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
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