Cynosure SculpSure User manual

OPERATOR’S MANUAL
SculpSure®
Laser System
operator

5 Carlisle Road
Westford, MA 01886, USA
cynosure.com
t) 978.256.4200
t) 800.886.2966
f) 978.256.6556
SculpSure®Operator’s Manual
P/N 850-7026-000 Rev 6
Updated November 2016

LuxLotion™ is a trademark and Cynosure®and SculpSure®are registered trademarks of
Cynosure, Inc.
© 2016 Cynosure, Inc. All rights reserved.
CRS Medical GmbH
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T:+49-6441/38 331-0
F:+49-6441/38 331-29
VR MEDICAL IMPORTADORA E DISTRIBUIDORA
DE PRODUTOS MEDICOS LTDA
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Telefone:(11) 2148-0900
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SculpSure®Laser System Limited Software License
The original SculpSure software installed on your SculpSure system and any SculpSure software upgrades installed on your SculpSure
system by authorized representatives of Cynosure, Inc. (“Cynosure”) are owned by Cynosure. You may not tamper with this software
(including unauthorized upgrades), disclose it to third parties, or use it for any purpose other than running your SculpSure system. Cynosure
does not grant you any other rights to use or disclose the original software or any upgrades, and any further uses will be prosecuted by
Cynosure to the maximum extent possible. Any other use of the SculpSure software, including any upgrades, explicitly is prohibited. In
addition, you may not disclose the SculpSure software, any upgrades, or any of its features and benefits to a third party.

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Table of Contents
Cautions and Warnings ............................................................................................ 8
Chapter 1 Introduction......................................................................................... 9
About the System..................................................................................................................9
Intended User........................................................................................................................9
Indications for Use................................................................................................................9
Contraindications................................................................................................................10
Cautionary Criteria..............................................................................................................10
About the Manual ...............................................................................................................11
Additional Information .......................................................................................................11
Chapter 2 Equipment Safety.............................................................................. 13
Potential Hazards................................................................................................................13
Safety ..................................................................................................................................16
Safety Features....................................................................................................................19
Device Labels......................................................................................................................22
Chapter 3 Site Preparation................................................................................. 25
Spatial Requirements..........................................................................................................25
Electrical Requirements......................................................................................................25
Operating Environment.......................................................................................................26
Storage and Transport Requirements..................................................................................26
Transporting the Laser........................................................................................................27
Chapter 4 System Description ........................................................................... 29
Components ........................................................................................................................29
Delivery System..................................................................................................................35
Pager System.......................................................................................................................35
PAC Key.............................................................................................................................36
Pause Button .......................................................................................................................37
Applicators: How to Remove, How to Attach....................................................................38
Chapter 5 Software Description ........................................................................ 49
Common Icons and Buttons................................................................................................50
Operations Screens..............................................................................................................52
To Terminate Treatment.....................................................................................................59
Loss of Contact...................................................................................................................60
Treatment in Sustain Mode After Loss of Contact.............................................................61
To Link and Unlink Applicators.........................................................................................62
To Lock the System............................................................................................................65
To Unlock the System.........................................................................................................65

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To Change the PIN..............................................................................................................65
To Verify the Current PIN..................................................................................................67
To Change Onscreen Languages ........................................................................................68
Chapter 6 System Specifications ...................................................................... 69
General Specifications........................................................................................................69
Chapter 7 Laser Operation ................................................................................ 71
Laser Start-Up.....................................................................................................................71
Setting Treatment Parameters.............................................................................................72
Laser Shutdown ..................................................................................................................72
Chapter 8 Maintenance .................................................................................... 73
Air Filter Maintenance........................................................................................................74
Adding Coolant...................................................................................................................75
Care and Handling: System Exterior ..................................................................................77
Power Verification..............................................................................................................79
Troubleshooting..................................................................................................................80
Fault Codes, Descriptions, and Possible User Actions.......................................................82
Chapter 9 Customer Support............................................................................. 91
Direct-Purchase Warranty...................................................................................................91
Distributor-Purchased Warranty.........................................................................................91
Warranty Claims.................................................................................................................91
Installation...........................................................................................................................91
Customer Service................................................................................................................92
Items Commonly Ordered...................................................................................................92
Appendix A Service Procedures .......................................................................... 93
System Battery Replacement..............................................................................................93
Line Cord Replacement ......................................................................................................93
Fuse Replacement...............................................................................................................94
Cables..................................................................................................................................94
External Laser Calibration..................................................................................................95
Appendix B EMC Declaration............................................................................... 97

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Glossary of Symbols and Abbreviations
The following international symbols and abbreviations may be used on the device, device
packaging and/or in this manual.
Symbols
Declaration of Conformity to
Medical Device Directive
93/42/EEC.
4002503
ETL Listed.
Conforms to: UL STD 60601-1, IEC STD 60601-1-4, IEC STD 60601-2-22
Certified to: CAN/CSA STD C22.2 NO. 601.1
Temperature Limit
per EN ISO 15223-1.
Located on shipping crate.
This End Up
per EN ISO 15223-1.
Located on shipping crate.
Fragile, handle with care
per EN ISO 15223-1.
Located on shipping crate.
Keep Dry per EN ISO 15223-1.
Located on shipping crate.
Humidity Limit
per EN ISO 15223-1
Located on shipping crate.
ATMOSPHERIC PRESSURE
(upper limit top right, lower
limit bottom left). Located on
the shipping box.
Type BF applied part per
EN60601-1.
Located on System and
Applicator.
Optical Fiber Applicator
per EN60601-2-22.
Located on System.
Filling per IEC TR 60878
Located on system.
Remote Interlock Connector
per EN60601-2-22.
Located on System.
WEEE symbol per EN50419.
Located on System and
Applicator.
Manufacturer per
EN ISO 15223-1.
Located on System and
Applicator.
Attention, consult
accompanying documents.
Located on System.
Non-ionizing Radiation.
Located on System.
Date of Manufacture
per EN ISO 15223-1.
Located on System.
Laser Hazard Warning.
Located on System and
Applicator.
Off—power disconnection
from mains.
Located on System.
Alternating Current. Located
on System.
Earth ground.
Located on System.
On—power connection to
mains.
Located on System.
Ethernet; networking.
Located on System.
Emergency Stop Switch.
Located on System.
Serial Number
per EN ISO 15223-1.
Located on System and
Applicator.
USB connection.
Located on System.
Follow Instructions for Use.
Located on System.
Catalog Number
per EN ISO 15223-1.
Located on System and
Applicator.
Authorized representative in
the European community
EN ISO 15223-1. Located on
System and Applicator.

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Cautions and Warnings
The following is a list of the Cautions and Warnings that appear in this manual as well as the
SculpSure Clinical Reference Guide.
WARNING: CynosureLasers must be used
with accessories and cables as approved by
Cynosure®. Failure of which may result in
increased emissions or decreased immunity
of the system.
WARNING: Lasers can cause eye injury.
Never perform any set-up or maintenance
procedures on the SculpSure Laser that
bypass the safety features or lead to
greater exposure beyond normal output.
WARNING: Do not sharply bend or
improperly secure the umbilical. Damage
to the laser fibers, Applicator or laser
delivery system and harm to the client or
laser operator may result.
CAUTION: Portable and mobile radio
frequency (RF) communication equipment
can affect the SculpSure workstation.
WARNING: No modification of this
equipment is allowed. Modification of
equipment can result in improper
operation causing possible injury.
WARNING: Do not treat over a previously
treated area if there are any unresolved
nodules, hardness, or other adverse side
effects.
WARNING: Exercise particular care when
using system in oxygen rich environment.
Laser may cause ignition by accelerating the
combustion of flammable material.
CAUTION: Take anti-static precautions
when replacing the battery; failure to take
proper anti-static precautions could
damage the laser system.
CAUTION: When attempting to move the
system, always pull SculpSure by its
handle. Do not push the machine.
Toppling of the system may result.
CAUTION: Do not submerge the Applicator
in any fluid. Damage may result.
CAUTION: The SculpSure Laser System
may be dangerous if used improperly.
Please follow the instructions in this
Operator’s Manual.
CAUTION: Do not treat over scars, or
bony areas such as the hips or ribs.
Discomfort and adverse skin effects may
result.
CAUTION: Do not touch or contaminate the
exposed laser fiber at the Applicator’s
connection point. Keep the laser fiber
capped or installed in the system at all
times. Contamination of the laser fiber may
result in damage to the system.
CAUTION: Use of controls, adjustments, or
performance of procedures other than
those specified herein may result in
hazardous radiation exposure. To avoid
these hazards, the precautions described in
this Operator’s Manual must be observed
when installing, operating, moving or
servicing the system.
CAUTION: The Applicator contains
delicate optical components that may
suffer severe damage if dropped, jarred or
bumped. When not in use, the Applicator
should be securely maintained.
Cynosureis not responsible for damage
caused by dropping, abuse, misuse, or
negligence of the Applicator.
CAUTION: Do not use any organic solvent,
acid or alkali solution on the display or it
may become damaged.
CAUTION: Do not use any optical
instrument to view the light-emitting end of
the Applicator. Injury may result.
CAUTION: Do not operate the Applicator
within 22cm of the eyes. Injury may
result.
CAUTION: Performing maintenance
procedures with the System while it is
powering up, or less than ten (10) minutes
after disconnecting the System, may be
hazardous to the operator and destructive
to the System.
CAUTION: Ensure there are no belts,
tissues, drapes, clothing or any foreign
material between the Frames and the
Applicators, and ensure there is nothing
caught between the Applicators and the
skin. Injury to client may result.
CAUTION: Ensure all the equipment used
for System calibration is calibrated prior
to performing the system diode
calibration. If the calibration standard is
inaccurate or not used correctly, then the
system will also be inaccurate after
calibration.
WARNING: To avoid the risk of electric
shock, this equipment must only be
connected to a supply mains with
protective earth.
CAUTION: Do not pull the system by the
Applicators or umbilical connections.
Toppling of the system, or damage to the
system, may result.
CAUTION: Do not stack treatments or
treat over the same site during the same
visit. Discomfort and adverse skin effects
may result.
CAUTION: Ensure the Belt has no wear or
tear. Wear or tear to the Belt could result in
improper Applicator to client contact,
diminished treatment results, and client
injury.
WARNING: Care should be taken while
moving or transporting the SculpSure Laser
System, especially on inclines and
thresholds, as system instability can cause
damage to the system and/or possible
injury.
CAUTION: Do not treat over areas of
deep, thick skin folds where the
Applicator may not cool the area
adequately. Discomfort and adverse skin
effects may result.
CAUTION: Do not place the Applicator’s
treatment window directly over the
umbilicus. Discomfort and side effects may
result.
CAUTION: When treating over a tattoo
there is an increased risk of adverse skin
effects and discomfort if the Applicator(s) is
not in full contact with the skin.

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Chapter 1 Introduction
About the System
The Cynosure SculpSure Laser System is a diode laser system.
Electrically efficient semiconductors generate optical radiation
(1060 nm) which is used to deliver laser energy to subcutaneous
tissue layers. SculpSure’s cooling and electrical systems assist in
maintaining safe and comfortable skin surface temperatures. The
Cynosure SculpSure Laser System is capable of peak powers of
200 Watts in continuous wave (CW) mode.
Intended User
The SculpSure laser system is intended for use by professional
operators. The operator should seek to comply with laws and
regulations that restrict the use of the device. Prior to use, the
operator should successfully complete Cynosure laser training and
clinical training programs.
Federal (USA) law restricts this device to sale by or on the order of a
physician or other practitioner licensed by the law of the state in which he/she practices to use or
order the use of the device.
Federal law and some international laws also require that this device be utilized under the direction
of a physician. This device should only be used by healthcare professionals authorized under US
state or international laws to treat clients. All persons treating clients with this device should
determine whether they are authorized healthcare professionals under the applicable US state or
international laws.
Indications for Use
The SculpSure laser system is intended for non-invasive lipolysis of the flank and abdomen to
achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired
aesthetic affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
NOTE: Device is to be sold to and used by trained professionals only. A qualified practitioner is
solely responsible for evaluating each subject’s suitability to undergo light-based treatment and for
informing those being treated about any risks involved with the treatment, pre-and post-treatment
care, and any other relevant information.

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Contraindications
As with any procedure, it is the physician’s responsibility to determine whether SculpSure is
an appropriate treatment option for their clients.
Treatment using the SculpSure system is contraindicated in any client who:
Has open lesions and wounds. Treatment should only be applied to intact, healthy skin,
with no evidence of compromised wound healing.
Has an unrepaired abdominal hernia.
Has had prior treatment with parental gold therapy (gold sodium thiomalate).
Is pregnant and/or breastfeeding.
Cautionary Criteria
Treatment using the SculpSure system is cautioned in any client who:
Has a history of immunosuppression / immune deficiency disorders, including HIV infection
or AIDS, or use of immunosuppressive medications.
Is currently taking antiplatelets, thrombolytics, anti-inflammatories or anticoagulants-
including but not limited to the heavy use of aspirin, i.e., greater than 81 mg per day.
Has a coagulation disorder.
Has had a previous procedure or surgery in the treatment area that may have resulted in
decreased sensation, scar/fibrotic tissue or large scars that may interfere with the treatment.
Has an active tan, or the need to be exposed to artificial tanning devices or excessive sunlight
a week (7 days) before or after treatment.
Has a tattoo in the treatment area.
Has a history of skin photosensitivity disorders, or is taking photo-sensitized medication.
Has a neuropathic disorder, impaired skin sensation, or diabetic neuropathy.
Has a history of keloid formation.
Has a history or evidence of squamous cell carcinoma or melanoma.

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About the Manual
The SculpSure Operator’s Manual provides the following information about the laser:
Equipment Safety
Site Preparation
Storage and Transport
Laser Operation
Maintenance
Customer Support
The Caution and Warning Symbol indicates a potentially hazardous situation that, if not
avoided, could result in damage to the equipment and serious injury to the operator, those being
treated, or staff.
Although the manual provides useful information on the use and maintenance of the laser, it is not
intended to be a complete guide. Refer to the SculpSure Clinical Reference Guide for specific
treatment information. Cynosure suggests that all health care professionals who plan to use the
laser seek further training in its proper use. The custodian of the laser shall take steps to prevent its
unauthorized use.
This manual is to be considered part of the SculpSure Laser and should be kept in close proximity
to the device. Observation to the instructions for use is the supposition for proper usage and
handling of the system so as to ensure operator and client safety.
CAUTION: Use of controls, adjustments, or performance of procedures other than those
specified herein may result in hazardous radiation exposure. To avoid these hazards, the
precautions described in this Operator’s Manual must be observed when installing,
operating, moving or servicing the system.
PLEASE NOTE:
Customer and operator agrees that it is their sole responsibility to fully understand and comply
with local, state and federal laws, rules, and regulations in the use of this System.
Additional Information
Upon request, Cynosure will provide circuit diagrams, component part lists, descriptions,
calibration instructions or other information not already contained within the manual, to assist
appropriately qualified technical personnel to repair those parts of the SculpSure system that are
designated by Cynosure as repairable. “Appropriately qualified technical personnel” refers to
personnel who have undergone Cynosure’s service training course for the SculpSure system and
have been authorized in its repair.

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Chapter 2 Equipment Safety
Potential Hazards
As with any equipment, there are potential hazards. This section of the manual describes potential
hazards and precautions that can be taken to avoid them. This section also describes laser safety
features designed to minimize potential hazards. Before using the laser system, familiarize yourself
with this information.
WARNING: No modification of this equipment is allowed. Modification of equipment
can result in improper operation causing possible injury.
In the United States, the facility operating the laser system should follow OSHA guidelines and
applicable ANSI standards for the safe use of lasers.
In Canada, the system should be installed and operated in accordance with CAN/CSA Z386: Safe
Use of Lasers in Health Care Facilities.
In Australia and New Zealand, the facility operating the system should be aware of the
requirements of AS/NZS 2211.1: Safety of Laser Products—Part 1: Equipment Classification,
Requirements and User’s Guide.
Customer and operator agree that it is their sole responsibility to fully understand and comply with
local, state, and federal laws, rules, and regulations in the use of this system.
WARNING: Cynosure Lasers must be used with accessories and cables as approved by
Cynosure. Failure of which may result in increased emissions or decreased immunity of
the system.
CAUTION: The Applicator contains delicate optical components that may suffer severe
damage if dropped, jarred or bumped. When not in use, the Applicator should be
securely maintained. Cynosure is not responsible for damage caused by dropping, abuse,
misuse, or negligence of the Applicator.
CAUTION: The SculpSure Laser System may be dangerous if used improperly. Please
follow the instructions in this Operator’s Manual.
CAUTION: Ensure the Belt has no wear or tear. Wear or tear to the Belt could
result in improper Applicator to client contact, diminished treatment results, and
client injury.

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Electrical Hazard
No part of the exterior housing should be removed. Do not open the protective panels unless you
are trained and authorized to do so.
WARNING: To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
Electromagnetic Compatibility Hazards
The SculpSure Laser has special precautions regarding electromagnetic compatibility hazards
(EMC), and needs to be installed and operated according to the EMC information provided in
Appendix B starting on page 97 of this manual.
CAUTION: Portable and mobile radio frequency (RF) communication equipment can
affect the SculpSure workstation.
NOTE: The SculpSure Laser should not be used adjacent to, or stacked with, other equipment, unless
specified by Cynosure. If the system must be used adjacent to, or stacked with other equipment, then
observe the laser in its configuration to verify that operation is normal.
Optical Hazard
The laser emits an intense energy beam of invisible laser light radiation that can cause serious eye
damage with direct or even indirect optical contact.
WARNING: Lasers can cause eye injury. Never perform any set-up or maintenance
procedures on the SculpSure Laser that bypass the safety features or lead to
greater exposure beyond normal output.
CAUTION: Do not operate the Applicator within 22 cm of the eyes. Injury may
result.
CAUTION:Do not use any optical instrument to view the light-emitting end of the
Applicator. Injury may result.
Please follow these precautions to avoid optical damage to operators, assisting personnel and
clients.
Mark treatment room with a laser warning sign to avoid unnecessary personnel from
entering during treatment.
Limit entry to the treatment room only to personnel who are assisting in treatment and are
trained in the use of the equipment.
Do not attempt to use the Applicator if it has been dropped or shows signs of physical
damage. If the Applicator is damaged, contact the CynosureCustomer Service.
Direct the activated laser only at the intended area of treatment.
Place one person in charge of the laser system’s controls during the treatment.
Ensure that all appropriate staff members are trained to shut off the laser in the event of an
emergency.

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Laser-Induced Fire Hazard
The potential for fire hazard exists because of the nature of laser treatments. Any material that
absorbs emitted energy, no matter how brief, will increase in temperature. This phenomenon is the
basis of many useful medical and surgical applications. It also is the reason that these applications
often require precautions against the risk of igniting combustible materials in and around the
treatment area.
If the laser beam contacts any surface, that surface can absorb the laser energy. This raises the
surface temperature, whether the surface is skin, hair, clothes or any flammable substance.
The system is not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
WARNING: Exercise particular care when using system in oxygen rich
environment. Laser may cause ignition by accelerating the combustion of
flammable material.
When the SculpSure Laser is used, the following precautions should be taken to prevent a laser-
induced fire:
Use non-flammable substances for uses such as anesthesia, skin preparation, and cleaning
instruments.
Keep a minimum of combustible materials (e.g., alcohol) in the treatment room.
Ensure that the System and ancillary equipment are working properly before beginning a
procedure.
Never direct the light output at anything other than the intended treatment area, especially
reflective objects such as mirrors.
Exercise particular care in the use of oxygen. The presence of oxygen can accelerate the
combustion of any flammable material.
When they are required, gauze and drapes in the treatment area may be made fire-retardant
by keeping them moist with water or saline.
Clothing should be kept away from the area of treatment.
Know the location and operation of the nearest fire extinguisher.
Keep a portable fire extinguisher in close proximity to laser treatment areas and know how
to operate.
Water should be immediately available to quench nonelectrical fires.
Turn off the SculpSure System when not in use. This will prevent accidental light
emissions.

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Safety
Personnel operating and maintaining the SculpSure System should be familiar with the safety
information provided in this Chapter.
Cynosure assumes no liability whatsoever for any damage, loss, or injury resulting from an
application of a product which is not in strict accordance with the instructions provided with the
product. Cynosure also assumes no liability for any damage or injury arising as a result of operator
error or mistake, including, but not limited to, injury arising from operator’s lack of qualification
to administer the treatment in the individual circumstances or as a result of errors or mistakes
committed by such operator who would otherwise be considered as having the necessary
professional skills to apply such treatment.
Read the Installation and Operation Instructions thoroughly before connecting the SculpSure Laser
to the main power connection and prior to use. The SculpSure Laser must be set, regulated, and
used in accordance with the instructions listed in this Manual. Failure to observe safety warnings
and precautions may present a risk of hazardous exposure to light-based radiation.
All people operating the SculpSure Laser or in its vicinity must be aware of the potential hazards
of the System output and should take the proper safeguards as described in this Operator’s Manual.
High voltages are present inside the SculpSure Laser, and any light emitting device may cause
injury if used improperly.
The SculpSure Laser has been designed and validated in accordance with this Operator’s Manual.
As with any light-based device, never look directly at the light output.
Only individuals with appropriate safety training and knowledge should operate, assist in the
operation of, or provide maintenance to the SculpSure Laser. Only the operator should be
responsible for System controls during a procedure.
No one other than Cynosure-authorized personnel may service inside the protective covers of the
SculpSure Laser Base Module or Applicator.
Routine maintenance should be performed by the operator thirty (30) minutes after the SculpSure
Laser is shut down and disconnected from power.
CAUTION: Performing maintenance procedures with the System while it is
powering up, or less than ten (10) minutes after disconnecting the System, may be
hazardous to the operator and destructive to the System.
WARNING: Do not sharply bend or improperly secure the umbilical. Damage to
the laser fibers, Applicator or laser delivery system and harm to the client or laser
operator may result.
CAUTION: Do not pull the system by the Applicators or umbilical connections.
Toppling of the system, or damage to the system, may result.

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Safety Training
It is recommended that, in addition to laser safety training of all personnel, the operator/institution
adopt a training and safety program as outlined in the latest revision of the ANSI Standard Z-
136.3, the American National Standard for the Safe Use of Lasers in Health Care Facilities.
Practitioners should consider the following training options, among other choices, available:
1. An accredited training course.
2. “Hands-on” training.
3. Attendance of courses presented during academy or college meetings.
4. Continuing education programs.
5. Credentialing programs.
All practitioners handling lasers, including physicians, nurses and other professionals, should
complete a training program which may include subjects such as basic laser physics, laser safety,
tissue interaction, laser operating procedures, laser set-up procedures, potential hazards, and hands-
on experience.
Treatment Safety
Never look directly at the light coming from the light-emitting end of the Applicator as this
may cause eye injury.
A well-trained staff fosters safety.
Education for those being treated is important and information about the nature and
expectations of the treatment should be provided.
Room Safety
Identify the treatment room clearly. For any laser treatment, a laser safety warning sign
must be displayed outside the treatment door.
Restrict entry to the treatment room when the System is in use. Allow access to the
treatment room only to personnel who are well-trained and essential to the procedure.
As an option for additional safety, the remote interlock can be connected to the treatment
room door.
When the System is not in use, ensure that it is rendered inaccessible to unauthorized
personnel. Keep System in a locked or secure environment.
Make sure that all personnel are familiar with the System controls and know how to
instantly shut down the System if necessary.
Block all windows to the treatment room to prevent light from escaping the treatment
room.

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Staff and Client Safety
The following operator guidelines are provided as a general outline of procedures for properly
using the SculpSure Laser.
Do not use the SculpSure Laser on persons who meet the contraindications listed in the
Clinical Applications chapter.
Heed all Cautionary Criteria specified for the SculpSure Laser System.
Identify the treatment room clearly, posting appropriate laser warning signs in prominent
locations where the laser is in use.
Restrict entry to the treatment room when the system is in use. Allow access to the
treatment room only to those personnel both essential to the procedure and well trained in
system safety.
Never operate the system in the presence of flammable liquids (such as alcohol) or
flammable anesthetics (such as ether). Moisten combustible materials (such as gauze and
swabs) with water or saline for safety.
Ensure that the system and ancillary equipment are working properly before beginning a
procedure.
Always ensure that the Applicator is in proper contact with the area to be treated.

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Safety Features
The SculpSure Laser offers several safety features to prevent its misuse or unintentional activation.
All personnel who operate the system or assist during treatment should be familiar with these
safety features.
Arm (umbilical management system)
Emergency laser stop
Keyswitch
Power button
(circuit breaker)
Remote interlock
Casters (locking)
Casters
(positional lock)
Pause button

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Laser Danger Sign
Cynosuresupplies a laser danger sign with each Laser. Cynosure recommends posting this sign at
the entrance to the treatment room where the system will be used. Please check the policy of your
facility.
Key Switch
The key switch controls the electrical activation of the laser system. Only those authorized
personnel who have access to the key can start the laser system. Keep the laser start key in a secure
location to prevent use by unauthorized personnel.
Emergency Laser Stop
The emergency laser stop is a dedicated override switch for immediate shut down of the system.
Standby Mode
Standby mode is designed to prevent unintentional activation of the laser. When the laser is in
standby mode the system is on, but the operator cannot activate the laser beam. When the
treatment screen is initialized, the system is in standby mode.
The system changes from Standby to Ready when the Applicator(s) are in place and in proper
contact with the skin.
Delayed Ready Mode
As required by the Center for Devices and Radiological Health of the U.S. Food and Drug
Administration and International Standards (EN60601-2-22 and EN60825-1), there is a 3-second
delay from the time Ready mode button is pressed and lasing begins. This delay, during which the
laser beeps three times, provides time for the operator to be prepared before treatment begins.
If the system detects three minutes of inactivity after entering ready mode, it will automatically
revert back to standby mode.
Automatic Shutdown Feature
When a certain type of fault occurs, the laser automatically shuts down and a fault code, message
and corrective action are displayed. For a complete list of faults and failure analysis information,
see “Troubleshooting,” starting on page 80.
Remote Interlock
Cynosureprovides a remote interlock that can connect to the doors of the laser treatment room.
When the remote interlock is active, the laser automatically shuts down if anyone enters the
treatment room. The remote interlock plug should remain in the connector if this feature is not
being used.
Audible Tone
Laser emission is indicated by a pulsed tone at the start of the period of each emission cycle during
treatment.