Syneron Candela VelaShape III User manual

System User Manual
PB81499EN

PB81499EN
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Copyright © 2015 Syneron Medical Ltd. All rights reserved.
Syneron Medical Ltd. reserves the right to make changes to its products or specifications to improve performance,
reliability, or manufacturability. Information furnished by Syneron Medical Ltd. is believed to be accurate and
reliable. However, Syneron Medical Ltd. assumes no responsibility for its use. No license is granted by its
implication or otherwise under any patent or patent rights of Syneron Medical Ltd.
No part of this document may be produced or transmitted in any form or by any means, electronic or mechanical,
for any purpose, without the express written permission of Syneron Medical Ltd.
Data is subject to change without notification.
Syneron Medical Ltd. has patents and pending patent applications, trademarks, copyrights, or other intellectual
property rights covering subject matter in this document. The furnishing of this document does not give you any
license to these patents, trademarks, copyrights, or other intellectual property rights except as expressly provided in
any written agreement from Syneron Medical Ltd.
Specifications are subject to change without notice.
Manual Catalog Part Number: PB81499EN
Revision Release Date: January 2015
●Before using the device, please check local regulations. If any local legislation is violated,
use cannot be authorized.
●In the United States, federal law restricts prescription medical devices to be sold by or on
the order of a physician, or properly licensed practitioner. Syneron makes no
representations regarding federal, state, or local laws or regulations that might apply to the
use and operation of this device.
Contact information for equipment manufacturer and technical services:
●Syneron, Inc.
3 Goodyear, Suite A
Irvine, CA 92618
USA
Tel: + 1.866.259.6661 (toll free)
●CEpartner4u B.V.
Esdoornlaan 13
3951 DB Maarn
The Netherlands
Tel: + 31.343.442.524
Fax: + 31.343.442.162
●Syneron Medical (HK) Ltd.
Room 3103, 31/F, Hopewell Centre,
183 Queen's Road East, Wan Chai, Hong Kong
Tel: [phone]
[phone]
Fax: [phone]
●Syneron Medical Ltd.
P.O. Box 550
Industrial Zone, Tavor Building
Yokneam Illit 20692
Israel
Tel: + 972.73.244.2200
Fax: + 972.73.244.2202
●Website: www.Syneron-Candela.com
●E-mail: [e-mail]

Table of Contents
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TABLE OF CONTENTS
1. Before You Start.......................................................................................................................................8
Conventions Used in this Manual........................................................................................................8
Explanation of the Symbols Used in the System.................................................................................9
2. Safety .....................................................................................................................................................10
Introduction........................................................................................................................................10
System Safety Features ....................................................................................................................11
Patient and Personnel Safety............................................................................................................11
Grounding the System.......................................................................................................................12
Operating the System........................................................................................................................12
Infrared Energy Safety Issues ...........................................................................................................12
Radio Frequency Energy Safety Issues............................................................................................12
Mechanical Rollers Safety Issues (Vsmooth Applicator)...................................................................13
Electrical and Mechanical Safety.......................................................................................................13
Maintaining the System .....................................................................................................................13
Fire Hazards ......................................................................................................................................14
System Classifications.......................................................................................................................14
System Nameplate ............................................................................................................................15
3. System Description ................................................................................................................................16
System Overview...............................................................................................................................17
Console .........................................................................................................................................17
Applicators.....................................................................................................................................18
Anatomy of Cellulite...........................................................................................................................20
The VelaShape III Procedure............................................................................................................20
Heating of Dermis and Hypodermis with elōs....................................................................................22
Mechanical Effects of Vacuum on the Skin.......................................................................................22
4. System Installation.................................................................................................................................23
Unpacking the System.......................................................................................................................23
Equipment List...................................................................................................................................25
Cover Packs ......................................................................................................................................25
System Dimensions...........................................................................................................................26
Installation Process............................................................................................................................27
Moving the System within the Facility................................................................................................30
Moving the System to another Facility...............................................................................................30
Electrical Requirements.....................................................................................................................30
Environmental Requirements ............................................................................................................31
5. Operating Instructions............................................................................................................................32
Activating the System........................................................................................................................32
Automatic Vacuum and RF Test...................................................................................................32
Setting Treatment Parameters – Tablet Control Panel .....................................................................33
Default Settings.............................................................................................................................35
Setting Treatment Parameters – Applicator Control Panel ...............................................................35
Utilities Mode .....................................................................................................................................37
System Information Screen...........................................................................................................37
Maintenance Screen .....................................................................................................................38
Settings Screen.............................................................................................................................39
User Diagnostics Screen...............................................................................................................40
Service Mode Screen....................................................................................................................41

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Video List Screen..........................................................................................................................42
Initiating Treatment............................................................................................................................43
6. Clinical Guide: Cellulite and Circumference Treatment.........................................................................44
Realistic Expectations .......................................................................................................................44
Indications .........................................................................................................................................44
Contraindications...............................................................................................................................44
Possible Side Effects.........................................................................................................................46
Pre-Treatment Preparation................................................................................................................46
Selecting the Appropriate Treatment Type........................................................................................47
VelaShape III Measurement..............................................................................................................48
Circumference...............................................................................................................................49
Cellulite .........................................................................................................................................50
Treatment Procedure.........................................................................................................................51
Applicator Positioning....................................................................................................................52
Test Spot.......................................................................................................................................52
Treatment Technique: Identifying the Applicator and Cover.............................................................52
Treatment Using the VContour Applicator....................................................................................52
Treatment Protocol Using the Circumference Mode.........................................................................53
Treatment Protocol of Large Areas Using Circumference Mode (Medium Cover).......................53
Treatment Protocol of Small Areas Using Circumference Mode (Small Cover)...........................56
Treatment Protocol Using Deep Mode..............................................................................................57
Treatment Protocol of Focal Fat Deposits Using Deep Mode (Large and Medium Covers)........57
Cellulite Mode Treatment Protocol Using the VSmooth Applicator...................................................63
Treatment Protocol Using Cellulite Mode .....................................................................................63
Treatment Options with Cellulite Mode.........................................................................................68
Endpoints (When to Stop Treating an Area).....................................................................................69
Post-Treatment Care.........................................................................................................................70
Treatment Conclusion .......................................................................................................................70
7. Maintenance...........................................................................................................................................71
Cleaning the Console........................................................................................................................71
Cleaning and Maintaining the VSmooth Applicator...........................................................................72
Replacing the VSmooth Applicator's Filters..................................................................................74
Cleaning and Maintaining the VContour Applicator ..........................................................................75
Cleaning the VContour Applicator's Filter.....................................................................................76
Cleaning the System Air Filter...........................................................................................................77
8. Troubleshooting Guide...........................................................................................................................78
9. System Specifications............................................................................................................................81
Output Parameters............................................................................................................................81
Treatment Area Footprints.................................................................................................................81
Control Panel.....................................................................................................................................81
Electrical Requirements.....................................................................................................................81
Environmental Requirements............................................................................................................82
Treatment Room...........................................................................................................................82
Storage/Transportation .................................................................................................................82
Degree of Protection Against Ingress of Water ............................................................................82
System Console Dimensions [W x D x H].........................................................................................82
Weight................................................................................................................................................82
10. Electromagnetic Compliance...............................................................................................................83
Electromagnetic Emissions ...............................................................................................................83
Electromagnetic Immunity.................................................................................................................84

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Recommended Separation Distances...............................................................................................86
LIST OF FIGURES
Figure 1: System Nameplate Location.......................................................................................................15
Figure 2: VelaShape III System .................................................................................................................17
Figure 3: VContour Applicator [Left: Operator Panel / Right: Applicator Elements]..................................18
Figure 4: VSmooth Applicator Elements....................................................................................................19
Figure 5: Anatomy of Cellulite....................................................................................................................20
Figure 6: elōs Heating and Mechanical Manipulation Action ....................................................................20
Figure 7: Before Treatment........................................................................................................................21
Figure 8: After VelaShape III Treatment Reduction in the Size of the Fat Cells and Fat Chambers........21
Figure 9: Unpacking the System................................................................................................................23
Figure 10: System Dimensions ..................................................................................................................26
Figure 11: Umbilical Support Mast.............................................................................................................27
Figure 12: Mast and Umbilical Cable Installation.......................................................................................27
Figure 13: Umbilical Connection Port.........................................................................................................28
Figure 14: Applicator on Handle.................................................................................................................28
Figure 15: Service Panel............................................................................................................................29
Figure 16: Main Menu Screen....................................................................................................................33
Figure 17: Treatment Settings Ribbon.......................................................................................................34
Figure 18: Default Settings.........................................................................................................................35
Figure 19: Applicator Control Panels .........................................................................................................35
Figure 20: Applicator Control Panel Display ..............................................................................................36
Figure 21: Control Panel Buttons...............................................................................................................36
Figure 22: Parameter Icons and Level Displays ........................................................................................36
Figure 23: System Information Screen; About VelaShape III Tab.............................................................37
Figure 24: System Information Screen; Counters Tab...............................................................................37
Figure 25: Maintenance Screen.................................................................................................................38
Figure 26: Settings Screen; Date & Time Tab...........................................................................................39
Figure 27: Settings Screen; Display Settings Tab .....................................................................................39
Figure 28: Settings Screen; Audio Settings Tab........................................................................................40
Figure 29: User Diagnostics Screen ..........................................................................................................40
Figure 30: Service Mode Screen................................................................................................................41
Figure 31: Video List Selection Tab...........................................................................................................42
Figure 32: Maintenance Videos (example) ................................................................................................42
Figure 33: Practice Enhancement Videos (example).................................................................................43
Figure 34: Illustration of Circumference Measurements: A) Fixed Distance between the Legs;
B) Labeling the circumference; C) Measuring Horizontally;
D) Labeling the Arm Against a Wall..........................................................................................49
Figure 35: Illustration of cellulite stages (A- Stage Zero; B- Stage One; C- Stage Two; D- Stage Three) 50
Figure 36: Sub-Area Divided into Segments..............................................................................................53
Figure 37: Identifying Sub-Areas and Segments for Anterior and Posterior Abdomen
Circumference Reduction..........................................................................................................53
Figure 38: Cycle 1 “HorizontalSnake-Like” ...............................................................................................54
Figure 39: Cycle 2 “VerticalSnake-Like”....................................................................................................55
Figure 40: Sub-Area Divided into Segments..............................................................................................56
Figure 41: Cycle 1 and Cycle 2 in Small Sub-Areas..................................................................................57

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Figure 42: Deep Mode protocol Segmentation..........................................................................................57
Figure 43: Flanks (A) and Middle Back (B) Segmentation for the Treatment of Focal Fat Deposit..........58
Figure 44: Cycle 1-Step #1 “Horizontal Snake-Like” .................................................................................60
Figure 45: Cycle 1 – Step #2 “Vertical Snake-Like”...................................................................................61
Figure 46: Cellulite Mode Protocol Sub-Area Segmentation.....................................................................63
Figure 47: Segment A Treatment Illustration.............................................................................................65
Figure 48: Segment B Treatment Illustration.............................................................................................65
Figure 49: Segment C Treatment Illustration.............................................................................................66
Figure 50: Segment D Treatment Illustration.............................................................................................66
Figure 51: Horizontal Snake-Like...............................................................................................................67
Figure 52: Vertical Snake-Like...................................................................................................................67
Figure 53: Removing the VSmooth Replaceable Cover............................................................................72
Figure 54: VSmooth Applicator's Internal Components.............................................................................73
Figure 55: Replacing the VSmooth Applicator's Filters..............................................................................74
Figure 56: Applicator's Internal Components.............................................................................................75
Figure 57: Replacing the VelaShape III Applicator's Filter ........................................................................76
Figure 58: Cleaning the Air Filter...............................................................................................................77

Before You Start
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1. BEFORE YOU START
Warning
●Read this manual to become familiar with all safety requirements
and operating procedures before attempting to operate the system.
●Any intense optical energy or radio frequency (RF) device can
cause injury if used improperly.
●High voltage is present inside the system. Always be aware of the
possible dangers and take proper safeguards as described in this
manual.
●The VelaShape III system must be serviced only by Syneron
Medical Ltd. qualified personnel.
Conventions Used in this Manual
The following conventions in the form of notes, cautions and warnings are used
in this manual:
Note
The content of this Note offers general information that is important to
keep in mind.
Caution
A Caution alerts the user to the possibility of a potentially hazardous
situation which, if not avoided, may result in minor or moderate injury to
the user or damage to the equipment.
Warning
A Warning alerts the user to the possibility of injury, death, or serious
adverse reactions associated with the use or misuse of the system.

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Explanation of the Symbols Used in the System
Symbol Description
Refer to instruction manual/booklet
Caution!
0344 CE Compliance Symbol
Waste of Electrical and Electronic Equipment (WEEE)
compliance symbol
RF Interference may occur in the vicinity of equipment
with the following symbol
Product Shelf-Life: product may not be stored for longer
than this period after being opened for the first time
Fuse
Type BF Equipment
Manufacturer
Authorized Representative in the European Union

Safety
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2. SAFETY
This chapter describes the safety issues regarding the use and maintenance of the
VelaShape III system, with special emphasis on optical and electrical safety.
Introduction
The system is designed for safe and reliable treatment, when used in accordance
with proper operation and maintenance procedures. Only trained practitioners are
qualified to operate the system. The user and all other personnel operating or
maintaining the system should be familiar with the safety information provided in
this chapter. Syneron Medical Ltd. assumes no liability whatsoever for any
damage or injury as a result of an application of a product which is not in strict
accordance with the instructions provided with the product. The primary
consideration should be to maximize safety for both treating attendant and the
patient.
Warning
●Read this chapter to be familiar with all of its safety requirements
and operating procedures prior to operating the system.
●Any intense optical energy or RF device can cause injury if used
improperly.
●High voltage is present inside the system.
●Always be aware of the possible dangers and take proper
safeguards as described in this manual.
●In the event of adverse effects or injury/illness, immediately
contact:
- In North America: Syneron, Inc.
- In Europe: CEpartner4u B.V.
- Outside North America and Europe: Syneron Medical Ltd.
●For complete contact information please refer to page 3 of this
manual.

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System Safety Features
The VelaShape III system incorporates the following safety features:
●The power electronics cannot be activated unless an applicator has been
connected to the system.
●Upon system activation, IR, RF, and Vacuum are at Level 0on the control
panel.
●During activation, the system performs a self-test of the hardware to detect
any faults, so that you can shut down the system if necessary.
●IR and RF energies are not delivered unless full contact with the tissue is
conducted and the applicator's trigger or footswitch is pressed.
Patient and Personnel Safety
When handling the VelaShape III system, the primary safety concern should be
the safety of both the treating attendant and the patient. Follow these personal
safety guidelines to maintain a high level of personnel safety:
●Make sure that only well-trained attendants perform treatment.
●Before activating the system, make sure any long hair of the treating attendant
or the patient is safely pulled back and tied.
●Ascertain that all jewelry is removed.
●Prior to scheduling treatments, obtain a detailed patient history to verify that
the patient is eligible and is in fit condition to undergo treatment.
●Fully inform the patient regarding the treatment protocol, the likely results
and any risks associated with treatment.
●Improper treatment may cause local burns.
●Opaque eye protection should be used when working within a 30 cm (12")
proximity to the patient's eyes.
Warning
Prior to system activation, any personnel operating or maintaining the
system should be familiar with the safety information provided in this
chapter.

Safety
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Grounding the System
When installing the system, ensure that the system is grounded through the
grounding conductor in the power cable. This protective grounding is essential
for safe operation.
Operating the System
●Keep all system panels closed. Do not remove the panels and do not touch
any of the system's inner components.
●Keep your hands away from the applicator during system start-up.
●Keep the applicator dry and clean.
●Do not allow the replaceable applicator covers to come in contact with hard
materials, excessive heat or humidity; these may damage the RF electrodes.
●Never use the system in the presence of explosive or flammable materials.
●Make sure that all treatment personnel are familiar with the system's controls
and know how to shut down the system in the event of an emergency.
Infrared Energy Safety Issues
The VelaShape III emits gentle heating infrared light in a continuous wave mode.
Light emission is contained within the applicator chamber and occurs only when
the operator presses the trigger button on the applicator or footswitch, when an
adequate vacuum seal is achieved and the RF electrodes are in full contact with
the treated surface. Opaque eye protection should be used when working within a
30 cm (12") proximity to the patient's eyes.
Do not aim the applicator at anything but the intended target area; it should
always be oriented toward the treatment area, and the trigger button or footswitch
pressed only when full contact is made with the skin. In rare cases superficial
crusting may be formed on the skin from the IR effect.
Radio Frequency Energy Safety Issues
The RF energy provides gentle heating that is distributed deep into the skin via
bi-polar electrodes. Full coupling of both electrodes to the skin, after applying
VelaSpray Ease or any other recommended product, is necessary before pressing
the trigger button or footswitch, so that the RF energy is safely conducted to
penetrate the skin. If coupling with the skin is broken due to incomplete contact
or removing the applicator from the treatment site while the trigger or footswitch
is pressed, IR and RF modes are disabled and an error message on the control
panel indicates insufficient coupling. The trigger or footswitch should be released
immediately and the applicator should be re-oriented on the skin. In rare cases
superficial crusting may be formed on the skin from the RF effect.

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Because of the heating effect by RF energy, highly conductive objects such as
superficial metal or conductive implants, rods, plates or pins should be avoided in
the treatment area.
Mechanical Rollers Safety Issues (Vsmooth Applicator)
Beware of any loose material in or near the immediate treatment area that may
get caught in the rollers. There should be no loose cords, clothing, hair, etc. in the
treatment area. Ensure integrity of rollers' coating before and during treatment.
Electrical and Mechanical Safety
●Keep all system panels closed. Removing the panels creates a safety hazard.
●Keep hands away from the applicator during system start-up.
●Perform maintenance procedures when the system is shut down and
disconnected from its electrical power source.
●The system's cables are equipped with isolation coating and the electronic
circuitry is also isolated from the mains power supply. In addition, the
system’s plastic covers serve as a means of isolation.
●Move the system slowly and carefully. The system weighs approximately
20 kg (44 lbs.) and may cause injury if proper care is not used when moving it.
●The system is grounded through the grounding conductor in the power cable.
This protective grounding is essential for safe operation. The RF electrodes
are the only non-grounded component of the system, due to the nature of the
treatment.
●Portable and mobile RF communications equipment can affect medical
electrical equipment, Interference may occur in the vicinity of the equipment.
●The use of accessories and cables other than those specified may result in
increased emissions or decreased immunity of the device. It is forbidden to
connect any third-party equipment to the system without written approval
from Syneron Medical.
Maintaining the System
●Only authorized Syneron technicians are qualified to service the system.
●Shut down the system and disconnect the power cable before performing any
maintenance procedures (see Chapter 7).

Safety
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Fire Hazards
●The absorption of optical energy or conduction of RF raises the temperature
of the absorbing material. Do not use the system in the presence of explosive
or flammable materials.
●Do not use flammable substances when preparing the skin for treatment.
●If alcohol is used for disinfecting, it must be allowed to dry thoroughly before
the system is used.
System Classifications
●Electric shock protection: Class A, Group I
●Protection against ingress of liquids: Ordinary equipment
●Not suitable for use in presence of flammable substances.

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System Nameplate
The following illustration (see Figure 1) displays the location of the system's
nameplate, which includes the system's identification, regulatory and electrical
requirement information:
Figure 1: System Nameplate Location

System Description
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3. SYSTEM DESCRIPTION
The VelaShape III is a device that combines elōs technology (electro optical
synergy) with mechanical manipulation of the skin using gentle vacuum suction.
The system is designed for use in medical and aesthetic practices, to be user-
friendly, safe and reliable. It integrates the following technologies:
●Infrared (IR) optical energy.
●Bipolar conductive radio frequency (RF) current.
●Mechanical manipulation (vacuum with or without massage rollers).
These three technologies work together to provide dermal and sub-dermal
heating, and mechanical modifications resulting in improved blood circulation,
enhanced lymphatic drainage, as well as an increased metabolic rate of the
adipose tissue.
While this system is considered safe for both the operator and the patient, it
should be operated only by trained, qualified treating attendants.

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System Overview
The system includes three core modules: the Console,Applicator and Touch-
Screen Control Panel (see Figure 2).
Figure 2: VelaShape III System
Console
The VelaShape III console houses the following components:
●Power supply
●IR LEDs power supply
●Vacuum pump
●Main CPU
●RF generator
●Tablet
●Other power components

System Description
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Applicators
The VSmooth and VContour applicators are used for the physical
implementation of the RF current, IR energy and mechanical manipulation
treatment parameters.
The VContour applicator (see Figure 3) utilizes RF and mechanical
manipulation by vacuum. It is used for circumference reduction and focal fat
deposit treatment in different body areas such as: abdomen, flanks, thigh, arms,
middle-back, submental, etc.
The VSmooth applicator (see Figure 4) utilizes IR, RF and mechanical
manipulation by vacuum and massage rollers. It is used for cellulite and skin
treatment in different zones such as: abdomen, thigh, buttocks, arms, etc.
The VelaShape III applicators are composed of a permanent handpiece and a
replaceable cover. The replaceable covers of the VelaShape III applicators are
usable for limited periods of time.
The replaceable cover of the VelaShape III applicator should be replaced
according to the schedule printed on the cover's storage box, or sooner if one of
the following is observed:
●After cleaning the replaceable cover and applicator spring connectors, an
Improve Vacuum Seal message appears on the screen.
●Electrodes appear damaged.
The filter should be cleaned or replaced according to the schedule printed on the
cover's storage box, or sooner if a reduction in vacuum effectiveness is observed.
Figure 3 shows the display and selector controls that are located on the operator
panel of the applicator as well as on the touch-screen control panel (see Figure 3).
Figure 3: VContour Applicator [Left: Operator Panel /
Right: Applicator Elements]
Figure 4 shows the VSmooth applicator and its operating elements:

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Figure 4: VSmooth Applicator Elements
Note
The images in the figures are for illustration purposes only.
The applicator is applied to the treatment area so that all four edges of the
aperture make a seal with the skin. This allows the vacuum to be effective and
ensures that the RF electrodes are fully coupled to the skin. Failure to achieve full
contact between the RF electrodes and skin, or failure to achieve proper vacuum
will result in disabled IR and RF energies, indicated by an RF out of range
message on the system’s control panel and applicator screen.

System Description
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Anatomy of Cellulite
Cellulite is characterized by
Dimpled Skin Surface – mattress-
like appearance (see Figure 5). The
fat cells are located in chambers
which are separated by vertical and
horizontal Connective Tissue
Septae. The Septae are anchored
rigid fibers that do not stretch with
the skin as the volume within the
walls of the chamber increases.
When the fat chamber becomes too
distended by enlarged fat cells and
by retained intercellular fluids, it protrudes beyond the length of the vertical
septae, pushing up the skin's surface and resulting in a dimpled skin appearance.
The VelaShape III Procedure
The application of elōs (IR and RF energies) to the dermis/hypodermis is
intended to deploy heat to the tissues that contribute to cellulite. The vacuum
contributes to increased blood circulation (see Figure 6). The blood, which is one
of the targets of the hyperthermic effect of the IR and RF, responds in a higher
diffusivity of oxygen. This in turn increases the metabolic breakdown of stored
fat by the fat cells (lipolysis), thereby reducing the size of the fat cells.
Consequently, the bumpiness of the skin, which is largely caused by distended fat
cells protruding up from the anchored
connective tissue septae, is reduced.
Figure 5: Anatomy of Cellulite
Figure 6: elōs Heating and
Mechanical Manipulation Action