Iridex PASCAL Synthesis - Table of Contents

PASCAL
®
Synthesis Ophthalmic Scanning Laser Systems Page 7 of 141
88292-EN, Rev D
Table of Contents
INTRODUCTION ................................................................................................................................. 5
INTENDED USE / INDICATIONS FOR USE ....................................................................................... 5
Table of Contents .................................................................................................................................... 7
CAUTIONS & WARNINGS ................................................................................................................ 10
Disclaimer .............................................................................................................................................. 11
Console Labels .................................................................................................................................. 11
Additional Labels ............................................................................................................................... 14
Operator Manual Symbol Definitions ..................................................................................................... 15
General Safety and Regulatory Information .......................................................................................... 15
Ocular Protection ................................................................................................................................... 16
Laser Safety Eyewear ........................................................................................................................... 17
Electrical Hazards ................................................................................................................................. 18
Non Homogeneous Pattern Delivery ..................................................................................................... 19
Fiber Optic Cable Assembly .................................................................................................................. 19
Pattern Titration ..................................................................................................................................... 19
Titration ................................................................................................................................................. 20
Fire Hazard ............................................................................................................................................ 20
Protecting Non-target Tissues ............................................................................................................... 21
Operational Safety ................................................................................................................................. 21
Additional Safety Considerations .......................................................................................................... 24
Regulatory Compliance Safety Features ............................................................................................... 25
Key Lock Switch ............................................................................................................................ 25
Laser Emission Indicator ............................................................................................................... 25
Door Interlock ................................................................................................................................ 25
Emergency Stop ............................................................................................................................ 25
Protective Housing ........................................................................................................................ 25
Safety Interlocks ............................................................................................................................ 25
Safety Shutter ................................................................................................................................ 25
Location of Controls ....................................................................................................................... 26
Manual Reset ................................................................................................................................ 26
Electrical Fault Detection Circuitry ................................................................................................. 26
Location of Regulatory and Other System Labels ......................................................................... 26
Ophthalmic Applications ........................................................................................................................ 26
Contraindications ................................................................................................................................... 28
Potential Complications or Side Effects ................................................................................................ 28
Adverse Effects and Complications ....................................................................................................... 29
Posterior Segment Laser Procedures ........................................................................................... 29
Anterior Segment Laser Procedures ............................................................................................. 29
System Components ............................................................................................................................. 31
Laser Console ............................................................................................................................... 31
Touchscreen LCD Control Panel ................................................................................................... 31
Slit Lamp (model SL-PA04) ........................................................................................................... 32
Footswitch ..................................................................................................................................... 32
Door Interlock Plug ........................................................................................................................ 32
Micro Manipulator .......................................................................................................................... 33
Power Knob ................................................................................................................................... 33
3D Controller (Purchased Separately) ........................................................................................... 34