AMO Catalys OptiMedica User manual
Part Number: 0160-6411, Rev A, 02/2019 Page 3 of 314
Software Release: cOS 5.00
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: +1-408-273-4100 or your
local representative
AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 USA
1-877-266-4543 (in the USA) or +1-408-273-4100 (outside the USA)
Product of USA
AMO Ireland
Block B
Liffey Valley Office Campus
Quarryvale, Co. Dublin, Ireland
Part Number: 0160-6411, Rev A, 02/2019 Page 5 of 314
Software Release: cOS 5.00
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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1 Indications for Use, Contraindications,
Warnings, and Precautions
This chapter contains the following major sections:
•1.1 Indications for Use, page 11
•1.2 Contraindications, page 11
•1.3 Warnings, page 11
•1.4 Precautions, page 13
•1.5 Adverse Effects, page 16
•1.6 User Training and Certification, page 17
•1.7 Target Patient Profile, page 18
•1.8 Target Operator Profile, page 18
1.1 Indications for Use
The OPTIMEDICA CATALYS® Precision Laser System is indicated for use in patients undergoing
cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include
anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc
cuts/incisions in the cornea, each of which may be performed either individually or
consecutively during the same procedure.
1.2 Contraindications
The CATALYS® System is contraindicated in patients with corneal ring and/or inlay implant(s).
The CATALYS® System is contraindicated in patients with severe corneal opacities, corneal
abnormalities, significant corneal edema, or diminished aqueous clarity that obscures OCT
imaging of the anterior lens capsule.
The CATALYS® System is contraindicated for pediatric use (i.e., patients younger than 22 years of
age).
Descemetocele with impending corneal rupture.
Any contraindications to cataract surgery.
1.3 Warnings
• Every day, prior to use, a trained operator must verify that the CATALYS® System is
aligned.
• Never open the laser console protective covers or attempt internal repairs or
adjustments not specifically detailed in this operator manual. Opening the covers will
expose you to high voltage components, the laser resonator, and possible laser radiation.
Indications for Use, Contraindications, Warnings, and Precautions
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• Installation, maintenance, and repair should be performed only by OPTIMEDICA-certified
personnel per the manufacturer’s recommendation and institutional standards.
• Routinely inspect the system components for obvious signs of damage. Do not operate
the laser if any of the components are damaged or if the cords are faulty or frayed.
• Do not use in the presence of flammables or explosives such as volatile anesthetics,
alcohol, certain surgical preparation solutions, or other such substances. An explosion
and/or fire could occur. Refer to Fire Hazards on page 224 for detailed warnings.
• Never place hands or other objects in the path of the laser beam. Severe burns could
occur.
• Do not use caustic cleaners or strong detergents when cleaning the CATALYS® System.
• If the system becomes unresponsive at any time, press the emergency laser stop button
and turn the key to the (off) position.
• Do not use the system if the touchscreen and/or the control panel is either unresponsive
or blank. If restarting the system does not resolve the problem, contact the OPTIMEDICA
Service Department at +1.800.511.0911.
• The (laser emission) indicator is displayed on the touchscreen control panel at all
times the laser is energized to warn the user that the system is capable of emitting laser
energy. Precautions, such as wearing appropriate laser safety eyewear, should be taken if
required.
• Prior to INTEGRAL GUIDANCE System imaging and laser treatment, the suction ring must
be completely filled with sterile buffered saline solution, such as Alcon BSS (Alcon P/N
351/55005-1) or equivalent. Use the video image to verify that no air bubbles are
entrapped within the sterile buffered saline solution after the suction ring is captured.
The video image should provide a sharp and clear image of the patient's eye.
• Continuously monitor the video image immediately before and throughout each laser
treatment. Continuously verify that the suction ring remains completely filled with sterile
buffered saline solution. If any air bubbles and/or a meniscus appear on the video image
before treatment, do not initiate laser treatment. If air bubbles and/or a meniscus appear
during treatment, terminate the laser treatment by immediately releasing the laser
footswitch.
• Continuously verify that the eye has not moved with respect to its initial presentation at
the time of fluid confirmation. If the eye moves during INTEGRAL GUIDANCE System
imaging, press the RESCAN EYE button. If the eye moves during laser treatment,
terminate the laser treatment by immediately releasing the laser footswitch.
• Before initiating laser treatment, inspect the images created from the OCT data, surface
fits, and overlaid pattern in both axial and sagittal views, and review the treatment
parameters on the Final Review Screen for accuracy.
• Safety margins for all incisions are preserved only if custom fit adjustments to ocular
surface(s) are applied in accordance with the instructions for use. Refer to Customizing
Surface Fits on page 133 for detailed instructions on applying custom fit adjustments.
Indications for Use, Contraindications, Warnings, and Precautions
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Purposeful misuse of custom fit adjustments to ocular surface(s) can result in patient
injury and complication(s) and therefore must be avoided.
• If a laser capsulotomy is interrupted, the system will not allow you to re-initiate the
capsulotomy, as precise co-registration with the initial capsulotomy cannot be assured.
Instead, use standard continuous curvilinear capsulorrhexis (CCC) surgical technique to
complete the treatment.
• If at any point during laser delivery the patient becomes undocked (e.g., due to vacuum
loss), the treatment will be interrupted and cannot be continued. Do not resume
treatment afterwards. Revert to traditional cataract surgery.
• If the treatment is interrupted by a “Critical Error”, the system will go to a safe state and
be disabled. Do not resume treatment afterwards. Revert to traditional cataract surgery.
• Never look directly into the laser aperture or scattered laser light from reflective surfaces
when the treatment beam is activated. Severe eye damage could occur.
• Standard continuous curvilinear capsulorrhexis (CCC) surgical technique must be used for
surgical removal of the capsulotomy disc. The capsulotomy may have residual uncut
areas that should be completed by advancing the capsule through the incompletely cut
area in a circumferential fashion, rather than pulling it radially. The use of improper
capsulotomy disc removal technique may potentially cause or contribute to anterior
capsule tear and/or a noncircular, irregularly shaped capsulotomy.
• Verify that the suction ring is correctly connected to the disposable lens component of
the LIQUID OPTICS™ Interface during the initial patient docking procedure.
• To prevent unanticipated performance which may adversely impact patients, no
modification of this equipment is allowed.
• If the Mobile Patient Bed battery drops to the critically low level while paired to the
CATALYS® System (as indicated by a solid red battery status icon on the control pendant
and a partially filled red Bluetooth connection status icon on the touchscreen), the bed
will maintain connection to the system but will not have adequate power to articulate all
motors. The user must connect the bed to an AC wall outlet and then disconnect and
reconnect the bed to the CATALYS® System before full motor function is re-enabled.
1.4 Precautions
• The system should be used only by qualified physicians who have extensive knowledge of
the use of this device and have been trained by OPTIMEDICA-certified personnel.
• Use of controls or adjustments or performance of procedures other than those specified
herein (System Misuse) may result in hazardous radiation exposure.
• Users should be aware of general laser warnings, precautions, and adverse effects. Read
this operator manual thoroughly and be familiar with its contents prior to using this
equipment.
• The key should not be turned to the start position for more than two seconds. If the key is
held at the start position for more than two seconds, the system will do a hard shutdown
Indications for Use, Contraindications, Warnings, and Precautions
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and may require service by OPTIMEDICA personnel. If the control panel remains blank for
an extended period of time during system start-up, press the Power button on the front
of the control panel to turn on the control panel. If the control panel remains blank, turn
off the system with the key, wait at least one minute, and then restart the system. If the
screen is still blank, turn off the system and contact OPTIMEDICA Service.
• When not in use, laser equipment should be protected against unqualified use by
removing the key from the key switch.
• Never perform maintenance on any part of the CATALYS® System when it is in use with a
patient.
• When the CATALYS® System is interconnected with other medical electrical equipment,
leakage currents may be additive. Ensure that all systems are installed according to the
requirements of IEC 60601-1.
• Treatment can be discontinued at any time by pressing the patient vacuum, capture, or
patient lock O (off) button on the docking keypad or by pressing the emergency laser
stop button on the system front panel. During laser emission, the treatment can also be
discontinued by releasing the laser footswitch or by pressing the PAUSE TREATMENT
button on the control panel.
• If the system displays a “Clearable Error” message, press the OK button to clear the error
and continue the treatment. Alternatively, when in doubt, always choose the safest
approach and shut down the system and abort the treatment.
•The CATALYS® System has not been adequately evaluated in patients with a cataract
greater than Grade 4 (via LOCS III); therefore, no conclusions regarding either safety or
effectiveness are presently available.
• Cataract surgery may be more difficult in patients with an axial length less than 22 mm or
greater than 26 mm, and/or an anterior chamber depth less than 2.5 mm, due to
anatomical restrictions.
• Use caution when treating patients who may be taking medications such as alpha
blockers (e.g., Flomax®, tamsulosin HCL [Boehringer Ingelheim GmbH, Ingelheim am
Rhein, Germany]), as these medications may be related to Intraoperative Floppy Iris
Syndrome (IFIS). This condition may include poor preoperative pupil dilation, iris
billowing and prolapse, and progressive intraoperative miosis. These conditions may
require modification of surgical technique, such as the utilization of iris hooks, iris dilator
rings, or viscoelastic substances.
• Adequate iris dilation medication protocol should be used to ensure iris dilation of at
least 1.0 mm larger than the intended capsulotomy diameter.
• Surgical removal of the cataract more than 30 minutes after laser anterior capsulotomy
and laser lens fragmentation has not been clinically evaluated. The clinical effects of
delaying surgical removal more than 30 minutes after laser anterior capsulotomy and
laser lens fragmentation are unknown.
Indications for Use, Contraindications, Warnings, and Precautions
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• After removal of the capsulotomy disc, if any capsulotomy thread remnant (less than 50
μm nominal thickness) is seen, do not remove it. Removal of a capsulotomy thread
remnant could potentially cause or contribute to an anterior capsule tear and/or a non-
circular, irregularly-shaped capsulotomy.
•The LIQUID OPTICS™ Interface is intended for single use only.
• Do not use the LIQUID OPTICS™ Interface after the expiration date on the package.
• Inspect all packaging for the LIQUID OPTICS™ Interface prior to use. Do not use if the
sterile barrier has been breached, if the package is damaged in any way, or if the device
has been dropped.
• Do not attempt to capture the disposable lens if the fluid reservoir is full. After suction
has been established, periodically verify and do not allow the maximum volume of fluid
to fill beyond where the tubing enters the fluid reservoir. Refer to Figure 4.37 on page
192 for an illustration of the highest acceptable level of fluid. If the fluid reservoir does
become full, replace the entire LIQUID OPTICS™ Interface before continuing.
• The touchscreen control panel must be kept dry at all times.
• Use blunt dissection to separate the edges of corneal incisions. Avoid using sharp
instruments for manipulating the corneal incision, to preserve the original incision
geometry and to prevent unintended dissection.
• Full-thickness corneal cuts or incisions should be performed with instruments and
supplies on standby, to seal the eye in case of anterior chamber collapse or fluid leakage.
• Patients who will undergo full-thickness corneal incisions with the CATALYS® System
should be given the same standard surgical preparation as used for patients undergoing
cataract surgery for the removal of the crystalline lens.
• During intraocular surgery on patients who have undergone full-thickness corneal
incisions with the CATALYS® System, care should be taken if an eyelid speculum is used, to
limit pressure from the speculum onto the open eye.
• Patients who will be transported between the creation of a full-thickness corneal incision
and the completion of the intraocular surgery should have their eye covered with a sterile
rigid eye shield, to avoid inadvertent eye injury during transport.
• Patients must be able to lie flat and motionless in a supine position.
• Patients must be able to tolerate local or topical anesthesia.
• In the event a corneal incision is interrupted and resumed, do not attempt to force the
incision open if it is not blunt dissectible. If the corneal incision is not blunt dissectible,
use a bladed instrument to create a separate corneal incision to continue with the
procedure.
• Do not connect anything other than a USB flash drive to the CATALYS® System USB ports.
• Connection of the CATALYS® System to a customer network that includes other
networked equipment could result in previously unidentified risks. During system
installation, OPTIMEDICA-trained personnel will review the installation site network with
Indications for Use, Contraindications, Warnings, and Precautions
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the installation site IT administrator to identify, analyze, evaluate, and control these risks.
Subsequent changes to the installation site network could introduce new risks due to:
─ Changes to the network configuration
─ Connection of additional devices to the network
─ Disconnection of devices from the network
─ Update and/or upgrade of equipment connected to the network
The internal Hardware Security Appliance (HSA) installed on the CATALYS® System is
designed to mitigate these risks to an acceptable level. If system performance or speed
degrades when connected to a network, disconnect the CATALYS® System from the
network and contact OPTIMEDICA Service for assistance.
1.5 Adverse Effects
Complications associated with the CATALYS® System include mild Petechiae and subconjunctival
hemorrhage due to vacuum pressure of the LIQUID OPTICS™ Interface suction ring.
Potential complications and adverse events generally associated with the performance of
capsulotomy and lens fragmentation, or creation of a partial-thickness or full-thickness cut or
incision of the cornea, include:
Acute corneal clouding, age-related macular degeneration, amaurosis, anterior and/or pos-
terior capsule tear/rupture, astigmatism, capsulorrhexis notch during phacoemulsification,
capsulotomy/lens fragmentation or cut/incision decentration, cells in anterior chamber,
choroidal effusion, choroidal hemorrhage, conjunctival hyperemia/injection/erythema/ che-
mosis, conjunctivitis (allergic/viral), corneal abrasion/deepithelization/epithelial defect, cor-
neal edema, cystoid macula edema, Descemet’s detachment, decentered or dislocated
intraocular lens implant, diplopia, dropped or retained lens, dry eye/superficial punctate
keratitis, edema, elevated intraocular pressure, endothelial decompensation, floaters, glau-
coma, halo, inflammation, incomplete capsulotomy, intraoperative floppy iris syndrome, iris
atrophy/extrusion, light flashes, meibomitis, ocular discomfort (for example, pain, irritation,
scratchiness, itching, foreign body sensation), ocular trauma, petechiae, photophobia, pig-
ment changes/pigment in corneal endothelium/foveal region, pingueculitis, posterior cap-
sule opacification, posterior capsule rupture, posterior vitreous detachment, posteriorly
dislocated lens material, pupillary contraction, red blood cells in the anterior chamber (not
hyphema), residual cortex, retained lens fragments, retinal detachment, retinal hemor-
rhage, scar in Descemet’s membrane, shallowing or collapsing of the anterior chamber, scor-
ing of the posterior corneal surface, snailtrack on endothelium, steroid rebound effect,
striae in Descemet’s, subconjunctival hemorrhage, thermal injury to adjacent eye tissues,
toxic anterior shock syndrome, vitreous in the anterior chamber, vitreous band, vitreous
loss, wound dehiscence, wound or incision leak, zonular dehiscence.
Indications for Use, Contraindications, Warnings, and Precautions
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1.6 User Training and Certification
All users are required to participate in training provided by OPTIMEDICA personnel prior to
treating patients with the CATALYS® Precision Laser System. Training will be tailored for the
surgeon(s) and support staff and will consist of lectures and hands-on experience with the
equipment. Users may be trained and certified for two different roles: surgeon and system
operator. In addition, OPTIMEDICA technical and clinical support personnel will observe and
assist each user according to designated role during treatment of 10 patients, or as required for
each user to achieve competence.
The training presentation will include a general review of this manual, with emphasis on those
topics of particular individual relevance for the different user roles. The curriculum will cover:
• Plan (template driven treatment planning);
•Engage the LIQUID OPTICS™ Interface (docking and vacuum controls);
• Visualize/Customize (INTEGRAL GUIDANCE System 3-D OCT imaging, automated surface
detection and laser exclusion zones); and
• Treat (parameter choices and patterns for all treatments).
The curriculum and hands-on training are divided according to user roles. Overall, the
curriculum addresses the following:
1. System Overview
a. Laser safety
b. Specifications and operation
c. Emergency system shutdown
d. System error codes and their mitigation
e. Daily system alignment verification and warm-up requirements
f. System maintenance
2. Workflow Considerations
3. Use of the Graphical User Interface
a. Treatment planning
b. Treatment
4. Use of the LIQUID OPTICS™ Interface
a. Packaging and handling of the LIQUID OPTICS™ Interface
b. Docking with the LIQUID OPTICS™ Interface: Vacuum, Capture, and Lock
5. Use of INTEGRAL GUIDANCE System imaging
a. Acquisition of the INTEGRAL GUIDANCE System data
b. Surface detection and adjustments
c. Laser treatment exclusion zones
6. Use of the Mobile Patient Bed (if applicable)
a. Safety information
Indications for Use, Contraindications, Warnings, and Precautions
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b. Specifications and operation
c. Emergency shutdown
d. Maintenance
7. Review of the clinical trial results – text and iPad presentation
8. Indications for use, contraindications, warnings, and precautions
The hands-on training includes but is not limited to:
a. Treatment planning
b. Mobile Patient Bed or patient chair controls
c. Installing the LIQUID OPTICS™ Interface
d. Patient, head, and eye positioning
e. Use of CATALYS® System controls including the Graphical User Interface
f. Docking with the LIQUID OPTICS™ Interface with an artificial eye and head
g. The INTEGRAL GUIDANCE System process and custom adjustments
h. Treatment application
Upon the recommendation of the OPTIMEDICA-certified Clinical Application Specialist, each
user will be certified as competent, according to the defined user roles, in the operation and use
of the CATALYS® System and ancillary equipment, as well as being well-informed about
indications for use, contraindications, warnings, precautions, and laser safety. Users who
successfully complete the certification will receive a signed certificate from OPTIMEDICA
personnel.
1.7 Target Patient Profile
• Male or female; age > 22 years; anthropometric characteristics fall within 2nd and 98th
percentile in all target markets
• Weight: Patient weight is limited to a maximum of 181 kg (399 lb)
• Height: Patient height is limited to a maximum of 1.93 m (76 in)
•Health:
─ ASA category 1: approx. 5% of patient population
─ ASA category 2: approx. 54% of patient population
─ ASA category 3: approx. 40% of patient population
─ ASA category 4: approx. 1% of patient population
• Nationality: Multiple
• Mobility: Ambulatory, ability to successfully transfer to patient bed/chair, with help if
necessary
1.8 Target Operator Profile
• Male or female; age > 18 years; anthropometric characteristics fall within 5th and 95th
percentile in all target markets
Indications for Use, Contraindications, Warnings, and Precautions
Part Number: 0160-6411, Rev A, 02/2019 Page 19 of 314
Software Release: cOS 5.00
Physician
• Education: Board-certified ophthalmologist
• Knowledge and experience:
─ Experienced in performing cataract surgery
─ Fully trained in the use of the device
• Permissible impairments:
─ Vision: Mildly impaired but corrected to 20/30
─ Hearing: Mildly impaired but corrected to 85% of normal hearing
─ Mobility: No impairment that can limit use of system controls and application of
suction ring; must be able to load and unload patient and move patient bed/chair
Nurse
• Education: Registered nurse (RN)
• Knowledge and experience:
─ Experienced in assisting in ophthalmologic procedures
─ Fully trained to support the physician during the treatment
• Permissible impairments:
─ Vision: Mildly impaired but corrected to 20/30
─ Hearing: Mildly impaired but corrected to 85% of normal hearing
─ Mobility: No impairment; must be able to assist with positioning the patient, loading/
unloading the patient, and moving the patient bed/chair
─ Hand-eye coordination: No impairment
Technician/operator
• Education: 2-year associate degree; high school education and certificate from hospital,
vocational, or military school; and/or on-the-job training
• Knowledge and experience:
─ Fully trained to operate the system and support the physician during the treatment
• Primary duties (operating and frequently used functions): Positioning patient on bed/
chair, entering patient information, entering incision parameters, generating reports,
preparing system for use, verifying laser alignment
• Permissible impairments:
─ Vision: Mildly impaired but corrected to 20/30
─ Hearing: Mildly impaired but corrected to 85% of normal hearing
─ Mobility: No impairment; must be able to assist with positioning the patient, loading/
unloading the patient, and moving the patient bed/chair
─ Hand-eye coordination: No impairment
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