Radiancy SpaTouch Elite User manual

User Manual
January 2011, Revision 02

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© 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]

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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

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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