for
treating diabetic retinopathy and macular lens nucleus. Anatomy. Optically defined zone in
degeneration, to destroy leaking and new blood central position of eye’s lens that becomes denser
vessels (neo-vascularization); on iris or trabecular with age, eventually hardening and filing the entire
meshwork to decrease pressure in glaucoma; to open lens. See also CATARACT (16-12).
posterior lens capsule following extracapsular
cataract extraction. lesion. Pathologic condition. Localized, abnormal
change in tissue formulation due to injury or
lateral canthus (KAN-thus), outer canthus. damage.
Anatomy. Angle formed by the junction of upper and
lower eyelids on the side away from the nose. benign. Does not threaten health or life; non-
cancerous.
lateral rectus muscle (LR). Anatomy. Extraocular
muscle responsible for eye movement outward from malignant. Having uncontrolled growth,
the straight-ahead position (abduction). Attached to tending to produce death or deterioration;
the outer side of the eyeball; innervated by the 6th cancerous.
cranial (abducens) nerve.

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Chapter 16 - Glossary

leukocyte. Anatomy. White blood cell; part of the lymphocyte (LIM-foh-site). Pathologic condition.
body’s immune system. There are 5 types: basophil, Type of white blood cell. May be large or small, B-
eosinophil, lymphocyte, monocyte, and neutrophil. cell or T-cell. Important in immune system response
and inflammatory system response.
leukopenia (loo-koh-PEEN-ee-uh). Clinical sign.
Abnormally low number of white blood cells in the lymphoma (lim-FOH-muh). Pathologic condition.
blood. Tumor of lymphoid tissue, often malignant.

lid retraction. Clinical sign. A “puffed up” upper lyse (lice). Rupturing of a cell wail, with release of
eyelid that exposes more white of the eye (sclera) inner contents.
than normal. Results in ‘stare’ appearance. Common
sign of thyroid eye disease. lysozyme (LY-so-zime). Basic enzyme present in
saliva and team, which functions as antibacterial
lid speculum (SPEK-yoo-lurn). Instrument. Device agent. Also called muramidase.
used to hold the eyelids open and apart for
examination or surgery. macula lutea (MAK-yoo-Iuh LOO-tee-uh),
macula. 1. Anatomy. Literally, yellow spot. Small,
Lidocaine (LY-doh-kayn). Drug. Anesthetic agent specialized central area of the retina, surrounding
given by injection for eye surgery. the fovea; responsible for acute central vision.

limbal approach. Surgical procedure. Method of macular edema. Abnormal accumulation of fluid in
gaining access to eyeball by cutting through the Intercellular spaces of macula, resulting in
conjunctiva at cornea-scleral junction (limbus). decreased visual acuity.

limbal-based flap. Surgical procedure. Type of macular degeneration. Pathologic condition. One
conjunctival flap; method of gaining access to of the most common causes of decreased vision after
eyeball by cutting conjunctiva several mm from the age 60. Usually evident as a loss of pigment from
cornea-scleral junction (limbus) and making a flap pigment epithelium and deposits of yellowish
toward the limbus. Used to cover limbal incision site material in the sub-pigment epithelial layer in the
into the eye, e.g., during a cataract extraction. See central retinal zone. Abnormal new blood vessels
also FORNIX-BASED FLAP (16-23). may grow under the retina and leak fluid and blood.
Similar changes can occur in younger patients as
limbus, comea-scleral junction. Anatomy. part of a hereditary disease.
Transitional zone where the cornea joins the sclera
and the bulbar conjunctiva attaches to the eyeball. magnetic resonance imaging (MRI). Diagnostic
About 1-2 mm wide. test. Type of imaging technique using high intensity
magnets and computers; permits examination of soft
lipid. Fat and fat-like substances. tissues inside body that cannot be seen with X-ray.
Newer term for NMR (nuclear magnetic resonance).
luxation. Pathologic condition. Displacement of the
eye’s crystalline lens caused by broken or absent malignant lesion, cancer. Pathologic condition.
zonules that normally provide support. See also Malignant tissue of potentially unlimited growth
SUBLUXATION (16-49). that expands locally by invasion and throughout the
body by metastasis.
lymph node (limff). Anatomy. Mass of lymphocytes
found in various locations along lymph vessels; marginal blepharitis (blef-uh-RY-tis). Pathologic
serves as a filter of tissue fluids. Part of body’s condition. Inflammation of the eyelid margin, with
immune system response and inflammatory system redness, swelling, itching, and scaly skin. See also
response. SEBERRHEIC BLEPHARITIS (16-46).

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Chapter 16 - Glossary

mature cataract. Pathologic condition. Opaque lens vessel that supplies part of the heart with nutrients,
with no clear zones remaining, but not yet shrunken. resulting in death (infarction) of some of the heart
Causes marked decrease of vision. Used to be called muscle.
“ripe”.
microorganism. Animal or plant of microscopic
medial canthus (MEE-dee-ul KAN-thus), inner size, such as a bacterium, virus, fungus, or parasite.
canthus. Anatomy. Angle formed by the junction of
the upper and lower eyelids, near the nose. migraine (MY-grayn). Pathologic condition.
Severe headache caused by spasm, then dilation, of
medial rectus (MR). Anatomy. Muscle attached to blood vessel within skull. Often one-sided and
the outside of the eyeball on the nasal side; accompanied by nausea; may be preceded by aura of
responsible for moving the eye from straight-ahead taste or smell, “lightning flashes” or expanding
position inward (adduction). Innervated by 3rd circles of light (scintillating scotoma).
(oculomotor) cranial nerve.
MlC. (minimal inhibitory concentration).
meibomian glands (my-BOH-mee-un), tarsal Diagnostic test. The least amount of an antibiotic
glands. Anatomy. Oil glands within the eyelid tissue needed to inhibit the growth of a particular organism
(tarsus) whose ducts open onto the eyelid margin usually expressed in mg/ml.
just behind the gray line. Secretions supply outer
portion of tear film, which prevents rapid tear miosis (my-OH-sis). Function. Condition in which
evaporation and tear overflow and provides tight the pupil is constricted. Occurs as a normal response
eyelid closure. See also CHALAZION (16-14). to a bright light stimulus, to focusing on a near
object (accommodation), or to instillation of certain
melanin (MEL-un-nin). Primary pigment in body; drugs.
responsible for many normal and abnormal color
variations. miotic (my-AH-tik). 1. Refers to small pupils. 2.
Drug. Chemical that reduces size of pupils by
melanoma (met-uh-NOH-muh). Pathologic stimulating parasympathetic nervous system or by
condition. Malignant tumor arising from pigmented blocking sympathetic nervous system.
tissue. Common eye tumor.
Moll glands. Anatomy. Sweat glands near eyelash
meniscus lens (men-IS-kus), convexo-concave follicles on the eyelid margins. See also STYE (16-
lens. Optical device. Lens that has an outward- 48).
curving (convex) front surface and an inward-
curving (concave) back surface. monocular (mon-AHK-yoo-lur). Referring to, or
located in, one eye only.
metastasis (muh-TAS-tuh-suhs). Pathologic
condition. Transfer of disease-producing cells or monocyte. Anatomy. Type of white blood cell.
microorganisms from disease site to another part of
the body, producing similar disease in the new MRI (magnetic resonance imaging). Diagnostic
location. Often refers to cancer cells. See also test. Type of imaging technique using high intensity
MALIGNANT LESION (16-32). magnets and computers; permits examination of soft
tissues inside body that cannot be seen with X-rays.
methazolamide (meth-uh-ZOH-luh-mide). Drug. Newer tern for NMR (nuclear magnetic resonance).
Oral mediation that lowers intraocular pressure by
decreasing aqueous secretion. Used in treating mucin (MYOO-sin). Anatomy. Moist, viscid
glaucoma. See also CARBONIC ANHYDRASE secretions from small mucous glands, such as found
INHIBITOR (16-12), NEPTAZANE (16-35). in the conjunctiva and linings of the mouth and nose;
serves as a protective lubricant.
Ml (myocardial infarction), coronary, heart attack.
Pathologic condition. Sudden blockage of a blood

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Chapter 16 - Glossary

muscle cone. Anatomy. Cone-shaped tissue behind refractive. Caused by increased index of
eyeball, formed by the medial rectus, lateral rectus, refraction of the lens, as in nuclear sclerosis
superior rectus, inferior rectus, and superior oblique (type of cataract.)
muscles, and their muscle sheaths and intermuscular
membranes. Tip of cone is at innermost point (apex) Naphcon (NAF-kon). Drug. Trade name of
of the orbit. naphazoline, decongestant eye drop that constricts
blood vessels. Used to whiten eye.
muscle hook. Surgical instrument. Blunt-ended
device used to help locate and to hold an extraocular nasal. Location. 1. Refers to inward (toward nose)
muscle. direction. 2. That half of eye or visual field from
vertical midline inward. See also TEMPORAL (16-
muscle sheath. Anatomy. Thin, fibrous tissue that 50).
forms an enclosure for a extraocular muscle.
nasal sinuses. Anatomy. The ethmoid, frontal,
Mydriacyl (mid-RY-uh-sil). Drug. Trade name of maxillary, and sphenoid sinuses.
tropicamide, eye drop that dilates pupils and
paralyzes accommodation; used in eye nasolacrimal duct (NLD) (nay-zoh-LAK-rih-mul),
examinations. See also CYCLOPLEGIA (16-19), lacrlmal duct, tear duct. Anatomy. Tear drainage
MYDRIATIC (16-34). channel that extends from lacrimal sac to an opening
in the mucous membrane of the nose.
mydriasis (myd-RY-uh-sis). Function. Increase in
pupil size (dilation) occurring normally In the dark nasolacrimal duct obstruction, blocked tear duct.
or artificially through the use of drugs. Pathologic condition. Incomplete opening of tear
duct causing tears to continually flow over the
mydriatic (mid-ree-AT-ik). Drug. Drug that causes cheek. See also DACRYOCYSTORHINOSTOMY
pupillary enlargement (dilation). Stimulates (16-19), LACRIMAL PROBE (16-30).
sympathetic nerve fibers, causing iris dilator to
contract, or blocks parasympathetic nerve fibers, nasolacrimal probing, probing. Surgical
paralyzing the iris sphincter muscle. See also procedure. Opening the tear drainage system by
CYCLOPLEGIA (16-19), MYDRIACYL (16-34), passing a thin metal rod through the passageway and
NEOSYNEPHRINE (16-35). pressing gently to break any obstruction.

myocardial infarction (Ml), “coronary,” heart nearsightedness, myopia. Refractive error.


attack. Pathologic condition. Sudden blockage of a Overpowered eye in which parallel light rays from a
blood vessel that supplies part of the heart with distant object are brought to focus in front of the
nutrients, resulting in death (infarction) of some of retina. Requires minus lens correction to “weaken”
the heart muscle. eye optically and permit clear distance vision. Types
listed under MYOPIA (16-34).
myopia (my-OH-pee-uh), nearsightedness.
Refractive error. Optical defect in which light rays near vision. Measurement. Visual acuity tested at 16
entering the eye are bent unequally in different in (approx. 40 cm), corresponding to normal reading
meridians, preventing formation of a sharp focus on distance.
the retina. Light is focused in front of the retina.
Requires a minus lens correction to “weaken” the necrosis. Clinical sign. Death of cells or tissue in a
eye optically and permit clear distance vision. localized area; caused by disease, injury, or
insufficient blood supply.
axial. Caused by an eyeball that is too long for
its optical power. needle holder. Surgical instrument. Device that
holds a suture needle.
curvature. Caused by curvature of cornea or
lens that is too steep for actual eyeball length.

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Chapter 16 - Glossary

Neisseria gonorrhea. Microorganism. Gram- indicates a defect in the (retinal) rods. May be
negative, spherical bacteria. Causes severe eye progressive.
infections, especially in newborn whose mothers
have venereal disease. night vision, rod vision, scotopic vision. Function.
Refers to visual acuity at low light levels; primarily
neomycin (nee-oh-MY-sin). Drug. Antibiotic a function of (retinal) rods. Maximum sensitivity
effective against many gram-positive and gram- usually occurs after 30 minutes in dark.
negative microorganisms that infect the eyes.
nodal point, optical center. Optics. Reference point
neoplasm. Pathologic condition. New abnormal on optical system’s principal axis through which
growth of tissue that has no physiological function; incoming light rays are not bent by lens or optical
usually malignant. surface, so that incident and transmitted rays make
equal angles with the optic axis. In the eye, lies on
Neosporin (nee-oh-SPOR-in). Drug. Trade name of the optic axis near the rear surface of the lens.
ointment containing polymyxin B, bacitracin and
neomycin; used to treat conjunctivitis. non-steroid anti-inflammatory drugs (NSAIDs).
Drug. Group of prosta-glandin-inhibiting drugs
Neosynephrine (nee-oh-sin-EF-rin). Drug. Trade (i.g., aspirin, Indocin, ibuprofen); used as a
name of phenylephrine hydrochloride. Used in low substitute for steroids in controlling inflammations
concentrations to whiten the conjunctiva; used in such as non-glaucomatous anterior uveitis.
stronger concentrations to dilate the pupil. Effectiveness has not been proven.

neovascularization (nee-oh-VAS-kyoo-lur-in- nuclear. 1. Anatomic defect. Refers to optically


ZAY-shun). Pathologic condition. Abnormal dense center of crystalline lens of eye. 2. Anatomy.
formation of new blood vessels, usually on or under Refers to cranial nerve nuclei in brain.
the retina, or on the surface of the iris. Typically
seen in diabetic retinopathy, blockages of central nutritional amblyopia (am-blee-OH-pee-uh).
retinal vein, and macular degeneration. Functional defect. Vision loss accompanied by
dense central visual field defects in both eyes;
Neptazane. Drug. Trade name of methazolamide caused by deficiency in thiamine and other B
tablets, oral medication that lowers intraocular vitamins, usually in patients who consume excessive
pressure by decreasing aqueous formation. Used to tobacco and alcohol. See also AMBLYOPIA (16-7).
treat glaucoma. See also CARBONIC
ANHYDRASE INHIBITOR (16-12). nyctalopia (nik-tuh-LOH-pee-uh), night blindness.
Functional defect. Inefficient dark adaptation that
neuritis. Pathologic condition. Inflammation of a results in markedly reduced vision in dim
nerve; for example, optic neuritis is an inflammation illumination. Usually indicated defect in (retinal)
of the optic nerve. rods, affecting dark adaptation. May be progressive.

neuropathy (noor-AHP-uh-thee). Pathologic O.D. Doctor of optometry. See OPTOMETRIST


condition. Non-inflammatory nerve abnormality. (16-37).

neutrophil (NOO-troh-fihl), polymorphonuclear O.D. (oculus dexter). Right eye.


leukocyte, poly. Anatomy. Type of white blood cell
important in combating acute infections, especially O.S. (oculus sinister). Left eye.
those associated with bacteria.
obstruction. Pathologic condition. Blockage; may
night blindness, nyctalopia. Functional defect. be complete or partial.
Inefficient dark adaptation that results in markedly
reduced vision in dim illumination. Usually occlusion. 1. Pathologic condition. Blockage, as of
a blood vessel. 2. Treatment. Covering one eye, as

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Chapter 16 - Glossary

with a patch after surgery, injury, or in amblyopia. 3. caused by maternal gonococcal infection. Baby’s
Test technique. Covering one eye. eyes are contaminated during passage through birth
canal. See also CREDE’S PROPHYLAXIS (16-18).
Octopus. Instrument. Trade name of computerized
apparatus for detection and mapping of visual field ophthalmologist (ahf-thal- MAH-loh-jist). Medical
defects. See also PERIMETER (16-38). specialist. Physician specializing in refractive,
medical, and surgical treatment of eye diseases and
ocularist (ahk-yoo-LEHR-ist). Vision care disorders.
specialist. Professional trained to design and fit
artificial eyes. ophthalmology (ahf-thal-MAH-loh-gee). Medical
specialty. Deals with the eye, its function and
ocular motility, motility. Science, function, test. diseases. Includes diagnosis and management.
Deals with extraocular muscles and their effect on
eye movements. See also BINOCULARITY (16- ophthalmoplegia (ahf-thal-muh-PLEE-juh).
11), STRABISMUS (16-48). Pathologic condition. Paralysis of more than one
eye muscle, in one or both eyes.
oculist (AHK-yoo-list). Obsolete term for
ophthalmologist. external. Acquired paralysis of all extraocular
muscles, causing restriction of eye movement,
oculus dexter. See OD. and the levator muscle, causing droopy lid
(ptosis).
oculus sinister. See OS.
ophthalmoscope (ahf-THAL-muh-skohp).
ocutome (AHK-yoo-tohm). Surgical instrument. Instrument. Device used for examining the interior
Needle-like cutting and aspirating device, with of the eye, especially the fundus (retinal).
independent irrigating system; for cutting and
removing vitreous and/or cataracts. direct. Provides a magnified (15x) upright
image with a small (8º) field of view.
open angle glaucoma (OAG) (glaw-KOH-muh),
chronic open angle glaucoma, primary open angle indirect. Provides a magnified (3x) inverted
glaucoma. Pathologic condition. Most common image and a wide field of view. Consists of
type of glaucoma, usually found in both eyes. bright light source worn on the examiner’s head
Associated with increased intraocular pressure. and a hand-held plus lens. The binocular model
Characteristic visual field loss and optic nerve allows stereoscopic depth perception of the
damage caused by gradual blockage of aqueous fundus.
outflow from eye despite an apparently open
anterior chamber angle. If untreated, results in optical zone. Optics. Central, optical portion of the
gradual, painless, irersible loss of vision. cornea or of a contact lens.

operating microscope. Instrument. Modified optic cup. Anatomy. 1. White depression in center of
microscope used for microsurgery on the eye. optic disc; usually occupies about one-third or less
Mounted on a stand or the ceiling, has foot-operated of total disc diameter. 2. Embryology. Early stage in
focusing controls, observer eye pieces, and a beam developing eye; outpouching from the primitive
splitter for camera attachment. brain.

Ophthaine (AHF-thayn). Trade name of optic disc, disc, optic nerve head. Anatomy. Exit site
proparacaine, anesthetic eye drop. of retinal nerve fibers from eye.

ophthalmia neonatorum (ahf-THAL-mee-uh nee- optician (ahp-TISH-un), dispensing optician,


oh-nuh-TOR-um). Pathologic condition. Acute ophthalmic dispenser. Vision care specialist.
conjunctival inflammation in newborn; usually Professional who makes and adjusts optical aids,

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Chapter 16 - Glossary

e.g., eyeglass lenses and frames, from refraction osmotic agent (ahz-MAH-tik). Drug. Medication
prescriptions supplied by an ophthalmologist or that lowers intraocular pressure by increasing
optometrist. osmotic pressure in blood and tissues to draw fluid
from the eye.
optic nerve head. See optic disc.
outer canthus (KAN-thus). lateral canthus.
optics. Science. Branch of physics involved with Anatomy. Angle formed by junction of upper and
light, its refraction and reflection by lenses, prisms, lower eyelids on side away from nose.
mirrors, and the eye. See also LENS (16-31),
PHYSIOLOGIC OPTICS (16-39). outer nuclear layer. Anatomy. Retinal layer that
contains rod and cone nuclei.
optometer (ahp-TAHM-ih-tur). Instrument. Device
that measures amount of accommodation exerted by pachymetry (pak-AHM-ih-tree), pachometry (pak-
an eye as an object is viewed. OM-ih-tree). Test. For measuring corneal thickness.

optometrist (ahp-TAHM-uh-trist). Vision care palpebral (pal-PEE-brul). Referring to eyelid.


specialist. Non-medical professional trained to
prescribe eyeglasses or contact lenses, examine palpebral conjunctiva (kahn-junk-TY-vuh).
eyes, and detect eye disease. O.D. (16-36) Anatomy. Mucous membrane lining the inner
surfaces of upper and lower eyelids.
ora serrata (OR-uh seh-RAH-tuh). Anatomy. Front
edge of the retina; has tooth-like appearance. Border palsy, paralysis. Functional defect. Complete or
located about 6.5 mm behind the cornea-scleral partial loss of muscle function, usually due to nerve
junction (limbus). damage.

orbit. Anatomy. Pyramid-shaped (apex toward back paracentesis (pehr-uh-sen-TEE-sis), anterior


of head) cavity in the skull, about 2 inches deep and chamber tap, keratocentesis. Surgical procedure.
lined by the orbital bones; contains the eyeball, its Corneal puncture with removal of some anterior
muscles, blood supply, nerve supply, and fat. chamber fluid (aqueous humor) for analysis or to
reduce eye pressure quickly and temporarily.
orbital cellulitis (sel-yoo-LY-tis). Pathologic
condition. Infection of orbital contents, often caused parasympathetic nervous system. Anatomy. Part of
by streptococci or staphylococci; produces swelling the autonomic nervous system. Controlled by
and redness of eyelids, bulging eye (proptosis), acetylcholine, chemical that allows nerve
limitation of eye movement, and swelling of orbital transmission, aided by enzyme cholinesterase.
tissues. Usually spreads from infected ethmoid, Nerve fibers to eye travel with the 3rd cranial
sphenoid, maxillary, or frontal sinuses into the bony (oculomotor) nerve, and provide innervation to
cavity (orbit) containing the eyeball. ciliary body (for accommodation and aqueous
production) and iris sphincter, to decrease pupil size
orthoptics. Vision care field. Study and treatment of (miosis).
defective eye coordination, binocular vision, or
functional amblyopia by non-surgical methods, e.g., parasympathetic drug, cholinergic blocking drug.
glasses, prisms, or exercises. Results in improved Drug. Blocks parasympathetic nerves by inhibiting
comfort and efficiency of binocular function. action of acetylcholine in nerve transmission;
produces enlarged pupils (mydriasis) and ciliary
orthoptist (or-THAHP-tist). Vision care specialist. muscle paralysis (cycloplegia), resulting in loss of
Certified allied health professional who works for an focusing ability at near (accommodation). Used for
ophthalmologist; analyzes and treats patients with cycloplegic refraction and to treat uveitis. See also
dysfunctions of binocularity and/or ocular motility. MYDRIACYL (16-34).

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Chapter 16 - Glossary

parasympathomimetic (pehr-uh-sim-path-oh-mim- Shearing, Simcoe. See also ANTERIOR


ET-ik). Refers to a chemical that enhances the action CHAMBER INTRAOCULAR LENS (16-8).
of acetylcholine in nerve transmission, making the
parasympathetic nervous system more effective. penetrating keratoplasty (PKP) (KEHR-uh-toh-
plas-tee). Surgical procedure. Removal of full
parasympathomimetic drug, cholinergic thickness of cornea and replacement with donor
stimulating drug. Drug. Mimics actions of macula. cornea. See also CORNEAL TRANSPLANT (16-
parasympathetic nervous system by simulating 18), LAMELLAR KERATOPLASTY (16-30).
acetylcholine chemically or by inactivating
cholinesterase; causes small pupils (miosis), perfusion (pur-FYOO-zhun). Medical term.
increased aqueous outflow, dilation of blood Forcing a liquid to flow over or through an organ.
vessels, and increased accommodation. Used to treat
glaucoma and accommodative esotropia. See also peribulbar injection, periocular injection.
ANTICHOLINESTERASE (16-8), Technique. Injection of drugs through the skin or
PILOCARPINE (16-39). conjunctiva to surround the eyeball.

parenteral (puh-RENT-uh-rul). Method. perimeter (pur-IM-ih-tur). Instrument. Device for


Introduction of medication, etc., by any route other plotting central or peripheral field of vision.
than the mouth, usually by injection.
perimetry (pur-RIM-ih-tree). Test. Method of
paresthesia (pehr-iz-THEE-zhuh). Symptom. charting extent of a stationary eye’s field of vision
Unusual sensation (e.g., tingling) usually associated with various test objects. Aids in detection of
with irritation or injury of a nerve. Common side damage to sensory visual pathways.
effect of the drug, Diamox.
kinetic. Stimuli are moved from non-seeing
parspiana incision. Surgical procedure. Surgical area until they are first perceived.
cut into the eyeball that passes through the sclera
and then pars plana area of the ciliary body, between static. Stimuli are not moved but are gradually
the pars plicata and the ora serrata. Common site for increased in intensity until first perceived.
instruments used for vitrectomy procedures.
peripheral iridectomy (PI) (ir-ih-DEK-tuh-mee).
patent (PAY-tunt). Open, as in a channel. Surgical procedure. Removal of full-thickness
wedge of iris tissue at iris base (near corneal
pathologic, pathological. Medical term. Altered or limbus), usually between 10 and 2 o’clock
caused by disease or abnormal function. See also meridians. Permits aqueous to flow more easily
PHYSIOLOGIC (16-39). from posterior to anterior chamber. See also
SECTOR IRIDECTOMY (16-46).
Patient Eye Level. The vertical distance from the
patient eye level to the aspiration ports of the peripheral nervous system (PNS). Anatomy. Nerves
Stellaris PC Vision Enhancement System. The that connect parts of the body to the central nervous
Stellaris PC system has a feature to adjust patent eye system.
level offset if the patient eye level is not at the same
level as the aspiration port. The offset range is - phaco- (FAY-koh), phako-. Prefix; refers to natural
15cm to +15cm. lens of eye (crystalline lens).

PC IOL (posterior chamber intraocular lens). phacoemulsification (fay-koh-ee-mul-sih-fih-


Optical device. Plastic lens that may be surgically KAY-shun). Surgical procedure. Use of ultrasonic
implanted into the posterior chamber (behind the vibration to shatter and break up a cataract, making
iris) to replace the eye’s natural lens after cataract it easier to remove. Delivered by tip of an irrigation-
extraction. Examples: Anis, Bechert, Pearse, aspiration instrument.

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Chapter 16 - Glossary

phagocyte (FAG-oh-site). Anatomy. Cell that light into electrical impulses for transmission of
scavenges, removing microorganisms, debris, and message to brain.
foreign proteins from body tissues.
physiologic. Medical term. Normal condition or
phakic (FAY-kik). Refers to an eye that still function. See also PATHOLOGIC (16-38).
possesses its natural lens.
pigment epithelium (PE) (ep-ih-THEE-lee-um),
phako-. See phaco-. retinal pigment epithelium. Anatomy. Pigment cell
layer just outside the retina that nourishes the retinal
phenylephrine hydrochloride (fen-il-EF-rin hy- visual cells and is firmly attached to underlying
droh-KLOR-ide). Drug. Stimulates sympathetic choroid and overlying retinal visual cells.
nerves, causing pupil to enlarge, breaking iris-to- Composed of one layer of hexagonal cells that are
lens adhesions (posterior synechia), treating iritis densely packed with pigment granules.
and preventing iris cyst formation caused by
phospholipin iodide. See also NEOSYNEPHRINE Pilocar (PY-loh-kahr). Drug. Trade name of
(16-35). pilocarpine; eye drop used in treatment of glaucoma.

phlebitis (fluh-BY-tus), thrombophiebitis. pilocarpine (pi-loh-KAHR-peen). Drug. Stimulates


Pathologic condition. Inflammation of a vein. parasympathetic nerve receptors directly; produces
small pupils (miosis), increase in accommodation,
phlyctenular keratoconjunctivitis (flik-TEN-yoo- and increased aqueous outflow. Used in treatment of
lur KEHR-uh-toh-kon-junk-tih-VY-tis). Pathologic glaucoma. See also PARASYMPATHOMIMETIC
condition. Inflammation of conjunctiva and corneal DRUG (16-38).
associated with small, nodular lesions
(phlyctenules) at the corneal edge; may promote pinhole (PH). Test instrument. Opaque disc with
abnormal new blood vessel growth one or multiple holes ranging from 0.5 to 2 mm in
(neovascularization). Suspected cause is diameter. Looking through the hole(s) with one will
hypersensitivity to bacterial proteins, particularly result in improved vision if reduced vision is caused
tuberculoprotein or staphylococcal protein. by optical defect or refractive error.

phlyctenule (flik-TEN-yool). Anatomic defect. “pink eye,” conjunctivitis. Pathologic condition.


Wedge-shaped, nodular lesion (lymphocytic Inflammation of the conjunctiva (mucous
infiltration) found at corneal edge. May promote membrane that covers the white of eye and inner
abnormal new blood vessel growth surface of eyelids). Characterized by discharge,
(neovascularization). See also PHLYCTENULAR grittiness, redness, and swelling. Contagious;
KERATOCONJUNCTIVITIS (16-39). usually viral in origin.

phoropter (FOR-ahp-tur, for-AHP-tur). Instrument. pit, optic nerve pit. Congenital defect. Incomplete
Refraction device combining a large variety of colombo of the optic disc, sometimes associated
spherical and cylindrical lenses, prisms, occluders with fluid leakage under the retina that simulates
and pinholes; used for determining and eye’s optical central serous choroidopathy.
correction.
PKP. Abbiation for PENETRATING
photophobia (foh-toh-FOH-bee-uh). Symptom. KERATOPLASTY (16-38).
Abnormal sensitivity to, and discomfort from, light.
Frequently associated with excessive tearing. Often plano (PLAY-noh). Optics. Lens that has no
due to inflammation of iris or cornea. focusing power, neither plus nor minus.

photoreceptors (foh-toh-ree-SEP-turz), retinal plano concave. Optics. Minus-powered lens, flat on


elements, retinal visual cells, sensory receptors. one side and curved inward on the other side.
Anatomy. Rods and cones; retinal cells that convert

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Chapter 16 - Glossary

plano convex. Optics. Plus-powered lens, flat on posterior chamber (PC). Anatomy. Space between
one side and curved outward on the other side. the back of the iris and the front face of the vitreous;
filled with aqueous fluid.
plus cylinder. Optical device. Lens with no optical
power in one meridian (axis) and maximum plus- posterior chamber intraocular lens (PC IOL).
power in the perpendicular direction. Optical device. Plastic lens that may be surgically
implanted into the posterior chamber (behind the
plus lens, converging lens, convex lens. Optical iris) to replace the natural lens of the eye after
device. Lens, thicker in center than at edges, that cataract extraction. Examples: Anis, Bechert,
adds optical power to incoming light rays. Used for Pearse, Shearing, Simcoe. See also ANTERIOR
correcting farsightedness (hyperopia). CHAMBER INTRAOCULAR LENS (16-8).

PMMA (polymethyl methacrylate). Chemical. posterior hyaloid membrane (PHM) (HY-uh-loyd).


Plastic polymer used to make hard contact lenses Anatomy. Condensed tissue layer that attaches
and intraocular lenses (IOLs). vitreous firmly to internal surface of retina (limiting
membrane). Separates vitreous from anterior
pneumatic tonometer. See chamber.
PNEUMOTOMOMETER (16-40).
posterior pole. Anatomy. Posterior (back) curvature
pneumo (NOO-moh), streptococcus pneumoniae. of eyeball; usually refers to the retina between the
Microorganism. One of most common gram- optic nerve and the macular area.
positive bacteria causing eye infections, especially
corneal ulcers. Bacteria grow in pairs. See also posterior segment. Anatomy. Back section of the
PSEUDOMONAS AERUGINOSA (16-41), eye comprised of the vitreous and retina.
STAPHYLOCOCCUS AUREUS (16-48).
posterior subcapsular cataract (PSC), cupuliform
pneumotonometer (noo-moh-tuh-NAHM-ih-tur), cataract. Pathologic condition. Common type of
pneumatic tonometer. Instrument. Gas-pressurized lens opacity located on rear surface of the lens.
device that measures intraocular pressure by Occurs in elderly patients as one type of “senile
blowing a puff of air against the cornea to flatten it cataract”; may occur at any age after chronic
slightly, does not require instrument contact with intraocular inflammations or prolonged use of
eye. See also APPLANATION TONOMETRY (16- steroid drugs.
9).
posterior synechia (sin-EE-kee-uh). Pathologic
poly (methylmethacrylate) (PAH-lee-METH-il- condition. Adhesions binding pupillary margin and
meth-AK-ri-layt). See PMMA (16-40). back surface of iris onto front lens surface. See also
ANTERIOR SYNECHIA (16-8), PUPILLARY
Polysporin (pah-lee-SPOR-in). Drug. Trade name BLOCK (16-42).
of antibiotic ointment used to treat corneal and
conjunctival infections. Contains polymyxin B and posterior uveitis (yoo-vee-I-tis). Pathologic
bacitracin. condition. Choroidal or ciliary body inflammation;
may produce cellular debris in vitreous and
port. Opening in a tube-like instrument, usually at exudative retinal opacities.
the side, such as the aspiration port of a vitrectomy
instrument. potential acuity meter (PAM). Instrument. Device
useful in helping to predict visual acuity potential
posterior. Location. Located on or near the back of when an opacity (e.g., cataract) is present. Projects
an organ or of the body. See also ANTERIOR (16- brightly illuminated Snellen chart through the least
8). dense areas of an opacity onto the retina.

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Chapter 16 - Glossary

power. Optics. Lens focusing ability in diopters. a thin metal rod through the passageway and
Can be plus or minus. pressing gently to break any obstruction.

precautions. Possibility of unwanted or undesirable prolapse (PROH-laps). Pathologic condition.


side-effects occurring; disclosing undesirable Slipping of tissue or an organ out of its normal
concomitant possible events or reactions. position.

pre-corneal tear film (KOR-nee-ul), tear film. proparacaine hydrochloride. Drug. Rapid, short-
Anatomy. Liquid that bathes cornea and conjunctiva. acting anesthetic eye drop. See also OPTHAINE
Composed of 3 layers: outermost oily layer secreted (16-36), .
by meibomian glands, middle aqueous layer
secreted by lacrimal gland, innermost mucin layer prophylaxis (proh-fuh-LAK-suhs). Medical term.
produced by the conjunctival goblet cells. Measures taken to prevent the development or
spread of disease.
Pred Forte (pred FOR-tay). Drug. Trade name for
prednisone acetate, anti-inflammatory (steroid) eye Propine. Drug. Trade name of dipivefrin; prodrug
drop. used in glaucoma control.

prednisolone (pred-NIS-us-lohn). Drug. Anti- proptosis (prahp-TOH-sis), exophthalmos.


inflammatory steroid used in treatment of ocular Anatomic defect. Abnormal protrusion or bulging
inflammation. forward of the eyeball.

prednisone (PRED-nih-sohn). Drug. Anti- prosthesis (prahs-THEE-sis), shell. “False eye”;


inflammatory steroid used in treatment of ocular Plexiglas shell painted to resemble a natural eye.
inflammation. Cosmetic replacement after removal of eye
(enucleation); fits in conjunctival sac under eyelids
presbyopia (prez-bee-OH-pee-uh). Functional and over a buried implant.
defect. “Old age vision.” Refractive condition in
which there is a diminished power of pseudoexfoliation. Pathologic condition. Deposits
accommodation arising from loss of elasticity of the of unknown composition and origin appearing on
crystalline lens, as occurs with aging. Usually lens surfaces, ciliary processes, zonules, and
becomes significant after age 45. innermost iris surfaces, and in anterior chamber and
trabecular meshwork. May be associated with high
Pressurized Infusion. Similar to AFI, pressurized intraocular pressure and/or cataracts.
air is used to drive irrigation into the eye for anterior
surgery. Pseudomonas aeruginosa (soo-duh-MOH-nus eh-
roo-jin-OH-suh). Microorganism. Long, slender,
primary open angle glaucoma (POAG) (glaw- gram-negative rod bacteria frequently found in
KOH-muh), chronic open angle glaucoma, open contaminated fluorescein solutions, saline,
angle glaucoma. Pathologic condition. Most sulfonamides, and contact lens solutions. If
common type of glaucoma; usually affects both untreated, can cause severe eye infections, with
eyes. Associated with increased intraocular corneal “melting” and rapid loss of eye (within
pressure. Characteristic visual field loss and optic days). Most virulent of common bacterial causes of
nerve damage caused by gradual blockage of corneal ulcers. See also STREPTOCOCCUS
aqueous outflow from the eye despite an apparently PNEUMONIAE (16-48).
open anterior chamber angle. If untreated, results in
gradual, painless, irersible loss of vision. pseudophakia (SOO-doh-FAY-kee-uh). Condition
of having an intraocular lens (IOL) implant as a
probing, nasolacrimal probing. Surgical replacement for a cataractous lens. False lens.
procedure. Opening tear drainage system by passing

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Chapter 16 - Glossary

pseudophakos (soo-doh-FAY-kus). Implant, punctum. Anatomy. Opening in lacrimal canaliculi,


Intraocular lens, IOL. Optical device. Plastic lens located on the upper and lower eyelid margin near
that may be surgically implanted to replace natural the nose. Entrance to the tear drainage system from
lens of eye. Examples: Binkhorst, Choyce, eye surface into nose. See also INFERIOR
Copeland, Fyoderov, Kelman, Kratz, Shearing, PUNCTUM (16-27), SUPERIOR PUNCTUM (16-
Sheets, Sinskey, Simcoe, Tennant, Worst. 49).

pterygium (tur-IJ-ee-um). Pathologic condition. pupil. Anatomy. Variable-sized, black circular


Abnormal wedge-shaped growth on bulbar opening in center of iris; iris regulates amount of
conjunctiva; may gradually advance onto cornea, light that enters the eye via pupil size.
requiring surgical removal. Probably related to sun
irritation. pupil dilator, dilator muscle, dilator pupillae, iris
dilator. Anatomy. Smooth muscle of iris that extends
ptosis (TOH-sis), blepharoptosis. Functional radically from center, like wheel spokes, from the
defect. Drooping of upper eyelid. May be congenital pupillary margin to the iris periphery. Innervated by
or caused by paralysis or weakness (paresis) of 3 rd sympathetic fibers. Contracting muscle enlarges
(oculomotor) cranial nerve or sympathetic nerves, or pupillary opening.
by excessive weight of upper lids.
pupillary block. Functional defect. Blockage of
ptotic (TAH-tik). Refers to a droopy eyelid. See normal aqueous flow through pupil, from posterior
ptosis. chamber into interior chamber, caused by tight
contact between pupillary margin of iris and lens or
Pulse Mode Ultrasound. An intermittent ultrasound vitreous face.
pulse modulation with fixed rate. Ultrasound power
is linearly controlled with the Foot Control. radial keratotomy (RK) (ker-ruh-TAHT-uh-mee).
Surgical procedure. Four to 16 radial cuts made in
purulent (PYUR-yuh-lunt). Containing or the periphery of the cornea to allow the central
consisting of pus. cornea to flatten, reducing its optical power and
thereby nearsightedness. Controversial technique;
punctal plug. Surgical device. Plastic materials long term effectiveness and safety have not been
(polyhydroxyethyl methacrylate or silicone) established.
inserted into punctum to prevent normal tear
drainage so as to preserve tears for moistening RD. Abbiation for RETINAL DETACHMENT (16-
cornea and conjunctiva. 43).

punctate keratic precipitates (PUNK-tayt kehr-AT- red eye. Pathological condition. Lay term applied to
ik pree-SIP-ih-taytz). Clinical sign. Small grey or any condition with dilation of conjunctival or ciliary
whitish lesions composed of clumps of white blood blood vessels; innumerable causes, esp. irritation
cells and plasma cells that adhere to back corneal and infection. See also CONJUNCTIVITIS (16-16).
surface (endothelium). Typical of non-
granulomatous uveitis. red reflux. Function. Normal red glow emerging
from the pupil when the interior of the eye is
punctate keratitis (kehr-uh-TY-tus), superficial illuminated.
punctate keratitis, Thygeson’s superficial punctate
keratitis. Pathologic condition. Corneal disease of reflux. To cause to flow back or spill out, or the
unknown cause, characterized by small superficial material that flows back.
corneal lesions. Other symptoms include foreign
body sensation and sensitivity to bright lights. refraction. 1. Optics. Bending of light rays as they
Sometimes recurs after spontaneous remissions. travel from a clear medium of one density to another
of a different density. 2. Test. Determination of an
eye’s refractive error and the best corrective lenses

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Chapter 16 - Glossary

to be prescribed; series of test lenses in graded consists of layers that include rods and cones,
powers are presented to determine which provide bipolar cells, amacrine cells, ganglion cells,
sharpest, clearest vision. horizontal cells, Mueller cells, and all
interconnecting nerve fibers. See also OUTER
cycloplegic. Test. Assessment of refractive NUCLEAR LAYER (16-37).
error after lens accommodation has been
paralyzed with cycloplegic eye drops. retinal (ret-in-AL). Obsolete term for retinaldehyde.
Eliminates variability in optical power caused
by a contact lens. retinaldehyde (ret-ih-NAL-duh-hide). Chemical.
Aldehyde of vitamin A. Part of photosensitive
manifest. Test. Assessment of refractive error pigment found in rod and cone outer segments.
without using cycloplegic eye drops. Necessary for chemical conversion of light energy
to electrical energy.
refractive error. Functional defect. Optical defect in
an unaccommodating eye; parallel light rays are not retinal detachment (RD), detachment. Pathologic
brought to sharp focus precisely on the retina, thus condition. Separation of sensory retina from
producing a blurred retinal image. Can be corrected underlying pigment epithelium. Disrupts visual cell
by eyeglasses or contact lenses. See also structure and thus markedly disturbs vision. Almost
AMETROPIA (16-7). always caused by a retinal tear; often requires
immediate surgical repair. See also CHOROIDAL
refractive keratoplasty (KEHR-uh-toh-plas-tee). DETACHMENT (16-14), SCLERAL BUCKLE
Surgical procedure. Any surgery on the cornea (16-45).
using corneal donor tissue (graft) to change the
optical power of the eye. See also retinal hole, retinal break, retinal tear. Pathologic
EPIKERATOPHAKIA (16-21). condition. Hole in retinal tissue. Usually caused by
vitreous tug or traction; sometimes created
refractive surgery. Surgical procedure. Several deliberately during vitrectomy surgery.
procedures used for altering the shape of the cornea
and thus how it bends light, in order to change the retinal pigment epithelium (RPE) (ep-ih-THEE-
eye’s refractive error. Includes lamellar and lee-um), pigment epithelium. Anatomy. Pigment
penetrating keratoplasty, epikeratophakia, cell layer just outside retina that nourishes retinal
keratomileusis, keratophakea, laser sculpturing, and visual cells, and is firmly attached to underlying
radial keratotomy. choroid and overlying retinal visual cells.
Composed of one layer of hexagonal cells that are
relaxing incision. Surgical procedure. Linear cuts densely packed with pigment granules.
used to reduce excessive tension in tissue. In the
cornea, used for flattening it to correct residual retinal tear. See RETINAL HOLE (16-43).
astigmatism and/or myopia following corneal
transplantation. See also RADIAL retinitis (ret-ih-NY-tis). Pathologic condition.
KERATOTOMY (16-42), REFRACTIVE Inflammation of the retina.
KERATOPLASTY (16-43).
retinitis pigmentosa (RP) (pig-men-TOH-suh), ret.
resolution. The process of making distinguishable pig. Pathologic condition. Hereditary, progressive
the different parts of an object. Image quality. retinal degeneration in both eyes. Night blindness
develops, usually in childhood, followed by loss of
retina (RET-ih-nuh), tunica nervosa ocull. peripheral visual field (initially as ring-shaped
Anatomy. Part of the eye (originally part of brain) defect), progressing over many years to tunnel
that converts images form the eye’s optical system vision and finally blindness.
into electrical impulses sent along the optic nerve for
transmission to the brain. Forms the thin retinoblastoma (ret-in-noh-blas-TOH-muh).
membranous lining of rear two-thirds of the globe; Pathologic condition. Hereditary, malignant

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Chapter 16 - Glossary

intraocular tumor that develops from retinal visual RK. Abbiation for RADIAL KERATOTOMY (16-
cells. If untreated, numerous seedling nodules 42).
produce secondary tumors, gradually filling the eye
and extending along optic nerve to the brain, ending rod vision, night vision, scotopic vision. Function.
in death. Most common childhood ocular Refers to vision at low light levels. Primarily a
malignancy. function of (retinal) rods; maximum sensitivity
usually occurs after 30 minutes in the dark.
retinol (RET-ih-nol), vitamin A. Chemical. Vitamin
A alcohol. Stored in the liver and perhaps retinal rods. Anatomy. Light-sensitive retinal receptor cells,
pigment epithelium. Ultimately modified and used specialized to work at low light levels (night vision).
by rods and cones as the photosensitive pigment A normal retina contains 150 million rods. See also
responsible for initiating the visual process. CONES (16-15), RHODOPSIN (16-44).

retinopathy (ret-in-AHP-uh-thee). Pathologic rubella (roo-BEL-uh), German measles.


condition. Non-inflammatory retinal abnormality. Pathologic condition. Common mild viral infection;
when contracted during a woman’s 1st trimester of
diabetic. Spectrum of retinal changes accompanying pregnancy, can generate fetal abnormalities, such as
longstanding diabetes mellitus. Background mental retardation, heart disease, hearing defects,
retinopathy (non-proliferative) is the early stage; and eye defects e.g., cataracts, glaucoma, retinal
may advance to proliferative retinopathy, which changes, and eye deviations. See also RUBEOLA
consists of growth of abnormal new blood vessels (16-44).
(neovascularization) and accompanying fibrous
tissue. running sutures, continuous sutures. Surgical
technique. Type of suture in which the stitches are
drug abuse. Various types of retinal pathology not tied separately.
caused by long-term intravenous drug abuse.
S-Factor. Calculation. The surgeon factor which
hypertensive. Retinal changes found in people identifies the space between the lens and the iris.
who have high blood pressure. Employed in the IOL power calculation formula
developed by Dr. Jack Holladay. S-Factor is the lens
retinopexy (RET-in-oh-pek-see). Surgical constant used in this formula.
procedure. Use of diathermy to repair a detached
retina. safety lens. Optical device. Eyeglass lens treated
(with heat, chemicals, or lamination) to resist
retrobulbar (ret-roh-BUL-bar). Location. Behind breakage and splintering from direct blows.
the eyeball but within the orbit.
sarcoma. Pathologic condition. Malignant tumor of
retrobulbar injection. Injection of a drug behind the connective tissue.
eyeball, into the middle of the muscle cone. Usually
for anesthesia and akinesia (immobilization) of an sc (without (sin) correction). Signifies that vision
eye. was tested while the patient was not wearing
eyeglasses or contact lenses.
rhodopsin (roh-DAHP-sin), visual purple.
Chemical. Primary photopigment of rods; one of 4 scanning electron microscope (SEM). Scientific
photosensitive pigments in the retina. Composed of instrument. Type of electron microscope designed to
vitamin A aldehyde plus the protein opsin. As light allow extremely high magnification, for
strikes the photopigment, it bleaches and begins a examination of the surfaces of any fixed tissue or
chain of electrical impulses that travel along the other material.
optic nerve to the brain.
Schiotz tonometer (SHEE-ahtz). Instrument.
Mechanical device designed to measure tension

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Chapter 16 - Glossary

inside the eye (intraocular pressure) by indenting trabecular meshwork, and behind the forward
anesthetized cornea with weighted metal plunger. attachment of ciliary muscle fibers.
See also INDENTATION TONOMETER (16-27).
sclerectomy. Surgical procedure. Removal of a
Schlemm’s canal (schlemz), canal of Schlemm. piece of sclera.
Anatomy. Circular channel deep in cornea-scleral
junction (limbus); collects aqueous fluid from sclerectomy (posterior). Surgical procedure.
anterior chamber of the eye and delivers it into the Removal of a small segment of sclera from the rear
blood stream. of the globe.

Schwalbe’s line (SHWAHL-beez). Anatomy. sclerokeratoplasty (SKLEH-roh-KEHR-uh-toh-


Peripheral edge of Descemet’s membrane in the plas-tee). Surgical procedure. Removal and
cornea. replacement of entire corneal width including a rim
of sclera that extends 2-3 mm beyond cornea-scleral
scintigraphy (sin-TIG-ruh-fee) or junction (limbus).
dacryoscintigraphy. Test. Photographing and
measuring a radioactive tracer in the tear film as it sclerostomy (skleh-RAHS-tuh-mee). Surgical
travels through the tear drainage system. procedure. Opening made into the sclera; may be
left permanently, such as for fluid drainage.
sclera (SKLEH-ruh), tunica fibrosa ocull, white of
the eye. Anatomy. Opaque, fibrous, protective outer sclerotomy (shleh-RAH-tuh-mee). Surgical
layer of the eye; contains collagen and elastic fibers. procedure. Incision into the sclera.
Directly continuous with cornea in front and with
sheath covering optic nerve behind. scleritis (skleh-RY-tis). Pathologic condition.
Inflammation of the sclera.
scleral buckle (SKLEH-rul). Surgical procedure.
Used in repair of a retinal detachment; the sclera is scopolamine (skuh-PAUL-uh-meen). Drug. Eye
indented or “buckled” inward, usually by sewing a drop that blocks parasympathetic nerves, causing
piece of preserved sclera or silicone rubber to its paralysis of iris sphincter (dilation) and ciliary body
outer surface. (cycloplegia) for 2-3 days. Used in treatment of
anterior uveitis.
scleral depressor. Instrument. Rounded rod or a
thimble with a prong. In a retinal examination, used scotoma (skuh-TOH-muh), blind spot. Functional
for pressing on the sclera so that the ora serrata can defect. Non-seeing area within the visual field that
be viewed with an ophthalmoscope. may occur with damage to the visual pathways or
retina. A physiologic blind spot (“the blind spot”,
scleral flap. Surgical procedure. Section of sclera blind spot of Mariotte) exists normally and marks
that has been dissected on 2 or 3 sides; used to the site of the optic nerve.
expose the deeper sclera or inside of eye. Part of
trabeculectomy procedure for glaucoma, scotopic adaptation (skoh-TOP-ik). Pathologic
iridocyclectomy for removal of a small intraocular condition. Adaptation to low levels of luminance at
tumor, and (seldom) for retinal detachment surgery. which only rod vision is operative.

scleral ring. Surgical instrument. Single or double scotopic vision, night vision, rod vision. Function.
ring temporarily sewn to the sclera during eye Refers to vision at low light levels; primarily a
surgery requiring a wide opening, to provide function of (retinal) rods. Maximum sensitivity
mechanical support and prevent collapse of the usually after 30 minutes in the dark.
globe.
scurvy (SKUR-vee). Pathologic condition. Disease
scleral spur. Anatomy. Mass of sclera fibers caused by vitamin C deficiency. Can result in eye
bordered in front by the canal of Schlemm and the findings caused by orbital bleeding (e.g., bulging

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Chapter 16 - Glossary

eyeballs) and hemorrhages in the eyelids, anterior shallow angle. Anatomic variation. Type of open
chamber, vitreous space, and conjunctiva. angle in which the space between the iris and cornea
is shallower than normal. Increases the potential for
sebaceous gland. Anatomy. Any of the group of restricting drainage of aqueous fluid through
cells in the skin that excrete a greasy lubricant; trabecular meshwork. See also ACUTE ANGLE
usually open into hair follicles. See also CLOSURE GLAUCOMA (16-6).
MEIBOMIAN GLAND (16-33), ZEISS GLAND
(16-55). Sheets lens. Optical device. Trade name of plastic
intraocular lens used as replacement for an extracted
seborrheic blepharitis (seb-ur-EE-ik blef-ur-I-tis). cataract; implanted into the posterior chamber
Pathologic condition. Chronic dandruff-like against the posterior lens capsule.
inflammation of the eyelid margin, with redness,
swelling, itching, and scaly skin. shingles, herpes zoster. Pathologic condition.
Painful condition caused by the chickenpox virus.
secondary glaucoma (glaw-KOH-muh). Pathologic When the 1st division (ophthalmic nerve) of the 5 th
condition. Increased intraocular pressure resulting (trigeminal) cranial nerve is affected, extremely
from a known cause, such as inflammation, painful, blister-like skin lesions are produced on the
degeneration, trauma, or tumor growths within the face, sometimes with inflammation of the cornea,
eye. See also GLAUCOMA (16-23). sclera, ciliary body, and optic nerve.

secondary implant. Optical device. Intraocular lens sickle cell disease. Pathologic condition. Hereditary
implanted into an eye as a 2nd surgical procedure (to blood cell disorder predominantly affecting blacks.
replace an extended cataract) at a later date. Results in comma-shaped capillaries in the
conjunctiva, and retinal changes, e.g., abnormal
sector iridectomy (ir-ih-DEK-toh-mee). Surgical formation of new vessels (neovascularization) into
procedure. Removal of a wedge-shaped section of “sea-fans,” arterial blockage, capillary closure,
the iris root, leaving a keyhole-shaped pupil. angioid streaks, and iridescent, refractile, glistening
retinal deposits.
senile macular degeneration (SMD) (MAK-yoo-
lur), age-related macular degeneration. Pathologic silicone lens (SIL-ih-kohn). Optical device.
condition. One of the most common causes of Oxygen-permeable contact lens that is soft and
decreased vision after age 60. Usually evident as a flexible, and maintains its size and shape whether or
loss of pigment from pigment epithelium and not it is kept in a solution.
deposits of yellowish material in the sub-pigment
epithelial layer in the central retinal zone. Abnormal Simcoe lens. Optical device. Trade name of plastic
new blood vessels may grow under the retina and intraocular lens used as replacement for an extracted
leak fluid and blood. cataract; implanted into the posterior chamber
against the posterior lens capsule.
sepsis (SEP-sis). Pathologic condition. Toxic
condition resulting from the spread of bacteria or simple hyperopic astigmatism (hy-pur-AHP-ik uh-
their toxic products from a focus of infection STIG-muh-tizm). Refractive error. Optical defect in
somewhere in the body. which light rays entering the eye are bent unequally
in different meridians, preventing formation of a
septicemia. Pathologic condition. Pathogenic or sharp focus on the retina. Instead, rays form one
septic products of bacteria in the bloodstream. focal line on the retina, while in the meridian 90º
away they form another focal line in the vitreous, in
sequelae (suh-KWEL-I). Medical term. Aftereffects front of the retina. Corrected by a minus cylinder.
(usually an abnormality) of disease, injury,
procedure, or treatment. Sinskey lens. Optical device. Trade name of plastic
intraocular lens used as replacement for an extracted

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Chapter 16 - Glossary

cataract; implanted into the posterior chamber specular endothelial microscopy (SPEK-yoo-lur
against the posterior lens capsule. en-doh-THEE-lee-ul my-KRAHS-kuh-pee),
specular microscopy. Test. Magnified visualization
slit lamp, biomicroscope. Instrument. Table-top of the corneal endothelial cells (pattern and density)
microscope for examining the eye; consists of a by a technique that uses light reflection from
microscope of low magnifying power (6x to 40x) endothelium. Non-contact methods use of modified
and a light source that projects a rectangular beam slit lamp microscope to focus light on the epithelium
that can be changed in size and focus. Allows and produce an illuminated specular reflex on it. In
examination of cornea, lens, and otherwise clear contact methods the instrument touches the corneal
fluids and membranes in layer-by-layer detail. One surface.
of the most important ophthalmic instruments.
specular microscope (SPEK-yoo-lur), endothelial
Snellen chart. Test chart. For assessing visual camera. Instrument. Used for examining and
activity. Rows of letters, numbers, or symbols in photographing size and regularity of corneal
standardized graded sizes, with a designated endothelial cells, which line undersurface of the
distance at which each row should be legible to a cornea. Particularly useful in determining risk to the
normal eye. Usually tested at 6 m (20 ft). cornea from cataract extraction.

Snellen letter. Test standard. Letter constructed so specular photography. Pictures of the corneal
that at a specified distance from the eye it subtends endothelium taken with a specular microscope
an angle of 5 minutes of arc; each portion of the (endothelial camera).
letter subtends an angle of 1 minute of arc.
speculum (SPEK-yoo-lum). Instrument. Device for
sodium hyaluronate. Drug. Thick, elastic gel; used holding eyelids apart. Used during surgical
temporarily during eye surgery to help stabilize procedures to give better access to the eyeballs.
structures in their normal positions and protectively
coat them. See also HEALON (16-25). spherical aberration. Optics. Image distortion
caused by the increased bending of light rays that
soft exudates (EKS-ih-dayts), cotton-wool spots. occurs when rays strike a lens its edge, in
Clinical spots. “Fluffy-looking” (resembling tufts of comparison to those that strike nearer the center.
cotton) white deposits within retinal nerve fiber
layer; represent small patches of retina that have lost spherical lens. Optical device. Lens with smooth
their blood supply by vessel obstruction. Often spherical surfaces that bend light rays equally in all
associated with hypertensive and diabetic meridians.
retinopathies and certain collagen vascular diseases.
Gradually disappear without treatment, leaving sphero-cylindrical lens (SFIR-oh sih-LIN-druh-
some functional loss. kul), toric lens. Optical device. Any lens with a
cylindrical component; used for correcting an eye’s
soft tip probe. Ultrasound. An ultrasound handpiece astigmatic refractive error. Most eyeglasses are of
(transducer) that uses a water standoff between the this type.
probe and the eye. When the probe is applanated to
the eye, the water filled section contours to the eye spherical lens. Optical device. Lens with smooth
providing a more accurate measurement. spherical surfaces that bend light rays equally in all
meridians.
solid tip probe. Ultrasound. A-Scan probe with hard
front surface which does not require filling with sphincterotomy. Surgical procedure. A cut through
water. The eye contours to the probe. the iris sphincter muscle.

spectacles. Optical device. Eyeglasses. SR. Abbiation for SUPERIOR RECTUS.

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Chapter 16 - Glossary

SRK formula. Measurement. One of several Stevens-Johnson syndrome. Pathologic condition.


formulas for calculating the proper power for an Severe conjunctival disease found in about 50% of
intraocular lens prior to cataract surgery. Uses the patients who have erythema multiforme, and
A-Constant as the lens factor in the equation. See allergic type of skin disease. Inflammation may
also BINKHORST EQUATION (16-10). result in adhesions binding lower eyelids and
conjunctiva to the eyeball (symblepharon), eyelid
Staphylococcus epidermidis (staf-il-oh-KAHK-us scarring, dry eyes, and closure of the tear ducts.
ep-ih-DUR-mid-is). Microorganism. Gram-
positive, round bacteria found normally in the skin strabismus (struh-BIZ-mus), deviation,
around the eye. heterotropia, squint, tropia. Functional defect. Eye
misalignment caused by extraocular muscle
staphyloma (staf-ih-LOH-muh). Pathologic imbalance: one fovea is not directed at same object
condition. Bulging of part of the uvea (e.g., iris, as the other. Deviation is present even when both
ciliary body) into an area of thin, stretched sclera. If eyes are uncovered.
no uveal tissue is included in the stretched area, the
condition is called an ectasia. Streptococcus pneumoniae (strep-tuh-KAHK-us
noo-MOH-nee-ee), pneumo. Microorganism. One
stasis. Pathologic condition. Slowing or stoppage of of the most common gram-positive bacteria causing
normal flow of blood or bodily fluid. eye infections, esp. corneal ulcers. Bacterial grow in
pairs. See also PSEUDOMONAS AERUGINOSA
steamy cornea, corneal edema. Clinical sign. Hazy, (16-41).
swollen cornea.
striae (STREE-uh). Anatomic defect. Wrinkles or
stereopsis (stehr-ee-AHP-sis), binocular depth folds. Seen in the choroid and cornea.
perception, stereoscopic vision, third grade fusion.
Function. Visual blending of two similar but not string of pearls. Clinical sign. Concentration of
identical images (one falling on each retina) into inflammatory cells in the vitreous; resembles a pearl
one, with resulting visual perception of solidity and necklace. Type of sarcoid.
depth.
stroma (corneal), substantia propria. Anatomy.
stereoscope (STEHR-ee-uh-skohp). Instrument. Middle tissue layer that forms 90% of cornea.
Device for viewing a stereogram; images intended Composed of layered collagen fibrils and cells.
for each eye are kept optically separate. Used for
developing fusional amplitudes or for recreational stroma (iris). Anatomy. Primary substance of the
viewing. iris. Contains pigment cells that determine eye color,
and two non-striated muscles: the ring shaped
stereoscopic vision (stehr-ee-uh-SKAHP-ik). See sphincter and the radially-fibered dilator.
STEREOPSIS (16-48).
stye, external hordeolum, hordeolum. Pathologic
stereotaxic surgery (stehr-ee-oh-TAK-sik). condition. Acute pustular infection of the oil glands
Surgical procedure. Technique in which the head of Zeiss, located in an eyelash follicle at the eyelid
(and sometimes eye) are firmly stabilized by a series margin.
of clamps. Used so that movement of instruments
inside the head or eyeball can be carefully subacute sclerosing panencephalitis (SSPE)
controlled. (sklur-OHS-ing pan-en-cef-uh-LY-tis). Pathologic
condition. Late complication from a childhood viral
steroid, corticosteroid. Drug. Medication used to disease (e.g., measles). Affects the brain and retinal
treat inflammatory and allergic diseases. With long- tissue, with macular or perimacular inflammation,
term use, serious side effects possible, e.g., cataracts retinal swelling (edema), and hemorrhage. Begins
and glaucoma. See also PREDNISONE (16-41), with personality changes and seizures; death occurs
PREDNISOLONE (16-41). within a few months. No known treatment.

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Chapter 16 - Glossary

subconjunctival hemorrhage (sub-kahn-junk-TY- inward), and movement of the eye outward from
vul HEM-uh-rij). Clinical sign. Bleeding from a midline (abduction). Innervated by the 4th
small blood vessel under the conjunctiva; often (trochlear) cranial nerve.
spontaneous or from coughing. Creates a harmless
but striking bright-red blood appearance over the superior punctum (PUNK-tum), upper punctum.
sclera. Blood absorbs in about 1 week without Anatomy. Dimple-like opening in upper eyelid
treatment. margin near nose. Marks the upper entrance to the
eye’s tear drainage system.
subconjunctival injection. Method of injecting
ocular drugs between the conjunctiva and Tenon’s superior rectus (SR). Anatomy. Muscle attached to
capsule. the outside of the eyeball, at the top, 8 mm from the
limbus; innervate by the 3rd (oculomotor) cranial
subcutaneous (sub-kyoo-TAY-nee-us). Location. nerve. Responsible for elevation of the eyeball
Under the skin. (which increases as eye moves outward from
midline), eyeball intorsion (which increases as eye
subluxation (sub-luks-AY-shun), dislocation lens. moves toward the nose), and movement of the eye
Pathologic condition. Partial or complete inward toward the nose (adduction).
displacement of crystalline lens from its normal
position; caused by broken or absent zonules. See sutures. 1. Anatomy. Irregular junctions between
also LUXATION (16-32). immovable bones. In the crystalline lens, the Y-
shaped junction zone of the lens fiber tips. 2.
sulcus fixation. Surgical procedure. One way a Material. “Thread” used in surgically stitching
plastic intraocular lens is held in place. The tissue. 3. Method. Joining tissue by surgical stitches.
footplates (haptics) of a posterior chamber IOL are See also BRIDLE SUTURE (16-11), RUNNING
set into the natural groove (ciliary sulcus). See also SUTURE (16-44).
CAPSULAR FIXATION (16-12).
sympathetic nervous system. Anatomy. Part of the
sulfonamide (sul-FON-ah-mide). Drug. Sulfa autonomic nervous system responsible for “fight or
drugs, generally associated with a broad spectrum of flight” response. Innervates iris dilator muscle in the
bacteriostatic activity. Sulfonamides have been eye, Mueller’s muscle in eyelid and secretion by
largely supplemented by more effective and less ciliary epithelium, and controls size (diameter) of
toxic drugs. blood vessels in the eye.

superior. Location. On or near the upper part of an sympatholytic drug (sim-path-oh-LIT-ik),


organ or of the body. See also INFERIOR (16-27). adrenergic blocking drug. Used in control of
glaucoma. Blocks action of sympathetic nerves by
superficial punctate keratitis (SPK) (PUNK-tayt inactivating epinephrine in nerve impulse
kehr-uh-TY-tus), punctate kertitis, Thygeson’s transmission; sometimes causes pupillary
superficial punctate keratitis. Pathologic condition. constriction. See also TIMOLOL MALEATE (16-
Corneal disease characterized by small superficial 51).
corneal lesions; other symptoms include foreign
body sensation and sensitivity to bright lights. Cause sympathomimetic drug (sim-path-oh-mim-ET-ik),
unknown; sometimes recurs after spontaneous adrenergic stimulating drug. Drug. Used to control
remission. glaucoma (mechanically opens anterior chamber
angle to increase aqueous outflow, and decreases
superior oblique (SO) (oh-BLEEK or oh-BLIKE). aqueous secretion form ciliary epithelium), to dilate
Anatomy. Muscle attached to the outside of the pupil without affecting accommodation, and
eyeball behind the equator, at the top responsible for “whiten” eye by constricting dilated conjunctival
eyeball intorsion (which increases as eye moves blood vessels. Mimics action of sympathetic
outward), depression (which increases as eye moves nervous system. See also EPINEPHRINE (16-21).

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Chapter 16 - Glossary

synechia (sin-EEK-ee-uh). Pathologic condition. the lacrimal sac to an opening in the mucous
adhesions that bind the iris to any adjacent membrane of the nose.
structures.
tear film, pre-corneal tear film. Anatomy. Liquid
anterior. Between iris and cornea. that bathes cornea and conjunctiva. Composed of 3
layers: outermost oily layer secreted by meibomian
peripheral anterior. Between iris periphery and gland, middle aqueous layer secreted by lacrimal
cornea; occurs with unrelieved attacks of angle- gland, innermost mucin layer produced by the
closure glaucoma; may occur following injury conjunctival goblet cells.
or surgery.
tear film breakup time, breakup time, tear breakup
posterior. Between iris and lens; occurs time. Measurement. Time interval between a blink
commonly in uveitis. and the development of a dry spot in pre-corneal tear
film; less than 10 seconds is abnormal. Spot is
synergist (SIN-ur-jist). Function. Extraocular visible after fluorescein staining, especially with
muscle that assists primary muscle in that eye for cobalt blue beam on slit lamp.
making a particular eye movement. Additive effect.
2 + 2 = 5. tear sac, lacrimal sac. Anatomy. Bag-like tear
collecting structure lying under the skin near bridge
syphilis (SIF-ih-lus). Pathologic condition. A of nose. Tears enter from the common canaliculus
venereal disease; in late stages may affect optic and leave from the lacrimal duct on the nose.
nerves (producing visual field loss) and cause
Argyll-Robertson pupils, interstitial keratitis, temporal. Location. 1. Refers to the direction
uveitis, vitreitis, retinal vasculitis, and choroiditis. leading toward the ear or temple, away from the
nose. 2. That half of the eye on the visual field from
systemic (sis-THE-mik). Medical term. Affecting the vertical midline outward. See also NASAL.
the body generally, rather than a specific (local)
area. tendon. Anatomy. Strong, fibrous band of tissue that
attaches muscle to another part of the body, e.g., the
tachycardia (tak-ih-KAHR-dee-uh). Clinical sign. extraocular muscles to sclera.
Unusually rapid heart rate. May be physiological, as
after exercise, or pathological. tenectomy (the-NEK-tuh-mee). Surgical
procedures. Removal of a portion of a muscle’s
tamponade (tam-puh-NAHD). Medical term. tendon. Weakens the muscle’s action; stitching the
Closure or blockage of a wound or body cavity by ends together strengthens the action.
pressing or plugging, especially to stop bleeding.
tenotomy (ten-AHT-uh-mee). Surgical procedure.
tarsal glands (TAR-sul), meibomian glands. Cutting a muscle’s tendon without actually
Anatomy. Oil glands within eyelid tissue (tarsus) removing any of the severed tissue. Used for
whose ducts open onto the eyelid margin just behind weakening a muscle’s action.
the gray line. Secretions supply outer portion of the
tear film, which prevents rapid tear evaporation and tension by applanation (TA, TAP) (ap-lan-AY-
tear overflow and provides tight eyelid closure. See shun), applanation tonometry. Measurement.
also CHALAZION (16-14). Determination of intraocular pressure by measuring
the force required to flatten a specific amount of
tarsus (TAHR-sul), tarsal plate. Anatomy. Dense, central cornea. See also GOLDMANN
plate-like framework within upper and lower eyelids INDENTATION TONOMETRY (16-27),
that provides stiffness and shape. PNEUMOTONOMETER (16-40).

tear duct, lacrimal duct, nasolacrimal duct. tetracaine hydrochloride. Drug. Anesthetic eye
Anatomy. Tear drainage channel that extends from drop.

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thrombophlebitis (thrahm-boh-fluh-BY-tus), toxin. Poisonous substance derived from a living


phlebitis. Pathologic condition. Inflammation of a organism; capable of causing formation of
vein. antibodies.

thrombus (THRAHM-bus). Pathologic condition. trabecular meshwork (truh-BEK-yoo-lur),


Clot of blood formed within a blood vessel and cribform ligament, ligamentum pectinatum iridis,
remaining attached there, sometimes blocking all scleral trabeculae, trabeculum. Anatomy. Mesh-
flow. Can result from slowed circulation, abnormal like structure inside eye at iris-scleral junction of
blood, or abnormal blood vessel walls. anterior chamber angle. Filters aqueous fluid and
controls its flow into the canal of Schlemm, prior to
timolol maleate (TIM-oh-lol MAY-ee-ayt). Drug. its leaving the anterior chamber.
Beta-adrenergic-blocking agent that reduces
aqueous secretion; used as eye drop for controlling trabeculectomy (truh-bek-yoo-LEK-tuh-mee).
glaucoma. Produces no effect on pupil or on Surgical procedure. Removal of part of the
accommodation. See also SYMPATHOLYTIC trabecular meshwork to increase outflow of aqueous
DRUG (16-49), TIMOPTIC (16-51). humor from the eye; type of filtering procedure used
in the treatment of glaucoma.
Timoptic (tim-AHP-tik). Drug. Trade name of
timolol maleate, used in controlling glaucoma. trabeculotomy (truh-bek-yoo-LAHT-uh-mee).
Surgical procedure. An incision into the trabeculum
tobramycin (toh-bruh-MY-sin). Drug. Broad to increase drainage of aqueous from an eye with
spectrum antibiotic eye drop used to treat external glaucoma. Can be performed from outside
eye infections. See also TOBREX (16-51), (trabeculotomy ab externo) or inside the eye.
AMINOGLYCOSIDE (16-7).
ab externo. Cutting from outside the eye inward
Tobrex. Drug. Trade name for tobramycin, eye drop to reach Schlemm’s canal, the trabecular
used in control of some types of external eye meshwork and the anterior chamber; treatment
infections. for congenital glaucoma, especially when there
is a cloudy cornea.
tonometer (tuh-NAHM-ih-tur). Instrument. Device
that measures intraocular pressure. trabeculum. See TRABECULAR MESHWORK
(16-51).
applanation. Measures force required to flatten
a small area of central cornea. Does not indent trachoma (truh-KOH-muh). Pathologic condition.
globe, so actual intraocular pressure is not Severe, chronic, contagious conjunctival eyelid and
disturbed. Usually attaches to slit lamp. corneal infection; caused by chlamydial
microorganisms; leads to corneal blood vessel
indentation. Measures amount that the cornea formation, corneal clouding, conjunctival and eyelid
is indented by a fixed weight that artificially scarring, and dry eyes. Leading cause of blindness in
raises the pressure. Somewhat less accurate the world.
than applanation. Example: Schiotz.
trachoma inclusion conjunctivitis virus family
pneumotonometer, pneumatic tonometer. (TRIC) (in-KLOO-zhun, kun-junk-tih-VY-tus).
Blows puff of air against cornea and flattens it Microorganism. Chlamydial microorganisms that
slightly. Gas pressurized; does not require any cause conjunctivitis-producing conjunctival
instrument contact with eye. follicles and intracellular inclusion bodies (seen on
microscope slide specimens).
toric lens (TOR-ik), sphero-cylindrical lens.
Optical device. Lens with a cylindrical component; transducer. Ultrasound. Piezo-electric crystal
used for correcting an eye’s astigmatic refractive which is used to transmit and receive ultrasound
error. Most eyeglasses are of this type. signals.

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Chapter 16 - Glossary

transillumination. Test. Use of an intense light 20/20, 6/6. Normal visual acuity. Upper number
beam, such as a slit lamp or small flashlight, to shine indicates that a patient is able to see standardized
through translucent eye tissue to better visualize symbols on a chart 20 ft (6 m) away; lower number
ocular tumors, cysts, or hemorrhages. indicates that the same symbols can be seen at 20 ft
by an eye with a normal optical system. See also
transposition. 1. Surgical procedure. Repositioning SNELLEN CHART (16-47).
a normal extraocular muscle beside a non-
functioning muscle to correct an eye deviation. 2. UGH syndrome. Pathologic condition. Acronym
Mathematical formula. Converting prescription for (Uveitis, Glaucoma, Hyphema) for complications
a sphero-cylindrical lens from plus-cylinder form that occur secondary to intraocular lens implantation
into equivalent minus-cylinder form, or vice versa. in the anterior chamber; caused by rubbing of the
lens loops (haptics) on sensitive adjacent tissue
trauma. Medical term. Injury. structures.

trephine (TREE-fine). 1. Surgical instrument. ultrasonography. See ULTRASOUND (16-52).


Cutting tool that makes a circular hole in tissue, e.g.,
corneal “button” for a corneal transplant. 2. Surgical ultrasound, echography, ultrasonography. Test.
procedure. Small (2 mm) hole through the sclera at Transmission of high frequency sound waves into
the limbus, for treatment of glaucoma (use prior to the eye, which are reflected by the ocular tissues and
1960). displayed on a screen so that internal structures can
be visualized. Aids in diagnosis of eye, orbital
trifocal (TRY-foh-kul). Optical device. Eyeglass problems and in determining the eyes axial length.
lens that incorporates 3 lenses of different powers. See also A-SCAN (16-9), B-SCAN (16-11).
Main portion is usually focused for distance (20 ft),
center segment for about 2 ft, and lowest segment unilateral. Referring to or located on one side of the
for near (14 in). body.

tropia (TROH-pee-uh), deviation, heterotropia, uniocular (yoo-nee-AHK-yoo-lur). Referring to or


squint, strabismus. Functional defect. Eye affecting one eye.
misalignment cause by extraocular muscle
imbalance: one fovea is not directed at same object upper canaliculus (kan-uh-LIK-yoo-lus), superior
as the other. Deviation is present even with both canaliculus. Anatomy. Part of tear drainage system.
eyes uncovered. Thin, elastic duct within upper eyelid, near nose;
connects upper punctum to the common canaliculus.
tropicamide. (trahp-ih-KAM-ide). Drug. A syntheic
anti-cholinergic C17H20N202. Eye drop that blocks upper punctum, superior punctum. Anatomy.
parasympathetic nerves, producing dilated pupils Dimple-like opening in the upper eyelid margin near
and paralyzed accommodation (cycloplegia) for the nose. Marks the upper entrance to the eye’s tear
about 3 hours. See also MYDRIACYL (16-34). drainage system.

tuberculosis. Pathologic condition. Communicable upside down ptosis. Clinical sign. Lower eyelid that
disease caused by tubercle bacillus, affecting entire is higher than normal, giving appearance of a
body, especially lungs. Eye findings include blurred “sunken” eye. Caused by loss of sympathetic
vision, “mutton fat” keratic precipitates, “cell and innervation (Homer’s syndrome).
flare,” iris nodules, gray isolated masses (tubercles)
in the choroid. urinalysis (U/A) (yur-un-AL-uhs-is). Lab test.
Chemical analysis of urine, to test for abnormal
tunnel vision, tubular visual fields. Functional loss. contents (e.g., albumin, pus, sugar) that may
Loss of peripheral visual field with the retention of indicate systemic disease.
some degree of central field. Typical of the end
stages of glaucoma and retinitis pigmentosa.

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Chapter 16 - Glossary

uvea (YOO-vee-uh), tunica vascularis ocull, uveal Vacuum Response. Speed with which system
tract. Anatomy. Pigmented layers of eye (iris, ciliary generates commanded vacuum level. Stellaris PC
body, choroid) that contain the majority of the blood Vision Enhancement System has a vacuum response
vessel supply. range of 1 to 5 (1= fastest).

uveal tract. The iris, ciliary body, and choroid. Vistech system. Test. Test for contrast sensitivity,
ability to detect detail with gradations in grayness
uveitis (yoo-vee-I-tis). Pathologic condition. between test target and background.
Inflammation of any of the structures of the uveal
tract: iris, ciliary body, or choroid. visual purple, rhodopsin. Chemical. Primary
photopigment of the rods; one of four photosensitive
Vacuum Response. Speed with which system pigments found in the retina. Consists of retinal (a
generates commanded vacuum level. Stellaris PC derivative of vitamin A) and the protein opsin. As
Vision Enhancement System has a vacuum response light strikes the photopigment, it bleaches and
range of 1 to 5 (1= fastest). begins a chain of electrical impulses that travel
along the optic nerve to the brain.
vascular. Medical term. Referring to, affecting, or
constituting a blood or lymph vessel. vitamin A, retinol. Chemical. Vitamin A alcohol.
Stored in the liver and perhaps retinal pigment
vasculature. Anatomy. Arrangement of blood epithelium. Ultimately modified and used by the
vessels in an organ or part. rods and cones as the photosensitive pigment
responsible for initiating the visual process.
vasculitis. Pathologic condition. Inflammation of a
blood or lymph vessel. vitamin A deficiency. Pathologic condition.
Chronic long-term lack of vitamin A; affects eyes
vector. An A-Scan image which is displayed in severely, causing conjunctival and corneal dryness
conjunction with a B-Scan, represents one line of (xerosis), corneal softening (keratomalacia),
information pulled from the B-Scan. conjunctival dry (Bitot) spots, and night blindness.
See also XEROPHTHALMIA (16-55).
velocity. Rate at which sound is determined to travel.
vitamin B1 (thiamine) deficiency, beriberi.
vertex distance. The distance between the cornea Pathologic condition. Nervous system and
and the optical center of the lenses in a pair of gastrointestinal disturbances usually accompanied
glasses. by conjunctivitis and/or staphylococcal
inflammation of the eyelids. Long-term deficiency
vertigo. Symptom. Dizziness. can lead to optic nerve damage and amblyaphia.

viral conjunctivitis (kun-junk-tih-VY-tis), “pink- vitamin B12 (cobalamin) deficiency. Pathologic


eye”. Pathologic condition. Viral inflammation of condition. Can cause pernicious anemia (made
the conjunctiva (mucous membrane that covers worse by heavy smoking) with, possibly, optic nerve
white of eye and inner eyelid surfaces). degeneration and atrophy.
Characterized by discharge, grittiness, redness and
swelling. Usually contagious. vitamin C (ascorbic acid) deficiency. Pathologic
condition. Eye signs include hemorrhages in the
virus. Microorganism. Tiny particle of lids, conjunctiva, iris, retina, anterior chamber and
nucleoprotein that is capable of penetrating cells, orbit, which can result in the eye bulging forward
multiplying and infecting host tissue. (proptosis). See also SCURVY (16-45).

viscosurgery. Technique. Performing eye surgery vitamin D deficiency. Pathologic condition. May
with the aid of viscoelastic fluids. See also cause lamellar cataracts.
SODIUM HYALURONATE (16-47).

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Chapter 16 - Glossary

vitrectomy (vih-TREK-tuh-mee). Surgical vitreous hemorrhage, vitreal bleed. Pathologic


procedure. Removal of vitreous, blood, and/or condition. Blood in the vitreous; may be the result of
membranes from the eye, usually by entering blunt eye trauma, blood leakage from abnormal new
through the pars plana with a needle-like rotary retinal vessel networks (neovascularization),
cutter that has fluid injection and suction vitreous detachment, or retinal tear.
capabilities.
vitreous opacities. Anatomic defect. Obstructions in
“open sky.” Opening eye from the front to gain the vitreous gel, such as foreign body, blood, or
access, such as by incising the corneal edge (limbus) inflammatory debris.
for at least 180º, or removing a corneal button and
extracting the lens. vitreous tap. Surgical procedure. Puncture into the
vitreous to remove a small sample, usually for
vitreous (VIT-ree-us), vitreous gel. Anatomy. culturing or microscopic study.
Transparent, colorless, gelatinous mass (fine
collagen fibrils and hyaluronic acid); fills rear two- vitreous touch. Pathologic condition. Cataract
thirds of interior of the eyeball, between the lens and between vitreous gel and corneal endothelium,
the retina. following cataract extraction. Sometimes causes
endothelial damage with resultant corneal swelling.
vitreous base. Anatomy. Dense, ribbon-like (2 mm
wide) firm attachment of vitreous surface to the water bath probe. Ultrasound. Probe which uses
peripheral retina and ora serrata. water as a median of transmission between
transducer and cornea.
vitreous bulge. Forward protrusion of vitreous gel
into anterior chamber; common during and water drinking test. Test. Aid in diagnosis of
following cataract extraction. primary open angle glaucoma. Patient drinks 1 quart
of water in 5 minutes to stress the aqueous drainage
vitreous detachment, posterior vitreous mechanism. Intraocular pressure is then measured
detachment. Pathologic condition. separation of over the next hour. Pressure rise of 8 mm of mercury
vitreous gel from the retinal surface. Frequently suggests presence of open angle glaucoma.
occurs with aging as the vitreous liquefies, but may
occur in diseases such as diabetes and in severe warnings. Drugs. High probability of unwanted or
myopia. Usually innocuous, though can create undesirable side-effects occurring; disclosing
retinal tears that may lead to retinal detachment. contraindicated concomitant therapy.

vitreous face. Anatomy. 1. Condensation of the front Weck Cells. Surgical material. Trade name of small
(anterior) surface (face) of the vitreous, resting pieces of highly absorbent cellulose sponge used
behind the lens. 2. Condensation of the posterior during eye surgery to absorb blood, vitreous, and
surface of the vitreous that attaches to the retina’s other fluids.
inner limiting membrane. See also ANTERIOR
HYALOID MEMBRANE (16-8), POSTERIOR “with-the-rule” astigmatism (uh-STIG-muh-tizm).
HYALOID MEMBRANE (16-40). Refractive error. Optical power that is greater (more
plus power) in the vertical meridian of an eye than in
vitreous floaters, floaters. Pathologic condition. the horizontal meridian. Corrected by a plus-
Any particles that float in the vitreous and cast cylinder lens with its axis at 90º. See also
shadows on the retina; described by patients as “AGAINST-THE-RULE” ASTIGMATISM (16-7).
spots, cobwebs, spiders, etc. Occur normally with
aging or in association with vitreous detachments, wound dehiscence. Pathologic condition. Breaking
retinal tears, or intraocular inflammations. open or coming apart of the layers of a wound.

vitreous gel. See VITREOUS (16-54).

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Chapter 16 - Glossary

wound leak. Abnormal condition. Escape of fluid or 16.4 Common Medical


tissue through a cut or wound. May be a
complication of ocular surgery, requiring repair. Abbreviations

Xenon lamp. A type of lamp used in the Stellaris PC Below are some commonly used medical
Vision Enhancement System to provide abbreviations.
endoillumination. It contains pure xenon gas and
emits whiter light with a full spectrum. AAGG - acute angle closure glaucoma

Xenon-Mercury lamp. A type of lamp used in a.c. - before meals (ante cibum)
Stellaris PC Vision Enhancement System to provide
endoillumination. It contains xenon gas and small AC - anterior chamber
amounts of mercury metal, and emits greener light.
AGD - anterior chamber depth
xerophthalmia (zir-ahf-THAL-mee-uh).
Pathologic condition. Drying of eye surfaces; AGG - angle closure glaucoma
characterized by loss of corneal and conjunctival
luster, Bowman’s membrane degeneration, and AC IOL - anterior chamber intraocular lens
infiltration of corneal stroma with cells and fluid.
Associated with vitamin A deficiency and any ad lib - as desired (ad libitum)
condition in which the eyelids do not close
completely. AIDS - autoimmune deficiency syndrome

xerosis (zir-OH-sis). Functional defect. AL - axial length


Conjunctival and corneal dryness caused by
deficiency of tears or conjunctival secretions. ARMD - age-related macular degeneration

YAG laser. Surgical instrument. Short pulsed, high ASAP - as soon as possible
energy light beam that con be precisely focused by
computer to cut, perforate, or fragment tissue. See AXI - axial length
also ARGON LASER (16-9).
b.i.d. - twice a day (bis in die)
Zeis glands (zyss). Anatomy. Oil-producing glands
that surround eyelashes; ducts enter lash follicles BSS - balanced saline solution
near eyelid margins. See also STYE (16-48).
c - with (cum)
Zephiran. Trade name for benzalkonium chloride.
Preservative commonly used in ophthalmic CAG - closed angle glaucoma
solutions. Causes allergy in some patients.
CBC - complete blood count
zonules (ZAHN-yoolz), zonules of Zinn. Anatomy.
Radially arranged fibers that suspend the lens from C/D - cup-to-disc ratio
the ciliary body and hold it in position. See also
ACCOMMODATION (16-6).
CME - cystoid macular edema
zonulysis (zahn-yoo-LY-sis). Surgical procedure.
CNAG - chronic narrow angle glaucoma
Installation of enzyme (alphachymotrypsin) into
aqueous to dissolve lens zonules. Facilitates surgical
CNS - central nervous system
removal of entire lens during cataract extraction.
CO2 - carbon dioxide

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Chapter 16 - Glossary

MS - multiple sclerosis
COAG - chronic open angle glaucoma
NA - not applicable
conj - conjunctiva, conjunctival
Neo - neosynephrine
COPD - chronic obstructive pulmonary disease
n.p.o. - Nothing by mouth (nil per os)
D - diopter
NICU - neonatal intensive care unit
DC - discontinue
O2 - oxygen
DC, D/C - discharge (from hospital, clinic or care)
OD - overdose
DCR - dacryocystorhinostomy
OD - doctor of optometry
DOB - date of birth
OD - right eye (oculus dexter)
ECCE - extracapsular cataract extraction
Ophth. - ophthalmology, ophthalmic, etc.
e.g. - For example (exempligrata)
OR - operating room
EKF - epikeratophakia
OS - left eye (oculus sinister)
E.R. - Emergency room
OU - both eyes (oculi utreque)
FBS - foreign body sensation
P - intraocular lens power
GC - gonococcus (gonorrhea)
PARAM - parameters
GTT - drop
PBK - pseudophakic ballous keratopathy
ICCE - itracapsular cataract extraction
p.c. - After meals (post cibum)
IOL - intraocular lens
PCL - posterior chamber lens
IOP - intraocular pressure
PC Lens - posterior chamber lens
IV - intravenously
PI - peripheral iridectomy or iridotomy
K -keratometry
PICU - pediatric intensive care unit
K1 & K2 - corneal curvature readings supplied by a
Keratometer PK - penetrating keratoplasty

LKP - lamellar keratoplasty PKE - phacoemulsification

MI - myocardial infarction; heart attack PKP - penetrating keratoplasty

MICU - medical intensive care unit PMMA - poly(methylmethacrylate)

MRI - magnetic resonance image p.o. - By mouth (per os)

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Chapter 16 - Glossary

po - post-operative RP - retinitis pigmentosa

PPL - pars plane lensectomy RPE - retinitis pigment epithelium

PPV - pars plane vitrectomy RT - right

p.r.n. - When necessary: as the occasion arises (pro Rx - treatment: glasses, medicine, etc.
re nata)
sc - subcutaneous
PX - prognosis
s.c. - Without correction (sine correctia)
PXE - pseudo-xanthoma elasticum
SFAC - surgeon factor
PXF - pseudo exfoliation
SI - sector iridectomy
q.a.m - Every day before noon (Qua que ante
meridiem) SICU - surgical intensive care unit

q.d. - Everyday (qque die) SLE - slit lamp exam

q.h. - Every hour (qua que hora) SMP - simultaneous macular perception

q.h.s - Every bedtime (qua que hore somni) SPH - sphere

q.i.d. - 4 times a day (quater in die) SRK - abbiation for the regression IOL power
calculation developed by Doctors Smith, Retzlaff &
q.n - Every night (quaque nocte) Kraff

q.n.s. - Quantity not sufficient (quantum non sub q - subcutaneous (under the skin)
sufficiat)
TB - tuberculosis
q.o.d. - Every other day (quaque alteradie)
t.i.d. - 3 times a day (ter in die)
q. p.m. - Every day after noon (quaque post
meridiem) Trab. - trabeculectomy

q.s. - Sufficient quantity (quantum sufficiat) UGH - uveitis glaucoma hyphema syndrome

q3h - Every three hours (quaque 3 hora) UNG - ointment

RBC - red blood cell (erythrocyte) UTI - urinary tract infection

RD - retinal detachment VEL - velocity

REF - refractive Vit - vitreous

ret pig - retinitis pigmentosa WBC - white blood cells

RK - radial keratotomy

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Chapter 16 - Glossary

16.5 Fundamentals of Medical cephal/o - head


Etymology chol/e - bile

Etymology - The history of linguistic form by con - with


analyzing a words component parts.
contra - against
Throughout your educational process you have
encountered and will continue to encounter words core/o - pupil
that appear foreign or new to you. Upon further
study you realize that a segment of the word (prefix, corne/o - cornea
suffix, or word root) is familiar to you ie.
Appendectomy- Surgical removal (ectomy) of the cycl/o - ciliary body
appendix.
cyst - bladder
In medicine, 50% to 75% of all scientific terms are
developed by combining various Greek and Latin cyt/o - cell
prefixes, suffixes, and word roots. The following list
of medical and ophthalmic component word parts dacry/o - tears
will be beneficial in your future medical objectives.
It is from the combining of word components like derm/o - skin
those listed below that the medical community
creates words to describe medical conditions and dextr/o - right
treatments. For example, dacryocystorhinostomy
(DAK-ree-oh-sis-toh-ry-NOHS-toh-mee) is dipl/o - two, double
creating an opening (ostomy) between the lacrimal
sac (cyst) and the nose (rhino) so the tears (dacry) dys - bad
can property filter out of the eye.
ect - outside
While this list is not all inclusive, it is intended to
serve as a guide and astarting point. ectomy - excislon of

algia - pain emes/is - vomiting

angi/o - vessel emia - blood

anter/o - before, In front of erythr/o - red

arm- against esthesia - feeling

arter/I/o - artery extra - outside of

bi - two febr/I - fever

blephar/o - eyelid flu, flux - flow

brady - slow gastr/o - stomach

carcin/o - malignancy hem/o, hemat/o - blood

centesis - puncture hepat/o - liver

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Chapter 16 - Glossary

heter/o - different neur/o - nerve

hist/o - tissue ocuI/o - eye

hom/o - same old - form

hydr/o - water ologist - one who studies, a specialist

hyper - over ology - study of

hypo - under oma - tumor

iatr - physician ophthalm/o - eye

idi/o - personal, one’s own, peculiar opia - vision

inter - between opt/o, optlc/o - vision

intra - within osis - condition of

irid/o - iris ostomy - fornung a new opening

itis - inflammation of ot/o - ear

kerat/o - cornea otomy - incision into

lacrim/o - tear pachy - thicken

leuk/o - white para - around, near

lip/o - fat peps, pept - digest

lys/o - destruction per - through

macro - large peri - around

mal - bad pexy - fixation

melan/o - black phac/o, phako - lens of the eye

micro - small pharmac - drug

mono - one phleb/o - veins

nas/o - nose phob/ia - fear

necr/o - dead phot - light

neo - new plas/o - formation

nephr/o - kidney plast/o - repair

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Chapter 16 - Glossary

plegia - paralysis tachy - fast

pne - breathing tel/e - distant, far

pneumo - lung therap/o - treatment

poly - many thermo - heat

post - behind tome - Instrument that cuts

poster/a - behind tox - poison

pseud/o - false tram - across

ptosis - drooping traumat/o - trauma

py/o - pus tri -three

pyr/o - fire, fever uni – one

ren/o - kidney vas/o- vessel

retlin/o - retina

retr/o - behind, in back of

rhe -flow

rhin/o - nose

scler/o - sclera

scler/o - tough, hard

scope, scopy - examining

scot/o - darkness

sep -decay

sinistr/o - left

spasm - twitching

stasis - slow, stop

stigmat/o - mark, point

sub - under

syn - together

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Chapter17 - Revision History

17 Service Manual Revision History

The information contained in this manual is current as of its publication date. Product design and/or specifications may
change without notice. This service manual may be updated periodically.

Revision Effective Date Reason for Change


A 2008 April 14 Original Document
Updated to include new
service procedures and
B 2008 April 21 image changes

Updated for MICS (2.0)


changes and Stellaris
C 2010 April 27 PC.
Corrected missing
E information in Chapter 11

Depot version removed.


Minor updates
throughout to reflect
F 2016 August 01 hardware updates .

Table 17.1: Revision History

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Chaper 17 - Revision History

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Chapter 18 - Addendum

18 Addendum

18.1 Tools

Figure 18.1. Adapter, 1/4" Hexagonal to 3/8" Square

Figure 18.2. Adapter, 1/4" Square to 1/4" Hexagonal

Figure 18.3. Bit, Cross Tip

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Chaper 18 - Addendum

Figure 18.4. Bit, Hexagonal.

Figure 18.5. Small Wire Cutters.

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Chapter 18 - Addendum

Figure 18.6. Extension.

Figure 18.7. Flashlight.

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Chaper 18 - Addendum

Figure 18.8. Gun, Cable Tie.

Figure 18.9. Handle, Bit Driver, Offset, Ratcheting.

Figure 18.10. Pliers, Needlenose

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Chapter 18 - Addendum

Figure 18.11. Ratchet.

Figure 18.12. Rubber Lube.

Figure 18.13. Rule, Steel.

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Chaper 18 - Addendum

Figure 18.14. Ruler, metric, capable of measuring 102 cm.

Figure 18.15. Safety Glasses, Edmund Optics NT55-162.

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Chapter 18 - Addendum

Figure 18.16. Scissors.

Figure 18.17. Screwdriver, Cross Tip.

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Chaper 18 - Addendum

Figure 18.18. Screwdriver, Flat Tip.

Figure 18.19. Stubby Screwdriver.

Figure 18.20. Socket, Deep

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Chapter 18 - Addendum

Figure 18.21. Socket.

Figure 18.22. Socket.

Figure 18.23. Soldering Iron, Battery Operated.

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Chaper 18 - Addendum

Figure 18.24. Stripper, Wire.

Figure 18.25. Torque Driver.

Figure 18.26. V-Jaw Pliers.

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Chapter 18 - Addendum

Figure 18.27. Wrench, Combination.

Figure 18.28. Wrench, Hexagonal.

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Chaper 18 - Addendum

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Index

Index

A
AC Input Fuse Replacement .................................................................................................................... 11-62
Accessories Drawer Cover ......................................................................................................................... 11-4
Advanced Flow Module............................................................................................................................... 3-1
AFM Electrical Diagram .................................................................................................................... 4-37
AFM Pneumatics Diagram ................................................................................................................. 4-37
Cleaning ................................................................................................................................................ 7-4
Error Codes ......................................................................................................................................... 9-16
General Description ............................................................................................................................ 1-16
Removal ............................................................................................................................................ 11-26
Safety Precautions ................................................................................................................................ 2-8
Specifications ..................................................................................................................................... 3-14
Technical Description ......................................................................................................................... 4-27
Advanced Fluidics Module Module
Troubleshooting Guide ....................................................................................................................... 9-19
Anterior Module, see Ultrasound Module
B
Battery
AA Alkaline........................................................................................................................................ 1-39
Charging, Foot Control ....................................................................................................................... 1-29
Disposal ................................................................................................................................................ 2-6
Foot Control ........................................................................................................................................ 1-29
General Information............................................................................................................................ 1-29
Removal, Foot Control ..................................................................................................................... 11-54
Replacement, Remote Control .......................................................................................................... 11-56
Bipolar Handpiece
Cleaning ................................................................................................................................................ 7-2
C
Caution
Definition .............................................................................................................................................. 1-7
Cleaning Requirements ................................................................................................................................ 7-1
Clock Menu ............................................................................................................................................... 1-12
Compressor Module
Error Codes ......................................................................................................................................... 9-38
General Description ............................................................................................................................ 1-20
Pneumatic Diagram (Original)............................................................................................................ 4-67
Removal ............................................................................................................................................ 11-39
Technical Description ......................................................................................................................... 4-62
Troubleshooting Guide ....................................................................................................................... 9-39
Compressor Module Deluxe ........................................................................................................................ 3-1
D
dacryoscintigraphy ................................................................................................................................... 16-45
Danger
Definition .............................................................................................................................................. 1-7
Device Relationship Management ............................................................................................................. 1-40
Disassembly and Assembly

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Index

User Interface Computer ....................................................................................................... 11 -19, 11-57


DRM .......................................................................................................................................................... 1-40
E
Electromechanical Base
General Description ............................................................................................................................ 1-13
Power and Pneumatic Distribution (BPS) ........................................................................................... 4-12
Power and Pneumatic Distribution (Posterior) ................................................................................... 4-14
Power and Pneumatic Distribution (SPS) ........................................................................................... 4-13
Technical Description ........................................................................................................................... 4-3
Troubleshooting Guide ......................................................................................................................... 9-9
External Air Connector ................................................................................................................................ 6-9
F
Fluidics Module Error Codes ..................................................................................................................... 9-21
Foot Control ................................................................................................................................................. 3-1
Battery Charging Options ................................................................................................................... 1-30
Error Codes ......................................................................................................................................... 9-59
Foot Control Electrical Diagram ....................................................................................................... 4-102
General Description ............................................................................................................................ 1-27
Setup ................................................................................................................................................... 6-11
Specifications...................................................................................................................................... 3-19
Technical Description ......................................................................................................................... 4-99
Troubleshooting Guide ....................................................................................................................... 9-65
Foot Control Battery
Removal ............................................................................................................................................ 11-54
Foot Control Interface Board ....................................................................................................................... 3-1
Error Codes ......................................................................................................................................... 9-64
General Description ............................................................................................................................ 1-38
Removal ............................................................................................................................................ 11-55
Troubleshooting Guide ....................................................................................................................... 9-65
Foot Control Receiver .................................................................................................................................. 3-1
Foot Control, Integrated Laser ..................................................................................................................... 3-1
Fragmentation Handpiece
Cleaning ................................................................................................................................................ 7-3
Front Lower Access Panel ......................................................................................................................... 11-4
G
Graphical User Interface ............................................................................................................................ 1-10
H
Handpiece
Bipolar .................................................................................................................................................. 7-2
Fragmentation ....................................................................................................................................... 7-3
High Speed Vitrectomy ........................................................................................................................ 7-3
Phacoemulsification .............................................................................................................................. 7-2
High Speed Vitrectomy Handpiece
Cleaning ................................................................................................................................................ 7-3
Hydrophobic Filter Replacement ................................................................................................................. 7-5
I
Installing Module ..................................................................................................................................... 11-18
Instructions .................................................................................................................................................. 1-7
Integrated Laser Foot Control ...................................................................................................................... 3-1

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Index

IV Pole ......................................................................................................................................................... 3-1


General Description ............................................................................................................................ 1-25
Removal............................................................................................................................................ 11-50
Setting Maximum Height ................................................................................................................... 1-26
Specifications ..................................................................................................................................... 3-19
Technical Description ......................................................................................................................... 4-96
IV Pole Controller ........................................................................................................................................ 3-1
General Description ............................................................................................................................ 1-26
Removal............................................................................................................................................ 11-52
L
Laser Head and Controller ........................................................................................................................... 3-1
M
Main Power Switch Location..................................................................................................................... 6-10
Maximum IV Pole Height .......................................................................................................................... 1-26
More Screens ............................................................................................................................................. 1-12
MultiMedia Center
Error Codes......................................................................................................................................... 9-70
General Description ............................................................................................................................ 1-40
Specifications ..................................................................................................................................... 3-21
Troubleshooting Guide ....................................................................................................................... 9-72
Multimedia Center ....................................................................................................................................... 3-1
Cleaning ................................................................................................................................................ 7-3
Technical Desciption ........................................................................................................................ 4-103
N
Note
Definition .............................................................................................................................................. 1-7
P
Packing Material ........................................................................................................................................ 6-20
Phacoemulsification Handpiece
Cleaning ................................................................................................................................................ 7-2
Posterior Compressor Module ..................................................................................................................... 3-1
Electrical Diagram (Posterior) ............................................................................................................ 4-73
General Desciption ............................................................................................................................. 1-21
Pneumatic (Noise Abated) Diagram ................................................................................................... 4-68
Pneumatic Diagram (Posterior) .......................................................................................................... 4-72
Removal ............................................................................................................................................ 11-39
Technical Description ......................................................................................................................... 4-68
Posterior Compressor Module (PCM) Troubleshooting Guide ................................................................. 9-43
Posterior Fluidics Module ............................................................................................................................ 3-1
General Description ............................................................................................................................ 1-18
PFM Electrical Diagram ..................................................................................................................... 4-62
PFM Pneumatics Diagram .................................................................................................................. 4-61
Removal ............................................................................................................................................ 11-26
Specifications ..................................................................................................................................... 3-16
Technical Description ......................................................................................................................... 4-51
Troubleshooting Guide ....................................................................................................................... 9-31
Posterior Illumination Module ..................................................................................................................... 3-1
Error Codes ......................................................................................................................................... 9-44
General Description ............................................................................................................................ 1-22
Removal ............................................................................................................................................ 11-29

Top of Chapter Customer Service Manual Revision F Page index-3

This document contains information that is the confidential and proprietary property of Bausch & Lomb. Any dissemination, distribution or
copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Index

Safety Precautions ................................................................................................................................ 2-8


Specifications...................................................................................................................................... 3-18
Technical Description ......................................................................................................................... 4-73
Troubleshooting Guide ............................................................................................................. 9-47, 9-48
Posterior Module, see Ultrasound Module
Power Cable ................................................................................................................................................. 3-2
Power Module ............................................................................................................................................ 1-24
Power Module with Battery Backup ............................................................................................................ 3-1
General Description ............................................................................................................................ 1-24
Removal ............................................................................................................................................ 11-41
Technical Description ......................................................................................................................... 4-79
Power Module without Battery Backup ....................................................................................................... 3-1
General Description ............................................................................................................................ 1-25
Module .............................................................................................................................................. 11-44
Technical Description ......................................................................................................................... 4-84
R
Remote Control .......................................................................................................................................... 1-38
Error Codes ......................................................................................................................................... 9-68
General Description ............................................................................................................................ 1-38
Specifications...................................................................................................................................... 3-21
Technical Description ....................................................................................................................... 4-102
Troubleshooting Guide ....................................................................................................................... 9-69
Wireless Remote Electrical Block Diagram ..................................................................................... 4-103
Remote Control Battery
Replacement ..................................................................................................................................... 11-56
Removing Module ................................................................................................................................... 11-18
S
Schlemm’s canal ...................................................................................................................................... 16-45
Schwalbe’s line ........................................................................................................................................ 16-45
scintigraphy.............................................................................................................................................. 16-45
Skin Disassembly and Assembly ............................................................................................................... 11-3
Slide Displays and Controls ....................................................................................................................... 1-12
Specifications
EMI ....................................................................................................................................................... 3-7
Spin Buttons............................................................................................................................................... 1-11
Symbols ....................................................................................................................................................... 1-4
System
Cleaning ................................................................................................................................................ 7-1
De-Installation .................................................................................................................................... 6-18
Installation ............................................................................................................................................ 6-4
Packing System................................................................................................................................... 6-20
Unpacking Corrugated Box .................................................................................................................. 6-1
T
Time
Definition .............................................................................................................................................. 1-7
Tip
Definition .............................................................................................................................................. 1-7
Torque Specifications ................................................................................................................................ 11-1
TruLink
Agent Overview .................................................................................................................................. 13-1

Customer Service Manual Revision F Top of Chapter


Page index-4
This document contains information that is the confidential and proprietary property of Bausch & Lomb. Any dissemination, distribution or
copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.
Index

Genearl Description ............................................................................................................................ 1-40


Initiating a Remote Session ................................................................................................................ 13-2
U
Ultrasound Module ...................................................................................................................................... 3-1
Error Codes......................................................................................................................................... 9-10
General Description ............................................................................................................................ 1-14
Removal............................................................................................................................................ 11-24
Safety Precautions ................................................................................................................................ 2-7
Specifications ....................................................................................................................................... 3-9
Technical Description ......................................................................................................................... 4-16
Troubleshooting Guide ....................................................................................................................... 9-13
Ultrasound Electrical Block Diagram ................................................................................................. 4-27
Ultrasound Module with HSV ..................................................................................................................... 3-1
Ultrasound Module with Laser - Stellaris PC .............................................................................................. 3-1
User Interface Computer .............................................................................................................................. 3-1
Disassembly and Assembly .................................................................................................. 11-19, 11-57
Error Codes ........................................................................................................................................... 9-2
General Description ............................................................................................................................ 1-10
Plastic UIC Upgrade ............................................................................................................................. 8-4
Removal............................................................................................................................................ 11-19
Specifications ....................................................................................................................................... 3-8
Technical Description ........................................................................................................................... 4-1
Troubleshooting Guide ......................................................................................................................... 9-4
V
Vacuum Fluidics Module............................................................................................................................. 3-1
General Description ............................................................................................................................ 1-17
Removal............................................................................................................................................ 11-26
Specifications ..................................................................................................................................... 3-16
Technical Description ......................................................................................................................... 4-38
Troubleshooting Guide ....................................................................................................................... 9-26
VFM Pneumatics Diagram ................................................................................................................. 4-49
W
Warning
Definition .............................................................................................................................................. 1-7
Wireless Remote .......................................................................................................................................... 3-1
Wireless Remote Control
see Remote Control ............................................................................................................................ 1-38

Top of Chapter Customer Service Manual Revision F Page index-5

This document contains information that is the confidential and proprietary property of Bausch & Lomb. Any dissemination, distribution or
copying of this document is strictly prohibited without the prior written consent of Bausch & Lomb.

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