multi-application, multi-technology … · lists electrical, space and environmental requirements...

O P E R A T O R ’ S M A N U A L

M U L T I - A P P L I C A T I O N ,M U L T I - T E C H N O L O G Y P L A T F O R M

Copyright © 2010, 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®, Harmony®XL, HarmonyPixel™ , Pixel®, Sonata®, Soprano®, Soprano®XL, Tenor™ , Pixel® CO2, Hair Removal in Motion™ , DualChill™ , BlendMode™ , Wellbeing Through Technology® and The Magic of Light® are the trademarks of Alma Lasers, Ltd.

Alma Lasers Ltd. 14 Halamish St., P.O.B. 3021 Caesarea Industrial Park Caesarea, Israel 38900 Tel: +972-4-627-5357 Fax: +972-4-627-5368 Email: [email protected] Alma Lasers, Inc. 485 Half Day Road Suite # 100 Buffalo Grove, IL 60089 Tel: 1-224-377-2000 Fax: 1-224-377-2050 Email: [email protected] Website: www.almalasers.com Authorized Representative in the EC: A B C Lasers 292 Hills Road, Great Shelford Cambridge, CB2 0QG, UK Tel: +44 (0) 845 170 7788 Fax: +44 (0) 1223 846471

Catalog No. OMSP20011001 Revision 2, October 2010

mailto:[email protected]


www.almalasers.com

Scope of Manual

Scope of This Manual This Operator's Manual incorporates the following chapters:

Chapter 1 Introduction Offers a few basic precautions concerning the use of the SopranoXL system, its care and maintenance, and a list of definitions for abbreviations and acronyms that will be found throughout the manual.

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 system and its various components. Detailed specifications of all facets of the system appear at the end of this chapter.

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. 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 SopranoXL system platform's accessories and spare parts.

Chapter 9 Ordering Information

Clinical Guide for pivotal clinical information and pre-procedure activities.

Appendix A Clinical Guide: General Clinical Information

Clinical Guide for use of the SopranoXL system's diode laser module to remove unwanted hair and to effect long-term hair reduction in SHR mode.

Appendix B Clinical Guide: Diode Laser Module; SHR Mode

Clinical Guide for use of the SopranoXL system's diode laser module to remove unwanted hair and to effect long-term hair reduction in SHR mode, in particularly small areas.

Appendix C Clinical Guide: Diode Laser Module; SHR Stack Sub-Mode

Clinical Guide for use of the SopranoXL system's diode laser module to remove unwanted hair and to effect long-term hair reduction in LHR mode.

Appendix D Clinical Guide: Diode Laser Module; LHR Mode

Soprano®XL Operator's Manual i

Scope of Manual

Soprano®XL Operator's Manual ii

Appendix E * Clinical Guide: NIR Module; Muscle & Joint Pain Relief

Clinical Guide for use of the SopranoXL system's NIR module for relief of minor muscle pain and joint pain and stiffness.

Appendix F * Clinical Guide: Dorsal Hand Rejuvenation

Clinical Guide for use of the SopranoXL system's NIR module for dorsal hand rejuvenation.

* The NIR module discussed in this manual is not available in Canada.

Table of Contents

Soprano®XL Operator's Manual iii

Table of Contents

CHAPTER 1 Introduction Page

1.1. Use of this Manual ............................................................................................ 1-2 1.2. Physician Responsibility ................................................................................... 1-3 1.3. Maintenance ...................................................................................................... 1-3 1.4. Modification of the System............................................................................... 1-3 1.5. Resale Inspection............................................................................................... 1-3 1.6. Abbreviations and Acronyms............................................................................ 1-4

CHAPTER 2 Safety Page

2.1. Introduction ....................................................................................................... 2-2 2.2. System Safety Measures.................................................................................... 2-3

2.2.1. Electrical Safety................................................................................ 2-3 2.2.2. Light and Laser Safety...................................................................... 2-3

2.3. The Treatment Room......................................................................................... 2-5 2.4. General Precautions and Cautions..................................................................... 2-6

2.4.1. Precautions ....................................................................................... 2-6 2.4.2. Cautions............................................................................................ 2-6

2.5. Warnings Related to Laser/Intense Light Emission .......................................... 2-7 2.5.1. Burn Hazards .................................................................................... 2-7 2.5.2. Direct and Reflected Eye Exposure Hazards.................................... 2-7 2.5.3. Safety Eyewear................................................................................. 2-7 2.5.4. Explosion and Fire Hazards.............................................................. 2-8 2.5.5. High Voltage Hazards ...................................................................... 2-8 2.5.6. Grounding the System ...................................................................... 2-8

2.6. System Safety Features ..................................................................................... 2-9 2.6.1. Emergency Shut-Off Knob............................................................... 2-9 2.6.2. Light Emission Indicators................................................................. 2-9 2.6.3. Remote Interlock Connector........................................................... 2-10 2.6.4. Double-Tiered Security for Laser Emission................................... 2-10 2.6.5. Footswitch ...................................................................................... 2-10 2.6.6. Tissue Cooling System................................................................... 2-10 2.6.7. Module Design ............................................................................... 2-10

2.7. Equipment Classification and Compliance ..................................................... 2-11

Table of Contents

2.7.1. Classification of the System According to IEC 60601-1................ 2-11 2.8. Device Labels ..................................................................................................2-12

2.8.1. System Labels.................................................................................2-12 2.8.2. Module Labels ................................................................................2-15 2.8.3. Packaging Label .............................................................................2-17

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. Unpack the System............................................................................................3-5 3.5. System Installation ............................................................................................3-7

3.5.1. Connect the Module's Cradle and Umbilical Support Roller ...........3-7 3.5.2. Module Connection ..........................................................................3-8 3.5.3. Remote Interlock Connection ...........................................................3-9 3.5.4. Footswitch Connection ...................................................................3-10 3.5.5. Filling the Coolant Reservoir..........................................................3-10

3.6. Cooling System Drainage................................................................................3-10 3.7. Moving the System..........................................................................................3-10

CHAPTER 4 System Description Page

4.1. Introduction .......................................................................................................4-2 4.2. General System Description and Intended Use .................................................4-2 4.3. System Components and Controls.....................................................................4-3

4.3.1. Main Console....................................................................................4-4 4.3.2. System Controls................................................................................4-5 4.3.3. Power Supply Modules.....................................................................4-5 4.3.4. System Controller .............................................................................4-6

4.3.4.1. System Software 4-6 4.3.4.2. Error Detection 4-6

4.3.5. Cooling System.................................................................................4-6 4.3.5.1. Water Cooling System 4-6 4.3.5.2. Integrated Contact Tissue Cooling System 4-7

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4.3.5.3. Fans 4-7 4.3.6. Isolation Transformer ....................................................................... 4-7

4.4. SopranoXL Modules ........................................................................................... 4-8 4.4.1. Diode Laser Module ......................................................................... 4-8

4.4.1.1. Hair Removal Mode Descriptions 4-8 4.4.2. NIR Module.................................................................................... 4-10

4.5. System Specifications ..................................................................................... 4-11 4.5.1. Diode Laser Module Output ........................................................... 4-11 4.5.2. NIR Module Output........................................................................ 4-12 4.5.3. Operation and Control .................................................................... 4-12 4.5.4. Physical .......................................................................................... 4-13 4.5.5. System Requirements ..................................................................... 4-13 4.5.6. Delivery Systems............................................................................ 4-13 4.5.7. Classifications................................................................................. 4-14

CHAPTER 5 Controls and Indicators Page

5.1. Introduction ....................................................................................................... 5-2 5.2. Control Panel..................................................................................................... 5-2

5.2.1. LCD Touch-Screen Panel................................................................. 5-3 5.2.2. Tissue Cooling System Status Indicator........................................... 5-4 5.2.3. Emergency Shut-off Knob................................................................ 5-4 5.2.4. Light/Laser Emission Indicators....................................................... 5-4 5.2.5. Keyswitch ......................................................................................... 5-5

5.3. Service Panel ..................................................................................................... 5-5 5.3.1. Main Circuit Breaker ........................................................................ 5-6 5.3.2. Main Power Switch .......................................................................... 5-6 5.3.3. Buzzer Potentiometer ....................................................................... 5-6

5.4. Diode Laser Module's Trigger........................................................................... 5-7 5.5. Footswitch ......................................................................................................... 5-8

CHAPTER 6 Operating Instructions Page

6.1. Introduction ....................................................................................................... 6-2 6.2. Error Detection.................................................................................................. 6-2 6.3. Preparing the System for Operation .................................................................. 6-3 6.4. Operating the System ........................................................................................ 6-3

6.4.1. Starting the System........................................................................... 6-4

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Table of Contents

6.4.1.1. Diode Laser Module 6-4 6.4.1.2. NIR Module 6-6

6.4.2. Working with the Control Panel .......................................................6-6 6.4.3. Setting Operating Parameters – LHR Mode.....................................6-7

6.4.3.1. Setting the Repetition Rate in LHR Pulse Types I through VI 6-9

6.4.4. Setting Operating Parameters – SHR Stack Mode......................... 6-11 6.4.5. Setting Operating Parameters – NIR Module.................................6-12 6.4.6. Saving Parameter Settings ..............................................................6-14 6.4.7. Initiating Light/Laser Emission ......................................................6-14 6.4.8. Pause in Operation..........................................................................6-15 6.4.9. Changing Parameters during Operation..........................................6-15

6.5. Turning the System Off ...................................................................................6-15

CHAPTER 7 Maintenance Page

7.1. Introduction .......................................................................................................7-2 7.2. Periodic Service.................................................................................................7-2 7.3. Service Information ...........................................................................................7-3 7.4. Routine Maintenance.........................................................................................7-4

7.4.1. Cleaning and Disinfecting the System..............................................7-4 7.4.2. Modules ............................................................................................7-4 7.4.3. Filling/Draining the Cooling System's Water Reservoir ..................7-5

7.4.3.1. Water Filling Procedure 7-6 7.4.3.2. Water Draining Procedure 7-7

CHAPTER 8 Troubleshooting Page

8.1. Introduction .......................................................................................................8-2 8.2. Warranty............................................................................................................8-2 8.3. Troubleshooting Guides ....................................................................................8-2

CHAPTER 9 Ordering Information Page

9.1. Ordering Information Parts List ........................................................................9-2

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Table of Contents

APPENDIX A Clinical Guide - General Clinical Information Page

A.1. Introduction ...................................................................................................... A-2 A.2. Training Requirements ..................................................................................... A-2 A.3. Intended Use and Indications ........................................................................... A-2 A.4. General Contraindications................................................................................ A-3 A.5. Adverse Effects of Treatment........................................................................... A-3 A.6. Potential Side Effects of Treatment.................................................................. A-4 A.7. Eye Protection .................................................................................................. A-4 A.8. Optical Safety................................................................................................... A-5 A.9. Fire Safety ........................................................................................................ A-5 A.10. Definitions........................................................................................................ A-6

A.10.1. Fluence ............................................................................................ A-6 A.10.2. KiloJoules (kJ)................................................................................. A-6 A.10.3. Segmentation ................................................................................... A-6 A.10.4. Pre-Treatment .................................................................................. A-6 A.10.5. Pulse Type ....................................................................................... A-6 A.10.6. DualChill™ Technique..................................................................... A-7

A.11. Counseling........................................................................................................ A-7 A.12. Photography ..................................................................................................... A-8 A.13. Post-Treatment Care......................................................................................... A-8

APPENDIX B Clinical Guide - SHR Mode Page

B.1. Introduction ...................................................................................................... B-2 B.2. Intended Use and Indications ........................................................................... B-2 B.3. Contraindications ............................................................................................. B-2 B.4. Pre-Treatment................................................................................................... B-3

B.4.1. General ............................................................................................ B-3 B.4.2. Counseling....................................................................................... B-3 B.4.3. SHR Mode Skin Test....................................................................... B-4

B.5. Treatment ......................................................................................................... B-5 B.5.1. General ............................................................................................ B-5 B.5.2. System Default Parameters.............................................................. B-6 B.5.3. Treatment Procedure ....................................................................... B-7 B.5.4. Treatment Areas .............................................................................. B-8

B.6. Treatment Parameters....................................................................................... B-9 B.7. Suggested Setup Parameters for SHR Mode.................................................. B-10

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Table of Contents

B.8. SHR Mode – Suggestions for Treating Thin, Light Colored Hair................. B-10 B.9. Post-Treatment Care ....................................................................................... B-11 B.10. Concluding Treatment .................................................................................... B-11 B.11. Follow-Up ...................................................................................................... B-12

APPENDIX C Clinical Guide - SHR Stack Sub-Mode Page

C.1. Introduction ...................................................................................................... C-2 C.2. Intended Use and Indications ........................................................................... C-2 C.3. Contraindications.............................................................................................. C-2 C.4. Pre-Treatment ................................................................................................... C-3

C.4.1. General............................................................................................. C-3 C.4.2. Counseling ....................................................................................... C-4 C.4.3. SHR Stack Sub-Mode Skin Test...................................................... C-4

C.5. Treatment.......................................................................................................... C-5 C.6. Treatment Parameters ....................................................................................... C-7

C.6.1. Suggested Setup Parameters for SHR Stack Sub-Mode .................. C-8 C.7. Total Energy (kJ) Invested per Area Size (cm2)............................................... C-9 C.8. Post-Treatment Care ....................................................................................... C-10 C.9. Concluding Treatment .................................................................................... C-10 C.10. Follow-Up ...................................................................................................... C-11

APPENDIX D Clinical Guide - LHR Mode Page

D.1. Introduction ...................................................................................................... D-2 D.2. Intended Use and Indications ........................................................................... D-2 D.3. Contraindications.............................................................................................. D-2 D.4. Pre-Treatment ................................................................................................... D-3

D.4.1. General............................................................................................. D-3 D.4.2. Counseling ....................................................................................... D-3 D.4.3. LHR Mode Skin Test....................................................................... D-4 D.4.4. Topical Anesthesia........................................................................... D-4

D.5. Treatment.......................................................................................................... D-5 D.6. Treatment Parameters ....................................................................................... D-7 D.7. Suggested Setup Parameters for LHR Mode.................................................... D-7 D.8. Concluding Treatment ...................................................................................... D-8 D.9. Follow-Up ........................................................................................................ D-8

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Table of Contents

APPENDIX E Clinical Guide -NIR Module Page

E.1. Introduction .......................................................................................................E-2 E.2. Intended Use and Indications ............................................................................E-2 E.3. Contraindications ..............................................................................................E-2 E.4. Pre-Treatment....................................................................................................E-3

E.4.1. General .............................................................................................E-3 E.4.2. Counseling........................................................................................E-3 E.4.3. Module Operation.............................................................................E-3 E.4.4. Module Parameters ...........................................................................E-4 E.4.5. NIR Mode Skin Test.........................................................................E-4

E.5. Treatment ..........................................................................................................E-4 E.6. Suggested Setup Parameters for NIR Mode......................................................E-7 E.7. Post-Treatment Care..........................................................................................E-8 E.8. Concluding Treatment.......................................................................................E-8 E.9. Follow-Up .........................................................................................................E-8

APPENDIX F Clinical Guide -Dorsal Hand Rejuvenation Page

F.1. Introduction .......................................................................................................F-2 F.2. Intended Use and Indications ............................................................................F-2 F.3. Optical Safety....................................................................................................F-3 F.4. Skin Test............................................................................................................F-3 F.5. Treatment ..........................................................................................................F-4 F.6. Suggested Setup Parameters..............................................................................F-5 F.7. Post-Treatment Care..........................................................................................F-6 F.8. Follow-Up .........................................................................................................F-6

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Table of Contents

List of Figures

Figure Description Page

Figure 2-1: Treatment Room Warning Sign........................................................................2-5 Figure 2-2: Identification Labels .......................................................................................2-12 Figure 2-3: Laser Emission Danger Warning Label..........................................................2-13 Figure 2-4: Diode Laser Class 4 Label..............................................................................2-13 Figure 2-5: Laser Emission Danger Label.........................................................................2-13 Figure 2-6: Electrical Requirement and Hazard Labels ....................................................2-14 Figure 2-7: Grounded Cable Warning Label.....................................................................2-14 Figure 2-8: Module Identification Labels .........................................................................2-15 Figure 2-9: Laser Aperture Warning Label on Diode Laser Module ................................2-15 Figure 2-10: Laser/Light Emission Warning Labels .........................................................2-16 Figure 2-11: Shipping Crate Label ....................................................................................2-17 Figure 3-1: System Dimensions ..........................................................................................3-3 Figure 3-2: SopranoXL Shipping Crate ................................................................................3-5 Figure 3-3: Unpacking the System (1) ................................................................................3-5 Figure 3-4: Unpacking the System (2) ................................................................................3-6 Figure 3-5: Unpacking the System (3) ................................................................................3-6 Figure 3-6: Module's Cradle and Umbilical Support Roller Connection ............................3-7 Figure 3-7: Module Connection ..........................................................................................3-8 Figure 3-8: Remote Interlock and Footswitch Connections ................................................3-9 Figure 4-1: Major System Components...............................................................................4-3 Figure 4-2: Block Diagram..................................................................................................4-4 Figure 4-3: System Controls................................................................................................4-5 Figure 4-4: Diode Laser Module .........................................................................................4-9 Figure 4-5: Near Infrared (NIR) Module...........................................................................4-10 Figure 5-1: Control Panel ....................................................................................................5-2 Figure 5-2: LCD Touch-Screen Panel .................................................................................5-3 Figure 5-3: Tissue Cooling System Status Indicator ...........................................................5-4 Figure 5-4: Service Panel ....................................................................................................5-5 Figure 5-5: Diode Laser Module's Trigger ..........................................................................5-7 Figure 5-6: Footswitch ........................................................................................................5-8 Figure 6-1: Treatment Area Selection Screen (Female) ......................................................6-4 Figure 6-2: Diode Laser Module Operating Screen (SHR Mode).......................................6-5 Figure 6-3: Diode Laser Module Operating Screen (LHR Mode) ......................................6-5 Figure 6-4: NIR Module Operating Screen .........................................................................6-6 Figure 6-5: Operating Screen Elements...............................................................................6-7

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Table of Contents

Figure 6-6: SHR Stack Mode ............................................................................................ 6-11 Figure 6-7: Operating Screen Elements – NIR Module.................................................... 6-12 Figure 7-1: Water Filling Kit .............................................................................................. 7-5 Figure 7-2: Water Reservoir Filling Port on the Service Panel........................................... 7-6 Figure 7-3: Draining the Water from the Reservoir ............................................................ 7-7 Figure B-1: Grid Marking Using 8 Landmarks................................................................. B-3 Figure B-2: Recommended Default Parameters in the Lower Leg Treatment Area .......... B-5 Figure C-1: Grid marking using 8 landmarks ................................................................... C-3 Figure C-2: Location of the Stack Button on the Treatment Area Screen;

Select Stacking Mode (Stacks per Pulse) ....................................................... C-6 Figure C-3: Total Energy (kJ) Invested per Facial Area Size ............................................ C-9 Figure D-1: Displayed Default Parameters in the LHR Screens ........................................ D-5 Figure E-1: Treatment Phases .............................................................................................E-6

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Soprano®XL Operator's Manual 1-1

CHAPTER 1 System Overview

Chapter Contents: Section Title Page

1.1. Use of this Manual............................................................................. 1-2 1.2. Physician Responsibility.................................................................... 1-3 1.3. Maintenance....................................................................................... 1-3 1.4. Modification of the System ............................................................... 1-3 1.5. Resale Inspection ............................................................................... 1-3 1.6. Abbreviations and Acronyms ............................................................ 1-4

System Overview

1.1. Use of this Manual The SopranoXL 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 SopranoXL.

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 SopranoXL 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 guides in this manual, which includes 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 Soprano®XL Operator's Manual

http://www.almalasers.com/

System Overview

1.2. Physician Responsibility Federal (USA) law restricts the use of this device for sale by or on the order of a physician. 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.

1.3. Maintenance The SopranoXL 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 SopranoXL 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 SopranoXL 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.


System Overview


1.6. Abbreviations and Acronyms " Inches °C Degree(s) Centigrade/Celsius °F Degree(s) Fahrenheit A Ampere (s) AC Alternating current AFT Advanced Fluorescence Technology CFR Code of Federal Regulations cm Centimeter(s) CW Continuous wave Hz Hertz IEC International Electrotechnical Commission J Joule(s) J/cm2 Joule(s) per square centimeter Kg. Kilogram(s) Lbs. Pound(s) LCD Liquid crystal display LED Light emitting diode LHR Laser hair removal m Meter(s) mm Millimeter(s) msec Millisecond NIR Near Infrared nm Nanometers OD Optical density PWM Pulse width modulation Rep Rate Repetition rate Sec Second(s) SHR Super hair removal SPF Skin protection factor TEC Thermoelectric cooling V Volt(s) VAC Volt(s) AC W Watt(s)


CHAPTER 2 Safety


2.1. Introduction ....................................................................................... 2-2 2.2. System Safety Measures .................................................................... 2-3 2.3. The Treatment Room......................................................................... 2-5 2.4. General Precautions and Cautions ..................................................... 2-6 2.5. Warnings Related to Laser/Intense Light Emission........................... 2-7 2.6. System Safety Features...................................................................... 2-9 2.7. Equipment Classification and Compliance...................................... 2-11 2.8. Device Labels .................................................................................. 2-12

Safety

2.1. Introduction This chapter describes general safety issues regarding the use of the SopranoXL system, with special emphasis on optical and electrical safety.

Warning

Hazardous voltages are energized when the emergency stop button is engaged.

Note

Federal law (USA) restricts this device to sale by, 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.

With proper operation and maintenance, trained and qualified medical practitioners can use the SopranoXL system safely. The supervising physician and all other personnel operating or maintaining the SopranoXL 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.


Safety

2.2. System Safety Measures The SopranoXL system was designed to maximize safety for both patient and personnel. The following are some of the SopranoXL's preventive safety measures:

2.2.1. Electrical Safety 1. A semi-automatic circuit breaker, located on the service panel, protects the

system by tripping when power overload occurs. To resume normal operation, lift the circuit breaker handle and restart the system.

2. Software protection, including:

• The software checks all safety related hardware after the system is switched on.

• Emission timing is regulated by interrupts every 1 msec.

• A watchdog cycle continuously monitors operation of the system during treatment.

• If an error occurs, the system displays a warning message to the operator and disables further operation.

3. A self-test of the attached module is performed when the system is turned on. The test includes module identification.

4. A self-test of the electrical circuitry takes place after the system is turned on. The test circuits continuously monitor system operation during treatment.

2.2.2. Light and Laser Safety 1. Closed lightguide geometry is used to transmit light to the treatment site. Light

is emitted only through the front plane of the lightguide.

2. The system incorporates a safety remote interlock connector for connecting an external interlock on the entrance door to the treatment room. The external remote interlock is serially connected with the footswitch; therefore when installed, disables the system and prevents operation when the entrance door is opened.

3. An emergency shutoff knob expedites shutdown when necessary. When pressed, it immediately shuts down system operation.

4. A password on the service screen prevents unauthorized changes to the system's basic operating parameters.


Safety

5. The system features two emission indicators: a yellow emission indicator lamp located on the top of the control panel and a buzzer.

• The yellow emission indicator lamp flashes when the system is ready to trigger pulses, and becomes a continuous light when a pulse is triggered.

• A warning buzzer sounds when the system is ready to trigger a pulse.

6. Emission is enabled only when the operator switches to Ready mode and presses the footswitch (minimum risk).

7. Laser emission (from the diode module) is enabled only if both the footswitch and the module's trigger are pressed at the same time. The trigger reduces the risk of unintentional laser emission.

8. Water is circulated through the module as soon as the system is turned on in order to cool the light source.

9. The flow and temperature of the water are monitored in order to eliminate the risk of module overheating. Light emission is not permitted if the water flow stops or if the water temperature is equal to or higher than 40ºC (104ºF).

10. The system is equipped with a pneumatic footswitch for ease of use. It is pneumatic to eliminate the possibility of any short-circuiting in the foot-switch's wiring and to increase its durability to fluids.

Warning

• Any light or laser emitting device can cause injury if used improperly. High voltages are present inside the SopranoXL system. Personnel who work with lasers must always be aware of the possible dangers and must take the proper safeguards as described in this manual.

• Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the SopranoXL system by children or incapacitated persons may be dangerous.


Safety

2.3. The Treatment Room The treatment room must be clearly labeled with signs indicating that high intensity laser energy is in use. The treatment room sign that is supplied with the SopranoXL system is shown in Figure 2-1.

Figure 2-1: Treatment Room Warning Sign

The treatment room should not include any light reflecting objects such as a mirror.

Access to the SopranoXL treatment room should be allowed only to personnel essential to the procedure and who are well trained in the required safety procedures.

Assure that all of the treatment room personnel are familiar with the SopranoXL controls and know how to shut down the system instantly.


Safety

2.4. General Precautions and Cautions The following precautions, cautions and warnings must be observed for the safe use of the SopranoXL system.

2.4.1. Precautions • Physicians and clinicians should read this manual thoroughly before attempting

to operate the SopranoXL system.

• Any module's lightguide must be kept clean at all times. Remember to clean the cooling gel from the lightguides after each patient.

• 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 module or its umbilical cable.

2.4.2. Cautions • Only Alma Lasers authorized personnel may service the SopranoXL system. This

includes making internal adjustments to the power supply, cooling system, optics, modules, etc.

• Verify that the SopranoXL is wired for the appropriate electrical voltage of your country (120 VAC or 230 VAC).

• 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.

• Never allow untrained personnel to operate the system.

• Never press the module's trigger and/or footswitch unless the module is safely oriented at a specific and intended target.

• The modules and tips must always be visually inspected before treating the patient. If any wear or damage is apparent, do not use the module or tip.

• Never leave the system turned on, open or unattended during system maintenance.


Safety

2.5. Warnings Related to Laser/Intense Light Emission

2.5.1. Burn Hazards The SopranoXL emits high-intensity light/laser radiation which is invisible to the human eye and can cause third degree burns.

2.5.2. Direct and Reflected Eye Exposure Hazards It is essential that all people present in the treatment room during the treatment (patient and medical personnel) protect their eyes by wearing Alma Lasers recommended protective eyewear.

It is good practice to instruct the patient to close their eyes during treatment even when wearing protective eye glasses.

If the patient cannot wear the protective eyewear, fit the patient with opaque eye protection that completely blocks light from the eyes.

If the treatment area is very close to the eyes (e.g. eyelids), protect the eyes with corneal shields.

Warning

Different protective eyewear is indicated for use with the Diode or NIR modules. Make sure you choose the correct type.

2.5.3. Safety Eyewear • All personnel must use safety eyewear and must ascertain that the eyewear

provides adequate protection: for the diode laser module OD>6 at wavelength range of 750-890nm, and for the NIR module OD>3 at 600-1800nm.

• The safety glasses and opaque eye protectors supplied with the system offer adequate protection for both modules, and more can be ordered from your Alma Lasers representative.


Safety

2.5.4. Explosion and Fire Hazards The absorption of optical energy raises the temperature of the absorbing material. Take precautions to reduce the risk of igniting combustible materials in and around the treatment area.

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 SopranoXL system, allow it to dry thoroughly before operating the system.

Flammable materials must be kept at a safe distance from the system.

2.5.5. High Voltage Hazards The system utilizes 120/230 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 SopranoXL 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 SopranoXL system turned on, open or unattended.

2.5.6. Grounding the System The system is grounded through the grounding conductor in the power cable and internal grounding pin.


Safety

2.6. System Safety Features The SopranoXL system is equipped with a number of safety features. All treatment room personnel should be familiar with the location and operation of these safety features.

2.6.1. Emergency Shut-Off Knob This red knob is used for emergency shutdown. When pressed, it immediately shuts off power to the entire system.

To release the emergency shut-off knob, turn it clockwise. Otherwise, the system will remain off.

Caution

Use the emergency shut-off knob only in the event of an emergency.

2.6.2. Light Emission Indicators The system features two light emission indicators: a yellow LED located on top of the control console and a buzzer.

The yellow LED has three modes:

• Off - when the system is turned on, and in Standby mode

• Blinking – during Ready mode

• Continuous – during light emission (module's trigger and/or footswitch are pressed)

The buzzer beeps:

• Once when the system switches to Ready mode

• Intermittently during light emission, at the same rate as the pulse repetition rate: i.e., if the repetition rate is 2 Hz (pulses per second), the buzzer will beep two times per second.


Safety

2.6.3. Remote Interlock Connector The system incorporates a safety remote interlock connector that should be connected to an external microswitch on the entrance door to the treatment room. The external remote interlock is serially connected with the footswitch; therefore when installed, it disables the system and prevents operation when the entrance door is opened.

2.6.4. Double-Tiered Security for Laser Emission Diode laser beam emission is enabled only when the operator presses both the footswitch and module trigger; therefore accidental lasing may only occur due to double error condition (minimum risk).

2.6.5. 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.

2.6.6. Tissue Cooling System The module lightguides are cooled by a thermoelectric cooling method to reduce patient discomfort during treatment and to reduce post-procedure side effects, such as local skin redness and swelling. The tissue is cooled through a metallic ring and a cold sapphire window. The lightguide's temperature is reduced to 4ºC (39ºF) during system operation.

2.6.7. Module Design Several aspects of the module design contribute to the safety of the SopranoXL system:

• Since the light or laser beam is generated in the module itself and not in the console (as in conventional lasers), there is no need for an articulated arm or other beam delivery system with inherent beam quality and alignment concerns. Instead, the SopranoXL modules incorporate a one-piece light mixer that combines the emission from thousands of emitters to produce a uniform square beam. Since light emission is confined to the module, there is no hazardous optical radiation in the console or the umbilical cable.

• The lightguide is placed against the patient’s skin during the system use, reducing stray light while increasing the therapeutic effect.


Safety

2.7. Equipment Classification and Compliance The SopranoXL system complies with the following standards:

• US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for Class IV Laser Products

• IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988 including Amendments # 1 (1991) and # 2 (1995

• IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: Collateral Standard; Electromagnetic Compatibility - Requirements and Tests (2001 + A1:2004)

The SopranoXL system should be installed and operated according to CAN/CSA-Z386-01: Laser Safety in Health Care Facility.

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

• Light/Laser emission indicators

• Key switch

• Fluence display

• Emergency shut-off knob

• Remote interlock connector

• Footswitch connector

• Trigger button (diode laser module)

• Proper labeling

In accordance with the regulations, a recommended routine inspection and maintenance schedule is provided in chapter 7: Maintenance.

2.7.1. Classification of the System According to IEC 60601-1 • According to the method of protection against electric shock:

the system is Class I equipment.

• According to the degree of protection against electric shock: the laser head is type B applied part.

• Equipment is not suitable for use in presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.


Safety

2.8. Device Labels 2.8.1. System Labels

The following Warning, Certification and Identification labels are adhered to the SopranoXL system:

• Identification – located on the system's rear panel. This label contains the following information:

Manufacturer's details

Name of the system

Assurance that the system complies with the US Federal Performance Standards

Serial number and date of manufacture

The system's electrical requirements

Caution: US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

Caution: Consult Operating Instructions

Degree and type of protection against electric shock

Label # 1 is adhered to systems shipped to countries with 100-120VAC. Label # 2 is adhered to systems shipped to countries with 220-240VAC.

Figure 2-2: Identification Labels


Safety

• Laser Emission Danger – including light source type and radiation parameters, and indicating that the diode laser module is a Class IV device (see Figure 2-3), located on the rear panel of the system.

Figure 2-3: Laser Emission Danger Warning Label

• Diode Laser Class 4 – located on the rear panel of the system (see Figure 2-4).

Figure 2-4: Diode Laser Class 4 Label

• Laser Emission Danger – located on the rear panel of the system (see Figure 2-5). Warns against possible exposure to laser beam radiation.

• The same label also is also adhered to the diode module, near the tip.

Figure 2-5: Laser Emission Danger Label


Safety

• Electrical Requirement and Hazard – located next to the power cable connection port

115VAC

230VACOr

Figure 2-6: Electrical Requirement and Hazard Labels

• Grounded power cable warning label, located next to the power cable connection port:

Figure 2-7: Grounded Cable Warning Label


Safety


2.8.2. Module Labels The following warnings and identification labels are attached to the system module connectors:

• Module Identification Label – is located on the bottom of the module connector. it includes the following information:

Manufacturer's details

Name and part number of the module

Serial number and date of manufacture

CE-MDD compliance symbol

Assurance that the system complies with the US Federal Performance Standards

Figure 2-8: Module Identification Labels *

• Laser Aperture Warning – located near the diode module's tip:

Figure 2-9: Laser Aperture Warning Label on Diode Laser Module


Safety


• Laser/Light Module Emission Danger – warns against possible exposure to laser beam radiation and specifies the type and classification of laser beams present.

Figure 2-10: Laser/Light Emission Warning Labels

Other informative labels placed around the system:

• Stop Lasing label located above the emergency shut-off knob

• Interlock label located on the service panel to identify the interlock connection port

• Footswitch label located on the service panel to identify the footswitch connection port FOOTSWITCH

• Vent label identifies the connection port for the air vent of the cooling system's water reservoir VENT

• Fill label identifies the connection port for the accessory used by the service technician to fill the cooling system's water reservoir

FILL

• Drain label identifies the connection port for the accessory used by the service technician to drain the cooling system's water reservoir

DRAIN

Safety

Deionized Water Only

• Only deionized water may be introduced into the SopranoXL's cooling system

• Buzzer – denotes the location of the system warning buzzer's volume potentiometer. BUZZER

2.8.3. Packaging Label The following label is attached to the SopranoXL system's shipping crate:

Figure 2-11: Shipping Crate Label



CHAPTER 3 Installation


3.1. Introduction ....................................................................................... 3-2 3.2. Equipment List .................................................................................. 3-2 3.3. Facility Requirements........................................................................ 3-3 3.4. Unpack the System ............................................................................ 3-5 3.5. System Installation............................................................................. 3-7 3.6. Cooling System Drainage ................................................................ 3-10 3.7. Moving the System.......................................................................... 3-10

Installation

3.1. Introduction The SopranoXL system is designed for installation in an office or a clinic and requires minimal site preparation. When the SopranoXL system is purchased, complete on-site installation, including initial system testing and calibration, is included.

System transportation and installation is carried out by Alma Lasers authorized technical personnel, who will do the following:

• Unpack the system and position it in its pre-selected location.

• Verify the integrity of the system and its components.

• Connect system components (modules, footswitch, interlock connector).

• Plug the system into a designated electrical outlet.

• Fill the cooling system reservoir with deionized water.

• Test the system for proper calibration and functional operation of all components and software.

• Coordinate the performance of an on-site safety inspection, if required.

Note

Any damage to the packaging or to the system found prior to opening the package should be reported to your Alma Lasers representative and to the insurance carrier.

3.2. Equipment List The SopranoXL platform includes the following:

• SopranoXL system console

• The selection of modules that have been purchased with the platform

• Module and umbilical support mast

• Set of keys

• Remote interlock connector

• Pneumatic footswitch

• Safety eyewear appropriate to the modules purchased

• Opaque eye protectors

• Operator's manual

• Water filling kit for the cooling system

• Laser radiation danger sign


Installation

3.3. Facility Requirements Before unpacking the system, ensure that the site meets the requirements described in the following sections.

3.3.1. Space and Positioning Space should be allocated with adequate ventilation and free airflow. The working area for the system should be prepared according to the system dimensions presented in Figure 3-1. In order to guarantee proper ventilation, always keep the sides of the system at least 20" (0.5m) from the wall or from other obstructions to air flow. After positioning the system, lock the breaks on the front wheels by pressing the pedals on top of each wheel.

120

cm (4

7”)

40 cm (16”)

35 cm (14”) Figure 3-1: System Dimensions


Installation

3.3.2. Electrical Requirements The system is factory pre-wired for the local line voltage, as ordered by the customer. Accordingly, the system will require a separate line supply of:

• 120 VAC ±10%, 13A, 50/60 Hz, single phase, Or: • 230 VAC ±10%, 6A, 50/60 Hz, single phase

Input power lines should be free of transients, voltage and current spikes, sags and surges. Consequently, the system power line should not be shared with other heavy variable loads such as elevators, air conditioning systems, large motors, etc.

The system is grounded through the grounding conductor in the power cable that is plugged into the wall power outlet. Good grounding is essential for safe operation.

Caution

• Verify that the SopranoXL system is wired for the appropriate line voltage of your country (120 or 230VAC).

• The system should be connected to a separate power line with separate circuit breakers. Alma Lasers cannot guarantee adequate performance unless the system is connected to a dedicated circuit.

3.3.3. Environmental Requirements Air Quality:

The system should operate in a non-corrosive atmosphere. Corrosive materials such as acids can damage electrical wiring, electronic components and the surfaces of optical components.

Air-borne dust particles should be kept to a minimum. Dust particles absorb light and heat up. Hot particles located on the optical lenses can damage them. Metallic dust is destructive to electrical equipment.

Water Quality:

The system should be operated using deionized water only. Regular tap water contains sediments that may damage the cooling system.

Temperature:

To ensure that the system performs optimally, maintain room temperature between 20°C and 25°C (68°F - 77°F) and relative humidity of less than 80%.

Note

When the system is used intensively it emits heat. Therefore, it is recommended to install air conditioning in the room in which the system will be used.


Installation

3.4. Unpack the System 1. The SopranoXL system is delivered in a cardboard crate as shown in

Figure 3-2:

Figure 3-2: SopranoXL Shipping Crate

2. Refer to Figure 3-3: open the top panel of the crate (A), and remove the lower foam brace (B).

3. Push the system such that the wheels are touching the bottom panel of the crate.

Figure 3-3: Unpacking the System (1)


Installation

4. Remove the top foam brace (see Figure 3-4).


Refer to Figure 3-5:

5. Lift the crate with the system to an upright position.

6. The front wheels of the SopranoXL system are fitted with brakes. To lock a wheel, push its brake lever firmly down. To release, move the lever up. When the system is stationary, the brakes must be in the locked position. Release the brakes only when moving the system.

7. Unlock the front wheels and carefully pull the system out of the crate.



Installation

3.5. System Installation

3.5.1. Connect the Module's Cradle and Umbilical Support Roller Refer to Figure 3-6:

1. Connect the module's cradle to its support stem in the middle of the support mast; press the cradle onto the stem until it snaps into place.

2. Connect the umbilical support roller to its support stem on the end of the support mast; press the roller onto the stem until it snaps into place.

Figure 3-6: Module's Cradle and Umbilical Support Roller Connection

Caution

• Never use the module or the umbilical cable to move the system.

• Do not use the module mast for moving or lifting the system.


Installation

3.5.2. Module Connection Connection of the module to the console is shown in Figure 3-7. It is designed to enable easy replacement of the module when required. The module connection port is located on the middle-left side of the front panel. For insertion and removal of the connector, proceed as follows (refer to Figure 3-7):

1. Insert the module connector into the connection port, as shown in view A, as far as it will go in.

2. Turn the connector latch in a clockwise direction (B).

3. As you turn the latch, the connector will continue to go into the port until you can turn it no more – at this point the module is properly connected to the system (C).

4. To disconnect the module, reverse steps 1 through 3 above.

Caution

Never use tools to tighten the module connector – finger-tight pressure is sufficient.

ModuleConnectionPort

ConnectorLatch

A

B

Locked (C)

Figure 3-7: Module Connection


Installation

3.5.3. Remote Interlock Connection The SopranoXL system is equipped with a remote interlock connector to provide maximum safety. The connector is situated on the service panel (see Figure 3-8). An external switch should be connected to this connector to create a remote interlock system. This switch should be mounted on the entrance door, so that if the door opens the switch contacts also open and disable system operation.

To connect the remote interlock:

1. Turn the system off.

2. Remove the connector from the port on the system rear panel.

3. Open the connector cover.

4. Solder the two wires from the door switch to pins 1 & 2 (short-circuited on delivery with a white wire).

5. Close the connector cover.

6. Reconnect to the port on the service panel.

7. Turn the system on.

Remote InterlockConnector

FootswitchConnector

Main CircuitBreaker

Figure 3-8: Remote Interlock and Footswitch Connections


Installation


3.5.4. Footswitch Connection The footswitch supplied with the system is pneumatically operated for increased safety.

To connect the footswitch, connect the footswitch's black tube to the connection port on the system's service panel (see Figure 3-8).

3.5.5. Filling the Coolant Reservoir The cooling system's reservoir must be filled with deionized water. It is imperative that the level of the water in the reservoir be checked every three months and deionized water added if necessary.

Refer to Chapter 7: Maintenance for instructions of how to properly fill the water reservoir.

3.6. Cooling System Drainage If the system is to be stored in a cold area where the temperature may fall below 0ºC (32ºF), the deionized water must be drained from the cooling system. Only Alma Lasers authorized service personnel may perform this procedure.

3.7. Moving the System To move the system within the clinic, do the following:

1. Seat the module in its cradle.

2. Disconnect the power cable.

3. Release the wheel breaks.

4. Slowly push or pull the system using the handle.

Caution

• Never use the module or the umbilical cable to move the system.

• Do not use the module mast for moving or lifting the system.

If the system is to be moved to another facility, consult your Alma Lasers service representative.


CHAPTER 4 System Description *


4.1. Introduction ....................................................................................... 4-2 4.2. General System Description and Intended Use ................................. 4-2 4.3. System Components and Controls..................................................... 4-3 4.4. SopranoXL Modules............................................................................ 4-8 4.5. System Specifications...................................................................... 4-11


System Description

4.1. Introduction This chapter provides a detailed description of the SopranoXL system. The description covers the system's main components, controls and functional sub-systems and system & module specifications.

4.2. General System Description and Intended Use The SopranoXL system is a multi-application, multi-technology platform that supports the following technologies:

• Diode laser technology

• Near-infrared light technology (NIR)

The Diode module is intended for the removal of unwanted hair and to effect stable, long-term hair reduction.

The NIR module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The complete system consists of its console, two available modules and a footswitch. The module is pressed against the patient's skin and a light pulse is delivered when the module's trigger and/or the footswitch are activated. The module's tip is cooled by the SopranoXL's cooling system.

Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system's micro-controller through and LCD touch-screen.


System Description

4.3. System Components and Controls The SopranoXL system consists of the following major components (see Figure 4-1):

1. The main console unit that incorporates the control panel, power supply modules, cooling system, service panel and isolating transformer.

2. Modules (with umbilical cable and connector) that incorporate the optical head, tissue cooling system (the cold plate) and the trigger (diode laser module).

3. Footswitch

Control Panel

NIR Module

Diode LaserModule

Footswitch

ModuleConnector

Console

Figure 4-1: Major System Components


System Description

Figure 4-2 presents a block diagram of the SopranoXL system:

CurrentDriver

Light

Handpiece

Flow SW & Temperature SW /Level SW

Trigger

RelayPower Supply

25V1500W

Power Supply12V

Water CoolingSystem

Touch-Screen Controller TEC

Controller

PowerMeter

PowerSupply

24V

Key SwitchFoot SwitchInterlockRed LampBuzzer

InsulationTransformer

EmergencyShut Off Knob

230V/120V1 2

Figure 4-2: Block Diagram

4.3.1. Main Console The console unit incorporates the following system components:

• Control panel

• Power supply modules

• System controller

• Cooling system

• Isolation transformer


System Description

4.3.2. System Controls The SopranoXL system controls offer the following features (see Figure 4-3):

• Emergency Shutoff Knob – this is a red, mushroom-like knob designed for emergency shutdown of the system.

• Control Panel – this touch-controlled screen provides information on the status and settings of the SopranoXL system. The various screens of the display are described in detail in Chapter 6 – Operating Instructions.

• Keyswitch – turns on the system when activated.

• Light Emission Indicator – see Section 2.6.2.

Touch-ScreenControl Panel

Light EmissionIndicator

Keyswitch

EmergencyShut-Off Knob

Figure 4-3: System Controls

4.3.3. Power Supply Modules Three power supply modules deliver electrical power to the system's components:

• 1500W/25V - supplies MEG-50, light/laser current driver

• 150W/12V - delivers power to the water pump and thermoelectric tissue cooling system

• 70W/24V – delivers power to the LCD and micro-controller board

The current supply to the connected module is enabled only if the following three conditions are met:

1. No system malfunctions are detected by the software.

2. The system is in Ready mode.

3. The module's trigger and/or the footswitch are activated.


System Description

4.3.4. System Controller This board controls the operation of the sub-systems in real-time. It incorporates an advanced microprocessor, memory chip, and both digital and analog interfaces.

4.3.4.1. System Software

The SopranoXL system incorporates embedded software. The software supports the graphic user interface, controls the system operating parameters and runs routine tests to ensure proper operation.

4.3.4.2. Error Detection

This SopranoXL system is equipped with self-testing software that continuously monitors system operation, using the watchdog feature. The software continuously checks the hardware status, and if an error condition is detected:

• An error message is displayed

• The audible alarm signal is activated

Refer to Chapter 8: Troubleshooting for further details.

4.3.5. Cooling System The cooling system incorporates:

• Water-cooling system

• Integrated Contact Tissue Cooling System

• Fans

4.3.5.1. Water Cooling System

Water cooling is achieved in a closed-loop system operating with deionized water to ensure long life of the light resonator. The cooling system comprises a heat exchanger, a water reservoir, a water pump, a particle filter and a deionizing filter. The system also includes a temperature sensor and flow & level switches to protect the system from a cooling system malfunction. As a safety feature, the light/laser energy emission is disabled when the water temperature reaches the high limit of 40ºC (104ºF).


System Description

4.3.5.2. Integrated Contact Tissue Cooling System

The module lightguides are cooled by a thermoelectric cooling method to reduce patient discomfort during treatment and to reduce post-procedure side effects, such as local skin redness and swelling. The tissue is cooled through a metallic ring and a cold sapphire window. The lightguide's temperature is reduced to 4ºC (39ºF) during system operation.

A thermistor monitors and keeps the temperature at this level to prevent over-cooling of the treated area. The tissue cooling system is designed to cease operation in case of a pause in operation lasting for more than 5 minutes. This feature is included to prevent undesired condensation of water drops on the tip.

In addition to the integrated contact cooling, the SopranoXL's diode laser hand-piece is equipped with an adapter that is designed to connect a Zimmer Cryo to further enhance the cooling capabilities.

The green indicator (in the left lower corner of the LCD) will turn on when the temperature of the tissue cooling system reaches the correct operating range.

For enhanced patient safety and comfort, the SopranoXL diode module is equipped with a dedicated Zimmer Cryo adapter when operating in LHR mode.

4.3.5.3. Fans

Five fans are located inside the system. Four fans cool the water system and the other fan cools the interior space of the console.

4.3.6. Isolation Transformer The isolation transformer reduces the leakage current in the system to the ground for safety. It is designed as a medical grade unit.


System Description

4.4. SopranoXL Modules

4.4.1. Diode Laser Module The diode module enables lasing fluence up to 120 J/cm² at the module's laser aperture. The laser energy is delivered through a 12x10mm tip in two modes:

• LHR (Laser Hair Removal mode)

• SHR (Super Hair Removal mode)

The module provides pre-selected pulse durations as a function of the selected pulse type and fluence.

The SopranoXL's diode laser module is intended for hair removal and long-term hair reduction. It is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.

The optical bench and the tissue cooling system are located inside the ergonomi-cally designed module. The diode laser module is divided into three parts: an umbilical cable, a connector and the module itself.

Power and control signals are exchanged with the console via the umbilical cable. The length of the cable is 170 cm (67"), which enables free access to any body part.

The diode laser module is shown in Figure 4-4. It incorporates the laser diode array with the lightguide, the protective sapphire window, the cold plate, the module's trigger (housed in the handle) and the Zimmer Cryo adapter (used with LHR mode).

Caution

• The module contains delicate optical components which may suffer severe damage if dropped. Except during treatment, the module should be kept in its cradle at all times.

• When moving the system, the module should be disconnected from the system and stored in its carrying case.

4.4.1.1. Hair Removal Mode Descriptions

The SopranoXL's diode laser module has two operating modes: SHR and LHR.

The SHR Mode provides the ideal combination for efficient hair removal:

1. The SHR mode uses the optimal hair removal wavelength for deep penetration into the dermis where the hair follicle is located.

2. The SHR mode has consistent, high average power capabilities to enable the 10 pulse-per-second repetition rate for “hair rem oval in-motion”.


System Description

3. The SHR mode enables a low fluence, "in-motion" approach for virtually painless hair removal.

The diode laser module also includes the traditional, higher-fluence LHR (Laser Hair Removal) mode. The module can be used safely on all skin types, including tanned skin, and has been shown to provide long-term hair reduction.

Module

Figure 4-4: Diode Laser Module


System Description

4.4.2. NIR Module The SopranoXL's NIR module emits light in the near infrared spectrum generated by a pulsed-light source. The module provides pre-selected pulse durations as a function of the selected power (Watts).


The module's light source emits a pulse when it is activated by pressing the footswitch. The light passes through an aperture, into a lightguide that is located on the module tip.

The operator holds the module by its handle in order to position the lightguide against the patient’s skin.

The module's contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the LCD control panel.

The NIR module is operated only by pressing the footswitch.

The NIR module is shown in Figure 4-5:

Figure 4-5: Near Infrared (NIR) Module


System Description

4.5. System Specifications

4.5.1. Diode Laser Module Output Laser Type

• CW

• GaA1As diode laser array

Wavelength

• 810 ± 10 nm

Application Modes

• SHR mode – single pulse type

• LHR mode – 6 pulse types: I, II, III, IV, V & VI

Fluence

• SHR mode – up to 20 J/cm2 in increments of 1 J/cm2

• LHR Pulse Types I through VI – up to 120 J/cm2 in increments of 1 J/cm2

Pulse Repetition Rate

• SHR mode – up to 10 Hz

• LHR Pulse Types I through VI – 0.5, 1.0, 2.0, 3.0 Hz

Spot Size

• 12 x 10 mm

Output Stability

• ± 10%


System Description

4.5.2. NIR Module Output Light Technology

• Near-infrared light

Wavelength

• Peak emission at 1300 nm

Output Power

• 30 to 100 Watts

Power Control

• PWM

Exposure Mode

• Pulsed

Spot Size

• 30 x 60 mm (18 cm2)

4.5.3. Operation and Control System Control

• Fully computerized, microprocessor based

Graphic User Interface

• LCD touch-screen

Light/Laser Emission Indicators

• Visual, illuminating yellow indicator:

OFF when no lasing occurs

Blinking during Ready mode

Illuminating continuously during light emission


System Description

• Audible indicator:

Activated during light emission, when pressing the operation softkeys (user-controlled) and upon detection of an error condition

4.5.4. Physical Dimensions

• 35 cm wide x 40 cm deep x 120 cm high

• 14" wide x 16" deep x 47" high

Weight

• 50 Kg (110 lbs)

4.5.5. System Requirements Power Supply

• 120VAC, 13A, 50-60 Hz, single phase

• 230VAC, 6A, 50-60 Hz, single phase

Circuit Breaker

• 120VAC, 13A, 50-60 Hz

• 230VAC, 6A, 50-60 Hz

4.5.6. Delivery Systems Modules

• Multi-use

• Non-sterile

Tip Cooling

• Thermo-electrical cooling (TEC)

• Cooling temperature: 4ºC (39ºF)


System Description


4.5.7. Classifications CDRH Laser Classification according to 21CFR 1040.10

• Class IV

Laser Classification according to EN 60825-1

• Class 4

Mode of Protection against Electric Shock

• Class I Equipment

Degree of Protection against Electric Shock

• Type B Equipment


CHAPTER 5 Controls and Indicators *


5.1. Introduction ....................................................................................... 5-2 5.2. Control Panel ..................................................................................... 5-2 5.3. Service Panel ..................................................................................... 5-5 5.4. Diode Laser Module's Trigger ........................................................... 5-7 5.5. Footswitch ......................................................................................... 5-8


Controls and Indicators

5.1. Introduction This chapter details the controls, indicators and connection ports of the SopranoXL system:

• Control Panel

LCD Touch-Screen Panel

Emergency Shut-Off Knob

Light/Laser Emission Indicators

Keyswitch

• Service Panel

Circuit Breaker

Main Power Switch

Buzzer Potentiometer

• Module Trigger (diode laser module)

• Footswitch

5.2. Control Panel The control panel incorporates all the controls necessary to operate the SopranoXL system, including a back-lit LCD graphic display with built-in touch-screen technology, keyswitch, emergency shut-off knob and light/laser emission indicators (audio and visible).

Touch-ScreenControl Panel

Light EmissionIndicator

Keyswitch

EmergencyShut-Off Knob

Figure 5-1: Control Panel



5.2.1. LCD Touch-Screen Panel The LCD touch-screen panel presents all SopranoXL screens that are described in Chapter 6 of this manual. The LCD specifies the selected fluence, skin type, repetition rate and number of accumulated pulses (in a specific session and total).

The left-side arrow softkeys on the touch-screen are used to increase or decrease the displayed operating parameters, the four bottom softkeys are used to toggle between Standby/Ready modes and other parameters and options. Refer to Chapter 6 for detailed explanations regarding the softkeys. Figure 5-2 presents a sample view of the LCD screen.

Figure 5-2: LCD Touch-Screen Panel



5.2.2. Tissue Cooling System Status Indicator The green indicator bar is illuminated when the tissue cooling system is at the proper temperature cooling range (see circle in Figure 5-3).

Figure 5-3: Tissue Cooling System Status Indicator

5.2.3. Emergency Shut-off Knob In case of emergency the red shut-off knob (see Figure 5-1) should be pressed to switch off all electrical power supply to the system. To resume operation release the knob (by a quarter of a turn clockwise).

5.2.4. Light/Laser Emission Indicators The yellow emission lamp, located on the control panel (see Figure 5-1), indicates the following:

• Off - when the system is turned on, and in Standby mode

• Blinking – during Ready mode

• Continuous – during light/laser emission (footswitch or footswitch and module's trigger are pressed)



5.2.5. Keyswitch The keyswitch is located on the system's control panel. It is used to turn on the main operating menu after the system is activated. To switch the system into operational mode, the keyswitch is turned a quarter of a turn, clockwise (see Figure 5-1).

Warning

To avoid misuse of the system, do not leave the key in the keyswitch while the system is unattended.

5.3. Service Panel The service panel (see Figure 5-4) is located on the system's back side. It incorporates all the required controls and connections for the system.

Power CableInlet

Figure 5-4: Service Panel



5.3.1. Main Circuit Breaker A semi-automatic circuit breaker, located on the service panel, protects the system against power overload.

When the circuit breaker's handle is in the lower position, electrical power is not supplied to the system. To initiate system operation, lift the circuit breaker's handle into the upper position (see Figure 5-4).

5.3.2. Main Power Switch The main switch is located on the service panel (see Figure 5-4). This is a green switch used to activate the LCD display. A correct operation sequence starts with switching on the main switch prior to turning on the keyswitch.

5.3.3. Buzzer Potentiometer The buzzer potentiometer (see Figure 5-4) is used to regulate the output volume of the audible alarm signal.



5.4. Diode Laser Module's Trigger The module's trigger is the push-button located on the handle of the diode laser module, shown by the arrow in Figure 5-5.

Diode laser energy emission is enabled only when both the diode laser module's trigger and the footswitch are activated.

Module

Figure 5-5: Diode Laser Module's Trigger

Warning

If the system is in Ready mode, light or laser beam emission occurs when the module trigger and the footswitch are activated.



5.5. Footswitch Diode Laser Module: diode laser energy emission occurs when the footswitch is activated at the same time as the module's trigger. This requirement for simultaneous activation of both triggers minimizes the risk of unintentional laser beam emission.

NIR Module: near infrared energy occurs when the footswitch is activated.

The footswitch (see Figure 5-6) is enabled only when the system is in Ready mode. Activation of the footswitch in Standby mode does not result in light emission.

The footswitch is a pneumatic pedal that connects to the system through the footswitch connection port on the service panel (see Figure 5-6).

Figure 5-6: Footswitch

Warning

• If the system is in Ready mode, laser energy emission from the diode laser module occurs when the footswitch and module's trigger are activated.

• If the system is in Ready mode, intense pulsed light emission from the NIR module occurs when the footswitch is activated.



CHAPTER 6 Operating Instructions *


6.1. Introduction ....................................................................................... 6-2 6.2. Error Detection .................................................................................. 6-2 6.3. Preparing the System for Operation .................................................. 6-3 6.4. Operating the System......................................................................... 6-3 6.5. Turning the System Off ................................................................... 6-15


Operating Instructions

6.1. Introduction This chapter describes in detail the operating instructions for the SopranoXL system.

Caution

• This system may only be operated by a licensed practitioner, according to the local laws in every country.

• A laser radiation danger sign, supplied with this system (see Figure 2-1), should be placed at the entrance to the treatment room whenever the system is in use.

• Improper use or adjustment of this system may invalidate the SopranoXL service warranty agreement. Please contact your authorized Alma Lasers distributor before attempting to use the system in any manner other than those specified in this manual.

6.2. Error Detection This system is equipped with self-testing software that continuously monitors system operation by means of watchdog software & circuitry and by interrupts. The software continuously checks the hardware for any error condition:

• The LCD displays an error message and disables further operation.

• The audible indicator sounds an alarm signal which is longer than the normal light or laser emission signals.

In such a case you should shut the system down and restart it. If the problem still persists, refer to Chapter 8 – Troubleshooting – for further instructions.



6.3. Preparing the System for Operation 1. Plug the system into the main power outlet.

2. Insert the key into the keyswitch.

3. Connect the remote interlock to the treatment room's entrance door, if required (see Chapter 3).

4. Connect the footswitch to the service panel (see Chapter 3).

5. Connect the desired module to the module connection port.

6. The patient and all personnel in the room should wear safety eyewear specific to the module in use (see Chapter 2).

7. Lift up the circuit breaker on the rear panel to the upper position.

8. Connect the Zimmer system to the diode laser module via the adapter and adjust the operating parameters according to the manufacturer's instructions.

6.4. Operating the System 1. Turn on the system (refer to Section 6.4.1.).

2. Select male or female treatment area (LHR and/or SHR modes.

3. Set the operating parameters (refer to Section 6.4.3.).

4. Set the system to Ready mode.

5. Activate the footswitch and/or the module's trigger to initiate light/laser emission (refer to Section 6.4.7.).

Warning

• The SopranoXL system emits intense light/laser pulses through the module. Make sure that all personnel are protected against accidental exposure to these pulses, either directly from the module or indirectly from a reflecting surface.

• To protect against eye damage and discomfort, make sure that everyone present in the room is wearing Alma Lasers recommended protective eyewear.

• Never look directly at the pulse coming from the module, even when wearing appropriate protective eyewear.

• Never point the module so that it discharges into free space. Make sure that the module is pointed at the treatment site during actual treatment.



6.4.1. Starting the System To start the SopranoXL system:

1. Verify that the emergency shut-off knob is not engaged. If it is, release it by turning clockwise until the knob pops up.

2. Toggle the main power switch (on the service panel) to the On position; a splash screen will appear while the system is testing itself for proper functionality.

3. Turn the key switch one quarter of a turn clockwise; the system will initiate the treatment operating software application.

6.4.1.1. Diode Laser Module

1. When starting the system with the diode laser module (for hair removal) is connected to the system, the Treatment Area Selection screen for the female body will appear (see Figure 6-1).

Figure 6-1: Treatment Area Selection Screen (Female)

2. If the patient is a male, press the Male icon in the lower-right corner of the screen; the Treatment Area Selection screen for the female body will be replaced with a similar screen for the male body.

3. If you wish to treat the patient in LHR mode, press the LHR icon in the lower-left corner of the screen; the LHR treatment screen will appear (see Figure 6-3).



4. Select the desired treatment area by pressing the appropriate highlighted area in the body illustration on the touch-screen LCD panel; the diode laser module's operating screen will appear (see Figure 6-2).

Figure 6-2: Diode Laser Module Operating Screen (SHR Mode)

Figure 6-3: Diode Laser Module Operating Screen (LHR Mode)



6.4.1.2. NIR Module

When starting the system with the NIR module (for skin tightening) is connected to the system, the NIR module's operating screen will appear (see Figure 6-4).

Figure 6-4: NIR Module Operating Screen

6.4.2. Working with the Control Panel The system is operated by touching the softkeys on the touch-screen control panel to select and adjust treatment parameters. In general, the operating parameters in the SopranoXL modules are set up in the same fashion. Figure 6-5 and Figure 6-7 present the control panel's softkeys and informative tags and the following sections offer explanations to all of the tools and information tags on the screens.



6.4.3. Setting Operating Parameters – LHR Mode The system is operated by touching the softkeys on the touch-screen control panel to select and adjust treatment parameters. Figure 6-5 presents the control panel's elements and softkeys:

1

2

3

98

410 5 6 7 Figure 6-5: Operating Screen Elements

1. Operating Mode Display – the selection of Pulse Type is done with the Pulse Type softkey. Touch the softkey appropriate to the desired pulse type: I, II, III, IV, V or VI.

2. Fluence – to set the fluence parameter touch the Fluence softkey on the screen. To increase or decrease the parameter settings, use the ▲ or ▼ arrow keys on the left side of the screen; the exhibited fluence value will change in increments of 1 J/cm2.

3. Pulse Repetition Rate – to set the pulse repetition rate parameter, touch the Repetition Rate softkey on the screen. To increase or decrease the parameter setting, use the ▲ or ▼ arrow keys on the left side of the screen; the exhibited rate in Hertz (Hz) will change accordingly.

4. Home Button – returns the view to the Treatment Area Selection screen (see Figure 6-1).

5. Standby/Ready – this soft-key toggles the Spa Accord system between Standby and Ready modes. Touch the red Ready button when you are ready to start the treatment; the red button will change to green and laser emission will be enabled when the footswitch and trigger are both pressed. Touch the green (Standby) button to return the system to Standby mode.



Note

When the system is emitting the treatment beam, this button will appear as a green indicator.

6. Saving Parameter Settings – Refer to Section 6.4.6.

7. New Session – press this button to recycle the system to a new session; the session pulse counter will reset to zero (paragraph # 8 below).

8. Session Pulse Counter - this field counts the number of laser pulses emitted by the module in the current session. The field is reset to 0 (zero) when a new session is started (by pressing the New Session button).

9. Total Module Pulse Counter – this field counts the total number of pulses emitted by the module, and it cannot be reset. This field will automatically reset to zero only when a new module is connected to the system.

10. The cooling system is ready for operation only after the indicator in the Cooling field appears blue. This takes about 1-2 minutes

Warning

Once the system enters Ready mode, laser emission will start upon activation of the footswitch and the module's trigger.



6.4.3.1. Setting the Repetition Rate in LHR Pulse Types I through VI

Refer to arrows # 3 in Figure 6-5:

To set the pulse repetition rate parameter, touch the Repetition Rate softkey on the screen. To increase or decrease the parameter setting, use the ▲ or ▼ arrow keys on the left side of the screen; the exhibited fluence value will change accordingly.

The available repetition rates in the various Pulse Type modes are presented in the following table:

Pulse Type I

From Fluence of: To Fluence of: Maximum Repetition Rate [Hz]

1 J/cm2 74 J/cm2 3

75 J/cm2 111 J/cm2 2

112 J/cm2 120 J/cm2 1

Pulse Type II


1 J/cm2 50 J/cm2 3

51 J/cm2 73 J/cm2 2

74 J/cm2 120 1

Pulse Type III


1 J/cm2 40 J/cm2 3

41 J/cm2 58 J/cm2 2

59 J/cm2 119 J/cm2 1

120 J/cm2 120 J/cm2 0.5

Pulse Type IV


1 J/cm2 32 J/cm2 3

33 J/cm2 49 J/cm2 2

50 J/cm2 97 J/cm2 1

98 J/cm2 120 J/cm2 0.5



Pulse Type V


1 J/cm2 35 J/cm2 3

36 J/cm2 52 J/cm2 2

53 J/cm2 104 J/cm2 1

105 J/cm2 120 J/cm2 0.5

Pulse Type VI


1 J/cm2 15 J/cm2 3

16 J/cm2 23 J/cm2 2

24 J/cm2 46 J/cm2 1

47 J/cm2 90 J/cm2 0.5



6.4.4. Setting Operating Parameters – SHR Stack Mode After the gender and facial treatment area has been selected, you can select the SHR Stack Mode for operation.

The Stack Sub-Mode (see Figure 6-6) can be toggled on or off with the two appropriate buttons on the screen:

– press this button to enter and work with the Stack Mode.

– press this button to re-enter and work with the normal SHR mode.

Total Energy – to set the total energy parameter touch the Total Energy softkey on the screen. To increase or decrease the parameter settings, use the ▲ or ▼ arrow keys on the left side of the screen; the exhibited value expresses the total energy applied per session, counted in Kilojoules (kJ).

Refer to Appendix B of this manual for complete clinical information about the Stack Mode.

Figure 6-6: SHR Stack Mode



6.4.5. Setting Operating Parameters – NIR Module

Note

If you want to use the default parameter settings as they appear in the Standby screen, you may skip this section and proceed to Section 6.4.7.

1

2

3

98

4

10 5 6 7 Figure 6-7: Operating Screen Elements – NIR Module

1. The NIR tag is exhibited when the Near Infrared module is connected to the system.

2. Power Setting – to set the fluence parameter touch the Fluence softkey on the screen. To increase or decrease the parameter settings, use the ▲ or ▼ arrow keys on the left side of the screen; the exhibited power value will change accordingly.

3. Power Keys – use these ▲ or ▼ arrow keys on the left side of the screen to change the power value.

4. Total Energy – this window displays the total energy (measured in kiloJoules) applied during the current treatment session.



5. Standby/Ready – this soft-key toggles the Spa Accord system between Standby and Ready modes. Touch the red Ready button when you are ready to start the treatment; the red button will change to green and laser emission will be enabled when the footswitch and trigger are both pressed. Touch the green (Standby) button to return the system to Standby mode.

Note

When the system is emitting the treatment beam, this button will appear as a green indicator.

6. Saving Parameter Settings – Refer to Section 6.4.6.

7. New Session – press this button to recycle the system to a new session; the session pulse counter will reset to zero (paragraph # 8 below).

8. Session Pulse Counter - this field counts the number of laser pulses emitted by the module in the current session. The field is reset to 0 (zero) when a new session is started (by pressing the New Session button).

9. Total Module Pulse Counter – this field counts the total number of pulses emitted by the module, and it cannot be reset. This field will automatically reset to zero only when a new module is connected to the system.

10. The cooling system is ready for operation only after the indicator in the Cooling field appears green. This takes about 1-2 minutes

Warning

Once the system enters Ready mode, light emission will start upon activation of the footswitch.



6.4.6. Saving Parameter Settings Upon system turn-on, the controller loads the default set of operating parameters appropriate to the module connected to the system. If desired, you can save your own sets of operating parameters to replace the default settings.

Note

Saving new settings overwrites the default parameters (or any previously-saved settings).

To save a proprietary protocol of operating parameters:

1. Access the Standby screen.

2. Set the desired operating parameters (refer to Section 6.4.3).

3. Touch the Save softkey; the system deletes the default (or any previously saved) settings, and stores the new protocol.

4. The system will recall the last-saved set of parameters the next time it is turned on.

6.4.7. Initiating Light/Laser Emission 1. The Cooling indicator should appear green. Do not begin treatment until it does.

2. Position the module's lightguide on the area to be treated.

3. Press the footswitch if operating with the NIR module. Diode laser energy emission is enabled only when both the footswitch and the module's trigger are activated together.

Note

If the footswitch and/or the module's trigger are inadvertently activated while the system is not in Ready mode, light emission will not occur and an audible alarm signal will sound.

4. The lightguide should always be in contact with the treated area during treatment. An audio signal sounds with each emitted pulse.

5. The pulse counter is updated with each pulse. To reset the counter, touch the Reset softkey on the bottom of the screen, otherwise automatic reset will occur when the system is shut down.

6. To stop light/laser emission at any time, release the footswitch and/or the module's trigger.



6.4.8. Pause in Operation As a standard safety measure whenever light emission is not immediately required, the system should be set to Standby mode. Before leaving the room, the operator should turn the system off as described in Section 6.5.

6.4.9. Changing Parameters during Operation The application mode, fluence, timer and repetition rate can be changed during system operation. To change the operating parameters perform the following:

1. Release the trigger (diode laser module).

2. Release the footswitch.

3. Return to the Standby screen.

4. Change the setup parameters as described in Section 6.4.3.

5. Return to Ready mode.

6.5. Turning the System Off To turn off the system:

1. Set the system to Standby mode.

2. Turn the keyswitch counter-clockwise a quarter of a turn.

3. Toggle the main power switch to the Off position.

4. Move the circuit breaker's handle to the lower position.

5. Disconnect the power cable from the mains outlet.

6. Clean the modules (refer to Chapter 7: Maintenance).

7. Seat the modules in their appropriate cradles.

Note

To turn off the system in case of emergency, press the emergency shut-off knob. To release the knob, rotate the knob clockwise until it pops up.

Warning

To prevent unauthorized use of the system, do not leave the key in the keyswitch unattended.



CHAPTER 7 Maintenance


7.1. Introduction ....................................................................................... 7-2 7.2. Periodic Service ................................................................................. 7-2 7.3. Service Information ........................................................................... 7-3 7.4. Routine Maintenance ......................................................................... 7-4

Maintenance

7.1. Introduction This chapter contains maintenance instructions for the SopranoXL system.

Routine maintenance may be performed by clinic staff unless otherwise specified. Any maintenance procedure not mentioned in this chapter must be performed only by Alma Lasers authorized technical personnel.

The system is designed to operate reliably without any need for operator maintenance. However, the outer surfaces of the system should be kept clean for hygienic reasons and the lightguides should be cleaned between sessions to enable effective treatment.

Warning

Maintenance by the operator should be performed only when the system is shut down and disconnected from the mains power source. Performing maintenance procedures with the system turned on may be hazardous to the operator and/or destructive to the system.

7.2. Periodic Service The system should be periodically inspected and maintained to keep it in peak operating condition.

The following routine service operations should be performed by Alma Lasers authorized technical personnel every 6 months:

• General system check

• Interior inspection, including cleaning accumulated layers of dust

• Verification of the light output power rates with a power meter

• Cooling system:

Check the water level in the cooling system; refill if necessary

Replace the deionizer filter

Clean the radiator

Clean the fins of the heat exchanger's fan

Clean the water particle filter

Check the water quick-connector O-rings on the modules connectors


Maintenance

Warning

• The SopranoXL system generates hazardous voltages within the main console.

• The interior of the system may be serviced only by Alma Lasers authorized technical personnel.

7.3. Service Information In communications with Alma Lasers authorized representatives regarding the system, always include the part number and serial number indicated on the identification label located on the system service panel.

Warning

• Unauthorized servicing or modification of this system not described in this manual may expose the operator or patient to potential high voltage and laser radiation hazards.

• Improper use or adjustment of this system may invalidate the service warranty agreement.

Questions or problems should be referred to your Alma Lasers representative, or to the Alma Lasers Service Centers at:

Alma Lasers Ltd. 14 Halamish St., P.O.B. 3021 Caesarea Industrial Park Caesarea, Israel 38900 Tel: + (972) 4-627-5357 Fax: + (972) 4-627-5368 Email: [email protected]

Alma Lasers, Inc. 485 Half Day Road, Suite # 100 Buffalo Grove, IL 60089 Tel: 1-224-377-2000 Fax: 1-224-377-2050 Email: [email protected] Website: www.almalasers.com



www.almalasers.com

Maintenance

7.4. Routine Maintenance The following routine maintenance procedures should be performed by the clinic staff on a regular basis determined by the clinic protocol.

Warning

• The SopranoXL system generates high voltages and intense light / pulsed laser radiation when powered up.

• Always turn the system off and unplug the power cable before performing maintenance procedures.

• The interior of the system or its components may be serviced only by Alma Lasers authorized technical personnel.

7.4.1. Cleaning and Disinfecting the System In order to prevent the system from overheating, it is important to periodically check the air intake and outlet filters on the front, both sides and rear panels of the system. Clean the dust from these filters once a week.

The outer surface of the system may be wiped clean with a soft cotton cloth swabbed in 70% alcohol.

7.4.2. Modules A preventive inspection of the modules should be done on a daily basis. Inspection consists of checking the integrity and the appearance of the lightguides.

The outer surface of the module's body and the umbilical cable may be wiped clean with a soft cotton cloth swabbed in 70% alcohol.

The lightguide window should be cleaned following each patient treatment. Use a gentle optical lens cleaning solution, such as Fisherbrand® Optical Lens Cleaner or equivalent.


Maintenance

7.4.3. Filling/Draining the Cooling System's Water Reservoir The SopranoXL cooling system's water reservoir must be filled (or refilled) with deionized water in the following instances:

• Upon installation of a new system.

• If the water level is found to be low during a periodic maintenance check (by Alma Lasers Service personnel).

• If the following error message appears on the LCD screen: Water level low. Add water

Filling/refilling the water reservoir is done with the water filling kit that is supplied with the SopranoXL system, which includes (see Figure 7-1):

• A water filling tube, with a funnel connected to one side and a quick-connector attached to the other side

• An elbowed white CPC connector

• A five liter (1.3 gallon) container of deionized water

Figure 7-1: Water Filling Kit

Caution

Never fill the water reservoir with regular tap water. Use only deionized water.


Maintenance

7.4.3.1. Water Filling Procedure

1. Connect the elbow connector to the left port marked Vent on the lower right side of the service panel.

2. Connect the clear tube with the funnel to the port marked FILL on the upper right side of the service panel (see Figure 7-2).

Fill Port

Figure 7-2: Water Reservoir Filling Port on the Service Panel

3. Use the supplied 5 liter (1.3 gal.) container of deionized water, and pour it slowly into the funnel. Align the clear tubing with the service panel (see Figure 7-2). Stop filling as soon as the water starts to spill from the Vent port.

4. Plug in the main power supply cable.

5. Connect the desired module to the system.

6. Turn the system on and let it run for five minutes. You may experience a failure to start due to a low water error (Water level low. Add water). Repeat turning the system on until it runs smoothly.

7. Turn the system off.

8. Repeat steps 3 and 6 several times, until no more water can be added (spills out of the elbow right away).

9. Disconnect the Fill/Drain Kit components.

10. Turn the system on; it is ready for operation.


Maintenance

7.4.3.2. Water Draining Procedure

If the system is to be stored in a cold area where the temperature may fall below 0ºC (32ºF), the deionized water must be drained from the cooling system.

Draining is required when the system needs to be moved or shipped away, particularly in cold weather (to avoid freezing hazards).

1. Place a shallow container able to contain about 2 liters (0.5 gal.) of water and locate it adjacent to the service panel.

2. Connect the clear tube with the funnel to the port marked VENT on the service panel (see Figure 7-3).

3. Connect the elbow connector to the port marked DRAIN on the service panel, pointing down into the container.

4. Water will start draining from the elbow connector to the container. Allow it to bleed dry.

Figure 7-3: Draining the Water from the Reservoir



CHAPTER 8 Troubleshooting


8.1. Introduction ....................................................................................... 8-2 8.2. Warranty ............................................................................................ 8-2 8.3. Troubleshooting Guides .................................................................... 8-2

Troubleshooting

8.1. Introduction The SopranoXL system is equipped with a self-testing software routine that continuously monitors the system operation. If a system malfunction is detected, an error message will appear on the LCD display.

An error will disable the system operation and the operator should turn the system off using the keyswitch and the main switch.

The following troubleshooting tables do not attempt to list all possible system failures. Any fault not listed should be referred to Alma Lasers Service personnel.

Warning

Do not attempt to open or disassemble the system covers.

8.2. Warranty The system warranty period is one year.

Note

Improper use or adjustment of this system may invalidate the service warranty agreement. Please contact your authorized Alma Lasers distributor before attempting to troubleshoot this system in any manner other than specified in this manual.

8.3. Troubleshooting Guides Table 8-1 provides a list of alarms and error messages that may appear on the screen, their possible causes and corrective actions to be performed. If the corrective actions listed in the table do not solve the problem, contact your Alma Lasers Service representative.

Table 8-2 lists some probable system malfunctions for which no messages are displayed. If the corrective actions listed in the tables do not solve the problem, contact your Alma Lasers service representative.

The following troubleshooting guides do not attempt to list all possible system failures. Any fault not listed should be referred to your Alma Lasers service representative.

Please advise the Alma Lasers Service Department of all error messages that occur, with the exception Connect interlock.


Troubleshooting

Table 8-1: Error Message Troubleshooting Guide

Error Message/Alarm Probable Cause Corrective Action

Audible Alarm Signal (Buzzer) Initiated

Both the footswitch and the module's trigger are activated in Standby mode when an attempt is made to go to Ready mode

Release the footswitch and the module's trigger; the audible alarm is disabled

Head Error iButton Failed No module connected

1. Reconnect the module to the system and resume normal operation

2. Contact Alma Lasers Service

Head error VB1=0 VB2=0 System software malfunction Contact Alma Lasers Service

Save Data Error Failure to save data on iButton



FlowSw OFF Error Cooling system malfunction

1. Turn system off, wait 1 minute and restart; resume normal operation

2. If problem persists, contact Alma Lasers Service

Flow Sw Error

1. Flow switch malfunction.

2. Water pump malfunction



IButton Inc Failed

1. Module connection

2. System malfunction



RS232 CS Error System malfunction



RS232 WD Error RS232 may be disconnected.




Troubleshooting

Table 8-1: Error Message Troubleshooting Guide (continued)

Error Message/Alarm Probable Cause Corrective Action

Connect Interlock Treatment room door (with installed remote interlock connection switch) has been opened

1. Close the door, restart the system via the keyswitch and resume normal operation

2. Make sure the remote interlock is properly connected to the service panel

Date Time Error An attempt to change the date was made. Contact Alma Lasers Service

Fill the water reservoir with deionized water (see Chapter 7). Water Level Low Low water level.

Driver Error Laser Off Power supply malfunction.



Driver Error Over Temp Power supply malfunction.



Driver Error Over Curr Power supply malfunction.




Troubleshooting

Table 8-2: System Malfunctions Troubleshooting Guide

Symptom Probable Cause Corrective Action

Display does not work when the key switch is turned on.

1. Emergency shut-off knob is engaged.

2. The circuit breaker handle is in the Down position.

3. No mains power supply.

4. Display malfunction.

1. Turn off the system, turn the emergency shut-off knob clockwise and restart the system.

2. Lift up the circuit breaker handle.

3. Check if the mains power supply is present, and the power cable is properly plugged into the wall outlet.


The module's tip is not cold when the circuit breaker is up, and the main switch is in the On position.

1. Insufficient cooling time.

2. Pause in operation for more than 5 minutes.

3. Hardware malfunction.

1. Wait for 1-2 minutes and try again.

2. Activate the footswitch and the module's trigger to reset the TEC timer system. Wait for 1-2 minutes and try again.

3. Contact Alma Lasers Service.

Laser/light emission is not initiated when the footswitch and/or the module's trigger are activated.

1. The system is in Standby mode.

2. The footswitch's tube is not connected to the service panel.

3. Circuit breaker malfunction.

1. Change to Ready mode.

2. Check the footswitch's tube connection.

3. Contact Alma Lasers Service.



CHAPTER 9 Ordering Information


9.1. Ordering Information Parts List......................................................... 9-2

Ordering Information


9.1. Ordering Information Parts List This chapter offers information necessary for ordering SopranoXL accessories.

The following table displays the names of the items by which you should place your orders with your Alma Lasers distributor.

Description

SopranoXL Diode Laser Module

SopranoXL NIR Module *

Cradle for Module

Support Roller for Umbilical Cable

Safety Eyewear for the Diode Laser Module OD 6+ (x 2)

Safety Eyewear for the NIR Module OD 3+ (x 2)

Opaque Eye Protectors

Laser Danger Sign

Footswitch Pedal

Remote Interlock Connector

Set of Spare Operation Keys

SopranoXL System Operator's Manual

* Not available in Canada

Soprano®XL Operator's Manual A-1

APPENDIX A Clinical Guide –

General Clinical Information *


A.1. Introduction ...................................................................................... A-2 A.2. Training Requirements ..................................................................... A-2 A.3. Intended Use and Indications............................................................ A-2 A.4. General Contraindications ................................................................ A-3 A.5. Adverse Effects of Treatment ........................................................... A-3 A.6. Potential Side Effects of Treatment .................................................. A-4 A.7. Eye Protection................................................................................... A-4 A.8. Optical Safety ................................................................................... A-5 A.9. Fire Safety......................................................................................... A-5 A.10. Definitions ........................................................................................ A-6 A.11. Counseling ........................................................................................ A-7 A.12. Photography...................................................................................... A-8 A.13. Post-Treatment Care ......................................................................... A-8


General Clinical Information

A.1. Introduction The information in this chapter and the following Clinical Guides are provided to aid professionals in the use of the SopranoXL system. It adds to or reinforces information presented in the operator’s manual concerning instructions for use, precautions and warnings necessary to reduce the risk of injury. All operators must read the entire operator’s manual before reviewing this appendix and before operating the system.

A.2. Training Requirements The SopranoXL system is designed to be operated only by personnel properly trained in its handling and use. All personnel who operate the system must read the operator’s manual. This includes physicians, nurses, technical staff or other professional staff members.

Alma Lasers provides in-service training for the SopranoXL system. At the end of this in-service training, personnel are considered trained for the operation of the SopranoXL system.

The physician is responsible for contacting the local licensing agencies to determine any credentials required by law for clinical use and operation of the device.

A.3. Intended Use and Indications The Diode module is indicated for: the removal of unwanted hair and to effect stable, long-term hair reduction.


A-2 Soprano®XL Operator's Manual


A.4. General Contraindications • Cancer; in particularly, skin cancer

• Pregnancy (including IVF)

• Use of photosensitive medication and herbs for which 810nm light exposure is contra-indicated

• Diseases which may be stimulated by light at 810nm

• Prolonged exposure to sun or artificial tanning during the 3 to 4 weeks prior to treatment and post treatment

• Active infection of herpes simplex in the treatment area

• History of keloid scarring

• Diabetes (insulin dependent)

• Fragile and dry skin

• Hormonal disorders (that are stimulated under intense light)

• Use of anticoagulants

• Epilepsy

• History of coagulopathies

A.5. Adverse Effects of Treatment The use of the SopranoXL system is similar to the use of other light-based technologies. Historically, traditional systems have demonstrated the ability to cause a certain degree of controlled and uncontrolled tissue damage. In addition, there are the following risks:

• Severe or prolonged erythema (redness) and edema (swelling) within 2-24 hours of treatment that could last for several weeks.

• Irritation, itching, a mild burning sensation or pain (similar to sunburn) may occur within 48 hours of treatment at the application site.

• Blisters, epidermal erosions, or peri-lesional hyperpigmentation may develop and remain evident for several days to several weeks following treatment.

• Eye damage from reflected or prolonged unprotected exposure to intense light. Protective goggles (appropriate to the wavelength) must be worn during all treatments to prevent eye injury.



• It is important to observe tissue reaction during treatment. Poor patient screening and excessive optical energy may cause thermal damage and cause unwanted adverse effects.

A.6. Potential Side Effects of Treatment • Discomfort – when a pulse is triggered, some patients experience various

degrees of discomfort. Some patients describe the sensation as stinging, while others liken it to a rubber band snap or a burning sensation that may last for up to one hour after treatment. Most patients tolerate the sensation during treatment, but some patients may require a topical anesthetic.

• Damage to Natural Skin Texture – in some cases, a crust or blister may form. Normal wound care should be followed.

• Change of Pigmentation – there may be a change of pigmentation in the treated area. Most cases of hypopigmentation or hyperpigmentation occur in people with skin types IV to VI, or when the treated area has been exposed to sunlight within 3 weeks before or after treatment.

In some patients, hyper-pigmentation occurs despite protection from the sun. This discoloration usually fades in three to six months, but in rare cases, (mainly hypo-pigmentation) the change of pigment may be permanent.

• Scarring – there is a chance of scarring; such as, enlarged hypertrophic or keloid scars. To reduce the chance of scarring, it is important to carefully follow all pre- and post-treatment instructions.

• Excessive Swelling – immediately after treatment, especially on the nose and cheeks, the skin may swell temporarily. Swelling usually subsides within hours, but may continue for up to seven days.

• Fragile Skin – the skin at or near the treatment site may become fragile. If this happens makeup should be avoided, and the area should not be rubbed (as this might tear the skin).

• Bruising – purpura, or bruising, may appear on the treated area which may last from a few hours to several days.

A.7. Eye Protection • It is essential that all people present in the treatment room during the treatment

(patient and medical personnel) protect their eyes by wearing Alma Lasers recommended protective eyewear.



• Diode Laser Module: all personnel must use safety eyewear and must ascertain that the eyewear provides adequate protection (OD>7).

• NIR Module:

⇒ The patient must be fitted with protective eyewear of at least OD 5+

⇒ The operator must wear protective eyewear of at least OD 3+

• It is good practice to instruct the patient to close their eyes during treatment even when wearing protective eye glasses.

• If the patient cannot wear the protective eyewear, fit the patient with opaque eye protection that completely blocks light from the eyes.

• If the treatment area is very close to the eyes (e.g. eyelids), protect the eyes with corneal shields.

A.8. Optical Safety • Guard against accidental exposure to laser emission.

• Never look directly at the light emission from the SopranoXL module or at any reflecting surface, even when wearing protective eyewear.

• Always set the system to Standby mode when there is a pause in treatment; this prevents inadvertent laser emission.

• Press the module's trigger and/or footswitch only when the beam is aimed at the target tissue under direct visualization.

A.9. Fire Safety • Remove any hair from the treatment site. Use only drapes soaked in sterile water

near the treatment site if required.

• Make sure a fire extinguisher (rated for electrical fires) is available at all times.

• Avoid the use of flammable tissue-prepping agents or allow the material to completely evaporate before using the laser.

• Do not use the system in the presence of flammable, explosive anesthetic gases or oxygen.

• Any oxygen tubes present in the room should be of a laser-safe type.



A.10. Definitions

A.10.1. Fluence The energy density output, measured in Joules per squared centimeter (J/cm2), is set by the user for every treatment. The fluence is the total energy delivered in the selected pulse type (measured in Joules), divided by the spot size (measured in cm2).

With a large spot size the scattering effect is minimized, resulting in a constant fluence and deeper penetration. The greater the fluence is, the higher the temperature of the target hair or tissue, the surrounding tissue and the epidermis.

A.10.2. KiloJoules (kJ) The accumulative or total energy delivered to tissue for a given area. The product of the Fluence (J/cm2) x Time (seconds) divided by 1000 (See tables and figures in the following appendices).

A.10.3. Segmentation Segmentation is the method by which the treatment area (i.e., back) is divided to multiple, equal size grids of 100 cm2. Each grid receives a fixed energy dose expressed in kJ (example: 6-8 kJ).

A.10.4. Pre-Treatment The treatment parameters depend on the skin type. Before the treatment parameters are selected make sure that the area is marked and has well defined boundaries (15x15 cm or 30 x7.5 cm). In cases where the treatment area is hairy, shave and clean the treatment site to eliminate any surface hair and debris that could interfere with the treatment.

A.10.5. Pulse Type Each pulse type in the diode laser module's LHR mode consists of pre-defined pulse parameters: BlendMode™ ratio and the total Pulse Width of the pre-heating pulse segment and the therapeutic pulse segment.



• BlendMode – the delivery of the fluence via a patented software-controlled pulse management method that blends the pre-heating pulse and the therapeutic pulse into optimized pulses for each skin type.

This unique technique creates pre-heating conditions which elevate the temperature of the target gradually and effectively while minimizing damage to the surrounding tissue.

• Pulse Width – the total duration of each of the pulses segments (the pre-heating segment and the therapeutic segment), measured in milliseconds. The pulse widths in the LHR mode of the diode laser module are software-controlled and are set by the user using the Pulse Type softkey.

A.10.6. DualChill™ Technique The DualChill technique provides cooling before, during and after the pulse, providing more protection to the epidermis by reducing the initial epidermal temperature and thereby the maximum temperature reached in the epidermis during the pulse. This reduces patient’s discomfort. Equally important with DualChill, it enables the fluence to be raised when necessary without increasing adverse effects.

Dense hair (approx. 30-40 hairs per cm2) produces higher temperatures due to the higher melanin concentration per cm2. Cooling of the follicles by heat conductivity produces excess heat in the surrounding tissues, which can result in tissue damage. Therefore as hair density increases, fluence should be reduced.

The DualChill technique combines two cooling methods:

1. Integrated sapphire tip contact cooling, and

2. The proven active cooling ability of the Zimmer Cryo via the Zimmer adapter on the module.

A.11. Counseling During the first visit, the physician (or an authorized member of the staff) should:

• Determine why the patient is seeking the treatment and clearly understand his/her expectations.

• Discuss the treatment with the patient:

The SopranoXL therapy may consist of multiple treatments given over several months.

There may be some discomfort or pain associated with the treatment.

Transient erythema/edema may appear immediately following the treatment.

Gradual recovery of the dermatological condition may take a few months.




There is a small risk of adverse reactions, such as changes in the texture and pigmentation of the skin, which are usually transient (see Adverse Effects of Treatment on page A-3 and Potential Side Effects of Treatment on page A-4).

A.12. Photography When working with the diode laser module, it is recommended to take "before and after" photographs to document the treatment progress. These photographs provide objective evidence because many patients are not able to assess the progress of treatment through the gradual improvement.

Standard conditions and similar camera speed, flash and focal distance should be used to photograph all patients. This consistency enables an objective comparison of photos taken at different times.

A.13. Post-Treatment Care Cold (not frozen) packs should be applied immediately post-treatment to cool the treatment site, reduce swelling and ease discomfort. Pre-chilled 10x10 cm gauze pads, previously soaked with water may be used.

Care should be taken to prevent trauma to the treated area for the first four or five days following the treatment: avoid hot baths, aerobic exercise, massage, etc.

• Exposure to Sunlight – patients should apply high-factor sun protection (SPF >30), and protect the treated area from exposure to direct sunlight for at least one month post-treatment. Tanning after treatment sessions may enhance melanin regeneration, which may result in hyper-pigmentation.

• Makeup – makeup may be applied on the day following treatment unless blistering or crusts develop. Since the skin is sensitive during this period, take special care while removing makeup to avoid damage to the skin, which can predispose the site to infection.

• Other Post-Treatment Recommendations – if the treatment site is exposed to dirt, it should be covered with a dressing for ten days. Patients should be advised not to participate in rough sports or similar activities for several days following the treatment, until the skin returns to its normal condition.

Soprano®XL Operator's Manual B-1

APPENDIX B Clinical Guide – SHR Mode


B.1. Introduction .......................................................................................B-2 B.2. Intended Use and Indications.............................................................B-2 B.3. Contraindications...............................................................................B-2 B.4. Pre-Treatment ....................................................................................B-3 B.5. Treatment...........................................................................................B-5 B.6. Treatment Parameters ........................................................................B-9 B.7. Suggested Setup Parameters for SHR Mode ...................................B-10 B.8. SHR Mode – Suggestions for Treating Thin, Light Colored Hair...B-10 B.9. Post-Treatment Care ........................................................................B-11 B.10. Concluding Treatment .....................................................................B-11 B.11. Follow-Up........................................................................................B-12

Clinical Guide – SHR Mode

B.1. Introduction This appendix is provided to aid professionals in the use of the SopranoXL system operating with the diode laser module in SHR mode.

It adds to or reinforces information presented in the operator’s manual concerning instructions for use, precautions and warnings necessary to reduce the risk of injury. All operators must read the entire operator’s manual before reviewing this appendix and before operating the system.

B.2. Intended Use and Indications The SopranoXL diode laser module is intended for hair removal and long-term hair reduction. The SopranoXL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.

The diode laser module is indicated for: the removal of unwanted hair and to effect stable, long-term hair reduction.

B.3. Contraindications • Cancer; in particularly, skin cancer


• Use of photosensitive medication and herbs for which laser exposure is contra-indicated

• Diseases which may be stimulated by laser exposure







• Epilepsy


B-2 Soprano®XL Operator's Manual


B.4. Pre-Treatment

B.4.1. General

The treatment parameters for hair removal depend on skin type, hair color, type, density and depth of hair to be treated. Once treatment parameters are selected, shave and clean the treatment site to eliminate any surface hair and debris that could interfere with the treatment. Mark the treatment area with 10 x 15 cm grids using 8 landmarks. The number of grids needed to cover a given area may vary according to the (body) size of each individual.

During the first visit the physician (or an authorized staff member) should:

• Take a detailed patient medical history, including previous treatment modalities, and examine the dermatological condition for suitability of treatment with the SopranoXL system.

Figure B-1: Grid Marking Using 8 Landmarks

• Exclude from treatment anyone who has had prolonged sun exposure or artificial tanning during the last 48 hours.

• Exclude from treatment anyone who is expecting to have prolonged sun exposure during the upcoming month.

• Patients with a history of herpes simplex in the treatment area should take preventive medication (such as Zovirax™) prior to treatment.

• Determine why the patient is seeking treatment and understand his/her expectations.

• Discuss treatment goals with the patient.

• It is recommended to shave the treatment area 12-24 hours prior to treatment.

B.4.2. Counseling During the first visit, the physician (or an authorized member of the staff) should:









There is a small risk of adverse reactions, such as changes in the texture and pigmentation of the skin, which are usually transient.

B.4.3. SHR Mode Skin Test Fluence is critical to optimize the treatment efficacy and minimize any expected side effects. Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters:

Table B-1: SHR Mode Skin Test Parameters

Skin Type (Fitzpatrick I-VI) Fluence (J/cm2) Grid Size

(cm2) Accumulative Energy (kJ)

I 10 150 8 – 10

II 10 150 8 – 10

III 10 150 8 – 10

IV 8 150 8 – 10

V 7 150 7 – 9

VI 5 150 7 – 9 • Shave the area

• Cover the treatment area (150 cm2) with a coat (1-2mm) of cold ultrasound gel.

• Always perform a skin test on the intended treatment area during the first treatment session.

• It is recommended to wait ~15 minutes for skin types I-III and 30 minutes for skin types IV-VI.



B.5. Treatment

B.5.1. General The SopranoXL system has recommended preset parameters that correlate to the desired treatment area. Once selecting the desired treatment area from the system's touch screen, the screen displays the recommended fluence (expressed in J/cm2), total energy (expressed in kJ), treatment time (expressed in seconds) and number of grids, as displayed in Figure B-2.

The default fluence and total energy parameters can be adjusted by the operator when the system is in Standby mode.

Figure B-2: Recommended Default Parameters in the Lower Leg Treatment Area



B.5.2. System Default Parameters The following table exhibits the default parameters in each treatment area:

Table B-2: System Default Parameters

Default Parameters Treatment Area Fluence

(J/cm2) Total Energy

(kJ) Treatment Time (sec)*

Number of Grids **

Upper arm 10 8 80 3

Lower arm 10 8 80 2

Upper leg 10 8 80 6

Lower leg 10 8 80 4

Axilla 10 6 60 1

Bikini line 10 6 60 3

Lower abdomen

(umbilical area) 10 8 80 1

Female

Face 10 6 60 1

Abdomen 10 8 80 6

Chest 10 8 80 8

Shoulders 10 8 80 5

Back 10 8 80 14

Male

Face 10 6 60 1

(*) The treatment time is a calculation of the time it would take to deliver the desired total energy according to the current fluence settings. The treatment time is automatically calculated by the system.

(**) The number of grids is based on average body size (female/male). Lower or higher number of grids may be indicated for patient's smaller/larger surface areas.



B.5.3. Treatment Procedure Treatment can begin after the Treatment Area has been selected from the system's touch screen.

Warning

Delivering excessive energy to the treatment site can result in thermal damage to the skin, possibly leading to hypertrophy and/or atrophy and/or abnormal pigmentation.

1. Always perform a skin test to establish the cutaneous reaction when beginning

treatment.

2. Carefully diagnose the skin test.

3. Ensure that the patient is lying comfortably with eye protection in place. All personnel in the treatment room should wear appropriate eye protection as well. The operator should have good access to the treatment area and to the controls of the SopranoXL system.

4. Clean the skin to remove perfumes, cosmetics and sunscreens.

5. Cover the treatment area (150 cm2) with a thin coat (1-2mm) of cold ultrasound gel.

6. Select the appropriate Treatment Area from the system's touch screen.

7. If necessary, adjust the default fluence (expressed in J/cm2) and total energy (expressed in kJ) parameters displayed on the screen (refer to Chapter 6).

8. Verify that the module's tip is cold. The In-Motion technique should be initiated only with active sapphire contact cooling and a thin layer of gel on the treated area. No other cooling means are necessary (i.e. Zimmer).

9. Place the module perpendicular to the skin and establish contact with the skin. Press the tip against the skin with moderate pressure to achieve adequate contact.

Warning

It is important to contact the skin prior to laser beam emission.

10. If the pulse has the desired effect, continue treatment with the same fluence.

11. Start treatment by simultaneously activating the module's trigger and the footswitch.

12. Move the module in a rotational (circular), progressive in-motion, ring-like pattern over the entire grid area; the module should always be in constant movement, where the In-Motion principle is to move the module away from the “hot” spot/area to the neighboring “colder” spot/area.



13. If the hair density in the treatment area is high and hair color is dark, the speed of the In-Motion circular motion technique should be increased; make sure to use effective cooling means.

14. The patient should report comfortable/tolerable heat sensation in the treated area during the procedure. If patient is reporting discomfort, reduce fluence by 1 J/cm2.

15. Add cold gel to the treatment/grid area as required.

16. Occasionally examine the treatment site for a change in skin color and morphological changes around the follicles (erythema/edema). The smell of burnt hair may sometimes be detected, although absence of this phenomenon does not necessarily indicate that the present fluence is ineffective.

17. Clinical end-points: erythema, hyperemia, perifollicular erythema and edema.

18. If adverse skin effects occur (such as excessive reddening) before good follicular response is achieved, decrease the fluence by ~10% to reduce the aggressiveness of the treatment.

19. If the skin shows no end-points and no morphological changes are observed, you may raise the fluence by 5-10% until the desired effect is achieved.

Warning

The light emitted by the SopranoXL laser system is capable of causing serious eye damage or blindness. For maximum safety, metal goggles must be worn by the patient for all facial treatments.

20. After treatment it is recommended to cool the area immediately (see Section B.9: Post-Treatment Care).

B.5.4. Treatment Areas The SopranoXL system can be used bilaterally in the following areas:

Female: Male:

• Upper arm • Abdomen

• Lower arm • Chest

• Upper leg • Shoulders

• Lower leg • Back

• Axilla • Face

• Bikini line

• Lower abdomen (naval area)

• Face



B.6. Treatment Parameters The SopranoXL system is equipped with a set of SHR application mode settings. Once the desired treatment area is selected from the system's touch screen, the screen displays the recommended preset parameters of fluence (expressed in J/cm2), total energy (expressed in kJ), treatment time (expressed in seconds) and number of grids, as displayed in Figure B-2. These presets are based on successful results obtained by experienced operators. In addition, operators can adjust and set their own parameter values.

The SHR application mode treatment parameters consist of laser energy (Fluence), accumulative energy (kJ) and a high repetition rate. For each treatment in SHR mode, the fluence and total energy parameters can be adjusted by the operator.

At a fluence of up to 10 J/cm2, the pulse repetition rate is fixed at 10 Hz.

At fluence settings between 10-20 J/cm2, the pulse repetition rate is reduced as the fluence increases according to the following table:

Table B-3: Correlation of Fluence to Repetition Rate

Fluence (J/cm2) Repetition Rate (Hz)

20 5

18 6

16 6

14 7

12 8 Therefore, when the operator sets the fluence parameter to over 10 J/cm2, the pulse repetition rate reduces from 10 Hz at a fluence of 10 J/cm2, down to 5 Hz at fluence of 20 J/cm2.



B.7. Suggested Setup Parameters for SHR Mode

Table B-4: Suggested Setup Parameters for SHR Mode



I 10 150 8 – 10

II 10 150 8 – 10

III 10 150 8 – 10

IV 8 150 8 – 10

V 7 150 7 – 9

VI 5 150 7 – 9 • Skin test must be done before the first treatment.

• New settings for each subsequent treatment should be based on hair and skin clinical findings of the previous treatment

• All fluences are based on patient tolerance and skin reaction. Do not increase fluence if there has been ANY adverse skin reaction at a lower setting.

B.8. SHR Mode – Suggestions for Treating Thin, Light Colored Hair

The SopranoXL system delivers laser energy at a fluence of up to 20 J/cm2.

For patients with skin types I-IV with thin, vellus, light colored hair, it is advisable to increase the fluence to over 10 J/cm2 in order to apply maximal damage to this type of hair. For patients with light skin types, the lighter the hair color and the thinner the hair in the desired treatment area, the higher the selected fluence (J/cm2) should be.

The operator should be aware that at a fluence of 10-20 J/cm2, the pulse repetition rate reduces as the fluence increases, as described in Section B.6.



B.9. Post-Treatment Care Cold (not frozen) packs should be applied immediately post-treatment to cool the treatment site, reduce swelling and ease discomfort. Pre-chilled 10x10 cm gauze pads, previously soaked with water may be used.





B.10. Concluding Treatment Determining when treatment should be concluded is left to the discretion of the professional staff, or to the patient achieving satisfaction with the treatment results.




B.11. Follow-Up Measures presented below are only the manufacturer's recommendations for follow-up. They may serve as a basis for defining your treatment regimen.

• Patients should return for examination of the treatment site between six to eight weeks after treatment and for additional treatment, if necessary.

• If no additional treatment is necessary, the patient should return for an additional re-examination three to four months later, or when any new hair has grown in the treatment area.

• If there has been partial hair clearance, treatment should be continued and the patient should return between six to eight weeks for examination and for additional treatment, if necessary.

• If no change is noted, treatment parameters should be changed. With multiple treatments, increase the time intervals between treatment sessions (after the second one), to allow any new hair to grow in the treatment area. New growth will vary based on the body area (growth cycle) and on the individual patient (gender, hormonal problems, etc.).

• Patients should be instructed to avoid sun exposure after and in between treatments.

All adverse side effects should be reported to the treating physician with a follow-up report sent to the Director of Clinical Operations at Alma Lasers:




www.almalasers.com

Soprano®XL Operator's Manual C-1

APPENDIX C Clinical Guide –

SHR Stack Sub-Mode


C.1. Introduction .......................................................................................C-2 C.2. Intended Use and Indications.............................................................C-2 C.3. Contraindications...............................................................................C-2 C.4. Pre-Treatment ....................................................................................C-3 C.5. Treatment...........................................................................................C-5 C.6. Treatment Parameters ........................................................................C-7 C.7. Total Energy (kJ) Invested per Area Size (cm2) ................................C-9 C.8. Post-Treatment Care ........................................................................C-10 C.9. Concluding Treatment .....................................................................C-10 C.10. Follow-Up........................................................................................C-11

Clinical Guide – SHR Stack Sub-Mode

C.1. Introduction This appendix is provided to aid professionals in the use of the SopranoXL system operating with the diode laser module in SHR Stack sub-mode.


C.2. Intended Use and Indications The SopranoXL diode laser module is intended for hair removal and long-term hair reduction. The SopranoXL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.


The SHR Stack sub-mode is intended for use in small-size treatment areas such as facial (i.e., upper lip etc.) and/or small grid body areas (i.e., fingers etc.).

C.3. Contraindications • Cancer; in particularly skin cancer


• Use of photosensitive medication and herbs for which laser exposure is contra-indicated

• Diseases which may be stimulated by laser exposure







• Epilepsy


C-2 Soprano®XL Operator's Manual


C.4. Pre-Treatment

C.4.1. General

The treatment parameters for hair removal depend on skin type, hair color, type, density and depth of hair to be treated. Once treatment parameters are selected, shave and clean the treatment site to eliminate any surface hair and debris that could interfere with the treatment. Mark the treatment area with 10 x 5 cm grids using 8 landmarks. The number of grids needed to cover a given area may vary according to the (face/body) size of each individual.

Figure C-1: Grid marking using 8 landmarks

During the first visit the physician (or an authorized staff member) should:







• It is recommended to shave the treatment area 12-24 hours prior to treatment.



C.4.2. Counseling During the first visit, the physician (or an authorized member of the staff) should:








C.4.3. SHR Stack Sub-Mode Skin Test Fluence is critical to optimize the treatment efficacy and minimize any expected side effects. Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters:

Table C-1: SHR Stack Sub-Mode Skin Test Parameters



I 7 50 3 – 4

II 7 50 3 – 4

III 7 50 3 – 4

IV 6 50 2.5 – 3.5

V 5 50 2 – 3

VI 5 50 1.5 – 2.5 • Shave the area

• Cover the treatment area (50 cm2) with a coat (1-2mm) of cold ultrasound gel.

• Always perform a skin test on the intended treatment area during the first treatment session.

• It is recommended to wait ~15 minutes for skin types I-III and 30 minutes for skin types IV-VI.



C.5. Treatment The SopranoXL system has recommended preset parameters that correlate to the desired treatment area. Once selecting the desired treatment area from the system's touch screen, the screen displays the recommended fluence (expressed in J/cm2), total energy (expressed in kJ), treatment time (expressed in seconds) and number of grids, as displayed in Figure C-3.

The default fluence and total energy parameters can be adjusted by the operator when the system is in Standby mode.

Treatment can begin after the Treatment Area has been selected from the system's touch screen.

Warning


1. Always perform a skin test to establish the cutaneous reaction when beginning treatment.




5. Cover the treatment area (50 cm2) with a coat of cold ultrasound gel (1-2mm).

6. Select the appropriate Treatment Area from the system's touch screen.

7. Select the desired stacking mode (number of stacks per pulse) by pressing the Stack button repeatedly until the button shows 5, 4, 3 or 2 stacks for each press of the button, as displayed in Figure C-3.

8. Adjust the default fluence and total energy parameters displayed on the screen according to the recommendations provided in Table C-2, Table C-3 and Figure C-3.

9. Verify that the module's tip is cold. The In-Motion technique should be initiated only with active sapphire contact cooling and a thin layer of gel on the treated area. No other cooling means (i.e., Zimmer) are necessary.

10. Place the module perpendicular to the skin and establish contact with the skin. Press the tip against the skin with moderate pressure to achieve adequate contact.



Figure C-2: Location of the Stack Button on the Treatment Area Screen; Select

Stacking Mode (Stacks per Pulse)

Warning


11. If the pulse has the desired effect, continue treatment with the same fluence.

12. Start treatment by simultaneously activating the module's trigger and the footswitch.

13. Move the module in a rotational (circular), progressive in-motion, ring-like pattern over the entire grid area; the module should always be in constant movement, where the In-Motion principle is to move the module away from the “hot” spot/area to the neighboring “colder” spot/area.

14. If the hair density in the treatment area is high and hair color is dark, the speed of the In-Motion circular motion technique should be increased; make sure to use effective cooling means.

15. The patient should report comfortable/tolerable heat sensation in the treated area during the procedure. If patient reports discomfort, reduce fluence by 1 J/cm2.

16. Add cold gel to the treatment/grid area as required.

17. Occasionally examine the treatment site for a change in skin color and morphological changes around the follicles (erythema/edema). The smell of



burnt hair may sometimes be detected, although absence of this phenomenon does not necessarily indicate that the present fluence is ineffective.

18. Clinical end-points: erythema, hyperemia, perifollicular erythema and edema.

19. If adverse skin effects occur (such as excessive reddening) before good follicular response is achieved, decrease the fluence by ~10% to reduce the aggressiveness of the treatment.

20. If the skin shows no end-points and no morphological changes are observed, you may raise the fluence by 5-10% until the desired effect is achieved.

Warning


21. After treatment it is recommended to cool the area immediately (see Section C.8: Post-Treatment Care).

C.6. Treatment Parameters The SopranoXL system is equipped with a set of SHR Stack sub-mode application settings. These presets are based on successful results obtained by experienced users. In addition, users can select and set their own parameter values.

The SHR Stack sub-mode application treatment parameters consist of laser energy of up to 10 J/cm2 (Fluence) and a fixed repetition rate of 10 Hz. For each treatment with the SHR Stack sub-mode, the fluence (J/cm2) and total energy (kJ) parameters must be set by the operator.

The SHR Stack sub-mode application is available at a fluence of up to 10 J/cm2.




C.6.1. Suggested Setup Parameters for SHR Stack Sub-Mode

Table C-2: Suggested Setup Parameters for SHR Stack sub-Mode

Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

# of Stacks per Pulse

Accumulative Energy (kJ)

I 8 5 3 - 4

II 7 5 – 4 3 - 4

III 7 4 3 - 4

IV 6 4 – 3 3 - 4

V 5 3 2.5 – 3.5

VI 5 2 2 – 3 • Skin test is recommended before the first treatment.

• Skin test must be done before the first treatment.

• New settings for each subsequent treatment should be based on hair and skin clinical findings of the previous treatment.



C.7. Total Energy (kJ) Invested per Area Size (cm2)

1

23

4

Figure C-3: Total Energy (kJ) Invested per Facial Area Size

Table C-3: Total Energy (kJ) Invested per Area Size

Area No. Treatment Area Total kJ # Grids *

1 Upper Lip 3 – 5 1

2 Chin 3 – 5 1

3 Submental 6 – 10 2

4 Side Wigs/beard 3 – 10 1 – 2

5 Finger 0.5 0.1

(*) Based on ~50 cm2 area

• Total kJ represents range of average face size (male/female)

• Lower or higher kJ may be indicated for patient's smaller/larger surface areas

• Using a standard grid of 50 cm2 is equivalent to 3-5 kJ



C.8. Post-Treatment Care Cold (not frozen) packs should be applied immediately post-treatment to cool the treatment site, reduce swelling and ease discomfort. Pre-chilled 10x10 cm gauze pads, previously soaked with water may be used.





C.9. Concluding Treatment Determining when treatment should be concluded is left to the discretion of the professional staff, or to the patient achieving satisfaction with the treatment results.



C.10. Follow-Up Measures presented below are only the manufacturer's recommendations for follow-up. They may serve as a basis for defining your treatment regimen.











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Soprano®XL Operator's Manual D-1

APPENDIX D Clinical Guide – LHR Mode


D.1. Introduction ...................................................................................... D-2 D.2. Intended Use and Indications............................................................ D-2 D.3. Contraindications.............................................................................. D-2 D.4. Pre-Treatment ................................................................................... D-3 D.5. Treatment.......................................................................................... D-5 D.6. Treatment Parameters ....................................................................... D-7 D.7. Suggested Setup Parameters for LHR Mode .................................... D-7 D.8. Concluding Treatment ...................................................................... D-8 D.9. Follow-Up......................................................................................... D-8

Clinical Guide – LHR Mode

D.1. Introduction This appendix is provided to aid professionals in the use of the SopranoXL system operating with the diode laser module in LHR mode.


D.2. Intended Use and Indications The SopranoXL diode laser module is intended for hair removal and long-term hair reduction. The SopranoXL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.


D.3. Contraindications • Cancer; in particularly, skin cancer


• Use of photosensitive medication and herbs for which 810nm light exposure is contra-indicated

• Diseases which may be stimulated by light at 810nm







• Epilepsy


D-2 Soprano®XL Operator's Manual


D.4. Pre-Treatment

D.4.1. General During the first visit the physician (or an authorized staff member) should:







D.4.2. Counseling During the first visit, the physician (or an authorized member of the staff) should:










D.4.3. LHR Mode Skin Test Fluence is critical to optimize the treatment efficacy and minimize any expected side effects. Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters:

Table D-1: LHR Mode Skin Test Parameters

Skin Type (Fitzpatrick I-VI) Pulse Type Hair Type Fluence

(J/cm2) Coarse / Dark 45

I I Fine / Light 35

Coarse / Dark 40 II I

Fine / Light 30 Coarse / Dark 35

III II Fine / Light 35

Coarse / Dark 30 IV III

Fine / Light 30

V IV or V All must undergo a patch test 15

VI IV or V All must undergo a patch test 15

• All skin tests and treatments must be done with Zimmer Cryo

• Patch test must be done before the first treatment


• It is recommended to wait ~30 minutes for skin types I-III and 45 minutes for skin types IV-V.

D.4.4. Topical Anesthesia Due to the unique BlendMode capabilities and the DualChill Technique incorporated into the SopranoXL diode laser module, the procedure can be administered without topical anesthesia. However, there may be patients who prefer to undergo the treatment using a topical anesthetic (such as Emla®) which renders the procedure without any sensation.

Topical anesthetics are generally applied for a period of time (up to 1 hour) prior to treatment. Be certain to remove all of the topical anesthetics prior to treatment.

Any use of topical anesthesia is at the physician's discretion, and should be used according the manufacturer's recommendations.



D.5. Treatment In order to enter LHR mode, press the LHR button located in the lower left corner of the Treatment Area Selection screen (see Figure 6-1).

The default fluence and pulse repetition rate parameters are displayed on each Pulse Type screen as displayed in Figure D-1. These parameters can be adjusted by the operator when the system is in Standby mode.

Figure D-1: Displayed Default Parameters in the LHR Screens

Treatment can begin after the treatment parameters are selected (Pulse Type, Fluence and Pulse Repetition Rate).

Warning


1. Ensure that the patient is lying comfortably with eye protection in place. All

personnel in the treatment room should wear appropriate eye protection as well. The operator should have good access to the treatment area and to the controls of the SopranoXL system.


3. Press the Reset softkey to reset the pulse counter.

4. Choose the appropriate settings (Application Mode, Pulse Type, Fluence and Rep Rate). Once the parameters are chosen, the operator may choose to save these settings. This enables the operator to use these settings for groups of patients with similar characteristics who visit the practice.



5. Verify that the module's tip is cold.

6. Place the module perpendicular to the skin and establish contact with the skin. Press the tip against the skin with moderate pressure to make good contact.

Warning


7. Always perform a skin test to establish the cutaneous reaction when beginning

treatment.


9. If the pulse has the desired effect, continue treatment with the same parameters.

10. Start treatment by simultaneous activation of the module's trigger and the footswitch.

11. Occasionally examine the treatment site for a change in skin color and morphological changes around the follicles (erythema/edema). The smell of burnt hair may sometimes be detected, although absence of this phenomenon does not necessarily indicate that the present set of parameters is ineffective.

12. If adverse skin effects occur (such as excessive reddening) before good follicular response is achieved, adjust the treatment parameters to reduce the aggressiveness of the treatment. Aggressiveness may be reduced by either decreasing the fluence by 5-10% or by changing the pulse type to a less aggressive one (moving to a higher pulse type).

13. If the skin shows no adverse effects and no morphological changes are observed, you may raise the energy by 5-10% until the desired effect is achieved.

Warning


14. After treatment it is recommended to cool the area immediately (see

Section A-13).

Note

It is not recommended to treat hair that is lighter than the surrounding skin.




D.6. Treatment Parameters The SopranoXL's diode laser module is equipped with a set of LHR application mode settings. These presets are based on successful results obtained by experienced users. In addition, users can select and set their own parameter values.

The LHR application mode treatment parameters consist of laser pulse parameters (Pulse Type) and laser energy (Fluence). For each treatment with the LHR mode, these parameters are to be set by selecting one of the six pulse types, and then selecting the treatment fluence & repetition rate.

D.7. Suggested Setup Parameters for LHR Mode

Table D-2: Suggested Setup Parameters for LHR Mode

Skin Type (Fitzpatrick I-VI) Pulse Type Hair Type Fluence (J/cm2)

Coarse / Dark 45 – 50 I I

Fine / Light 50 – 55 Coarse / Dark 45 – 50

II I Fine / Light 50 – 55

Coarse / Dark 40 – 50 III II

Fine / Light 45 – 50 Coarse / Dark 30 – 50

IV III Fine / Light 35 – 45

V IV or V All must undergo a patch test 15 – 25

VI IV or V All must undergo a patch test 15 – 25

• All skin tests and treatments must be done with Zimmer Cryo

• Patch test must be done before the first treatment





D.8. Concluding Treatment Determining when treatment should be concluded is left to the discretion of the professional staff, or to the patient achieving satisfaction with the treatment results.

D.9. Follow-Up Measures presented below are only the manufacturer's recommendations for follow-up. They may serve as a basis for defining your treatment regimen.










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Soprano®XL Operator's Manual E-1

APPENDIX E Clinical Guide – NIR Module *


E.1. Introduction .......................................................................................E-2 E.2. Intended Use and Indications.............................................................E-2 E.3. Contraindications...............................................................................E-2 E.4. Pre-Treatment ....................................................................................E-3 E.5. Treatment...........................................................................................E-4 E.6. Suggested Setup Parameters for NIR Mode ......................................E-7 E.7. Post-Treatment Care ..........................................................................E-8 E.8. Concluding Treatment .......................................................................E-8 E.9. Follow-Up..........................................................................................E-8


Clinical Guide – NIR Module

E.1. Introduction This section is provided to aid professionals in the use of the SopranoXL System operating in NIR mode.


E.2. Intended Use and Indications The NIR module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, skin tightening through deep thermal heating, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

E.3. Contraindications • Cancer; in particularly skin cancer


• Use of photosensitive medication and herbs for which near-infrared light exposure is contra-indicated




• Diabetes (insulin dependent)


• Open wounds, skin injuries or recent inflammation or burns.

• Hemorrhage or patient receiving anticoagulation treatment

• Acute inflammation


E-2 Soprano®XL Operator's Manual


• History of coagulopathies (thrombophlebitis)


• Epilepsy

E.4. Pre-Treatment

E.4.1. General During the first visit the physician (or an authorized staff member) should:

• Take a detailed patient medical history, including previous treatment modalities, and examine suitability of the treatment by the SopranoXL system.



E.4.2. Counseling During the first visit, the physician (or an authorized member of the staff) should:


⇒ There may be some discomfort or pain associated with the treatment

⇒ Transient erythema/edema may appear immediately following the treatment

• Carefully diagnose the skin test

E.4.3. Module Operation The SopranoXL's NIR module will be applied to the skin using the In-Motion technique. Apply a thin layer of mineral oil on the treatment area. In this technique the module is moved continuously on the skin surface in rotational/circular or linear motions. The module should be moved in straight or circular movements within the treatment area. Before applying the module to the skin, the practitioner should feel on his/her own skin that the sapphire contact cooling (tip) of the module is cold. The module should be moved in intervals of 30 seconds.

Using the module on the skin in a stationary mode is strictly prohibited.



E.4.4. Module Parameters The SopranoXL in NIR mode delivers up to 100 Watts. The pulse repetition rate is set (fixed) at 10 PPS (10 Hz). The total cumulative energy – expressed in kiloJoules (kJ) – is displayed on the control panel.

E.4.5. NIR Mode Skin Test Always perform a skin test on the intended treatment area. Use the in-motion technique (with a thin coat of mineral oil) where the module is in constant motion on the testing area. After covering the area with a thin layer of mineral oil, place the module on the skin according to the following exposure settings. The skin test should be performed on the treatment area. It is recommended to evaluate the tested skin area and wait ~5 minutes for skin types I-III and 10 minutes for skin types IV-VI.

Fluence is critical to optimize the treatment efficacy and minimize any expected side effects. Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters:

Table E-1: Skin Test Parameters *


Power Setting (Watts)

Time of Exposure (sec)

Total Energy (kJ)

I 50 – 60 60 3.0 – 3.6

II 50 – 60 60 3.0 – 3.6

III 50 – 60 60 3.0 – 3.6

IV 50 – 60 60 3.0 – 3.6

V 40 – 50 60 2.4 – 3.0

VI 40 – 50 60 2.4 – 3.0

(*) In-Motion technique

E.5. Treatment Treatment can begin after the treatment area has been cleaned.

Warning






3. Apply a thin layer of mineral oil on the entire treatment area.

4. Select the appropriate fluence.

5. Check baseline skin temperature with a laser thermometer.


7. Place the module perpendicular to the skin and establish contact with the skin. Press the tip against the skin with moderate pressure to ensure good contact.

Warning

It is important to contact the skin prior to energy emission.

8. Always perform a skin test to establish the cutaneous reaction when beginning treatment.

9. Start treatment by activating the module with the footswitch.

10. The TEC cooling system reaches the target temperature within two minutes after the system was turned on and the module was selected; the practitioner should check/touch the TEC on the tip of the module, to ensure that it is cold before commencing treatment.

11. The module should be operated on the skin In-Motion – never stationary!

12. The overall goal of the treatment is to raise and maintain the skin temperature on the target tissue in the therapeutic temperature range of 104-111.2°F (40-44°C) for the recommended accumulative energy (expressed in kJ).

13. The treatment includes two distinct phases: Pre-Therapeutic (Phase I) and Therapeutic (Phase II); the goal of the pre-therapeutic phase is to raise the basal (ambient) skin temperature from ~88-89.5°F (~31-32°C) to 102-104°F (39-40°C) within 60 seconds (max). Refer to Figure E-1.

14. The goal of the therapeutic phase (Phase II) is to increase and maintain the skin temperature of 104-111.2°F (40-44°C), without causing any patient discomfort.

15. It is recommended the practitioner check the skin temperature, using the infrared thermometer provided with the system, every ~ 30 seconds.

16. Treatment technique: the tip of the module must be in complete contact with the skin and slightly pressed towards the skin.

17. During the In-Motion treatment mode the practitioner will move the module (while in contact with the skin) in a circular or linear pattern within the treatment area during each cycle (i.e., 30 sec).



30-60 sec. 30-120 sec.

Baseline

Phase I Phase II

43 C o

[ C]t o

39 C o

Max

Min

[Sec]

Figure E-1: Treatment Phases

18. The In-Motion technique should always maintain the principle of moving the module from the warm area to an area that is less warm while keeping the module in contact with the skin.

19. The recommended total energy invested (expressed in kJ) is considered for the Therapeutic Phase only (not the Pre-Therapeutic Phase)!

20. After every two cycles (i.e., after every 60 sec) within the Therapeutic Phase, the practitioner will rub/massage the skin in a direction towards the lymph nodes located in the nearest treatment area, in order to drain the excess fluids and to alleviate the heat sensation.

21. In cases when the treatment causes discomfort for any reason (i.e., heat), the practitioner should immediately release the footswitch to cease energy emission, while keeping the cooled module tip in contact with the skin. This will help to alleviate any discomfort sensation.

22. Application of the "stationary" mode with the module positioned in-place on the skin is strictly prohibited!

23. If adverse skin effects occur (such as excessive reddening) before a good endpoint response is achieved, decrease the fluence by 5-10% to reduce the aggressiveness of the treatment.

24. If the skin shows no adverse effects and no morphological changes are observed, you may raise the fluence by 5-10% until the desired effect is achieved.



Warning

The light emitted by the SopranoXL system is capable of causing serious eye damage or blindness. For maximum safety, metal goggles must be worn by the patient for all facial treatments.

25. After treatment it is recommended to cool the area immediately (see Section E.7– Post-Treatment Care).

E.6. Suggested Setup Parameters for NIR Mode The SopranoXL system is equipped with NIR application mode settings. These presets are based on successful results obtained by experienced users. In addition, users can select and set their own parameter values.

The NIR application mode treatment parameters consist of light energy (power) and pulse frequency of 10 Hz.

Table E-2: Suggested Treatment Parameters *


Power Setting (Watts)

Time of Exposure (minutes)

Total Energy (kJ)

I 50 – 70 12 – 15 36 – 63

II 50 – 70 12 – 15 36 – 63

III 50 – 70 12 – 15 36 – 63

IV 50 – 70 12 – 15 36 – 63

V 50 – 70 10 – 12 30 – 50

VI 50 – 70 10 – 12 30 – 50

(*) In-Motion technique




E.7. Post-Treatment Care Care should be taken to prevent trauma to the treated area for the 24-48 hours following treatment: avoid hot baths, aerobic exercise, massage, etc.

• Exposure to Sunlight – patients should apply high-factor sun protection (SPF >30), and protect the treated area from exposure to direct sunlight for at least one month post-treatment. Tanning after treatment sessions may enhance melanin regeneration, which may result in hyperpigmentation.


E.8. Concluding Treatment Determining when treatment should be concluded is left to the discretion of the professional staff, or to the patient achieving satisfaction with the treatment results.

E.9. Follow-Up Measures presented below are only the manufacturer's recommendations for follow-up. They may serve as a basis for defining your treatment regimen.

• Patients should return for evaluation of the treatment results two weeks after treatment and for additional treatment, if necessary.






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Soprano®XL Operator's Manual F-1

APPENDIX F Clinical Guide – Dorsal Hand

Rejuvenation *


F.1. Introduction ....................................................................................... F-2 F.2. Intended Use and Indications............................................................. F-2 F.3. Optical Safety .................................................................................... F-3 F.4. Skin Test ............................................................................................ F-3 F.5. Treatment........................................................................................... F-4 F.6. Suggested Setup Parameters .............................................................. F-5 F.7. Post-Treatment Care .......................................................................... F-6 F.8. Follow-Up.......................................................................................... F-6


Clinical Guide – Dorsal Hand Rejuvenation

F.1. Introduction This appendix is provided to aid professionals in the use of the SopranoXL system operating with the NIR mode (near infrared light module) for the treatment of the dorsal aspect of the hand for photo-aged and photo-damaged skin imperfections.


F.2. Intended Use and Indications The SopranoXL NIR module is intended for skin rejuvenation of the dorsal aspect of the hands due to photo-aged and photo-damaged imperfections.

The objective of rejuvenating of the hands is to remove and improve photodamaged skin pigmentations and superficial blood vessels, tightening the dorsal aspect of the hand.

The NIR (near-infra red light) module is indicated for: improvement in skin texture.

The SopranoXL system with its NIR module is indicated for use on Fitzpatrick skin types I-V.

F-2 Soprano®XL Operator's Manual


F.3. Optical Safety • It is essential that all people present in the treatment room (patient and medical

personnel) protect their eyes by wearing Alma Lasers recommended protective eyewear.

• The eyewear for the operator should be of an optical density of 7 (OD>7)

• It is good practice to instruct the patient to close their eyes during treatment, even when wearing protective the metal eye glasses.

• Guard against accidental exposure to light/laser emission.

• Never look directly at the laser emission from the SopranoXL module or at any reflecting surface, even when wearing protective eyewear.

• Always set the system to Standby mode when there is a pause in treatment; this prevents inadvertent light/laser emission.

• Press the footswitch and module trigger only when the beam is aimed at the target tissue under direct visualization.

F.4. Skin Test • A skin test must be performed on each hand before the first treatment.

• Cover the treatment area (back of the hand) with a coat of mineral oil.

• New settings for each subsequent treatment should be based on clinical indication and skin color.

• It is recommended to wait ~30 minutes for skin types I-III and 45 minutes for skin types IV-V after the skin test.

• Fluence is critical to optimize the treatment efficacy and minimize any expected side effects. Always perform the skin test on the intended treatment area during the first treatment session, according to the following parameters:

Table F-1: NIR Mode Skin Test Parameters

Skin Type [Fitzpatrick I-V] Energy [W] Total Energy [kJ] Test/Hand Area

[cm2]

I 60 – 70 16 – 18 60 – 100

II 60 – 70 16 – 18 60 – 100

III 60 – 70 16 – 18 60 – 100

IV 50 – 60 13 – 15 60 – 100

V 50 – 60 15 60 – 100



F.5. Treatment The full area of the hand (dorsal aspect) will be considered as the Treatment Area for the right and left hands.

Treatment can begin after the treatment fluence parameter of the NIR mode has been selected.

Warning


1. Always perform a skin test to establish the cutaneous reaction before beginning treatment.

2. Ensure that the patient is lying comfortably with appropriate eye protection in place. All personnel in the treatment room should wear appropriate eye protection as well. The operator should have easy access to the treatment area and to the system controls.

3. Remove rings, bracelets, watches or other accessories from the hand area.

4. Clean and dry the dorsal aspect of the hand's skin.

5. Press the Reset softkey to reset the pulse counter and total energy counter.

6. Cover the treatment area with a coat of mineral oil.

7. Choose the appropriate settings (Watts) from the NIR mode's screen. Once the parameters have been selected, the operator may choose to save these settings. This enables the operator to use these settings for groups of patients with similar characteristics.


9. Place the module perpendicular to the skin and establish contact with the skin. Press the tip with mild pressure against the skin.

Warning

It is important to contact the skin prior to light/laser emission.

10. Start treatment by activation of the footswitch.

11. Move the module on the skin in linear & semi-circular motions over the entire hand area.

12. Occasionally examine the treatment site for a change in skin color and morphological changes in the treatment area (erythema/edema).



13. If adverse skin effects occur (such as excessive reddening) before completing the treatment, adjust the parameters to reduce the aggressiveness of the treatment. Aggressiveness may be reduced by either decreasing the fluence by 5-10% or by reducing the number of passes.

14. If the skin shows no adverse effects and no morphological changes are observed, you may raise the energy by 5-10% until the desired effect is achieved.

15. Repeat the procedure until investing the recommended total energy (kJ).

16. Add mineral oil to the treatment/grid area as required.

17. Clinical end points: erythema, hyperemia and edema.

Warning


18. After treatment it is recommended to cool the area immediately (see Section F.7).

F.6. Suggested Setup Parameters Table F-2: Suggested Setup Parameters

Skin Type [Fitzpatrick I-V] Energy [W] Total Energy [kJ] Hand Area [cm2]

I 60 – 70 16 – 18 60 – 100

II 60 – 70 16 – 18 60 – 100

III 60 – 70 16 – 18 60 – 100

IV 50 – 60 13 – 15 60 – 100

V 50 – 60 13 – 15 60 – 100 • A skin test must be performed before the first treatment.

• New settings for each subsequent treatment should be based on skin color and clinical findings of the previous treatment.


• Concluding treatment: determining when treatment should be concluded is left to the discretion of the professional staff, or to the patient achieving satisfaction with the treatment results.



F.7. Post-Treatment Care • Cold (not frozen) packs should be applied immediately post-treatment to cool

the treatment site, reduce swelling and ease discomfort. Pre-chilled 10x10 cm gauze pads, previously soaked with water may be used.

• Care should be taken to prevent trauma to the treated area for the first four or five days following the treatment: avoid hot baths, aerobic exercise, massage, etc.




F.8. Follow-Up Measures presented below are only the manufacturer's recommendations for follow-up. They may serve as a basis for defining your treatment regimen.

• Patients should return for examination of the treatment site between three to four weeks after treatment and for additional treatment, if necessary.

• Full treatment may require between 4-6 treatments with 3-4 week intervals between treatments.

• If no additional treatment is necessary, the patient should return for an additional re-examination two months later.

• If there has been partial pigmented lesion clearance, treatment should be continued and the patient should return between three to four weeks for examination and for additional treatment, if necessary.

• If no change is noted, treatment parameters should be changed. With multiple treatments, increase the number of passes for each treatment area and/or the fluence parameters.









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