LUMENIS PULSE 50H User manual

Holmium Surgical Lasers
Operator's Manual
Lumenis PULSE 50H/100H
®TM

Lumenis®PulseTM 50H / 100H Laser Systems
UM-20006520DE, 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
other media without the express written permission of Lumenis. Permitted
copies must carry the same proprietary and copyright notices as were
affixed to the original. Under the law, copying includes translation into
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, Pulse 50 and Pulse 100 are trademarks or
registered trademarks of Lumenis.
Copyright © Lumenis (Germany) GmbH
Catalog Part Number: UM-20006520DE
July 2015
Revision A
Manufactured by Lumenis (Germany) GmbH
Heinrich-Hertz-Strasse 3
D-63303 Dreieich-Dreieichenhain
Germany
Tel: [phone]
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.

Lumenis®PulseTM 50H / 100H Laser Systems Table of Contents
UM-20006520DE, Rev. A Page 3
Table of Contents
Table of Contents ......................................................................................................... 3
Chapter 1: Introduction ............................................................................................... 7
Reference to the Lumenis Pulse Systems ..................................................................... 8
Manual Conventions ...................................................................................................... 8
System Description and Main Features ......................................................................... 9
Laser System Console .................................................................................10
Touch-Screen Control Panel ........................................................................10
User Interface Language ..............................................................................10
Footswitch ....................................................................................................10
Optical Fibers ...............................................................................................11
Component Checklist ................................................................................................... 11
Chapter 2: Theory of Operation ................................................................................ 12
Laser Power Parameters ............................................................................................. 12
Chapter 3: Safety ....................................................................................................... 14
Introduction .................................................................................................................. 14
Optical Hazards ........................................................................................................... 14
Laser Safety Eyewear ..................................................................................14
Additional Ocular Protection .........................................................................15
Electrical Hazards ........................................................................................................ 16
Fire Hazards ................................................................................................................ 16
Additional Safety Considerations ................................................................................. 16
Protecting Non-Target Tissues .................................................................................... 17
Laser Emission Indicators ............................................................................................ 18
Warning, Certification and Identification Labels ........................................................... 18
Explanation of the symbols used in the labels .............................................19
Chapter 4: Clinical Guide .......................................................................................... 22
Indications for Use ....................................................................................................... 24
Contraindications ......................................................................................................... 24

Lumenis®PulseTM 50H / 100H Laser Systems Table of Contents
UM-20006520DE, Rev. A Page 4
Specific Contraindications in Urology ..........................................................24
Specific Contraindications in Gynecology ...................................................24
Warnings and Precautions ........................................................................................... 24
Complications .............................................................................................................. 25
Detailed Indications for Use ......................................................................................... 26
Urology ........................................................................................................27
Arthroscopy .................................................................................................28
General Surgery ..........................................................................................29
ENT Surgery ................................................................................................30
Gynecological Surgery ................................................................................30
Gastroenterology Surgery ...........................................................................31
Pulmonary Surgery ......................................................................................31
Dermatology and Plastic Surgery ................................................................32
Chapter 5: Preparing the System for Use ................................................................ 33
Moving the Laser System Console .............................................................................. 34
Connecting the Footswitch ........................................................................................... 35
Connecting the External Door Interlock Connector ...................................................... 36
Plugging in the Main Power Cable ............................................................................... 37
Connecting the Optical Fiber ....................................................................................... 38
SIS (Secured Identification System) Technology ........................................41
Chapter 6: Operating Instructions ............................................................................ 42
Emergency Stop Switch ............................................................................................... 42
Safety Eyewear ............................................................................................................ 43
Verification of Connections .......................................................................................... 43
Powering on the System .............................................................................................. 43
Restarting the Laser System ........................................................................................ 43
Treatment Screen Description ..................................................................................... 44
Laser Emission Indicators ...........................................................................46
Intra-Operative Instructions .......................................................................................... 47
Post-Operative Instructions .......................................................................................... 49
Moving the Laser Console ........................................................................................... 50

Lumenis®PulseTM 50H / 100H Laser Systems Table of Contents
UM-20006520DE, Rev. A Page 5
Chapter 7 - Troubleshooting and Maintenance ....................................................... 51
Handling Error Messages and Notifications ................................................................. 51
Troubleshooting ........................................................................................................... 52
Initialization Error Message Appears ...........................................................52
System Does Not Turn On ...........................................................................52
Inadequate or No Aiming Beam ...................................................................52
No Laser Energy Emission ..........................................................................52
“Popping” or “Tapping” Coming Sound from the Fiber Port .........................53
Fiber Burn Back ...........................................................................................53
Unrecognized Fiber .....................................................................................53
A Notification or Error Message Appears on the Control Panel ...................53
System Overheats .......................................................................................54
Message Appears: Attach an Authorized Fiber ...........................................54
Message Appears: Attach fiber ....................................................................54
Message Appears: Attach footswitch ...........................................................54
Message Appears: Check footswitch ...........................................................55
Message Appears: Check interlock .............................................................55
Message Appears: Insert debris shield ........................................................55
Message Appears: No lasers .......................................................................55
Message Appears: Energy high ...................................................................55
Message Appears: Energy low ....................................................................55
Message Appears: Rate high .......................................................................56
Message Appears: Rate low ........................................................................56
Routine Periodic Maintenance ..................................................................................... 57
Hospital/Clinic Staff Maintenance ................................................................................ 58
Visual Inspection ..........................................................................................58
Routine Exterior Cleaning ............................................................................58
Remote Interlock Check ...............................................................................58
Emergency Stop Button Check ....................................................................59
Inspect the Debris Shield .............................................................................59
Change the Debris Shield Optic ..................................................................62
Professional Maintenance ............................................................................................ 63

Lumenis®PulseTM 50H / 100H Laser Systems Table of Contents
UM-20006520DE, Rev. A Page 6
Energy Detectors Calibration 63
Chapter 8: System Requirements and General Information .................................. 65
Installation .................................................................................................................... 65
Accessories .................................................................................................................. 65
Tools (Optional) ........................................................................................................... 66
Electrical Requirements ............................................................................................... 66
Electrical Utilities .......................................................................................................... 66
Systems Designed For Use Outside of Europe ...........................................66
Systems Designed For Use in European Communities Under the MDD .....66
External Door Interlock Pin Assignments .....................................................67
Compliance With International Standards .................................................................... 68
Emergency Stop Button ...............................................................................68
Keyswitch .....................................................................................................68
Laser Emission Indicators ............................................................................68
External Door Interlock .................................................................................68
Protective Housing .......................................................................................68
Safety Shutter ...............................................................................................68
Manual Reset ...............................................................................................69
Electronic Fault Detection Circuitry ..............................................................69
Safety Interlocks ...........................................................................................69
Precision of Displayed Values ......................................................................69
Space Requirements ................................................................................................... 69
System Specifications .................................................................................................. 70
Laser Safety Eyewear ..................................................................................71
Replacement Parts Part Numbers ...............................................................71
Compatible Optical Fibers ...........................................................................71
Decontamination of Returned Equipment .................................................................... 72
Customer Service and Warranty .................................................................................. 72
Appendix A: EMC Guidance and Manufacturer's Declaration ............................... 73
Electromagnetic Emissions .......................................................................................... 73
Electromagnetic Immunity ........................................................................................... 74
Recommended Separation Distances ......................................................................... 76

Lumenis®PulseTM 50H / 100H Laser Systems Chapter 1: Introduction
UM-20006520DE, Rev. A Page 7
Chapter 1: Introduction
The Lumenis Pulse 50H and Lumenis Pulse 100H holmium laser systems
provide 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 and the appropriate optical fiber
operator manuals, 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.
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 50H / 100H Laser Systems Reference to the Lumenis Pulse Systems
UM-20006520DE, Rev. A Page 8
Reference to the Lumenis Pulse Systems
This operator's manual discusses two laser systems: the Lumenis Pulse
50H system and the Lumenis Pulse 100H system.
• In many places the instructions in this manual are identical for both
systems. In these instances the manual refers generically to the
System.
• In instances where the instructions are explicit to one or the other
system, the manual refers specifically to the Pulse 50H system or to
the Pulse 100H system.
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 50H / 100H Laser Systems System Description and Main Features
UM-20006520DE, Rev. A Page 9
System Description and Main Features
The Lumenis Pulse 50H or Pulse 100H laser system comprises the
following main components and features:
• Laser system console
• Rotatable control panel with touch-screen technology
• Dual-pedal footswitch
• Security Identification System (SIS) technology
• Green aiming beam
Figure 1: Lumenis Pulse 50H / Pulse 100H Laser System Console

Lumenis®PulseTM 50H / 100H Laser Systems Laser System Console
UM-20006520DE, Rev. A Page 10
Laser System Console
The laser system console houses the control screen, the laser control
keyswitch, emergency stop knob, main On/Off switch, 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
To change the language displayed in the user interface screens consult
with Lumenis Customer Service.
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 50H / 100H Laser Systems Optical Fibers
UM-20006520DE, Rev. A Page 11
Optical Fibers
A variety of optical fibers are available for use with the Lumenis Pulse
50H and Lumenis Pulse 100H laser systems. Lumenis fibers incorporate
Security Identification System (SIS) technology. Refer to the appropriate
optical fiber’s instruction guide for specific operating instructions.
Component Checklist
• Lumenis Pulse 50H or Pulse 100H laser system console.
• Detachable dual-pedal footswitch.
• External door interlock connector.
•Keys
• Operator’s manual.

Lumenis®PulseTM 50H / 100H Laser Systems Chapter 2: Theory of Operation
UM-20006520DE, Rev. A Page 12
Chapter 2: 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 50H or 100H 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 50H or Pulse 100H can deliver a maximum average
power of 50W or 100W respectively obtained, i.e., by delivery of 2 x 25 Hz.

Lumenis®PulseTM 50H / 100H Laser Systems Laser Power Parameters
UM-20006520DE, Rev. A Page 13
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 the stone into particles versus disintegrating
the stone 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.

Lumenis®PulseTM 50H / 100H Laser Systems Chapter 3: Safety
UM-20006520DE, Rev. A Page 14
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.
System Maximum Permissible Exposure Nominal Ocular Hazard Distance
Lumenis Pulse 50H 2 mJ/cm21.9 meters
Lumenis Pulse 100H 2 mJ/cm21.9 meters
System W avel en g t h Used Minimum Optical Density (OD) Protection Level
Lumenis Pulse 50H
H o : Y A G (2.1 µm) 3.0 DI LB3
Lumenis Pulse 100H H o : Y A G (2.1 µm) 3.0 DI LB3

Lumenis®PulseTM 50H / 100H Laser Systems Additional Ocular Protection
UM-20006520DE, Rev. A Page 15
Laser safety eyewear must meet the requirements as per EN207 and
ANSI Z136.1.
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. External door interlocks that automatically disable the laser when the
treatment room door is opened may be installed.
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 50H / 100H Laser Systems Electrical Hazards
UM-20006520DE, Rev. A Page 16
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 cords 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.
Additional Safety Considerations
CAUTION:
Smoke evacuation may be required if using the laser system in open-air
procedures.

Lumenis®PulseTM 50H / 100H Laser Systems Protecting Non-Target Tissues
UM-20006520DE, Rev. A Page 17
Protecting Non-Target Tissues
WARNING:
• When using an optical fiber, always inspect it to ensure that it has not
been kinked, punctured, fractured, or otherwise damaged. The optical
fiber may be damaged if stepped on, pulled, left lying in a vulnerable
position, kinked, or tightly coiled. Do not clamp the optical fiber with
a hemostat or other instruments. If sterile tape is used, always remove
the tape before lifting the optical fiber. A damaged optical fiber may
cause accidental laser exposure or injury to the treatment room
personnel or patient, and/or fire in the treatment room.
• Never deliver the treatment beam to the target tissue if the aiming
beam integrity has not been verified; the optical fiber may be
damaged. A damaged optical fiber may cause accidental laser
exposure to the treatment room personnel or patient, and/or fire in the
treatment room.
• Except during actual treatment, the laser system must always be in
Standby mode. Maintaining the laser system in Standby mode
prevents accidental laser exposure if the footswitch is inadvertently
pressed.
CAUTION:
• To prevent accidental laser discharge, always make sure that the
footswitch is not being operated while connecting the optical fiber.
• Never place hands or other objects in the path of the laser beam.
Severe burns could occur.
• Only the person directing the aim of the laser beam should have access
to the laser system footswitch. Use caution pressing the laser system
footswitch when it is in proximity to footswitches for other equipment.
Verify the footswitch pressed is the correct one in order to avoid
accidental laser exposure.
• Never discharge the laser system without a target to absorb it and
without consideration given to what lies behind the target. Place
energy-absorbing material behind the target tissue when aiming the
laser at an oblique target.

Lumenis®PulseTM 50H / 100H Laser Systems Laser Emission Indicators
UM-20006520DE, Rev. A Page 18
Laser Emission Indicators
• An audible signal is emitted during lasing. A different audible sound
is used for the left and right pedals.
• When lasing, a lasing emission indicator appears on the screen.
Warning, Certification and Identification Labels
As required by national and international regulatory agencies, appropriate
warning labels have been mounted in the specified locations.
Figure 3 displays the identification and certification labels affixed to the
system and the symbols displayed in the labels:

Lumenis®PulseTM 50H / 100H Laser Systems Explanation of the symbols used in the
UM-20006520DE, Rev. A Page 19
Figure 3: Location of Regulatory Compliance Labels
Explanation of the symbols used in the labels
The labels located on the system's front and rear panels contain the following information:
Symbol Description
Lumenis, Energy to Healthcare
CE Compliance
STOP
SYSTEM
SERIES
SYSTEM
SERIES
LASER CLASS 4/IV
Holmium:YAG:2.1 μm, 3.5 J max.
600 μs pulsem ax.
LASER CLASS3R/Illa
DSPPLaser:532nm, 5 mW max.CW
VISIBLE AND INVISIBLELASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTEREDRADIATION
CLASS4 LASERPRODUCTperIEC/EN60825-1/2007
CLASSIV LASERPRODUCT per 21CFR1040.10AND1040.11
LB-20001720_A
exceptfor deviations pursuant to Notice 50, dated June 24, 2007
LASER CLASS 4/IV
Holmium: YAG: 2.1 μm, 3.5 J max.
600 μs pulse max.
LASER CLASS 3R/Illa
DSPP Laser: 532 nm, 5 mW max. CW
VISIBLE AND INVISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT per IEC/EN 60825-1/2007
CLASS IV LASER PRODUCT per 21 CFR 1040.10 AND 1040.11
LB -20001720_A
except for deviations pursuant to Notice 50, dated June 24, 2007
LB-20001260DE_A
LASERCLASS 4/IV
Holmium:YAG:2.1μm,3.5Jmax.
600μspulsemax.
LASERCLASS3R/Illa
DSPPLaser:532nm,5mW max.CW
VISIBLEANDINVISIBLELASER RADIATION
AVOIDEYEORSKINEXPOSURE TO DIRECT
OR SCATTEREDRADIATION
CLASS4LASERPRODUCT per IEC/EN60825-1/2007
CLASSIVLASERPRODUCTper21CFR 1040.10AND 1040.11
LB-20001720_A
exceptfordeviationspursuantto Notice50,datedJune24, 2007
LB-20001260DE_A

Lumenis®PulseTM 50H / 100H Laser Systems Explanation of the symbols used in the
UM-20006520DE, Rev. A Page 20
Manufacturer
Date of Manufacture
Catalog Number
Serial Number
Series Series Number
System Model Name
Follow Instruction for Use
Electrical Requirements
Type BF Equipment
This device contains:
FCC ID: Z97-1149466
This device contains:
FCC ID: Z97-1149466
Laser Class 4/IV
Holmium:YAG Laser: 2.1µm, 3.5J max. 600 µs pulse max.
Laser Class 4/IV
DSSP Laser: 532nm, 5mW max. CW
Visible and Invisible Laser Radiation
Avoid eye or Skin Exposure to Direct or Scattered Radiation
Class 4 laser product per IEC 60825-1:2007
CLASS IV LASER PRODUCT per 21 CFR 1040.10 & 1040.11
except for deviations pursuant to Notice 50, Dated June 24, 2007
Non-Ionizing Electromagnetic Radiation
Symbol Description
LASER CLASS 4/IV
Holmium: YAG: 2.1 μm, 3.5 J max.
600 μs pulse max.
LASER CLASS 3R/Illa
DSPP Laser: 532 nm, 5 mW max. CW
VISIBLE AND INVISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT per IEC/EN 60825-1/2007
CLASS IV LASER PRODUCT per 21 CFR 1040.10 AND 1040.11
LB -20001720_A
except for deviations pursuant to Notice 50, dated June 24, 2007