Iridex PASCAL Synthesis - Additional Labels

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PASCAL

Synthesis Ophthalmic Scanning Laser Systems Page 14 of 141

88292-EN, Rev D

Laser Aperture Label

Laser Emission Warning

Warning, Hot Surface Label

Warning, this surface may be

extremely hot.

General Warning Label

Additional Labels

Footswitch

Ingress Protection

“Hospital Grade” Cord Grounding Instructions

Main Page

Introduction5
Intended Use / Indications for Use5
Table of Contents7
Cautions & Warnings10
Disclaimer11
Console Labels11
Additional Labels14
Operator Manual Symbol Definitions15
General Safety and Regulatory Information15
Ocular Protection16
Laser Safety Eyewear17
Electrical Hazards18
Non Homogeneous Pattern Delivery19
Fiber Optic Cable Assembly19
Pattern Titration19
Titration20
Fire Hazard20
Protecting Non-Target Tissues21
Operational Safety21
Additional Safety Considerations24
Regulatory Compliance Safety Features25
Key Lock Switch25
Laser Emission Indicator25
Door Interlock25
Emergency Stop25
Protective Housing25
Safety Interlocks25
Safety Shutter25
Location of Controls26
Manual Reset26
Electrical Fault Detection Circuitry26
Location of Regulatory and Other System Labels26
Ophthalmic Applications26
Contraindications28
Potential Complications or Side Effects28
Adverse Effects and Complications29
Posterior Segment Laser Procedures29
Anterior Segment Laser Procedures29
System Components31
Laser Console31
Touchscreen LCD Control Panel31
Slit Lamp (Model SL-PA04)32
Footswitch32
Door Interlock Plug32
Micro Manipulator33
Power Knob33
Controller (Purchased Separately)34
3D Controller Action34
LIO (Laser Indirect Ophthalmoscope) - Optional Accessory35
System Installation and Setup36
Connecting the System Components37
System Start-Up and Shut-Down39
Starting the System39
Shutting down the System (Standard Shut-Down)39
Emergency Shut-Down39
Control Screen Description40
Home Screen40
Posterior Treatment Screen41
Anterior Treatment Screen46
Posterior Pattern Descriptions/Pattern Parameters49
Single Spot50
Array51
Triple Ring60
Line61
Hexagon74
Single Spot75
Anterior Pattern Descriptions/Pattern Parameters77
Array78
Pattern Titration79
Endpoint Management with Landmark Patterns (Optional)81
System Software Setup83
System Setup Screen83
Patient Information Feature85
Progressive Titrate87
Physician Preferences> Window87
Edit Physician Preferences> Window88
Contact Lens Selection Screen89
Favorites Window90
Edit Favorites> Window92
Treatment Report Window94
Export Treatment Report96
Procedure to Prepare the USB Drive before the First Time Use97
Treatment Reports98
Intraoperative Instructions102
Slit Lamp Treatment Procedure102
LIO Treatment Procedure103
Between Patient Treatments104
System Shut-Down104
Maintenance Instructions105
Annual Maintenance105
System Repair105
User Maintenance105
Cleaning the Console External Surfaces105
Cleaning the Control Panel Screen105
Maintaining Effectiveness of Grounds105
Replacing the Fuses106
System Specifications107
Troubleshooting Guide110
System Does Not Turn on111
Error Messages114
Calibration Procedure121
Disclaimer Warning121
Calibration Instructions121
System Relocation Instructions122
Room Preparation122
Instructions for Use123
Intended Use Environment123
Patient Environment123
Electromagnetic Compatibility125
Ophthalmology References131
General Information on Usage132
Intended Patient Population132
Intended User Profile132
Accessories132
Warranty Information133
Warranty Shipments, Returns, and Adjustments133
Decontamination of Returned Equipment134
US Technical Service Information134
Decontamination Certification135
Disposal136
Pattern Scanning Laser Trabeculoplasty (PSLT) (Optional)137
Anterior Pattern Descriptions/Pattern Parameters139
Array140
PASCAL ® Synthesis Ophthalmic Scanning Laser Systems141
PASCAL Synthesis Ophthalmic Scanning Laser Systems141
PSLT 3 Row141

Iridex PASCAL Synthesis - Additional Labels

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