PB92971EN CO2RE User Manual - English - ECO-4784

System User Manual
PB92971EN
Copyright © 2017, Syneron Medical Ltd. All rights reserved.
Syneron Medical Ltd. reserves the right to make changes to its products or specifications to improve performance,
reliability, or manufacturability. Information furnished by Syneron Medical Ltd. is believed to be accurate and
reliable. However, Syneron Medical Ltd. assumes no responsibility for its use. No license is granted by its implication
or otherwise under any patent or patent rights of Syneron Medical Ltd.
No part of this document may be produced or transmitted in any form or by any means, electronic or mechanical, for
any purpose, without the express written permission of Syneron Medical Ltd.
Data is subject to change without notification.
Syneron Medical Ltd. has patents and pending patent applications, trademarks, copyrights, or other intellectual
property rights covering subject matter in this document. The furnishing of this document does not give you any
license to these patents, trademarks, copyrights, or other intellectual property rights except as expressly provided in
any written agreement from Syneron Medical Ltd.
Specifications are subject to change without notice.
Manual Catalog Part Number: PB92971EN
Revision Release Date: March 2017
● Before using the device, please check local regulations. If any local legislation is violated,
use cannot be authorized.
● In the United States, federal law restricts prescription medical devices to be sold by or on
the order of a physician, or properly licensed practitioner. Syneron-Candela makes no
representations regarding federal, state, or local laws or regulations that might apply to
the use and operation of this device.
Contact information for equipment manufacturer and technical services:

● Syneron, Inc.
3 Goodyear
Irvine, CA 92618, USA At the end of its useful life, this Syneron-
Tel: + 1.866.259.6661 (toll free) Candela system and its accessories must not be
Fax: + 1.949.716.8287 disposed of as unsorted municipal waste, but
segregated from other waste types for eventual
● CEpartner4u B.V. treatment and recovery at an approved recycling
Esdoornlaan 13 facility.
3951 DB Maarn
The Netherlands
Tel: + 31.343.442.524
Fax: + 31.343.442.162
● Syneron Medical (HK) Ltd.
Rm. 2502-03 HopeWell Centre, 183 Queen’s Road East
Wanchai, Hong Kong
Tel: +852.2543.4326
Fax: +852.2543.4327
● Syneron Medical Ltd.
P.O. Box 550
Industrial Zone, Tavor Building
Yokneam Illit 2069200
Israel
Tel: + 972.73.244.2200
Fax: + 972.73.244.2202
● Websites: www.Syneron-Candela.com
● E-mail: info@Syneron-Candela.com
User Manual
Table of Contents
CHAPTER 1: Safety and Regulatory Page
1.1. Introduction ....................................................................................................................... 1-1
1.2. Burn Hazard ...................................................................................................................... 1-1
1.3. Reflected and Direct Eye Exposure Hazard ...................................................................... 1-2
1.4. Laser Safety Eyewear ........................................................................................................ 1-2
1.5. Explosion and Fire Hazard ................................................................................................ 1-2
1.6. Electrical Safety ................................................................................................................ 1-3
1.6.1. High Voltage Hazard ............................................................................................... 1-3
1.6.2. Grounding the System ............................................................................................. 1-3
1.6.3. Using the Proper Power Receptacle and Plug ......................................................... 1-3
1.7. Safety Precautions ............................................................................................................. 1-3
1.7.1. Electrical and Mechanical Safety ............................................................................ 1-3
1.7.2. Ocular Safety ........................................................................................................... 1-4
1.7.3. Smoke Evacuation and Laser Plume Pollution Hazards ......................................... 1-4
1.7.4. Surgical Safety ........................................................................................................ 1-5
1.7.5. Operating Safety Precautions .................................................................................. 1-5
1.8. System Safety Features ..................................................................................................... 1-5
1.8.1. Keyswitch ................................................................................................................ 1-5
1.8.2. Safety Shutter .......................................................................................................... 1-5
1.8.3. Footswitch ............................................................................................................... 1-6
1.8.4. Double-Tiered Laser Emission Security ................................................................. 1-6
1.8.5. System Self-Testing ................................................................................................ 1-6
1.8.6. Emergency Shut-Off Knob...................................................................................... 1-6
1.8.7. Safety Fuses............................................................................................................. 1-6
1.8.8. Laser Beam Emission Indicators ............................................................................. 1-7
1.8.9. Remote Interlock Connector ................................................................................... 1-7
1.8.10. Fault Detection ........................................................................................................ 1-7
1.9. Compliance with International Standards ......................................................................... 1-8
1.10. Glossary of the Symbols Used in the System ................................................................... 1-9
1.11. System Labels ................................................................................................................. 1-10
CHAPTER 2: Installation Page

2.1. Introduction ............................................................................................................................ 2-1
2.2. Equipment List ....................................................................................................................... 2-1
2.3. Facility Requirements ............................................................................................................ 2-2
2.3.1. Electrical Requirements ................................................................................................ 2-2
PB92971EN TOC-1
Table of Contents User Manual
2.3.2. Space and Positioning Requirements ............................................................................ 2-3

2.3.3. Environmental Requirements ........................................................................................ 2-4
2.4. Installation .............................................................................................................................. 2-4
2.4.1. Unpacking and Inspection ............................................................................................. 2-4
2.4.2. Install the Articulated Arm ............................................................................................ 2-5
2.4.3. Connect the Lens Assembly .......................................................................................... 2-6
2.4.4. System Connections ...................................................................................................... 2-7
2.4.4.1. Power Cable Connection.................................................................................. 2-7
2.4.4.2. Footswitch Connection .................................................................................... 2-8
2.4.4.3. Remote Interlock Connection .......................................................................... 2-8
2.5. Initial System Testing............................................................................................................. 2-9
2.5.1. System Controls ............................................................................................................ 2-9
2.5.2. System Start-Up .......................................................................................................... 2-10
2.5.3. Footswitch Connection Check .................................................................................... 2-10
2.5.4. Emergency Shutoff Knob Check................................................................................. 2-11
2.5.5. Door Interlock Check .................................................................................................. 2-11
2.6. Moving the System............................................................................................................... 2-12
CHAPTER 3: System Description Page

3.1. General Laser Theory ............................................................................................................. 3-1
3.2. CO2 Laser Theory of Operation ............................................................................................. 3-2
3.3. System Description ................................................................................................................ 3-2
3.3.1. Control Panel ................................................................................................................. 3-5
3.3.2. Optical System .............................................................................................................. 3-5
3.3.3. Laser Beam Scanning System ....................................................................................... 3-6
3.3.4. External Remote Interlock System ................................................................................ 3-6
3.3.5. Footswitch ..................................................................................................................... 3-6
3.3.6. Laser Delivery Accessories ........................................................................................... 3-7
3.3.6.1. Lens Assemblies .............................................................................................. 3-7
3.3.6.2. Handpieces ....................................................................................................... 3-7
3.4. System Specifications ............................................................................................................ 3-9
3.4.1. Laser Output .................................................................................................................. 3-9
3.4.2. Delivery System .......................................................................................................... 3-11
3.4.3. Operation and Control ................................................................................................. 3-12
3.4.4. System Requirements .................................................................................................. 3-12
3.4.5. Physical Dimensions ................................................................................................... 3-13
3.4.6. Environmental Requirements ...................................................................................... 3-13
3.4.7. Classifications ............................................................................................................. 3-13
TOC-2 PB92971EN
User Manual Table of Contents
CHAPTER 4: Operating Instructions Page

4.1. Introduction ............................................................................................................................ 4-1
4.2. Before Starting the System ..................................................................................................... 4-1
4.3. Connect the Laser Delivery Accessories ................................................................................ 4-2
4.4. System Operation ................................................................................................................... 4-3
4.4.1. CO2RE Aesthetics Mode ............................................................................................... 4-3
4.4.2. CO2RE Surgical Mode .................................................................................................. 4-7
4.4.3. CO2RE Intima Mode ..................................................................................................... 4-8
4.4.4. Utilities Screen Elements ............................................................................................ 4-10
4.5. System Shut-Down ............................................................................................................... 4-11
CHAPTER 5: Maintenance Page

5.1. Introduction ............................................................................................................................ 5-1
5.2. Service Information ................................................................................................................ 5-1
5.3. Routine Maintenance.............................................................................................................. 5-1
5.3.1. Visual Inspection ........................................................................................................... 5-2
5.3.2. Cleaning the System ...................................................................................................... 5-2
5.4. Disposable Intima Handpieces ............................................................................................... 5-2
5.5. Reusable Handpiece Cleaning and Sterilization .................................................................... 5-3
5.5.1. Cleaning Procedure – Reusable Aesthetic or Surgical Handpieces .............................. 5-4
5.5.2. Sterilization Procedure – Reusable Aesthetic or Surgical Handpieces ......................... 5-5
5.5.3. Maximum Allowed Sterilization Cycles ....................................................................... 5-5
5.6. Periodic Preventive Maintenance ........................................................................................... 5-6
5.6.1. Emergency Shutoff Knob Check................................................................................... 5-6
5.6.2. Door Interlock Check .................................................................................................... 5-7
5.6.3. Laser Beam Alignment Check ...................................................................................... 5-7
5.7. Fuse Replacement .................................................................................................................. 5-9
5.8. Moving and Transporting the System .................................................................................. 5-10
5.8.1. Moving the Assembled System ................................................................................... 5-10
5.8.2. Transporting the System.............................................................................................. 5-10
CHAPTER 6: Troubleshooting Page

6.1. Introduction ............................................................................................................................ 6-1
6.2. High Voltage Warning ........................................................................................................... 6-1
6.3. Troubleshooting Guides ......................................................................................................... 6-2
PB92971EN TOC-3
APPENDIX A: Clinical Guide - Aesthetic & Surgical Applications Page

A.1. CO2 Laser: Fractional Ablative Skin Resurfacing ................................................................A-1
A.2. Indications for Use ................................................................................................................A-1
A.3. Contraindications...................................................................................................................A-1
A.4. Realistic Expectations ...........................................................................................................A-3
A.5. Test Spots ..............................................................................................................................A-3
A.6. Possible Side Effects .............................................................................................................A-4
A.7. Pre-Treatment Preparation ....................................................................................................A-4
A.8. Treatment Procedure .............................................................................................................A-5
A.9. Treatment Parameters ............................................................................................................A-7
A.10. Post-Treatment Care ............................................................................................................A-7
A.11. Follow-Up ...........................................................................................................................A-8
A.12. Treatment Conclusion .........................................................................................................A-8
APPENDIX B: Clinical Guide - Fractional Vaginal, Vulval and Introitus Treatments Page
B.1. CO2 Vulvovaginal Laser Treatment ...................................................................................... B-1
B.2. Indications for Use................................................................................................................. B-1
B.3. Contraindications ................................................................................................................... B-1
B.4. Realistic Expectations............................................................................................................ B-2
B.5. Possible Side Effects ............................................................................................................. B-3
B.6. Pre-Treatment ........................................................................................................................ B-3
B.7. Test spots ............................................................................................................................... B-4
B.8. Internal Treatment Procedure ................................................................................................ B-5
B.8.1. Internal Treatment ........................................................................................................ B-5
B.8.2. External Treatment ....................................................................................................... B-6
B.9. Treatment Parameters ............................................................................................................ B-7
B.10. Post-Treatment Care ............................................................................................................ B-7
B.11. Follow-Up ............................................................................................................................ B-8
B.12. Treatment Conclusion.......................................................................................................... B-8
B.13. After the Treatment Session ................................................................................................ B-8
C.1. Electromagnetic Emissions.................................................................................................... C-1
C.2. Electromagnetic Immunity .................................................................................................... C-2
C.3. Recommended Separation Distances..................................................................................... C-4
TOC-4 PB92971EN
User Manual Table of Contents
List of Figures
Figure 1-1: System Labels Locations .......................................................................................... 1-10
Figure 2-1: Physical Dimensions .................................................................................................. 2-3
Figure 2-2: Unpacked Articulated Arm ........................................................................................ 2-5
Figure 2-3: Articulated Arm Installation ....................................................................................... 2-5
Figure 2-4: Lens Assembly Connection ........................................................................................ 2-6
Figure 2-5: Service Panel .............................................................................................................. 2-7
Figure 2-6: Remote Interlock Connector ...................................................................................... 2-8
Figure 3-1: CO2RE Laser System ................................................................................................. 3-4
Figure 3-2: CO2RE Main Treatment Screen (sample) .................................................................. 3-5
Figure 3-3: Beam Scanning Principle (Hexagon Scan Pattern Example
with Ring 1 Ablation Spot Option) ............................................................................ 3-6
Figure 3-4: CO2RE Handpieces and Lenses.................................................................................. 3-8
Figure 4-1: Lens Assembly Connection ........................................................................................ 4-2
Figure 4-2: Handpiece Connection ............................................................................................... 4-2
Figure 4-3: Main Menu Screen – Fractional/Full Resurfacing ..................................................... 4-3
Figure 4-4: Handpiece and Lens Confirmation Screen – Fractional/Full Resurfacing ................ 4-4
Figure 4-5: Treatment Screen Elements – CO2RE Aesthetics Mode ............................................ 4-5
Figure 4-6: Treatment Screen – CO2RE Surgical Mode ............................................................... 4-7
Figure 4-7: Main Menu Screen – Intima ....................................................................................... 4-8
Figure 4-8: Handpiece and Lens Confirmation Screen – Intima External and Internal ............... 4-8
Figure 4-9: Treatment Screen – CO2RE Intima Modes (left: External / right: Internal).............. 4-9
Figure 4-10: Utilities Screen Elements ....................................................................................... 4-10
Figure 4-11: Password Entry Keypad ......................................................................................... 4-11
Figure 5-1: Laser Beam Alignment Check Results ....................................................................... 5-8
Figure 5-2: Replacing the Fuses .................................................................................................... 5-9
Figure 6-1: Sample System Error Message ................................................................................... 6-2
Figure B-1: Handpiece Rotation by 90° ........................................................................................ B-6
PB92971EN TOC-5
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TOC-6 PB92971EN
CHAPTER 1
Safety and Regulatory
1.1. Introduction
The CO2RE system is a carbon dioxide laser device operating at a
wavelength of 10,600nm. The CO2 laser delivers pulses to create a distinct
pattern of affected tissue.
The CO2RE system has been specially designed to minimize accidental

exposure to hazardous radiation.
Caution
● The CO2RE system should be operated only by a physician
trained to operate the CO2RE system. Training should be in
accordance with applicable local regulations. Please contact
Syneron-Candela for additional information regarding training.
● Improper use or adjustment of this system may invalidate the
service warranty agreement. Please contact your authorized
Syneron-Candela representative before attempting to use the
system in any manner other than those specified in this
manual.
Warning
Use of controls or adjustments, or performance of procedures
other than those specified herein may result in hazardous
radiation exposure. Therefore personnel operating or servicing this
system must be thoroughly familiar with all safety requirements
and operating procedures
1.2. Burn Hazard

CO2 laser radiation is invisible to the human eye and is capable of inflicting
third degree burns, even when unfocused.
PB92971EN 1-1
Safety and Regulatory User Manual
1.3. Reflected and Direct Eye Exposure Hazard

The laser beam emitted by the system is invisible radiation that is hazardous
to the human eye.
As a precaution against accidental exposure to the output laser beam or its

reflections, all personnel and patients must use appropriate safety eyewear.
Warning
Do not stare into the laser beam or allow it to be reflected from
any reflective surface. Even rough or black metal can reflect
laser radiation.
1.4. Laser Safety Eyewear

Laser safety eyewear is routinely required with most lasers. When using the
laser system, safety eyewear should be determined based on the Maximum
Permissible Exposure (MPE), Nominal Hazard Zone (NHZ), the Nominal
Ocular Hazard Distance (NOHD), and the optical density (OD) for each of
the available laser emissions and the configuration of the treatment room
(within the controlled area). For additional information, refer to the current
revisions of ANSI Z136.1, ANSI Z136.3, or European Standard IEC 60825.
All personnel who are within the NOHD are considered to be within the
controlled area and shall wear eye protection with a minimum optical density
(OD) of 5.0.
Laser safety eyewear must also be resistant to physical damage or photo-
bleaching resulting from laser exposure as per ANSI Z136.1. For operators
who must comply with EN 207, the safety eyewear must have a protection
class of L5.
Laser safety eyewear can be ordered from your Syneron-Candela
representative.
1.5. Explosion and Fire Hazard

This equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide. Do not operate
in the presence of volatile solvents such as alcohol or gasoline.
Flammable drapes, oxygen lines, surgical gowns, gauze and other ignitable
materials must be kept clear of the laser beam. The use of non-flammable
materials and instruments is advised. Flame retardant surgical drapes, gowns,
etc., are recommended. A readily accessible fire extinguisher in the vicinity
of the system is also recommended.
1-2 PB92971EN
User Manual Safety and Regulatory
1.6. Electrical Safety

1.6.1. High Voltage Hazard
The CO2RE system generates high electrical voltage within the main
console. To avoid injury, do not operate the system before ensuring that all
panels are properly installed. Do not remove or disassemble any panels.
1.6.2. Grounding the System
Proper grounding is essential for safe operation. The system is grounded

through the grounding conductor in the power cable. To ensure grounding
reliability always plug the power cable into a properly wired hospital grade
power receptacle.
1.6.3. Using the Proper Power Receptacle and Plug
● Use only a power receptacle and plug that are in good condition and are
specified for the system.
● Use only a hospital grade plug and a correctly matched power receptacle.
● To remove the power cable from the receptacle, hold it by the plug.
Never pull on the power cable to remove the plug from the receptacle.
1.7. Safety Precautions

1.7.1. Electrical and Mechanical Safety
● Only Syneron-Candela-authorized technical personnel may service the

system inside its protective covers. Dangerous voltages are present inside
the system.
● Maintenance should be performed by the operator only when the system

is shut down and disconnected from power. Performing maintenance
procedures with the system powered up may be hazardous to the operator
and destructive to the system.
● The system's cables are equipped with isolation coating and the
electronic circuitry is also isolated from the mains power supply. In
addition, the system’s plastic covers serve as a means of isolation.
● Do not operate the system if it has been subjected to mechanical impact.
● Never leave the system turned on or unattended during system

maintenance.
PB92971EN 1-3
1.7.2. Ocular Safety
● Guard against accidental exposure to the laser beam by ensuring that all
personnel and patients wear protective eyewear whenever the system is
in use.
● Clearly identify the room in which the laser system is located, and post
the warning sign (supplied with the system) in a visible location.
● Allow access to the treatment room only to personnel essential to the

procedure and well trained in the required safety procedures.
● Make sure that all treatment room personnel are familiar with the
system's controls and know how to shut down the system instantly.
● Do not power up the CO2RE system or connect it to the wall electrical

outlet if the articulated arm is not assembled on the system, and/or if the
footswitch is not connected to the service panel.
● Never look directly into the laser beam emitted from the articulated arm's
endjoint – with or without the lens assembly and handpiece – even when
wearing protective eyewear.
● Never direct the laser beam at anything other than the targeted treatment
site.
1.7.3. Smoke Evacuation and Laser Plume Pollution Hazards
Caution
Laser plume may contain viable tissue particulates.
● A commercial smoke evacuator designed for use with surgical lasers may
be used; these are usually most effective when the plume is extensive.
The vacuum tubing or probe used to evacuate the laser plume should not
be used to suction blood or fluids unless it is specifically designed and
set up to perform both functions simultaneously.
● Special in-line vacuum systems designed for evacuation of the laser

plume may be installed. Flow capabilities should be adequate to
effectively remove the laser plume.
1-4 PB92971EN
1.7.4. Surgical Safety
● Never use surgical accessories that have not been sterilized. Use of non-
sterilized accessories creates a potential risk of infection which may each
lead to significant medical complications.
● Do not treat patients with the CO2RE system if the aiming beam is not
coincident with the treatment beam (see Section 5.5.3).
● Do not treat patients with the CO2RE system if the aiming beam is not
operating.
1.7.5. Operating Safety Precautions
● Never leave the system in Ready mode unattended.
● Always turn off the system when it is not in use (after a 10-minute
interval of inactivity, the system automatically goes into Idle mode).
● Never allow untrained personnel to operate the system.
● Never press the footswitch without first verifying that the handpiece is
safely oriented.
1.8. System Safety Features

The CO2RE system is equipped with a diverse array of safety features. All
treatment room personnel should be familiar with the location and operation
of these safety features.
1.8.1. Keyswitch
The keyswitch ensures that unauthorized persons do not use the laser system.
When set to On the system is enabled. When set to Off the system is
disabled. To prevent unsafe and unauthorized use of the system when it is
not being used, remove the key and keep it in a secure location.
1.8.2. Safety Shutter
A spring-loaded, software driven safety shutter inside the console blocks the
laser beam. The safety shutter will open only when the system is in Ready
mode.
PB92971EN 1-5
1.8.3. Footswitch
The footswitch is the only means of emitting the CO2 laser beam, and it is
disabled except when the system is in Ready mode.
1.8.4. Double-Tiered Laser Emission Security
CO2 laser beam emission is enabled only when the system is set to Ready
mode and the operator presses the footswitch; accidental laser beam emission
may only occur due to a double error condition.
1.8.5. System Self-Testing
A self-test of the electrical circuits occurs after the system is switched on.
The test circuits continuously monitor system operation during treatment.
1.8.6. Emergency Shut-Off Knob
This red knob is designed for emergency shutdown. When pressed, it

immediately disables laser beam emission.
To release the emergency shut-off knob, turn it clockwise in the direction of

the arrows. Otherwise laser emission will remain disabled.
1.8.7. Safety Fuses
The CO2RE system is surge-protected by a pair of safety fuses that will de-
activate if the current consumption exceeds 7.1 A.
Fuse type: Littlefuse 0217005.HXP – 5x20mm.
1-6 PB92971EN
1.8.8. Laser Beam Emission Indicators
The system features two laser emission indicators: one amber LED and one
red LED located on the control panel.
The LEDs have three modes of operation:

● Flashing Amber LED – in initialization mode, before the system
transitions to Standby and Ready mode.
● Amber LED – in Standby or Ready mode, alerting the operator that
laser emission may be enabled.
● Flashing Red LED – during initialization tests (shutter closed) and
laser emission (shutter open, footswitch pressed).
There is an additional audible indicator in the form of a buzzer, that sounds

during initialization and when interlock errors occur.
1.8.9. Remote Interlock Connector
The system incorporates a safety remote interlock socket for connecting an

external interlock on the entrance door to the treatment room. The external
remote interlock, when installed, disables the system and prevents operation
when the entrance door is open.
1.8.10. Fault Detection
The CO2RE system incorporates micro-processing controllers which

constantly monitor system status. Any malfunction or deviation from
specified operating parameters resulting in an unsafe condition will cause the
laser to shut down. An error message will then be displayed on the control
panel LCD.
PB92971EN 1-7
1.9. Compliance with International Standards

The CO2RE system is designed to comply with the following standards:
● US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for

Class IV laser products
● EN 60825-1 Radiation safety of laser products
● European Medical Device Directive 93/42/EEC
● EN 60601-1 Standard for safety of medical equipment
● EN 60601-2-22 Particular requirements for the safety of diagnostic

and therapeutic laser equipment
● EN 60601-1-2 Standards for electromagnetic compatibility of

medical electrical equipment
In compliance with these standards, the system is equipped with:
● Laser emission indicators
● Output energy display
● Emergency shut-off knob
● Remote interlock connector
● Proper labeling
In accordance with the regulations, a recommended routine inspection and

maintenance schedule is provided in Chapter 5 – Maintenance.
Warning
No modifications to this equipment are allowed.
1-8 PB92971EN
1.10. Glossary of the Symbols Used in the System
Symbol Description
Refer to Instruction Manual/Booklet
Caution!
Invisible Laser Radiation Warning

Symbol
Location of Emergency Stop Button
CE Compliance Symbol
0344
CSA Compliance Symbol
Pushing Prohibited
Stepping Prohibited
Fuse
| Power On
 Power Off
Alternating Current
Storage temperature minimum &
maximum limits
Waste of Electrical and Electronic
Equipment (WEEE) compliance
symbol
RF Interference may occur in the
vicinity of equipment with the
following symbol
Type B Equipment
Manufacturer
Authorized Representative in the

European Union
PB92971EN 1-9
1.11. System Labels

Figure 1-1 displays the locations of the following labels:
1. Nameplate Label: includes the system's identification, regulatory and
electrical requirement information.
2. Laser Danger Label: warns against laser radiation hazards, and displays
the classifications and maximal output parameters of the lasers present in
the system.
Syneron Medical Ltd.

Industrial Zone, Tavor Building
Yokneam Illit, P.O. Box 550
Israel 2069200
FG70411
Z11371239
Series No: 01
100-240V~7.1A
POWER: 50-60 Hz
0344
Figure 1-1: System Labels Locations
1-10 PB92971EN
CHAPTER 2
Installation
2.1. Introduction
The CO2RE system is designed for installation in a clinical environment and
requires minimal site preparation. The customer carries out the installation
by doing the following:
● Unpack the system and position it in its pre-selected location.
● Verify the integrity of the system and its components.
Refer to the current revisions of the following standards regulating the safe
use of laser systems:
● In the USA: the American National Standards Institute (ANSI) Standard
Z136.3: Safe Use of Lasers in Health Care Facilities and Z136.1: Safe
Use of Lasers
● In Canada: the Canadian Standards Association (CSA) Standard
CAN/CSA-Z386-01: Laser Safety in Health Care Facilities
2.2. Equipment List

The CO2RE system includes the following:
● CO2RE laser system console.
● Articulated arm assembly.
● Reusable, sterilizable standard handpieces 1 (two units).
● Disposable, Hygienic Intima handpiece for internal single use.
● Disposable, Hygienic Intima handpiece for external single use
● Reusable, sterilizable surgical handpiece.
● Silver lens assembly – 150 microns spot size.
● Purple lens assembly – 150 microns spot size.
● Gold lens assembly – 120 microns spot size.
● Protective eyewear for the CO2 wavelength (10,600 nm / OD 5.0) for
the operator (two units).
● Opaque eye protectors for the patient ● Footswitch
● Remote interlock connector ● Laser danger sign
● Operator's manual ● Set of keys
● Quick-reference guide ● Power cable
1
Optional Fractional handpiece may be ordered from Syneron-Candela.
PB92971EN 2-1
Installation User Manual
2.3. Facility Requirements

Before unpacking the system, ensure that the site meets the requirements
described in the following sections.
2.3.1. Electrical Requirements
The CO2RE system incorporates a universal power supply module that

allows it to be connected to standard electrical outlets anywhere. The
system's electrical requirements are:
● 100 – 240 VAC; 7.1A; 50-60Hz; Single Phase
The electrical requirements are printed on the system's nameplate, located on

the system's rear panel.
Input power lines should be free of transients, voltage and current spikes,
sags and surges. Consequently, the system power line should not be shared
with other heavy variable loads such as elevators, air conditioning systems,
large motors, etc.
It is recommended that the system be connected to a separate power line with

separate circuit breakers. Syneron-Candela cannot guarantee performance
unless the system is connected to a dedicated circuit.
Warning
● For continued protection against fire, replace the fuse only
with one of the same type and rating.
● Proper grounding is essential for safe operation.
● Do not replace any electric part of the system except fuses.
● Only authorized Syneron technicians are qualified to service
the system.
2-2 PB92971EN
User Manual Installation
2.3.2. Space and Positioning Requirements
Space should be allocated with adequate ventilation and free air flow. The
working area for the system should be prepared according to the dimensions
shown in Figure 2-1.
Note that power cable and switch are situated on the rear panel of the system.
Ensure easy and quick access to them.
Height: 70” (177 cm)
Height: 46.1” (117 cm)
”
.3
: 17 )
pth cm
De (44
Width: 15.75” (40 cm)
Figure 2-1: Physical Dimensions
Caution
● Do not leave the console unattended on a ramp with an
incline greater than 5 degrees. Wheel locks are intended to
secure the console's location on a level floor.
● The wheel locks may not be able to maintain the position of
the console on certain surfaces. When not moving, all four
wheels should be locked.
PB92971EN 2-3
2.3.3. Environmental Requirements
Air Quality:
The system should operate in a non-corrosive atmosphere. Corrosive
materials such as acids can damage electrical wiring, electronic components
and the surfaces of optical components.
Air-borne dust particles should be kept to a minimum. Dust particles absorb

light and heat up. Hot particles located on the optical components can
damage them. Metallic dust is destructive to electrical equipment.
Temperature:
For optimal operation of the system, maintain room temperature between 10-
30ºC (59-86ºF) and relative humidity of up to 80%.
2.4. Installation
2.4.1. Unpacking and Inspection
The system has passed full quality assurance testing before shipment and
should be operational upon delivery.
Unpack the system's console, carefully lift it out of the shipping box and set
it on the floor.
Warning
● Any damage to the packaging or to the system found prior to
opening the packaging, or during unpacking and installation
of the system, should be immediately reported to Syneron-
Candela and to the insurance carrier.
● Severe damage to the system may occur if it is knocked
over or is allowed to fall. If such an occurrence happens
contact Syneron- Candela Service immediately.
2-4 PB92971EN
2.4.2. Install the Articulated Arm
Installation of the articulated arm to the console is described below. The

articulated arm's connection port is located on the system's top panel.
1. Remove the articulated arm from its packaging.
Distal Endjoint
Proximal Connector
Figure 2-2: Unpacked Articulated Arm
Refer to Figure 2-3:
2. Position the articulated arm vertically above the connection port.
3. Carefully set the proximal connector (A) into the system's connection
port (B).
4. Engage and tighten the threaded knob until it is firmly hand-tight (C).
A C
B
Figure 2-3: Articulated Arm Installation
Caution
Do not power up the CO2RE system or connect it to the wall
electrical outlet if the articulated arm is not assembled on the
system.
PB92971EN 2-5
2.4.3. Connect the Lens Assembly
Caution
The CO2RE system should be operated only with original
Syneron- Candela accessories. Attaching any other type of
accessory may damage the system and may invalidate the
service warranty agreement.
1. Remove the lens assembly from its packaging.
2. Screw the proximal end of the lens assembly (A) into the articulated
arm's endjoint (B).
A B
Figure 2-4: Lens Assembly Connection
Note
Connection of the handpiece will be discussed in Chapter 4 –
Operating Instructions.
2-6 PB92971EN
2.4.4. System Connections
The service panel is located on the lower section of the system's rear panel
and incorporates the following (see Figure 2-5):
1. Power cable connection port (see Section 2.4.4.1).
2. Main power switch.
3. Footswitch connection port (see Section 2.4.4.2).
4. Remote interlock connection (see Section 2.4.4.3).
5. Fuse housing (see chapter 5 – Maintenance).
6. Service data connection port (for service personnel).
7. Software updating expansion port (for service personnel).
8. External equipotential ground connection port.
Figure 2-5: Service Panel
2.4.4.1. Power Cable Connection
Connect the supplied power cable to its connection port in the system's
service panel (see Figure 2-5).
Connect the other side of the cable to the main power supply.
PB92971EN 2-7
2.4.4.2. Footswitch Connection
To connect the footswitch, place it on the floor, plug its connector into the
footswitch connection port located in the service panel (see Figure 2-5) and
turn the connector clockwise to lock it.
A polarizer in the port prevents incorrect connection of the cable.
Caution
Do not power up the CO2RE system or connect it to the wall electrical
outlet if the footswitch is not connected to the system.
2.4.4.3. Remote Interlock Connection
The CO2RE system is equipped with a remote interlock connector to provide

maximum safety. The connector is situated in the service panel (see
Figure 2-5). An external switch should be connected to this connector to
create a remote interlock system. This switch should be mounted at the
entrance door, so that if the door opens, the switch contacts also open and
disable system operation.
The remote interlock connection on both sides – the system's connector and
the treatment room's door – should be performed by a qualified electrician.
To connect the remote interlock (see Figure 2-6):

1. Remove the connector from the port on the system's service panel and
unscrew the connector's cover.
2. Solder the two wires from the door switch to pins 1 & 2 (short-circuited
on delivery).
3. Close the connector's cover.
4. Reconnect to the port on the system's service panel.
For further information or assistance, contact Syneron Customer Support.
Figure 2-6: Remote Interlock Connector
2-8 PB92971EN
2.5. Initial System Testing

Prior to clinical use, test out the CO2RE system to verify that the system,
including its built-in safety features, is operational.
Read the entire operating manual before turning on the system. Of particular
importance is Chapter 1 – Safety.
The CO2RE system may not be operated by any person who has not
received training from a Syneron-Candela clinical representative.
Before system testing, ensure that the laser operating area is safe and secure.
As when performing any laser procedure, flammable materials should be
moistened or beyond contact of the laser beam. All personnel should wear
protective eyewear.
The system test includes the following procedures, which should be

performed in the order indicated:
1. System Startup – see Section 2.5.2.
2. Footswitch Interlock Check – see Section 2.5.3.
3. Emergency Shutoff Knob Check – see Section 2.5.4.
4. Door Interlock Check – see Section 2.5.5.
If at any point during the test the system does not perform as described,
discontinue use and contact Customer Service.
2.5.1. System Controls
Before beginning the initial system test, familiarize yourself with the system
controls described below.
The main control panel is located at the top of the console and incorporates
the touch-screen LCD panel.
Refer to Chapter 3: for initial system testing it is important to know the

locations of the main On/Off switch, the Keyswitch, the Emergency
Shutoff Knob and the Laser Emission indicator.
PB92971EN 2-9
2.5.2. System Start-Up
1. Ensure that the emergency shutoff knob is not engaged (pressed in). If it
is, turn it clockwise until it releases and pops out.
2. Turn the keyswitch to the horizontal position; the system will be enabled.
3. Turn the system's main On/Off switch – located on the service panel (see
Figure 2-5) – to the On position; the software will initialize and the
system will perform a series of internal power-up routines. When these
have completed satisfactorily, the Treatment Menu screen will appear
on the LCD (see Chapter 4).
4. If the system does not perform as described, discontinue use and contact
Syneron-Candela Service. If the system performs as described, continue
on to the footswitch connection check (see Section 2.5.3).
Note
Attempting to start the system without turning the keyswitch will
generate an error message pop-up on the LCD. Follow the on-
screen instructions to clear the error.
2.5.3. Footswitch Connection Check
Laser beam emission is disabled when the footswitch is not connected or is

improperly connected. To check this:
1. Set the system to Ready mode.
2. Unplug the footswitch; the system should display the following error
message: Footswitch Not Connected.
3. If the system does not display the error message and remains in Ready
mode, discontinue use and contact Syneron-Candela Service.
4. If the system does display the error message, it is functioning properly.

Follow the on-screen instructions to clear the message.
2-10 PB92971EN
2.5.4. Emergency Shutoff Knob Check
The emergency shutoff knob is designed to immediately disable laser

emission when pressed. To check this:
1. While the system is on and the main Treatment screen is displayed,

press the emergency shutoff knob; the system will display the following
error message: Emergency Stop Button Set.
2. If the system does not display the error message and remains in operative

2.5.5. Door Interlock Check
Laser beam emission is disabled when the remote interlock plug is not
connected or is improperly connected to the service panel, even if it is not
wired to an actual door interlock. To check this:

unplug the remote interlock plug; the system should display the
following error message: External Remote Interlock Activated.

PB92971EN 2-11
2.6. Moving the System

To move the system within the clinic:
1. Disconnect the power cable.
2. Slowly push or pull the system using the handles built into the front and
rear panels, to the desired location. Use the same handles to lift the
system off the floor.
3. When moving the system, do not leave it unattended. The wheel locks
may not be able to maintain the position of the console on certain
surfaces. When not moving, all four wheels should be locked.
If the system is to be moved to another facility, refer to Chapter 5.
Caution
● Never push or pull the system by the articulated arm; the
system's optical alignment may be seriously impaired by
doing so.
● Do not push or pull the system by the touch-screen control
panel.
Warning
To avoid injury, do not transport on a ramp with an incline
greater than 5 degrees. Do not leave the console unattended on
a ramp with an incline greater than 5 degrees. Wheel locks are
intended to secure console location on a level floor.
2-12 PB92971EN
CHAPTER 3
System Description
3.1. General Laser Theory

LASER is the acronym for Light Amplification by Stimulated Emission of
Radiation. The laser is a device consisting of an active medium and a
pumping source, enclosed in a pump cavity. The pumping source "pumps"
the active medium from its ground energy state to an excited state. If
"population inversion" between two excited states takes place (where the
higher energy state is more populated) stimulated emission of radiation
(photons) can occur. This emission is resonated (reflected back and forth)
within the optical resonator and is amplified. A portion of this amplified
electromagnetic radiation is then emitted as a laser beam.
The main properties of the beam are:

● Monochromaticity - the radiation is within an extremely narrow
wavelength range on the spectrum.
● High degree of collimation - unidirectional beam with very small
divergence.
● Coherence - all photons are in phase, both in space and time.
The high degree of collimation and coherence enable the focusing of the
beam to small spot sizes.
The active (lasing) medium of a laser can be either gas, liquid or solid. Most
gas lasers consist of atoms, molecules, or mixtures of both. Solid-state lasers
consist of atoms or ions "doped" in some solid matrix. Liquid lasers consist
of higher molecular weight molecules dissolved in liquids.
Under specific pumping conditions, all these materials can undergo the
unnatural phenomenon of "population inversion" that results in stimulated
emission of radiation at a wavelength characteristic of the active medium.
PB92971EN 3-1
System Description User Manual
3.2. CO2 Laser Theory of Operation

The CO2RE laser generates an invisible infrared beam of light. It is designed
to deliver a concentrated energy in a small focal spot in order to vaporize
tissue.
This system incorporates a RF-excited CO2 (carbon dioxide) laser assembly.
In the CO2RE system the resonant cavity is produced by placing the active
medium, a CO2 gas mixture, between two mirrors so that the photons can
bounce back and forth. One of the mirrors is made partially transmissive and,
as the beam propagates between the mirrors, some energy is allowed to exit.
The RF (radio-frequency) power supply (pumping source) provides voltage to
the electrodes which produce an electrical discharge perpendicular to the laser
resonator. The discharged electrons collide with the CO2 molecules in the gas
mixture, and excite them to a vibrational level (an asymmetric stretching
mode).
The stimulated emission takes place between this level and a lower
vibrationally excited level (a symmetric stretching mode), resulting in laser
emission in the far infrared range at a wavelength of 10,600 nanometers.
The CO2 laser wavelength falls in the mid-infrared region of the
electromagnetic spectrum. This wavelength is invisible to the human eye.
CO2 laser energy is readily absorbed by water in tissue. Since soft tissue is
comprised primarily of water, CO2 laser energy can be used effectively for
the excision, incision, ablation, vaporization and coagulation of soft tissue.
3.3. System Description

The CO2RE is an advanced computer-controlled laser system, composed of
the following units:
● System Controls – situated on the top and front of the system's console
(see Figure 3-1), incorporating:
 Keyswitch and emergency shutoff knob.
 A liquid crystal display (LCD) with touch-screen technology.
● Interface Module – serves as an interface between the system's main

computer and modules.
● Optical Bench – the optical bench is comprised of the following series

of components:
 CO2 Laser Assembly – creates the laser beam. The laser is a sealed-
off, RF-excited CO2 laser resonator. The assembly generates a
narrow, concentrated beam of invisible infrared light at a wavelength
of 10,600 nanometers. The laser energy is released from the output of
the laser assembly to the next components of the optical bench.
3-2 PB92971EN
User Manual System Description
 Automatic Safety Shutter – a spring-loaded, software driven safety

shutter inside the console blocks the laser beam. The safety shutter
will open only when the system is in Ready mode and the footswitch
is pressed.
 Optical Detector Assembly – monitors the laser output energy by
absorbing the CO2 laser light that is reflected by the shutter mirror
during calibration mode.
 Scanner Assembly – a programmable 2-axis laser beam scanning
device that allows the physician to select the skin area coverage from
a selection of predetermined patterns in different sizes, based on the
skin area to be treated (see Section 3.3.3).
 Articulated Arm – the beam delivery articulated arm is mounted on
top of the console (see Figure 3-1).
 Lens Assemblies – see Section 3.3.6.1.
 Handpieces – see Section 3.3.6.2.
● Power Supply Modules – provide low DC voltage to the system's

electronic components and computers, and high DC voltage for laser
generation.
● Cooling System – forced air fans to ensure that the laser assembly is
kept at a constant, optimal operating temperature.
● Electronic and Software Systems – control, display, and monitor the

system; the computer:
 Translates operator commands to signals and controls.
 Controls the interface module's operation.
 Incorporates the operating system and runs the self-test routine.
 Monitors and regulates laser output energy.
 Automatically tests the system, monitors its performance, and
indicates specific malfunctions.
 Automatically disables the laser during unsafe operating conditions.
 Acts on commands from the control panel and updates the display.
PB92971EN 3-3
Articulated
Arm Assembly
Handpiece
Touch-Screen
Control Panel
Handles
System
Controls
Console
Footswitch
Figure 3-1: CO2RE Laser System
3-4 PB92971EN
3.3.1. Control Panel
The LCD control panel communicates with the system by means of an

overlaid touch-screen panel. All commands are inserted into the system by
"pressing" the appropriate "buttons" on the LCD. Figure 3-2 presents a
sample control screen; all aspects of the operating system will be discussed
in Chapter 4 of this manual: Operating Instructions.
Figure 3-2: CO2RE Main Treatment Screen (sample)
3.3.2. Optical System
The laser system consists of the following optical elements:

● An RF-exited CO2 laser assembly that is sealed-off and air cooled, all
packaged in a monolithic housing.
● A 5 mW diode aiming laser that delivers red laser light at a wavelength of
650 nanometers coaxial with the therapeutic CO2 laser. A mirror and
beam splitter couple the aiming beam into the optical path of the CO2
laser.
● An optical detector assembly that monitors the output of the CO2 laser by
absorbing the laser light energy that is reflected by the shutter mirror in
calibration mode.
● The beam conditioning assembly includes two computerized scanners to
scan the laser beam in X and Y axes (see Section 3.3.3).
● A 7-jointed articulated arm beam delivery system.
PB92971EN 3-5
3.3.3. Laser Beam Scanning System
By scanning the focused beam in both X and Y axis directions, the system
will emit pin-point laser beams adjacent to each other that form a laser spot.
The energy distribution within each spot is even.
The X and Y axis scanning enables laying down several spots to form a pre-
defined pattern, where the operator can control the distance between the
spots (fractional percentage setting), as shown in Figure 3-3:
Non-ablated
Area
Figure 3-3: Beam Scanning Principle (Hexagon Scan Pattern Example with
Ring 1 Ablation Spot Option)
3.3.4. External Remote Interlock System
The system is equipped with a remote interlock connection port, which

should be connected to an external switch to create a remote interlock
connection. The external switch should be mounted on the treatment room's
entrance door so that if the door is opened in the middle of a laser procedure,
the remote interlock will immediately disable laser beam emission, and an
External Remote Interlock Activated message will appear on the control
panel's LCD display. To resume operation, the external switch must be
closed. Follow the on-screen instructions to clear the message.
3.3.5. Footswitch
Laser emission occurs only when the footswitch is pressed. The footswitch is
enabled only when the system is in Ready mode. The footswitch is a water-
tight pedal with a metal guard, to prevent accidental activation.
3-6 PB92971EN
3.3.6. Laser Delivery Accessories
3.3.6.1. Lens Assemblies
Three color-coded lens assembles are supplied with the system (see Figure
3-4). The lens is permanently fixed inside an assembly designed to keep the
lens safe and easy to handle when connecting, disconnecting and cleaning.
● The silver lens assembly delivers a pin-point laser beam diameter of
150 microns.
● The purple lens assembly delivers a pin-point laser beam diameter of
150 microns.
● The gold lens assembly delivers a pin-point laser beam diameter of
120 microns.
The lens assemblies are designed to be used as non-sterile accessories.
3.3.6.2. Handpieces
The CO2RE system is operated with four types of handpieces (see

Figure 3-4):
● Standard handpiece: two of these are delivered with the system.
● Surgical handpiece (delivered with system): designed to be used

primarily in cutting mode (see Chapter 4). The surgical handpiece is
tapered and has a distance gauge at the end to allow the doctor to point it
accurately and see exactly where the laser energy will be delivered. This
is particularly useful for certain types of cuts, such as those around the
eyes, when the accuracy of beam placement is critical.
● Intima handpieces – Internal & External (delivered with system):

designed to be used with the Intima modality for fractional vaginal,
vulval and introitus treatments (see Appendix B). The Intima Internal
handpiece is equipped with a side-firing lens.
● Fractional handpiece (optional accessory): with a fairly wide opening at

the tip and a peg at the end of it. The wide opening allows the fractional
patterns to be projected through the handpiece and on to the treatment
site with higher visibility than the standard handpiece.
The design of the handpieces maintain the proper distance between the lens
assembly and the surface of the patient's treated site, in order to deliver
scanned patterns according to the requested energy, scan shape and size.
PB92971EN 3-7
Standard Handpiece
Surgical Handpiece
Intima Handpiece - Internal
Intima Handpiece - External
Fractional
Handpiece
(optional)
Gold Lens Assembly Silver Lens Assembly

(120 micron beam diameter) (150 micron beam diameter)
Purple Lens Assembly

(150 micron beam diameter)
Figure 3-4: CO2RE Handpieces and Lenses
3-8 PB92971EN
3.4. System Specifications

3.4.1. Laser Output
Laser Type
● CO2
Wavelength
● 10,600 nm
Laser Emission Mode

● Pulsed
Output Power
● Max. peak: 60 Watts
Laser Beam Energy

● Variable from 1 – 70 1 mJ
Pulse Repetition Rate

● Up to 16.7 kHz
Pulse Duration
● 2 – 1166 µsec
Power Stability
● ±1.5 watts (±5%)
Mode Quality (M2)

● < 1.2
Beam Size
● Ø 1.8 ±0.5 mm
Beam Divergence
● 7.5 ±0.5 mrad (full angle)
Polarization
● >100:1 linear (orthogonal to mounting pads)
1
30 – 80 mJ outside the United States
PB92971EN 3-9
Table 3-1: Operating Modes – Aesthetic and Surgical*
Energy Fluence Fractional Est. Ablation

Mode Application
Settings [mJ] [J/cm2] Density [%] Depth [µm]
CO2RE Light Light peel 30 – 60 3.3 – 7.1 30 – 50 20 – 40
Epidermal
CO2RE Mid resurfacing
46.3 – 257.6 8.2 – 24.8 20 – 40 100 – 200
Deep fractional
CO2RE Deep resurfacing 30 – 80 2 170 – 4532 1–5 500 – 750
CO2RE Mid and Deep 46.3 – 129 8.9 – 24.8 100 – 200
20 – 40
Fusion modes combined 30 – 802 170 – 4532 500 – 750
Full thickness
Classic resurfacing
1 – 10 5.6 – 56.4 100 100 – 200
0.2 mm x
Incision and selected line length
Surgical excision of lesions
5 – 40 28.1 – 226 N/A
0.2 mm2 freehand
5-15W
(*) The energy settings for Light and Mid modes (30-60 mJ and 46.3-257.6 mJ,
respectively) are provided per ablated spot (and are shown on the control panel), while the
energy settings for Deep mode (50-70 mJ) are provided per pin point (per pixel).
Caution
Proceed with caution when performing advanced off-the-face
treatments, reduce parameters accordingly.
Table 3-2: Operating Modes – Intima
Handpiece Energy Fractional

Mode Application Pattern
Type Settings [mJ] Density [%]
Intima Treatment to the vaginal
CO2RE Deep 30 – 55 Square 3–5
Internal canal (Internal)
Light Fractional
CO2RE Light 30 – 60 Any 30 – 50
Resurfacing (External)
Mid Fractional
CO2RE Mid 60 – 90 Any 20 – 40
Intima Resurfacing (External)
External Deep Fractional
CO2RE Deep 50 – 802 Any 1–5
CO2RE Mid and Deep Combined 60 – 90
Any 50 – 40
Fusion (External) 50 – 802
2
70 mJ / 170 – 396 J/cm2 in the United States
3-10 PB92971EN
Scanned Pattern Shapes

● Fractionated patterns for Light, Mid, Deep & Fusion modes:
 Hexagon
 Square
 Rectangle
 Triangle
 Ring
● Non-fractionated patterns for Classic mode (shallow):
 Square
 Rectangle
 Circle
● Cutting patterns for Surgical mode (deep):
 Square / Rectangle
 Circle
 Line
 Freehand
Maximum Scan Area

● 10 mm diameter
Aiming Laser
● 5mW, 650nm (red) diode laser
3.4.2. Delivery System
Articulated Arm
● Lightweight, aluminum fiber, 7-joint, pneumatically balanced
● Treatment radius at full arm extension: 85 cm / 33.5 inches
● Horizontal rotation: 360°
Lens Assemblies
● Silver 150 µm spot size
● Purple 150 µm spot size
● Gold 120 µm spot size
PB92971EN 3-11
Handpieces
● Standard Fractional
● Intima – Internal and External
● Surgical
● Short Fractional (optional)
3.4.3. Operation and Control
User Interface
● 10.4", high-resolution, color liquid crystal display (LCD)
● Touch-screen technology
System Turn-On
● On/Off switch on service panel
● Keyswitch on front panel
● Password-protected access
System Turn-Off
● Keyswitch on front panel

● On/Off switch on service panel
● Emergency shutoff knob (for emergency situations only)
Laser Emission Control

● Footswitch
Laser Emission Indicators

● Solid amber LED in Standby and Ready modes
● Flashing red LED during laser emission
3.4.4. System Requirements
Electrical Requirements
● 100-240 VAC self-sensing, 50-60 Hz, 7.1 A, single phase
3-12 PB92971EN
3.4.5. Physical Dimensions
Dimensions
● Width: 15.75" (40 cm)
● Depth: 17.3" (44 cm)
● Height at top of control panel: 46.1" (117 cm)
● Height at top of articulated arm: 70" (177 cm)
Weight
● 58 Lbs. (26 Kg)
3.4.6. Environmental Requirements
Treatment Room
● Temperature: 15 – 30°C [59 – 86°F]
● Relative humidity: Up to 80%
● Atmospheric pressure range: 70 – 106 kPa
Storage/Transportation
● Temperature: 10 – 55°C [50 – 131°F]
● Relative humidity: 10 – 80%
● Atmospheric pressure range: 70 – 106 kPa
Degree of Protection Against Ingress of Water

● IPX0 – Ordinary Equipment
3.4.7. Classifications
Type of protection against electrical shock

● Class I Equipment
Degree of protection against electrical shock

● Type B Equipment
Electromagnetic Compatibility
● Class A
Laser Classification
● Class IV
PB92971EN 3-13
● The CO2RE system is classified as a IIb device defined by the

Medical Device Directive (93/42/EEC) for CE marking [Amended by
2007/47/EC].
3-14 PB92971EN
CHAPTER 4
Operating Instructions
4.1. Introduction
This chapter describes in detail the operating instructions for the CO2RE laser
system.
Detailed clinical treatment information may be found in Appendix A of this

manual – Clinical Guide. This chapter concerns itself mainly with the
operation of the laser system.
Warning
● Use of controls or adjustments, or performance of procedures
other than those specified herein may result in hazardous
radiation exposure.
● Do not operate the system without first familiarizing yourself with
all sections of this manual. Special attention should be paid to the
safety precautions in Chapter 1.
● CO2 laser radiation is invisible to the human eye and is capable of
inflicting third degree burns, of igniting flammable materials and of
being reflected by metallic and other reflecting objects.
● A sign warning of the danger of laser radiation should be placed
at the entrance to the treatment room whenever the laser is used.
● Everyone in the treatment room should wear protective eyewear.
● Never treat patients with the CO2RE system if the aiming beam is
not operating.
4.2. Before Starting the System

Verify that:
1. The footswitch is connected to its port in the system's service panel,
before the system is plugged into the power outlet.
2. The articulated arm is assembled on the system.
3. The system is plugged into an appropriate power outlet.
4. The emergency shut-off knob is not engaged. If it is, turn to release it.
5. The remote safety interlock plug is connected to its port in the system's
service panel.
6. The patient, surgeon and all other personnel in the room are wearing
safety eyewear.
PB92971EN 4-1
Operating Instructions User Manual
4.3. Connect the Laser Delivery Accessories

Two accessories must be connected to the articulated arm's endjoint:
● The lens assembly
● The handpiece
1. Perform a visual inspection of the handpiece before use.
2. Refer to Figure 4-1: connect the lens assembly to the articulated arm's
endjoint by screwing the proximal end of the lens assembly (A) into the
articulated arm's endjoint (B).
A B
Figure 4-1: Lens Assembly Connection
3. Refer to Figure 4-2: prepare the handpiece and connect it to the lens
assembly by screwing the proximal end of the handpiece (A) onto the
lens assembly (B).
B
A
Figure 4-2: Handpiece Connection
Warning
● Connection of the laser accessories not according to these
instructions can cause injury.
● Inspect the handpiece prior to use for any damage following
sterilization. Do not use handpiece if any corrosion, warping, or
corruption of the metal surface is evident.
4-2 PB92971EN
User Manual Operating Instructions
4.4. System Operation

1. Turn the keyswitch on the system's front panel to the horizontal position;
the system will be enabled.
2. Turn the system's main On/Off switch – located on the service panel – to
the On position; the software will initialize and the system will perform a
series of internal power-up routines.
3. Upon turn-on, a self-test routine starts that checks out the system. During
this time the laser system will automatically run an initialization process
of its components which takes approximately one minute to complete. If
a fault is detected, the system issues an appropriate error message (see
Chapter 6). Once the system satisfactorily completes the self-test routine,
it is ready for operation.
4. After the self-test routines are complete the system will display the Main
Menu screen (see Figure 4-3). Select the CO2RE mode of operation –
CO2RE Aesthetics, CO2RE Surgical or CO2RE Intima – by pressing
the appropriate button on the left side of the screen; the selected mode's
button becomes colored.
4.4.1. CO2RE Aesthetics Mode
If you selected CO2RE Aesthetics the Resurfacing menu will appear on the
right side of the screen, where you may select the desired treatment mode by
pressing the appropriate button: Light, Mid, Deep, Fusion or Classic.
Figure 4-3: Main Menu Screen – Fractional/Full Resurfacing
PB92971EN 4-3
● The following table displays the available energy settings, fractional

percentage and estimated depth ablation of the CO2RE system's fractional
and full resurfacing treatment modalities:
Table 4-1: Available Parameters per Treatment Mode
Handpiece Energy Fractional

Mode Application Pattern
Type Settings [mJ] Density [%]
Intima / Treatment to the vaginal
CO2RE Deep 30 – 55 Square 3–5
Internal canal (Internal)
Light Fractional
Fractional CO2RE Light
30 – 60 Any 30 – 50
Mid Fractional
Fractional CO2RE Mid
60 – 90 Any 20 – 40
Deep Fractional
Fractional CO2RE Deep 50 – 802 Any 1–5
CO2RE Mid and Deep Combined 60 – 90
Fractional Any 50 – 40
Fusion (External) 50 – 802
Caution
● After you have selected the desired CO2RE treatment mode the
Handpiece and Lens Confirmation screen will appear (see Figure 4-4).
Figure 4-4: Handpiece and Lens Confirmation Screen –

Fractional/Full Resurfacing
4-4 PB92971EN
● Press the  button to confirm that the displayed Fractional/Full

Resurfacing handpiece and 150 µm lens are connected to the system's
articulated arm; the Main Treatment screen will appear (see Figure 4-5).
Figure 4-5 presents the main Treatment screen. The numbered tags in the
illustration correspond to the following numbered explanations and
definitions of the screens elements:
1. Treatment Mode Selector – the default mode when accessing this screen
is the one selected in the Treatment Menu screen (see Figure 4-3); note
the Fusion button in Figure 4-5 as an example. To change the mode press
any of the other mode buttons. To change to Classic or Surgical mode
you will have to go back to the Treatment Menu screen by pressing the
Home button.
2. Pattern Shape Selector – press the appropriate button to select the
desired scanned pattern shape; the pressed button will change color to
express its being selected.
The selectable shapes are: Hexagon (), Square (■), Rectangle ( ),

Triangle (▲) and Ring ().
3. Repeat Mode On/Off Toggle – when toggled to On, the system will
emit laser pulses repeatedly for as long as the footswitch is pressed at the
rate selected in the Repeat (seconds) selector (see # 9 below).
4. Random Mode On/Off Toggle:
● When toggled to On, the laser pixels are applied in a randomized
manner until the entire pattern is completed.
● When toggled to Off, the laser pixels are applied in a logical sequence
until the entire pattern is completed.
11 10
13
6 1
4
8
3
2
15
5
16
14
9
12
Figure 4-5: Treatment Screen Elements – CO2RE Aesthetics Mode
PB92971EN 4-5
5. Output Energy – press the + or – buttons to increase or decrease the

CO2 energy level output (in milliJoules) to the patient's skin. Set the
energy for:
● Ring of the scanned pattern – CO2RE Light, CO2RE Mid and
CO2RE Fusion modes.
● Core of the scanned pattern – CO2RE Deep and CO2RE Fusion
modes.
6. Pattern Size Selector – press the + or – buttons to increase or decrease
the size of the scanned pattern.
7. Fractional Coverage Selector – press the + or – buttons to increase or
decrease the fractional coverage to the desired value within the range
available for the selected mode (see Table 4-1).
8. Ring Size Selector – press the + or – buttons to increase or decrease the
size of the scanned ring (in CO2RE Light and CO2RE Mid modes).
9. Repeat – press the + or – buttons to increase or decrease the time
interval between scanned patterns while the footswitch is continuously
pressed (see # 3 above).
10. Scanned Pattern Preview – displays a graphic preview of how the
scanned pattern will appear given the selected parameters.
11. Tissue Effect Illustration: displays the relative depth of the CO2 energy
penetration into the skin and spot size, changes for each treatment mode.
12. Home – pressing the Home button will return the system to the Main
Menu screen (see Figure 4-3).
13. Standby and Ready Buttons – press the Ready button to set the system
to Ready mode; CO2 energy pulses will be emitted through the
handpiece when the footswitch is pressed. Press the Standby button to
set the system back to Standby mode. When the system is in Ready
mode, pressing any other button will automatically return the system to
Standby mode.
14. Help – press this button to access the CO2RE system software's help
module.
15. Ring Fluence J/cm2 – displays the system-calculated fluence of the ring
of a single pattern delivered to the treatment site.
16. Core Fluence J/cm2 – displays the system-calculated fluence of the core
of a single pattern delivered to the treatment site.
4-6 PB92971EN
4.4.2. CO2RE Surgical Mode
If you selected CO2RE Surgical on the Main Menu screen (see Figure 4-3)
the screen will transition to a Lens Selection screen. Press the return-arrow
button to toggle and select the 120 µm or 150 µm lens, and then press the 
button to confirm that the displayed Surgical handpiece and selected lens are
connected to the system's articulated arm; the Main Treatment screen will
appear (see Figure 4-6).
The CO2RE Surgical mode is operated basically in the same manner as the
CO2RE Aesthetics mode, but with only the parameter options appropriate
for surgical mode: Pattern Size, output energy (Core mJ) and Repeat.
The selectable shapes are: Square (■), Line ( ), Ring () and
Freehand ( ).
The available operating parameters are:

● Energy Core (Square, Line & Ring 5 – 40 mJ
Shapes):
● Core Fluence: 28.1 – 226 J/cm2
● Power (Freehand Shape Only): 5 – 15 Watts
● Estimated Ablation Depth: 0.2 mm
Figure 4-6: Treatment Screen – CO2RE Surgical Mode
PB92971EN 4-7
4.4.3. CO2RE Intima Mode
If you selected CO2RE Intima the Women's Intimate Wellness menu will
appear on the right side of the screen, where you may select the desired
treatment mode by pressing the appropriate button: Internal or External.
Figure 4-7: Main Menu Screen – Intima
Refer to Figure 4-8: press the return-arrow button to toggle and select the
External or Internal modes, confirm that you have the correct handpiece and
lens assembly connected to the system (as shown in the selected mode) and
then press the  button to finalize the selection; the External or Internal
Intima Treatment screen will appear (see Figure 4-9).
Figure 4-8: Handpiece and Lens Confirmation Screen –

Intima External and Internal
4-8 PB92971EN
The CO2RE Intima mode is operated basically in the same manner as the
CO2RE Aesthetics mode, but with only the parameter options appropriate
for the Intima modes: Pattern Size, fractional coverage, output energy
(Core mJ) and Repeat.
The selectable shapes are: Hexagon (), Square (■), Rectangle ( ),

Triangle (▲) and Ring ().
The available operating parameters are:

Energy Fractional
Handpiece Type Application Pattern
Settings [mJ] Density [%]
Treatment to the vaginal canal
Intima Internal (Internal)
30 – 55 Square 3–5
Light Fractional Resurfacing

30 – 60 Any 30 – 50
(External)
Mid Fractional Resurfacing
60 – 90 Any 20 – 40
(External)
Intima External
Deep Fractional Resurfacing
50 – 802 Any 1–5
(External)
Mid and Deep Combined 60 – 90
Any 50 – 40
(External) 50 – 802
Figure 4-9: Treatment Screen – CO2RE Intima Modes

(left: External / right: Internal)
PB92971EN 4-9
4.4.4. Utilities Screen Elements
The Utilities screen may be accessed by pressing the Utilities button on the
Main Menu screen (see Figure 4-3).
The numbered tags in the illustration correspond to the following numbered

explanations and definitions of the screen's elements:
1. Update Firmware – Operating this option should be done only under the
direct advice of a Syneron-Candela service representative. This requires
the use of the system's administrator password (see Figure 4-11).
2. Factory Settings – this area of the software is designed for the exclusive
use of Syneron-Candela-qualified service personnel, and is protected by a
proprietary service password.
3. Reset Parameters – pressing this button reset all of the system's

operating parameters back to the default levels set by the factory. This
option requires the use of the system's administrator password.
4. License – press this button to access the operating license code input
screen (consult with your Syneron distributor).
5. Backlight – press the + or – buttons to increase or decrease the

brightness level of the LCD.
6. Aim Beam Intensity – press the + or – buttons to increase or decrease

the brightness level of the red aiming beam.
5
1
6 2
7 8
Figure 4-10: Utilities Screen Elements
4-10 PB92971EN
7. Machine Information – when discussing the system with service

personnel, you may be requested to read the information in this area to
them. Pressing the More button cycles through additional pages of
information that may help the service personnel in assisting you in the
event of a service problem.
8. Home – press the Home button to return to the Treatment Menu screen
(see Figure 4-3).
Figure 4-11: Password Entry Keypad
4.5. System Shut-Down

1. Turn off the main On/Off switch in the service panel.
2. Turn off and remove the key from the keyswitch, and store it in a secure
location to prevent unauthorized use of the laser system.
PB92971EN 4-11
THIS PAGE LEFT BLANK INTENTIONALLY
4-12 PB92971EN
CHAPTER 5
Maintenance
5.1. Introduction
This chapter contains the maintenance instructions for the CO2RE laser
system. Routine maintenance may be performed by clinic staff unless
otherwise specified. Any maintenance procedure not mentioned in this
chapter must be performed only by Syneron-Candela authorized technical
personnel.
The system is designed to operate reliably without the need for operator
maintenance. However, the outer surfaces of the system should be kept clean
for medical reasons (see Section 5.3.2.).
5.2. Service Information

In communications with authorized Syneron-Candela representatives
regarding the system, always include the serial and part numbers from the
nameplate, located on the rear side of the system (see Chapter 1).
Questions or problems should be referred to your Syneron-Candela

representative.
Warning
● Unauthorized servicing or modification of this system, not
described in this manual, may expose the operator/patient to
potential electrical and laser radiation hazards.
● Improper use or adjustment of this system may invalidate the
service warranty agreement.
5.3. Routine Maintenance
Warning
● The CO2RE system generates high voltages and laser energy
radiation.
● The interior of the system may be serviced only by Syneron-
Candela authorized technical personnel.
PB92971EN 5-1
Maintenance User Manual
5.3.1. Visual Inspection
The exterior of the system should be inspected once a week to ensure that
there are no loose cable connections, that there is no damage to the system
and that the touch-screen panel is intact. Contact Syneron-Candela Service if
any damage is found.
5.3.2. Cleaning the System
The external surfaces of the system (console and articulated arm) and the
footswitch should be cleaned when the system is received, and thereafter as
required by the facility's cleaning protocol.
The outer surfaces of the system and the lens assembly may be wiped clean
with a soft, lint-free cloth dipped in 70% isopropyl alcohol, or a hospital-
grade disinfectant solution such as Cidex * or equivalent.
The optical lens housed in the lens assembly may be cleaned with a soft, lint-
free cloth dipped in 99% isopropyl alcohol, or hospital-grade acetone.
Visually inspect the outer surfaces of the system and the lens to verify that it
is completely free of soil and there are no signs of degradation (e.g.
discoloration, pitting or cracked seals).
Caution
Do not allow the lens to come into contact with water or any water-
based product; dry water stains can become hot-spots during laser
emission, damaging the lens' optical coating.
5.4. Disposable Intima Handpieces

● The disposable Intima handpieces are designed for single-use only.
● The handpiece must be cleaned with soap and water to remove the bulk
of extraneous material.
● The handpiece should then be wiped with an alcohol wipe (70% alcohol)
or soaked for two minutes in sodium hypochlorite at 500 ppm,
OR:
● The handpiece should be immersed for 15 minutes in 70% alcohol.
*
Cidex® is a product of ASP®, a Johnson & Johnson company.
5-2 PB92971EN
User Manual Maintenance
● The handpiece should be completely air-dried (electronic compressed air

dust off tool may be used).
● Make sure all alcohol has been evaporated before use.
● The operator must wear disposable (non-sterile) gloves when positioning

the labia during passage of the probe.
● At completion of the procedure, gloves should be discarded and hands

washed thoroughly with soap and water.
● Discard the disposable Intima handpiece after a single use after

treatment.
5.5. Reusable Handpiece Cleaning and Sterilization
Warning
● Never use a handpiece that has not been cleaned and

disinfected. Use of unclean handpiece creates a potential risk
of infection which may lead to significant medical
complications.
● Do Not Reuse: reuse of a disposable Intima handpiece
creates a potential risk of infection which may each lead to
significant medical complications, and may damage the
handpiece as well.
● Do Not Use Wet Handpiece: never use a handpiece that has
not been completely air dried following cleaning.
Caution
The following cleaning and sterilization instructions are designed
for the CO2RE reusable aesthetic or surgical handpieces.
PB92971EN 5-3
5.5.1. Cleaning Procedure – Reusable Aesthetic or Surgical Handpieces
Caution
Always clean the handpiece immediately after use before stains
dry.
1. Disassemble the handpiece.
2. Remove visible debris by soaking the reusable aesthetic or surgical

handpieces for ten minutes in a poly-enzymatic detergent (i.e. Enzol †)
solution, mixed according to the manufacturer's recommendations.
3. Use a cloth to rub exterior surfaces.
4. Use brush to clean the inner lumen of the handpiece.
5. Rinse well under running water, holding the handpiece such that the
water runs through it.
6. Completely immerse the handpiece in 70% isopropyl alcohol for ten

minutes. While soaking:
● Use a cloth to rub exterior surfaces.
● Vigorously move the handpiece inside the alcohol bowl such that
the alcohol will run through it.
7. Allow the handpiece to air-dry until all alcohol has evaporated.
†
Enzol® Enzymatic Detergent is a product of ASP®, a Johnson & Johnson company.
5-4 PB92971EN
5.5.2. Sterilization Procedure – Reusable Aesthetic or Surgical Handpieces
Caution
Do not use flash sterilization - this may damage the handpiece
surfaces.
Warning
Ensure that all steam sterilization vessels are valid before use.
1. Start the sterilization process only after (and immediately after)

completing the cleaning procedure of the reusable aesthetic or surgical
handpieces as described in Section 5.5.1 above.
2. Place the handpiece in an autoclave pouch, and put the pouch in the
autoclave.
3. Sterilize the handpiece in a gravity displacement, steam autoclave

according to the parameters in the table below.
4. Remove the handpiece from the autoclave and allow it to cool to room
temperature.
5. Store the handpiece in a clean environment. If the sterile pouch has been
compromised in any way, re-sterilize just prior to use in order to
minimize the chance of contamination.
Form of Autoclave: Steam autoclave

Sterilizer Type: Gravity displacement
Method: Wrapped
Minimum Exposure Time: 60 minutes
Minimum Drying Time: 45 minutes
Temperature: 250°F / 121°C
Pressure: ~ 1.5 Bar / 22 PSI
5.5.3. Maximum Allowed Sterilization Cycles
The CO2RE handpiece parts are allowed to be subjected to no more than ten
sterilization cycles. After the tenth use the handpiece must be properly
discarded.
PB92971EN 5-5
5.6. Periodic Preventive Maintenance

The system should be inspected annually and maintained by Syneron-
Candela to keep it in peak operating condition.
During the periodic service the system's protective panels must be opened.
Therefore, this is performed only by Syneron-Candela service personnel.
Table 5-1: Recommended Routine Inspection and Maintenance Schedule
Inspection / Service Frequency Performed by

Lens assembly cleaning After each procedure Clinic Staff
Routine external cleaning and
As required by clinic protocol Clinic Staff
disinfection
Inspect cables and all external
Weekly Clinic Staff
surfaces for damage
Inspect electrical connections Weekly Clinic Staff
Check emergency stop switch Weekly (see Section 5.6.1) Clinic Staff
Check door interlock Weekly (see Section 5.6.2) Clinic Staff
Laser beam alignment check Weekly (see Section 5.6.3) Clinic Staff
Annually (or as required by
Electrical safety checks Syneron-Candela Service
institutional procedures)
Check cooling system Annually Syneron-Candela Service
Annually, or as required if system
Check and perform power meter
does not perform to specifications, or Syneron-Candela Service
calibration procedures
occurrence of error messages.
5.6.1. Emergency Shutoff Knob Check
The emergency shutoff knob is designed to immediately disable laser

emission when pressed. To check this:
press the emergency shutoff knob; the system will display the following
error message: Emergency Stop Button Set.

5-6 PB92971EN
5.6.2. Door Interlock Check
Laser beam emission is disabled when the door interlock plug is not
connected or is improperly connected to the service panel, even if it is not
wired to an actual door interlock. To check this:

unplug the remote interlock plug; the system should display the
following error message: External Remote Interlock Activated.
5.6.3. Laser Beam Alignment Check
Warning
Laser beam alignment checks are extremely important for the safe
operation of your laser equipment. Do not use the laser if aiming
and treatment beams are not coincident; contact Syneron-Candela
service immediately. Misalignment of aiming and treatment beams
may result in laser exposure to non-target tissues and possible
injury.
Perform the beam alignment check as follows:
1. Verify that all persons in the treatment room are wearing appropriate
laser safety eyewear.
2. Mark an “X” on a wooden tongue depressor and moisten with water.
3. Turn on the laser system.
4. Set the laser's operating parameters as follows:

● Laser mode: CO2RE Light
● Pattern shape: Ring
● Output energy: 30 mJ (Lowest available)
● Size: 4 x 10 (Largest available)
● Fractional density: 50% (Max.)
5. Press the Ready button to set the laser to Ready mode.
6. Position the distal end of the handpiece's tip on the tongue depressor in a
perpendicular orientation.
PB92971EN 5-7
7. Direct the aiming beam at the center of the “X,” and press the laser
footswitch. Observe the burned pattern on the tongue depressor; it
should appear sharp and non-diffused.
8. Verify that the burn spot lies within the area of the aiming beam's red
outline (see Figure 5-1).
Aiming Beam Burn Pattern: Burn Pattern: Burn Pattern:

Pattern Perfect Alignment Acceptable Alignment Unacceptable Alignment
Figure 5-1: Laser Beam Alignment Check Results
9. If the burn is not within the aiming beam, if the burn is unacceptable, or
if the aiming beam is not visible:
● Verify that the lens assembly is securely attached to the articulated
arm.
● It may be helpful to move the articulated arm or rotate the articulated
arm knuckles closest to the endjoint. Sometimes changing the
orientation of the articulated arm knuckles can affect aiming beam
transmission, particularly if the articulated arm is extended or moved
during a procedure.
● If the brightness of the aiming beam fluctuates greatly or if the
aiming beam is not visible, contact Syneron-Candela Service.
10. Repeat the beam alignment procedure. If the beam alignment is still
unacceptable, contact Syneron-Candela Service.
11. Press the Standby button to set the laser to Standby mode until ready for
use.
5-8 PB92971EN
5.7. Fuse Replacement

To replace burnt fuses:
1. Turn off the system and disconnect the power cable from the outlet.
2. Unplug the power cable from the connection port on the service panel.
3. Remove the fuse housing as shown in Figure 5-2.
4. Remove the burnt fuses from the housing and replace them with the new
ones.
5. Make sure that the fuses fit snugly within the fuse housing.
6. Insert the fuse housing into its receptacle and push it in until it snaps into
place.
7. Connect the power cable to the system and to the mains outlet.
8. Turn on the system and verify that it is functioning properly.
Figure 5-2: Replacing the Fuses
Caution
● Make sure that the type and rating of the new fuses and the
replaced fuses match.
● Always replace both fuses at the same time.
PB92971EN 5-9
5.8. Moving and Transporting the System

5.8.1. Moving the Assembled System
The CO2RE laser system can easily be moved between rooms in a medical
practice by rolling the console on the base-mounted wheels using the top-
and bottom-mounted maneuvering handles. Disconnect the footswitch and
power cable prior to moving the system between rooms.
5.8.2. Transporting the System
Prepare the system for transport as follows:
1. Unplug the system from the wall outlet.
2. Disconnect the power cable from the service panel.
3. Disconnect the footswitch from the service panel.
4. Disconnect the articulated arm from the system (see Chapter 2).
5. When moving the system, do not leave it unattended. The wheel locks
may not be able to maintain the position of the console on certain
surfaces. When not moving, all four wheels should be locked.
6. Consult Syneron-Candela Service for shipping advice.
Caution
Do not ship the system without the factory packaging materials.
Doing so may result in damage to the components during shipping
and void the warranty. Contact Syneron-Candela if packaging
materials or repacking instructions are required.
Warning
To avoid injury, do not transport on a ramp with an incline greater
than 5 degrees. Do not leave the console unattended on a ramp
with an incline greater than 5 degrees. Wheel locks are intended to
secure console location on a level floor.
5-10 PB92971EN
CHAPTER 6
Troubleshooting
6.1. Introduction
The CO2RE laser system is equipped with self-testing software that
continuously monitors system operation. If a system malfunction is detected,
an error message will appear on the LCD display screen. Should a
malfunction occur, consult the troubleshooting guides in Table 6-1 and
Table 6-2.
Do not attempt to open or disassemble the system's covers.
Caution
Improper use or adjustment of this system may invalidate the
service warranty agreement. Please contact your authorized
Syneron-Candela representative before attempting to troubleshoot
this system in any manner other than those specified in this
manual.
6.2. High Voltage Warning
Warning
The system generates high electrical voltage and laser radiation in
the main cabinet and laser aperture. Only Syneron-Candela-
authorized technical personnel are qualified to service the interior
of the system.
PB92971EN 6-1
Troubleshooting User Manual
6.3. Troubleshooting Guides

Table 6-1 provides a list of system error messages that may appear on the
LCD panel during laser operations, probable causes and recommended
actions that may be performed by the facility's staff. If the problem is not
resolved, contact Syneron-Candela Service.
A system error message will be displayed on the control panel's LCD screen
as a popup, shown in the sample in Figure 6-1:
Figure 6-1: Sample System Error Message
Table 6-2 lists some possible symptoms that indicate malfunctions that do
not appear on the LCD panel. If the corrective action listed in the table does
not solve the problem, contact Syneron-Candela Service.
The following troubleshooting tables do not attempt to list all possible

system errors. Any issue not listed in the troubleshooting tables should be
referred to Syneron-Candela Service.
6-2 PB92971EN
User Manual Troubleshooting
Table 6-1: System Error Troubleshooting Guide
Error Message Probable Cause Recommended Actions

1. Restart the system.
Key Lock Not System operation attempted without
Turned On turning the keyswitch. 2. If the problem persists, contact
Syneron-Candela Service.
1. Turn the emergency shutoff knob
to disengage, and restart the
Emergency Stop System operation attempted while system.
Button Set emergency shutoff knob is engaged.
2. If the problem persists, contact
1. Release the footswitch and make
Change of laser mode or operating the desired change; re-enter
Activated Footswitch parameter attempted while the Ready mode.
footswitch is pressed. 2. If the problem persists, contact
1. Check the footswitch connection
System operation attempted while the to the service panel; resume
Footswitch Not footswitch is not connected or is normal operation.
Connected improperly connected to the service
panel. 2. If the problem persists, contact
1. Allow the system to cool to room
temperature and resume normal
The temperature inside the laser operation.
System Overheating console has reached a high level of 2. Lower the ambient temperature in
120 °F/50 ° C . the treatment room.
Syneron-Candela Service,
1. Allow the system to cool to room
temperature and resume normal
The temperature inside the laser operation.
console has reached a critical level of
System Overheated 2. Lower the ambient temperature in
140 °F/60 ° C ; the laser has shut the treatment room.
down.
1. Check and ensure that the
interlock plug is connected to the
Remote interlock plug is disconnected service panel.
External Remote from the service panel, or the 2. Check and ensure that the
Interlock Activated interlocked treatment room door is treatment room door – if
open. interlocked – is closed.
Shutter Error Internal safety hardware malfunction. 2. If the problem persists, contact
PB92971EN 6-3
Troubleshooting User Manual
Table 6-1: System Error Troubleshooting Guide (continued)
Error Message Probable Cause Recommended Actions

Laser Power Error CO2 Laser assembly malfunction. 2. If the problem persists, contact
Aiming Beam Error Diode aiming laser malfunction. 2. If the problem persists, contact
Table 6-2: Undisplayed System Malfunctions Troubleshooting Guide
Symptom Probable Cause Action

1. Emergency shut-off knob is 1. Turn the knob to release it and
engaged. restart system.
2. No AC power from wall outlet. 2. Check if AC power is available
System does not from wall outlet, and power cable
operate when plugged is properly plugged into AC outlet.
in and turned on.
3. Tripped circuit breaker (clinic 3. Reset circuit breaker.
power supply).
4. Burnt system fuse(s). 4. Replace fuses (see Chapter 5).
Keyswitch is stuck in
Keyswitch malfunction. Contact Syneron-Candela Service.
On or Off position
1. Optical lens in lens assembly is 1. Clean optical lens.
damaged or dirty.
Treatment laser is less
2. Optical alignment is deficient. 2. Contact Syneron-Candela
effective than it should
3. Laser malfunction. Service.
be.
3. Contact Syneron-Candela
Service.
1. System is not in Ready mode. 1. Set system to Ready mode.
Laser emission does
2. Footswitch malfunction. 2. Turn system off and contact
not occur when
footswitch is pressed.
3. Laser malfunction. 3. Contact Syneron-Candela Service
1. Optical lens in lens assembly is 1. Clean optical lens.
Aiming beam is weak damaged or dirty.
or not available. 2. Aiming beam diode laser or 2. Contact Syneron-Candela
power supply malfunction. Service.
1. Recalibrate touch-screen (see
System not 1. Touch-screen out of calibration.
Chapter 4).
responding to control
panel commands 2. Contact Syneron-Candela
2. Touch-screen malfunction.
Service.
Laser emission
Discontinue use of the system and
indicator does not Burnt LED.
contact Syneron-Candela Service.
flash in Ready mode.
6-4 PB92971EN
APPENDIX A
Clinical Guide
Aesthetic & Surgical Applications
A.1. CO2 Laser: Fractional Ablative Skin Resurfacing

This chapter provides you with the information required for Fractional
Ablative Resurfacing using the CO2RE laser system. The 10,600nm laser
energy is conducted via an articulated arm equipped with a series of folding
mirrors, and is delivered to the target tissue after being scanned by a double-
axis scanner into a pattern of pre-determined shape, size, depth and applied
energy.
A.2. Indications for Use

The CO2RE system is indicated for use in the performance of dermatological
procedures requiring ablation, coagulation and resurfacing of soft tissue,
including skin.
A.3. Contraindications
● Pregnant and/or breastfeeding.
● Permanent implant in the facial skin area, such as an injected chemical
substance.
● History of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treated area, unless treatment is conducted following a
prophylactic regimen.
● Patients with vitiligo and melasma are at risk; ablative fractional laser
application may aggravate the skin condition.
● Current active acne.
● Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g.,
ibuprofen- containing agents) one week before and after each treatment
session.
● Use of retinoids, antioxidants or therapeutic skin nourishing
supplements within 2 months of treatment or during the study and oral
retinoids within 6 months of treatment.
● Having received a facial dermabrasion or chemical peel treatment
within 3 months of treatment or during the study.
● Having received treatment with light, RF or other devices in the treated
area within 6 months of treatment.
PB92971EN A-1
Clinical Guide – Aesthetic & Surgical Applications User Manual
● Having received Botox®/collagen/fat injections or other methods of

augmentation with injected or implanted material in the treated area
within 9 months of treatment.
● Having undergone a resurfacing procedure, face lift or eyelid surgery
within one year of treatment.
● Having undergone any other surgery in the treated area within 6
months of treatment (or more if skin has not healed completely).
● History of keloid scarring or of abnormal wound healing.
● Suffering from current or history of significant skin conditions in the
treated area or inflammatory skin conditions, including, but not limited
to: excessive skin dryness, psoriasis, eczema, rash, rosacea
(particularly severe open wound stage), varicella scars, open
lacerations or abrasions and active cold sores or herpes sores prior to
treatment (duration of resolution as per physician's discretion) or
during the treatment course.
● History of immunosuppression/immune deficiency disorders
(including HIV infection or AIDS) or currently using
immunosuppressive medications.
● History of epidermal or dermal disorders (particularly if involving
collagen or microvascularity).
● History of pigmentary disorders, particularly tendency for hyper- or
hypopigmentation.
● Suffering from hormonal imbalance, as per physician's discretion.
● Having a known anticoagulative or thromboembolic condition or
taking anticoagulation medications one week prior to and during the
treatment course.
● Having or undergoing any form of treatment for active cancer, or
having a history of skin cancer or any other cancer in the areas to be
treated, including actinic keratosis, presence of malignant or pre-
malignant pigmented lesions.
● Suffering from significant concurrent illness, such as cardiac disorders,
diabetes (type I or II), or pertinent neurological disorders.
● Vascular lesion, tattoo or permanent make-up in the treated area.
● Excessively tanned in areas to be treated or unable/unlikely to refrain
from tanning during the course of treatment.
● As per the physician's discretion, any physical or mental condition
which might make it unsafe for the treatment to be administered.
(*) Although not recommended, these conditions may be treated at the
discretion of, and under the full responsibility of the medical director/
physician. In such a case, a small area should be treated and assessed a
few days later to determine if the patient will tolerate the treatment
without developing short-term adverse effects.
A-2 PB92971EN
User Manual Clinical Guide – Aesthetic & Surgical Applications
Caution
In case of uncertainty regarding potential side effects, have the
patient consult his/her physician and bring a written consent for
treatment.
A.4. Realistic Expectations

● The degree of response to CO2RE treatment will vary among patients and
will depend on the patient's clinical and physiological condition at the
start of the treatment regimen. Some patients may have better response
than others.
● Results appear gradually: immediate transient improvement can be

noticed after each treatment; however maximum long-term effect is
usually noticed 2-4 months after treatment conclusion.
● The degree of improvement and the number of sessions required are

individual and will vary according to the degree of severity of the skin's
condition, as well as other factors.
● Potential benefits may include improvement of wrinkles and skin texture

(as manifested by smoothness, tightness, brightness, etc.) and possibly
also improvement of pigmentation.
A.5. Test Spots

● Prior to the first complete session perform a test spot in a non-
conspicuous area of the treatment site. Test spots are performed to
establish the following requirements:
● Confirm the patient's suitability for treatment. It is recommended to

perform a test spot and assess the patient’s response to treatments several
days prior to treatment.
● Establish and confirm treatment parameters: It is recommended to

perform test spots at several energy levels, using the smallest spot size to
ensure that the expected response is observed and that the healing process
following treatment is as expected. Treatment parameters can be adjusted
accordingly.
● According to patient tolerance to the test spot, you may determine

treatment parameters and which anesthesia is needed. In addition, it is
advisable to perform a test spot whenever changing parameters.
Note
Asian skin-type patients – after spot testing enforce a longer
"waiting period" than apparent skin type.
PB92971EN A-3
Warning
Results of test spots cannot predict possible long-term adverse
effects.
A.6. Possible Side Effects
Warning
CO2RE's fully ablative Classic and Surgical modes carry the same
risks as other fully ablative systems present including the potential
for scarring and hyper/hypopigmentation. Use of these modes
should be confined to small areas or lesions. Caution should be
exercised to reduce the potential for side effects.
Side effects may be experienced during treatment or shortly afterwards in

certain regions (periorbital, neck, chest). Milder laser settings (density and
energy) are recommended in these areas. Side effects should be reported
immediately to the physician for proper treatment.
These are the side effects that may appear in the treatment area:
● Tenderness
● Purpura
● Erythema lasting longer than normal
● Edema
● Bruising
● Damage to natural skin texture (scratching, crusting, blister, burn)
● Hyperpigmentation or hypopigmentation
● Herpes simplex
● Bacterial and/or fungal infection
● Scarring
A.7. Pre-Treatment Preparation

● Determine if the patient can be treated and has no contraindications for
treatment.
● Determine why the patient is seeking treatment and what his/her

expectations are.
● Complete or update the patient's medical and physical history.
A-4 PB92971EN
● Inform the patient about the treatment protocol, typical treatment results
and possible adverse effects and discomfort.
● Advise the patient about pre- and post-treatment care instructions.
● Instruct the patient about the safety issues of the treatment.
● The patient should arrive for treatment with clean skin. There should be
no lotion, make-up, perfume, powder or bath/shower oil present on the
skin in the area to be treated.
● It is suggested to take a photo of the treated area before the treatment and
at the follow-up visit to assess clinical response.
● Clean the treatment area with antibacterial preparation.
● For male patients: treatment in hair-bearing areas may result in some

damage to the follicles and subsequent loss of hair. If reduction of the hair
growth or ingrown hair is undesired, the beard area and other hair
growing zones should not be treated.
A.8. Treatment Procedure
Warning
To reduce the risk of infection and cross contamination, a recently
sterilized treatment handpiece should be used.
If a system malfunction occurs during treatment and CO2 laser
emission cannot be stopped, aim the handpiece to a neutral target
and press the emergency stop button.
Treatments may be performed every 4-6 (±1) weeks depending on the

treatment mode used. Treatment should conform to all laser safety
instructions and should be conducted according to the following guidelines:
1. Dedicated eye protection must be worn during treatment by both the
patient and staff.
2. Treatment should be performed while the patient is lying down
comfortably; the operator should have easy access to the patient's treated
area.
3. Ensure that the aiming beam is visible before and in-between pulses.
4. Care must be taken to avoid unintended exposure of the treatment beam
to the patient's eyes or non-target skin. Such exposure can cause possible
damage. Accordingly, the eyes should be protected with non-reflective
eye shields.
5. Anesthetic cream 15-30% lidocaine should be applied to the treated area
1 hour before treatment. Additional anesthetic options may include the
use of refrigerated air and /or injectable lidocaine. The anesthetic cream
PB92971EN A-5
should be carefully removed and the skin should be degreased with

alcohol to obtain a completely dry skin surface.
6. The distal part of the handpiece should be clean and dry. The applied part
of the handpiece is its reusable distal tip. The distal tip must be in direct
contact with the skin prior to pulsing.
7. Once the laser operating parameters have been selected and the
handpiece positioned at the proper treatment area, press the footswitch to
activate the laser treatment.
Warning
If at any time the system stops functioning due to laser
malfunction, turn it off and contact Syneron-Candela Service.
8. The operator may choose between the available ablative modes (CO2RE
Light, CO2RE Mid, CO2RE Deep, and CO2RE Fusion) used for
fractional skin resurfacing and treatment of lines and wrinkles, and the
fully ablative Classic resurfacing and Surgical incision/excision modes.
9. The operator can further choose between five treatment patterns
(hexagon, triangle, square, rectangle or ring) for the fractional treatment
modes and a smaller number of shapes lines and freehand patterns for the
fully ablative Classic and Surgical modes.
10. Prior to applying laser pulses to the patient, confirm spot pattern and
laser alignment. Perform a test spot using a tongue depressor moistened
with water. Make sure that pattern is full and the same as on the screen
(complete laser alignment test instructions may be found in Chapter 5 –
Maintenance).
11. The operator’s decisions are determined when taking into consideration
not only the severity of the treated condition, but also the specific
anatomical location and proximity to bones, nose, eyelids, etc.
Warning
CO2RE's digital SuperPulse laser easily produces the desired
treatment effect without the post-pulse heat deposition and other
characteristics common to prior generation SuperPulse and CW
mode lasers. To prevent the occurrence of unwanted side effects,
do not attempt to reproduce with CO2RE the profound redness,
tissue char or other treatment endpoints common to these older
systems.
12. Treatment should be single-pass and non-overlapping. Do not wipe after

treating. The immediate responses, indicative of the desired effect, are
erythema, edema and a distinct stippled gray fractional epidermolysis
pattern that adds in visualization of treatment progress. Fine-tuning of
the parameters (based on the tests spots) will be done before proceeding
to treat the entire facial sub-area with the selected parameters.
Modification of parameters per treated area within a treatment session
should only be carried out if required due to safety concerns.
A-6 PB92971EN
13. Treatment consists of a single pass over the designated area. A second
pass may be performed on crow’s feet, wrinkles or shoulders of rhytids.
14. Unless otherwise instructed, the energy parameters can be modified
between the treatment visits, as per the physician's discretion.
A.9. Treatment Parameters

Selecting the appropriate fractional, full ablative or surgical treatment mode
depends on the desired impact and the nature of the lesion.
Table A-1: Treatment Parameters – Aesthetic & Surgical Modes*

Energy Fluence Fractional Est. Ablation
Mode Application
Settings [mJ] [J/cm2] Density [%] Depth [µm]
CO2RE Light Light peel 30 – 60 3.3 – 7.1 30 – 50 20 – 40
Epidermal
CO2RE Mid resurfacing
46.3 – 257.6 8.2 – 24.8 20 – 40 100 – 200
Deep fractional
CO2RE Deep 30 – 70 * 170 – 396* 1–5 500 – 750
resurfacing
CO2RE Combination of Mid 46.3 – 129 8.9 – 24.8 100 – 200
20 – 40
Fusion and Deep modes 30 – 70* 170 – 396* 500 – 750
Full thickness
Classic resurfacing
1 – 10 5.6 – 56.4 100 100 – 200
0.2 mm x
Incision and selected line length
Surgical excision of lesions
5 – 40 28.1 – 226 N/A
0.2 mm2 freehand
5-15W
(*) The energy settings for Light and Mid modes (30-60 mJ and 46.3-257.6 mJ,
respectively) are provided per ablated spot (and are shown on the control panel), while the
energy settings for Deep mode (50-70 mJ) are provided per pin point (per pixel).
Caution
Proceed with caution when treating skin types IV and V, keeping fractional
density below 20%.
A.10. Post-Treatment Care

● Transient skin erythema and edema may occur up to a few days after the
treatment, but normally do not last longer. If the patient feels significant
*
30 – 80 mJ / 170 – 453 J/cm2 outside the United States
PB92971EN A-7
discomfort longer than that, cool/cold compresses (wet cold gauzes) may
be applied to relieve it. Gauzes should be kept cold using cold saline
solution. Post-treatment emollient cream may be applied over the
treatment area.
● On the night following treatment, patients should wash the treated area
gently with lukewarm water and avoid hot water in these areas. The skin
should be kept very clean to avoid infection; any mechanical or thermal
damage to the area must be avoided.
● Moisturizer can be applied 1–2 days after each treatment and then should
be applied regularly throughout the course of the treatment. Make-up may
be applied only 3–5 days after each treatment, if desired, unless an
adverse event occurs in the area. Generally patients may use regular
soaps, but not scrub soaps or exfoliants. The patient should wait 1–2 days
or until the scabs shed off before shaving. At the beginning of the
treatment, the physician should review the patient's routine skin care
regimen and may suggest modifications if the patient uses products that
are not recommended for use during the course of the treatment.
● Tanning of any sort (sun exposure, tanning beds, and artificial sunless
tanning lotions) is not allowed in the treated areas during the entire course
of the treatment since it might cause hyperpigmentation.
● Patients should be instructed to use a high factor sunscreen with SPF of at
least 30, and to protect the treated area from direct sunlight for the entire
course of the treatment.
A.11. Follow-Up
The following are recommendations for post-treatment follow-up. They may
serve as a basis for defining your treatment regimen.
● The patient should return for follow up visits 4-7 days after treatment, 4-6
weeks and 12 weeks after treatment for evaluation of the treatment area.
● Examine the treatment area and evaluate the results.
● Update the patient history while being mindful of new medications, etc.
● If the patient has experienced adverse events, they should be treated
according to physician discretion.
A.12. Treatment Conclusion

Improvement will take some time to be apparent and may typically be seen
over a period of up to 2–4 months. Improvement is affected by the clinical
conditions at the start of the treatment regimen and the treatment mode
applied. Treatment should be concluded when the results are satisfactory to
the patient or according to the physician's discretion.
A-8 PB92971EN
APPENDIX B
Clinical Guide – Fractional Vaginal,
Vulval and Introitus Treatments
B.1. CO2 Vulvovaginal Laser Treatment

This chapter provides you with the information required for treatment of the
vulva (vestibule and introitus) and vaginal canal using the CO2RE laser
system. The 10,600 nm laser energy is conducted via an articulated arm
equipped with a series of folding mirrors, and is delivered to the target tissue
after being scanned by a double-axis scanner into a pattern of pre-determined
shape, size, depth and applied energy.
B.2. Indications for Use

The CO2RE system is intended for use in the performance of dermatological
procedures requiring ablation, coagulation and resurfacing of soft tissue,
including skin.
The Intima is intended for the treatment of vulvovaginal atrophy (VVA) and
vaginal rejuvenation.
B.3. Contraindications
● Pregnant and/or breastfeeding.
● Abnormal cell cytology.
● Evidence of dysplasia and occult or active infection.
● Injury or bleeding in external vaginal area.
● Undiagnosed vaginal bleeding.
● History of diseases stimulated by heat, such as recurrent Herpes Simplex
in the treated area, unless treatment is conducted following a prophylactic
regimen.
● Active malignancy or history of malignancy in the past five years.
● Active electrical implant anywhere in the body, such as a pacemaker or
an internal defibrillator.
● Suffering from significant concurrent illness, such as cardiac disorders,
diabetes (type I or II), lupus, porphyria or pertinent neurological
disorders (i.e., any disease state that in the opinion of the physician
would interfere with the treatment or healing process).
● Having a known anti-coagulative or thromboembolic condition or taking
anticoagulation medications one week prior to and during the treatment
PB92971EN B-1
Clinical Guide – Fractional Vaginal, Vulval and Introitus Treatments User Manual
course (to allow inclusion, temporary cessation of use as per the patient
physician's discretion).
● History of immunosuppression/immune deficiency disorders (including
HIV infection or AIDS) or currently using immunosuppressive
medications.
● Suffering from hormonal imbalance, whether related to thyroid, pituitary,
or androgen.
● History of significant lymphatic drainage problems.
● History of cancer which required lymph node biopsy or dissection.
● Suffering from significant conditions in the treated areas or inflammatory
conditions, including but not limited to open lacerations or abrasions of
the treatment area prior to treatment or during the treatment course.
● History of keloid scarring, abnormal wound healing and/or prone to
bruising.
● History of epidermal or dermal disorders (particularly if involving
collagen or microvascularity), including collagen vascular disease or
vasculitic disorders.
● Use of isotretinoin (Accutane®) within six months of treatment or during
treatment.
● On systemic corticosteroid therapy six months prior to and throughout
the course of treatment.
● Dysplastic nevi in the area to be treated.
● Surgery or any other procedure for Vaginal Tightening in the last
12 months.
Warning
Do not treat the patient if there are signs of injury, laceration or
bleeding in the external or internal vaginal area.
B.4. Realistic Expectations

The degree of response to CO2RE treatment will vary among patients and
will depend on the patient's clinical and physiological condition at the start of
the treatment regimen. Some patients may have a better response than others.
Results appear gradually: immediate transient improvement can be noticed
after each treatment; however maximum long-term effect is usually noticed
2-4 months after treatment conclusion.
Generally, three treatments at 3±1 week intervals are recommended. The
degree of improvement and the number of sessions required are individual
and will vary according to the degree of severity of the skin's condition, as
well as other factors.
B-2 PB92971EN
User Manual Clinical Guide – Fractional Vaginal, Vulval and Introitus Treatments
Potential benefits may include improvement of skin texture of external

genitalia, possibly also improvement of pigmentation, and improvement in
the symptoms of vaginal disease (itching; burning; painful sexual
intercourse; thickened or thin skin on the vulva, stinging or irritation).
B.5. Possible Side Effects

Side effects may be experienced during treatment or shortly afterwards in the
treatment area. Side effects should be reported immediately to the physician
for proper treatment.
These are the side effects that may appear, but are not limited to, in the
treatment area:
● Ecchymosis
● Purpura
● Bruising
● Swelling
● Twinge (pain)
● Numbness
● Infection
● Blisters
● Itching
● Scarring
● Burns
● Vulvodynia
B.6. Pre-Treatment
● Determine if the patient can be treated and has no contraindications for
treatment.
● Determine why the patient is seeking treatment and what her

expectations are.
● Complete or update the patient's medical and physical history.
● Inform the patient about the treatment protocol, typical treatment results
and possible adverse effects and discomfort.
● Advise the patient about pre- and post-treatment care instructions.
● Instruct the patient about the safety issues of the treatment.
PB92971EN B-3
● The patient should arrive for treatment with clean skin. There should be
no lotion, make-up, perfume, powder or bath/shower oil present on the
area to be treated.
● The patient should be fully undressed from the waist down and be
comfortable on the treatment table in a dorsal lithotomy position to
provide clear exposure to the treatment area.
● The external treated area should be thoroughly washed with disinfecting

solution.
● Introduce the speculum cage into the introitus.
● The internal treated area (vestibule, introitus and vaginal canal) should be
thoroughly washed with disinfecting solution.
● The disinfecting solution should be carefully dried from the treated area
and removed from the mucosa. This can be done with folded gauze and
ringed forceps.
● It is recommended to take photos of the visible treated area before the

treatment and at the follow-up visit to assess clinical response.
B.7. Test spots

● Confirm the patient's suitability for treatment. Perform a test spot and
assess the patient’s response to treatment prior to treatment.
● Establish and confirm treatment parameters: it is recommended to

perform test spots at several energy levels, using the smallest spot size to
ensure that the expected response is observed and that the healing process
following treatment is as expected. For internal treatment, the immediate
response for test spots in the vaginal canal is a whitening of the tissue
with visible contraction; the whitening fades while a mild erythema may
remain. Other immediate responses that may occur are mild bleeding and
tissue retraction. Treatment parameters can be adjusted accordingly.
● Test spot results will indicate if the patient can tolerate the treatment
without developing adverse effects. According to patient tolerance to the
test spot, you may determine treatment parameters and if anesthesia is
required (generally not). In addition, it is advisable to perform a test spot
whenever changing parameters.
B-4 PB92971EN
B.8. Internal Treatment Procedure

B.8.1. Internal Treatment
● Dedicated eye protection must be worn during treatment by both the

patient and staff.
● Care must be taken to avoid unintended exposure of the treatment beam

to the patient's eyes or skin. Such exposure can cause possible damage.
Accordingly, the eyes should be protected with non-reflective eye
shields.
● With use of the different handpieces, both the vulva (vestibule and
introitus – external) and the vagina (vaginal canal – internal) can be
treated during the same procedure.
● The handpiece must be cleaned with soap and water to remove the bulk
of extraneous material.
● The handpiece should then be wiped with an alcohol wipe (70% alcohol)
or soaked for two minutes in sodium hypochlorite at 500 ppm,
OR:
● The handpiece should be immersed for 15 minutes in 70% alcohol.
● The handpiece should be completely air-dried (electronic compressed air

dust-off tool may be used).
● Make sure all alcohol has evaporated before use.
● The operator must wear disposable (non-sterile) gloves when positioning

the labia during passage of the probe.
● Prepare the CO2RE system for the treatment procedure, including

attachment of the swivel (purple color-coded) lens and an internal
handpiece.
● Turn the CO2RE system on and select the parameters according to

Table B-1.
● Insert the vaginal/internal handpiece to the interior edge of treatment (up

to 11 cm in the vaginal canal), using the 1 cm engraved notches on the
handpiece. A small quantity/few drops of baby oil can be used to allow a
more comfortable insertion into the introitus. Do not introduce oil into
the canal. Apply the oil gently over the introitus and not directly onto the
handpiece.
● The handpiece should be positioned with contact to the vaginal wall

(contact between laser window to the vaginal wall).
PB92971EN B-5
● Press the footswitch to release a single pulse (pulse #1). Retract the
handpiece 1 cm posterior towards the vulva (external) area and release an
additional single pulse.
● Repeat a single pulse to each 1 cm depth until the handpiece is retracted

from the vaginal canal.
● Rotate the handpiece by 45-90° and reinsert in the vaginal canal. Release
a pulse and continue with a single pulse after each 1 cm retraction.
Figure B-1: Handpiece Rotation by 90°
● Repeat with 4 – 8 rotations until handpiece has been rotated a full 360°.
● After completion of the final pass, fully retract the probe and cage.
● At completion of the procedure, gloves should be discarded and hands

washed thoroughly with soap and water.
B.8.2. External Treatment
● The distal part of the applicator should be clean and dry. The applicator
should be held perpendicular to and in close contact with the skin. In the
same manner, the distal end of the applicator should be moved to the
designated spot.
● The choice of treatment settings should take into consideration the
patient's skin type, tendency to bruise, the specific anatomical location
(vulva) and the necessary ablation depth (which is influenced from the
amount of water in the vaginal tissue).
● Use a cloth to gently clean the exterior surfaces with medical grade
alcohol. Allow the handpiece to air-dry until all the alcohol evaporates.
● Select the ablation mode to CO2RE Deep.
● Select the desired pattern shape, size, energy and density.
● Once the laser operating parameters have been selected and the
handpiece positioned at the proper treatment area, press the footswitch to
activate the laser treatment.
● Treatment should be single-pass over the designated area and non-
overlapping.
B-6 PB92971EN
B.9. Treatment Parameters

Selecting the appropriate treatment mode depends on the desired impact to
the area being treated and the nature of the lesion.
Table B-1: Treatment Parameters – Intima Mode

Handpiece Energy
Application Fractional Density
Type Settings [mJ]
Intima Treatment to the
40 – 55 4% – 5%
Internal vaginal canal (Internal)
3% – 4%
Pattern:
Intima Deep Fractional Hexagon:
40 – 55
External Resurfacing (External) 4.3 x 5.0 or 6.4 x 7.5mm
Square:
7.5 x 7.5 or 7.8 x 7.8mm
B.10. Post-Treatment Care

● A vaginal suppository for moisture may be prescribed for 3-5 nights
(optional).
● Temporary erythema (redness) and edema (swelling), mild bleeding,
tissue retraction, as well as heat and tightening sensations, may occur up
to a few hours after the treatment. If the patient feels significant
discomfort longer than a few hours, over-the-counter pain medication
such as Ibuprofen may be used.
● On the evening after the treatment, patients should wash the treated areas
gently with lukewarm water and avoid very hot or cold water in these
areas. Generally, patients may use their regular soaps after treatment, as
long as these are not soap scrubs or exfoliates.
● There should be no use of tampons for seven days post-procedure.
● Patients should be instructed to abstain from sexual activities for a period
of seven days post-procedure.
● The treated areas should also not be exposed to potential mechanical
damage at least 48 hours post-treatment.
● Any pain, fever or unusual discharge should be immediately reported.
● The patient should return for follow-up one week after treatment for
evaluation of the treatment area.
PB92971EN B-7
B.11. Follow-Up
The following are recommendations for post-treatment follow-up. They may
serve as a basis for defining the treatment regimen.
● The patient should return for follow-up visits 4-7 days after treatment,
4-6 weeks and 12 weeks after treatment for evaluation of the treatment
area.
● Examine the treatment area and evaluate the results.
● Update the patient history while being mindful of new medications, etc.
● If the patient has experienced adverse events, they should be treated
according to physician discretion.
B.12. Treatment Conclusion

Improvement will take some time to be apparent and may typically be seen
over a period of up to 2–4 months. Improvement is affected by the clinical
conditions at the start of the treatment regimen and the treatment mode
applied. Treatment should be concluded when the results are satisfactory to
the patient or according to the physician's discretion.
B.13. After the Treatment Session

Remove the disposable Intima handpiece/s (internal and/or external) and
discard as bio-hazardous waste.
B-8 PB92971EN
APPENDIX C
Electromagnetic Compliance
C.1. Electromagnetic Emissions

The CO2RE system is intended for use in the following electromagnetic
environment. The owner of the system and/or the user must ensure that it is
operated the correct environment.
Emissions Test Compliance

CISPR 11: RF Emissions Group 1
The CO2RE system must emit electromagnetic energy in order to perform its
intended function. Nearby electronic equipment may be affected.
Emissions Test Compliance

CISPR 11: RF Emissions Class A
IEC 61000-3-2: Harmonic Emissions Class A
IEC 61000-3-3: Voltage fluctuations/flicker emissions Complies
The CO2RE system is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those directly
connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes, provided the following warning
statement is heeded:
Warning
This system is intended for use by health care professionals only.
This system may cause interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigating measures,
such as re-orienting or relocating the system or shielding the
location.
PB92971EN C-1
Electromagnetic Compliance User Manual
C.2. Electromagnetic Immunity
Immunity Test IEC 60601 Test Level Compliance

IEC 61000-4-2: Electrostatic ±2, 4, 6 kV Contact
± 6 kV contact ± 8 kV air
Discharge (ESD) ±2, 4, 8 kV Air
IEC 61000-4-4: Electrical Fast ± 2 kV for power supply lines ±2 kV

Transient/Burst ± 1 kV for input/output lines ± 1 kV
± 1 kV differential Mode 1.0 DM
IEC 61000-4-5: Surge
± 2 kV common mode 2.0 CM
IEC 61000-4-8: Power
3 A/m 3 A/m
Frequency (50/60 Hz) Magnetic Field
<5 % UT (>95 % dip in UT) for <5 % UT (>95 % dip in UT) for
0.5 cycle 0.5 cycle
40% UT (60% dip in UT) 40% UT (60% dip in UT)
IEC 61000-4-11: Voltage Dips,
for 5 cycles for 5 cycles
Short Interruptions and Voltage
Variations on Power Supply Input 70% UT (30% dip in UT) 70% UT (30% dip in UT)
Lines for 25 cycles for 25 cycles
5% UT (95% dip in UT) 5% UT (95% dip in UT)
for 250 cycles for 250 cycles
● Floors should be wood, concrete or ceramic tile. If floors are covered

with synthetic material, the relative humidity should be at least 30%.
● Mains power quality should be that of a typical commercial or hospital

environment.
● If the CO2RE system is required to operate during power interruptions,

the system should be powered from an uninterruptible power supply.
● Power frequency magnetic fields should be at levels characteristic of a

typical location in a typical commercial or hospital environment.
Note
UT is the AC mains voltage prior to application of the test level.
C-2 PB92971EN
User Manual Electromagnetic Compliance
Electromagnetic Immunity (Continued)
IEC 60601
Immunity Test Compliance Guidelines
Test Level
d =1.17 * SQRT(P) 80 MHz to 800 MHz
d =2.33 * SQRT(P) 800 MHz to 2.5 GHz
Where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
61000-4-3: 3 V/m 80 MHz 3 V/m 80 MHz to Field strengths from fixed RF
Radiated RF to 2.5 GHz 2.5 GHz transmitters, as deter-mined by an
electromagnetic site survey1, should be
less than the compliance level in each
frequency range2.
Interference may occur in the vicinity of
equipment marked with this symbol:
Portable and mobile RF communications

equipment should be used no closer to
any part of the CO2RE system, including
cables, than the recommended
61000-4-6: 3 VRMS 150 kHz 3 VRMS 150 kHz separation distance calculated from the
Conducted RF to 80 MHz to 80 MHz equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d =1.17 * SQRT(P)
(1) 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 CO2RE system is
used exceeds the applicable RF compliance level above, the CO2RE system should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the CO2RE system.
(2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Note
● At 80 and 800 MHz, the higher frequency range applies.
● These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
PB92971EN C-3
Electromagnetic Compliance User Manual
C.3. Recommended Separation Distances

The following are the recommended separation distances between portable
and mobile RF communications equipment and the CO2RE system.
The CO2RE system is intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. The owner of the system
and/or the user can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
equipment (transmitters) and the CO2RE system as recommended below,
according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed below, 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's manufacturer.
Rated Maximum Separation Distance According to Frequency of Transmitter (M)

Output Power of 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Transmitter (W) d = 1.17 SQRT(P) d = 1.17 SQRT(P) d = 2.33 SQRT(P)
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
Note
At 80 and 800 MHz, the higher frequency range applies.
C-4 PB92971EN

PB92971EN CO2RE User Manual - English - ECO-4784

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System User Manual

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CHAPTER 2: Installation Page

2.3.2. Space and Positioning Requirements ............................................................................ 2-3

CHAPTER 3: System Description Page

CHAPTER 4: Operating Instructions Page

CHAPTER 5: Maintenance Page

CHAPTER 6: Troubleshooting Page

APPENDIX A: Clinical Guide - Aesthetic & Surgical Applications Page

THIS PAGE LEFT BLANK INTENTIONALLY

The CO2RE system has been specially designed to minimize accidental

1.2. Burn Hazard

1.3. Reflected and Direct Eye Exposure Hazard

As a precaution against accidental exposure to the output laser beam or its

1.4. Laser Safety Eyewear

1.5. Explosion and Fire Hazard

1.6. Electrical Safety

1.6.2. Grounding the System

Proper grounding is essential for safe operation. The system is grounded

1.6.3. Using the Proper Power Receptacle and Plug

1.7. Safety Precautions

● Only Syneron-Candela-authorized technical personnel may service the

● Maintenance should be performed by the operator only when the system

● Do not operate the system if it has been subjected to mechanical impact.

● Never leave the system turned on or unattended during system

1.7.2. Ocular Safety

● Allow access to the treatment room only to personnel essential to the

● Do not power up the CO2RE system or connect it to the wall electrical

1.7.3. Smoke Evacuation and Laser Plume Pollution Hazards

● Special in-line vacuum systems designed for evacuation of the laser

1.7.4. Surgical Safety

1.7.5. Operating Safety Precautions

● Never leave the system in Ready mode unattended.

● Never allow untrained personnel to operate the system.

1.8. System Safety Features

1.8.2. Safety Shutter

1.8.4. Double-Tiered Laser Emission Security

1.8.5. System Self-Testing

1.8.6. Emergency Shut-Off Knob

This red knob is designed for emergency shutdown. When pressed, it

To release the emergency shut-off knob, turn it clockwise in the direction of

1.8.7. Safety Fuses

Fuse type: Littlefuse 0217005.HXP – 5x20mm.

1.8.8. Laser Beam Emission Indicators

The LEDs have three modes of operation:

There is an additional audible indicator in the form of a buzzer, that sounds

1.8.9. Remote Interlock Connector

The system incorporates a safety remote interlock socket for connecting an

1.8.10. Fault Detection

The CO2RE system incorporates micro-processing controllers which

1.9. Compliance with International Standards

● US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for

● EN 60825-1 Radiation safety of laser products

● European Medical Device Directive 93/42/EEC

● EN 60601-1 Standard for safety of medical equipment

● EN 60601-2-22 Particular requirements for the safety of diagnostic

● EN 60601-1-2 Standards for electromagnetic compatibility of

In compliance with these standards, the system is equipped with:

● Laser emission indicators

● Output energy display

● Emergency shut-off knob

● Remote interlock connector

In accordance with the regulations, a recommended routine inspection and