LIGHTSEERDUE

LightSheer ®
Duet ™
Diode Laser System
Operator Manual
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 the
Lumenis group of companies. 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 information in this document is
accurate, the instructions, photos, figures, illustrations, tables, specifications, and schematics contained
herein are subject to change without notice.
LightSheer, LightSheer Duet, the LightSheer logo, ChillTip, OptiPulse, AutoPace, Lumenis, and the
Lumenis logo are trademarks or registered trademarks of the Lumenis group of companies. Cavicide® is
the property of Metrex Research Corporation. Virex™ is the property of S.C. Johnson Commercial
Markets, Inc.
© Copyright Lumenis Ltd.

P/N: UM-1080310
Revision B
Effective Date: February, 2011
0473
Manufactured by Lumenis, Ltd. Authorized Representative:
P.O.B. 240 Lumenis GmbH Germany
Yokneam 20692, Israel Heinrich-Hertz-Strasse 3
Tel: +972.4.959.9000 D-63303 Dreieichenhain
Germany
Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE)

In accordance with Directive 2002/96/EC 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/recycling to
understand what arrangements Lumenis has made in each EU Member State.
3
Contents
Safety and Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Ocular hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Regulatory
Electrical hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Laser plume precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Fire hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Health hazard during treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Chemical hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Clean-up procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
LightSheer Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Safety interlocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Audible emission indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Electronic shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Handpiece enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Handpiece trigger. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Handpiece design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
LightSheer Duet safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Location of Regulatory and System Labels . . . . . . . . . . . . . . . . . . . . . . . 19
Operation Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
HS handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
ET handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
LightSheer Duet Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Inspecting the components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Laser console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
External door interlock plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
LightSheer® Duet™ Laser System Operator Manual

UM-1080310, Rev. B
4 Contents
HS and ET handpiece holsters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Installation Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Laser Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Unpacking the LightSheer Duet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Installing the holsters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Attaching the handpieces to the LightSheer Duet . . . . . . . . . . . . . . . . . . . . . . 38
Installing an external door interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Connection Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Plugging in the main power cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
External door interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
USB port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
RJ-45 Ethernet Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Disconnecting and storing the laser components . . . . . . . . . . . . . . . . . . . . . . 44
Laser Console Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Operator training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Moving the laser console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Turning on the laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
LightSheer Duet System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Calibrating the handpieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Turning off the laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Restarting the laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Treatment Screen Basics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
HS handpiece Treatment Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
ET Handpiece Treatment Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Physician recommended preset values for the ET handpiece . . . . . . . . . . . . . 71
Physician recommended preset values for the HS handpiece . . . . . . . . . . . . . 73
Save As User Preset screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Create a user preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
“System Cooling” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Recoverable error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Non-recoverable error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Setting System Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Laser Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Preoperative instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Intraoperative instructions for the HS handpiece . . . . . . . . . . . . . . . . . . . . . . 85
Intraoperative instructions for the ET handpiece . . . . . . . . . . . . . . . . . . . . . . . 86
Postoperative instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Patient Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Patient consultation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Pre-treatment procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Dosimetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
HS handpiece placement and technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

UM-1080310, Rev. B
Contents 5
ET handpiece placement and technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Skin cooling with the ET handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Tip cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Maintenance Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Cleaning during treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Cleaning and disinfecting the handpiece between patients . . . . . . . . . . . . . . 103
Cleaning the energy meter windows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Cleaning the touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Cleaning the console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
HS handpiece Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Replacing the HS handpiece disposable insert . . . . . . . . . . . . . . . . . . . . . . . 106
Understanding the HS handpiece filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Laser will not turn on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Laser fails to operate properly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Information Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Errors requiring a system restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Errors limiting system functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Errors requiring user attention and may require a system restart . . . . . . . . . . 112
Errors identifying hardware problems and/or requiring user attention . . . . . . 113
Calibration Details and Output Monitoring . . . . . . . . . . . . . . . . . . . . . 115
Automated calibration procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
General approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Detailed approach - ET handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Detailed approach - HS handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Decontamination of Returned Equipment . . . . . . . . . . . . . . . . . . . . . . 121
Returning the Laser to Lumenis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Indications Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

HS handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
for Use
ET handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Theory of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Relative contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

UM-1080310, Rev. B
6 Contents
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Complications and Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Clinical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Hair removal and permanent hair reduction. . . . . . . . . . . . . . . . . . . . . . . . . 131
Pseudofolliculitis barbae treatment using the ET handpiece . . . . . . . . . . . . . 133
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Hair removal with LightSheer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Other applications with LightSheer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Customer Support, Sales, and Service . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Appendix 1 EMC Guidance and Manufacturer’s Declarations . . . . . . . . . . . . . . . 141
Appendix 2 Accessory Kit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

UM-1080310, Rev. B
7
Safety and
Regulatory

UM-1080310, Rev. B
8 Safety and Regulatory
THIS PAGE LEFT BLANK INTENTIONALLY

UM-1080310, Rev. B
Regulatory Compliance 9
Regulatory Compliance
The LightSheer Duet system complies with 21 CFR, Chapter I, Subchapter J,
as administered by the Center for Devices and Radiological Health (CDRH)
of the Food and Drug Administration (FDA). CE-labeled devices comply
with all appropriate performance standards as specified in Annex II of the
Medical Device Directive MDD 93/42/EEC as ammended by 2007/47/EC.
The LightSheer system is classified as a Class IV laser by the CDRH and as a
Class 4 laser by the European Standard EN 60825-1.
WARNING - Use of controls or adjustments or performance of

procedures other than those specified herein may result in hazardous
laser radiation exposure.
The following precautions are extensive but may not be complete. Laser users
are advised to supplement these precautions with information regarding
technological advances in surgical products and techniques as they become
available to the medical laser user community through medical literature. For
more information refer to ANSI Z136.3, ANSI Z136.1, and EN 207 for
recommendations on the safe use of lasers in health care facilities. Please
follow the recommendations of the latest edition of these standards. In
particular, the use of safety eyewear with an adequate optical density rating for
the LightSheer wavelength must be used for all persons with the potential for
laser exposure.
All persons operating the LightSheer Duet laser system or in the vicinity of the
laser must be aware of the potential hazards. Be certain all personnel carefully
review the following safety information. Only authorized individuals with
appropriate laser training and knowledge should operate, assist in the
operation of, or provide maintenance to the LightSheer system. For
information on training, contact Lumenis Customer Support.
In Canada this device must be installed and operated according to
CAN/CSA-Z386-92: Laser Safety in Health Care Facilities.
There are no user-serviceable parts in the LightSheer system, and all service
and repair must be performed only by the factory or authorized field service
technicians. See the Maintenance and Troubleshooting section of this manual
for troubleshooting and routine maintenance instructions.

UM-1080310, Rev. B
Ocular hazards
WARNING - The light emitted by the LightSheer laser is capable of

causing serious eye damage or blindness.
The LightSheer system is to be operated only in an enclosed room with

protective eyewear for all persons. Direct eye exposure is not safe at any
distance within the room. All windows in the laser room must be covered with
opaque material, and measures should be taken to prevent unauthorized access
to the room. A remote interlock is provided, which can be connected to the
treatment room doors disabling laser output if the door is opened during a
procedure. In addition, compliance with ANSI Z136.3 and EN 60825-1
requires that laser safety signs be posted at all entrances whenever the laser is in
use. An approved sign is provided with each system along with protective
eyewear. Additional eyewear or safety signs may be obtained from Customer
Support.
WARNING - All persons in the treatment room, including the

patient, must wear appropriate eye protection whenever the main
power and keyswitch are on. The protective eyewear must have an
optical density (OD) of 5 or greater at the wavelength of 790 – 830
nanometers. For users outside the U.S., the appropriate standard
may be EN 207, in which case the safety eyewear must have a
protection class of L5.
WARNING - While operating the LightSheer system, never look

directly into the laser aperture at the distal end of the handpiece,
even if you are wearing laser safety glasses. Serious eye injury or
blindness could result.
WARNING - Avoid directing the laser beam anywhere other than

within the holster or at the intended treatment area. Stray laser light
and reflection is always a potential hazard and may cause serious
injury.
WARNING - Do not treat eyebrows, eyelashes, or other areas within

the bony area surrounding the orbit. The light emitted by the
LightSheer laser is capable of causing serious eye damage or
blindness. For maximum safety, metal eye goggles must be worn by
the patient for all facial treatments.
Ocular safety considerations:

• Identify the laser room clearly by posting approved laser safety
signs in prominent locations.
• Cover all windows to prevent laser light from escaping the laser
room.
• Restrict entry to the laser room when the laser is in use. Allow
access only to those personnel both essential to the procedure and
well trained in laser safety.

UM-1080310, Rev. B
• Never direct the laser beam at anything other than within the
holster or at the intended treatment site.
• Never look directly into the laser aperture at the distal end of the
handpiece.
• All persons in the treatment room must wear approved laser safety
eyewear with an optical density of 5 or greater at the LightSheer
wavelength of 790 - 830 nanometers. For users outside the U.S.,
the appropriate standard may be EN 207, in which case the safety
eyewear must have a protection class of L5. This includes the
operator, patient, nurses, and any other persons in the room.
• Do not attempt to remove the protective covers on the handpiece,
which could allow exposure to high-intensity laser light.
Electrical hazards
The LightSheer Duet laser system uses high-voltage internal components,
which have the potential to cause serious injury or fatal electrical shock. It is
possible for the high voltage components to retain a charge for some period of
time even after the laser has been turned off.
No part of the exterior housing, except the holsters, should be removed except
by trained and authorized LightSheer laser technicians. Do not soak or spray
the laser console, handpieces or touchscreen in fluids because this can result in
damage to the equipment and electrical shock. Do not operate the system if
the power cord is frayed or otherwise damaged. Clean the touchscreen only
when the LightSheer system is turned off.
WARNING - Opening the exterior housings may cause exposure to

hazardous optical radiation and electrical voltage even after the laser
has been turned off. No portion of the exterior housing, except the
holsters, should be removed by anyone other than a trained and
authorized technicians. Do not operate the system if the power cord
is frayed or otherwise damaged.
WARNING - Do not operate the laser system if any coolant leakage

or spillage is observed, as this may lead to electric shock or death.
Turn off the laser and contact your Lumenis representative.

UM-1080310, Rev. B
Laser plume precautions
CAUTION - The user should be aware that laser plumes do present

a potential hazard. Plumes may be potentially hazardous, both in
terms of particulate matter and infectivity. Special care must be
taken to limit the exposure of both patient and user to any laser
plume smoke or vapor.
CAUTION - Laser plume may contain viable tissue particulates.
CAUTION - The user should wear surgical masks that remove

particles as small as 0.3 µm. Surgical gloves should also be worn.
Fire hazards
The potential for fire hazards exists because the absorption of laser energy may
raise the temperature of any material. While this principle is the basis of many
useful medical and surgical applications, it requires that precautions be taken
against igniting combustible materials. For the LightSheer Duet laser system,
the following precautions should be taken:
• Allow any flammable liquids used for cleaning the skin or
handpiece insert, such as alcohol, to fully evaporate before
treatment.
• Anesthetics administered topically or by inhalation must be
approved as nonflammable.
• Exercise particular care in the use of oxygen, which can accelerate
the combustion of any flammable material.
• Avoid using combustible materials, such as gauze and drapes, in the
treatment area. When required, these materials may be made more
fire resistant by keeping them moist with water. Clothing should be
kept well away from the area of treatment.
• Do not operate the laser with any cover or drape over the laser.
WARNING - Do not operate the LightSheer system in the presence

of flammable liquids (such as alcohol or acetone) or flammable gases
(such as ether).

UM-1080310, Rev. B
Health hazard during treatment

High power laser light targets the melanin in the hair and the hair shaft. The
heat absorbed by the melanin is transferred to the cells in the follicle, resulting
in effective hair removal and permanent reduction. The heated hairs will
sometimes vaporize, leading to the “burning hair smell” which often
accompanies laser hair removal. While generally safe, this laser plume can
condense on the cold ChillTip of the LightSheer. Condensed on the ChillTip,
the hair material may harden and will absorb subsequent pulses of laser light.
While most of the ChillTip will remain very cold, the burned hair material
will become very hot and can lead to burns as the insert is moved across the
epidermis. Lumenis has received reports of injuries to patients including
superficial burns, 1st degree burns, 2nd degree burns and hyperpigmentation
that are directly attributed to the failure of the user to keep the ChillTip clean
during hair removal procedures.
Chemical hazard
WARNING - Always wear gloves during treatment and it is

recommended to wear long sleeves. This prevents skin
contamination with the cooling solution if there is a break in the
cooling lines.
The LightSheer laser is cooled by a closed loop cooling system. The system is
used to maintain the operating temperature of the lasers in the handpiece and
the ChillTip for the ET handpiece.
Prevention
Always inspect the system and handpiece before powering up. Do not move
the system around with the handpiece or umbilical, this will stress the
umbilical and also cause the system to fall over if the wheels are locked on the
system or cart.
Clean-up procedure
Turn off the system and unplug from the AC outlet. Use paper towels to wipe
up all of the spill. Use any household cleaning agent to wipe down the area
affected to prevent skin contact and to remove the slipping hazard if it spills
on the floor.
If in contact with skin, immediately wash with soap and water and remove
affected clothing. If there are skin irritations, seek medical attention.
If in contact with eyes, flush for 15 minutes and seek medical attention.
The cooling solution to be used is an Ethylene Glycol mixture. It has a light
green color and feels silky to the touch. It is diluted to 80% water and 20%
Ethylene Glycol.

UM-1080310, Rev. B
LightSheer Safety Features

The LightSheer laser system is designed to be safe and convenient for both the
operator and patient. The most important safety-related features for all
systems are described below. See the Operation section of this manual for
descriptions and operating instructions for these and all other system features.
Safety features unique to the laser system or handpiece are in the following
sections. New devices and applications will be added as an appendix in the
manual.
Safety interlocks
The LightSheer system contains a comprehensive monitoring system that
allows operation only when numerous safety conditions have been met. A
fault must be corrected and the system reset before laser operation is re-
enabled. The monitoring system includes the following:
• Remote interlock: An external door interlock receptacle and plug
are provided to disable the laser if the treatment room doors are
opened.
• System time out which disables the laser if it has not been used for
15 minutes. This feature is designed to help prevent unintended
exposure and reduce mechanical wear.
• Energy monitoring to verify that the laser output is within specific
energy tolerances for every laser pulse. If abnormally low or high
laser current (indicative of optical energy) is detected, a system
fault is triggered and the user is notified.
• Temperature monitoring which disables system operation if the
diode temperature or ChillTip (on the ET handpiece only) is
outside the operating range.
Audible emission indicator

For operator feedback and safety, each laser pulse is accompanied by an
audible beep. No attempt should be made to disable or impair this emission
indicator, and in the unlikely event that emission occurs without an audible
beep, use of the system should be discontinued until proper performance is
established.

UM-1080310, Rev. B
LightSheer Safety Features 15
Electronic shutter
As a safety feature and in compliance with U.S. and international regulations,
the LightSheer Duet system contains an electronic shutter to help prevent
inadvertent laser emission. Located in the console, the shutter is an electronic
switch that is independent of, and in addition to, the normal energy circuit for
the laser pulse. The shutter is directly controlled by the handpiece enable and
system mode; laser emission is prohibited by the shutter if the system
handpiece enable is active and the laser is not in ready mode. This is unlike
conventional lasers, which rely upon shutters to block the beam during warm-
up, alignment, and other times.
Handpiece enable
To help prevent unintended emission, laser output occurs only if the
handpiece enable is active, the laser is in ready mode, and the handpiece
trigger is pressed.
ET handpiece
With the laser in ready mode, the operator must first press the handpiece
enable button, which opens the safety shutter, and then press the handpiece
trigger to delivery the treatment pulses to the patient. The enable button is
unlit when disabled and lit when enabled. The enable button becomes
disabled after being idle for more than 30 seconds.
HS handpiece
With the laser in ready mode, the operator must first press the handpiece
enable button, which opens the shutter, and then press the handpiece trigger
to initiate the vacuum function. Once the target vacuum is reached, the
treatment pulses are delivered to the patient. The enable button is unlit when
disabled and lit when enabled. The enable button becomes disabled after
being idle for more than 30 seconds.

UM-1080310, Rev. B
Handpiece trigger
ET handpiece
With the handpiece enable active and the system in ready mode, the laser can
be fired repetitively by (1) either pressing and releasing the trigger for each
pulse, or (2) keeping the trigger continuously pressed, in which case the laser
will fire repetitively for as long as the handpiece trigger is pressed.
HS handpiece
With the handpiece enable active and the system in ready mode, the laser can
be fired by pressing and releasing the handpiece trigger for each treatment of
1-3 pulses. The trigger must be pressed each time to perform multiple
treatments.
Handpiece design
Several aspects of the ET and HS handpiece design also contribute to the
safety of the LightSheer Duet system. Since the laser emission originates in the
handpiece itself and not in the console as in conventional lasers, there is no
need for an articulated arm or other beam delivery system with inherent beam
quality and alignment concerns. The laser emission is confined to the
handpiece, so there is no hazardous optical radiation in the console or
umbilical.
ET Handpiece
The sapphire tip is placed against the patient’s skin during system use,
reducing stray light while increasing the therapeutic effectiveness.
The ET handpiece console connector is keyed to connect to the left side of the
system (when facing the system).
HS handpiece
The handpiece is placed against the patient’s skin during use; a vacuum pump
creates suction and draws the skin into the treatment handpiece, thus
reducing stray light while increasing the therapeutic effectiveness.
The HS handpiece console connector is keyed to connect to the right side of
the system (when facing the unit).

UM-1080310, Rev. B
LightSheer Safety Features 17
LightSheer Duet safety features

Keyswitch
To prevent unauthorized use, the laser can only be turned on with the master
key, the key can only be removed when the laser is turned off, and the laser
only operates when the key is inserted into the keyswitch. When the
keyswitch is turned to the (on) position, the laser power-up sequence is
initiated.
Emergency stop switch

Releasing the handpiece trigger will stop all laser emission. In the event of an
emergency, the laser can be shut down immediately by pushing the emergency
stop button located near the keyswitch on the console. To restore operation,
rotate the button in the clockwise direction until it pops out again. Then
follow the standard startup sequence. Since the emergency stop switch is not
intended for routine use, follow the procedure in the Operation section of this
manual for normal shutdown.

UM-1080310, Rev. B

UM-1080310, Rev. B
Location of Regulatory and System Labels 19
Location of Regulatory and System Labels

As required by national and international regulatory agencies, appropriate
warning labels have been mounted in specified locations.
STOP
Emergency stop label
Regulatory
compliance labels
ON/OFF Keyswitch
Location of regulatory compliance labels

UM-1080310, Rev. B
HS handpiece
Laser aperture label
Handpiece danger label and

handpiece manufacturing label
ET handpiece
Laser aperture label
Location of regulatory compliance labels on handpieces

UM-1080310, Rev. B
Location of Regulatory and System Labels 21
55ºC
(131ºF)
-5ºC
(23ºF)
HUMIDITY TEMPERATURE
90% @ 35ºC -5ºC – 55ºC
32% @ 55ºC 23ºF – 131ºF
Nonoperating environmental specifications (on shipping box)
Manufactured by MONTH/YEAR
P/N, REV
P.O.B. 240
S/N
Yokneam 20692, Israel
+972.4.959.9000
Model name, serial number,
Lumenis contact information CSA compliance and manufacturing date
This equipment
conforms to provision
Caution: U.S. federal U.S. 21.CFR 1040.10
law restricts this and 1040.11 as
U.S. AND INTERNATIONAL device to sale by or applicable
PATENTS PENDING on the order of a
physician (for FDA-compliant systems)
Patents pending FDA sales restriction DHHS certification
EC REP
Lumenis (Germany) GmbH 100 - 240 V~

Heinrich-Hertz-Str. 3
D-63303 Dreieich-Dreieichenhain
Germany
0473
Phone: +49 (0)6103-8335-0
Authorized CE Mark Electrical

Representative specification
Regulatory compliance labels

UM-1080310, Rev. B
!
(Read and comprehend the
operator manual before use.) Type B electric Type BF electric
Attention, read manual Mains connection shock protection shock protection
HS handpiece ET handpiece
External interlock
receptacle Keyswitch ON Keyswitch OFF
Handpiece manufacture date, Handpiece manufacture date,

part number, and serial number part number, and serial number
Manufactured by: Manufactured by:
L LUMENIS R
L LUMENIS R
MONTH YEAR REV MONTH YEAR REV
P/N P/N
S/N S/N
LASER CLASS 4/IV LASER CLASS 4/IV

WAVELENGTH : 790-830 nm WAVELENGTH : 790-830 nm
PULSE ENERGY: 85 J max PULSE ENERGY: 102 J max
PULSE DURATION: 5-400 ms PULSE DURATION: 30-400 ms
PULSE RATE: 3 Hz max PULSE RATE: 3 Hz max
VISIBLE AND INVISIBLE LASER RADIATION VISIBLE AND INVISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO AVOID EYE OR SKIN EXPOSURE TO
LB-1077922
LB-1077932
DIRECT OR SCATTERED RADIATION DIRECT OR SCATTERED RADIATION

CLASS 4 LASER PRODUCT per EN 60825-1/2001 CLASS 4 LASER PRODUCT per EN 60825-1/2001
CLASS IV LASER PRODUCT per 21 CFR 1040.10 &1040.11 CLASS IV LASER PRODUCT per 21 CFR 1040.10 &1040.11
except for deviations pursuant to Notice 50, Dated June 24, 2007 except for deviations pursuant to Notice 50, Dated June 24, 2007
ET handpiece danger label HS handpiece danger label
Regulatory compliance labels

UM-1080310, Rev. B
23
Operation

UM-1080310, Rev. B
24 Operation

UM-1080310, Rev. B
Introduction 25
Introduction
WARNING - Lasers generate a highly concentrated beam of light

that may cause injury if improperly used. To protect the patient and
the operating personnel, the entire laser operator manual, including
all Safety and Regulatory sections, should be carefully read and
comprehended before operation.
The LightSheer laser system delivers pulsed infrared light intended for hair
removal, permanent hair reduction, the treatment of leg veins, and benign
pigmented lesions.
Based on state-of-the-art diode laser technology, the LightSheer system offers
many advantages, including the combination of a favorable wavelength,
excellent pulse characteristics, and unique integrated cooling in a lightweight
and compact instrument. The console provides touchscreen computer control
and a user-friendly interface, ensuring that treatments are performed with
confidence and convenience.
The LightSheer Duet laser system consists of a console with touchscreen, a
power cable, a large aperture, high-speed (HS) handpiece, and a standard (ET)
handpiece.
HS handpiece
The HS handpiece features an open tip to which vacuum is applied. The
vacuum draws the patient’s skin into the tip before laser treatment, and
releases the skin upon delivery of the pulses. The combination of larger
aperture and vacuum affords the customer a faster treatment rate by covering a
larger skin area with each laser pulse.
ET handpiece
The ET handpiece features a chilled sapphire tip that is pressed against the
patient’s skin during treatment. By conductively cooling the skin, the chilled
handpiece tip increases the tolerated fluence, provides partial anesthesia, and
reduces temperature-rise in the melanin-rich epidermis.

UM-1080310, Rev. B
26 Operation
LightSheer Duet Components

The LightSheer Duet laser system is comprised of:
• a laser console with touchscreen and integrated holsters for
handpiece calibration and storage
• a large aperture, high-speed (HS) handpiece
• a standard (ET) handpiece
• an external door interlock plug
• all electrical cables necessary for proper connection
Touchscreen
HS handpiece External door

interlock plug
ET handpiece
HS handpiece umbilical
Utility drawer
ET handpiece umbilical
Main (AC) power cable

Laser system brake
Laser console
LightSheer Duet components

UM-1080310, Rev. B
LightSheer Duet Components 27
Inspecting the components

When unpacking your LightSheer System, and before each use, inspect the
components for dirt, debris, or damage.
Inspect each handpiece for cracks or other visible damage. A damaged
handpiece may cause electrical shock, unintended laser exposure, injury to
treatment room personnel or the patient, and/or fire in the treatment room.
Inspect each handpiece and handpiece umbilical for punctures or coolant
leaks. Leaks or spills may result in electrical shock and/or death. Furthermore,
loss of coolant may cause the laser system to overheat due to inadequate
cooling.
Ensure that the power cord is not punctured or worn.
If any component requires cleaning, follow the directions provided in the
Maintenance section of this manual.
If any component appears damaged, contact your local Lumenis service
representative.
Laser console
The laser console houses the touchscreen, main power keyswitch, emergency
stop button, control electronics, and power supply. The laser console also
includes integrated holsters, which are used for both calibration and storage of
the LightSheer Duet handpieces.
Touchscreen
The touchscreen provides an interface for operating and calibrating the
system. Press the touchscreen lightly with a finger to select the on-screen
functions.
WARNING - Clean the touchscreen regularly as instructed in the

Maintenance chapter of this manual to ensure proper performance.
Excessive treatment oil, gel, lotion, or other contaminants on the
touchscreen may cause erratic operation of the user interface
buttons.
External door interlock plug

The external door interlock plug must be inserted into the (external
interlock) receptacle on the rear of the laser console for the laser to operate.
The plug may be wired to an external switch to disable the laser if the
treatment room doors are opened during treatment.

UM-1080310, Rev. B
28 Operation
Handpieces
Each handpiece contains laser diode arrays that generate the laser treatment
light. Power and control signals are exchanged with the main console via the
handpiece umbilical. Each handpiece is equipped with a wrist strap to prevent
damage to the handpiece if inadvertently dropped.
The handpiece contains delicate optical components which may be damaged if

dropped. The handpiece should be placed in the holster when not being used
for treatment. The wrist strap should be worn whenever the system is in use.
When the system is not in use, the handpiece should be secured to the console
by looping the wrist strap around the wrist strap hook.
Do not allow sunblock or sunscreen products to contact the handpiece. The

ingredients found in sunblock and sunscreen products may cause deterioration
or damage to the handpiece material. If sunblock or sunscreen does contact
the handpiece, clean the handpiece immediately to prevent possible damage.
HS handpiece
The HS handpiece operates by drawing the patient’s skin into the handpiece
and against the aperture with a vacuum pump. The combination of larger
aperture and vacuum affords a faster treatment rate by covering a larger skin
area with each laser pulse.
HS handpiece disposable insert

The HS handpiece uses a removable, disposable insert that attaches to the
handpiece aperture, and which must be replaced between patients, or during
patient treatment if the tip becomes dirty or if the internal filters become
clogged.
Replace the disposable insrt as needed, according to the instructions provided
in the Maintenance section of this manual.

UM-1080310, Rev. B
Enable button
Trigger
Vacuum check
mode indicator
Wrist strap Aperture
HS handpiece
Disposable insert
HS handpiece disposable insert

UM-1080310, Rev. B
30 Operation
ET handpiece
The ET handpiece features a sapphire tip that provides contact cooling to the
patient’s skin during treatment. Cooling fluid is exchanged with the main
console via the handpiece umbilical.
In standard operation, the handpiece tip is placed against the patient's skin
and a laser pulse is delivered when the enable button is on and the handpiece
trigger is pressed.
For hair removal and treatment of benign pigmented lesions, direct pressure
with the handpiece tip allows light to penetrate more deeply, decreases the
amount of blood in the dermis, and conductively cools the epidermis if the tip
is chilled. For treatment of leg veins, contact between the handpiece tip and
skin is maintained for epidermal cooling, but no pressure is applied.
Wrist strap Enable button
Trigger Chill tip/

Laser aperture
ET Handpiece

UM-1080310, Rev. B
HS and ET handpiece holsters

The HS and ET handpiece holsters are used to position and hold the
handpieces during system calibration. Calibration is required after powering
the system on, and may be initiated at other times by inserting a handpiece
into its respective holster and firing the laser.
The holsters also provide convenient locations for resting the handpieces when
moving the laser or when adjusting treatment parameters during patient
treatment. Store handpieces in the holsters when the system is not in use.
If the protective glass window below a holster becomes dirty or covered with
spilled liquid, remove the holster and clean the window according to the
instructions provided in the Maintenance chapter of this operator manual.
Wrist strap hook

The wrist strap hook is used to secure the handpiece when the system is not in
use. Loop the wrist strap around the wrist strap hook whenever the system is
being moved to prevent the handpiece from falling out and being damaged.
Wrist strap hook
ET handpiece HS handpiece
holster holster
Handpiece holsters and wrist strap hook

UM-1080310, Rev. B
32 Operation
Installation Instructions
Laser Preparation
The laser is shipped directly from the factory to your site. Before using the
laser, you must unpack the laser console, install the handpiece holsters, and
attach the handpieces.
Guidelines to observe when moving the laser between locations are described
under “Moving the laser console” later in this chapter.
Inquire from your local Lumenis representative for in-service training to
ensure that you and your staff are experienced with the performance and
safety considerations of the laser.

UM-1080310, Rev. B
Installation Instructions 33
Unpacking the LightSheer Duet

1 Disconnect the three straps that secure the cardboard cap to the top of the
shipping box.
2 Lift the cardboard box up and over the console.
Cardboard box
Shipping straps

UM-1080310, Rev. B
34 Operation
3 Unbuckle the straps that secure the protective foam.
4 Remove the protective foam surrounding the console.
5 Remove and unpack the handpiece holsters.
6 Remove the keyed section of foam from the bottom and place the ramp in
front of the system.
7 Remove the plastic covering from the laser console.
8 Remove the laser system from the bottom of the cardboard box.
Holsters
Protective foam
Keyed foam

UM-1080310, Rev. B
Installing the holsters

1 Unpack the holsters from their shipping container and locate the handpiece
cradles on the laser console. The ET handpiece cradle is on the left side of the
console; the HS handpiece cradle is on the right side of the console.
ET handpiece
holster HS handpiece
holster
Location of holsters on the laser console
Install the HS handpiece holster
2 Place the HS handpiece holster into the cradle on the laser console, as shown.
Identify the HS handpiece holster by the handle rest bar. The ET handpiece
holster does not have a handle rest bar.
Handle rest bar

on HS holster.

UM-1080310, Rev. B
36 Operation
3 Press the upper-front of the holster until you feel or hear it snap securely into
place. Press the sides and bottom of the holster until you feel or hear it snap
securely into place.

UM-1080310, Rev. B
Install the ET handpiece holster
4 Place the ET handpiece holster into the cradle, as shown.
5 Squeeze the sides of the holster and push it into position, then release.
6 Ensure that both holsters are properly seated, with no gaps between the holster
and console.
Holsters properly seated, with no gaps between holster and console

UM-1080310, Rev. B
38 Operation
Attaching the handpieces to the LightSheer Duet

Attach the HS and ET handpieces to the laser console as follows:
1 Unpack the HS and ET handpieces from their respective boxes.
WARNING - The ET handpiece umbilical connector connects to the

umbilical port on the left side of the laser console and the HS
handpiece connector connects to the umbilical port on the right side
of the laser console. They are not interchangable. Attempting to
force an umbilical connector into an incorrect umbilical port may
damage either the port or the connector.
2 Securely seat each handpiece inside its matching holster and loop its
handpiece strap around the center hook to prevent accidental damage while
attaching the handpiece umbilical to the laser console.
The handpiece umbilical cables may be very stiff when new. This is a normal
result of the manufacturing process, which tightly integrates a large number of
smaller cables into a convenient single cable. Your umbilical cables will become
increasingly flexible and easier to position with regular use of the laser system.
Once the handpiece umbilical cables are connected to the laser console, it is
usually not necessary to disconnect them. They should only be disconnected
when necessary due to repair, replacement, shipping, or recycling of the
system.
Wrist strap hook
holster holster
Handpiece holsters and wrist strap hooks

UM-1080310, Rev. B
3 Align the umbilical connector with its corresponding umbilical port on the
laser console.
The ports and connectors are "keyed" to prevent accidental connection to the
wrong port. If the connector is not going into position smoothly, check that the
electrical connections are aligned and that the center element of both the
connector and umbilical port are the same color.
Keyed center Keyed center

element element
umbilical port umbilical port
Align the elements on the

connector with the corresponding
elements on the umbilical ports,
then plug the connector into the
port. HS handpiece connector,
with white center element, is
shown.
4 Plug the connector into the port and push briskly until you feel both of the
two locking mechanisms “click” into place. After feeling the first “click”, push
harder on the opposite side of the plug until you hear the second “click”.

UM-1080310, Rev. B
40 Operation
Installing an external door interlock

You may elect to install a remote switch (door interlock device) to monitor the
treatment room door where the laser system is used. If the interlocked door is
opened, the system will not emit laser light. The remote interlock plug (a ¼
inch mono audio plug) must be connected to a customer supplied door
switch, where the switch is closed when the door is closed. The door switch
contact must be rated for at least 12VDC/2A service, and the total length of
cable from the door switch to the interlock plug should not exceed 5 m (16 ft.
If the laser system will be used in more that one room or at different sites, it
will be necessary to wire each laser room door with a remote switch. Extra ¼
inch mono audio plugs are available for purchase.
The interlock plug must be wired as follows:
Tip: Connect the plug tip to the N.O. (Normally Open) contact of the
switch. When the door is closed, the N.O. switch contact should be
connected to switch COM (Ground Common).
Shaft: Connect the plug shaft to switch COM.
1 Unscrew to remove Cover 2 Remove Jumper

Sleeve Terminal
Sleeve Jumper Wire
Tip
Cover Tip Terminal
3 Install Door Interlock Wires 4 Install Cover

N.O. (Sleeve)
COM (Tip)
COM (Tip)
N.O. (Sleeve)
Door Switch Assembly
5m (MAX)

UM-1080310, Rev. B
Connection Instructions 41
Connection Instructions
Plugging in the main power cable
1 Ensure that the keyswitch is in the (off ) position.
2 Ensure that the main power circuit breaker is in the O (off ) position.
3 Unwrap the main power cable from the cable wrap on the rear of the laser
console.
4 Insert the matching end of the main power cable into the main power
receptacle on the rear of the laser console.
5 Insert the main power plug into the wall socket.
6 Verify that the key is inserted into the keyswitch and turned to the On
position.
7 Verify that the Emergency stop switch is not engaged (turn the switch
clockwise to verify).
8 When ready to use the laser, remember to switch the main power circuit
breaker to the I (on) position.
Main power cable
Main power Main power

circuit breaker receptacle
Power cable connection

UM-1080310, Rev. B
42 Operation
External door interlock

The external door interlock is a safety feature that disables the laser if the
treatment room doors are opened or the interlock plug is removed.
Use of an external door interlock is optional; however, you must insert the
interlock plug into the (interlock) receptacle whether or not you are
using an external door interlock. The laser remains inoperative until the plug
is inserted into the receptacle.
When using an external door interlock, the laser automatically disables and
returns to standby mode if the treatment door is opened or the interlock plug
is removed. To resume treatment, close the treatment room door or reinsert
the interlock plug, and press Ready on the touchscreen.
The LightSheer Duet system is shipped with an external door interlock plug
already connected. To set up a remote interlock switch, see “Installing an
external door interlock” in this chapter, or contact your local Lumenis service
representative.
External door
interlock plug
External interlock
receptacle
External door interlock

UM-1080310, Rev. B
Connection Instructions 43
USB port
For Lumenis service use only.
USB port
USB port
RJ-45 Ethernet Port

For Lumenis service use only.
RJ-45 Ethernet port
Ethernet port

UM-1080310, Rev. B
44 Operation
Disconnecting and storing the laser components

1 Place the laser in standby mode.
2 Turn the keyswitch to the (off ) position and remove the key to prevent
unauthorized use of the laser.
3 Turn off the main circuit breaker located on the back of the system.
4 Unplug the main power plug from the wall socket.
5 Wrap the power cable around the laser console handle.
6 Inspect and clean the handpieces, as instructed in the Maintenance chapter of

this operator manual.
7 Store the handpieces in the corresponding holsters on the laser console.
8 If desired, disconnect the external door interlock, if used.
9 Clean the exterior surfaces of the laser, as instructed in the Maintenance

chapter of this operator manual.

UM-1080310, Rev. B
Laser Console Basics 45
Laser Console Basics

Operator training
CAUTION - In the United States, federal law restricts this device to

sale by or on the order of a physician, or any other practitioner
licensed by the law of the state in which he/she practices to use or
order the use of the device.
CAUTION - The LightSheer Duet system is only to be used by those

adequately trained in the safe handling and operation of this system.
It is strongly recommended that, in addition to laser safety training of all

clinic or operating room personnel, the user and institution adopt a training
and safety program. For additional information, refer to the latest revision of
ANSI Z136.3 or the latest revision of IEC 60825-1.
Users should attend:
• a training course,
• a hands-on training course under the preceptorship of a qualified
user, and
• specialty-specific courses presented during academy or college
meetings.
In addition to training, the practitioner should keep current with the relevant
medical literature and thoroughly read and understand this manual.

UM-1080310, Rev. B
46 Operation
Moving the laser console

Ensure that the laser is properly disconnected, as instructed in the previous
section.
If engaged, disengage the system brake by cycling the brake foot lever to the
raised (up) position.
Using the laser console handle, move the laser to the desired site.
To avoid tipping the laser console when moving it, always observe the following
precautions:
• Disengage the system brake
• Grasp the laser console handle while moving the laser
• Always pull the laser console to the desired location
• Never push the laser console
As with any heavy equipment, use caution when tilting the laser console or
moving it up or down an incline. For optimum safety, use a second person
when moving up or down a steep incline.
Do not move the laser console rapidly over uneven surfaces; doing so may
damage the equipment.
To prevent damage to the instrument, do not move the console by pulling on

the handpiece or the umbilical. Pull the console by using the console handle to
reposition the system.
Laser
console
handle
Disengage the
system brake
before moving
the laser
Do not push the laser system Grasping the laser console

handle, pull the laser to the
desired location

UM-1080310, Rev. B
Laser Console Basics 47
Position the laser console a minimum of 50 centimeters (20 inches) from

walls, furniture, or other equipment.
Adequate space around the laser console ensures proper air circulation for
system cooling.
If desired, engage the system brake by cycling the brake foot lever to the
pressed (down) position.

UM-1080310, Rev. B
48 Operation
Turning on the laser

1 Verify the Emergency Stop switch is not engaged by turning the switch
clockwise.
2 Insert the key into the keyswitch.
3 Turn the key to the (on) position.
4 Verify that the main power cable is connected.
5 Verify that the main power circuit breaker is in the I (on) position.
A laser self-test and warm-up begin.
The self-test and warm-up take approximately one minute. When the self-test
is successfully completed, the handpiece selection screen displays on the
touchscreen.
If any fault conditions are encountered during the laser self-test and warm-up,
refer to the “Troubleshooting Guide” in the Maintenance chapter.
Emergency
stop switch
Keyswitch
Main power
circuit breaker
Main power circuit breaker and keyswitch

UM-1080310, Rev. B
LightSheer Duet System Operation 49
LightSheer Duet System Operation

When the self-test is successfully completed, the vacuum warning message
displays on the touchscreen.
Self-test screen
Select the desired handpiece, either by selecting the corresponding icon on the
touchscreen, or by removing the handpiece from its holster.
Upon selecting the desired handpiece, the calibration screen appears. Follow
the calibration procedure, as described in the following section.
Quit button
View the utility Select the ET Select the HS

screen handpiece handpiece
Handpiece selection screen

UM-1080310, Rev. B
50 Operation
Calibrating the handpieces

Handpiece calibration is required upon system startup. Calibration is also
recommended prior to each treatment. After calibration, the treatment screen
for the selected handpiece displays on the touchscreen and the startup
procedure is complete.
Energy calibration determines the optical output and verifies that the pulse
energy is within specific tolerances. During calibration, an energy meter
located beneath the handpiece holster measures the output energy of the
handpiece. The system automatically sets the laser parameters over the
operating range, determines the electrical parameters, and compares the
measured and expected pulse energies.
If the system is already turned on, the operator may initiate a recalibration
from the treatment screen at any time by positioning the handpiece in the
holster, placing the system in Ready mode and waiting for the status indicator
to display “READY”, enabling the handpiece, and pressing the handpiece
trigger. Calibration is recommended prior to the start of each treatment.
WARNING - The handpiece tip and energy meter window must be

clean to ensure accurate calibration. An unclean tip or window will
result in higher than indicated fluence, which may cause epidermal
damage.

UM-1080310, Rev. B
Handpiece calibration procedure
1 On the LightSheer Duet startup screen, select the handpiece that you intend
to calibrate. A screen will appear, reminding you to wear safety eyewear and
clean the handpiece tip.
Pre-calibration warning: wear safety eyewear and clean handpiece tip
For accurate energy calibration, the handpiece tip and energy meter window
must be clean and free of condensation. If condensation is present, dry the
handpiece tip with a clean, dry gauze pad. If the handpiece tip or energy meter
window is not clean, clean according to the instructions in the Maintenance
chapter of this manual.
2 Press OK to proceed to the next step.

UM-1080310, Rev. B
52 Operation
3 Remove the handpiece from the holster.
ET handpiece calibration screen — remove the handpiece
HS handpiece calibration screen — remove the handpiece

UM-1080310, Rev. B
4 If calibrating an HS handpiece, ensure that the disposable insert is attached to

the handpiece. Press OK to continue.
CAUTION - Do not attempt to calibrate the HS handpiece without

first attaching a disposable insert.
HS handpiece calibration screen — ensure disposable insert is attached

UM-1080310, Rev. B
54 Operation
5 Carefully reinsert the handpiece into the holster.

Verify that the handpiece aperture is pointing downward at the energy meter
and that the handpiece is fully seated in the holster. A proximity switch will
allow laser emission during calibration only if the tip of the handpiece is
located within the holster.
The touchscreen displays the calibration sequence and prompts the user to
complete each step.
ET handpiece calibration screen — reinsert the handpiece
HS handpiece calibration sequence — reinsert the handpiece

UM-1080310, Rev. B
6 When the enable icon appears (flashing arrow pointing at the enable button),
press the handpiece enable button to enable the laser.
Enable button
Trigger
Vacuum check
mode indicator
Enable button
Trigger
Location of handpiece enable and trigger buttons

UM-1080310, Rev. B
56 Operation
ET handpiece calibration screen — press the enable button
HS handpiece calibration screen — press the enable button

UM-1080310, Rev. B
7 Press and hold the handpiece trigger.
WARNING - While operating the LightSheer Duet system, never

look directly into the laser aperture at the distal end of the
handpiece, even if you are wearing laser safety glasses. Serious eye
injury or blindness could result.
When the trigger icon appears (flashing arrow pointing at the trigger), press
the handpiece trigger to fire the laser. Keep the handpiece trigger pressed
until all calibration shots are fired as indicated by the progress bar.
ET handpiece calibration screen — press and hold the trigger
HS handpiece calibration screen — press and hold the trigger

UM-1080310, Rev. B
58 Operation
8 Wait until the system finishes performing the calibration.

Progress is displayed on the touchscreen, and a beeping sound will be audible
when the laser fires.
If the handpiece is removed from the holster or the handpiece trigger is

released before the calibration is complete, the procedure is immediately
stopped and must be repeated.
ET handpiece calibration screen — “calibrating”
HS handpiece calibration screen — “calibrating”
9 Release the handpiece trigger.

UM-1080310, Rev. B
10 If necessary, clean the handpiece tip and the energy meter window and then
repeat the calibration sequence.
If an abnormal energy is measured, a screen will prompt you to clean the
handpiece tip and the energy meter window (below the holster) because
contamination or condensation can affect the reading. Carefully perform the
cleaning per the Maintenance chapter of this manual and repeat the
calibration sequence.
Location of energy meter Location of energy meter

window for ET handpiece window for HS handpiece
Handpiece calibration screens — clean energy meter window
11 Repeat the calibration for the other handpiece, as needed.

After calibration is completed, the treatment screen is displayed and normal
operation can proceed.
In compliance with national and international regulations, additional details
of the calibration procedure are provided in the Maintenance chapter of this
manual, although this information is intended for authorized service
personnel only.

UM-1080310, Rev. B
60 Operation
Turning off the laser

1 From the HS or ET treatment screen, press M (return to main) to return to
the startup screen.
Return to the main screen Return to the main screen
2 Press the Quit button on the startup screen and follow any prompts presented
by the system.
Quit button Shutdown prompt
3 Turn the keyswitch to the (off ) position. Remove the key to prevent
unauthorized use of the laser.

UM-1080310, Rev. B
Restarting the laser

1 Turn the keyswitch to the (off ) position; wait 5 seconds.
2 Turn the keyswitch to the (on) position.
Emergency stop
In an emergency, press the emergency stop button on the front of the laser
console to immediately turn off the laser.
To restore operation, rotate the button clockwise until it pops out and restart
the instrument with the keyswitch. Use the keyswitch, rather than the
emergency stop button for routine shutdown.
When the main power cable is connected to the electrical source, some
internal circuits remain energized. To de-energize all internal circuits, unplug
the main power plug from the wall socket, or turn off the main power circuit
breaker.
STOP
Emergency stop
button
Keyswitch

UM-1080310, Rev. B
62 Operation
Treatment Screen Basics

The LightSheer Duet laser system displays a unique treatment screen
according to the handpiece you have selected. Touchscreen controls common
to both the HS and ET handpiece screens are described in the following
paragraphs.

Maintenance chapter of this manual to ensure proper performance.
touchscreen may cause erratic operation of the user interface.
Return to the main

screen
Tip counter
Pulse counter Laser Standby/Ready

reset button mode selector
Pulse counter field
Controls and indicators common to both HS and ET handpieces

(HS handpiece screen is shown)

UM-1080310, Rev. B
Tip counter
The tip counter registers the number of shots remaining before the LightSheer
Duet system suspends treatment and prompts the operator to inspect the
handpiece tip. If necessary, clean the ET handpiece sapphire tip or replace the
HS handpiece disposable insert, as described in the Maintenance section of
this manual.
After verifying the tip, press OK to clear the warning, reset the counter, and
continue treatment.
Resume treatment
and reset the
counter after
verifying the tip
Tip counter
Verify the ET handpiece tip before resuming treatment
Resume treatment
and reset the
counter after
verifying the tip
Tip counter
Verify the HS handpiece tip before resuming treatment

UM-1080310, Rev. B
64 Operation
Pulse counter field

The pulse counter field displays (upper number) a reset-able counter useful for
recording the number of pulses in a single session or for other short term uses,
and (lower number) a cumulative counter that records the total number of
shots on the LightSheer Duet system.
Press the >0< button to reset the session counter to zero.
Reset to zero Pulse counter field

Upper number: number of pulses delivered by
the currently selected handpiece during the
current session
Lower number: displays the total number of
pulses delivered by the currently selected
handpiece.
Pulse counter and counter reset button (ET handpiece screen is shown)

UM-1080310, Rev. B
Selecting the Laser Mode: Ready or Standby
WARNING - Except during actual treatment, the laser must always

be in standby mode. Maintaining the laser in standby mode prevents
accidental laser exposure if the handpiece trigger is inadvertently
pulled.
WARNING - Verify that all persons in the treatment room are

wearing the appropriate laser safety eyewear before placing the laser
in ready mode.
In ready mode, the trigger is enabled and the treatment beam is available. In
standby mode, the trigger is disabled; no treatment beam is available.
• To select Ready mode, press Ready; the three indicators display the
progress of transition from Standby to Ready mode. The green
Ready button illuminates when Ready mode is active.
• To select Standby mode, press Standby. The red Standby button
illuminates to indicate that the laser is in Standby mode.
The laser automatically switches from ready mode to standby mode if it

remains idle for more than 5 minutes.
Even after selecting ready mode, you must press the handpiece enable button
on your handpiece before pulling the handpiece trigger will fire the laser.
Ready mode button

Standby mode and indicator
Ready mode progress indicator
Ready and Standby controls (HS handpiece screen is shown)

UM-1080310, Rev. B
66 Operation
HS handpiece Treatment Screen

After you have selected the HS handpiece on the startup screen and
calibration is completed, the HS handpiece treatment screen is displayed.
Load user presets Save user presets
Load Physician Clinical Indications

Recommended Presets
Clinical indications
screen selector
Pulse repeat field

Fluence field
Vacuum level
Vacuum on/off
HS handpiece treatment screen
Field Description
Pulse repeat Select 1, 2 or 3 to deliver up to three laser shots for each press of the trigger, at a rate of up to
2 shots per second.
Fluence Select from 4.5 to 12 J/cm2 in increments of 0.1 J/cm2.
For the 30 ms mode the maximal fluence will be 6 J/cm2.
Vacuum level Selects the vacuum level: highest (18 inHg), medium (12 inHg), or lowest (8 inHg) available level.
Vacuum on/off Toggles the vacuum pump on or off; only available when the laser is in Standby mode.
Will automatically activate when the laser is placed in ready mode.
OptiPulse OptiPulse has four user-selectable modes: 30 ms”, “Custom”, “100 ms” and “400 ms”.
With “Custom” mode selected, the system will select the optimal pulse width based on the fluence
and number of pulses selected.
Pulse interval Displays actual pulse interval between pulses from 333 ms to 2000 ms. It is displayed at the bottom
of the "No. Pulses" field.

UM-1080310, Rev. B
ET Handpiece Treatment Screen

After you have selected the ET handpiece on the startup screen and calibration
is completed, the ET handpiece treatment screen is displayed.
Load user presets Save user presets
Load Physician Current clinical
Recommended Presets settings
Clinical indications
screen selector
Fluence field
Pulse rate field Fluence bar
Fluence J/cm2
Increase fluence
OptiPulse™ mode
Decrease fluence
Toggle chill tip on/off
ET handpiece treatment screen
Control/Indicator Description
Rate (Hz) Select the “Fast” (1-3 Hz), “Med” (0.5-1.0 Hz) or “Slow” (0.5 Hz); the actual rate will be
displayed at the bottom of the pulse rate field.
OptiPulse OptiPulse has four user-selectable modes: “AUTO”, “30 ms”, “100 ms”, and “400 ms”. In
(Pulse width) “30 ms”, “100 ms”, and “400 ms” modes, the pulse width is fixed at 30 ms, 100 ms, and 400 ms
respectively, independent of the fluence setting. In “AUTO” mode, the system selects the pulse
width allowable at a given fluence.
Fluence field Displays the selected fluence, numerically, and as a bar indicating the fluence level in relation to
the maximum available fluence for your current Rate and OptiPulse settings. Press the increase
or decrease fluence selectors to adjust the desired fluence.
Toggle chill tip on/off When first turned on, the ChillTip requires approximately 30 seconds to cool to its operating
temperature, during which time the “COOLING” message is displayed on the screen. The laser
cannot be fired if the ChillTip is on, but not adequately cold. For safety, the ChillTip is turned
on by default and a confirmation screen appears when the ChillTip is switched off. In addition, if
the ChillTip is turned off, the “OFF” indicator flashes red as a warning to the user. The status
indicator on the treatment screen also indicates if the ChillTip is turned off.
Using the LightSheer Duet system when the ChillTip is off can result in epidermal damage. Use
extreme care when operating the system with the ChillTip off. Except in rare circumstances, the
system should always be operated with the ChillTip turned on.

UM-1080310, Rev. B
68 Operation
Clinical indications Displays the clinical indications screen, described in the following section.
screen selector
Load physician • Loads the physician recommended presets for the currently selected clinical indications into
recommended presets the treatment screen. Presets are Rate, OptiPulse selection, and Fluence.
• This button is disabled if there are no clinical indications currently selected, or if there are no
Lumenis presets for the currently selected clinical indications.
Load user presets • Loads previously-saved user presets for the currently selected clinical indications into the
treatment screen. Presets are Rate, OptiPulse selection, and Fluence.
• This button is disabled if there are no clinical indications currently selected, or if there are no
previously-saved user presets for the currently selected clinical indications.
Save user presets Opens the Clinical Indications screen, which lets you save your currently selected treatment
parameters for future retrieval with the Load user presets button.
Current clinical settings Displays the currently selected patient clinical settings, if selected:
• skin type (I through VI)
• hair color (Blonde/Red, Light brown, dark brown, or black)
• hair texture (Fine, Coarse, or Dense)
Hair with less melanin (pigment) is a known treatment challenge, and may
result in less than optimal results.
Hair color must be darker than skin color to be safely and effectively treated.
In cases where hair color is lighter than skin color, no presets are available.

UM-1080310, Rev. B
Clinical Indications Screen for ET Handpiece
Select the skin type
Select the hair color
Select the hair texture
Load physician
recommended presets
Load User presets

Presets for currently selected
clinical indications
Clinical Indications Screen for HS Handpiece
Select the skin type
Select the hair color
Select the hair texture
Load physician
recommended presets
Load User presets

Presets for currently selected
clinical indications

UM-1080310, Rev. B
70 Operation
Skin Type Selects the skin type
Hair Color Selects the hair color
Hair Texture Selects the hair texture
Treatment Parameters • Displays the Lumenis or User presets for the currently selected skin type, hair color, and
display hair texture. Presets are Rate, OptiPulse selection, and Fluence.
• This field is displayed only after the Lumenis Preset or User Preset button has been pressed.
Load physician • Loads the physician recommended treatment presets for the currently selected clinical indi-
recommended presets cations into the treatment parameters display. Presets are Rate, OptiPulse selection, and
Fluence.
• This button is disabled if there are no clinical indications currently selected, or if there are
no Lumenis presets for the currently selected clinical indications.
Load user presets • Loads previously-saved user treatment presets for the currently selected clinical indications
into the treatment parameters display. Presets are Rate, OptiPulse selection, and Fluence.
• This button is disabled if there are no clinical indications currently selected, or if there are
no previously-saved user presets for the currently selected clinical indications.
OK Accepts the user selections and closes the screen. This button is inactive until the user has
selected the skin type, hair color, and hair texture.
Cancel Closes the Clinical Indications screen without making a selection.

UM-1080310, Rev. B
Physician recommended preset values for the ET handpiece

Skin Type Hair Color Hair Texture Fluence (J/cm2) Pulse Duration [ms]
Fine 40 Auto
Blond/Red Coarse 35 Auto
Dense 35 30
Fine 40 Auto
Light Brown Coarse 35 Auto
Dense 35 30
I
Fine 40 Auto
Dark Brown Coarse 35 Auto
Dense 35 30
Fine 40 Auto
Black Coarse 35 Auto
Dense 35 30
Fine 35 Auto
Blond/Red Coarse 30 Auto
Dense 30 30
Fine 35 Auto
Light Brown Coarse 30 Auto
Dense 30 30
II
Fine 35 Auto
Dark Brown Coarse 30 Auto
Dense 30 30
Fine 35 Auto
Black Coarse 30 Auto
Dense 30 30
Fine 30 Auto
Blond/Red Coarse 25 30
Dense 20 30
Fine 30 Auto
Light Brown Coarse 25 30
Dense 20 30
III
Fine 30 Auto
Dark Brown Coarse 25 30
Dense 20 30
Fine 30 Auto
Black Coarse 25 30
Dense 20 30

UM-1080310, Rev. B
72 Operation
Skin Type Hair Color Hair Texture Fluence [J/cm2] Pulse Duration [ms]
Fine No Preset No Preset
Blond/Red Coarse No Preset No Preset
Dense No Preset No Preset
Fine 20 30
Light Brown Coarse 26 100
Dense 24 100
IV
Fine 20 30
Dense 24 100
Fine 20 30
Black Coarse 26 100
Dense 24 100
Light Brown Coarse No Preset No Preset
V
Fine 22 100
Dense 16 100
Fine 22 100
Black Coarse 18 100
Dense 16 100
Light Brown Coarse No Preset No Preset
VI
Fine 25 400
Dense 20 400
Fine 25 400
Black Coarse 20 400
Dense 20 400

UM-1080310, Rev. B
Physician recommended preset values for the HS handpiece

Hair Hair Fluence Pulse Duration Level of Number of
Skin Type
Color Texture (J/cm2) [ms] Vacuum Pulses
Fine 11 Custom Medium 1
Blond/Red Coarse 10 Custom Medium 1
Dense 9 Custom Medium 1
Light
Coarse 10 Custom Medium 1
Brown
I
Dark
Brown
Black Coarse 10 Custom Medium 1
Light
Brown
II
Dark
Brown
Light
Brown
III
Dark
Brown

UM-1080310, Rev. B
74 Operation
Hair Hair Fluence Pulse Duration Level of Number of

Skin Type
Color Texture (J/cm2) [ms] Vacuum Pulses
Light
Brown
IV
Dark
Brown
Fine No Preset No Preset No Preset No Preset
Blond/Red Coarse No Preset No Preset No Preset No Preset
Dense No Preset No Preset No Preset No Preset
Fine 6 100 Medium 1
Light
Coarse 5 400 Medium 1
Brown
Dense 4.5 400 Medium 1
V
Fine 5.5 400 Medium 1
Dark
Brown
Black Coarse 5 400 Medium 1
Fine No Preset No Preset Medium 1
Blond/Red Coarse No Preset No Preset No Preset 1
Dense No Preset No Preset No Preset 1
Fine No Preset No Preset No Preset 1
Light
Coarse No Preset No Preset No Preset 1
Brown
Dense No Preset No Preset No Preset 1
VI
Dark
Brown
Black Coarse 5 400 Medium 1

UM-1080310, Rev. B
Save As User Preset screen

1 Click on the Save Button:
Open the Save As User Preset screen
Press OK to save
2 Select OK after verifying settings. Preset is now saved.

UM-1080310, Rev. B
76 Operation
Create a user preset

1 Click on the Clinical Indications screen selector button.
2 Select skin and hair options. If Lumenis or user preset buttons are highlighted,
the parameter already exists.
Clinical Indications

UM-1080310, Rev. B
3 If neither is on, select the OK button to return to the treatment screen

window.
4 Click on the Save button.
5 Select the OK button after verifying settings. Preset is now saved.
Open the Save As User Preset screen
Press OK to save

UM-1080310, Rev. B
78 Operation
System Messages
“System Cooling”
When necessary, the system will pause operation to activate cooling of the
selected handpiece. During system cooling the LightSheer Duet system
automatically returns to standby mode, the Ready button on the touchscreen
is disabled, and the enable buttons on the handpieces deactivate. You may still
set parameters; however, the system cannot be returned to ready mode until
after the required operating temperature is reached and the “System Cooling”
message clears.
HS handpiece “System Cooling” message
ET handpiece “System Cooling” message

UM-1080310, Rev. B
System Messages 79
Recoverable error
Clear recoverable errors by pressing the Clear button on the error message.
Continue the procedure; if the error continues to appear, contact your
Lumenis representative.
Example of a recoverable error
Non-recoverable error
Non-recoverable errors require a system restart. To restart the system after a
non-recoverable error, turn the keyswitch to the (off ) position, wait 30
seconds, and then turn the keyswitch to the (on) position. If the error
persists, contact your Lumenis representative.
Example of a non-recoverable error

UM-1080310, Rev. B
80 Operation
Setting System Options
Select the Utility Menu screen

UM-1080310, Rev. B
Setting System Options 81
Utility menu Description

System Information Displays information about the system software and the connected handpieces.
Press System Information again to display the current system software revision.
Display the handpiece hardware information
Display the current system software revision
Idle Mode Press to place system into idle mode. System will also enter into idle mode automatically after a period
of inactivity.

UM-1080310, Rev. B
82 Operation
User Preferences • Adjust the system volume by pressing the - or + buttons on the touchscreen until the system beeps
at the desired volume.
• Press the Change button or press on the desired language button to select the desired language.
System Operating • Pressing the Vacuum Purge button will cause the system to reverse the vacuum direction and elim-
Tools inate any blockage within the HS handpiece vacuum lines. This is only for laser systems which use
the HS handpiece. It is recommended to purge once at the beginning of the day or as needed for
better vacuum.
• The Enter Code button is intended for use by authorized Lumenis service personnel to access the
service screen and special operating modes.
Purge the HS handpiece vacuum
Enter code

UM-1080310, Rev. B
Setting System Options 83
System Upgrade • Press the Upgrade button on the Utility screen.

• Connect the USB drive into the front panel’s USB portand press Start.
• Wait for the upgrade processto complete.
• For handpieces complete the upgrade first, shutdown the system, install the handpiece, and restart.

UM-1080310, Rev. B
84 Operation
Laser Operation
Preoperative instructions
1 Verify that the laser and its components are properly connected, as instructed
in “Connection Instructions” in this chapter.
2 Post the “Laser in Use” warning sign outside the treatment room door.
3 If necessary, turn on the main electrical service (wall circuit breaker).
4 Ensure that all persons in the treatment room are wearing the appropriate laser
safety eyewear. See “Ocular hazards” in the Safety and Regulatory chapter for
laser safety eyewear information.
5 If using the HS handpiece, install a new disposable insert prior to treating the
patient.
6 If using the ET handpiece, clean the sapphire tip, as described in the

Maintenance section of this operator manual.
7 If the laser is not already on, turn on the laser, as instructed in “Laser Console
Basics” in this chapter.
8 Select the HS or ET handpiece and perform the startup calibration. After

calibration, the treatment screen is displayed and the startup procedure is
complete. If the system is already on, new calibration is unnecessary.

UM-1080310, Rev. B
Laser Operation 85
Intraoperative instructions for the HS handpiece

1 Prepare the patient, as described in “Patient Treatment” in this chapter.
WARNING - Do not apply treatment gel to the patient’s skin when

using the HS handpiece. Unlike the ET handpiece, treatment gel is
not needed and should not be used with the HS handpiece.

Maintenance section of this manual to ensure proper performance.
2 Select the desired pulse repeat, fluence, and vacuum settings.

Always check the fluence reading prior to triggering the laser to verify that the
desired value is displayed on the screen.
3 Reset the pulse counter, if desired.

If the number of laser pulses for this session will be tracked, press the reset
button to the left of the shot counter to zero the counter.
4 Position the handpiece for treatment. Refer to “Patient Treatment” in this

chapter for recommendations on correctly positioning the handpiece.
5 Select ready mode on the laser touchscreen.
6 Press the handpiece enable button to enable the handpiece.
7 Press the handpiece trigger to fire the laser.

For safety, laser output occurs only if the handpiece is enabled, vacuum
suction has been applied, and the handpiece trigger is pressed.
If the HS handpiece cannot achieve sufficient vacuum suction, the system will
display a notification message; release and then re-press the trigger to clear the
message.
For operator feedback and safety, an audible beep accompanies each laser
pulse as an emission indicator.
WARNING - Immediately cease use of the laser if the touchscreen

becomes unresponsive, or if the trigger fails in the pressed state.
Deactivate the laser either by pressing the emergency stop button or
turning the laser keyswitch to the OFF position. After waiting one
minute, turn the keyswitch to the ON position. If the laser remains
unresponsive, do not use the laser; contact your local Lumenis
service representative.

UM-1080310, Rev. B
86 Operation
Intraoperative instructions for the ET handpiece

1 Prepare the patient, as described in “Patient Treatment” in this chapter.

Maintenance section of this manual to ensure proper performance.
2 Select the desired rate, OptiPulse pulse width, and fluence.

Set the fluence by pressing the fluence adjustment up and down arrows to
increase or decrease the setting.
Always check the fluence reading prior to triggering the laser to verify that the
desired value is displayed on the screen.
3 Reset the pulse counter, if desired.

If the number of laser pulses for this session will be tracked, press the reset
button to the left of the shot counter to zero the counter.
4 Press the ChillTip button to toggle the cooling to the sapphire tip on and off.
For safety, the ChillTip is turned on by default and a confirmation screen
appears when the ChillTip is switched off.
WARNING - Using the LightSheer Duet system when the ChillTip is

off can result in epidermal damage. Use extreme care when
operating the system with the ChillTip off. Except in rare
circumstances, the system should always be operated with the
ChillTip turned on.
5 When the ChillTip is turned on (also the default), verify the ET handpiece is
properly chilling by physically touching the ChillTip.
6 Apply a thin layer of gel to the area to be treated to facilitate ChillTip

movement across skin and improve contact cooling.
7 Position the handpiece for treatment. Refer to “Patient Treatment” in this

chapter for recommendations on correctly positioning the handpiece.
8 Select ready mode on the laser touchscreen.
9 Press the handpiece enable button to enable the handpiece.

UM-1080310, Rev. B
Laser Operation 87
10 Press the handpiece trigger to fire the laser.

For safety, laser pulses will occur only if both the handpiece is enabled and the
handpiece trigger is pressed. Pressing and releasing the handpiece trigger will
result in a single pulse being fired from the laser. Fire additional pulses by
pressing and releasing the handpiece trigger for each additional pulse.
The maximum pulse repetition frequency allowed by the system is two pulses
per second, so very rapid triggering will not result in more rapid firing.
The laser may be operated in a repetitively pulsed mode by continuously
holding down the handpiece trigger. In this case, the laser will automatically
fire at the default pulse repetition rate until the handpiece trigger is released.
WARNING - Repeatedly treating the same spot on the epidermis

may cause burns; therefore, the handpiece should be moved around
while in repetitively pulsed mode.
WARNING - Ensure that the chilled sapphire tip is in contact with

the skin prior to laser emission. Repetitively pulsed mode should be
utilized only by experienced users, since proper handpiece technique
is essential to ensure tip contact with skin prior to emission. Refer to
“Patient Treatment” later in this chapter.
For operator feedback and safety, an audible beep accompanies each laser
pulse as an emission indicator.
WARNING - Immediately cease use of the laser if the touchscreen

becomes unresponsive, or if the trigger fails in the pressed state.
Deactivate the laser either by pressing the emergency stop button or
turning the laser keyswitch to the OFF position. After waiting one
minute, turn the keyswitch to the ON position. If the laser remains
unresponsive, do not use the laser; contact your local Lumenis
service representative.

UM-1080310, Rev. B
88 Operation
Pulse width and fluence combinations in OptiPulse “AUTO” mode

With OptiPulse set to “AUTO” mode, the pulse width for a given fluence is
set to a predetermined value; the pulse width (in ms) will be equal to half the
fluence value displayed on the touchscreen. The following table shows
examples of the fluence and “AUTO” pulse width combinations across the
operating range:
Fluence (J/cm2) Pulse width (ms)
10 5
15 7.5
20 10
25 12.5
30 15
35 17.5
40 20
60 30
Pulse Width and Fluence Combinations in OptiPulse “Auto” Mode
Note that the pulse width (in ms) is the fluence (in J/cm2) divided by two.
The OptiPulse “AUTO” mode is not available with a fluence setting above
60 J/cm2.
In “30 ms”, “100 ms”, and “400 ms” modes, the pulse width is fixed at 30 ms,
100 ms, and 400 ms respectively, independent of the fluence setting.
Pulse width and fluence combinations in OptiPulse “CUSTOM” mode

(HS handpiece)
With OptiPulse set to “CUSTOM” mode, the pulse width for a given fluence
is set to a calculated value. The pulsewidth is based on current available and
calculated to the fastest pulsewidth available. The OptiPulse "CUSTOM"
mode is only available from 30ms to 70ms.
In “30 ms”, “100 ms” and “400 ms” modes, the pulse width is fixed at 30 ms,
100 ms, and 400 ms respectively, independent of the fluence setting.

UM-1080310, Rev. B
Laser Operation 89
Postoperative instructions
When patient treatment is complete:
1 Place the laser in standby mode.
2 Turn off the laser, as instructed in “Laser Console Basics” in this chapter.
3 If the HS handpiece was used, discard the HS disposable insert.
4 Clean and store the handpiece.

After patient treatment, clean the handpiece according to the instructions
provided in the Maintenance section of this manual. After cleaning, place the
handpiece in its holster.


UM-1080310, Rev. B
90 Operation
Patient Treatment
Patient treatment is the responsibility of licensed practitioners; therefore, the
following information is provided only as a general guideline. Users should
consult experienced practitioners and medical journals for more detailed and
current information.
See the Indications for Use chapter in this operator manual for information on
indications for use, contraindications, warnings, precautions, complications
and side effects.
WARNING - The maximum tolerated fluence is generally inversely

proportional to skin pigmentation for a given pulse width. As the skin
pigmentation increases, the fluence is usually decreased to reduce
laser absorption and heating in the epidermis. When treating darker
skin, delivering the fluence over a longer pulse duration can also
reduce epidermal heating. As noted below, skin cooling reduces
temperature rise in the epidermis and is necessary to avoid potential
epidermal damage, especially in tanned or darker skinned patients.
WARNING - Do not treat eyebrows, eyelashes, or other areas within

the bony area surrounding the orbit. The light emitted by the
LightSheer Duet laser is capable of causing serious eye damage or
blindness. For maximum safety, metal eye goggles must be worn by
the patient for all facial treatments.
Patient consultation
The physician should conduct a patient consultation prior to treatment and
provide detailed information on the nature of their problem, the treatment
options, risks, benefits, complications, and anticipated outcome prior to
treatment. As part of the consultation, the patient should be informed that
multiple treatments may be necessary. Those patients having leg vein or
benign pigmented lesion treatments should be informed that hair removal
may occur at the treatment site as a result of the treatment. The patient
consultation should also include a medical history and exam with particular
attention paid to contraindications. Patients should be treated with test spots
and assessed for side effects before a full treatment is performed.

UM-1080310, Rev. B
Patient Treatment 91
Pre-treatment procedure
WARNING - Carefully shave the skin surface immediately prior to

treatment. Visible hairs can get very hot when the laser fires and
cause localized thermal injury to the epidermis. After shaving,
thoroughly clean the patient’s skin surface to remove any hair debris.
WARNING - The prior use of depilatories or other hair removal

treatments, such as waxing, plucking, or electrolysis, within 6 weeks
prior to treatment is a relative contraindication.
Hair removal and permanent hair reduction

In the hair removal clinical studies of the LightSheer diode laser system, the
treatment area was typically shaved and cleaned immediately prior to laser
treatment. Shaving reduces pain by eliminating the absorption of laser energy
by surface hair. Carefully shave and clean the skin surface since visible hairs
can get very hot when the laser fires and cause localized thermal injury to the
epidermis.
Treatment of leg veins and benign pigmented lesions

For treatment of leg veins or benign pigmented lesions, the treatment area
should be carefully shaved and cleaned immediately prior to laser treatment.
These steps minimize the risk of epidermal injury, pain, odor, and debris.
Carefully shave and clean the skin surface since visible hairs can get very hot
when the laser fires and cause localized thermal injury to the epidermis.

UM-1080310, Rev. B
92 Operation
Dosimetry
The two dosimetry parameters for the LightSheer diode laser system are pulse
width and fluence. General dosimetry considerations are described below.
Physicians are strongly advised to consult experienced practitioners and
medical journals for more detailed and current information.
General principles
In selective photothermolysis, pulsed laser energy is absorbed by a
chromophore or pigmented target (melanin or oxyhemoglobin, in this case)
which has greater optical absorption at the laser wavelength than surrounding
tissue. During the pulse, absorption converts radiant energy into heat within
the target, raising its temperature. The heat is initially confined to the target
but will begin to conduct to the cooler surrounding tissue. However, the
conduction time is relatively slow, and for a suitably brief pulse, the
temperature of the target may have resulted in thermal denaturation while the
surrounding tissue remains below this threshold. Thus, higher fluence
generally results in greater heating since more optical energy is delivered to the
absorbing chromophore.
Skin color
The maximum tolerated fluence is generally inversely proportional to skin
pigmentation for a given pulse width. As the skin pigmentation increases, the
fluence is usually decreased to reduce laser absorption and heating in the
epidermis. When treating darker skin, delivering the fluence over a longer
pulse duration can also reduce epidermal heating. As noted below, skin
cooling reduces temperature rise in the epidermis and is necessary to avoid
potential epidermal damage, especially in tanned or darker skinned patients.
When treating dark-skinned patients (phototypes V & VI) with the ET
handpiece and OptiPulse 400 ms mode, test spots should be administered prior
to treatment to determine the maximum tolerated dose (MTD). Begin treatment
with a conservative fluence setting, below the MTD, to minimize side effects.
Furthermore, exercise caution when treating phototypes V & VI with the HS
handpiece as well: begin with low fluence and single pulses to minimize side
effects.
Always perform a test patch on the intended treatment area during the first
treatment session.
For skin types I-IV, wait at least 2-30 minutes after performing the test spot to
observe skin tissue reaction; and adjust parameters as needed.
For skin styles V & VI, wait at least 48 to 72 hours after performing the test
spot to observe skin tissue reaction; and adjust parameters as needed.
See the Indications for Use section of this manual for more information.

UM-1080310, Rev. B
Hair color
The minimum fluence for effective hair removal is generally correlated with
hair color. For the same efficacy, higher fluence is usually necessary for lighter-
haired patients since their hair contains relatively little melanin. Pulse
duration is generally correlated with hair diameter. Shorter pulse durations are
effective for finer hair, while longer pulse durations are effective for coarser
hair.
HS handpiece placement and technique

Typically, the handpiece is positioned using a “pick and place” technique:
1 Press the enable button prior to applying the tip onto the tissue.
2 Position the handpiece tip on the target tissue, making a complete seal prior to
pressing the trigger.
3 Press the trigger button to initiate treatment. The system will activate the
vacuum. Once the specified amount of vacuum (High, Medium, or Low) has
been applied, the laser energy is delivered.
4 The trigger button needs to be held during the entire cycle. When the
programmed cycle of 1-3 pulses is completed, the trigger button can be
released.
5 After the vacuum is released, the handpiece can be repositioned to the next
treatment area.
If at any point during treatment the operator decides to discontinue the cycle,
the button can be released and the treatment will be terminated.

UM-1080310, Rev. B
94 Operation
Two ways of holding the HS handpiece during treatment are shown below.
Two ways of holding the HS handpiece during treatment

UM-1080310, Rev. B
Coverage technique using the HS handpiece
Lumenis does not make recommendations regarding the practice of medicine.

The following guidelines are provided as a guide. Individual treatment should be
based on clinical training, clinical observation of laser-tissue interaction, and
appropriate clinical endpoints.
The treatment area of the HS handpiece is 22 x 35 millimeters, which is a

smaller area than the footprint of the HS handpiece tip; therefore, to assure
continuous and complete coverage, it is necessary to overlap vacuumed/
treated areas by approximately 30% side-to-side and by 40% from end to tip.
Overlap successive
treatments to assure
continuous total treated
area. Treated areas are
shown in gray.
1
Vacuumed/
treated area
2
HS handpiece
footprint
Assuring continuous end-to-tip coverage using the HS handpiece

UM-1080310, Rev. B
96 Operation
Vacuumed/
treated area 1 2 3 4
HS handpiece
footprint
Overlap successive
treatments to assure
continuous total
treated area. Treated
areas are shown in
gray.
Assuring continuous side-to-side coverage using the HS handpiece

UM-1080310, Rev. B
ET handpiece placement and technique

Typically, the handpiece is positioned using a “pick and place” or “bouncing”
technique. For hair removal and treatment of benign pigmented lesions, the
tip is pressed against the skin with moderate pressure to make good contact
and then the laser is fired. For treatment of leg veins, contact is made with the
skin, but no pressure is applied.
For proper epidermal cooling, the chilled sapphire tip should contact the skin
approximately 1/10 – 1/4 second before the pulse. In the “pick and place”
method, the tip is picked up from the skin immediately after the pulse, moved
to the next treatment location, and then lowered against the skin. In the
“bouncing” technique, the tip is kept continuously in contact with the skin
and moved (in a bouncing manner) to the next treatment location
immediately after the laser pulse, making sure that the insert is pressed to the
skin when the laser light is applied.
WARNING - Ensure that the chilled sapphire tip is in contact with

the skin prior to laser emission.
WARNING - Repetitively pulsed mode should be utilized only by

experienced users, since proper handpiece technique is essential to
ensure tip contact with skin prior to emission.
Skin cooling with the ET handpiece

By conductively cooling the skin, the chilled handpiece tip can increase the
tolerated fluence by reducing the temperature-rise in the epidermis and
providing partial anesthesia. Skin cooling with the ChillTip is highly
recommended for all patients being treated with the ET handpiece, especially
in tanned or darker-skinned patients who will have greater absorption of laser
energy in the epidermis than will fair-skinned patients. Due to the stretching
and lower fluences used with the HS handpiece, contact skin cooling is not
necessary.
Tip cleaning
WARNING - The sapphire tip of the ET handpiece must be kept

clean during patient treatment. Foreign matter on the tip will get
hot due to absorption of laser light and can cause epidermal injury
and substantially increased pain.
Carefully follow the cleaning instructions in the Maintenance section of this

operator manual.

UM-1080310, Rev. B
98 Operation

UM-1080310, Rev. B
99
Maintenance

UM-1080310, Rev. B
100 Maintenance

UM-1080310, Rev. B
Introduction 101
Introduction
The only user-performed maintenance required for the LightSheer Duet
system is frequent cleaning of the handpiece, handpiece tip, touchscreen, and
energy meter window.
To ensure proper performance, it is recommended that a check of the internal
energy meter be performed annually by an authorized field service technician
or by returning the system to the factory.
In the event that the LightSheer Duet system fails to operate properly, please
consult the Troubleshooting Guide later in this chapter. If the problem
persists, contact Customer Support at (877) LUMENIS.
There are no user-serviceable parts, and all service and repair should be
performed only by the factory or authorized field service technicians.
WARNING - Opening any protective exterior housing, except the

holsters, may cause exposure to hazardous optical radiation and
electrical voltage even after the laser has been turned off, may result
in damage to the instrument, and may void the warranty. Only
trained and authorized LightSheer Duet technicians should perform
service and repairs.

UM-1080310, Rev. B
102 Maintenance
Cleaning and Disinfecting
WARNING - Do not spray, soak, or pour any type of fluid or cleaning

agent directly on the handpiece, console, or touchscreen as it could
lead to operator injury or result in damage to the equipment.
CAUTION - Do not allow sunblock or sunscreen products to contact

the handpiece. The ingredients found in sunblock and sunscreen
products may cause deterioration or damage to the handpiece
material. If sunblock or sunscreen does contact the handpiece, clean
the handpiece immediately to prevent possible damage.

Cleaning during treatment

HS handpiece
WARNING - The disposable insert must be kept clean during patient

treatment. Foreign matter on the disposable insert will get hot due
to absorption of laser light and can cause epidermal injury.
Prepare the patient’s skin by shaving any existing hair and cleaning the skin
prior to conducting treatment.
Keep the HS handpiece’s window and disposable insert clean at all time
during treatment. Whenever you see any contamination on the window’s
surface, use a lint-free gauze pad wetted with alcohol to clean the window and
then clean with a dry gauze pad. Frequently observe the disposable insert for
damage and replace it if necessary.
The window of the HS handpiece is fabricated of fused silica and thus is

extremely hard. Vigorous wiping with a gauze pad will not harm the window.

UM-1080310, Rev. B
Cleaning and Disinfecting 103
ET handpiece
WARNING - The sapphire tip of the ET handpiece must be kept

clean during patient treatment. Foreign matter on the tip will get
hot due to absorption of laser light and can cause epidermal injury
and substantially increased pain.
The sapphire ChillTip on the ET handpiece must be cleaned often,

depending on the treatment area and hair density. Wipe more frequently in
areas of high hair density. The wiping should be performed with gauze pads
wetted with distilled water. Follow by wiping with a clean, dry gauze pad to
ensure that any residue or haze is completely removed. This cleaning typically
requires only a few moments during treatment.
The clear region of the ET handpiece tip is fabricated of sapphire and thus is
extremely hard. Vigorous wiping with a gauze pad will not harm the sapphire
tip.
Cleaning and disinfecting the handpiece between patients

HS handpiece
The HS handpiece tip is not reusable; replace the HS tip with a new
disposable insert between each new patient.
ET handpiece
The ET handpiece and handpiece tip must be thoroughly cleaned between
patients to avoid potential cross contamination. Use an antibacterial/ antiviral
cleaning solution that is compatible with the handpiece materials, such as
Cavicide® or Virex™; follow the manufacturer’s recommendations on the
product label.
Never use an abrasive cleanser or cleaning pad that could scratch the
handpiece or handpiece tip.
Never use any fibrous wipe or towel that could leave lint on the tip, as the
fibers could carbonize on the tip and result in patient burns.

UM-1080310, Rev. B
104 Maintenance
Cleaning the energy meter windows

Each handpiece has a corresponding holster on the laser console. Beneath the
holster is a glass-covered energy meter. If this protective glass window on
either holster becomes dirty or covered with spilled liquid, remove the holsters
and clean the window.
To remove, place fingers in the holster and gently pull the insert out of the
console top.
Before cleaning, wear gloves to avoid getting fingerprints or smudges on the
window. Clean the window in the same manner as the handpiece tip or by
using common glass cleaners. Remove any residue or haze remaining on the
energy meter window by wiping with a clean, dry towel.
To reinstall the holsters, see “Installing the holsters” in the Operation section
of this operator manual.
Cleaning the touchscreen

WARNING - The LightSheer Duet system should be turned off prior

to cleaning the touchscreen.
WARNING - Do not clean the touchscreen with an abrasive cleaner

or material as it can result in damage to the touchscreen.
To clean the touchscreen, apply a small amount of a non-abrasive glass cleaner

to a clean, soft cloth. Using the cloth, gently wipe the surface of the
touchscreen to remove any dirt. Completely wipe away any residue remaining
from the glass cleaner. When cleaning, do not force debris or fluid into the
gasket surrounding the touchscreen as excessive debris can cause the
touchscreen to malfunction. Allow the touchscreen and the surrounding
gasket to dry before resuming operation.
WARNING - Clean the touchscreen regularly to ensure proper

performance. Excessive treatment oil, gel, lotion, or other
contaminants on the touchscreen may cause erratic operation of the
user interface buttons.

UM-1080310, Rev. B
Cleaning and Disinfecting 105
Cleaning the console

Clean the external surfaces of the laser console and handpiece periodically
with a cloth wetted with a cleaner, such as alcohol, distilled water, Cavicide®,
or Virex™. Dry with a clean cloth.


UM-1080310, Rev. B
106 Maintenance
HS handpiece Maintenance
The HS handpiece uses a removable, disposable insert that attaches to the
handpiece aperture, and which must be replaced between patients, or during
patient treatment if the tip becomes dirty or if the filters become clogged.
Replacing the HS handpiece disposable insert

Replace the disposable insert as follows.
1 Pull the disposable insert from the handpiece, as shown.
2 Push the new insert into the handpiece until seated.
Disposable insert

UM-1080310, Rev. B
HS handpiece Maintenance 107
Understanding the HS handpiece filters

Each disposable insert contains two filters: one filter is active and the other is
reserve. If the vacuum performance of the HS handpiece appears to decline
during use, visually inspect the filters of the insert. If the active filter seems to
be clogged, remove the tip, rotate it 180 degrees and reinsert it into the
handpiece to use the reserve filter. Run a vacuum check and resume regular
treatment. If both filters are clogged, replace the disposable insert, as described
in this chapter.
It is normal for some burned hair to become attached to the interior surfaces
of the disposable insert during treatment. These small bits of debris do not
substantially affect the performance of the HS handpiece.
Filter
Filter
Remove insert and rotate to use the other filter

UM-1080310, Rev. B
108 Maintenance
Troubleshooting Guide
Laser will not turn on
Verify that the following items have been completed:
• The AC power cord is firmly and fully inserted into the power
socket on the back panel and into a live electrical wall socket.
• The main power circuit breaker is in the I (on) position.
• The keyswitch is turned to the on position.
• The emergency stop button has been disengaged by rotating the
button clockwise until it pops out.
If the problem persists, call Customer Support.
Laser fails to operate properly

Maximum fluence is less than 100 J/cm2 for the ET handpiece
The LightSheer Duet only allows a fluence setting above 60 J/cm2 in
OptiPulse 400 ms mode. Verify that 400 ms mode has been selected from the
treatment screen. If fluence is still insufficient for treatment, carefully clean
the handpiece tip and energy meter window and recalibrate the system. If
fluence is still insufficient for treatment, contact Customer Support.
OptiPulse “AUTO” mode is disabled (ET handpiece)

OptiPulse “AUTO” mode is not available with a fluence setting above 60 J/
cm2. Verify that the fluence setting displayed on the treatment screen is less
than or equal to 60 J/cm2. If “AUTO” mode is still not available, carefully
clean the handpiece tip and energy meter window and recalibrate the system.
If “AUTO” pulse width mode is still disabled and is required for treatment,
contact Customer Support. Note that operation in “30 ms”, “100 ms”, or
“400 ms” mode will usually still be enabled.
Calibration does not progress

For calibration to proceed, the following steps must be performed in order: (1)
lift the handpiece out of the holster, (2) reinsert the handpiece in the holster,
(3) press the enable button on the handpiece, (4) depress the handpiece
trigger, and (5) continue to depress the handpiece trigger until all calibration
shots are fired. Note that the order of the above sequence is enforced and the
touchscreen will prompt the user to complete each step in order. A common
user error is to release the handpiece trigger before all calibration shots have
been fired.
If the system does not sense the handpiece in the holster, ensure that the
handpiece is correctly positioned in the holster. Also verify that nothing is
blocking the proximity sensor located beneath the holster.

UM-1080310, Rev. B
Troubleshooting Guide 109
If the problem persists, contact Customer Support.
Laser will not fire

The laser will fire only when the status displays “READY”.
If using the ET handpiece and the status displays “COOLING”, wait for the
ChillTip to reach its operating temperature, at which point the status will
change to “STANDBY”. If the status displays “READY”, and depressing the
handpiece trigger while the HP is enabled does not result in emission, contact
Customer Support.
If using the HS handpiece, you must wait until the proper vacuum level is
reached at the tip before you can fire the laser. To ensure that the proper
vacuum level is reached, verify that the tip is fully sealed against the tissue and
that the disposable insert is not clogged.
Laser remains in “COOLING” status

The “COOLING” message is displayed only when the ChillTip
is actively cooling, which normally requires about 30 seconds.
If the status does not eventually change from “COOLING” to “STANDBY”,
it indicates a cooling problem and it is necessary to contact Customer
Support.
Low Fluence – Full fluence range is not available with OptiPulse set to 400 ms
mode
The laser is incapable of delivering the requested fluence in 400 ms mode.
Shut down the system. Carefully clean the handpiece tip and protective
window above the energy meter. Restart and recalibrate the system. Enter the
treatment screen and attempt to set the desired fluence. If the available fluence
is still insufficient for the desired treatment, contact Customer Support. Note:
if this error occurs, the user should still be able to set a different set of
treatment parameters.
Low Fluence – Full fluence range is not available in all OptiPulse modes of oper-
ation
The laser is incapable of delivering the requested fluence in the requested
OptiPulse mode. Shut down the system. Carefully clean the handpiece tip and
protective window above the energy meter. Restart and recalibrate the system.
Enter the treatment screen and attempt to set the desired fluence. If the
available fluence is still insufficient for the desired treatment, contact
Customer Support. Note: if this error occurs, the user should still be able to
operate the system with a different set of treatment parameters.
Paused: Please wait while the laser system cools to proper operating temperature
This message will appear temporarily upon returning from “sleep” mode.
Occasionally, if the laser has been stored in a hot location, this message will

UM-1080310, Rev. B
110 Maintenance
appear temporarily. This behavior is normal and the message will clear
automatically when the laser cools. However, if the message appears for longer
than five minutes, it indicates a possible malfunction of the cooling system
and the LightSheer Duet system should be turned off to prevent damage from
overheating. Contact Customer Support.
Paused: Remote interlock is open

This message appears whenever the remote interlock switch is open. If the
switch has not been wired to the clinic room door or other remote switch,
ensure that the interlock switch jumper plug on the rear of the upper console
is fully seated in its receptacle. If the remote interlock connector has been
externally wired, check the external circuit.
Stopped: A system fault has been detected

The system reports a fault when it detects an abnormal hardware or software
error.
If the fault is related to calibration, shut down the system as described in
“Turning off the laser” in the Operation chapter of this manual, and carefully
clean the handpiece tip and the energy meter window located beneath the
holster (see “Cleaning and Disinfecting” in this manual). Restart the system
and perform another calibration. If the fault occurs again, note the error code
and contact Customer Support.
If the system fault is unrelated to calibration (for example, the fault occurs
while firing in the treatment screen), restart the system and attempt to
perform another calibration and enter the treatment screen. If the fault occurs
again, note the error code and contact Customer Support.
Information Messages
These messages are used to inform the user of actions that are ongoing and
delay the treatment or limit the treatment available. These are not error
messages and do not require a service call, but messages to let operator know
of any changes.
Message Description
This shows that the life of the laser package in the handpiece is begin-
This handpiece has a limited ning to shorten. This is not an alarm to immediately return the hand-
functionality piece. If you do not use the full treatment range available, it is still okay
to use.
This message will appear the first time after initial calibration and the
system goes into the selected treatment screen. Between treatments, the
System Cooling
system may need to cool. The message will clear when cooling is
complete.

UM-1080310, Rev. B
Error Messages 111
Error Messages
The LightSheer Duet laser system displays two types of errors: errors requiring
a system restart, and errors advising the user of hardware problems and/or
requiring user attention. If a problem persists, even after performing the
recommended action, contact your Lumenis service representative.
Errors requiring a system restart
Error # Error Message Recommended User Action

E32 Watchdog timer error
E104 5V power supply out of range
E105 3.3V power supply out of range
Turn system off. Wait 30 seconds and then turn system on.
E142 TEC temperature sensor failure
If problem persists after system restart – call Lumenis service.
E147 Coolant temperature sensor failure
E171 FPGA error
E400 Unable to connect to control processor
E54 HS handpiece disconnected Turn system off. Reconnect handpiece or connect new handpiece. Wait
E70 ET handpiece disconnected 30 seconds, and then turn system on.
Errors limiting system functionality

E123 EPI pump fuse broken
E141 EPI temperature out of range Can still use the HS handpiece.
E143 EPI temperature sensor failure Turn system off. Wait 30 seconds and then turn system on.
ET backplane temperature sensor If problem persists after system restart – call Lumenis service.
E145
failure
E124 Vacuum pump fuse broken Can still use the ET handpiece.
HS backplane temperature sensor Turn system off. Wait 30 seconds and then turn system on.
E146
failure If problem persists after system restart – call Lumenis service.

UM-1080310, Rev. B
112 Maintenance
Errors requiring user attention and may require a system restart

E81, E83 Laser diode over current
E82, E84 Diode current too low
E86 Power supply fault
E88 Power supply voltage error on PCB
E90 Pulse width out of range
E94 Laser-off over current (A)
E95 Laser-off over current (B)
E98 Software internal error
E103 -12V power supply out of range
E106 Drive 24V power supply out of range
E107 Drive 16.5V power supply out of range
E108 Drive 12V power supply out of range
E109 Drive dirty 12V p.supply out of range
E110 Drive -12V power supply out of range
Clear error. If error persists, turn the system off, wait 30 seconds, and
E111 Drive 5V power supply out of range then turn the system on. If problem persists after system restart – call
Lumenis service.
E112 Main TEC over current
E113 EPI TEC over current
E114 Electronic Shutter Failure
E115 Electronic Shutter Failure
E122 Coolant pump fuse burned. Call service.
E320 ET calibration out of range
E321 ET calibration inconsistent
E322 ET calibration not self consistent
E340 HS calibration out of range
E341 HS calibration inconsistent
E342 HS calibration not self consistent
E401 Serial protocol retry limit exceeded
E402 Serial protocol output buffer underflow
E403 HASP not connected
E427 Persistent files corrupted. Call service.
E600 Demo mode current too high

UM-1080310, Rev. B
Error Messages 113
Errors identifying hardware problems and/or requiring user attention

Check door is closed, check door interlock is seated. Clear
E21 Remote Interlock Open
error.
E43, E44 HS handpiece trigger error
Press and release trigger button. Clear error.
E63, E64 ET handpiece trigger error
Verify that the removable tip is correctly inserted by
E45, E46 HS Handpiece tip error
removing and then reinserting the tip. Clear error.
E47 Release HS handpiece enable button Release the handpiece enable button.
E65 Release ET handpiece enable button Release the handpiece enable button.
E48 HS Handpiece enable failed to time-out.
Clear error. Place laser in Ready mode. Press Enable button.
E66 ET Handpiece enable failed to time-out
E49 HS Handpiece tip not installed Install the disposable insert.
E50 ET Handpiece must be in the cradle
Put handpiece into cradle.
E67 HS Handpiece must be in the cradle
E51 HS H.P. SPI flash memory error
Clear the error message.
E68 ET H.P. SPI flash memory error
E52 Remove handpiece from the cradle Remove handpiece from the cradle.
E53 HS trigger pressed
E69 ET trigger pressed Release the handpiece trigger.
E132 Heat sink over temperature

E133 EPI over temperature
E136 Coolant over temperature
Wait for system to cool down.
E137 ET diode temperature out of range
E138 HS diode temperature out of range
E144 Please wait for system warm up

UM-1080310, Rev. B
114 Maintenance
Troubleshooting Form
The following form is provided to assist the user in recording error messages
and codes that are displayed on the screen. Please provide this information
when contacting Customer Support. This information will assist Customer
Support in more quickly determining the cause of the problem.
Treatment Parameters/System
Date Code Number Error Message
Settings When Error Occurred

UM-1080310, Rev. B
Calibration Details and Output Monitoring 115
Calibration Details and Output Monitoring

Details of the energy calibration procedure and output monitoring are
provided in this section for compliance with governmental regulations only.
See “Calibrating the handpieces” in the Operation chapter of this manual for
operator calibration instructions.
WARNING - Do not attempt to manually calibrate or otherwise

adjust the output of the laser. Such action may cause exposure to
hazardous optical radiation and electrical voltage, result in damage
to the instrument, and void the warranty. Only trained and
authorized LightSheer Duet technicians should perform
maintenance and service.
Automated calibration procedure

Automated calibration procedure is a required procedure that executes on
every system startup upon handpiece selection or after 25000 pulses fired in
one treatment/power up session. The user must follow the instructions
displayed on the screen. The system will make all calculations and
adjustments automatically.
General approach
The purpose of the automated calibration is to determine a transfer function
between optical energy and drive current for every laser pulse width mode for
every handpiece. During normal operation, the LightSheer Duet’s software
uses the transfer function to set the drive current to accurately produce the
desired fluence.
The general approach is as follows:
1 The laser output is measured as a function of input parameters.
2 A generalized transfer function is calculated, correlating input and output

parameters.
3 The newly calculated transfer function is checked against the previous transfer
function for abnormality.

UM-1080310, Rev. B
116 Maintenance
Detailed approach - ET handpiece

Within the Treatment mode, the user may request 30ms, 100ms, 400ms, and
Auto (5-30ms) pulse width modes. Calibration begins by compartmentalizing
the calibration data into pulse width mode categories. Specifically, each pulse
width mode has its own unique calibration data, exclusive of the other modes
except for Auto mode, which uses the 30ms calibration data.
Each pulse width mode is calibrated by firing a number of fixed pulse width
shots (30ms for 30ms mode and Auto mode, 100ms for 100ms mode, and
thirteen 5ms pulses in a 389ms envelope for 400ms mode) at two current
levels. Once all calibration shots have been successfully fired, transfer
functions are calculated.
For 100 msec mode and 400 msec mode, the least square fit functions will be
used to describe transfer functions. For Auto mode, the 30ms values for Slope
Efficiency and Threshold Intercept are used.
The next step is calculating the maximum fluence value for each mode of
operation.
The final phase of the calibration calculation series is determining the
headroom, the additional capacity above ‘normal operation’, for each mode.
ET handpiece calibration data acquired in 6 shots:
Pulse # Pulse width Current Used for mode:
1 30 12 A 30 ms; AUTO
2 30 45 A 30 ms; AUTO
3 100 9.5 A 100ms
4 100 26 A 100ms
5 400 12 A 400 ms Burst
6 400 38 A 400 ms Burst

UM-1080310, Rev. B
Calibration Details and Output Monitoring 117
Detailed approach - HS handpiece

Within the Treatment mode, the user may request 30ms, 100ms, 400ms, and
Custom (30-70ms) pulse width modes. Calibration begins by
compartmentalizing the calibration data into pulse width mode categories.
Specifically, each pulse width mode has its own unique calibration data,
exclusive of the other modes except Custom mode, which uses the 30ms
calibration data and 70 ms calibration data.
Each pulse width mode is calibrated by firing a number of fixed pulse width
shots (30ms and 70ms for 30ms mode and Custom mode, 100ms for 100ms
mode, and thirteen 5ms pulses in a 389ms envelope for 400ms mode) at two
current levels. Once all calibration shots have been successfully fired, transfer
functions are calculated.
For 100 msec mode and 400 msec mode the least square fit functions will be
used to describe transfer functions. For Custom mode, the 30ms and 70ms
values for Slope Efficiency and Threshold Intercept are used.
The next step is calculating the maximum fluence value for each mode of
operation.
The final phase of the calibration calculation series is determining the
headroom, the additional capacity above ‘normal operation’, for each mode.
HS handpiece calibration data acquired in 8 shots:
Pulse # Pulse width Current Used for mode:
1 30 18 A 30 ms; Custom
2 30 38 A 30 ms; Custom
3 70 18 A Custom
4 70 38 A Custom
5 100 12 A 100ms
6 100 26 A 100ms
7 400 15 A 400 ms Burst
8 400 38 A 400 ms Burst

UM-1080310, Rev. B
118 Maintenance
Electrical Utilities
The LightSheer Duet laser system is designed to meet UL60601-1, IEC
60601-1, IEC 60601-2-22, IEC 60825-1, and CSA 22.2. The laser is
available in one electrical configuration with a universal input ranging from
100–240 V~, 15 Amps maximum current.
The supplied Hospital Grade cord set should be used with a standard 20 A
wall outlet. The supplied cord set will vary according to the electrical
conventions for the country in which the laser will operate.
CAUTION - To verify that the system is disconnected from the

power mains, observe that the main power cord is disconnected
from the system’s main power receptacle and from the wall socket.
Electromagnetic Compatibility
Like other electrical medical equipment, the LightSheer Duet requires special
precautions to ensure electromagnetic compatibility with other electrical
medical devices. To ensure electromagnetic compatibility (EMC), the LightSheer
Duet must be installed and operated according to the EMC information
provided in this manual. See Appendix 1, EMC Guidance and Manufacturer’s
Declarations.
The LightSheer Duet has been designed and tested to comply with
IEC60601-1-2:2001+A1:2004 (Edition 2.1) requirements for EMC with
other devices.
WARNING - This system is intended for the use by health care

professionals only. This system may cause radio interference or may
disrupt the operation of nearby equipment. It may be necessary to
take mitigation measures, such as re-orienting or relocating the
system or shielding the location.
CAUTION - Portable and mobile RF communications equipment

may affect the normal function of the LightSheer Duet.
WARNING - Do not use cables or accessories other than those

provided with the LightSheer Duet, as this may result in increased
electromagnetic emissions or decreased immunity to such emissions.
WARNING - If the LightSheer Duet is used adjacent to or stacked

with other equipment, observe and verify normal operation of the
laser system in the configuration in which it will be used prior to
using it in a surgical procedure.

UM-1080310, Rev. B
Technical Specifications 119
Technical Specifications
Laser Handpiece ET Handpiece HS Handpiece
Type AlGaAs laser diode array
Nominal wavelength 790 – 830 nm
Maximum peak power (average during pulse) 1600 W
Pulse width 5 – 400 ms 30 – 400 ms
Pulse repetition rate ≤ 3 Hz ≤ 3 Hz
Pulse fluence 10 – 100 J/cm2 4.5 – 12 J/cm2
Pulse energy 85 J max 102 J max
Spot size (W × D) mm (in.) 9 × 9 mm (0.35 × 0.35 in.) 22 × 35 mm (0.87 × 1.4 in.)
Beam divergence 20° × 20° nominal 33° × 33° nominal
Classifications
FDA classification Class II medical device
CDRH classification Class IV laser
MDD classification IIB
IEC 60825-1 classification Class 4 laser
IEC 60601-1 classification Class I, Type BF
Operation classification Intermittent/Continuous
Nominal ocular hazard distance 50 m (164 feet)
Protective eyewear
Optical density at 790 – 830 nm >5
Input power recommended service
Voltage 100 – 240 V
Frequency 50/60 Hz
Current 15 A
Utility connection Single-phase grounded outlet
Physical parameters
Size (W × D × H) cm (in.) 44 × 50 × 112 cm

(17.4 × 19.7 × 44 in.)
Weight 48 kg (105 lbs.)
Operating radius of umbilical 1.8 m (71 in.)
Environmental requirements (operating conditions)
Temperature 15 – 40°C, 60 – 104°F
Humidity 10 – 70%

UM-1080310, Rev. B
120 Maintenance
Pressure 90 – 110 kPa (13 – 16 psi)
Environmental requirements (nonoperating conditions)
Maximum altitude Standard commercial shipping altitude
Temperature -5 – 55°C (23 – 131°F)
Humidity 90% at 35°C (95°F) non-condensing

32% at 55°C (137°F) non-condensing
Vibration Meets MIL 810E-514.4 transportation and vibration requirements;

capable of surviving transport by standard air, sea, and land carriers.
Shock Meets the requirements of ASTM D6179

UM-1080310, Rev. B
Warranty Information 121
Warranty Information
For specific and detailed warranty information for this instrument, please refer
to the first page of your purchase “Agreement” and the last page of the “Terms
and Conditions of Sale.”
Decontamination of Returned Equipment

To comply with United States postal and transportation law, equipment
shipped to Lumenis US offices for repair or return must be properly
decontaminated with a chemical germicide that is commercially available and
cleared for use as a “Hospital Disinfectant.” To ensure that all equipment has
been properly decontaminated, a signed Decontamination Certificate
(provided at the back of this manual) must be enclosed in the package, or
Lumenis will assume that the product is contaminated and will assess the
customer with cleaning costs.
Any decontamination inquiries should be directed to the Lumenis US service
offices.
Returning the Laser to Lumenis

To package the laser for return shipment to Lumenis, you must disconnect the
handpieces from the laser console, remove the holster, and then separately
pack the laser console, handpieces, and any other components that require
shipment.
1 Shut down the laser, as described in the Operation section of this manual.
2 Disconnect the handpieces.
3 Pack the handpieces.
4 Remove the holster.
5 Pack the laser console by reversing the instructions described in “Unpacking

the laser console” in the Operation chapter of this manual.

UM-1080310, Rev. B
122 Maintenance

UM-1080310, Rev. B
123
Indications
for Use
LightSheer® Duet™ & Laser System Operator Manual

UM-1080310, Rev. B
124 Indications for Use

UM-1080310, Rev. B
Introduction 125
Introduction
WARNING - The Indications for Use and Safety and Regulatory

sections of this operator manual should be carefully read and
comprehended in their entirety before attempting to use the laser
system. Particular attention should be given to all cautions and
warnings pertaining to the safe use of the laser.
The use of a laser instrument for an application is at the physician’s discretion

except in cases where the indication has been contraindicated.
The LightSheer Duet laser system is intended to effect temporary hair removal
and/or permanent hair reduction. Permanent hair reduction is defined as a
long-term stable reduction in the number of hairs regrowing after a treatment
regime. The number of regrowing hairs must be stable over a time greater than
the duration of the complete growth cycle of hair follicles, which varies from
4 – 12 months according to body location. Permanent hair reduction does not
necessarily imply the elimination of all hairs in a treated area.
The LightSheer Duet system is intended for use on all skin types (Fitzpatrick
skin types I – VI), including tanned skin. HS handpiece treatments should
only be performed on tanned skin after the recommended test spot protocol
has been employed, to verify the appropriate parameter settings prior to any
treatment. Use added caution due to sun exposure.
HS handpiece
In addition to temporary hair removal and permanent hair reduction, the
LightSheer HS handpiece is intended for the treatment of benign vascular and
pigmented lesions.
ET handpiece
In addition to temporary hair removal, permanent hair reduction, leg veins,
and benign vascular lesions, the LightSheer ET handpiece is intended for the
treatment of vascular lesions including angiomas, hemangiomas,
telangiectasias; as well as the treatment of pseudofollilculitis barbae and
benign pigmented lesions.

UM-1080310, Rev. B
Theory of operation
The therapeutic basis of the LightSheer Duet laser system is selective
photothermolysis. To effect hair removal, the 800 nanometer laser light
penetrates deeply into the dermis where the optical energy is preferentially
absorbed by the melanin in hair, causing a rapid heating of the hair shaft and
follicle that disables the follicle. For leg vein treatment, the optical energy is
absorbed by oxyhemoglobin, causing photocoagulation of blood vessels in the
dermis. For benign pigmented lesions, the optical energy is absorbed by
melanin-containing cells in the pigmented lesion, causing rapid heating and
thermal damage to the lesion. The duration of the laser pulses is long enough
to disable the hair follicle, coagulate the vein, or be absorbed by the target
chromophore, while short enough to limit heat transfer to the surrounding
tissue.
As with any laser, appropriate care must be taken to ensure safe and proper
use. The entire user manual should be thoroughly reviewed and understood
before operating the instrument. Furthermore, as discussed below, the
operator should attend a laser training course before using the LightSheer
system.

UM-1080310, Rev. B
Contraindications 127
Contraindications
Patients who have had prior problems with laser therapy, should be carefully
screened before treatment. Additionally, persons known to form skin keloids
may be more prone to scarring after any skin trauma, including laser
treatment.
Laser hair removal, treatment of leg veins, or treatment of benign pigmented
lesions should not be attempted in patients with:
• active infections in the treatment site;
• active infection or a history of herpes simplex in the treatment area;
• use of oral Isotretinoin (such as Accutane) within the preceding
6 months;
• history of keloid formation;
• history of livedo reticularis, an autoimmune vascular disease;
• hypersensitivity at the treatment site to any agents, solution, or gel
used in the treatment, if no alternative exists;
• use of anticoagulants before the washout period, per the package
insert, and at the physician’s discretion;
• presence of refluxing varicose veins feeding the telangiectases;
• personal history of melanoma;
• dysplastic nevi in the area to be treated;
• history of bleeding disorders;
• history of collagen, vascular or immunosuppression disorders;
• tattoos at the treatment sites;
• significant concurrent skin conditions affecting areas to be treated
or any inflammatory skin conditions;
• active cold sores, open lacerations or abrasions on the area to be
treated;
• history of immune deficiency (including HIV infection or AIDS).
Relative contraindications
• history of erythema ab igne, which is an acquired persistent
reticulated erythematous and pigmented rash of the skin produced
by prolonged or repeated exposure to moderately intense heat or
infrared radiation;
• use of depilatories or other hair removal treatments, such as
waxing, plucking, tweezing, or electrolysis, in the treatment area
within the preceding 6 weeks;
• chronic or cutaneous viral, fungal or bacterial infections in the
treatment area;

UM-1080310, Rev. B
• photosensitivity disorder that can be exacerbated by infrared light;

• history of skin cancer or pre-cancerous lesions at the treatment
sites;
• use of medications, herbal supplements, perfumes or cosmetics that
may affect sensitivity to light.
Warnings
Darker skin types and individuals with a suntan are at a higher risk for
pigmentary changes in the treatment area. These patients should be treated
with lower fluences and/or longer pulse durations than similar skin types that
are untanned.
Sun exposure to the treatment area immediately after treatment and for one
month following treatment may also increase the risk of pigmentary changes
in the treatment area. Patients should be instructed to use a broad spectrum
sunscreen (SPF 15 or greater) on a daily basis.
Observe all safety precautions described in the Safety and Regulatory chapter
and elsewhere in this manual.
WARNING - The light emitted by the LightSheer laser is capable of

causing serious eye damage or blindness. All persons in the
treatment room, including the patient, the operator, and any
observers, must wear appropriate eye protection whenever the main
power and keyswitch are on.

UM-1080310, Rev. B
Precautions 129
Precautions
The physician should only attempt laser treatment after adequate training and
familiarity with laser safety and with the device.
CAUTION - The laser can cause epidermal injury. The risk increases
with greater laser fluence and skin pigmentation.
In general, both treatment effectiveness and inflammatory response to skin

injury are fluence related. Higher fluence levels result in greater effectiveness
and also higher inflammatory response and increased likelihood of epidermal
damage. Begin treatment with a conservative exposure dose and increase the
fluence gradually until the desired effect is observed.
CAUTION - Perform test spots on patients and assess side effects

before performing a full treatment. Side effects may not develop
until several days following exposure. The risk of side effects is
greater on dark-skinned patients, however, light-skinned patients
may also develop side effects.
Complications and Side Effects

The most common side effects are erythema, edema (redness and swelling),
and perifollicular edema, which may occur immediately after laser treatment
and typically resolve within a few days.
Other side effects may include hyperpigmentation and hypopigmentation
(darkening or lightening of the skin) of the treated areas. Side effects of
treatment are fluence-dependent and skin type dependent. Transient skin
pigmentation changes may resolve within a few months, but may last longer.
In rare cases, skin pigmentation changes may be permanent.
The following complications and side effects may also be observed:
• irritation, itching, burning sensation, or pain during treatment or
following treatment;
• superficial erosions of the treated area may be visible after laser
treatment;
• burns;
• crusting and blistering of the treated area;
• erythema ab igne, which is the development of an acquired
persistent reticulated erythematous and pigmented rash of the skin
produced by prolonged or repeated exposure to moderately intense
heat or infrared radiation;
• transient exacerbation of hair growth;

UM-1080310, Rev. B
• purpura confined to the exposure area may be evident for several

days following treatment;
• pruritis may occur in rare cases;
• contact dermatitis or irritant dermatitis may occur in some cases;
• infection at the treatment site;
• mild to moderate pain may occur during or after treatment;
• as with the use of any laser system, scarring is a possibility, but is
rare;
In the event of a death or serious injury/illness, immediately contact
Regulatory Affairs at Lumenis, 5302 Betsy Ross Dr., Santa Clara, CA,
95054, USA, telephone number (877) LUMENIS, (877) 586-3647 (toll
free). For those outside of the United States, refer to the Customer Support,
Sales, and Service listing for the representative in your area to contact. A
serious injury/serious illness is an injury or illness that is: a) life threatening,
even if temporary in nature; b) results in permanent impairment of a body
function or permanent damage to a body structure; or c) necessitates
medical or surgical intervention to preclude permanent impairment of a
body function or permanent damage to a body structure. Permanent
damage or impairment is defined as irreversible damage or impairment that
is not trivial.

UM-1080310, Rev. B
Clinical Studies 131
Clinical Studies
Hair removal and permanent hair reduction
The results of clinical studies have shown that the length of time necessary to
determine whether a treated area exhibits a stable, long-term or permanent
hair reduction varies according to the specific body site treated. If a treated
area exhibits a reduction in hair for a period longer than the total growth cycle
for that area, then the hair reduction may be expected to be stable, long-term
or permanent. The following table shows the duration of hair growth cycles
for the body sites treated in the clinical studies cited in this report.
Telogen Anagen Total

Location
(months) (months) (months)
Back 3-6 3-6 6-12
Thigh 3-6 3-6 6-12
Arm 3-5 1-2 4-7
Calf 3-4 4-5 7-9
Duration of Growth Cycles
Clinical studies have been conducted at the Massachusetts General Hospital

and the Laser and Skin Surgery Center of New York to assess the safety and
effectiveness of the LightSheer system for permanent hair reduction. A
combined total of 92 patients were treated and were followed up at 1, 3, 6,
and 9 months after 1 or 2 treatments with the LightSheer system. Thirty-five
(35) patients also had follow up after 12 months. Hair loss was defined as the
percentage of terminal hairs absent after treatment compared with the number
before treatment. The percentage of hair loss was evaluated at each follow up
visit after 1 and 2 treatments.
Seven test sites and 1 control site were mapped on each patient's thigh, back,
arm, or calf. The test sites were treated with fluences ranging from 15 – 40 J/
cm2. After one month, two of the test sites received a second treatment with
fluences of 40 J/cm2. Clinical assessment and digital imaging were performed
within one hour of laser treatment.
The results of this study show that there are two separate effects: hair growth
delay and permanent hair reduction. A growth delay, or temporary loss of hair,
is seen in all patients (100%) at all laser fluences tested. Temporary hair loss is
generally sustained for 1 – 3 months.
At 6 months and thereafter, hair regrowth stabilized and there was no
significant difference between regrowth at the 6, 9, and 12 month follow ups.
A subsequent published extension to this study reported continued
stabilization at an average of 20 months following treatment1. This indicates a
stable number of hairs and is consistent with the definition of permanent

UM-1080310, Rev. B
reduction of hair and with the growth cycle of hair follicles, which is 6 – 12
months for the back and thighs, and shorter for other body sites.
On average, a significant, permanent reduction in hair was seen at the 12
month follow up at all test sites and fluences as compared to untreated sites.
The amount of hair loss increases with higher fluence levels and with multiple
treatments. Approximately 89% of patients demonstrated permanent hair loss
at 12 months. The average percentage of permanent hair loss for each test site
is presented in the following table.
Number of Average Permanent Hair

Fluence
Treatments Reduction After 12 Months
5 ms, 15 J/cm2 1 26.6%
10 ms, 20 J/cm2 1 25.9%
2
15 ms, 30 J/cm 1 29.4%
20 ms, 40 J/cm2 1 32.5%
20 ms, 40 J/cm2 2 46.6%
20 ms, 40 J/cm2 3x 2 46.2%
2
20 ms, 40 J/cm 3x 1 38.5%
Control 0 5.5%
Average Percentage of Permanent Hair Reduction
Eleven percent of patients showed less than 10% hair loss when
treated with the LightSheer system, so cannot be considered to have any
permanent hair loss.
1. Goldberg D. Topical solution-assisted laser hair removal. Lasers Surg Med 1995;suppl 7(44).

UM-1080310, Rev. B
Clinical Studies 133
Pseudofolliculitis barbae treatment using the ET handpiece

General treatment modalities used for pseudofolliculitis barbae (topical
tretinoin cream, corticosteroids, topical and oral antibiotics, surgical
depilation, electrolysis, and tedious shaving regimens) have had disappointing
results. The LightSheer system provides sufficient tissue penetration needed
for follicular damage, causing temporary or permanent hair reduction in hair
density in the areas treated, and improving the acute and chronic changes of
pseudofolliculitis barbae.
In one clinical study1, patients with lighter skin types (predominantly I–III)
were treated using a pulse width of 20 ms and treatment fluences which
ranged from 30–38 J/cm2. The results of these studies have shown complete
hair-growth delays of 3 to 6 weeks’ duration (depending on the treatment site)
and a decrease in hair density of greater than 50%. In this clinical trial, all
patients reported greater than 75% improvements in pseudofolliculitis
papules and pustule formation after three treatments. These patients were
uniformly satisfied with their treatment and noted improvement after just one
treatment session.
In another clinical study2, patients with darker skin types (IV–VI) were safely
treated using pulse widths of 30 and 100 ms and fluences ranging from 20–45
J/cm2. Test spots were routinely performed and results were observed at one
week. In most instances, treatment fluences were chosen to be 5 J/cm2 less
than the maximum tolerated to provide a safety margin. Most patients noted a
significant reduction in pseudofolliculitis barbae activity after a single
treatment.
1. Kauvar ANB. Treatment of pseudofolliculitis with a pulsed infrared laser. Arch Dermatol
2000;136:1343-6.
2. Adrian RM, Shay KP. 800 nanometer diode laser hair removal in African American patients: a
clinical and histologic study. J Cutan Laser Ther 2000;2(4):183-90.

UM-1080310, Rev. B
Bibliography
A partial bibliography of medical and scientific articles pertinent to laser-
based hair removal, leg vein treatment, and benign pigmented lesion
treatment is listed below. As the field is rapidly evolving, operators are strongly
urged to stay current with the relevant literature.
Hair removal with LightSheer

Peer Reviewed Articles
1. Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types.
Dermatologic Therapy,2004; 17(2): 177-83.
2. Rao J, Goldman MP. Prospective, comparative evaluation of three laser
systems used individually and in combination for axillary hair removal.
Dermatol Surg, Dec 2005; 31(12): 1671-6; discussion 1677.
3. Benedetto AV, Lewis AT. Pilonidal sinus disease treated by depilation using
an 800 nm diode laser and review of the literature. Dermatol Surg, May 2005;
31(5): 587-91.
4. Bouzari N, Tabatabai H, Abbasi Z, Firooz A, Dowlati Y. Laser hair removal:
comparison of long-pulsed Nd:YAG, long-pulsed alexandrite, and long-
pulsed diode lasers. Dermatol Surg, Apr 2004; 30(4 Pt 1): 498-502.
(PBP000280)
5. Manuskiatti WM, Tantikun N. Treatment of Trichostasis Spinulosa in Skin
Phototypes III, IV, and V with an 800 nm Pulsed Diode Laser. Dermatologic
Surgery, 2003; Vol. 29: 85-88.
6. Klavuhn KG, Green D. Importance of Cutaneous Cooling During
Photothermal Epilation: Theoretical and Practical Considerations. Lasers in
Surgery and Medicine, 2002; Vol. 31: 97-105.
7. Eremia S, Li C, Newman N. Laser Hair removal with Alexandrite Versus
Diode Laser Using Four Treatment Sessions: 1-Year Results. Dermatologic
Surgery, 2001; Vol. 27: 925-930.
8. Hamilton MM, Dayan SH, Caniol PJ. Laser Hair Removal Update. Facial
Plastic Surgery, 2001; Vol. 17(3): 219-222.
9. Handrick C, Alster TS. Comparison of Long-Pulsed Diode and Long-
Pulsed Alexandrite Lasers for Hair Removal: A Long-Term Clinical and
Histologic Study.Dermatologic Surgery, 2001; Vol. 27: 622-626.
10. Lou WW, Quintana AT, Geronemus RG, Grossman, MC. Prospective
Study of Hair Reduction by Diode Laser (800 nm) with Long-Term Follow-
Up. Dermatologic Surgery, 2000; Vol. 26: 428-432. (PB0000213)

UM-1080310, Rev. B
Bibliography 135
11. Lin TY, Dierickx CC, Campos VB, Farinelli WA, Rosenthal RR.
Reduction of Regrowing Hair Shaft Size and Pigmentation After Ruby and
Diode Laser Treatment. Archive of Dermatology, 2000; Vol. 292: 60-67.
12. Campos VB, Dierickx CC, Farinelli WA, Lin TY, Manuskiatti W,
Anderson RR. Hair Removal with an 800-nm Pulsed Diode Laser. Journal of
American Academy of Dermatology, 2000; Vol. 43: 442-447.
13. Dierickx CC. Hair Removal by Lasers and Intense Pulsed Light Sources.
Seminars in Medicine and Surgery, 2000; Vol. 19: 267-275.
14. Adrian RM, Shay KS. 800 Nanometer Diode Laser Hair Removal in
African American Patients: A Clinical and Histologic Study. Journal of
Cutaneous Laser Therapy, 2000; Vol. 2: 183-190.
15. Dierickx CC, Alora MB, Dover JS. A Clinical Overview of Hair Removal
Using Lasers and Light Sources. Dermatologic Clinics, 1999; Vol. 17: 357-
366.
16. Williams RM, Gladstone HB, Moy RL. Hair Removal Using an 810 nm
Gallium Aluminum Arsedide Semiconductor Diode Laser. Dermatologic
Surgery, 1999; Vol. 25: 935-937.
17. Yamauchi PS, Kelly AP, Lask GP. Treatment of Pseudofolliculitis Barbae
with the Diode Laser. Journal of Cutaneous Laser Therapy, 1999; Vol. 1: 109-
111.
White Papers
18. Narurkar V. Evaluation of a New 400 ms Extended Pulse LightSheer
System for Safe and Effective Hair Removal. Lumenis, 2003. (PBP000270)
19. Campos VB. Safe and Effective Long-term Hair Reduction in Tanned
Patients Using an 800 nm Diode Laser. Lumenis, 2002. (PB0000234) Japan
Society of Aesthetic Surgery, November 14, 1999. Lumenis, 2000.
20. Kazmi A. Laser Hair Removal with an 800 nm Diode Laser – A
Retrospective Study of 1000 Women with Skin Types II to VI. Lumenis,
2002. (PB0000142)
21. Dierickx CC, Anderson RR, Campos VB, Grossman MC. Effective,
Permanent Hair Reduction Using a Pulsed, High-Power Diode Laser.
Lumenis, 2002. (PB0000218)
22. Battle EF Jr, Anderson RR. Study of Very Long-Pulsed (100 ms) High-
Powered Diode laser for Hair Reduction on All Skin Types. Lumenis, 2002.
(PB0000174)
23. Adrian RM. LightSheer 800 nm Pulsed, High-Power Diode Laser Hair
Removal System. Lumenis, 2002. (PB0000219)

UM-1080310, Rev. B
24. Pardo RJ, Fahey J. Use of the LightSheer Diode Laser System for Hair
Reduction: Safety and Efficacy in Large Series of Treatments. Lumenis, 2002.
(PB0000217)
25. Dierickx CC. Laser Hair Removal: Scientific Principles and Practical
Aspects. Lumenis, 2002. (PB0000173)
26. Anderson RR. Laser Hair Removal: A Lecture Presented to the 77th
Congress of the Japan Society of Aesthetic Surgery, November 14, 1999.
Lumenis, 2000.
27. Kono T, Nozaki M. Diode Laser-Assisted Hair Removal in Asians: A
Study of 101 Japanese Patients. Coherent, 2000.
28. Klavuhn KG. Epidermal Protection: A Comparative Analysis of Sapphire
Contact and Cryogen Spray Cooling. Coherent, 2000. (PBP000133)
29. Klavuhn KG. Illumination Geometry: The Importance of Laser Beam
Spatial Characteristics. Coherent, 2000. (PBP000132)
30. Klavuhn KG. Coverage Rate: The Influence of Laser Parameters on
Treatment Time. Coherent, 2000. (PBP000131)
Other applications with LightSheer

Peer Reviewed Articles
1. Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian
J Dermatol Venereol Leprol, Jan-Feb 2005; 71(1): 31-4.
2. Soden CE, Smith K, Skelton H. Histologic Features Seen in Changing Nevi
After Therapy with an 810 nm Pulsed Diode Laser for Hair Removal in
Patients with Dysplastic Nevi. International Journal of Dermatology, 2001;
Vol. 40: 500-504.
3. Boyd AS, Binhalm JQ. Use of an 800-nm pulsed-diode laser in the
treatment of recalcitrant dissecting cellulites of the scalp. Archives of
Dermatology, 2002; Vol. 138: 1291-1293.
White Papers
4. Kilmer SB, Chotzen VA, McClaren M. Use of LightSheer Diode Laser for
the Treatment of Benign Pigmented Lesions. Lumenis, 2000. (PB0000215)
5. Campos MD, Anderson RR, Diereckx CC. Use of an 800 nm High-Power
Diode Laser for the Treatment of Leg Vein Telangiectasia. Lumenis, 2002.
(PB0000216)

UM-1080310, Rev. B
Customer Support, Sales, and Service 137
Customer Support, Sales, and Service

In addition to the following Lumenis offices, which provide customer
support, sales, and service, Lumenis has distributors worldwide. Contact your
local office for the distributor in your vicinity.
Lumenis Lumenis Ltd.

5302 Betsy Ross Dr. Yokneam, Israel
Santa Clara, CA, 95054, USA Tel:+ 972.4.959.9000
General Sales and Service: Fax:+ 972.4.959.9050
Tel:408.764.3000 / 877.LUMENIS
Fax:408.764.3999 / 800.505.1133 Lumenis Japan Co. Ltd.
Service Center: Tokyo, Japan
Tel: 877.LUMENIS or 877.586.3647 Tel:+ 81.3.5789.8300
Fax: 408.763.3327 Fax:+ 81.3.5789.8301
Lumenis (Germany) GmbH* Lumenis (HK) Ltd.

Heinrich-Hertz-Strasse 3 Hong Kong
63303 Dreieich-Dreieichenhain, Germany Tel:+ 852.2174.2800
Tel:+ 49.6103.8335.0 Fax:+ 852.2722.5151
Fax:+ 49.6103.8335.300
(*Authorized Representative per Medical Device Directive Lumenis (China) Ltd.
93/42/EEC as ammended by 2007/47/EC) Beijing, China
Tel:+ 86.10.6510.2620
Lumenis (France) SARL Fax:+ 86.10.6510.2621
Orsay, France
Tel:+ 33.1.69.33.14.20
Fax:+ 33.1.60.19.57.23
Lumenis (Italy) SRL

Rome, Italy
Tel:+ 39.06.90.75.230
Fax:+ 39.06.90.75.269
Lumenis (UK) Ltd.

London, United Kingdom
Tel:+ 44.20.8324.4200
Fax:+ 44.20.8324.4222
Internet: www.Lumenis.com
Email: information@lumenis.com

UM-1080310, Rev. B

UM-1080310, Rev. B
139
Appendix 1

UM-1080310, Rev. B
140 Appendix 1

UM-1080310, Rev. B
EMC Guidance and Manufacturer’s Declarations 141
EMC Guidance and Manufacturer’s Declarations
Guidance and Manufacturer's Declaration Electromagnetic Emissions

LightSheer Duet is intended for use in the electromagnetic environment specified below. The customer or the user of Light-
Sheer Duet should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment - guidance
RF emissions CISPR 11 Group 1 LightSheer Duet uses RF energy only for its internal function;
therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class A LightSheer Duet is suitable for use in all establishments other
than domestic, and may be used in domestic establishments and
Harmonic emissions Class A those directly connected to the public low-voltage power supply
IEC61000-3-2 network that supplies buildings used for domestic purposes, pro-
Voltage Fluctuations/ flicker Complies vided the following warning statement is heeded:
emissions IEC61000-3-3
Warning: This system is intended for use by health care profes-
sionals only. This system may cause radio interference or may
disrupt the operation of nearby equipment. It may be necessary
to take mitigation measures, such as re-orienting or relocating
the system or shielding the location.

UM-1080310, Rev. B
142 Appendix 1
Guidance and Manufacturer's Declaration: Electromagnetic Immunity

Immunity Test IEC 60601 Test Compliance Level Electromagnetic
Level Environment: Guidance
Electrostatic Discharge (ESD) ±6kV contact ±2,4,6kV contact Floors should be wood, con-
crete, or ceramic tile. If floors
IEC61000-4-2 ±8kV air ±2,4,8kV air are covered with synthetic
material, the relative humidity
should be at least
30%.
Electrical fast transient/burst ±2kV for power supply lines ±2kV line to ground Mains power quality should be
that of a typical commercial
IEC61000-4-4 ±1kV for input/output lines ±1kV line to line or hospital environment.
Surge ±1kV differential mode ±0.5, 1kV differential mode Mains power quality should be
that of a typical commercial
IEC61000-4-5 ±2kV common mode ±0.5, 1, 2kV common mode or hospital environment.
Voltage dips, short interrup- <5% Ut (>95% dip in Ut) for <5% Ut (>95% dip in Ut) for Mains power quality should be
tions and voltage variations on 0.5 cycle 0.5 cycle that of a typical commercial
power supply input lines or hospital environment. If
40% Ut (60% dip in Ut) for 5 40% Ut (60% dip in the user of LightSheer Duet
IEC61000-4-11 cycles Ut) for 5 cycles requires continued operation
during power mains interrup-
70% Ut (30% dip in Ut) for 25 70% Ut (30% dip in tions, it is recommended that
cycles Ut) for 25 cycles LightSheer Duet be powered
from an uninterrupted power
<5% Ut (>95% dip in Ut) for 5 <5% Ut (>95% dip in Ut) for 5 supply or a battery.
sec. sec.
Power frequency (50/60Hz) 3 A/m N/A Power-frequency magnetic
magnetic field fields should be at levels char-
acteristic of a typical location
IEC 61000-4-8 in a typical commercial or
hospital environment.
NOTE: Ut is the a.c. mains voltage prior to application of the test level.

UM-1080310, Rev. B
EMC Guidance and Manufacturer’s Declarations 143
Guidance and Manufacturer's Declaration: Electromagnetic Immunity

Immunity Test IEC 60601 Test Compliance Electromagnetic Environment: Guidance
Level Level
Portable and mobile RF communications equipment should
be used no closer to any part of the LightSheer Duet system,
including its cables, than the recommended separation dis-
tance calculated from the equation applicable to the fre-
quency of the transmitter.
Recommended Separation Distance

Conducted RF 3 Vrms 3V d = 1.17P
IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 V/m d = 1.17P 80 MHz to 800 MHz
IEC 61000-4-3 80MHz to 2.5 GHz
d = 2.33P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the trans-

mitter in watts (W) according to the transmitter manufac-
turer and d is the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters, as determined by

an electromagnetic site survey (a), should be less than the
compliance level in each frequency range(b).
Interference may occur in the vicinity of equipment marked

with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflec-
tion from structures, objects, and people.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If
the measured field strength in the location in which the LightSheer Duet system is used exceeds the applicable RF compliance
level above, the LightSheer Duet system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the LightSheer Duet unit.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

UM-1080310, Rev. B
144 Appendix 1
Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the LightSheer Duet System
The LightSheer Duet system is intended for use in an electromagnetic environment in which radiated RF disturbances are con-
trolled. The user of the LightSheer Duet system can help prevent electromagnetic interference by maintaining a minimum dis-
tance between portable and mobile RF communications equipment (transmitters) and the LightSheer Duet system as
recommended below, according to the maximum output power of the communications equipment.
Separation distance (m) according to frequency of transmitter
Rated maximum output power

(W) of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.17P d = 1.17P d = 2.33P

0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating
of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.

UM-1080310, Rev. B
145
Appendix 2

UM-1080310, Rev. B
146 Appendix 2

UM-1080310, Rev. B
Accessory Kit Components 147
Accessory Kit Components
Power Cord, 15A, 125VAC Power Cord, 20A, 250VAC
Operator Manual Multi-Language Operator Manual CD

UM-1080310, Rev. B
148 Appendix 2
Guideline: LightSheer Leg Veins Treatment Guideline: LightSheer 9mm Treatment 400 ms
Disposable Inserts (x 30) Safety Glasses

UM-1080310, Rev. B
Accessory Kit Components 149
Opaque Eye Shields Opaque Eye Shields Foam Replacements
DANGER
INVISIBLE LASER RADIATION
PROTECTIVE EYEWEAR
REQUIRED WHEN LASER
IS IN USE
OUTPUT 102J MAX
DURATION 5-400 ms
WAVELENGTH 790-830 nm
CLASS IV LASER PRODUCT
LB-1073740, Rev A
Laser Danger Door Sign System Keys

UM-1080310, Rev. B
150 Appendix 2

UM-1080310, Rev. B

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LightSheer ®

Diode Laser System

© Copyright Lumenis Ltd.

Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE)

LightSheer® Duet™ Laser System Operator Manual

HS and ET handpiece holsters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

LightSheer® Duet™ Laser System Operator Manual

ET handpiece placement and technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Maintenance Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Indications Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

LightSheer® Duet™ Laser System Operator Manual

Appendix 1 EMC Guidance and Manufacturer’s Declarations . . . . . . . . . . . . . . . 141

Appendix 2 Accessory Kit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

LightSheer® Duet™ Laser System Operator Manual

LightSheer® Duet™ Laser System Operator Manual

THIS PAGE LEFT BLANK INTENTIONALLY

LightSheer® Duet™ Laser System Operator Manual

WARNING - Use of controls or adjustments or performance of

LightSheer® Duet™ Laser System Operator Manual

WARNING - The light emitted by the LightSheer laser is capable of

The LightSheer system is to be operated only in an enclosed room with

WARNING - All persons in the treatment room, including the

WARNING - While operating the LightSheer system, never look

WARNING - Avoid directing the laser beam anywhere other than

WARNING - Do not treat eyebrows, eyelashes, or other areas within

Ocular safety considerations:

LightSheer® Duet™ Laser System Operator Manual

WARNING - Opening the exterior housings may cause exposure to

WARNING - Do not operate the laser system if any coolant leakage

LightSheer® Duet™ Laser System Operator Manual

Laser plume precautions

CAUTION - The user should be aware that laser plumes do present

CAUTION - Laser plume may contain viable tissue particulates.

CAUTION - The user should wear surgical masks that remove

WARNING - Do not operate the LightSheer system in the presence

LightSheer® Duet™ Laser System Operator Manual

Health hazard during treatment

WARNING - Always wear gloves during treatment and it is

LightSheer® Duet™ Laser System Operator Manual

LightSheer Safety Features

Audible emission indicator

LightSheer® Duet™ Laser System Operator Manual

LightSheer® Duet™ Laser System Operator Manual

LightSheer® Duet™ Laser System Operator Manual

LightSheer Duet safety features

Emergency stop switch

LightSheer® Duet™ Laser System Operator Manual

THIS PAGE LEFT BLANK INTENTIONALLY

LightSheer® Duet™ Laser System Operator Manual

Location of Regulatory and System Labels

Emergency stop label

Location of regulatory compliance labels

LightSheer® Duet™ Laser System Operator Manual

Laser aperture label

Handpiece danger label and

Location of regulatory compliance labels on handpieces

LightSheer® Duet™ Laser System Operator Manual

Nonoperating environmental specifications (on shipping box)

Patents pending FDA sales restriction DHHS certification

Lumenis (Germany) GmbH 100 - 240 V~