Candela AlexTriVantage User manual

Operator’s Manual
PN 8501-00-1800 Revision 05
May 2007
Candela Corporation
Alex TriVantage ™
0123

Copyright and Disclaimer
Copyright © 2007 Candela Corporation. All rights reserved.
Contact Information
(EC Authorized Representative)
Scanlan Group B.V.
Aalsmeerderweg 610
1437 EJ Schiphol-Rozenburg
The Netherlands
Phone: [phone]
Fax: [phone]
Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886
Telephone [phone]
Toll Free [phone] (Technical Assistance)
Toll Free (800) 73-LASER (Customer Service)
Website: www.candelalaser.com
Trademarks
All brand names and product names used in this manual are trademarks, registered trademarks or trade names of their
respective holders.
Limit of Liability
The publisher has used their best efforts in preparing this manual. Candela Corporation makes no representation or warranty
with respect to the accuracy or completeness of the contents of this manual and specifically disclaims any implied warranties
of merchantability or fitness for any particular purpose and shall in no event be liable for any loss of profit or any other
commercial damage including but not limited to special, incidental, consequential, or other damages.
The information in this manual is subject to change without notice at the discretion of Candela Corporation.
Caution: Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
Federal (USA) law restricts this device to sale by or on the order of a physician or other
practitioner licensed by the law of the state in which he/she practices to use or order the use
of the device.
Federal law and some international laws also require that this device be utilized under the
direction of a physician. This device should only be used by healthcare professionals
authorized under US state or international law to treat patients. All persons treating patients
with this device should determine whether they are authorized healthcare professionals
under the applicable US state or international law.

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Table of Contents
Copyright and Disclaimer
Preface
Book Conventions ........................................................................................................... vii
Intended Audience .......................................................................................................... vii
General Safety Statements and Guidelines ................................................................... viii
Routine Maintenance ............................................................................................... viii
Definitions of Symbols (Labeling on the Equipment and Location).......................... viii
Using this Manual .......................................................................................................... xiii
Chapter 1: Getting Started
Overview ....................................................................................................................... 1-2
Laser Treatment of Skin Pigmentation Abnormalities ............................................. 1-2
Indications for Use ........................................................................................................ 1-3
Contraindications and Precautions ............................................................................... 1-3
Patient Selection ........................................................................................................... 1-4
Tattoos..................................................................................................................... 1-4
Pigmented Lesions.................................................................................................. 1-4
Warnings, Cautions, and Precautions........................................................................... 1-5
Warnings and Cautions........................................................................................... 1-5
General Hazards ............................................................................................... 1-5
Optical Hazards................................................................................................. 1-7
Electrical and Mechanical Hazards ................................................................... 1-8
Flash Fire Hazards............................................................................................ 1-9
Fire Hazards.................................................................................................... 1-10
Laser Generated Air Contaminants (LGAC) ................................................... 1-10
Electromagnetic Interference .......................................................................... 1-11
Precautions ........................................................................................................... 1-11
General Precautions ....................................................................................... 1-11
Laser Room Precautions................................................................................. 1-11
Optical Precautions ......................................................................................... 1-12
Oxygen (with or without other gases).............................................................. 1-12
Hair.................................................................................................................. 1-12
Gauze, Drapes, and Clothing.......................................................................... 1-13
Masks, Cannula and Airway Materials ............................................................ 1-13
Treatment Area Preparation............................................................................ 1-13
Anesthetics...................................................................................................... 1-13
Instruments ..................................................................................................... 1-13

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Extinguishing Fires.......................................................................................... 1-13
Safety Features........................................................................................................... 1-14
On/Off Keylock Switch .................................................................................... 1-14
Emergency Laser Stop Button ........................................................................ 1-14
Screen Lock Button......................................................................................... 1-14
Lasing Beep Sound Alert ................................................................................ 1-14
Ready Indicator ............................................................................................... 1-14
Delivery System Cable Indicator..................................................................... 1-15
Standby and Ready Operating Modes ............................................................ 1-15
Remote Interlock ............................................................................................. 1-15
Chapter 2: Understanding the Laser
Introduction ................................................................................................................... 2-3
The Laser System......................................................................................................... 2-3
System Description ................................................................................................. 2-3
Front Panel ................................................................................................................... 2-5
Touch Screen/Display Panel ................................................................................... 2-5
Controls and Connections....................................................................................... 2-6
Ready Indicator ................................................................................................. 2-6
Emergency Laser Stop...................................................................................... 2-7
On/Off Keylock Switch ...................................................................................... 2-8
Calibration Port ................................................................................................. 2-9
Delivery System Receptacle ............................................................................. 2-9
Locking Wheels....................................................................................................... 2-9
Rear Panel .................................................................................................................. 2-10
Main Power Switch and Power Cord ..................................................................... 2-11
Remote Interlock.................................................................................................... 2-11
Water Receptacle................................................................................................... 2-11
Footswitch Connector ............................................................................................ 2-11
USB Port ................................................................................................................ 2-11
Handle.................................................................................................................... 2-11
Delivery System .......................................................................................................... 2-12
Delivery System Cable.......................................................................................... 2-13
Handpieces ........................................................................................................... 2-14
Distance Gauge .................................................................................................... 2-15
Footswitch............................................................................................................. 2-15
Fiber Pole.............................................................................................................. 2-16
Cabling........................................................................................................................ 2-17
Connecting the Handpiece to the Delivery System Cable .................................... 2-17
Connecting the Delivery System Cable ................................................................ 2-18
Touch Screen/Display Panel....................................................................................... 2-19
Applications Menu................................................................................................. 2-20
Candela Clinical Treatment Guidelines........................................................... 2-22
System Status Messages...................................................................................... 2-22
Calibration Button ................................................................................................. 2-23
Standby/Ready Button and Status Area................................................................ 2-23
Standby/Ready Button .................................................................................... 2-23
Status Area ..................................................................................................... 2-25
Fluence Controls and Indicators ........................................................................... 2-26
Pulse Duration Control.......................................................................................... 2-26
Spot Size Identifier Bar ......................................................................................... 2-27

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Pulse Rate Control ................................................................................................ 2-27
Pulse Count and Pulse Count Reset Button ......................................................... 2-27
Treatment Summary Button .................................................................................. 2-28
System Configuration and Maintenance Mode Button.......................................... 2-28
Setting the System Configuration.................................................................... 2-29
Setting Maintenance Mode ............................................................................. 2-31
Screen Lock Button............................................................................................... 2-31
Dialog Boxes ......................................................................................................... 2-33
Chapter 3: Using the Laser
Introduction ................................................................................................................... 3-2
Performing a Laser Treatment ...................................................................................... 3-2
Before You Begin .................................................................................................... 3-2
Treatment Procedure .............................................................................................. 3-3
Chapter 4: Maintaining the Laser
General Information ...................................................................................................... 4-2
Cleaning and Disinfecting ............................................................................................. 4-3
Cleaning the Exterior of the Laser System.............................................................. 4-3
Cleaning the Handpieces, Distance Gauge, and Lens ........................................... 4-3
Cleaning the Touch Screen/Display Panel .............................................................. 4-4
Maintaining the Fiber Optic Delivery System ................................................................ 4-5
Maintaining the Water Cooling System......................................................................... 4-5
Calibration Procedure ................................................................................................... 4-6
System Calibration Requirements........................................................................... 4-6
Initiating a Calibration........................................................................................ 4-6
Calibration Procedure ....................................................................................... 4-6
Chapter 5: Troubleshooting the Laser
Introduction ................................................................................................................... 5-2
Troubleshooting ............................................................................................................ 5-2
Fault Messages............................................................................................................. 5-3
Chapter 6: Specifications
System Specifications................................................................................................... 6-2
Electrical Requirements .......................................................................................... 6-4
Ground Continuity Tests ................................................................................... 6-5
Environmental Requirements.................................................................................. 6-5
Space ................................................................................................................ 6-5
Air Quality.......................................................................................................... 6-5
Humidity ............................................................................................................ 6-5
Ambient Temperature ....................................................................................... 6-6
Relocation ......................................................................................................... 6-6
Mobile Use ........................................................................................................ 6-6
Transport and Storage ...................................................................................... 6-6
Internal Cooling Water Requirements ..................................................................... 6-6
Chapter 7: Laser System Packing Lists, Accessories, and Replacement Parts
Laser Parts and Accessory Kit...................................................................................... 7-2
Chapter 8: Service Internal Calibration Procedure

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Calibration Schedule..................................................................................................... 8-2
Introduction ............................................................................................................. 8-2
Parts List ................................................................................................................. 8-2
Internal Calibration........................................................................................................ 8-4
Starting the Circuit Calibration Procedure............................................................... 8-4
Laser Energy Circuit CAL ...................................................................................... 8-4
Final Verification of User Calibration Energy .......................................................... 8-5
Appendix A: Pre-Treatment Visit
General ......................................................................................................................... A-1
Counseling .................................................................................................................... A-1
Photographs.................................................................................................................. A-2
Appendix B: Treating the Patient
Training Requirements.................................................................................................. B-1
Determining the Therapeutic Energy Level................................................................... B-1
Treatment...................................................................................................................... B-2
Tattoos .................................................................................................................... B-2
Pigmented Lesions ................................................................................................. B-3
Determining the End of Treatment................................................................................ B-3
Adverse Effects............................................................................................................. B-3
Appendix C: Post-Treatment Care
General ......................................................................................................................... C-1
Makeup ......................................................................................................................... C-1
Other Recommendations .............................................................................................. C-1
Appendix D: Electromagnetic Compatibility
Regulatory Classifications....................................................................................... D-2
Index

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Preface
Welcome to the Candela Corporation’s AlexTriVantage Operator’s Manual.
Book Conventions
This guide contains the following information highlights and cross-references:
Cross references indicate the location of additional information regarding the chosen
topic. References may include either headings on specific pages or entire chapters.
Intended Audience
This guide is intended for use by physicians.
Warning: Warns the user regarding actions that may result in physical
damage to the system or personal injury.
Caution: Cautions the user regarding actions that may result in operational
issues or data loss.
Note: Identifies important points, helpful hints, special circumstances, or alternative
methods.

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General Safety Statements and Guidelines
Routine Maintenance
Only qualified personnel who are fully informed of the system’s safety hazards should
operate, maintain, and troubleshoot this equipment.
Definitions of Symbols (Labeling on the Equipment and Location)
This section details the meaning, intent, and location of the labels (containing symbols) that
appear on the AlexTriVantage Laser System.
Label Description
Label 1: Keylock Switch - OFF position. When the switch is in
the OFF position, all circuits, except the Keylock Switch circuit,
have been de-energized.
Label 1: Keylock Switch - ON position. When the switch is in
the ON position, all circuits are energized and the laser system
is fully functional.
Label 1: Keylock Switch - START position. This is a spring-
loaded keylock switch used to start system operation. This
position does not start the release of energy.
Label 2: Emergency Laser Stop. Pushing the Laser Stop
button will stop the laser immediately.
Label 3 and 19: Indicates laser radiation is being emitted from
this device.
Label 4: This label indicates that the protective panel encloses
a Class 4 laser radiation.
Label 5: Identification Label indicates manufacturer's
information, date of manufacture and power requirements of
the device.

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Label Description
Label 6: Indicates laser emission characteristics and
classification per the IEC/EN standards.
Label 7: Indicates U.S. patents that may be covered on this
laser system.
Label 8: Indicates that selected requirements under CDRH 21
CFR 1040.10 & 1040.11 were waived for comparable IEC
requirements as allowed by Laser Notice 50.
Label 9: This label indicates that a tip hazard may exist while
transporting the laser system. To avoid a tip hazard, move the
laser at a normal to slow pace, do not make sudden turns, and
use caution when traversing the system across slopes or
ramps.
OLabel 10: Main Power Switch - OFF position.
| Label 10: Main Power Switch - ON position.
Label 11: Remote interlock circuit for door switch. Indicates the
location of the remote interlock circuit that can be connected to
a door switch to shut down the laser if the door is opened
during laser emission. The symbol illustrates that an open
connection will inhibit the lasing function.
Label 12: Warning - Main Power Switch. This label draws
attention to the main power switch. The switch should be
placed in the OFF position when the system is not being used.
When the system is being used, the switch should be placed in
the ON position.
Label 13: IEC Type B Applied Part symbol. Provides delivery
system information. The icon of a man indicates that the
delivery system is equipped with a “Type B” applied part.
Label 14: Waste Electrical and Electronic Equipment symbol.
Indicates that the AlexTriVantage laser system and its
components cannot be disposed of as regular trash. Contact
Candela for disposal information.

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Label Description
Label 15: Footswitch Connection. Indicates the location of the
Footswitch connection on the rear of the laser system.
Label 16: USB Software Upgrade Port. Indicates the location
of the USB port on the rear of the laser system.
Contact Candela Clinical Sales or Service for the latest
software upgrades.
Label 17: CAUTION: Risk of electrical shock if laser covers are
removed or serviced by unauthorized persons. There are lethal
voltages inside the system enclosure.
Label 18: Water reservoir. Indicates that the reservoir should
be filled with deionized or distilled water. The reservoir should
be filled approximately once a week.
Label 20: Refer to the Operator’s Manual for the safe use of
this device.
Label 21: Provides delivery system information. The icon of a
man indicates that the delivery system is equipped with a
“Type B” applied part in accordance with IEC/EN 60601-1
Laser aperture is at the end of the fiber applicator.
Label 22: CAUTION: Remove the distance gauge before
inserting the Handpiece into the Calibration port.