ALMA LASER HarmonyXL ROW Op Modules Manual (Final 13-02-13)

Modules Operator’s Manual

Copyright © 2012, 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] Website: www.almalasers.com Authorized Representative in the EC: ABC Lasers Ltd. Hill Farm Road Duxford Business Centre Cambridge, CB22 4QT, UK Tel: +44 (0) 845 170 7788 Fax: +44 (0) 1223 836460

Catalog No. OMHA27070801 Revision 11, November 2012

Scope of Manual

Scope of This Manual This manual provides a description, technical specifications, operating instructions, ordering information and clinical guides for the HarmonyXL modules in the following chapters: Chapter

Module Name

Wavelength

Clinical Applications

1

Introduction

2

High Power UV Module

300 – 380nm

Psoriasis and Vitiligo.

3

Acne Module

420 – 950nm

Acne clearance.

4

Acne Pro Module

420 – 950nm

Acne clearance.

5

SVL Module

515 – 950nm

Superficial vascular lesions.

6

SVL Module (cooled)

515 – 950nm

Superficial vascular lesions.

7

VP Module

540 – 950nm

Vascular and Pigmented lesions.

8

VP Module (cooled)

540 – 950nm

Vascular and pigmented lesions.

9

Dye-VL Module

500 – 600nm


10

Dye-VL Pro Module

500 – 600nm


11

LED Module

Yellow

• Increased blood flow, muscle relaxation & pain relief.

• Treatment of rhytids, fine lines and wrinkles 1.

12

SR Module

570 – 950nm

Skin rejuvenation.

13

SR Module (cooled)

570 – 950nm

Skin rejuvenation.

14

SSR Module (cooled)

540 – 950nm

Skin rejuvenation ("S" mode).

15

Dye-SR Pro Module

560 – 650nm


16

HR Module

650 – 950nm

Hair removal.

17

SHR Pro Module (cooled)

NIR

• Hair removal. • Long-term or permanent hair reduction ("S" mode).

18

SHR Pro 5 Module (cooled)

NIR

Long-term or permanent hair reduction [5 cm2 spot size].

19

ST Module

NIR

Scar revision and treatment of striae.

1

In Canada

Harmony®XL Modules Operator's Manual

i

Scope of Manual

Chapter

Module Name

Wavelength

Clinical Applications

20

SST Module (cooled)

NIR

Scar revision and treatment of striae ("S mode).

21

Laser QS 1064/532nm Module

1064nm & 532nm

Tattoo removal, deep pigmented lesions.

22

Laser QS 1064/532nm High Power Module

1064nm & 532nm

Tattoo removal, deep pigmented lesions.

23

Laser 1064nm Module

1064nm

Vascular lesions, leg veins, hair removal and PFB.

24

Laser 1064nm (cooled) High Power Module

1064nm

Vascular lesions, leg veins, hair removal and PFB.

25

Laser 1064F Pro Module

1064nm

Onychomycosis (nail fungus), vascular lesions, leg veins, hair removal and PFB.

26

Laser 1064F Pro (cooled) Module

1064nm

Onychomycosis (nail fungus), vascular lesions, leg veins, hair removal and PFB.

27

Laser 1320nm Module

1320nm

Wrinkles and acne scars.

28

Laser 1320nm (cooled) Module

1320nm

Wrinkles and acne scars.

29

• Pixel Pro Module

2940nm

Fractional ablative skin resurfacing.

• Laser 2940nm (Low Power) Module 30

iPixelEr 2940nm Module

2940nm

Fractional ablative skin resurfacing.

31

iPixelEr 2940nm and Impact Modules

iPixelEr: 2940nm

Dermatological procedures.

32

Alex 755 Laser Module 2

755nm

• Hair removal. • Pigmented lesions.

33

NIR Body Module 3

NIR

• Muscle pain relief. • Joint pain and stiffness.

34

NIR Face Module3

NIR

• Muscle pain relief. • Joint pain and stiffness.

2 3

ii

Impact: N/A

Not available in EU and Canada Not available in Canada


Table of Contents

Table of Contents CHAPTER 1

Introduction 1.1. 1.2.

CHAPTER 2

CHAPTER 3

Scope of This Manual ....................................................................................... 1-2 Module Specifications ....................................................................................... 1-2 1.2.1. AFT, UV, NIR & LED, Non-Laser, Non-Cooled Modules ............... 1-3 1.2.2. AFT and NIR, Non-Laser, Cooled Modules ..................................... 1-4 1.2.3. 'S' Mode Cooled Modules ................................................................. 1-5 1.2.4. Laser Modules .................................................................................. 1-6

High Power UV Module 2.1. 2.2. 2.3. 2.4. 2.5. 2.6.

Page

UV Module Description .................................................................................... 2-2 UV Module Specifications ................................................................................ 2-2 UV Module Operating Screen ........................................................................... 2-3 UV Module Regulatory Labels ......................................................................... 2-4 Ordering Information ........................................................................................ 2-4 UV Module Clinical Guide ............................................................................... 2-5 2.6.1. Pre-Treatment .................................................................................. 2-5 2.6.1.1. Assessing the Condition 2-5 2.6.1.2. UV Light Source Indications 2-5 2.6.1.3. UV Light Source Contraindications 2-5 2.6.1.4. Minimal Erythema Dose (MED) Test 2-6 2.6.2. Treatment.......................................................................................... 2-7 2.6.3. Suggested UV Setup Parameters ...................................................... 2-7 2.6.4. Vitiligo & Re-Pigmentation .............................................................. 2-8 2.6.5. Follow-up ......................................................................................... 2-9

Acne Module 3.1. 3.2. 3.3. 3.4. 3.5. 3.6.

Page

Page

Acne Module Description ................................................................................. 3-2 Acne Module Specifications ............................................................................. 3-2 Acne Module Operating Screen ........................................................................ 3-3 Acne Module Regulatory Labels....................................................................... 3-4 Ordering Information ........................................................................................ 3-4 Acne Module Clinical Guide............................................................................. 3-5 3.6.1. Indications for Use ........................................................................... 3-5 3.6.2. Contraindications ............................................................................. 3-5 3.6.3. Module Operation ............................................................................ 3-6 3.6.4. Pre-Treatment .................................................................................. 3-6


iii

Table of Contents

3.6.4.1. Patient Evaluation 3-6 3.6.4.2. Skin Test 3-6 3.6.5. Treatment .......................................................................................... 3-7 3.6.6. Suggested Setup Parameters............................................................. 3-7 3.6.7. Follow-Up ......................................................................................... 3-8

CHAPTER 4

Acne Pro Module 4.1. 4.2. 4.3. 4.4. 4.5. 4.6.

4.7.

CHAPTER 5

iv

Acne Pro Module Description ........................................................................... 4-2 Acne Pro Module Specifications ....................................................................... 4-2 Acne Pro Module Operating Screen .................................................................. 4-3 Acne Pro Module Regulatory Labels ................................................................ 4-4 Ordering Information......................................................................................... 4-4 Acne Pro Module Clinical Guide ...................................................................... 4-5 4.6.1. Pre-Treatment ................................................................................... 4-5 4.6.1.1. Module Operation 4-5 4.6.1.2. Patient Evaluation 4-6 4.6.1.3. Indications 4-6 4.6.1.4. Contraindications 4-6 4.6.1.5. Skin Test 4-7 4.6.2. Treatment .......................................................................................... 4-7 4.6.3. Suggested Setup Parameters............................................................. 4-8 4.6.4. Follow-Up ......................................................................................... 4-9 Acne Operating Mode ..................................................................................... 4-10 4.7.1. Pre-Treatment ................................................................................. 4-10 4.7.1.1. Assessing the Condition 4-10 4.7.1.2. Indications 4-10 4.7.1.3. Contraindications 4-10 4.7.1.4. Skin Test 4-11 4.7.2. Treatment ........................................................................................ 4-11 4.7.3. Suggested Setup Parameters........................................................... 4-12 4.7.4. Follow-Up ....................................................................................... 4-12

SVL Module 5.1. 5.2. 5.3. 5.4. 5.5. 5.6.

Page

Page

SVL Module Description .................................................................................. 5-2 SVL Module Specifications .............................................................................. 5-2 SVL Module Operating Screen ......................................................................... 5-3 SVL Module Regulatory Labels ........................................................................ 5-4 Ordering Information......................................................................................... 5-4 SVL Module Clinical Guide .............................................................................. 5-5 5.6.1. Indications for Use ........................................................................... 5-5


Table of Contents

5.6.2. 5.6.3.

Contraindications ............................................................................. 5-5 Pre-Treatment .................................................................................. 5-6 5.6.3.1. Assessing the Condition 5-6 5.6.3.2. Preparing the Lesion for Treatment 5-6 5.6.3.3. Skin Test 5-6 5.6.4. Treatment.......................................................................................... 5-7 5.6.5. Suggested Setup Parameters ............................................................ 5-8 5.6.6. Follow-up ......................................................................................... 5-8

CHAPTER 6

SVL Cooled Module 6.1. 6.2. 6.3. 6.4. 6.5. 6.6.

CHAPTER 7

SVL Cooled Module Description ...................................................................... 6-2 SVL Cooled Module Specifications .................................................................. 6-2 SVL Cooled Module Operating Screen............................................................. 6-3 SVL Cooled Module Regulatory Labels ........................................................... 6-4 Ordering Information ........................................................................................ 6-4 SVL Cooled Module Clinical Guide ................................................................. 6-5 6.6.1. Indications for Use ........................................................................... 6-5 6.6.2. Contraindications ............................................................................. 6-5 6.6.3. Pre-Treatment .................................................................................. 6-6 6.6.3.1. Assessing the Condition 6-6 6.6.3.2. Preparing the Lesion for Treatment 6-6 6.6.3.3. Skin Test 6-6 6.6.4. Treatment.......................................................................................... 6-7 6.6.5. Suggested Setup Parameters ............................................................ 6-8 6.6.6. Follow-up ......................................................................................... 6-8

VP Module 7.1. 7.2. 7.3. 7.4. 7.5. 7.6.

Page

Page

VP Module Description ..................................................................................... 7-2 VP Module Specifications ................................................................................. 7-2 VP Module Operating Screen............................................................................ 7-3 VP Module Regulatory Labels .......................................................................... 7-4 Ordering Information ........................................................................................ 7-4 VP Module Clinical Guide for Vascular Lesions .............................................. 7-5 7.6.1. Indications for Use ........................................................................... 7-5 7.6.2. Contraindications ............................................................................. 7-5 7.6.3. Pre-Treatment .................................................................................. 7-6 7.6.3.1. Assessing the Condition 7-6 7.6.3.2. Preparing the Lesion for Treatment 7-6 7.6.3.3. Skin Test 7-7 7.6.4. Treatment.......................................................................................... 7-7


v

Table of Contents

7.7.

CHAPTER 8

VP Cooled Module 8.1. 8.2. 8.3. 8.4. 8.5. 8.6.

8.7.

vi

7.6.5. Suggested VP Setup Parameters for Vascular Lesions .................... 7-8 7.6.6. Follow-up.......................................................................................... 7-9 VP Module Clinical Guide for Pigmented Lesions ......................................... 7-10 7.7.1. Indications for Use ......................................................................... 7-10 7.7.2. Contraindications ........................................................................... 7-10 7.7.3. Pre-Treatment ................................................................................. 7-10 7.7.3.1. Assessing the Condition 7-10 7.7.3.2. Preparing the Lesion for Treatment 7-10 7.7.3.3. Skin Test 7-11 7.7.4. Treatment ........................................................................................ 7-11 7.7.5. Suggested VP Setup Parameters for Pigmented Lesions ................ 7-12 7.7.6. Follow-up........................................................................................ 7-13

Page

VP Cooled Module Description ........................................................................ 8-2 VP Cooled Module Specifications .................................................................... 8-2 VP Cooled Module Operating Screen ............................................................... 8-3 VP Cooled Module Regulatory Labels.............................................................. 8-4 Ordering Information......................................................................................... 8-4 VP Cooled Module Clinical Guide for Vascular Lesions ................................. 8-5 8.6.1. Indications for Use ........................................................................... 8-5 8.6.2. Contraindications ............................................................................. 8-5 8.6.3. Pre-Treatment ................................................................................... 8-6 8.6.3.1. Assessing the Condition 8-6 8.6.3.2. Preparing the Lesion for Treatment 8-6 8.6.3.3. Skin Test 8-7 8.6.4. Treatment .......................................................................................... 8-7 8.6.5. Suggested Cooled VP Setup Parameters for Vascular Lesions ........ 8-8 8.6.6. Follow-up.......................................................................................... 8-9 VP Cooled Module Clinical Guide for Pigmented Lesions ............................ 8-10 8.7.1. Indications for Use ......................................................................... 8-10 8.7.2. Contraindications ........................................................................... 8-10 8.7.3. Pre-Treatment ................................................................................. 8-10 8.7.3.1. Assessing the Condition 8-10 8.7.3.2. Preparing the Lesion for Treatment 8-10 8.7.3.3. Skin Test 8-11 8.7.4. Treatment ........................................................................................ 8-11 8.7.5. Suggested Cooled VP Setup Parameters for Pigmented Lesions ... 8-12 8.7.6. Follow-up........................................................................................ 8-13


Table of Contents

CHAPTER 9

Dye-VL Module 9.1. 9.2. 9.3. 9.4. 9.5. 9.6.

9.7.

9.8.

Dye-VL Module ................................................................................................ 9-3 Dye-VL Module Specifications ........................................................................ 9-3 Dye-VL Module Operating Screen ................................................................... 9-4 Dye-VL Module Regulatory Labels .................................................................. 9-5 Ordering Information ........................................................................................ 9-5 Dye-VL Module Clinical Guide for Vascular Lesions...................................... 9-6 9.6.1. Indications for Use ........................................................................... 9-6 9.6.2. Contraindications ............................................................................. 9-6 9.6.3. Pre-Treatment .................................................................................. 9-7 9.6.3.1. Preparing the Lesion for Treatment 9-7 9.6.3.2. Skin Test 9-7 9.6.4. Treatment.......................................................................................... 9-7 9.6.5. Suggested Dye-VL Setup Parameters for Vascular Lesions ............. 9-8 9.6.6. Follow-up ......................................................................................... 9-8 Dye-VL Module Clinical Guide for Pigmented Lesions................................. 9-10 9.7.1. Indications for Use ......................................................................... 9-10 9.7.2. Contraindications ........................................................................... 9-10 9.7.3. Pre-Treatment ................................................................................ 9-10 9.7.3.1. Assessing the Condition 9-10 9.7.3.2. Preparing the Lesion for Treatment 9-10 9.7.3.3. Skin Test 9-11 9.7.4. Treatment........................................................................................ 9-11 9.7.5. Suggested Dye-VL Setup Parameters for Pigmented Lesions ........ 9-12 9.7.6. Follow-up ....................................................................................... 9-12 Dye-SVL Mode Clinical Guide....................................................................... 9-13 9.8.1. Indications for Use ......................................................................... 9-13 9.8.2. Contraindications ........................................................................... 9-13 9.8.3. Module Operation .......................................................................... 9-14 9.8.4. Pre-Treatment ................................................................................ 9-14 9-14 9.8.4.1. Assessing the Condition 9.8.4.2. Skin Test 9-14 9.8.5. Treatment (In-Motion Technique) .................................................. 9-15 9.8.6. Suggested Setup Parameters .......................................................... 9-16 9.8.7. Stationary Protocol ........................................................................ 9-16 9.8.8. Treatment of Small Areas ............................................................... 9-17 9.8.9. Follow-up ....................................................................................... 9-17

CHAPTER 10 Dye-VL Pro Module 10.1. 10.2. 10.3.

Page

Page

Dye-VL Pro Module........................................................................................ 10-3 Dye-VL Pro Module Specifications ................................................................ 10-3 Dye-VL Pro Module Operating Screen ........................................................... 10-4


vii

Table of Contents

10.4. 10.5. 10.6.

10.7.

10.8.

Dye-VL Pro Module Regulatory Labels ......................................................... 10-5 Ordering Information....................................................................................... 10-5 Dye-VL Pro Module Clinical Guide for Vascular Lesions ............................. 10-6 10.6.1. Indications for Use ......................................................................... 10-6 10.6.2. Contraindications ........................................................................... 10-6 10.6.3. Pre-Treatment ................................................................................. 10-7 10.6.3.1. Assessing the Condition 10-7 10.6.3.2. Preparing the Lesion for Treatment 10-7 10.6.3.3. Skin Test 10-7 10.6.4. Treatment ........................................................................................ 10-8 10.6.5. Suggested Dye-VL Pro Setup Parameters for Vascular Lesions .... 10-9 10.6.6. Follow-up........................................................................................ 10-9 Dye-VL Pro Module Clinical Guide for Pigmented Lesions ........................ 10-10 10.7.1. Indications for Use ....................................................................... 10-10 10.7.2. Contraindications ......................................................................... 10-10 10.7.3. Pre-Treatment ............................................................................... 10-10 10.7.3.1. Assessing the Condition 10-10 10.7.3.2. Preparing the Lesion for Treatment 10-10 10.7.3.3. Skin Test 10-11 10.7.4. Treatment ...................................................................................... 10-11 10.7.5. Suggested Dye-VL Pro Setup Parameters for Pigmented Lesions .......................................................................................... 10-12 10.7.6. Follow-up...................................................................................... 10-12 Dye-SVL Mode Clinical Guide ..................................................................... 10-13 10.8.1. Indications for Use ....................................................................... 10-13 10.8.2. Contraindications ......................................................................... 10-13 10.8.3. Module Operation......................................................................... 10-14 10.8.4. Pre-Treatment ............................................................................... 10-14 10.8.4.1. Assessing the Condition 10-14 10.8.4.2. Skin Test 10-14 10.8.5. Treatment (In-Motion Technique) ................................................ 10-15 10.8.6. Suggested Setup Parameters......................................................... 10-16 10.8.7. Stationary Protocol....................................................................... 10-16 10.8.8. Treatment of Small Areas ............................................................. 10-17 10.8.9. Follow-up...................................................................................... 10-18

CHAPTER 11 LED Module 11.1. 11.2. 11.3. 11.4. 11.5. 11.6. viii

Page

LED Module Description ................................................................................ 11-2 LED Module Specifications ............................................................................ 11-2 LED Module Operating Screen ....................................................................... 11-3 LED Module Regulatory Labels ..................................................................... 11-4 Ordering Information....................................................................................... 11-4 LED Module Clinical Guide ........................................................................... 11-5 Harmony®XL Modules Operator's Manual

Table of Contents

11.6.1. 11.6.2. 11.6.3.

Indications for Use ......................................................................... 11-5 Contraindications ........................................................................... 11-5 Pre-Treatment ................................................................................ 11-5 11.6.3.1. Patient Evaluation 11-5 11.6.3.2. Skin Test 11-6 11.6.4. Treatment........................................................................................ 11-6 11.6.5. Suggested LED Setup Parameters .................................................. 11-7 11.6.6. Follow-Up ...................................................................................... 11-7

CHAPTER 12 SR Module 12.1. 12.2. 12.3. 12.4. 12.5. 12.6.

SR Module Description ................................................................................... 12-2 SR Module Specifications ............................................................................... 12-2 SR Module Operating Screen .......................................................................... 12-3 SR Module Regulatory Labels ........................................................................ 12-4 Ordering Information ...................................................................................... 12-4 SR Module Clinical Guide .............................................................................. 12-5 12.6.1. Indications for Use ......................................................................... 12-5 12.6.2. Contraindications ........................................................................... 12-5 12.6.3. Pre-Treatment ................................................................................ 12-6 12.6.3.1. Assessing the Condition 12-6 12.6.3.2. Skin Test 12-6 12.6.4. Treatment........................................................................................ 12-7 12.6.5. Suggested SR Setup Parameters ..................................................... 12-8 12.6.6. Follow-up ....................................................................................... 12-8

CHAPTER 13 SR Cooled Module 13.1. 13.2. 13.3. 13.4. 13.5. 13.6.

Page

Page

SR Cooled Module Description ...................................................................... 13-2 SR Cooled Module Specifications .................................................................. 13-2 SR Cooled Module Operating Screen ............................................................. 13-3 SR Cooled Module Regulatory Labels ............................................................ 13-4 Ordering Information ...................................................................................... 13-4 SR Cooled Module Clinical Guide.................................................................. 13-5 13.6.1. Indications for Use ......................................................................... 13-5 13.6.2. Contraindications ........................................................................... 13-5 13.6.3. Pre-Treatment ................................................................................ 13-6 13.6.3.1. Assessing the Condition 13-6 13.6.3.2. Skin Test 13-6 13.6.4. Treatment........................................................................................ 13-7 13.6.5. Suggested Cooled SR Setup Parameters ........................................ 13-8 13.6.6. Follow-up ....................................................................................... 13-8


ix

Table of Contents

CHAPTER 14 SSR Module 14.1. 14.2. 14.3. 14.4. 14.5. 14.6. 14.7.

SSR Module Description ................................................................................. 14-2 SSR Module Specifications ............................................................................. 14-2 SSR Module Operating Screen ........................................................................ 14-3 Total Energy in the SSR Module..................................................................... 14-4 SSR Module Regulatory Labels ...................................................................... 14-4 Ordering Information....................................................................................... 14-4 SSR Module Clinical Guide ............................................................................ 14-5 14.7.1. Indications for Use ......................................................................... 14-5 14.7.2. Contraindications ........................................................................... 14-5 14.7.3. Module Operation........................................................................... 14-6 14.7.4. Pre-Treatment ................................................................................. 14-6 14.7.4.1. Assessing the Condition 14-6 14.7.4.2. Skin Test 14-7 14.7.5. Treatment (In-Motion Technique) .................................................. 14-7 14.7.6. Suggested Setup Parameters........................................................... 14-8 14.7.7. Stationary Protocol......................................................................... 14-8 14.7.8. Treatment of Small Areas ............................................................. 14-10 14.7.9. Follow-up...................................................................................... 14-11

CHAPTER 15 Dye-VL Pro Cooled Module 15.1. 15.2. 15.3. 15.4. 15.5. 15.6.

15.7.

x

Page

Page

Dye-SR Pro Module Description..................................................................... 15-3 Dye-SR Pro Module Specifications................................................................. 15-3 Dye-SR Pro Module Operating Screen ........................................................... 15-4 Dye-SR Pro Module Regulatory Labels .......................................................... 15-5 Ordering Information....................................................................................... 15-5 Dye-SR Pro Module Clinical Guide for Vascular Lesions.............................. 15-6 15.6.1. Indications for Use ......................................................................... 15-6 15.6.2. Contraindications ........................................................................... 15-6 15.6.3. Pre-Treatment ................................................................................. 15-7 15.6.3.1. Assessing the Condition 15-7 15.6.3.2. Preparing the Lesion for Treatment 15-7 15.6.3.3. Skin Test 15-7 15.6.4. Treatment ........................................................................................ 15-8 15.6.5. Suggested Dye-SR Pro Setup Parameters for Vascular Lesions .... 15-9 15.6.6. Follow-up........................................................................................ 15-9 Dye-SR Pro Module Clinical Guide for Pigmented Lesions ......................... 15-10 15.7.1. Indications for Use ....................................................................... 15-10 15.7.2. Contraindications ......................................................................... 15-10 15.7.3. Pre-Treatment ............................................................................... 15-10 15.7.3.1. Assessing the Condition 15-10 15.7.3.2. Preparing the Lesion for Treatment 15-10 Harmony®XL Modules Operator's Manual

Table of Contents

15.8.

15.7.3.3. Skin Test 15-11 15.7.4. Treatment...................................................................................... 15-11 15.7.5. Suggested Dye-SR Pro Setup Parameters for Pigmented Lesions .......................................................................................... 15-12 15.7.6. Follow-up ..................................................................................... 15-12 Dye-SSR Mode Clinical Guide ..................................................................... 15-14 15.8.1. Indications for Use ....................................................................... 15-14 15.8.2. Contraindications ......................................................................... 15-14 15.8.3. Module Operation ........................................................................ 15-15 15.8.4. Pre-Treatment .............................................................................. 15-15 15.8.4.1. Assessing the Condition 15-15 15.8.4.2. Skin Test 15-15 15.8.5. Treatment (In-Motion Technique) ................................................ 15-16 15.8.6. Suggested Setup Parameters ........................................................ 15-17 15.8.7. Stationary Protocol ...................................................................... 15-17 15.8.8. Treatment of Small Areas ............................................................. 15-18 15.8.9. Follow-up ..................................................................................... 15-19

CHAPTER 16 HR Module 16.1. 16.2. 16.3. 16.4. 16.5. 16.6.

HR Module Description .................................................................................. 16-2 HR Module Specifications .............................................................................. 16-2 HR Module Operating Screen ......................................................................... 16-3 HR Module Regulatory Labels ....................................................................... 16-4 Ordering Information ...................................................................................... 16-4 HR Module Clinical Guide ............................................................................. 16-5 16.6.1. Indications for Use ......................................................................... 16-5 16.6.2. Contraindications ........................................................................... 16-5 16.6.3. Pre-Treatment ................................................................................ 16-6 16.6.3.1. Patient Evaluation 16-6 16.6.3.2. Skin Test 16-6 16.6.4. Treatment........................................................................................ 16-6 16.6.5. Suggested HR Setup Parameters .................................................... 16-8 16.6.6. Follow-Up ...................................................................................... 16-9

CHAPTER 17 SHR Pro Module 17.1. 17.2.

17.3.

Page

Page

SHR Pro Module Description ......................................................................... 17-3 SHR Pro Module Specifications ..................................................................... 17-4 17.2.1. HR Mode......................................................................................... 17-4 17.2.2. SHR Mode....................................................................................... 17-4 Lightguide Footprint Size Selection ................................................................ 17-4


xi

Table of Contents

17.4. 17.5. 17.6. 17.7. 17.8.

17.9.

SHR Pro Module Operating Screens ............................................................... 17-5 Total Energy in the SHR Pro Module ............................................................. 17-6 SHR Pro Module Regulatory Labels ............................................................... 17-6 Ordering Information....................................................................................... 17-6 SHR Pro Module Clinical Guide – HR Mode ................................................. 17-7 17.8.1. Indications for Use ......................................................................... 17-7 17.8.2. Contraindications ........................................................................... 17-7 17.8.3. Pre-Treatment ................................................................................. 17-8 17.8.3.1. Patient Evaluation 17-8 17.8.3.2. Skin Test 17-8 17.8.4. Treatment ........................................................................................ 17-8 17.8.5. Suggested HR Setup Parameters .................................................. 17-10 17.8.6. Follow-Up ..................................................................................... 17-11 SHR Pro Module Clinical Guide – SHR Mode ............................................. 17-12 17.9.1. Indications for Use ....................................................................... 17-12 17.9.2. Contraindications ......................................................................... 17-12 17.9.3. Module Operation in SHR Mode .................................................. 17-12 17.9.4. Pre-Treatment ............................................................................... 17-13 17.9.4.1. Patient Evaluation 17-13 17.9.4.2. Skin Test 17-13 17.9.5. Treatment ...................................................................................... 17-14 17.9.6. Suggested Setup Parameters......................................................... 17-16 17.9.7. Treatment of Small Areas ............................................................. 17-17 17.9.8. Follow-Up ..................................................................................... 17-17

CHAPTER 18 SHR Pro 5 Module 18.1. 18.2.

18.3. 18.4. 18.5. 18.6. 18.7. 18.8.

xii

Page

SHR Pro 5 Module Description ....................................................................... 18-3 SHR Pro 5 Module Specifications ................................................................... 18-4 18.2.1. HR Mode ......................................................................................... 18-4 18.2.2. SHR Mode ....................................................................................... 18-4 Lightguide Footprint Size Selection ................................................................ 18-4 SHR Pro 5 Module Operating Screens ............................................................ 18-5 Total Energy in the SHR Pro 5 Module .......................................................... 18-6 SHR Pro 5 Module Regulatory Labels ............................................................ 18-6 Ordering Information....................................................................................... 18-6 SHR Pro 5 Pro Module Clinical Guide – HR Mode........................................ 18-7 18.8.1. Indications for Use ......................................................................... 18-7 18.8.2. Contraindications ........................................................................... 18-7 18.8.3. Pre-Treatment ................................................................................. 18-8 18.8.3.1. Patient Evaluation 18-8 18.8.3.2. Skin Test 18-8 18.8.4. Treatment ........................................................................................ 18-8


Table of Contents

18.9.

18.8.5. Suggested HR Setup Parameters .................................................. 18-10 18.8.6. Follow-Up .................................................................................... 18-11 SHR Pro 5 Pro Module Clinical Guide – SHR Mode ................................... 18-12 18.9.1. Indications for Use ....................................................................... 18-12 18.9.2. Contraindications ......................................................................... 18-12 18.9.3. Module Operation in SHR Mode .................................................. 18-12 18.9.4. Pre-Treatment .............................................................................. 18-12 18.9.4.1. Patient Evaluation 18-12 18.9.4.2. Skin Test 18-13 18.9.5. Treatment...................................................................................... 18-14 18.9.6. Suggested Setup Parameters ........................................................ 18-16 18.9.7. Follow-Up .................................................................................... 18-17

CHAPTER 19 ST Module 19.1. 19.2. 19.3. 19.4. 19.5. 19.6.

ST Module Description ................................................................................... 19-2 ST Module Specifications ............................................................................... 19-2 ST Module Operating Screen .......................................................................... 19-3 ST Module Regulatory Labels ........................................................................ 19-4 Ordering Information ...................................................................................... 19-4 ST Module Clinical Guide .............................................................................. 19-4 19.6.1. Indications for Use ......................................................................... 19-5 19.6.2. Contraindications ........................................................................... 19-5 19.6.3. Pre-Treatment ................................................................................ 19-5 19.6.3.1. Assessing the Condition 19-5 19.6.4. Module Operation .......................................................................... 19-6 19.6.4.1. Module Parameters 19-6 19.6.5. Skin Test ......................................................................................... 19-6 19.6.5.1. Face 19-7 19.6.5.2. Abdomen 19-7 19.6.6. Treatment........................................................................................ 19-7 19.6.6.1. In-Motion Protocol 19-7 19.6.6.2. Stationary Protocol 19-8 19.6.7. Suggested Setup Parameters .......................................................... 19-9 19.6.7.1. Face 19-9 19.6.7.2. Abdomen 19-9 19.6.8. Follow-Up .................................................................................... 19-10

CHAPTER 20 SST Module 20.1. 20.2.

Page

Page

SST Module Description ................................................................................. 20-2 SST Module Specifications ............................................................................. 20-2


xiii

Table of Contents

20.3. 20.4. 20.5. 20.6. 20.7.

SST Module Operating Screen ........................................................................ 20-3 Total Energy in the SST Module ..................................................................... 20-4 SST Module Regulatory Labels ...................................................................... 20-4 Ordering Information....................................................................................... 20-4 SST Module Clinical Guide ............................................................................ 20-5 20.7.1. Indications for Use ......................................................................... 20-5 20.7.2. Contraindications ........................................................................... 20-5 20.7.3. Module Operation........................................................................... 20-6 20.7.4. Pre-Treatment ................................................................................. 20-6 20.7.4.1. Assessing the Condition 20-6 20.7.4.2. Skin Test 20-6 20.7.5. Treatment ........................................................................................ 20-7 20.7.5.1. In-Motion Protocol 20-7 20.7.5.2. Stationary Protocol 20-8 20.7.6. Suggested Setup Parameters (In-Motion Protocol) ........................ 20-9 20.7.7. Treatment of Small Areas ............................................................. 20-10 20.7.8. Follow-Up ..................................................................................... 20-10

CHAPTER 21 Laser QS Module 21.1. 21.2.

21.3. 21.4. 21.5. 21.6.

xiv

Page

Laser QS 1064/532nm Module Description .................................................... 21-2 Laser QS 1064/532nm Module Specifications ................................................ 21-3 21.2.1. Standard Tip Module Specifications ............................................... 21-3 21.2.2. 532nm KTP Tip Module Specifications .......................................... 21-3 Laser QS 1064/532nm Module Operating Screen ........................................... 21-4 Laser QS 1064/532nm Module Regulatory Labels ......................................... 21-5 Ordering Information....................................................................................... 21-5 Laser QS 1064/532nm Module Clinical Guide ............................................... 21-6 21.6.1. Indications for Use ......................................................................... 21-6 21.6.1.1. Absolute Contraindications 21-7 21.6.1.2. Relative Contraindications 21-7 21.6.2. Pre-Treatment ................................................................................. 21-8 21.6.2.1. Assessing the Condition 21-8 21.6.2.2. Preparing the Tattoo for Treatment 21-8 21.6.2.3. Skin Test 21-9 21.6.3. Treatment ...................................................................................... 21-10 21.6.4. Suggested Setup Parameters......................................................... 21-11 21.6.5. Post-Treatment Care .................................................................... 21-11 21.6.6. Follow-Up ..................................................................................... 21-12


Table of Contents

CHAPTER 22 Laser QS High Power Module 22.1. 22.2.

22.3. 22.4. 22.5. 22.6.

QS 1064/532nm High Power Module Description ......................................... 22-2 Laser QS 1064/532nm High Power Module Specifications............................ 22-3 22.2.1. Module Specifications with Standard and Pixel Tips ..................... 22-3 22.2.2. Module Specifications with CVD (Continuous Variable Defocusing) Tip .............................................................................. 22-3 22.2.3. Module Specifications with 532nm KTP Tip .................................. 22-3 QS 1064/532nm High Power Module Operating Screen ................................ 22-4 QS 1064/532nm High Power Module Regulatory Labels............................... 22-5 Ordering Information ...................................................................................... 22-5 QS 1064/532nm High Power Module Clinical Guide..................................... 22-6 22.6.1. Indications for Use ......................................................................... 22-6 22.6.1.1. Absolute Contraindications 22-7 22.6.1.2. Relative Contraindications 22-7 22.6.2. Pre-Treatment ................................................................................ 22-8 22.6.2.1. Assessing the Condition 22-8 22.6.2.2. Preparing the Tattoo for Treatment 22-8 22.6.2.3. Skin Test 22-9 22.6.3. Treatment Procedure – Standard Tips ......................................... 22-10 22.6.4. Treatment Procedure – Pixel Tip ................................................. 22-11 22.6.5. Suggested Setup Parameters ........................................................ 22-11 22.6.6. Post-Treatment Care – Tattoos (Standard Tips) .......................... 22-12 22.6.7. Post-Treatment Care – Pigmented Lesions (Pixel Tip) ................ 22-12 22.6.8. Follow-Up .................................................................................... 22-13

CHAPTER 23 Laser 1064nm Module 23.1. 23.2. 23.3. 23.4. 23.5. 23.6.

Page

Page

Laser 1064nm Module Description ................................................................. 23-2 Laser 1064nm Module Specifications ............................................................. 23-2 Laser 1064nm Module Operating Screens ...................................................... 23-3 Laser 1064nm Module Regulatory Labels ...................................................... 23-4 Ordering Information ...................................................................................... 23-5 Laser 1064nm Module Clinical Guide ............................................................ 23-6 23.6.1. Assessing the Condition .................................................................. 23-6 23.6.2. Indications for Use ......................................................................... 23-6 23.6.3. Contraindications ........................................................................... 23-7 23.6.3.1. Vascular Lesions, Veins and Wrinkles 23-7 23.6.3.2. Hair Removal and PFB 23-7 23.6.4. Vascular Lesions ............................................................................ 23-8 23.6.4.1. Preparing the Lesion for Treatment 23-8 23.6.4.2. Skin Test 23-8 23.6.4.3. Treatment 23-8 23.6.4.4. Vascular Lesions Suggested Setup Parameters 23-10


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Table of Contents

23.6.5.

Non-Ablative Treatment of Facial Wrinkles ................................. 23-10 23.6.5.1. Skin Test 23-10 23.6.5.2. Treatment 23-10 23.6.5.3. Facial Wrinkles Suggested Setup Parameters 23-11 23.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB).. 23-12 23.6.6.1. Pre-Treatment Patient Evaluation 23-12 23.6.6.2. Skin Test for Hair Removal and PFB 23-12 23.6.6.3. Treatment 23-13 23.6.6.4. Suggested Setup Parameters for Hair Removal and PFB 23-14 23.6.7. Follow Up ..................................................................................... 23-14 23.6.7.1. Vascular Lesions and Leg Veins 23-14 23.6.7.2. Hair Removal and PFB 23-15

CHAPTER 24 Laser 1064nm Cooled High Power Module 24.1. 24.2. 24.3. 24.4. 24.5. 24.6.

xvi

Page

Laser 1064nm Cooled High Power Module Description ................................ 24-2 Laser 1064nm Cooled High Power Module Specifications ............................ 24-2 1064nm Cooled High Power Module Operating Screens................................ 24-3 Laser 1064nm Cooled High Power Module Regulatory Labels ...................... 24-4 Ordering Information....................................................................................... 24-5 Laser 1064nm Cooled High Power Module Clinical Guide............................ 24-6 24.6.1. Assessing the Condition .................................................................. 24-6 24.6.2. Indications for Use ......................................................................... 24-6 24.6.3. Contraindications ........................................................................... 24-7 24.6.3.1. Vascular Lesions, Veins and Wrinkles 24-7 24.6.3.2. Hair Removal and PFB 24-7 24.6.4. Vascular Lesions............................................................................. 24-8 24.6.4.1. Preparing the Lesion for Treatment 24-8 24.6.4.2. Skin Test 24-8 24.6.4.3. Treatment 24-8 24.6.4.4. Vascular Lesions Suggested Setup Parameters 24-10 24.6.5. Non-Ablative Treatment of Facial Wrinkles ................................. 24-10 24.6.5.1. Skin Test 24-10 24.6.5.2. Treatment 24-10 24.6.5.3. Facial Wrinkles Suggested Setup Parameters 24-11 24.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB).. 24-12 24.6.6.1. Pre-Treatment Patient Evaluation 24-12 24.6.6.2. Skin Test for Hair Removal and PFB 24-12 24.6.6.3. Treatment 24-13 24.6.6.4. Suggested Setup Parameters for Hair Removal and PFB 24-14 24.6.7. Follow Up ..................................................................................... 24-14 24.6.7.1. Vascular Lesions and Leg Veins 24-14 24.6.7.2. Hair Removal and PFB 24-15


Table of Contents

CHAPTER 25 Laser 1064F Pro Module 25.1. 25.2. 25.3. 25.4. 25.5. 25.6.

25.7.

Page

Laser 1064F Pro Module Description ............................................................. 25-3 Laser 1064F Pro Module Specifications ......................................................... 25-4 Laser 1064F Pro Module Operating Screens .................................................. 25-4 Laser 1064F Pro Module Regulatory Labels .................................................. 25-5 Ordering Information ...................................................................................... 25-5 Laser 1064nm Cooled High Power Module Clinical Guide ........................... 25-6 25.6.1. Assessing the Condition .................................................................. 25-6 25.6.2. Indications for Use ......................................................................... 25-6 25.6.3. Contraindications ........................................................................... 25-7 25.6.3.1. Vascular Lesions, Veins and Wrinkles 25-7 25.6.3.2. Hair Removal and PFB 25-7 25.6.4. Vascular Lesions ............................................................................ 25-8 25.6.4.1. Preparing the Lesion for Treatment 25-8 25.6.4.2. Skin Test 25-8 25.6.4.3. Treatment 25-8 25.6.4.4. Vascular Lesions Suggested Setup Parameters 25-10 25.6.5. Non-Ablative Treatment of Facial Wrinkles ................................. 25-10 25.6.5.1. Skin Test 25-10 25.6.5.2. Treatment 25-10 25.6.5.3. Facial Wrinkles Suggested Setup Parameters 25-11 25.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB) . 25-12 25.6.6.1. Pre-Treatment Patient Evaluation 25-12 25.6.6.2. Skin Test for Hair Removal and PFB 25-12 25.6.6.3. Treatment 25-13 25.6.6.4. Suggested Setup Parameters for Hair Removal and PFB 25-14 25.6.7. Follow Up ..................................................................................... 25-14 25.6.7.1. Vascular Lesions and Leg Veins 25-14 25.6.7.2. Hair Removal and PFB 25-15 Laser 1064F Pro Module Clinical Guide for Nail Fungus ............................ 25-16 25.7.1. Assessing the Condition ................................................................ 25-16 25.7.2. Indications for Use ....................................................................... 25-16 25.7.3. Contraindications ......................................................................... 25-16 25.7.4. Adverse Effects of Treatment ........................................................ 25-17 25.7.5. Preparation for Treatment ........................................................... 25-17 25.7.5.1. Patient Positioning 25-17 25.7.5.2. Infected Toenails by Size and Anatomy 25-18 25.7.5.3. Preparing the Nail for Treatment 25-18 25.7.6. Treatment Phase 1 – Q-Switched Module .................................... 25-19 25.7.6.1. Patch Test – Q-Switched Module 25-19 25.7.6.2. Treatment Procedure – Q-Switched Module 25-19 25.7.6.3. Suggested Setup Parameters – Q-Switched Module 25-20 25.7.6.4. Clinical End-Points 25-20 25.7.7. Treatment Phase 2 –1064F Pro Module ...................................... 25-21 25.7.7.1. Patch Test –1064F Pro Module 25-21 25.7.7.2. Treatment Procedure –1064F Pro Module 25-21


xvii

Table of Contents

25.7.7.3. Suggested Setup Parameters –1064F Pro Module 25-22 25.7.7.4. Clinical End-Points 25-22 25.7.8. Combination with Local Substances ............................................. 25-22 25.7.9. Post-Treatment Care .................................................................... 25-23 25.7.10. Follow Up ..................................................................................... 25-23

CHAPTER 26 Laser 1064F Pro Cooled Module 26.1. 26.2. 26.3. 26.4.

26.5. 26.6. 26.7.

26.8.

xviii

Page

1064F Pro Cooled Module Description ........................................................... 26-3 Laser 1064F Pro Cooled Module Specifications ............................................. 26-3 Laser 1064F Pro Cooled Module Operating Screens ...................................... 26-4 Operating Parameters ...................................................................................... 26-5 26.4.1. Long Pulse Mode ............................................................................ 26-5 26.4.2. Nail Fungus Mode .......................................................................... 26-5 Laser 1064F Pro Cooled Module Regulatory Labels ...................................... 26-6 Ordering Information....................................................................................... 26-6 Clinical Guide: Long Pulse Mode ................................................................... 26-7 26.7.1. Assessing the Condition .................................................................. 26-7 26.7.2. Indications for Use ......................................................................... 26-7 26.7.3. Contraindications ........................................................................... 26-8 26.7.3.1. Vascular Lesions, Veins and Wrinkles 26-8 26.7.3.2. Hair Removal and PFB 26-8 26.7.4. Vascular Lesions............................................................................. 26-9 26.7.4.1. Preparing the Lesion for Treatment 26-9 26.7.4.2. Skin Test 26-9 26.7.4.3. Treatment 26-9 26.7.4.4. Vascular Lesions Suggested Setup Parameters 26-11 26.7.5. Non-Ablative Treatment of Facial Wrinkles ................................. 26-11 26.7.5.1. Skin Test 26-11 26.7.5.2. Treatment 26-11 26.7.5.3. Facial Wrinkles Suggested Setup Parameters 26-12 26.7.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB).. 26-13 26.7.6.1. Pre-Treatment Patient Evaluation 26-13 26.7.6.2. Skin Test for Hair Removal and PFB 26-13 26.7.6.3. Treatment 26-14 26.7.6.4. Suggested Setup Parameters for Hair Removal and PFB 26-15 26.7.7. Follow Up ..................................................................................... 26-15 26.7.7.1. Vascular Lesions and Leg Veins 26-15 26.7.7.2. Hair Removal and PFB 26-16 Clinical Guide: Nail Fungus .......................................................................... 26-17 26.8.1. Assessing the Condition ................................................................ 26-17 26.8.2. Indications for Use ....................................................................... 26-17 26.8.3. Contraindications ......................................................................... 26-17 26.8.4. Adverse Effects of Treatment ........................................................ 26-18


Table of Contents

26.8.5.

Preparation for Treatment ........................................................... 26-18 26.8.5.1. Patient Positioning 26-18 26.8.5.2. Infected Toenails by Size and Anatomy 26-19 26.8.5.3. Preparing the Nail for Treatment 26-19 26.8.6. Treatment Phase 1 – Q-Switched Module .................................... 26-20 26.8.6.1. Patch Test – Q-Switched Module 26-20 26.8.6.2. Treatment Procedure – Q-Switched Module 26-20 26.8.6.3. Suggested Setup Parameters – Q-Switched Module 26-21 26.8.6.4. Clinical End-Points 26-21 26.8.7. Treatment Phase 2 – Laser 1064F Pro Cooled Module ............... 26-22 26.8.7.1. Patch Test – Laser 1064F Pro Cooled Module 26-22 26.8.7.2. Treatment Procedure – Laser 1064F Pro Cooled Module 26-22 26.8.7.3. Suggested Setup Parameters – Laser 1064F Pro Cooled Module 26-23 26.8.7.4. Clinical End-Points 26-23 26.8.8. Combination with Local Substances............................................. 26-23 26.8.9. Post-Treatment Care .................................................................... 26-24 26.8.10. Follow Up ..................................................................................... 26-24

CHAPTER 27 Laser 1320nm Module 27.1. 27.2. 27.3. 27.4. 27.5. 27.6.

Laser 1320nm Module Description ................................................................. 27-2 Laser 1320nm Module Specifications ............................................................. 27-2 Laser 1320nm Module Operating Screens ...................................................... 27-3 Laser 1320nm Module Regulatory Labels ...................................................... 27-4 Ordering Information ...................................................................................... 27-4 Laser 1320nm Module Clinical Guide ............................................................ 27-5 27.6.1. Indications for Use ......................................................................... 27-5 27.6.2. Contraindications ........................................................................... 27-5 27.6.3. Pre-Treatment ................................................................................ 27-6 27.6.3.1. Assessing the Condition 27-6 27.6.3.2. Skin Test 27-6 27.6.4. Treatment........................................................................................ 27-7 27.6.5. Suggested Setup Parameters .......................................................... 27-8 27.6.6. Follow-up ....................................................................................... 27-8

CHAPTER 28 Laser 1320nm Cooled Module 28.1. 28.2. 28.3.

Page

Page

Laser 1320nm Cooled Module Description .................................................... 28-2 Laser 1320nm Cooled Module Specifications ................................................ 28-3 Tip Installation ................................................................................................ 28-4


xix

Table of Contents

28.4. 28.5. 28.6. 28.7.

1320nm Cooled Module Operating Screens .................................................... 28-6 Laser 1320nm Cooled Module Regulatory Labels .......................................... 28-7 Ordering Information....................................................................................... 28-7 Laser 1320nm Cooled Module Clinical Guide ................................................ 28-8 28.7.1. Indications for Use ......................................................................... 28-8 28.7.2. Contraindications ........................................................................... 28-8 28.7.3. Assessing the Condition .................................................................. 28-9 28.7.4. Pre-Treatment ................................................................................. 28-9 28.7.4.1. Assessing the Condition 28-9 28.7.4.2. Skin Test 28-9 28.7.5. Treatment ...................................................................................... 28-10 28.7.6. Suggested Setup Parameters......................................................... 28-11 28.7.7. Follow-up...................................................................................... 28-11

CHAPTER 29 Pixel & Pixel Pro 2940nm Modules 29.1. 29.2. 29.3. 29.4. 29.5. 29.6.

xx

Page

Pixel and Pixel Pro 2940nm Modules Description .......................................... 29-2 Pixel & Pixel Pro Modules Specifications ...................................................... 29-3 Pixel & Pixel Pro 2940nm Modules Operating Screen ................................... 29-4 Pixel & Pixel Pro Modules Regulatory Labels ................................................ 29-4 Ordering Information....................................................................................... 29-5 Pixel & Pixel Pro 2940nm Modules Clinical Guide........................................ 29-6 29.6.1. Indications for Use with Standard Accessory Tips ......................... 29-6 29.6.1.1. Dermatology and Plastic Surgery 29-6 29.6.1.2. General Surgery 29-7 29.6.1.3. Genitourinary 29-7 29.6.1.4. Gynecology 29-7 29.6.1.5. Oral/Maxillofacial 29-7 29.6.1.6. Otorhinolaryngology / Head and Neck (ENT) 29-8 29.6.1.7. Ophthalmology 29-8 29.6.1.8. Podiatry 29-8 29.6.2. Indications for Use with Pixel Accessory Tips ............................... 29-8 29.6.3. Contraindications ........................................................................... 29-8 29.6.4. Pre-Treatment ................................................................................. 29-9 29.6.4.1. Assessing the Condition 29-9 29.6.4.2. Skin Test 29-9 29.6.4.3. Prior to Treatment Day 29-10 29.6.4.4. Treatment Day 29-10 29.6.5. Treatment Using Pixel Mode ........................................................ 29-11 29.6.5.1. Prior to Treatment Day 29-12 29.6.5.2. Treatment Day 29-13 29.6.6. Suggested Setup Parameters......................................................... 29-14 29.6.7. Post-Treatment Care & Follow-Up .............................................. 29-15


Table of Contents

CHAPTER 30 iPixelEr 2940nm Module 30.1. 30.2. 30.3. 30.4. 30.5. 30.6.

iPixelEr 2940nm Module Description .............................................................. 30-2 iPixelEr 2940nm Module Specifications .......................................................... 30-3 iPixelEr Module 2940nm Module Operating Screen ....................................... 30-4 iPixelEr Module 2940nm Module Regulatory Labels ...................................... 30-4 Ordering Information ...................................................................................... 30-5 iPixelEr Clinical Guide ..................................................................................... 30-6 30.6.1. Indications for Use with Standard Accessory Tips ......................... 30-6 30.6.1.1. Dermatology and Plastic Surgery 30-6 30.6.1.2. General Surgery 30-7 30.6.1.3. Genitourinary 30-7 30.6.1.4. Gynecology 30-7 30.6.1.5. Oral/Maxillofacial 30-7 30.6.1.6. Otorhinolaryngology / Head and Neck (ENT) 30-8 30.6.1.7. Ophthalmology 30-8 30.6.1.8. Podiatry 30-8 30.6.2. Indications for Use with Pixel Accessory Tips ............................... 30-8 30.6.3. Contraindications ........................................................................... 30-8 30.6.4. Pre-Treatment ................................................................................ 30-9 30.6.4.1. Assessing the Condition 30-9 30.6.4.2. Skin Test 30-9 30.6.4.3. Prior to Treatment Day 30-10 30.6.4.4. Treatment Day 30-10 30.6.5. Treatment Procedure ................................................................... 30-11 30.6.6. Suggested Setup Parameters ........................................................ 30-13 30.6.7. Post-Treatment Care & Follow-Up .............................................. 30-14

CHAPTER 31 iPixelEr 2940nm and Impact Modules 31.1.

31.2.

31.3. 31.4.

31.5. 31.6.

Page

Page

Module Descriptions ....................................................................................... 31-3 31.1.1. iPixelEr 2940nm Module Description ............................................. 31-3 31.1.2. Impact Module Description ............................................................ 31-4 Module Specifications ..................................................................................... 31-5 31.2.1. iPixelEr 2940nm Module Specifications .......................................... 31-5 31.2.2. Impact Module Specifications ........................................................ 31-5 Operating Screens ........................................................................................... 31-6 Regulatory Labels ........................................................................................... 31-6 31.4.1. iPixelEr Module 2940nm Module .................................................... 31-6 31.4.2. Impact Module ................................................................................ 31-7 Ordering Information ...................................................................................... 31-8 Clinical Guide: iPixelEr and Impact Applications ............................................ 31-9 31.6.1. Introduction .................................................................................... 31-9 31.6.2. Training Requirements ................................................................... 31-9


xxi

Table of Contents

31.6.3.

Intended Use ................................................................................... 31-9 31.6.3.1. iPixelEr 2940nm Module Component 31-9 31.6.3.2. Impact Module Component 31-9 31.6.4. Contraindications ......................................................................... 31-10 31.6.4.1. iPixelEr 2940nm Module Component 31-10 31.6.4.2. Impact Module Component 31-10 31.6.4.3. Special Considerations 31-11 31.6.5. Accessories and Equipment .......................................................... 31-11 31.6.5.1. iPixelEr 2940nm Module 31-11 31.6.5.2. Impact Module 31-11 31.6.5.3. Impact Meso-Kits 31-11 31.6.6. Pre-Treatment Information ........................................................... 31-12 31.6.6.1. General 31-12 31.6.6.2. Counseling 31-12 31.6.6.3. Photography 31-12 31.6.6.4. Patient Selection Criteria 31-12 31.6.6.5. Treatment Areas 31-13 31.6.6.6. Meso-kits 31-13 31.6.6.6.1. Impact Meso-Striae Kit 31-13 31.6.6.6.2. Impact Meso-Wrinkles Kit 31-13 31.6.6.6.3. Impact Meso-Skin Rejuvenation Kit 31-14 31.6.6.6.4. Impact Meso-Scars Kit 31-14 31.6.6.7. Number of Treatments and Treatment Intervals 31-14 31.6.7. Treatment ...................................................................................... 31-15 31.6.7.1. Treatment Objectives 31-15 31.6.7.1.1. iPixel Modality 31-15 31.6.7.1.2. Impact Module 31-15 31.6.7.2. Treatment Technique 31-15 31-15 31.6.7.2.1. iPixelEr Modality 31.6.7.2.2. Impact Module 31-16 31.6.8. Treatment Protocol ....................................................................... 31-16 31.6.8.1. Pre-Treatment 31-16 Er 31.6.9. iPixel 2940nm Module ............................................................... 31-16 31.6.10. Impact Module .............................................................................. 31-17 31.6.11. Suggested Setup Parameters......................................................... 31-19 31.6.11.1. iPixelEr 2940nm Modality 31-19 31.6.11.2. Impact Module 31-19 31.6.12. Post-Treatment Care and Follow-Up ........................................... 31-20 31.6.12.1. Open Wound Care 31-20 31.6.13. Closed Wound Care ...................................................................... 31-20

CHAPTER 32 Alex 755 Module 32.1. 32.2. 32.3. xxii

Page

Alex 755 Laser Module Description ............................................................... 32-2 Alex 755 Laser Module Specifications ........................................................... 32-2 Alex 755 Laser Module Operating Screen ...................................................... 32-3 Harmony®XL Modules Operator's Manual

Table of Contents

32.4. 32.5. 32.6.

Alex 755 Laser Module Regulatory Labels .................................................... 32-4 Ordering Information ...................................................................................... 32-4 Alex 755 Laser Module Clinical Guide .......................................................... 32-5 32.6.1. Indications for Use ......................................................................... 32-5 32.6.2. Pigmented Lesions .......................................................................... 32-5 32.6.2.1. Assessing the Condition 32-5 32.6.2.2. Contraindications 32-5 32.6.2.3. Preparing the Lesion for Treatment 32-6 32.6.2.4. Skin Test 32-6 32.6.2.5. Treatment 32-7 32.6.2.6. Pigmented Lesions Suggested Setup Parameters 32-8 32.6.2.7. Follow Up 32-8 32.6.3. Hair Removal ................................................................................. 32-9 32.6.3.1. Contraindications 32-9 32.6.3.2. Pre-Treatment Patient Evaluation 32-9 32.6.3.3. Skin Test for Hair Removal and PFB 32-9 32.6.3.4. Treatment 32-10 32.6.3.5. Suggested Setup Parameters for Hair Removal 32-11 32.6.3.6. Follow Up 32-11

CHAPTER 33 NIR Body Module 33.1. 33.2. 33.3. 33.4. 33.5. 33.6.

33.7.

Page

NIR Body Module Description ....................................................................... 33-3 NIR Body Module Specifications ................................................................... 33-4 NIR Body Module Operating Screen .............................................................. 33-4 NIR Body Module Regulatory Labels............................................................. 33-5 Ordering Information ...................................................................................... 33-5 NIR Body Module Clinical Guide – General Applications............................. 33-6 33.6.1. Introduction .................................................................................... 33-6 33.6.2. Intended Use and Indications ......................................................... 33-6 33.6.3. Contraindications ........................................................................... 33-6 33.6.4. Pre-Treatment ................................................................................ 33-7 33.6.4.1. General 33-7 33.6.4.2. Counseling 33-7 33.6.4.3. Module Operation 33-7 33.6.4.4. Module Parameters 33-7 33.6.4.5. NIR Body Module Skin Test 33-8 33.6.5. Treatment........................................................................................ 33-9 33.6.6. Suggested Setup Parameters ........................................................ 33-11 33.6.7. Post-Treatment Care .................................................................... 33-12 33.6.8. Concluding Treatment .................................................................. 33-12 33.6.9. Follow-Up .................................................................................... 33-12 NIR Body Module Clinical Guide – Dorsal Hand Rejuvenation .................. 33-13 33.7.1. Introduction .................................................................................. 33-13


xxiii

Table of Contents

33.7.2. 33.7.3. 33.7.4. 33.7.5. 33.7.6. 33.7.7.

Intended Use and Indications ....................................................... 33-13 Skin Test ........................................................................................ 33-14 Treatment ...................................................................................... 33-14 Suggested Setup Parameters......................................................... 33-16 Post-Treatment Care .................................................................... 33-16 Follow-Up ..................................................................................... 33-17

CHAPTER 34 NIR Face Module 34.1. 34.2. 34.3. 34.4. 34.5. 34.6.

Page

NIR Face Module Description......................................................................... 34-2 NIR Face Module Specifications..................................................................... 34-3 NIR Face Module Operating Screen ............................................................... 34-3 NIR Face Module Regulatory Labels .............................................................. 34-4 Ordering Information....................................................................................... 34-4 NIR Face Module Clinical Guide – General Applications .............................. 34-5 34.6.1. Introduction .................................................................................... 34-5 34.6.2. Intended Use and Indications ......................................................... 34-5 34.6.3. Contraindications ........................................................................... 34-5 34.6.4. Pre-Treatment ................................................................................. 34-6 34.6.4.1. General 34-6 34.6.4.2. Counseling 34-6 34.6.4.3. Module Operation 34-6 34.6.4.4. Module Parameters 34-6 34.6.4.5. NIR Face Module Skin Test 34-7 34.6.5. Treatment ........................................................................................ 34-8 34.6.6. Suggested Setup Parameters......................................................... 34-10 34.6.7. Post-Treatment Care .................................................................... 34-11 34.6.8. Concluding Treatment .................................................................. 34-11 34.6.9. Follow-Up ..................................................................................... 34-11

List of Figures Figure

Description

Page

Figure 2-1: UV Module (Violet Color Code) .......................................................................................... 2-2 Figure 2-2: UV Module Operating Screen............................................................................................... 2-3 Figure 2-3: UV Module Regulatory Labels ............................................................................................. 2-4 Figure 3-1: Acne Module (Blue Color Code) .......................................................................................... 3-2 Figure 3-2: Acne Module Operating Screen ............................................................................................ 3-3 Figure 3-3: Acne Module Regulatory Labels .......................................................................................... 3-4 Figure 4-1: Acne Pro Module (Blue Color Code) ................................................................................... 4-2

xxiv


Table of Contents

Figure 4-2: Acne Pro Module Operating Screen ..................................................................................... 4-3 Figure 4-3: Acne Pro Module Regulatory Labels.................................................................................... 4-4 Figure 5-1: SVL Module (Turquoise Color Code) .................................................................................. 5-2 Figure 5-2: SVL Module Operating Screen............................................................................................. 5-3 Figure 5-3: SVL Module Regulatory Labels ........................................................................................... 5-4 Figure 6-1: SVL Cooled Module (Turquoise Color Code)...................................................................... 6-2 Figure 6-2: SVL Cooled Module Operating Screen ................................................................................ 6-3 Figure 6-3: SVL Cooled Module Regulatory Labels............................................................................... 6-4 Figure 7-1: VP Module (Green Color Code) ........................................................................................... 7-2 Figure 7-2: VP Module Operating Screen ............................................................................................... 7-3 Figure 7-3: VP Module Regulatory Labels ............................................................................................. 7-4 Figure 8-1: VP Cooled Module (Green Color Code) .............................................................................. 8-2 Figure 8-2: VP Cooled Module Operating Screen................................................................................... 8-3 Figure 8-3: VP Cooled Module Regulatory Labels ................................................................................. 8-4 Figure 9-1: Dye-VL Module (Light Green)............................................................................................. 9-3 Figure 9-2: Dye-VL Module Operating Screens ..................................................................................... 9-4 Figure 9-3: Dye-VL Module Regulatory Labels ..................................................................................... 9-5 Figure 10-1: Dye-VL Pro Module (Light Green) .................................................................................. 10-3 Figure 10-2: Dye-VL Pro Module Operating Screens ........................................................................... 10-4 Figure 10-3: Dye-VL Pro Module Regulatory Labels ........................................................................... 10-5 Figure 11-1: LED Module ..................................................................................................................... 11-2 Figure 11-2: LED Module Operating Screen ........................................................................................ 11-3 Figure 11-3: LED Module Regulatory Labels ....................................................................................... 11-4 Figure 12-1: SR Module (Yellow Color Code) ..................................................................................... 12-2 Figure 12-2: SR Module Operating Screen ........................................................................................... 12-3 Figure 12-3: SR Module Regulatory Labels .......................................................................................... 12-4 Figure 13-1: SR Cooled Module (Yellow Color Code) ......................................................................... 13-2 Figure 13-2: SR Cooled Module Operating Screen ............................................................................... 13-3 Figure 13-3: SR Cooled Module Regulatory Labels ............................................................................. 13-4 Figure 14-1: SSR Module (Green Color Code) ..................................................................................... 14-2 Figure 14-2: SSR Module Operating Screen ......................................................................................... 14-3 Figure 14-3: SSR Module Regulatory Labels ....................................................................................... 14-4 Figure 15-1: Dye-SR Pro Module (Orange Color Code) ....................................................................... 15-3 Figure 15-2: Dye-SR Pro Module Operating Screen ............................................................................. 15-4 Figure 15-3: Dye-SR Pro Module Regulatory Labels ........................................................................... 15-5 Figure 16-1: HR Module (Red Color Code) .......................................................................................... 16-2 Figure 16-2: HR Module Operating Screen........................................................................................... 16-3 Figure 16-3: HR Module Regulatory Labels ......................................................................................... 16-4 Figure 17-1: SHR Pro Module (Brown Color Code)............................................................................. 17-3 Figure 17-2: SHR Pro Cooling Module Operating Screens .................................................................. 17-5 Figure 17-3: SHR Pro Module Regulatory Labels ................................................................................ 17-6 Figure 18-1: SHR Pro 5 Module Handpiece (Brown Color Code)........................................................ 18-3 Figure 18-2: SHR Pro 5 Cooling Module Operating Screens ............................................................... 18-5


xxv

Table of Contents

Figure 18-3: SHR Pro 5 Module Regulatory Labels.............................................................................. 18-6 Figure 19-1: ST Module (Burgundy Color Code) ................................................................................. 19-2 Figure 19-2: ST Module Operating Screen ............................................................................................ 19-3 Figure 19-3: ST Module Regulatory Labels .......................................................................................... 19-4 Figure 20-1: SST Module (Burgundy Color Code) ............................................................................... 20-2 Figure 20-2: SST Module Operating Screen ......................................................................................... 20-3 Figure 20-3: SST Module Regulatory Labels ........................................................................................ 20-4 Figure 21-1: 1064/532nm Laser QS Module ......................................................................................... 21-2 Figure 21-2: Laser QS 1064/532nm Module Operating Screen with Standard Tip .............................. 21-4 Figure 21-3: Laser QS 1064/532nm Module Regulatory Labels ........................................................... 21-5 Figure 22-1: 1064/532nm Laser QS High Power Module ..................................................................... 22-2 Figure 22-2: Laser QS 1064/532nm High Power Module Operating Screen with Standard 5mm Tip (Left) and 5x5 Pixel Tip (Right) ....................................................................................... 22-4 Figure 22-3: Laser QS 1064/532nm High Power Module Regulatory Labels....................................... 22-5 Figure 23-1: Laser 1064nm Module ...................................................................................................... 23-2 Figure 23-2: Laser 1064nm Screen ........................................................................................................ 23-3 Figure 23-3: Laser 1064nm Module Regulatory Labels ........................................................................ 23-4 Figure 24-1: Laser 1064nm Cooled High Power Module...................................................................... 24-2 Figure 24-2: Laser 1064nm Screen ........................................................................................................ 24-3 Figure 24-3: Laser 1064nm Cooled High Power Module Regulatory Labels ....................................... 24-4 Figure 25-1: Laser 1064F Pro Module................................................................................................... 25-3 Figure 25-2: Laser 1064F Pro Screens................................................................................................... 25-4 Figure 25-3: Laser 1064F Pro Module Regulatory Labels .................................................................... 25-5 Figure 25-4: Correct Patient Positioning ............................................................................................. 25-17 Figure 25-5: Treatment Area Definitions ............................................................................................ 25-18 Figure 25-6: Lasing Path of Each Pass over the Toenail Plate during Treatment ............................... 25-19 Figure 26-1: Laser 1064F Pro Cooled Module ...................................................................................... 26-3 Figure 26-2: Laser 1064F Pro Cooled Screens ...................................................................................... 26-4 Figure 26-3: Laser 1064F Pro Cooled Module Regulatory Labels ........................................................ 26-6 Figure 26-4: Correct Patient Positioning ............................................................................................. 26-18 Figure 26-5: Treatment Area Definitions ............................................................................................ 26-19 Figure 26-6: Lasing Path of Each Pass over the Toenail Plate during Treatment ............................... 26-20 Figure 27-1: Laser 1320nm Module ...................................................................................................... 27-2 Figure 27-2: Laser 1320nm Module Screen .......................................................................................... 27-3 Figure 27-3: Laser 1320nm Module Regulatory Labels ........................................................................ 27-4 Figure 28-1: Laser 1320nm Cooled Module .......................................................................................... 28-2 Figure 28-2: Connection Feet for the Tips ............................................................................................. 28-4 Figure 28-3: Pixel Tip Replacement Procedure (1) ............................................................................... 28-4 Figure 28-4: Pixel Tip Replacement Procedure (2) ............................................................................... 28-5 Figure 28-5: Pixel Tip Replacement Procedure (3) ............................................................................... 28-5 Figure 28-6: Laser 1320nm Screen ........................................................................................................ 28-6 Figure 28-7: Laser 1320nm Cooled Module Regulatory Labels ........................................................... 28-7 Figure 29-1: Laser 2940nm Modules ..................................................................................................... 29-2

xxvi


Table of Contents

Figure 29-2: Erbium 2940nm Modules Screens .................................................................................... 29-4 Figure 29-3: Laser 2940nm Modules Regulatory Labels ...................................................................... 29-4 Figure 30-1: iPixelEr Laser 2940nm Module ......................................................................................... 30-2 Figure 30-2: iPixelEr 2940nm Module Screen ........................................................................................ 30-4 Figure 30-3: iPixelEr 2940nm Module Regulatory Labels ..................................................................... 30-4 Figure 31-1: iPixelEr Laser 2940nm Module ......................................................................................... 31-3 Figure 31-2: Impact Module .................................................................................................................. 31-4 Figure 31-3: iPixelEr 2940nm Module Screen ........................................................................................ 31-6 Figure 31-4: Impact Module Screen ...................................................................................................... 31-6 Figure 31-5: iPixelEr 2940nm Module Regulatory Labels ..................................................................... 31-7 Figure 31-6: Impact Module Regulatory Label ..................................................................................... 31-7 Figure 31-7: Treatment Grid – Four Blocks of 10x10 cm ................................................................... 31-17 Figure 31-8: Impact Rotational Movement inside the Grid ................................................................. 31-18 Figure 32-1: Alex 755 Laser Module .................................................................................................... 32-2 Figure 32-2: Alex 755 Laser Screen ...................................................................................................... 32-3 Figure 32-3: Alex 755 Laser Module Regulatory Labels ...................................................................... 32-4 Figure 33-1: NIR Body Module ............................................................................................................ 33-3 Figure 33-2: NIR Body Screen .............................................................................................................. 33-4 Figure 33-3: NIR Body Module Regulatory Labels .............................................................................. 33-5 Figure 33-4: Treatment Phases ............................................................................................................ 33-10 Figure 34-1: NIR Face Module.............................................................................................................. 34-2 Figure 34-2: NIR Face Screen ............................................................................................................... 34-3 Figure 34-3: NIR Face Module Regulatory Labels ............................................................................... 34-4 Figure 34-4: Treatment Phases .............................................................................................................. 34-9


xxvii

CHAPTER 1 Introduction Chapter Contents: Section

Title

Page

1.1.

Scope of This Manual ........................................................................ 1-2

1.2.

Module Specifications ....................................................................... 1-2

1.2.1.

AFT, UV, NIR & LED, Non-Laser, Non-Cooled Modules ........... 1-3

1.2.2.

AFT and NIR, Non-Laser, Cooled Modules .................................. 1-4

1.2.3.

'S' Mode Cooled Modules .............................................................. 1-5

1.2.4.

Laser Modules ................................................................................ 1-6


1-1

Introduction

1.1.

Scope of This Manual The purpose of this manual is to offer the HarmonyXL operator all of the information required to operate the system and its modules in a safest and most efficient manner. This manual and the Modules manual have been prepared to aid medical and technical personnel to understand and operate the system. Do not operate the system before reading this manual, the Modules Manual and gaining a clear understanding of system operation. If any part of these manuals 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 HarmonyXL system should read this manual and the Modules Manual, and become thoroughly familiar with all its safety requirements and operating procedures. The information provided in these manuals is not intended to replace the professional training on the clinical use of the system. Please contact your Alma Lasers representative for current information on available training. For clinical information, refer to the Clinical Guide chapters in this manual, which include set up guidelines for each application. These manuals should always accompany the system and all operating personnel must know their location. Additional copies of these manuals are available from Alma Lasers or your local Alma Lasers representative. Warning Any laser or pulsed light-emitting device can cause injury if used improperly. High voltages are present inside the HarmonyXL system. Personnel who work with lasers or pulsed light sources must always be aware of the possible dangers and must take the proper safeguards as described in the Safety chapter of the System manual.

1.2.

Module Specifications The tables on the following pages present the technical specifications of each of the HarmonyXL system's modules. Each of the following chapters in this manual is dedicated to a particular module offering appropriate descriptions, operating instructions, specifications, ordering part numbers and clinical guidance.

1-2


Introduction

1.2.1. AFT, UV, NIR & LED, Non-Laser, Non-Cooled Modules Applications

Technology

Wavelength (nm)

Pulse Widths / Timers

Spot Size (cm2)

Pulse Repetition Rate (Hz)

Energy Density (J/cm2)

High Power UV

Pigment restoration

Pulsed UV

300 – 380

30, 40, 50 msec

6.4

1/2

2000 – 4500 mJ/cm2

Acne

Acne clearance

AFT

420 – 950

30, 40, 50 msec

6.4

1/2

5 – 25

S-Acne: 10 Hz

S-Acne: 0.3 – 1.2 J/cm2

Acne: 1 / 2

Acne: 5 – 25

Module

S-Acne: 1, 3, 30 sec. Acne Pro

Acne clearance

AFT

420 – 950

Acne: 30, 40, 50 msec.

6.4

SVL

Superficial vascular lesions

AFT

515 – 950

10, 12, 15 msec

6.4

2/3

5 – 25

VP

Vascular and pigmented lesions

AFT

540 – 950

10, 12, 15 msec

6.4

2/3

5 – 25

SR

Skin rejuvenation

AFT

570 – 950

10, 12, 15 msec

6.4

2/3

5 – 25

HR

Hair removal

AFT

650 – 950

30, 40, 50 msec

6.4

2/3

5 – 25

ST

Scar revision & Treatment of Striae

Pulsed NIR

NIR

10, 30 & 90 seconds

6.4

2

1–7

LED

Various skin conditions

LED

Yellow

Pulsed / CW

N/A

N/A

N/A

Impact

Dermatological procedures

Acoustic pressure

N/A

N/A

N/A

N/A

N/A


1-3

Introduction

1.2.2. AFT and NIR, Non-Laser, Cooled Modules Applications

Technology

Wavelength (nm)

Pulse Widths / Timers

Spot Size (cm2)



SVL

Superficial vascular lesions

AFT

515 – 950

10, 12, 15 msec

3

2/3

5 – 30

VP


AFT

540 – 950

10, 12, 15 msec

3

2/3

5 – 30

SR

Skin rejuvenation

AFT

570 – 950

10, 12, 15 msec

3

2/3

5 – 30

Dye-SR Pro


AFT

550 – 650

SR: 1

SR: Up to 15

SSR: 3

SSR: 1 – 4

VL Mode: 1

Dye-VL Pro


AFT

VL Mode: Up to 15

SVL Mode: 3

SVL Mode: 1–4

Hair removal

AFT

650 – 950

2/3

5 – 30

Muscle pain, joint pain & stiffness

Pulsed NIR

NIR

18

Muscle pain, joint pain & stiffness

Pulsed NIR

NIR

6.4

Module

HR 1 NIR Body

2

NIR Face 2

1 2

500 – 600

SR: 10, 12, 15 msec SSR: 30 sec. VL Mode: 10, 12, 15 msec SVL Mode: 30 sec. 30, 40, 50 msec

3

3

3

The cooled HR and cooled SHR are two modules in one: Cooled SHR Pro, incorporating two technologies. Refer to the appropriate chapter. The NIR module discussed in this manual is not available in Canada.

1-4


Introduction

1.2.3. 'S' Mode Cooled Modules Module SSR SHR Pro 1 SHR Pro 5 SST

3

Technology

Wavelength (nm)

Timers

Spot Size (cm2)



Super skin rejuvenation

In-Motion AFT

540 – 950

1, 3 & 30 seconds

3

2

1 – 15

Super hair removal

In-Motion AFT

NIR

1, 3 & 30 seconds

3

3

3–7

Super hair removal

In-Motion AFT

NIR

1, 3 & 30 seconds

5

3

3–7

Scar revision & Treatment of Striae

In-Motion AFT

NIR

1, 3 & 30 seconds

3

5

0.5 – 3.5

Applications

3

Cooled SHR Pro module with a 5 cm2 spot size. Refer to the appropriate chapter.


1-5

Introduction

1.2.4. Laser Modules Module

Laser QS 1064 / 532nm

Laser QS 1064 / 532nm; High Power

Laser 1064nm

Laser 1064nm; High Power

Laser 1064F Pro

1-6

Technology

Wavelength (nm)

Pulse Width / Mode

Spot Size

Pulse Frequency (Hz)

Energy Density / Fluence / Depth

Tattoo removal

Q-Switched Nd:YAG

1064

20 nsec

1, 2, 3, 4, 5, 6 mm

1, 2, 5

400 – 1200 mJ/p

Deep pigmented lesions

Q-Switched Nd:YAG

1064

20 nsec

5 x 5 Pixels

1, 2, 5

400 – 1200 mJ/p

Tattoo removal

FD Q-Switched Nd:YAG

1064/532

20 nsec

2 mm (KTP)

1, 2, 5

400 – 1200 mJ/p

Tattoo removal

Q-Switched Nd:YAG

1064

20 nsec

3, 5 mm

1, 2, 4

500 – 1200 mJ/p

Deep pigmented lesions

Q-Switched Nd:YAG

1064

20 nsec

3, 5 mm 5x5 Pixel

1, 2, 4

500 – 1200 mJ/p

Tattoo removal & nail fungus


1064/532

20 nsec

3 mm (KTP)

1, 2, 4

500 – 1200 mJ/p

Vascular lesions

Nd:YAG

1064

10 msec

2 mm

1

30 – 450 J/cm2

Leg veins

Nd:YAG

1064

15, 45, 60 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

12, 15, 45 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

15 msec

10 mm

1

20 – 50 J/cm2

Vascular lesions

Nd:YAG

1064

10 msec

2 mm

1

30 – 450 J/cm2

Leg veins

Nd:YAG

1064

12, 15, 45 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

12, 15, 45 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

15 msec

10 mm

1

20 – 50 J/cm2

Vascular lesions

Nd:YAG

1064

10 msec

2 mm

1

30 – 450 J/cm2

Leg veins

Nd:YAG

1064

15, 45, 60 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

12, 15, 45 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

15 msec

10 mm

1

20 – 50 J/cm2

Nail fungus

Nd:YAG

1064

0.1 – 3.0 ms

1 mm

10, 20, 30

100 – 200 mJ/P

Applications


Introduction

Laser Modules (continued) Technology

Wavelength (nm)

Pulse Width / Mode

Spot Size

Pulse Frequency (Hz)

Energy Density / Fluence / Depth

Vascular lesions

Nd:YAG

1064

10 msec

2 mm

1

30 – 450 J/cm2

Leg veins

Nd:YAG

1064

15, 45, 60 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

12, 15, 45 msec

6 mm

1

30 – 150 J/cm2

Hair removal

Nd:YAG

1064

15 msec

10 mm

1

20 – 50 J/cm2

Nail fungus

Nd:YAG

1064

0.1 – 3.0 ms

1 mm

10, 20, 30

100 – 200 mJ/P

Laser 1320nm Cooled

Wrinkles and acne scars

Nd:YAG

1320

30, 40, 50 msec

6 mm

1

1 – 40 J/cm2

Pixel Pro (2940nm)

Fractional ablative skin resurfacing

2940

Short, Medium, Long

7 x 7 Pixels 9 x 9 Pixels 1 mm 4 mm

5

Short: 300-1200 mJ/P Medium: 600-1800 mJ/P Long: 800-2500 mJ/P

2940

Short, Medium, Long

7 x 7 Pixels 9 x 9 Pixels 1 mm 4 mm

5

Short: 600-800 mJ/P Medium: 600-1000 mJ/P Long: 600-1400 mJ/P

7 x 7 Pixels

2/5

2940

Short, Medium, Long

7 x 1 Pixels (roller)

4

4 mm

4

Module

Applications

Laser 1064F Pro Cooled

Laser 2940nm

Er

iPixel 2940nm

Alex 755nm

4

4

Er:YAG


Er:YAG


Hair removal

Er:YAG

Alexandrite

755

5 mm 8 mm

2

Short: 200-1200 mJ/P Medium: 600-1800 mJ/P Long: 800-2500 mJ/P 1 – 32 J/cm2 1 – 12 J/cm2

Not available in EU and Canada


1-7

Introduction

1-8 Harmony®XL Modules Operator's Manual

CHAPTER 2 High Power UV Module – Psoriasis & Vitiligo Chapter Contents: Section

Title

Page

2.1.

UV Module Description .................................................................... 2-2

2.2.

UV Module Specifications ................................................................ 2-2

2.3.

UV Module Operating Screen ........................................................... 2-3

2.4.

UV Module Regulatory Labels .......................................................... 2-4

2.5.

Ordering Information ......................................................................... 2-4

2.6.

UV Module Clinical Guide ................................................................ 2-5

2.6.1.

Pre-Treatment ................................................................................... 2-5

2.6.2.

Treatment.......................................................................................... 2-7

2.6.3.

Suggested UV Setup Parameters ...................................................... 2-7

2.6.4.

Vitiligo & Re-Pigmentation ............................................................. 2-8

2.6.5.

Follow-up ......................................................................................... 2-9


2-1

UV Module – Psoriasis and Vitiligo

2.1.

UV Module Description The UV module has an ultraviolet high-power targeted phototherapy module which uses spectral irradiance in the ultraviolet waveband to target and treat large and small areas while avoiding exposure to healthy skin. A complete discussion of the UV module clinical applications may be found in Section 2.6. The UV module has a violet identification section (see Figure 2-1).

Figure 2-1: UV Module (Violet Color Code)

2.2.

2-2

UV Module Specifications • Light Source:

High-pressure xenon lamp

• Spectrum:

300 – 380nm

• Energy Density (Fluence):

2000 – 4500 mJ/cm2 adjustable in 100 mJ/cm2 increments

• Treatment Area (spot size):

40 x 16 mm (6.4 cm2)

• Pulse Duration:

30, 40, 50 msec.

• Pulse Repetition Rate:

1/2 Hz.



2.3.

UV Module Operating Screen The UV module main operating screen (see Figure 2-2) is displayed when the UV module is connected to the system:

Figure 2-2: UV Module Operating Screen Operating parameters available in this module: 1. 2.

Fluence – the available fluence range is from 2000 to 4500 mJ/cm2 in

increments of 100 J/cm2.

Pulse Width – three pulse widths are available:

• 30 ms • 40 ms • 50 ms


2-3


2.4.

UV Module Regulatory Labels Figure 2-3 presents the regulatory identification and caution labels adhered to the UV module connector:

Figure 2-3: UV Module Regulatory Labels

2.5.

Ordering Information The following table offers names of accessories specific to the UV module that may be ordered form Alma Lasers. Table 2-1: UV Module Accessories Description UV (Ultraviolet) Module Masking Templates Set for UV Module UV Safety Glasses 100% UV Protection

2-4



2.6.

UV Module Clinical Guide The HarmonyXL High Power UV Module emits light in the 300-380nm range and is intended for use in all skin types to treat psoriasis, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma - including vitiligo (acquired leukoderma), and hypopigmented skin presenting in striae (stretch marks), post-surgical scars, traumatic scars, acne scars, grafted skin, burn scars, laser skin resurfacing, chemically peeled skin, etc. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

2.6.1.

Pre-Treatment

2.6.1.1.

Assessing the Condition The treatment parameters for any given skin condition depend on the lesion type, skin type, depth and density of the lesion to be treated.

2.6.1.2.

UV Light Source Indications The UV Light source (300-380nm) is indicated for:

• The treatment of leukoderma, including vitiligo (acquired leukoderma) • The treatment of psoriasis, atopic dermatitis (eczema), and seborrheic dermatitis • Use on all skin types (Fitzpatrick I-VI), including tanned skin 2.6.1.3.

UV Light Source Contraindications • Tanned skin (active tan) through sun exposure in the past 2 weeks or tanning bed use in the previous 30 days

• Active herpes simplex, etc. at the treatment site • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.)

• History of keloid scarring • Epilepsy • UV photosensitivity (e.g., xeroderma pigmentosum) • Pregnancy; until menstruation returns and end of breast feeding


2-5


• Diabetes (because of increased possible photosensitivity and poor wound healing)

2.6.1.4.

Minimal Erythema Dose (MED) Test For an effective treatment, light fluence to a psoriatic lesion should be sufficiently high to induce visible erythema, without adverse side effects to the healthy skin. However, in order to select the appropriate initial fluence for a treatment, the operator should perform a MED test a day or two before therapeutic treatment as follows: 1.

Select an uninvolved area of healthy, untanned skin (e.g. upper buttocks/lower back).

2.

Using the MED template provided, expose a series of test spots according to skin type, as indicated in Table 2-2.

3.

Evaluate the test spots 24 hours following exposure.

4.

To determine the patient’s MED, identify the lowest dose test spot that exhibits a definitively bordered and uniform slight redness.

Table 2-2: Proposed Range of MED Test Spot Fluence (mJ/cm2) for the UV Module Test Spot #

Skin Type I – II

Skin Type III – IV

Skin Type V – VI

Waiting Period

1

2000

2200

2400

24 hours

2

2100

2300

2500

24 hours

3

2200

2400

2600

24 hours

4

2300

2500

2700

24 hours

5

2400

2600

2800

24 hours

6

2500

2700

2900

24 hours

Note In vitiligo and re-pigmentation reduce the energy by 15%-20%.

2-6



2.6.2.

Treatment 1.

Clean the skin to remove perfumes, cosmetics and sunscreens.

2.

Begin initial treatment with predetermined fluence, beginning at approximately 70-90% of the MED and increasing the settings in 10-20% increments at each subsequent treatment (in the absence of side effects). Slight erythema is a desired endpoint 20-24 hours after treatment.

3.

A treatment mask may be used to protect the healthy skin from unintended UV exposure.

4.

Do not apply gel.

5.

Place the module perpendicular to the skin and touch the skin. Do not apply pressure.

6.

Set the initial fluence parameter according to the skin test results.

7.

Trigger a light pulse by pressing the footswitch.

8.

Treatment should overlap the healthy skin at the periphery of the treated sites by approximately one or two millimeters.

9.

To start, treatments may be administered twice per week for the first two weeks. Subsequent treatments may remain on the same schedule or be given at the frequency of once every other week, according to the operator’s discretion.

10. If prominent adverse reactions are noted from the prior treatment, the next treatment may be skipped or the dose reduced until symptoms resolve. 11. After re-pigmentation, additional maintenance treatments may be continued at the same - or reduced - dose and frequency.

2.6.3.

Suggested UV Setup Parameters

Table 2-3: Suggested UV Setup Parameters Skin Type (Fitzpatrick I – VI)

Module

Pulse Width (msec)

Fluence (mJ/cm2)

Comments

I – II

UV 300-380nm (Violet)

30, 40

MED x 0.9

If no adverse effects, increase fluence by 10-20% every 2-3 treatments

III


30, 40

MED x 0.8


IV – VI


50

MED x 0.7



2-7


2.6.4.

Vitiligo & Re-Pigmentation The approach to the treatment with the UV module is similar to that of Psoriasis.

• The treatment doses are gradually increased during the course of treatment in various increments. The initial dose and the increments depend on the body location, skin type and skin response.

• The number of sessions is dependent on the body location. Areas that usually respond well, such as the face, neck and bikini line require fewer treatment sessions. Skin types that respond well are usually dark skin (IV-V).

• Re-pigmentation improvement scale should be evaluated using the following clinical scale: complete, moderate, mild, and none.

• Number of session treatments per week: 2 • Duration of the treatments: 6-10 weeks (this average range may depend on the rate and extent of improvement).

Table 2-4: Initial Treatment Parameters for Vitiligo and Re-Pigmentation Starting Dosage (mJ/cm2)

Resultant Erythema <24 hours after treatment, fluence should be increased by:

Resultant Erythema 48-60 hours after treatment, fluence should be decreased by:

Resultant Erythema 60-72 hours after treatment, postpone the next treatment and decrease fluence by:

Periocular

2000

5%

5%

10%

Face, scalp, ear, neck, axilla, bikini

2000

10%

10%

15%

Arm, leg, trunk

2000

15%

15%

20%

Wrist

2200

15%

15%

20%

Elbow

2200

20%

20%

25%

Knee

2200

20%

20%

25%

Hand, feet

2300

20%

20%

25%

Finger, toe

2500

20%

20%

25%

Treatment Area

2-8



2.6.5.

Follow-up • After treatment there is typically mild erythema. At higher fluences blistering can occur, mimicking a severe sunburn reaction. If any blistering or erosions occur, the area should be covered with antibiotic ointment or hydrophilic petrolatum until healed.

• Avoid exposure of the skin to UV (sun exposure or the use of tanning beds) or self-tan for at least 2 weeks

• Avoid picking or scratching the treated area • Avoid rough handling of the area treated • Avoid very hot baths / showers / steam baths / sauna • Avoid exfoliating or peels for 1 week • Avoid rough sports for 24-48 hrs • Avoid wearing tight clothing • Keep the area clean and dry • Hydrate the body by drinking plenty of water • Use sun block of at least SPF 30+ • 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 followup report sent to the Director of Clinical Operations at Alma Lasers: 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]


2-9

CHAPTER 3 Acne Module – Acne Clearance Chapter Contents: Section

Title

Page

3.1.

Acne Module Description .................................................................. 3-2

3.2.

Acne Module Specifications .............................................................. 3-2

3.3.

Acne Module Operating Screen......................................................... 3-3

3.4.

Acne Module Regulatory Labels ....................................................... 3-4

3.5.


3.6.

Acne Module Clinical Guide ............................................................. 3-5

3.6.1.

Indications for Use ........................................................................... 3-5

3.6.2.

Contraindications.............................................................................. 3-5

3.6.3.

Module Operation............................................................................. 3-6

3.6.4.

Pre-Treatment ................................................................................... 3-6

3.6.5.

Treatment.......................................................................................... 3-7

3.6.6.

Suggested Setup Parameters ............................................................. 3-7

3.6.7.

Follow-Up ........................................................................................ 3-8


3-1

Acne Module – Acne Clearance

3.1.

Acne Module Description The Acne module has a high-power targeted phototherapy module for clearance of inflammatory acne. It employs Alma Laser's proprietary AFT pulsed light technology in the blue wavelength range (420-950nm) along with adjustable parameters to permeate the tissue and reach the P.acnes target. A complete discussion of the Acne module clinical applications may be found in Section 3.6. The Acne module has a blue identification section (see Figure 3-1).

Figure 3-1: Acne Module (Blue Color Code)

3.2.

3-2

Acne Module Specifications • Light Source:

Pulsed light with AFT and EDF

• Spectrum:

420 – 950nm


5 – 25 J/cm2


6.4 cm2

• Timers:

30, 40 & 50 msec


1/2 Hz

• Cooling:

None



3.3.

Acne Module Operating Screen The Acne module main operating screen (see Figure 3-2) is displayed when the Acne module is connected to the system:

Figure 3-2: Acne Module Operating Screen Operating parameters available in this module: 1.

Fluence – the available fluence range is from 5 to 25 J/cm2 in increments of

1 J/cm2.

2.

Timers – 30, 40 & 50 msec

3.

Pulse Repetition Rate – fixed at 1/2 Hz


3-3


3.4.

Acne Module Regulatory Labels Figure 3-3 presents the regulatory identification and caution labels adhered to the Acne module connector:

Figure 3-3: Acne Module Regulatory Labels

3.5.

Ordering Information The following table offers names of accessories specific to the Acne module that may be ordered form Alma Lasers. Table 3-1: Acne Module Accessories Description Acne Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

3-4



3.6.

Acne Module Clinical Guide The HarmonyXL system with the Acne (blue color code) module emits visible light in the wavelength range of 420-950nm. This range targets porphyrins (photosensitizers), which are normally produced by the propionibacterium acne (P.acnes). P.acnes are a type of bacteria that colonize inside the sebaceous gland and clog it. A photo-chemical reaction induced by porphyrins, triggered by the 420-950nm wavelength of light, induces the photo excitation process and the destruction of the bacteria. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

3.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 420-950nm Acne module (with and without contact-cooling) is indicated for:

• The treatment of moderate inflammatory acne vulgaris. • Use on all skin types (Fitzpatrick I-VI).

3.6.2.

Contraindications • Tanned skin (active tan) through sun exposure or tanning bed use in the previous 30 days. • Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc., at the treatment site. • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.). • History of keloid scarring • Epilepsy • St. John’s Wort (herbal remedy) for depression in the past three months (because of increased photosensitivity) • Isotretinoin – Roaccutane in the previous 3-6 months • Tretinoin – Retin A for the past 2 weeks • Pregnancy (including IVF) • Diabetes


3-5


The treatment parameters for acne reduction depend on the patient’s skin type and the acne lesion type. Therefore, the first steps are assessing the skin type and performing the skin test.

3.6.3.

Module Operation The module should be applied to the skin using Stationary technique. In this technique the practitioner places the module on the skin for the entire exposure time and fluence conditions. In Stationary technique the module should be positioned in complete contact with the skin and slightly pressed towards the skin. A thin layer of pre-cooled ultrasonic gel should be used during the skin test and the actual treatment on all skin types.

3.6.4.

Pre-Treatment

3.6.4.1.

Patient Evaluation Before the treatment, the patient should be evaluated/documented for his/her acne condition, location and type. In addition, acne history that includes medications or other past acne related regimens should be documented.

3.6.4.2.

Skin Test Always perform the skin test on the intended treatment area before the first treatment session according to the following parameters and assessment waiting period:

Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Acne 420-950nm (Blue)

30, 40

6–8

30 min.

IV – VI


50

5

60 min.

3-6



3.6.5.

Treatment Treatment can begin after the Acne module has been connected to the Harmony system and the treatment parameters selected (fluence and pulse width) according to the table in Section 3.6.4.2.

3.6.6.

1.


2.

Apply a thin layer (usually 1-2mm thick and 3mm thick for darker skin types) of refrigerated (43-50°F/6-10°C) cooling gel to the treatment site. The gel will provide a thermal sink for the absorbed and reflected energy, provide some cooling to the skin itself, and additional comfort to the patient during treatment.

3.

Place the module perpendicular to the skin, pressed lightly to the skin surface ensuring a good seal. It is best not to overlap spots by more than 10%. If overlapping does occur, wait at least one minute between pulses on the same spot.

4.


5.


6.

Perform one pass (Stationary Mode) on the right side of the face and one pass on the left side. Repeat the passes on each side.

7.

Treatments may be administered twice per week over a four week time period (total of 8 treatments).

8.

If adverse reactions are observed from the prior treatment, the next treatment may be skipped or the dose reduced until symptoms resolve.

9.

It is recommended to cool the area immediately after the treatment (see Appendix B in the System Manual – Post-Treatment Care).

Suggested Setup Parameters Table 3-2: Acne Suggested Setup Parameters Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


30, 40

8 – 10

IV – VI


40, 50

7–8


3-7


3.6.7.

Follow-Up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen. • Patients should be scheduled 48-72 hours after treatment for examination of the treatment site and for additional treatment, if necessary. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments. • Treatments may be administered twice per week over a four week time period (total of 8 treatments). All adverse side effects should be reported to the treating physician with a followup report sent to the Director of Clinical Operations at Alma Lasers: 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]

3-8


CHAPTER 4 Acne Pro Module – Acne Clearance Chapter Contents: Section

Title

Page

4.1.

Acne Module Description .................................................................. 4-2

4.2.

Acne Module Specifications .............................................................. 4-2

4.3.

Acne Module Operating Screen......................................................... 4-3

4.4.

Acne Module Regulatory Labels ....................................................... 4-4

4.5.


4.6.

Acne Module Clinical Guide ............................................................. 4-5

4.6.1.

Indications for Use ............................. Error! Bookmark not defined.

4.6.2.

Contraindications................................ Error! Bookmark not defined.

4.6.3.

Module Operation............................... Error! Bookmark not defined.

4.6.4.

Pre-Treatment ..................................... Error! Bookmark not defined.

4.6.5.

Treatment............................................ Error! Bookmark not defined.

4.6.6.

Suggested Setup Parameters ............... Error! Bookmark not defined.

4.6.7.

Follow-Up .......................................... Error! Bookmark not defined.


4-1

Acne Pro Module – Acne Clearance

4.1.

Acne Pro Module Description The Acne Pro module has a high-power targeted phototherapy module for clearance of inflammatory acne. It employs Alma Laser's proprietary AFT pulsed light technology in the blue wavelength range (420-950nm) along with adjustable parameters to permeate the tissue and reach the P.acnes target. A complete discussion of the Acne Pro module clinical applications may be found in Section 4.6. The Acne Pro module has a blue identification section (see Figure 4-1).

Figure 4-1: Acne Pro Module (Blue Color Code)

4.2.

Acne Pro Module Specifications • Light Source:


• Spectrum:

420 – 950nm


6.4 cm2 S-Acne Mode

4-2

2

Acne Mode


0.3 – 1.2 J/cm

5 – 25 J/cm2

• Timers:

2 msec.

30, 40, 50 msec


10 Hz

1 / 3 Hz



4.3.

Acne Pro Module Operating Screen The Acne Pro module main operating screen (see Figure 4-2) is displayed when the Acne Pro module is connected to the system:

Figure 4-2: Acne Pro Module Operating Screen Operating parameters available in this module: 1.

2.

3.

Fluence – the available fluence range is:

•

Acne Mode: from 5 to 25 J/cm2 in increments of 1 J/cm2.

•

SAcne Mode: from 0.3 to 1.2 J/cm2 in increments of 0.1 J/cm2.

Timers:

•

Acne Mode: 30, 40 & 50 msec

•

SAcne Mode: 2 msec

Pulse Repetition Rate:

•

Acne Mode: fixed at 1/2 Hz

•

SAcne Mode: 10 Hz


4-3


4.4.

Acne Pro Module Regulatory Labels Figure 4-3 presents the regulatory identification and caution labels adhered to the Acne Pro module connector:

Figure 4-3: Acne Pro Module Regulatory Labels

4.5.

Ordering Information The following table offers names of accessories specific to the Acne Pro module that may be ordered form Alma Lasers. Table 4-1: Acne Pro Module Accessories Description Acne Pro Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

4-4



4.6.

Acne Pro Module Clinical Guide The HarmonyXL system with the Acne Pro module (blue color code) in SAcne operating mode is indicated for the improvement of mild to moderate inflammatory acne vulgaris. This range targets porphyrins (photo-sensitizers), which are normally produced by the propionibacterium acne (P.acnes) bacteria. P.acnes are a type of bacteria that colonize inside the sebaceous gland and clog it. A photo-chemical reaction induced by porphyrins, triggered by the module's light, induces the photo excitation process and the destruction of the P.acnes bacteria. The module may be operated with 3 different time intervals: 1, 3 and 30 seconds. In the 1- and 3-second interval the module is used in a Stationary technique. In the 30-second interval the module is used in the In-Motion technique (see Section B.1.2). The 1- and 3-second intervals may be used on small (localized) areas, while the 30-second interval (recommended) is used for full face treatment. The Acne Pro module has no thermo-electric coupling (TEC) technology; therefore, contact cooling is not an option. The spot size is 6.4cm2 and the pulse repetition rate is fixed at 10 Hz. The total energy invested at any given time is expressed in kiloJoules (kJ). Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

4.6.1.

Pre-Treatment

4.6.1.1.

Module Operation The module can be applied to the skin using two different operating techniques: Stationary and In-Motion (recommended technique). In the Stationary technique, the practitioner places the module on the skin for the entire exposure time and fluence conditions, and the module should be positioned in complete contact with the skin and slightly pressed towards the skin. In the In-Motion technique, the module is moved continuously on the skin for the entire exposure time and fluence conditions, and moved along the skin in continuous linear or circular movements within the treatment area. A thin layer of pre-cooled ultrasonic gel should be used during the skin test and the actual treatment on all skin types.


4-5


4.6.1.2.

Patient Evaluation Before the treatment, the patient should be evaluated/documented for his/her acne condition, location and type. In addition, acne history that includes medications or other past acne related regimens should be documented.

4.6.1.3.

Indications The Advanced Fluorescence Technology (AFT) 420-950nm Acne Pro module is indicated for:

• The treatment of moderate inflammatory acne vulgaris. • Use on all skin types (Fitzpatrick I-VI). 4.6.1.4.

Contraindications • Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc., at the treatment site • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.) • History of keloid scarring • Epilepsy • St. John’s Wort (herbal remedy) for depression in the past three months (because of increased photosensitivity) • Isotretinoin – Roaccutane or Tretinoin – Retin A for the treatment of acne in the previous 3-6 months • Pregnancy (including IVF) • Diabetes The treatment parameters for acne reduction depend on the patient’s skin type and the acne lesion type. Therefore, the first steps are assessing the skin type and performing the skin test.

4-6



4.6.1.5.

Skin Test Always perform the skin test on the intended treatment area during the first treatment session according to the following parameters. The In-Motion technique must be used*. Pre-cooled ultrasonic gel must be applied on the skin. Initially treat the right side followed by the left side of the face/body. Repeat.

4.6.2.


Fluence (J/cm2)

Total Energy (kJ) **

I

1

9.6

II

1

9.6

III

1

9.6

IV

0.8

9.6

V

0.8

9.6

VI

0.8

9.6

(*)

The 1- and 3-second interval is indicated for the Stationary technique.

(**)

The total energy is adjusted for 10x10 cm (100cm2) area.

Treatment Treatment can begin after the Acne Pro module has been connected to the HarmonyLite system and the fluence selected according to the table in Section B.1.1.5. 1.


2.

Provide appropriate eye protection (OD>5) goggles for the patient and the medical staff in the enclosed treatment room.

3.

Apply a thin layer (usually 1-2mm thick for all skin types) of refrigerated ultrasonic gel (43-50°F/6-10°C) to the treatment site. The gel will provide: 1) a thermal sink for the absorbed and reflected energy, thus providing some cooling to the skin itself; 2) comfort to the patient during treatment and; 3) friction reduction/lubrication during the In-Motion technique.

4.


5.

Apply the In-Motion technique. "In-Motion” Technique: • Move the module on the surface of the skin and, only when the module is in full contact and “in-motion”, trigger the footswitch. • Move the module in a paintbrush/circular pattern to cover the entire grid area. This repeated pattern (multi-cycles) may last several minutes, depending on the recommended total energy (kJ) you wish to deliver in the grid area.


4-7


• After completing a single cycle, raise the module from the skin, re-position at the point where you began treatment in this grid and repeat another pass on the entire area, going in a paintbrush/circular pattern. • After delivering the recommended amount of total energy (kJ), move to the contra-lateral side and repeat as above. 6.

In most cases, the operation time interval should be set to 30 seconds for large areas; the 1- and 3-second operation intervals should be selected for small areas on the face, chest or back (using the Stationary technique rather than the In-Motion technique).

7.

Place the module perpendicular to the skin, pressed lightly to the skin surface.

8.

Perform the recommended cycles on the right and left side of the face. Repeat the cycles on each side.

9.

Clinical end points: mild erythema for skin types I-IV; late response erythema for skin types V-VI.

10. If adverse reactions are observed from the prior treatment, the next treatment may be skipped or the fluence reduced until symptoms resolve. 11. It is recommended to cool the area immediately after the treatment (see Appendix F – Post-Treatment Care).

4.6.3.

Suggested Setup Parameters

(*)

4-8


Fluence (J/cm2)

Total Energy (kJ) *

I

1 – 1.2

9.6 – 11.5

II

1 – 1.2

9.6 – 11.5

III

1 – 1.2

9.6 – 11.5

IV

1 – 1.2

9.6 – 11.5

V

0.8 – 1.0

9.6 – 11.5

VI

0.8 – 1.0

9.6 – 11.5

The number of cycles and the total energy is adjusted for 10x10 cm (100cm2) area.



4.6.4.

Follow-Up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen. • Patients should be scheduled 48-72 hours after treatment for examination of the treatment site and for additional treatment, if necessary. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments. • Treatments may be administered twice per week for a period of 4-5 weeks (total of 8-10 treatments). All adverse side effects should be reported to the treating physician with a followup report sent to the Director of Clinical Operations at Alma Lasers: 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]


4-9


4.7.

Acne Operating Mode The HarmonyXL system with the Acne Pro module (blue color code) in Acne operating mode emits visible light in the wavelength range of 420-950nm. This range targets porphyrins (photo-sensitizers), which are normally produced by the propionibacterium acne (P.acnes). P.acnes are a type of bacteria that colonize inside the sebaceous gland and clog it. A photo-chemical reaction induced by porphyrins, triggered by the 420-950nm wavelength of light, induces the photo excitation process and the destruction of the bacteria. Caution The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

4.7.1.

Pre-Treatment

4.7.1.1.

Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth and density.

4.7.1.2.

Indications The Advanced Fluorescence Technology (AFT) 420-950nm Acne Pro module is indicated for:

• The treatment of moderate inflammatory acne vulgaris. • Use on all skin types (Fitzpatrick I-VI). 4.7.1.3.

Contraindications • Tanned skin (active tan) through sun exposure or tanning bed use in the previous 30 days.

• Hypopigmentation (Vitiligo). • Any inflammatory skin condition e.g. eczema, active herpes simplex, etc. at the treatment site.

• Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.).

• History of keloid scarring. • Epilepsy • St. John’s Wort (herbal remedy) for depression in the past 3 months (because of increased photosensitivity).

4-10



• Isotretinoin – Roaccutane or Tretinoin – Retin A for the treatment of acne or other dermatological conditions in the previous 3-6 months.

• Pregnancy; until menstruation returns and end of breast feeding. • Diabetes (because of increased possible photosensitivity and poor wound healing).

The treatment parameters for the acne reduction depend on the patient’s skin type and the acne lesion type. Therefore, the first steps are assessing the skin type and performing the skin test.

4.7.1.4.

Skin Test Always perform the skin test on the intended treatment area during the first treatment session according to the following parameters and assessment waiting period:


Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Acne Pro 420-950nm (Blue)

30, 40

6–8

30 min.

IV – VI


50

5

60 min.

4.7.2.

Treatment Treatment can begin after the AFT Acne Pro module has been connected to the HarmonyLite system and the treatment parameters selected (fluence and pulse width) according to the table in Section B.2.3. 1.


2.

Apply a thin layer (usually 1-2mm thick and 3mm thick for darker skin types) of refrigerated (43-50°F/6-10°C) cooling gel to the treatment site. The gel will provide a thermal sink for the absorbed and reflected energy, provide some cooling to the skin itself, and additional comfort to the patient during treatment.

3.

Place the module perpendicular to the skin, pressed lightly to the skin surface ensuring a good seal. It is best not to overlap spots by more than 10%. If overlapping does occur, wait at least one minute between pulses on the same spot.

4.


5.


6.

Perform one pass on the right side of the face and one pass on the left side. Repeat the passes on each side.

7.

Treatments may be administered twice per week over a four week time period (total of 8 treatments).


4-11


4.7.3.

4.7.4.

8.

If adverse reactions are observed from the prior treatment, the next treatment may be skipped or the dose reduced until symptoms resolve.

9.

It is recommended to cool the area immediately after the treatment.

Suggested Setup Parameters Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


30, 40

8 – 10

IV – VI


40, 50

7–8

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

• Patients should be invited 48-72 hours after treatment for examination of the treatment site and for additional treatment, if necessary.

• Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments.


4-12


CHAPTER 5 SVL Module – Superficial Vascular Lesions Chapter Contents: Section

Title

Page

5.1.

SVL Module Description ................................................................... 5-2

5.2.

SVL Module Specifications ............................................................... 5-2

5.3.

SVL Module Operating Screen ......................................................... 5-3

5.4.

SVL Module Regulatory Labels ........................................................ 5-4

5.5.


5.6.

SVL Module Clinical Guide .............................................................. 5-5

5.6.1.


5.6.2.


5.6.3.

Pre-Treatment ................................................................................... 5-6

5.6.4.

Treatment.......................................................................................... 5-7

5.6.5.


5.6.6.

Follow-up ......................................................................................... 5-8


5-1

SVL Module – Superficial Vascular Lesions

5.1.

SVL Module Description The SVL module has a high-power targeted phototherapy module for non-invasive treatment of small and shallow vascular lesions. The SVL module allows treatment of a broad spectrum of vascular imperfections be selectively targeting oxyhemoglobin, deoxyhemoglobin and melanin. A complete discussion of the SVL module clinical applications may be found in Section 5.6. The SVL module has a turquoise identification section (see Figure 5-1).

Figure 5-1: SVL Module (Turquoise Color Code)

5.2.

5-2

SVL Module Specifications • Light Source:


• Spectrum:

515 – 950nm


5 – 25 J/cm2


6.4 cm2

• Available Pulse Widths:

10, 12, 15 msec


2/3 Hz

• Cooling:

None



5.3.

SVL Module Operating Screen The SVL module main operating screen (see Figure 5-2) is displayed when the SVL module is connected to the system.

Figure 5-2: SVL Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.


• 10 msec • 12 msec • 15 msec 3.



5-3


5.4.

SVL Module Regulatory Labels Figure 5-3 presents the regulatory identification and caution labels adhered to the SVL module connector:

Figure 5-3: SVL Module Regulatory Labels

5.5.

Ordering Information The following table offers names of accessories specific to the SVL module that may be ordered form Alma Lasers. Table 5-1: SVL Module Accessories Description SVL (Superficial Vascular Lesions) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

5-4



5.6.

SVL Module Clinical Guide The treatment of superficial (small and shallow) vascular lesions with the Harmony system can be performed using the SVL module (turquoise color code). Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

5.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 515-950nm SVL515 module is indicated for:

• The treatment of benign cutaneous vascular lesions including port wine stains,

hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

• Use on Fitzpatrick skin types I-III.

5.6.2.

Contraindications • Tanned skin (active tan) through sun exposure or tanning bed use in the previous 30 days

• Patients with Fitzpatrick skin type VI • Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g. eczema, active herpes simplex, etc. at the treatment site

• Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.)

• History of keloid scarring • Epilepsy • St. John’s Wort (herbal remedy) for depression in the past 3 months (because of increased photosensitivity)

• Isotretinoin – Roaccutane in the previous 3-6 months • Tretinoin – Retin A in the last 2 weeks • Pregnancy; until menstruation returns and end of breast feeding • Diabetes (because of increased possible photosensitivity and poor wound healing)


5-5


5.6.3.

Pre-Treatment

5.6.3.1.

Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth (shallow) and size (small). In principle, treat the larger (superficial) vessels first and only after they are closed proceed to treat the smaller (superficial) vessels. This avoids refilling the small vessels by the larger, intact feeders.

5.6.3.2.

Preparing the Lesion for Treatment If the lesion is smaller than the lightguide's footprint, use the template provided by Alma Lasers to protect the tissue surrounding the lesion. To use the template, select a suitable pre-cut hole so that only the lesion area is fully exposed to the margin. Place the template on the treatment site and cover it with a thin layer of gel (underneath and on top of the template) before treatment.

5.6.3.3.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters:

Table 5-2: SVL Skin Test parameters Skin Type (Fitzpatrick I-III)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – II

SVL (Turquoise)

10, 12

14 – 16

30 min

III

SVL (Turquoise)

15

12 – 14

30 min

5-6



5.6.4.

Treatment • The SVL module will treat superficial redness associated with rosacea or postacne rosacea.

• Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses.

• Treatment can begin after the suitable module has been connected to the

Harmony system and the treatment parameters (fluence and pulse width) are selected according to the Skin Test table in Section 5.6.3.3.

1.


2.

Apply a thin layer (usually 1-2mm thick) of refrigerated cooling gel (43-50°F/6-10°C) to the treatment site. The gel will provide a thermal sink for the absorbed and reflected energy, provide some cooling to the skin itself, and additional comfort to the patient during treatment.

Caution Do not treat a vascular lesion through a tattoo or a pigmented lesion that has not been examined by a physician. Any hair covering a vascular lesion must be removed before treatment. 3.

Place the SVL module perpendicular to the skin and touch the gel with the lightguide. Do not apply pressure (the lightguide should gently touch the skin).

4.

It is best not to overlap treatment spots by more than 10%, but if overlapping does occur wait at least one minute between pulses on the same spot.

5.


6.

Trigger a light pulse by pressing the footswitch only when the light guide is fully with contact to the skin.

7.

Wipe off the gel and examine carefully. The desired effect is darkening of the vessel due to blood coagulation and erythema and/or edema along the vessel, indicating a stimulated immune reaction, without changes in the surrounding epidermis.

8.

If, along with a good response in the vessel, adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), reduce the fluence by 10-20%.

9.

If the skin shows no adverse effects and changes observed in the vessel are unsatisfactory you should increase the fluence by 10-20% and test again.

10. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before treatment. After treatment, remove the gel from the treated areas. Do not reuse gel. 11. After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care).


5-7


5.6.5.


Table 5-3: Suggested SVL Setup Parameters Skin Type (Fitzpatrick I-III)

Target Vessel Depth

Module

Fluence (J/cm2)

Pulse Width (msec)

I – II

Shallow; Small

SVL (Turquoise)

16 – 18

10, 12, 15

III

Shallow; Small

SVL (Turquoise)

14 – 16

10, 12, 15

5.6.6.

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

• Within three weeks after the treatment patients should return for

examination of the treatment site and for additional treatment, if necessary.

• If no additional treatment is necessary, patients should return for an additional examination two months later.

• In case of a partial clearance of the lesion, the treatment should be continued using the same parameters and the patient should return for examination and for additional treatment, if necessary after three weeks.

• If no change in the lesion is noted, fluence should be increased by at least 10%.

• Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments.


5-8


CHAPTER 6 SVL Cooled Module – Superficial Vascular Lesions Chapter Contents: Section

Title

Page

6.1.

SVL Cooled Module Description ...................................................... 6-2

6.2.

SVL Cooled Module Specifications .................................................. 6-2

6.3.

SVL Cooled Module Operating Screen ............................................. 6-3

6.4.

SVL Cooled Module Regulatory Labels ........................................... 6-4

6.5.


6.6.

SVL Cooled Module Clinical Guide ................................................. 6-5

6.6.1.


6.6.2.


6.6.3.

Pre-Treatment ................................................................................... 6-6

6.6.4.

Treatment.......................................................................................... 6-7

6.6.5.


6.6.6.

Follow-up ......................................................................................... 6-8


6-1

SVL Cooled Module – Superficial Vascular Lesions

6.1.

SVL Cooled Module Description The SVL cooled module has a high-power targeted phototherapy module for noninvasive treatment of small and shallow vascular lesions. The SVL cooled module allows treatment of a broad spectrum of vascular imperfections be selectively targeting oxyhemoglobin, deoxyhemoglobin and melanin. A complete discussion of the SVL cooled module clinical applications may be found in Section 6.6. The SVL cooled module has a turquoise identification section (see Figure 6-1). This module incorporates a contact-cooling mechanism.

Figure 6-1: SVL Cooled Module (Turquoise Color Code)

6.2.

6-2

SVL Cooled Module Specifications • Light Source:


• Spectrum:

515 – 950nm


5 – 30 J/cm2


3 cm2

• Available Pulse Widths:

10, 12, 15 msec


2/3 Hz

• Cooling:

TEC



6.3.

SVL Cooled Module Operating Screen The SVL cooled module main operating screen (see Figure 6-2) is displayed when the SVL cooled module is connected to the system. The SVL cooled module's contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the screen:

• COOLING ON (default mode) • COOLING OFF (touch the COOLING ON softkey)

Figure 6-2: SVL Cooled Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.


• 10 msec • 12 msec • 15 msec 3.



6-3


6.4.

SVL Cooled Module Regulatory Labels Figure 6-3 presents the regulatory identification and caution labels adhered to the SVL cooled module connector:

Figure 6-3: SVL Cooled Module Regulatory Labels

6.5.

Ordering Information The following table offers names of accessories specific to the SVL cooled module that may be ordered form Alma Lasers. Table 6-1: SVL Cooled Module Accessories Description SVL (Superficial Vascular Lesions) Cooled Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

6-4



6.6.

SVL Cooled Module Clinical Guide The treatment of superficial (small and shallow) vascular lesions with the HarmonyXL system can be performed using the SVL Cooled (turquoise color code) module (spot size 3 cm2). Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

6.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 515-950nm SVL515 module (with and without contact-cooling) is indicated for:



• Use on Fitzpatrick skin types I-IV.

6.6.2.


• Patients with Fitzpatrick skin type V & VI • Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g. eczema, active herpes simplex, etc. at the treatment site





6-5


6.6.3.

Pre-Treatment

6.6.3.1.

Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth (shallow) and size (small). In principle, treat the larger (superficial) vessels first and only after they are closed proceed to treat the smaller (superficial) vessels. This avoids refilling the small vessels by the larger, intact feeders.

6.6.3.2.

Preparing the Lesion for Treatment If the lesion is smaller than the lightguide's footprint, use the template provided by Alma Lasers to protect the tissue surrounding the lesion. To use the template, select a suitable pre-cut hole so that only the lesion area is fully exposed to the margin. Place the template on the treatment site and cover it with a thin layer of gel (underneath and on top of the template) before treatment.

6.6.3.3.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters with cooling ON:

Table 6-2: Cooled SVL Skin Test Parameters

6-6

Fitzpatrick Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Cooled SVL-950nm (turquoise color code)

10, 12

12 – 20

30 min

IV


15

7 – 12

45 – 60 min



6.6.4.

Treatment • The SVL cooled module will treat superficial vascular redness associated with rosacea or post-acne rosacea.

• Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses.

• Treatment can begin after the suitable module has been connected to the

Harmony system and the treatment parameters (fluence and timer interval) are selected according to the Skin Test table in Table 6-2.

1.


2.

Apply a thin layer (usually 1-2mm thick) of refrigerated cooling gel (43-50°F/ 6-10°C) to the treatment site. The gel will provide a thermal sink for the absorbed and reflected energy, provide some cooling to the skin itself, and additional comfort to the patient during treatment.


Place the SVL cooled module perpendicular to the skin and touch the gel with the lightguide. Do not apply pressure (the lightguide should gently touch the skin).

4.


5.


6.

Trigger a light pulse by pressing the footswitch only when the light guide is fully with contact to the skin.

7.

Wipe off the gel and examine carefully. The desired effect is darkening of the vessel due to blood coagulation and erythema and/or edema along the vessel, indicating a stimulated immune reaction, without changes in the surrounding epidermis.

8.


9.




6-7


6.6.5.


Table 6-3: Suggested Cooled SVL Setup Parameters Fitzpatrick Skin Type

Target Vessel Depth

Module

Fluence (J/cm2)

Pulse Width (msec)

I – III

Shallow; Small


12 – 25

10, 12

IV

Shallow; Small


7 – 14

15

6.6.6.









6-8


CHAPTER 7 VP Module – Vascular & Pigmented Lesions Chapter Contents: Section

Title

Page

7.1.

VP Module Description ..................................................................... 7-2

7.2.

VP Module Specifications ................................................................. 7-2

7.3.

VP Module Operating Screen ............................................................ 7-3

7.4.

VP Module Regulatory Labels .......................................................... 7-4

7.5.


7.6.

VP Module Clinical Guide for Vascular Lesions .............................. 7-5

7.6.1.


7.6.2.


7.6.3.

Pre-Treatment ................................................................................... 7-6

7.6.4.

Treatment.......................................................................................... 7-7

7.6.5.

Suggested VP Setup Parameters for Vascular Lesions..................... 7-8

7.6.6.

Follow-up ......................................................................................... 7-9

7.7.

VP Module Clinical Guide for Pigmented Lesions ......................... 7-10

7.7.1.

Indications for Use ......................................................................... 7-10

7.7.2.

Contraindications............................................................................ 7-10

7.7.3.

Pre-Treatment ................................................................................. 7-10

7.7.4.

Treatment........................................................................................ 7-11

7.7.5.

Suggested VP Setup Parameters for Pigmented Lesions................ 7-12

7.7.6.

Follow-up ....................................................................................... 7-13


7-1

VP Module – Vascular & Pigmented Lesions

7.1.

VP Module Description The VP module has a high-power targeted phototherapy module for non-invasive treatment of vascular and pigmented lesions. The VP module allows treatment of a broad spectrum of vascular imperfections be selectively targeting oxyhemoglobin, deoxyhemoglobin and melanin. A complete discussion of the VP module clinical applications may be found in Section 7.6. The VP module has a green identification section (see Figure 7-1).

Figure 7-1: VP Module (Green Color Code)

7.2.

7-2

VP Module Specifications • Light Source:


• Spectrum:

540 – 950nm


5 – 25 J/cm2


6.4 cm2

• Pulse Widths:

10, 12, 15 msec


2/3 Hz

• Cooling:

None



7.3.

VP Module Operating Screen The VP module main operating screen (see Figure 7-2) is displayed when the VP module is connected to the system.

Figure 7-2: VP Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.


• 10 msec • 12 msec • 15 msec 3.



7-3


7.4.

VP Module Regulatory Labels Figure 7-3 presents the regulatory identification and caution labels adhered to the VP module connector:

Figure 7-3: VP Module Regulatory Labels

7.5.

Ordering Information The following table offers names of accessories specific to the VP module that may be ordered form Alma Lasers. Table 7-1: VP Module Accessories Description VP (Vascular/Pigmented Lesions) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

7-4



7.6.

VP Module Clinical Guide for Vascular Lesions The treatment of Vascular Lesions with the HarmonyXL system can be performed using (one – or a combination of) three modules of the following types: VP 540-950nm (green color code), SR 570-950nm (yellow color code) and the 1064nm Long Pulse Nd:YAG laser module. • The SR modules are discussed in detail in Chapters 6 & 12 of this manual. • The 1064nm laser modules are discussed in detail in Chapters 19 & 20 of this manual The VP module is indicated for vascular lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

7.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 540-950 nm VP module is indicated for:

• The treatment of benign pigmented epidermal lesions including dyschromia,

hyperpigmentation, melasma and ephelides (freckles), lentigines, nevi, melasma, and café-au-lait macules.



• Use on all skin types (Fitzpatrick I-IV).

7.6.2.


• Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g. eczema, active herpes simplex, etc. at the treatment site


• History of keloid scarring • Epilepsy


7-5


• St. John’s Wort (herbal remedy) for depression in the past 3 months (because of increased photosensitivity)


7.6.3.

Pre-Treatment

7.6.3.1.

Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth and density. In principle, treat the larger vessels first and only after they are closed proceed to treat the smaller vessels. This avoids refilling the small vessels by the larger, intact feeders.

7.6.3.2.

Preparing the Lesion for Treatment If the lesion is smaller than the lightguide's footprint, use the template provided by Alma Lasers to protect collateral tissue surrounding the lesion. To use the template, select a suitable pre-cut hole so that only the lesion area is fully exposed to the margin. Place the template on the treatment site and cover it with a thin layer of gel (underneath and on top of the template) before treatment.

7-6



7.6.3.3.


Table 7-2: Vascular Lesions Skin Test Parameters* Skin Type (Fitzpatrick I-IV)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

VP 540-950nm (green color code)

10, 12

16 – 20

30 min

IV


15

10 – 14

24 – 48 hours

(*) The pulses must not be emitted sequentially!

7.6.4.

Treatment • The VP 540nm module will treat vessels up to < 1mm. • Treatment is applied perpendicular to the target and a second pass is usually

recommended once appropriate safe settings are found. Do not stack pulses. It is recommended to keep the contact cooling on during treatment with the VP module (see Figure 7-2).

• Treatment can begin after the module has been connected to the HarmonyXL

system and the treatment parameters (fluence and timer interval) are selected according to the Skin Test parameters in Table 7-2.

1.


2.

Apply a thin layer (usually 1mm thick and 2mm for darker skin types) of refrigerated (43-50°F/6-10°C) cooling gel to the treatment site. This aids skin cooling during the pulse sequence and improves coupling of the light into the skin and additional comfort to the patient during treatment.


Place the module's lightguide perpendicular to the skin and touch the gel with the lightguide. Do not apply pressure (the lightguide should gently touch the skin).

4.


5.


6.


7.

Wipe off the gel and examine carefully. Remember: darker skin types take longer to respond than lighter skin types. The desired effect is darkening of the


7-7


vessel due to blood coagulation and erythema and/or edema along the vessel, indicating a stimulated immune reaction, without changes in the surrounding epidermis. 8.


9.



7.6.5.

Suggested VP Setup Parameters for Vascular Lesions

Table 7-3: Suggested VP Setup Parameters for Vascular Lesions* Skin Type (Fitzpatrick I- IV)

Max. Number of Repetitions

Module

Fluence (J/cm2)

Pulse Width (msec)

I – III

2


19 – 22

10, 12

IV

2


12 – 19

15


7-8



7.6.6.










7-9


7.7.

VP Module Clinical Guide for Pigmented Lesions The Pigmented Lesions application of the HarmonyXL system can be performed with the VP 540-950nm (green color code) and the SR 570-950nm (yellow color code) modules. The SR modules are discussed in detail in Chapters 6 & 12 of this manual. The VP module is indicated for pigmented lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

7.7.1.

Indications for Use Refer to Section 7.6.1.

7.7.2.

Contraindications Refer to Section 7.6.2.

7.7.3.

Pre-Treatment

7.7.3.1.


7.7.3.2.

Preparing the Lesion for Treatment If the lesion is smaller than the lightguide's footprint, use the template provided by Alma Lasers to protect collateral tissue surrounding the lesion. To use the template, select a suitable pre-cut hole so that only the lesion area is fully exposed. Place the template on the treatment site and cover it with a thin layer of gel (underneath and on top of the template) before treatment.

7-10



7.7.3.3.


Table 7-4: Pigmented Lesions Skin Test Parameters Skin Type (Fitzpatrick I- IV)

Module

I – III

IV

7.7.4.

Lesion Color

Pulse Width (msec)

Fluence (J/cm2)


Light

10, 12

18 – 20

Dark

12, 15

16 – 18


Light

15

10 – 14

Dark

15

6–8

Waiting Period

30 min.

30 min.

Treatment Treatment may begin after the module has been connected to the HarmonyXL system and the treatment parameters (fluence and timer interval) are selected according to the Skin Test parameters in Table 7-4. 1.


2.

Apply a thin layer (usually 1mm thick and 2mm for darker skin types) of refrigerated (43-50°F/6-10°C) cooling gel to the treatment site. This aids skin cooling during the pulse sequence and improves coupling of the light into the skin.

3.


4.

It is best not to overlap treatment sites by more than 10%, but if overlapping does occur wait at least one minute between pulses over the same spot.

5.


6.


7.

Wipe off the gel and diagnose carefully. Remember: darker skin types take longer to respond than lighter skin types. The desired “positive” effect is to observe a change in lesion color (graying or darkening for brown pigment) or morphological changes (superficial texture change to the lesion), without changes in the surrounding epidermis.

8.

If, along with a positive response in the lesions, adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), you should reduce the fluence by 10-20%.

9.

If the skin shows no adverse effects and changes observed in the lesions are unsatisfactory, you should increase the fluence by 10-20%.


7-11


10. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before each pass/treatment. After treatment, remove the gel from treated areas. Do not reuse gel. 11. After treatment, it is recommended to cool the area immediately (see Appendix C in the System Manual – Post-Treatment Care).

7.7.5.

Suggested VP Setup Parameters for Pigmented Lesions

Table 7-5: Suggested VP Setup Parameters for Pigmented Lesions Skin Type (Fitzpatrick I- IV)

Lesion Color

Module

Pulse Width (msec)

Fluence (J/cm2)

Light


10, 12

18 – 22

Dark


12, 15

16 – 20

Light


15

10 – 16

Dark


15

8– 10

I – III

IV

7-12



7.7.6.










7-13

CHAPTER 8 VP Cooled Module – Vascular & Pigmented Lesions Chapter Contents: Section

Title

Page

8.1.

VP Cooled Module Description......................................................... 8-2

8.2.

VP Cooled Module Specifications..................................................... 8-2

8.3.

VP Cooled Module Operating Screen ............................................... 8-3

8.4.

VP Cooled Module Regulatory Labels .............................................. 8-4

8.5.


8.6.

VP Cooled Module Clinical Guide for Vascular Lesions.................. 8-5

8.6.1.


8.6.2.


8.6.3.

Pre-Treatment ................................................................................... 8-6

8.6.4.

Treatment.......................................................................................... 8-7

8.6.5.

Suggested Cooled VP Setup Parameters for Vascular Lesions ........ 8-8

8.6.6.

Follow-up ......................................................................................... 8-9

8.7.

VP Cooled Module Clinical Guide for Pigmented Lesions ............. 8-10

8.7.1.


8.7.2.


8.7.3.

Pre-Treatment ................................................................................. 8-10

8.7.4.

Treatment........................................................................................ 8-11

8.7.5.

Suggested Cooled VP Setup Parameters for Pigmented Lesions ... 8-12

8.7.6.

Follow-up ....................................................................................... 8-13


8-1

VP Cooled Module – Vascular & Pigmented Lesions

8.1. VP Cooled Module Description The VP cooled module has a high-power targeted phototherapy module for noninvasive treatment of vascular and pigmented lesions. The VP cooled module allows treatment of a broad spectrum of vascular imperfections be selectively targeting oxyhemoglobin, deoxyhemoglobin and melanin. A complete discussion of the VP cooled module clinical applications may be found in Section 8.6. The VP cooled module has a green identification section (see Figure 8-1). This module incorporates a contact-cooling mechanism.

Figure 8-1: VP Cooled Module (Green Color Code)

8.2. VP Cooled Module Specifications

8-2

• Light Source:


• Spectrum:

540 – 950nm


5 – 30 J/cm2


3 cm2

• Pulse Widths:

10, 12, 15 msec


2/3 Hz

• Cooling:

TEC



8.3. VP Cooled Module Operating Screen The VP cooled module main operating screen (see Figure 8-2) is displayed when the VP cooled module is connected to the system. The VP cooled module's contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the screen:


Figure 8-2: VP Cooled Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.


• 10 msec • 12 msec • 15 msec 3.



8-3


8.4. VP Cooled Module Regulatory Labels Figure 8-3 presents the regulatory identification and caution labels adhered to the VP cooled module connector:

Figure 8-3: VP Cooled Module Regulatory Labels

8.5. Ordering Information The following table offers names of accessories specific to the VP cooled module that may be ordered form Alma Lasers. Table 8-1: VP Cooled Module Accessories Description VP (Vascular/Pigmented Lesions) Cooled Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

8-4



8.6. VP Cooled Module Clinical Guide for Vascular Lesions The treatment of Vascular Lesions with the HarmonyXL system can be performed using (one – or a combination of) three modules of the following types: VP 540-950nm (green color code), SR 570-950nm (yellow color code) and the 1064nm Long Pulse Nd:YAG laser module. • The SR modules are discussed in detail in Chapters 6 & 12 of this manual. • The 1064nm laser modules are discussed in detail in Chapters 19 & 20 of this manual. The VP cooled module (with integrated contact cooling) is indicated for vascular lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

8.6.1. Indications for Use The Advanced Fluorescence Technology (AFT) 540-950 nm VP module is indicated for:





• Use on all skin types (Fitzpatrick I-V).

8.6.2. Contraindications • Tanned skin (active tan) through sun exposure or tanning bed use in the previous 30 days



• History of keloid scarring • Epilepsy Harmony®XL Modules Operator's Manual

8-5




8.6.3. Pre-Treatment 8.6.3.1.


8.6.3.2.


8-6



8.6.3.3.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session with the cooling mode On and according to the following parameters:

Table 8-2: Vascular Lesions Skin Test Parameters Fitzpatrick Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Cooled VP 540-950nm (green color code)

10, 12

14 – 23

30 min

IV


12, 15

12 – 17

24 – 48 hours

V


15

8 – 12

24 – 48 hours*

(*) It is imperative to wait 48 hours

8.6.4. Treatment • The VP 540nm cooled module will treat vessels up to < 1mm. • Treatment is applied perpendicular to the target and a second pass is usually

recommended once appropriate safe settings are found. Do not stack pulses. It is recommended to keep the contact cooling on during treatment with the VP cooled module (see Figure 8-2).



1.


2.

Operate the module with Cooling mode ON.

3.


4.

Other cooling means, such as small ice packs or forced cold air/Zimmer are also recommended (i.e., post-treatment).




8-7


6.


7.


8.


9.

Wipe off the gel and examine carefully. Remember: darker skin types take longer to respond than lighter skin types. The desired effect is darkening of the vessel due to blood coagulation and erythema and/or edema along the vessel, indicating a stimulated immune reaction, without changes in the surrounding epidermis.

10. If, along with a good response in the vessel, adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), reduce the fluence by 10-20%. 11. If the skin shows no adverse effects and changes observed in the vessel are unsatisfactory you should increase the fluence by 10-20% and test again. 12. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before treatment. After treatment, remove the gel from the treated areas. Do not reuse gel. 13. After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care).

8.6.5. Suggested Cooled VP Setup Parameters for Vascular Lesions Table 8-3: Suggested Cooled VP Setup Parameters for Vascular Lesions* Fitzpatrick Skin Type

Target Vessel Depth

Module

Fluence (J/cm2)

Pulse Width (msec)

I – III

2


14 – 23

10, 12

IV

2


12 – 17

12, 15

V

2


8 – 12

15

(*) Cooling mode ON

8-8



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









8-9


8.7. VP Cooled Module Clinical Guide for Pigmented Lesions The Pigmented Lesions application of the HarmonyXL system can be performed with the VP 540-950nm (green color code) and the SR 570-950nm (yellow color code) modules. The SR modules are discussed in detail in Chapters 6 & 12 of this manual. The VP cooled module (with integrated contact cooling) is indicated for pigmented lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

8.7.1. Indications for Use Refer to Section 8.6.1.

8.7.2. Contraindications Refer to Section 8.6.2.

8.7.3. Pre-Treatment 8.7.3.1.


8.7.3.2.


8-10



8.7.3.3.


Table 8-4: Pigmented Lesions Skin Test Parameters Fitzpatrick Skin Type

Module

Lesion Color

Pulse Width (msec)

Fluence (J/cm2)

I – III


Light

10, 12

14 – 23

Dark

15

14 – 20


Light

12, 15

12 – 17

IV

Dark

15

10 – 14

V


Dark

15

8 – 12

Waiting Period 30 min.

24 – 48 hours 24 – 48 hours*


8.7.4. Treatment Treatment may begin after the module has been connected to the HarmonyXL system and the treatment parameters (fluence and timer interval) are selected according to the Skin Test parameters in Table 8-4. 1.


2.

Operate the module with Cooling mode ON.

3.


4.


5.


6.


7.


8.


9.



8-11


10. If, along with a positive response in the lesions, adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), you should reduce the fluence by 10-20%. 11. If the skin shows no adverse effects and changes observed in the lesions are unsatisfactory, you should increase the fluence by 10-20%. 12. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before each pass/treatment. After treatment, remove the gel from treated areas. Do not reuse gel. 13. After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care).

8.7.5. Suggested Cooled VP Setup Parameters for Pigmented Lesions Table 8-5: Suggested Cooled VP Setup Parameters for Pigmented Lesions* Skin Type (Fitzpatrick I-VI)

Lesion Color

Module

Pulse Width (msec)

Fluence (J/cm2)

Light


10, 12

14 – 23

Dark


15

14 – 20

Light


12, 15

12 – 17

Dark


15

10 – 17

Dark


15

8 – 12

I – III

VI

V

(*) Cooling mode ON

8-12












8-13

CHAPTER 9 Dye-VL Module – Vascular & Pigmented Lesions Chapter Contents: Section

Title

Page

9.1.

Dye-VL Module ................................................................................ 9-3

9.2.

Dye-VL Module Specifications ......................................................... 9-3

9.3.

Dye-VL Module Operating Screen .................................................... 9-4

9.4.

Dye-VL Module Regulatory Labels .................................................. 9-5

9.5.


9.6.

Dye-VL Module Clinical Guide for Vascular Lesions ...................... 9-6

9.6.1.


9.6.2.


9.6.3.

Pre-Treatment ................................................................................... 9-7

9.6.4.

Treatment.......................................................................................... 9-7

9.6.5.

Suggested Dye-VL Setup Parameters for Vascular Lesions ............ 9-8

9.6.6.

Follow-up ......................................................................................... 9-8

9.7.

Dye-VL Module Clinical Guide for Pigmented Lesions ................. 9-10

9.7.1.


9.7.2.


9.7.3.

Pre-Treatment ................................................................................. 9-10

9.7.4.

Treatment........................................................................................ 9-11

9.7.5.

Suggested Dye-VL Setup Parameters for Pigmented Lesions ....... 9-12

9.7.6.

Follow-up ....................................................................................... 9-12

9.8. 9.8.1.

Dye-SVL Mode Clinical Guide ....................................................... 9-13 Indications for Use ......................................................................... 9-13


9-1

Dye-VL Module – Vascular & Pigmented Lesions

9-2

9.8.2.

Contraindications ............................................................................ 9-13

9.8.3.

Module Operation ........................................................................... 9-14

9.8.4.

Pre-Treatment ................................................................................. 9-14

9.8.5.

Treatment (In-Motion Technique) .................................................. 9-15

9.8.6.

Suggested Setup Parameters ........................................................... 9-16

9.8.7.

Stationary Protocol ......................................................................... 9-16

9.8.8.

Treatment of Small Areas ............................................................... 9-17

9.8.9.

Follow-up........................................................................................ 9-17



9.1.

Dye-VL Module The Dye-VL module has a high-power targeted phototherapy module for noninvasive treatment of vascular and pigmented lesions. The Dye-VL module allows treatment of a broad spectrum of vascular imperfections be selectively targeting oxyhemoglobin, deoxyhemoglobin and melanin. The Dye-VL module may be operated in two separate modes: Dye-VL and DyeSVL. A complete discussion of the Dye-VL module clinical applications may be found later in this chapter. The Dye-VL module has a light green identification section (see Figure 9-1).

Figure 9-1: Dye-VL Module (Light Green)

9.2.

Dye-VL Module Specifications • Light Source:


• Spectrum:

500 – 600nm


1 cm2


9-3


9.3.

Dye-VL Module Operating Screen The Dye-VL module main operating screens (see Figure 9-2) are displayed when the Dye-VL module is connected to the system.

• To switch from Dye-VL to Dye-SVL mode, press the Dye-VL softkey on the screen.

• To switch from Dye-SVL to Dye-VL mode, press the Dye-SVL softkey on the screen.

Figure 9-2: Dye-VL Module Operating Screens Operating parameters available in this module: Dye-VL Mode

9-4

2

Dye-SVL Mode


1 – 15 J/cm

1 – 4 J/cm2

• Pulse Duration:

10, 12, 15 msec.

6 sec.


1 / 2 Hz

3 Hz



9.4.

Dye-VL Module Regulatory Labels Figure 9-3 presents the regulatory identification and caution labels adhered to the Dye-VL module connector:

Figure 9-3: Dye-VL Module Regulatory Labels

9.5.

Ordering Information The following table offers names of accessories specific to the Dye-VL module that may be ordered form Alma Lasers. Table 9-1: Dye-VL Module Accessories Description Dye-VL (Vascular/Pigmented Lesions) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)


9-5


9.6.

Dye-VL Module Clinical Guide for Vascular Lesions The treatment of vascular lesions with the HarmonyXL system can be performed using the Dye-VL 500-600nm (light green color code) module. The Dye-VL module is indicated for vascular lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

9.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 500-600 nm Dye-VL module is indicated for:






9.6.2.





• Isotretinoin – Roaccutane in the previous 3-6 months • Tretinoin – Retin A in the last 2 weeks • Pregnancy; until menstruation returns and end of breast feeding

9-6




9.6.3.

Pre-Treatment

9.6.3.1.


9.6.3.2.



Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Dye-VL 500-600nm (light green color code)

10, 12

10 – 12

30 min

IV


12, 15

6–9

24 – 48 hours


9.6.4.

Treatment • The Dye-VL module will treat vessels up to < 1mm. • Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses.



1.


2.


3.

Cooling means, such as small ice packs or forced cold air/Zimmer are recommended (i.e., post-treatment).


9-7




5.


6.


7.


8.


9.


10. If the skin shows no adverse effects and changes observed in the vessel are unsatisfactory you should increase the fluence by 10-20% and test again. 11. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before treatment. After treatment, remove the gel from the treated areas. Do not reuse gel. 12. After treatment, it is recommended to cool the area immediately.

9.6.5.

Suggested Dye-VL Setup Parameters for Vascular Lesions

Table 9-3: Suggested Dye-VL Setup Parameters for Vascular Lesions

9.6.6.


Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


10, 12

10 – 13

IV


12, 15

6 – 10


9-8










9-9


9.7.

Dye-VL Module Clinical Guide for Pigmented Lesions The Pigmented Lesions application of the HarmonyXL system can be performed with the Dye-VL 500-600nm (light green color code) module. The Dye-VL module is indicated for pigmented lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

9.7.1.

Indications for Use Refer to Section 9.6.1.

9.7.2.


9.7.3. 9.7.3.1.

Pre-Treatment Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth and density.

9.7.3.2.


9-10



9.7.3.3.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session and according to the following parameters:


Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III


10, 12

10 – 12

30 min

IV


12, 15

6–9

24 – 48 hours


9.7.4.

Treatment Treatment may begin after the module has been connected to the HarmonyXL system and the treatment parameters (fluence and timer interval) are selected according to the Skin Test parameters in Table 9-4. 1.


2.


3.


4.


5.


6.


7.


8.


9.


10. If the skin shows no adverse effects and changes observed in the lesions are unsatisfactory, you should increase the fluence by 10-20%.


9-11


11. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before each pass/treatment. After treatment, remove the gel from treated areas. Do not reuse gel. 12. After treatment, it is recommended to cool the area immediately.

9.7.5.

Suggested Dye-VL Setup Parameters for Pigmented Lesions

Table 9-5: Suggested Dye-VL Setup Parameters for Pigmented Lesions

9.7.6.


Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


10, 12

10 – 13

IV


12, 15

6 – 10






• If no change in the lesion is noted, fluence should be increased by at least 10%. • Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments.

9-12



9.8.

Dye-SVL Mode Clinical Guide The Skin Rejuvenation application of the HarmonyXL system is performed using the Dye-VL (light green color code) module in Dye-SVL mode. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

9.8.1.

Indications for Use The Dye-VL module in Dye-SVL mode is indicated for:




9.8.2.

Contraindications • Hypopigmentation (Vitiligo). • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc., at the treatment site. • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.). • History of keloid scarring. • Epilepsy. • St. John's Wort (herbal remedy) for depression in the past three months (because of increased photosensitivity). • Isotretinoin – Roaccutane or Tretinoin – In the past 3-6 months. • Retin A - In the past 2 weeks. • Pregnancy (including IVF). • Diabetes.


9-13


9.8.3.

Module Operation The Dye-VL module in Dye-SVL mode may be operated with 3 different time intervals: 1, 3 and 30 seconds. In the 1-second and 3-second intervals, the module is used employing the Stationary technique. In the 30-second interval, the module is used employing the In-Motion technique (see Section 9.8.5). The 1-second and 3-second intervals are used on small areas where you want to treat localized, small, superficial pigmented or vascular lesions (i.e., back of the hand or upper lip). The 30-second interval is used on large areas where you want to treat signs of photodamage/ photoaging irregularities (dyschromia, lentigines, freckles, etc.). The Dye-VL module incorporates thermo-electric coupling (TEC) technology; the module can be operated in two conditions: Cooling On (default) and Off. The module spot size is 3cm2 and the pulse repetition rate is fixed at 3 Hz. The total energy delivered at any given time interval is expressed in kilojoules (kJ). Ultrasonic gel should be used in both Stationary and In-Motion techniques.

9.8.4.

Pre-Treatment

9.8.4.1.


9.8.4.2.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session, with the Cooling mode On and according to the following parameters: Table 9-6: Dye-SVL Skin Test Parameters (30 second interval) Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *

Total Energy [kJ] **

I – II

3–4

On

2.4 – 3.2

III

2–3

On

1.6 – 2.4

IV

2

On

1.6

The 1-second and 3-second time intervals are indicated for the Stationary technique. (*) Ultrasonic gel must be applied to the skin in both Cooling On or Off modes. (**) The total energy is adjusted for 10x10 cm (100cm2) area. Important: a thin coat of ultrasonic gel must be applied on the skin for ALL skin types.

9-14



9.8.5.

Treatment (In-Motion Technique) Treatment can begin after the Dye-VL module has been connected to the HarmonyXL system and the treatment parameters selected (fluence) according to Table 9-7. 1.


2.


3.

Apply a thin layer (usually 1-2mm thick for all skin types) of refrigerated cooling gel (43-50°F/6-10°C) to the treatment site. The gel will provide: a) a thermal sink for the absorbed and reflected energy, thus providing some cooling to the skin itself; b) comfort to the patient during treatment and; c) friction reduction/lubrication during the In-Motion technique.

4.


5.

Apply the In-Motion technique: • Move the module on the surface of the skin and, only when the module is in full contact and "in-motion", then trigger the footswitch. • Move the module in continuous linear or circular motions, to cover the entire grid area. This repeated pattern may last several minutes, depending on the recommended total energy (kJ). • After completing a single interval, raise the module from the skin, reposition at the point where you began treatment in this grid and repeat another interval on the entire area. • After completing the recommended number of intervals, move to the contralateral side and repeat as above.

6.

In most cases, operation time intervals should be set for 30 seconds for large areas; the 1-second and 15-second intervals should be selected for small areas on the face, chest or back (using the Stationary technique rather than the InMotion technique).

7.


8.

Perform the recommended cycles on the right and left side of the face. Repeat the intervals on each side.

9.

Clinical end points: mild-to-moderate erythema for skin types I-IV; mild erythema for skin type V.

10. If adverse reactions are observed from the prior treatment, the next treatment may be skipped or the dose reduced until the symptoms resolve. 11. It is recommended to cool the area immediately after the treatment. Note Always perform a skin test on the intended treatment area during the first treatment session.


9-15


9.8.6.

Suggested Setup Parameters Table 9-7: Dye-SVL Suggested Setup Parameters (30 second interval) Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *


I – II

3–4

On

3.2 – 4.3

III

2–3

On

2.1 – 3.2

IV

2

On

2.1

(*) Ultrasonic gel must be applied to the skin. (**) The total energy is adjusted for 10x10 cm (100cm2) area. The 1-second and 3-second time intervals are indicated for the Stationary technique

9.8.7.

9-16

Stationary Protocol 1.

In the stationary technique, use the 3-second interval; up to 10% overlapping is an acceptable tolerance.

2.

Set the initial exposure time and fluence parameters according to Table 9-6.

3.

Trigger a pulse by continuously pressing the footswitch for the entire time interval; the module will stop emitting light automatically unless interrupted by the operator (releasing the footswitch). In order to continue, the footswitch must be pressed again.

4.

Check skin reaction; if there is no apparent skin reaction – repeat until clinical end points are visible.

5.

Treatment parameters may be increased by 10% every other treatment and subjected to the conditions in the area treated and patient's tolerance.

6.

Following treatment, gently cleanse the ultrasonic gel from the treated area.

7.

If adverse skin effects occur (such as excessive reddening or swelling), you may either reduce the exposure time (1 sec interval) or reduce the fluence.

8.




9.8.8.

Treatment of Small Areas Table 9-8: Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – II

3–4

On

0.3 – 0.4

III

2–3

On

0.2 – 0.3

IV

2

On

0.2

(*) Apply gel Table 9-9: Small Area Parameters, 3-25 cm2, 1 Second, In-Motion* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – II

3–4

On

0.3 – 0.4

III

2–3

On

0.2 – 0.3

IV

2

On

0.2

(*) Apply gel

9.8.9.

Follow-up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen. • Within three weeks after treatment patients should return for examination of the treatment site and for additional treatment, if necessary. • If no additional treatment is necessary, patients should return for an additional examination one month later. • Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments. • Treatment intervals: treatment is reapplied (assuring there have been no adverse reactions) every 3-4 weeks.


9-17

CHAPTER 10 Dye-VL Pro Module – Vascular & Pigmented Lesions Chapter Contents: Section

Title

Page

10.1.

Dye-VL Pro Module ........................................................................ 10-3

10.2.

Dye-VL Pro Module Specifications ................................................ 10-3

10.3.

Dye-VL Pro Module Operating Screen ........................................... 10-4

10.4.

Dye-VL Pro Module Regulatory Labels.......................................... 10-5

10.5.

Ordering Information ....................................................................... 10-5

10.6.

Dye-VL Pro Module Clinical Guide for Vascular Lesions ............. 10-6

10.6.1. Indications for Use ......................................................................... 10-6 10.6.2. Contraindications............................................................................ 10-6 10.6.3. Pre-Treatment ................................................................................. 10-7 10.6.4. Treatment........................................................................................ 10-8 10.6.5. Suggested Dye-VL Pro Setup Parameters for Vascular Lesions .... 10-9 10.6.6. Follow-up ....................................................................................... 10-9 10.7.

Dye-VL Pro Module Clinical Guide for Pigmented Lesions......... 10-10

10.7.1. Indications for Use ....................................................................... 10-10 10.7.2. Contraindications.......................................................................... 10-10 10.7.3. Pre-Treatment ............................................................................... 10-10 10.7.4. Treatment...................................................................................... 10-11 10.7.5. Suggested Dye-VL Pro Setup Parameters for Pigmented Lesions.......................................................................................... 10-12 10.7.6. Follow-up ..................................................................................... 10-12 10.8.

Dye-SVL Mode Clinical Guide ..................................................... 10-13


10-1

Dye-VL Pro Module – Vascular & Pigmented Lesions

10.8.1. Indications for Use ........................................................................ 10-13 10.8.2. Contraindications .......................................................................... 10-13 10.8.3. Module Operation ......................................................................... 10-14 10.8.4. Pre-Treatment ............................................................................... 10-14 10.8.5. Treatment (In-Motion Technique) ................................................ 10-15 10.8.6. Suggested Setup Parameters ......................................................... 10-16 10.8.7. Stationary Protocol ....................................................................... 10-16 10.8.8. Treatment of Small Areas ............................................................. 10-17 10.8.9. Follow-up...................................................................................... 10-18

10-2



10.1. Dye-VL Pro Module The Dye-VL Pro module has a high-power targeted phototherapy module for noninvasive treatment of vascular and pigmented lesions. The Dye-VL Pro module allows treatment of a broad spectrum of vascular imperfections be selectively targeting oxyhemoglobin, deoxyhemoglobin and melanin. The Dye-VL Pro module may be operated in two separate modes: Dye-VL and Dye-SVL. A complete discussion of the Dye-VL Pro module clinical applications may be found in Sections 10.6 and 10.7. The Dye-VL Pro module has a light green identification section (see Figure 10-1).

Figure 10-1: Dye-VL Pro Module (Light Green)

10.2. Dye-VL Pro Module Specifications • Light Source:


• Spectrum:

500 – 600nm


3 cm2


10-3


10.3. Dye-VL Pro Module Operating Screen The Dye-VL Pro module main operating screens (see Figure 10-2) are displayed when the Dye-VL Pro module is connected to the system.

• To switch from Dye-VL to Dye-SVL mode, press the Dye-VL softkey on the screen.

• To switch from Dye-SVL to Dye-VL mode, press the Dye-SVL softkey on the screen.

Figure 10-2: Dye-VL Pro Module Operating Screens Operating parameters available in this module: Dye-VL Pro Mode

10-4

2

Dye-SVL Mode


Up to 15 J/cm

1 – 4 J/cm2

• Pulse Duration:

10, 12, 15 msec.

1, 3, 30 sec.


1 Hz

3 Hz



10.4. Dye-VL Pro Module Regulatory Labels Figure 10-3 presents the regulatory identification and caution labels adhered to the Dye-VL Pro module connector:

Figure 10-3: Dye-VL Pro Module Regulatory Labels

10.5. Ordering Information The following table offers names of accessories specific to the Dye-VL Pro module that may be ordered form Alma Lasers. Table 10-1: Dye-VL Pro Module Accessories Description Dye-VL Pro (Vascular/Pigmented Lesions) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)


10-5


10.6. Dye-VL Pro Module Clinical Guide for Vascular Lesions The treatment of vascular lesions with the HarmonyXL system can be performed using the Dye-VL Pro 500-600nm (light green color code) module. The Dye-VL Pro module is indicated for vascular lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

10.6.1. Indications for Use The Advanced Fluorescence Technology (AFT) 500-600 nm Dye-VL Pro module is indicated for:











10-6




10.6.3. Pre-Treatment 10.6.3.1.


10.6.3.2.


10.6.3.3.



Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Dye-VL Pro 500-600nm (light green color code)

10, 12

10 – 12

30 min

IV


12, 15

6–9

24 – 48 hours



10-7


10.6.4. Treatment • The Dye-VL Pro module will treat vessels up to < 1mm. • Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses.



1.


2.


3.




5.


6.


7.


8.


9.



10-8



10.6.5. Suggested Dye-VL Pro Setup Parameters for Vascular Lesions Table 10-3: Suggested Dye-VL Pro Setup Parameters for Vascular Lesions Fitzpatrick Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


10, 12

10 – 13

IV


12, 15

6 – 10










10-9


10.7. Dye-VL Pro Module Clinical Guide for Pigmented Lesions The Pigmented Lesions application of the HarmonyXL system can be performed with the Dye-VL Pro 500-600nm (light green color code) module. The Dye-VL Pro module is indicated for pigmented lesions. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.



10.7.3. Pre-Treatment 10.7.3.1.


10.7.3.2.


10-10



10.7.3.3.



Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III


10, 12

10 – 12

30 min

IV


12, 15

6–9

24 – 48 hours




2.


3.


4.


5.


6.


7.


8.


9.


10. If the skin shows no adverse effects and changes observed in the lesions are unsatisfactory, you should increase the fluence by 10-20%.


10-11


11. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before each pass/treatment. After treatment, remove the gel from treated areas. Do not reuse gel. 12. After treatment, it is recommended to cool the area immediately.

10.7.5. Suggested Dye-VL Pro Setup Parameters for Pigmented Lesions Table 10-5: Suggested Dye-VL Pro Setup Parameters for Pigmented Lesions Fitzpatrick Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


10, 12

10 – 13

IV


12, 15

6 – 10







All adverse side effects should be reported to the treating physician with a followup report sent to the Director of Clinical Operations at Alma Lasers: 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] 10-12



10.8. Dye-SVL Mode Clinical Guide The Skin Rejuvenation application of the HarmonyXL system is performed using the Dye-VL Pro (light green color code) module in Dye-SVL mode. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

10.8.1.

Indications for Use The Dye-VL Pro module in Dye-SVL mode is indicated for:




10.8.2.



10-13


10.8.3.

Module Operation The Dye-VL Pro module in Dye-SVL mode may be operated with 3 different time intervals: 1, 3 and 30 seconds. In the 1-second and 3-second intervals, the module is used employing the Stationary technique. In the 30-second interval, the module is used employing the In-Motion technique (see Section 10.8.5). The 1-second and 3-second intervals are used on small areas where you want to treat localized, small, superficial pigmented or vascular lesions (i.e., back of the hand or upper lip). The 30-second interval is used on large areas where you want to treat signs of photodamage/ photoaging irregularities (dyschromia, lentigines, freckles, etc.). The Dye-VL Pro module incorporates thermo-electric coupling (TEC) technology; the module can be operated in two conditions: Cooling On (default) and Off. The module spot size is 3cm2 and the pulse repetition rate is fixed at 3 Hz. The total energy delivered at any given time interval is expressed in kilojoules (kJ). Ultrasonic gel should be used in both Stationary and In-Motion techniques.

10.8.4.

Pre-Treatment

10.8.4.1. Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth and density.

10.8.4.2. Skin Test Always perform a skin test on the intended treatment area before the first treatment session, with the Cooling mode On and according to the following parameters: Table 10-6: Dye-SVL Skin Test Parameters (30 second interval) Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *


I – II

3–4

On

2.4 – 3.2

III

2–3

On

1.6 – 2.4

IV

2

On

1.6


10-14



10.8.5.

Treatment (In-Motion Technique) Treatment can begin after the Dye-VL Pro module has been connected to the HarmonyXL system and the treatment parameters selected (fluence) according to Table 10-7. 1.


2.


3.


4.


5.


6.


7.


8.


9.

Clinical end points: mild-to-moderate erythema for skin types I-IV; mild erythema for skin type V.



10-15


10.8.6.

Suggested Setup Parameters Table 10-7: Dye-SVL Suggested Setup Parameters (30 second interval) Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *


I – II

3–4

On

3.2 – 4.3

III

2–3

On

2.1 – 3.2

IV

2

On

2.1


10.8.7.

10-16



2.


3.


4.


5.


6.


7.


8.




10.8.8.

Treatment of Small Areas Table 10-8: Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – II

3–4

On

0.3 – 0.4

III

2–3

On

0.2 – 0.3

IV

2

On

0.2

(*) Apply gel

Table 10-9: Small Area Parameters, 3-25 cm2, 1 Second, In-Motion* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – II

3–4

On

0.3 – 0.4

III

2–3

On

0.2 – 0.3

IV

2

On

0.2

(*) Apply gel


10-17


10.8.9.

Follow-up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen. • Within three weeks after treatment patients should return for examination of the treatment site and for additional treatment, if necessary. • If no additional treatment is necessary, patients should return for an additional examination one month later. • Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments. • Treatment intervals: treatment is reapplied (assuring there have been no adverse reactions) every 3-4 weeks. All adverse side effects should be reported to the treating physician with a followup report sent to the Director of Clinical Operations at Alma Lasers: 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]

10-18


CHAPTER 11 LED Module Chapter Contents: Section

Title

Page

11.1.

LED Module Description ................................................................ 11-2

11.2.

LED Module Specifications ............................................................ 11-2

11.3.

LED Module Operating Screen ....................................................... 11-3

11.4.

LED Module Regulatory Labels ...................................................... 11-4

11.5.


11.6.

LED Module Clinical Guide ............................................................ 11-5

11.6.1. Indications for Use ......................................................................... 11-5 11.6.2. Contraindications............................................................................ 11-5 11.6.3. Pre-Treatment ................................................................................. 11-5 11.6.4. Treatment........................................................................................ 11-6 11.6.5. Suggested LED Setup Parameters .................................................. 11-7 11.6.6. Follow-Up ...................................................................................... 11-7


11-1

LED Module

11.1. LED Module Description The LED module (see Figure 11-1) incorporates an array of diodes that emit yellow light. The module may be configured to operate in one of the following modes:

• Continuous Wave • Repeat A complete discussion of the LED module clinical applications may be found in Section 11.6.

Figure 11-1: LED Module

11.2. LED Module Specifications

11-2

• Light Source:

Light emitting diode array

• Spectrum:

Yellow

• Optical Power:

1.5W

• Pulse Mode # 1:

Repeat (Pulsed)

• Pulse Mode # 2:

CW (Continuous Wave)

• Timers:

Repeat CW -

up to 70 seconds up to 70 minutes


LED Module

11.3. LED Module Operating Screen The LED module main operating screen (see Figure 11-2) is displayed when the LED module is connected to the system:

Figure 11-2: LED Module Operating Screen Operating parameters available in this module: 1.

Operating Mode – the LED module can be operated in one of the following

wave modes:

• Repeat (pulsed)Wave • CW (Continuous Wave) 2.

Wave Duration:

• Repeat – up to 70 seconds • CW – up to 70 minutes


11-3

LED Module

11.4. LED Module Regulatory Labels Figure 11-3 presents the regulatory identification and caution labels adhered to the LED module connector:

Figure 11-3: LED Module Regulatory Labels

11.5. Ordering Information The following table offers names of accessories specific to the LED module that may be ordered form Alma Lasers. Table 11-1: LED Module Accessories Description LED (Yellow) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

11-4


LED Module

11.6. LED Module Clinical Guide The HarmonyXL system with the LED module emits 590nm (yellow) diode light. The LED module can be operated in one of two modes: continuous wave (CW) and Repeat (pulsed) wave. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

11.6.1.

Indications for Use The 590nm LED module is indicated to: • Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain. • Provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Note In Canada the module is indicated for the treatment of rhytids, fine lines and wrinkles.

11.6.2.

Contraindications • History of cancer • Active inflammatory skin disorder • Drug-related photosensitivity

11.6.3.

Pre-Treatment

11.6.3.1.

Patient Evaluation Before LED treatment procedures, the patient should be evaluated for the presence of pre-existing conditions of skin disease that may cause skin sensitivity or photosensitivity.


11-5

LED Module

11.6.3.2.

Skin Test Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters in the table below.

Table 11-2: LED Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Module

Time of Exposure (sec / min)*

Mode

Waiting Period (minutes)

I

LED

30 / 20

Repeat/CW

10

II

LED

30 / 20

Repeat/CW

10

III

LED

30 / 20

Repeat/CW

10

IV

LED

30 / 20

Repeat/CW

10

V

LED

30 / 20

Repeat/CW

10

VI

LED

30 / 20

Repeat/CW

10

(*) Pulsed/CW

11.6.4.

Treatment Treatment can begin after the LED module is connected to the system and the treatment parameters are selected according to the table in Table 11-2. 1.


2.

Identify the treatment area and position the patient accordingly.

3.

Patient should be seated in a chair or lying down on a treatment bed.

4.

Provide appropriate eye protection (or eye shields) for the patient and the medical staff inside the enclosed treatment room.

5.

Select the operating mode according to the clinical indication – • CW (Continuous Wave), up to 70 minutes, or • Repeat, up to 70 seconds

11-6

6.

Hold the module at a distance of 1-2 cm (0.4"-0.8") from the skin surface (perpendicular to the skin) for the entire exposure time.

7.

Continuous Wave mode (CW): treatment should be performed twice per week for 4-5 consecutive weeks (8-10 treatments).

8.

Repeat mode: treatment should be performed on 3 to 5 consecutive days postlaser or IPL procedure (3-5 treatments).


LED Module

11.6.5.

Suggested LED Setup Parameters The following table shows the recommended parameters based on the patient hair color and skin type: Table 11-3: Suggested LED Setup Parameters Skin Type (Fitzpatrick I-VI)

Module

Time of Exposure (sec / min) *

Mode

I

LED

30 / 20

Repeat/CW

II

LED

30 / 20

Repeat/CW

III

LED

30 / 20

Repeat/CW

IV

LED

30 / 20

Repeat/CW

V

LED

30 / 20

Repeat/CW

VI

LED

30 / 20

Repeat/CW

(*) Pulsed/CW

11.6.6.

Follow-Up Measures presented below are only the manufacturer's recommendations for followup for the acne clearance treatment. They may serve as a basis for defining your treatment regimen.

• Patients should apply daily sunscreen with SPF 30 between treatments and at least one week after the last treatment.

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

• Patient should return for examination 1 and 3 months after the last treatment and for additional treatment, if necessary.

• If no additional treatment is necessary, the patient should return for an additional re-examination six months later.



11-7

CHAPTER 12 SR Module – Skin Rejuvenation Chapter Contents: Section

Title

Page

12.1.

SR Module Description ................................................................... 12-2

12.2.

SR Module Specifications ............................................................... 12-2

12.3.

SR Module Operating Screen .......................................................... 12-3

12.4.

SR Module Regulatory Labels......................................................... 12-4

12.5.


12.6.

SR Module Clinical Guide............................................................... 12-5

12.6.1. Indications for Use ......................................................................... 12-5 12.6.2. Contraindications............................................................................ 12-5 12.6.3. Pre-Treatment ................................................................................. 12-6 12.6.4. Treatment........................................................................................ 12-7 12.6.5. Suggested SR Setup Parameters ..................................................... 12-8 12.6.6. Follow-up ....................................................................................... 12-8


12-1

SR Module – Skin Rejuvenation

12.1. SR Module Description The SR module has a high-power targeted phototherapy module for skin rejuvenation. It employs Alma Laser's proprietary AFT pulsed light technology in the yellow wavelength range (570-950nm) along with adjustable parameters for effective rejuvenation of the skin. A complete discussion of the SR module clinical applications may be found in Section 12.6. The SR module has a yellow identification section (see Figure 12-1).

Figure 12-1: SR Module (Yellow Color Code)

12.2. SR Module Specifications

12-2

• Light Source:


• Spectrum:

570 – 950nm


5 – 25 J/cm2


6.4 cm2

• Pulse Widths:

10, 12, 15 msec


2/3 Hz

• Cooling:

None



12.3. SR Module Operating Screen The SR module main operating screen (see Figure 12-2) is displayed when the SR module is connected to the system:

Figure 12-2: SR Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.


• 10 msec • 12 msec • 15 msec 3.



12-3


12.4. SR Module Regulatory Labels Figure 12-3 presents the regulatory identification and caution labels adhered to the SR module connector:

Figure 12-3: SR Module Regulatory Labels

12.5. Ordering Information The following table offers names of accessories specific to the SR module that may be ordered form Alma Lasers. Table 12-1: SR Module Accessories Description SR (Skin Rejuvenation) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

12-4



12.6. SR Module Clinical Guide The Skin Rejuvenation application of the HarmonyXL system is performed using the SR 570-950nm (yellow color code) module or the Long Pulse Nd:YAG (1064nm) module. The 1064nm laser modules are discussed in detail in Chapters 19 & 20 of this manual The SR 570-950nm module is indicated for the treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles), and for the non-ablative treatment of facial fine lines & texture improvement (skin rejuvenation). Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

12.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 570-950 SR module is indicated for:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

• The treatment of face and body vascular and pigmented lesions. • Use on all skin types (Fitzpatrick I-V).

12.6.2.





• Isotretinoin – Roaccutane in the previous 3-6 months


12-5


• Tretinoin – Retin A in the last 2 weeks • Pregnancy; until menstruation returns and end of breast feeding • Diabetes (because of increased possible photosensitivity and poor wound healing)

12.6.3.

Pre-Treatment

12.6.3.1.


12.6.3.2.


Table 12-2: SR Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

SR 570-950nm (yellow color code)

10, 12

16 – 20

30 min.

IV


15

8 – 12

30 min.

V


15

6 – 10

24 – 48 hours

12-6



12.6.4.

Treatment Treatment can begin after the suitable module has been connected to the HarmonyXL system and the treatment parameters (fluence and timer interval) are selected according to Table 12-2. Note Always perform a skin test on the intended treatment area during the first treatment session. 1.


2.

Apply a thin layer (usually 1mm thick and 2mm for darker skin types) of refrigerated (43-50°F/6-10°C) cooling gel to the treatment site. The gel will provide a thermal sink for the absorbed and reflected energy, provide some cooling to the skin itself, and additional comfort to the patient during treatment.

3.

Place the lightguide perpendicular to the skin and touch the gel with the lightguide. Do not apply pressure (the lightguide should gently touch the skin).

4.


5.

Trigger a light pulse by pressing the footswitch and the module trigger simultaneously.

6.

Wipe off the gel.

7.

If adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), you should reduce the fluence by 10-20%.

8.

If no change in the skin is noted, then the fluence should be increased by 10-20%.

9.

To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before treatment. After treatment, remove the gel from treated areas. Do not reuse gel.

10. After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care).


12-7


12.6.5.

Suggested SR Setup Parameters

Table 12-3: Suggested SR Setup Parameters Skin Type (Fitzpatrick I-VI)

Module

# of Pulses per Spot *

Pulse Width (msec)

Fluence (J/cm2)

I – III


2

10, 12

18 – 24

IV


2

12, 15

10 – 14

V


2

15

6 – 10


12.6.6.


• Within three weeks after the treatment patients should return for examination of the treatment site and for additional treatment, if necessary.

• If no additional treatment is necessary, patients should return for an additional examination one month later.



12-8


CHAPTER 13 SR Cooled Module – Skin Rejuvenation Chapter Contents: Section

Title

Page

13.1.

SR Cooled Module Description ....................................................... 13-2

13.2.

SR Cooled Module Specifications ................................................... 13-2

13.3.

SR Cooled Module Operating Screen.............................................. 13-3

13.4.

SR Cooled Module Regulatory Labels ............................................ 13-4

13.5.


13.6.

SR Cooled Module Clinical Guide .................................................. 13-5

13.6.1. Indications for Use ......................................................................... 13-5 13.6.2. Contraindications............................................................................ 13-5 13.6.3. Pre-Treatment ................................................................................. 13-6 13.6.4. Treatment........................................................................................ 13-7 13.6.5. Suggested Cooled SR Setup Parameters ........................................ 13-8 13.6.6. Follow-up ....................................................................................... 13-8


13-1

SR Cooled Module – Skin Rejuvenation

13.1. SR Cooled Module Description The SR cooled module has a high-power targeted phototherapy module for skin rejuvenation. It employs Alma Laser's proprietary AFT pulsed light technology in the yellow wavelength range (570-950nm) along with adjustable parameters for effective rejuvenation of the skin. A complete discussion of the SR cooled module clinical applications may be found in Section 13.6. The SR cooled module has a yellow identification section (see Figure 13-1). This module incorporates a contact-cooling mechanism.

Figure 13-1: SR Cooled Module (Yellow Color Code)

13.2. SR Cooled Module Specifications

13-2

• Light Source:


• Spectrum:

570 – 950nm


5 – 30 J/cm2


3 cm2

• Pulse Widths:

10, 12, 15 msec


2/3 Hz

• Cooling:

TEC



13.3. SR Cooled Module Operating Screen The SR cooled module main operating screen (see Figure 13-2) is displayed when the SR cooled module is connected to the system:

Figure 13-2: SR Cooled Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.


• 10 msec • 12 msec • 15 msec 3.



13-3


13.4. SR Cooled Module Regulatory Labels Figure 13-3 presents the regulatory identification and caution labels adhered to the SR cooled module connector:

Figure 13-3: SR Cooled Module Regulatory Labels

13.5. Ordering Information The following table offers names of accessories specific to the SR cooled module that may be ordered form Alma Lasers. Table 13-1: SR Cooled Module Accessories Description SR (Skin Rejuvenation) Cooled Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

13-4



13.6. SR Cooled Module Clinical Guide The Skin Rejuvenation application of the HarmonyXL system is performed using the SR 570-950nm (yellow color code) module or the Long Pulse Nd:YAG (1064nm) module. The 1064nm laser modules are discussed in detail in Chapters 19 & 20 of this manual. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

13.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 570-950 SR module is indicated for:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

• The treatment of cutaneous lesions, including scars and striae. • Use on all skin types (Fitzpatrick I-VI).

13.6.2.





• Isotretinoin – Roaccutane in the previous 3-6 months • Retin-A – In the past 2 weeks • Pregnancy; until menstruation returns and end of breast feeding


13-5



13.6.3.

Pre-Treatment

13.6.3.1.


13.6.3.2.


Table 13-2: Cooled SR Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Cooled SR 570-950nm (yellow color code)

10, 12

20 – 24

30 min.

IV


15

16 – 20

30 min.

V – VI


15

6 – 10

24 – 48 hours*


13-6



13.6.4.

Treatment Treatment can begin after the suitable module has been connected to the HarmonyXL system and the treatment parameters (fluence and timer interval) are selected according to Table 13-2. Note Always perform a skin test on the intended treatment area during the first treatment session. 1.


2.

Apply a thin layer (usually 1mm thick and 2mm for darker skin types) of refrigerated (43-50°F/6-10°C) cooling gel to the treatment site. The gel will provide a thermal sink for the absorbed and reflected energy, provide some cooling to the skin itself, and additional comfort to the patient during treatment.

3.

Place the lightguide perpendicular to the skin and touch the gel with the lightguide. Do not apply pressure (the lightguide should gently touch the skin).

4.


5.

Trigger a light pulse by pressing the footswitch and the module trigger simultaneously.

6.

Wipe off the gel.

7.


8.


9.

To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before treatment. After treatment, remove the gel from treated areas. Do not reuse gel.



13-7


13.6.5.

Suggested Cooled SR Setup Parameters Table 13-3: Suggested Cooled SR Setup Parameters

13.6.6.


Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


10, 12

20 – 25

IV


15

16 – 20

V – VI


15

6 – 10



• If no additional treatment is necessary, patients should return for an additional examination one month later.



13-8


CHAPTER 14 SSR Module – Super Skin Rejuvenation Chapter Contents: Section

Title

Page

14.1.

SSR Module Description ................................................................. 14-2

14.2.

SSR Module Specifications ............................................................. 14-2

14.3.

SSR Module Operating Screen ........................................................ 14-3

14.4.

Total Energy in the SSR Module ..................................................... 14-4

14.5.

SSR Module Regulatory Labels ...................................................... 14-4

14.6.


14.7.

SSR Module Clinical Guide ............................................................ 14-5

14.7.1. Indications for Use ......................................................................... 14-5 14.7.2. Contraindications............................................................................ 14-5 14.7.3. Module Operation........................................................................... 14-6 14.7.4. Pre-Treatment ................................................................................. 14-6 14.7.5. Treatment (In-Motion Technique) .................................................. 14-7 14.7.6. Suggested Setup Parameters ........................................................... 14-8 14.7.7. Stationary Protocol ......................................................................... 14-8 14.7.8. Treatment of Small Areas ............................................................. 14-10 14.7.9. Follow-up ..................................................................................... 14-11


14-1

SSR Module – Super Skin Rejuvenation

14.1. SSR Module Description The SSR module has a high-power targeted phototherapy module for skin rejuvenation. It employs Alma Laser's proprietary AFT pulsed light technology along with adjustable parameters for effective rejuvenation of the skin. A complete discussion of the SSR module clinical applications may be found in Section 0. The SSR module has a green identification section (see Figure 14-1). This module incorporates a contact-cooling mechanism.

Figure 14-1: SSR Module (Green Color Code)

14.2. SSR Module Specifications

14-2

• Light Source:



1 – 15 J/cm2


3 cm2

• Timers:

1, 3 & 30 seconds


2 Hz

• Cooling:

TEC



14.3. SSR Module Operating Screen The SSR module main operating screen (see Figure 14-2) is displayed when the SSR module is connected to the system: The SSR module's contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the screen:


Figure 14-2: SSR Module Operating Screen Operating parameters available in this module: 1.


1 J/cm2.

2.

Timers – 1, 3 & 30 seconds

3.

Pulse Repetition Rate – fixed at 2 Hz


14-3


14.4. Total Energy in the SSR Module The SSR module's operating screen exhibits the total energy applied per session, counted in Kilojoules (see kJ counter in top-right corner of Figure 14-2): Note If the system stays in SSR mode during patient rotation, it is important to reset the Total Energy by pressing the Reset key.

14.5. SSR Module Regulatory Labels Figure 14-3 presents the regulatory identification and caution labels adhered to the SSR module connector:

Figure 14-3: SSR Module Regulatory Labels

14.6. Ordering Information The following table offers names of accessories specific to the SSR module that may be ordered form Alma Lasers. Table 14-1: SSR Module Accessories Description SSR (Super Skin Rejuvenation) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

14-4



14.7. SSR Module Clinical Guide The Skin Rejuvenation application of the HarmonyXL system is performed using the SSR (green color code) module. The SSR module is indicated for the treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles), and for the non-ablative treatment of facial fine lines & texture improvement (skin rejuvenation). Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

14.7.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 540-950 nm SSR module is indicated for:

• The treatment of moderate inflammatory acne vulgaris. • The treatment of benign pigmented epidermal lesions including dyschromia,




• Use on all skin types (Fitzpatrick I-VI).

14.7.2.

Contraindications • Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc., at the treatment site • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.) • History of keloid scarring • Epilepsy • St. John's Wort (herbal remedy) for depression in the past three months (because of increased photosensitivity) • Isotretinoin – Roaccutane or Tretinoin – In the past 3-6 months • Retin A - In the past 2 weeks • Pregnancy (including IVF) • Diabetes


14-5


14.7.3.

Module Operation The SSR module may be operated with 3 different time intervals: 1, 3 and 30 seconds. In the 1-second and 3-second intervals, the module is used employing the Stationary technique. In the 30-second interval, the module is used employing the In-Motion technique (see Section 14.7.5). The 1-second and 3-second intervals are used on small areas where you want to treat localized, small, superficial pigmented or vascular lesions (i.e., back of the hand or upper lip). The 30-second interval is used on large areas where you want to treat signs of photodamage/ photoaging irregularities (dyschromia, lentigines, freckles etc). The SSR module incorporates thermo-electric coupling (TEC) technology; the module can be operated under two conditions: Cooling On (default) and Cooling Off. The module spot size is 3cm2 and the pulse repetition rate is fixed at 2 Hz. The total energy delivered at any given time interval is expressed in kilojoules (kJ). Ultrasonic gel should be used in both Stationary and In-Motion techniques.

14.7.4.

Pre-Treatment

14.7.4.1.


14-6



14.7.4.2.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session, with the Cooling mode On and according to the following parameters: Table 14-2: SSR Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *


I – III

8–9

On

5.4

IV

6–7

On

5.4

V – VI

4–5

On

5.4


14.7.5.

Treatment (In-Motion Technique) Treatment can begin after the SSR module has been connected to the HarmonyXL system and the treatment parameters selected (fluence) according to Table 14-3. 1.


2.


3.


4.


5.

Apply the In-Motion technique: • Move the module on the surface of the skin and, only when the module is in full contact and "in-motion", then trigger the footswitch. • Move the module in continuous linear or circular motions, to cover the entire grid area. This repeated pattern may last several minutes, depending on the recommended total energy (kJ). • After completing a single interval, raise the module from the skin, reposition at the point where you began treatment in this grid and repeat another interval on the entire area.


14-7


• After completing the recommended number of intervals, move to the contralateral side and repeat as above. 6.


7.


8.


9.

Clinical end points: mild-to-moderate erythema for skin types I-IV; mild erythema for skin types V-VI.

10. If adverse reactions are observed from the prior treatment, the next treatment may be skipped or the dose reduced until the symptoms resolve. 11. It is recommended to cool the area immediately after the treatment (see Appendix C in the System Manual – Post-Treatment Care). Note Always perform a skin test on the intended treatment area during the first treatment session.

14.7.6.

Suggested Setup Parameters Table 14-3: SSR Suggested Setup Parameters Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *


I – III

8 – 10

On

5.4 – 6.3

IV

7–9

On

5.4 – 6.3

V – VI

6–8

On

5.4 – 6.3


14.7.7.

14-8



2.


3.

Trigger a pulse by continuously pressing the footswitch for the entire time interval; the module will stop emitting light automatically unless interrupted by



the operator (releasing the footswitch). In order to continue, the footswitch must be pressed again. 4.


5.


6.


7.


8.

It is recommended to cool the area immediately after the treatment (see Appendix B in the System Manual – Post-Treatment Care).


14-9


14.7.8.

Treatment of Small Areas Table 14-4: Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – III

8–9

On

3.0 – 3.6

IV

6–7

On

3.0 – 3.6

V - VI

4–5

On

3.0 – 3.6

Table 14-5: Small Area Parameters, 3-25 cm2, 1 Second, In-Motion Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – III

10 – 12

On

3.0 – 3.6

IV

8–9

On

3.0 – 3.6

V - VI

7–8

On

3.0 – 3.6

Table 14-6: Small Area Parameters, Up To 3 cm2, 3 Seconds, Stationary* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]**

I – III

6–8

On

IV

4–6

On

V - VI

4–5

On

(*) Repeat twice (**) Apply gel Table 14-7: Small Area Parameters, Up To 3 cm2, 1 Second, Stationary* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]**

I – III

8 – 10

On

IV

6–8

On

V - VI

4–6

On

(*) Repeat twice (**) Apply gel

14-10



14.7.9.

Follow-up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen. • Within three weeks after treatment patients should return for examination of the treatment site and for additional treatment, if necessary. • If no additional treatment is necessary, patients should return for an additional examination one month later. • Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments. • Treatment intervals: treatment is reapplied (assuring there have been no adverse reactions) every 3-4 weeks. All adverse side effects should be reported to the treating physician with a followup report sent to the Director of Clinical Operations at Alma Lasers: 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]


14-11

CHAPTER 15 Dye-SR Pro Module – Vascular & Pigmented Lesions Chapter Contents: Section

Title

Page

15.1.

Dye-SR Pro Module Description ..................................................... 15-3

15.2.

Dye-SR Pro Module Specifications ................................................. 15-3

15.3.

Dye-SR Pro Module Operating Screen............................................ 15-4

15.4.

Dye-SR Pro Module Regulatory Labels .......................................... 15-5

15.5.


15.6.

Dye-SR Pro Module Clinical Guide for Vascular Lesions .............. 15-6

15.6.1. Indications for Use ......................................................................... 15-6 15.6.2. Contraindications............................................................................ 15-6 15.6.3. Pre-Treatment ................................................................................. 15-7 15.6.4. Treatment........................................................................................ 15-8 15.6.5. Suggested Dye-SR Pro Setup Parameters for Vascular Lesions .... 15-9 15.6.6. Follow-up ....................................................................................... 15-9 15.7.

Dye-SR Pro Module Clinical Guide for Pigmented Lesions ......... 15-10

15.7.1. Indications for Use ....................................................................... 15-10 15.7.2. Contraindications.......................................................................... 15-10 15.7.3. Pre-Treatment ............................................................................... 15-10 15.7.4. Treatment...................................................................................... 15-11 15.7.5. Suggested Dye-SR Pro Setup Parameters for Pigmented Lesions 15-12 15.7.6. Follow-up ..................................................................................... 15-12 15.8.

Dye-SSR Mode Clinical Guide ..................................................... 15-14

15.8.1. Indications for Use ....................................................................... 15-14


15-1

Dye-SR Pro Module – Skin Rejuvenation

15.8.2. Contraindications .......................................................................... 15-14 15.8.3. Module Operation ......................................................................... 15-15 15.8.4. Pre-Treatment ............................................................................... 15-15 15.8.5. Treatment (In-Motion Technique) ................................................ 15-16 15.8.6. Suggested Setup Parameters ......................................................... 15-17 15.8.7. Stationary Protocol ....................................................................... 15-17 15.8.8. Treatment of Small Areas ............................................................. 15-18 15.8.9. Follow-up...................................................................................... 15-19

15-2



15.1. Dye-SR Pro Module Description The Dye-SR Pro module has a high-power targeted phototherapy module for noninvasive treatment of vascular and pigmented lesions. The Dye-SR Pro module allows treatment of a broad spectrum of vascular imperfections be selectively targeting oxyhemoglobin, deoxyhemoglobin and melanin. The Dye-SR Pro module may be operated in two separate modes: Dye-SR and

Dye-SSR.

A complete discussion of the cooled Dye-SR Pro module applications may be found in Sections 15.6 and 15.7 of this manual. The cooled Dye-SR Pro module has an orange identification section (see Figure 15-1). This module incorporates a contact-cooling mechanism.

Figure 15-1: Dye-SR Pro Module (Orange Color Code)

15.2. Dye-SR Pro Module Specifications • Light Source:


• Spectrum:

550 – 650nm


3 cm2

• Cooling:

TEC


15-3


15.3. Dye-SR Pro Module Operating Screen The Dye-SR Pro module main operating screens (see Figure 15-2) are displayed when the Dye-SR Pro module is connected to the system:

• To switch from Dye-SR to Dye-SSR mode, press the Dye-SR softkey on the screen.

• To switch from Dye-SSR to Dye-SR mode, press the Dye-SSR softkey on the screen.

Figure 15-2: Dye-SR Pro Module Operating Screen Operating parameters available in this module: SR Mode

15-4

SSR Mode


Up to 15 J/cm2

1 – 4 J/cm2

• Pulse Duration:

10, 12, 15 msec.

1, 3, 30 sec.


1 Hz

3 Hz



15.4. Dye-SR Pro Module Regulatory Labels Figure 15-3 presents the regulatory identification and caution labels adhered to the Dye-SR Pro module connector:

Figure 15-3: Dye-SR Pro Module Regulatory Labels

15.5. Ordering Information The following table offers names of accessories specific to the Dye-SR Pro module that may be ordered form Alma Lasers. Table 15-1: Dye-SR Pro Module Accessories Description Dye-SR Pro (Vascular/Pigmented Lesions) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)


15-5


15.6. Dye-SR Pro Module Clinical Guide for Vascular Lesions The treatment of vascular lesions with the HarmonyXL system can be performed using the Dye-SR Pro 550-650nm (orange color code) module. The Dye-SR Pro module is indicated for vascular lesions. Warning The appropriate protective eyewear should be worn by both the operator and the customer when using this module.

15.6.1. Indications for Use The Advanced Fluorescence Technology (AFT) Dye-SR Pro module is indicated for:





• Use on Fitzpatrick skin types I-V.






15-6




15.6.3. Pre-Treatment 15.6.3.1.


15.6.3.2.


15.6.3.3.



Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III

Dye-SR Pro 550-650nm (orange color code)

10, 12

11 – 13

30 min

IV


12, 15

7 – 10

24 – 48 hours

V


15

5–7

24 – 48 hours*



15-7


15.6.4. Treatment • The Dye-SR Pro cooled module will treat vessels up to < 1mm. • Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses.



1.


2.

Apply a thin layer (usually 1mm thick and 2mm for darker skin types) of refrigerated (43-50°F/6-10°C) cooling gel to the treatment site. This aids skin cooling during the pulse sequence and improves coupling of the light into the skin and additional comfort to the customer during treatment.

3.




5.


6.


7.


8.


9.



15-8



15.6.5. Suggested Dye-SR Pro Setup Parameters for Vascular Lesions Table 15-3: Suggested Dye-SR Pro Setup Parameters for Vascular Lesions Fitzpatrick Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


10, 12

11 – 14

IV


12, 15

8 – 11

V


15

5–7


• Within three weeks after the treatment customers should return for


• If no additional treatment is necessary, customers should return for an additional examination two months later.

• In case of a partial clearance of the lesion, the treatment should be continued using the same parameters and the customer should return for examination and for additional treatment, if necessary after three weeks.


• Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Customers should be instructed to avoid sun exposure after and in between treatments.



15-9


15.7. Dye-SR Pro Module Clinical Guide for Pigmented Lesions The Pigmented Lesions application of the HarmonyXL system can be performed with the Dye-SR Pro module. The Dye-SR Pro module is indicated for pigmented lesions. Warning The appropriate protective eyewear should be worn by both the operator and the customer when using this module.



15.7.3. Pre-Treatment 15.7.3.1.


15.7.3.2.


15-10



15.7.3.3.



Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III


10, 12

11 – 13

30 min

IV


12, 15

7 – 10

24 – 48 hours

V


15

5–7

24 – 48 hours*




2.


3.


4.


5.


6.


7.


8.


9.



15-11


10. If the skin shows no adverse effects and changes observed in the lesions are unsatisfactory, you should increase the fluence by 10-20%. 11. To maximize the cooling/coupling properties of the applied gel, make sure to apply the gel immediately before each pass/treatment. After treatment, remove the gel from treated areas. Do not reuse gel. 12. After treatment, it is recommended to cool the area immediately.

15.7.5. Suggested Dye-SR Pro Setup Parameters for Pigmented Lesions Table 15-5: Suggested Dye-SR Pro Setup Parameters for Pigmented Lesions Fitzpatrick Skin Type

Module

Pulse Width (msec)

Fluence (J/cm2)

I – III


10, 12

11 – 14

IV


12, 15

8 – 11

V


15

5–7


• Within three weeks after the treatment customers should return for


• If no additional treatment is necessary, customers should return for an additional examination two months later.

• In case of a partial clearance of the lesion, the treatment should be continued using the same parameters and the customer should return for examination and for additional treatment, if necessary after three weeks.


• Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Customers should be instructed to avoid sun exposure after and in between treatments.

15-12





15-13


15.8. Dye-SSR Mode Clinical Guide The Skin Rejuvenation application of the HarmonyXL system is performed using the Dye-SR Pro (orange color code) module in Dye-SSR mode. Warning The appropriate protective eyewear should be worn by both the operator and the customer when using this module.

15.8.1.

Indications for Use The Dye-SR Pro module in Dye-SSR mode is indicated for:



• Use on Fitzpatrick skin types I-V.

15.8.2.


15-14



15.8.3.

Module Operation The Dye-SR Pro module in Dye-SSR mode may be operated with 3 different time intervals: 1, 3 and 30 seconds. In the 1-second and 3-second intervals, the module is used employing the Stationary technique. In the 30-second interval, the module is used employing the In-Motion technique (see Section 15.8.5). The 1-second and 3-second intervals are used on small areas where you want to treat localized, small, superficial pigmented or vascular lesions (i.e., back of the hand or upper lip). The 30-second interval is used on large areas where you want to treat signs of photodamage/ photoaging irregularities (dyschromia, lentigines, freckles, etc.). The Dye-SR Pro module incorporates thermo-electric coupling (TEC) technology; the module can be operated in two conditions: Cooling On (default) and Off. The module spot size is 3cm2 and the pulse repetition rate is fixed at 3 Hz. The total energy delivered at any given time interval is expressed in kilojoules (kJ). Ultrasonic gel should be used in both Stationary and In-Motion techniques.

15.8.4.

Pre-Treatment


15.8.4.2. Skin Test Always perform a skin test on the intended treatment area before the first treatment session, with the Cooling mode On and according to the following parameters: Table 15-6: Dye-SSR Skin Test Parameters (30 second interval) Fitzpatrick Skin Type

Fluence (J/cm2)

Cooling [On/Off] *


I – II

3–4

On

2.4 – 3.2

III

2–3

On

1.6 – 2.4

IV

2

On

1.6

V

1–2

On

0.8 – 1.6

The 1-second and 3-second time intervals are indicated for the Stationary technique. (*) Ultrasonic gel must be applied to the skin in both Cooling On or Off modes. (**) The total energy is adjusted for 10x10 cm (100cm2) area. Important: a thin coat of ultrasonic gel must be applied on the skin for ALL skin types. Harmony®XL Modules Operator's Manual

15-15


15.8.5.

Treatment (In-Motion Technique) Treatment can begin after the Dye-SR Pro module has been connected to the HarmonyXL system and the treatment parameters selected (fluence) according to Table 15-7. 1.


2.

Provide appropriate eye protection (OD>5) goggles for the customer and the operating staff in the enclosed treatment room.

3.

Apply a thin layer (usually 1-2mm thick for all skin types) of refrigerated cooling gel (43-50°F/6-10°C) to the treatment site. The gel will provide: a) a thermal sink for the absorbed and reflected energy, thus providing some cooling to the skin itself; b) comfort to the customer during treatment and; c) friction reduction/lubrication during the In-Motion technique.

4.


5.


6.


7.


8.


9.

End-points: mild-to-moderate erythema for skin types I-IV; mild erythema for skin type V.


15-16



15.8.6.

Suggested Setup Parameters Table 15-7: Dye-SSR Suggested Setup Parameters (30 second interval) Fitzpatrick Skin Type

Fluence (J/cm2)

Cooling [On/Off] *


I – II

3–4

On

3.2 – 4.3

III

2–3

On

2.1 – 3.2

IV

2

On

2.1

V

1–2

On

1.0 – 2.1


15.8.7.



2.


3.


4.

Check skin reaction; if there is no apparent skin reaction – repeat until endpoints are visible.

5.

Treatment parameters may be increased by 10% every other treatment and subjected to the conditions in the area treated and customer's tolerance.

6.


7.


8.



15-17


15.8.8.

Treatment of Small Areas Table 15-8: Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion* Fitzpatrick Skin Type

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – II

3–4

On

0.3 – 0.4

III

2–3

On

0.2 – 0.3

IV

2

On

0.2

V

1–2

On

0.1 – 0.2

(*) Apply gel

Table 15-9: Small Area Parameters, 3-25 cm2, 1 Second, In-Motion* Fitzpatrick Skin Type

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – II

3–4

On

0.3 – 0.4

III

2–3

On

0.2 – 0.3

IV

2

On

0.2

V

1–2

On

0.1 – 0.2

(*) Apply gel

15-18



15.8.9.

Follow-up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen. • Within three weeks after treatment customers should return for examination of the treatment site and for additional treatment, if necessary. • If no additional treatment is necessary, customers should return for an additional examination one month later. • Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Customers should be instructed to avoid sun exposure after and in between treatments. • Treatment intervals: treatment is reapplied (assuring there have been no adverse reactions) every 3-4 weeks. • 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: 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]


15-19

CHAPTER 16 HR Module – Hair Removal Chapter Contents: Section

Title

Page

16.1.

HR Module Description................................................................... 16-2

16.2.

HR Module Specifications ............................................................... 16-2

16.3.

HR Module Operating Screen ......................................................... 16-3

16.4.

HR Module Regulatory Labels ........................................................ 16-4

16.5.


16.6.

HR Module Clinical Guide .............................................................. 16-5

16.6.1. Indications for Use ......................................................................... 16-5 16.6.2. Contraindications............................................................................ 16-5 16.6.3. Pre-Treatment ................................................................................. 16-6 16.6.4. Treatment........................................................................................ 16-6 16.6.5. Suggested HR Setup Parameters .................................................... 16-8 16.6.6. Follow-Up ...................................................................................... 16-9


16-1

HR Module – Hair Removal

16.1. HR Module Description The HR module has a high-power targeted module for hair removal. It employs Alma Laser's proprietary AFT pulsed light technology in the red wavelength range (650-950nm) along with adjustable parameters for effective hair removal. A complete discussion of the HR module clinical applications may be found in Section 16.6. The HR module has a red identification section (see Figure 16-1).

Figure 16-1: HR Module (Red Color Code)

16.2. HR Module Specifications

16-2

• Light Source:


• Spectrum:

650 – 950nm


5 – 25 J/cm2


6.4 cm2

• Pulse Widths:

30, 40, 50 msec


2/3 Hz

• Cooling:

None



16.3. HR Module Operating Screen The HR cooling module main operating screen (see Figure 16-2) is displayed when the HR module is connected to the system.

Figure 16-2: HR Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.


• 30 msec • 40 msec • 50 msec 3.



16-3


16.4. HR Module Regulatory Labels Figure 16-3 presents the regulatory identification and caution labels adhered to the HR module connector:

Figure 16-3: HR Module Regulatory Labels

16.5. Ordering Information The following table offers names of accessories specific to the HR module that may be ordered form Alma Lasers. Table 16-1: HR Module Accessories Description HR (Hair Removal) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

16-4



16.6. HR Module Clinical Guide The HarmonyXL system with the HR 650-950nm module is designed for the removal of unwanted hair and to effect stable long-term or permanent hair reduction. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

16.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) 650-950nm HR module is indicated for:

• The removal of unwanted hair and to effect stable long-term or permanent hair reduction.

• Use on all skin types (Fitzpatrick I-VI), including tanned skin.

16.6.2.

Contraindications • History of local or recurrent skin infection • Pregnancy (including IVF procedure) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – in the past 3-6 months • Retin-A – in the past 2 weeks • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis • Previous treatment modalities – method, frequency and date of last treatment, as well as response

• Recent (in the past 2 weeks) suntan or exposure to a tanning bed • Tattoos or nevi present • Past or ongoing medical condition (diabetes, epilepsy, high or low blood pressure, or others)

• Present medications: Photosensitizing medications Gold therapy


16-5


16.6.3.

Pre-Treatment

16.6.3.1.

Patient Evaluation Before hair removal procedures, the patient should be evaluated for the presence of conditions that may cause hypertrichosis:

• Hormonal • Familial • Drug (i.e., corticosteroids, hormones, immunosuppressive self or spousal use of minoxidil)

• Tumor 16.6.3.2.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters in the table below. The treatment parameters for hair removal depend on the skin type, hair color, density and depth. Once treatment parameters are selected, shave the treatment site to eliminate any surface hair that could interfere with the treatment.

Table 16-2: HR Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I

HR 650-950nm (Red)

30

20

30 minutes

II

HR 650-950nm (Red)

30

18

30 minutes

III

HR 650-950nm (Red)

40

16

30 minutes

IV

HR 650-950nm (Red)

50

12

24 – 48 hours

V

HR 650-950nm (Red)

50

8

24 – 48 hours

VI

HR 650-950nm (Red)

50

6

24 – 48 hours

16.6.4.

Treatment Treatment can begin after the HR module is connected and the treatment parameters are selected (fluence and timer interval) according to Table 16-2.

16-6

1.


2.

Apply a thin layer (usually ~1 mm and ~2 mm for darker types) of refrigerated cooling gel (43-50°F/6-10°C) to the treatment site. The gel will provide a thermal sink for the absorbed and reflected energy, provide some cooling to the skin itself, and additional comfort to the patient during treatment.



3.

Place the module perpendicular to the skin and touch the skin to ensure a good seal. Do not apply excessive pressure on the skin.

4.


5.


6.

Examine the treatment site for any change of the skin color and morphological changes around the follicles (erythema/edema). The smell of burnt hair may sometimes be detected, although a lack of smell does not necessarily indicate that the present parameters are ineffective.

7.

It is recommended to wait 30 minutes after a test shot has been triggered for skin types I-IV, and 24-48 hours for skin types V and VI before proceeding.

8.

If there are no noticeable changes in the hair follicles, or adverse effects, increase the settings by 10-20% (skin types I-IV). Do not increase settings on skin type V or VI until the initial test has been reviewed 24-48 hours after treatment.

9.

If adverse skin effects occur (such as excessive reddening) before good follicular response is achieved, reduce the settings by 10-20%.

10. Make the above adjustments and test again on an adjacent area until adverse effects on the skin no longer appear. 11. After treatment it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care).


16-7


16.6.5.

Suggested HR Setup Parameters The following table shows the recommended parameters based on the patient hair color and skin type:

Table 16-3: Suggested HR Setup Parameters Skin Type (Fitzpatrick I-VI) I

II

III

IV

V

VI

Hair Color

Module

Fluence (J/cm2)

Pulse Width (msec)

Light

HR 650-950nm (Red)

20 – 25

30, 40

Dark

HR 650-950nm (Red)

19 – 23

30, 40

Light

HR 650-950nm (Red)

20 – 25

30, 40

Dark

HR 650-950nm (Red)

19 – 23

30, 40

Light

HR 650-950nm (Red)

18 – 24

30, 40

Dark

HR 650-950nm (Red)

17 – 22

30, 40

Light

HR 650-950nm (Red)

16 – 20

40, 50

Dark

HR 650-950nm (Red)

14 – 18

40, 50

Light

HR 650-950nm (Red)

Up to 15

50

Dark

HR 650-950nm (Red)

Up to 13

50

Light

N/A

N/A

N/A

Dark

HR 650-950nm (Red)

Up to 10

50

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

16-8



16.6.6.


• 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.).




16-9

CHAPTER 17 SHR Pro Module – Super Hair Removal Chapter Contents: Section

Title

Page

17.1.

SHR Pro Module Description .......................................................... 17-3

17.2.

SHR Pro Module Specifications ...................................................... 17-4

17.2.1. HR Mode ........................................................................................ 17-4 17.2.2. SHR Mode ...................................................................................... 17-4 17.3.

Lightguide Footprint Size Selection ................................................ 17-4

17.4.

SHR Pro Module Operating Screens ............................................... 17-5

17.5.

Total Energy in the SHR Pro Module.............................................. 17-6

17.6.

SHR Pro Module Regulatory Labels ............................................... 17-6

17.7.


17.8.

SHR Pro Module Clinical Guide – HR Mode ................................. 17-7

17.8.1. Indications for Use ......................................................................... 17-7 17.8.2. Contraindications............................................................................ 17-7 17.8.3. Pre-Treatment ................................................................................. 17-8 17.8.4. Treatment........................................................................................ 17-8 17.8.5. Suggested HR Setup Parameters .................................................. 17-10 17.8.6. Follow-Up .................................................................................... 17-11 17.9.

SHR Pro Module Clinical Guide – SHR Mode ............................. 17-12

17.9.1. Indications for Use ....................................................................... 17-12 17.9.2. Contraindications.......................................................................... 17-12 17.9.3. Module Operation in SHR Mode ................................................. 17-12 17.9.4. Pre-Treatment ............................................................................... 17-13


17-1

SHR Pro Module – Super Hair Removal

17.9.5. Treatment ...................................................................................... 17-14 17.9.6. Suggested Setup Parameters ......................................................... 17-16 17.9.7. Treatment of Small Areas ............................................................. 17-17 17.9.8. Follow-Up ..................................................................................... 17-17

17-2



17.1. SHR Pro Module Description The SHR Pro module incorporates two separate wavelengths in one module, both effecting long-term or permanent hair reduction:

• Proprietary AFT pulsed light in the red wavelength range along with adjustable parameters.

• Near infrared wavelength range. A complete discussion of the SHR Pro module clinical applications may be found in Section 17.8. The SHR Pro module has a brown identification section (see Figure 17-1). This module incorporates a contact-cooling mechanism.

Figure 17-1: SHR Pro Module (Brown Color Code)


17-3


17.2. SHR Pro Module Specifications 17.2.1.

17.2.2.

HR Mode • Light Source:



5 – 25 J/cm2


3 cm2

• Pulse Widths:

30, 40, 50 msec


2/3 Hz

• Cooling:

TEC

SHR Mode • Light Source:

Near Infrared pulsed light


3 – 7 J/cm2


3 cm2

• Timer:

1, 3 and 30 seconds


3 Hz

• Cooling:

TEC

17.3. Lightguide Footprint Size Selection Since the SHR modules are available with several different lightguide footprint sizes, the system will require the operator to select the footprint size of the SHR module's lightguide prior treatment application. After connecting your particular SHR module to the system, and turning the system on, a Select Lightguide screen will appear offering all available lightguide footprint sizes available: 3cm2, 5cm2 or 6.4cm2 (see Chapter 6 in the System Operator's manual). Select the footprint size by pressing key appropriate to the module connected to the system. Note In the latest series of HarmonyXL modules offered by Alma Lasers, the lightguide size is already programmed in the module. In such a case, the pop-up window will offer only the one correct footprint size; press that key to continue.

17-4



17.4. SHR Pro Module Operating Screens The SHR Pro module main operating screen (see Figure 17-2) is displayed when the SHR Pro module is connected to the system.

• To switch from HR to SHR mode, press the SHR soft-key on the SHR screen. • To switch from SHR to HR mode, press the HR soft-key on the HR screen The SHR Pro module's contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the screen:

• COOLING ON (default mode) • COOLING OFF (touch the COOLING ON softkey) HR Mode

SHR Mode

Figure 17-2: SHR Pro Cooling Module Operating Screens Operating parameters available in HR mode: 1.

Fluence – the available range is from 5 to 25 J/cm2 in increments of 1 J/cm2.

2.


• 30 msec 3.

• 40 msec

• 50 msec


Operating parameters available in SHR mode: 1.


1 J/cm2.

2.

Timer – 1, 3 and 30 seconds

3.



17-5


17.5. Total Energy in the SHR Pro Module The SHR Pro module's SHR operating screen exhibits the total energy applied per session, counted in Kilojoules (see kJ counter in top-right corner of Figure 17-2): Note If the system stays in SHR Pro mode during patient rotation, it is important to reset the Total Energy by pressing the Reset key.

17.6. SHR Pro Module Regulatory Labels Figure 17-3 presents the regulatory identification and caution labels adhered to the SHR Pro module connector:

Figure 17-3: SHR Pro Module Regulatory Labels

17.7. Ordering Information The following table offers names of accessories specific to the SHR Pro module that may be ordered form Alma Lasers. Table 17-1: SHR Pro Module Accessories Description SHR Pro (Super Hair Removal) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

17-6



17.8. SHR Pro Module Clinical Guide – HR Mode The HarmonyXL system with the SHR Pro module is indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

17.8.1.

Indications for Use The SHR Pro module in HR mode is indicated for:



17.8.2.

Contraindications • History of local or recurrent skin infection • Pregnancy (including IVF procedure) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – In the past 3-6 months • Retin-A – In the past 2 weeks • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis • Previous treatment modalities – method, frequency and date of last treatment, as well as response

• Recent suntan or exposure to a tanning bed • Tattoos or nevi present • Past or ongoing medical condition (diabetes, epilepsy, high or low blood pressure, or others)



17-7


17.8.3.

Pre-Treatment

17.8.3.1.



• Tumor 17.8.3.2.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters in the table below. The treatment parameters for hair removal depend on the skin type, hair color, density and depth. Once treatment parameters are selected, shave the treatment site to eliminate any surface hair that could interfere with the treatment.

Table 17-2: Cooled HR Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Mode

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I

HR

30

15

30 minutes

II

HR

30

15

30 minutes

III

HR

40

12

30 minutes

IV

HR

50

9

24 – 48 hours

V

HR

50

7

24 – 48 hours

VI

HR

50

5

24 – 48 hours

17.8.4.

Treatment Treatment can begin after the SHR Pro module is connected, set to HR mode and the treatment parameters are selected (fluence and timer interval) according to Table 17-2.

17-8

1.


2.




3.


4.


5.


6.


7.


8.


9.




17-9


17.8.5.

Suggested HR Setup Parameters The following table shows the recommended parameters based on the patient hair color and skin type:


II

III

IV

V

VI

Hair Color

Mode

Fluence (J/cm2)

Pulse Width (msec)

Light

HR

20 – 25

30, 40

Dark

HR

19 – 23

30, 40

Light

HR

20 – 25

30, 40

Dark

HR

19 – 23

30, 40

Light

HR

18 – 24

30, 40

Dark

HR

17 – 22

30, 40

Light

HR

16 – 20

30, 40

Dark

HR

14 – 18

30, 40

Light

HR

Up to 15

50

Dark

HR

Up to 13

50

Light

N/A

N/A

N/A

Dark

HR

Up to 13

50


17-10



17.8.6.










17-11


17.9. SHR Pro Module Clinical Guide – SHR Mode The HarmonyXL system with the SHR Pro module is indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

17.9.1.

Indications for Use The SHR Pro module in SHR mode is indicated for:


• The treatment pseudofolliculitis barbae (PFB). • Use on all skin types (Fitzpatrick I-VI), including tanned skin.

17.9.2.

Contraindications Refer to Section 17.8.2

17.9.3.

Module Operation in SHR Mode The module may be operated under 3 different time intervals: 1, 3 and 30 seconds. In the 1- and 3-second interval the module is used in Stationary technique. In the 30-second interval the module is used in the In-Motion technique (see Section 17.9.5). The 1- and 3-second intervals are used on small areas (face mustache, chin etc). The 30-second interval is used on larger areas (body – arms, chest, back, legs, axilla, bikini line etc). The SHR Pro NIR module incorporates thermo-electric coupling (TEC) technology; the module can be operated under two conditions: cooling ON (default) and cooling OFF. The spot size is 3 cm2 and the pulse repetition rate is fixed at 3 Hz. Ultrasonic gel should be used in both techniques in OFF or ON cooling modes. Appropriate eye protection for the client and the operator is mandatory.

17-12



17.9.4.

Pre-Treatment

17.9.4.1.

Patient Evaluation Refer to Section 17.8.3.1

17.9.4.2.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the parameters in Table 17-4. The treatment parameters for hair removal depend on the skin type, hair color, hair type, and the density and depth of the hair. Initially, shave the treatment site to eliminate any surface hair that could interfere with the treatment. Mark a grid (using a red pen) on an area of 10x10 cm (100cm2). Treat with the In-Motion technique within each treatment grid, as per treatment description in Section 17.9.5. Table 17-4: SHR Pro Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *


I

7

On

6.0

II

7

On

6.0

III

7

On

6.0

IV

6

On

6.0

V

5

On

6.0

VI

5

On

6.0

The 1-second and 3-second time intervals are indicated for the Stationary technique. (*)

Ultrasonic gel must be applied to the skin in both Cooling On or Off modes.

(**)

In-Motion technique; the total energy is adjusted for 10x10 cm or 4x25cm (100cm2) area.


17-13


17.9.5.

Treatment Treatment can begin after the SHR Pro module is connected, set to SHR mode and the treatment parameter (fluence), treatment interval, and cooling (On/Off) is selected according to Table 17-5. 1.

Shave the treatment site to eliminate any surface hair that could interfere with the treatment; remove any hairs debris with adhesive tape.

2.


3.

Mark a grid (using a red pen) on an area of treatment of about 10x10 cm. Mark additional adjacent grids as needed based on the area size.

4.


5.

Apply a thin layer (usually 1-2mm thick) of refrigerated (43-50°F / 6-10°C) cooling gel to the treatment site when module cooling is Off or On. The gel will provide: a) a thermal sink for the absorbed and reflected energy, thus providing some cooling to the skin itself; b) comfort to the patient during treatment and; c) friction reduction/lubrication during the In-Motion technique.

6.

Set the initial fluence and operation time interval (1, 3 or 30 sec) parameter according to the skin test results and the size of the treatment area.

7.

In most cases, operation time intervals should be set for 30 seconds for large areas; the 1- and 3-second interval should be selected for very small areas on the face, like the upper lip and chin (using the Stationary technique rather than the In-Motion technique).

8.


9.

Treat within the grid area in an In-Motion technique according to the recommended parameters and passes.

10. In-Motion Technique:

• Move the module on the surface of the skin and, only when the module is in full contact and "in-motion", then trigger the footswitch.

• Move the module in continuous linear or circular motions, to cover the

entire grid area. This repeated pattern may last several minutes, depending on the recommended total energy (kJ).

• After completing a single interval, raise the module from the skin, re-

position at the point where you began treatment in this grid and repeat another interval on the entire area.

• After completing the recommended number of intervals, move to the contra-lateral side and repeat as above.

• Check skin reaction; if the skin reaction is not apparent - repeat. Repeat until clinical end points are visible.

• Observe for erythema or perifollicular erythema/edema (i.e., end points).

17-14



• Examine the treatment site for change of skin color and morphological

changes around the follicles (erythema/edema). The smell of burnt hair may sometimes be detected, although its absence does not necessarily indicate that the present parameters are ineffective.

11. Stationary Technique: apply ultrasonic gel to the treatment area in both On and Off cooling modes.

• In the Stationary technique, use the 1- or 3-second interval; up to 10% overlapping is an acceptable tolerance.

12. Set the fluence parameters according to the parameters indicated in Table 17-4 (provided that the patient has tolerated the skin test). 13. Trigger a pulse by continuously pressing the footswitch for the entire time interval; the module will stop emitting light automatically unless interrupted by the operator (releasing the footswitch). In order to continue, the footswitch must be pressed again.


• Observe for erythema or perifollicular erythema/edema (i.e., end points). • Examine the treatment site for change of skin color and morphological


14. If there are no noticeable changes on the skin (Skin Types IV-VI) or near the hair follicles when the cooling is On, do not repeat. 15. If adverse skin effects occur (such as excessive reddening) before the desired follicular response is achieved, adjust the treatment parameters to reduce the aggressiveness of the treatment. 16. After treatment it is recommended to cool the area immediately with cold (water based) cloth or gauze, and apply Aloe Vera gel.


17-15


17.9.6.

Suggested Setup Parameters The treatment parameters for hair removal depend on the skin type, hair color, hair type and the density & depth of the hair. Treat using with the In-Motion technique within each treatment grid, as per the explanation in Section 17.9.5. Table 17-5: SHR Pro Suggested Setup Parameters

(*)


Fluence (J/cm2)

Cooling [On/Off] *


I

7

On

6.0 – 7.8

II

7

On

6.0 – 7.8

III

7

On

6.0 – 7.8

IV

6

On

6.0 – 7.8

V

6

On

6.0 – 7.8

VI

5

On

6.0 – 7.8


(**) The total energy is adjusted for 10x10 cm or 4x25cm (100cm2) area at 30 sec intervals. The 1- and 3-second operation is indicated for the Stationary technique. In the Stationary mode multiple pulses/repetitions should be employed until clinical end-points are visible. Table 17-6: Suggested Total Energy (kJ) delivered per Anatomic Site Anatomical Area

Number of Grids

Total Energy (kJ)

Chest & Abdomen

15

90 – 117

Axilla

0.5

3.0 – 3.9 *

Back

18

108 – 140

Bikini

0.5

3.0 – 3.9 *

Upper Arm

6

36 – 46 *

Lower Arm

4

24 – 31 *

Upper Leg

9

54 – 70 *

Lower Leg

7

42 – 54 *

(*) Unilateral

17-16



17.9.7.

Treatment of Small Areas Table 17-7: Small Area Parameters, 3-25 cm2, 1 or 3 Seconds, In-Motion Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – III

5–6

On

Up to 5.4

IV

4–5

On

Up to 5.4

V - VI

3–4

On

Up to 5.4

Table 17-8: Small Area Parameters, Up To 3 cm2, 1 or 3 Seconds, Stationary* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – III

5

On

Up to 0.9

IV

4

On

Up to 0.9

V - VI

3

On

Up to 0.9

(*) Repeat twice.

17.9.8.

Follow-Up Refer to Section 17.8.6


17-17

CHAPTER 18 SHR Pro 5 Module (5 cm2) – Super Hair Removal Chapter Contents: Section

Title

Page

18.1.

SHR Pro 5 Module Description ....................................................... 18-3

18.2.

SHR Pro 5 Module Specifications ................................................... 18-4

18.2.1. HR Mode ........................................................................................ 18-4 18.2.2. SHR Mode ...................................................................................... 18-4 18.3.

Lightguide Footprint Size Selection ................................................ 18-4

18.4.

SHR Pro 5 Module Operating Screens ............................................ 18-5

18.5.

Total Energy in the SHR Pro 5 Module........................................... 18-6

18.6.

SHR Pro 5 Module Regulatory Labels ............................................ 18-6

18.7.


18.8.

SHR Pro 5 Pro Module Clinical Guide – HR Mode ........................ 18-7

18.8.1. Indications for Use ......................................................................... 18-7 18.8.2. Contraindications............................................................................ 18-7 18.8.3. Pre-Treatment ................................................................................. 18-8 18.8.4. Treatment........................................................................................ 18-8 18.8.5. Suggested HR Setup Parameters .................................................. 18-10 18.8.6. Follow-Up .................................................................................... 18-11 18.9.

SHR Pro 5 Pro Module Clinical Guide – SHR Mode.................... 18-12

18.9.1. Indications for Use ....................................................................... 18-12 18.9.2. Contraindications.......................................................................... 18-12 18.9.3. Module Operation in SHR Mode ................................................. 18-12 18.9.4. Pre-Treatment ............................................................................... 18-12


18-1

SHR Pro 5 Module – Super Hair Removal

18.9.5. Treatment ...................................................................................... 18-14 18.9.6. Suggested Setup Parameters ......................................................... 18-16 18.9.7. Follow-Up ..................................................................................... 18-17

18-2



18.1. SHR Pro 5 Module Description The SHR Pro 5 module has a high-power targeted handpiece for hair removal. It operates in the near infrared wavelength range along with adjustable parameters for effective hair removal. A complete discussion of the SHR Pro 5 module clinical applications may be found in Section 18.8. The SHR Pro 5 module handpiece has a brown identification section (see Figure 18-1). This module incorporates a contact-cooling mechanism.

Figure 18-1: SHR Pro 5 Module Handpiece (Brown Color Code)


18-3


18.2. SHR Pro 5 Module Specifications 18.2.1.

18.2.2.

HR Mode • Light Source:



5 – 20 J/cm2


5 cm2

• Pulse Widths:

30, 40, 50 msec


2/3 Hz

• Cooling:

TEC

SHR Mode • Light Source:

Near Infrared pulsed light


3 – 7 J/cm2


5 cm2

• Timer:

1, 3 and 30 seconds


3 Hz

• Cooling:

TEC

18.3. Lightguide Footprint Size Selection Since the SHR modules are available with several different lightguide footprint sizes, the system will require the operator to select the footprint size of the SHR module's lightguide prior treatment application. After connecting your particular SHR module to the system, and turning the system on, a Select Lightguide screen will appear offering all available lightguide footprint sizes available: 3cm2, 5cm2 or 6.4cm2 (see Chapter 6 in the System Operator's manual). Select the footprint size by pressing key appropriate to the module connected to the system. Note In the latest series of HarmonyXL modules offered by Alma Lasers, the lightguide size is already programmed in the module. In such a case, the pop-up window will offer only the one correct footprint size; press that key to continue.

18-4



18.4. SHR Pro 5 Module Operating Screens The SHR Pro 5 module main operating screen (see Figure 18-2) is displayed when the module is connected to the system.

• To switch from HR to SHR mode, press the SHR soft-key on the SHR screen. • To switch from SHR to HR mode, press the HR soft-key on the HR screen The SHR Pro 5 module's contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the screen:

• COOLING ON (default mode) • COOLING OFF (touch the COOLING ON softkey) HR Mode

SHR Mode

Figure 18-2: SHR Pro 5 Cooling Module Operating Screens Operating parameters available in HR mode: 1.

Fluence – the available range is from 5 to 20 J/cm2 in increments of 1 J/cm2.

2.


• 30 msec 3.

• 40 msec

• 50 msec


Operating parameters available in this module: 1.


1 J/cm2.

2.


3.



18-5


18.5. Total Energy in the SHR Pro 5 Module The SHR Pro 5 module's operating screen exhibits the total energy applied per session, counted in Kilojoules (see kJ counter in top-right corner of Figure 18-2): Note If the system stays in SHR mode during patient rotation, it is important to reset the Total Energy by pressing the Reset key.

18.6. SHR Pro 5 Module Regulatory Labels Figure 18-3 presents the regulatory identification and caution labels adhered to the SHR Pro 5 module handpiece connector:

Figure 18-3: SHR Pro 5 Module Regulatory Labels

18.7. Ordering Information The following table offers names of accessories specific to the SHR Pro 5 module that may be ordered form Alma Lasers. Table 18-1: SHR Pro 5 Module Accessories Description SHR Pro 5 (Super Hair Removal) Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

18-6



18.8. SHR Pro 5 Pro Module Clinical Guide – HR Mode The HarmonyXL system with the SHR Pro 5 module is indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

18.8.1.

Indications for Use The SHR Pro 5 module in HR mode is indicated for:



18.8.2.

Contraindications • History of local or recurrent skin infection • Pregnancy (including IVF procedure) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – In the past 3-6 months • Retin-A – In the past 2 weeks • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis • Previous treatment modalities – method, frequency and date of last treatment, as well as response

• Recent suntan or exposure to a tanning bed • Tattoos or nevi present • Past or ongoing medical condition (diabetes, epilepsy, high or low blood pressure, or others)



18-7


18.8.3.

Pre-Treatment

18.8.3.1.



• Tumor 18.8.3.2.

Skin Test Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters in the table below. The treatment parameters for hair removal depend on the skin type, hair color, density and depth. Once treatment parameters are selected, shave the treatment site to eliminate any surface hair that could interfere with the treatment.

Table 18-2: Cooled HR Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Mode

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I

HR

30

15

30 minutes

II

HR

30

15

30 minutes

III

HR

40

12

30 minutes

IV

HR

50

9

24 – 48 hours

V

HR

50

7

24 – 48 hours

VI

HR

50

5

24 – 48 hours

18.8.4.

Treatment Treatment can begin after the SHR Pro 5 module is connected, set to HR mode and the treatment parameters are selected (fluence and timer interval) according to Table 18-2.

18-8

1.


2.




3.


4.


5.


6.


7.


8.


9.




18-9


18.8.5.

Suggested HR Setup Parameters Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters. The recommended parameters are based on the patient hair color and skin type:


II

III

IV

V

VI

Hair Color

Mode

Fluence (J/cm2)

Pulse Width (msec)

Light

HR

15 – 20

30

Dark

HR

13 – 18

30

Light

HR

15 – 20

30

Dark

HR

13 – 18

30

Light

HR

15 – 20

40

Dark

HR

12 – 17

40

Light

HR

15 – 17

40

Dark

HR

10 – 15

50

Light

HR

Up to 15

50

Dark

HR

Up to 13

50

Light

N/A

N/A

N/A

Dark

HR

Up to 12

50


18-10



18.8.6.










18-11


18.9. SHR Pro 5 Pro Module Clinical Guide – SHR Mode The HarmonyXL system with the SHR Pro 5 Near Infrared (NIR) module is indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

18.9.1.

Indications for Use The Advanced Fluorescence Technology (AFT) SHR Pro 5 cm module is indicated for:


• The treatment pseudofolliculitis barbae (PFB). • Use on all skin types (Fitzpatrick I-VI), including tanned skin.

18.9.2.


18.9.3.

Module Operation in SHR Mode The module may be operated under 3 different time intervals: 1, 3 and 30 seconds. In the 1- and 3-second interval the module is used in Stationary technique. In the 30-second interval the module is used in the In-Motion technique (see Section 18.9.5). The 1- and 3-second intervals are used on small areas (face mustache, chin etc). The 30-second interval is used on larger areas (body – arms, chest, back, legs, axilla, bikini line etc). The SHR Pro 5 NIR module incorporates thermo-electric coupling (TEC) technology; the module can be operated under two conditions: cooling ON (default) and cooling OFF. The spot size is 5cm2 and the pulse repetition rate is fixed at 3 Hz. Ultrasonic gel should be used in both techniques in OFF or ON cooling modes. Appropriate eye protection for the client and the operator is mandatory.

18.9.4.

Pre-Treatment

18.9.4.1.

Patient Evaluation Refer to Section 18.8.3.1.

18-12



18.9.4.2.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the parameters in Table 18-4. The treatment parameters for hair removal depend on the skin type, hair color, hair type, and the density and depth of the hair. Initially, shave the treatment site to eliminate any surface hair that could interfere with the treatment. Mark a grid (using a red pen) on an area of 15x10 cm (150cm2). Treat with the In-Motion technique within each treatment grid, as per treatment description in 18.9.5. Table 18-4: SHR Pro 5 Skin Test Parameters** Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off] *


I

7

On

10.0

II

7

On

10.0

III

7

On

10.0

IV

6

On

10.0

V

5

On

10.0

VI

5

On

10.0

The 1-second and 3-second time intervals are indicated for the Stationary technique. (*) Ultrasonic gel must be applied to the skin in both Cooling On or Off modes. (**) In-Motion technique; the total energy is adjusted for 15x10 cm (~150cm2) area.


18-13


18.9.5.

Treatment Treatment can begin after the SHR Pro 5 NIR module is connected and the treatment parameter (fluence), treatment interval, and cooling (On/Off) is selected according to Table 18-5. 1.

Shave the treatment site to eliminate any surface hair that could interfere with the treatment; remove any hair debris with adhesive tape.

2.


3.

Mark a grid (using a red pen) on an area of treatment of about 150cm2. Mark additional adjacent grids as needed based on the area size.

4.


5.

Apply a thin layer (usually 1-2mm thick) of refrigerated (43-50°F / 6-10°C) cooling gel to the treatment site when module cooling is Off or On. The gel will provide: a) a thermal sink for the absorbed and reflected energy, thus providing some cooling to the skin itself; b) comfort to the patient during treatment and; c) friction reduction/lubrication during the In-Motion technique.

6.

Set the initial fluence and operation time interval (1, 3 or 30 sec) parameter according to the skin test results and the size of the treatment area.

7.

In most cases, operation time intervals should be set for 30 seconds for large areas; the 1- and 3-second interval should be selected for very small areas on the face, like the upper lip and chin (using the Stationary technique rather than the In-Motion technique).

8.


9.

Treat within the grid area in an In-Motion technique according to the recommended parameters and passes.

10. In-Motion Technique:

• Move the module on the surface of the skin and, only when the module is in full contact and "in-motion", then trigger the footswitch.

• Move the module in continuous linear or circular motions, to cover the

entire grid area. This repeated pattern may last several minutes, depending on the recommended total energy (kJ).

• After completing a single interval, raise the module from the skin, re-

position at the point where you began treatment in this grid and repeat another interval on the entire area.

• After completing the recommended number of intervals, move to the contra-lateral side and repeat as above.


• Observe for erythema or perifollicular erythema/edema (i.e., end points).

18-14



• Examine the treatment site for change of skin color and morphological


11. Stationary Technique: apply ultrasonic gel to the treatment area in both On and Off cooling modes.

• In the Stationary technique, use the 1- or 3-second interval; up to 10% overlapping is an acceptable tolerance.

12. Set the fluence parameters according to the parameters indicated in Table 18-4 (provided that the patient has tolerated the skin test). 13. Trigger a pulse by continuously pressing the footswitch for the entire time interval; the module will stop emitting light automatically unless interrupted by the operator (releasing the footswitch). In order to continue, the footswitch must be pressed again.


• Observe for erythema or perifollicular erythema/edema (i.e., end points). • Examine the treatment site for change of skin color and morphological


14. If there are no noticeable changes on the skin (Skin Types IV-VI) or near the hair follicles when the cooling is On, do not repeat. 15. If adverse skin effects occur (such as excessive reddening) before the desired follicular response is achieved, adjust the treatment parameters to reduce the aggressiveness of the treatment. 16. After treatment it is recommended to cool the area immediately with cold (water based) cloth or gauze, and apply Aloe Vera gel.


18-15


18.9.6.

Suggested Setup Parameters The treatment parameters for hair removal depend on the skin type, hair color, hair type and the density & depth of the hair. Treat using with the In-Motion technique within each treatment grid, as per the explanation in Section 18.9.5. Table 18-5: SHR Pro 5 Suggested Setup Parameters

(*)


Fluence (J/cm2)

Cooling [On/Off] *


I

7

On

10.0 – 13.0

II

7

On

10.0 – 13.0

III

7

On

10.0 – 13.0

IV

6

On

10.0 – 13.0

V

5

On

10.0 – 13.0

VI

5

On

10.0 – 13.0


(**) The total energy is adjusted for 15x10 cm (~150cm2) area, at 30 sec intervals. The 1- and 3-second operation is indicated for the Stationary technique. In the Stationary mode multiple pulses/repetitions should be employed until clinical end-points are visible. Table 18-6: Suggested Total Energy (kJ) delivered per Anatomic Site Anatomical Area

18-16

Number of Grids

Total Energy (kJ)

Chest & Abdomen

10

100 – 130

Axilla

0.5

5.0 – 6.5 **

Back

12

120 – 156

Bikini

0.5

5.0 – 6.5 **

Upper Arm

4

40 – 52 **

Lower Arm

3

30 – 39 **

Upper Leg

6

60 – 78 **

Lower Leg

5

50 – 65 **

(*)

Based on full surface area/circumference

(**)

Unilateral



Table 18-5: Suggested Total Energy (kJ) delivered –Small areas (up to 25cm2) Anatomical Area

Number of Grids

Total Energy (kJ)

Sideburns

1

4.3 – 6.5 *

Upper lip perioral

1

2.6 – 5.2 *

Chin

1

2.6 – 5.2 *

Submental

1

4.3 – 6.5 *

(*)

18.9.7.

Unilateral



• 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 no change is noted, treatment parameters and the number of passes 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.).


• Treatment intervals: treatment is reapplied (assuring there have been no adverse reactions) at 4-8 week intervals.

• 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:

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]


18-17

CHAPTER 19 ST Module – Scar Revision & Treatment of Striae Chapter Contents: Section

Title

Page

19.1.

ST Module Description.................................................................... 19-2

19.2.

ST Module Specifications................................................................ 19-2

19.3.

ST Module Operating Screen .......................................................... 19-3

19.4.

ST Module Regulatory Labels ......................................................... 19-4

19.5.


19.6.

ST Module Clinical Guide ............................................................... 19-4

19.6.1. Indications for Use ......................................................................... 19-5 19.6.2. Contraindications............................................................................ 19-5 19.6.3. Pre-Treatment ................................................................................. 19-5 19.6.4. Module Operation........................................................................... 19-6 19.6.5. Skin Test ......................................................................................... 19-6 19.6.6. Treatment........................................................................................ 19-7 19.6.7. Suggested Setup Parameters ........................................................... 19-9 19.6.8. Follow-Up .................................................................................... 19-10


19-1

ST Module – Scar Revision & Striae Treatment

19.1. ST Module Description The Harmony ST NIR (burgundy color code) module emits light in the near infrared spectrum generated by a pulsed-light source. The ST module can be used to treat cutaneous lesions such as striae, stretch marks and scar revision. A complete discussion of the ST module clinical applications may be found in Section 19.6. The ST module has a burgundy identification section (see Figure 19-1).

Figure 19-1: ST Module (Burgundy Color Code)

19.2. ST Module Specifications

19-2

• Light Source:

Pulsed light

• Spectrum:

Near Infrared


1 – 7 J/cm2


6.4 cm2

• Timers:

10, 30, 90 seconds


2 Hz

• Cooling:

None



19.3. ST Module Operating Screen The ST module main operating screen (see Figure 19-2) is displayed when the ST module is connected to the system:

Figure 19-2: ST Module Operating Screen Operating parameters available in this module: 1. 2.


1 J/cm2.

Timers – there are three timer settings in this module:

•

10 Seconds

•

30 Seconds

•

90 Seconds


19-3


19.4. ST Module Regulatory Labels Figure 19-3 presents the regulatory identification and caution labels adhered to the ST module connector:

Figure 19-3: ST Module Regulatory Labels

19.5. Ordering Information The following table offers names of accessories specific to the ST module that may be ordered form Alma Lasers. Table 19-1: ST Module Accessories Description ST Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

19.6. ST Module Clinical Guide The Harmony ST NIR (burgundy color code) module emits light in the near infrared spectrum generated by a pulsed-light source. The ST module can be used to treat cutaneous lesions such as striae, stretch marks and scar revision. Caution The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

19-4



19.6.1.

Indications for Use The Advanced Fluorescence Technology (AFT) ST module is indicated for:

• The treatment of cutaneous lesions including warts, scars and striae. • Use on all skin types (Fitzpatrick I-VI), including tanned skin.

19.6.2.


• Whole body tattoos or very large areas • Eye-liner or lip-liner tattoos in treatment area • Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site


• History of keloid scarring • Epilepsy • Gold therapy • Photosensitizing drugs; tetracycline, St. John’s Wort (herbal remedy) in the past 3 months for depression (because of increased photosensitivity)

• Isotretinoin – Roaccutane in the previous 3-6 months • Tretinoin – Retin A in the last 2 weeks • Diabetes (owing to possible photosensitivity and poor wound healing) • Pregnancy • Impaired immune system • Scleroderma

19.6.3.

Pre-Treatment

19.6.3.1.



19-5


19.6.4.

Module Operation The module can be applied to the skin using two different free-hand techniques: Stationary and In-Motion (recommended technique). In stationary technique, the practitioner places the module on the skin for the entire exposure time and fluence conditions. In the in-motion technique, the module is moved continuously on the skin for the entire exposure time and fluence conditions. In the stationary technique, the module should be positioned in complete contact with the skin and slightly pressed towards the skin. In the in-motion technique, the module should be moved along the skin in continuous circular movements within the treatment area.

19.6.4.1.

Module Parameters J/cm2

10 sec 1

30 sec1

90 sec1

1

10

30

90

2

20

60

180

3

35

90

270

4

40

120

360

5

55

150

450

6

60

180

540

7

70

210

630

The ST module delivers between 1-7 J/cm2 per pulse. The time interval options for the module operation are 10, 30 and 90 seconds. The time elapsed is displayed on the screen for each interval, along with auditory beep. The total fluence depends on the exposure time. In stationary technique (10 second exposure) the total fluence is 10-70 J/cm2 (see above table). The fluence delivered when using the In-Motion technique depends on the size of the treatment area.

19.6.5.

Skin Test Always perform a skin test on the intended treatment area (forehead, face, or neck areas) before the first treatment session. After covering the area with thin (<1mm) layer of cold ultrasonic gel, place the module on the skin according to the following exposure settings/techniques. The skin test should be performed on the treatment area.

1

19-6

Energy settings in J/cm2 are displayed vertically



19.6.5.1.

19.6.5.2.

19.6.6.

Face Mode

Test Spot No.

Exposure Time [Sec]

Fluence [J/cm2]

Accumulative Fluence

In-Motion

1

30

4

120

In-Motion

2

30

5

150

In-Motion

3

30

6

180

Mode

Test Spot No.

Exposure Time [Sec]

Fluence [J/cm2]


In-Motion

1

30

4

120

In-Motion

2

30

5

150

In-Motion

3

30

6

180

Abdomen

Treatment After the ST module has been connected to the Harmony system and suitable settings (time exposure and fluence) have been selected, the treatment can begin.

19.6.6.1.

In-Motion Protocol 1.


2.

In areas where hair exists, the hair must be shaved or trimmed.

3.


4.

Apply room-temperature ultrasonic gel (thin layer ~1mm) to the skin and place the module perpendicular to the skin. During the treatment add ultrasonic gel to the treatment area as needed. Do not apply pressure (the lightguide should gently touch the skin).

5.

Skin tissue heating is specific to the individual patient and area, and therefore should be monitored/gauged to the individual patient's tolerance.

6.

Clinical end-points: skin should appear red/pink (mild-moderate erythema); patient should report that the skin feels warm.

7.

If no visible end-points appear but the patient reports deep heat sensation during the treatment, do not repeat treatment.


19-7


19.6.6.2.


In the stationary technique, up to 10% overlapping is an acceptable tolerance.

2.

Set the initial exposure time and fluence parameters according to the skin test results.

3.


4.

Treatment parameters may be increased by 10% every other treatment and subjected to the conditions in the area treated and the patient's tolerance.

5.


6.


7.

If adverse skin effects occur (such as excessive reddening or swelling), you may either reduce the exposure time or reduce the fluence.

8.

After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care). Note Always perform a skin test on the intended treatment area during the first treatment session.

19-8



19.6.7.

Suggested Setup Parameters The face/neck and the abdomen are divided into 6 bilateral areas: upper-right (1); upper-left (2); mid-right (3); mid-left (4); lower-right (5); lower-left (6).

19.6.7.1.

Face Exposure Time [Sec]

Fluence [J/cm2]


Forehead, Neck

90

4–7

360 – 630

Submental, Cheeks, Jowls

90

5–7

450 – 630

Exposure Time [Sec]

Fluence [J/cm2]


Upper Abdomen

90

5–7

450 – 630

Mid-Lateral Abdomen

90

5–7

450 – 630

Lower Abdomen

90

5–7

450 – 630

Area

19.6.7.2.

Abdomen Area

If the patient is uncomfortable with the temperature after 3 x 90 sec passes stop treatment for this session. Passes may be increased if the patient has easily tolerated 3 passes of 90 seconds each.


19-9


19.6.8.


• Patients should be invited four weeks after treatment for examination of the treatment site and for additional treatment, if necessary.

• Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments.


19-10


CHAPTER 20 SST Module – Super Skin Tightening Chapter Contents: Section

Title

Page

20.1.

SST Module Description ................................................................. 20-2

20.2.

SST Module Specifications ............................................................. 20-2

20.3.

SST Module Operating Screen ........................................................ 20-3

20.4.

Total Energy in the SST Module ..................................................... 20-4

20.5.

SST Module Regulatory Labels....................................................... 20-4

20.6.


20.7.

SST Module Clinical Guide............................................................. 20-5

20.7.1. Indications for Use ......................................................................... 20-5 20.7.2. Contraindications............................................................................ 20-5 20.7.3. Module Operation........................................................................... 20-6 20.7.4. Pre-Treatment ................................................................................. 20-6 20.7.5. Treatment........................................................................................ 20-7 20.7.6. Suggested Setup Parameters (In-Motion Protocol) ........................ 20-9 20.7.7. Treatment of Small Areas ............................................................. 20-10 20.7.8. Follow-Up .................................................................................... 20-10


20-1

SST Module – Super Skin Tightening

20.1. SST Module Description The Harmony SST module emits light in the near infrared spectrum generated by a pulsed-light source. The SST module can be used to treat cutaneous lesions such as striae, stretch marks – scar revision and reduce the presence of wrinkles. A complete discussion of the SST module clinical applications may be found in Section 20.7. The SST module has a burgundy identification section (see Figure 20-1). This module incorporates a contact-cooling mechanism.

Figure 20-1: SST Module (Burgundy Color Code)

20.2. SST Module Specifications

20-2

• Light Source:

Near-infrared pulsed light


0.5 – 3.5 J/cm2


3 cm2

• Timers:

1, 3 and 30 seconds


5 Hz

• Cooling:

TEC



20.3. SST Module Operating Screen The SST module main operating screen (see Figure 20-2) is displayed when the SST module is connected to the system: The SST module's contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the screen:


Figure 20-2: SST Module Operating Screen Operating parameters available in this module: 1.

Fluence – the available fluence range is from 0.5 to 3.5 J/cm2 in increments of

0.1 J/cm2.

2.


3.



20-3


20.4. Total Energy in the SST Module The SST module's operating screen exhibits the total energy applied per session, counted in Kilojoules (see kJ counter in top-right corner of Figure 20-2): Note If the system stays in SST mode during patient rotation, it is important to reset the Total Energy by pressing the Reset key.

20.5. SST Module Regulatory Labels Figure 20-3 presents the regulatory identification and caution labels adhered to the SST module connector:

Figure 20-3: SST Module Regulatory Labels

20.6. Ordering Information The following table offers names of accessories specific to the SST module that may be ordered form Alma Lasers. Table 20-1: SST Module Accessories Description SST Module Light Safety Glasses (OD 3+) Dark Safety Glasses (OD 5+)

20-4



20.7. SST Module Clinical Guide The HarmonyXL SST module (burgundy color code) emits light in the near infrared spectrum generated by a pulsed-light source. The SST module can be used to treat cutaneous lesions such as striae, stretch marks – scar revision and reduce the presence of wrinkles. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

20.7.1.

Indications for Use The Advanced Fluorescence Technology (AFT) SST module is indicated for:

• The treatment of cutaneous lesions including warts, scars and striae. • Use on all skin types (Fitzpatrick I-VI), including tanned skin.

20.7.2.

Contraindications • Whole body tattoos or very large areas • Eye-liner or lip-liner tattoos in treatment area • Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.) • History of keloid scarring • Epilepsy • Photosensitizing drugs; gold therapy, tetracycline, St. John’s Wort (herbal remedy) in the past 3 months for depression (because of increased photosensitivity) • Isotretinoin (Roaccutane or Tretinoin) – In the previous 3-6 months • Retin – A – In the past 2 weeks • Diabetes (owing to possible photosensitivity and poor wound healing) • Pregnancy • Impaired immune system • Scleroderma


20-5


20.7.3.

Module Operation The SST module may be operated with 3 different time intervals: 1, 3 and 30 seconds. In the 1-second and 3-second intervals, the module is used employing the Stationary technique. In the 30-second interval, the module is used employing the In-Motion technique (see Section 20.7.5). The 1-second and 3-second intervals are used on small area (face – upper lip, under chin, etc.). The 30-second interval is used on large areas (body – abdomen, neck, arms, and chest). The SST module incorporates thermo-electric coupling (TEC) technology; the module can be operated under two conditions: Cooling ON (default) and Cooling OFF. The spot size is 3 cm2 and the pulse repetition rate is fixed at 5 Hz. The total energy delivered at any given time interval is expressed in kilojoules (kJ).

20.7.4.

Pre-Treatment

20.7.4.1.


20.7.4.2.

Skin Test Always perform a skin test on the intended treatment area (forehead, face, abdomen or neck areas) before the first treatment session. After covering the area with a thin layer (~1mm) of room temperature ultrasonic gel, place the module on the skin according to the following exposure settings/techniques. Table 20-2: SST Skin Test Parameters – Forehead, Cheeks and Neck

20-6


Fluence (J/cm2)

Total Energy [kJ]*

Cooling**

I – III

3.5

16.2

On

IV

3.2

16.2

On

V – VI

2.8

16.2

On



Table 20-3: SST Skin Test Parameters – Abdomen, Thigh and Upper Arm Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Total Energy [kJ]*

Cooling**

I – III

3.5

17.4

On

IV

3.2

17.4

On

V – VI

2.8

17.4

On

(*)

The number of cycles and the total energy are adjusted for a 10x15 cm (150cm2) area.

(**) Ultrasonic gel must be applied to the skin in both Cooling On or Off modes. The 1-second and 3-second time intervals are indicated for the Stationary technique.

20.7.5.

Treatment Treatment can begin after the SST module has been connected to the HarmonyXL system and the treatment parameters selected (time exposure and fluence) according to the Suggested Setup Parameters tables in Section 20.7.6.

20.7.5.1.

In-Motion Protocol 1.


2.

In areas where hair exists, the hair must be shaved or trimmed.

3.


4.

Apply room-temperature ultrasonic gel (thin layer ~1mm) to the skin and place the module perpendicular to the skin. During the treatment add ultrasonic gel to the treatment area as needed. Do not apply pressure (the lightguide should gently touch the skin).

5.

Skin tissue heating is specific to the individual patient and area, and therefore should be monitored/gauged to the individual patient's tolerance.

6.


7.

If no visible end-points appear but the patient reports deep heat sensation during the treatment, do not repeat treatment.


20-7


20.7.5.2.


In the stationary technique, up to 10% overlapping is an acceptable tolerance.

2.

Set the initial exposure time and fluence parameters according to the skin test results.

3.


4.

Treatment parameters may be increased by 10% every other treatment and subjected to the conditions in the area treated and the patient's tolerance.

5.


6.


7.

If adverse skin effects occur (such as excessive reddening or swelling), you may either reduce the exposure time or reduce the fluence.

8.

After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care). Note Always perform a skin test on the intended treatment area during the first treatment session.

20-8



20.7.6.

Suggested Setup Parameters (In-Motion Protocol) For treatment purposes, the face/neck and the abdomen should be divided into six bilateral areas: upper-right (1); upper-left (2); mid-right (3); mid-left (4); lowerright (5); lower-left (6). Table 20-4: SST Suggested Setup Parameters – Forehead, Cheeks and Neck Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Total Energy [kJ]*

Cooling**

I – III

3.5

16.2 – 22.2

On

IV

3.2

16.2 – 22.2

On

V – VI

2.8

16.2 – 22.2

On

Table 20-5: SST Suggested Setup Parameters – Abdomen, Thigh and Upper Arm Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Total Energy [kJ]*

Cooling**

I – III

3.5

17.4 – 23.4

On

IV

3.2

17.4 – 23.4

On

V – VI

2.8

17.4 – 23.4

On

(*)

The number of cycles and the total energy are adjusted for a 10x15 cm (150cm2) area.

(**) Ultrasonic gel must be applied to the skin and cooling mode must always be On. The 1-second and 3-second time intervals are indicated for the Stationary technique.


20-9


20.7.7.

Treatment of Small Areas Table 20-6: Small Area Parameters, 3-25 cm2, 1 or 3 Seconds, In-Motion Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – III

3.5

On

10.5 – 13.5

IV

3.0

On

10.5 – 13.5

V - VI

2.5

On

10.5 – 13.5

Table 20-7: Small Area Parameters, Up To 3 cm2, 1 or 3 Seconds, Stationary* Skin Type (Fitzpatrick I-VI)

Fluence (J/cm2)

Cooling [On/Off]

Total Energy [kJ]

I – III

3.0

On

0.6 – 1.2

IV

2.5

On

0.6 – 1.2

V - VI

2.0

On

0.6 – 0.9

(*) Repeat twice

20.7.8.

Follow-Up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen. • Patients should be invited four weeks after treatment for examination of the treatment site and for additional treatment, if necessary. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments. • Treatment intervals: treatment is reapplied (assuring there have been no adverse reactions) at 2-4 week intervals. All adverse side effects should be reported to the treating physician with a followup report sent to the Director of Clinical Operations at Alma Lasers: 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]

20-10


CHAPTER 21 Laser QS 1064/532nm Module – Tattoo Removal and Vascular Lesions Chapter Contents: Section

Title

Page

21.1.

Laser QS 1064/532nm Module Description .................................... 21-2

21.2.

Laser QS 1064/532nm Module Specifications ................................ 21-3

21.2.1. Standard Tip Module Specifications .............................................. 21-3 21.2.2. 532nm KTP Tip Module Specifications ......................................... 21-3 21.3.

Laser QS 1064/532nm Module Operating Screen ........................... 21-4

21.4.

Laser QS 1064/532nm Module Regulatory Labels ......................... 21-5

21.5.


21.6.

Laser QS 1064/532nm Module Clinical Guide ............................... 21-6

21.6.1. Indications for Use ......................................................................... 21-6 21.6.2. Pre-Treatment ................................................................................. 21-8 21.6.3. Treatment...................................................................................... 21-10 21.6.4. Suggested Setup Parameters ......................................................... 21-11 21.6.5. Post-Treatment Care ..................................................................... 21-11 21.6.6. Follow-Up .................................................................................... 21-12


21-1

Laser QS 1064/532nm Module - Tattoo Removal & Vascular Lesions

21.1. Laser QS 1064/532nm Module Description The Laser QS 1064/532nm module has a high-power targeted laser module for the non-invasive removal of various colored tattoos, as well as deep and superficial, benign pigmented lesions. The module can be operated in Laser QS or Frequency Doubled (FD) Laser QS modes, depending on the connected tip. A complete discussion of the Laser QS 1064/532nm module's clinical applications may be found in Section 21.6 of this manual. The Laser QS 1064/532nm module is identified by QS 1064nm printed on the module (see Figure 21-1).

Figure 21-1: 1064/532nm Laser QS Module

21-2



21.2. Laser QS 1064/532nm Module Specifications 21.2.1.

21.2.2.

Standard Tip Module Specifications • Light Source:

Q-Switched Nd:YAG

• Wavelength:

1064nm

• Pulse Width:

fixed at 20 nsec

• Spot Size:

1, 2 mm (3, 4, 5 & 6 mm optional)

• Pulse Frequency:

1, 2, 5 Hz


400 – 1200 mJ/pulse

532nm KTP Tip Module Specifications • Light Source:


• Wavelength:

532nm


400 – 1200 mJ/pulse

• Tip Spot Size

2 mm

• Pulse Width:

fixed at 20 nsec


1, 2, 5 Hz


21-3


21.3. Laser QS 1064/532nm Module Operating Screen The Laser QS 1064/532nm module main operating screen (see Figure 21-2) is displayed when the Laser QS 1064/532nm laser module is connected to the system:

Figure 21-2: Laser QS 1064/532nm Module Operating Screen with Standard Tip Operating parameters available in this module:

21-4

1.

There are six standard tips (1 mm through 6 mm), and one 532nm KTP 2 mm tip available for use with this laser module. The system automatically recognizes the resident tip and displays its size in the top-right corner of the screen.

2.

Fluence – the available fluence range is from 400 to 1200 mJ/pulse in increments of 100 mJ/pulse.

3.

Pulse Frequency:

1, 2, 5 Hz

4.

Pulse Width:

fixed at 20 nsec



21.4. Laser QS 1064/532nm Module Regulatory Labels Figure 21-3 presents the regulatory identification and caution labels adhered to the Laser QS 1064/532nm module connector:

Figure 21-3: Laser QS 1064/532nm Module Regulatory Labels

21.5. Ordering Information The following table offers names of accessories specific to the Laser QS 1064/532nm module that may be ordered form Alma Lasers. Table 21-1: Laser QS 1064/532nm Module Accessories Description Laser QS 1064/532nm Module (inc. 1, 2 & 3 mm tips) 1 mm tip for Laser QS 1064/532nm Module 2 mm tip for Laser QS 1064/532nm Module 3 mm tip for Laser QS 1064/532nm Module 4 mm tip for Laser QS 1064/532nm Module 5 mm tip for Laser QS 1064/532nm Module 6 mm tip for Laser QS 1064/532nm Module 2 mm KTP tip for Laser QS 1064/532nm Module Safety Glasses for 1064nm (OD 7+) KTP Safety Glasses for FD QS 1064nm


21-5


21.6. Laser QS 1064/532nm Module Clinical Guide The Laser QS 1064/532nm (1064nm and 532nm KTP) module is indicated for tattoo removal and the treatment of benign epidermal pigmented (solar lentigines, nevi of Ota and Ito and Café-au-lait macules) and superficial vascular lesions. The Laser QS 1064nm tip is indicated for the treatment of deep pigmented lesions. The 1064nm and 532nm (bright green light) wavelength and the nanosecond pulse domain is chosen based upon the significant attraction to a dark pigment chromophore while minimizing the nonspecific thermal effects from the primary endogenous chromophores. Warning

• The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

• When using the 532nm KTP tip appropriate eyewear protection must be used by both the practitioner and the patient (and anyone else in the room).

• Different eyewear is indicated and therefore must be used for the 1064nm vs. the 532nm wavelength.

21.6.1.

Indications for Use The 1064/532nm Frequency-Doubled (FD) Nd:YAG laser module tips are indicated for:

• Incision, excision, ablation, vaporization of soft tissue. • Tattoo removal: Blue Black Yellow Red Green

• Vascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, and spider hemangiomas). Angiomas (cherry, spider) Telangiectasia Spider nevi

21-6



• Benign pigmented lesions: Café-au-lait (macules) Lentigines (senile and solar) Freckles (ephelides) Chloasma Nevi Nevus spillus Nevus of Ota Becker's nevi

21.6.1.1.

Absolute Contraindications • Cellulitis (MRSA) • Psoriasis • Lichen Planus • Lichen Nitidus • Renal Failure (Acute or Chronic) • Malignancy • Multiple Sclerosis • Vitiligo • Immunosuppression • Keloids • Certain Medications (i.e. Accutane) • Collagen Vascular Diseases

21.6.1.2.

Relative Contraindications • Poorly Controlled Diabetes Mellitus • Thrombocytopenia • Peripheral Vascular Disease • Anemia • Bleeding Disorders • Rheumatoid Arthritis/ Juvenile Rheumatoid Arthritis


21-7


• Subnormal Intelligence or Psychiatric Disorders • History of Post-Inflammatory Hyperpigmentation • Chronic Disease (Crohn’s Disease, IBD, etc.)

21.6.2.

Pre-Treatment

21.6.2.1.

Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth and density. Before treatment the practitioner should conduct a full tattoo patient history: When was the tattoo placed? What inks/dyes were used? Where were the inks mixed together to make the color? Is there any white ink in the tattoo to the patient's knowledge? Has the patient attempted to remove or alter the tattoo previously? If so - how? Has the patient used oral retinoids with in the past year? History of herpes infection or cold sores? History of keloid formation or easy scarring, current suntan, tanning bed or bronze use? Fitzpatrick skin type? The treatment parameters for tattoos depend on the skin and on the characteristics of the tattoo itself (i.e., professional, amateur or traumatic). Color, depth, skin type, age of the tattoo and density of colors are all important factors when deciding on parameters for tattoo removal. The composition of an amateur tattoo is elemental carbon and the professional - organic dyes mixed with metallic elements. Response rate for tattoo removal is a function of pigment depth, total pigment volume as well as surface area.

21.6.2.2.

Preparing the Tattoo for Treatment Most practitioners will apply a topical anesthetic (i.e. EMLA) on the tattoo area 60 minutes before treatment. This may not be necessary for tattoos that are less dense based upon the design or on the age of the tattoo. The Laser QS HarmonyXL module has different spot size tips. It may be desirable to alternate the spot size beginning with a large spot size tip on the first treatment.

21-8



21.6.2.3.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters. It is important to ensure that the patient is not tanned. Warning Appropriate protective eyewear protection must be used by both the practitioner and the patient (and anyone else in the room).

Table 21-2: Tattoo Removal Skin Test Parameters for Blue, Black & Green Tattoos (standard tips) Skin Type

Spot Size


Energy (mJ)

Waiting Period

I – VI

1, 2, 3 mm

1, 2, 5

500 – 700

24 – 48 hours

Table 21-3: Tattoo Removal Skin Test Parameters for Red Tattoos (KTP tip) Skin Type

Spot Size


Energy (mJ)

Waiting Period

I – III

2 mm

1, 2, 5

600

24 – 48 hours

IV – VI

2 mm

1, 2, 5

400 – 600

24 – 48 hours

Note It is recommended that the patient return for treatment 24 – 48 hours after the skin test.


21-9


21.6.3.

Treatment 1.

Clean and dry the skin to remove the EMLA cream from the tattoo area.

2.

Appropriate protective eyewear protection must be used by both the practitioner and the patient (and anyone else in the room).

3.

Place the module perpendicular to the tattooed skin.

4.

Overlapping should not exceed 10%.

5.

Set the initial fluence parameter according to the skin test results

6.

Trigger the Laser QS laser by pressing the footswitch and the module trigger simultaneously.

7.

Diagnose carefully. Remember: darker skin types take longer to respond than lighter skin types. The desired effect is a change in tattoo color (whitening effect), without changes in the surrounding epidermis.

8.

If, along with a good response in the tattoo, adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), you should reduce the fluence by 10-20% and attempt to treat in an adjoining area.

9.

If the skin shows no adverse effects or extended side effects and changes observed in the tattoo color are unsatisfactory, you may increase the fluence.

10. After treatment it is recommended to cool the area immediately, apply antibacterial ointment and cover the treated tattoo area with sterile pad gauze. 11. Recommended treatment intervals: between eight and twelve weeks. Note The Laser QS 1064nm module can remove black, blue & green pigmented tattoos with the 1064nm wavelength, and red & brown pigments with the 532nm KTP wavelength. Caution It is imperative that the tips and their lenses remain clean and free of debris. The tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.

21-10



21.6.4.


Table 21-4: Suggested Setup Parameters for Blue, Black & Green Tattoos Skin Type

Spot Size

Wavelength


Energy (mJ/P)

I – VI

1, 2, 3

1064nm

1, 2, 5

600 – 1000

Table 21-5: Suggested Setup Parameters for Red Tattoos Skin Type

Wavelength


Energy (mJ/P)

I – III

532nm KTP

1, 2, 5

800 – 1100

IV – VI

532nm KTP

1, 2, 5

700 – 1000

Caution Small spot size and high fluence often cause bleeding.

21.6.5.

Post-Treatment Care • Apply a layer of Polysporin ointment, Petrolatum, or Bacitracin, beneath a dressing of nonstick gauze and paper tape.

• Instruct the patient to change the dressing twice daily after first gently cleansing the area with soap and water; continue until re-epithelialized.

• Keep the area moist with antibiotic ointment at all times. • Apply Aloe Vera gel for soothing. • Avoid direct exposure to the sun on the treatment area; use UVA/UVB sun blockers.


21-11


21.6.6.


• Patients should return no sooner than eight weeks after the last treatment, for examination of the treatment site and for additional treatment, if necessary.

• If no additional treatment is necessary, the patient should return for a follow-up examination after two months.

• If there has been partial clearance of the tattoo, treatment should be continued, and the patient should return after a minimum of eight weeks for examination and for additional treatment, if necessary.

• If no change is noted in the tattoo, fluence should be increased by at least 10%, and the patient should return no sooner than four weeks for an examination.



21-12


CHAPTER 22 Laser QS 1064/532nm High Power Module – Tattoo Removal and Pigmented & Vascular Lesions Chapter Contents: Section

Title

Page

22.1.

QS 1064/532nm High Power Module Description .......................... 22-2

22.2.

Laser QS 1064/532nm High Power Module Specifications ............ 22-3

22.2.1. Module Specifications with Standard and Pixel Tips ..................... 22-3 22.2.2. Module Specifications with CVD (Continuous Variable Defocusing) Tip 22-3 22.2.3. Module Specifications with 532nm KTP Tip ................................. 22-3 22.3.

QS 1064/532nm High Power Module Operating Screen................. 22-4

22.4.

QS 1064/532nm High Power Module Regulatory Labels ............... 22-5

22.5.


22.6.

QS 1064/532nm High Power Module Clinical Guide ..................... 22-6

22.6.1. Indications for Use ......................................................................... 22-6 22.6.2. Pre-Treatment ................................................................................. 22-8 22.6.3. Treatment Procedure – Standard Tips .......................................... 22-10 22.6.4. Treatment Procedure – Pixel Tip .................................................. 22-11 22.6.5. Suggested Setup Parameters ......................................................... 22-11 22.6.6. Post-Treatment Care – Tattoos (Standard Tips) ........................... 22-12 22.6.7. Post-Treatment Care – Pigmented Lesions (Pixel Tip) ................ 22-12 22.6.8. Follow-Up .................................................................................... 22-13


22-1

QS 1064/532nm High Power - Tattoo Removal and Pigmented & Vascular Lesions

22.1. QS 1064/532nm High Power Module Description The Laser QS 1064/532nm module has a high-power targeted laser module for the non-invasive removal of various colored tattoos, as well as deep and superficial, benign pigmented lesions. The module can be operated in Standard QS, Pixel QS or Frequency Doubled (FD) QS modes, depending on the connected tip. A complete discussion of the Laser QS 1064/532nm high power module's clinical applications may be found in Section 22.6 of this manual. The Laser QS 1064/532nm module is identified by QS 1064nm printed on the module.

Figure 22-1: 1064/532nm Laser QS High Power Module

22-2



22.2. Laser QS 1064/532nm High Power Module Specifications 22.2.1. Module Specifications with Standard and Pixel Tips • Light Source:

Q-Switched Nd:YAG

• Wavelength:

1064nm

• Pulse Width:

fixed at 20 nsec

• Spot Size:

3, 5 mm Standard 5x5 mm Pixel


1, 2, 4 Hz


500 – 1200 mJ/pulse

22.2.2. Module Specifications with CVD (Continuous Variable Defocusing) Tip • Light Source:

Q-Switched Nd:YAG

• Wavelength:

1064nm

• Pulse Width:

fixed at 20 nsec

• Spot Size:

variable from 1 to 5 mm


1, 2, 4 Hz


500 – 1200 mJ/pulse

22.2.3. Module Specifications with 532nm KTP Tip • Light Source:


• Wavelength:

532nm


500 – 1200 mJ/pulse

• Tip Spot Size

3 mm

• Pulse Width:

fixed at 20 nsec


1, 2, 4 Hz


22-3


22.3. QS 1064/532nm High Power Module Operating Screen The Laser QS 1064/532nm high power module main operating screen (see Figure 22-2) is displayed when the Laser QS 1064/532nm laser module is connected to the system:

Figure 22-2: Laser QS 1064/532nm High Power Module Operating Screen with Standard 5mm Tip (Left) and 5x5 Pixel Tip (Right) Operating parameters available in this module: 1.

There are two standard tips (3 mm and 5 mm), one 5x5 Pixel tip, one 532nm KTP (3 mm) tip and a CVD tip available for use with this laser module. The system automatically recognizes the resident tip and displays its size in the topright corner of the screen.

2.

Fluence – the available fluence range is from 500 to 1200 mJ/pulse in

3.

Pulse Frequency:

1, 2, 4 Hz

4.

Pulse Width:

fixed at 20 nsec

increments of 100 mJ/pulse.

The CVD (Continuous Variable Defocusing) tip is designed to enable switching between spot sizes of 1 to 5 mm just by rotating the tip to the correct scale mark on the body of the tip. Switching between the spot sizes will change the power density for more or less aggressive treatment as required; the larger the spot size – the deeper the penetration will be.

22-4



22.4. QS 1064/532nm High Power Module Regulatory Labels Figure 22-3 presents the regulatory identification and caution labels adhered to the Laser QS 1064/532nm high power module connector:

Figure 22-3: Laser QS 1064/532nm High Power Module Regulatory Labels

22.5. Ordering Information The following table offers names of accessories specific to the Laser QS 1064/532nm high power module that may be ordered form Alma Lasers. Table 22-1: Laser QS 1064/532nm High Power Module Accessories Description Laser QS 1064/532nm High Power Module (inc. 3 & 5 mm Standard tips) 3 mm Standard Tip for Laser QS 1064/532nm Module 5 mm Standard Tip for Laser QS 1064/532nm Module 5x5 mm Pixel Tip for Laser QS 1064/532nm Module 3 mm KTP tip for Laser QS 1064/532nm Module CVD (Continuous Variable Defocus) tip for Laser QS Module Safety Glasses for 1064nm (OD 7+) KTP Safety Glasses for FD QS 1064nm


22-5


22.6. QS 1064/532nm High Power Module Clinical Guide The Laser QS 1064/532nm (1064nm and 532nm KTP) high power module is indicated for tattoo removal and the treatment of benign epidermal pigmented (solar lentigines, nevi of Ota and Ito and Café-au-lait macules) and superficial vascular lesions. The Laser QS 1064nm standard tips and Pixel tip are indicated for the treatment of deep pigmented lesions. The 1064nm and 532nm (bright green light) wavelength and the nanosecond pulse domain is chosen based upon the significant attraction to a dark pigment chromophore while minimizing the nonspecific thermal effects from the primary endogenous chromophores. Warning

• The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

• When using the 532nm KTP tip appropriate eyewear protection must be used by both the practitioner and the patient (and anyone else in the room).

• Different eyewear is indicated and therefore must be used for the 1064nm vs. the 532nm wavelength.

22.6.1. Indications for Use The QS 1064 Pixel tip is indicated for the non-invasive treatment of pigmented and vascular lesions. The 1064/532nm Frequency-Doubled (FD) Nd:YAG laser module with Standard tips QS tips is indicated for:

• Incision, excision, ablation, vaporization of soft tissue. • Tattoo removal: Blue Black Yellow Red Green

• Vascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, and spider hemangiomas). Angiomas (cherry, spider) Telangiectasia Spider nevi

22-6



• Benign pigmented lesions: Café-au-lait (macules) Lentigines (senile and solar) Freckles (ephelides) Chloasma Nevi Nevus spillus Nevus of Ota Becker's nevi

22.6.1.1.

Absolute Contraindications • Cellulitis (MRSA) • Psoriasis • Lichen Planus • Lichen Nitidus • Renal Failure (Acute or Chronic) • Malignancy • Multiple Sclerosis • Vitiligo • Immunosuppression • Keloids • Certain medications (i.e. Accutane) • Collagen Vascular Diseases

22.6.1.2.

Relative Contraindications • Poorly Controlled Diabetes Mellitus • Thrombocytopenia • Peripheral Vascular Disease • Anemia • Bleeding Disorders • Rheumatoid Arthritis/ Juvenile Rheumatoid Arthritis


22-7


• Subnormal Intelligence or Psychiatric Disorders • History of Post-Inflammatory Hyperpigmentation • Chronic Disease (Crohn’s Disease, IBD, etc.)

22.6.2. Pre-Treatment 22.6.2.1.

Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and the lesion type, depth and density. Before treatment the practitioner should conduct a full tattoo patient history: When was the tattoo placed? What inks/dyes were used? Where were the inks mixed together to make the color? Is there any white ink in the tattoo to the patient's knowledge? Has the patient attempted to remove or alter the tattoo previously? If so - how? Has the patient used oral retinoids with in the past year? History of herpes infection or cold sores? History of keloid formation or easy scarring, current suntan, tanning bed or bronze use? Fitzpatrick skin type? The treatment parameters for tattoos depend on the skin and on the characteristics of the tattoo itself (i.e., professional, amateur or traumatic). Color, depth, skin type, age of the tattoo and density of colors are all important factors when deciding on parameters for tattoo removal. The composition of an amateur tattoo is elemental carbon and the professional - organic dyes mixed with metallic elements. Response rate for tattoo removal is a function of pigment depth, total pigment volume as well as surface area.

22.6.2.2.

Preparing the Tattoo for Treatment Most practitioners will apply a topical anesthetic (i.e. EMLA) on the tattoo area 60 minutes before treatment. This may not be necessary for tattoos that are less dense based upon the design or on the age of the tattoo. The Laser QS HarmonyXL high power module has different spot size tips. It may be desirable to alternate the spot size beginning with a large spot size tip on the first treatment.

22-8



22.6.2.3.

Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters. It is important to ensure that the patient is not tanned. Warning Appropriate protective eyewear protection must be used by both the practitioner and the patient (and anyone else in the room).

Table 22-2: Tattoo Removal Skin Test Parameters for Blue, Black & Green Tattoos (standard and CVD tips) Skin Type

Spot Size


Energy (mJ)

Waiting Period

I – VI

3 mm

1, 2, 4

500

24 – 48 hours

I – VI

5 mm

1, 2, 4

500 – 700

24 – 48 hours

Table 22-3: Tattoo Removal Skin Test Parameters for Red Tattoos (KTP tip) Skin Type

Spot Size


Energy (mJ)

Waiting Period

I – III

3 mm

1, 2, 4

500 – 600

24 – 48 hours

IV – VI

3 mm

1, 2, 4

500

24 – 48 hours

Note It is recommended that the patient return for treatment 24 – 48 hours after the skin test.

Table 22-4: Pigmented Lesions Skin Test Parameters (Pixel Tip) Skin Type


Energy (mJ)

Accumulative Energy Joules/Grid

Treatment Area Grid (cm2)

Waiting Period

I – III

4

1000 – 1200

500

20

15 – 30

IV

4

800 – 1000

500

20

15 – 30

V – VI

2

600 – 800

500

20

15 – 30


22-9


22.6.3. Treatment Procedure – Standard Tips 1.

Clean and dry the skin to remove the EMLA cream from the tattoo area.

2.


3.

Place the module perpendicular to the tattooed skin.

4.

Overlapping should not exceed 10%.

5.

Set the initial fluence parameter according to the skin test results

6.

Trigger the Laser QS laser by pressing the footswitch and the module trigger simultaneously.

7.

Diagnose carefully. Remember: darker skin types take longer to respond than lighter skin types. The desired effect is a change in tattoo color (whitening effect), without changes in the surrounding epidermis.

8.

If, along with a good response in the tattoo, adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), you should reduce the fluence by 10-20% and attempt to treat in an adjoining area.

9.

If the skin shows no adverse effects or extended side effects and changes observed in the tattoo color are unsatisfactory, you may increase the fluence.

10. After treatment it is recommended to cool the area immediately, apply antibacterial ointment and cover the treated tattoo area with sterile pad gauze. 11. Recommended treatment intervals: between eight and twelve weeks. Note The Laser QS 1064nm high power module can remove black, blue & green pigmented tattoos with the 1064nm wavelength, and red & brown pigments with the 532nm KTP wavelength. Caution It is imperative that the tips and their lenses remain clean and free of debris. The tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.

22-10



22.6.4. Treatment Procedure – Pixel Tip 1.

Clean and dry the skin.

2.


3.

Mark a ~20cm2 area grid (either round or rectangular shape) on the intended treatment area; place the module perpendicular to the skin surface (pigmented lesion).

4.

Technique: in-motion; overlapping: 50-80%.

5.


6.

Lightly position the tip on the surface of the skin.

7.

Trigger the laser by pressing the footswitch and the module's trigger simultaneously.

8.

Move the module's Pixel tip on the entire grid area until the recommended Accumulative Joules (J) reading has been reached; check the skin reaction for clinical end-points such as slight erythema; move the tip to the next adjacent grid area and repeat the same and cover the entire intended treatment area.

9.

Recommended treatment intervals: 3-4 weeks.

22.6.5. Suggested Setup Parameters Table 22-5: Suggested Setup Parameters for Blue, Black & Green Tattoos (Standard and CVD Tips) Skin Type

Spot Size

Wavelength


Energy (mJ/P)

I – VI

3 mm

1064nm

1, 2, 4

500 – 800

I – VI

5 mm

1064nm

1, 2, 4

600 – 1000

Table 22-6: Suggested Setup Parameters for Red Tattoos Skin Type

Wavelength (nm)


Energy (mJ/P)

I – III

532nm KTP

1, 2, 4

500 – 800

IV – VI

532nm KTP

1, 2, 4

500 – 600

Table 22-7: Suggested Setup Parameters for Pigmented Lesions (Pixel Tip) Skin Type

Energy (mJ/P)

Overlapping (%)

PRR (Pulse Repetition Rate)

Accumulative Energy (J) *

I – III

1000 – 1200

50 – 80

4

500

IV – VI

800 – 1000

50 – 80

2

500

2

(*) per 20 cm area Harmony®XL Modules Operator's Manual

22-11


Table 22-8: Recommended CVD Tip Spot Sizes for Tattoo Removal Skin Type

Spot Size [mm]

I – II

1–3

III – IV

4–5

V – VI

5

Table 22-9: Recommended CVD Tip Spot Sizes for Pigmented Lesions Skin Type

Spot Size [mm]

I – II

3

III – IV

4–5

V – VI

5

22.6.6. Post-Treatment Care – Tattoos (Standard Tips) • Apply a layer of Polysporin ointment, Petrolatum, or Bacitracin, beneath a dressing of nonstick gauze and paper tape.

• Instruct the patient to change the dressing twice daily after first gently cleansing the area with soap and water; continue until re-epithelialized.

• Keep the area moist with antibiotic ointment at all times. • Apply Aloe Vera gel for soothing. • Avoid direct exposure to the sun on the treatment area; use UVA/UVB sun blockers.

22.6.7. Post-Treatment Care – Pigmented Lesions (Pixel Tip) • Keep the area moist with hydrating ointment 24-72 hours post treatment. • Apply Aloe Vera gel for soothing. • Avoid direct exposure to the sun on the treatment area; use UVA/UVB sun blockers.

22-12



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

• Patients should return no sooner than eight weeks after the last treatment, for examination of the treatment site and for additional treatment, if necessary.


• If there has been partial clearance of the tattoo, treatment should be continued, and the patient should return after a minimum of eight weeks for examination and for additional treatment, if necessary.

• If no change is noted in the tattoo, fluence should be increased by at least 10%, and the patient should return no sooner than four weeks for an examination.




22-13

CHAPTER 23 Laser 1064nm Module – Vascular Lesions, Leg Veins, Hair Removal and PFB Chapter Contents: Section

Title

Page

23.1.

Laser 1064nm Module Description ................................................. 23-2

23.2.

Laser 1064nm Module Specifications ............................................. 23-2

23.3.

Laser 1064nm Module Operating Screens....................................... 23-3

23.4.

Laser 1064nm Module Regulatory Labels....................................... 23-4

23.5.


23.6.

Laser 1064nm Module Clinical Guide............................................. 23-6

23.6.1. Assessing the Condition ................................................................. 23-6 23.6.2. Indications for Use ......................................................................... 23-6 23.6.3. Contraindications............................................................................ 23-7 23.6.4. Vascular Lesions ............................................................................ 23-8 23.6.5. Non-Ablative Treatment of Facial Wrinkles ................................ 23-10 23.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB) .. 23-12 23.6.7. Follow Up ..................................................................................... 23-14


23-1

Laser 1064nm Module – Vascular Lesions, Leg Veins, Hair Removal & PFB

23.1.

Laser 1064nm Module Description The Laser 1064nm module has a high-power targeted laser for the treatment of vascular lesions and leg veins, hair removal and pseudofolliculitis barbae (PFB). The module emits a high energy laser pulse in the 1064nm wavelength and timer intervals up to 60 msec. A complete discussion of the Laser 1064nm module clinical applications may be found in Section 23.6. The Laser 1064nm module is identified by 1064nm printed on the module (see Figure 23-1).

Figure 23-1: Laser 1064nm Module

23.2.

Laser 1064nm Module Specifications • Light Source:

Nd:YAG

• Wavelength:

1064nm


1 Hz

• Operating Parameters with 2 mm Tip:

23-2

 Pulse Widths:

10 msec

 Energy Density (Fluence):

30 – 450 J/cm2



• Operating Parameters with 6 mm Tip:  Pulse Widths:

15, 45, 60 msec


30 – 150 J/cm2


23.3.

 Pulse Width:

15 msec


20 – 50 J/cm2

Laser 1064nm Module Operating Screens The Laser 1064nm module main operating screen (see Figure 23-2) is displayed when the Laser 1064nm laser module is connected to the system:

Figure 23-2: Laser 1064nm Screen


23-3



There are three tips (2, 6 & 10 mm), available for use with this laser module. The system automatically recognizes the resident tip and displays its size in the top-right corner of the screen.

2.

Vascular Lesions – using the 2 mm tip delivers:

3.

4.

23.4.

• Fluence:

30 – 450 J/cm2


fixed at 1 Hz

• Pulse Widths:

10 msec

Leg Veins – using the 6 mm tip delivers:

• Fluence:

30 – 150 J/cm2


fixed at 1 Hz

• Pulse Widths:

15, 45 and 60 msec

Hair Removal – using the 6mm / 10mm tips deliver:

• Fluence:

6mm tip: 30 – 150 J/cm2 / 10mm tip: 20 – 50 J/cm2


fixed at 1 Hz

• Pulse Widths:

6 mm tip: 45, 60 msec 10 mm tip: fixed at 15 msec

Laser 1064nm Module Regulatory Labels Figure 23-3 presents the regulatory identification and caution labels adhered to the Laser 1064nm module connector:

Figure 23-3: Laser 1064nm Module Regulatory Labels

23-4



23.5.

Ordering Information The following table offers names of accessories specific to the Laser 1064nm module that may be ordered form Alma Lasers. Table 23-1 Laser 1064nm Module Accessories Description Laser 1064nm Module (including 2 & 6 mm tips) 2 mm tip for Laser 1064nm Module 6 mm tip for Laser 1064nm Module 10 mm tip for Laser 1064nm Module Safety Glasses for 1064nm (OD 7+)


23-5


23.6.

Laser 1064nm Module Clinical Guide The Laser 1064nm module is indicated for: • Coagulation and hemostasis of vascular lesions and soft tissue using one of two optical tips (2mm and 6mm) • Non-ablative treatment of facial wrinkles • Permanent hair reduction and PFB Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

23.6.1.


23.6.2.

Indications for Use The Laser 1064nm module is indicated for treatment and clearance of: • Benign vascular lesions such as, but not limited to treatment of:  Port wine stains  Hemangiomas  Warts  Superficial and deep telangiectasias (venulectasias)  Reticular veins (0.1-4.0 mm diameter) of the leg  Rosacea  Venus lake  Leg veins  Spider veins  Poikiloderma of Civatte  Angiomas  Facial and leg veins • Removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles

23-6



• Removal or lightening of unwanted hair (with and without adjuvant preparation) • Treatment of pseudofolliculitis barbae (PFB)

23.6.3.

Contraindications

23.6.3.1.

Vascular Lesions, Veins and Wrinkles • Tanned skin (active tan) through sun exposure or tanning bed use in the previous 30 days





23.6.3.2.

Hair Removal and PFB • History of local or recurrent skin infection • Pregnancy (including IVF) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – past and present • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis • Previous treatment modalities – method, frequency and date of last treatment, as well as response


23-7


• Tattoos or nevi present on the treated area • Past or ongoing medical condition (diabetes, epilepsy, high or low blood pressure, or others)

23.6.4.

Vascular Lesions

23.6.4.1.


23.6.4.2.

Skin Test Always perform a skin test on the intended treatment area according before the first treatment session to the following parameters:

Table 23-2: Skin Test Parameters for Vascular Lesions Skin Type (Fitzpatrick I-VI) I – III

IV – VI

23.6.4.3.

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

Laser 1064nm; 6mm tip

15, 45, 60

80 – 100

2 – 4 hours


10

200

2 – 4 hours


15, 45, 60

60 – 80

48 – 72 hours


10

150

48 – 72 hours

Treatment • The Laser 1064nm laser module has three optical tips for vascular lesions that

are replaceable; to detach, grasp the tip at its base and turn counter-clockwise. To attach the tip – grasp the tip and thread it onto the aperture end of the module by turning it clockwise until snug.

• The 2mm tip is used to treat vessels 0.5 to 1.5mm in diameter (available fluence up to 450 J/cm2). The 6mm tip is used to treat vessels 1.5 to 4mm in diameter (available fluence up to 150 J/cm2).

Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses. Appropriate cooling methods, such as cold air, are recommended when using the Laser 1064nm module. Treatment can begin after the module and the appropriate tip have been connected to the HarmonyXL system and the treatment parameters (fluence and pulse width) are selected according to Table 23-2.

23-8



1.


2.

Cooling means such as ice pack or forced cold air/Zimmer are recommended.


The module tip should be slightly pressed against the vessel/vascular lesion.

4.


5.


6.

Trigger a laser pulse by pressing the footswitch and the module trigger simultaneously.

7.

Examine carefully. Remember: darker skin types take longer to respond than lighter skin types. The desired effect is darkening of the vessel due to blood coagulation and erythema and/or edema along the vessel, indicating a stimulated immune reaction, without changes in the surrounding epidermis.

8.


9.


10. After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care). Caution It is imperative that the tips and their lenses remain clean and free of debris. The tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.


23-9


23.6.4.4.

Vascular Lesions Suggested Setup Parameters

Table 23-3: Vascular Lesions Suggested Setup Parameters Skin Type (Fitzpatrick I-VI)

Target Vessel Depth

Module

Fluence (J/cm2)

Pulse Width (msec)

Deep


Up to 150

15, 45, 60

Superficial


Up to 350

10

Deep


Up to 120

15, 45, 60

Superficial


Up to 250

10

I – III

IV – VI

23.6.5.

Non-Ablative Treatment of Facial Wrinkles

23.6.5.1.

Skin Test Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters:

Table 23-4: Skin Test Parameters for Facial Wrinkles Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III


45, 60

80 – 100

24 – 48 hours

IV – VI


45, 60

60 – 80

24 – 48 hours

23.6.5.2.

Treatment Treatment can begin after the module has been connected to the HarmonyXL system and the treatment parameters (fluence and time interval) are selected according to Table 23-4. Note Always perform a skin test on the intended treatment area during the first treatment session.

23-10

1.


2.


3.

The 6mm module tip should be slightly compressed and centered over the wrinkle.

4.


5.




6.


7.


8.

After treatment, it is recommended to cool the area immediately (see Appendix C in the System Manual – Post-Treatment Care).

Caution It is imperative that the tips and their lenses remain clean and free of debris. The tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.

23.6.5.3.

Facial Wrinkles Suggested Setup Parameters

Table 23-5: Facial Wrinkles Suggested Setup Parameters Skin Type (Fitzpatrick I-VI)

Module

# of Pulses per Spot

Pulse Width (msec)

Fluence (J/cm2)

I – III


1

12, 15, 45

Up to 150

IV – VI


1

12, 15, 45

Up to 120


23-11


23.6.6.

Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB)

23.6.6.1.

Pre-Treatment Patient Evaluation Before hair removal procedures, the patient should be evaluated/ documented for the presence of conditions that may cause hypertrichosis: • Hormonal • Familial • Drug (i.e., corticosteroids, hormones, immunosuppressive self or spousal use of minoxidil) • Tumor • Photosensitizing drugs (gold therapy, etc.)

23.6.6.2.

Skin Test for Hair Removal and PFB Always perform a skin test on the intended treatment area before the first treatment session according to the parameters in Table 23-6. The treatment parameters for hair removal depend on the skin type, hair color, hair type and the density & depth of the hair. Initially, shave the treatment site to eliminate any surface hair that could interfere with the treatment.

Table 23-6: Skin Test Parameters for Hair Removal & PFB Treatment Skin Type (Fitzpatrick I-VI)

Module

Tip/ Spot Size

Pulse Width (msec)

Fluence (J/cm2) *

Waiting Period

I

Laser 1064nm

6mm

45, 60

80 – 100

5 – 7 Days

II

Laser 1064nm

6mm

45, 60

70 – 80

5 – 7 Days

III

Laser 1064nm

6mm

45, 60

70 – 80

5 – 7 Days

Laser 1064nm

6mm

45, 60

60 – 70

5 – 7 Days

Laser 1064nm

10mm

15

40 – 50

5 – 7 Days

Laser 1064nm

10mm

15

40 – 50

5 – 7 Days

Laser 1064nm

10mm

15

30 – 40

5 – 7 Days

Laser 1064nm

10mm

15

30 – 40

5 – 7 Days

Laser 1064nm

10mm

15

30 – 40

5 – 7 Days

IV

V

VI

23-12



23.6.6.3.

Treatment Treatment can begin after the module and tip are connected and the treatment parameters are selected according to Table 23-7. Caution External cooling means must be applied to the skin, e.g., cold pack, Zimmer, etc. 1.


2.


3.


4.

Set the initial fluence and pulse width parameters according to the skin test results.

5.

Apply ultrasonic gel to the treatment area.

6.


7.

Observe for erythema or perifollicular erythema/edema (i.e., end-points).

8.

Examine the treatment area for change of skin color and morphological changes around the follicles (erythema/edema). The smell of burnt hair may sometimes be detected, although its absence does not necessarily indicate that the present parameters are ineffective.

9.

If there are no noticeable changes on the skin (Skin Types IV-VI) or near the hair follicles do not repeat.

10. 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. 11. After treatment it is recommended to cool the area immediately with cold cloth or gauze and apply Aloe Vera gel. Caution It is imperative that the tips and their lenses remain clean and free of debris. The tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.


23-13


23.6.6.4.

Suggested Setup Parameters for Hair Removal and PFB The treatment parameters for hair removal depend on the skin type, hair color, hair type and the density & depth of the hair. Table 23-7: Suggested Setup Parameters Skin Type (Fitzpatrick) I

II

III

Hair Color

Fluence (J/cm2)

Pulse Width (msec)

Light

Up to 150

45*, 60*

Dark

Up to 150

45*, 60*

Light

Up to 150

45*, 60*

Dark

Up to 150

45*, 60*

Light

Up to 150

45*, 60*

Dark

Up to 150

45*, 60*

Light

Up to 120* 40 – 50**

45*, 60* 15**

Dark

Up to 100* 40 – 50**

45*, 60* 15**

Light

40 – 50

15**

Dark

30 – 40

15**

Light

40 – 50

15**

Dark

30 – 40

15**

IV

V

VI

(*)

6mm spot size

(**) 10mm spot size

23.6.7.

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

23.6.7.1.

Vascular Lesions and Leg Veins • Within three weeks after the treatment patients should return for examination of the treatment site and for additional treatment, if necessary.


• In case of a partial clearance of the lesion, the treatment should be continued

using the same parameters and the patient should return for examination and for additional treatment, if necessary after three weeks.

23-14




23.6.7.2.

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









23-15

CHAPTER 24 Laser 1064nm Module – Vascular Lesions, Leg Veins, Hair Removal and PFB Chapter Contents: Section

Title

Page

24.1.

Laser 1064nm Cooled High Power Module Description................. 24-2

24.2.

Laser 1064nm Cooled High Power Module Specifications............. 24-2

24.3.

1064nm Cooled High Power Module Operating Screens ................ 24-3

24.4.

Laser 1064nm Cooled High Power Module Regulatory Labels ...... 24-4

24.5.


24.6.

Laser 1064nm Cooled High Power Module Clinical Guide ............ 24-6

24.6.1. Assessing the Condition ................................................................. 24-6 24.6.2. Indications for Use ......................................................................... 24-6 24.6.3. Contraindications............................................................................ 24-7 24.6.4. Vascular Lesions ............................................................................ 24-8 24.6.5. Non-Ablative Treatment of Facial Wrinkles ................................ 24-10 24.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB) .. 24-12 24.6.7. Follow Up ..................................................................................... 24-14


24-1


24.1. Laser 1064nm Cooled High Power Module Description The Laser 1064nm module has a high-power targeted laser for the treatment of vascular lesions and leg veins, hair removal and pseudofolliculitis barbae (PFB). The module emits a high energy laser pulse in the 1064nm wavelength and timer intervals up to 60 msec. A complete discussion of the Laser 1064nm cooled high power module clinical applications may be found in Section 24.6. The Laser 1064nm cooled high power module is identified by 1064nm printed on the module.

Figure 24-1: Laser 1064nm Cooled High Power Module

24.2. Laser 1064nm Cooled High Power Module Specifications • Light Source:

Nd:YAG

• Wavelength:

1064nm


1 Hz


24-2

 Pulse Widths:

10 msec


30 – 450 J/cm2




12, 15, 45 msec


30 – 150 J/cm2

• Operating Parameters with 10 mm Tip:  Pulse Width:

15 msec


20 – 50 J/cm2

24.3. 1064nm Cooled High Power Module Operating Screens The Laser 1064nm module main operating screen (see Figure 24-2) is displayed when the Laser 1064nm laser cooled high power module is connected to the system:

Figure 24-2: Laser 1064nm Screen


24-3



There are three tips (2, 6 & 10 mm), available for use with this laser module. The system automatically recognizes the resident tip and displays its size in the top-right corner of the screen.

2.


3.

4.

• Fluence:

30 – 450 J/cm2


fixed at 1 Hz

• Pulse Widths:

10 msec


• Fluence:

30 – 150 J/cm2


fixed at 1 Hz

• Pulse Widths:

12, 15 and 45 msec


• Fluence:



fixed at 1 Hz

• Pulse Widths:

15, 45 msec 10 mm tip: fixed at 15 msec

24.4. Laser 1064nm Cooled High Power Module Regulatory Labels Figure 24-3 presents the regulatory identification and caution labels adhered to the Laser 1064nm cooled high power module connector:

Figure 24-3: Laser 1064nm Cooled High Power Module Regulatory Labels

24-4



24.5. Ordering Information The following table offers names of accessories specific to the Laser 1064nm cooled high power module that may be ordered form Alma Lasers. Table 24-1 Laser 1064nm Cooled High Power Module Accessories Description Laser 1064nm Cooled High Power Module (incl. 2 & 6 mm tips) 2 mm tip for Laser 1064nm Module 6 mm tip for Laser 1064nm Module 10 mm tip for Laser 1064nm Module (optional) Safety Glasses for 1064nm (OD 7+)


24-5


24.6. Laser 1064nm Cooled High Power Module Clinical Guide The Laser 1064nm module is indicated for: • Coagulation and hemostasis of vascular lesions and soft tissue using one of two optical tips (2mm and 6mm) • Non-ablative treatment of facial wrinkles • Permanent hair reduction and PFB Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

24.6.1.


24.6.2.

Indications for Use The Laser 1064nm cooled high power module is indicated for treatment and clearance of: • Benign vascular lesions such as, but not limited to treatment of:  Port wine stains  Hemangiomas  Warts  Superficial and deep telangiectasias (venulectasias)  Reticular veins (0.1-4.0 mm diameter) of the leg  Rosacea  Venus lake  Leg veins  Spider veins  Poikiloderma of Civatte  Angiomas  Facial and leg veins

24-6



• Removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles • Removal or lightening of unwanted hair (with and without adjuvant preparation) • Treatment of pseudofolliculitis barbae (PFB)

24.6.3.

Contraindications

24.6.3.1.






24.6.3.2.

Hair Removal and PFB • History of local or recurrent skin infection • Pregnancy (including IVF) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – past and present • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis


24-7


• Previous treatment modalities – method, frequency and date of last treatment, as well as response


24.6.4.

Vascular Lesions

24.6.4.1.


24.6.4.2.


Table 24-2: Skin Test Parameters for Vascular Lesions Skin Type (Fitzpatrick I-VI)

I – III

IV – VI

24.6.4.3.

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

Cooled High Power 1064nm; 6 mm tip

12, 15, 45

80 – 100

2 – 4 hours


10

200

2 – 4 hours


12, 15, 45

60 – 80

48 – 72 hours


10

150

48 – 72 hours




Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses.

24-8



Treatment can begin after the module and the appropriate tip have been connected to the HarmonyXL system and the treatment parameters (fluence and pulse width) are selected according to Table 24-2. 1.


2.




4.


5.


6.


7.


8.


9.




24-9


24.6.4.4.



Target Vessel Depth

Module

Fluence (J/cm2)

Pulse Width (msec)

I – III

Deep


Up to 150

12, 15, 45

I – III

Superficial


Up to 350

10

IV – VI

Deep


Up to 120

12, 15, 45

IV – VI

Superficial


Up to 250

10

24.6.5.


24.6.5.1.


Table 24-4: Skin Test Parameters for Facial Wrinkles Skin Type (Fitzpatrick I-VI) I – III IV – VI

24.6.5.2.

Module Cooled High Power 1064nm; 6 mm tip

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

45

80 – 100

2 – 4 hours

45

60 – 80

24 – 48 hours


24-10

1.


2.


3.




4.


5.


6.


7.


8.



24.6.5.3.


Table 24-5: Facial Wrinkles Suggested Setup Parameters Skin Type (Fitzpatrick I-VI) I – III IV – VI




Pulse Width (msec)

Fluence (J/cm2)

1

45

Up to 150

1

45

Up to 120

24-11


24.6.6.


24.6.6.1.


24.6.6.2.



Module

Tip/ Spot Size

Pulse Width (msec)

Fluence (J/cm2) *

Waiting Period

I

Laser 1064nm

6mm

15, 45

80 – 100

24 – 48 hours

II

Laser 1064nm

6mm

15, 45

70 – 80

24 – 48 hours

III

Laser 1064nm

6mm

15, 45

70 – 80

24 – 48 hours

Laser 1064nm

6mm

15, 45

60 – 70

24 – 48 hours

Laser 1064nm

10mm

15

40 – 50

24 – 48 hours

Laser 1064nm

10mm

15

40 – 50

24 – 48 hours

Laser 1064nm

10mm

15

30 – 40

24 – 48 hours

Laser 1064nm

10mm

15

40 – 50

24 – 48 hours

Laser 1064nm

10mm

15

30 – 40

24 – 48 hours

IV

V

VI

24-12



24.6.6.3.



2.


3.


4.


5.


6.


7.


8.


9.




24-13


24.6.6.4.


II

III

IV

V

VI

(*)

Hair Color

Fluence (J/cm2)

Pulse Width (msec)

Light

Up to 150

15*, 45*

Dark

Up to 150

15*, 45*

Light

Up to 150

15*, 45*

Dark

Up to 150

15*, 45*

Light

Up to 150

15*, 45*

Dark

Up to 150

15*, 45*

Light

Up to 120 40 – 50**

15**, 45*

Dark

40 – 50**

15**

Light

40 – 50

15**

Dark

30 – 40

15**

Light

40 – 50

15**

Dark

30 – 40

15**

6mm spot size

(**) 10mm spot size

24.6.7.


24.6.7.1.





24-14




24.6.7.2.










24-15

CHAPTER 25 Laser 1064F Pro Module – Vascular Lesions, Leg Veins, Hair Removal, PFB and Onychomycosis (Nail Fungus) Chapter Contents: Section

Title

Page

25.1.

Laser 1064F Pro Module Description.............................................. 25-3

25.2.

Laser 1064F Pro Module Specifications.......................................... 25-4

25.3.

Laser 1064F Pro Module Operating Screens ................................... 25-4

25.4.

Laser 1064F Pro Module Regulatory Labels ................................... 25-5

25.5.


25.6.

Laser 1064nm Cooled High Power Module Clinical Guide ............ 25-6

25.6.1. Assessing the Condition ................................................................. 25-6 25.6.2. Indications for Use ......................................................................... 25-6 25.6.3. Contraindications............................................................................ 25-7 25.6.4. Vascular Lesions ............................................................................ 25-8 25.6.5. Non-Ablative Treatment of Facial Wrinkles ................................ 25-10 25.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB) .. 25-12 25.6.7. Follow Up ..................................................................................... 25-14 25.7.

Laser 1064F Pro Module Clinical Guide for Nail Fungus............. 25-16

25.7.1. Assessing the Condition ............................................................... 25-16 25.7.2. Indications for Use ....................................................................... 25-16 25.7.3. Contraindications.......................................................................... 25-16 25.7.4. Adverse Effects of Treatment ....................................................... 25-17 25.7.5. Preparation for Treatment............................................................. 25-17


25-1

Laser 1064F Pro Module – Vascular Lesions, Leg Veins, Hair Removal, PFB & Nail Fungus

25.7.6. Treatment Phase 1 – Q-Switched Module .................................... 25-19 25.7.7. Treatment Phase 2 –1064F Pro Module ....................................... 25-21 25.7.8. Combination with Local Substances ............................................ 25-22 25.7.9. Post-Treatment Care ..................................................................... 25-23 25.7.10. Follow Up ..................................................................................... 25-23

25-2



25.1. Laser 1064F Pro Module Description The Laser 1064F Pro module has a high-power targeted laser for the treatment of vascular lesions and leg veins, hair removal, PFB and nail fungus. The module emits a high energy laser pulse in the 1064nm wavelength and a pulse repetition rate of up to 30 Hz. A complete discussion of the Laser 1064F Pro module onychomycosis (nail fungus) applications may be found in Section 25.6. The Laser 1064F Pro module is identified by 1064F printed on the module (see Figure 25-1).

Figure 25-1: Laser 1064F Pro Module


25-3


25.2. Laser 1064F Pro Module Specifications • Light Source:

Nd:YAG

• Wavelength:

1064nm

• Fluence:

100 – 200 mJ/P


10 – 30 Hz

• Beam Diameter (from tip):

1 mm

25.3. Laser 1064F Pro Module Operating Screens The Laser 1064F Pro module main operating screens (see Figure 25-2) are displayed when the module is connected to the system and the appropriate mode is selected:

Figure 25-2: Laser 1064F Pro Screens

25-4



25.4. Laser 1064F Pro Module Regulatory Labels Figure 25-3 presents the regulatory identification and caution labels adhered to the Laser 1064F Pro module connector:

Figure 25-3: Laser 1064F Pro Module Regulatory Labels

25.5. Ordering Information The following table offers names of accessories specific to the Laser 1064F Pro module that may be ordered form Alma Lasers. Table 25-1 Laser 1064F Pro Module Accessories Description Laser 1064F Pro Module (including 1 mm tip) 1 mm tip for Laser 1064F Pro Module Safety Glasses for 1064nm (OD 7+)


25-5


25.6. Laser 1064nm Cooled High Power Module Clinical Guide The Laser 1064nm module is indicated for: • Coagulation and hemostasis of vascular lesions and soft tissue using one of two optical tips (2mm and 6mm) • Non-ablative treatment of facial wrinkles • Permanent hair reduction and PFB Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

25.6.1.


25.6.2.

Indications for Use The Laser 1064nm cooled high power module is indicated for treatment and clearance of: • Benign vascular lesions such as, but not limited to treatment of:  Port wine stains  Hemangiomas  Warts  Superficial and deep telangiectasias (venulectasias)  Reticular veins (0.1-4.0 mm diameter) of the leg  Rosacea  Venus lake  Leg veins  Spider veins  Poikiloderma of Civatte  Angiomas  Facial and leg veins

25-6



• Removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles • Removal or lightening of unwanted hair (with and without adjuvant preparation) • Treatment of pseudofolliculitis barbae (PFB)

25.6.3.

Contraindications

25.6.3.1.






25.6.3.2.

Hair Removal and PFB • History of local or recurrent skin infection • Pregnancy (including IVF) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – past and present • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis


25-7


• Previous treatment modalities – method, frequency and date of last treatment, as well as response


25.6.4.

Vascular Lesions

25.6.4.1.


25.6.4.2.


Table 25-2: Skin Test Parameters for Vascular Lesions Skin Type (Fitzpatrick I-VI)

I – III

IV – VI

25.6.4.3.

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period


12, 15, 45

80 – 100

2 – 4 hours


10

200

2 – 4 hours


12, 15, 45

60 – 80

48 – 72 hours


10

150

48 – 72 hours




Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses.

25-8



Treatment can begin after the module and the appropriate tip have been connected to the HarmonyXL system and the treatment parameters (fluence and pulse width) are selected according to Table 25-2. 1.


2.




4.


5.


6.


7.


8.


9.




25-9


25.6.4.4.



Target Vessel Depth

Module

Fluence (J/cm2)

Pulse Width (msec)

I – III

Deep


Up to 150

12, 15, 45

I – III

Superficial


Up to 350

10

IV – VI

Deep


Up to 120

12, 15, 45

IV – VI

Superficial


Up to 250

10

25.6.5.


25.6.5.1.


Table 25-4: Skin Test Parameters for Facial Wrinkles Skin Type (Fitzpatrick I-VI) I – III IV – VI

25.6.5.2.


Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

45

80 – 100

2 – 4 hours

45

60 – 80

24 – 48 hours


25-10

1.


2.


3.




4.


5.


6.


7.


8.



25.6.5.3.


Table 25-5: Facial Wrinkles Suggested Setup Parameters Skin Type (Fitzpatrick I-VI) I – III IV – VI




Pulse Width (msec)

Fluence (J/cm2)

1

45

Up to 150

1

45

Up to 120

25-11


25.6.6.


25.6.6.1.


25.6.6.2.



Module

Tip/ Spot Size

Pulse Width (msec)

Fluence (J/cm2) *

Waiting Period

I

Laser 1064nm

6mm

15, 45

80 – 100

24 – 48 hours

II

Laser 1064nm

6mm

15, 45

70 – 80

24 – 48 hours

III

Laser 1064nm

6mm

15, 45

70 – 80

24 – 48 hours

Laser 1064nm

6mm

15, 45

60 – 70

24 – 48 hours

Laser 1064nm

10mm

15

40 – 50

24 – 48 hours

Laser 1064nm

10mm

15

40 – 50

24 – 48 hours

Laser 1064nm

10mm

15

30 – 40

24 – 48 hours

Laser 1064nm

10mm

15

40 – 50

24 – 48 hours

Laser 1064nm

10mm

15

30 – 40

24 – 48 hours

IV

V

VI

25-12



25.6.6.3.



2.


3.


4.


5.


6.


7.


8.


9.




25-13


25.6.6.4.


II

III

IV

V

VI

(*)

Hair Color

Fluence (J/cm2)

Pulse Width (msec)

Light

Up to 150

15*, 45*

Dark

Up to 150

15*, 45*

Light

Up to 150

15*, 45*

Dark

Up to 150

15*, 45*

Light

Up to 150

15*, 45*

Dark

Up to 150

15*, 45*

Light

Up to 120 40 – 50**

15**, 45*

Dark

40 – 50**

15**

Light

40 – 50

15**

Dark

30 – 40

15**

Light

40 – 50

15**

Dark

30 – 40

15**

6mm spot size

(**) 10mm spot size

25.6.7.


25.6.7.1.





25-14




25.6.7.2.










25-15


25.7. Laser 1064F Pro Module Clinical Guide for Nail Fungus The Laser 1064F Pro and Q-Switched modules of the HarmonyXL platform can be used in combination for: •

The treatment of Onychomycosis (nail fungus); toes with clinical signs of infection – documented with positive KOH (potassium hydroxide) or culture test.

•

Each treatment session should include both modules as such: the Q-Switched module should be applied on the fungus-infected nail first, immediately followed by application of the 1064F module. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

25.7.1.

Assessing the Condition The treatment parameters for any given nail condition depend on the nail's reaction to the previous treatment, the fungal infection severity, nail thickness and the patient's subjective heat sensation and tolerance to heat.

25.7.2.

Indications for Use The Laser Nd:YAG 1064F Pro module of the HarmonyXL platform is indicated for the treatment of Onychomycosis (nail fungus). Toes with clinical signs of infection – documented with positive KOH (potassium hydroxide) or culture test.

25.7.3.

Contraindications • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.).

• Systemic antifungal therapy in the past 6 months. • Usage of antifungal therapy which changes nails pigmentation. • Usage of nail coloring dyes which changes nail pigmentation. • Pregnancy • Existence of subungual hematoma or nevoid subungual formation. • Existence of bacterial nail infection that which are changing nail pigmentation. • Existence of concomitant of nail disorders such as psoriasis of nail plate, lichen planus and/or atopic dermatitis.

25-16



25.7.4.

Adverse Effects of Treatment The use of the Laser 1064F Pro module and/or the Q-switched module may cause:

• Heating sensation or pain – patient may experience a local heating

sensation or pain during, or just following the treatment. However such pain is expected to be transient and to resolve within few minutes.

• Erythema – may be present in the treated area and will likely disappear after 24 hours.

• Burns – might occur if the operator does not follow instructions, i.e. energy is too high or stacking pulses on the same spot. If such a burn occurs, it should be treated conventionally.

25.7.5.

Preparation for Treatment

25.7.5.1.

Patient Positioning The patient should be seated on a medical bed with the feet positioned on a soft platform placed on an elevated surface (see Figure 25-4). A clean, soft disposable paper sheet should be placed under the patient's feet. The practitioner and the patient should have visual and verbal communication during the laser treatment.

Figure 25-4: Correct Patient Positioning


25-17


25.7.5.2.

Infected Toenails by Size and Anatomy The practitioner should assess the size and thickness of the infected nail. The small infected nails (digits) should receive 1/5 to 1/4 the amount of energy (dosage) that the hallux (largest toe) is receiving.

Figure 25-5: Treatment Area Definitions

25.7.5.3.

Preparing the Nail for Treatment Gloves must be worn by the practitioner prior to the initiation of the treatment; treatments should be done on clean, nail-lacquer-free nails. The nail should be placed on an elevated, solid, stationary surface where the nail plate is facing up towards the operator and the laser module.

25-18



25.7.6.

Treatment Phase 1 – Q-Switched Module

25.7.6.1.

Patch Test – Q-Switched Module Always perform a patch test on the intended treatment area according to the following parameters:

Table 25-8: Q-Switched Patch Test Parameters for Onychomycosis (Hallux Nail) Module

Repetition Rate [Hz]

Fluence [mJ/P

Number of Passes (Toe Nail Size)

Waiting Period

Q-Switched; 3 mm tip

2

800 – 1000

3 – 4 passes over the nail

48 – 72 Hours

Table 25-9: Q-Switched Patch Test Parameters for Onychomycosis (Digit Nail) Module


Fluence [mJ/P


Waiting Period


2

700 – 900


48 – 72 Hours

25.7.6.2.

Treatment Procedure – Q-Switched Module 1.

Clean the nail plate to remove nail lacquer, creams, cosmetics and powder/talc.

2.

External cooling (i.e. Zimmer) can be used for pain management.

3.

The Q-Switched module tip should be in contact and perpendicular to the nail plate when the treatment is applied.

4.

Set the initial fluence and repetition rate parameters according to the patch test results.

5.


6.

While lasing, the module tip should be moved over the entire nail in a circular path as described in Figure 25-6, until the recommended number of passes is delivered to the nail.

7.

It is best not to overlap treatment spots by more than 10%.

8.

Do not stack pulses.


Figure 25-6: Lasing Path of Each Pass over the Toenail Plate during Treatment 25-19


9.

A total of 5-10 passes over the nail should be delivered during the treatment, with a 30-60 second waiting period between every 3-4 passes. The thicker the nail is, the greater the number of passes should be.

10. If the patient is experiencing an uncomfortable level of heat, the operator should stop lasing for about 10 seconds and then continue the treatment. 11. It should be noted that the pain tolerance lowers with each pass. 12. Treat each hallux and digit toe with a total of four passes. 13. Examine the nail carefully. If adverse skin effects occur (such as reddening of the nail underlying skin), reduce the fluence by 10-20%. Note White flashes or sparks may occur during treatment.

25.7.6.3.

Suggested Setup Parameters – Q-Switched Module

Table 25-10: Q-Switched Onychomycosis (Hallux Nail) Suggested Setup Parameters Module


Fluence [mJ/P



2

900 – 1100

5-10 passes over the nail, with 30-60 sec waiting period between every 3-4 passes.

Table 25-11: Q-Switched Onychomycosis (Digit Nail) Suggested Setup Parameters Module


Fluence [mJ/P



2

800 – 1000


25.7.6.4.

Clinical End-Points The expected clinical end-points of the Q-Switched treatment for Onychomycosis are: •

Fixed number of passes (5-10) in each nail.

•

Whitening and shading off the nail infected color.

•

Patient's local heat/stinging sensation. Note The 1064F laser treatment should be done immediately after treatment with the Q-Switched Nd:YAG laser module.

25-20



25.7.7.

Treatment Phase 2 –1064F Pro Module

25.7.7.1.

Patch Test –1064F Pro Module Always perform a patch test on the intended treatment area according to the following parameters:

Table 25-12: Patch Test Parameters for Onychomycosis (Hallux Nail) Module


Fluence [mJ/P

Accumulative Energy [J] (Toe Nail Size)

Waiting Period

1064F Pro; 1 mm tip

20 – 30

200

600 J, with 5-10 second waiting period between passes as needed.

48 – 72 Hours

Table 25-13: Patch Test Parameters for Onychomycosis (Digit Nail) Module


Fluence [mJ/P


Waiting Period

1064F Pro; 1 mm tip

20

200


48 – 72 Hours

25.7.7.2.

Treatment Procedure –1064F Pro Module 1.

Clean the nail plate to remove nail lacquer, creams, cosmetics and powder/talc, etc.

2.


3.

The laser module's tip should be in contact with, and perpendicular to the nail plate when the treatment is applied.

4.


5.

Trigger a laser pulse by pressing the footswitch and the module's trigger simultaneously.

6.

While lasing, the module's tip should be moved over the entire nail in a circular path as shown in Figure 25-6, proceed with every additional pass immediately after finishing the previous pass as to create a constant circular motion of continuous multiple passes over each nail.

7.

An accumulative energy of about 600 J over the hallux nails and of about 150 J over the digit nails should be delivered during the treatment. The thicker the nail, the higher the amount of accumulative energy that should be delivered to the nail.

8.

If the patient is experiencing an uncomfortable level of heat, pause the treatment for 5-10 seconds and then continue the treatment.

9.

Examine the nail carefully. If adverse skin effects occur (such as reddening of the nail's underlying skin), reduce the fluence by 10-20%.


25-21


25.7.7.3.

Suggested Setup Parameters –1064F Pro Module

Table 25-14: Laser 1064F Pro Suggested Setup Parameters for Onychomycosis (Hallux Nail) Module


Fluence [mJ/P


1064F Pro; 1 mm tip

30

200

600-650 J, with 5-10 second waiting period between passes as needed

Table 25-15: Laser 1064F Pro Suggested Setup Parameters for Onychomycosis (Digit Nail) Module


Fluence [mJ/P


1064F Pro; 1 mm tip

20 – 30

200


25.7.7.4.

Clinical End-Points The expected clinical end-points of the 1064F Pro module treatment for Onychomycosis are:

• Fixed amount of accumulative energy (J) in each nail. • Patient's local heat sensation.

25.7.8.

Combination with Local Substances After using the Laser 1064F Pro module, the relevant local substances/ materials should be applied. Combining the application of these local substances/ materials on the treated nail in addition to the laser treatments could reduce the risk of fungal re-infection between laser treatments. The applied substances/materials should be used in accordance with the manufacturer's instructions and according to the following recommendations:

• Immediately after treatment apply Zinc Undizlate, Zinc Undecenoate, Salicylic acid, Benzoic acid, or Talc.

• Apply Salicylic acid and/or Benzoic acid daily. • Other proposed local substances can include nail drops containing Bifonazole or similar, which should be applied once a day, or nail lacquer containing Amorolfine or similar, which should be applied twice a week.

• Lavender oil should be applied twice a day.

25-22



25.7.9.

Post-Treatment Care To help prevent re-infection:

• Apply anti-fungal cream between treatments twice per day for up to three months, depending severity of the infection.

• Apply anti-fungal powder to all shoes at least once per week for at least one month between the treatments.

• Nail polish may be applied 24 hours after treatment. • The average time interval between treatments is 2-3 weeks.

25.7.10.


• Within two weeks after the first treatment patients should return for examination of the treatment site.

• In case of a partial clearance of the nail fungus, the patient should return for examination after three months.

• If the partial clearance of the nail fungus continues, the patient should return for examination three months after the last treatment, when further nail growth is expected (a full growth of the nail could take 6-12 months).

• Intervals between treatments should be 2-3 weeks. • Number of treatments should be 3-4. • Patients should be instructed to continue the application of local substances/

materials (such as Salicylic acid, Benzoic acid, Talc or similar) after each laser treatment and in between treatments, until full growth of the nail plate is observed.



25-23

CHAPTER 26 Laser 1064F Pro Cooled Module – Vascular Lesions, Leg Veins, Hair Removal, PFB and Onychomycosis (Nail Fungus) Chapter Contents: Section

Title

Page

26.1.

Laser 1064F Pro Module Description.............................................. 26-3

26.2.

Laser 1064F Pro Module Specifications.......................................... 26-3

26.3.

Laser 1064F Pro Module Operating Screens ................................... 26-4

26.4.

Operating Parameters....................................................................... 26-5

26.4.1. Long Pulse Mode............................................................................ 26-5 26.4.2. Nail Fungus Mode .......................................................................... 26-5 26.5.

Laser 1064F Pro Module Regulatory Labels ................................... 26-6

26.6.


26.7.

Clinical Guide: Long Pulse Mode ................................................... 26-7

26.7.1. Assessing the Condition ................................................................. 26-7 26.7.2. Indications for Use ......................................................................... 26-7 26.7.3. Contraindications............................................................................ 26-8 26.7.4. Vascular Lesions ............................................................................ 26-9 26.7.5. Non-Ablative Treatment of Facial Wrinkles ................................ 26-11 26.7.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB) .. 26-13 26.7.7. Follow Up ..................................................................................... 26-15 26.8.

Clinical Guide: Nail Fungus .......................................................... 26-17

26.8.1. Assessing the Condition ............................................................... 26-17


26-1

Laser 1064F Pro Cooled Module – Vascular Lesions, Leg Veins, Hair Removal, PFB & Nail Fungus

26.8.2. Indications for Use ........................................................................ 26-17 26.8.3. Contraindications .......................................................................... 26-17 26.8.4. Adverse Effects of Treatment ....................................................... 26-18 26.8.5. Preparation for Treatment ............................................................. 26-18 26.8.6. Treatment Phase 1 – Q-Switched Module .................................... 26-20 26.8.7. Treatment Phase 2 – Laser 1064F Pro Module............................. 26-22 26.8.8. Combination with Local Substances ............................................ 26-23 26.8.9. Post-Treatment Care ..................................................................... 26-24 26.8.10. Follow Up ..................................................................................... 26-24

26-2



26.1.

1064F Pro Cooled Module Description The Laser 1064F Pro Cooled module has a high-power targeted laser for the treatment of vascular lesions and leg veins, hair removal and PFB in Long Pulse mode and onychomycosis in Nail Fungus mode. The module emits a high energy laser pulse in the 1064nm wavelength and timer intervals up to 60 msec. A complete discussion of the Laser 1064F Pro Cooled module clinical applications may be found later in this chapter. The Laser 1064F Pro Cooled module is identified by 1064F printed on the module (see Figure 26-1).

Figure 26-1: Laser 1064F Pro Cooled Module

26.2.

Laser 1064F Pro Cooled Module Specifications • Light Source:

Nd:YAG

• Wavelength:

1064nm


1 Hz


26-3



10 msec


30 – 450 J/cm2


15, 45, 60 msec


30 – 150 J/cm2

• Operating Parameters with 10 mm Tip:  Pulse Width:

15 msec


20 – 50 J/cm2


26.3.

 Pulse Repetition Rate:

10 – 30 Hz


100 – 200 mJ/P

Laser 1064F Pro Cooled Module Operating Screens The Laser 1064F Pro Cooled module main operating screens (see Figure 26-2) are displayed when the Laser 1064F Pro Cooled module is connected to the system and the appropriate mode is selected:

Figure 26-2: Laser 1064F Pro Cooled Screens

26-4



26.4.

Operating Parameters There are four tips (1, 2, 6 & 10 mm), available for use with this laser module. The system automatically recognizes the resident tip and displays its size in the top-right corner of the screen.

26.4.1.

Long Pulse Mode 1.

2.

3.

26.4.2.


• Fluence:

30 – 450 J/cm2


fixed at 1 Hz

• Pulse Widths:

10 msec


• Fluence:

30 – 150 J/cm2


fixed at 1 Hz

• Pulse Widths:

15, 45 and 60 msec


• Fluence:



fixed at 1 Hz

• Pulse Widths:

6 mm tip: 45, 60 msec 10 mm tip: fixed at 15 msec

Nail Fungus Mode 4.

Nail Fungus – using the 1 mm tip delivers

•

Fluence:

100 – 200 mJ/P

•

Pulse Frequency:

10 – 30 Hz


26-5


26.5.

Laser 1064F Pro Cooled Module Regulatory Labels Figure 26-3 presents the regulatory identification and caution labels adhered to the Laser 1064F Pro Cooled module connector:

Figure 26-3: Laser 1064F Pro Cooled Module Regulatory Labels

26.6.

Ordering Information The following table offers names of accessories specific to the Laser 1064F Pro Cooled module that may be ordered form Alma Lasers. Table 26-1 Laser 1064F Pro Cooled Module Accessories Description Laser 1064F Pro Cooled Module (incl. 2 & 6 mm tips) 2 mm tip for Laser 1064F Pro Cooled Module 6 mm tip for Laser 1064F Pro Cooled Module 10 mm tip for Laser 1064F Pro Cooled Module 1 mm tip for Laser 1064F Pro Cooled Module (Nail Fungus) Safety Glasses for 1064nm (OD 7+)

26-6



26.7.

Clinical Guide: Long Pulse Mode The Laser 1064F Pro Cooled module in Long Pulse is indicated for: • Coagulation and hemostasis of vascular lesions and soft tissue using one of two optical tips (2mm and 6mm) • Non-ablative treatment of facial wrinkles • Permanent hair reduction and PFB Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

26.7.1.


26.7.2.

Indications for Use The Laser 1064F Pro Cooled module is indicated for treatment and clearance of: • Benign vascular lesions such as, but not limited to treatment of:  Port wine stains  Hemangiomas  Warts  Superficial and deep telangiectasias (venulectasias)  Reticular veins (0.1-4.0 mm diameter) of the leg  Rosacea  Venus lake  Leg veins  Spider veins  Poikiloderma of Civatte  Angiomas  Facial and leg veins • Removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles


26-7


• Removal or lightening of unwanted hair (with and without adjuvant preparation) • Treatment of pseudofolliculitis barbae (PFB)

26.7.3.

Contraindications

26.7.3.1.






26.7.3.2.

Hair Removal and PFB • History of local or recurrent skin infection • Pregnancy (including IVF) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – past and present • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis • Previous treatment modalities – method, frequency and date of last treatment, as well as response

26-8




26.7.4.

Vascular Lesions

26.7.4.1.


26.7.4.2.

Skin Test Always perform a skin test on the intended treatment area according before the first treatment session to the following parameters:

Table 26-2: Skin Test Parameters for Vascular Lesions Skin Type (Fitzpatrick I-VI) I – III

IV – VI

26.7.4.3.

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

Laser 1064F Pro Cooled; 6mm tip

15, 45, 60

80 – 100

2 – 4 hours


10

200

2 – 4 hours


15, 45, 60

60 – 80

48 – 72 hours


10

150

48 – 72 hours

Treatment • The Laser 1064F Pro Cooled laser module has three optical tips for vascular

lesions that are replaceable; to detach, grasp the tip at its base and turn counterclockwise. To attach the tip – grasp the tip and thread it onto the aperture end of the module by turning it clockwise until snug.


Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses. Appropriate cooling methods, such as cold air, are recommended when using the Laser 1064F Pro Cooled module. Treatment can begin after the module and the appropriate tip have been connected to the HarmonyXL system and the treatment parameters (fluence and pulse width) are selected according to Table 26-2.


26-9


1.


2.




4.


5.


6.


7.


8.


9.



26-10



26.7.4.4.


Table 26-3: Vascular Lesions Suggested Setup Parameters Skin Type (Fitzpatrick I-VI) I – III

IV – VI

Target Vessel Depth

Module

Fluence (J/cm2)

Pulse Width (msec)

Deep


Up to 150

15, 45, 60

Superficial


Up to 350

10

Deep


Up to 120

15, 45, 60

Superficial


Up to 250

10

26.7.5.


26.7.5.1.


Table 26-4: Skin Test Parameters for Facial Wrinkles Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III


45, 60

80 – 100

24 – 48 hours

IV – VI


45, 60

60 – 80

24 – 48 hours

26.7.5.2.

Treatment Treatment can begin after the module has been connected to the HarmonyXL system and the treatment parameters (fluence and time interval) are selected according to Table 26-4. Note Always perform a skin test on the intended treatment area during the first treatment session. 1.


2.


3.


4.


5.



26-11


6.


7.


8.



26.7.5.3.


Table 26-5: Facial Wrinkles Suggested Setup Parameters Skin Type (Fitzpatrick I-VI)

Module


Pulse Width (msec)

Fluence (J/cm2)

I – III


1

45, 60

Up to 150

IV – VI


1

45, 60

Up to 120

26-12



26.7.6.


26.7.6.1.


26.7.6.2.



Module

Tip/ Spot Size

Pulse Width (msec)

Fluence (J/cm2) *

Waiting Period

I


6mm

45, 60

80 – 100

5 – 7 Days

II


6mm

45, 60

70 – 80

5 – 7 Days

III


6mm

45, 60

70 – 80

5 – 7 Days


6mm

45, 60

60 – 70

5 – 7 Days


10mm

15

40 – 50

5 – 7 Days


10mm

15

40 – 50

5 – 7 Days


10mm

15

30 – 40

5 – 7 Days


10mm

15

30 – 40

5 – 7 Days


10mm

15

30 – 40

5 – 7 Days

IV

V

VI


26-13


26.7.6.3.



2.


3.


4.


5.


6.


7.


8.


9.



26-14



26.7.6.4.


II

III

Hair Color

Fluence (J/cm2)

Pulse Width (msec)

Light

Up to 150

45*, 60*

Dark

Up to 150

45*, 60*

Light

Up to 150

45*, 60*

Dark

Up to 150

45*, 60*

Light

Up to 150

45*, 60*

Dark

Up to 150

45*, 60*

Light

Up to 120* 40 – 50**

45*, 60* 15**

Dark

Up to 100* 40 – 50**

45*, 60* 15**

Light

40 – 50

15**

Dark

30 – 40

15**

Light

40 – 50

15**

Dark

30 – 40

15**

IV

V

VI

(*)

6mm spot size

(**) 10mm spot size

26.7.7.


26.7.7.1.






26-15



26.7.7.2.









26-16



26.8.

Clinical Guide: Nail Fungus The Laser 1064F Pro Cooled and Q-Switched modules of the HarmonyXL platform can be used in combination for: •

The treatment of Onychomycosis (nail fungus); toes with clinical signs of infection – documented with positive KOH (potassium hydroxide) or culture test.

•

Each treatment session should include both modules as such: the Q-Switched module should be applied on the fungus-infected nail first, immediately followed by application of the Laser 1064F Pro Cooled module. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

26.8.1.

Assessing the Condition The treatment parameters for any given nail condition depend on the nail's reaction to the previous treatment, the fungal infection severity, nail thickness and the patient's subjective heat sensation and tolerance to heat.

26.8.2.

Indications for Use The Laser Nd:YAG 1064F Pro module of the HarmonyXL platform is indicated for the treatment of Onychomycosis (nail fungus). Toes with clinical signs of infection – documented with positive KOH (potassium hydroxide) or culture test.

26.8.3.

Contraindications • Skin cancer or any other cancer and/or any cancer drug therapy (such as Ducabaxine, Fluorouracil, Methotrexate, etc.).

• Systemic antifungal therapy in the past 6 months. • Usage of antifungal therapy which changes nails pigmentation. • Usage of nail coloring dyes which changes nail pigmentation. • Pregnancy • Existence of subungual hematoma or nevoid subungual formation. • Existence of bacterial nail infection that which are changing nail pigmentation. • Existence of concomitant of nail disorders such as psoriasis of nail plate, lichen planus and/or atopic dermatitis.


26-17


26.8.4.

Adverse Effects of Treatment The use of the Laser 1064F Pro Cooled module and/or the Q-switched module may cause:

• Heating sensation or pain – patient may experience a local heating

sensation or pain during, or just following the treatment. However such pain is expected to be transient and to resolve within few minutes.

• Erythema – may be present in the treated area and will likely disappear after 24 hours.

• Burns – might occur if the operator does not follow instructions, i.e. energy is too high or stacking pulses on the same spot. If such a burn occurs, it should be treated conventionally.

26.8.5.

Preparation for Treatment

26.8.5.1.

Patient Positioning The patient should be seated on a medical bed with the feet positioned on a soft platform placed on an elevated surface (see Figure 26-4). A clean, soft disposable paper sheet should be placed under the patient's feet. The practitioner and the patient should have visual and verbal communication during the laser treatment.

Figure 26-4: Correct Patient Positioning

26-18



26.8.5.2.

Infected Toenails by Size and Anatomy The practitioner should assess the size and thickness of the infected nail. The small infected nails (digits) should receive 1/5 to 1/4 the amount of energy (dosage) that the hallux (largest toe) is receiving.

Figure 26-5: Treatment Area Definitions

26.8.5.3.

Preparing the Nail for Treatment Gloves must be worn by the practitioner prior to the initiation of the treatment; treatments should be done on clean, nail-lacquer-free nails. The nail should be placed on an elevated, solid, stationary surface where the nail plate is facing up towards the operator and the laser module.


26-19


26.8.6.

Treatment Phase 1 – Q-Switched Module

26.8.6.1.

Patch Test – Q-Switched Module Always perform a patch test on the intended treatment area according to the following parameters:

Table 26-8: Q-Switched Patch Test Parameters for Onychomycosis (Hallux Nail) Module


Fluence [mJ/P


Waiting Period


2

800 – 1000


48 – 72 Hours

Table 26-9: Q-Switched Patch Test Parameters for Onychomycosis (Digit Nail) Module


Fluence [mJ/P


Waiting Period


2

700 – 900


48 – 72 Hours

26.8.6.2.

Treatment Procedure – Q-Switched Module 1.

Clean the nail plate to remove nail lacquer, creams, cosmetics and powder/talc.

2.


3.

The Q-Switched module tip should be in contact and perpendicular to the nail plate when the treatment is applied.

4.


5.


6.

While lasing, the module tip should be moved over the entire nail in a circular path as described in Figure 26-6, until the recommended number of passes is delivered to the nail.

7.

It is best not to overlap treatment spots by more than 10%.

8.

Do not stack pulses.

Figure 26-6: Lasing Path of Each Pass over the Toenail Plate during Treatment 26-20



9.

A total of 5-10 passes over the nail should be delivered during the treatment, with a 30-60 second waiting period between every 3-4 passes. The thicker the nail is, the greater the number of passes should be.

10. If the patient is experiencing an uncomfortable level of heat, the operator should stop lasing for about 10 seconds and then continue the treatment. 11. It should be noted that the pain tolerance lowers with each pass. 12. Treat each hallux and digit toe with a total of four passes. 13. Examine the nail carefully. If adverse skin effects occur (such as reddening of the nail underlying skin), reduce the fluence by 10-20%. Note White flashes or sparks may occur during treatment.

26.8.6.3.

Suggested Setup Parameters – Q-Switched Module

Table 26-10: Q-Switched Onychomycosis (Hallux Nail) Suggested Setup Parameters Module


Fluence [mJ/P



2

900 – 1100


Table 26-11: Q-Switched Onychomycosis (Digit Nail) Suggested Setup Parameters Module


Fluence [mJ/P



2

800 – 1000


26.8.6.4.

Clinical End-Points The expected clinical end-points of the Q-Switched treatment for Onychomycosis are: •

Fixed number of passes (5-10) in each nail.

•

Whitening and shading off the nail infected color.

•

Patient's local heat/stinging sensation. Note The 1064 nm laser treatment should be done immediately after treatment with the Q-Switched Nd:YAG laser module.


26-21


26.8.7.

Treatment Phase 2 – Laser 1064F Pro Cooled Module

26.8.7.1.

Patch Test – Laser 1064F Pro Cooled Module Always perform a patch test on the intended treatment area according to the following parameters:

Table 26-12: Patch Test Parameters for Onychomycosis (Hallux Nail) Module


Fluence [mJ/P


Waiting Period

1064F Pro Cooled; 1 mm tip

20 – 30

200


48 – 72 Hours

Table 26-13: Patch Test Parameters for Onychomycosis (Digit Nail) Module


Fluence [mJ/P


Waiting Period


20

200


48 – 72 Hours

26.8.7.2.

26-22

Treatment Procedure – Laser 1064F Pro Cooled Module 1.

Clean the nail plate to remove nail lacquer, creams, cosmetics and powder/talc, etc.

2.


3.

The laser module's tip should be in contact with, and perpendicular to the nail plate when the treatment is applied.

4.


5.

Trigger a laser pulse by pressing the footswitch and the module's trigger simultaneously.

6.

While lasing, the module's tip should be moved over the entire nail in a circular path as shown in Figure 26-6, proceed with every additional pass immediately after finishing the previous pass as to create a constant circular motion of continuous multiple passes over each nail.

7.

An accumulative energy of about 600 J over the hallux nails and of about 150 J over the digit nails should be delivered during the treatment. The thicker the nail, the higher the amount of accumulative energy that should be delivered to the nail.

8.

If the patient is experiencing an uncomfortable level of heat, pause the treatment for 5-10 seconds and then continue the treatment.

9.

Examine the nail carefully. If adverse skin effects occur (such as reddening of the nail's underlying skin), reduce the fluence by 10-20%. Harmony®XL Modules Operator's Manual


26.8.7.3.

Suggested Setup Parameters – Laser 1064F Pro Cooled Module

Table 26-14: Laser 1064F Pro Cooled Suggested Setup Parameters for Onychomycosis (Hallux Nail) Module


Fluence [mJ/P



30

200


Table 26-15: Laser 1064F Pro Cooled Suggested Setup Parameters for Onychomycosis (Digit Nail) Module


Fluence [mJ/P



20 – 30

200


26.8.7.4.

Clinical End-Points The expected clinical end-points of the 1064nm LP Nd:YAG treatment for Onychomycosis are:

• Fixed amount of accumulative energy (J) in each nail. • Patient's local heat sensation.

26.8.8.

Combination with Local Substances After using the Laser 1064F Pro Cooled module, the relevant local substances/ materials should be applied. Combining the application of these local substances/ materials on the treated nail in addition to the laser treatments could reduce the risk of fungal re-infection between laser treatments. The applied substances/materials should be used in accordance with the manufacturer's instructions and according to the following recommendations:

• Immediately after treatment apply Zinc Undizlate, Zinc Undecenoate, Salicylic acid, Benzoic acid, or Talc.

• Apply Salicylic acid and/or Benzoic acid daily. • Other proposed local substances can include nail drops containing Bifonazole or similar, which should be applied once a day, or nail lacquer containing Amorolfine or similar, which should be applied twice a week.

• Lavender oil should be applied twice a day.


26-23


26.8.9.

Post-Treatment Care To help prevent re-infection:

• Apply anti-fungal cream between treatments twice per day for up to three months, depending severity of the infection.

• Apply anti-fungal powder to all shoes at least once per week for at least one month between the treatments.

• Nail polish may be applied 24 hours after treatment. • The average time interval between treatments is 2-3 weeks.

26.8.10.


• Within two weeks after the first treatment patients should return for examination of the treatment site.

• In case of a partial clearance of the nail fungus, the patient should return for examination after three months.

• If the partial clearance of the nail fungus continues, the patient should return for examination three months after the last treatment, when further nail growth is expected (a full growth of the nail could take 6-12 months).

• Intervals between treatments should be 2-3 weeks. • Number of treatments should be 3-4. • Patients should be instructed to continue the application of local substances/

materials (such as Salicylic acid, Benzoic acid, Talc or similar) after each laser treatment and in between treatments, until full growth of the nail plate is observed.


26-24


CHAPTER 27 Laser 1320nm Module – Wrinkles and Acne Scars Chapter Contents: Section

Title

Page

27.1.

Laser 1320nm Module Description ................................................. 27-2

27.2.

Laser 1320nm Module Specifications ............................................. 27-2

27.3.

Laser 1320nm Module Operating Screens....................................... 27-3

27.4.

Laser 1320nm Module Regulatory Labels....................................... 27-4

27.5.


27.6.

Laser 1320nm Module Clinical Guide............................................. 27-5

27.6.1. Indications for Use ......................................................................... 27-5 27.6.2. Contraindications............................................................................ 27-5 27.6.3. Pre-Treatment ................................................................................. 27-6 27.6.4. Treatment........................................................................................ 27-7 27.6.5. Suggested Setup Parameters ........................................................... 27-8 27.6.6. Follow-up ....................................................................................... 27-8


27-1

1320nm Module – Fine Lines, Wrinkles & Acne

27.1. Laser 1320nm Module Description The Laser 1320nm module has a high-power targeted laser module for the treatment of fine lines and wrinkles, acne and acne scars. The 1320nm wavelength achieves deep penetration and selective targeting of water-containing tissue to induce treatment by affecting a rise in dermal temperature. In acne treatment, the dermal heating achieved disrupts the sebaceous glands while involution of the glands induces a long-term remission of the acne. A complete discussion of the Laser 1320nm module clinical applications may be found in Section 27.6. The Laser 1320nm module is identified by 1320nm printed on the module (see Figure 27-1).

Figure 27-1: Laser 1320nm Module

27.2. Laser 1320nm Module Specifications

27-2

• Light Source:

Nd:YAG

• Wavelength:

1320nm

• Pulse Widths:

30, 40, 50 msec


1 Hz

• Tip Spot Size:

6 mm


5 – 40 J/cm2



27.3. Laser 1320nm Module Operating Screens The Laser 1320nm module main operating screen (see Figure 27-2) is displayed when the Laser 1320nm laser module is connected to the system:

Figure 27-2: Laser 1320nm Module Screen


There is one 6 mm tip available for use with this module. The system automatically recognizes the resident tip and displays its size in the top-right corner of the screen.

2.

Wrinkles & Acne Scars – using the 6 mm tip delivers:

• Fluence:

5 – 40 J/cm2


1 Hz.

• Pulse Widths:

30, 40, 50 msec


27-3


27.4. Laser 1320nm Module Regulatory Labels Figure 27-3 presents the regulatory identification and caution labels adhered to the Laser 1320nm module connector:

Figure 27-3: Laser 1320nm Module Regulatory Labels

27.5. Ordering Information The following table offers names of accessories specific to the Laser 1320nm module that may be ordered form Alma Lasers. Table 27-1 Laser 1320nm Module Accessories Description Laser 1320nm Module (inc. 6 mm tip) 6 mm tip for Laser 1320nm Module Safety Glasses for 1320nm (OD7+)

27-4



27.6. Laser 1320nm Module Clinical Guide The Laser 1320nm module is designed for the non-ablative treatment of facial wrinkles (periorbital and perioral) and fine lines, atrophic acne (rolling and boxcar) scars and mild-to-moderate inflammatory acne vulgaris. The thermal energy delivered at optimal pulse durations penetrates the skin and starts a wound healing response. The result in both modes is an increase in collagen fiber density, alignment, homogenization, and contraction in the papillary dermis. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

27.6.1.

Indications for Use The 1320nm Nd:YAG laser module is indicated for the treatment of:

• Fine lines and wrinkles • Periorbital wrinkles • Perioral wrinkles • Back acne • Atrophic acne scars • Mild to moderate inflammatory acne vulgaris

27.6.2.


• Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site


• A history of keloid scarring • Epilepsy • St. John’s Wort (herbal remedy) for depression in the past 3 months (because of increased photosensitivity)


27-5


• Isotretinoin – Roaccutane or Tretinoin – Retin A for the treatment of acne or other dermatological conditions in the previous 3-6 months

• Pregnancy; until menstruation returns and end of breast feeding • Diabetes (owing to possible photosensitivity and poor wound healing)

27.6.3.

Pre-Treatment


27.6.3.2. Skin Test Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters. Table 27-2: Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III


30, 40

25 – 30

5 – 7 days

IV – VI


40, 50

15 – 20

5 – 7 days

Note Treated area must be cooled before, during and after the treatment with ice-packs or the Zimmer air cooling device.

27-6



27.6.4.

Treatment After the Laser 1320nm module has been connected to the HarmonyXL system and the treatment parameters (fluence and timer interval) have been selected according to Table 27-3, treatment can begin. The number of passes depends on skin reaction and clinical end-points (slight erythema). Treatments should be spaced 4 weeks apart and every 6 months during the maintenance period. Note Always perform a sensitivity test patch on the intended treatment area during the first treatment session. 1.


2.

Apply cooling (Zimmer or ice pack) to the intended treatment area for 5-10 seconds prior to lasing. Keep the cooling tool available during the full course of the treatment.

3.


4.

Place the module tip perpendicular to the skin and touch the skin with the tip. The tip should slightly be compressed against the target tissue.

5.

Trigger a laser pulse by pressing both the footswitch and module trigger simultaneously.

6.

Apply 3-4 passes (non-sequential) on the target area. In a more rapid fashion, apply one pass of the laser across the entire facial area (from the maxillary prominence to the mandible).

7.

Immediately after lasing stops, apply cooling means to the treated area (or continue cooling from the Zimmer air cooling device). It is appropriate to use an ice pack for 5 seconds and continue lasing thereafter.

8.

Visualize the treated area and check for adverse side effects.

9.

If adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), you may either increase the timer interval or reduce the fluence by 20%. Recheck your settings against the skin test results and settings.



27-7


27.6.5.


Table 27-3: Suggested Setup Parameters Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Number of Passes

I – III


30, 40

Up to 40

3–4

IV – VI


40, 50

Up to 30

3–4

27.6.6.


• Patients should return no sooner than three weeks after treatment. This planned examination of the treatment site should provide a progress evaluation and additional treatment opportunity, if required.

• If there has been a partial effect, treatment should be continued and the patient should return after three weeks for examination and additional treatment, if necessary.


• If no change is noted, fluence should be increased by at least 10%. • Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments.


27-8


CHAPTER 28 Laser 1320nm Cooled Module – Wrinkles and Acne Scars Chapter Contents: Section

Title

Page

28.1.

Laser 1320nm Cooled Module Description ..................................... 28-2

28.2.

Laser 1320nm Cooled Module Specifications ................................. 28-3

28.3.

Tip Installation ................................................................................. 28-4

28.4.

1320nm Cooled Module Operating Screens .................................... 28-6

28.5.

Laser 1320nm Cooled Module Regulatory Labels .......................... 28-7

28.6.


28.7.

Laser 1320nm Cooled Module Clinical Guide ................................ 28-8

28.7.1. Indications for Use ......................................................................... 28-8 28.7.2. Contraindications............................................................................ 28-8 28.7.3. Assessing the Condition ................................................................. 28-9 28.7.4. Pre-Treatment ................................................................................. 28-9 28.7.5. Treatment...................................................................................... 28-10 28.7.6. Suggested Setup Parameters ......................................................... 28-11 28.7.7. Follow-up ..................................................................................... 28-11


28-1

Laser 1320nm Cooled Module – Wrinkles and Acne Scars

28.1.

Laser 1320nm Cooled Module Description The Laser 1320nm cooled module has a high-power targeted laser for the treatment of wrinkles and acne scars. The module emits a high energy laser pulse in the 1320nm wavelength and timer intervals up to 60 msec. A complete discussion of the Laser 1320nm cooled module clinical applications may be found in Section 28.7. The Laser 1320nm cooled module is identified by 1320nm printed on the module.

Figure 28-1: Laser 1320nm Cooled Module

28-2



28.2.

Laser 1320nm Cooled Module Specifications • Light Source:

Nd:YAG

• Wavelength:

1320nm


1 Hz

• Magnetized Foot for 6mm standard tip:

Smaller-diameter foot

• Magnetized Foot for 5x5 Pixel Tip: Larger-diameter foot • Operating Parameters with 6 mm Tip:  Pulse Widths:

30, 40, 50 msec


40 J/cm2

• Operating Parameters with 5x5 Pixel Tip:  Energy Density (Fluence):


1 – 11 J/cm2

28-3


28.3.

Tip Installation The Laser 1320nm cooled module requires two separate models of the tip's magnetized connection foot for the 6mm Standard or 5x5 Pixel tip: •

The 6mm standard tip requires the smaller magnetized foot, shown on the left side of Figure 28-2.

•

The 5x5 Pixel tip requires the larger magnetized foot, shown on the right side of Figure 28-2.

Figure 28-2: Connection Feet for the Tips When changing from one style of tip to the other, proceed as follows: 1.

Remove the standard-style tip from the module, and detach the magnetized foot (see Figure 28-3).

Figure 28-3: Pixel Tip Replacement Procedure (1)

28-4



2.

Refer to Figure 28-4: remove the blue distance spacer from the Pixel tip (A) and screw the tip into the module (B).

Figure 28-4: Pixel Tip Replacement Procedure (2) 3.

Insert the Larger size magnetized foot to the module (see Figure 28-5).

Figure 28-5: Pixel Tip Replacement Procedure (3) Caution Take care not to insert the smaller magnetized foot by mistake.


28-5


28.4.

1320nm Cooled Module Operating Screens The Laser 1320nm module main operating screen (see Figure 28-6) is displayed when the Laser 1320nm laser cooled module is connected to the system:

Figure 28-6: Laser 1320nm Screen Operating parameters available in this module: 1.

There are two tips (6 & 5x5 Pixel), available for use with this laser module. The system automatically recognizes the resident tip and displays its size in the top-right corner of the screen.

2.

Acne Scars and Wrinkles – using the 6 mm tip delivers:

3.

28-6

• Fluence:

1 – 40 J/cm2


fixed at 1 Hz

• Pulse Widths:

30, 40, 50 msec

Skin Remodeling – using the 5x5 Pixel tip deliver:

• Fluence:

1 – 11 J/cm2


fixed at 1 Hz



28.5.

Laser 1320nm Cooled Module Regulatory Labels Figure 28-7 presents the regulatory identification and caution labels adhered to the Laser 1320nm cooled module connector:

Figure 28-7: Laser 1320nm Cooled Module Regulatory Labels

28.6.

Ordering Information The following table offers names of accessories specific to the Laser 1320nm cooled module that may be ordered form Alma Lasers. Table 28-1 Laser 1320nm Cooled Module Accessories Description Laser 1320nm Cooled Module (Including 6 mm & 5x5 Pixel tips) 6 mm tip for Laser 1320nm Module 5x5 Pixel mm tip for Laser 1320nm Module Safety Glasses for 1320nm (OD 7+)


28-7


28.7.

Laser 1320nm Cooled Module Clinical Guide The Laser 1320nm cooled module is designed for the non-ablative treatment of facial wrinkles (periorbital and perioral) and fine lines, atrophic acne (rolling and boxcar) scars and mild-to-moderate inflammatory acne vulgaris. The thermal energy delivered at optimal pulse durations penetrates the skin and starts a wound healing response. The result in both modes is an increase in collagen fiber density, alignment, homogenization, and contraction in the papillary dermis. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

28.7.1.

Indications for Use The 1320nm Nd:YAG laser module is indicated for the treatment of:

• Fine lines and wrinkles • Periorbital wrinkles • Perioral wrinkles • Back acne • Atrophic acne scars • Mild to moderate inflammatory acne vulgaris

28.7.2.


• Hypopigmentation (Vitiligo) • Any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site


• A history of keloid scarring • Epilepsy • St. John’s Wort (herbal remedy) for depression in the past 3 months (because of increased photosensitivity)

28-8



• Isotretinoin – Roaccutane or Tretinoin – Retin A for the treatment of acne or other dermatological conditions in the previous 3-6 months

• Pregnancy; until menstruation returns and end of breast feeding • Diabetes (owing to possible photosensitivity and poor wound healing)

28.7.3.

Assessing the Condition The treatment parameters for any given skin condition depend on the skin type and severity of acne scars and wrinkles.

28.7.4.

Pre-Treatment


28.7.4.2. Skin Test Always perform a skin test on the intended treatment area during the first treatment session according to the following parameters. Table 28-2: Skin Test Parameters Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Waiting Period

I – III


30, 40

25 – 30

24 – 48 hours

IV – VI


40, 50

20 – 25

24 – 48 hours

I – III

Laser 1320nm; 5x5 Pixel tip

30, 40

6–8

15 – 30 minutes

IV – VI


40, 50

6–8

15 – 30 minutes

Note Treated area must be cooled before, during and after the treatment with ice-packs or the Zimmer air cooling device.


28-9


28.7.5.

Treatment After the Laser 1320nm module has been connected to the HarmonyXL system and the treatment parameters (fluence and timer interval) have been selected according to Table 21 3, treatment can begin. The number of passes depends on skin reaction and clinical end-points (slight erythema). Treatments should be spaced 4 weeks apart and every 6 months during the maintenance period. Note Always perform a sensitivity test patch on the intended treatment area during the first treatment session. 1.


2.


3.

Place the cooled module tip perpendicular to the skin and touch the skin with the tip. The tip should slightly be compressed against the target tissue.

4.


5.

Apply 3-4 passes (non-sequential) on the target area. In a more rapid fashion, apply one pass of the laser across the entire facial area (from the maxillary prominence to the mandible).

6.

Immediately after lasing stops, keep the tip in contact with the skin in order to cool the treated area.

7.

Visualize the treated area and check for adverse side effects.

8.

If adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), you may either increase the timer interval or reduce the fluence by 20%. Recheck your settings against the skin test results and settings.

9.

After treatment, it is recommended to cool the area immediately (see Appendix B in the System Manual – Post-Treatment Care).

Caution It is imperative that the tips and their lenses remain clean and free of debris. The tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary.

28-10



28.7.6.


Table 28-3: Suggested Setup Parameters Skin Type (Fitzpatrick I-VI)

Module

Pulse Width (msec)

Fluence (J/cm2)

Number of Passes

I – III


30, 40

Up to 40

3–4

IV – VI


40, 50

Up to 30

3–4

I – III


30, 40

Up to 10

3–4

IV – VI


40, 50

Up to 8

3–4

28.7.7.


• Patients should return no sooner than three weeks after treatment. This planned examination of the treatment site should provide a progress evaluation and additional treatment opportunity, if required.

• If there has been a partial effect, treatment should be continued and the patient should return after three weeks for examination and additional treatment, if necessary.


• If no change is noted, fluence should be increased by at least 10%. • Intervals between treatments can be increased in successive treatments. • Treatment is complete when satisfactory results are obtained. • Patients should be instructed to avoid sun exposure after and in between treatments.



28-11

CHAPTER 29 Pixel & Pixel Pro 2940nm Modules – Fractional Ablative Skin Resurfacing Chapter Contents: Section

Title

Page

29.1.

Pixel and Pixel Pro 2940nm Modules Description .......................... 29-2

29.2.

Pixel & Pixel Pro Modules Specifications....................................... 29-3

29.3.

Pixel & Pixel Pro 2940nm Modules Operating Screen ................... 29-4

29.4.

Pixel & Pixel Pro Modules Regulatory Labels ................................ 29-4

29.5.


29.6.

Pixel & Pixel Pro 2940nm Modules Clinical Guide ........................ 29-6

29.6.1. Indications for Use with Standard Accessory Tips......................... 29-6 29.6.2. Indications for Use with Pixel Accessory Tips .............................. 29-8 29.6.3. Contraindications............................................................................ 29-8 29.6.4. Pre-Treatment ................................................................................. 29-9 29.6.5. Treatment Using Pixel Mode........................................................ 29-11 29.6.6. Suggested Setup Parameters ......................................................... 29-14 29.6.7. Post-Treatment Care & Follow-Up .............................................. 29-15


29-1

Pixel & Pixel Pro Modules – Fractional Ablative Skin Resurfacing

29.1. Pixel and Pixel Pro 2940nm Modules Description Two laser modules are described in this chapter: • Pixel 2940nm module (low power) • Pixel Pro 2940nm module (high power) The Pixel & Pixel Pro 2940nm modules – when using a standard tip – enable controlled treatment for skin resurfacing. The precise tissue ablation and small zone of residual thermal damage result in faster re-epithelialization and improved morbidity. The Pixel & Pixel Pro 2940nm modules – when using a Pixel tip – provide technology for fractional ablative skin resurfacing and laser peeling, employing a gradual procedure that stimulates the replacement of aged and photo-damaged skin. A complete discussion of the Pixel Pro and Laser 2940nm modules' clinical applications may be found in Section 29.6. The Pixel & Pixel Pro 2940nm modules are identified by 2940nm printed on the module (see Figure 29-1).

Standard Tip

Pixel Module

Pixel Tip

Pixel Pro Module

Figure 29-1: Laser 2940nm Modules

29-2



29.2. Pixel & Pixel Pro Modules Specifications • Light Source:

Er:YAG

• Wavelength:

2940nm

• Available Tips:

1 mm, 4 mm (Standard) 7 x 7 Pixel and 9 x 9 Pixel

• Operating Parameters with 1 mm Tip in Surgi Light mode:  Energy Density (Fluence):

100 – 1400 mJ/P

 Pulse Frequency:

5 Hz

• Operating Parameters with 4 mm Tip in Skin Remodeling mode:  Depth:

10 – 350 μm


5 Hz

• Operating Parameters with 4 mm Tip in Gentle Peel mode:  Depth:

1 – 20 μm


5 Hz

• Pixel Pro Module's Operating Parameters with 7x7 & 9x9 Pixel Tips:  Energy Density (Fluence) in Short mode:

300 – 1200 mJ/P

 Energy Density (Fluence) in Medium mode:

600 – 1800 mJ/P

 Energy Density (Fluence) in Long mode:

800 – 2500 mJ/P


5 Hz

• Pixel 2940nm Module's Operating Parameters with 7x7 & 9x9 Pixel Tips:  Energy Density (Fluence) in Short mode:

600 – 800 mJ/P


600 – 1000 mJ/P


600-1400 mJ/P


5 Hz


29-3


29.3. Pixel & Pixel Pro 2940nm Modules Operating Screen The Pixel & Pixel Pro 2940nm modules' main operating screen (see Figure 29-2) is displayed when either of the modules is connected to the system:

Pixel Pro Module in Stacking Mode

Pixel Pro Module in Non-Stacking Mode

Figure 29-2: Erbium 2940nm Modules Screens

29.4. Pixel & Pixel Pro Modules Regulatory Labels Figure 29-3 presents the regulatory identification and caution labels adhered to the modules' connectors:

Figure 29-3: Laser 2940nm Modules Regulatory Labels

29-4



29.5. Ordering Information The following table offers names of accessories specific to the Pixel & Pixel Pro 2940nm modules that may be ordered form Alma Lasers. Table 29-1 Laser 2940nm Module Accessories Description Pixel Pro Module (inc. 1 & 4mm and 7x7 & 9x9 Pixel tips) Pixel 2940nm Module (inc. 1 & 4mm and 7x7 & 9x9 Pixel tips) 1 mm tip for Laser 2940nm Module 4 mm tip for Laser 2940nm Module 7 x 7 Pixel mm tip for Laser 2940nm Module 9 x 9 Pixel mm tip for Laser 2940nm Module Safety Glasses for 2940nm (OD 6+)


29-5


29.6. Pixel & Pixel Pro 2940nm Modules Clinical Guide The Skin Resurfacing application of the HarmonyXL system is performed using the Pixel & Pixel Pro 2940nm modules with standard 1mm or 4mm tips. The modules are indicated for ablative resurfacing procedures including wrinkles and scar revision. The modules deliver precise tissue ablation utilizing either the 1mm or 4mm spot size with minimal collateral thermal damage of the superficial (watercontaining) cutaneous tissue. Fractional Ablative Skin Resurfacing is performed with the HarmonyXL system using the 7x7 or 9x9 Pixel tips. The Pixel mode is indicated for fractional ablative resurfacing procedures including fine lines, wrinkles and scar revision. The Pixel mode's operation is based on the principle of fractional ablative skin resurfacing where only a fraction of the skin mosaic is injured, leaving uninjured skin areas. The intact, undamaged skin around the treatment site promotes quicker healing for a faster recovery. The 2940nm module can be used with two different matrix size tips - 7x7 matrix (49 pixels) or 9x9 matrix (81 pixels). Depending on the Pixel matrix used, the Pixel laser single shot produces high energy density and depth of penetration which can range between 100-150 microns in an area of about 1.2 cm2. The fewer number of Pixels (49 pixels vs. 81 pixels), the greater the penetration depth. Each Pixel matrix has a repetition rate of 5 Hz. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using these modules.

29.6.1.

Indications for Use with Standard Accessory Tips The 2940nm Er:YAG laser module with standard and scanner accessory tips (with and without contact-cooling) is indicated for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands):

29.6.1.1. Dermatology and Plastic Surgery • Skin resurfacing • Treatment of wrinkles • Epidermal nevi • Telangiectasia • Spider veins • Actinic chelitis

29-6



• Keloids • Verrucae • Skin tags • Anal tags • Keratoses • Scar revision (including acne scars) • Debulking benign tumors • Debulking cysts • Superficial skin lesions • Diagnostic biopsies • Decubitis ulcers 29.6.1.2. General Surgery • Surgical incision/excision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.

29.6.1.3. Genitourinary Treatment of:

• Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar lesions, polyps, and familial polyps of the colon.

29.6.1.4. Gynecology Treatment of:

• Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.

29.6.1.5. Oral/Maxillofacial Treatment of:

• Benign oral tumors, oral and glossal lesions, and gingivectomy.


29-7


29.6.1.6. Otorhinolaryngology / Head and Neck (ENT) Treatment of:

• Ear, nose and throat lesions, polyps, cysts, hyperkeratosis. • Excision of carcinogenic tissue and oral leukoplakia. 29.6.1.7. Ophthalmology Treatment of:

• Soft tissue surrounding the eye and orbit. 29.6.1.8. Podiatry Treatment of:

• Warts, plantar verrucae, large mosaic Verrucae. • Matrixectomy

29.6.2.

Indications for Use with Pixel Accessory Tips The 2940nm Er:YAG laser module (with and without contact cooling) with Pixel accessory tips is indicated for use in soft tissue for dermatology and plastic surgery:

• Skin resurfacing

29.6.3.

Contraindications • Bacterial or viral infection • Impaired immune system • Patient has used Isotretinoin in the past 6-9 months • Scleroderma • Extensive radiation therapy • Poor healing in the treatment area • Pregnancy and breast feeding • Skin type VI Other possible contraindications may include irregular pigmentation of the skin, Vitiligo or Psoriasis and recurrent infections (prior eye lift surgery is a possible contraindication for resurfacing of the face).

29-8



29.6.4.

Pre-Treatment


29.6.4.2. Skin Test The purpose of the skin test is to rule out any unexpected adverse side effects that may be induced by the skin's response. Always perform a skin test on the intended treatment area before the first session according to the following sequence: Table 29-2: Skin Test Parameters for the Standard 1mm & 4mm Tips Module

Mode

Spot Size

Ablation Depth (µm)

Energy (mJ/P)

Frequency (Hz)

Laser 2940nm

Gentle Peel

4 mm

1 – 20

---

5

Laser 2940nm

Skin Remodeling

4 mm

10 – 350

---

5

Laser 2940nm

Surgi Light

1 mm

---

100 – 1400

5

Table 29-3: Skin Test Parameters for the Pixel Pro Module with 7x7 and 9x9 Pixel Tips Test Spot #

Matrix Dots

Energy (mJ/P)

Pulse Mode

Frequency (Hz)

Number of Passes / Stacks1

1

9x9 7x7

1800 1400

L L

2*, 5**

1/3

2

9x9 7x7

2000 1600

L L

2, 5

1/3

3

9x9 7x7

2500 1800

L L

2, 5

1/3

(*) (**)

"No Stack" mode "Stack" mode


29-9


Table 29-4: Skin Test Parameters for the Pixel 2940nm Module with 7x7 and 9x9 Pixel Tips Test Spot #

Matrix Dots

Energy (mJ/P)

Pulse Mode

Frequency (Hz)

Number of Passes / Stacks1

1

9x9 7x7

600 600

L L

5

1/3

2

9x9 7x7

800 800

L L

5

1/3

3

9x9 7x7

1000 1000

L L

5

1/3

It is recommended also that treating physicians familiarize themselves with Er:YAG treatment based on clinical literature; general pre- and post-treatment procedures are provided below. These general guidelines are not intended to be a substitute for clinical education, judgment, and/or experience of the physician.

29.6.4.3. Prior to Treatment Day 1.

Pretreatment with topical hydroquinone, Tretinoin and or/glycolic acid preparations for skin types III– V may be helpful in reducing the potential risk of post-laser resurfacing hyperpigmentation.

2.

Prophylactic oral antiviral agents may be helpful for the prevention of facial herpes simplex Virus 1 (HSV-1) reactivation until full re-epithelialization occurs. It is generally recommended to begin prophylactic antiviral agents 24 hours prior to laser resurfacing and continuing as described by the agent protocol.

29.6.4.4. Treatment Day 1.

Clean the skin to remove perfume, cosmetics and sunscreens.

2.

Anesthesia is required for most applications of the standard Er:YAG laser as well as for the Pixel Er:YAG laser. Topical anesthesia (example: EMLA cream) is normally sufficient for most patients. Remove all topical anesthetics just prior to treatment.

3.

Provide appropriate eye protection (or eye shields) for the patient and the medical staff inside the enclosed treatment room. Goggles should be OD 6+ and labeled for 2940nm.

4.

Set the initial fluence and pulse mode parameters according to the condition being treated. The system allows for a choice of three treatment modes.

5.

Place the module perpendicular to the skin. Do not apply pressure (the tip should gently touch the skin). Do not apply gel to the skin prior to treatment.

6.

Up to 20% overlapping is acceptable.

7.


1

29-10

1

It is advisable to use smoke evacuation and a mask during the procedure.



8.

Depth of treatment should be customized to the specific indication (scars vs. wrinkles).

9.

Following treatment gently cleanse the treated area of skin fragments with a moist cloth using normal saline solution.

10. If adverse skin effects occur (such as excessive reddening or swelling), you may either change the pulse frequency or reduce the fluence.

29.6.5.

Treatment Using Pixel Mode It is recommended also that treating physicians familiarize themselves with Er:YAG treatment based on clinical literature; general pre- and posttreatment procedures are provided below. These general guidelines are not intended to be a substitute for clinical education, judgment, and/or experience of the physician. 1.

Anesthesia: prior to treatment the skin in the areas intended for treatment should be cleansed with a mild, non-alcoholic, non-abrasive agent. A commercially available topical anesthetic cream should be applied one hour prior to treatment. During and post-treatment cooling with the Zimmer Cryo can be used to minimize redness or a sunburned feeling.

2.

It is advisable to use a smoke evacuator and a mask during the procedure.

3.

Matrix size: use the 7x7 tip for more aggressive and stacking technique on scars, etc. The 7x7 matrix should be used when greater penetration is required. Use the 9x9 tip for periorbital, full passes and less aggressive treatments.

4.

Depth of penetration with a low power Pixel: 25-50 microns ablation plus 75-100 microns thermal injury zones on 3-5 stacks.

5.

Depth of penetration with a high power Pixel: 50-100 microns ablation plus 100-125 microns thermal injury zones with 3-5 stacks.

6.

Fluence on skin with the high power Pixel module: conservative 1200-1600, moderate 1700-2000, aggressive up to 2500 mJ/P.

7.

Fluence on skin with the low power Pixel module: conservative 600-800, moderate 1000, aggressive up to 1400 mJ/pulse.

8.

Free-hand (random passes): the Pixel 2940nm tip is moved randomly on the treatment area and repeated passes are employed.

9.

The free-hand passes technique is recommended for indications such as photodamage/photo-age signs and symptoms.

10. Free-hand with the high power module: number of passes: 1 = conservative, 2 = moderate, 3 = aggressive. 11. Free-hand with the low power module: number of passes: 2 = conservative, 3 = moderate, 4= aggressive. 12. Stationary (stacking): the tip of the Pixel 2940nm is placed stationarily on the treatment area and repeated pulses are employed.


29-11


13. Stationary technique is recommended for structures residing below the epidermis such as acne scars, fine lines, wrinkles, etc. 14. Stationary with the high power module: number of stacks: 2 = conservative, 4 = moderate, 6 = aggressive. The number of stacks depends on the structure topography (acne scars vs. hypertrophic scar vs. wrinkles) and the desired level of penetration i.e., the greater the number of stacks, the higher the penetration. 15. Stationary with the low power module: number of stacks: 3 = conservative, 5 = moderate, 7 = aggressive. The number of stacks depends on the structure topography (acne scars vs. hypertrophic scar vs. wrinkles) and the desired level of penetration i.e., the greater the number of stacks, the higher the penetration. 16. Downtime after first treatment: redness and sunburn feeling for several hours or up to 2 days if aggressive treatment has been performed. Pale (conservative) to dark brown (aggressive) Pixel pattern on days 3-5 with flaking. Swelling in aggressively treated areas through day 5. Full recovery by days 5-7. Down time is decreased with subsequent treatments. Since this is an Erbium laser, patients with more moisture in their skin may experience more redness and sensation and achieve better results in fewer treatments. Similarly, a patient with dry skin may require more treatments. 17. Number of sessions: three for aggressive to five for conservative treatments at 2-4 weeks apart. Results will continue to improve over 6 months once treatments are complete. 18. Precautions: Do not perform Pixel 2940nm treatments over Botox or Restylane for two weeks post-injection. Use an anti-viral before treatments if there is a history of cold sores. Make sure the skin is clean and dry before treatment. Note Always perform a skin test on the intended treatment area during the first treatment session (see Section 29.6.4.).

29.6.5.1. Prior to Treatment Day

29-12

1.

Pre-treatment with topical hydroquinone, Tretinoin and or/glycolic acid preparations for skin types III- IV may be helpful in reducing the potential risk of post-laser resurfacing hyperpigmentation.

2.

Prophylactic oral anti-viral agents may be helpful for the prevention of facial Herpes simplex virus 1 (HSV-1) reactivation until full re-epithelialization occurs. It is generally recommended to begin prophylactic anti-viral agents 24 hours prior to laser resurfacing and continuing as described by the protocol of the agent.



29.6.5.2. Treatment Day

2

1.


2.

Provide appropriate eye protection for the patient (or eye shields) and for the medical staff inside the enclosed treatment room. Goggles should be OD>6 and labeled for the 2940nm wavelength.

3.

Set the initial energy levels according to the skin test, treatment area, and clinical indication.

4.


5.

The treatment technique can be either stationary (for deeper penetration) overlapping pulses on the same area, or non-stationary – random, non-overlap passes.

6.

In the non-stationary mode, up to 50% overlapping is acceptable.

7.

Trigger a laser pulse by pressing both the footswitch and module simultaneously.

• Endpoint: erythema • Number of Treatments: 2 – 4 • Treatment Intervals: 3 – 4 weeks 8.

Depth of treatment should be individualized to the specific indication (scars vs. wrinkles).

9.

Following treatment, gently cleanse the treated area from skin fragments with a moist cloth and follow post-op care guidelines.

10. If adverse skin effects occur (such as excessive reddening or swelling), you may either change the program mode or reduce the fluence.

Caution It is imperative that the Pixel tips and their lenses remain clean and free of debris. The Pixel tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.

2

It is advisable to use smoke evacuation and a mask during the procedure


29-13


29.6.6.


Table 29-5: Suggested Setup Parameters for the Standard Tips Module

Mode

Spot Size

Ablation Depth (µm)

Energy (mJ/P)

Frequency (Hz)

Laser 2940nm

Gentle Peel

4 mm

1 – 20

---

5

Laser 2940nm

Skin Remodeling

4 mm

10 – 350

---

5

Laser 2940nm

Surgi Light

1 mm

---

100 – 1400 mJ/P

5

Table 29-6: Suggested Setup Parameters for the Pixel Pro Module with 7x7 and 9x9 Pixel Tips Spot Size (mm)

Matrix Dots

Energy (mJ/P)

Pulse Mode

Number of Passes/Stacks*

Frequency (Hz)

11 x 11

9x9 7x7

1800 1800

L L

1-3 / 2-6 1-3 / 2-6

2*, 5**

11 x 11

9x9 7x7

2000 2000

L L

1-3 / 2-6 1-3 / 2-6

2, 5

11 x 11

9x9 7x7

2500 2500

L L

1-3 / 2-6 1-3 / 2-6

2, 5

(*) (**)

Note – Pixel 2940nm Module: 7 x 7 matrix = 49 Pixels = 51 mJ/Pixel 9 x 9 matrix = 81 Pixels = 31 mJ/Pixel


Table 29-7: Suggested Setup Parameters for the Pixel 2940nm Module with 7x7 and 9x9 Pixel Tips Spot Size (mm)

Matrix Dots

Energy (mJ/P)

Pulse Mode


Frequency (Hz)

11 x 11

9x9 7x7

1000 1000

L L

2-4 / 3-7 2-4 / 3-7

5

11 x 11

9x9 7x7

1200 1200

L L

2-4/ 3-7 2-4 / 3-7

5

11 x 11

9x9 7x7

1400 1400

L L

2-4 / 3-7 2-4 / 3-7

5

Note – Pixel 2940nm Module: 7 x 7 matrix = 49 Pixels = 28 mJ/Pixel 9 x 9 matrix = 81 Pixels = 17 mJ/Pixel (*) The number of passes or stacks depends on the desired level of penetration i.e., the greater the penetration, the greater the number of passes/stacks.

29-14



29.6.7.

Post-Treatment Care & Follow-Up Meticulous wound care (open or closed techniques) is crucial after skin resurfacing; below are the Alma Lasers recommendations for follow-up. Physicians may refer to them, and then determine their own suitable regime.

• Open wound care technique: During open wound care technique, soak with 0.25% acetic acid, normal saline, or cool tap water for 20 minutes every 2-4 hours, followed by gentle wiping of the skin. Cold compresses are immediately followed by the application of a bland emollient ointment. Popular ointments include Catrix®-10 (Lescarden) and Aquaphor® Healing Ointment (Beiersdorf AG).

• Closed wound care technique: provides a semi-occlusive environment that

may protect the wound from exogenous bacteria and foster exchange of oxygen and water vapor. Drainage of the wound exudates via the dressing may prevent excess crust and simplify wound management. For the closed wound care technique popular dressings include the composite foam Flexzan® (Dow Hickam Pharmaceuticals), the hydrogel product 2nd Skin® (Bionet), the plastic mesh N-terface® (Winfield Laboratories), and the polymer film Silon-TSR® (Bio Med Sciences). The frequency of soaks and ointment application decreases as reepithelialization progresses and is tapered off when re-epithelialization is complete (normally within 5-6 days).

• By 7-10 days after the procedure, soaks are replaced with gentle cleansing, and patients switch to the application of a moisturizer-sunscreen.

• Following re-epithelialization, gentle cleansings begin a day or two later. The use of ointment is replaced during the day by use of a lighter moisturizersunscreen. At night time, ointment is more slowly replaced.

• Patients should return to the clinic 3-7 days post-treatment for examination of the treatment site and for additional treatment, if necessary.

• If no additional treatment is necessary, the patient should return for an additional examination after two months.

• Treatment is complete when satisfactory results are obtained. • Avoid sun exposure during pre- and post-operative period. • If adverse side effects occur (hyperpigmentation), sun protection and spotresurfacing depigmenting agents such as hydroquinone will help obtain resolution.



29-15



29-16


CHAPTER 30 iPixelEr 2940nm Module – Fractional Ablative Skin Resurfacing Chapter Contents: Section

Title

Page

30.1.

iPixelEr 2940nm Module Description .............................................. 30-2

30.2.

iPixelEr 2940nm Module Specifications .......................................... 30-3

30.3.

iPixelEr Module 2940nm Module Operating Screen ........................ 30-4

30.4.

iPixelEr Module 2940nm Module Regulatory Labels ...................... 30-4

30.5.


30.6.

iPixelEr Clinical Guide ..................................................................... 30-6

30.6.1. Indications for Use with Standard Accessory Tips......................... 30-6 30.6.2. Indications for Use with Pixel Accessory Tips .............................. 30-8 30.6.3. Contraindications............................................................................ 30-8 30.6.4. Pre-Treatment ................................................................................. 30-9 30.6.5. Treatment Procedure ................................................................... 30-11 30.6.6. Suggested Setup Parameters ......................................................... 30-13 30.6.7. Post-Treatment Care & Follow-Up .............................................. 30-14


30-1

iPixelEr 2940nm Module – Fractional Ablative Skin Resurfacing

30.1. iPixelEr 2940nm Module Description The iPixelEr 2940nm module – when using a standard tip – enables controlled treatment for skin resurfacing. The precise tissue ablation and small zone of residual thermal damage result in faster re-epithelialization and improved morbidity. When using the iPixelEr tip the module provides technology for fractional ablative skin resurfacing and laser peeling, employing a gradual procedure that stimulates the replacement of aged and photo-damaged skin. A complete discussion of the Pixel Pro and Laser 2940nm modules' clinical applications may be found in Section 30.6. The iPixelEr 2940nm module is identified by iPixelEr printed on the module (see Figure 30-1).

Figure 30-1: iPixelEr Laser 2940nm Module

Note Refer to the HarmonyXL System Operator's Manual for particular instructions on disinfecting and sterilizing the wheeled tip section of the iPixelEr 2940nm module.

30-2



30.2. iPixelEr 2940nm Module Specifications • Light Source:

Er:YAG

• Wavelength:

2940nm

• Available Tips:

4 mm (Standard) 7x7 Pixel 7 x 1 iPixelEr

• Operating Parameters with 4 mm Tip in Short mode:  Energy Density (Fluence):

200 – 1200 mJ/P


4 Hz (Stack) 2 Hz (Non-Stack)

• Operating Parameters with 4 mm Tip in Medium mode:  Energy Density (Fluence):

600 – 1800 mJ/P



• Operating Parameters with 4 mm Tip in Long mode:  Energy Density (Fluence):

800 – 2500 mJ/P



• Operating Parameters with 7x7 Pixel Tip:  Energy Density (Fluence) in Short mode:

200 – 1200 mJ/P


600 – 1800 mJ/P


800 – 2500 mJ/P


2 Hz (Non-Stacking) 5 Hz (Stacking)

• Operating Parameters with 7x1 iPixelEr Tip:  Energy Density (Fluence) in Short mode:

200 – 600 mJ/P


300 – 800 mJ/P


400 – 1000 mJ/P


4 Hz


30-3


30.3. iPixelEr Module 2940nm Module Operating Screen The iPixelEr 2940nm module's main operating screen (see Figure 30-2) is displayed when the module is connected to the system:

Figure 30-2: iPixelEr 2940nm Module Screen

30.4. iPixelEr Module 2940nm Module Regulatory Labels Figure 30-3 presents the regulatory identification and caution labels adhered to the module's connector:

Figure 30-3: iPixelEr 2940nm Module Regulatory Labels

30-4



30.5. Ordering Information The following table offers names of accessories specific to the 2940nm modules that may be ordered from Alma Lasers:

• Pixel 2940nm laser module • Pixel Pro 2940nm laser module • iPixelEr 2940nm laser module Table 30-1 Laser 2940nm Module Accessories Description iPixelEr 2940nm Module (including 4 mm standard, 7 mm Pixel and 7x1 iPixelEr tips) 4 mm tip for iPixelEr 2940nm module 7 x 7 Pixel tip for iPixelEr 2940nm module 7 x 1 iPixelEr tip for iPixelEr 2940nm module Safety Glasses for iPixelEr 2940nm (OD 6+)


30-5


30.6. iPixelEr Clinical Guide The Skin Resurfacing application of the HarmonyXL system is performed using the iPixelEr 2940nm module with the following tips: standard 4 mm, 7x7 pixel (passive) and iPixelEr 7x1 pixel (additive) tips. The module and its assorted tips are indicated for ablative resurfacing procedures including wrinkles and scar revision. The module delivers precise tissue ablation utilizing either the 4 mm spot size with minimal collateral thermal damage of the superficial (water-containing) cutaneous tissue. Fractional Ablative Skin Resurfacing is performed with the HarmonyXL system using the 7x7 Pixel or 7x1 iPixelEr tips. The Pixel mode is indicated for fractional ablative resurfacing procedures including fine lines, wrinkles and scar revision. The Pixel mode's operation is based on the principle of fractional ablative skin resurfacing where only a fraction of the skin mosaic is injured, leaving uninjured skin areas. The intact, undamaged skin around the treatment site promotes quicker healing for a faster recovery. The iPixelEr module can be used with two different matrix size tips - 7x7 matrix (49 pixels) or 7x1 matrix (7 pixels, 1 row). The fluence for the 7x7 tip is up to 51 mJ/Pixel and up to 260 mJ/Pixel for the 7 x1 (roller) tip at a fluence of 1800 mJ/Pulse. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

30.6.1.

Indications for Use with Standard Accessory Tips The iPixelEr laser module with standard (4 mm tip) and fractional accessory tips (7x7 or 7x1) is indicated for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands):

30.6.1.1. Dermatology and Plastic Surgery • Skin resurfacing • Treatment of wrinkles • Epidermal nevi • Telangiectasia • Spider veins • Actinic chelitis • Keloids

30-6



• Verrucae • Skin tags • Anal tags • Keratoses • Scar revision (including acne scars) • Debulking benign tumors • Debulking cysts • Superficial skin lesions • Diagnostic biopsies • Decubitis ulcers 30.6.1.2. General Surgery • Surgical incision/excision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.

30.6.1.3. Genitourinary Treatment of:

• Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar lesions, polyps, and familial polyps of the colon.

30.6.1.4. Gynecology Treatment of:

• Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.

30.6.1.5. Oral/Maxillofacial Treatment of:

• Benign oral tumors, oral and glossal lesions, and gingivectomy.


30-7


30.6.1.6. Otorhinolaryngology / Head and Neck (ENT) Treatment of:

• Ear, nose and throat lesions, polyps, cysts, hyperkeratosis. • Excision of carcinogenic tissue and oral leukoplakia. 30.6.1.7. Ophthalmology Treatment of:

• Soft tissue surrounding the eye and orbit. 30.6.1.8. Podiatry Treatment of:

• Warts, plantar verrucae, large mosaic Verrucae. • Matrixectomy

30.6.2.

Indications for Use with Pixel Accessory Tips The iPixelEr laser module (with and without contact cooling) with Pixel accessory tips is indicated for use in soft tissue for dermatology and plastic surgery:

• Skin resurfacing

30.6.3.

Contraindications • Bacterial or viral infection • Impaired immune system • Patient has used Isotretinoin in the past 6-9 months • Scleroderma • Extensive radiation therapy • Poor healing in the treatment area • Pregnancy and breast feeding • Skin type VI (7x7 pixel tip); Skin types V & VI (7x1 pixel tip) Other possible contraindications may include irregular pigmentation of the skin, Vitiligo or Psoriasis and recurrent infections (prior eye lift surgery is a possible contraindication for resurfacing of the face).

30-8



30.6.4.

Pre-Treatment


30.6.4.2. Skin Test The purpose of the skin test is to rule out any unexpected adverse side effects that may be induced by the skin's response. Always perform a skin test on the intended treatment area before the first session according to the following sequence: Table 30-2: Skin Test Parameters for the Standard 4mm Tip Skin Type

Mode

Spot Size

Intensity

Fluence (mJ/Pulse)

Frequency (Hz)

I–V

Short

4 mm

Mild

800

4

I–V

Medium

4 mm

Moderate

1200

4

I – IV

Long

4 mm

Aggressive

1800

4

Table 30-3: Skin Test Parameters for the 7x7 Pixel Tip Mode

Skin Type

Energy (mJ/Pulse)

Pulse Mode

Frequency (Hz)

Number of Passes / Stacks

Stack Non-Stack

I–V

1400 1600

L L

2*, 5**

1–2

Stack Non-Stack

I – IV

1600 1600

L L

2, 5

1–2

Stack Non-Stack

I – III

1800 2000

L L

2, 5

1–2

(*) (**)


Table 30-4: Skin Test Parameters for the 7x1 iPixelEr Tip Intensity

Skin Type

Energy (mJ/Pulse)

Pulse Mode

Number of Passes

Mild

I – IV

600

Medium

1 (XY)

Moderate

I – IV

700

Medium

1 (XY)

Aggressive

I – IV

800

Medium

1 (XY)

It is recommended also that treating physicians familiarize themselves with Er:YAG treatment based on clinical literature; general pre- and post-treatment procedures are provided below. These general guidelines are not intended to be a substitute for clinical education, judgment, and/or experience of the physician.


30-9


30.6.4.3. Prior to Treatment Day 1.

Pretreatment with topical hydroquinone, Tretinoin and or/glycolic acid preparations for skin types III– V may be helpful in reducing the potential risk of post-laser resurfacing hyperpigmentation.

2.

Prophylactic oral antiviral agents may be helpful for the prevention of facial herpes simplex Virus 1 (HSV-1) reactivation until full re-epithelialization occurs. It is generally recommended to begin prophylactic antiviral agents 24 hours prior to laser resurfacing and continuing as described by the agent protocol.

30.6.4.4. Treatment Day

*

1.

Clean the skin to remove perfume, cosmetics and sunscreens.

2.

Anesthesia is required for most applications of the standard Er:YAG laser mode as well as for the Pixel Er:YAG laser modes. Topical anesthesia (example: EMLA cream) is normally sufficient for most patients. Remove all topical anesthetics just prior to treatment.

3.

Provide appropriate eye protection (or eye shields) for the patient and the medical staff inside the enclosed treatment room. Goggles should be OD 6+ and labeled for 2940nm.

4.

Set the initial fluence and pulse mode parameters according to the condition being treated. The system allows for a choice of three treatment modes.

5.


6.

Up to 20% overlapping is acceptable.

7.


8.

Depth of treatment should be customized to the specific indication (scars vs. wrinkles).

9.

Following treatment gently cleanse the treated area of skin fragments with a moist cloth using normal saline solution.

10. If adverse skin effects occur (such as excessive reddening or swelling), you may either change the pulse frequency or reduce the fluence.

*

30-10




30.6.5.

Treatment Procedure

†

It is recommended also that treating physicians familiarize themselves with Er:YAG treatment based on clinical literature; general pre- and posttreatment procedures are provided below. These general guidelines are not intended to be a substitute for clinical education, judgment, and/or experience of the physician. 1.

Anesthesia: prior to treatment the skin in the areas intended for treatment should be cleansed with a mild, non-alcoholic, non-abrasive agent. A commercially available topical anesthetic cream should be applied one hour prior to treatment. During and post-treatment cooling with the Zimmer Cryo can be used to minimize redness or a sunburned feeling.

2.

It is advisable to use a smoke evacuator and a mask during the procedure.

3.

iPixelEr roller tip (7x1): initially cover the treatment area in the vertical direction (Y) followed by horizontal (X) strokes at a pace of ~1cm/sec on the treatment area. 1 pass = vertical-horizontal (XY).

4.

Fluence on skin with the iPixelEr module and 7x1 iPixelEr roller tip: mild up to 1200 mJ/P, moderate up to 1600 mJ/P, aggressive up to 1800 mJ/P.

5.

Recommended number of passes (average) over the entire treatment area is 2-4

6.

7x7 tip (49 pixels): cover the treatment area by stamping (stationary) the surface of the skin in Stack (5 Hz) or Non-Stacked (2 Hz) mode. It is recommended to repeat the stack mode (2-3 repetitions) on skin types I-III and only 1 repetition in skin types IV-V.

7.

Matrix size: use the 7x7 or the 7x1 tip for more aggressive and stacking technique on scars, etc. The iPixelEr 7x1 tip should be used when greater penetration is required.

8.

Depth of penetration with the Pixel 7x7 tip: 50-100 microns ablation plus 100-125 microns thermal injury zones with 3-5 stacks.

9.

Depth of penetration with iPixelEr 7x1 roller tip: 100-150 microns ablation plus 75-100 microns thermal injury zones.

10. Fluence on skin with the Pixel 7x7 tip: mild 1200-1600 mJ/P, moderate 17002000 mJ/P, aggressive up to 2500 mJ/P. 11. Free-hand (random passes): the tip is moved randomly on the treatment area and repeated passes are employed. 12. The free-hand passes technique is recommended for indications such as photodamage/photo-age signs and symptoms. 13. Intensity with the free-hand technique: number of passes: 1 = conservative, 2 = moderate, 3 = aggressive. 14. Stationary (stacking): the Pixel 7x7 tip is placed stationarily on the treatment area and repeated pulses are employed.

†



30-11


15. Stationary technique is recommended for structures residing below the epidermis such as acne scars, fine lines, wrinkles, etc. 16. Stationary technique – number of stacks: 2 = conservative, 4 = moderate, 6 = aggressive. The number of stacks depends on the structure topography (acne scars vs. hypertrophic scar vs. wrinkles) and the desired level of penetration i.e., the greater the number of stacks, the higher the penetration. 17. Downtime after first treatment: redness and sunburn feeling for several hours or up to 2 days if aggressive treatment has been performed. Pale (conservative) to dark brown (aggressive) Pixel pattern on days 3-5 with flaking. Swelling in aggressively treated areas through day 5. Full recovery by days 5-7. Down time is decreased with subsequent treatments. Since this is an Erbium:YAG laser, patients with more moisture in their skin may experience more redness and sensation and achieve better results in fewer treatments. Similarly, a patient with dry skin may require more treatments. 18. Number of sessions: three for aggressive to five for conservative treatments at 2-4 weeks apart. Results will continue to improve over 6 months once treatments are complete. 19. Precautions: Do not perform Pixel 2940nm treatments over Botox® or Restylane® for two weeks post-injection. Use an anti-viral before treatments if there is a history of cold sores. Make sure the skin is clean and dry before treatment. Note Always perform a skin test on the intended treatment area during the first treatment session (see Section 30.6.4.).

Caution It is imperative that the Pixel tips and their lenses remain clean and free of debris. The Pixel tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.

30-12



30.6.6.


Table 30-5: Suggested Setup Parameters for the Standard Tips Skin Type

Mode

Spot Size

Intensity

Energy (mJ/Pulse)

Frequency (Hz)

I – IV

Short

4 mm

Mild

Up to 1000

4

I – IV

Medium

4 mm

Moderate

Up to 1600

4

I – IV

Long

4 mm

Aggressive

Up to 2500

4

Table 30-6: Suggested Setup Parameters for the 7x7 Pixel Tip Skin Type

Matrix Dots

Energy (mJ/P)

Pulse Mode


Frequency (Hz)

I – IV

7x7

1800

L

1–3/2–6

2*, 5**

I – IV

7x7

2000

L

1–3/2–6

2, 5

I – IV

7x7

2500

L

1–3/2–6

2, 5

(*) (**)

Note: 7x7 matrix = 49 Pixels = 51 mJ/Pixel


Table 30-7: Suggested Setup Parameters for the 7x1 iPixelEr Tip Skin Type

Energy (mJ/P)

Pulse Mode

Number of Passes

Overlapping (%)

Intensity

I – III

Up to 600

Short

1 – 2 (XY)

20 – 50

Mild

IV

Up to 600

Short

1 (XY)

20 – 50

Mild

I – III

Up to 800

Medium

1 – 2 (XY)

20 – 50

Moderate

IV

Up to 800

Medium

1 (XY)

20 – 50

Moderate

I – III

Up to 1000

Long

1 – 2 (XY)

20 – 50

Aggressive

IV

Up to 1000

Long

1 (XY)

20 – 50

Aggressive

Waiting Interval Between Passes

5 – 10 sec.

Note: 7x1 matrix = 7 Pixels = 145 mJ/Pixel (*) The number of passes or stacks depends on the desired level of penetration i.e., the greater the penetration, the greater the number of passes/stacks.


30-13


30.6.7.

Post-Treatment Care & Follow-Up Meticulous wound care (open or closed techniques) is crucial after skin resurfacing; below are the Alma Lasers recommendations for follow-up. Physicians may refer to them, and then determine their own suitable regime.

• Open wound care technique: During open wound care technique, soak with 0.25% acetic acid, normal saline, or cool tap water for 20 minutes every 2-4 hours, followed by gentle wiping of the skin. Cold compresses are immediately followed by the application of a bland emollient ointment. Popular ointments include Catrix®-10 (Lescarden) and Aquaphor® Healing Ointment (Beiersdorf AG).

• Closed wound care technique: provides a semi-occlusive environment that

may protect the wound from exogenous bacteria and foster exchange of oxygen and water vapor. Drainage of the wound exudates via the dressing may prevent excess crust and simplify wound management. For the closed wound care technique popular dressings include the composite foam Flexzan® (Dow Hickam Pharmaceuticals), the hydrogel product 2nd Skin® (Bionet), the plastic mesh N-terface® (Winfield Laboratories), and the polymer film Silon-TSR® (Bio Med Sciences). The frequency of soaks and ointment application decreases as re-epithelialization progresses and is tapered off when re-epithelialization is complete (normally within 5-6 days).


• Following re-epithelialization, gentle cleansings begin a day or two later. The use of ointment is replaced during the day by use of a lighter moisturizersunscreen. At night time, ointment is more slowly replaced.


• If no additional treatment is necessary, the patient should return for an additional examination after two months.

• Treatment is complete when satisfactory results are obtained. • Avoid sun exposure during pre- and post-operative period. • If adverse side effects occur (hyperpigmentation), sun protection and spotresurfacing depigmenting agents such as hydroquinone will help obtain resolution.


30-14





30-15

CHAPTER 31 iPixelEr 2940nm and Impact Modules – Dermatological Procedures Chapter Contents: Section 31.1.

Title

Page

Module Descriptions........................................................................ 31-3

31.1.1. iPixelEr 2940nm Module Description ............................................. 31-3 31.1.2. Impact Module Description ............................................................ 31-4 31.2.

Module Specifications ..................................................................... 31-5

31.2.1. iPixelEr 2940nm Module Specifications ......................................... 31-5 31.2.2. Impact Module Specifications ........................................................ 31-5 31.3.

Operating Screens ............................................................................ 31-6

31.4.

Regulatory Labels ............................................................................ 31-6

31.4.1. iPixelEr Module 2940nm Module ................................................... 31-6 31.4.2. Impact Module................................................................................ 31-7 31.5.


31.6.

Clinical Guide: iPixelEr and Impact Applications ............................ 31-9

31.6.1. Introduction .................................................................................... 31-9 31.6.2. Training Requirements ................................................................... 31-9 31.6.3. Intended Use ................................................................................... 31-9 31.6.4. Contraindications.......................................................................... 31-10 31.6.5. Accessories and Equipment .......................................................... 31-11 31.6.6. Pre-Treatment Information ........................................................... 31-12 31.6.7. Treatment...................................................................................... 31-15 31.6.8. Treatment Protocol ....................................................................... 31-16 Harmony®XL Modules Operator's Manual

31-1

iPixelEr 2940nm and Impact Modules – Dermatological Procedures

31.6.9. iPixelEr 2940nm Module ............................................................... 31-16 31.6.10. Impact Module .............................................................................. 31-17 31.6.11. Suggested Setup Parameters ......................................................... 31-19 31.6.12. Post-Treatment Care and Follow-Up ............................................ 31-20 31.6.13. Closed Wound Care ...................................................................... 31-20

31-2



31.1. Module Descriptions 31.1.1.

iPixelEr 2940nm Module Description When using the iPixelEr tip the iPixelEr 2940nm module provides technology for fractional ablative skin resurfacing and laser peeling, employing a gradual procedure that stimulates the replacement of aged and photo-damaged skin. A complete discussion of the Pixel Pro and Laser 2940nm modules' clinical applications may be found in Section 31.6. The iPixelEr 2940nm module is identified by iPixelEr printed on the module (see Figure 31-1).

Figure 31-1: iPixelEr Laser 2940nm Module

Note Refer to the HarmonyXL System Operator's Manual for particular instructions on disinfecting and sterilizing the wheeled tip section of the iPixelEr 2940nm module.


31-3


31.1.2.

Impact Module Description The Impact module is a sonotrode that emits gentle acoustic waves and air pressure which help to advance topical cosmetic products into the top layers of the skin, creating a "push and pull" effect within the channels to release the buildup of intracellular fluid and help the product more rapidly advance into the skin to the targeted tissue depth.

Figure 31-2: Impact Module

Note Refer to the HarmonyXL System Operator's Manual for particular instructions on replacing the disposable tips of the Impact module.

31-4



31.2. Module Specifications 31.2.1.

iPixelEr 2940nm Module Specifications • Light Source:

Er:YAG

• Wavelength:

2940nm

• Available Tips:

7x7 Pixel 7 x 1 iPixelEr

• Operating Parameters with 7x7 Pixel Tip:  Energy Density (Fluence) in Short mode:

200 – 1200 mJ/P


600 – 1800 mJ/P


800 – 2500 mJ/P 2 Hz (Non-Stacking) 5 Hz (Stacking)


• Operating Parameters with 7x1 iPixelEr Tip:

31.2.2.

 Energy Density (Fluence) in Short mode:

200 – 600 mJ/P


300 – 800 mJ/P


400 – 1000 mJ/P


4 Hz

Impact Module Specifications • Impact Frequency:

Up to 100 Hz

• Max. Pulse Energy:

100%


31-5


31.3. Operating Screens The iPixelEr 2940nm module's main operating screen (see Figure 31-3) is displayed when the module is connected to the system:

Figure 31-3: iPixelEr 2940nm Module Screen The Impact module's main operating screen (see Figure 31-4) is displayed when the module is connected to the system:

Figure 31-4: Impact Module Screen

31.4. Regulatory Labels 31.4.1.

iPixelEr Module 2940nm Module Figure 31-5 presents the regulatory identification and caution labels adhered to the iPixelEr module's connector:

31-6



Figure 31-5: iPixelEr 2940nm Module Regulatory Labels

31.4.2.

Impact Module Figure 31-5 presents the regulatory identification label adhered to the Impact module's connector:

Figure 31-6: Impact Module Regulatory Label


31-7


31.5. Ordering Information The following table offers names of accessories specific to the iPixelEr 2940nm and Impact modules that may be ordered from Alma Lasers: Table 31-1 Laser iPixelEr 2940nm and Impact Module Accessories Description iPixelEr 2940nm Module (including 7 mm Pixel and 7x1 iPixelEr tips) 7 x 7 Pixel tip for iPixelEr 2940nm module 7 x 1 iPixelEr tip for iPixelEr 2940nm module Safety Glasses for iPixelEr 2940nm (OD 6+) Impact Module Impact Module Disposable Tips (pack of 20)

31-8



31.6. Clinical Guide: iPixelEr and Impact Applications 31.6.1.

Introduction This clinical guide is provided to aid professionals in the use of the HarmonyXL system. The system incorporates two distinct applicator technologies: •

iPixel Er:YAG 2940nm module fractionated energy (iPixelEr)

•

Acoustic pressure (Impact)

The information provided in this appendix adds to or reinforces information presented in the HarmonyXL system 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.

31.6.2.

Training Requirements The HarmonyXL 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 HarmonyXL system. At the end of this in-service training, personnel are considered trained for the operation of the HarmonyXL 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.

31.6.3.

Intended Use The HarmonyXL system and its modules are intended for use in dermatological procedures.

31.6.3.1. iPixelEr 2940nm Module Component Refer to Section 30.6.1 and 30.6.2 in Chapter 30 of this manual for a complete listing of all iPixelEr indications.

31.6.3.2. Impact Module Component The Impact module is intended to transport the applied cosmeceutical into the biological tissue for the treatment of selected aesthetic/medical conditions such as:

• Skin rejuvenation

• Striae

• Wrinkles

• Scars


31-9


31.6.4.

Contraindications

31.6.4.1. iPixelEr 2940nm Module Component • Bacterial or viral infection. • Impaired immune system. • Isotretinoin in the past 12 months. • Scleroderma • Extensive radiation therapy. • Burns in the treatment area. • Poor healing in the treatment area. • Metal implants near the treatment area. • Implantable pacemaker or automatic defibrillator/cardioverter (AICD). • Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months. • Cancer • Active collagen or vascular disease. • Pregnancy or IVF procedure. 31.6.4.2. Impact Module Component • Undiagnosed somatic pain. • Cancer or history of cancer. • Psoriasis • Decreased circulation. • Infection • Pregnancy (including IVF). • Central nervous system tissue. • Pacemakers • Thrombophlebitis • Uncontrolled bleeding or blood-thinning medication (Coumadin®). • Heart disease (CAD, CHF, Post-MI, etc.). • Abdominal wall hernias. • Diabetes (uncontrolled). • Hepatitis 31-10



31.6.4.3. Special Considerations • Alcohol consumption (acute). • Recent surgical procedures. • Acute inflammation. • Decreased sensation. • Dental metallic structure (i.e., bridge). • Recent (less than 1 month) use of dermal fillers.

31.6.5.

Accessories and Equipment

31.6.5.1. iPixelEr 2940nm Module • Prophylactic Anti-viral (Valtrex®, Famvir®, etc.). • Moist occlusion (Aquaphor®, Vaseline, etc.). • Gentle cleanser (Cetaphil®, etc.). • Intraocular shields and topical anesthetic. 31.6.5.2. Impact Module • Surgical marker/pen. • Template (15 x 10 cm). • Wooden spatula. • Medical/office bed (pneumatic recommended). 31.6.5.3. Impact Meso-Kits • Impact Meso-Striae kit. • Impact Meso-Wrinkles kit. • Impact Skin Rejuvenation kit.


31-11


31.6.6.

Pre-Treatment Information

31.6.6.1. 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 the dermatology condition for suitability of treatment with the iPixelEr 2940nm module.

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

• Discuss the treatment regimen with the patient. 31.6.6.2. Counseling During the first visit, the physician (or an authorized member of the staff) should inform the patient of the following:

• Identify and discuss the skin condition and the desired treatment area with the patient.

• Inform the patient that acceptable results will likely require a number of treatments administered over several months.

• There may be very mild discomfort associated with the treatment. • Transient erythema/edema may appear immediately following treatment. • No local anesthetic will be used anytime during the treatment regimen. 31.6.6.3. Photography 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. Photographs should be taken before each treatment/visit and at the two months follow-up visit. 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.

31.6.6.4. Patient Selection Criteria Motivated patients with realistic expectations should be selected for treatment.

31-12



31.6.6.5. Treatment Areas The iPixelEr 2940nm module can be used bilaterally in the following areas:

• Body • Face 31.6.6.6. Meso-kits Before using the Impact module the relevant cosmeceuticals should be applied. The applied cosmeceuticals should be in accordance to the treatment indication as described below.

31.6.6.6.1. Impact Meso-Striae Kit • Meso Anti-Wrinkle • 1% Hyaluronic acid • Ascorbic Acid Before use, prepare a Meso-Wrinkle kit mix according to the following ratio: Add ~3ml Meso HA 1% + ~5ml Meso Anti-Wrinkle + ~2ml Ascorbic acid solution* and mix gently. (*) Ascorbic acid should be dissolved before mixed: 1g into 10 ml distilled water.

31.6.6.6.2. Impact Meso-Wrinkles Kit • Meso Anti-Wrinkle • 1% Hyaluronic acid • Ascorbic Acid Before use, prepare a Meso-Wrinkle kit mix according to the following ratio: Add ~3ml Meso HA 1% + ~5ml Meso Anti-Wrinkle + ~2ml Ascorbic acid solution* and mix gently. (*) Ascorbic acid should be dissolved before mixed: 1g into 10 ml distilled water.


31-13


31.6.6.6.3. Impact Meso-Skin Rejuvenation Kit • Meso Whitening • 1% Hyaluronic acid • Ascorbic Acid Before use, prepare a Meso-Skin Rejuvenation kit mix according to the following ratio: Add ~1ml Meso HA 1% + ~8ml Meso Whitening+ ~1ml Ascorbic acid solution* and mix gently. (*) Ascorbic acid should be dissolved before mixed: 1g into 10 ml distilled water.

31.6.6.6.4. Impact Meso-Scars Kit • Meso Anti-Wrinkle • 1% Hyaluronic acid • Ascorbic Acid Before use, prepare a Meso-Striae kit mix according to the following ratio: Add ~3ml Meso HA 1% + ~5ml Meso Anti-Wrinkle + ~2ml *Ascorbic acid solution and mix gently. (*) Ascorbic acid should be dissolved before mixed: 1g into 10 ml distilled water.

31.6.6.7. Number of Treatments and Treatment Intervals The recommended number of treatments is 4-6 at 14-21-days intervals (one treatment every 14 -21days).

31-14



31.6.7.

Treatment The treatment regimen with the HarmonyXL system involves two separate treatment protocols: iPixel modality and Impact ultrasound module. The treatment protocol comprises of two sequential procedures on the same day: 1.

Initially with the iPixelEr module & iPixelEr operating mode, and;

2.

Immediately followed by the Impact module.

31.6.7.1. Treatment Objectives 31.6.7.1.1. iPixel Modality Create controlled preliminary perforation of the skin.

31.6.7.1.2. Impact Module Accelerate the delivery of the cosmeceutical through epidermis into the targeted biological tissue (dermis).

31.6.7.2. Treatment Technique 31.6.7.2.1. iPixelEr Modality • Stationary (stacked pulses) using the 7x7 (49 pixels) tip: where the iPixelEr

module is positioned stationary on the treatment area and repeated pulses are employed.

• Multiple Passes using the 7x1 iPixelEr roller tip: where the iPixelEr module is rolled on the treatment area and repeated passes are employed.

Warning It is advisable to use smoke evacuator and a mask during the procedure.


31-15


31.6.7.2.2. Impact Module The treatment technique involves coupling of the Impact tip to the surface of the skin and keeping it moving in circular motions inside the grids over the treatment area.

31.6.8.

Treatment Protocol

31.6.8.1. Pre-Treatment 1.

Pre-treatment with topical hydroquinone, Tretinoin and or/glycolic acid preparations for skin types III–IV may be helpful in reducing the potential risk of post-skin resurfacing hyperpigmentation.

2.

Prophylactic oral antiviral agents may be helpful for the prevention of facial Herpes Simplex Virus 1 (HSV-1) reactivation until full re-epithelialization occurs. It is generally recommended to begin prophylactic antiviral agents 24 hours prior to RF resurfacing and continuing as described by the agent protocol.

3.

Perform a medical history assessment and check for contraindications (see Section 31.6.4).

4.

Establish the diagnosis/clinical condition – screen the patient for pain, muscle spasms, and cellulite severity.

5.

Standardize photography conditions and take pictures.

6.

Ensure that the iPixelEr treatment tip has been cleaned and sterilized using the sterilization kit before treatment.

7.

Ensure that a new disposable Impact tip is connected to the Impact module.

8.

Establish the patient in a proper position such that the area to be treated is most accurately assessed and featured.

9.

Remove all jewelry or pendants, including necklaces, bracelets, watches, earrings, piercing, etc.

10. Remove all makeup, moisturizers or oils from the treatment area.

31.6.9.

31-16

iPixelEr 2940nm Module 1.


2.

Provide appropriate eye protection for the patient (or eye shields) and the medical staff inside the enclosed treatment room. Goggles should be OD>6 and labeled for 2940nm wavelength.

3.

Set the initial energy levels according to the skin test, treatment area, and clinical indication.

4.

Position the module perpendicular to the skin. Do not apply pressure (the tip should gently touch the skin). Do not apply gel to the skin prior to treatment.



5.

The module's treatment technique can be either Stationary (for deeper penetration) – overlap pulses on the same area using the 7x7 (49 pixels) tip, or Multiple Passes – rolling the iPixel module over the treatment area in random non-overlap passes using the 7x1 iPixel roller tip.

6.

In the non-stationary mode, up to 50% overlapping is acceptable.

7.

Position the module tip in contact with the skin; trigger a laser pulse by pressing the footswitch and the module trigger.

8.

Depth of treatment should be individualized to the specific indication (scars vs. fine lines vs. photodamaged skin).

9.

Following treatment gently cleanse the treated area from skin fragments with a moist cloth and follow post-op care guidelines.

10. If adverse skin effects occur (such as excessive reddening or swelling), you may either change the pulse mode or reduce the fluence. 11. Topical anesthesia should be removed just prior to treatment. 12. Use of a smoke evacuator is required to eliminate the treatment-generated smoke plume. 13. Do not debride (wipe off eschar). The denatured eschar will serve as a completely bio-compatible wound dressing. 14. For more aggressive treatment in areas with deeper rhytids, more laxity or more dyschromia: perform multiple passes or increase the energy. Warning This may increase the overall healing time.

31.6.10.

Impact Module 1.

Mark the treatment grid (recommended 10x10 cm) on the area to be treated (see Figure 31-7). Turn the system on and select the Impact module from the control panel.

Figure 31-7: Treatment Grid – Four Blocks of 10x10 cm Harmony®XL Modules Operator's Manual

31-17


2.

Cover the entire area with the relevant mixed Meso-Kit according to the relevant indication (refer to section 31.6.6.6) by dripping the mix and apply it into the treated area.

3.

Select the Impact module from the control panel.

4.

Set the Frequency, Impact %, and Time of the treatment according to the suggested setup parameters that are in accordance to the treatment area and clinical indication.

5.

Prepare the Impact module for operation by positioning it perpendicular to the skin.

6.

Press the STBY (Standby) softkey; this will “pre-activate” the Impact component of the module.

7.

When the system has transitioned to Ready mode, press the footswitch one time; the Impact module will immediately activate.

8.

Start working with the module; move it in rotational movements within the 15x10 cm area (see Figure 31-8)

9.

To end the treatment press the footswitch again; this will cease operation of the Impact module.

Figure 31-8: Impact Rotational Movement inside the Grid

31-18



31.6.11.


31.6.11.1. iPixelEr 2940nm Modality Table 31-2: iPixelEr 7x1 roller Tip Suggested Setup Parameters iPixelEr Roller Tip

Pulse Mode

Number of Passes

Overlapping [%]

Waiting Interval Between Passes

Up to 600

Short

1–2

20 – 50

5 – 10 sec

IV – V

Up to 500

Short

1–2

20 – 50

5 – 10 sec

VI

Up to 400

Short

1

20 – 50

5 – 10 sec

Skin Type

Energy [mJ/P]

7x1

I – III

7x1 7x1

Table 31-3: Pixel 7x7 Tip Suggested Setup Parameters Matrix Dots

Skin Type

Energy [mJ/P]

Pulse Mode


Frequency [Hz]

7x7

I – III

Up to 600

Short

1–3/1–2

2*, 4**

7x7

IV – V

Up to 500

Short

1–2/1

2*, 4**

7x7

VI

Up to 400

Short

1–2/1

2*, 4**

(*)

"No Stack" mode [The number of passes or stacks depends on the desired level of penetration i.e., the greater the penetration, the greater the number of passes/stacks].

(**) "Stack" mode

31.6.11.2. Impact Module Table 31-4: Impact Suggested Setup Parameters – Striae Treatment Area

Frequency [Hz]

Impact [%]

Time [Min.]

Abdomen

50

50

2* – 4**

Thighs

50

50

2* – 4**

2

(*) 50cm grid (**) 100cm2 grid Table 31-5: Impact Suggested Setup Parameters – Wrinkles, Skin Rejuvenation Treatment Area

Frequency [Hz]

Impact [%]

Time [Min.]

Neck

50

40

2* – 4**

Face

50

50

2* – 4**

Periorbital

50

40

2* – 4**

Décolleté

50

40

2* – 4**

2

(*) 50cm grid (**) 100cm2 grid Harmony®XL Modules Operator's Manual

31-19


31.6.12.

Post-Treatment Care and Follow-Up

31.6.12.1. Open Wound Care • Open wound care technique allows ongoing surveillance of resurfaced skin.

These regimens theoretically seem to be less likely to foster infection since there is no dressing under which bacteria may be trapped. However, open methods may be more painful and inconvenient for the patient.

• Shortly after treatment, a topical emollient such as Aquaphor®, Humatrix®,

Biafin® or other equivalent occlusive ointment should be applied over the area. The occlusive ointment should be applied 3 times a day for one week or until the epidermis is completely healed.

• The patient may apply cool compresses if desired, or Zimmer cooler if available. • If necessary, over the counter analgesics may be taken for pain management. It should be noted however, that subjects should be instructed to use only acetaminophen-based products, such as Tylenol®.

• The patient may gently wash the area with a mild soap to help exfoliate, but should reapply occlusive moisturizer for at least 4 days.

• The patient may shower the next day but avoid hot water on the treated area. • Apply normal skin-care moisturizer and sun block after 4th–5th day. • Discontinue Obagi®, Retin-A, etc. regimen until day 7. On day 7 microderm or

use an aggressive exfoliant or micro-peel. Make-up can be applied to minimize pixel appearance. Avoid topical exfoliation for 4 weeks.

31.6.13. Closed Wound Care • Closed wound care technique provides a semi-occlusive environment that may

protect the wound from exogenous bacteria and foster exchange of oxygen and water vapor. Drainage of the wound exudates via the dressing may prevent excess crust and simplify wound management.

• For closed wound care technique, popular dressings include for example the composite foam Flexzan® (Dow Hickam Pharmaceuticals), the hydro-gel product 2nd Skin® (Bionet), the plastic mesh N-Terface® (Winfield Laboratories), and the polymer film Silon-TSR® (Bio Med Sciences).

• The frequency of soaks and ointment application decreases as re-

epithelialization progresses and is tapered off when re-epithelialization is complete (normally within 5-6 days).


• Gentle cleansings begin a day or two following re-epithelialization. The use of

ointment is replaced during the day by use of a lighter moisturizer-sunscreen. At night, ointment is more slowly replaced.

31-20




• If no additional treatment is necessary, the patient should return for follow-up examination two months later.

• Treatment is complete when satisfactory results are obtained. • Avoid sun exposure during pre- and post-operative period. • If adverse side effects occur (hyperpigmentation), use sun protection and post-

resurfacing depigmenting agents such as hydroquinone to help obtain resolution.



31-21

CHAPTER 32 Alex 755 Laser Module* – Hair Removal and Pigmented Lesions Chapter Contents: Section

Title

Page

32.1.

Alex 755 Laser Module Description................................................ 32-2

32.2.

Alex 755 Laser Module Specifications............................................ 32-2

32.3.

Alex 755 Laser Module Operating Screen ...................................... 32-3

32.4.

Alex 755 Laser Module Regulatory Labels ..................................... 32-4

32.5.


32.6.

Alex 755 Laser Module Clinical Guide ........................................... 32-5

32.6.1. Indications for Use ......................................................................... 32-5 32.6.2. Pigmented Lesions.......................................................................... 32-5 32.6.3. Hair Removal ................................................................................. 32-9

*

Not available in EU and Canada


32-1

Alex 755 Laser Module – Hair Removal & Pigmented Lesions

32.1.

Alex 755 Laser Module Description The Alex 755 laser module has a high-power targeted laser. The module emits a high-energy laser pulse at the 755nm wavelength for two clinical indications:

• Permanent Hair Reduction • Treatment of Benign Pigmented Lesions A complete discussion of the Alex 755 laser module clinical applications may be found in Section 32.6. The Alex 755 laser module is identified by 755nm printed on the module (see Figure 32-1).

Figure 32-1: Alex 755 Laser Module

32.2.

Alex 755 Laser Module Specifications • Light Source:

Alexandrite

• Wavelength:

755nm


2 Hz

• Energy Density (Fluence) with 5 mm Tip: 1 – 32 J/cm2 • Energy Density (Fluence) with 8 mm Tip: 1 – 12 J/cm2

32-2



32.3.

Alex 755 Laser Module Operating Screen The Alex 755 Laser module main operating screen (see Figure 32-2) is displayed when the Alex 755 laser module is connected to the system:

Figure 32-2: Alex 755 Laser Screen Operating parameters available in this module: 1.

There are two tips (5 & 8 mm), available for use with this laser module. The system automatically recognizes the resident tip and displays its size in the topright corner of the screen.

2.

Hair Removal – using the 5 mm tip delivers:

3.

• Fluence:

up to 32 J/cm2


2 Hz

Pigmented Lesions – using the 8 mm tip delivers:

• Fluence:

1 – 12 J/cm2


2 Hz


32-3


32.4.

Alex 755 Laser Module Regulatory Labels Figure 32-3 presents the regulatory identification and caution labels adhered to the Alex 755 laser module connector:

Figure 32-3: Alex 755 Laser Module Regulatory Labels

32.5.

Ordering Information The following table offers names of accessories specific to the Alex 755 laser module that may be ordered form Alma Lasers. Table 32-1 Alex 755 Laser Module Accessories Description Alex 755 Laser Module (including 5mm tip) 5 mm tip for Alex 755 Laser Module 8 mm tip for Alex 755 Laser Module Safety Glasses for 755nm (OD 7+)

32-4



32.6.

Alex 755 Laser Module Clinical Guide The clinical effect of the alexandrite laser is based on the principle of selective photothermolysis. Energy emitted at a wavelength of 755nm (red) is strongly absorbed by dark pigments, such as melanin, but only rather weakly by hemoglobin. As a result, laser radiation is scattered deep into the dermis and impinges on red-light absorbing dark hair shafts and pigmented follicular cells, thus elevating their temperature and creating coagulation. Energy density has to be sufficiently high to damage the targeted tissue while pulse duration should not exceed the thermal relaxation time of a typical follicle radius to avoid thermal conduction to the skin surrounding the follicle. Warning The appropriate protective eyewear should be worn by both the operator and the patient when using this module.

32.6.1.

Indications for Use The Alex 755 laser module is indicated for treatment and clearance of: • Benign pigmented lesions. • Removal of unwanted hair for stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles.

32.6.2.

Pigmented Lesions


32.6.2.2. Contraindications • Tanned skin (active tan) through sun exposure or tanning bed use in the previous 30 days



• History of keloid scarring • Epilepsy


32-5




32.6.2.3. Preparing the Lesion for Treatment If the lesion is smaller than the lightguide's footprint, use the template provided by Alma Lasers to protect collateral tissue surrounding the lesion. To use the template, select a suitable pre-cut hole so that only the lesion area is fully exposed to the margin. Place the template on the treatment site and cover it with a thin layer of gel (underneath and on top of the template) before treatment.

32.6.2.4. Skin Test Always perform a skin test on the intended treatment area before the first treatment session according to the following parameters: Table 32-2: Skin Test Parameters for Pigmented Lesions

32-6


Module

Fluence (J/cm2)

Waiting Period

I - III

Alex 755 Laser; 8mm tip

8 – 10

2 – 4 hours

IV


7–8

48 – 72 hours

IV- VI


5–6

48 – 72 hours



32.6.2.5. Treatment The Alex 755 laser module has two optical tips for pigmented lesions that are replaceable; to detach, grasp the tip at its base and turn counter-clockwise. To attach the tip – grasp the tip and thread it onto the aperture end of the module by turning it clockwise until snug. Treatment is applied perpendicular to the target and a second pass is usually recommended once appropriate safe settings are found. Do not stack pulses. Appropriate cooling methods, such as cold air, are recommended when using the Alex 755 laser module. Treatment can begin after the module and the appropriate tip have been connected to the HarmonyXL system and the treatment parameters (fluence and pulse width) are selected according to Table 32-2. 1.


2.


Caution Do not treat pigmented lesion through a tattoo or a pigmented lesion that has not been examined by a physician. Any hair covering a pigmented lesion must be removed before treatment. 3.

The module tip should be slightly pressed against the pigmented lesion.

4.


5.


6.


7.

Examine carefully. Remember: darker skin types take longer to respond than lighter skin types. The desired effect is darkening of the pigmented lesion and its melanocytes as well as erythema and/or edema along the pigment, indicating a stimulated immune reaction, without changes in the surrounding epidermis.

8.

If, along with a good response in the pigment, adverse skin effects occur (such as excessive reddening or swelling in the shape of the lightguide), reduce the fluence by 10-20%.

9.

If the skin shows no adverse effects and changes observed in the pigmented lesions are unsatisfactory you should increase the fluence by 10-20% and test again.



32-7



32.6.2.6. Pigmented Lesions Suggested Setup Parameters Table 32-3: Pigmented Lesions Suggested Setup Parameters Skin Type (Fitzpatrick I-VI)

Module

Tip/Spot Size

Fluence (J/cm2)

I – III

Alex 755 Laser

8mm tip

8 – 12

IV – VI

Alex 755 Laser

8mm tip

6 – 10

32.6.2.7. Follow Up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen






32-8



32.6.3.

Hair Removal

32.6.3.1. Contraindications • History of local or recurrent skin infection • Pregnancy (including IVF) • History of herpes simplex, especially perioral • History of genital herpes, important when treating the pubic or bikini area • History of keloids/hypertrophic scaring • Isotretinoin – past and present • Epilepsy • History of Koebnerizing skin disorders, such as vitiligo and psoriasis • Previous treatment modalities – method, frequency and date of last treatment, as well as response


32.6.3.2. Pre-Treatment Patient Evaluation Before hair removal procedures, the patient should be evaluated/ documented for the presence of conditions that may cause hypertrichosis: • Hormonal • Familial • Drug (i.e., corticosteroids, hormones, immunosuppressive self or spousal use of minoxidil) • Tumor • Photosensitizing drugs (gold therapy, etc.)

32.6.3.3. Skin Test for Hair Removal and PFB Always perform a skin test on the intended treatment area before the first treatment session according to the parameters in Table 32-4. The treatment parameters for hair removal depend on the skin type, hair color, hair type and the density & depth of the hair. Initially, shave the treatment site to eliminate any surface hair that could interfere with the treatment.


32-9


Table 32-4: Skin Test Parameters for Hair Removal Skin Type (Fitzpatrick I-VI)

Tip/ Spot Size (mm)

Fluence (J/cm2) *

I

22 – 25

II

22 – 25

III IV

20 – 22

5

18 – 20

V

12 – 16

VI

10 – 12

Waiting Period

24 – 48 hours

(*) Ultrasonic gel must be applied to the skin.

32.6.3.4. Treatment Treatment can begin after the module and tip are connected and the treatment parameters are selected according to Table 32-5. Caution External cooling means must be applied to the skin, e.g., cold pack, Zimmer, etc. 1.


2.


3.


4.


5.


6.


7.


8.


9.

If there are no noticeable changes on the skin (Skin Types IV-VI) or near the hair follicles, do not attempt to redo/overlap (sequentially) in the same area.

10. 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.

32-10



11. After treatment it is recommended to cool the area immediately with cold cloth or gauze and apply Aloe Vera gel. Caution It is imperative that the tips and their lenses remain clean and free of debris. The tips and the lenses must be cleaned with a cotton swab and warm water after each treatment. During long treatments, the operator should visually inspect the tip attachment and clean it as necessary. Refer to Chapter 7 in the System Manual - Maintenance.

32.6.3.5. Suggested Setup Parameters for Hair Removal The treatment parameters for hair removal depend on the skin type, hair color, hair type and the density & depth of the hair. Table 32-5: Suggested Setup Parameters Skin Type (Fitzpatrick)

Fluence (J/cm2)

I – II

25 – 30

III

22 – 24

IV

18 – 21

V

12 – 17

VI

8 – 11

Tip/Spot Size (mm)

5

32.6.3.6. Follow Up Measures presented below are only the manufacturer's recommendations for followup. They may serve as a basis for defining your treatment regimen







32-11





32-12


CHAPTER 33 NIR Body Module* – Muscle and Joints Pain Relief Chapter Contents: Section

Title

Page

33.1.

NIR Body Module Description ........................................................ 33-3

33.2.

NIR Body Module Specifications .................................................... 33-4

33.3.

NIR Body Module Operating Screen .............................................. 33-4

33.4.

NIR Body Module Regulatory Labels ............................................. 33-5

33.5.


33.6.

NIR Body Module Clinical Guide – General Applications ............. 33-6

33.6.1. Introduction .................................................................................... 33-6 33.6.2. Intended Use and Indications ......................................................... 33-6 33.6.3. Contraindications............................................................................ 33-6 33.6.4. Pre-Treatment ................................................................................. 33-7 33.6.5. Treatment........................................................................................ 33-9 33.6.6. Suggested Setup Parameters ......................................................... 33-11 33.6.7. Post-Treatment Care ..................................................................... 33-12 33.6.8. Concluding Treatment .................................................................. 33-12 33.6.9. Follow-Up .................................................................................... 33-12 33.7.

NIR Body Module Clinical Guide – Dorsal Hand Rejuvenation .. 33-13

33.7.1. Introduction .................................................................................. 33-13 33.7.2. Intended Use and Indications ....................................................... 33-13 33.7.3. Skin Test ....................................................................................... 33-14

*

Not available in Canada


33-1

NIR Body Module – Muscle & Joints Pain Relief

33.7.4. Treatment ...................................................................................... 33-14 33.7.5. Suggested Setup Parameters ......................................................... 33-16 33.7.6. Post-Treatment Care ..................................................................... 33-16 33.7.7. Follow-Up ..................................................................................... 33-17

33-2



33.1. NIR Body Module Description The HarmonyXL's NIR Body module (see Figure 33-1) emits light in the near infrared spectrum generated by a pulsed-light source. The module provides preselected pulse durations as a function of the selected power (W). The NIR Body 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 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 Body module is operated only by pressing the footswitch. A complete discussion of the NIR Body module clinical applications may be found in Section 33.6.

Figure 33-1: NIR Body Module


33-3


33.2. NIR Body Module Specifications • Light Source:

Near-infrared light

• Wavelength:

Peak emission at 1300 nm

• Output Power:

50 to 100 W

• Exposure Mode:

Pulsed

• Spot Size:

30 x 60 mm (18 cm2)

33.3. NIR Body Module Operating Screen The NIR Body module main operating screen (see Figure 33-2) is displayed when the NIR Body module is connected to the system:

Figure 33-2: NIR Body Screen Operating parameters available in this module:

33-4

1.

Power: the light power applied to the skin can be adjusted from 30 to 100 W.

2.

Repetition Rate: fixed at 10 Hz.

3.

Total Energy: The operating screen exhibits the total energy applied per session, counted in Kilojoules.



33.4. NIR Body Module Regulatory Labels Figure 33-3 presents the regulatory identification and caution labels adhered to the NIR Body module connector:

Figure 33-3: NIR Body Module Regulatory Labels

33.5. Ordering Information The following table offers names of accessories specific to the NIR Body module that may be ordered form Alma Lasers. Table 33-1 NIR Body Module Accessories Description NIR Body Module Safety Eyewear for the NIR Body Module (OD 3+)


33-5


33.6. NIR Body Module Clinical Guide – General Applications 33.6.1.

Introduction This section is provided to aid professionals in the use of the HarmonyXL System operating the NIR Body module. 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.

33.6.2.

Intended Use and Indications The NIR Body 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.

33.6.3.

Contraindications • Cancer; in particularly skin cancer • Pregnancy (including IVF) • Use of photosensitive medication and herbs for which near-infrared light exposure is contra-indicated

• 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 • Open wounds, skin injuries or recent inflammation or burns. • Hemorrhage or patient receiving anticoagulation treatment • Acute inflammation • Hormonal disorders (that are stimulated under intense light) • History of coagulopathies (thrombophlebitis) • Use of anticoagulants • Epilepsy 33-6



33.6.4.

Pre-Treatment

33.6.4.1.

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 HarmonyXL system.

• 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.

33.6.4.2.

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

• Discuss the treatment with the patient: ⇒ 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 33.6.4.3.

Module Operation The HarmonyXL's NIR Body 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.

33.6.4.4.

Module Parameters The HarmonyXL delivers up to 100W. 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.


33-7


33.6.4.5.

NIR Body Module 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 33-2: Skin Test Parameters * Skin Type (Fitzpatrick I-VI)

Power Setting (W)

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

50

60

2.4 – 3.0

VI

50

60

2.4 – 3.0

(*) In-Motion technique

33-8



33.6.5.

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

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 HarmonyXL system.

2.


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.

6.

Verify that the module's tip is cold.

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 33-4. 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.


33-9


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).

Figure 33-4: 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.

33-10



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 HarmonyXL 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 33.6.7– Post-Treatment Care).

33.6.6.

Suggested Setup Parameters The HarmonyXL system is equipped with NIR Body 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 NIR Body module's treatment parameters consist of light energy (power) and pulse frequency of 10 Hz. Table 33-3: Suggested Treatment Parameters * Skin Type (Fitzpatrick I-VI)

Power Setting (W)

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



33-11


33.6.7.

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.

• 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.

33.6.8.

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.

33.6.9.


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



33-12



33.7. NIR Body Module Clinical Guide – Dorsal Hand Rejuvenation 33.7.1.

Introduction This appendix is provided to aid professionals in the use of the HarmonyXL system operating with the NIR Body module for the treatment of the dorsal aspect of the hand for photo-aged and photo-damaged skin imperfections. 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.

33.7.2.

Intended Use and Indications The HarmonyXL NIR Body 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 Body (near-infra red light) module is indicated for: improvement in skin texture. The HarmonyXL system with its NIR Body module is indicated for use on Fitzpatrick skin types I-V.


33-13


33.7.3.

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 33-4: NIR Body Skin Test Parameters

33.7.4.

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

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 power parameter of the NIR Body module has been selected. 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.

33-14

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 (W) from the NIR Body 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.

8.


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 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 The light emitted by the HarmonyXL 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. 18. After treatment it is recommended to cool the area immediately (see Section 33.7.6).


33-15


33.7.5.

Suggested Setup Parameters Table 33-5: 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.

• 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.

• 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.

33.7.6.

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.


(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.

33-16



33.7.7.


• 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.




33-17

CHAPTER 34 NIR Face Module* – Muscle and Joints Pain Relief Chapter Contents: Section

Title

Page

34.1.

NIR Face Module Description ......................................................... 34-2

34.2.

NIR Face Module Specifications ..................................................... 34-3

34.3.

NIR Face Module Operating Screen................................................ 34-3

34.4.

NIR Face Module Regulatory Labels .............................................. 34-4

34.5.


34.6.

NIR Face Module Clinical Guide – General Applications .............. 34-5

34.6.1. Introduction .................................................................................... 34-5 34.6.2. Intended Use and Indications ......................................................... 34-5 34.6.3. Contraindications............................................................................ 34-5 34.6.4. Pre-Treatment ................................................................................. 34-6 34.6.5. Treatment........................................................................................ 34-8 34.6.6. Suggested Setup Parameters ......................................................... 34-10 34.6.7. Post-Treatment Care ..................................................................... 34-11 34.6.8. Concluding Treatment .................................................................. 34-11 34.6.9. Follow-Up .................................................................................... 34-11

*

Not available in Canada


34-1

NIR Face Module – Muscle & Joints Pain Relief

34.1.

NIR Face Module Description The HarmonyXL's NIR Face module (see Figure 34-1) emits light in the near infrared spectrum generated by a pulsed-light source. The module provides preselected pulse durations as a function of the selected power (W). The NIR Face 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, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms. 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 Face module is operated only by pressing the footswitch. A complete discussion of the NIR Face module clinical applications may be found in Section 34.6.

Figure 34-1: NIR Face Module

34-2



34.2.

34.3.

NIR Face Module Specifications • Light Source:

Near-infrared light

• Wavelength:

Peak emission at 1300 nm

• Output Power:

5 to 25 W

• Exposure Mode:

Pulsed

• Spot Size:

6.4 cm2

NIR Face Module Operating Screen The NIR Face module main operating screen (see Figure 34-2) is displayed when the NIR Face module is connected to the system:

Figure 34-2: NIR Face Screen Operating parameters available in this module: 1.

Power: the light power applied to the skin can be adjusted from 30 to 100 W.

2.

Repetition Rate: fixed at 10 Hz.

3.

Total Energy: The operating screen exhibits the total energy applied per session, counted in Kilojoules.


34-3


34.4.

NIR Face Module Regulatory Labels Figure 34-3 presents the regulatory identification and caution labels adhered to the NIR Face module connector:

Figure 34-3: NIR Face Module Regulatory Labels

34.5.

Ordering Information The following table offers names of accessories specific to the NIR Face module that may be ordered form Alma Lasers. Table 34-1 NIR Face Module Accessories Description NIR Face Module Safety Eyewear for the NIR Face Module (OD 3+)

34-4



34.6. NIR Face Module Clinical Guide – General Applications 34.6.1.

Introduction This section is provided to aid professionals in the use of the HarmonyXL system operating the NIR Face module on the face and neck areas with the non-cooled 6.4cm2 spot size NIR Face module. 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.

34.6.2.

Intended Use and Indications The NIR Face 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.

34.6.3.

Contraindications • Cancer; in particularly skin cancer • Pregnancy (including IVF) • Use of photosensitive medication and herbs for which near-infrared light exposure is contra-indicated

• 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 • Open wounds, skin injuries or recent inflammation or burns. • Hemorrhage or patient receiving anticoagulation treatment • Acute inflammation • Hormonal disorders (that are stimulated under intense light) • History of coagulopathies (thrombophlebitis) • Use of anticoagulants • Epilepsy Harmony®XL Modules Operator's Manual

34-5


34.6.4.

Pre-Treatment

34.6.4.1.

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 HarmonyXL system.

• 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.

34.6.4.2.

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

• Discuss the treatment with the patient: ⇒ 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 34.6.4.3.

Module Operation The HarmonyXL's NIR Face module will be applied to the skin using the In-Motion technique. Apply a thin layer of ultrasonic gel on the treatment area. In this technique the module is moved continuously on the skin surface in rotational/ circular or linear motions. Carefully, before applying the module to the skin, the practitioner should feel on his/her own skin that the module tip radiates heat. The module should be moved in intervals of 30 seconds when skin temperature should be detected by thermometer. Using the module on the skin in a stationary mode is strictly prohibited.

34.6.4.4.

Module Parameters The HarmonyXL delivers up to 100W. 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.

34-6



34.6.4.5.

NIR Face Module Skin Test Always perform a skin test on the intended treatment area. Use the in-motion technique (with a thin coat of ultrasonic gel) 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 34-2: Skin Test Parameters * Skin Type (Fitzpatrick I-VI)

Power Setting (W)

Time of Exposure (sec)

Total Energy (kJ)

I

20 – 25

60

0.3 – 0.6

II

20 – 25

60

0.3 – 0.6

III

20 – 25

60

0.3 – 0.6

IV

20 – 22

80

0.3 – 0.6

V

18 – 20

90

0.3 – 0.6

VI

18 – 20

90

0.3 – 0.6



34-7


34.6.5.

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

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 HarmonyXL system.

2.


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.

6.


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 34-4. 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.

34-8



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).

Figure 34-4: 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.


34-9


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 HarmonyXL 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 34.6.7– Post-Treatment Care).

34.6.6.

Suggested Setup Parameters The HarmonyXL system is equipped with NIR Face 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 NIR Face module's treatment parameters consist of light energy (power) and pulse frequency of 10 Hz. Table 34-3: Suggested Treatment Parameters * Skin Type (Fitzpatrick I-VI)

Power Setting (W)

Total Energy(kJ)**

I

20 – 25

8 – 10

II

20 – 25

8 – 10

III

20 – 25

8 – 10

IV

20 – 24

8 – 10

V

20 – 22

8 – 10

VI

18 – 20

8 – 10


34-10



34.6.7.

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.


(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.

• 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.

34.6.8.

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.

34.6.9.


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




34-11

ALMA LASER HarmonyXL ROW Op Modules Manual (Final 13-02-13)

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