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Norlase Leaf - User Manual
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®
Green Laser Photocoagulator
Operator Manual
Norlase ApS
Norlase Inc.
USA
Brydehusvej
13
895 Hurlingame Ave
Ballerup 2750 DEN
MARK
Redwood City, CA
94063
USA
P
hone
: +45
93
97
74
72
Phone
:
+1.650
.489.0083
Toll Free 833.667
.5273 USA Only
™
2
Table of Contents
Main Page
Table of Contents
3
Indications for Use / Intended Use
5
Introduction
5
Package Contents
6
Slit Lamp Laser Adapter
6
Touchscreen Tablet Control Panel
7
Footswitch
8
Laser Power Supply
8
Keys
8
Tablet Charger and Cable
8
Pairing Cable
8
Tablet Stand
8
User Manual
8
System Preparation and Setup
9
Connecting the System Components
10
Attaching the Norlase Laser to a Slit Lamp
12
System Start-Up and Shut-Down
14
Starting the System
14
Shutting down the System
16
Standard Shut-Down
16
Emergency Shut-Down
16
Home Screen
17
Using the Touchscreen Interface
18
Changing Parameters on Power, Duration and Interval
18
Changing Laser Status, Laser Mode, Aiming Beam Power and Counter Reset
19
Changing the Spot Size Diameter
20
Using Voice Control (Optional Feature)
22
List of Voice Commands
23
Voice Control Settings
24
Tablet Volume Control
25
Changing Background Color on Tablet
26
Using Μsec Mode
27
Setting a Custom Μsec Duty Cycle
29
Presets Menu
30
Settings Tab
32
Pulse Count Callout
32
Treatment Record Log Files
32
Aligning the Laser to the Slit Lamp Visual and Illumination Axis
33
Intraoperative Instructions
34
Slit Lamp Treatment Procedure
34
Between Patient Treatments
35
System Shut-Down
35
Annual Maintenance
35
System Repair
35
Inspection and Cleaning
35
Cleaning the Console External Surfaces
35
Cleaning the Control Panel Screen
36
Inspecting the Power Supply
36
Norlase Leaf Specifications
37
Troubleshooting Guide
41
Pairing an Unpaired Tablet with Laser Console
45
Pairing a Paired Tablet to a Different Laser Console
45
Error Messages
46
Error States
46
Calibration Check Procedure
53
Disclaimer Warning
53
Calibration Check Instructions
53
System Relocation Instructions
54
Room Preparation
54
General Safety and Regulatory Information
55
Ocular Protection
55
Laser Safety Eyewear
56
Electrical Hazards
58
Fire Hazard
59
Protecting Non-Target Tissues
59
Operational Safety
60
Additional Safety Considerations
62
Regulatory Compliance Safety Features
63
Key Lock Switch
63
Laser Emission Indicator
63
Door Interlock / External Emission Indicator
63
Emergency Stop
64
Protective Housing
64
Safety Interlocks
64
Safety Shutter
64
Location of Controls
64
Manual Reset
64
Electrical Fault Detection Circuitry
64
Location of Regulatory and Other System Labels
64
Console Labels
65
Slit Lamp Adapter (SLA) Labels
68
Additional Labels
69
Electromagnetic Compatibility
70
Indications for Use
74
Usage Precautions (before Use)
74
Usage Precautions (During Use)
75
Usage Precautions (after Use)
76
Contraindications
76
Precautions in Patient Selection
77
Precautions in Photocoagulation
77
Adverse Effects and Complications
79
Posterior Segment Laser Procedures
79
Anterior Segment Laser Procedures
79
Rarely, Severe Iritis May Occur, Related to Either an Unusual Patient Response or Improper Spot Location
80
Residual Risk
80
Ophthalmology References
81
Warranty Information
82
Warranty Shipments, Returns, and Adjustments
82
Decontamination of Returned Equipment
83
US Technical Service Information
83
Decontamination Certification
84
Weee Disposal
85
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Norlase Leaf Specifications
General
Brand
Norlase
Model
Leaf
Category
Medical Equipment
Language
English
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