Almaco Lasers Accent xl User manual

OPERATOR’S MANUAL
RADIOFREQUENCY SYSTEM
AAAP11090601

Copyright © 2007, Alma Lasers, Ltd.
No part of this manual may be reproduced or copied in any form by any means - graphic, electronic or mechanical, including
photocopying, typing, or information retrieval systems - without written permission of Alma Lasers.
System specifications and the information contained in this document are subject to change without notice.
All rights reserved. Alma Lasers Ltd., its logo, Accent™, Accent XL™, Aria®, Aria SHR™, Harmony™, HarmonyPixel™,
Pixel®, Sonata™, Soprano™, Soprano XL™, Tenor™, Hair Removal in Motion™, DualChill™and BlendMode™are the trademarks
of Alma Lasers, Ltd.
Alma Lasers Ltd.
14 Halamish St., P.O.B 3021
Caesarea Industrial Park
Caesarea, Israel 38900
Tel: [phone]
Fax: [phone]
Email: [email protected]
Alma Lasers, Inc.
485 Half Day Road
Suite # 100
Buffalo Grove, IL 60089
Tel: [phone]
Fax: [phone]
Email: [email protected]
Website: www.almalasers.com
Authorized Representative in the EC:
MEDES LTD., 6 Beaumont Gate, Shenley Hill
Radlett, Herts WD7 7AR, United Kingdom
Tel/Fax: + 44(0) 1923859810
Catalog No. AAAP11090601
Revision 1, May 2007

Table of Contents
Scope of This Manual
This operator's manual incorporates the following chapters:
Chapter 1 System Overview Contains a general introduction to the Accent XL system.
Contains explanations and directions concerning safety
measures for operating the system, international standard
compliance, classifications and regulatory labels.
Chapter 2 Safety
Lists electrical, space and environmental requirements for
installation of the system.
Chapter 3 Installation
Contains a detailed overview of the Accent XL system and
its various sub-systems and handpieces, including technical
specifications for the system and each of the handpieces.
Chapter 4 System Description
Describes the control and service panels, footswitch and
various connections to the system, and functional indicators.
Chapter 5 Controls and
Indicators
Explains how to operate the system, offering basic
information and common instructions for operation. Specific
operating instructions for each of the handpieces may be
found in the clinical guide.
Chapter 6 Operating
Instructions
Provides a detailed review of how to maintain the system.
Chapter 7 Maintenance
Lists the system error messages that might appear during
operation, their probable causes and what corrective actions
to perform.
Chapter 8 Troubleshooting
Provides information on how to order the Accent XL
system's accessories.
Chapter 9 Ordering
Information
Clinical Guide for pivotal clinical information, including
pre-, intra- and post-procedure activities.
Appendix A Clinical Guide
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Table of Contents
Table of Contents
CHAPTER 1 System Overview Page
1.1. Use of this Manual.............................................................................................1-2
1.2. Physician Responsibility ...................................................................................1-2
1.3. Maintenance ......................................................................................................1-3
1.4. Modification of the System...............................................................................1-3
1.5. Resale Inspection...............................................................................................1-3
1.6. Abbreviations and Acronyms............................................................................1-3
CHAPTER 2 Safety Page
2.1. Introduction.......................................................................................................2-2
2.2. System Safety Features......................................................................................2-2
2.2.1. Software............................................................................................2-2
2.2.2. Keyswitch..........................................................................................2-3
2.2.3. Password ..........................................................................................2-3
2.2.4. Footswitch ........................................................................................2-3
2.2.5. Emergency Shut-Off Knob................................................................2-3
2.2.6. Input Power ......................................................................................2-3
2.2.7. RF Emission Indicators ....................................................................2-4
2.2.8. Radiofrequency Emission .................................................................2-4
2.2.9. Output Power Control ......................................................................2-4
2.2.10. Grounding the System.......................................................................2-4
2.2.11. Fuse Protection.................................................................................2-4
2.2.12. Cooling System .................................................................................2-5
2.3. General Precautions and Cautions.....................................................................2-5
2.3.1. Precautions.......................................................................................2-5
2.3.2. Cautions............................................................................................2-5
2.3.3. Burn Hazards....................................................................................2-6
2.3.4. Explosion and Fire Hazards.............................................................2-6
2.3.5. High Voltage Hazards ......................................................................2-6
2.3.6. Radiofrequency Operation Safety.....................................................2-7
2.4. Equipment Classification and Compliance........................................................2-8
2.5. Device Labels....................................................................................................2-9
2.5.1. System Labels ...................................................................................2-9
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Table of Contents
2.5.2. Packaging Label.............................................................................2-11
CHAPTER 3 Installation Page
3.1. Introduction.......................................................................................................3-2
3.2. Equipment List..................................................................................................3-2
3.3. Facility Requirements .......................................................................................3-3
3.3.1. Space and Positioning......................................................................3-3
3.3.2. Electrical Requirements ...................................................................3-4
3.3.3. Environmental Requirements ...........................................................3-4
3.4. Connecting the Footswitch................................................................................3-5
3.5. Filling the Coolant Reservoir............................................................................3-5
3.6. Adjusting the Handpiece Support Arms............................................................3-6
3.7. Connecting the Handpiece ................................................................................3-8
3.8. Connecting the Dummy Handpiece Connector...............................................3-11
3.9. Storage and Transportation .............................................................................3-12
3.9.1. Cooling System Drainage...............................................................3-12
3.9.2. Moving the System..........................................................................3-12
CHAPTER 4 System Description Page
4.1. Introduction.......................................................................................................4-2
4.2. System Components and Controls ....................................................................4-2
4.2.1. System Console.................................................................................4-3
4.2.2. The Control Panel ............................................................................4-3
4.2.3. The Service Panel.............................................................................4-3
4.2.4. Handpieces.......................................................................................4-4
4.2.5. System Software................................................................................4-6
4.2.6. Cooling System.................................................................................4-6
4.2.7. Fans..................................................................................................4-6
4.3. System Features.................................................................................................4-6
4.3.1. Operator-Selectable Operating Parameters ....................................4-6
4.3.2. Save Option ......................................................................................4-7
4.3.3. Tissue Cooling..................................................................................4-7
4.3.4. Technician Mode..............................................................................4-8
4.4. System Specifications .......................................................................................4-8
4.4.1. Output...............................................................................................4-8
4.4.2. Operation and Control.....................................................................4-9
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Table of Contents
4.4.3. Physical ............................................................................................4-9
4.4.4. System Requirements......................................................................4-10
4.4.5. Delivery System ..............................................................................4-10
4.4.6. Classifications ................................................................................4-10
CHAPTER 5 Controls and Indicators Page
5.1. Introduction.......................................................................................................5-2
5.2. Control Panel Components................................................................................5-2
5.2.1. Keyswitch..........................................................................................5-3
5.2.2. Emergency Shut-Off Knob................................................................5-4
5.2.3. RF Emission Indicators ....................................................................5-4
5.2.4. RUN LED..........................................................................................5-4
5.2.5. Touch-Screen Panel..........................................................................5-5
5.3. Service Panel Components................................................................................5-6
5.4. Handpiece Trigger.............................................................................................5-7
5.5. Footswitch.........................................................................................................5-8
5.6. Handpiece Connection Ports .............................................................................5-9
CHAPTER 6 Operating Instructions Page
6.1. Introduction.......................................................................................................6-2
6.2. Prepare the System for Operation......................................................................6-2
6.3. Operating the System ........................................................................................6-2
6.4. Turn on the System............................................................................................6-3
6.5. Select the Handpiece .........................................................................................6-5
6.6. Graphic User Interface ......................................................................................6-5
6.7. Set the Operating Parameters ............................................................................6-7
6.7.1. Set the Power....................................................................................6-7
6.7.2. Set the Time ......................................................................................6-7
6.7.3. Set the Cooling Mode .......................................................................6-8
6.7.4. Set the System to Ready Mode ..........................................................6-8
6.8. Emitting Radiofrequency Energy......................................................................6-8
6.9. Pause in Operation.............................................................................................6-9
6.10. Changing Operation Parameters during Operation ...........................................6-9
6.11. Saving the Settings............................................................................................6-9
6.12. Switch to a Different Handpiece .....................................................................6-10
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Table of Contents
6.13. System Shut-Down..........................................................................................6-10
6.14. Error Detection................................................................................................6-11
CHAPTER 7 Maintenance Page
7.1. Introduction.......................................................................................................7-2
7.2. Periodic Service.................................................................................................7-2
7.3. Service Information...........................................................................................7-3
7.4. Routine and Preventive Maintenance................................................................7-4
7.4.1. Cleaning and Disinfecting the System..............................................7-4
7.4.2. Cleaning and Disinfecting the Handpieces......................................7-4
7.5. Filling and Draining the Cooling System..........................................................7-5
7.5.1. Filling the Cooling System ...............................................................7-5
7.5.2. Draining the Cooling System............................................................7-7
7.6. Fuse Replacement .............................................................................................7-8
CHAPTER 8 Troubleshooting Page
8.1. Introduction.......................................................................................................8-2
8.2. Troubleshooting Guides....................................................................................8-2
CHAPTER 9 Ordering Information Page
9.1. Ordering Information Parts List........................................................................9-2
APPENDIX A Clinical Guide Page
A.1. Introduction...................................................................................................... A-2
A.2. Training Requirements..................................................................................... A-2
A.3. Intended Use and Indications........................................................................... A-2
A.4. Contraindications ............................................................................................. A-2
A.5. Special Considerations..................................................................................... A-3
A.6. Adverse Effects of Treatment........................................................................... A-3
A.7. Accessories and Equipment.............................................................................. A-3
A.8. Pre-Treatment Information............................................................................... A-4
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Table of Contents
A.8.1. General.............................................................................................A-4
A.8.2. Counseling........................................................................................A-4
A.9. Photography......................................................................................................A-5
A.10. Treatment..........................................................................................................A-5
A.10.1. Handpieces: Practical Considerations of Operation and
Technique..........................................................................................A-6
A.10.2. Facial Treatment Areas....................................................................A-7
A.10.3. Treatment Objectives........................................................................A-8
A.10.4. End-Points........................................................................................A-8
A.10.5. Handpiece Operation........................................................................A-8
A.11. Treatment Protocol...........................................................................................A-8
A.12. Treatment Guidelines in the Periorbital & Perioral Areas..............................A-10
A.12.1. Unipolar Handpiece .......................................................................A-10
A.12.2. Bipolar Handpiece..........................................................................A-11
A.13. Post-Treatment ...............................................................................................A-14
A.14. Follow-Up ......................................................................................................A-14
List of Figures
Figure Description Page
Figure 2-1: Identification Label ..............................................................................................................2-9
Figure 2-2: Electrical Requirement and Hazard Label..........................................................................2-10
Figure 2-3: Shipping Crate Label..........................................................................................................2-11
Figure 3-1: System Dimensions ..............................................................................................................3-3
Figure 3-2: Footswitch Connection Port .................................................................................................3-5
Figure 3-3: Handpiece Support Arms and Locks....................................................................................3-6
Figure 3-4: Releasing the Handpiece Support Arm Lock .......................................................................3-6
Figure 3-5: Adjusting the Height of the Handpiece Support Arm ..........................................................3-7
Figure 3-6: Handpieces on the Handpiece Holders.................................................................................3-8
Figure 3-7: Control Panel Opened..........................................................................................................3-8
Figure 3-8: Inserting the Handpiece into the Port...................................................................................3-9
Figure 3-9: Hooking the Locking Handle to the Fastener Pin.................................................................3-9
Figure 3-10: Pushing Down the Locking Handle..................................................................................3-10
Figure 3-11: Connecting the Second Handpiece...................................................................................3-10
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Table of Contents
3-12: Closing the Control Panel (with the Handpieces Connected) ..........................................3-10
Figure
Figure 3-13: Dummy Handpiece Connector.........................................................................................3-11
Figure 3-14: System Handle..................................................................................................................3-12
Figure 4-1: The Accent XL System ........................................................................................................4-2
Figure 4-2: Accent XL Handpieces.........................................................................................................4-4
Figure 4-3: Handpiece Components........................................................................................................4-5
Figure 5-1: Accent XL Control Panel.....................................................................................................5-2
Figure 5-2: Control Panel Components...................................................................................................5-3
Figure 5-3: Service Panel Components...................................................................................................5-6
Figure 5-4: Handpiece Trigger................................................................................................................5-7
Figure 5-5: Footswitch............................................................................................................................5-8
Figure 5-6: Handpiece Connection Ports under the Control Panel.........................................................5-9
Figure 6-1: Keyswitch Off Screen ..........................................................................................................6-3
Figure 6-2: System Start Screen..............................................................................................................6-4
Figure 6-3: Handpiece Selection Screen.................................................................................................6-4
Figure 6-4: Main Treatment Screen Elements ........................................................................................6-5
Figure 7-1: Water Filling/Draining Kit...................................................................................................7-5
Figure 7-2: Connecting the Elbow Fitting to the VENT Port .................................................................7-5
Figure 7-3: Connecting the Funnel Tube to the FILL/DRAIN Port........................................................7-6
Figure 7-4: Disconnecting the Funnel Tube and the Elbow Fitting from the Ports' Quick-Connectors.7-6
Figure 7-5: Draining the Cooling System...............................................................................................7-7
Figure 7-6: Fuse Housing Removal ........................................................................................................7-8
Figure A-1: Accent XL Handpieces.......................................................................................................A-5
Figure A-2: Facial Treatment Areas....................................................................................................... A-7
Accent XL™Operator's Manual
vii

CHAPTER 1
System Overview
Chapter Contents:
Section Title Page
1.1. Use of this Manual............................................................................. 1-2
1.2. Physician Responsibility.................................................................... 1-2
1.3. Maintenance....................................................................................... 1-3
1.4. Modification of the System ............................................................... 1-3
1.5. Resale Inspection............................................................................... 1-3
1.6. Abbreviations and Acronyms............................................................ 1-3
Accent XL™Operator's Manual 1-1

System Overview
1.1. Use of this Manual
The Accent XL system is designed to meet international safety and performance
standards. Personnel operating the system must have a thorough understanding of
the proper operation of the Accent XL.
This manual has been prepared to aid medical and technical personnel to understand
and operate the system. Do not operate the system before reading this manual and
gaining a clear understanding of system operation. If any part of this manual is not
clear, please contact your Alma Lasers representative for clarification.
Warning
Use of controls or adjustments, or performance of procedures other than those
specified herein may put the operator and/or the patient at risk. Therefore, before
attempting to use or operate the system, personnel operating the Accent XL system
should read this manual and become thoroughly familiar with all its safety
requirements and operating procedures.
The information provided in this manual is not intended to replace the professional
training on the clinical use of the system. Please contact your Alma Lasers
representative for current information on available training. For clinical
information, refer to the Clinical Guide appendices that include set up guidelines
for each application.
This manual should always accompany the system and all operating personnel must
know its location. Additional copies of this manual are available from Alma Lasers
or your local Alma Lasers representative.
For further information about Alma Lasers, visit the company website at:
http://www.almalasers.com.
1.2. Physician Responsibility
Federal (USA) law restricts prescription of medical devices for sale by or on the
order of a physician, or properly licensed practitioner. The properly licensed
practitioner will be responsible for the use and operation of the device and for all
operator qualifications. Alma Lasers makes no representations regarding federal,
state or local laws or regulations that might apply to the use and operation of any
medical device. The physician is responsible for contacting his or her local
licensing agencies to determine any credential required by law for clinical use and
the operation of the device.
1-2 Accent XL™Operator's Manual

System Overview
1.3. Maintenance
The Accent XL system is a precision, technical medical device that requires
periodic routine maintenance service, which must be performed by Alma Lasers
authorized technical personnel. Failure to obtain service voids all warranties
expressed and implied. Please contact Alma Lasers or your local representative for
details.
1.4. Modification of the System
Unauthorized modification of the hardware, software or specifications of the
Accent XL system voids all warranties, expressed and implied. Alma Lasers takes
no responsibility for the use or operation of such a modified device.
1.5. Resale Inspection
The Accent XL is a precision, technical medical device. If any Alma Lasers device
is resold by anyone other than an authorized sales representative, Alma Lasers
offers a resale inspection by an Alma Lasers technician to assure that the device is
working in accordance with manufacturer’s specifications. Using the device after it
has been resold and before it has been inspected is a misuse of the device, which
may result in injuries and voids all warranties, expressed and implied.
Alma Lasers also offers service contracts and extended warranties for its devices.
For more information about the services or about the costs of inspections or service
calls, please contact Alma Lasers or your local representative.
1.6. Abbreviations and Acronyms
°C Degree(s) Centigrade/Celsius
Degree(s) Fahrenheit
°F
Ampere(s)
A
Alternating current
AC
Code of Federal Regulations
CFR
Centimeter(s)
cm
Direct current
DC
Hertz
Hz
Accent XL™Operator's Manual 1-3

System Overview
International Electrotechnical Commission
IEC
Impedance matching network
IMN
Infrared
IR
Joule(s)
J
Kilogram(s)
Kg.
Pound(s)
Lb.
Liquid crystal display
LCD
Light emitting diode
LED
Meter(s)
m
Millimeter(s)
mm
Mega
M
Pulse width modulation
PWM
Radiofrequency
RF
Second(s)
Sec
Thermoelectric cooling
TEC
Volt(s)
V
Volt(s) alternating current
VAC
Volt(s) direct current
VDC
Watt(s)
W
1-4 Accent XL™Operator's Manual

CHAPTER 2
Safety
Chapter Contents:
Section Title Page
2.1. Introduction ....................................................................................... 2-2
2.2. System Safety Features...................................................................... 2-2
2.3. General Precautions and Cautions..................................................... 2-5
2.4. Equipment Classification and Compliance........................................ 2-8
2.5. Device Labels .................................................................................... 2-9
Accent XL™Operator's Manual 2-1

Safety
2.1. Introduction
This chapter describes general safety issues regarding the use of the Accent XL
system, with special emphasis on radiofrequency and electrical safety.
Warning
Hazardous voltages are energized when the emergency shut-off knob is engaged.
Note
Federal law (USA) restricts this device to only be sold to, or on
the order of a physician or any practitioner licensed by the law
of the state in which he or she practices or intends to use or
order the use of the device.
The Accent XL system is intended for use in dermatologic and general surgical
procedures.
With proper operation and maintenance, trained and qualified medical practitioners
can use the system safely. The supervising physician and all other personnel
operating or maintaining the Accent XL must be familiar with the safety
information provided in this chapter.
The primary consideration should be for the safety of the patient, the physician and
other personnel. Patient safety is mainly assured with a well trained staff and a well
laid out treatment room. Patient education is also important, including information
about the nature of the treatment.
2.2. System Safety Features
The Accent XL system was designed to maximize safety for both patient and
personnel. The following are some of the Accent XL's preventive safety measures:
2.2.1. Software
•Once the system is turned on, the software checks all safety-related hardware
features.
•A watchdog cycle continuously monitors the safe system operation during the
treatment.
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Safety
•If an error occurs, the system displays a warning message and, if necessary, the
software shuts down the system.
2.2.2. Keyswitch
•The system can be turned on only when the key is inserted in the keyswitch.
•When not in operation, the key should be removed to prevent unauthorized use
of the system.
2.2.3. Password
The password on the service screen switches the system to Technician mode.
A separate additional password is required to enter to the Handpiece Calibration
screen.
These passwords prevent unauthorized modifications of the system's settings.
2.2.4. Footswitch
The system is equipped with a pneumatic footswitch to eliminate the possibility of
short-circuiting in the footswitch wiring and to increase its durability to fluids.
2.2.5. Emergency Shut-Off Knob
When pressed, the emergency shut-off knob cuts the power supply to the system,
which results in immediate shut-down of the entire system.
2.2.6. Input Power
The system's isolation transformer insulates the device and reduces current leakage.
The system is also fuse-protected against mains power surges.
Accent XL™Operator's Manual 2-3

Safety
2.2.7. RF Emission Indicators
The red light indicator on the control panel and the blue LED indicator on the
handpieces are illuminated both prior to and during radiofrequency emission:
•In Ready mode, the indicators blink to indicate that radiofrequency
emission will occur when the handpiece trigger or the footswitch is pressed.
•During radiofrequency emission, the indicators are illuminated
continuously.
2.2.8. Radiofrequency Emission
The system enables radiofrequency emission only when the following conditions
are met:
1. The system is in Ready mode.
2. The handpiece trigger or the footswitch is pressed.
The system does not allow radiofrequency emission in any other condition.
2.2.9. Output Power Control
The system controls output power using PWM (Pulse Width Modulation). The
maximum power never exceeds the preinstalled radiofrequency power limits.
2.2.10. Grounding the System
The system is grounded through the grounding conductor in the power cable and
internal grounding pin.
2.2.11. Fuse Protection
The system is protected by two slow blow type fuses. The fuses are located in the
fuse housing on the rear panel.
For detailed instructions on fuse replacement, refer to Chapter 8.
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Safety
2.2.12. Cooling System
The cooling system cools the active handpiece by a constant flow of coolant
(deionized water). The system continuously monitors the flow rate and temperature
of the coolant.
A protection system stops the operation if:
•The coolant flow drops below the permitted level
•The coolant temperature rises above the permitted level
•The level of the coolant drops below the permitted level
2.3. General Precautions and Cautions
The following precautions, cautions and warnings must be observed for the safe use
of the Accent XL system.
2.3.1. Precautions
•Physicians and clinicians should read this manual thoroughly before attempting
to operate the Accent XL system.
•Handpieces and handpiece tips must be kept clean at all times.
•The system weighs approximately 110 lbs. (50 kg) and may cause injury if
proper care is not used when moving it. The system is well balanced and is
designed to be moved, but should always be moved carefully and slowly. Never
pull the system by the handpieces.
2.3.2. Cautions
•Only Alma Lasers authorized personnel may service the Accent XL system.
This includes making internal adjustments to the power supply, cooling system,
handpieces, etc.
•Maintenance performed by the operator must only take place when the system is
shut down and disconnected from the electrical power source. Performing
maintenance procedures with the system powered-up can be hazardous to the
operator and/or destructive to the system.
•Always turn off the system when it is not in use.
•Never leave the system in Ready mode unattended.
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Safety
•Never allow untrained personnel to operate the system.
•Never press the trigger or footswitch unless the handpiece is safely oriented at a
specific and intended target.
•Never leave the system turned on, open or unattended during system
maintenance.
2.3.3. Burn Hazards
The Accent XL system is a state-of-the-art radiofrequency system for medical,
aesthetic and cosmetic applications. The system emits radiofrequency energy that
can damage the skin in case of the use of excessive energy.
2.3.4. Explosion and Fire Hazards
•The system is not suitable for use in the presence of flammable mixtures with
air or oxygen.
•Do not operate in the presence of volatile solvents such as alcohol, gasoline or
other solvents.
•Do not use any flammable substances such as alcohol or acetone in the
preparation of the skin for treatment. If necessary, use soap and water to clean
before treatment.
•If alcohol is used to clean and disinfect any part of the Accent XL system,
allow it to dry thoroughly before operating the system.
•Flammable materials must be kept at a safe distance from the system.
2.3.5. High Voltage Hazards
The system utilizes 110-120 VAC. To avoid personnel injury, do not operate the
system before ensuring that the exterior panels are properly closed. Do not attempt
to remove or disassemble the exterior panels.
The Accent XL system produces very high voltages in various components. Some
components may retain a charge after the power supply has been turned off, so no
part of the exterior housing should be removed, except by Alma Lasers authorized
personnel.
Whenever system maintenance is performed, never leave the Accent XL system
turned on, open or unattended.
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