Omha27070801 Om Harmony XL Pro Applicators Row

Copyright © 2017, Alma Lasers GmbH. All rights reserved.
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.
Alma Lasers, its logo and Harmony™ are either registered trademarks or trademarks of Alma Lasers Inc. in
the USA and/or other countries.
Alma Lasers GmbH

Nordostpark 100-102
90411 Nuernberg, Germany
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99
Email: info@almalasers.com
Website: http://www.almalasers.com
0459
Catalog No. OMHA27070801

Revision 9, January 2018
Table of Contents
Scope of This Manual

This manual provides a description, technical specifications, operating instructions,
ordering information and clinical guides for the Harmony XL Pro modules in the
following chapters:
Chapter Module Name Wavelength Clinical Applications
1. Introduction
2. H. Power UV Module 270 – 380nm Psoriasis and Vitiligo.
3. Acne Module 420 – 950nm Moderate inflammatory acne
vulgaris.
4. 'S'Acne Module 420 – 950nm Moderate inflammatory acne
vulgaris.
5. VL Module 515 – 950nm Superficial vascular lesions.
6. SVL Cooled Module 515 – 950nm Superficial vascular lesions.
7. VL/PL Module 440 – 950nm Vascular and Pigmented lesions.
8. VL/PL Cooled Module 440 – 950nm Vascular and pigmented lesions.
9. Dye-VL Module 500 – 600nm Vascular and pigmented lesions.
10. Yellow LED 560 – 620nm Increased blood flow, muscle
relaxation & pain relief.
Treatment of rhytids, fine lines
and wrinkles1.
11. SR Module 570 – 950nm Skin rejuvenation.
12. SR Cooled Module 570 – 950nm Skin rejuvenation.
13. SSR Cooled Module 540 – 950nm Skin rejuvenation ("S" mode).
14. Dye-SR Module 550 – 650nm Vascular and pigmented lesions.
15. HR Module 650 – 950nm Hair removal.
16. SHR (3) Module 650 – 950nm Hair removal.
Long-term or permanent hair
reduction ("S" mode).
17. SHR (5) Module 650 – 950nm Long-term or permanent hair
reduction [5 cm2 spot size].
18. ST Module 780 – 950nm Scar revision and treatment of
striae.
19. SST Cooled Module 780 – 950nm Scar revision and treatment of
striae ("S mode).
20. Q-SW Pro (ClearLift) 1064nm & 532nm Tattoo removal and vascular
Module lesions.
21. H.P.Q-SW Pro 1064nm & 532nm Tattoo removal, skin rejuvenation
(ClearLift) Module and pigmented vascular lesions.
22. L.P. 1064nm Pro 1064nm Vascular lesions, leg veins, hair
Module removal, wrinkles and PFB.
1 In Canada
Harmony XL Pro Operator's Manual i

Table of Contents
Chapter Module Name Wavelength Clinical Applications
23. Cooled L.P. Pro 1064nm Vascular lesions, leg veins, hair
Module removal, facial wrinkles and PFB.
24. Fungus L.P. Pro 1064nm Onychomycosis (nail fungus),
Module vascular lesions, leg veins, hair
removal and PFB.
25. L.P. 1320 Module 1320nm Wrinkles and acne scars.
26. Cooled L.P. 1320 1320nm Wrinkles and acne scars.
Module
27. iPixel Pro Module 2940nm Fractional ablative skin
resurfacing.
28. NIR Face Module2 1300nm Muscle pain relief.
Joint pain and stiffness.
29. Er:Glass Module3 1540nm Acne, Acne Scars and Benign
Facial Lesions
30. NIR Body Module 1300nm Muscle and Joints Pain Relief
31. Cryotherapy (ZERO) N/A Acne, and Hyperhidrosis
Module
32. SHR (6.4) Module 700-950 nm Removal of unwanted hair and to
effect stable long-term or
permanent hair reduction
2 Not available in Canada

3 Not available in the USA
ii Harmony XL Pro Operator's Manual

Table of Contents
Table of Contents
1.1 Scope of This Manual ...................................................................... 1-2

1.2 Module Specifications...................................................................... 1-3
1.2.1 AFT, UV, NIR & LED, Non-Laser, Non-Cooled
Modules .............................................................................. 1-4
1.2.2 AFT and NIR, Non-Laser, Cooled Modules....................... 1-5
1.2.3 'S' Mode Cooled Modules ................................................... 1-6
1.2.4 Cryotherapy (Zero) Module ............................................... 1-6
1.2.5 Laser Modules.................................................................... 1-7
1.2.6 Laser Modules (continued) ................................................ 1-8
2.1 H. Power UV Module Description ................................................... 2-2

2.2 H. Power UV Module Specifications ............................................... 2-2
2.3 H. Power UV Module Operating Screen ......................................... 2-3
2.4 H. Power UV Module Regulatory Labels ........................................ 2-4
2.5 Ordering Information ...................................................................... 2-4
2.6 H. Power 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
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
3.6 Acne Module Clinical Guide ............................................................ 3-5
3.6.1 Pre-Treatment ................................................................... 3-5
3.6.2 Treatment .......................................................................... 3-7
3.6.3 Suggested Setup Parameters ............................................ 3-8
Harmony XL Pro Operator's Manual iii

Table of Contents
3.6.4 Follow-Up........................................................................... 3-8
4.1 'S'Acne Module Description............................................................. 4-2

4.3 'S'Acne Module Operating Screen ................................................... 4-3
4.4 'S'Acne Module Regulatory Labels .................................................. 4-4
4.6 'S'Acne Module Clinical Guide ........................................................ 4-5
4.6.1 Pre-Treatment ................................................................... 4-5
4.6.2 Treatment .......................................................................... 4-7
4.6.4 Follow-Up........................................................................... 4-9
5.1 VL Module Description ................................................................... 5-2

5.2 VL Module Specifications ................................................................ 5-2
5.3 VL Module Operating Screen.......................................................... 5-3
5.4 VL Module Regulatory Labels ........................................................ 5-4
5.6 VL Module Clinical Guide ............................................................... 5-5
5.6.1 Indications for Use............................................................. 5-5
5.6.2 Contraindications .............................................................. 5-5
5.6.3 Pre-Treatment ................................................................... 5-6
5.6.4 Treatment .......................................................................... 5-7
5.6.6 Follow-up ........................................................................... 5-9
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
6.6 SVL Cooled Module Clinical Guide................................................. 6-5
iv Harmony XL Pro Operator's Manual

Table of Contents

6.6.3 Pre-Treatment ................................................................... 6-6
6.6.4 Treatment .......................................................................... 6-7
6.6.6 Follow-up ........................................................................... 6-9
7.1 VL/PL Module Description .............................................................. 7-2

7.2 VL/PL Module Specifications .......................................................... 7-2
7.3 VL/PL Module Operating Screen .................................................... 7-3
7.4 VL/PL Module Regulatory Labels ................................................... 7-4
7.6 VL/PL Module Clinical Guide for Vascular Lesions ....................... 7-5
7.6.3 Pre-Treatment ................................................................... 7-6
7.6.4 Treatment .......................................................................... 7-7
7.6.5 Suggested VL/PL Setup Parameters for Vascular
Lesions ............................................................................... 7-8
7.6.6 Follow-up ........................................................................... 7-9
7.7 VL/PL 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 VL/PL Setup Parameters for Pigmented
Lesions ............................................................................. 7-12
7.7.6 Follow-up ......................................................................... 7-13
8.1 VL/PL Cooled Module Description .................................................. 8-2

8.2 VL/PL Cooled Module Specifications .............................................. 8-2
8.3 VL/PL Cooled Module Operating Screen ........................................ 8-3
8.4 VL/PL Cooled Module Regulatory Labels ....................................... 8-4
8.5.1 VL/PL Cooled Module Clinical Guide for Vascular
Lesions ............................................................................... 8-5
Harmony XL Pro Operator's Manual v

Table of Contents

8.5.4 Pre-Treatment ................................................................... 8-6
8.5.5 Treatment .......................................................................... 8-7
8.5.6 Suggested VL/PL Cooled Setup Parameters for
Vascular Lesions ................................................................ 8-8
8.5.7 Follow-up ........................................................................... 8-9
8.6 VL/PL Cooled Module Clinical Guide for Pigmented Lesions ...... 8-10
8.6.3 Pre-Treatment ................................................................. 8-10
8.6.4 Treatment ........................................................................ 8-11
Pigmented Lesions........................................................... 8-13
8.6.6 Follow-up ......................................................................... 8-14
9.1 Dye-VL Module................................................................................ 9-2

9.2 Dye-VL Module Specifications ........................................................ 9-2
9.3 Dye-VL Module Operating Screen .................................................. 9-3
9.4 Dye-VL Module Regulatory Labels ................................................. 9-4
9.6 Dye-VL Module Clinical Guide for Vascular Lesions ..................... 9-5
9.6.3 Pre-Treatment ................................................................... 9-6
9.6.4 Treatment .......................................................................... 9-7
9.6.5 Follow-up ........................................................................... 9-9
9.7 Dye-VL Module Clinical Guide for Pigmented Lesions ................ 9-10
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 ......................................................................... 9-13
9.8 Dye-SVL Mode Clinical Guide ...................................................... 9-14
vi Harmony XL Pro Operator's Manual

Table of Contents

9.8.3 Module Operation ............................................................ 9-14
9.8.4 Pre-Treatment ................................................................. 9-15
9.8.5 Treatment (In-Motion Technique)................................... 9-16
9.8.6 Suggested Setup Parameters .......................................... 9-17
9.8.7 Stationary Protocol .......................................................... 9-18
9.8.8 Treatment of Small Areas ............................................... 9-18
9.8.9 Follow-up ......................................................................... 9-19
10.1 Yellow LED Module Description ................................................... 10-2

10.2 Yellow LED Module Specifications ............................................... 10-2
10.3 Yellow LED Module Operating Screen ......................................... 10-3
10.4 Yellow LED Module Regulatory Labels ........................................ 10-4
10.5 Ordering Information .................................................................... 10-4
10.6 Yellow LED Module Clinical Guide .............................................. 10-5
10.6.3 Pre-Treatment ................................................................. 10-5
10.6.4 Treatment ........................................................................ 10-6
10.6.5 Suggested Yellow LED Setup Parameters ...................... 10-7
10.6.6 Follow-Up ......................................................................... 10-7
11.1 SR Module Description.................................................................. 11-2

11.2 SR Module Specifications .............................................................. 11-2
11.3 SR Module Operating Screen ........................................................ 11-3
11.4 SR Module Regulatory Labels....................................................... 11-4
11.6 SR Module Clinical Guide ............................................................. 11-5
11.6.3 Pre-Treatment ................................................................. 11-6
11.6.4 Treatment ........................................................................ 11-7
11.6.5 Suggested SR Setup Parameters..................................... 11-8
11.6.6 Follow-up ......................................................................... 11-8
Harmony XL Pro Operator's Manual vii

Table of Contents
12.1 SR Cooled Module Description...................................................... 12-2

12.2 SR Cooled Module Specifications .................................................. 12-2
12.3 SR Cooled Module Operating Screen ............................................ 12-3
12.4 SR Cooled Module Regulatory Labels........................................... 12-4
12.6 SR Cooled Module Clinical Guide ................................................. 12-5
12.6.3 Pre-Treatment ................................................................. 12-6
12.6.4 Treatment ........................................................................ 12-7
12.6.5 Suggested SR Cooled Setup Parameters......................... 12-8
12.6.6 Follow-up ......................................................................... 12-8
13.1 SSR Cooled Module Description ................................................... 13-2

13.2 SSR Cooled Module Specifications ................................................ 13-2
13.3 SSR Cooled Module Operating Screen.......................................... 13-3
13.4 Total Energy in the SSR Cooled Module ...................................... 13-4
13.5 SSR Cooled Module Regulatory Labels ........................................ 13-4
13.7 SSR Cooled Module Clinical Guide ............................................... 13-5
13.7.4 Pre-Treatment ................................................................. 13-6
13.7.8 Treatment of Small Areas ............................................. 13-10
13.7.9 Follow-up ....................................................................... 13-11
14.1 Dye-SR Module Description .......................................................... 14-3

14.2 Dye-SR Module Specifications ...................................................... 14-3
viii Harmony XL Pro Operator's Manual

Table of Contents
14.3 Dye-SR Module Operating Screen ................................................ 14-4

14.4 Dye-SR Module Regulatory Labels ............................................... 14-5
14.6 Dye-SR Module Clinical Guide for Vascular Lesions ................... 14-6
14.6.3 Pre-Treatment ................................................................. 14-7
14.6.4 Treatment ........................................................................ 14-9
14.6.5 Suggested Dye-SR Setup Parameters for Vascular
Lesions ........................................................................... 14-10
14.6.6 Follow-up ....................................................................... 14-11
14.7 Dye-SR Module Clinical Guide for Pigmented Lesions .............. 14-12
14.7.1 Indications for Use......................................................... 14-12
14.7.2 Contraindications .......................................................... 14-12
14.7.3 Pre-Treatment ............................................................... 14-12
14.7.4 Treatment ...................................................................... 14-13
14.7.5 Suggested Dye-SR Setup Parameters for Pigmented
Lesions ........................................................................... 14-14
14.7.6 Follow-up ....................................................................... 14-15
14.8 Dye-SSR Mode Clinical Guide .................................................... 14-16
14.8.3 Module Operation .......................................................... 14-17
14.8.4 Pre-Treatment ............................................................... 14-17
14.8.5 Treatment (In-Motion Technique)................................. 14-18
14.8.6 Suggested Setup Parameters ........................................ 14-19
14.8.7 Stationary Protocol ........................................................ 14-19
14.8.9 Follow-up ....................................................................... 14-21
15.1 HR Module Description ................................................................. 15-2

15.2 HR Module Specifications ............................................................. 15-2
15.3 HR Module Operating Screen ....................................................... 15-3
15.4 HR Module Regulatory Labels ...................................................... 15-4
15.6 HR Module Clinical Guide ............................................................ 15-5
Harmony XL Pro Operator's Manual ix

Table of Contents

15.6.3 Pre-Treatment ................................................................. 15-6
15.6.4 Treatment ........................................................................ 15-7
15.6.5 Suggested HR Setup Parameters .................................... 15-8
15.6.6 Follow-Up......................................................................... 15-9
16.1 SHR (3) Module Description ......................................................... 16-2

16.2 SHR (3) Module Specifications...................................................... 16-3
16.2.1 HR Mode .......................................................................... 16-3
16.2.2 SHR Mode ........................................................................ 16-3
16.3 Lightguide Footprint Size Selection ............................................. 16-3
16.4 SHR (3) Module Operating Screens .............................................. 16-4
16.5 Total Energy in the SHR (3) Module ............................................ 16-5
16.6 SHR (3) Module Regulatory Labels .............................................. 16-6
16.8 SHR (3) Module Clinical Guide – HR Mode ................................. 16-6
16.8.3 Pre-Treatment ................................................................. 16-8
16.8.4 Treatment ........................................................................ 16-8
16.8.5 Suggested HR Setup Parameters .................................. 16-10
16.8.6 Follow-Up....................................................................... 16-11
16.9 SHR (3) Module Clinical Guide – SHR Mode ............................. 16-12
16.9.3 Module Operation in SHR Mode ................................... 16-12
16.9.4 Pre-Treatment ............................................................... 16-12
16.9.5 Treatment ...................................................................... 16-14
16.9.8 Follow-Up....................................................................... 16-17

17.2 SHR (5) Module Specifications...................................................... 17-3
x Harmony XL Pro Operator's Manual

Table of Contents
17.2.1 HR Mode .......................................................................... 17-3

17.2.2 SHR Mode ........................................................................ 17-3
17.8 SHR (5) Pro Module Clinical Guide –HR Mode ............................ 17-6
17.8.3 Pre-Treatment ................................................................. 17-7
17.8.4 Treatment ........................................................................ 17-8
17.8.6 Follow-Up ....................................................................... 17-10
17.9.4 Pre-Treatment ............................................................... 17-11
17.9.5 Treatment ...................................................................... 17-13
17.9.7 Follow-Up ....................................................................... 17-16
18.1 ST Module Description .................................................................. 18-2

18.2 ST Module Specifications .............................................................. 18-2
18.3 ST Module Operating Screen ........................................................ 18-3
18.4 ST Module Regulatory Labels ....................................................... 18-4
18.6 ST Module Clinical Guide ............................................................. 18-4
18.6.3 Pre-Treatment ................................................................. 18-5
18.6.5 Skin Test .......................................................................... 18-6
18.6.6 Treatment ........................................................................ 18-7
Harmony XL Pro Operator's Manual xi

Table of Contents
18.6.8 Follow-Up....................................................................... 18-10
19.1 SST Cooled Module Description.................................................... 19-2

19.2 SST Cooled Module Specifications ................................................ 19-2
19.3 SST Cooled Module Operating Screen .......................................... 19-3
19.4 Total Energy in the SST Cooled Module ...................................... 19-4
19.5 SST Cooled Module Regulatory Labels......................................... 19-4
19.7 SST Cooled Module Clinical Guide ............................................... 19-5
19.7.4 Pre-Treatment ................................................................. 19-6
19.7.5 Treatment ........................................................................ 19-7
19.7.6 Suggested Setup Parameters (In-Motion Protocol) ........ 19-9
19.7.8 Follow-Up....................................................................... 19-10
20.1 Q-SW Pro Module Description ...................................................... 20-2

20.2 Q-SW 1064 Module Specifications ................................................ 20-3
20.2.1 Standard Tip Module Specifications ............................... 20-3
20.2.2 532nm KTP Tip Module Specifications ........................... 20-3
20.2.3 5X5 Pixel Tip Module Specifications ............................... 20-3
20.3 Q-SW Pro Module Operating Screen ............................................ 20-4
20.4 Q-SW 1064 Module Regulatory Labels ......................................... 20-5
20.6 Q-SW Pro Module Clinical Guide ................................................. 20-6
20.6.2 Pre-Treatment ................................................................. 20-8
20.6.3 Treatment ...................................................................... 20-10
20.6.5 Post-Treatment Care ..................................................... 20-11
20.6.6 Follow-Up....................................................................... 20-12
xii Harmony XL Pro Operator's Manual

Table of Contents
21.1 H.P.Q-SW Pro Module Description ............................................... 21-2

21.2 H.P.Q-SW Pro Module Specifications ........................................... 21-4
21.2.1 Module Specifications with Standard and Pixel Tips ..... 21-4
21.2.2 Module Specifications with 532nm KTP Tip................... 21-4
21.3 H.P.Q-SW Pro Module Operating Screen ..................................... 21-5
21.4 H.P.Q-SW Pro Module Regulatory Labels .................................... 21-7
21.6 H.P.Q-SW Pro Module Clinical Guide .......................................... 21-8
21.6.2 Pre-Treatment ............................................................... 21-10
21.6.3 Treatment Procedure – Standard Tips/iPixel roller
7x1 .................................................................................. 21-13
21.6.4 Treatment Procedure – Pixel Tip / iPixel Roller 5X5.... 21-14
21.6.6 Post-Treatment Care – Tattoos (Standard Tips and
iPixel tip 1X7) ................................................................ 21-17
21.6.7 Post-Treatment Care – Pigmented Lesions / Skin
rejuvenation (standard tips, Pixel 5x5 gauged Tip /
iPixel roller 7X1) ............................................................ 21-17
21.6.8 Follow-Up ....................................................................... 21-18
22.1 L.P. 1064 Pro Module Description ................................................ 22-2

22.2 L.P. 1064 Pro Module Specifications ............................................ 22-2
22.3 L.P. 1064 Pro Module Operating Screen ...................................... 22-3
22.4 L.P. 1064 Pro Module Regulatory Labels ..................................... 22-5
22.6 L.P. 1064 Pro Module Clinical Guide............................................ 22-6
22.6.1 Assessing the Condition .................................................. 22-6
22.6.4 Vascular Lesions .............................................................. 22-8
22.6.5 Non-Ablative Treatment of Facial Wrinkles ................. 22-10
Harmony XL Pro Operator's Manual xiii

Table of Contents
22.6.6 Hair Removal & Treatment of Pseudofolliculitis

Barbae (PFB) ................................................................. 22-12
22.6.7 Follow Up ....................................................................... 22-15
23.1 Cooled L.P. Pro Module Description ............................................. 23-2

23.2 Cooled L.P. Pro Module Specifications ......................................... 23-2
23.3 Cooled L.P. Pro Module Operating Screens.................................. 23-3
23.4 Cooled L.P. Pro Module Regulatory Labels .................................. 23-4
23.6 Cooled L.P. Pro Module Clinical Guide ........................................ 23-5
Barbae (PFB) ................................................................. 23-11
23.6.7 Follow Up ....................................................................... 23-14
24.1 Fungus L.P. Pro Module Description ............................................ 24-3

24.2 Fungus L.P. Pro Module Specifications ........................................ 24-3
24.3 Fungus L.P. Pro Module Operating Screens ................................ 24-4
24.4 Operating Parameters................................................................... 24-5
24.4.1 Long Pulse Mode.............................................................. 24-5
24.4.2 Nail Fungus Mode ........................................................... 24-5
24.5 Fungus L.P. Pro Module Regulatory Labels ................................. 24-6
24.7 Clinical Guide: Long Pulse Mode .................................................. 24-7
xiv Harmony XL Pro Operator's Manual

Table of Contents
24.7.6 Follow Up ....................................................................... 24-13

24.8 Clinical Guide: Nail Fungus ....................................................... 24-15
24.8.1 Assessing the Condition ................................................ 24-15
24.8.4 Adverse Effects of Treatment ........................................ 24-16
24.8.5 Preparation for Treatment ............................................ 24-16
24.8.6 Treatment Phase 1 – Q-Switched Module..................... 24-18
24.8.7 Treatment Phase 2 – Fungus L.P. Pro Module ............. 24-20
24.8.9 Follow Up ....................................................................... 24-23
25.1 L.P. 1320 Module Description ....................................................... 25-2

25.2 L.P. 1320 Module Specifications ................................................... 25-2
25.3 L.P. 1320 Module Operating Screens ........................................... 25-3
25.4 L.P. 1320 Module Regulatory Labels ............................................ 25-4
25.6 L.P. 1320 Module Clinical Guide .................................................. 25-4
25.6.3 Pre-Treatment ................................................................. 25-6
25.6.4 Treatment ........................................................................ 25-6
25.6.6 Follow-up ......................................................................... 25-8
26.1 Cooled L.P. 1320 Module Description ........................................... 26-2

26.2 Cooled L.P. 1320 Module Specifications ....................................... 26-3
26.3 Tip Installation.............................................................................. 26-4
26.4 Cooled L.P. 1320 Module Operating Screens ............................... 26-6
26.5 Cooled L.P. 1320 Module Regulatory Labels ................................ 26-7
26.7 Cooled L.P. 1320 Module Clinical Guide ...................................... 26-8
Harmony XL Pro Operator's Manual xv

Table of Contents

26.7.4 Pre-Treatment ................................................................. 26-9
26.7.5 Treatment ...................................................................... 26-10
26.7.7 Follow-up ....................................................................... 26-11
27.1 iPixel Pro Module Description ...................................................... 27-2

27.2 iPixel Pro Module Specifications................................................... 27-3
27.3 iPixel Pro Module Operating Screen ............................................ 27-4
27.4 iPixel Pro 2940nm Module Regulatory Labels ............................. 27-4
27.6 iPixel Pro Clinical Guide ............................................................... 27-5
27.6.1 Indications for Use with Standard Accessory Tips ......... 27-6
27.6.2 Indications for Use with Pixel Accessory Tips ................ 27-7
27.6.4 Pre-Treatment ................................................................. 27-8
27.6.5 Treatment Procedure..................................................... 27-10
27.6.7 Post-Treatment Care & Follow-Up ............................... 27-13
28.1 NIR Face Module Description ....................................................... 28-2

28.2 NIR Face Module Specifications ................................................... 28-3
28.3 NIR Face Module Operating Screen ............................................. 28-3
28.4 NIR Face Module Regulatory Labels ............................................ 28-4
28.6 NIR Face Module Clinical Guide – General Applications ............ 28-5
28.6.1 Introduction ..................................................................... 28-5
28.6.2 Intended Use and Indications ......................................... 28-5
28.6.4 Pre-Treatment ................................................................. 28-6
28.6.5 Treatment ........................................................................ 28-8
28.6.8 Concluding Treatment ................................................... 28-11
xvi Harmony XL Pro Operator's Manual

Table of Contents
28.6.9 Follow-Up ....................................................................... 28-11
29.1 Er Glass Module Description ........................................................ 29-2

29.2 Er Glass Module Specifications .................................................... 29-3
29.3 Er Glass Module Operating Screens ............................................. 29-3
29.4 Er Glass Module Regulatory Labels ............................................. 29-4
29.6 Er Glass Module Clinical Guide.................................................... 29-5
29.6.1 Pre-Treatment ................................................................. 29-5
29.6.2 Treatment ........................................................................ 29-6
29.6.3 Suggested Setup Parameters - Acne ............................... 29-7
29.6.4 Treatment ........................................................................ 29-8
29.6.5 Suggested Setup Parameters – Acne Scars .................... 29-9
29.6.6 Treatment ...................................................................... 29-10
29.6.7 Suggested Setup Parameters – Benign Facial and
Body Lesions (Stretch marks, melasma, surgical
scars) .............................................................................. 29-11
29.6.8 Follow-up ....................................................................... 29-12
30.1 NIR Body Module Description ...................................................... 30-2

30.2 NIR Body Module Specifications................................................... 30-3
30.3 NIR Body Module Operating Screen ............................................ 30-4
30.4 NIR Body Module Regulatory Labels ........................................... 30-5
30.6 NIR Body Module Clinical Guide – General Applications ........... 30-6
30.6.1 Introduction ..................................................................... 30-6
30.6.4 Pre-Treatment ................................................................. 30-7
30.6.5 Treatment ........................................................................ 30-9
30.6.9 Follow-Up ....................................................................... 30-12
Harmony XL Pro Operator's Manual xvii

Table of Contents
30.7 NIR Body Module Clinical Guide – Dorsal Hand Rejuvenation 30-13
30.7.1 Introduction ................................................................... 30-13
30.7.2 Intended Use and Indications ....................................... 30-13
30.7.3 Skin Test ........................................................................ 30-14
30.7.4 Treatment ...................................................................... 30-14
30.7.7 Follow-Up....................................................................... 30-18
31.1 Cryotherapy Module Description .................................................. 31-2

31.2 ZERO Cryotherapy Module Specifications ................................... 31-3
31.3 ZERO Module Operating Screens ................................................. 31-3
31.4 ZERO Module Regulatory Labels ................................................. 31-5
31.6 ZERO Module Clinical Guide........................................................ 31-6
31.6.1 Pre-Treatment ................................................................. 31-6
31.6.2 Treatment ........................................................................ 31-8
31.6.3 Suggested Setup Parameters - Acne ............................. 31-10
31.6.4 Treatment ...................................................................... 31-11
31.6.5 Suggested Setup Parameters - Hyperhidrosis .............. 31-13
31.6.6 Follow-up ....................................................................... 31-14
32.1 SHR (6.4) Module Description ...................................................... 32-2

32.2 SHR (6.4) Module Specifications................................................... 32-3
32.2.1 HR Mode .......................................................................... 32-3
32.2.2 SHR Mode ........................................................................ 32-3
32.4 SHR (6.4) Module Operating Screens ........................................... 32-4
32.5 Total Energy in the SHR (6.4) Module ......................................... 32-5
32.6 SHR (6.4) Module Regulatory Labels ........................................... 32-5
32.8 SHR (6.4) Pro Module Clinical Guide – HR Mode ........................ 32-6
xviii Harmony XL Pro Operator's Manual

Table of Contents
32.8.3 Pre-Treatment ................................................................. 32-7

32.8.4 Treatment ........................................................................ 32-7
32.8.6 Follow-Up ....................................................................... 32-10
32.9 SHR (6.4) Pro Module Clinical Guide – SHR Mode .................... 32-11
32.9.4 Pre-Treatment ............................................................... 32-12
32.9.5 Treatment ...................................................................... 32-13
32.9.7 Follow-Up ....................................................................... 32-16
Harmony XL Pro Operator's Manual xix

List of Figures
List of Figures
Figure Description Page
Figure 2-1. H. Power UV Module (Violet Color Code).................................. 2-2
Figure 2-2. H. Power UV Module Operating Screen .................................... 2-3
Figure 2-3. H. Power 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. 'S'Acne Module (Blue Color Code) ............................................. 4-2
Figure 4-2. 'S'Acne Module Operating Screen.............................................. 4-3
Figure 4-3. 'S'Acne Module Regulatory Labels ............................................ 4-4
Figure 5-1. VL Module (Turquoise Color Code) ........................................... 5-2
Figure 5-2. VL Module Operating Screen .................................................... 5-3
Figure 5-3. VL 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 presents the regulatory identification and caution labels
adhered to the SVL cooled module connector: ......................... 6-4
Figure 6-4. SVL Cooled Module Regulatory Labels ..................................... 6-4
Figure 7-1. VL/PL Module (Green Color Code) ............................................ 7-2
Figure 7-2. VL/PL Module Operating Screen............................................... 7-3
Figure 7-3. VL/PL Module Regulatory Labels ............................................. 7-4
Figure 8-1. VL/PL Cooled Module (Green Color Code) ................................ 8-2
Figure 8-2. VL/PL Cooled Module Operating Screen ................................... 8-3
Figure 8-3. VL/PL Cooled Module Regulatory Labels.................................. 8-4
Figure 9-1. Dye-VL Module Operating Screens ........................................... 9-3
Figure 9-2. Dye-VL Module Regulatory Labels............................................ 9-4
Figure 10-1. Yellow LED Module ............................................................... 10-2
Figure 10-2. Yellow LED Module Operating Screen .................................. 10-3
Figure 10-3. Yellow LED Module Regulatory Labels ................................ 10-4
Figure 11-1. SR Module (Yellow Color Code) ............................................. 11-2
Figure 11-2. SR Module Operating Screen ................................................ 11-3
Figure 11-3. SR Module Regulatory Labels ............................................... 11-4
Figure 12-1. SR Cooled Module (Yellow Color Code) ................................. 12-2
xx Harmony XL Pro Operator's Manual

List of Figures
Figure 12-2. SR Cooled Module Operating Screen..................................... 12-3

Figure 12-3. SR Cooled Module Regulatory Labels ................................... 12-4
Figure 13-1. SSR Cooled Module (Green Color Code) ................................ 13-2
Figure 13-2. SSR Cooled Module Operating Screen .................................. 13-3
Figure 13-3. SSR Cooled Module Regulatory Labels ................................. 13-4
Figure 14-1. Dye-SR Module (Orange Color Code) .................................... 14-3
Figure 14-2. Dye-SR Module Operating Screen (SR/SSR Modes) ............. 14-4
Figure 14-3. Dye-SR Module Regulatory Labels ........................................ 14-5
Figure 15-1. HR Module (Red Color Code) ................................................. 15-2
Figure 15-2. HR Module Operating Screen ................................................ 15-3
Figure 15-3. HR Module Regulatory Labels ............................................... 15-4
Figure 16-1. SHR (3) Module (Brown Color Code) ..................................... 16-2
Figure 16-2. SHR (3) Cooling Module Operating Screen (HR/SHR
mode) ...................................................................................... 16-4
Figure 16-3. SHR (3) Module Regulatory Labels ....................................... 16-6
Figure 17-1. SHR (5) Module Handpiece (Brown Color Code) ................... 17-2
Figure 17-2. SHR (5) Module Operating Screens (HR/SHR modes) .......... 17-4
Figure 17-3. SHR (5) Module Regulatory Labels ....................................... 17-5
Figure 18-1. ST Module (Burgundy Color Code) ........................................ 18-2
Figure 18-2. ST Module Operating Screen ................................................. 18-3
Figure 18-3. ST Module Regulatory Labels................................................ 18-4
Figure 19-1. SST Cooled Module (Burgundy Color Code) .......................... 19-2
Figure 19-2. SST Cooled Module Operating Screen................................... 19-3
Figure 19-3. SST Cooled Module Regulatory Labels ................................. 19-4
Figure 20-1. Q-SW 1064 Module ................................................................ 20-2
Figure 20-2. Q-SW 1064 Module Operating Screen with Standard Tip .... 20-4
Figure 20-3. Q-SW 1064 Module Regulatory Labels .................................. 20-5
Figure 21-1. H.P.Q-SW Pro Module ........................................................... 21-2
Figure 21-2. CVD Adjustable (1–5 mm) Tip ............................................... 21-3
Figure 21-3. H.P.Q-SW Pixel 5x5 mm Tips ................................................ 21-3
Figure 21-4. H.P.Q-SW Roller Tips ............................................................ 21-3
Figure 21-5. H.P.Q-SW Pro Module Operating Screens with Standard
5mm Tip (Top) and 5x5 Pixel Tip (Bottom) ........................... 21-5
Figure 21-6. H.P.Q-SW Pro Module Operating Screen with 7x1 Roller
Tip .......................................................................................... 21-6
Harmony XL Pro Operator's Manual xxi

List of Figures
Figure 21-7. H.P.Q-SW Pro Module Regulatory Labels............................. 21-7

Figure 22-1. L.P. 1064 Pro Module ............................................................. 22-2
Figure 22-2. L.P. 1064 Pro Screen .............................................................. 22-3
Figure 22-3. L.P. 1064 Pro Module Regulatory Labels .............................. 22-5
Figure 23-1. Cooled L.P. Pro Module.......................................................... 23-2
Figure 23-2. Cooled L.P. Pro Screen ........................................................... 23-3
Figure 23-3. Cooled L.P. Pro Module Regulatory Labels ........................... 23-4
Figure 24-1. Fungus L.P. Pro Module ........................................................ 24-3
Figure 24-2. Fungus L.P. Pro Screens ........................................................ 24-4
Figure 24-3. Fungus L.P. Pro Module Regulatory Labels ......................... 24-6
Figure 24-4. Correct Patient Positioning ................................................. 24-16
Figure 24-5. Treatment Area Definitions ................................................. 24-17
Figure 24-6. Lasing Path of Each Pass over the Toenail Plate during
Treatment ............................................................................ 24-18
Figure 25-1. L.P. 1320 Module ................................................................... 25-2
Figure 25-2. L.P. 1320 Module Screen ....................................................... 25-3
Figure 25-3. L.P. 1320 Module Regulatory Labels..................................... 25-4
Figure 26-1. Cooled L.P. 1320 Module ....................................................... 26-2
Figure 26-2. Connection Feet for the Tips.................................................. 26-4
Figure 26-3. Pixel Tip Replacement Procedure (1) .................................... 26-4
Figure 26-6. Cooled L.P. 1320 Screen......................................................... 26-6
Figure 26-7. Cooled L.P. 1320 Module Regulatory Labels ......................... 26-7
Figure 27-1. iPixel Pro Module ................................................................... 27-2
Figure 27-2. iPixel Pro Module Screen ....................................................... 27-4
Figure 27-3. iPixel Pro Module Regulatory Labels .................................... 27-4
Figure 28-1. NIR Face Module ................................................................... 28-2
Figure 28-2. NIR Face Screen .................................................................... 28-3
Figure 28-3. NIR Face Module Regulatory Labels..................................... 28-4
Figure 28-4. Treatment Phases .................................................................. 28-9
Figure 29-1. Er Glass Laser Handpiece ..................................................... 29-2
Figure 29-2. Er Glass Module Screen with Standard 4 mm Tip ............... 29-3
Figure 29-3. Er Glass Module Regulatory Labels ...................................... 29-4
xxii Harmony XL Pro Operator's Manual

List of Figures
Figure 30-1. NIR Body Module ................................................................... 30-3

Figure 30-2. NIR Body Screen .................................................................... 30-4
Figure 30-3. NIR Body Module Regulatory Labels .................................... 30-5
Figure 30-4. Treatment Phases ................................................................ 30-10
Figure 31-1. A-Zero HP, B-Zero HP with Pad holder and Antifreeze
membrane pad........................................................................ 31-2
Figure 31-2. ZERO Module Screen, Cooling phase .................................... 31-3
Figure 31-3. ZERO Module Screen, Heating phase ................................... 31-4
Figure 31-4. ZERO Module Regulatory Labels .......................................... 31-5
Figure 31-5. HDSS – Hyperhidrosis Disease Severity Scale ..................... 31-6
Figure 32-1. SHR Pro (6.4) Cooled Module Handpiece (Black Color
Code) ....................................................................................... 32-2
Figure 32-2. SHR (6.4) Cooling Module Operating Screens ...................... 32-4
Figure 32-3. SHR (6.4) Module Regulatory Labels .................................... 32-5
Harmony XL Pro Operator's Manual xxiii

List of Tables
List of Tables
Table Description Page
Table 2-1. H. Power UV Module Accessories ............................................... 2-4
Table 2-2. Proposed Range of MED Test Spot Fluence (mJ/cm2) for the
H. Power UV Module ............................................................... 2-6
Table 2-3. Suggested UV Setup Parameters ................................................ 2-7
Table 2-4. Initial Treatment Parameters for Vitiligo and Re-
Pigmentation ............................................................................ 2-8
Table 3-1. Acne Module Accessories ............................................................. 3-4
Table 4-1. 'S'Acne Module Accessories ......................................................... 4-4
Table 5-1. VL Module Accessories ................................................................ 5-4
Table 5-2. VL Skin Test parameters ............................................................ 5-6
Table 5-3. Suggested VL Setup Parameters ................................................ 5-8
Table 6-1. SVL Cooled Module Accessories .................................................. 6-4
Table 6-2. SVL Cooled Skin Test Parameters .............................................. 6-6
Table 6-3. Suggested SVL Cooled Setup Parameters .................................. 6-8
Table 7-1. VL/PL Module Accessories .......................................................... 7-4
Table 7-2. Vascular Lesions Skin Test Parameters* ................................... 7-6
Table 7-3. Suggested VL/PL Setup Parameters for Vascular Lesions* ....... 7-8
Table 7-4. Pigmented Lesions Skin Test Parameters ................................ 7-11
Table 7-5. Suggested VL/PL Setup Parameters for Pigmented Lesions ... 7-12
Table 8-1. VL/PL Cooled Module Accessories .............................................. 8-4
Table 8-2. Vascular Lesions Skin Test Parameters ..................................... 8-6
Table 8-3. Suggested VL/PL Cooled Setup Parameters for Vascular
Lesions* .................................................................................... 8-8
Table 8-5. Suggested VL/PL Cooled Setup Parameters for Pigmented
Lesions* .................................................................................. 8-13
Table 9-1. Dye-VL Module (Light Green) ..................................................... 9-2
Table 9-2. Dye-VL Module Accessories......................................................... 9-4
Table 9-3. Vascular Lesions Skin Test Parameters ..................................... 9-6
Table 9-4. Suggested Dye-VL Setup Parameters for Vascular Lesions....... 9-8
Table 9-6. Suggested Dye-VL Setup Parameters for Pigmented Lesions .. 9-12
Table 9-7. Dye-SVL Skin Test Parameters (30 second interval) ............... 9-15
xxiv Harmony XL Pro Operator's Manual

List of Tables
Table 9-8. Dye-SVL Suggested Setup Parameters (30-second interval).... 9-17

Table 9-9. Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion* ....... 9-18
Table 9-10. Small Area Parameters, 3-25 cm2, 1 Second, In-Motion* ....... 9-18
Table 10-1. Yellow LED Module Accessories ............................................. 10-4
Table 10-2. Yellow LED Skin Test Parameters ......................................... 10-6
Table 10-3. Suggested Yellow LED Setup Parameters .............................. 10-7
Table 11-1. SR Module Accessories ............................................................ 11-4
Table 11-2. SR Skin Test Parameters ........................................................ 11-6
Table 11-3. Suggested SR Setup Parameters ............................................. 11-8
Table 12-1. SR Cooled Module Accessories ................................................ 12-4
Table 12-2. SR Cooled Skin Test Parameters ............................................ 12-6
Table 12-3. Suggested SR Cooled Setup Parameters ................................. 12-8
Table 13-1. SSR Cooled Module Accessories .............................................. 13-4
Table 13-2. SSR Cooled Skin Test Parameters .......................................... 13-7
Table 13-3. SSR Cooled Suggested Setup Parameters............................... 13-9
Table 13-4. Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion ..... 13-10
Table 13-5. Small Area Parameters, 3-25 cm2, 1 Second, In-Motion ....... 13-10
Table 13-6. Small Area Parameters, Up To 3 cm2, 3 Seconds,
Stationary* ........................................................................... 13-10
Table 13-7. Small Area Parameters, Up To 3 cm2, 1 Second,
Stationary* ........................................................................... 13-10
Table 14-1. Dye-SR Module Accessories ..................................................... 14-5
Table 14-2. Vascular Lesions Skin Test Parameters ................................. 14-7
Table 14-3. Suggested Dye-SR Setup Parameters for Vascular Lesions . 14-10
Table 14-4. Pigmented Lesions Skin Test Parameters ............................ 14-13
Table 14-5. Suggested Dye-SR Setup Parameters for Pigmented
Lesions.................................................................................. 14-14
Table 14-6. Dye-SSR Skin Test Parameters (30 second interval) ........... 14-17
Table 14-7. Dye-SSR Suggested Setup Parameters (30 second interval) 14-19
Table 14-8. Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion* ... 14-20
Table 14-9. Small Area Parameters, 3-25 cm2, 1 Second, In-Motion* ..... 14-20
Table 15-1. HR Module Accessories............................................................ 15-4
Table 15-2. HR Skin Test Parameters........................................................ 15-6
Table 15-3. Suggested HR Setup Parameters ............................................ 15-8
Table 16-1. SHR (3) Module Accessories .................................................... 16-6
Harmony XL Pro Operator's Manual xxv

List of Tables
Table 16-2. Cooled HR Skin Test Parameters............................................ 16-8

Table 16-3. Suggested HR Setup Parameters .......................................... 16-10
Table 16-4. SHR (3) Skin Test Parameters .............................................. 16-13
Table 16-5. SHR (3) Suggested Setup Parameters .................................. 16-16
Table 16-6. Suggested Total Energy (kJ) delivered per Anatomic Site ... 16-16
Table 16-7. Small Area Parameters, 3-25 cm2, 1 or 3 Seconds, In-
Motion .................................................................................. 16-17
Table 16-8. Small Area Parameters, Up To 3 cm2, 1 or 3 Seconds,
Stationary* ........................................................................... 16-17
Table 17-1. SHR (5) Module Accessories .................................................... 17-6
Table 17-2. HR Cooled Skin Test Parameters............................................ 17-8
Table 17-4. SHR (5) Skin Test Parameters** .......................................... 17-12
Table 17-5. SHR (5) Suggested Setup Parameters .................................. 17-15
Table 17-6. Suggested Total Energy (kJ) delivered per Anatomic Site ... 17-15
Table 17-7. Suggested Total Energy (kJ) delivered –Small areas (up to
25cm2) ................................................................................... 17-16
Table 18-1. ST Module Accessories ............................................................ 18-4
Table 19-1. SST Cooled Module Accessories .............................................. 19-4
Table 19-2. SST Cooled Skin Test Parameters – Forehead, Cheeks and
Neck........................................................................................ 19-6
Table 19-3. SST Cooled Skin Test Parameters – Abdomen, Thigh and
Upper Arm ............................................................................. 19-7
Table 19-4. SST Cooled Suggested Setup Parameters – Forehead,
Cheeks and Neck.................................................................... 19-9
Table 19-5. SST Cooled Suggested Setup Parameters – Abdomen,
Thigh and Upper Arm ............................................................ 19-9
Table 19-6. Small Area Parameters, 3-25 cm2, 1 or 3 Seconds, In-
Motion .................................................................................. 19-10
Table 19-7. Small Area Parameters, Up To 3 cm2, 1 or 3 Seconds,
Stationary* ........................................................................... 19-10
Table 20-1. Q-SW 1064 Module Accessories............................................... 20-5
Table 20-2. Tattoo Removal Skin Test Parameters for Blue, Black &
Green Tattoos (standard tips)................................................ 20-9
Table 20-3. Tattoo Removal Skin Test Parameters for Red Tattoos
(KTP tip)................................................................................. 20-9
xxvi Harmony XL Pro Operator's Manual

List of Tables
Table 20-4. Tattoo Removal Skin Test Parameters for for Blue, Black
& Green Tattoos with Pixel Tip ............................................. 20-9
Table 20-5. Suggested Setup Parameters for Blue, Black & Green
Tattoos .................................................................................. 20-11
Table 20-6. Suggested Setup Parameters for Red Tattoos (1064/532
KTP Tip) ............................................................................... 20-11
Tattoos with Pixel Tip .......................................................... 20-11
Table 21-1. H.P.Q-SW Pro Module Accessories.......................................... 21-7
Table 21-2. Tattoo Removal Skin Test Parameters for Blue, Black &
Green Tattoos (standard tips) .............................................. 21-11
Table 21-3. Tattoo Removal Skin Test Parameters for Red Tattoos
(KTP tip) ............................................................................... 21-11
Tattoos (iPixel Roller Tip 7X1) ............................................ 21-11
Table 21-5. Skin Rejuvenation Skin Test Parameters (Gauged 5x5
Pixel Tip) .............................................................................. 21-12
Table 21-6. Skin Rejuvenation Skin Test Parameters (iPixel roller 7X1)21-12
Tattoos (Standard Tips) ....................................................... 21-15
Tattoos (iPixel Roller Tip 1X7) ............................................ 21-15
Table 21-9. Suggested Setup Parameters for Red Tattoos ...................... 21-15
Table 21-10. Suggested Setup Parameters for deep gauged tips
(Stationary Pixel tip)............................................................ 21-15
Table 21-11. Suggested Setup Parameters for Superficial gauged tips
Table 21-12. Suggested Setup Parameters for Melasma Treatment
Table 21-13. Suggested Setup Parameters for Superficial gauged tips
(iPixel roller 7X1) ................................................................. 21-16
Table 21-14. Suggested Setup Parameters for Melasma Treatment
(iPixel Roller 75X1) .............................................................. 21-17
Table 22-1. L.P. 1064 Pro Module Accessories ........................................... 22-5
Table 22-2. Skin Test Parameters for Vascular Lesions ............................ 22-8
Table 22-3. Vascular Lesions Suggested Setup Parameters.................... 22-10
Table 22-4. Skin Test Parameters for Facial Wrinkles ............................ 22-10
Table 22-5. Facial Wrinkles Suggested Setup Parameters...................... 22-11
Harmony XL Pro Operator's Manual xxvii

List of Tables
Table 22-6. Skin Test Parameters for Hair Removal & PFB Treatment 22-12
Table 22-7. Suggested Setup Parameters ................................................ 22-15
Table 23-1. Cooled L.P. Pro Module Accessories ........................................ 23-5
Table 23-2. Skin Test Parameters for Vascular Lesions............................ 23-7
Table 23-3. Vascular Lesions Suggested Setup Parameters ..................... 23-9
Table 23-4. Skin Test Parameters for Facial Wrinkles............................ 23-10
Table 23-5. Facial Wrinkles Suggested Setup Parameters ..................... 23-11
Table 23-6. Skin Test Parameters for Hair Removal & PFB Treatment 23-12
Table 24-1. Fungus L.P. Pro Module Accessories ...................................... 24-6
Table 24-2. Skin Test Parameters for Vascular Lesions............................ 24-9
Table 24-3. Vascular Lesions Suggested Setup Parameters ................... 24-11
Table 24-4. Skin Test Parameters for Facial Wrinkles............................ 24-11
Table 24-5. Facial Wrinkles Suggested Setup Parameters ..................... 24-12
Table 24-6. Q-Switched Patch Test Parameters for Onychomycosis
(Hallux Nail) ........................................................................ 24-18
Table 24-7. Q-Switched Patch Test Parameters for Onychomycosis
(Digit Nail) ........................................................................... 24-18
Table 24-8. Q-Switched Onychomycosis (Hallux Nail) Suggested Setup
Parameters ........................................................................... 24-19
Table 24-9. Q-Switched Onychomycosis (Digit Nail) Suggested Setup
Parameters ........................................................................... 24-19
Table 24-10. Patch Test Parameters for Onychomycosis (Hallux Nail) .. 24-20
Table 24-11. Patch Test Parameters for Onychomycosis (Digit Nail) ..... 24-20
Table 24-12. Laser 1064F Pro Cooled Suggested Setup Parameters for
Onychomycosis (Hallux Nail) .............................................. 24-21
Table 24-13. Laser 1064F Pro Cooled Suggested Setup Parameters for
Onychomycosis (Digit Nail) ................................................. 24-21
Table 25-1. L.P. 1320 Module Accessories.................................................. 25-4
Table 25-2. Skin Test Parameters .............................................................. 25-6
Table 25-3. Suggested Setup Parameters .................................................. 25-7
Table 26-1. Cooled L.P. 1320 Module Accessories...................................... 26-7
Table 26-2. Skin Test Parameters .............................................................. 26-9
Table 27-1. iPixel Pro Module Accessories ................................................. 27-5
Table 27-2. Skin Test Parameters for the Standard 1, 4mm Tip .............. 27-8
xxviii Harmony XL Pro Operator's Manual

List of Tables
Table 27-3. Skin Test Parameters for the 7x7 Pixel Tip ............................ 27-8
Table 27-4. Skin Test Parameters for the 7x1 iPixelEr Tip ........................ 27-8
Table 27-5. Suggested Setup Parameters for the Standard Tips ............ 27-12
Table 27-6. Suggested Setup Parameters for the 7x7 Pixel Tip .............. 27-12
Table 27-7. Suggested Setup Parameters for the 7x1 iPixelEr Tip .......... 27-12
Table 28-1. NIR Face Module Accessories.................................................. 28-4
Table 28-2. Skin Test Parameters * ........................................................... 28-7
Table 28-3. Suggested Treatment Parameters * ...................................... 28-10
Table 29-1. Er Glass Module Accessories ................................................... 29-4
Table 29-2. Skin Test Parameters for the Standard 4mm, 10mm & 7x7
Pixel Tips - Acne vulgaris ...................................................... 29-6
Table 29-3. Suggested Setup Parameters for the Standard 4 mm, 10
mm & 7x7 Pixel Tips .............................................................. 29-7
Table 29-4. Skin Test Parameters for the Standard 4mm, 10 mm & 7x7
Pixel Tips - Acne Scars........................................................... 29-8
mm & 7x7 Pixel Tips .............................................................. 29-9
Table 29-6. Skin Test Parameters for the Standard 4 mm, 10 mm &
7x7 Pixel Tips - Benign Facial Lesions ................................ 29-10
mm & 7x7 Pixel Tips ............................................................ 29-11
Table 30-1. NIR Body Module Accessories ................................................. 30-5
Table 30-2. Skin Test Parameters * ........................................................... 30-8
Table 30-3. Suggested Treatment Parameters * ...................................... 30-11
Table 30-4. NIR Body Skin Test Parameters ........................................... 30-14
Table 31-1. ZERO Module & Accessories ................................................... 31-5
Table 31-2. Skin Test Parameters for treating Acne ................................. 31-7
Table 31-3. Suggested Setup Parameters for the treating of Acne.......... 31-10
Table 31-4. Skin Test Parameters for treating Hyperhidrosis ................ 31-10
Table 31-5. Suggested Setup Parameters for treating Hyperhidrosis ..... 31-13
Table 32-1. SHR (6.4) Module Accessories ................................................. 32-6
Table 32-2. Cooled HR Skin Test Parameters............................................ 32-7
Table 32-4. SHR (6.4) Skin Test Parameters**........................................ 32-12
Table 32-5. SHR (6.4) Suggested Setup Parameters................................ 32-15
Harmony XL Pro Operator's Manual xxix

List of Tables
xxx Harmony XL Pro Operator's Manual

Introduction
Introduction
Chapter Contents:
Section Title Page
1.1 Scope of This Manual ...................................................................... 1-2
1.2 Module Specifications...................................................................... 1-3
1.2.1 AFT, UV, NIR & LED, Non-Laser, Non-Cooled
Modules .............................................................................. 1-4
1.2.2 AFT and NIR, Non-Laser, Cooled Modules....................... 1-5
1.2.3 'S' Mode Cooled Modules ................................................... 1-6
1.2.4 Cryotherapy (Zero) Module ............................................... 1-6
1.2.5 Laser Modules.................................................................... 1-7
1.2.6 Laser Modules (continued) ................................................ 1-8
Harmony XL Pro Operator's Manual 1-1

Introduction
1.1 Scope of This Manual

The purpose of this manual is to offer the Harmony XL Pro 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 under-standing 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 Harmony XL Pro 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 Harmony XL Pro
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 Harmony XL Pro Operator's Manual

Introduction
1.2 Module Specifications

The tables on the following pages present the technical specifications
of each of the Harmony XL Pro 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.

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

Wavelength Pulse Widths / Spot Size Pulse Repetition Energy Density
Module Applications Technology
(nm) Timers (cm2) Rate (Hz) (J/cm2)
H. Power UV Pigment restoration Pulsed UV 270 – 380 30, 40, 50 msec 6.4 1/2 2-4.5
Acne: 30, 40, 50
Acne: 1 / 2 Acne: 5 – 25S-
Acne and msec
Acne clearance AFT 420 – 950 6.4
'S' Acne Acne:
S-Acne: 2 sec S-Acne: 10 Hz
0.3 – 1.2
Superficial vascular
VL AFT 515 – 950 10, 12, 15 msec 6.4 2/3 5 – 25
lesions
Vascular and
VL/PL AFT 440 – 950 10, 12, 15 msec 6.4 2/3 5 – 25
pigmented lesions
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 1/2 5 – 25
Scar revision &
ST Pulsed NIR 780-950 10, 30 & 90 seconds 6.4 2 1–7
Treatment of Striae
Various skin Pulsed: Up to 70 sec Pulsed

Yellow LED LED 560-620 N/A 1.5W
conditions CW: Up to 70 min CW

Introduction
1.2.2 AFT and NIR, Non-Laser, Cooled Modules

Wavelength Pulse Widths / Spot Size Pulse Repetition Energy Density
Module Applications Technology
(nm) Timers (cm2) Rate (Hz) (J/cm2)
Superficial vascular
SVL Cooled AFT 515 – 950 10, 12, 15 msec 3 2/3 5 – 30
lesions
VL/PL Vascular and
AFT 440 – 950 10, 12, 15 msec 3 2/3 5 – 30
Cooled pigmented lesions
SR Cooled Skin rejuvenation AFT 570 – 950 10, 12, 15 msec 3 2/3 5 – 30
Vascular and SR: 10, 12, 15 msec SR: 1/2 SR: Up to 14

Dye-SR AFT 550 – 650 3
pigmented lesions SSR: 1, 3 & 30 sec SSR: 3 SSR: 1 – 4
VL Mode: VL Mode:
VL Mode: 1/2
Vascular and 10, 12, 15 msec Up to 15
Dye-VL AFT 500 – 600 3
pigmented lesions SVL Mode: SVL Mode:
SVL Mode: 3
1, 3, 30 sec 1–4
Muscle pain, joint
NIR Face4 NIR 1300 N/A 6.4 CW 5 – 25W
pain & stiffness
Muscle and Joints
NIR Body NIR 1300 N/A 18 Pulsed 50 –100 W
Pain Relief
Hair Removal AFT and EDF 30, 40, 50 msec 5 – 20
SHR (6.4) Super Hair 700-950 6.4 Pulsed
NIR 1, 3 and 30 sec 3–7
Removal
4 The NIR module discussed in this manual is not available in Canada.

Introduction
1.2.3 'S' Mode Cooled Modules

Wavelength Spot Size Pulse Repetition Energy Density
Module Applications Technology Timers
(nm) (cm2) Rate (Hz) (J/cm2)
Super skin
SSR Cooled In-Motion AFT 540 – 950 1, 3 & 30 seconds 3 2 1 – 15
rejuvenation
HR: 30, 40, 50 msec HR: 1/2 HR: 5-25
SHR (3) Super hair removal In-Motion AFT 650-950 3
SHR: 1, 3 & 30 seconds SHR: 3 SHR: 3 – 7
HR: 30, 40, 50 msec HR: 1/2 HR: 5-20
SHR (5) Super hair removal In-Motion AFT 650-950 5
SHR: 1, 3 & 30 seconds SHR: 3 SHR: 3 – 7
Scar revision &
SST Cooled In-Motion AFT 780-950 1, 3 & 30 seconds 3 5 0.5 – 3.5
Treatment of Striae
1.2.4 Cryotherapy (Zero) Module

Wavelength Temperature
Module Applications Technology Timers Thermal Plate Size
(nm) Range
Thermoelectric Auto: 15, 30, 120

Cryotherapy Acne, and coupling (TEC), seconds
N/A 5 cm in diameter -10ºC to +45ºC
(Zero) Hyperhidrosis Integrated
thermal plate Manual: 7–11 min

Introduction
1.2.5 Laser Modules

Pulse
Wavelength Pulse Width / Energy Density /
Module Applications Technology Spot Size Frequency
(nm) Mode Fluence / Depth
(Hz)
Q-Switched
Tattoo removal 1064 20 nsec 1, 2, 3, 4, 5, 6 mm 1, 2, 4 500 – 1200 mJ/p
Nd:YAG
Deep pigmented Q-Switched
Q-SW 1064 1064 20 nsec 5 x 5 Pixel 1, 2, 4 500 – 1200 mJ/p
lesions Nd:YAG
FD Q-Switched
Tattoo removal 532 20 nsec 2, 3, 4 mm KTP 1, 2, 4 500 – 1200 mJ/p
Nd:YAG
Q-Switched
Tattoo removal 1064 20 nsec 1, 2, 3, 4, 5, 6 mm 1, 2, 4 500 – 2400 mJ/p
Nd:YAG
Deep pigmented Q-Switched
1064 20 nsec 5x5 Pixel 1, 2, 4 500 – 2400 mJ/p
lesions Nd:YAG
H.P.Q-SW Pro
Tattoo removal & FD Q-Switched
532 20 nsec 2, 3, 4 mm KTP 1, 2, 4 500 – 2400 mJ/p
nail fungus Nd:YAG
Skin rejuvenation Q-Switched 5x5 Roller
1064 20 nsec N/A 500 – 2400 mJ/p
Tattoo removal Nd:YAG 7x1 Roller
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
L.P. 1064 Pro Hair removal Nd:YAG 1064 15 msec 10 mm 1 20 – 50 J/cm2
Wrinkles and acne Nd:YAG 1064 10 msec 5x5 Pixel 1 3 – 25 J/cm2
scars
Fungus L.P. Pro Leg veins Nd:YAG 1064 15, 45, 60 msec 6 mm 1 30 – 150 J/cm2
Nail fungus Nd:YAG 1064 0.1 – 3.0 msec 1 mm 10, 30 100 – 200 mJ/P

Introduction
1.2.6 Laser Modules (continued)

Pulse
Wavelength Pulse Width / Energy Density /
Module Applications Technology Spot Size Frequency
(nm) Mode Fluence / Depth
(Hz)
Wrinkles and acne Nd:YAG 1320 30, 40, 50 msec 6 mm 1 5 – 40 J/cm2

L.P. 1320
scars Nd:YAG 1320 30, 40, 50 msec 5x5 Pixel 1 1 - 11 J/cm2
Leg veins Nd:YAG 1064 15, 45, 60 msec 6 mm 1 30 – 150 J/cm2
Cooled LP Pro Hair removal Nd:YAG 1064 15 msec 10 mm 1 20 – 50 J/cm2
Wrinkles and acne Nd:YAG 1064
10 msec 5x5 Pixel 1 3 – 25 J/cm2
scars
Cooled L.P. Wrinkles and acne 30, 40, 50 msec 6 mm 5 – 40 J/cm2

Nd:YAG 1320 1
1320 scars 30, 40, 50 msec 5x5 Pixel 1-11 J/cm2
1 mm
Stack: 4 Short: 200-1200 mJ/P
4 mm Medium: 600-1800 mJ/P
Non-stack: 2 Long: 800-2500 mJ/P
Fractional ablative 7x7 Pixel
iPixel Pro Er:YAG 2940 0.5 – 1 msec
skin resurfacing
Short: 200-600 mJ/p
7x1 Scanner N/A Medium: 300-800 mJ/p
Long: 400-1000 mJ/p
4 mm
Acne, Acne Scars
Er:Glass and Benign Facial Er:Glass 1540 3 msec 10 mm 1, 2, 3 300 – 2000 mJ/P
Lesions
7 x 7 Pixel

Introduction

H. Power UV Module – Psoriasis &
Vitiligo
Chapter Contents:
Section Title Page
2.1 H. Power UV Module Description ................................................... 2-2
2.2 H. Power UV Module Specifications ............................................... 2-2
2.3 H. Power UV Module Operating Screen ......................................... 2-3
2.4 H. Power UV Module Regulatory Labels ........................................ 2-4
2.6 H. Power 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

H. Power UV Module – Psoriasis & Vitiligo
2.1 H. Power UV Module Description

The H. Power 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 H. Power UV module clinical applications
may be found in Section 2.6.
The H. Power UV module has a violet identification section (see
Figure 2-1).
Figure 2-1. H. Power UV Module (Violet Color Code)
2.2 H. Power UV Module Specifications

 Light Source High-pressure xenon lamp
 Spectrum 270 – 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 H. Power UV Module Operating Screen

The H. Power UV module main operating screen (see Figure 2-2) is
displayed when the H. Power UV module is connected to the system:
Figure 2-2. H. Power UV Module Operating Screen
Operating parameters available in this module:

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

2.4 H. Power UV Module Regulatory Labels

adhered to the H. Power UV module connector:
Figure 2-3. H. Power UV Module Regulatory Labels
2.5 Ordering Information

The following table offers names of accessories specific to the H. Power
UV module that may be ordered form Alma Lasers.
Table 2-1. H. Power UV Module Accessories
Description
H. Power UV (Ultraviolet) Module

H. Power UV Safety Glasses 100% UV Protection

2.6 H. Power UV Module Clinical Guide

The Harmony XL Pro H. Power UV Module emits light in the 270-
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
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.
UV Light Source Indications

The UV Light source (270-380nm) 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
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
 Diabetes (because of increased possible photosensitivity and poor
wound healing)

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:
Select an uninvolved area of healthy, untanned skin (e.g. upper
buttocks/lower back).
Using the MED template provided, expose a series of test spots
according to skin type, as indicated in Table 2-2.
Evaluate the test spots 24 hours following exposure.
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 H. Power UV Module
Skin Type III –

Test Spot # Skin Type I – II Skin Type V – VI Waiting Period
IV
1 2000 2100 2300 24 hours

2 2100 2200 2400 24 hours
3 2200 2300 2500 24 hours
Note
In vitiligo and re-pigmentation reduce the energy by 15%-20%.

2.6.2 Treatment
Clean the skin to remove perfumes, cosmetics and sunscreens.
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.
A treatment mask may be used to protect the healthy skin from
unintended UV exposure.
Do not apply gel.
Place the module perpendicular to the skin and touch the skin. Do
not apply pressure.
Set the initial fluence parameter according to the skin test results.
Trigger a light pulse by pressing the footswitch.
Treatment should overlap the healthy skin at the periphery of the
treated sites by approximately one or two millimeters.
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.
If prominent adverse reactions are noted from the prior treatment,
the next treatment may be skipped or the dose reduced until
symptoms resolve.
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
Pulse
Skin Type Fluence
Module Width Comments
(Fitzpatrick I – VI) (mJ/cm2)
(msec)
UV 270- If no adverse effects,

MED x
I – II 380nm 30, 40 increase fluence by 10-
0.9
(Violet) 20% every 2-3 treatments
MED x
III 380nm 30, 40 increase fluence by 10-
0.8
MED x
IV – VI 380nm 50 increase fluence by 10-
0.7

2.6.4 Vitiligo & Re-Pigmentation

The approach to the treatment with the H. Power 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
Treatment Starting Resultant Resultant Resultant

Area Dosage Erythema <24 Erythema 48-60 Erythema
(mJ/cm2) hours after hours after 60-72 hours after
treatment, fluence treatment, treatment,
should be fluence should postpone the
increased by: be decreased by: next treatment
and decrease
fluence by:
Periocular 2000 5% 5% 10%

Face, scalp,
ear, neck, 2000 10% 10% 15%
axilla, bikini
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%

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 follow-up report sent to the Director of Clinical Operations at
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Acne Module – Acne Clearance
Chapter Contents:
Section Title Page
3.1 Acne Module Description ................................................................ 3-2
3.3 Acne Module Operating Screen....................................................... 3-3
3.4 Acne Module Regulatory Labels ..................................................... 3-4
3.6 Acne Module Clinical Guide ............................................................ 3-5
3.6.1 Pre-Treatment ................................................................... 3-5
3.6.2 Treatment .......................................................................... 3-7
3.6.4 Follow-Up ........................................................................... 3-8

3.1 Acne Module Description

The Harmony XL Pro system with the Acne 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.
Figure 3-1. Acne Module (Blue Color Code)
Caution
3.2 Acne Module Specifications

 Light Source Pulsed light with AFT and EDF
 Treatment Area (spot size) 6.4 cm2
Acne Mode
Energy Density (Fluence): 5 – 25 J/cm2

Timers: 30, 40, 50 msec
Pulse Repetition Rate: 1 / 2 Hz

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

Fluence: 5–25 J/cm2 in increments of 1 J/cm2.
Pulse Width: 30, 40 & 50 msec
Pulse Repetition Rate: fixed at 1/2 Hz

3.4 Acne Module Regulatory Labels

adhered to the Acne module connector:
Figure 3-3. Acne Module Regulatory Labels

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+)

3.6 Acne Module Clinical Guide

The Harmony XL Pro system with the Acne module (blue color code) 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 pulse widths: 30, 40 and
50 msec.
The Acne 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 1/2 Hz. The total energy invested at any
given time is expressed in kilo-Joules (kJ).
Warning
3.6.1 Pre-Treatment
Module Operation
The module applied to the skin using Stationary operating. 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. A thin layer of pre-cooled ultrasonic gel
should be used during the skin test and the actual treatment on all
skin types.

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. The treatment parameters for any given skin condition
depend on the skin type and the lesion type, depth and density.
Indications
The Advanced Fluorescence Technology (AFT) 420–950nm Acne
module is indicated for:
 The treatment of moderate inflammatory acne vulgaris.
 Use on all skin types (Fitzpatrick I-VI).
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.
(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 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.
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.

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.
Skin Type Pulse Width Fluence Waiting

Module
(Fitzpatrick I-VI) (msec) (J/cm2) Period
Acne 420-
I – III 950nm 30, 40 6–8 30 min.
(Blue)
Acne 420-
IV – VI 950nm 50 5 60 min.
(Blue)
3.6.2 Treatment
Treatment can begin after the AFT Acne module has been connected to
the Harmony XL Pro system and the treatment parameters selected
(fluence and pulse width) according to the table in Section 0.
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.
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.
Perform one pass on the right side of the face and one pass on the
left side. Repeat the passes on each side.
Treatments may be administered twice per week over a four-week
period (total of 8 treatments).
If adverse reactions are observed from the prior treatment, the
next treatment may be skipped, or the dose reduced until
symptoms resolve.
It is recommended to cool the area immediately after the
treatment.

3.6.3 Suggested Setup Parameters

Skin Type Pulse Width Fluence
Module
(Fitzpatrick I-VI) (msec) (J/cm2)
Acne 420-950nm
I – III 30, 40 8 – 10
(Blue)
Acne 420-950nm
IV – VI 40, 50 7–8
(Blue)
3.6.4 Follow-Up
Measures presented below are only the manufacturer's
recommendations for follow-up. They may serve as a basis for defining
your treatment regimen.
 Patients should 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.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

'S'Acne Module – Acne Clearance
Chapter Contents:
Section Title Page
4.1 'S'Acne Module Description ............................................................. 4-2
4.3 'S'Acne Module Operating Screen ................................................... 4-3
4.4 'S'Acne Module Regulatory Labels .................................................. 4-4
4.6 'S'Acne Module Clinical Guide ........................................................ 4-5
4.6.1 Pre-Treatment ................................................................... 4-5
4.6.2 Treatment .......................................................................... 4-7
4.6.4 Follow-Up ........................................................................... 4-9

4.1 'S'Acne Module Description

The 'S'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 'S'Acne module clinical applications may
be found in Section 4.6.
The 'S'Acne module has a blue identification section (see Figure 4-1).
Figure 4-1. 'S'Acne Module (Blue Color Code)
4.2 Acne Module Specifications

S-Acne Mode
Energy Density (Fluence): 0.3 – 1.2 J/cm2

Timers: 1, 3, 30 sec
Pulse Repetition Rate: 10 Hz

4.3 'S'Acne Module Operating Screen

The 'S'Acne module main operating screen (see Figure 3-2) is displayed
when the 'S'Acne module is connected to the system:
Figure 4-2. 'S'Acne Module Operating Screen

Fluence: 0.3–1.2 J/cm2 in increments of 0.1 J/cm2.
Timers: 1, 3 & 30 sec
Pulse Repetition Rate: fixed at 10 Hz

4.4 'S'Acne Module Regulatory Labels

adhered to the 'S'Acne module connector:
Figure 4-3. 'S'Acne Module Regulatory Labels

The following table offers names of accessories specific to the 'S'Acne
Table 4-1. 'S'Acne Module Accessories
Description
Handpiece S'Acne 420–50nm (6.4) for Harmony XL


4.6 'S'Acne Module Clinical Guide

The Harmony XL Pro system with the 'S'Acne module (blue color code)
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 4.6.2). 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 'S'Acne 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 kilo-Joules (kJ).
Warning
4.6.1 Pre-Treatment
Module Operation
When the module is applied to 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.

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.
Indications
The Advanced Fluorescence Technology (AFT) 420–950nm 'S'Acne
Contraindications
in the previous 30 days.
 Hypopigmentation (Vitiligo)
 Any inflammatory skin condition e.g., eczema, active herpes
simplex, etc., at the treatment site
 Epilepsy
 St. John’s Wort (herbal remedy) for depression in the past three
months (because of increased photosensitivity)
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.

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.
Skin Type
Fluence (J/cm2) Total Energy (kJ) **
(Fitzpatrick I-VI)
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.
4.6.2 Treatment
Treatment can begin after the 'S'Acne module has been connected to
the Harmony XL Pro system and the fluence selected according to the
table in Section 3.6.1.54.6.1.5.
Provide appropriate eye protection (OD>5) goggles for the patient
and the medical staff in the enclosed treatment room.
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.
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.
 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.
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).
skin surface.
Perform the recommended cycles on the right and left side of the
face. Repeat the cycles on each side.
Clinical end points: mild erythema for skin types I-IV; late
response erythema for skin types V-VI.
next treatment may be skipped or the fluence reduced until
symptoms resolve.
treatment (see Appendix F – Post-Treatment Care).

Skin Type
Fluence (J/cm2) Total Energy (kJ) *
(Fitzpatrick I-VI)
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
 Patients should be scheduled 48–72 hours after treatment for
necessary.
between treatments.
 Treatments may be administered twice per week for a period of 4-5
weeks (total of 8–10 treatments).
with a follow-up report sent to the Director of Clinical - at Alma
Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

VL Module – Superficial Vascular
Lesions
Chapter Contents:
Section Title Page
5.1 VL Module Description ................................................................... 5-2
5.2 VL Module Specifications ................................................................ 5-2
5.3 VL Module Operating Screen .......................................................... 5-3
5.4 VL Module Regulatory Labels ........................................................ 5-4
5.6 VL Module Clinical Guide ............................................................... 5-5
5.6.3 Pre-Treatment ................................................................... 5-6
5.6.4 Treatment .......................................................................... 5-7
5.6.6 Follow-up ........................................................................... 5-9

VL Module – Superficial Vascular Lesions
5.1 VL Module Description

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

 Light Source: Pulsed light with AFT and EDF
 Spectrum: 515 – 950nm
 Energy Density (Fluence): 5 – 25 J/cm2
 Treatment Area (spot size): 6.4 cm2
 Available Pulse Widths: 10, 12, 15 msec
 Pulse Repetition Rate: 2/3 Hz
 Cooling: None

5.3 VL Module Operating Screen

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

Fluence – the available fluence range is from 5 to 25 J/cm2 in
increments of 1 J/cm2.
 10 msec
 12 msec
 15 msec
Pulse Repetition Rate – fixed at 2/3 Hz

5.4 VL Module Regulatory Labels

adhered to the VL module connector:
Figure 5-3. VL Module Regulatory Labels

The following table offers names of accessories specific to the VL
Table 5-1. VL Module Accessories
Description
VL (Superficial Vascular Lesions) Module


5.6 VL Module Clinical Guide

The treatment of superficial (small and shallow) vascular lesions with
the Harmony XL Pro system can be performed using the VL module
(turquoise color code).
Warning
5.6.1 Indications for Use

The Advanced Fluorescence Technology (AFT) 515-950nm VL 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
in the previous 30 days
 Patients with Fitzpatrick skin type VI
simplex, etc. at the treatment site
 Epilepsy
 Isotretinoin – Roaccutane in the previous 3-6 months
 Tretinoin – Retin A in the last 2 weeks
wound healing)

5.6.3 Pre-Treatment
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.
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.
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. VL Skin Test parameters
Pulse
Skin Type Fluence Waiting
Module Width
(Fitzpatrick I-III) (J/cm2) Period
(msec)
I – II VL (Turquoise) 10, 12 14 – 16 30 min

III VL (Turquoise) 15 12 – 14 30 min

5.6.4 Treatment
 The VL module will treat superficial 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 XL Pro system and the treatment parameters
(fluence and pulse width) are selected according to the Skin Test
table in Section 5.6.3.3.
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.
Place the VL module perpendicular to the skin and touch the gel
with the lightguide. Do not apply pressure (the lightguide should
gently touch the skin).
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.
Trigger a light pulse by pressing the footswitch only when the light
guide is fully with contact to the skin.
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.
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%.
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.

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

Table 5-3. Suggested VL Setup Parameters
Pulse
Skin Type Target Vessel Fluence
Module Width
(Fitzpatrick I-III) Depth (J/cm2)
(msec)
VL
I – II Shallow; Small 16 – 18 10, 12, 15
(Turquoise)
VL
III Shallow; Small 14 – 16 10, 12, 15
(Turquoise)

5.6.6 Follow-up
 Within three weeks after the treatment patients should return for
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.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

SVL Cooled Module – Superficial Vascular Lesions
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
6.6 SVL Cooled Module Clinical Guide................................................. 6-5
6.6.3 Pre-Treatment ................................................................... 6-6
6.6.4 Treatment .......................................................................... 6-7
6.6.6 Follow-up ........................................................................... 6-9

6.1 SVL Cooled Module Description

The SVL cooled module has a high-power targeted phototherapy
module for non-invasive 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
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 SVL Cooled Module Specifications

 Energy Density (Fluence) 5 – 30 J/cm2
 Treatment Area (spot size) 3 cm2
 Available Pulse Widths 10, 12, 15 msec
 Pulse Repetition Rate 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 (Cooling 50%, Cooling 75%, or Cooling 100%)
 COOLING OFF (touch the COOLING ON softkey)
Figure 6-2. SVL Cooled Module Operating Screen

 10 msec
 12 msec
 15 msec

6.4 SVL Cooled Module Regulatory Labels

adhered to the SVL cooled module connector:
Figure 6-4. SVL Cooled Module Regulatory Labels

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


6.6 SVL Cooled Module Clinical Guide

The treatment of superficial (small and shallow) vascular lesions with
the Harmony XL Pro system can be performed using the SVL Cooled
(turquoise color code) module (spot size 3 cm2).
Warning

The Advanced Fluorescence Technology (AFT) 515-950nm SVL515
module (with and without contact-cooling) is indicated for:
 Use on Fitzpatrick skin types I-IV.
 Patients with Fitzpatrick skin type V & VI
 Epilepsy
wound healing)

6.6.3 Pre-Treatment
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.

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.
Skin Test
first treatment session according to the following parameters with
cooling ON:
Table 6-2. SVL Cooled Skin Test Parameters
Fitzpatrick Pulse Width Fluence Waiting

Module
Skin Type (msec) (J/cm2) Period
SVL Cooled -950nm

I – III (turquoise color 10, 12 12 – 20 30 min
code)
SVL Cooled -950nm
45 – 60
IV (turquoise color 15 7 – 12
min
code)
Note
The selection of cooling level should be based on the level of fluence,
pulse duration and skin type:
Cooling off – No Cooling; Cooling 50% - Low; Cooling 75% - Medium;
Cooling 100% - High

6.6.4 Treatment
 The SVL cooled module will treat superficial vascular redness
associated with rosacea or post-acne rosacea.
 Treatment can begin after the suitable module has been connected
to the Harmony XL Pro system and the treatment parameters
(fluence and timer interval) are selected according to the Skin Test
table in Table 6-2.
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.
Set the necessary cooling level from the control screen based on the
skin type, fluence and pulse duration.
Caution
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).
the same spot.
Trigger a light pulse by pressing the footswitch only when the light
guide is fully with contact to the skin.
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.


20% and test again.

Table 6-3. Suggested SVL Cooled Setup Parameters
Pulse
Fitzpatrick Target Fluence
Module Width
Skin Type Vessel Depth (J/cm2)
(msec)
SVL Cooled -950nm

Shallow;
I – III (turquoise color 12 – 25 10, 12
Small
code)
SVL Cooled -950nm
Shallow;
IV (turquoise color 7 – 14 15
Small
code)

6.6.6 Follow-up
necessary.
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

VL/PL Module – Vascular & Pigmented Lesions
VL/PL Module – Vascular &

Pigmented Lesions
Chapter Contents:
Section Title Page
7.1 VL/PL Module Description .............................................................. 7-2
7.2 VL/PL Module Specifications .......................................................... 7-2
7.3 VL/PL Module Operating Screen .................................................... 7-3
7.4 VL/PL Module Regulatory Labels ................................................... 7-4
7.6 VL/PL Module Clinical Guide for Vascular Lesions ....................... 7-5
7.6.3 Pre-Treatment ................................................................... 7-6
7.6.4 Treatment .......................................................................... 7-7
Lesions ............................................................................... 7-8
7.6.6 Follow-up ........................................................................... 7-9
7.7 VL/PL Module Clinical Guide for Pigmented Lesions .................. 7-10
7.7.3 Pre-Treatment ................................................................. 7-10
7.7.4 Treatment ........................................................................ 7-11
Lesions ............................................................................. 7-12
7.7.6 Follow-up ......................................................................... 7-13

7.1 VL/PL Module Description

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

 Pulse Widths 10, 12, 15 msec
 Cooling None

7.3 VL/PL Module Operating Screen

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

 10 msec
 12 msec
 15 msec

7.4 VL/PL Module Regulatory Labels

adhered to the VL/PL module connector:
Figure 7-3. VL/PL Module Regulatory Labels

The following table offers names of accessories specific to the VL/PL
Table 7-1. VL/PL Module Accessories
Description
VL/PL (Vascular/Pigmented Lesions) Module


7.6 VL/PL Module Clinical Guide for Vascular

Lesions
The treatment of Vascular Lesions with the Harmony XL Pro system
can be performed using (one – or a combination of) three modules of
the following types: VP 440-950nm (green color code), SR 570-950nm
(yellow color code) and the L.P. 1064 Pro laser module.
 The SR modules are discussed in detail in Chapters 11 & 12 of this
manual.
 The 1064nm laser modules are discussed in detail in Chapters 20
to 23 of this manual.
The VL/PL module is indicated for vascular lesions.
Warning

The Advanced Fluorescence Technology (AFT) 440-950 nm VL/PL
 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).
 Epilepsy


wound healing)
7.6.3 Pre-Treatment
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.

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.
Skin Test
Table 7-2. Vascular Lesions Skin Test Parameters*
Pulse
Module Width
(Fitzpatrick I-IV) (J/cm2) Period
(msec)
VL/PL 440-
I – III 950nm 10, 12 16 – 20 30 min
(green color code)
VL/PL 440-
24 – 48
IV 950nm 15 10 – 14
hours
(green color code)
(*) The pulses must not be emitted sequentially!

7.6.4 Treatment
 The VL/PL 440nm module will treat vessels up to < 1mm.
Do not stack pulses. It is recommended to keep the contact cooling
on during treatment with the VL/PL module (see Figure 7-2).
 Treatment can begin after the module has been connected to the
Harmony XL Pro system and the treatment parameters (fluence
and timer interval) are selected according to the Skin Test
parameters in Table 7-2.
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.
Caution
Place the module's lightguide perpendicular to the skin and touch

the same spot.
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.
20% and test again.



Lesions
Table 7-3. Suggested VL/PL Setup Parameters for Vascular Lesions*
Skin Type Max. Number Fluence Pulse Width

Module
(Fitzpatrick I- IV) of Repetitions (J/cm2) (msec)
VL/PL 440-950nm
I – III 2 19 – 22 10, 12
(green color code)
VL/PL 440-950nm
IV 2 12 – 19 15
(green color code)

7.6.6 Follow-up
necessary.
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

7.7 VL/PL Module Clinical Guide for Pigmented

Lesions
The Pigmented Lesions application of the Harmony XL Pro system can
be performed with the VL/PL 440-950nm (green color code) and the SR
570-950nm (yellow color code) modules.
The SR modules are discussed in detail in Chapters 11 & 12 of this
manual.
The VL/PL module is indicated for pigmented lesions.
Warning

Refer to Section 7.6.1.
7.7.3 Pre-Treatment

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.

Skin Test
Table 7-4. Pigmented Lesions Skin Test Parameters
Skin Type
Lesion Pulse Width Fluence Waiting
(Fitzpatrick Module
Color (msec) (J/cm2) Period
I- IV)
VL/PL 440-950nm Light 10, 12 18 – 20

I – III 30 min.
(green color code) Dark 12, 15 16 – 18
VL/PL 440-950nm Light 15 10 – 14

IV 30 min.
(green color code) Dark 15 6–8
7.7.4 Treatment
Treatment may begin after the module has been connected to the
Harmony XL Pro system and the treatment parameters (fluence and
timer interval) are selected according to the Skin Test parameters in
Table 7-4.
coupling of the light into the skin.
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.
Wipe off the gel and diagnose carefully. Remember: darker skin
“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.
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%.


lesions are unsatisfactory, you should increase the fluence by
10-20%.
make sure to apply the gel immediately before each
pass/treatment. After treatment, remove the gel from treated
areas. Do not reuse gel.
(see Appendix C in the System Manual – Post-Treatment Care).

Lesions
Table 7-5. Suggested VL/PL Setup Parameters for Pigmented Lesions
Skin Type Lesion Pulse Width Fluence

Module
(Fitzpatrick I- IV) Color (msec) (J/cm2)
VL/PL 440-950nm
Light 10, 12 18 – 22
(green color code)
I – III
VL/PL 440-950nm
Dark 12, 15 16 – 20
(green color code)
VL/PL 440-950nm
Light 15 10 – 16
(green color code)
IV
VL/PL 440-950nm
Dark 15 8– 10
(green color code)

7.7.6 Follow-up
necessary.
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

VL/PL Cooled Module – Vascular & Pigmented Lesions
VL/PL Cooled Module – Vascular &

Pigmented Lesions
Chapter Contents:
Section Title Page
8.1 VL/PL Cooled Module Description .................................................. 8-2
8.2 VL/PL Cooled Module Specifications .............................................. 8-2
8.3 VL/PL Cooled Module Operating Screen ........................................ 8-3
8.4 VL/PL Cooled Module Regulatory Labels ....................................... 8-4
Lesions ............................................................................... 8-5
8.5.4 Pre-Treatment ................................................................... 8-6
8.5.5 Treatment .......................................................................... 8-7
Vascular Lesions ................................................................ 8-8
8.5.7 Follow-up ........................................................................... 8-9
8.6 VL/PL Cooled Module Clinical Guide for Pigmented Lesions ...... 8-10
8.6.3 Pre-Treatment ................................................................. 8-10
8.6.4 Treatment ........................................................................ 8-11
Pigmented Lesions ........................................................... 8-13
8.6.6 Follow-up ......................................................................... 8-14

8.1 VL/PL Cooled Module Description

The VL/PL cooled module has a high-power targeted phototherapy
module for non-invasive treatment of vascular and pigmented lesions.
The VL/PL cooled module allows treatment of a broad spectrum of
vascular imperfections be selectively targeting oxyhemoglobin,
A complete discussion of the VL/PL cooled module clinical applications
The VL/PL cooled module has a green identification section (see
Figure 8-1).
Figure 8-1. VL/PL Cooled Module (Green Color Code)
8.2 VL/PL Cooled Module Specifications

 Cooling TEC

8.3 VL/PL Cooled Module Operating Screen

The VL/PL cooled module main operating screen (see Figure 8-2) is
displayed when the VL/PL cooled module is connected to the system.
The VL/PL 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 (Cooling 50%, Cooling 75%, or Cooling 100%).
COOLING OFF (touch the COOLING ON softkey)
Figure 8-2. VL/PL Cooled Module Operating Screen

 10 msec
 12 msec
 15 msec

8.4 VL/PL Cooled Module Regulatory Labels

adhered to the VL/PL cooled module connector:
Figure 8-3. VL/PL Cooled Module Regulatory Labels

The following table offers names of accessories specific to the VL/PL
cooled module that may be ordered form Alma Lasers.
Table 8-1. VL/PL Cooled Module Accessories
Description
VL/PL (Vascular/Pigmented Lesions) Cooled Module



Lesions
The treatment of Vascular Lesions with the Harmony XL Pro system
can be performed using (one – or a combination of) three modules of
the following types: VP 440-950nm (green color code), SR 570-950nm
(yellow color code) and the L.P. 1064 Pro laser module.
 The SR modules are discussed in detail in Chapters 11 & 12 of this
manual.
 The 1064nm laser modules are discussed in detail in Chapters 20
to 23 of this manual.
The VL/PL cooled module (with integrated contact cooling) is indicated
for vascular lesions.
Warning

The Advanced Fluorescence Technology (AFT) 440-950 nm VL/PL
Cooled module is indicated for:
 Use on all skin types (Fitzpatrick I-V).
 Epilepsy


wound healing)
8.5.4 Pre-Treatment

Skin Test
first treatment session with the cooling mode On and according to the
following parameters:
Table 8-2. Vascular Lesions Skin Test Parameters

Module
VL/PL Cooled 440-950nm

I – III 10, 12 14 – 23 30 min
(green color code)
IV 12, 15 12 – 17 24 – 48 hours
(green color code)
VL/PL Cooled 440-950nm 24 – 48
V 15 8 – 12
(green color code) hours*
(*) It is imperative to wait 48 hours
Note
Cooling 100% - High

8.5.5 Treatment
 The VL/PL cooled 440nm module will treat vessels up to < 1mm.
Do not stack pulses. It is recommended to keep the contact cooling
on during treatment with the VL/PL cooled module (see
Figure 8-2).
Operate the module with Cooling mode ON.
Other cooling means, such as small ice packs or forced cold
air/Zimmer are also recommended (i.e., post-treatment).
Caution

the same spot.

20% and test again.

Vascular Lesions
Table 8-3. Suggested VL/PL Cooled Setup Parameters for Vascular Lesions*
Fitzpatrick Target Vessel Fluence Pulse Width

Module
Skin Type Depth (J/cm2) (msec)

I – III 2 14 – 23 10, 12
(green color code)
IV 2 12 – 17 12, 15
(green color code)
V 2 8 – 12 15
(green color code)
(*) Cooling mode ON

8.5.7 Follow-up
necessary.
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

8.6 VL/PL Cooled Module Clinical Guide for

Pigmented Lesions
be performed with the VL/PL Cooled 440-950nm (green color code) and
the SR 570-950nm (yellow color code) modules.
The SR modules are discussed in detail in Chapters 11 & 12 of this
manual.
The VL/PL cooled module (with integrated contact cooling) is indicated
for pigmented lesions.
Warning

8.6.3 Pre-Treatment


Skin Test
first treatment session with the cooling mode ON and according to the
Fitzpatrick Lesion Pulse Width Fluence Waiting

Module
Skin Type Color (msec) (J/cm2) Period
VL/PL Cooled Light 10, 12 14 – 23

I – III 440-950nm 30 min.
(green color code) Dark 15 14 – 20
VL/PL Cooled Light 12, 15 12 – 17

24 – 48
IV 440-950nm
Dark 15 10 – 14 hours
(green color code)
VL/PL Cooled
24 – 48
V 440-950nm Dark 15 8 – 12
hours*
(green color code)
Note
Cooling 100% - High.
8.6.4 Treatment
Table 8-4.
Operate the module with Cooling mode ON.


over the same spot.
lesions are unsatisfactory, you should increase the fluence by 10-
20%.


Pigmented Lesions
Table 8-5. Suggested VL/PL Cooled Setup Parameters for Pigmented Lesions*
Skin Type Lesion Pulse Width Fluence

Module
(Fitzpatrick I-VI) Color (msec) (J/cm2)

Light 10, 12 14 – 23
(green color code)
I – III
Dark 15 14 – 20
(green color code)
Light 12, 15 12 – 17
(green color code)
VI
Dark 15 10 – 17
(green color code)

V Dark 15 8 – 12
(green color code)
(*) Cooling mode ON

8.6.6 Follow-up
necessary.
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Dye-VL Module – Vascular & Pigmented Lesions
Dye-VL Module – Vascular &

Pigmented Lesions
Chapter Contents:
Section Title Page
9.1 Dye-VL Module ................................................................................ 9-2
9.2 Dye-VL Module Specifications ........................................................ 9-2
9.3 Dye-VL Module Operating Screen .................................................. 9-3
9.4 Dye-VL Module Regulatory Labels ................................................. 9-4
9.6 Dye-VL Module Clinical Guide for Vascular Lesions ..................... 9-5
9.6.3 Pre-Treatment ................................................................... 9-6
9.6.4 Treatment .......................................................................... 9-7
9.6.5 Follow-up ........................................................................... 9-9
9.7 Dye-VL Module Clinical Guide for Pigmented Lesions ................ 9-10
9.7.3 Pre-Treatment ................................................................. 9-10
9.7.4 Treatment ........................................................................ 9-11
Lesions ............................................................................. 9-12
9.7.6 Follow-up ......................................................................... 9-13
9.8 Dye-SVL Mode Clinical Guide ...................................................... 9-14
9.8.4 Pre-Treatment ................................................................. 9-15
9.8.8 Treatment of Small Areas ............................................... 9-18

9.8.9 Follow-up ......................................................................... 9-19
9.1 Dye-VL Module

The Dye-VL module has a high-power targeted phototherapy module
for non-invasive treatment of vascular and pigmented lesions. The
Dye-VL module allows treatment of a broad spectrum of vascular
imperfections be selectively targeting oxyhemoglobin,
The Dye-VL module may be operated in two separate modes: Dye-VL
and Dye-SVL.
A complete discussion of the Dye-VL module clinical applications may
be found in Sections 9.6 and 9.7.
The Dye-VL module has a light green identification section (see
Figure 9-1).
Table 9-1. Dye-VL Module (Light Green)
9.2 Dye-VL Module Specifications

 Spectrum 500 – 600 nm

9.3 Dye-VL Module Operating Screen

The Dye-VL module main operating screens (see Figure 9-1) 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 9-1. Dye-VL Module Operating Screens

Dye-VL Mode Dye-SVL Mode
 Energy Density (Fluence): 1 to 15 J/cm2 1 – 4 J/cm2

 Pulse Duration: 10, 12, 15 msec. 1, 3, 30 sec.
 Pulse Repetition Rate: 1/2 Hz 3 Hz
9.4 Dye-VL Module Regulatory Labels

adhered to the Dye-VL module connector:
Figure 9-2. Dye-VL Module Regulatory Labels

The following table offers names of accessories specific to the Dye-VL
Table 9-2. Dye-VL Module Accessories
Description
Dye-VL (Vascular/Pigmented Lesions) Module


9.6 Dye-VL Module Clinical Guide for Vascular

Lesions
The treatment of vascular lesions with the Harmony XL Pro 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 Advanced Fluorescence Technology (AFT) 500-600 nm Dye-VL
 Epilepsy
wound healing)

9.6.3 Pre-Treatment

Skin Test
first treatment session with the cooling mode ON and according to the

Module
Dye-VL 500-600nm
I – III 10, 12 10 – 12 30 min
(light green color code)
Dye-VL 500-600nm
IV 12, 15 6–9 24 – 48 hours
Note

9.6.4 Treatment
 The Dye-VL module will treat vessels up to < 1mm.
Cooling means, such as small ice packs or forced cold air/Zimmer
are recommended (i.e., post-treatment).
Caution

the same spot.


20% and test again.
After treatment, it is recommended to cool the area immediately.
Suggested Dye-VL Setup Parameters for Vascular Lesions
Table 9-4. Suggested Dye-VL Setup Parameters for Vascular Lesions
Fitzpatrick Fluence
Module Pulse Width (msec)
Skin Type (J/cm2)
Dye-VL 500-600nm
I – III 10, 12 10 – 13
Dye-VL 500-600nm
IV 12, 15 6 – 10

9.6.5 Follow-up
necessary.
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

9.7 Dye-VL Module Clinical Guide for Pigmented

Lesions
be performed with the Dye-VL 500-600nm (light green color code)
module.
The Dye-VL module is indicated for pigmented lesions.
Warning

9.7.3 Pre-Treatment


Skin Test
first treatment session and according to the following parameters:
Fitzpatrick Pulse Width Fluence

Module Waiting Period
Skin Type (msec) (J/cm2)
Dye-VL 500-600nm
I – III 10, 12 10 – 12 30 min
Dye-VL 500-600nm
IV 12, 15 6–9 24 – 48 hours
9.7.4 Treatment
Table 9-4.
over the same spot.


lesions are unsatisfactory, you should increase the fluence by
10-20%.

Lesions
Table 9-6. Suggested Dye-VL Setup Parameters for Pigmented Lesions

Module
Dye-VL 500-600nm
I – III 10, 12 10 – 13
Dye-VL 500-600nm
IV 12, 15 6 – 10

9.7.6 Follow-up
necessary.
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

9.8 Dye-SVL Mode Clinical Guide

The Skin Rejuvenation application of the Harmony XL Pro system is
performed using the Dye-VL (light green color code) module in Dye-
SVL mode.
Warning
operator and the patient when using this module‫ץ‬

The Dye-VL module in Dye-SVL mode is indicated for:
simplex, etc., at the treatment site.
 Epilepsy.
 St. John's Wort (herbal remedy) for depression in the past three
 Isotretinoin – Roaccutane or Tretinoin – In the past 3-6 months.
 Retin A - In the past 2 weeks.
 Pregnancy (including IVF).
 Diabetes.
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
(Cooling 50%, Cooling 75%, or Cooling 100%) 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
Skin Test
first treatment session, with the Cooling mode On and according to the
Table 9-7. Dye-SVL Skin Test Parameters (30 second interval)
Skin Type Cooling Total Energy

Fluence (J/cm2)
(Fitzpatrick I-VI) [On/Off] * [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.
Important: a thin coat of ultrasonic gel must be applied on the skin for
ALL skin types.
Note

9.8.5 Treatment (In-Motion Technique)

Treatment can begin after the Dye-VL module has been connected to
(fluence) according to Table 9-7.
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.
Apply the In-Motion technique:
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
(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.
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 In-Motion technique).
skin surface.
face. Repeat the intervals on each side.
Clinical end points: mild-to-moderate erythema for skin types I-IV;
mild erythema for skin type V.


next treatment may be skipped, or the dose reduced until the
symptoms resolve.
treatment.
Note
Always perform a skin test on the intended treatment area during
the first treatment session.

Table 9-8. Dye-SVL Suggested Setup Parameters (30-second interval)

Fluence (J/cm2)
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 a 10x10 cm (100 cm2) area. The
1-second and 3-second time intervals are indicated for the

9.8.7 Stationary Protocol

In the stationary technique, use the 3-second interval; up to 10%
overlapping is an acceptable tolerance.
Set the initial exposure time and fluence parameters according to
Table 9-6.
Trigger a pulse by continuously pressing the footswitch for the
entire time interval; the module will automatically stop emitting
light, unless interrupted by the operator (releasing the footswitch).
In order to continue, the footswitch must be pressed again.
Check skin reaction; if there is no apparent skin reaction – repeat
until clinical end points are visible.
Treatment parameters may be increased by 10% every other
treatment and subjected to the conditions in the area treated and
patient's tolerance.
Following treatment, gently cleanse the ultrasonic gel from the
treated area.
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.
treatment.
9.8.8 Treatment of Small Areas

Table 9-9. Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion*

Fluence (J/cm2)
(Fitzpatrick I-VI) [On/Off] [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 9-10. Small Area Parameters, 3-25 cm2, 1 Second, In-Motion*

Fluence (J/cm2)
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
 Within three weeks after treatment patients should return for
necessary.
an additional examination one month later.
treatments.
between treatments.
 Treatment intervals: treatment is reapplied (assuring there have
been no adverse reactions) every 3-4 weeks.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Yellow LED Module
Yellow LED Module

Chapter Contents:
Section Title Page
10.1 Yellow LED Module Description ................................................... 10-2
10.2 Yellow LED Module Specifications ............................................... 10-2
10.3 Yellow LED Module Operating Screen ......................................... 10-3
10.4 Yellow LED Module Regulatory Labels ........................................ 10-4
10.6 Yellow LED Module Clinical Guide .............................................. 10-5
10.6.3 Pre-Treatment ................................................................. 10-5
10.6.4 Treatment ........................................................................ 10-6
10.6.5 Suggested Yellow LED Setup Parameters ...................... 10-7
10.6.6 Follow-Up ......................................................................... 10-7

Yellow LED Module
10.1 Yellow LED Module Description

The Yellow LED module (see Figure 10-1) 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 Yellow LED module clinical applications
Figure 10-1. Yellow LED Module
10.2 Yellow LED Module Specifications

 Light Source Light emitting diode array
 Spectrum 560 - 620nm
 Optical Power 1.5W
 Pulse Mode # 1 Repeat (Pulsed)
 Pulse Mode # 2 CW (Continuous Wave)
 Timers Repeat – up to 70 seconds

CW – up to 70 minutes

Yellow LED Module
10.3 Yellow LED Module Operating Screen

The Yellow LED module main operating screen (see Figure 10-2) is
displayed when the Yellow LED module is connected to the system:
Figure 10-2. Yellow LED Module Operating Screen

Operating Mode – the Yellow LED module can be operated in one
of the following wave modes:
 Repeat (pulsed) Wave
 CW (Continuous Wave)
The Repeat & CW is a soft-key that toggles between these two
modes, as shown in Figure 10-2.
Wave Duration:
 Repeat – up to 70 seconds
 CW – up to 70 minutes

Yellow LED Module
10.4 Yellow LED Module Regulatory Labels

adhered to the Yellow LED module connector:
Figure 10-3. Yellow LED Module Regulatory Labels

The following table offers names of accessories specific to the Yellow
LED module that may be ordered form Alma Lasers.
Table 10-1. Yellow LED Module Accessories
Description
Yellow LED Module


Yellow LED Module
10.6 Yellow LED Module Clinical Guide

The Harmony XL Pro system with the Yellow LED module emits 560-
620nm (yellow) diode light.
The Yellow LED module can be operated in one of two modes:
continuous wave (CW) and Repeat (pulsed) wave.
Warning

The 560nm Yellow 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.
 History of cancer
 Active inflammatory skin disorder
 Drug-related photosensitivity
10.6.3 Pre-Treatment
Patient Evaluation
Before Yellow 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.

Yellow LED Module
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 10-2. Yellow LED Skin Test Parameters
Skin Type Time of Exposure Waiting Period

Module Mode
(Fitzpatrick I-VI) (sec / min)* (minutes)
I Yellow LED 30 / 20 Repeat/CW 10

II Yellow LED 30 / 20 Repeat/CW 10
III Yellow LED 30 / 20 Repeat/CW 10
IV Yellow LED 30 / 20 Repeat/CW 10
V Yellow LED 30 / 20 Repeat/CW 10
VI Yellow LED 30 / 20 Repeat/CW 10
(*) Pulsed/CW
10.6.4 Treatment
Treatment can begin after the Yellow LED module is connected to the
system and the treatment parameters are selected according to the
table in Table 10-2.
Identify the treatment area and position the patient accordingly.
Patient should be seated in a chair or lying down on a treatment
bed.
Provide appropriate eye protection (or eye shields) for the patient
and the medical staff inside the enclosed treatment room.
Select the operating mode according to the clinical indication –
 CW (Continuous Wave), up to 70 minutes, or
 Repeat, up to 70 seconds
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.
Continuous Wave mode (CW): treatment should be performed
twice per week for 4-5 consecutive weeks (8-10 treatments).
Repeat mode: treatment should be performed on 3 to 5 consecutive
days post-laser or IPL procedure (3-5 treatments).

Yellow LED Module
10.6.5 Suggested Yellow LED Setup Parameters

The following table shows the recommended parameters based on the
patient hair color and skin type:
Table 10-3. Suggested Yellow LED Setup Parameters
Skin Type Time of Exposure

Module Mode
(Fitzpatrick I-VI) (sec / min) *
I Yellow LED 30 / 20 Repeat/CW

II Yellow LED 30 / 20 Repeat/CW
III Yellow LED 30 / 20 Repeat/CW
IV Yellow LED 30 / 20 Repeat/CW
V Yellow LED 30 / 20 Repeat/CW
VI Yellow LED 30 / 20 Repeat/CW
(*) Pulsed/CW
10.6.6 Follow-Up
 Measures presented below are only the manufacturer's
recommendations for follow-up 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.
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.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

SR Module – Skin Rejuvenation

Chapter Contents:
Section Title Page
11.1 SR Module Description.................................................................. 11-2
11.2 SR Module Specifications .............................................................. 11-2
11.3 SR Module Operating Screen ........................................................ 11-3
11.4 SR Module Regulatory Labels....................................................... 11-4
11.6 SR Module Clinical Guide ............................................................. 11-5
11.6.3 Pre-Treatment ................................................................. 11-6
11.6.4 Treatment ........................................................................ 11-7
11.6.5 Suggested SR Setup Parameters..................................... 11-8
11.6.6 Follow-up ......................................................................... 11-8

11.1 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
The SR module has a yellow identification section (see Figure 11-1).
Figure 11-1. SR Module (Yellow Color Code)
11.2 SR Module Specifications

 Cooling None

11.3 SR Module Operating Screen

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

 10 msec
 12 msec
 15 msec

11.4 SR Module Regulatory Labels

adhered to the SR module connector:
Figure 11-3. SR Module Regulatory Labels

The following table offers names of accessories specific to the SR
Table 11-1. SR Module Accessories
Description
SR (Skin Rejuvenation) Module


11.6 SR Module Clinical Guide

performed using the SR 570-950nm (yellow color code) module or the
L.P. 1064 Pro module.
The 1064nm laser modules are discussed in detail in Chapter 22
and Chapter 23 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 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).
 Epilepsy
wound healing)

Skin Test
Table 11-2. SR Skin Test Parameters

Module
SR 570-950nm
I – III 10, 12 16 – 20 30 min.
(yellow color code)
SR 570-950nm
IV 15 8 – 12 30 min.
(yellow color code)
SR 570-950nm 24 – 48
V 15 6 – 10
(yellow color code) hours

11.6.4 Treatment
Treatment can begin after the suitable module has been connected to
the Harmony XL Pro system and the treatment parameters (fluence
and timer interval) are selected according to Table 10-2.
Note

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 lightguide perpendicular to the skin and touch the gel
Trigger a light pulse by pressing the footswitch and the module
trigger simultaneously.
Wipe off the gel.
swelling in the shape of the lightguide), you should reduce the
fluence by 10-20%.
If no change in the skin is noted, then the fluence should be
increased by 10-20%.
treatment, remove the gel from treated areas. Do not reuse gel.

11.6.5 Suggested SR Setup Parameters

Table 11-3. Suggested SR Setup Parameters
Skin Type # of Pulses Pulse Width Fluence

Module
(Fitzpatrick I-VI) per Spot * (msec) (J/cm2)
SR 570-950nm
I – III 2 10, 12 18 – 24
(yellow color code)
SR 570-950nm
IV 2 12, 15 10 – 14
(yellow color code)
SR 570-950nm
V 2 15 6 – 10
(yellow color code)
11.6.6 Follow-up
necessary.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

SR Cooled Module – Skin
Rejuvenation
Chapter Contents:
Section Title Page
12.1 SR Cooled Module Description...................................................... 12-2
12.2 SR Cooled Module Specifications .................................................. 12-2
12.3 SR Cooled Module Operating Screen ............................................ 12-3
12.4 SR Cooled Module Regulatory Labels ........................................... 12-4
12.6 SR Cooled Module Clinical Guide ................................................. 12-5
12.6.3 Pre-Treatment ................................................................. 12-6
12.6.4 Treatment ........................................................................ 12-7
12.6.5 Suggested SR Cooled Setup Parameters ......................... 12-8
12.6.6 Follow-up ......................................................................... 12-8

SR Cooled Module – Skin Rejuvenation
12.1 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
The SR cooled module has a yellow identification section (see
Figure 12-1).
Figure 12-1. SR Cooled Module (Yellow Color Code)
12.2 SR Cooled Module Specifications

 Treatment Area (spot size): 3 cm2
 Pulse Widths: 10, 12, 15 msec
 Cooling: TEC

12.3 SR Cooled Module Operating Screen

The SR cooled module main operating screen (see Figure 12-2) is
displayed when the SR cooled module is connected to the system.
The SR cooled module's contact cooling mechanism can be turned on or
off by touching the appropriate soft-key in the bottom-left section of
the screen:
COOLING ON (Cooling 50%, Cooling 75%, or Cooling 100%)
Figure 12-2. SR Cooled Module Operating Screen

 10 msec
 12 msec
 15 msec

12.4 SR Cooled Module Regulatory Labels

adhered to the SR cooled module connector:
Figure 12-3. SR Cooled Module Regulatory Labels

The following table offers names of accessories specific to the SR cooled
Table 12-1. SR Cooled Module Accessories
Description
SR (Skin Rejuvenation) Cooled Module


12.6 SR Cooled Module Clinical Guide

performed using the SR 570-950nm (yellow color code) module or the
L.P. 1064 Pro module.
The 1064nm laser modules are discussed in detail in Chapters 20 to 23
of this manual.
Warning

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.
 Epilepsy
 Retin-A – In the past 2 weeks
wound healing)

Skin Test
Table 12-2. SR Cooled Skin Test Parameters
Skin Type
Pulse Width Fluence Waiting
(Fitzpatrick I- Module
(msec) (J/cm2) Period
VI)
SR Cooled 570-
I – III 950nm 10, 12 20 – 24 30 min.
(yellow color code)
SR Cooled 570-
IV 950nm 15 16 – 20 30 min.
(yellow color code)
SR Cooled 570-
24 – 48
V – VI 950nm 15 6 – 10
hours*
(yellow color code)

12.6.4 Treatment
Treatment can begin after the suitable module has been connected to
the Harmony XL Pro 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.
Clean the skin to remove perfumes, cosmetics and sunscreens

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 lightguide perpendicular to the skin and touch the gel
Trigger a light pulse by pressing the footswitch and the module
Wipe off the gel.
fluence by 10-20%.
treatment, remove the gel from treated areas. Do not reuse gel.

12.6.5 Suggested SR Cooled Setup Parameters

Table 12-3. Suggested SR Cooled Setup Parameters

Module
SR Cooled 570-950nm
I – III 10, 12 20 – 25
(yellow color code)
SR Cooled 570-950nm
IV 15 16 – 20
(yellow color code)
SR Cooled 570-950nm
V – VI 15 6 – 10
(yellow color code)
12.6.6 Follow-up
necessary.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

SSR Cooled Module – Super Skin
Rejuvenation
Chapter Contents:
Section Title Page
13.1 SSR Cooled Module Description ................................................... 13-2
13.2 SSR Cooled Module Specifications ................................................ 13-2
13.3 SSR Cooled Module Operating Screen.......................................... 13-3
13.4 Total Energy in the SSR Cooled Module ...................................... 13-4
13.5 SSR Cooled Module Regulatory Labels ........................................ 13-4
13.7 SSR Cooled Module Clinical Guide ............................................... 13-5
13.7.4 Pre-Treatment ................................................................. 13-6
13.7.9 Follow-up ....................................................................... 13-11

SSR Cooled Module – Super Skin Rejuvenation
13.1 SSR Cooled Module Description

The SSR Cooled 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 Cooled module clinical applications
The SSR Cooled module has a green identification section (see
Figure 13-1).
Figure 13-1. SSR Cooled Module (Green Color Code)
13.2 SSR Cooled Module Specifications

 Spectrum: 540-950
 Timers: 1, 3 & 30 seconds
 Pulse Repetition Rate: 3 Hz
 Cooling: TEC

13.3 SSR Cooled Module Operating Screen

The SSR Cooled module main operating screen (see Figure 13-2) is
displayed when the SSR Cooled module is connected to the system:
The SSR Cooled module's contact cooling mechanism can be turned on
or off by touching the appropriate soft-key in the bottom-left section of
the screen:
COOLING ON (Cooling 50%, Cooling 75%, or Cooling 100%)
Figure 13-2. SSR Cooled Module Operating Screen

Timers – 1, 3 & 30 seconds
Pulse Repetition Rate – fixed at 3 Hz

13.4 Total Energy in the SSR Cooled Module

The SSR Cooled module's operating screen exhibits the total energy
applied per session, counted in Kilojoules (see kJ counter in top-right
corner of Figure 13-2):
Note
If the system stays in SSR Cooled mode during patient rotation, it
is important to reset the Total Energy by pressing the Reset key.
13.5 SSR Cooled Module Regulatory Labels

adhered to the SSR Cooled module connector:
Figure 13-3. SSR Cooled Module Regulatory Labels

The following table offers names of accessories specific to the SSR
Cooled module that may be ordered form Alma Lasers.
Table 13-1. SSR Cooled Module Accessories
Description
SSR (Super Skin Rejuvenation) Cooled Module


13.7 SSR Cooled Module Clinical Guide

performed using the SSR Cooled (green color code) module. The SSR
Cooled 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 Advanced Fluorescence Technology (AFT) 540-950 nm SSR Cooled
simplex, etc., at the treatment site
 Epilepsy
 Isotretinoin – Roaccutane or Tretinoin – In the past 3-6 months
 Retin A - In the past 2 weeks
 Diabetes


The SSR Cooled module may be operated with 3 different time
intervals: 1, 3 and 30 seconds.
irregularities (dyschromia, lentigines, freckles etc).
The SSR Cooled module incorporates thermo-electric coupling (TEC)
technology; the module can be operated under two conditions: Cooling
On (Cooling 50%, Cooling 75%, or Cooling 100%) and Cooling Off.
in kilojoules (kJ).
techniques.

Skin Test
Table 13-2. SSR Cooled Skin Test Parameters

Fluence (J/cm2)
I – III 8–9 On (75/100%) 5.4

IV 6–7 On (75/100%) 5.4
V – VI 4–5 On (75/100%) 5.4
Off modes.
ALL skin types.
Note
The selection of cooling level should be based on the level of fluence, pulse
duration and skin type:

Treatment can begin after the SSR Cooled module has been connected
to the Harmony XL Pro system and the treatment parameters selected
the patient during treatment and; c) friction reduction/lubrication
during the In-Motion technique.


footswitch.
(kJ).
skin surface.
Clinical end points: mild-to-moderate erythema for skin types I-IV;
mild erythema for skin types V-VI.
next treatment may be skipped or the dose reduced until the
symptoms resolve.
treatment (see Appendix C in the System Manual – Post-
Treatment Care).
Note


Table 13-3. SSR Cooled Suggested Setup Parameters

Fluence (J/cm2)
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
(**) The total energy is adjusted for 10x10 cm (100cm2) area. The 1-
second and 3-second time intervals are indicated for the
Stationary technique

Table 13-2.
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.
until clinical end points are visible.
treated area.
treatment (see Appendix B in the System Manual – Post-
Treatment Care).


Table 13-4. Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion

Fluence (J/cm2)
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 13-5. Small Area Parameters, 3-25 cm2, 1 Second, In-Motion

Fluence (J/cm2)
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 13-6. Small Area Parameters, Up To 3 cm2, 3 Seconds, Stationary*
Skin Type Cooling

Fluence (J/cm2)
(Fitzpatrick I-VI) [On/Off]**
I – III 6–8 On
IV 4–6 On
V - VI 4–5 On
(*) Repeat twice
(**) Apply gel
Table 13-7. Small Area Parameters, Up To 3 cm2, 1 Second, Stationary*
Skin Type Cooling

Fluence (J/cm2)
(Fitzpatrick I-VI) [On/Off]**
I – III 8 – 10 On
IV 6–8 On
V - VI 4–6 On
(*) Repeat twice
(**) Apply gel

13.7.9 Follow-up
 Within three weeks after treatment patients should return for
necessary.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Dye-SR Module – Vascular &
Pigmented Lesions
Chapter Contents:
Section Title Page
14.1 Dye-SR Module Description .......................................................... 14-3
14.2 Dye-SR Module Specifications ...................................................... 14-3
14.3 Dye-SR Module Operating Screen ................................................ 14-4
14.4 Dye-SR Module Regulatory Labels ............................................... 14-5
14.6 Dye-SR Module Clinical Guide for Vascular Lesions ................... 14-6
14.6.3 Pre-Treatment ................................................................. 14-7
14.6.4 Treatment ........................................................................ 14-9
Lesions ........................................................................... 14-10
14.6.6 Follow-up ....................................................................... 14-11
14.7 Dye-SR Module Clinical Guide for Pigmented Lesions .............. 14-12
14.7.3 Pre-Treatment ............................................................... 14-12
14.7.4 Treatment ...................................................................... 14-13
Lesions ........................................................................... 14-14
14.7.6 Follow-up ....................................................................... 14-15
14.8 Dye-SSR Mode Clinical Guide .................................................... 14-16
14.8.3 Module Operation .......................................................... 14-17

Dye-SR Module – Vascular & Pigmented Lesions
14.8.4 Pre-Treatment ............................................................... 14-17

14.8.5 Treatment (In-Motion Technique)................................. 14-18
14.8.7 Stationary Protocol ........................................................ 14-19
14.8.9 Follow-up ....................................................................... 14-21

14.1 Dye-SR Module Description

The Dye-SR module has a high-power targeted phototherapy module
for non-invasive treatment of vascular and pigmented lesions. The
Dye-SR module allows treatment of a broad spectrum of vascular
imperfections be selectively targeting oxyhemoglobin,
The Dye-SR module may be operated in two separate modes: Dye-SR
and Dye-SSR.
A complete discussion of the cooled Dye-SR module applications may
be found in Sections 14.6 and 14.7 of this manual.
The cooled Dye-SR module has an orange identification section (see
Figure 14-1).
Figure 14-1. Dye-SR Module (Orange Color Code)
14.2 Dye-SR Module Specifications

 Cooling: TEC

14.3 Dye-SR Module Operating Screen

The Dye-SR module main operating screens (see Figure 14-2) are displayed when the Dye-SR
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 14-2. Dye-SR Module Operating Screen (SR/SSR Modes)

SR Mode SSR Mode
Energy Density (Fluence): Up to 14 J/cm2 1 – 4 J/cm2

Pulse Duration: 10, 12, 15 msec. 1, 3, 30 sec.
Pulse Repetition Rate: 1/2 Hz 3 Hz
14.4 Dye-SR Module Regulatory Labels

adhered to the Dye-SR module connector:
Figure 14-3. Dye-SR Module Regulatory Labels

The following table offers names of accessories specific to the Dye-SR
Table 14-1. Dye-SR Module Accessories
Description
Dye-SR (Vascular/Pigmented Lesions) Module


14.6 Dye-SR Module Clinical Guide for Vascular

Lesions
The treatment of vascular lesions with the Harmony XL Pro system
can be performed using the Dye-SR 550-650nm (orange color code)
module.
The Dye-SR module is indicated for vascular lesions.
Warning
operator and the customer when using this module

The Advanced Fluorescence Technology (AFT) Dye-SR module is
indicated for:
 Use on Fitzpatrick skin types I-V.
 Epilepsy
wound healing)


Skin Test
first treatment session with the cooling mode On and according to the
Pulse
Fitzpatrick Cooling Fluence Waiting
Module Width
Skin Type % (J/cm2) Period
(msec)
Dye-SR 550- 10 8–9

650nm
I – III 75/100 30 min
(orange color 12 9 – 10
code)
Dye-SR 550- 12 7 – 10
650nm 48
IV 75/100
(orange color 15 7 – 10 hours
code)
Dye-SR 550-
650nm 48
V 15 75/100 5–7
(orange color hours*
code)
Note


14.6.4 Treatment
 The Dye-SR cooled module will treat vessels up to < 1mm.
customer during treatment.
Cooling means, such as small ice packs or forced cold air/Zimmer
are recommended (i.e., post-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.

the same spot.


20% and test again.

Lesions
Table 14-3. Suggested Dye-SR Setup Parameters for Vascular Lesions

Module Cooling %
Dye-SR 550-650nm 8 – 10, 8 –

I – III 10, 12 75/100
(orange color code) 12
Dye-SR 550-650nm
IV 12, 15 75/100 8 – 11
(orange color code)
Dye-SR 550-650nm
V 15 75/100 5–7
(orange color code)

14.6.6 Follow-up
 Within three weeks after the 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 two months later.
continued using the same parameters and the customer should
after three weeks.
at least 10%.
treatments.
 Customers should be instructed to avoid sun exposure after and in
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

14.7 Dye-SR Module Clinical Guide for Pigmented

Lesions
be performed with the Dye-SR module.
The Dye-SR 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.



Skin Test
first treatment session and according to the following parameters:

Module
Dye-SR 550-650nm
I – III 10, 12 11 – 13 30 min
(orange color code)
Dye-SR 550-650nm 24 – 48
IV 12, 15 7 – 10
(orange color code) hours
Dye-SR 550-650nm 24 – 48
V 15 5–7
(orange color code) hours*
14.7.4 Treatment
Table 14-4.
over the same spot.


lesions are unsatisfactory, you should increase the fluence by 10-
20%.

Lesions
Table 14-5. Suggested Dye-SR Setup Parameters for Pigmented Lesions
Fitzpatrick
Module Pulse Width (msec) Fluence (J/cm2)
Skin Type
Dye-SR 550-650nm
I – III 10, 12 11 – 14
(orange color code)
Dye-SR 550-650nm
IV 12, 15 8 – 11
(orange color code)
Dye-SR 550-650nm
V 15 5–7
(orange color code)

14.7.6 Follow-up
 Within three weeks after the treatment customers should return
for examination of the treatment site and for additional treatment,
if necessary.
for an additional examination two months later.
continued using the same parameters and the customer should
after three weeks.
at least 10%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

14.8 Dye-SSR Mode Clinical Guide

performed using the Dye-SR (orange color code) module in Dye-SSR
mode.
Warning
the customer when using this module.

The Dye-SR module in Dye-SSR mode is indicated for:
 Use on Fitzpatrick skin types I-V.
simplex, etc., at the treatment site.
 Epilepsy.
 Isotretinoin – Roaccutane or Tretinoin – In the past 3-6 months.
 Retin A - In the past 2 weeks.
 Pregnancy (including IVF).
 Diabetes.


The Dye-SR module in Dye-SSR mode may be operated with 3
different time intervals: 1, 3 and 30 seconds.
irregularities (dyschromia, lentigines, freckles, etc.).
The Dye-SR module incorporates thermo-electric coupling (TEC)
technology; the module can be operated in two conditions: Cooling On
(Cooling 50%, Cooling 75%, or Cooling 100%) and Off.
in kilojoules (kJ).
techniques.
Skin Test
Table 14-6. Dye-SSR Skin Test Parameters (30 second interval)
Fitzpatrick Cooling Total Energy

Fluence (J/cm2)
Skin Type [On/Off] * [kJ] **
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
Off modes.

ALL skin types.
Note

Treatment can begin after the Dye-SR module has been connected to
Provide appropriate eye protection (OD>5) goggles for the
customer and the operating staff in the enclosed treatment room.
the customer during treatment and; c) friction
reduction/lubrication during the In-Motion technique.
footswitch.
(kJ).

skin surface.
End-points: mild-to-moderate erythema for skin types I-IV; mild
erythema for skin type V.
next treatment may be skipped, or the dose reduced until the
symptoms resolve.
treatment.
Note

Table 14-7. Dye-SSR Suggested Setup Parameters (30 second interval)

Fluence (J/cm2)
Skin Type [On/Off] * [kJ] **
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
(**) The total energy is adjusted for 10x10 cm (100cm2) area. The 1-
second and 3-second time intervals are indicated for the
Stationary technique

Table 14-6.


again.
until end- points are visible.
customer's tolerance.
treated area.
treatment.

Table 14-8. Small Area Parameters, 3-25 cm2, 3 Seconds, In-Motion*

Fluence (J/cm2)
Skin Type [On/Off] [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 14-9. Small Area Parameters, 3-25 cm2, 1 Second, In-Motion*

Fluence (J/cm2)
Skin Type [On/Off] [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

14.8.9 Follow-up
 Within three weeks after treatment customers should return for
necessary.
for an additional examination one month later.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

HR Module – Hair Removal
Chapter Contents:
Section Title Page
15.1 HR Module Description ................................................................. 15-2
15.2 HR Module Specifications ............................................................. 15-2
15.3 HR Module Operating Screen ....................................................... 15-3
15.4 HR Module Regulatory Labels ...................................................... 15-4
15.6 HR Module Clinical Guide ............................................................ 15-5
15.6.3 Pre-Treatment ................................................................. 15-6
15.6.4 Treatment ........................................................................ 15-7
15.6.6 Follow-Up ......................................................................... 15-9

15.1 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
The HR module has a red identification section (see Figure 15-1).
Figure 15-1. HR Module (Red Color Code)
15.2 HR Module Specifications

 Cooling: None

15.3 HR Module Operating Screen

The HR cooling module main operating screen (see Figure 15-2) is
displayed when the HR module is connected to the system.
Figure 15-2. HR Module Operating Screen

 30 msec
 40 msec
 50 msec

15.4 HR Module Regulatory Labels

adhered to the HR module connector:
Figure 15-3. HR Module Regulatory Labels

The following table offers names of accessories specific to the HR
Table 15-1. HR Module Accessories
Description
HR (Hair Removal) Module


15.6 HR Module Clinical Guide

The Harmony XL Pro 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 patient when using this module.

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.
 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
 Past or ongoing medical condition (diabetes, epilepsy, high or low
blood pressure, or others)
 Present medications:
 Photosensitizing medications
 Gold therapy
 Avoid treatment on tattooed and permanent make-up area or nevi
present

Note
Laser hair removal treatments can alter the appearance of tattoos and
permanent make-up. If you have a tattoo on the area you want to have treated,
you should avoid the tattoo area!
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
Skin Test
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 15-2. HR Skin Test Parameters

Module
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

15.6.4 Treatment
Treatment can begin after the HR module is connected and the
treatment parameters are selected (fluence and timer interval)
according to Table 15-2.
Apply a thin layer (usually ~1 mm and ~2 mm for darker types) of
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 module perpendicular to the skin and touch the skin to
ensure a good seal. Do not apply excessive pressure on the skin.
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.
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.
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.
If adverse skin effects occur (such as excessive reddening) before
good follicular response is achieved, reduce the settings by 10-20%.
Make the above adjustments and test again on an adjacent area
until adverse effects on the skin no longer appear.
After treatment it is recommended to cool the area immediately

15.6.5 Suggested HR Setup Parameters

The following table shows the recommended parameters based on the
patient hair color and skin type:
Table 15-3. Suggested HR Setup Parameters
Skin Type Hair Fluence Pulse Width

Module
(Fitzpatrick I-VI) Color (J/cm2) (msec)
Light HR 650-950nm (Red) 20 – 25 30, 40

I
Dark HR 650-950nm (Red) 19 – 23 30, 40
Light HR 650-950nm (Red) 20 – 25 30, 40
II
Dark HR 650-950nm (Red) 19 – 23 30, 40
Light HR 650-950nm (Red) 18 – 24 30, 40
III
Dark HR 650-950nm (Red) 17 – 22 30, 40
Light HR 650-950nm (Red) 16 – 20 40, 50
IV
Dark HR 650-950nm (Red) 14 – 18 40, 50
Light HR 650-950nm (Red) Up to 15 50
V
Dark HR 650-950nm (Red) Up to 13 50
Light N/A N/A N/A
VI
Dark HR 650-950nm (Red) Up to 10 50
Caution
It is not recommended to treat hair that is lighter than the surrounding skin.

15.6.6 Follow-Up
 Patients should return for examination of the treatment site
between six to eight weeks after treatment and for additional
treatment, if necessary.
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.).
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

SHR (3) Module – Super Hair
Removal
Chapter Contents:
Section Title Page
16.2 SHR (3) Module Specifications ...................................................... 16-3
16.2.1 HR Mode .......................................................................... 16-3
16.2.2 SHR Mode ........................................................................ 16-3
16.8 SHR (3) Module Clinical Guide – HR Mode ................................. 16-6
16.8.3 Pre-Treatment ................................................................. 16-8
16.8.4 Treatment ........................................................................ 16-8
16.8.5 Suggested HR Setup Parameters .................................. 16-10
16.8.6 Follow-Up ....................................................................... 16-11
16.9.4 Pre-Treatment ............................................................... 16-12
16.9.5 Treatment ...................................................................... 16-14

SHR (3) Module – Super Hair Removal
16.9.8 Follow-Up....................................................................... 16-17
16.1 SHR (3) Module Description

The SHR (3) 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 (3) module clinical applications may
The SHR (3) module has a brown identification section (see
Figure 16-1).
Figure 16-1. SHR (3) Module (Brown Color Code)

16.2 SHR (3) Module Specifications

16.2.1 HR Mode
 Cooling: TEC
16.2.2 SHR Mode

 Light Source: Near Infrared pulsed light
 Timer: 1, 3 and 30 seconds
 Cooling: TEC
16.3 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 Harmony XL Pro 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.

16.4 SHR (3) Module Operating Screens

The SHR (3) module main operating screen (see Figure 16-2) is
displayed when the SHR (3) 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 (3) 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 16-2. SHR (3) Cooling Module Operating Screen (HR/SHR mode)

Operating parameters available in HR mode:

Fluence – the available range is from 5 to 25 J/cm2 in increments of
1 J/cm2.
 30 msec
 40 msec
 50 msec
Operating parameters available in SHR mode:

Timer – 1, 3 and 30 seconds
16.5 Total Energy in the SHR (3) Module

The SHR (3) module's SHR operating screen exhibits the total energy
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.

16.6 SHR (3) Module Regulatory Labels

adhered to the SHR (3) module connector:
Figure 16-3. SHR (3) Module Regulatory Labels

The following table offers names of accessories specific to the SHR (3)
Table 16-1. SHR (3) Module Accessories
Description
SHR (3) Module (Super Hair Removal)

16.8 SHR (3) Module Clinical Guide – HR Mode

The Harmony XL Pro system with the SHR (3) module is indicated for
the removal of unwanted hair and to effect stable long-term or
Warning


The SHR (3) module in HR mode is indicated for:
bikini area
 Isotretinoin – In the past 3-6 months
 Epilepsy
psoriasis
 Recent suntan or exposure to a tanning bed
 Gold therapy
 Avoid treatment on tattooed and permanent make-up area, or nevi
present
Note
Laser hair removal treatments can alter the appearance of tattoos
and permanent make-up. If you have a tattoo on the area you want
to have treated, you should avoid the tattoo area!

Patient Evaluation
 Hormonal
 Familial
 Tumor
Skin Test
table below.
Table 16-2. Cooled HR Skin Test Parameters

Mode
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
16.8.4 Treatment
Treatment can begin after the SHR (3) module is connected, set to HR
mode and the treatment parameters are selected (fluence and timer
interval) according to Table 16-2.
 Clean the skin to remove perfumes, cosmetics and sunscreens.
 Apply a thin layer (usually ~1 mm and ~2 mm for darker types) of
 Set the necessary cooling level from the control screen based on the

 Place the module perpendicular to the skin and touch the skin to
 Set the initial fluence parameter according to the skin test results.
 Trigger a light pulse by pressing the footswitch.
 Examine the treatment site for any change of the skin color and
are ineffective.
 It is recommended to wait 30 minutes after a test shot has been
 If there are no noticeable changes in the hair follicles, or adverse
 If adverse skin effects occur (such as excessive reddening) before
 Make the above adjustments and test again on an adjacent area
 After treatment it is recommended to cool the area immediately


 The following table shows the recommended parameters based on
the patient hair color and skin type:
Skin Type Fluence Pulse Width

Hair Color Mode
(Fitzpatrick I-VI) (J/cm2) (msec)
Light HR 20 – 25 30, 40
I
Dark HR 19 – 23 30, 40
Light HR 20 – 25 30, 40
II
Dark HR 19 – 23 30, 40
Light HR 18 – 24 30, 40
III
Dark HR 17 – 22 30, 40
Light HR 16 – 20 30, 40
IV
Dark HR 14 – 18 30, 40
Light HR Up to 15 50
V
Dark HR Up to 13 50
Light N/A N/A N/A
VI
Dark HR Up to 13 50
Caution
It is not recommended to treat hair that is lighter than the surrounding skin.

16.8.6 Follow-Up
Patients should return for examination of the treatment site between
six to eight weeks after treatment and for additional treatment, if
necessary.
If no additional treatment is necessary, the patient should return for
an additional re-examination three to four months later, or when any
new hair has grown in the treatment area.
If there has been partial hair clearance, treatment should be
continued, and the patient should return between six to eight weeks
for examination and for additional treatment, if necessary.
If no change is noted, treatment parameters should be changed. With
multiple treatments, increase the time intervals between treatment
sessions (after the second one), to allow any new hair to grow in the
treatment area. New growth will vary based on the body area (growth
cycle) and on the individual patient (gender, hormonal problems, etc.).
Patients should be instructed to avoid sun exposure after and in
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

16.9 SHR (3) Module Clinical Guide – SHR Mode

Warning

The SHR (3) module in SHR mode is indicated for:
 The treatment pseudofolliculitis barbae (PFB).
16.9.3 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 16.9.5). 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 (Cooling 50%, Cooling 75%, or Cooling 100%) 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.
Patient Evaluation
Refer to Section 16.8.3.1

Skin Test
first treatment session according to the parameters in Table 16-4.
hair color, hair type, and the density and depth of the hair. Initially,
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 16.9.5.
Table 16-4. SHR (3) Skin Test Parameters

Fluence (J/cm2)
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
Off modes.
(**) In-Motion technique; the total energy is adjusted for 10x10 cm or
4x25cm (100cm2) area.
Note

16.9.5 Treatment
Treatment can begin after the SHR (3) module is connected, set to
SHR mode and the treatment parameter (fluence), treatment interval,
and cooling (On/Off) is selected according to Table 16-5.
Shave the treatment site to eliminate any surface hair that could
interfere with the treatment; remove any hairs debris with
adhesive tape.
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.
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
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.
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
Treat within the grid area in an In-Motion technique according to
the recommended parameters and passes.
In-Motion Technique:
footswitch.
(kJ).


 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).
 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.
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.
Set the fluence parameters according to the parameters indicated
in Table 16-4 (provided that the patient has tolerated the skin
test).
again.
end points).
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.
the desired follicular response is achieved, adjust the treatment
parameters to reduce the aggressiveness of the treatment.
with cold (water based) cloth or gauze, and apply Aloe Vera gel.


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 16.9.5.
Table 16-5. SHR (3) Suggested Setup Parameters

Fluence (J/cm2)
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
Off modes.
(**) 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 16-6. 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


Table 16-7. Small Area Parameters, 3-25 cm2, 1 or 3 Seconds, In-Motion

Fluence (J/cm2)
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 16-8. Small Area Parameters, Up To 3 cm2, 1 or 3 Seconds, Stationary*

Fluence (J/cm2)
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.
16.9.8 Follow-Up
Refer to Section16.8.6.

SHR (5) Module – Super Hair
Removal
Chapter Contents:
Section Title Page
17.2 SHR (5) Module Specifications ...................................................... 17-3
17.2.1 HR Mode .......................................................................... 17-3
17.2.2 SHR Mode ........................................................................ 17-3
17.8 SHR (5) Pro Module Clinical Guide –HR Mode ............................ 17-6
17.8.3 Pre-Treatment ................................................................. 17-7
17.8.4 Treatment ........................................................................ 17-8
17.8.6 Follow-Up ....................................................................... 17-10
17.9.4 Pre-Treatment ............................................................... 17-11
17.9.5 Treatment ...................................................................... 17-13
17.9.7 Follow-Up ....................................................................... 17-16

17.1 SHR (5) Module Description

The SHR (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 (5) module clinical applications may
The SHR (5) module handpiece has a brown identification section (see
Figure 17-1).
Figure 17-1. SHR (5) Module Handpiece (Brown Color Code)

17.2 SHR (5) Module Specifications

17.2.1 HR Mode
 Cooling: TEC
17.2.2 SHR Mode

 Cooling: TEC

application.
system.
Note
In the latest series of Harmony XL Pro 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 SHR (5) Module Operating Screens

The SHR (5) module main operating screen (see Figure 17-2) 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 (5) module's contact cooling mechanism can be turned on or
off by touching the appropriate soft-key in the bottom-left section of
the screen:
Figure 17-2. SHR (5) Module Operating Screens (HR/SHR modes)


Fluence – the available range is from 5 to 20 J/cm2 in increments of
1 J/cm2.
 30 msec
 40 msec
 50 msec
Operating parameters available in SHR mode:

17.5 Total Energy in the SHR (5) Module

The SHR (5) module's operating screen exhibits the total energy
Note
If the system stays in SHR mode during patient rotation, it is
17.6 SHR (5) Module Regulatory Labels

adhered to the SHR (5) module handpiece connector:
Figure 17-3. SHR (5) Module Regulatory Labels


The following table offers names of accessories specific to the SHR (5)
Table 17-1. SHR (5) Module Accessories
Description
SHR Pro 5 (Super Hair Removal) Cooled Module

17.8 SHR (5) Pro Module Clinical Guide –HR Mode

Warning

The SHR (5) module in HR mode is indicated for:
bikini area
 Epilepsy
psoriasis


 Gold therapy
 Avoid treatment on tattooed and permanent make-up area, or nevi
present
Note
Laser hair removal treatments can alter the appearance of tattoos
and permanent make-up. If you have a tattoo on the area you want
to have treated, you should avoid the tattoo area!
Patient Evaluation
 Hormonal
 Familial
 Tumor
Skin Test
table below.

Table 17-2. HR Cooled Skin Test Parameters

Mode
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 (5) module is connected, set to HR
mode and the treatment parameters are selected (fluence and timer
Apply a thin layer (usually ~1 mm and ~2 mm for darker types) of
are ineffective.



first treatment session according to the following parameters. The
recommended parameters are based on the patient hair color and skin
type:
Skin Type Hair Fluence Pulse Width

Mode
(Fitzpatrick I-VI) Color (J/cm2) (msec)
Light HR 15 – 20 30
I
Dark HR 13 – 18 30
Light HR 15 – 20 30
II
Dark HR 13 – 18 30
Light HR 15 – 20 40
III
Dark HR 12 – 17 40
Light HR 15 – 17 40
IV
Dark HR 10 – 15 50
V
Dark HR Up to 13 50
Light N/A N/A N/A
VI
Dark HR Up to 12 50
Caution
It is not recommended to treat hair that is lighter than the
surrounding skin.

17.8.6 Follow-Up
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

17.9 SHR (5) Module Clinical Guide – SHR Mode

The Harmony XL Pro system with the SHR (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 Advanced Fluorescence Technology (AFT) SHR (5) module is
indicated for:
 The treatment pseudofolliculitis barbae (PFB).

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 (5) NIR module incorporates thermo-electric coupling (TEC)
technology; the module can be operated under two conditions: cooling
ON (Cooling 50%, Cooling 75%, or Cooling 100%) 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.
Patient Evaluation
Refer to Section 17.8.3.1.

Skin Test
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 17.9.5.
Table 17-4. SHR (5) Skin Test Parameters**

Fluence (J/cm2)
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
Off modes.
(**) In-Motion technique; the total energy is adjusted for 15x10 cm
(~150cm2) area.
Note

17.9.5 Treatment
Treatment can begin after the SHR (5) NIR module is connected and
the treatment parameter (fluence), treatment interval, and cooling
(On/Off) is selected according to Table 17-5.
interfere with the treatment; remove any hair debris with adhesive
tape.
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.
treatment area.
very small areas on the face, like the upper lip and chin (using the
footswitch.
(kJ).


end points).
Stationary Technique: apply ultrasonic gel to the treatment area
in both On and Off cooling modes.
test).
again.
end points).


Table 17-5. SHR (5) Suggested Setup Parameters

Fluence (J/cm2)
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
Off modes.
(**) 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 17-6. Suggested Total Energy (kJ) delivered per Anatomic Site
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 17-7. Suggested Total Energy (kJ) delivered –Small areas (up to 25cm2)
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 *
(*) Unilateral
17.9.7 Follow-Up
 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.).
between treatments.
been no adverse reactions) at 4-8 week intervals.
Alma Lasers:
Alma Lasers GmbH
Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

ST Module – Scar Revision &
Treatment of Striae
Chapter Contents:
Section Title Page
18.1 ST Module Description .................................................................. 18-2
18.2 ST Module Specifications .............................................................. 18-2
18.3 ST Module Operating Screen ........................................................ 18-3
18.4 ST Module Regulatory Labels ....................................................... 18-4
18.6 ST Module Clinical Guide ............................................................. 18-4
18.6.3 Pre-Treatment ................................................................. 18-5
18.6.5 Skin Test .......................................................................... 18-6
18.6.6 Treatment ........................................................................ 18-7
18.6.8 Follow-Up ....................................................................... 18-10

ST Module – Scar Revision & Treatment of Striae
18.1 ST Module Description

The Harmony XL Pro 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
The ST module has a burgundy identification section (see Figure 18-1).
Figure 18-1. ST Module (Burgundy Color Code)
18.2 ST Module Specifications

 Light Source: Pulsed light
 Spectrum: 780 - 950nm
 Timers: 10, 30, 90 seconds
 Cooling: None

18.3 ST Module Operating Screen

The ST module main operating screen (see Figure 18-2) is displayed
when the ST module is connected to the system:
Figure 18-2. ST Module Operating Screen

Timers – there are three timer settings in this module:
 10 Seconds
 30 Seconds
 90 Seconds

18.4 ST Module Regulatory Labels

adhered to the ST module connector:
Figure 18-3. ST Module Regulatory Labels

The following table offers names of accessories specific to the ST
Table 18-1. ST Module Accessories
Description
ST Module
18.6 ST Module Clinical Guide

The Harmony XL Pro ST NIR (burgundy color code) module emits light
ST module can be used to treat cutaneous lesions such as striae,
stretch marks and scar revision.
Caution


The Advanced Fluorescence Technology (AFT) ST module is indicated
for:
 The treatment of cutaneous lesions including warts, scars and
striae.
 Whole body tattoos or very large areas
 Eye-liner or lip-liner tattoos in treatment area
 Epilepsy
 Gold therapy
 Photosensitizing drugs; tetracycline, St. John’s Wort (herbal
remedy) in the past 3 months for depression (because of increased
photosensitivity)
 Diabetes (owing to possible photosensitivity and poor wound
healing)
 Pregnancy
 Impaired immune system
 Scleroderma

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.
Module Parameters
J/cm2 10 sec** 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.
18.6.5 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.
** Energy settings in J/cm2 are displayed vertically

Face
Test Spot Exposure Time Fluence Accumulative

Mode
No. [Sec] [J/cm2] Fluence
In-Motion 1 30 4 120
Abdomen
Test Spot Exposure Time Fluence Accumulative

Mode
No. [Sec] [J/cm2] Fluence
18.6.6 Treatment
After the ST module has been connected to the Harmony XL Pro
system and suitable settings (time exposure and fluence) have been
selected, the treatment can begin.
In-Motion Protocol
In areas where hair exists, the hair must be shaved or trimmed.
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).
Skin tissue heating is specific to the individual patient and area,
and therefore should be monitored/gauged to the individual
Clinical end-points: skin should appear red/pink (mild-moderate
erythema); patient should report that the skin feels warm.
If no visible end-points appear but the patient reports deep heat
sensation during the treatment, do not repeat treatment.

Stationary Protocol
In the stationary technique, up to 10% overlapping is an
acceptable tolerance.
the skin test results.
again.
the patient's tolerance.
treated area.
swelling), you may either reduce the exposure time or reduce the
fluence.
Note
Always perform a skin test on the intended treatment area during the first
treatment session.


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).
Face
Exposure Fluence Accumulativ

Area
Time [Sec] [J/cm2] e Fluence
Forehead, Neck 90 4–7 360 – 630

Submental, Cheeks, Jowls 90 5–7 450 – 630
Abdomen
Exposure Fluence Accumulativ

Area
Time [Sec] [J/cm2] e Fluence
Upper Abdomen 90 5–7 450 – 630

Mid-Lateral Abdomen 90 5–7 450 – 630
Lower Abdomen 90 5–7 450 – 630
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.

18.6.8 Follow-Up
 Patients should be invited four weeks after treatment for
necessary.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

SST Cooled Module – Super Skin
Tightening
Chapter Contents:
Section Title Page
19.1 SST Cooled Module Description.................................................... 19-2
19.2 SST Cooled Module Specifications ................................................ 19-2
19.3 SST Cooled Module Operating Screen .......................................... 19-3
19.4 Total Energy in the SST Cooled Module....................................... 19-4
19.5 SST Cooled Module Regulatory Labels ......................................... 19-4
19.7 SST Cooled Module Clinical Guide ............................................... 19-5
19.7.4 Pre-Treatment ................................................................. 19-6
19.7.5 Treatment ........................................................................ 19-7
19.7.6 Suggested Setup Parameters (In-Motion Protocol)......... 19-9
19.7.8 Follow-Up ....................................................................... 19-10

SST Cooled Module – Super Skin Tightening
19.1 SST Cooled Module Description

The Harmony XL Pro SST Cooled module emits light in the near
infrared spectrum generated by a pulsed-light source. The SST Cooled
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 Cooled module clinical applications
The SST Cooled module has a burgundy identification section (see
Figure 19-1).
Figure 19-1. SST Cooled Module (Burgundy Color Code)
19.2 SST Cooled Module Specifications

 Light Source: Near-infrared pulsed light
 Energy Density (Fluence): 0.5 – 3.5 J/cm2
 Timers: 1, 3 and 30 seconds
 Cooling: TEC

19.3 SST Cooled Module Operating Screen

The SST Cooled module main operating screen (see Figure 19-2) is
displayed when the SST Cooled module is connected to the system.
The SST Cooled module's contact cooling mechanism can be turned on
or off by touching the appropriate soft-key in the bottom-left section of
the screen:
Figure 19-2. SST Cooled Module Operating Screen

Fluence – the available fluence range is from 0.5 to 3.5 J/cm2 in
increments of 0.1 J/cm2.

19.4 Total Energy in the SST Cooled Module

The SST Cooled module's operating screen exhibits the total energy
Note
If the system stays in SST Cooled mode during patient rotation, it
is important to reset the Total Energy by pressing the Reset key.
19.5 SST Cooled Module Regulatory Labels

adhered to the SST Cooled module connector:
Figure 19-3. SST Cooled Module Regulatory Labels

The following table offers names of accessories specific to the SST
Cooled module that may be ordered form Alma Lasers.
Table 19-1. SST Cooled Module Accessories
Description
SST Cooled Module


19.7 SST Cooled Module Clinical Guide

The Harmony XL Pro SST Cooled module (burgundy color code) emits
light in the near infrared spectrum generated by a pulsed-light source.
The SST Cooled module can be used to treat cutaneous lesions such as
striae, stretch marks – scar revision and reduce the presence of
wrinkles.
Warning

The Advanced Fluorescence Technology (AFT) SST Cooled module is
indicated for:
 The treatment of cutaneous lesions including warts, scars and
striae.
 Whole body tattoos or very large areas
 Eye-liner or lip-liner tattoos in treatment area
 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
healing)
 Pregnancy
 Scleroderma


The SST Cooled module may be operated with 3 different time
intervals: 1, 3 and 30 seconds.
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 Cooled module incorporates thermo-electric coupling (TEC)
technology; the module can be operated under two conditions: Cooling
ON (Cooling 50%, Cooling 75%, or Cooling 100%) 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).
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 19-2. SST Cooled Skin Test Parameters – Forehead, Cheeks and Neck
Fluence Total Energy

Skin Type (Fitzpatrick I-VI) Cooling**
(J/cm2) [kJ]*
I – III 3.5 16.2 On

IV 3.2 16.2 On
V – VI 2.8 16.2 On

Table 19-3. SST Cooled 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.
Note
19.7.5 Treatment
Treatment can begin after the SST Cooled module has been connected
to the Harmony XL Pro system and the treatment parameters selected
(time exposure and fluence) according to the Suggested Setup
Parameters tables in Section 19.7.6.
In-Motion Protocol
In areas where hair exists, the hair must be shaved or trimmed.
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).
Skin tissue heating is specific to the individual patient and area,
and therefore should be monitored/gauged to the individual
If no visible end-points appear but the patient reports deep heat
sensation during the treatment, do not repeat treatment.

Stationary Protocol
In the stationary technique, up to 10% overlapping is an
acceptable tolerance.
the skin test results.
again.
the patient's tolerance.
treated area.
swelling), you may either reduce the exposure time or reduce the
fluence.
Note

19.7.6 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); lower-right (5); lower-left (6).
Table 19-4. SST Cooled Suggested Setup Parameters – Forehead, Cheeks and Neck
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 19-5. SST Cooled Suggested Setup Parameters – Abdomen, Thigh and Upper Arm
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.


Table 19-6. Small Area Parameters, 3-25 cm2, 1 or 3 Seconds, In-Motion

Fluence (J/cm2)
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 19-7. Small Area Parameters, Up To 3 cm2, 1 or 3 Seconds, Stationary*

Fluence (J/cm2)
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
19.7.8 Follow-Up
 Patients should be invited four weeks after treatment for
necessary.
between treatments.
been no adverse reactions) at 2–4 weeks intervals.
Alma Lasers:
Alma Lasers GmbH
Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Q-SW 1064 (ClearLift) Module –
Tattoo Removal and Vascular
Lesions
Chapter Contents:
Section Title Page
20.1 Q-SW Pro Module Description ...................................................... 20-2
20.2 Q-SW 1064 Module Specifications ................................................ 20-3
20.2.1 Standard Tip Module Specifications ............................... 20-3
20.2.2 532nm KTP Tip Module Specifications ........................... 20-3
20.2.3 5X5 Pixel Tip Module Specifications ............................... 20-3
20.3 Q-SW Pro Module Operating Screen ............................................ 20-4
20.4 Q-SW 1064 Module Regulatory Labels ......................................... 20-5
20.6 Q-SW Pro Module Clinical Guide ................................................. 20-6
20.6.2 Pre-Treatment ................................................................. 20-8
20.6.3 Treatment ...................................................................... 20-10
20.6.6 Follow-Up ....................................................................... 20-12

Q-SW 1064 (ClearLift) Module – Tattoo Removal and Vascular Lesions
20.1 Q-SW Pro Module Description

The Q-SW 1064 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 QSW or Frequency Doubled (FD)
Laser QSW modes, depending on the connected tip.
A complete discussion of the Q-SW 1064 module's clinical applications
may be found in Section 20.6 of this manual.
The Q-SW 1064 module is identified by QS 1064nm printed on the
module (see Figure 20-1).
Figure 20-1. Q-SW 1064 Module

20.2 Q-SW 1064 Module Specifications

20.2.1 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)
5x5 Pixel
 Pulse Frequency: 1, 2, 4 Hz
 Energy Density (Fluence): 500 – 1200 mJ/pulse
20.2.2 532nm KTP Tip Module Specifications

 Light Source: FD Q-Switched Nd:YAG
 Tip Spot Size: 2, 3, 4 mm
20.2.3 5X5 Pixel Tip Module Specifications

 Light Source: Switched Nd:YAG
 Tip Spot Size: 5 x 5 mm

20.3 Q-SW Pro Module Operating Screen

The Q-SW 1064 module main operating screen (see Figure 20-2) is
displayed when the Q-SW 1064 laser module is connected to the
system:
Figure 20-2. Q-SW 1064 Module Operating Screen with Standard Tip

There are six standard tips (1 mm through 6 mm), one 5x5 Pixel
tip and three 532nm KTP (2, 3 and 4 mm) tips 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.
Fluence – the available fluence range is from 500 to 3000 mJ/pulse
in increments of 100 mJ/pulse.
Pulse Frequency: 1, 2, 4 Hz
Pulse Width: fixed at 20 nsec

20.4 Q-SW 1064 Module Regulatory Labels

adhered to the Q-SW 1064 nm module connector:
Figure 20-3. Q-SW 1064 Module Regulatory Labels

The following table offers names of accessories specific to the Q-SW
1064 module that may be ordered form Alma Lasers.
Table 20-1. Q-SW 1064 Module Accessories
Description
Q-SW 1064 Module (inc. 1, 2 & 3 mm tips)

Safety Glasses for 1064nm (OD 7+)
KTP Safety Glasses for FD QSW 1064nm

20.6 Q-SW Pro Module Clinical Guide

The Q-SW 1064 (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 Q-SW 1064 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
 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.

The Q-SW 1064 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

 Benign pigmented lesions:

 Café-au-lait (macules)
 Lentigines (senile and solar)
 Freckles (ephelides)
 Chloasma
 Nevi
 Nevus spillus
 Nevus of Ota
 Becker's nevi
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
Relative Contraindications
 Poorly Controlled Diabetes Mellitus
 Thrombocytopenia
 Peripheral Vascular Disease
 Anemia
 Bleeding Disorders
 Rheumatoid Arthritis/ Juvenile Rheumatoid Arthritis
 Subnormal Intelligence or Psychiatric Disorders
 History of Post-Inflammatory Hyperpigmentation
 Chronic Disease (Crohn’s Disease, IBD, etc.)

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.
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 QSW Harmony XL Pro 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.

Skin Test
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 20-2. Tattoo Removal Skin Test Parameters for Blue, Black & Green Tattoos (standard
tips)
Skin Type Spot Size Pulse Repetition Energy (mJ) Waiting Period
Rate (Hz)
I – VI 1, 2, 3 mm 1, 2, 4 600 – 700 24 – 48 hours

I-VI 4,5,6mm 1,2,4, 700 - 800 24 - 48 hours
Table 20-3. Tattoo Removal Skin Test Parameters for Red Tattoos (KTP tip)
Rate (Hz)
I – III 2,3,4 mm 1, 2, 4 600 24 – 48 hours

IV – VI 2,3,4 mm 1, 2, 4 600 24 – 48 hours
Table 20-4. Tattoo Removal Skin Test Parameters for for Blue, Black & Green Tattoos with
Pixel Tip
Rate (Hz)
I – III 5 x 5mm 1, 2, 4 600 - 800 24 – 48 hours

IV – VI 5 x 5mm 1, 2, 4 600 - 700 24 – 48 hours
Note
It is recommended that the patient return for treatment 24 – 48
hours after the skin test.

20.6.3 Treatment
Clean and dry the skin to remove the EMLA cream from the tattoo
area.
Appropriate protective eyewear protection must be used by both
the practitioner and the patient (and anyone else in the room).
Place the module perpendicular to the tattooed skin.
Overlapping should not exceed 10%.
Set the initial fluence and the pulse repetition rate parameter
according to the skin test results.
Trigger the Laser QSW laser by pressing the footswitch and the
module trigger simultaneously.
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.
If, along with a good response in the tattoo, adverse skin effects
lightguide), you should reduce the fluence by 10-20% and attempt
to treat in an adjoining area.
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.
After treatment it is recommended to cool the area immediately,
apply antibacterial ointment and cover the treated tattoo area with
sterile pad gauze.
Recommended treatment intervals: between eight and twelve
weeks.
Note
The Q-SW 1064 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.


Table 20-5. Suggested Setup Parameters for Blue, Black & Green Tattoos
Pulse Repetition
Skin Type Spot Size Wavelength Energy (mJ/P)
Rate (Hz)
I – VI 1, 2, 3 1064nm 1, 2, 4 600 – 1000

I – VI 4, 5, 6 1064nm 1, 2, 4 700 – 1200
Table 20-6. Suggested Setup Parameters for Red Tattoos (1064/532 KTP Tip)
Skin Type Spot Size Pulse Repetition Rate (Hz) Energy (mJ/P)
I – III 2, 3, 4, 1, 2, 4 800 – 1100

IV – VI 2, 3, 4, 1, 2, 4 700 – 1000
Table 20-7. Suggested Setup Parameters for Blue, Black & Green Tattoos with Pixel Tip
Pulse Repetition
Skin Type Spot Size Wavelength Energy (mJ/P)
Rate (Hz)
I – VI 5x5 1064nm 1, 2, 4 600 – 1200
Caution
Small spot size and high fluence often cause bleeding.
High repetition rate – use lower fluence setting.
20.6.5 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.

20.6.6 Follow-Up
 Patients should return no sooner than eight weeks after the last
treatment, for examination of the treatment site and for additional
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.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

H.P.Q-SW Pro (ClearLift) Module –
Tattoo Removal, Skin Rejuvination
and Pigmented & Vascular
Lesions
Chapter Contents:
Section Title Page
21.1 H.P.Q-SW Pro Module Description ............................................... 21-2
21.2 H.P.Q-SW Pro Module Specifications ........................................... 21-4
21.2.1 Module Specifications with Standard and Pixel Tips ..... 21-4
21.2.2 Module Specifications with 532nm KTP Tip................... 21-4
21.3 H.P.Q-SW Pro Module Operating Screen ..................................... 21-5
21.4 H.P.Q-SW Pro Module Regulatory Labels .................................... 21-7
21.6 H.P.Q-SW Pro Module Clinical Guide .......................................... 21-8
21.6.2 Pre-Treatment ............................................................... 21-10
21.6.3 Treatment Procedure – Standard Tips/iPixel roller
7x1 .................................................................................. 21-13
21.6.4 Treatment Procedure – Pixel Tip / iPixel Roller 5X5.... 21-14
iPixel tip 1X7) ................................................................ 21-17
iPixel roller 7X1) ............................................................ 21-17
21.6.8 Follow-Up ....................................................................... 21-18

H.P.Q-SW Pro (ClearLift) Module – Tattoo Removal, Skin Rejuvination and Pigmented &
Vascular Lesions
21.1 H.P.Q-SW Pro Module Description

The H.P.Q-SW Pro 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, wrinkles, fine lines and skin
tightening.
The module can be operated in Standard QS, Pixel QS (fractional) or
Frequency Doubled (FD) QS modes, depending on the connected tip.
A complete discussion of the H.P.Q-SW Pro module's clinical
applications may be found in Section 21.6 of this manual.
Figure 21-1. H.P.Q-SW Pro Module

Vascular Lesions
Figure 21-2. CVD Adjustable (1–5 mm) Tip
Figure 21-3. H.P.Q-SW Pixel 5x5 mm Tips
Figure 21-4. H.P.Q-SW Roller Tips

Vascular Lesions
21.2 H.P.Q-SW Pro Module Specifications

21.2.1 Module Specifications with Standard and Pixel Tips
 Light Source: Q-Switched Nd:YAG
 Spot Size: 3 & 5 mm Standard (1–5mm CVD
continuous variable defocus tip
5x5 fractional tip + 4D gauged
tips 5x5 fractional roller tip
 Pulse Frequency: 1, 2, 3, 4 Hz
 Energy Density (Fluence): 400-2400 mJ/P (1 to 3 Hz)
400-1200 mJ/P (4 Hz and roller)
21.2.2 Module Specifications with 532nm KTP Tip

 Light Source: FD Q-Switched Nd:YAG
 Tip Spot Size 3 mm
 Pulse Frequency: 1, 2, 3, 4 Hz

Vascular Lesions
21.3 H.P.Q-SW Pro Module Operating Screen

The H.P.Q-SW Pro module main operating screen (see Figure 21-5) is
displayed when the H.P.Q-SW Pro module is connected to the system:
Figure 21-5. H.P.Q-SW Pro Module Operating Screens with Standard 5mm Tip (Top) and 5x5
Pixel Tip (Bottom)

Vascular Lesions
Figure 21-6. H.P.Q-SW Pro Module Operating Screen with 7x1 Roller Tip

There are two standard tips (3 mm and 5 mm), one 5x5 Pixel tip,
one 532nm KTP (3 mm) tip and a Roller tip (7x1) 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.
Fluence – the available fluence range is from 500 to 2400 mJ/pulse
in increments of 100 mJ/pulse for the 3mm & 5mm tips and for the
4-D gauged tips. The available fluence for the iPixel roller (7x1)
range is from 400-1200.
Pulse Frequency: 1, 2, 3, 4 Hz
Pulse Width: fixed at 20 nsec

Vascular Lesions
21.4 H.P.Q-SW Pro Module Regulatory Labels

adhered to the H.P.Q-SW Pro module connector:
Figure 21-7. H.P.Q-SW Pro Module Regulatory Labels

The following table offers names of accessories specific to the H.P.Q-
SW Pro module that may be ordered from Alma Lasers.
Table 21-1. H.P.Q-SW Pro Module Accessories
Description
H.P.Q-SW Pro Module (inc. 3 & 5 mm standard tips)

KTP Safety Glasses for FD QSW 1064nm

Vascular Lesions
21.6 H.P.Q-SW Pro Module Clinical Guide

The H.P.Q-SW Pro (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 H.P.Q-SW Pro standard tips and Pixel
tip are indicated for the treatment of deep pigmented and superficial
lesions as well as wrinkles, fine lines, skin laxity and skin tightening.
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
 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.

The QSW 1064 Pixel (5x5mm) tip using the deep gauged tips (-2), (-1),
(0) is indicated for the non-invasive treatment of:
 Epidermal-Dermal Melasma
 Fine lines
 Skin laxity
 Photodamage/ photoaging collagen remodeling
The QSW 1064 Pixel (5x5mm) tip using the superficial gauged tips (0)
(+1), (+2) is indicated for the non-invasive treatment of:
 Epidermal Melasma
 Photoaging / pigmentation
 Skin laxity
 Fine lines
The H.P.Q-SW Pro module with Standard tips (3 & 5mm spot size) is
indicated for:
 Tattoo removal:
 Blue

Vascular Lesions
 Black
 Yellow
 Red
 Green
 Vascular lesions:
 Hemangiomas (port wine stains/birthmarks, cavernous, cherry,
and spider hemangiomas).
 Angiomas (cherry, spider)
 Telangiectasia
 Spider nevi
 Benign pigmented lesions:
 Café-au-lait (macules)
 Lentigines (senile and solar)
 Freckles (ephelides)
 Chloasma
 Nevi
 Nevus spillus
 Nevus of Ota
 Becker's nevi
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
Relative Contraindications
 Poorly Controlled Diabetes Mellitus
 Thrombocytopenia
 Peripheral Vascular Disease
 Anemia

Vascular Lesions
 Bleeding Disorders
 Rheumatoid Arthritis/ Juvenile Rheumatoid Arthritis
 Subnormal Intelligence or Psychiatric Disorders
 History of Post-Inflammatory Hyperpigmentation
 Chronic Disease (Crohn’s Disease, IBD, etc.)
skin type and the lesion type, depth and density. As general, when
using the pixel QS tips, for rough skin and deep lesions use deep
gauged tips (-1, -2). For lax skin and superficial lesions, use the
superficial gauged tips (+1, +2). It is possible to combine some gauged
tips one after the other in the same session if the lesion is mixed.
21.6.2.1.1 Tattoo Treatment
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.
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 H.P.Q-SW Pro Harmony XL Pro 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.

Vascular Lesions
Skin Test
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)
Rate (Hz)
I – VI 3 mm 1, 2, 3 1800-2200 24 – 48 hours
I – VI 5 mm 1, 2, 3 1400--2000 24 – 48 hours
Table 21-3. Tattoo Removal Skin Test Parameters for Red Tattoos (KTP tip)
Rate (Hz)
I – III 3 mm 1, 2, 3 1800-2200 24 – 48 hours

IV – VI 3 mm 1, 2, 3 1600-1800 24 – 48 hours
Table 21-4. Suggested Setup Parameters for Blue, Black & Green Tattoos (iPixel Roller Tip
7X1)
Tattoo Type Gauged Number

Spot Energy
Skin Type tip Wavelength of
Size (mJ/P)
Passes
I – VI Deep Tattoo 1X7 (-1) 1064nm 2000 – 2400 1

Superficial (0) 1
I – VI 1X7 1064nm 1800-2000
Tattoo

Vascular Lesions
Table 21-5. Skin Rejuvenation Skin Test Parameters (Gauged 5x5 Pixel Tip)
Skin Indication Pulse Accumulative Treatment

Gauged Energy Waiting
Test Repetition Energy Area Grid
Tip (mJ) Period
Rate (Hz) Joules/Grid (cm2)
I – VI Wrinkles, Skin (-2), (- 3 1800- 800-1000 20 15 – 30

Tightening, 1), 0 2400
Photodamage
d / Photoaged
skin, Coll5
agen
remodeling,
rough skin
I – VI Photoaging / (+1) , 3 1800 – 600-800 20 15 – 30
pigmentation, (+2) 2200
I – VI (0), (+1) 3 1800- 600-800 20 15 – 30
Skin Laxity 2400
I – VI (0) 3 1800- 600-800 20 15-30

Fine lines 2200
Table 21-6. Skin Rejuvenation Skin Test Parameters (iPixel roller 7X1)
Skin Indications Gauged Energy Overlapping Accumulative Waiting

Type tip (mJ/P) (%) Energy (J)* Period
Wrinkles, Skin (-1) 50 – 80 800-1000 15 – 30

Tightening,
Photodamaged /
I – VI Photoaged skin, 1800-2400
Collagen
remodeling, rough
skin
Photoaging / (0) 50 – 80 600-800 15 – 30
I – VI 1800-2200
pigmentation
I – VI Skin Laxity (0) 1800-2400 50 – 80 600-800 15 – 30
I – VI Fine lines (0) 1800-2200 50 – 80 600-800 15 – 30
Note
It is recommended that the patient return for treatment 24 – 48
hours after the skin test.

Vascular Lesions
21.6.3 Treatment Procedure – Standard Tips/iPixel roller 7x1

Clean and dry the skin.
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).
Place the module perpendicular to the tattooed skin
Technique: in-motion; overlapping: 50-80%.
Lightly position the tip on the surface of the skin.
Trigger the laser by pressing the footswitch and the module's
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.
Recommended treatment intervals: 3-4 weeks.
Trigger the H.P.Q-SW Pro laser by pressing the footswitch and the
module trigger simultaneously.
Apply the pixel roller (7x1) on the surface of the skin and move it
within the treatment area grid (20cm2).
Use slow speed strokes; employing fast moving strokes will
automatically be detected by the software and will disable energy
discharge.
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.
If, along with a good response in the tattoo, adverse skin effects
tip spot), you should reduce the fluence by 10-20% and attempt to
treat in an adjoining area.
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.

Vascular Lesions
After treatment it is recommended to cool the area immediately,

apply antibacterial ointment and cover the treated tattoo area with
sterile pad gauze.
Recommended treatment intervals: between eight and twelve
weeks.
Note
The H.P.Q-SW Pro 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.
21.6.4 Treatment Procedure – Pixel Tip / iPixel Roller 5X5

Clean and dry the skin.
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).
Technique: in-motion; overlapping: 50-80%.
Lightly position the tip on the surface of the skin.
Trigger the laser by pressing the footswitch and the module's
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.
Recommended treatment intervals: 3-4 weeks.

Vascular Lesions

Table 21-7. Suggested Setup Parameters for Blue, Black & Green Tattoos (Standard Tips)
Skin Pulse Repetition

Spot Size Wavelength Energy (mJ/P)
Type Rate (Hz)
I – VI 1, 2, 3 mm 1064nm 1, 2, 3 600 – 1000

I – VI 4, 5 mm 1064nm 1, 2, 3 700-1200
Table 21-8. Suggested Setup Parameters for Blue, Black & Green Tattoos (iPixel Roller Tip 1X7)
Skin Tattoo Type Spot Gauged Energy Number of

Wavelength
Type Size tip (mJ/P) Passes
I – VI Deep Tattoo 1X7 (-1) 1064nm 1800 – 2400 1

Superficial (0) 1
I – VI 1X7 1064nm 1400 - 2000
Tattoo
Table 21-9. Suggested Setup Parameters for Red Tattoos
Pulse Repetition
Skin Type Spot Size Wavelength (nm) Energy (mJ/P)
Rate (Hz)
I – III 3 532nm KTP 1, 2, 3 800 – 1100

IV – VI 3 532nm KTP 1, 2, 3 700 – 1000
Table 21-10. Suggested Setup Parameters for deep gauged tips (Stationary Pixel tip)
Gauged PRR (Pulse

Energy Overlapping Accumulative Treatment
Indication Tip Repetition
(mJ/P) (%) Energy (J) * area grid
Rate)
Wrinkles,
Skin
Tightening, 0, (-1) , 1800-
50 – 80 3 800-1000 20
Collagen (-2) 2400
remodeling,
rough skin
(*) per 20 cm2 area

Vascular Lesions
Table 21-11. Suggested Setup Parameters for Superficial gauged tips (Stationary Pixel tip)
Gauged Energy Overlapping Pulse

Accumulative Treatment
Indication Tip (mJ/P) (%) Repetition
Energy (J) * area grid
Rate (Hz)
Photoaging / (+1), 1200-

10 – 20 3 600 20
pigmentation (+2) 1600
1200-
Skin Laxity 0 (+1) 50 – 80 3 1000 20
1600
2000-
Fine lines 0 2400 50 – 80 3 1000 20
(*) per 20 cm2 area
Table 21-12. Suggested Setup Parameters for Melasma Treatment (Stationary Pixel tip)
Gauged Energy Overlapping Pulse

Melasma Accumulative
Tip (mJ/P) (%) Repetition
Type Energy (J)*
Rate (Hz)
Epidermal (+2) 1200-1600 50 – 80 3 400-600

EDJ (+1) 1200-1600 50 – 80 3 400-600
Dermal 0 1800-2200 50 – 80 3 400-600
(*) per 20 cm2 area
Table 21-13. Suggested Setup Parameters for Superficial gauged tips (iPixel roller 7X1)
Skin Indications Gauged Overlapping (%) Accumulative

Energy (mJ/P)
Type tip Energy (J)*
Wrinkles, Skin (-1) 50 – 80 800-1000

Tightening,
Photodamaged /
I – VI Photoaged skin, 1800-2200
Collagen
remodeling,
rough skin
Photoaging / (0) 50 – 80 600-800
I – VI 1800-2200
pigmentation
I – VI Skin Laxity (0) 1800-2200 50 – 80 600-800
I – VI Fine lines (0) 1800-2200 50 – 80 600-800
(*) per 20 cm2 area

Vascular Lesions
Table 21-14. Suggested Setup Parameters for Melasma Treatment (iPixel Roller 75X1)
Gauged Energy (mJ/P) Overlapping (%) Accumulative

Melasma Type
Lens Energy (J)*
Epidermal (0) 1600-2000 50 – 80 600

EDJ (0) 1600-2200 50 – 80 600
Dermal 0 1600-2400 50 – 80 600
(*) per 20 cm2 area

iPixel tip 1X7)
 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.

iPixel roller 7X1)
 Keep the area moist with hydrating ointment 24-72 hours post
treatment.
 Apply Aquaphor, Dermatix, Cetaphil lotion or Aloe Vera gel for
soothing.
 Avoid direct exposure to the sun on the treatment area; use
UVA/UVB sun blockers.

Vascular Lesions
21.6.8 Follow-Up
 Measures presented below are only the manufacturer's
recommendations for follow-up. They may serve as a basis for
defining your treatment regimen.
 Patients should return no sooner than eight weeks after the last
treatment, for examination of the treatment site and for additional
 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.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

L.P. 1064 Pro Module – Vascular
Lesions, Leg Veins, Hair Removal,
Wrinkles and PFB
Chapter Contents:
Section Title Page
22.1 L.P. 1064 Pro Module Description ................................................ 22-2
22.2 L.P. 1064 Pro Module Specifications ............................................ 22-2
22.3 L.P. 1064 Pro Module Operating Screen ...................................... 22-3
22.4 L.P. 1064 Pro Module Regulatory Labels ..................................... 22-5
22.6 L.P. 1064 Pro Module Clinical Guide............................................ 22-6
Barbae (PFB) ................................................................. 22-12
22.6.7 Follow Up ....................................................................... 22-15

L.P. 1064 Pro Module – Vascular Lesions, Leg Veins, Hair Removal, Wrinkles and PFB
22.1 L.P. 1064 Pro Module Description

The L.P. 1064 Pro 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 L.P. 1064 Pro module clinical applications
The L.P. 1064 Pro module is identified by 1064nm printed on the
Figure 22-1. L.P. 1064 Pro Module
22.2 L.P. 1064 Pro Module Specifications

 Light Source: Nd:YAG
 Pulse Frequency: 1 Hz
 Operating Parameters with 2 mm Tip:
 Pulse Widths: 10 msec
 Energy Density (Fluence): 30 – 450 J/cm2
 Pulse Widths: 15, 45, 60 msec
 Pulse Width: 15 msec

 Operating Parameters with 5x5 Pixel Tip:

22.3 L.P. 1064 Pro Module Operating Screen

The L.P. 1064 Pro module main operating screen (see Figure 22-2) is
displayed when the L.P. 1064 Pro module is connected to the system:
Figure 22-2. L.P. 1064 Pro Screen


There are three standard tips (2, 6 & 10 mm) and one 5x5 Pixel tip
available for use with this laser module. The system automatically
recognizes the resident tip and displays its size in the upper-
middle section of the screen.
Vascular Lesions – using the 2-mm tip delivers:
 Fluence: 30 – 450 J/cm2

 Pulse Frequency: fixed at 1 Hz
Leg Veins – using the 6-mm tip delivers:

 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
 Pulse Widths: 6 mm tip: 45, 60 msec
10 mm tip: fixed at 15 msec
Wrinkles and Acne Scars – using the 5x5 Pixel tip deliver:

22.4 L.P. 1064 Pro Module Regulatory Labels

adhered to the L.P. 1064 Pro module connector:
Figure 22-3. L.P. 1064 Pro Module Regulatory Labels

The following table offers names of accessories specific to the L.P. 1064
Pro module that may be ordered form Alma Lasers.
Table 22-1. L.P. 1064 Pro Module Accessories
Description
L.P. 1064 Pro Module (including 2 & 6 mm tips)


22.6 L.P. 1064 Pro Module Clinical Guide

The L.P. 1064 Pro 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
22.6.1 Assessing the Condition


The L.P. 1064 Pro 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
 Removal or lightening of unwanted hair (with and without
adjuvant preparation)
 Treatment of pseudofolliculitis barbae (PFB)

Vascular Lesions, Veins and Wrinkles
 Epilepsy
wound healing)
Hair Removal and PFB

bikini area
 Isotretinoin – past and present
 Epilepsy
psoriasis
 Tattoos or nevi present on the treated area

22.6.4 Vascular Lesions

Skin Test
Always perform a skin test on the intended treatment area according
before the first treatment session to the following parameters:
Table 22-2. Skin Test Parameters for Vascular Lesions

L.P. 1064 Pro; 6mm tip 15, 45, 60 80 – 100 2 – 4 hours

I – III L.P. 1064 Pro; 2mm tip 10 200 2 – 4 hours
L.P. 1064 Pro; 5x5 Pixel tip 10 15 - 20 30 - 45 minutes
L.P. 1064 Pro; 6mm tip 15, 45, 60 60 – 80 48 – 72 hours
IV – VI L.P. 1064 Pro; 2mm tip 10 150 48 – 72 hours
Treatment
 The L.P. 1064 Pro 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 L.P. 1064 Pro module.
Treatment can begin after the module and the appropriate tip have
been connected to the Harmony XL Pro system and the treatment
parameters (fluence and pulse width) are selected according to
Table 22-2.

Cooling means such as ice pack or forced cold air/Zimmer are

recommended.
Caution
The module tip should be slightly pressed against the

vessel/vascular lesion.
the same spot.
Trigger a laser pulse by pressing the footswitch and the module
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.
20% and test again.
Caution

Vascular Lesions Suggested Setup Parameters

Table 22-3. Vascular Lesions Suggested Setup Parameters
Skin Type Target Vessel Fluence Pulse Width

Module
(Fitzpatrick I-VI) Depth (J/cm2) (msec)
Deep L.P. 1064 Pro; 6mm tip Up to 150 15, 45, 60
I – III L.P. 1064 Pro; 2mm tip Up to 350 10
Superficial
L.P. 1064 Pro; 5x5 Pixel tip 15-20 10
Deep L.P. 1064 Pro; 6mm tip Up to 120 15, 45, 60
IV – VI L.P. 1064 Pro; 2mm tip Up to 250 10
Superficial
L.P. 1064 Pro; 5x5 Pixel tip 10-15 10
22.6.5 Non-Ablative Treatment of Facial Wrinkles

Skin Test
Table 22-4. Skin Test Parameters for Facial Wrinkles

L.P. 1064 Pro; 6mm tip 45, 60 80 – 100 24 – 48 hours

I – III
L.P. 1064 Pro; 6mm tip 45, 60 60 – 80 24 – 48 hours
IV – VI

Treatment
Treatment can begin after the module has been connected to the
time interval) are selected according to Table 22-4.
Note

recommended.
The 6mm module tip should be slightly compressed and centered
over the wrinkle.
fluence by 10-20%.
Caution
Facial Wrinkles Suggested Setup Parameters

Table 22-5. Facial Wrinkles Suggested Setup Parameters

Module
(Fitzpatrick I-VI) per Spot (msec) (J/cm2)
L.P. 1064 Pro; 6mm tip 1 12, 15, 45 Up to 150

I – III
L.P. 1064 Pro; 5x5 Pixel tip 2 10 Up to 20
L.P. 1064 Pro; 6mm tip 1 12, 15, 45 Up to 120
IV – VI
L.P. 1064 Pro; 5x5 Pixel tip 2 10 Up to 15


Barbae (PFB)
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
 Tumor
 Photosensitizing drugs (gold therapy, etc.)
Skin Test for Hair Removal and PFB

hair color, hair type and the density & depth of the hair. Initially,
Table 22-6. Skin Test Parameters for Hair Removal & PFB Treatment
Skin Type Tip/ Spot Pulse Width Fluence Waiting

Module
(Fitzpatrick I-VI) Size (msec) (J/cm2) * Period
I L.P. 1064 Pro 6mm 45, 60 80 – 100 5 – 7 Days

II L.P. 1064 Pro 6mm 45, 60 70 – 80 5 – 7 Days
III L.P. 1064 Pro 6mm 45, 60 70 – 80 5 – 7 Days
L.P. 1064 Pro 6mm 45, 60 60 – 70 5 – 7 Days
IV
L.P. 1064 Pro 10mm 15 40 – 50 5 – 7 Days
L.P. 1064 Pro 10mm 15 40 – 50 5 – 7 Days
V
L.P. 1064 Pro 10mm 15 30 – 40 5 – 7 Days
L.P. 1064 Pro 10mm 15 30 – 40 5 – 7 Days
VI
L.P. 1064 Pro 10mm 15 30 – 40 5 – 7 Days

Treatment
Treatment can begin after the module and tip are connected and the
treatment parameters are selected according to Table 22-7.
Caution
External cooling means must be applied to the skin, e.g., cold pack, Zimmer,
etc.
tape.
Set the initial fluence and pulse width parameters according to the
skin test results.
Apply ultrasonic gel to the treatment area.
Observe for erythema or perifollicular erythema/edema (i.e., end-
points).
Examine the treatment area for change of skin color and
smell of burnt hair may sometimes be detected, although its
absence does not necessarily indicate that the present parameters
are ineffective.
or near the hair follicles do not repeat.
If adverse skin effects occur (such as excessive reddening), before
good follicular response is achieved, adjust the treatment
with cold cloth or gauze and apply Aloe Vera gel.
Caution
- Maintenance.


Suggested Setup Parameters for Hair Removal and PFB

hair color, hair type and the density & depth of the hair.
Table 22-7. Suggested Setup Parameters
Skin Type Pulse Width

Hair Color Fluence (J/cm2)
(Fitzpatrick) (msec)
Light Up to 150 45*, 60*

I
Dark Up to 150 45*, 60*
Light Up to 150 45*, 60*
II
Dark Up to 150 45*, 60*
Light Up to 150 45*, 60*
III
Dark Up to 150 45*, 60*
Up to 120* 45*, 60*
Light
40 – 50** 15**
IV
Up to 100* 45*, 60*
Dark
40 – 50** 15**
Light 40 – 50 15**
V
Dark 30 – 40 15**
Light 40 – 50 15**
VI
Dark 30 – 40 15**
(*) 6mm spot size
(**) 10mm spot size
22.6.7 Follow Up
Vascular Lesions and Leg Veins

necessary.
after three weeks.
at least 10%.


treatments.
between treatments.

Patients should return for examination of the treatment site between
six to eight weeks after treatment and for additional treatment, if
necessary.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Cooled L.P. Pro Module – Vascular
Lesions, Leg Veins, Hair Removal,
Facial Wrinkles and PFB
Chapter Contents:
Section Title Page
23.1 Cooled L.P. Pro Module Description ............................................. 23-2
23.2 Cooled L.P. Pro Module Specifications ......................................... 23-2
23.3 Cooled L.P. Pro Module Operating Screens .................................. 23-3
23.4 Cooled L.P. Pro Module Regulatory Labels .................................. 23-4
23.6 Cooled L.P. Pro Module Clinical Guide ........................................ 23-5
Barbae (PFB) ................................................................. 23-11
23.6.7 Follow Up ....................................................................... 23-14

Cooled L.P. Pro Module – Vascular Lesions, Leg Veins, Hair Removal, Facial Wrinkles
and PFB
23.1 Cooled L.P. Pro Module Description

The Cooled L.P. Pro 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 Cooled L.P. Pro module clinical
applications may be found in Section 23.6.
The Cooled L.P. Pro module is identified by 1064nm printed on the
module.
Figure 23-1. Cooled L.P. Pro Module
23.2 Cooled L.P. Pro Module Specifications


and PFB

23.3 Cooled L.P. Pro Module Operating Screens

The Cooled L.P. Pro module main operating screen (see Figure 23-2) is
displayed when the Cooled L.P. Pro module is connected to the system:
Figure 23-2. Cooled L.P. Pro Screen

and PFB

There are three standard tips (2, 6 & 10 mm) and one 5x5 Pixel tip
available for use with this laser module. The system automatically
recognizes the resident tip and displays its size in the upper-
middle section of the screen.
Vascular Lesions – using the 2 mm tip delivers:

Leg Veins – using the 6 mm tip delivers:

Hair Removal – using the 6mm / 10mm tips deliver:
 Fluence: 6mm tip: 30 – 150 J/cm2 / 10mm tip:

20 – 50 J/cm2
 Pulse Widths: 15, 45 msec
10 mm tip: fixed at 15 msec
Facial Wrinkles – using the 5x5 Pixel tip delivers:
23.4 Cooled L.P. Pro Module Regulatory Labels

adhered to the Cooled L.P. Pro module connector:
Figure 23-3. Cooled L.P. Pro Module Regulatory Labels

and PFB

The following table offers names of accessories specific to the Cooled
L.P. Pro module that may be ordered form Alma Lasers.
Table 23-1. Cooled L.P. Pro Module Accessories
Description
Cooled L.P. Pro Module (incl. 2 & 6 mm tips)

23.6 Cooled L.P. Pro Module Clinical Guide

The Cooled L.P. Pro module is indicated for:
Warning


The Cooled L.P. Pro module is indicated for treatment and clearance
of:
 Hemangiomas
 Warts
 Rosacea

and PFB
 Venus lake
 Leg veins
 Spider veins
 Angiomas
follicles
 Removal or lightening of unwanted hair (with and without
 Treatment of pseudofolliculitis barbae (PFB)
 Epilepsy
wound healing)

bikini area

and PFB
 Epilepsy
psoriasis

Skin Test
Pulse
Module Width
(Fitzpatrick I-VI) (J/cm2) Period
(msec)
Cooled L.P. Pro; 2–4

12, 15, 45 80 – 100
6 mm tip hours
I – III
Cooled L.P. Pro; 2–4
10 200
2 mm tip hours
Cooled L.P. Pro; 48 – 72

12, 15, 45 60 – 80
6 mm tip hours
IV – VI
Cooled L.P. Pro; 48 – 72
10 150
2 mm tip hours

and PFB
Treatment
 The Cooled L.P. Pro 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
stack pulses.
Table 23-2.
recommended.
Caution

the same spot.

and PFB

20% and test again.
Caution
– Maintenance.

Skin Type Pulse

Target Vessel Fluence
(Fitzpatrick Module Width
Depth (J/cm2)
I-VI) (msec)
Cooled L.P. Pro;

I – III Deep Up to 150 12, 15, 45
6 mm tip
Cooled L.P. Pro;
I – III Superficial Up to 350 10
2 mm tip
Cooled L.P. Pro;
IV – VI Deep Up to 120 12, 15, 45
6 mm tip
Cooled L.P. Pro;
IV – VI Superficial Up to 250 10
2 mm tip

and PFB

Skin Test

I – III Cooled L.P. Pro; 45 80 – 100 2 – 4 hours

IV – VI 6 mm tip 45 60 – 80 24 – 48 hours
I – III Cooled L.P. Pro; 10 20 - 25 30 – 45 minutes

5x5 Pixel tip
IV – VI 10 15 - 20 30 - 45 minutes
Treatment
Note

recommended.
over the wrinkle.
fluence by 10-20%.

and PFB

Caution
- Maintenance.


Module
I – III Cooled L.P. Pro; 1 45 Up to 150

IV – VI 6 mm tip 1 45 Up to 120
I – III Cooled L.P. Pro; 2 10 Up to 25
IV – VI 5 x 5 Pixel tip 2 10 Up to 20

Barbae (PFB)
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
 Tumor
 Photosensitizing drugs (gold therapy, etc.)
Skin Test for Hair Removal and PFB

hair color, hair type and the density & depth of the hair. Initially,

and PFB
Table 23-6. Skin Test Parameters for Hair Removal & PFB Treatment
Skin Type Tip/ Spot Pulse Width Fluence Waiting

Module
(Fitzpatrick I-VI) Size (msec) (J/cm2) * Period
I Cooled L.P. Pro 6mm 15, 45 80 – 100 24 – 48 hours

II Cooled L.P. Pro 6mm 15, 45 70 – 80 24 – 48 hours
III Cooled L.P. Pro 6mm 15, 45 70 – 80 24 – 48 hours
Cooled L.P. Pro 6mm 15, 45 60 – 70 24 – 48 hours
IV
Cooled L.P. Pro 10mm 15 40 – 50 24 – 48 hours
V
VI
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.
tape.
Set the initial fluence and pulse width parameters according to the
skin test results.
Apply ultrasonic gel to the treatment area.
Observe for erythema or perifollicular erythema/edema (i.e., end-
points).

and PFB
Examine the treatment area for change of skin color and

smell of burnt hair may sometimes be detected, although its
absence does not necessarily indicate that the present parameters
are ineffective.
or near the hair follicles do not repeat.
If adverse skin effects occur (such as excessive reddening), before
good follicular response is achieved, adjust the treatment
with cold cloth or gauze and apply Aloe Vera gel.
Caution
– Maintenance.

and PFB
Suggested Setup Parameters for Hair Removal and PFB

hair color, hair type and the density & depth of the hair.
Skin Type Pulse Width

Hair Color Fluence (J/cm2)
(Fitzpatrick) (msec)
Light Up to 150 15*, 45*

I
Dark Up to 150 15*, 45*
Light Up to 150 15*, 45*
II
Dark Up to 150 15*, 45*
Light Up to 150 15*, 45*
III
Dark Up to 150 15*, 45*
Up to 120
Light 15**, 45*
IV 40 – 50**
Dark 40 – 50** 15**
Light 40 – 50 15**
V
Dark 30 – 40 15**
Light 40 – 50 15**
VI
Dark 30 – 40 15**
(*) 6mm spot size
(**) 10mm spot size
23.6.7 Follow Up

necessary.
after three weeks.
at least 10%.

and PFB

treatments.
between treatments.

between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Fungus L.P. Pro Module –
Vascular Lesions, Leg Veins, Hair
Removal, PFB and
Onychomycosis (Nail Fungus)
Chapter Contents:
Section Title Page
24.1 Fungus L.P. Pro Module Description ............................................ 24-3
24.2 Fungus L.P. Pro Module Specifications ........................................ 24-3
24.3 Fungus L.P. Pro Module Operating Screens ................................ 24-4
24.4 Operating Parameters................................................................... 24-5
24.4.1 Long Pulse Mode.............................................................. 24-5
24.4.2 Nail Fungus Mode ........................................................... 24-5
24.5 Fungus L.P. Pro Module Regulatory Labels ................................. 24-6
24.7 Clinical Guide: Long Pulse Mode .................................................. 24-7
24.7.6 Follow Up ....................................................................... 24-13
24.8 Clinical Guide: Nail Fungus ....................................................... 24-15
24.8.1 Assessing the Condition ................................................ 24-15
24.8.4 Adverse Effects of Treatment ........................................ 24-16
24.8.5 Preparation for Treatment ............................................ 24-16

Fungus L.P. Pro Module – Vascular Lesions, Leg Veins, Hair Removal, PFB and
24.8.6 Treatment Phase 1 – Q-Switched Module .................... 24-18

24.8.7 Treatment Phase 2 – Fungus L.P. Pro Module............. 24-20
24.8.9 Follow Up ....................................................................... 24-23

24.1 Fungus L.P. Pro Module Description

The Fungus L.P. Pro 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 Fungus L.P. Pro module clinical
applications may be found later in this chapter.
The Fungus L.P. Pro module is identified by 1064F printed on the
Figure 24-1. Fungus L.P. Pro Module
24.2 Fungus L.P. Pro Module Specifications

 Light Source: Nd:YAG
 Wavelength: 1064nm
 Pulse Frequency: 1 Hz


 Pulse Repetition Rate: 10 & 30 Hz
 Energy Density (Fluence): 100 – 200 mJ/P
24.3 Fungus L.P. Pro Module Operating Screens

The Fungus L.P. Pro module main operating screens (see Figure 24-2)
are displayed when the Fungus L.P. Pro module is connected to the
system and the appropriate mode is selected:
Figure 24-2. Fungus L.P. Pro Screens

24.4 Operating Parameters

There are four tips (1, 2 & 6 mm), available for use with this laser
module. The system automatically recognizes the resident tip and
displays its size in the upper-middle section of the screen.
24.4.1 Long Pulse Mode

Vascular Lesions – using the 2 mm tip delivers:

Leg Veins – using the 6 mm tip delivers:

24.4.2 Nail Fungus Mode

Nail Fungus – using the 1 mm tip delivers
 Fluence: 100 – 200 mJ/P

 Pulse Frequency: 10 & 30 Hz

24.5 Fungus L.P. Pro Module Regulatory Labels

adhered to the Fungus L.P. Pro module connector:
Figure 24-3. Fungus L.P. Pro Module Regulatory Labels

The following table offers names of accessories specific to the Fungus
L.P. Pro module that may be ordered form Alma Lasers.
Table 24-1. Fungus L.P. Pro Module Accessories
Description
Fungus L.P. Pro Module (incl. 2 & 6 mm tips)


24.7 Clinical Guide: Long Pulse Mode

The Fungus L.P. Pro module in Long Pulse is indicated for:
Warning


The Fungus L.P. Pro module is indicated for treatment and clearance
of:
 Hemangiomas
 Warts
 Rosacea
 Venus lake
 Leg veins
 Spider veins
 Angiomas
follicles

 Removal or lightening of unwanted hair (with and without

 Treatment of pseudofolliculitis barbae (PFB)
 Epilepsy
wound healing)

bikini area
 Epilepsy
psoriasis


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

Module
Fungus L.P. Pro; 6mm tip 15, 45, 60 80 – 100 2 – 4 hours

I – III
Fungus L.P. Pro; 2mm tip 10 200 2 – 4 hours
48 – 72
Fungus L.P. Pro; 6mm tip 15, 45, 60 60 – 80
hours
IV – VI
48 – 72
Fungus L.P. Pro; 2mm tip 10 150
hours
Treatment
 The Fungus L.P. Pro 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
stack pulses. Appropriate cooling methods, such as cold air, are
recommended when using the Laser 1064F Pro Cooled module.
Table 24-2.

Caution

the same spot.
20% and test again.
Caution


Skin Type Target Pulse

Fluence
(Fitzpatrick I- Vessel Module Width
(J/cm2)
VI) Depth (msec)
Deep Fungus L.P. Pro; 6mm tip Up to 150 15, 45, 60

I – III
Superficial Fungus L.P. Pro; 2mm tip Up to 350 10
Deep Fungus L.P. Pro; 6mm tip Up to 120 15, 45, 60
IV – VI
Superficial Fungus L.P. Pro; 2mm tip Up to 250 10

Skin Test
Pulse
Module Width
(Fitzpatrick I-VI) (J/cm2) Period
(msec)
I – III Fungus L.P. Pro; 6mm tip 45, 60 80 – 100 24 – 48 hours

IV – VI Fungus L.P. Pro; 6mm tip 45, 60 60 – 80 24 – 48 hours
Treatment
Note

over the wrinkle.


fluence by 10-20%.
Caution
– Maintenance.


Module
I – III Fungus L.P. Pro; 6mm tip 1 45, 60 Up to 150

IV – VI Fungus L.P. Pro; 6mm tip 1 45, 60 Up to 120

24.7.6 Follow Up

necessary.
after three weeks.
at least 10%.
treatments.
between treatments.


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

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

24.8 Clinical Guide: Nail Fungus

The Fungus L.P. Pro and Q-Switched modules of the Harmony XL Pro
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 Fungus L.P. Pro module.
Warning

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.

The Fungus L.P. Pro module of the Harmony XL Pro 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.
 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.

24.8.4 Adverse Effects of Treatment

The use of the Fungus L.P. 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.
24.8.5 Preparation for Treatment

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 24-4).
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 24-4. Correct Patient Positioning

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 24-5. Treatment Area Definitions
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.

24.8.6 Treatment Phase 1 – Q-Switched Module

Patch Test – Q-Switched Module
Always perform a patch test on the intended treatment area according
to the following parameters:
Table 24-6. Q-Switched Patch Test Parameters for Onychomycosis (Hallux Nail)
Number of
Repetition Fluence Waiting
Module Passes
Rate [Hz] [mJ/P Period
(Toe Nail Size)
3 – 4 passes 48 – 72
Q-Switched; 3 mm tip 2 800 – 1000
over the nail Hours
Table 24-7. Q-Switched Patch Test Parameters for Onychomycosis (Digit Nail)
Number of
Repetition Fluence Waiting
Module Passes
Rate [Hz] [mJ/P Period
(Toe Nail Size)
3 – 4 passes 48 – 72
Q-Switched; 3 mm tip 2 700 – 900
over the nail Hours
Treatment Procedure – Q-Switched Module

Clean the nail plate to remove nail lacquer, creams, cosmetics and
powder/talc.
External cooling (i.e. Zimmer) can be used for pain management.
The Q-Switched module tip should be in contact and perpendicular
to the nail plate when the treatment is applied.
Set the initial fluence and repetition rate parameters according to
the patch test results.
Figure 24-6. Lasing Path of Each Pass over the Toenail Plate during Treatment


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.
It is best not to overlap treatment spots by more than 10%.
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.
If the patient is experiencing an uncomfortable level of heat, the
operator should stop lasing for about 10 seconds and then continue
the treatment.
It should be noted that the pain tolerance lowers with each pass.
Treat each hallux and digit toe with a total of four passes.
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.
Suggested Setup Parameters – Q-Switched Module

Table 24-8. Q-Switched Onychomycosis (Hallux Nail) Suggested Setup Parameters
Repetition Fluence Number of Passes

Module
Rate [Hz] [mJ/P (Toe Nail Size)
5-10 passes over the nail, with 30-60

Q-Switched; 3 mm tip 2 900 – 1100 sec waiting period between every 3-4
passes.
Table 24-9. Q-Switched Onychomycosis (Digit Nail) Suggested Setup Parameters
Repetition Fluence Number of Passes

Module
Rate [Hz] [mJ/P (Toe Nail Size)
5-10 passes over the nail, with 30-60

Q-Switched; 3 mm tip 2 800 – 1000 sec waiting period between every 3-4
passes.

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.
24.8.7 Treatment Phase 2 – Fungus L.P. Pro Module

Patch Test – Fungus L.P. Pro Module
Always perform a patch test on the intended treatment area according
to the following parameters:
Table 24-10. Patch Test Parameters for Onychomycosis (Hallux Nail)
Repetition Fluence Accumulative Energy [J] Waiting

Module
Rate [Hz] [mJ/P (Toe Nail Size) Period
600 J, with 5-10 second waiting

Fungus L.P. Pro; 1 48 – 72
20 – 30 200 period between passes as
mm tip Hours
needed.
Table 24-11. Patch Test Parameters for Onychomycosis (Digit Nail)
Repetition Fluence Accumulative Energy [J] Waiting

Module
Rate [Hz] [mJ/P (Toe Nail Size) Period
150 J, with 5-10 second waiting

Fungus L.P. Pro; 1 48 – 72
20 200 period between passes as
mm tip Hours
needed.

Treatment Procedure – Fungus L.P. Pro Module

Clean the nail plate to remove nail lacquer, creams, cosmetics and
powder/talc, etc.
External cooling (i.e. Zimmer) can be used for pain management.
The laser module's tip should be in contact with, and
perpendicular to the nail plate when the treatment is applied.
fluence and pulse duration.
Set the initial fluence and repetition rate parameters according to
the patch test results.
Trigger a laser pulse by pressing the footswitch and the module's
While lasing, the module's tip should be moved over the entire nail
in a circular path as shown in Figure 24-6, 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.
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.
If the patient is experiencing an uncomfortable level of heat, pause
the treatment for 5-10 seconds and then continue the treatment.
Examine the nail carefully. If adverse skin effects occur (such as
reddening of the nail's underlying skin), reduce the fluence by
10-20%.
Suggested Setup Parameters – Fungus L.P. Pro Module

Table 24-12. Laser 1064F Pro Cooled Suggested Setup Parameters for Onychomycosis (Hallux Nail)
Repetition Fluence Accumulative Energy [J]

Module
Rate [Hz] [mJ/P] (Toe Nail Size)
Fungus L.P. Pro; 1 mm 600-650 J, with 5-10 second waiting

30 200
tip period between passes as needed
Table 24-13. Laser 1064F Pro Cooled Suggested Setup Parameters for Onychomycosis (Digit Nail)
Repetition Fluence Accumulative Energy [J]

Module
Rate [Hz] [mJ/P] (Toe Nail Size)
Fungus L.P. Pro; 1 mm 150-200 J, with 5-10 second waiting

20 – 30 200
tip period between passes as needed

Clinical End-Points
The expected clinical end-points of the Fungus L.P. Pro treatment for
Onychomycosis are:
 Fixed amount of accumulative energy (J) in each nail.
 Patient's local heat sensation.
Combination with Local Substances

After using the Fungus L.P. 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.

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.

24.8.9 Follow Up
 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.

Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

L.P. 1320 Module – Wrinkles and
Acne Scars
Chapter Contents:
Section Title Page
25.1 L.P. 1320 Module Description ....................................................... 25-2
25.2 L.P. 1320 Module Specifications ................................................... 25-2
25.3 L.P. 1320 Module Operating Screens ........................................... 25-3
25.4 L.P. 1320 Module Regulatory Labels ............................................ 25-4
25.6 L.P. 1320 Module Clinical Guide .................................................. 25-4
25.6.3 Pre-Treatment ................................................................. 25-6
25.6.4 Treatment ........................................................................ 25-6
25.6.6 Follow-up ......................................................................... 25-8

L.P. 1320 Module – Wrinkles and Acne Scars
25.1 L.P. 1320 Module Description

The L.P. 1320 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 L.P. 1320 module clinical applications
The L.P. 1320 module is identified by 1320nm printed on the module
(see Figure 25-1).
Figure 25-1. L.P. 1320 Module
25.2 L.P. 1320 Module Specifications

 Tip Spot Size: 6 mm
5x5 Pixel
 Energy Density (Fluence): 6 mm tip: 5 – 40 J/cm2
5x5 Pixel tip: 1 – 11 J/cm2

25.3 L.P. 1320 Module Operating Screens

The L.P. 1320 module main operating screen (see Figure 25-2) is
displayed when the L.P. 1320 module is connected to the system:
Figure 25-2. L.P. 1320 Module Screen

There is one 6 mm tip and one 5x5 Pixel Tip available for use with this
 Using the 6 mm tip delivers:
 Fluence: 5–40 J/cm2
 Using the 5x5 Pixel tip delivers:
 Fluence: 1–11 J/cm2

25.4 L.P. 1320 Module Regulatory Labels

adhered to the L.P. 1320 module connector:
Figure 25-3. L.P. 1320 Module Regulatory Labels

The following table offers names of accessories specific to the L.P. 1320
Table 25-1. L.P. 1320 Module Accessories
Description
L.P. 1320 Module (inc. 6 mm tip)

Safety Glasses for 1320nm (OD7+)
25.6 L.P. 1320 Module Clinical Guide

The L.P. 1320 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 L.P. 1320 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
 A history of keloid scarring
 Epilepsy
months
healing)

Skin Test
first treatment session according to the following parameters.
Table 25-2. Skin Test Parameters

L.P. 1320; 6mm tip 30, 40 25 – 30 5 – 7 days

I – III
L.P. 1320; 5x5 Pixel tip 30,40 30 - 40 30 - 45 minutes
L.P. 1320; 6mm tip 40, 50 15 – 20 5 – 7 days
IV – VI
L.P. 1320; 5x5 Pixel tip 40,50 20 - 30 30 - 45 minutes
Note
Treated area must be cooled before, during and after the treatment
with ice-packs or the Zimmer air cooling device.
25.6.4 Treatment
After the L.P. 1320 module has been connected to the Harmony XL Pro
system and the treatment parameters (fluence and timer interval)
have been selected according to Figure 25-3, 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.

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.

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.
Trigger a laser pulse by pressing both the footswitch and module
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).
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.
Visualize the treated area and check for adverse side effects.
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.
Caution
– Maintenance.

Skin Type Pulse Width Fluence Number of

Module
(Fitzpatrick I-VI) (msec) (J/cm2) Passes
L.P. 1320; 6mm tip 30, 40 Up to 40 3–4

I – III
L.P. 1320; 5x5 Pixel tip 30,40 Up to 40 3-4
L.P. 1320; 6mm tip 40, 50 Up to 30 2–3
IV – VI
L.P. 1320; 5x5 Pixel tip 40, 50 Up to 30 2-3

25.6.6 Follow-up
 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%.
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Cooled L.P. 1320 Module –
Wrinkles and Acne Scars
Chapter Contents:
Section Title Page
26.1 Cooled L.P. 1320 Module Description ........................................... 26-2
26.2 Cooled L.P. 1320 Module Specifications ....................................... 26-3
26.3 Tip Installation.............................................................................. 26-4
26.4 Cooled L.P. 1320 Module Operating Screens ............................... 26-6
26.5 Cooled L.P. 1320 Module Regulatory Labels ................................ 26-7
26.7 Cooled L.P. 1320 Module Clinical Guide ...................................... 26-8
26.7.4 Pre-Treatment ................................................................. 26-9
26.7.5 Treatment ...................................................................... 26-10
26.7.7 Follow-up ....................................................................... 26-11

Cooled L.P. 1320 Module – Wrinkles and Acne Scars
26.1 Cooled L.P. 1320 Module Description

The Cooled L.P. 1320 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 Cooled L.P. 1320 module clinical
applications may be found in Section 26.7.
The Cooled L.P. 1320 module is identified by 1320nm printed on the
module.
Figure 26-1. Cooled L.P. 1320 Module

26.2 Cooled L.P. 1320 Module Specifications

 Magnetized Foot for 6mm standard tip:
Smaller-diameter foot
 Magnetized Foot for 5x5 Pixel Tip: Larger-diameter foot
 Energy Density (Fluence): 5 - 40 J/cm2

26.3 Tip Installation

The Cooled L.P. 1320 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 26-2.
 The 5x5 Pixel tip requires the larger magnetized foot, shown on
the right side of Figure 26-2.
Figure 26-2. Connection Feet for the Tips
When changing from one style of tip to the other, proceed as follows:
Remove the standard-style tip from the module, and detach the
magnetized foot (see Figure 26-3).
Figure 26-3. Pixel Tip Replacement Procedure (1)
Refer to Figure 26-4: remove the blue distance spacer from the
Pixel tip (A) and screw the tip into the module (B).

Insert the Larger size magnetized foot into the module (see
Figure 26-5).
Caution
Take care not to insert the smaller magnetized foot by mistake.

26.4 Cooled L.P. 1320 Module Operating Screens

The Cooled L.P. 1320 module main operating screen (see Figure 26-6)
is displayed when the Cooled L.P. 1320 module is connected to the
system:
Figure 26-6. Cooled L.P. 1320 Screen

There are two tips (6 & 5x5 Pixel), available for use with this laser
Acne Scars and Wrinkles – using the 6 mm tip delivers:
Skin Remodeling – using the 5x5 Pixel tip deliver:

26.5 Cooled L.P. 1320 Module Regulatory Labels

adhered to the Cooled L.P. 1320 module connector:
Figure 26-7. Cooled L.P. 1320 Module Regulatory Labels

The following table offers names of accessories specific to the Cooled
L.P. 1320 module that may be ordered form Alma Lasers.
Table 26-1. Cooled L.P. 1320 Module Accessories
Description
Cooled L.P. 1320 Module (Including 6 mm & 5x5 Pixel tips)


26.7 Cooled L.P. 1320 Module Clinical Guide

The Cooled L.P. 1320 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 Cooled L.P. 1320 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
 Epilepsy
months


healing)

skin type and severity of acne scars and wrinkles.
Skin Test
Table 26-2. Skin Test Parameters

Module
24 – 48
I – III Cooled L.P. 1320; 6mm tip 30, 40 25 – 30
hours
24 – 48
IV – VI Cooled L.P. 1320; 6mm tip 40, 50 20 – 25
hours
15 – 30
I – III Cooled L.P. 1320; 5x5 Pixel tip 30, 40 6–8
minutes
15 – 30
IV – VI Cooled L.P. 1320; 5x5 Pixel tip 40, 50 6–8
minutes
Note
Treated area must be cooled before, during and after the treatment
with ice-packs or the Zimmer air cooling device.

26.7.5 Treatment
After the Cooled L.P. 1320 module has been connected to the Harmony
XL Pro system and the treatment parameters (fluence and timer
interval) have been selected according to Table 26-3, 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

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.
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).
Immediately after lasing stops, keep the tip in contact with the
skin in order to cool the treated area.
Visualize the treated area and check for adverse side effects.
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.
Caution
and clean it as necessary.


Skin Type Pulse Width Fluence Number of

Module
(Fitzpatrick I-VI) (msec) (J/cm2) Passes
I – III Cooled L.P. 1320; 6mm tip 30, 40 Up to 40 3–4

IV – VI Cooled L.P. 1320; 6mm tip 40, 50 Up to 30 3–4
Cooled L.P. 1320; 5x5 Pixel
I – III 30, 40 Up to 10 3–4
tip
Cooled L.P. 1320; 5x5 Pixel
IV – VI 40, 50 Up to 8 3–4
tip
26.7.7 Follow-up
treatments.
between treatments.
Alma Lasers:
Alma Lasers GmbH
Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

iPixel Pro Module – Fractional
Ablative Skin Resurfacing
Chapter Contents:
Section Title Page
27.1 iPixel Pro Module Description ...................................................... 27-2
27.2 iPixel Pro Module Specifications ................................................... 27-3
27.3 iPixel Pro Module Operating Screen............................................. 27-4
27.4 iPixel Pro 2940nm Module Regulatory Labels ............................. 27-4
27.6 iPixel Pro Clinical Guide ............................................................... 27-5
27.6.1 Indications for Use with Standard Accessory Tips ......... 27-6
27.6.2 Indications for Use with Pixel Accessory Tips ................ 27-7
27.6.4 Pre-Treatment ................................................................. 27-8
27.6.5 Treatment Procedure ..................................................... 27-10
27.6.7 Post-Treatment Care & Follow-Up ............................... 27-13

iPixel Pro Module – Fractional Ablative Skin Resurfacing
27.1 iPixel Pro Module Description

The iPixel Pro 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 iPixel Pro modules' clinical applications
may be found in Section 27.627.6.
The iPixel Pro module is identified by iPixelEr printed on the module
(see Figure 27-1
Figure 27-1. iPixel Pro Module
Note
Refer to the Harmony XL Pro System Operator's Manual for
particular instructions on disinfecting and sterilizing the wheeled
tip section of the iPixel Pro module.

27.2 iPixel Pro Module Specifications

 Light Source: Er:YAG
 Available Tips: 1, 4 mm (Standard)
7x7 Pixel
7 x 1 iPixelEr
 Operating Parameters with 1, 4 mm Tip & 7x7 Pixel Tip in Short mode :
 Pulse Frequency: 4 Hz (Stack)
2 Hz (Non-Stack)
 Operating Parameters with 1, 4 mm Tip & 7x7 Pixel Tip in Medium

mode:
2 Hz (Non-Stack)
 Operating Parameters with 1, 4 mm Tip & 7x7 Pixel Tip in Long mode :
2 Hz (Non-Stack)
 Operating Parameters with 7x1 iPixelEr Tip:

 Pulse Width: 0.5 – 1 msec

27.3 iPixel Pro Module Operating Screen

The iPixel Pro module's main operating screen (see Figure 27-2) is
displayed when the module is connected to the system:
Figure 27-2. iPixel Pro Module Screen
27.4 iPixel Pro 2940nm Module Regulatory Labels

adhered to the module's connector:
Figure 27-3. iPixel Pro Module Regulatory Labels


The following table offers names of accessories specific to the iPixel Pro
modules that may be ordered from Alma Lasers:
Table 27-1. iPixel Pro Module Accessories
Description
iPixel Pro Module (including 4 mm standard, 7 mm Pixel and 7x1 iPixelEr

tips)
Safety Glasses for iPixel Pro (OD 6+)
27.6 iPixel Pro Clinical Guide

The Skin Resurfacing application of the Harmony XL Pro system is
performed using the iPixel Pro 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 Harmony
XL Pro 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 iPixel Pro 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

27.6.1 Indications for Use with Standard Accessory Tips

The iPixel Pro 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):
Dermatology and Plastic Surgery

 Skin resurfacing
 Treatment of wrinkles
 Epidermal nevi
 Telangiectasia
 Spider veins
 Actinic chelitis
 Keloids
 Verrucae
 Skin tags
 Anal tags
 Keratoses
 Scar revision (including acne scars)
 Debulking benign tumors
 Debulking cysts
 Superficial skin lesions
 Diagnostic biopsies
 Decubitis ulcers
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.
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.

Gynecology
Treatment of:
 Cervical intraepithelial neoplasia (CIN), herpes simplex,
endometrial adhesions, cysts, and condyloma.
Oral/Maxillofacial
Treatment of:
 Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otorhinolaryngology / Head and Neck (ENT)

Treatment of:
 Ear, nose and throat lesions, polyps, cysts, hyperkeratosis.
 Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology
Treatment of:
 Soft tissue surrounding the eye and orbit.
Podiatry
Treatment of:
 Warts, plantar verrucae, large mosaic Verrucae.
 Matrixectomy
27.6.2 Indications for Use with Pixel Accessory Tips

The iPixel Pro module (with and without contact cooling) with Pixel
accessory tips is indicated for use in soft tissue for dermatology and
plastic surgery:
 Skin resurfacing
 Bacterial or viral infection
 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).

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 27-2. Skin Test Parameters for the Standard 1, 4mm Tip
Fluence Frequency
Skin Type Mode Spot Size Intensity
(mJ/Pulse) (Hz)
I–V Short 1 mm, 4 mm Mild 800 4

I–V Medium 1 mm, 4 mm Moderate 1200 4
I – IV Long 1 mm, 4 mm Aggressive 1800 4
Table 27-3. Skin Test Parameters for the 7x7 Pixel Tip
Energy Pulse Frequency Number of

Mode Skin Type
(mJ/Pulse) Mode (Hz) Passes / Stacks
Stack L
I – III 1800 2*, 4** 1–2
Non-Stack L
Stack L
IV 1600 2*, 4** 1–2
Non-Stack L
Stack L
V 1400 2*, 4** 1–2
Non-Stack L
(*) "No Stack" mode
(**) Stack" mode
Table 27-4. Skin Test Parameters for the 7x1 iPixelEr Tip
Energy
Intensity Skin Type Pulse Mode Number of Passes
(mJ/Pulse)
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.

Prior to Treatment Day

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.
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.
Treatment Day††
Clean the skin to remove perfume, cosmetics and sunscreens.
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.
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.
Set the initial fluence and pulse mode parameters according to the
condition being treated. The system allows for a choice of three
treatment modes.
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.
Up to 20% overlapping is acceptable.
Depth of treatment should be customized to the specific indication
(scars vs. wrinkles).
Following treatment gently cleanse the treated area of skin
fragments with a moist cloth using normal saline solution.
swelling), you may either change the pulse frequency or reduce the
fluence.
†† It is advisable to use smoke evacuation and a mask during the procedure.

27.6.5 Treatment Procedure‡‡

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.
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.
It is advisable to use a smoke evacuator and a mask during the
procedure.
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).
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.
Recommended number of passes (average) over the entire
treatment area is 2-4
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.
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.
Depth of penetration with the Pixel 7x7 tip: 50-100 microns
ablation plus 100-125 microns thermal injury zones with 3-5
stacks.
Depth of penetration with iPixelEr 7x1 roller tip: 100-150 microns
ablation plus 75-100 microns thermal injury zones.
Fluence on skin with the Pixel 7x7 tip: mild 1200-1600 mJ/P,
moderate 1700-2000 mJ/P, aggressive up to 2500 mJ/P.
Free-hand (random passes): the tip is moved randomly on the
treatment area and repeated passes are employed.
‡‡ It is advisable to use smoke evacuation and a mask during the procedure.

The free-hand passes technique is recommended for indications

such as photo-damage/photo-age signs and symptoms.
Intensity with the free-hand technique: number of passes: 1 =
conservative, 2 = moderate, 3 = aggressive.
Stationary (stacking): the Pixel 7x7 tip is placed stationarily on the
treatment area and repeated pulses are employed.
Stationary technique is recommended for structures residing below
the epidermis such as acne scars, fine lines, wrinkles, etc.
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.
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.
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.
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
the first treatment session (see Section 27.6.4).
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.


Table 27-5. Suggested Setup Parameters for the Standard Tips
Energy Frequency
Skin Type Mode Spot Size Intensity
(mJ/Pulse) (Hz)
I – IV Short 1 mm, 4 mm Mild Up to 1000 4

I – IV Medium 1 mm, 4 mm Moderate Up to 1600 4
I – IV Long 1 mm, 4 mm Aggressive Up to 2500 4
Table 27-6. Suggested Setup Parameters for the 7x7 Pixel Tip
Number of
Skin Type Energy (mJ/P) Pulse Mode Frequency (Hz)
Passes/Stacks*
V 1800 L 1–3/2–6 2*, 4**

IV 2000 L 1–3/2–6 2*, 4**
I – III 2500 L 1–3/2–6 2*, 4**
(*) "No Stack" mode Note: 7x7 matrix = 49 Pixels = 51 mJ/Pixel
(**) Stack" mode
Table 27-7. Suggested Setup Parameters for the 7x1 iPixelEr Tip
Waiting
Skin Energy Pulse Number of Overlapping Interval
Intensity
Type (mJ/P) Mode Passes (%) Between
Passes
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
5 – 10 sec.
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
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.

27.6.7 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).
 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 moisturizer-sunscreen. At night time, ointment is more
slowly replaced.
 Patients should return to the clinic 3-7 days post-treatment for
necessary.
for an additional examination after two months.
 Avoid sun exposure during pre- and post-operative period.
 If adverse side effects occur (hyperpigmentation), sun protection
and spot-resurfacing depigmenting agents such as hydroquinone
will help obtain resolution.


between treatments.

Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

NIR Face Module§§ – Muscle and
Joints Pain Relief
Chapter Contents:
Section Title Page
28.1 NIR Face Module Description ....................................................... 28-2
28.2 NIR Face Module Specifications ................................................... 28-3
28.3 NIR Face Module Operating Screen ............................................. 28-3
28.4 NIR Face Module Regulatory Labels ............................................ 28-4
28.6 NIR Face Module Clinical Guide – General Applications ............ 28-5
28.6.1 Introduction ..................................................................... 28-5
28.6.4 Pre-Treatment ................................................................. 28-6
28.6.5 Treatment ........................................................................ 28-8
28.6.9 Follow-Up ....................................................................... 28-11
§§ Not available in Canada

NIR Face Module – Muscle and Joints Pain Relief
28.1 NIR Face Module Description

The Harmony XL Pro's NIR Face module (see Figure 28-1) emits light
module provides pre-selected 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 NIR Face module is operated only by pressing the footswitch.
A complete discussion of the NIR Face module clinical applications
Figure 28-1. NIR Face Module

28.2 NIR Face Module Specifications

 Light Source: Near-infrared light
 Wavelength: Peak emission at 1300 nm
 Output Power: 5 to 25 W
 Exposure Mode: CW
 Spot Size: 6.4 cm2
28.3 NIR Face Module Operating Screen

The NIR Face module main operating screen (see
Figure 28-2) is displayed when the NIR Face module is connected to

the system.
Operating Mode – the NIR Body module can be operated in one of the following repetition rate
the following repetition rate modes (see
 Figure 28-2):
 Continuous – In this mode, the module emits pulses
continuously.
 Timer - In Timer mode, the module emits pulses for two
seconds and stops for 1, 2, 3, 4, or 5 seconds.
Figure 28-2. NIR Face Screen


Power: the light power applied to the skin can be adjusted from 30
to 100 W.
Mode: CW.
Total Energy: The operating screen exhibits the total energy applied
per session, counted in kilo-Joules.
28.4 NIR Face Module Regulatory Labels

adhered to the NIR Face module connector:
Figure 28-3. NIR Face Module Regulatory Labels

The following table offers names of accessories specific to the NIR Face
Table 28-1. NIR Face Module Accessories
Description
NIR Face Module

Safety Eyewear for the NIR Face Module (OD 3+)

28.6 NIR Face Module Clinical Guide – General

Applications
28.6.1 Introduction
This section is provided to aid professionals in the use of the Harmony
XL Pro 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.
28.6.2 Intended Use and Indications

The NIR Face module is intended to emit energy in the infrared
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.
 Cancer; in particularly skin cancer
 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
 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

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 Harmony XL Pro 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.
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
Module Operation
The Harmony XL Pro'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.
Module Parameters
The Harmony XL Pro delivers up to 100W. The pulse repetition rate is
set (fixed) at 10 PPS (10 Hz). The total cumulative energy – expressed
in Kilo-Joules (kJ) – is displayed on the control panel.

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
Table 28-2. Skin Test Parameters *
Skin Type Time of Total Energy

Power Setting (W)
(Fitzpatrick I-VI) Exposure (sec) (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
(*) In-Motion technique

28.6.5 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.
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 Harmony
XL Pro system.
Apply a thin layer of mineral oil on the entire treatment area.
Select the appropriate fluence.
Check baseline skin temperature with a laser thermometer.
Verify that the module's tip is cold.
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.
Always perform a skin test to establish the cutaneous reaction

when beginning treatment.
Start treatment by activating the module with the footswitch.
The module should be operated on the skin In-Motion – never
stationary!
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).
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 28-4.

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.
It is recommended the practitioner check the skin temperature,
using the infrared thermometer provided with the system, every ~
30 seconds.
Treatment technique: the tip of the module must be in complete
contact with the skin and slightly pressed towards the skin.
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 28-4. Treatment Phases
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.
The recommended total energy invested (expressed in kJ) is
considered for the Therapeutic Phase only (not the Pre-Therapeutic
Phase)!
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.
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.

Application of the "stationary" mode with the module positioned

in-place on the skin is strictly prohibited!
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.
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 Harmony XL Pro 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.

(see Section 28.6.7 – Post-Treatment Care).

The Harmony XL Pro 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).
Table 28-3. 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


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.
28.6.8 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.
28.6.9 Follow-Up
 Patients should return for evaluation of the treatment results two
weeks after treatment and for additional treatment, if necessary.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Er Glass (ClearSkin) Module*** –
Acne, Acne Scars and Benign
Facial and Body Lesions
Chapter Contents:
Section Title Page
29.1 Er Glass Module Description ........................................................ 29-2
29.2 Er Glass Module Specifications .................................................... 29-3
29.3 Er Glass Module Operating Screens ............................................. 29-3
29.4 Er Glass Module Regulatory Labels ............................................. 29-4
29.6 Er Glass Module Clinical Guide.................................................... 29-5
29.6.1 Pre-Treatment ................................................................. 29-5
29.6.2 Treatment ........................................................................ 29-6
29.6.3 Suggested Setup Parameters - Acne ............................... 29-7
29.6.4 Treatment ........................................................................ 29-8
29.6.5 Suggested Setup Parameters – Acne Scars .................... 29-9
29.6.6 Treatment ...................................................................... 29-10
scars) .............................................................................. 29-11
29.6.8 Follow-up ....................................................................... 29-12
*** The Er Glass laser module is not available in the USA

Er Glass (ClearSkin) Module – Acne, Acne Scars and Benign Facial and Body Lesions
29.1 Er Glass Module Description

The Er Glass module is mid-infrared (1540nm) laser handpiece for the
treatment of active acne, acne scars and benign facial lesions
(melasma, striae). The Er Glass laser tip operates with integrated
suction and contact cooling mechanism. The Er Glass wavelength
achieves deep penetrationand 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.
The handpiece can be operated in standard mode or in Pixel mode,
depending on the connected tip.
A complete discussion of the Er Glass module clinical applications may
Figure 29-1. Er Glass Laser Handpiece

29.2 Er Glass Module Specifications

 Light Source: Er:Glass
 Pulse Widths: 3 msec
 Pulse Repetition Rate: 1, 2, 3, Hz
 Available Tips: 4mm, 10mm
7x7 Pixel
 Energy Density (Fluence): 300 – 2000 mJ/P
29.3 Er Glass Module Operating Screens

The Er Glass module main operating screen (see Figure 29-2) is
displayed when the Er Glass module handpiece is connected to the
system.
 The module can be operated with or without the vacuum feature
by pressing the soft-touch on the screen, which toggles between
these two operation modes.
Figure 29-2. Er Glass Module Screen with Standard 4 mm Tip


There are 4 mm & 10mm standard tips and 7x7 Pixel tips
available for use with this module. The system automatically
recognizes the resident tip and displays its size (or Pixel
designation) in the top-middle of the screen.
Acne & Acne Scars – using the 4 mm standard tip & 7x7 Pixel tip
delivers:
 Fluence: 300 – 2000 mJ/P
 Pulse Frequency: 1, 2, 3 Hz
Benign facial and body lesions – using the 4 mm & 10 mm standard
tips and 7x7 Pixel tip delivers:
 Fluence: 300 – 2000 mJ/P
 Pulse Frequency: 1, 2, 3 Hz
29.4 Er Glass Module Regulatory Labels

adhered to the Er Glass module handpiece connector:
Figure 29-3. Er Glass Module Regulatory Labels

The following table offers names and part numbers of accessories
specific to the Er Glass module that may be ordered form Alma Lasers.
Table 29-1. Er Glass Module Accessories
Description
Er Glass Laser Module

Safety Glasses for Er Glass (OD 7+)

29.6 Er Glass Module Clinical Guide

The Er Glass module is indicated for the non-ablative treatment of
acne vulgaris, atrophic acne (rolling and boxcar) scars and benign
facial lesions.
Standard 4mm, 10 mm tips – the thermal energy delivered at optimal
pulse durations penetrates the skin and starts a non-ablative wound
healing response.
Fractional 7x7 tip – the thermal energy is fractional delivered at optimal
pulse durations penetrates the skin and starts a non-ablative wound
healing response.
Suction & contact cooling – Upon contact with the skin, the laser tip
initiates mechanical suction and cooling - both operated in parallel.
Warning
operator and the patient when using this handpiece.
Contraindications
months
 Epilepsy

Skin Test – Acne

Table 29-2. Skin Test Parameters for the Standard 4mm, 10mm & 7x7 Pixel Tips - Acne vulgaris
Pulse* Number of* Number

Skin Type stacked pulses Fluence*
Tip* Repetition Rate of
(Fitzpatrick I-VI) (mJ/P)
(Hz) passes
4mm 2, 3/Stack 3–4 400 – 500 2 -3

I – III 10 mm 2,3/Stack 3-4 600-800 2–3
7x7 Pixel 3/Stack 6-8 700 - 900 2–3
4 mm 2, 3/Stack 3–4 400 – 500 2-3
IV – VI 10 mm 2,3/Stack 2–3 600-800 2–3
7x7 Pixel 3/Stack 6-8 - 800 2 -3
* Vacuum On
Note
Appropriate eye protective eye wares must be used by the patient and the
practitioner.
29.6.2 Treatment
After the Er Glass handpiece has been connected to the Harmony XL
Pro system – with the appropriate tips connected – and the treatment
parameters (fluence and timer interval) have been selected according
to Table 29-3 or Table 29-4, treatment can begin. The number of
passes depends on skin reaction and clinical end-points (slight
erythema). Treatments should be spaced 2-3 weeks apart and every 6
months during the maintenance period.
Note

Place the handpiece tip perpendicular to the skin and touch the
skin with the tip.
Upon contact with the skin surface, tip suction will commence
along with its contact cooling.

Trigger a laser pulse by pressing both the footswitch and

handpiece trigger simultaneously.
Apply laser on the target area (acne or acne scars)
Detach laser suction tip from the skin and reposition to the next
adjacent area.
Visualize the treated area and check skin reaction or adverse side
effects.
swelling in the shape of the lightguide or pain), you may either
increase the timer interval or reduce the fluence by 10-15%.
Recheck your settings against the skin test results and settings.
Caution
– Maintenance.
29.6.3 Suggested Setup Parameters - Acne

Table 29-3. Suggested Setup Parameters for the Standard 4 mm, 10 mm & 7x7 Pixel Tips
Pulse Number of
Skin Type Fluence Number of
Tip* Repetition stacked
(Fitzpatrick I-VI) (mJ/P)* passes
Rate (Hz)* pulses*
4 mm 2, 3/stack 3-4 500 – 700 -3

I – III 10 mm 2, 3/stack 3-4 600-800 2–3
7x7 Pixel 3/stack 6-8 800 - 1000 2 -3
4 mm 3-4 400 – 600
2, 3/stack 2 -3
IV – VI 10 mm 2-3 600-800
7x7 Pixel 3/stack 6-8 700 - 900 2-3
* Vacuum On

Skin Test – Acne Scars

Table 29-4. Skin Test Parameters for the Standard 4mm, 10 mm & 7x7 Pixel Tips - Acne Scars
Pulse Number of
Tip** Repetition stacked
(Fitzpatrick I-VI) (mJ/P)** passes**
Rate (Hz)** pulses**
4 mm 2, 3 3–4 400 – 500 2-3

I – III 10 mm 2,3 3-4 600 - 800 2-3
7x7 Pixel 3 3-4 700 - 900 2–3
4 mm 2, 3 3–4 400 – 500
2 -3
IV – VI 10 mm 2,3 3-4 500 - 700
7x7 Pixel 3 3-4 600 - 800 2-3
** Vacuum Off
Note
Appropriate eye protective eye wares must be used by the patient
and the practitioner.
29.6.4 Treatment
Note

skin with the tip.


Apply laser on the target area (acne or acne scars, stretch marks,
surgical scar, melasma).
adjacent area.
effects.
Caution
– Maintenance.
29.6.5 Suggested Setup Parameters – Acne Scars

Pulse Number of
(Fitzpatrick I-VI) (mJ/P)** passes
4 mm 2, 3 3-4 500 – 700

2–3
I – III 10 mm 2-3 3-4 600 - 800
7x7 Pixel 3 3–4 800 - 1000 2–3
4 mm 2, 3 3-4 500 – 700
2–3
IV – VI 10 mm 2-3 3-4 600 - 800
7x7 Pixel 3 2-3 700 - 900 2-3
** Vacuum Off

Skin Test – Benign Pigmented Lesions

Table 29-6. Skin Test Parameters for the Standard 4 mm, 10 mm & 7x7 Pixel Tips - Benign Facial
Lesions
Pulse Number of
4 mm 2, 3 3–4 400 – 500

2–3
I – III 10 mm 2,3 3-4 600 - 800
7x7 Pixel 3 3–4 700 - 900 2–3
4 mm 2, 3 3–4 400 – 500
2–3
IV – VI 10 mm 2, 3 2-3 600 - 800
7x7 Pixel 3 2-3 600 - 800 2–3
** Vacuum Off
Note
Appropriate eye protective eye wares must be used by the patient
and the practitioner.
29.6.6 Treatment
Note
skin with the tip.


Apply laser on the target area (acne or acne scars).
adjacent area.
effects.
Caution
- Maintenance.

scars)
Pulse Number of
4 mm 2, 3 3-4 500 – 700

2-3
I – III 10 mm 2, 3 3-4 800-1000
7x7 Pixel 3 6-8 800 - 1000 2-3
4 mm 2, 3 3-4 400 – 600
2-3
IV – VI 10 mm 2,3 3-4 700-800
7x7 Pixel 3 6-8 700 - 900 2-3
** Vacuum Off

29.6.8 Follow-up
treatments.
between treatments.

Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

NIR Body Module††† – Muscle and
Joints Pain Relief
Chapter Contents:
Section Title Page
30.1 NIR Body Module Description ...................................................... 30-2
30.2 NIR Body Module Specifications................................................... 30-3
30.3 NIR Body Module Operating Screen ............................................ 30-4
30.4 NIR Body Module Regulatory Labels ........................................... 30-5
30.6 NIR Body Module Clinical Guide – General Applications ........... 30-6
30.6.1 Introduction ..................................................................... 30-6
30.6.4 Pre-Treatment ................................................................. 30-7
30.6.5 Treatment ........................................................................ 30-9
30.6.9 Follow-Up ....................................................................... 30-12
30.7 NIR Body Module Clinical Guide – Dorsal Hand Rejuvenation 30-13
30.7.1 Introduction ................................................................... 30-13
30.7.2 Intended Use and Indications ....................................... 30-13
30.7.3 Skin Test ........................................................................ 30-14
30.7.4 Treatment ...................................................................... 30-14
30.7.7 Follow-Up ....................................................................... 30-18
††† Not available in Canada

NIR Body Module – Muscle and Joints Pain Relief
30.1 NIR Body Module Description

The HarmonyXL's NIR Body module (see Figure 30-1) emits light in
the near infrared spectrum generated by a pulsed-light source. The
module provides pre-selected pulse durations as a function of the
selected power (W).
The NIR Body module is intended to emit energy in the infrared
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

Figure 30-1. NIR Body Module
30.2 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)

30.3 NIR Body Module Operating Screen

The NIR Body module main operating screen (see
Figure 30-2) is displayed when the NIR Body module is connected to

the system:
Figure 30-2. NIR Body Screen

Power: the light power applied to the skin can be adjusted from 50
to 100 W.
Repetition Rate: fixed at 10 Hz (not displayed).
Total Energy: The operating screen exhibits the total energy applied
per session, counted in Kilojoules.

30.4 NIR Body Module Regulatory Labels

adhered to the NIR Body module connector:
Figure 30-3. NIR Body Module Regulatory Labels

The following table offers names of accessories specific to the NIR
Body module that may be ordered form Alma Lasers.
Table 30-1. NIR Body Module Accessories
Description
NIR Body Module

Safety Eyewear for the NIR Body Module (OD 3+)

30.6 NIR Body Module Clinical Guide – General

Applications
30.6.1 Introduction
This section is provided to aid professionals in the use of the
HarmonyXL System operating the NIR Body module.
system.

The NIR Body module is intended to emit energy in the infrared
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.
 Cancer; in particularly skin cancer
 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
 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

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.
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
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.
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.

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
Table 30-2. Skin Test Parameters *
Skin Type Time of Total Energy

Power Setting (W)
(Fitzpatrick I-VI) Exposure (sec) (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

30.6.5 Treatment
Treatment can begin after the treatment area has been cleaned.
Warning
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.
Apply a thin layer of mineral oil on the entire treatment area.
Select the appropriate fluence.
Check baseline skin temperature with a laser thermometer.
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.

when beginning treatment.
Start treatment by activating the module with the footswitch.
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.
The module should be operated on the skin In-Motion – never
stationary!
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).

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 30-4.
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.
It is recommended the practitioner check the skin temperature,
using the infrared thermometer provided with the system, every ~
30 seconds.
Treatment technique: the tip of the module must be in complete
contact with the skin and slightly pressed towards the skin.
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 30-4. Treatment Phases
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.
The recommended total energy invested (expressed in kJ) is
considered for the Therapeutic Phase only (not the Pre-Therapeutic
Phase)!
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.

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

(see Section 30.6.7– Post-Treatment Care).

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 30-3. Suggested Treatment Parameters *
Skin Type Time of Exposure Total Energy

Power Setting (W)
(Fitzpatrick I-VI) (minutes) (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


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.
which may result in hyperpigmentation.
30.6.8 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.
30.6.9 Follow-Up
 Patients should return for evaluation of the treatment results two
weeks after treatment and for additional treatment, if necessary.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

30.7 NIR Body Module Clinical Guide – Dorsal Hand

Rejuvenation
30.7.1 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.
system.

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.

30.7.3 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 30-4. NIR Body Skin Test Parameters
Skin Type Test/Hand

Energy [W] Total Energy [kJ]
[Fitzpatrick I-V] 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
30.7.4 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

before beginning treatment.
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.

Remove rings, bracelets, watches or other accessories from the

hand area.
Clean and dry the dorsal aspect of the hand's skin.
Press the Reset softkey to reset the pulse counter and total energy
counter.
Cover the treatment area with a coat of mineral oil.
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.
with the skin. Press the tip with mild pressure against the skin.
Warning
It is important to contact the skin prior to light emission.
Start treatment by activation of the footswitch.

Move the module on the skin in linear & semi-circular motions
over the entire hand area.
Occasionally examine the treatment site for a change in skin color
and morphological changes in the treatment area
(erythema/edema).
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.
are observed, you may raise the energy by 5-10% until the desired
effect is achieved.
Repeat the procedure until investing the recommended total
energy (kJ).
Add mineral oil to the treatment/grid area as required.
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.

(see Section 30.7.6).

Skin Type Total Energy

Energy [W] Hand Area [cm2]
[Fitzpatrick I-V] [kJ]
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.


 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.
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.

30.7.7 Follow-Up
between three to four weeks after treatment and for additional
 Full treatment may require between 4-6 treatments with 3-4 week
intervals between treatments.
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.
With multiple treatments, increase the number of passes for each
treatment area and/or the fluence parameters.
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Cryotherapy (ZERO) Module –
Acne, and Hyperhidrosis
Chapter Contents:
Section Title Page
31.1 Cryotherapy Module Description .................................................. 31-2
31.2 ZERO Cryotherapy Module Specifications ................................... 31-3
31.3 ZERO Module Operating Screens ................................................. 31-3
31.4 ZERO Module Regulatory Labels ................................................. 31-5
31.6 ZERO Module Clinical Guide ........................................................ 31-6
31.6.1 Pre-Treatment ................................................................. 31-6
31.6.2 Treatment ........................................................................ 31-8
31.6.3 Suggested Setup Parameters - Acne ............................. 31-10
31.6.4 Treatment ...................................................................... 31-11
31.6.5 Suggested Setup Parameters - Hyperhidrosis .............. 31-13
31.6.6 Follow-up ....................................................................... 31-14

Cryotherapy (ZERO) Module – Acne, and Hyperhidrosis
31.1 Cryotherapy Module Description

The Cryotherapy module is thermoelectric coupling (TEC) handpiece
for the treatment of acne and Hyperhidrosis (HH). The TEC operates
with an integrated thermal plate. The HP should always be used with
an antifreeze gel, membrane pad and Pad holder.
The ZERO HP achieves deep cooling penetration into the dermis.
For Active Acne mode - The dermal cooling disrupts the Sebaceous
glands while inactivation of the glands induces a long-term remission
of the acne.
For hyperhidrosis (HH) mode - The dermal cooling disrupts the
Eccrine glands while inactivation of the glands induces a long-term
remission of the HH.
The handpiece can be operated in a temperature ranged between -10ºC

to +45ºC, depending on the setup.
A B
Figure 31-1. A-Zero HP, B-Zero HP with Pad holder and Antifreeze membrane pad

31.2 ZERO Cryotherapy Module Specifications

 Thermal plate size: 5cm in diameter
 Temperature range: -10ºC to +45ºC
 Pad holder
31.3 ZERO Module Operating Screens

The ZERO module main operating screen (see Figure 31-2 and
Figure 31-3) is displayed when the ZERO module handpiece is
connected to the system.
 The module can be operated manually or automatically by pressing
the "Auto Mode" button on the screen, which toggles between these
two operations modes.
 In the automatic mode there are two protocols available: for HH or
Acne. Pressing the button on the top screen, toggles between these
two automatic protocols.
Figure 31-2. ZERO Module Screen, Cooling phase

Figure 31-3. ZERO Module Screen, Heating phase

Automatic mode - Two automatic protocols are available for use
with this module: Acne and HH. By choosing one of the
indications, the system changes the settings automatically.
Manual mode - The user selects the following setting manually:
 Cooling/Heating
 Temperature: -10ºC to +25ºC
 Time: end of session

31.4 ZERO Module Regulatory Labels

adhered to the ZERO module handpiece connector:
Figure 31-4. ZERO Module Regulatory Labels

The following table offers names and part numbers of accessories
specific to the ZERO module that may be ordered form Alma Lasers.
Table 31-1. ZERO Module & Accessories
Description
Handpiece Zero for HXL Pro

Pad Holder for Zero HP
Antifreeze gel / liquid in one 250cc bottle
Antifreeze membrane pads

31.6 ZERO Module Clinical Guide

The ZERO module is indicated for the non-ablative treatment of acne
and HH.
Acne automatic protocol – Upon contact with the skin, temperature
decreases gradually during treatment from +5ºC to 0ºC.
HH automatic protocol – Upon contact with the skin, temperature
decreases gradually during treatment from +5ºC to -5ºC.
Warning
Gloves should always be worn by the operator while using
antifreeze gel.
 Acne – The treatment parameters for any given skin condition
depend on the inflammatory lesions (papules or pustules)
 HH – Diagnosed axillary Hyperhidrosis disease severity scale
(HDSS) scale 3-4, see Figure 31-5.
Figure 31-5. HDSS – Hyperhidrosis Disease Severity Scale
 Perform Minor’s starch-iodine test as follow:

 Apply iodine on the axilla using dipped cotton wool
 Wait till the iodine will dry
 Apply starch on the axilla and remove excess
 Wait 10min
 Measure the dimensions of the dark area caused by the
reaction of the iodine with the starch

 It is recommended to perform the test in same conditions –

temperature, after rest, etc.
Contraindications
 Open laceration, abrasion, active cold sores or herpes sores on
treated area prior to enrolment
 History of immunosuppression/immune deficiency disorders,
epidermal or dermal disorders
 History or active cancer
 Significant concurrent illness which might be aggravated as a
result of treatment
 Pregnant, postpartum (<3 months) or nursing (<6 weeks)
 History of keloid formation or poor wound healing in a previously
injured skin area
 Active collagen or vascular disease
 Use of Botox for HH
 Seborrheic dermatitis, rosacea, or psoriasis
 Hyper sensitivity to cold
 Areas of impaired sensation/circulation
 Open wounds
 Raynaud disease
 Cryoglobulinemia
 Cold-agglutinin disease
Skin Test – Acne

Always perform a skin test on the intended treatment area prior to
Table 31-2. Skin Test Parameters for treating Acne
Protocol Time Temperature range
Auto protocol Stop after 2 minutes +5ºC to 0ºC
Note
Gloves should always be worn by the operator while using
antifreeze gel.

31.6.2 Treatment
 In general, the treatment is divided into three stages: Pre-
therapeutic phase (temperature above 0ºC), Therapeutic phase
(temperature at 0ºC or below) and Tissue recovery (thawing). The
handpiece temperature decreases gradually to enable the skin to
reach low temperature with less discomfort.
 Prior to treatment, operator should attach antifreeze membrane
pad to the handpiece using the pad holder and apply antifreeze gel
on the pad using a brush, until the pad is soaked with antifreeze
gel.
 Once the handpiece is ready to be used, the operator should select
whether to treat in auto mode or in manual mode.
 When working in Auto mode the temperature changes
automatically according to a pre-set parameter (see Table 31-3),
ranging from +5°C to 0°C.
 When working in Manual mode, the operator controls temperature
decrease. It is recommended to start treatment with +5°C and
decrease temperature gradually. Evaluate patient reaction during
treatment and decrease temperature accordingly.
 After the ZERO handpiece has been connected with the
appropriate pad holder and an Antifreeze gel soaked pad, and the
protocol has been selected, treatment can commence.
 The preferable technique in both modes is a “stationary” technique
and is depended on patient response and clinical end-points
(erythema).
 Treatment intervals should be 1-2 weeks apart and every 2 months
during the maintenance period.
Note
Always perform a sensitivity test on the intended treatment area
during the first treatment session.
Shave treated area.

Clean the skin to remove cosmetics and makeup.
Choose protocol according to the skin test results.
Wait for the Handpiece to reach the desired temperature.
Place handpiece in full contact on treated area and start by
pressing the footswitch.
Continue in a slow stationary manner, covering the whole
treatment area until treatment time is reached.

Once thawing begins (tissue recovery stage), detach Pad Holder

and antifreeze membrane pad, clean the handpiece from antifreeze
gel residuals and continue.
In the thawing stage, use "In motion" technique.
effects.
If adverse skin effects occur (such as frostbites, excessive redness,
swelling or pain), you may reduce the treatment temperature.
After treatment, advise patient to avoid aftershaves or creams the
same day.
Caution
It is imperative that the handpiece and pad holder remain clean
and free of debris. Both must be cleaned with a cotton swab soaked
with alcohol after each treatment. Refer to Chapter 7 in the System
Manual – Maintenance.

31.6.3 Suggested Setup Parameters - Acne

Table 31-3. Suggested Setup Parameters for the treating of Acne
10 minutes
Temp [°C] Time [sec]
Pre-therapeutic phase
+ 5°C 15
+4°C 15
+2°C 15
Auto protocol +1°C 15
Therapeutic phase
0°C 480 sec
Remove Pad holder and antifreeze membrane pad, wipe face
Thawing
+ 35°C 30 sec
+ 40°C 30 sec
Manual protocol 7-11 minutes (+5)ºC - (-10)ºC
Skin Test – Hyperhidrosis

Table 31-4. Skin Test Parameters for treating Hyperhidrosis
Auto protocol Stop after 2 minutes (+5)ºC -(-2)ºC
Note
Gloves should be worn by the operator when using antifreeze.

31.6.4 Treatment
 In general, the treatment is divided into three stages: Pre-
therapeutic phase (temperature above -2ºC), Therapeutic phase
(temperature at -2ºC or below) and Tissue recovery (thawing). The
handpiece temperature decreases gradually to enable the skin to
reach low temperature with less discomfort.
 Prior to treatment, operator should attach a pad to the handpiece
using the pad holder and apply antifreeze on the pad using a
brush, until the pad is soaked with antifreeze.
 Once the handpiece is ready to be used, the operator should select
whether to treat in auto mode or in manual mode.
 When working in Auto mode the temperature changes
automatically according to a pre-set parameter (see Table 31-5),
ranging from +5°C to -5°C.
 When working in Manual mode, the operator controls temperature
decrease. It is recommended to start treatment with +5°C and
decrease temperature gradually. Evaluate patient reaction during
treatment and decrease temperature accordingly.
 After the ZERO handpiece has been connected with the
appropriate pad holder and an Antifreeze soaked pad, and the
protocol has been selected, treatment can commence.
 The preferable technique in both modes is a “stationary” technique
and is depended on patient response and clinical end-points
(erythema).
 Treatment intervals should be 1-2 weeks apart and every 2 months
during the maintenance period.
Note
Shave treated area.

Clean the skin to remove cosmetics and deodorant residuals.
Choose protocol according to the skin test results.
Place handpiece in full contact on treated area and start by
pressing the footswitch.
Continue in a slow stationary manner, covering the whole
treatment area until treatment time is reached.
Once thawing begins (tissue recovery stage), detach Pad Holder
and pad, clean the handpiece from antifreeze gel residuals and
continue.

In the thawing stage, use "In motion" technique.

effects.
If adverse skin effects occur (such as frostbites, excessive redness,
swelling or pain), you may reduce the treatment temperature.
After treatment, advise patient to avoid deodorant the same day.
Caution
It is imperative that the applicator and pad holder remain clean
and free of debris. The applicator and Pad Holder must be cleaned
with a cotton swab soaked with alcohol after each treatment. Refer
to Chapter 7 in the System Manual – Maintenance.

31.6.5 Suggested Setup Parameters - Hyperhidrosis

Table 31-5. Suggested Setup Parameters for treating Hyperhidrosis
11 minutes
Temp [°C] Time [sec]
Pre-therapeutic phase
+ 5°C 30
+2°C 30
0°C 30
-2°C 30
Therapeutic phase
Auto protocol
-2°C 120 sec
-3°C 120 sec
-4°C 120 sec
-5°C 120sec
Remove Pad Holder and antifreeze membrane pad,

wipe axilla
Thawing
+ 25°C 30 sec
+ 30°C 30 sec
Manual protocol 7-11 minutes (+5)ºC - (-10)ºC

31.6.6 Follow-up
 Patients should return no sooner than one week after treatment.
This planned examination of the treatment site should provide a
progress evaluation and additional treatment opportunity, if
required.
and the patient should return for examination and additional
 If no change is noted, treatment temperature should be decreased.

Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

SHR (6.4) Module – Super Hair
Removal
Chapter Contents:
Section Title Page
32.1 SHR (6.4) Module Description ...................................................... 32-2
32.2 SHR (6.4) Module Specifications ................................................... 32-3
32.2.1 HR Mode .......................................................................... 32-3
32.2.2 SHR Mode ........................................................................ 32-3
32.4 SHR (6.4) Module Operating Screens ........................................... 32-4
32.5 Total Energy in the SHR (6.4) Module ......................................... 32-5
32.6 SHR (6.4) Module Regulatory Labels ........................................... 32-5
32.8 SHR (6.4) Pro Module Clinical Guide – HR Mode ........................ 32-6
32.8.3 Pre-Treatment ................................................................. 32-7
32.8.4 Treatment ........................................................................ 32-7
32.8.6 Follow-Up ....................................................................... 32-10
32.9 SHR (6.4) Pro Module Clinical Guide – SHR Mode .................... 32-11
32.9.4 Pre-Treatment ............................................................... 32-12
32.9.5 Treatment ...................................................................... 32-13
32.9.7 Follow-Up ....................................................................... 32-16

SHR (6.4) Module – Super Hair Removal
32.1 SHR (6.4) Module Description

The SHR (6.4) 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 (6.4) module clinical applications
The SHR (6.4) module handpiece has a black identification section (see
Figure 32-1).
Figure 32-1. SHR Pro (6.4) Cooled Module Handpiece (Black Color Code)

32.2 SHR (6.4) Module Specifications

32.2.1 HR Mode
 Spectrum: 700–950 nm
 Energy Density (Fluence): 5–20 J/cm2
 Cooling: TEC
32.2.2 SHR Mode

 Spectrum: 700-950 nm
 Energy Density (Fluence): 3–7 J/cm2
 Cooling: TEC

application.
system.
Note
In the latest series of Harmony XL Pro 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.

32.4 SHR (6.4) Module Operating Screens

The SHR (6.4) module main operating screen (see Figure 16-2) is
displayed when the module is connected to the system.
 To switch from HR to SHR mode, press the SHR soft-key on the HR
screen.
 To switch from SHR to HR mode, press the HR soft-key on the SHR
screen
The SHR (6.4) 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 OFF (touch the COOLING ON soft-key)
Figure 32-2. SHR (6.4) Cooling Module Operating Screens


 Fluence – the available range is from 5 to 20 J/cm2 in increments of
1 J/cm2.
 Pulse Width – three pulse widths are available:
 30 msec  40 msec  50 msec
 Pulse Repetition Rate – fixed at 3 Hz

 Fluence – the available fluence range is from 3 to 7 J/cm2 in
 Timer – 1, 3 and 30 seconds
 Pulse Repetition Rate – fixed at 3 Hz
32.5 Total Energy in the SHR (6.4) Module

The SHR (6.4) module's operating screen exhibits the total energy
corner of Figure 32-2).
Note
If the system stays in SHR mode during patient rotation, it is
32.6 SHR (6.4) Module Regulatory Labels

adhered to the SHR (6.4) module handpiece connector:
Figure 32-3. SHR (6.4) Module Regulatory Labels


The following table offers names of accessories specific to the SHR (6.4)
Table 32-1. SHR (6.4) Module Accessories
Description
SHR (6.4) Module (Super Hair Removal)

32.8 SHR (6.4) Pro Module Clinical Guide – HR Mode

The Harmony XL Pro system with the SHR (6.4) module is indicated
for the removal of unwanted hair and to effect stable long-term or
Warning

The SHR (6.4) module in HR mode is indicated for:
bikini area
 Epilepsy
psoriasis


 Tattoos or nevi present
 Gold therapy
Patient Evaluation
 Hormonal
 Familial
 Tumor
Skin Test
table below.
Table 32-2. Cooled HR Skin Test Parameters

Mode
IV HR 50 9 24 – 48 hours
V HR 50 7 24 – 48 hours
VI HR 50 5 24 – 48 hours
32.8.4 Treatment
Treatment can begin after the SHR (6.4) module is connected, set to
HR mode and the treatment parameters are selected (fluence and timer


Apply a thin layer of refrigerated cooling gel to the treatment site.
The gel will provide a thermal sink for the absorbed and reflected
are ineffective.


first treatment session according to the following parameters. The
recommended parameters are based on the patient hair color and skin
type:
Pulse
Skin Type Fluence
Hair Color Mode Width
(Fitzpatrick I-VI) (J/cm2)
(msec)
Light HR 15 – 20 30
I
Dark HR 13 – 18 30
Light HR 15 – 20 30
II
Dark HR 13 – 18 30
Light HR 15 – 20 40
III
Dark HR 12 – 17 40
Light HR 15 – 17 40
IV
Dark HR 10 – 15 50
V
Dark HR Up to 13 50
Light N/A N/A N/A
VI
Dark HR Up to 12 50
Caution
It is not recommended to treat hair that is lighter than the
surrounding skin.

32.8.6 Follow-Up
between treatments.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

32.9 SHR (6.4) Pro Module Clinical Guide – SHR

Mode
The Harmony XL Pro system with the SHR (6.4) Near Infrared (NIR)
module is indicated for the removal of unwanted hair and to effect
stable long-term or permanent hair reduction.
Warning

The Advanced Fluorescence Technology (AFT) SHR (6.4) cm module is
indicated for:
 The treatment of pseudofolliculitis barbae (PFB).

The module may be operated under 3 different time intervals: 1, 35
and 40 seconds. In the 1-sec interval, the module is used in Stationary
technique. In the 35 and 40-second intervals, the module is used in the
In-Motion technique (see Section 32.9.5). The 1-sec interval is used on
small areas. (face: mustache, chin, etc.). The 35 and 40 second interval
is used on larger areas (body – arms, chest, back, legs, axilla, bikini
line, etc.).
The SHR (6.4) 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 6.4cm2 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.

Patient Evaluation
Refer to Section 32.8.3.1.
Skin Test
interfere with the treatment. Mark a grid (using a white pen) on an
area of 150x2 cm (300cm2). Treat with the In-Motion technique within
each treatment grid, as per treatment description in 32.9.5.
Table 32-4. SHR (6.4) Skin Test Parameters**

Fluence (J/cm2)
I 7 On 12
II 7 On 12
III 7 On 12
IV 6 On 12
V 5 On 12
VI 5 On 12
(*) Ultrasonic gel must be applied to the skin in both Cooling On or Off
modes.
(**) In-Motion technique; the total energy is adjusted for 150x2 cm
(~300cm2) area.

32.9.5 Treatment
Treatment can begin after the SHR (6.4) NIR module is connected and
the treatment parameter (fluence), treatment interval, and cooling
(On/Off) is selected according to Table 32-5.
tape.
Mark a grid (using a white pen) on an area of treatment of about
300cm2. Mark additional adjacent grids as needed based on the
area size.
treatment area.
very small specific areas. (using the Stationary technique rather
than the In-Motion technique).
footswitch.
(kJ).


end points).
Stationary Technique: apply ultrasonic gel to the treatment area in
both On and Off cooling modes.
test).
again.
end points).


Table 32-5. SHR (6.4) Suggested Setup Parameters

Fluence (J/cm2)
I 7 On 12-15
II 7 On 12-15
III 7 On 12-15
IV 6 On 12-15
V 5 On 12-15
VI 5 On 12-15
(*) Ultrasonic gel must be applied to the skin in both Cooling On or Off
modes.
(**) The total energy is adjusted for 150x2 cm (~300cm2) 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.
(*) Unilateral

32.9.7 Follow-Up
between treatments.
been no adverse reactions) at 4–8 weeks intervals.
Alma Lasers:
Alma Lasers GmbH

Nordostpark 100-102
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99

Omha27070801 Om Harmony XL Pro Applicators Row

Uploaded by

Copyright:

Available Formats

Omha27070801 Om Harmony XL Pro Applicators Row

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Omha27070801 Om Harmony XL Pro Applicators Row

Uploaded by

Copyright:

Available Formats

Copyright © 2017, Alma Lasers GmbH. All rights reserved.

Alma Lasers GmbH

Catalog No. OMHA27070801

Scope of This Manual

Chapter Module Name Wavelength Clinical Applications

Harmony XL Pro Operator's Manual i

Chapter Module Name Wavelength Clinical Applications

2 Not available in Canada

ii Harmony XL Pro Operator's Manual

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

2.1 H. Power UV Module Description ................................................... 2-2

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

Harmony XL Pro Operator's Manual iii

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

4.1 'S'Acne Module Description............................................................. 4-2

5.1 VL Module Description ................................................................... 5-2

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

iv Harmony XL Pro Operator's Manual

6.6.2 Contraindications .............................................................. 6-5

7.1 VL/PL Module Description .............................................................. 7-2

8.1 VL/PL Cooled Module Description .................................................. 8-2

Harmony XL Pro Operator's Manual v

8.5.2 Indications for Use............................................................. 8-5

9.1 Dye-VL Module................................................................................ 9-2

vi Harmony XL Pro Operator's Manual

9.8.2 Contraindications ............................................................ 9-14

10.1 Yellow LED Module Description ................................................... 10-2

11.1 SR Module Description.................................................................. 11-2

Harmony XL Pro Operator's Manual vii

12.1 SR Cooled Module Description...................................................... 12-2

13.1 SSR Cooled Module Description ................................................... 13-2

14.1 Dye-SR Module Description .......................................................... 14-3

viii Harmony XL Pro Operator's Manual

14.3 Dye-SR Module Operating Screen ................................................ 14-4

15.1 HR Module Description ................................................................. 15-2

Harmony XL Pro Operator's Manual ix

15.6.1 Indications for Use........................................................... 15-5

16.1 SHR (3) Module Description ......................................................... 16-2

17.1 SHR (5) Module Description ......................................................... 17-2

x Harmony XL Pro Operator's Manual

17.2.1 HR Mode .......................................................................... 17-3

18.1 ST Module Description .................................................................. 18-2

Harmony XL Pro Operator's Manual xi

18.6.8 Follow-Up....................................................................... 18-10

19.1 SST Cooled Module Description.................................................... 19-2

20.1 Q-SW Pro Module Description ...................................................... 20-2

xii Harmony XL Pro Operator's Manual

21.1 H.P.Q-SW Pro Module Description ............................................... 21-2

22.1 L.P. 1064 Pro Module Description ................................................ 22-2

Harmony XL Pro Operator's Manual xiii

22.6.6 Hair Removal & Treatment of Pseudofolliculitis

23.1 Cooled L.P. Pro Module Description ............................................. 23-2

24.1 Fungus L.P. Pro Module Description ............................................ 24-3

xiv Harmony XL Pro Operator's Manual

24.7.6 Follow Up ....................................................................... 24-13

25.1 L.P. 1320 Module Description ....................................................... 25-2

26.1 Cooled L.P. 1320 Module Description ........................................... 26-2

Harmony XL Pro Operator's Manual xv

26.7.3 Assessing the Condition .................................................. 26-9