AMO Catalys OptiMedica User manual

Part Number: 0160-6411, Rev A, 02/2019 Page 1 of 314
Software Release: cOS 5.00
Operator Manual

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Part Number: 0160-6411, Rev A, 02/2019 Page 3 of 314
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This manual is copyrighted with all rights reserved. Under the copyright laws, this manual may
not be copied in whole or in part or reproduced in any other media without the express written
permission of OPTIMEDICA Corporation. Permitted copies must carry the same proprietary and
copyright notices as were affixed to the original under the law. Copying includes translation into
another language.
© AMO Manufacturing USA, LLC 2019
Note that while every effort has been made to ensure that the data given in this document is
accurate, the information, figures, illustrations, tables, specifications, and schematics contained
herein are subject to change without notice.
CATALYS, OPTIMEDICA, INTEGRAL GUIDANCE, and LIQUID OPTICS are trademarks of AMO
Manufacturing USA, LLC. All other trademarks are the intellectual property of their respective
owners.
The term “cOS” is defined as “cataract operating system” and is followed by a numeric version
number (e.g., cOS 5.00).
For Technical Support: 1-800-511-0911
To order replacement parts (spare parts) – Technical Support: 1-800-511-0911 or +1-408-273-
4100
To order consumables/disposable products (LOIs) – Customer Service: [phone] or your
local representative
AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 USA
1-877-266-4543 (in the USA) or [phone] (outside the USA)
Product of USA
AMO Ireland
Block B
Liffey Valley Office Campus
Quarryvale, Co. Dublin, Ireland

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Table of Contents
Indications for Use, Contraindications, Warnings, and Precautions.. 11
Indications for Use .............................................................................................. 11
Contraindications ................................................................................................ 11
Warnings............................................................................................................. 11
Precautions ......................................................................................................... 13
Adverse Effects.................................................................................................... 16
User Training and Certification ............................................................................ 17
Target Patient Profile .......................................................................................... 18
Target Operator Profile ....................................................................................... 18
Physician................................................................................................................... 19
Nurse ........................................................................................................................ 19
Technician/operator................................................................................................. 19
System Overview............................................................................. 21
Introduction ........................................................................................................ 21
CATALYS® System Components ........................................................................... 22
Touchscreen Control Panel—Graphical User Interface (GUI) .................................. 24
Docking Keypad........................................................................................................ 24
LIQUID OPTICS™ Interface ....................................................................................... 24
LIQUID OPTICS™ Interface Circular Label Reader .................................................... 25
Mobile Patient Bed or Patient Chair......................................................................... 25
Emergency Laser Stop Button .................................................................................. 26
Key Switch ................................................................................................................ 27
Vacuum and Laser Footswitches .............................................................................. 27
Door Interlock Connector......................................................................................... 28
Treatment Laser ....................................................................................................... 28
Optical Coherence Tomography............................................................................... 28
Video Subsystem ...................................................................................................... 29
Monitoring and Control Systems.............................................................................. 29
Bench Testing...................................................................................................... 30
Animal and Cadaver Testing ................................................................................ 30
Clinical Summary................................................................................................. 31
System Specifications .......................................................................................... 33
System Installation and Setup ............................................................................. 34
Overview .................................................................................................................. 34
Connecting the System Components ....................................................................... 35
Connecting to an NCast Telepresenter Video Recording System (optional)............ 36
Connecting to a Network (optional)......................................................................... 37
Firewall Configuration....................................................................................... 37
WAN Configuration ........................................................................................... 37
Network Ports .................................................................................................. 38

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Network Cabling................................................................................................ 38
Setting Up Network Printing and Remote Connectivity (optional) .......................... 38
Moving the System................................................................................................... 38
System Basics ...................................................................................................... 39
Starting Up the System............................................................................................. 39
Logging Into the System ........................................................................................... 40
Enabling the System ................................................................................................. 41
Verifying System Alignment ..................................................................................... 42
Disabling the System ................................................................................................ 51
Shutting Down the System....................................................................................... 52
Emergency Shutdown .............................................................................................. 54
Software Navigation........................................................................ 55
Overview............................................................................................................. 55
Control Screen Conventions..................................................................................... 56
Quick Navigation Bar................................................................................................ 57
Informational Icons .................................................................................................. 58
Administrative Screens........................................................................................ 58
Home Screen ............................................................................................................ 58
Users Screen............................................................................................................. 61
All Treatments & Reports Screen ............................................................................. 62
Treatment Results Screen ........................................................................................ 63
Printing the Treatment Report(s)...................................................................... 64
Saving the Treatment Report(s) ........................................................................ 66
Sample Report................................................................................................... 69
Surgeon Templates Overview Screen....................................................................... 75
Surgeon Template Screens....................................................................................... 76
Overlay Settings Screens ................................................................................... 78
General Preferences Screen.............................................................................. 80
Settings Screen......................................................................................................... 81
Software Info Window ............................................................................................. 82
Help Screen .............................................................................................................. 82
Planning Screens ................................................................................................. 83
Planning Screen Conventions................................................................................... 83
Default Details Screens ............................................................................................ 86
Treatment Template Screens ................................................................................... 91
Treatment Planning Screens .................................................................................... 97
Capsulotomy (Basic) Screen .............................................................................. 99
Capsulotomy Details Screen............................................................................ 100
Lens Fragmentation (Basic) Screen ................................................................. 101
Lens Fragmentation Details Screen................................................................. 103
Arcuate Incisions (Basic) Screen...................................................................... 104
Arcuate Incisions Details Screen ..................................................................... 106
Cataract Incisions (Basic) Screen..................................................................... 107
Cataract Incisions Primary Geometric Details Screen ..................................... 109

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Cataract Incisions Sideport(s) Geometric Details Screen ................................ 110
Cataract Incisions Primary Laser Details Screen.............................................. 112
Cataract Incisions Sideport(s) Laser Details Screen......................................... 113
Treatment Plan Summary Screen........................................................................... 115
Editing the Treatment Plan ............................................................................. 115
Surgical Timeout Screen .................................................................................... 116
Docking Screen.................................................................................................. 117
Connection Panel (Mobile Patient Bed only) ......................................................... 118
Home Panel (Mobile Patient Bed only) .................................................................. 119
Pivot Lock Panel (Mobile Patient Bed only) ........................................................... 120
Disposable Lens Panel ............................................................................................ 121
Vacuum Panel......................................................................................................... 122
Caster Lock Panel (Mobile Patient Bed only) ......................................................... 123
Latch Panel (patient chair only).............................................................................. 124
Capture Panel......................................................................................................... 125
Lock Panel............................................................................................................... 127
Verify Fluid Panel.................................................................................................... 129
Treatment Screens ............................................................................................ 131
Surface Mapping Review Screen ............................................................................ 131
Customizing Surface Fits ................................................................................. 133
INTEGRAL GUIDANCE System Dimensions ..................................................... 138
Incision Review Screens ......................................................................................... 139
Incision Adjustment Screens .................................................................................. 142
Adjust Capsulotomy Screens........................................................................... 142
Adjust Lens Fragmentation Screens................................................................ 145
Adjust Arcuate Incisions Screens..................................................................... 147
Adjust Cataract Incisions Screens.................................................................... 148
Final Review Screen................................................................................................ 152
Treatment Progress Screen .................................................................................... 154
Undocking Screen.............................................................................................. 155
Vacuum Panel......................................................................................................... 155
Connection Panel (Mobile Patient Bed only) ......................................................... 156
Latch Panel (patient chair only).............................................................................. 157
Capture Panel......................................................................................................... 158
Disposable Lens Panel ............................................................................................ 159
Treatment Results Screen.................................................................................. 160
CATALYS® System Procedure ......................................................... 161
Preoperative Instructions .................................................................................. 161
Preparing the Patient for Surgery .......................................................................... 161
Selecting Treatment Parameters............................................................................ 161
Capsulotomy Parameters ............................................................................... 162
Lens Fragmentation Parameters..................................................................... 164
Arcuate and Cataract Incision Parameters ..................................................... 167

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Intraoperative Instructions................................................................................ 175
Installing the LIQUID OPTICS™ Interface Components .......................................... 175
Scanning the Treatment Activation Label ....................................................... 176
Installing the Disposable Lens ......................................................................... 177
Installing the Fluid Reservoir........................................................................... 178
Positioning the Patient ........................................................................................... 179
Connecting the Mobile Patient Bed to the CATALYS® System............................... 181
Homing the Mobile Patient Bed............................................................................. 182
Placing the Mobile Patient Bed in Pivot Lock Mode............................................... 182
Attaching the Suction Ring ..................................................................................... 182
Capturing the Suction Ring..................................................................................... 186
Locking the Suction Ring/Disposable Lens Assembly to the Laser ......................... 190
Starting and Verifying INTEGRAL GUIDANCE System Imaging............................... 193
Performing Laser Treatment .................................................................................. 198
Instructions for Interrupted Treatments................................................................ 200
Treatments Interrupted Prior to Initiating Laser Delivery .............................. 200
Treatments Interrupted During Laser Delivery ............................................... 200
Postoperative Instructions ................................................................................ 202
Releasing the Patient.............................................................................................. 202
Disconnecting the Mobile Patient Bed from the CATALYS® System...................... 203
Removing the Suction Ring and Disposable Lens ................................................... 204
Maintenance ................................................................................. 205
System Cleaning ................................................................................................ 205
System Maintenance......................................................................................... 205
Electromagnetic Compatibility .......................................................................... 206
Bluetooth Characteristics .................................................................................. 212
System Error Codes, Faults, and Messages......................................................... 214
Error Types ............................................................................................................. 214
Critical Errors................................................................................................... 214
Clearable Errors............................................................................................... 216
No Treat Errors................................................................................................ 216
Warning Errors ................................................................................................ 217
Error Code Table..................................................................................................... 217
Calibration Disclaimer ....................................................................................... 218
Warranty........................................................................................................... 218
Company Information ....................................................................................... 218
Copyrights for Integrated Software Libraries ..................................................... 218
Decontamination of Returned Equipment ......................................................... 219
Decontamination Certification............................................................................... 220

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Safety and Regulatory ................................................................... 221
General Safety and Regulatory Information....................................................... 221
Ocular Protection .............................................................................................. 222
Laser Safety Eyewear.............................................................................................. 222
Normal System Operation............................................................................... 222
System Alignment Verification........................................................................ 222
Definitions from ANSI Z136.1-2007.................................................................... 223
Electrical Hazards .............................................................................................. 224
Fire Hazards ...................................................................................................... 224
Protecting Non-target Tissues ........................................................................... 224
Regulatory Compliance Safety Features............................................................. 225
Key Lock Switch ...................................................................................................... 225
Laser Emission Indicator......................................................................................... 225
Door Interlock ........................................................................................................ 225
Emergency Stop...................................................................................................... 225
Protective Housing ................................................................................................ 225
Safety Interlocks..................................................................................................... 225
Safety Shutter......................................................................................................... 225
Location of Controls ............................................................................................... 226
System Reset .......................................................................................................... 226
Electrical Fault Detection Circuitry......................................................................... 226
Location and Definition of Regulatory and Other System Labels........................... 226
System Labels.................................................................................................... 227
Appendix A – Mobile Patient Bed Instructions............................... 233
Appendix B – Patient Chair Instructions......................................... 287
Patient Chair Specifications.................................................................................... 293
Appendix C – LIQUID OPTICS™ Interface 12 Quick Reference Guide 295
Appendix D – Software Error Code Table ....................................... 299

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