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
This manual is copyrighted with all rights reserved. Under copyright laws,
this manual may not be copied in whole or in part or reproduced in any
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another language.
Please note that while every effort has been made to ensure that the data
given in this document is accurate, the information, figures, illustrations,
tables, specifications, and schematics contained herein are subject to
change without notice.
Lumenis, the Lumenis Logo and Pulse 60H are trademarks or registered
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
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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

Lumenis® PulseTM 60H Laser System Table of Contents
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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

Lumenis® PulseTM 60H Laser System Table of Contents
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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

Lumenis® PulseTM 60H Laser System Table of Contents
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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
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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.

Lumenis® PulseTM 60HLaser System Manual Conventions
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Manual Conventions
NOTE:
A Note is a statement that alerts the operator to particularly important
information.
CAUTION:
A Caution is a statement that alerts the operator to the possibility of a
problem with the device associated with its use or misuse. Such problems
include device malfunction, device failure, and damage to the device or
other property. The caution statement includes the precaution that should
be taken to avoid the hazard.
WARNING:
A Warning is a statement that alerts the operator to the possibility of
injury, death, or serious adverse reactions associated with the use or mis-
use of the device.

Lumenis® PulseTM 60HLaser System System Description and Main Features
UM-20057180EN, Rev. A Page 12
System Description and Main Features
The Lumenis Pulse 60H laser system comprises the following main
components and features:
• Laser system console
• Control panel with touch-screen technology
• Dual-pedal footswitch
• Security Identification System (SIS) technology
• Green aiming beam
Figure 1: Lumenis Pulse 60H Laser System Console
TEMPORARY
PLACEHOLDER

Lumenis® PulseTM 60HLaser System Laser System Console
UM-20057180EN, Rev. A Page 13
Laser System Console
The laser system console houses the control screen, emergency stop knob,
main On/Off switch, remote interlock, control electronics, laser source
and associated optics, and power supply. An optical fiber attaches to the
fiber connection port on the front of the console, enabling laser energy to
be delivered to the treatment site.
Touch-Screen Control Panel
The control panel is an LCD monitor with touch-screen technology that
allows the operator to select treatment settings outside of the sterile field.
User Interface Language
The user interface language is configured by the Lumenis service
engineer during system installation. The user may change the language as
desired from the list of available languages.
Footswitch
The dual-pedal footswitch activates the laser treatment beam when
pressed, and offers the ability to select treatment from two sets of
parameters by using the left or the right foot-pedal. It also incorporates a
Standby/Ready foot-operated button.
Figure 2: Dual-Pedal Footswitch

Lumenis® PulseTM 60HLaser System Optical Fibers
UM-20057180EN, Rev. A Page 14
Optical Fibers
A variety of optical fibers are available for use with the Lumenis Pulse
60H laser system. Lumenis fibers incorporate Security Identification
System (SIS) technology. Refer to the appropriate optical fiber’s
instruction guide for specific operating instructions.

Lumenis® PulseTM 60H Laser System Chapter 2: Theory of Operation
UM-20057180EN, Rev. A Page 15
Chapter 2: Theory of Operation
General Theory of Operation
A laser, an acronym for Light Amplification of Stimulated Emission of
Radiation, produces a highly concentrated beam of light of a given
wavelength. Laser energy is generated by converting electrical energy to
light energy using a flashlamp. The flashlamp energy is then used to
excite the lasing medium, in this case a holmium YAG crystal rod. The
laser energy is amplified in the laser resonator cavity and a small portion
of the energy is allowed to leak out as the laser working beam.
The Pulse 60H holmium laser system emits a laser beam at a wavelength
of 2100nm. This wavelength is strongly absorbed by water in tissue. Since
soft tissue is comprised primarily of water, holmium laser energy can be
used effectively for excision, incision, ablation, and vaporization when in
direct contact with soft tissue and for coagulation when in near contact
with soft tissue. Calculi (stones) also contain a sufficient amount of water
that absorbs the laser energy leading to lithotripsy.
When working in liquid environment the holmium laser energy provides
additional safety, since laser energy will be absorbed by the surrounding
liquid, limiting its reach to non-target tissue.
The holmium laser wavelength falls in the near-infrared region of the
electromagnetic spectrum. This wavelength is invisible to the human eye.
Therefore, a low-power, visible aiming beam is used to verify the laser’s
target tissue.
Laser Power Parameters
Tissue laser interaction is primarily governed by the laser wavelength and
the target tissue absorption coefficient at that wavelength, defining the
effectiveness of the laser energy absorption in the target tissue. However
additional characteristics of the specific laser system affect the laser tissue
interaction.
Pulsed lasers (such as the holmium laser) deliver an average power
(measured in Watts) that is achieved by multiplying the laser energy
emitted during each pulse (measured in Joules) and the frequency at
which these pulses are delivered (measured in Hertz).
The Lumenis Pulse 60H can deliver a maximum average power of 60W,
i.e., by delivery of 4 Joules x 15 Hz.

Lumenis® PulseTM 60H Laser System Theory of Operation – Moses Mode
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Holmium laser systems can deliver the same average power at different
settings to achieve different laser tissue effect. Changing the energy of
each pulse can be described as the “bite size” of the laser effect, whereas
the frequency as the “bite rate”. For example, setting the system at 50W
can be performed using the following sets of parameters: 2.5J at 20Hz or
2.0J at 25Hz.
When working with calculi, for example, these different settings may
affect the stone by breaking it into particles versus disintegrating it into
fine dust. The selection of the appropriate energy and frequency settings is
dependent on the procedure and specific target tissue.
Each pulse is delivered at a specific time frame, leading to fast heating
rise in temperature of the target tissue. By increasing the pulse duration,
the time frame of energy delivery to the tissue changes and thereby
changing the temperature profile of the tissue. A different temperature
profile may lead to a heating rather than a vaporizing effect and is useful
for example when blood vessel coagulation is desired.
The selection of appropriate power parameters and optical fiber is
dependent on the procedure and the specific patient condition. It is
recommended that you become familiar with laser characteristics and
techniques by attending courses and consulting with colleagues in order to
utilize the lasers capabilities in a safe manner.
Theory of Operation – Moses Mode
The Lumenis Pulse 60H holmium laser emits a laser beam at a
wavelength of 2100nm. This wavelength is strongly absorbed by water.
Since soft tissue is comprised primarily of water, holmium laser energy
can be used effectively for excision, incision, ablation, and vaporization
when in direct contact with soft tissue and for coagulation when in near
contact with soft tissue. Holmium laser energy is also very effective in
lithotripsy of calculi.
In a liquid environment when laser is emitted from the holmium fiber tip,
the water surrounding the tip heats to above the boiling temperature and a
vapor bubble is created. The vapor bubble expands from the fiber tip
towards the target tissue or stone. As only a portion of the pulse is
sufficient to create the vapor bubble, the remaining pulse energy travels
through the void contained in the bubble, and is less attenuated compared
to travel through liquid water.

Lumenis® PulseTM 60H Laser System Theory of Operation – Moses Mode
UM-20057180EN, Rev. A Page 17
When the distance between the fiber tip and the target is very small, this
phenomenon is not observed, as most of the energy reaches the target
tissue. In contact, the laser is therefore the most efficient. However, when
distance is increased, the relative energy that reaches the target is greatly
decreased, leading to reduced ablation efficiency of the laser energy. The
laser efficiency is therefore much dependent on the distance between the
fiber tip and the target. This is defined as the regular mode currently
available for all system applications.
The Moses mode introduces a modulation to the energy pulse that enables
emission of a controlled portion of energy to create the vapor bubble,
while leaving a larger portion as the effective energy portion that travels
through the vapor bubble to reach the target tissue. Laser efficiency is
therefore less dependent on the distance between the fiber tip and the
target, and laser energy is delivered with higher precision.
The Ho:YAG wavelength provides effective hemostasis without
damaging the surrounding or non-target tissues. Decreasing the laser
power density on vascularized tissue is an important tool in bleeding
control. Defocusing (increasing the fiber distance from the tissue) is a
common method for decreasing power density on tissue. When using the
Moses feature, due to its higher precision and reduced dependence on
fiber tip distance from the target, this technique will be less effective.

Lumenis® PulseTM 60H Laser System Chapter 3: Safety
UM-20057180EN, Rev. A Page 18
Chapter 3: Safety
Introduction
This chapter contains important safety information related to the use of
the laser system. All operating personnel should familiarize themselves
with the contents of this chapter before operating the laser system.
Users must take precautions to prevent exposure of laser energy to the
eyes and skin from either direct or diffusely reflected laser beams, except
as a therapeutic application. Additional precautions must be taken to
prevent fire, electrical injury, and explosion.
CAUTION:
Read this operator’s manual carefully. Use of controls or adjustments or
performance of procedures other than those specified herein may result in
hazardous laser radiation exposure.
Optical Hazards
Laser Safety Eyewear
The following specifications were calculated for this systems:
All personnel who are within the Nominal Ocular Hazard Distance are
considered to be within the controlled area and must wear eye protection
according to the following specifications:
WARNING:
Select the appropriate laser safety eyewear for the specific laser in use, by
verifying that the above specifications are indicated on the laser safety
eyewear that is at your disposal.
Laser safety eyewear must meet the requirements as per EN207 and
ANSI Z136.1.
System Maximum Permissible Exposure Nominal Ocular Hazard Distance
Lumenis Pulse 60H 2 mJ/cm21.9 meters
System W avel en g t h Used Minimum Optical Density (OD) Protection Level
Lumenis Pulse 60H
H o : Y A G (2.1 µm) 3.0 DI LB3

Lumenis® PulseTM 60H Laser System Additional Ocular Protection
UM-20057180EN, Rev. A Page 19
In addition to providing the required laser safety eyewear, take the
following steps to secure the treatment room, or the controlled area:
1. To alert personnel before they enter the controlled area, place a
warning sign on the outside of the treatment room door when the laser
is in use.
2. Close the treatment room door during operation of the laser.
3. Install an external door remote interlock that automatically disables
the laser when the treatment room door is opened.
4. Depending on the procedure, the physician must protect the patient’s
eyes with either laser safety eyewear or one of the following items
moistened with a nonflammable solution: thick cloth, eye pads, or
gauze 4 x 4s. For periorbital treatment, the physician must protect the
patient with dulled, metal eye shields.
Additional Ocular Protection
WARNING:
• Always verify that the optical fiber is properly connected to the laser
system. An improper connection may result in an inadvertent
secondary laser beam. Severe eye or tissue damage could occur.
• Never substitute prescription eyewear for the appropriate laser safety
eyewear, as severe eye damage could occur. Prescription eyewear can
concentrate the laser light to the eye and/or can be shattered by a high
power density beam, possibly causing severe eye damage.
• Use caution when performing procedures around the eyes. Severe and
irreversible eye damage and scarring may occur from direct or indirect
exposure to the treatment beam. The predominant ocular structures at
risk are dependent on the laser wavelength in use. In general, visible
and near-infrared wavelengths are most damaging to the retina, while
ultraviolet or infrared wavelengths are most damaging to the cornea
and sclera. Severity of injury depends on how concentrated or diffused
the treatment beam is and the length of exposure. A thorough
understanding of the specific ocular risks and safety precautions for
each laser wavelength is necessary to ensure the safety of the patient
and operating personnel.
• Never look directly into any optical fiber, handpiece, probe or laser
system aperture while the laser system is energized. Severe eye
damage could occur. Turn off the laser system before inspecting any
optical fiber or laser components.

Lumenis® PulseTM 60H Laser System Electrical Hazards
UM-20057180EN, Rev. A Page 20
Electrical Hazards
WARNING:
• Never open the laser system console protective covers. Opening the
covers will expose the user to high voltage components, the laser
resonator, and possible laser radiation. Only Lumenis-certified service
technicians are qualified to work inside the console.
• Do not operate the laser system if any of the cables are faulty or
frayed. The laser system should undergo routine inspection and
maintenance per Lumenis manufacturer’s recommendations and
institutional standards.
• To avoid risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
Fire Hazards
WARNING:
• Do not use this device in the presence of flammables or explosives,
such as volatile anesthetics, alcohol, certain surgical preparation
solutions, and similar substances. An explosion and/or fire could
occur.
• The treatment beam can ignite most non-metallic materials. Use fire
retardant drapes and gowns. The area around the treatment site can be
protected with towels or gauze sponges moistened with sterile saline
solution or sterile water. If allowed to dry, protective towels and
sponges can increase the potential fire hazard. A UL-approved fire
extinguisher and water should be readily available.
• When performing procedures in the perianal area, the flammability of
methane gas must be considered. Moistened sponges should be
inserted into the rectum.