Alma Lasers
Harmony XL PRO Modules Operators Manual Rev 1 Nov 2014
Operators Manual
367 Pages
Preview
Page 1
MODULES OPERATOR’S MANUAL
© 2014 Alma Lasers GmbH. All rights reserved. PBHA25081402
ClearLift ClearSkin Impact iPixel Er:YAG Speed AFT Cooled LP Nd: Yag ClearLift Roller Dye-VL NIR Dye-SR Dye Fungus High power UVB
Copyright © 2014, 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: http://www.alma-deutschland.de/kontakt/ansprechpartner Website: www.alma-lasers.de
Catalog No. OMHA27070801 Revision 1, November 2014
Scope of Manual
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
High Power UV Module
270 – 380nm
Psoriasis and Vitiligo.
3
Acne Module
420 – 950nm
Acne clearance.
4
SVL Module
515 – 950nm
Superficial vascular lesions.
5
SVL Cooled Module
515 – 950nm
Superficial vascular lesions.
6
VL/PL Module
440 – 950nm
Vascular and Pigmented lesions.
7
VL/PL Cooled Module
440 – 950nm
Vascular and pigmented lesions.
8
Dye-VL Pro Module
450 – 600nm
Vascular and pigmented lesions.
9
Yellow LED
560 – 620nm
Increased blood flow, muscle relaxation & pain relief.
Treatment of rhytids, fine lines and wrinkles1. 10
SR Module
570 – 950nm
Skin rejuvenation.
11
SR Cooled Module
570 – 950nm
Skin rejuvenation.
12
SSR Cooled Module
540 – 950nm
Skin rejuvenation ("S" mode).
13
Dye-SR Pro Module
550 – 650nm
Vascular and pigmented lesions.
14
HR Module
650 – 950nm
Hair removal.
15
SHR Pro (3) Cooled Module
650 – 950nm
Hair removal. Long-term or permanent hair reduction ("S" mode).
16
SHR Pro (5) Cooled Module
17
ST Module
1
650 – 950nm
Long-term or permanent hair reduction [5 cm2 spot size].
780 – 950nm
Scar revision and treatment of striae.
In Canada
Harmony XL Pro Modules Operator's Manual
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Scope of Manual
ii
Chapter
Module Name
Wavelength
Clinical Applications
18
SST Cooled Module
780 – 950nm
Scar revision and treatment of striae ("S mode).
19
QSW 1064nm Nd:YAG (ClearLift) Module
1064nm & 532nm
Tattoo removal and vascular lesions.
20
High Power QSW 1064nm Nd:YAG (ClearLift) Module
1064nm & 532nm
Tattoo removal, skin rejuvenation and pigmented vascular lesions.
21
LP 1064nm Nd:YAG Module
1064nm
Vascular lesions, leg veins, hair removal, wrinkles and PFB.
22
Cooled Long Pulse 1064nm Nd:YAG Module
1064nm
Vascular lesions, leg veins, hair removal, facial wrinkles and PFB.
23
Fungus 1064nm Nd:YAG Module
1064nm
Onychomycosis (nail fungus), vascular lesions, leg veins, hair removal and PFB.
24
LP 1320nm Nd:YAG Module
1320nm
Wrinkles and acne scars.
25
Cooled Long Pulse 1320nm Nd:YAG Module
1320nm
Wrinkles and acne scars.
26
iPixelEr 2940nm Scanner Module
2940nm
Fractional ablative skin resurfacing.
27
NIR Face Module2
1300nm
Muscle pain relief. Joint pain and stiffness.
28
Er:Glass 1540nm Module3
1540nm
2
Not available in Canada
3
Not available in the USA
Acne, Acne Scars and Benign Facial Lesions
Harmony XL Pro Modules Operator's Manual
Table of Contents
Table of Contents CHAPTER 1
Introduction 1.1. 1.2.
CHAPTER 2
CHAPTER 3
Scope of This Manual ... 1-2 Module Specifications ... 1-2 1.2.1. AFT, UV, NIR & LED, Non-Laser, Non-Cooled Modules ... 1-3 1.2.2. AFT and NIR, Non-Laser, Cooled Modules ... 1-4 1.2.3. 'S' Mode Cooled Modules ... 1-5 1.2.4. Laser Modules ... 1-6
High Power UV Module 2.1. 2.2. 2.3. 2.4. 2.5. 2.6.
3.7.
Page
High Power UV Module Description ... 2-2 High Power UV Module Specifications ... 2-2 High Power UV Module Operating Screen ... 2-3 High Power UV Module Regulatory Labels ... 2-4 Ordering Information ... 2-4 High 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
Acne Module 3.1. 3.2. 3.3. 3.4. 3.5. 3.6.
Page
Page
Acne Module Description ... 3-2 Acne Module Specifications ... 3-2 Acne Module Operating Screen ... 3-3 Acne Module Regulatory Labels ... 3-4 Ordering Information ... 3-4 Acne Module Clinical Guide ... 3-5 3.6.1. Pre-Treatment... 3-5 3.6.2. Treatment... 3-7 3.6.3. Suggested Setup Parameters ... 3-8 3.6.4. Follow-Up... 3-9 Acne Operating Mode ... 3-10 3.7.1. Pre-Treatment... 3-10 3.7.2. Treatment... 3-11
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Table of Contents
CHAPTER 4
3.7.3. 3.7.4.
Suggested Setup Parameters... 3-12 Follow-Up ... 3-12
SVL Module
Page
4.1. 4.2. 4.3. 4.4. 4.5. 4.6.
CHAPTER 5
SVL Cooled Module 5.1. 5.2. 5.3. 5.4. 5.5. 5.6.
CHAPTER 6
Page
SVL Cooled Module Description ... 5-2 SVL Cooled Module Specifications ... 5-2 SVL Cooled Module Operating Screen ... 5-3 SVL Cooled Module Regulatory Labels ... 5-4 Ordering Information... 5-4 SVL Cooled 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 5.6.5. Suggested Setup Parameters... 5-8 5.6.6. Follow-up... 5-8
VL/PL Module 6.1. 6.2. 6.3. 6.4. 6.5.
iv
SVL Module Description ... 4-2 SVL Module Specifications ... 4-2 SVL Module Operating Screen ... 4-3 SVL Module Regulatory Labels ... 4-4 Ordering Information... 4-4 SVL Module Clinical Guide ... 4-5 4.6.1. Indications for Use ... 4-5 4.6.2. Contraindications ... 4-5 4.6.3. Pre-Treatment ... 4-6 4.6.4. Treatment ... 4-7 4.6.5. Suggested Setup Parameters... 4-8 4.6.6. Follow-up... 4-8
Page
VL/PL Module Description ... 6-2 VL/PL Module Specifications ... 6-2 VL/PL Module Operating Screen ... 6-3 VL/PL Module Regulatory Labels ... 6-4 Ordering Information... 6-4
Harmony XL Pro Modules Operator's Manual
Table of Contents
6.6.
6.7.
CHAPTER 7
VL/PL Module Clinical Guide for Vascular Lesions ... 6-5 6.6.1. Indications for Use ... 6-5 6.6.2. Contraindications ... 6-5 6.6.3. Pre-Treatment... 6-6 6.6.4. Treatment... 6-7 6.6.5. Suggested VL/PL Setup Parameters for Vascular Lesions ... 6-8 6.6.6. Follow-up ... 6-9 VL/PL Module Clinical Guide for Pigmented Lesions ... 6-10 6.7.1. Indications for Use ... 6-10 6.7.2. Contraindications ... 6-10 6.7.3. Pre-Treatment... 6-10 6.7.4. Treatment... 6-11 6.7.5. Suggested VL/PL Setup Parameters for Pigmented Lesions ... 6-12 6.7.6. Follow-up ... 6-13
VL/PL Cooled Module 7.1. 7.2. 7.3. 7.4. 7.5.
7.6.
Page
VL/PL Cooled Module Description ... 7-2 VL/PL Cooled Module Specifications ... 7-2 VL/PL Cooled Module Operating Screen ... 7-3 VL/PL Cooled Module Regulatory Labels ... 7-4 Ordering Information ... 7-4 7.5.1. VL/PL Cooled Module Clinical Guide for Vascular Lesions ... 7-5 7.5.2. Indications for Use ... 7-5 7.5.3. Contraindications ... 7-5 7.5.4. Pre-Treatment... 7-6 7.5.5. Treatment... 7-7 7.5.6. Suggested VL/PL Cooled Setup Parameters for Vascular Lesions .. 7-8 7.5.7. Follow-up ... 7-9 VL/PL Cooled Module Clinical Guide for Pigmented Lesions ... 7-10 7.6.1. Indications for Use ... 7-10 7.6.2. Contraindications ... 7-10 7.6.3. Pre-Treatment... 7-10 7.6.4. Treatment... 7-11 7.6.5. Suggested VL/PL Cooled Setup Parameters for Pigmented Lesions... ... 7-12 7.6.6. Follow-up ... 7-13
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Table of Contents
CHAPTER 8
Dye-VL Pro Module 8.1. 8.2. 8.3. 8.4. 8.5. 8.6.
8.7.
8.8.
CHAPTER 9
vi
Dye-VL Pro Module ... 8-3 Dye-VL Pro Module Specifications ... 8-3 Dye-VL Pro Module Operating Screen ... 8-4 Dye-VL Pro Module Regulatory Labels ... 8-5 Ordering Information... 8-5 Dye-VL Pro Module Clinical Guide for Vascular Lesions ... 8-6 8.6.1. Indications for Use ... 8-6 8.6.2. Contraindications ... 8-6 8.6.3. Pre-Treatment ... 8-7 8.6.4. Treatment ... 8-8 8.6.5. Suggested Dye-VL Pro Setup Parameters for Vascular Lesions ... 8-9 8.6.6. Follow-up... 8-9 Dye-VL Pro Module Clinical Guide for Pigmented Lesions ... 8-10 8.7.1. Indications for Use ... 8-10 8.7.2. Contraindications ... 8-10 8.7.3. Pre-Treatment ... 8-10 8.7.4. Treatment ... 8-11 8.7.5. Suggested Dye-VL Pro Setup Parameters for Pigmented Lesions . 8-12 8.7.6. Follow-up... 8-12 Dye-SVL Mode Clinical Guide ... 8-13 8.8.1. Indications for Use ... 8-13 8.8.2. Contraindications ... 8-13 8.8.3. Module Operation... 8-14 8.8.4. Pre-Treatment ... 8-14 8.8.5. Treatment (In-Motion Technique) ... 8-15 8.8.6. Suggested Setup Parameters... 8-16 8.8.7. Stationary Protocol... 8-16 8.8.8. Treatment of Small Areas ... 8-17 8.8.9. Follow-up... 8-18
Yellow LED Module 9.1. 9.2. 9.3. 9.4. 9.5. 9.6.
Page
Page
Yellow LED Module Description ... 9-2 Yellow LED Module Specifications ... 9-2 Yellow LED Module Operating Screen ... 9-3 Yellow LED Module Regulatory Labels ... 9-4 Ordering Information... 9-4 Yellow LED Module Clinical Guide ... 9-5 9.6.1. Indications for Use ... 9-5 9.6.2. Contraindications ... 9-5 9.6.3. Pre-Treatment ... 9-5
Harmony XL Pro Modules Operator's Manual
Table of Contents
9.6.4. 9.6.5. 9.6.6.
Treatment... 9-6 Suggested Yellow LED Setup Parameters ... 9-7 Follow-Up... 9-7
CHAPTER 10 SR Module
Page
10.1. 10.2. 10.3. 10.4. 10.5. 10.6.
SR Module Description ... 10-2 SR Module Specifications ... 10-2 SR Module Operating Screen ... 10-3 SR Module Regulatory Labels ... 10-4 Ordering Information ... 10-4 SR Module Clinical Guide ... 10-5 10.6.1. Indications for Use ... 10-5 10.6.2. Contraindications ... 10-5 10.6.3. Pre-Treatment... 10-6 10.6.4. Treatment... 10-7 10.6.5. Suggested SR Setup Parameters ... 10-8 10.6.6. Follow-up ... 10-8
CHAPTER 11 SR Cooled Module 11.1. 11.2. 11.3. 11.4. 11.5. 11.6.
SR Cooled Module Description ... 11-2 SR Cooled Module Specifications ... 11-2 SR Cooled Module Operating Screen ... 11-3 SR Cooled Module Regulatory Labels ... 11-4 Ordering Information ... 11-4 SR Cooled Module Clinical Guide ... 11-5 11.6.1. Indications for Use ... 11-5 11.6.2. Contraindications ... 11-5 11.6.3. Pre-Treatment... 11-6 11.6.4. Treatment... 11-7 11.6.5. Suggested SR Cooled Setup Parameters ... 11-8 11.6.6. Follow-up ... 11-8
CHAPTER 12 SSR Cooled Module 12.1. 12.2. 12.3. 12.4.
Page
Page
SSR Cooled Module Description ... 12-2 SSR Cooled Module Specifications ... 12-2 SSR Cooled Module Operating Screen ... 12-3 Total Energy in the SSR Cooled Module ... 12-4
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12.5. 12.6. 12.7.
SSR Cooled Module Regulatory Labels... 12-4 Ordering Information... 12-4 SSR Cooled Module Clinical Guide... 12-5 12.7.1. Indications for Use ... 12-5 12.7.2. Contraindications ... 12-5 12.7.3. Module Operation... 12-6 12.7.4. Pre-Treatment ... 12-6 12.7.5. Treatment (In-Motion Technique) ... 12-7 12.7.6. Suggested Setup Parameters... 12-8 12.7.7. Stationary Protocol... 12-8 12.7.8. Treatment of Small Areas ... 12-9 12.7.9. Follow-up... 12-10
CHAPTER 13 Dye-SR Pro Cooled Module 13.1. 13.2. 13.3. 13.4. 13.5. 13.6.
13.7.
13.8.
viii
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Dye-SR Pro Module Description... 13-3 Dye-SR Pro Module Specifications... 13-3 Dye-SR Pro Module Operating Screen ... 13-4 Dye-SR Pro Module Regulatory Labels ... 13-5 Ordering Information... 13-5 Dye-SR Pro Module Clinical Guide for Vascular Lesions ... 13-6 13.6.1. Indications for Use ... 13-6 13.6.2. Contraindications ... 13-6 13.6.3. Pre-Treatment ... 13-7 13.6.4. Treatment ... 13-8 13.6.5. Suggested Dye-SR Pro Setup Parameters for Vascular Lesions ... 13-9 13.6.6. Follow-up... 13-9 Dye-SR Pro Module Clinical Guide for Pigmented Lesions ... 13-10 13.7.1. Indications for Use ... 13-10 13.7.2. Contraindications ... 13-10 13.7.3. Pre-Treatment ... 13-10 13.7.4. Treatment ... 13-11 13.7.5. Suggested Dye-SR Pro Setup Parameters for Pigmented Lesions 13-12 13.7.6. Follow-up... 13-12 Dye-SSR Mode Clinical Guide ... 13-14 13.8.1. Indications for Use ... 13-14 13.8.2. Contraindications ... 13-14 13.8.3. Module Operation... 13-15 13.8.4. Pre-Treatment ... 13-15 13.8.5. Treatment (In-Motion Technique) ... 13-16 13.8.6. Suggested Setup Parameters... 13-17 13.8.7. Stationary Protocol... 13-17 13.8.8. Treatment of Small Areas ... 13-18
Harmony XL Pro Modules Operator's Manual
Table of Contents
13.8.9.
Follow-up ... 13-19
CHAPTER 14 HR Module 14.1. 14.2. 14.3. 14.4. 14.5. 14.6.
HR Module Description ... 14-2 HR Module Specifications ... 14-2 HR Module Operating Screen ... 14-3 HR Module Regulatory Labels... 14-4 Ordering Information ... 14-4 HR Module Clinical Guide ... 14-5 14.6.1. Indications for Use ... 14-5 14.6.2. Contraindications ... 14-5 14.6.3. Pre-Treatment... 14-6 14.6.4. Treatment... 14-6 14.6.5. Suggested HR Setup Parameters ... 14-8 14.6.6. Follow-Up... 14-9
CHAPTER 15 SHR Pro (3) Cooled Module 15.1. 15.2.
15.3. 15.4. 15.5. 15.6. 15.7. 15.8.
15.9.
Page
Page
SHR Pro (3) Cooled Module Description ... 15-3 SHR Pro (3) Cooled Module Specifications ... 15-4 15.2.1. HR Mode... 15-4 15.2.2. SHR Mode... 15-4 Lightguide Footprint Size Selection ... 15-4 SHR Pro (3) Cooled Module Operating Screens... 15-5 Total Energy in the SHR Pro (3) Cooled Module ... 15-6 SHR Pro (3) Cooled Module Regulatory Labels... 15-6 Ordering Information ... 15-7 SHR Pro (3) Cooled Module Clinical Guide – HR Mode ... 15-7 15.8.1. Indications for Use ... 15-7 15.8.2. Contraindications ... 15-7 15.8.3. Pre-Treatment... 15-8 15.8.4. Treatment... 15-9 15.8.5. Suggested HR Setup Parameters ... 15-10 15.8.6. Follow-Up... 15-11 SHR Pro (3) Cooled Module Clinical Guide – SHR Mode... 15-12 15.9.1. Indications for Use ... 15-12 15.9.2. Contraindications ... 15-12 15.9.3. Module Operation in SHR Mode ... 15-12 15.9.4. Pre-Treatment... 15-13 15.9.5. Treatment... 15-14
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Table of Contents
15.9.6. 15.9.7. 15.9.8.
Suggested Setup Parameters... 15-16 Treatment of Small Areas ... 15-17 Follow-Up ... 15-17
CHAPTER 16 SHR Pro (5) Cooled Module 16.1. 16.2.
16.3. 16.4. 16.5. 16.6. 16.7. 16.8.
16.9.
SHR Pro (5) Cooled Module Description... 16-3 SHR Pro (5) Cooled Module Specifications... 16-4 16.2.1. HR Mode ... 16-4 16.2.2. SHR Mode ... 16-4 Lightguide Footprint Size Selection ... 16-4 SHR Pro (5) Cooled Module Operating Screens ... 16-5 Total Energy in the SHR Pro (5) Cooled Module ... 16-6 SHR Pro (5) Cooled Module Regulatory Labels ... 16-6 Ordering Information... 16-7 SHR Pro (5) Cooled Pro Module Clinical Guide – HR Mode ... 16-7 16.8.1. Indications for Use ... 16-7 16.8.2. Contraindications ... 16-7 16.8.3. Pre-Treatment ... 16-8 16.8.4. Treatment ... 16-9 16.8.5. Suggested HR Setup Parameters ... 16-10 16.8.6. Follow-Up ... 16-11 SHR Pro (5) Cooled Module Clinical Guide – SHR Mode ... 16-12 16.9.1. Indications for Use ... 16-12 16.9.2. Contraindications ... 16-12 16.9.3. Module Operation in SHR Mode ... 16-12 16.9.4. Pre-Treatment ... 16-13 16.9.5. Treatment ... 16-14 16.9.6. Suggested Setup Parameters... 16-16 16.9.7. Follow-Up ... 16-17
CHAPTER 17 ST Module 17.1. 17.2. 17.3. 17.4. 17.5. 17.6.
x
Page
Page
ST Module Description ... 17-2 ST Module Specifications ... 17-2 ST Module Operating Screen ... 17-3 ST Module Regulatory Labels... 17-4 Ordering Information... 17-4 ST Module Clinical Guide... 17-4 17.6.1. Indications for Use ... 17-5 17.6.2. Contraindications ... 17-5
Harmony XL Pro Modules Operator's Manual
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17.6.3. 17.6.4. 17.6.5. 17.6.6. 17.6.7. 17.6.8.
Pre-Treatment... 17-5 Module Operation ... 17-6 Skin Test ... 17-6 Treatment... 17-7 Suggested Setup Parameters ... 17-9 Follow-Up... 17-10
CHAPTER 18 SST Cooled Module 18.1. 18.2. 18.3. 18.4. 18.5. 18.6. 18.7.
SST Cooled Module Description ... 18-2 SST Cooled Module Specifications ... 18-2 SST Cooled Module Operating Screen ... 18-3 Total Energy in the SST Cooled Module ... 18-4 SST Cooled Module Regulatory Labels ... 18-4 Ordering Information ... 18-4 SST Cooled Module Clinical Guide ... 18-5 18.7.1. Indications for Use ... 18-5 18.7.2. Contraindications ... 18-5 18.7.3. Module Operation ... 18-6 18.7.4. Pre-Treatment... 18-6 18.7.5. Treatment... 18-7 18.7.6. Suggested Setup Parameters (In-Motion Protocol)... 18-9 18.7.7. Treatment of Small Areas ... 18-10 18.7.8. Follow-Up... 18-10
CHAPTER 19 QSW 1064nm Nd:YAG Module 19.1. 19.2.
19.3. 19.4. 19.5. 19.6.
Page
Page
QSW 1064nm Nd:YAG Module Description ... 19-2 QSW 1064nm Nd:YAG Module Specifications ... 19-3 19.2.1. Standard Tip Module Specifications... 19-3 19.2.2. 532nm KTP Tip Module Specifications ... 19-3 QSW 1064nm Nd:YAG Module Operating Screen ... 19-4 QSW 1064nm Nd:YAG Module Regulatory Labels... 19-5 Ordering Information ... 19-5 QSW 1064nm Nd:YAG Module Clinical Guide ... 19-6 19.6.1. Indications for Use ... 19-6 19.6.2. Pre-Treatment... 19-8 19.6.3. Treatment... 19-10 19.6.4. Suggested Setup Parameters ... 19-11 19.6.5. Post-Treatment Care ... 19-11 19.6.6. Follow-Up... 19-12
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CHAPTER 20 High Power QSW 1064nm Nd:YAG Module 20.1. 20.2.
20.3. 20.4. 20.5. 20.6.
High Power QSW 1064nm Nd:YAG Module Description ... 20-2 High Power QSW 1064nm Nd:YAG Module Specifications ... 20-4 20.2.1. Module Specifications with Standard and Pixel Tips ... 20-4 20.2.2. Module Specifications with 532nm KTP Tip ... 20-4 High Power QSW 1064nm Nd:YAG Module Operating Screen ... 20-5 High Power QSW 1064nm Nd:YAG Module Regulatory Labels... 20-7 Ordering Information... 20-7 High Power QSW 1064nm Nd:YAG Module Clinical Guide... 20-8 20.6.1. Indications for Use ... 20-8 20.6.2. Pre-Treatment ... 20-10 20.6.3. Treatment Procedure – Standard Tips / iPixel roller 1x7 ... 20-13 20.6.4. Treatment Procedure – Pixel Tip / iPixel Roller 5X5 ... 20-14 20.6.5. Suggested Setup Parameters... 20-14 20.6.6. Post-Treatment Care – Tattoos (Standard Tips and iPixel tip 1X7) ... ... 20-17 20.6.7. Post-Treatment Care – Pigmented Lesions / Skin rejuvenation ... (Pixel Tip / iPixel roller 5X5 ) ... 20-17 20.6.8. Follow-Up ... 20-18
CHAPTER 21 LP 1064nm Nd:YAG Module 21.1. 21.2. 21.3. 21.4. 21.5. 21.6.
xii
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Page
LP 1064nm Nd:YAG Module Description... 21-2 LP 1064nm Nd:YAG Module Specifications ... 21-2 LP 1064nm Nd:YAG Module Operating Screen ... 21-3 LP 1064nm Nd:YAG Module Regulatory Labels ... 21-5 Ordering Information... 21-5 LP 1064nm Nd:YAG Module Clinical Guide ... 21-6 21.6.1. Assessing the Condition ... 21-6 21.6.2. Indications for Use ... 21-6 21.6.3. Contraindications ... 21-7 21.6.4. Vascular Lesions... 21-8 21.6.5. Non-Ablative Treatment of Facial Wrinkles ... 21-10 21.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB).. 21-12 21.6.7. Follow Up ... 21-14
Harmony XL Pro Modules Operator's Manual
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CHAPTER 22 Cooled Long Pulse 1064nm Nd:YAG Module 22.1. 22.2. 22.3. 22.4. 22.5. 22.6.
Cooled Long Pulse 1064nm Nd:YAG Module Description... 22-2 Cooled Long Pulse 1064nm Nd:YAG Module Specifications... 22-2 Cooled Long Pulse 1064nm Nd:YAG Module Operating Screens ... 22-3 Cooled Long Pulse 1064nm Nd:YAG Module Regulatory Labels ... 22-5 Ordering Information ... 22-5 Cooled Long Pulse 1064nm Nd:YAG Module Clinical Guide ... 22-6 22.6.1. Assessing the Condition ... 22-6 22.6.2. Indications for Use ... 22-6 22.6.3. Contraindications ... 22-7 22.6.4. Vascular Lesions ... 22-8 22.6.5. Non-Ablative Treatment of Facial Wrinkles ... 22-11 22.6.6. Hair Removal & Treatment of Pseudofolliculitis Barbae (PFB) . 22-13 22.6.7. Follow Up ... 22-15
CHAPTER 23 Fungus 1064nm Nd:YAG Module 23.1. 23.2. 23.3. 23.4.
23.5. 23.6. 23.7.
23.8.
Page
Page
Fungus 1064nm Nd:YAG Module Description ... 23-3 Fungus 1064nm Nd:YAG Module Specifications ... 23-4 Fungus 1064nm Nd:YAG Module Operating Screens ... 23-5 Operating Parameters ... 23-6 23.4.1. Long Pulse Mode ... 23-6 23.4.2. Nail Fungus Mode ... 23-6 Fungus 1064nm Nd:YAG Module Regulatory Labels ... 23-7 Ordering Information ... 23-7 Clinical Guide: Long Pulse Mode ... 23-8 23.7.1. Assessing the Condition ... 23-8 23.7.2. Indications for Use ... 23-8 23.7.3. Contraindications ... 23-9 23.7.4. Vascular Lesions ... 23-10 23.7.5. Non-Ablative Treatment of Facial Wrinkles ... 23-12 23.7.6. Follow Up ... 23-14 Clinical Guide: Nail Fungus ... 23-16 23.8.1. Assessing the Condition ... 23-16 23.8.2. Indications for Use ... 23-16 23.8.3. Contraindications ... 23-16 23.8.4. Adverse Effects of Treatment ... 23-17 23.8.5. Preparation for Treatment ... 23-17 23.8.6. Treatment Phase 1 – Q-Switched Module ... 23-19 23.8.7. Treatment Phase 2 – Fungus 1064nm Nd:YAG Module ... 23-21 23.8.8. Combination with Local Substances... 23-22 23.8.9. Post-Treatment Care ... 23-23
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23.8.10. Follow Up ... 23-23
CHAPTER 24 LP 1320nm Nd:YAG Module 24.1. 24.2. 24.3. 24.4. 24.5. 24.6.
Page
LP 1320nm Nd:YAG Module Description... 24-2 LP 1320nm Nd:YAG Module Specifications ... 24-2 LP 1320nm Nd:YAG Module Operating Screens ... 24-3 LP 1320nm Nd:YAG Module Regulatory Labels ... 24-4 Ordering Information... 24-4 LP 1320nm Nd:YAG Module Clinical Guide ... 24-5 24.6.1. Indications for Use ... 24-5 24.6.2. Contraindications ... 24-5 24.6.3. Pre-Treatment ... 24-6 24.6.4. Treatment ... 24-7 24.6.5. Suggested Setup Parameters... 24-8 24.6.6. Follow-up... 24-8
CHAPTER 25 Cooled Long Pulse 1320nm Nd:YAG Module 25.1. 25.2. 25.3. 25.4. 25.5. 25.6. 25.7.
Cooled Long Pulse 1320nm Nd:YAG Module Description ... 25-2 Cooled Long Pulse 1320nm Nd:YAG Module Specifications ... 25-3 Tip Installation ... 25-4 Cooled Long Pulse 1320nm Nd:YAG Module Operating Screens ... 25-6 Cooled Long Pulse 1320nm Nd:YAG Module Regulatory Labels ... 25-7 Ordering Information... 25-7 Cooled Long Pulse 1320nm Nd:YAG Module Clinical Guide ... 25-8 25.7.1. Indications for Use ... 25-8 25.7.2. Contraindications ... 25-8 25.7.3. Assessing the Condition ... 25-9 25.7.4. Pre-Treatment ... 25-9 25.7.5. Treatment ... 25-10 25.7.6. Suggested Setup Parameters... 25-11 25.7.7. Follow-up... 25-11
CHAPTER 26 iPixelEr 2940nm Scanner Module 26.1. 26.2. 26.3. 26.4.
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iPixelEr 2940nm Scanner Module Description ... 26-2 iPixelEr Scanner 2940nm Er:YAG Module Specifications... 26-3 iPixelEr Scanner 2940nm Er:YAG Module Operating Screen ... 26-4 iPixelEr Scanner 2940nm Er:YAG 2940nm Module Regulatory Labels ... 26-4
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26.5. 26.6.
Ordering Information ... 26-5 iPixelEr Scanner 2940nm Er:YAG Clinical Guide ... 26-6 26.6.1. Indications for Use with Standard Accessory Tips ... 26-6 26.6.2. Indications for Use with Pixel Accessory Tips ... 26-8 26.6.3. Contraindications ... 26-8 26.6.4. Pre-Treatment... 26-9 26.6.5. Treatment Procedure ... 26-11 26.6.6. Suggested Setup Parameters ... 26-13 26.6.7. Post-Treatment Care & Follow-Up... 26-14
CHAPTER 27 NIR Face Module 27.1. 27.2. 27.3. 27.4. 27.5. 27.6.
NIR Face Module Description ... 27-2 NIR Face Module Specifications ... 27-3 NIR Face Module Operating Screen ... 27-3 NIR Face Module Regulatory Labels ... 27-4 Ordering Information ... 27-4 NIR Face Module Clinical Guide – General Applications ... 27-5 27.6.1. Introduction ... 27-5 27.6.2. Intended Use and Indications ... 27-5 27.6.3. Contraindications ... 27-5 27.6.4. Pre-Treatment... 27-6 27.6.5. Treatment... 27-8 27.6.6. Suggested Setup Parameters ... 27-10 27.6.7. Post-Treatment Care ... 27-11 27.6.8. Concluding Treatment ... 27-11 27.6.9. Follow-Up... 27-11
CHAPTER 28 Er:Glass 1540nm Module 28.1. 28.2. 28.3. 28.4. 28.5. 28.6.
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Er:Glass 1540nm Module Description ... 28-2 Er:Glass 1540nm Module Specifications ... 28-3 Er:Glass 1540nm Module Operating Screens ... 28-3 Er:Glass 1540nm Module Regulatory Labels ... 28-4 Ordering Information ... 28-5 Er:Glass 1540nm Module Clinical Guide ... 28-5 28.6.1. Pre-Treatment... 28-5 28.6.2. Treatment... 28-6 28.6.3. Suggested Setup Parameters - Acne ... 28-8 28.6.4. Treatment... 28-8 28.6.5. Suggested Setup Parameters – Acne Scars... 28-10
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28.6.6. 28.6.7. 28.6.8.
Treatment ... 28-10 Suggested Setup Parameters – Benign Facial Lesions ... 28-12 Follow-up... 28-12
List of Figures Figure
Description
Page
Figure 2-1: High Power UV Module (Violet Color Code) ... 2-2 Figure 2-2: High Power UV Module Operating Screen ... 2-3 Figure 2-3: High 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: SVL Module (Turquoise Color Code) ... 4-2 Figure 4-2: SVL Module Operating Screen ... 4-3 Figure 4-3: SVL Module Regulatory Labels ... 4-4 Figure 5-1: SVL Cooled Module (Turquoise Color Code) ... 5-2 Figure 5-2: SVL Cooled Module Operating Screen ... 5-3 Figure 5-3: SVL Cooled Module Regulatory Labels ... 5-4 Figure 6-1: VL/PL Module (Green Color Code) ... 6-2 Figure 6-2: VL/PL Module Operating Screen ... 6-3 Figure 6-3: VL/PL Module Regulatory Labels ... 6-4 Figure 7-1: VL/PL Cooled Module (Green Color Code) ... 7-2 Figure 7-2: VL/PL Cooled Module Operating Screen ... 7-3 Figure 7-3: VL/PL Cooled Module Regulatory Labels ... 7-4 Figure 8-1: Dye-VL Pro Module (Light Green) ... 8-3 Figure 8-2: Dye-VL Pro Module Operating Screens ... 8-4 Figure 8-3: Dye-VL Pro Module Regulatory Labels ... 8-5 Figure 9-1: Yellow LED Module... 9-2 Figure 9-2: Yellow LED Module Operating Screen ... 9-3 Figure 9-3: Yellow LED Module Regulatory Labels ... 9-4 Figure 10-1: SR Module (Yellow Color Code) ... 10-2 Figure 10-2: SR Module Operating Screen ... 10-3 Figure 10-3: SR Module Regulatory Labels ... 10-4 Figure 11-1: SR Cooled Module (Yellow Color Code) ... 11-2 Figure 11-2: SR Cooled Module Operating Screen ... 11-3 Figure 11-3: SR Cooled Module Regulatory Labels ... 11-4
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Figure 12-1: SSR Cooled Module (Green Color Code) ... 12-2 Figure 12-2: SSR Cooled Module Operating Screen... 12-3 Figure 12-3: SSR Cooled Module Regulatory Labels ... 12-4 Figure 13-1: Dye-SR Pro Module (Orange Color Code) ... 13-3 Figure 13-2: Dye-SR Pro Module Operating Screen ... 13-4 Figure 13-3: Dye-SR Pro Module Regulatory Labels ... 13-5 Figure 14-1: HR Module (Red Color Code) ... 14-2 Figure 14-2: HR Module Operating Screen... 14-3 Figure 14-3: HR Module Regulatory Labels ... 14-4 Figure 15-1: SHR Pro (3) Cooled Module (Brown Color Code)... 15-3 Figure 15-2: SHR Pro (3) Cooled Cooling Module Operating Screens ... 15-5 Figure 15-3: SHR Pro (3) Cooled Module Regulatory Labels ... 15-6 Figure 16-1: SHR Pro (5) Cooled Module Handpiece (Brown Color Code) ... 16-3 Figure 16-2: SHR Pro (5) Cooled Module Operating Screens ... 16-5 Figure 16-3: SHR Pro 5 Module Regulatory Labels ... 16-6 Figure 17-1: ST Module (Burgundy Color Code) ... 17-2 Figure 17-2: ST Module Operating Screen ... 17-3 Figure 17-3: ST Module Regulatory Labels ... 17-4 Figure 18-1: SST Cooled Module (Burgundy Color Code) ... 18-2 Figure 18-2: SST Cooled Module Operating Screen ... 18-3 Figure 18-3: SST Cooled Module Regulatory Labels ... 18-4 Figure 19-1: QSW 1064nm Nd:YAG Module ... 19-2 Figure 19-2: QSW 1064nm Nd:YAG Module Operating Screen with Standard Tip ... 19-4 Figure 19-3: QSW 1064nm Nd:YAG Module Regulatory Labels ... 19-5 Figure 20-1: High Power QSW 1064nm Nd:YAG Module ... 20-2 Figure 20-2 (cont.): High Power QSW Pixel 5x5 mm Tips ... 20-3 Figure 20-3: High Power QSW Roller Tips ... 20-3 Figure 20-4: High Power QSW 1064nm Nd:YAG Module Operating Screens with Standard 5mm Tip (Top) and 5x5 Pixel Tip (Bottom) ... 20-5 Figure 20-5: High Power QSW 1064nm Nd:YAG Module Operating Screen with 7x1 Roller Tip ... 20-6 Figure 20-6: High Power QSW 1064nm Nd:YAG Module Regulatory Labels ... 20-7 Figure 21-1: LP 1064nm Nd:YAG Module... 21-2 Figure 21-2: LP 1064nm Nd:YAG Screen ... 21-3 Figure 21-3: LP 1064nm Nd:YAG Module Regulatory Labels ... 21-5 Figure 22-1: Cooled Long Pulse 1064nm Nd:YAG Module ... 22-2 Figure 22-2: Cooled Long Pulse 1064nm Nd:YAG Screen ... 22-3 Figure 22-3: Cooled Long Pulse 1064nm Nd:YAG Module Regulatory Labels ... 22-5 Figure 23-1: Fungus 1064nm Nd:YAG Module... 23-3 Figure 23-2: Fungus 1064nm Nd:YAG Screens... 23-5 Figure 23-3: Fungus 1064nm Nd:YAG Module Regulatory Labels ... 23-7 Figure 23-4: Correct Patient Positioning ... 23-17 Figure 23-5: Treatment Area Definitions ... 23-18 Figure 23-6: Lasing Path of Each Pass over the Toenail Plate during Treatment ... 23-19
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Figure 24-1: LP 1320nm Nd:YAG Module ... 24-2 Figure 24-2: LP 1320nm Nd:YAG Module Screen ... 24-3 Figure 24-3: LP 1320nm Nd:YAG Module Regulatory Labels ... 24-4 Figure 25-1: Cooled Long Pulse 1320nm Nd:YAG Module ... 25-2 Figure 25-2: Connection Feet for the Tips ... 25-4 Figure 25-3: Pixel Tip Replacement Procedure (1) ... 25-4 Figure 25-4: Pixel Tip Replacement Procedure (2) ... 25-5 Figure 25-5: Pixel Tip Replacement Procedure (3) ... 25-5 Figure 25-6: Cooled Long Pulse 1320nm Nd:YAG Screen ... 25-6 Figure 25-7: Cooled Long Pulse 1320nm Nd:YAG Module Regulatory Labels... 25-7 Figure 26-1: iPixelEr Scanner 2940nm Er:YAG Module... 26-2 Figure 26-2: iPixelEr Scanner 2940nm Er:YAG Module Screen ... 26-4 Figure 26-3: iPixelEr Scanner 2940nm Er:YAG Module Regulatory Labels ... 26-4 Figure 27-1: NIR Face Module ... 27-2 Figure 27-2: NIR Face Screen ... 27-3 Figure 27-3: NIR Face Module Regulatory Labels ... 27-4 Figure 27-4: Treatment Phases ... 27-9 Figure 28-1: Er:Glass 1540nm Laser Handpiece ... 28-2 Figure 28-2: Er:Glass 1540nm Module Screen with Standard 4 mm Tip ... 28-3 Figure 28-3: Er:Glass 1540nm Module Regulatory Labels ... 28-4
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