LUMENIS PULSE 60H User manual

Holmium Surgical Laser
Operator's Manual
Lumenis PULSE 60H
®TM
TEMPORARY
PLACEHOLDER

Lumenis® PulseTM 60H Laser System
UM-20057180EN, Rev. A Page 2
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change without notice.
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trademarks of Lumenis.
Copyright © Lumenis Ltd.
Catalog Part Number: UM-20057180EN
September 2016
Revision A
Directive 2012/19/EU on Waste Electrical and Electronic Equipment
(WEEE)
In accordance with Directive 2012/19/EU on Waste Electrical and
Electronic Equipment (WEEE), any item which is marked with the
crossed-out wheelie bin symbol must not be disposed of as unsorted
municipal waste, but segregated from other waste types for eventual
treatment and recovery at an approved recycling facility.
By returning waste electrical and electronic equipment via the correct
segregated disposal channel, users can ensure the environmentally sound
treatment and disposal of the waste equipment, thereby reducing the
potential for any environmental or health risks that could arise as a result
of incorrect disposal.
Lumenis provides web-based collection, recycling and reporting
arrangements to the business end-user for equipment marked with the
crossed-out wheelie bin.
Please visit www.Lumenis.com/Homepage/About2/Recycle to understand
what arrangements Lumenis has made in each EU Member State.

Lumenis® PulseTM 60H Laser System
UM-20057180EN, Rev. A Page 3
Authorized Representative in the European Community:
Lumenis (Germany) GmbH
Heinrich-Hertz-Strasse 3
D-63303 Dreieich-Dreieichenhain
Germany
Tel: [phone]
Manufactured by Lumenis Ltd.
Yokneam Industrial park
6 Hakidma Street
P.O.B. # 240
Yokneam 2069204, Israel
Tel: [phone]
Fax: [phone]
www.Lumenis.com
0483
EC REP

Lumenis® PulseTM 60H Laser System Table of Contents
UM-20057180EN, Rev. A Page 4
Table of Contents
Table of Contents ......................................................................................................... 4
Chapter 1: Introduction ............................................................................................. 10
Manual Conventions .................................................................................................... 11
System Description and Main Features ....................................................................... 12
Laser System Console ................................................................................................. 13
Touch-Screen Control Panel ........................................................................................ 13
User Interface Language ............................................................................................. 13
Footswitch ....................................................................................................................13
Optical Fibers ............................................................................................................... 14
Chapter 2: Theory of Operation ................................................................................ 15
General Theory of Operation ....................................................................................... 15
Laser Power Parameters ............................................................................................. 15
Theory of Operation – Moses Mode ............................................................................ 16
Chapter 3: Safety ....................................................................................................... 18
Introduction ..................................................................................................................18
Optical Hazards ........................................................................................................... 18
Laser Safety Eyewear .................................................................................................. 18
Additional Ocular Protection ........................................................................................ 19
Electrical Hazards ........................................................................................................ 20
Fire Hazards ................................................................................................................ 20
Additional Safety Considerations ................................................................................. 21
Protecting Non-Target Tissues .................................................................................... 21
Laser Emission Indicators ............................................................................................ 23
Warning, Certification and Identification Labels ........................................................... 24
Description of System Labels: 25
Chapter 4: Clinical Guide .......................................................................................... 28
Indications for Use ....................................................................................................... 30
Contraindications ......................................................................................................... 30

Lumenis® PulseTM 60H Laser System Table of Contents
UM-20057180EN, Rev. A Page 5
Specific Contraindications in Urology .......................................................................... 30
Specific Contraindications in Gynecology .................................................................... 30
Warnings and Precautions ........................................................................................... 31
Complications .............................................................................................................. 32
Detailed Indications for Use ......................................................................................... 33
Urology ......................................................................................................................... 33
Arthroscopy .................................................................................................................. 34
General Surgery ........................................................................................................... 35
ENT Surgery ................................................................................................................ 36
Gynecological Surgery ................................................................................................. 36
Gastroenterology Surgery ............................................................................................ 37
Pulmonary Surgery ...................................................................................................... 37
Dermatology and Plastic Surgery ................................................................................ 38
Chapter 5: Preparing the System for Use ................................................................ 39
Moving the Laser Console ........................................................................................... 40
Connecting the Footswitch ........................................................................................... 41
Connecting the External Door Interlock Connector ...................................................... 42
Plugging in the Mains Power Cable ............................................................................. 43
Installing the Fiber Arm Support .................................................................................. 44
Connecting the Optical Fiber ....................................................................................... 45
SIS (Secured Identification System) Technology 47
Connecting the Suction System ................................................................................... 48
Main System Screens ................................................................................................ 51
Home Screen Description ............................................................................................ 51
Specialties Screen Description .................................................................................... 54
Treatment Screen Description ..................................................................................... 55
Laser Emission Indication ............................................................................................ 59
Chapter 6: Operating Instructions ............................................................................ 60
Emergency Stop Switch ............................................................................................... 60
Safety Eyewear ............................................................................................................ 61
Verification of Connections .......................................................................................... 61

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Powering Up the System ............................................................................................. 61
Restarting the Laser System ........................................................................................ 63
Setting the Treatment Parameters and Controls ......................................................... 64
Starting the Laser Treatment ....................................................................................... 67
Operating in Moses Mode with Moses Fibers .............................................................. 69
Selecting Moses Mode Treatment ............................................................................... 69
Intra-Operative Instructions .......................................................................................... 71
Post-Operative Instructions .......................................................................................... 73
Shutting Down the System ........................................................................................... 74
Advanced Operations ................................................................................................ 76
Saving Settings as Presets .......................................................................................... 76
Preset Management ..................................................................................................... 78
Introduction ..................................................................................................................78
Choosing Presets ......................................................................................................... 80
Creating New Presets .................................................................................................. 82
Editing Presets ............................................................................................................. 84
Duplicating Presets ...................................................................................................... 86
Deleting Presets ........................................................................................................... 88
Exporting Presets ......................................................................................................... 89
Favorites ...................................................................................................................... 91
Changing the Favorite Presets (Add, Remove and Reorder) ...................................... 91
Favorite: Quick Add .................................................................................................... 94
Favorite: Quick Remove .............................................................................................. 95
Reports ........................................................................................................................ 96
Exporting the Reports .................................................................................................. 97
Changing the Default Specialty .................................................................................. 100
Other Operations ....................................................................................................... 102
Turning Off the Aiming Beam ..................................................................................... 102
Changing Screen Settings ......................................................................................... 103
Adjusting Volume and Sound Indications .................................................................. 104
Changing Date and Time ........................................................................................... 107
Changing the Interface Language .............................................................................. 110

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Exporting Service Log ................................................................................................ 112
Restoring Default Settings ......................................................................................... 115
Case Saver Mode ...................................................................................................... 115
Help ............................................................................................................................ 116
Chapter 7 - Troubleshooting and Maintenance ..................................................... 117
Handling Error Messages and Notifications ............................................................... 117
Troubleshooting ......................................................................................................... 118
Initialization Error Message Appears ......................................................................... 118
System Does Not Turn On ......................................................................................... 118
Inadequate or No Aiming Beam ................................................................................. 118
No Laser Energy Emission ........................................................................................ 118
“Popping” or “Tapping” Coming Sound from the Fiber Port ....................................... 119
Fiber Burn Back ......................................................................................................... 119
Unrecognized Fiber .................................................................................................... 119
A Notification or Error Message Appears on the Control Panel ................................. 119
System Overheats ..................................................................................................... 120
Non-Specific Events of Unusual System Behavior .................................................... 120
Message Appears: Attach an Authorized Fiber ......................................................... 120
Message Appears: Attach fiber .................................................................................. 121
Message Appears: Attach footswitch ......................................................................... 121
Message Appears: Check footswitch ......................................................................... 121
Message Appears: Check interlock ........................................................................... 121
Message Appears: Insert debris shield ...................................................................... 121
Message Appears: No lasers ..................................................................................... 121
Message Appears: Energy high ................................................................................. 122
Message Appears: Energy low .................................................................................. 122
Message Appears: Rate high ..................................................................................... 122
Message Appears: Rate low ...................................................................................... 122
Routine Periodic Maintenance ................................................................................... 123
Hospital/Clinic Staff Maintenance .............................................................................. 124
Visual Inspection ........................................................................................................ 124
Routine Exterior Cleaning .......................................................................................... 124

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UM-20057180EN, Rev. A Page 8
Remote Interlock Check ............................................................................................. 124
Emergency Stop Button Check .................................................................................. 125
Inspect the Debris Shield ........................................................................................... 125
Remove the Debris Shield ......................................................................................... 125
Inspect the Optic ........................................................................................................ 126
Reinsert the Debris Shield ......................................................................................... 127
Professional Maintenance (to be updated by Yehudit and reviewed by Yoav) .......... 128
Energy Detectors Calibration ..................................................................................... 128
Chapter 8: System Requirements and Information .............................................. 130
Installation ..................................................................................................................130
Accessories ................................................................................................................ 130
Tools (Optional) ......................................................................................................... 131
Electrical Requirements ............................................................................................. 131
Electrical Utilities ........................................................................................................ 131
Systems Designed for Use in European Communities Under the MDD .................... 132
External Door Interlock Pin Assignments ................................................................... 132
Compliance with International Standards .................................................................. 133
Emergency Stop Button ............................................................................................. 133
Login Password ......................................................................................................... 133
Laser Emission Indicators .......................................................................................... 133
External Door Interlock .............................................................................................. 133
Protective Housing ..................................................................................................... 133
Safety Shutter ............................................................................................................ 133
Manual Restart ........................................................................................................... 134
Electronic Fault Detection Circuitry ............................................................................ 134
Safety Interlocks ........................................................................................................ 134
Precision of Displayed Values ................................................................................... 134
Space Requirements ................................................................................................. 134
System Specifications ................................................................................................ 135
Laser Safety Eyewear ................................................................................................ 136
Compatible Optical Fibers .......................................................................................... 136
Decontamination of Returned Equipment .................................................................. 136

Lumenis® PulseTM 60H Laser System Table of Contents
UM-20057180EN, Rev. A Page 9
Customer Service and Warranty ................................................................................ 136
Appendix A: EMC Guidance and Manufacturer's Declaration ............................. 137
Electromagnetic Emissions ........................................................................................ 137
Electromagnetic Immunity ......................................................................................... 138
Recommended Separation Distances ....................................................................... 140

Lumenis® PulseTM 60HLaser System Chapter 1: Introduction
UM-20057180EN, Rev. A Page 10
Chapter 1: Introduction
The Lumenis Pulse 60H holmium laser system provides utility in urology,
orthopedics, ENT, gynecology and general surgery applications. Fiber
delivery of holmium laser energy is ideal for minimally invasive surgery.
WARNING:
• Lasers generate a highly concentrated beam of light which may cause
injury if improperly used. To protect the patient and operating
personnel, the entire laser system operator’s manual and the
appropriate optical fiber instruction guides, including all Safety and
Regulatory sections, should be carefully read and comprehended
before operation.
• Lumenis medical lasers and laser optical fibers are intended solely for
physicians trained in the use of these instruments.
• No modification of this equipment is allowed.
In the USA:
CAUTION:
US federal law restricts this device to sale by or on the order of a
physician.
Lumenis lasers and delivery systems are precision medical instruments.
They have undergone extensive testing and with proper handling are
useful and reliable clinical instruments. If you have questions regarding
your laser system or optical fiber, contact Lumenis Customer Service.
NOTE:
All of the screen captures shown in this manual are for illustration only
and may differ depending on the specific version of your system and the
language selected.