Radiancy SpaTouch Elite User manual

User Manual
January 2011, Revision 02

iii
© 2010-2011 Radiancy Inc. All right reserved.
SpaTouch Elite User Manual, January 2011. Part Number: 2026120, Revision 02
Note: The information in this document is confidential and proprietary. It is provided to
customers and authorized representatives of Radiancy only. The content of this manual is
furnished for informational use only, is subject to change without notice and should not be
construed as a commitment by Radiancy Inc.
LHE and Radiancy are registered trademarks of Radiancy Inc. in the United States and/or in
other countries.
The Quality Management System of Radiancy Ltd. complies with the Quality Management
Standard ISO 13485-2003.
Manufacturer: Radiancy (Israel) Ltd., 5 Hanagar St., P.O. Box 7329, Hod
Hasharon, 45240, Israel, Tel: [phone], Fax: [phone]
www.radiancy.com
Authorized European Representative: Obelis S.A,, Av. de
Tervuren 34 Bte .44, B-1040 Brussels, Belgium. Tel: [phone]
5954, Fax: [phone], GSM 07545 4660, e-mail:
[email protected]
Contact Information
Customer satisfaction is a Radiancy priority. To help us in providing you with
the best possible product and support, please send us your comments and
suggestions. Contact us at the addresses and telephone numbers below:
US
Radiancy Inc.
40 Ramland Road South, Suite 200
Orangeburg, NY 10962
USA
Toll Free: 888 661-2220
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
Israel
Radiancy (Israel) Ltd.
5 Hanagar St., P.O. Box 7329
Hod Hasharon, 45240
Israel
Tel: + 972-9-775-7500
Fax: + 972-9-775-7511
E-mail: [email protected]

iv
TABLE OF CONTENTS
Glossary of Terms vi
1. Introduction to the System 1
2. System Description 2
2.1. System Components and Controls .............................................................. 2
2.2. Technical Information..................................................................................... 5
2.3. Safety Features............................................................................................... 6
2.4. Major Precautions & Warnings..................................................................... 6
2.5. Contraindications............................................................................................ 8
2.6. Labels............................................................................................................... 10
2.7. Compliance with International Standards ................................................... 12
3. Initial Set up 13
3.1. Unpacking SpaTouch Elite............................................................................ 13
3.2. Electrical Requirements................................................................................. 13
3.3. Installation........................................................................................................ 14
4. General Guidelines for the Operation of SpaTouch Elite 16
5. Operation 19
5.1. Turning on the System................................................................................... 19
5.2. Working with the Touch Panel & Screen .................................................... 19
5.3. Emitting a Pulse.............................................................................................. 21
5.4. Adjusting Energy Level.................................................................................. 22
5.5. About Ready Mode......................................................................................... 22
5.6. System Shut Down......................................................................................... 22
5.7. Alerts ................................................................................................................ 23
5.8. Mute.................................................................................................................. 23
5.9. System Fault ................................................................................................... 23
6. Pre-Treatment 24
6.1. Client History................................................................................................... 24
6.2. Side Effects ..................................................................................................... 24
6.3. Informed Consent Form................................................................................. 25
6.4. Anesthesia....................................................................................................... 25
6.5. Pre-Treatment Preparations ......................................................................... 25
6.6. Post Treatment Care...................................................................................... 27
7. Treatment Protocols 28
7.1. Indications........................................................................................................ 28
7.2. Pre-Treatment................................................................................................. 28
7.3. Pre-Treatment Test ........................................................................................ 28
7.4. Work Protocol.................................................................................................. 30
7.5. Post-Treatment Care ..................................................................................... 30
7.6. Considerations for Feminine Facial Hair..................................................... 30
8. Maintenance 32
8.1. Cleaning Instructions ..................................................................................... 32
8.2. Parts & Attachments ...................................................................................... 34
9. Troubleshooting 36
10.System Errors: 37
11.SpaTouch Elite Service 39
12.Adverse Events Report Form 40
13.Warranty 43

v
LIST OF FIGURES
Figure 1: SpaTouch Elite Main System ..................................................................... 2
Figure 2: Front View of Console & Panel................................................................... 3
Figure 3: Handpiece Connections ............................................................................. 3
Figure 4: Back Panel.................................................................................................. 4
Figure 5: Handpiece................................................................................................... 4
Figure 6: Footswitch................................................................................................... 5
Figure 7: Handpiece Connection ............................................................................. 14
Figure 8: Main Power Switch Location .................................................................... 19
Figure 9: Location of On/Off Button/Switch ............................................................. 19
Figure 10: Touch Panel and Work Screen............................................................... 20
Figure 11: Work Screen ........................................................................................... 21
Figure 12: System Readiness; Wait ........................................................................ 22
Figure 13: System Readiness; Ready ..................................................................... 22
Figure 14: Approaching Pulse Limit......................................................................... 23
Figure 15: Pulse Limit Exceeded ............................................................................. 23
Figure 16: Mute Activated ........................................................................................ 23
Figure 17: Mute Deactivated.................................................................................... 23
Figure 18: Fault Indicator ......................................................................................... 23
Figure 19: Handpiece Cleaning Tool ....................................................................... 32
Figure 20: Applying Alcohol to the Cleaning Tool.................................................... 32
Figure 21: Cleaning the Lamps................................................................................ 33
Figure 22: Cleaning the Reflector ............................................................................ 33
Figure 23: Area Adaptor........................................................................................... 34
Figure 24: Fuse Location ......................................................................................... 35
LIST OF TABLES
Table 1: Technical Specifications .............................................................................. 5
Table 2: International Standards Labels .................................................................. 10
Table 3: Additional Labels........................................................................................ 11
Table 4: Energy Level Setting.................................................................................. 28
Table 5: Treatment Course Recommendations....................................................... 31
Table 6: List of System Errors.................................................................................. 37

vi
GLOSSARY OF TERMS
Efficacy: The ability to produce a desired effect;
Erythema: A reddening of the skin.
Hyperpigmentation: A skin condition in which there is excessive
pigmentation, often seen as dark spots on the skin.
Hypopigmentation: A skin condition in which there is a lack of
pigmentation. The skin appears paler than normal.
Keloids/Hypertrophic scarring: Smooth, pink, raised, firm, fibrous growths
on the skin that form secondary to injury.
Photosensitivity: Extreme sensitivity to the sun leaving the patient prone to
sunburn. Some medicines have this side effect.
Pigmentation: The amount of melanin (molecules containing color) in the
skin, hair, & eyes.
Vellus (facial) hair: Fine baby peach-fuzz hair that is not easily visible to
the naked eye.

1SpaTouch Elite User Manual
1. INTRODUCTION TO THE SYSTEM
SpaTouch Elite is a Light & Heat Energy (LHE®) based device for the
treatment of Hair Removal (HR). It is based on the principle of selective
photothermolysis, utilizing specific wavelength range and pulse duration to
selectively coagulate the hair follicles with minimal effect to the surrounding
skin tissue.
SpaTouch Elite consists of a console, a footswitch and one handpiece. The
handpiece contains a pulse switch, a ready indicator light and one treatment
lamp. The handpiece is held by the operator and placed directly upon the
treatment area. The operator then simultaneously presses the footswitch
and the pulse button to emit the therapeutic pulse. In this manual, the term
operator applies to all qualified personnel trained to operate the SpaTouch
Elite system.
Important Note – The SpaTouch Elite user manual is meant as a
starting point for treatment, a reference guide of general
recommendations. As you gain more experience with the device, you
may use your personal expertise to better individualize treatment
parameters.

2 Revision 02, January 2011
2. SYSTEM DESCRIPTION
This chapter provides a detailed description of the SpaTouch Elite system,
its main components, controls, and technical specifications. Please review
this material to familiarize yourself with controls, ports and connectors, as
well as the consumable items used during treatment.
2.1. System Components and Controls
The SpaTouch Elite system consists of the following main components
(Figure 1):
System console (main unit)
Handpiece
Footswitch
Figure 1: SpaTouch Elite Main System
Console
Handpiece
Footswitch

CHAPTER 2
3SpaTouch Elite User Manual
2.1.1. Main Unit (System Console)
The main unit controls the operation of the entire system.
It includes the following major parts:
Front View:
Operation Panel, Display Screen, On Switch, Handpiece Cradle
Figure 2: Front View of Console & Panel
Right Side View:
Handpiece power and air connections
Figure 3: Handpiece Connections
Hand
p
iece Cradle
O
p
eration Panel
Dis
p
la
y
Screen
HP connections

SYSTEM DESCRIPTION
4 Revision 02, January 2011
Back View:
Power Cord Inlet, Main Power Switch, Fuse Drawer, Footswitch Port,
System Fan Outlet, Air Exhaust Port
Figure 4: Back Panel
2.1.2. Handpiece
The handpiece connects to the main unit by a spiral cable containing
electrical wiring and an air suction hose. The Handpiece consists of an LHE
lamp, pulse switch and pulse counter. When not in use, the handpiece
should be stored in its niche on the front of the main unit.
Figure 5: Handpiece
2.1.3. Footswitch
The footswitch arrives connected to the main unit. The system will emit a
pulse only if the footswitch and handpiece buttons are pressed
simultaneously.
Main Power Switch System Fan Outlet
Power Cord Inlet
Warning: Do not drop the handpiece. This may damage the lamp/handpiece.
Pulse Switch
Footswitch Port
Air Exhaust Port
Fuse Drawer
LHE Lamp
Green ‘Ready’
Indicator Li
g
hts