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

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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
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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

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5SpaTouch Elite User Manual
Figure 6: Footswitch
2.2. Technical Information
Table 1: Technical Specifications
Technical Specifications
Light Source Light & Heat Energy (LHE)
Wavelength Range
HR 400-1200 nm
HR V-VI (optional) 550-1200 nm
Fluence 4-11 J/cm2
Spot Size
Standard 25 x 50 mm
Adaptor Sizes 13 x 50 mm; 13 x 35 mm; 13 x 12 mm
XL (optional) 35 x 50 mm
Pulse Generation Method Capacitor bank electrical discharge switch
Physical Dimensions 43 cm x 43 x 22 cm / 16.93 x 16.93 x 8.66 in. (w/d/h)
Weight 7 kg.; 15.43 lbs .
Electrical Requirements Single phase 100-240VAC, 50/60Hz, 6.3A, 50-60 Hz
Operation Conditions
Temperature 5º-30º C
Humidity 30%-80% RH
Transport & Storage
Temperature -20º- 80º C
Humidity 0%-95% RH; 0.1-1.5 atm.

SYSTEM DESCRIPTION
6 Revision 02, January 2011
2.3. Safety Features
Many features were built in to the SpaTouch Elite to help insure the safety of
the user and client. The following are a few examples:
Pressing the “Start/Stop” button when the confirmation
screen appears ensures the operator has selected the
correct treatment mode and/or protocols.
The “Ready” indicator light on the handpiece advises the
user when the system is charging (unlit) or ready to emit a
pulse (lit).
The Footswitch prevents accidental pulses.
An internal and independent safety electronic circuit shuts
down pulse flashing ability in the event of a disabled blower.
2.4. Major Precautions & Warnings
2.4.1. Precautions
Verify that SpaTouch Elite's nominal voltage (see label at
the bottom of the system console) conforms to the electrical
voltage of your electrical outlet. Make sure that the electrical
outlet has proper grounding.
Do not open SpaTouch Elite’s outer case, as dangerous
voltages are present inside the system.
Only Radiancy certified personnel are authorized to perform
service within the protective covers of SpaTouch Elite.
This system may not be operated or played with by children.
Children must be supervised when they are around or near
the system.

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7SpaTouch Elite User Manual
Persons with reduced physical, sensory or mental
capabilities, or lack of experience and knowledge, may not
operate the system unless they have been given instruction
and are under supervision.
To perform routine maintenance always shut down the
system. Disconnect power and wait a minimum of 5 minutes.
Performing maintenance procedures while the system is
connected, or less than 5 minutes from disconnection may
be hazardous to the operator and destructive to the system.
Never use any flammable substance such as acetone or
alcohol on the skin prior to treatment.
Never use flammable substances or harsh chemicals to
clean or disinfect any part of the SpaTouch Elite system.
Always make sure to completely lift the Handpiece off the
client’s skin between pulses in order to avoid excessive
heating of the handpiece or skin.
When the Handpiece is replaced, repeat testing procedures
for each client during the first 500 pulses.
2.4.2. Warnings
Verify that all safety measures are working properly.
Delivering excessive energy to the treatment site may cause
thermal damage to the skin, resulting in burns, crusting, or
abnormal pigmentation.
As a safety precaution, always have a first aid kit equipped
to treat burns at your disposal.
Although SpaTouch Elite is considered an “eye-safe” device
when operated according to instructions, supplying clients

SYSTEM DESCRIPTION
8 Revision 02, January 2011
with protective eyewear during facial treatment will provide
extra protection against discomfort from light exposure.
Never look directly at the light coming from the handpiece as
this may cause temporary eye discomfort.
Look away during the flash to further prevent discomfort.
Never allow the handpiece to emit a pulse into ‘free space’.
Always make sure that the Handpiece is pointed at and in
full contact with the skin during pulse application.
Even when the Energy level on the screen is set at “0”, the
system can still trigger a pulse. Therefore be aware of the
position of the Handpiece at all times to avoid accidental
flashing.
Always remain in visual contact with the screen to ensure
that the established energy is the correct "working energy".
Pigmented moles and beauty spots and any suspicious
(abnormal) pigmented lesion should be covered with a non-
flammable white sticker.
2.5. Contraindications
The SpaTouch Elite should not be used on clients who:
Used any method of epilation other than shaving in the treatment
area within the past 30 days.
Have inflammatory skin conditions or open sores.
Are pregnant or lactating.
Have tanned by sun or artificial tanning machine within the last 21
days.
Have a tattoo or permanent makeup in the treatment area.
Have abnormal skin conditions due to different diseases, conditions
(e.g. diabetes) or medicinal intake.

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9SpaTouch Elite User Manual
Have a history of skin disorders such as vitiligo or psoriasis in the
treatment area.
Have a history of local skin infections.
Have been treated with isotretinoin (Accutane) within the past 6
months.
Have used any medications, herbal preparations or chemicals within
the past 6 weeks that cause photosensitivity. These include but are
not limited to gold therapy, tetracycline or sulfa drugs, and certain
psychiatric medications.
In case of uncertainty regarding photosensitizing side-effects, have
the client consult their physician.
Suffer from epilepsy.
Have diseases related to photosensitivity, such as Porphyria,
Polymorphic Light Eruption, Solar Urticaria, Lupus and other
autoimmune diseases.
Have a history of herpes outbreaks in the treatment area, unless the
client has consulted their physician and received prophylaxis
treatment prior to treatment.
Have a history of skin cancer or clients who have areas of potential
skin malignancies.
Have received chemotherapy or radiotherapy treatments within the
past 5 years should not be treated without their acting physician's
consent.
Have been on a steroid regimen (i.e., asthma) over the last 3
months.
Have an active implant, such as a pacemaker, incontinence device,
insulin pump, etc.
Have any other condition which in the practitioner’s opinion would
make it unsafe for them to be treated.

SYSTEM DESCRIPTION
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2.6. Labels
This section describes the labels affixed to SpaTouch Elite. It is
recommended that users review the meaning of these labels for everyday
use and in case any details are needed for service.
The table below briefly reviews a number of the internationally recognized
symbols that are found on the SpaTouch Elite main unit and its external
package.
Table 2: International Standards Labels
Symbol Meaning
Attention, consult accompanying documents before
use
Attention, consult accompanying documents before
use
Manufacturer
Authorized representitive in the European community
Degree of protection against electric shock: Type BF
applied part
Protect the environment by not disposing of this
product with household waste (2002/96/EC). Check
your local authority for recycling advice and facilities
(Europe only).
The CE mark represents the compliance to the
European Low Voltage Directive 2006/95/EC and the
Electromagnetic Compatibility Directive 2004/108/EC.
Voltage label - appears on the outer package.
The C-Tick mark represents compliance to Australian
EMC Regulations.
120-240 VAC

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11SpaTouch Elite User Manual
Additional stickers found on the main unit and the handpieces include serial
numbers of system parts and usage warnings.
Table 3: Additional Labels
Label Location and Comments
Located on the back of the system this label
includes manufacturer details, voltage
information, and the system’s serial number.
Handpiece label located on the SpaTouch
Elite handpiece.
On rear panel.
On rear panel.
This warning appears on all handpieces, next
to opening.

SYSTEM DESCRIPTION
12 Revision 02, January 2011
2.7. Compliance with International Standards
The SpaTouch Elite complies with the following international standards and
directives:
EMC Standards:
EN 55014-1, EN 55014-2,
EN 61000-3-2, EN 61000-3-3
Harmonized Standards:
EN 60335-1; EN 60335-2-27 -
Household and similar electrical appliances –Part 1:
EU Directives:
- Low Voltage Directive 2006/95/EC
- Electromagnetic Compatibility Directive
2004/108/EC
The CE mark represents the compliance to the European Low
Voltage Directive 2006/95/EC and the Electromagnetic Compatibility
Directive 2004/108/EC.

13SpaTouch Elite User Manual
3. INITIAL SET UP
3.1. Unpacking SpaTouch Elite
The SpaTouch Elite system is supplied with the following components:
Main Unit (console)
1 Standard Handpiece
oOptional Handpieces:
XL Handpiece
Handpiece for sensitive skin (V-VI*)
Client Safety Goggles
3 Small Area Adaptors
oNot compatible or available with the XL handpiece
1 pack of 10 hygienic rings
Footswitch
Power Cable
User Manual
2 Fuses
Treatment Coat
*The V-VI handpiece addresses the comfort, safety and efficacy issues of treating clients with
skin types V and VI.
3.2. Electrical Requirements
Before unpacking SpaTouch Elite, make sure the work site meets the
following electrical requirements. SpaTouch Elite requires a separate single
phase supply line with nominal voltage (according to the local line voltage):
Single phase 100-240 VAC, 50-60 Hz, 6.3A,
SpaTouch Elite is grounded via the grounding conductor in the power cable
that is plugged into the wall power outlet. Good grounding is essential for
safe operation of the device.
It is recommended that the system’s power cable not be placed on the same
circuit as devices with heavy variable loads, such as air conditioning units.

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14 Revision 02, January 2011
The fuses located within the unit are rated 5x20T, 250V 6.3A for 100-
240VAC.
Be sure to use the appropriate fuse for your region's electrical requirements.
When a fault in the system occurs, the fuse will burn out and the system will
not run.
3.3. Installation
SpaTouch Elite is designed for easy installation and does not require any
on-site preparation. Installation is carried out as follows:
Unpack the system and place it in a designated location. It
should be placed on a flat, stable surface, such as table,
counter or sturdy cart.
Verify that the system is intact and that all its components
are present.
Verify that the nominal voltage, recorded on the underside of
the unit, conforms to the electrical voltage of your country
(100-120V/220-240V).
3.3.1. Handpiece Connection
Connect the Handpiece according to the following instructions (Figure 7):
a. Align the Handpiece power and air connectors with its
power outlet and air suction inlet. Use the metal prongs
as a guide.
b. Snap into place.
Figure 7: Handpiece Connection
Power and air
connections.
Connected
hand
p
iece