Cynosure Cynergy User manual

Cynergy™
850-1065-000, Rev. 6
OPERATOR MANUAL
CYNOSURE
®
5 Carlisle Road, Westford, MA, 01886, USA
Phone: [phone] www.cynosurelaser.com

Distributors:
Cynosure, UK Ltd.
The Old Barn Offices
Lower Mount Farm, Long Lane
Cookham, Berkshire SL6 9EE
England
Telephone: [phone]
Telefax: 44-1628-520525
Cynosure France
86, Avenue Lenine
94250 Gentilly
France
Telephone: [phone]
Telefax: 33-1-49.85.6004
Cynosure, GmbH.
Robert-Bosch-Strasse 11A
D-63225 Langen
Germany
Telephone: [phone]
Telefax: 49-6103-20111-11
Cynosure KK
Kasuga Business Center Bldg. 1F
1-15-15 Nishikata, Bunkyo-Ku
Tokyo 113-0024
Telephone: [phone]
Telefax: [phone]
Cynosure, Inc.
220 Tagore, #01-01/2
Liberty Warehouse
Singapore 787600
Telephone: [phone]
Telefax: 65-6853-4309
™ Cynergy is a trademark of Cynosure, Inc.
® Cynosure is a registered trademark of Cynosure, Inc.
This manual is intended for both U.S. and international distribution.
© 2005 Cynosure, Inc. All rights reserved.
Document #850-1065-000, Rev. 6, 6/06

Cynergy Operator Manual 850-1065-000, Rev. 6 Page 1 of 78
Table of Contents
Glossary of Symbols and Abbreviations.................................................................................6
Section 1 Introduction.......................................................................................................7
About the Lasers .............................................................................................................7
About the Manual ...........................................................................................................7
Section 2 Equipment Safety..............................................................................................9
Potential Hazards ............................................................................................................9
Optical Hazard ....................................................................................................9
Electrical Hazard...............................................................................................10
Chemical Hazard...............................................................................................10
Potential Chemical Accidents and Appropriate Responses..............................10
Hot Water Hazard .............................................................................................10
Laser-Induced Fire Hazard ...............................................................................11
Electromagnetic Compatibility Hazards...........................................................11
Laser Safety Features....................................................................................................12
Key Switch........................................................................................................12
Emergency Laser Stop ......................................................................................12
Standby Mode ...................................................................................................12
Delayed Ready Mode........................................................................................12
Automatic Shutdown Feature ...........................................................................13
Remote Interlock...............................................................................................13
Audible Tone ....................................................................................................13
Laser Warning Sign ..........................................................................................13
Locking Casters ................................................................................................13
Device Labels ...................................................................................................14
Figure 1A–Device Labels in Position...............................................................14
Figure 1B–Device Labels Used ........................................................................15
Section 3 Site Preparation ..............................................................................................17
Spatial Requirements ....................................................................................................17
Electrical Requirements................................................................................................17
Environmental Requirements........................................................................................18
Storage and Transport Requirements............................................................................18
Disposal of Waste Electrical and Electronic Equipment..............................................18

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Section 4 Laser Description............................................................................................19
Main Components.........................................................................................................19
Figure 2A–Main Components, Front................................................................19
Figure 2B–Main Components, Inside Front Door ............................................20
Figure 2C–Main Components, Rear View........................................................21
Figure 2D–Main Components, Right Side from Rear ......................................22
Key Switch........................................................................................................22
Handpieces and Delivery Optical Fiber........................................................................23
Connecting the Optical Fiber............................................................................23
Changing Handpieces .......................................................................................23
Figure 3–Handpiece..........................................................................................24
Trigger Switches ...............................................................................................24
Front Control Panel.......................................................................................................25
Figure 4–Front Control Panel ...........................................................................25
Emergency Laser Stop ......................................................................................25
Cal Port .............................................................................................................25
Display ..............................................................................................................25
Display Screens.............................................................................................................26
Home Screen.....................................................................................................26
Figure 5A–Home Screen...................................................................................26
Treatment Screens.............................................................................................27
Figure 5B–PDL Screen.....................................................................................27
Figure 5C–YAG Screen....................................................................................27
Treatment Screen Elements ..............................................................................28
Figure 5D–Laser Screen Elements ...................................................................28
MultiPlex Treatment Screen .............................................................................30
Figure 5E–MultiPlex Laser Screen...................................................................30
Utility Screen ....................................................................................................31
Figure 5F–Utility Screen ..................................................................................31
Option Screen ...................................................................................................33
Figure 5G–Option Screen .................................................................................33
System Specifications ...................................................................................................34
General Specifications ......................................................................................34
Fluence Specifications ..................................................................................................35
Cynergy PDL ....................................................................................................35
Cynergy YAG ...................................................................................................36
Cynergy MultiPlex Option................................................................................37

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Section 5 Laser Operation ..............................................................................................39
Laser Start-Up...............................................................................................................39
Laser Shutdown ............................................................................................................39
Laser Calibration...........................................................................................................40
Energy Regulation During Treatment...........................................................................40
Laser Operation.............................................................................................................41
Changing Treatment Parameters...................................................................................41
Section 6 Clinical Application–YAG .............................................................................43
Laser Operator Training Requirements–YAG..............................................................43
Indications, Contraindications and Adverse Effects–YAG ..........................................44
Indications.........................................................................................................44
Contraindications ..............................................................................................44
Adverse Effects.................................................................................................44
Pretreatment Recommendations–YAG.........................................................................45
Determine Suitability........................................................................................45
Inform Patient About the Treatment.................................................................45
Photographs ......................................................................................................45
Treatment Recommendations–YAG.............................................................................46
Minimizing Adverse Effects.............................................................................46
Setting Energy Level ........................................................................................46
Number and Length of Treatment Sessions......................................................46
Determining End of Treatment .........................................................................46
Posttreatment Recommendations–YAG .......................................................................46
Section 7 Clinical Application–PDL ..............................................................................47
Laser Operator Training Requirements–PDL...............................................................47
Indications, Contraindications and Adverse Effects–PDL ...........................................48
Indications.........................................................................................................48
Contraindications ..............................................................................................48
Adverse Effects.................................................................................................48
Patient Selection–PDL..................................................................................................48
Pretreatment Recommendations–PDL..........................................................................49
Determine Suitability........................................................................................49
Inform Patient About the Treatment.................................................................49
Photographs ......................................................................................................49
Treatment Recommendations–PDL..............................................................................50
Minimizing Adverse Effects.............................................................................50
Setting Energy Level ........................................................................................50

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Number and Length of Treatment Sessions......................................................50
Determining End of Treatment .........................................................................50
Posttreatment Recommendations–PDL ........................................................................50
Section 8 Clinical Application–MultiPlex Option ........................................................51
Laser Operator Training Requirements–MultiPlex ......................................................51
Indications, Contraindications and Adverse Effects–MultiPlex...................................52
Indications.........................................................................................................52
Contraindications ..............................................................................................52
Adverse Effects.................................................................................................52
Patient Selection–MultiPlex .........................................................................................52
Pretreatment Recommendations–MultiPlex .................................................................53
Determine Suitability........................................................................................53
Inform Patient About the Treatment.................................................................53
Photographs ......................................................................................................53
Treatment Recommendations–MultiPlex .....................................................................54
Minimizing Adverse Effects.............................................................................54
Setting Energy Level ........................................................................................54
Number and Length of Treatment Sessions......................................................54
Determining End of Treatment .........................................................................54
Posttreatment Recommendations–MultiPlex................................................................54
Section 9 Maintenance ....................................................................................................55
Cleaning and Disinfecting Equipment..........................................................................55
Adding Water to the Reservoir .....................................................................................55
Dye Kit Methodology ...................................................................................................56
Dye Injection.....................................................................................................56
Replacing the Dye Kit...................................................................................................57
Figure 6A–Disconnecting and Removing Dye Filter .......................................57
Figure 6B–Detaching/Inserting Dye Inject Bottle............................................58
Troubleshooting ............................................................................................................59
Faults.................................................................................................................59
Fault Code Table...............................................................................................59
Self Test ............................................................................................................61
Troubleshooting Chart ......................................................................................62
Transferring Diagnostic Data............................................................................63
Figure 7A–USB Access Panel Location...........................................................63
Figure 7B–USB Slot Location..........................................................................64

Cynergy Operator Manual 850-1065-000, Rev. 6 Page 5 of 78
Section 10 Customer Support...........................................................................................65
Direct-Purchase Warranty.............................................................................................65
Distributor-Purchased Warranty ...................................................................................65
Warranty Claims ...........................................................................................................65
Installation ....................................................................................................................66
Customer Service..........................................................................................................66
Scope of Service ...............................................................................................66
Contacting Customer Service ...........................................................................66
Appendix A Service Calibration .........................................................................................67
Schedule for Calibration ...............................................................................................67
Overview.......................................................................................................................67
Required Equipment .....................................................................................................68
Calibration Procedures..................................................................................................68
Calibrating the Resonator Port, YAG ...........................................................................69
Calibrating the Resonator Port, PDL ............................................................................70
Calibrating the Cal Port, YAG......................................................................................71
Calibrating the Cal Port, PDL.......................................................................................72
Appendix B Electromagnetic Compatibility......................................................................73
Appendix C Declaration of Conformity .............................................................................77

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Glossary of Symbols and Abbreviations
The following symbols and abbreviations may be used on the Cynergy laser and/or in
this manual.
Symbols
Declaration of Conformity to
Medical Device Directive 93/42/EEC
CE Mark to Directive 93/465/EEC
Optical Fiber Applicator
per EN60601-2-22: 1996
Type B applied part per EN60601-1: 1990
Emergency Laser Stop
per EN60601-2-22: 1996
Attention, consult accompanying documents
Off—power disconnection
from mains
Laser Hazard Warning
On—power connection to
mains
Dangerous Voltage Foot Switch
Non-ionizing Radiation
WEEE symbol per EN50419
Remote Interlock Connector per
EN60601-2-22: 1996
Other
Symbols
Hand Switch
Abbreviations
°C Degrees Celsius V Volts
A Amperes DVM Digital Voltmeter
mA Milliamp Hz Hertz
µA Microamp J Joule
AC Alternating Current J/cm² Joule per square centimeter
cm Centimeter kW Kilowatt
mm Millimeter ms Millisecond
nm Nanometer ΩOhms
CW Continuous Wave mΩMilliohms

Cynergy Operator Manual 850-1065-000, Rev. 6 Page 7 of 78
Section 1 Introduction
About the Lasers
The Cynergy laser combines two lasers—a high-powered pulse dye laser (PDL) and a Nd:YAG
laser—into one unit with a common delivery system. The result is a multi-application
dermatological laser that treats small red vessels, scars, rosacea, vascular lesions and sun-
damaged skin using the pulse dye wavelength, as well as treating larger facial and leg veins,
vascular lesions, and unwanted hair on all skin types using the YAG wavelength. The laser is
also available with the Cynergy MultiPlex option that combines both wavelengths in a single
pulse offering improved clinical outcome. This manual addresses both lasers including the
MultiPlex option.
The laser is designed to effectively couple the laser energy directly to the target while leaving
the surrounding tissue unharmed. This principle is known as Selective Photothermolysis (SPT).
By careful selection of the wavelength, pulse width, spot size, energy and cooling method, the
effectiveness of the laser on the target is maximized, while any heating to surrounding tissue is
minimized. Thermokinetic Selectivity®, or TKS®, is a corollary of SPT. It uses a laser pulse
width that is much longer than the thermal relaxation time of small surrounding structures, yet
less than the thermal relaxation time of the large target. This allows the small surrounding
structures to remain cool while the larger target heats up to the destruction point.
The Cynergy with Multiplex™ Option, which allows treatment with both PDL and YAG in a
single pulse, further exploits the principles of SPT and TKS for maximum efficacy in the
treatment of cutaneous vascular lesions.
About the Manual
The Cynergy Operator Manual provides the following information about the laser:
♦Equipment Safety
♦Site Preparation
♦Laser Operation
♦Maintenance
♦Customer Support
♦Storage and Transport
Although the manual provides useful information on the use and maintenance of the laser, it is
not intended to be a complete guide. Cynosure suggests that all health care professionals who
plan to use the laser seek further training in its proper use. The custodian of the laser shall take
steps to prevent its unauthorized use.
CAUTION: Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
® Thermokinetic Selectivity and TKS are registered trademarks of Cynosure, Inc. / Cynergy with Multiplex is a trademark of Cynosure, Inc.

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Cynergy Operator Manual 850-1065-000, Rev. 6 Page 9 of 78
Section 2 Equipment Safety
Potential Hazards
As with any equipment, there are potential hazards. Before using the laser, operators should be
aware of the following types of hazards: optical, electrical and combustible. This section of the
manual describes these potential hazards and suggests precautions. This section also describes
safety features designed to minimize potential hazards.
Optical Hazard
The laser emits an intense energy beam of invisible and visible laser light radiation that can
cause serious eye damage with direct or even indirect optical contact.
WARNING: Always wear the protective eyewear supplied with the laser system. Failure to
wear the appropriate protective eyewear can result in serious eye injury.
Please follow these precautions to avoid optical damage to laser operators, assisting personnel
and patients.
♦All persons in the room during treatment must wear the protective eyewear recommended
by Cynosure. See “System Specifications” starting on page 34 for recommendations.
♦Never look directly into the handpiece, fiber or fiber opening, even while wearing
protective eyewear.
♦Mark treatment rooms with the laser warning signs to avoid unnecessary personnel
entering room during treatment.
♦Limit entry to the treatment room only to personnel who are assisting in treatment and
are trained in the use of the equipment.
♦Cover windows and other openings in the treatment room to avoid the inadvertent escape
of laser light.
♦Direct the activated laser only at the intended area of treatment.
♦Place one person in charge of the laser system’s controls during the treatment.
♦Cover reflective objects, such as jewelry or mirrors, which could deflect the laser beam to
an area other than the intended treatment area.
♦Put the laser into Standby Mode when the laser is not in use. When in Standby Mode, the
laser beam cannot be inadvertently activated.
♦Ensure that all appropriate staff members are trained to shut off the laser in the case of an
emergency.
♦Keep the laser start-up key in a safe place outside of the treatment room when the laser is
not in use.

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Electrical Hazard
The laser system uses high voltage. Do not open the protective panels unless you are trained and
authorized to do so.
Chemical Hazard
The Cynergy laser uses a dye medium. Handle the dye with care, both to protect against toxicity
and against staining. Operators should follow these precautions:
♦Wear rubber or plastic gloves when handling the dye.
♦Do not dispose of dye down drains.
♦Return empty dye bottles and used filters to Cynosure.
♦Avoid spillage on fabrics or on any porous material.
Potential Chemical Accidents and Appropriate Responses
The following table lists potential chemical accidents and their appropriate emergency responses.
Chemical Accident Appropriate Emergency Response
Ingestion of dye or solvent Drink water, induce vomiting, and seek immediate
medical attention.
Excessive inhalation of dye or solvent Go outdoors and inhale fresh air.
Seek medical attention if symptoms appear.
Eyes exposed to dye or dye solvent Rinse eyes with water.
Seek medical attention if symptoms appear.
Skin exposed to dye or dye solvent Immediately wash the exposed skin area with plain
water, then with soap and water.
Hot Water Hazard
The laser uses water cooling to maintain the system at its proper operating temperature. This
water can become very hot (greater than 50 ºC) and could scald. Do not perform any
maintenance on the water system while hot. Always let the system cool down before changing
the deionizing filter or adding deionized or distilled water.

Cynergy Operator Manual 850-1065-000, Rev. 6 Page 11 of 78
Laser-Induced Fire Hazard
When the laser beam contacts an exterior surface, that surface can absorb the laser energy. This
raises the surface temperature, whether the surface is skin, hair, clothes or any flammable
substance. Operators should take the following precautions to prevent a laser-induced fire:
♦Use non-flammable substances for uses such as anesthesia, skin preparation, and cleaning
or disinfecting instruments.
♦Be especially careful with the use of oxygen. Oxygen accelerates both the severity and
the extent of a fire.
♦Keep a minimum of combustible materials (e.g., alcohol) in the treatment room. If
treatment requires the use of gauze, first soak it in water.
♦Always keep a small fire extinguisher and water in the treatment room.
Electromagnetic Compatibility Hazards
The Cynergy laser has special precautions regarding electromagnetic compatibility hazards
(EMC), and need to be installed and operated according to the EMC information provided in
Appendix B, starting on page 73 of this manual.
CAUTION: Portable and mobile radio frequency (RF) communication equipment can
affect the Cynergy laser.
CAUTION: The Cynergy laser should not be used adjacent to, or stacked with, other
equipment other than the Cynergy PL system. If the laser must be used adjacent to, or
stacked with other equipment, then observe the laser in its configuration to verify that
operation is normal.

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Laser Safety Features
The laser offers several safety features to prevent its misuse or unintentional activation. All
personnel who operate the laser or assist in the operation should be familiar with these safety
features.
Key Switch
The Key Switch controls the electrical activation of the laser system. Only those authorized
personnel who have access to the key can start the laser system. Keep the laser start key in a
secure location to prevent use by unauthorized personnel.
Emergency Laser Stop
The Emergency Laser Stop is a dedicated override switch for immediate shut down of the
laser system.
Standby Mode
Standby Mode is designed to prevent unintentional or accidental activation of the laser. The
system enters Standby Mode when the operator presses the Standby Key on the touch screen, or
when laser is selected from the Home screen at start up. The laser status is displayed on the
upper-left part of the screen.
When the laser is in Standby Mode, the system is on but the operator cannot activate the laser
beam without first pressing the Ready Key on the touch panel.
Delayed Ready Mode
From Standby Mode, press the Ready Key to activate the laser. As required by the Center for
Devices and Radiological Health of the U.S. Food and Drug Administration and International
Standards (IEC601-2-22 and 825-1), there is a 3-second delay from the time the Ready Key
is pressed until the laser can be activated. This delay, during which there is an audible beep and
the ready key is lit, provides time for personnel to prepare before the beginning of treatment.

Cynergy Operator Manual 850-1065-000, Rev. 6 Page 13 of 78
Automatic Shutdown Feature
When certain faults occur, the laser automatically shuts down and a fault code, message and
corrective action is displayed. For a complete list of faults and failure analysis information, see
“Troubleshooting,” starting on page 59.
Remote Interlock
Cynosure provides a remote interlock circuit that can connect to a door switch of a treatment
room. When the remote interlock is wired in series with a door switch, the laser automatically
shuts down if anyone enters the treatment room. Contact Cynosure for detailed instructions on
how to implement this function.
Audible Tone
Laser emission is indicated by a pulsed tone for the period of the emission.
Laser Warning Sign
Cynosure supplies a laser warning sign with each laser system. We recommend posting the sign
at all entrances to rooms with an operating laser. Please check the policy of your hospital or
clinic.
Locking Casters
The front casters of the laser may be locked into place. On the top of the front casters is a
locking lever. To lock the casters, press down on the front of the lever. To release the casters, lift
the lever into the original horizontal position.

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Device Labels
The Cynergy laser comes with a series of required safety labels. Be sure that all personnel are
familiar with these labels and their meanings.
Figure 1A–Device Labels in Position

Cynergy Operator Manual 850-1065-000, Rev. 6 Page 15 of 78
Figure 1B–Device Labels Used

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Cynergy Operator Manual 850-1065-000, Rev. 6 Page 17 of 78
Section 3 Site Preparation
When preparing the laser site, operators should consider the spatial, electrical, environmental,
transportation and storage requirements of the laser unit.
Spatial Requirements
The Cynergy and Cynergy III systems, which include the Cynergy Pulse Light (PL) system, have
the following dimensions:
Cynergy Laser
Cynergy III
Cynergy w/Cynergy PL
Height: 40" (101 cm) 48" (121 cm)
Width: 18" (46 cm) 19" (48 cm)
Depth 31" (79 cm) 31" (79 cm)
Weight 270 lbs (123 kg) 310 lbs (141 kg)
For more information on the pulse light system, please refer to the Cynosure PL Operator
Manual.
Electrical Requirements
Please consider the following electrical requirements before installing the laser unit:
♦The AC line power requirements for the laser are:
200-240 VAC, Single Phase
30 Amps
50-60 Hz
♦The plug is NEMA L6-30.
♦Power receptacles must be within 15 feet of the laser site.
♦The power receptacle must be grounded.
♦The laser should not share a power line with other heavy power-load equipment such as
air conditioners or elevators. Ideally, the laser unit should be on a separate power line
with a separate circuit breaker.