Norlase Leaf - Additional Labels

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Leaf User Manual

P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 69 of 85

Additional Labels

Foot Switch Label

Control Tablet Label

Power Supply Label

_____________________

“XX” denotes the version number.

Main Page

Table of Contents3
Indications for Use / Intended Use5
Introduction5
Package Contents6
Slit Lamp Laser Adapter6
Touchscreen Tablet Control Panel7
Footswitch8
Laser Power Supply8
Keys8
Tablet Charger and Cable8
Pairing Cable8
Tablet Stand8
User Manual8
System Preparation and Setup9
Connecting the System Components10
Attaching the Norlase Laser to a Slit Lamp12
System Start-Up and Shut-Down14
Starting the System14
Shutting down the System16
Standard Shut-Down16
Emergency Shut-Down16
Home Screen17
Using the Touchscreen Interface18
Changing Parameters on Power, Duration and Interval18
Changing Laser Status, Laser Mode, Aiming Beam Power and Counter Reset19
Changing the Spot Size Diameter20
Using Voice Control (Optional Feature)22
List of Voice Commands23
Voice Control Settings24
Tablet Volume Control25
Changing Background Color on Tablet26
Using Μsec Mode27
Setting a Custom Μsec Duty Cycle29
Presets Menu30
Settings Tab32
Pulse Count Callout32
Treatment Record Log Files32
Aligning the Laser to the Slit Lamp Visual and Illumination Axis33
Intraoperative Instructions34
Slit Lamp Treatment Procedure34
Between Patient Treatments35
System Shut-Down35
Annual Maintenance35
System Repair35
Inspection and Cleaning35
Cleaning the Console External Surfaces35
Cleaning the Control Panel Screen36
Inspecting the Power Supply36
Norlase Leaf Specifications37
Troubleshooting Guide41
Pairing an Unpaired Tablet with Laser Console45
Pairing a Paired Tablet to a Different Laser Console45
Error Messages46
Error States46
Calibration Check Procedure53
Disclaimer Warning53
Calibration Check Instructions53
System Relocation Instructions54
Room Preparation54
General Safety and Regulatory Information55
Ocular Protection55
Laser Safety Eyewear56
Electrical Hazards58
Fire Hazard59
Protecting Non-Target Tissues59
Operational Safety60
Additional Safety Considerations62
Regulatory Compliance Safety Features63
Key Lock Switch63
Laser Emission Indicator63
Door Interlock / External Emission Indicator63
Emergency Stop64
Protective Housing64
Safety Interlocks64
Safety Shutter64
Location of Controls64
Manual Reset64
Electrical Fault Detection Circuitry64
Location of Regulatory and Other System Labels64
Console Labels65
Slit Lamp Adapter (SLA) Labels68
Additional Labels69
Electromagnetic Compatibility70
Indications for Use74
Usage Precautions (before Use)74
Usage Precautions (During Use)75
Usage Precautions (after Use)76
Contraindications76
Precautions in Patient Selection77
Precautions in Photocoagulation77
Adverse Effects and Complications79
Posterior Segment Laser Procedures79
Anterior Segment Laser Procedures79
Rarely, Severe Iritis May Occur, Related to Either an Unusual Patient Response or Improper Spot Location80
Residual Risk80
Ophthalmology References81
Warranty Information82
Warranty Shipments, Returns, and Adjustments82
Decontamination of Returned Equipment83
US Technical Service Information83
Decontamination Certification84
Weee Disposal85

Norlase Leaf - Additional Labels

Table of Contents

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