VelaShape II

User Manual
PB70286EN
Copyright © 2016 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: PB70286EN
Revision Release Date: September 2016
● 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-Candela 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
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.
Rm. 2502-03 HopeWell Centre, 183 Queen’s Road East
Wanchai, Hong Kong
Tel: +852.2543.4326
Fax: +852.2543.4327
● Syneron Medical Ltd.
P.O. Box 550
Industrial Zone, Tavor Building
Yokneam Illit 2069200
Israel
Tel: + 972.73.244.2200
Fax: + 972.73.244.2202
● Website: www.Syneron-Candela.com
● E-mail: info@Syneron-Candela.com
PB70286EN 3
Table of Contents
TABLE OF CONTENTS
1. Before You Start .................................................................................................................................. 7
Conventions Used in this Manual ................................................................................................... 7
Explanation of the Symbols Used in the System ............................................................................ 8
2. Safety .................................................................................................................................................. 9
Introduction ..................................................................................................................................... 9
System Safety Features ............................................................................................................... 10
Patient and Personnel Safety ....................................................................................................... 10
Installing the System..................................................................................................................... 11
Operating the System ................................................................................................................... 11
Infrared Energy Safety Issues ...................................................................................................... 11
Radio-Frequency Energy Safety Issues ....................................................................................... 12
Mechanical Rollers Safety Issues ................................................................................................. 12
Electrical and Mechanical Safety .................................................................................................. 12
Maintaining the System ................................................................................................................ 13
Fire Hazards ................................................................................................................................. 13
System Classifications .................................................................................................................. 13
System Nameplate ....................................................................................................................... 14
3. System Description ........................................................................................................................... 15
System Overview .......................................................................................................................... 16
Console .................................................................................................................................... 16
Applicators ................................................................................................................................ 17
Communication Terminal ......................................................................................................... 19
Anatomy of Cellulite ...................................................................................................................... 20
The VelaShape II Procedure ........................................................................................................ 20
Heating of Dermis and Hypodermis with elōs............................................................................... 22
Mechanical Effects on the Skin..................................................................................................... 22
4. System Installation ............................................................................................................................ 23
Unpacking the System .................................................................................................................. 24
Equipment List .............................................................................................................................. 25
Consumable Supplies ................................................................................................................... 25
Installation Process....................................................................................................................... 26
Moving the System within the Facility........................................................................................... 31
Moving the System to another Facility.......................................................................................... 31
Electrical Requirements ................................................................................................................ 32
Environmental Requirements ....................................................................................................... 33
5. Operating Instructions ....................................................................................................................... 34
Activating the System ................................................................................................................... 34
Automatic Vacuum and RF Test ................................................................................................... 35
Defining the Treatment Mode ....................................................................................................... 36
Controlling the Treatment Level ................................................................................................... 37
Communication Terminal Messages ............................................................................................ 37
Initiating Treatment ....................................................................................................................... 38
6. Clinical Guide: Cellulite and Thighs Circumferences Treatment....................................................... 39
Realistic Expectations................................................................................................................... 39
4 PB70286EN
User Manual Table of Contents
Indications .................................................................................................................................... 39
Contraindications .......................................................................................................................... 39
Possible Side Effects .................................................................................................................... 41
Pre-Treatment Preparation ........................................................................................................... 41
Selecting the Appropriate Treatment Type................................................................................... 42
VelaShape II Circumference Measurement ................................................................................. 43
Treatment Procedure.................................................................................................................... 44
Treatment Protocols ..................................................................................................................... 48
Treatment Parameters.................................................................................................................. 49
Post-Treatment Care .................................................................................................................... 50
Treatment Conclusion .................................................................................................................. 50
7. Maintenance ...................................................................................................................................... 51
Cleaning the Console ................................................................................................................... 51
Cleaning and Maintaining the Vsmooth Applicator ...................................................................... 51
Replacing the Vsmooth Applicator's Filters ............................................................................. 54
Cleaning and Maintaining the Vcontour Applicator ...................................................................... 54
Cleaning/Replacing the Applicator Cover ................................................................................ 54
Cleaning the Vcontour Applicator's Filter ................................................................................. 56
Cleaning the Air Grids .................................................................................................................. 57
Cleaning the System Air Filter ...................................................................................................... 58
Upgrading the System Software ................................................................................................... 59
8. Troubleshooting Guide ...................................................................................................................... 60
9. System Specifications ....................................................................................................................... 62
Parameters ................................................................................................................................... 62
Treatment Area Footprints............................................................................................................ 62
Electrical Requirements (Factory-Configured per Customer Order) ............................................ 62
Environmental Requirements ....................................................................................................... 62
Treatment Room ...................................................................................................................... 62
Transportation and Storage ..................................................................................................... 62
Degree of Protection Against Ingress of Water ....................................................................... 63
Dimensions ................................................................................................................................... 63
Weight........................................................................................................................................... 63
10. Electromagnetic Regulation ............................................................................................................ 64
Electromagnetic Emissions .......................................................................................................... 64
Electromagnetic Immunity ............................................................................................................ 65
Recommended Separation Distances .......................................................................................... 67
LIST OF FIGURES
Figure 1: System Nameplate Location ....................................................................................................... 14
Figure 2: VelaShape II System .................................................................................................................. 16
Figure 3: Vsmooth Applicator [Left: Operator Panel / Right: Applicator Elements] .................................. 18
Figure 4: Vcontour Applicator [Left: Operator Panel / Right: Applicator Elements] .................................. 18
Figure 5: Communication Terminal ............................................................................................................ 19
Figure 6: Anatomy of Cellulite .................................................................................................................... 20
Figure 7: elōs Heating and Mechanical Manipulation Action ..................................................................... 20
PB70286EN 5
Table of Contents
Figure 8: Before Treatment ........................................................................................................................ 21

Figure 9: IR Heats the Tissue Up To 2 mm. RF Heats the Tissue Up To 20 mm in Depth ...................... 21
Figure 10: After VelaShape II Treatment Reduction in the Size of the Fat Cells and Fat Chambers ....... 21
Figure 11: Assembled VelaShape II System.............................................................................................. 23
Figure 12: Umbilical Support Mast ............................................................................................................. 26
Figure 13: Inserting the Umbilical Support Mast ........................................................................................ 27
Figure 14: Vcontour Applicator Cradle ....................................................................................................... 27
Figure 15: Dual-Connector Assembly Electronic & Vacuum Sockets ........................................................ 28
Figure 16: Inserting the Dual-Connector Assembly ................................................................................... 28
Figure 17: Installing the Communication Terminal (1) ............................................................................... 29
Figure 18: Installing the Communication Terminal (2) ............................................................................... 29
Figure 19: Communication Terminal Connection ....................................................................................... 30
Figure 20: Connecting the Applicators ....................................................................................................... 30
Figure 21: Operator Panels ........................................................................................................................ 36
Figure 22: Illustration of Circumference Measurements: A) Fixed Distance between the Legs;
B) Labeling the circumference; C) Measuring Horizontally;
D) Labeling the Arm Against a Wall. ......................................................................................... 43
Figure 23: Removing the Vsmooth Replaceable Cover ............................................................................. 52
Figure 24: Vsmooth Applicator's Internal Components .............................................................................. 53
Figure 25: Replacing the Vsmooth Applicator's Filters .............................................................................. 54
Figure 26: Vcontour Applicator's Internal Components.............................................................................. 55
Figure 27: Replacing the Small Applicator's Filter ..................................................................................... 56
Figure 28: Air Filter and Grids .................................................................................................................... 57
Figure 29: Cleaning the Air Filter ............................................................................................................... 58
Figure 30: Replacing the Software Plug..................................................................................................... 59
6 PB70286EN
User Manual Before You Start
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 II system must be serviced only by Syneron-
Candela 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 effects associated with the use or misuse of the
system.
PB70286EN 7
Before You Start
Explanation of the Symbols Used in the System
Symbol Description
Refer to Instruction Manual/Booklet
Caution!
CE Compliance Symbol
0344
CSA Compliance Symbol (212603 CSA master

contract number)
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
8 PB70286EN
User Manual Safety
2. SAFETY
This chapter describes the safety issues regarding the use and maintenance of the
VelaShape II system, with special emphasis on optical and electrical safety.
Note
Protect the VelaShape II system against unqualified use by removal
of the key from the keyswitch when the system is unattended.
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-Candela 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.
PB70286EN 9
Safety
System Safety Features

The VelaShape II system incorporates the following safety features:
• The system is activated by a key that should be available only to trained

personnel.
• 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 0 on the
operator panels.
• 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.
Patient and Personnel Safety

When handling the VelaShape II 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.
• 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.
• 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.
• Improper treatment technique may cause local burns.
Warning
• Prior to system activation, any personnel operating or maintaining
the system should be familiar with the safety information provided
in this chapter.
• Opaque eye protection should be used when working within a 30
cm (12") proximity to the patient's eyes.
10 PB70286EN
User Manual Safety
Installing 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 applicators during system start-up.
• Always turn the system off before connecting/disconnecting an applicator, or

the Dual Connector.
• Keep the applicators clean and dry.
• 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 instantly.
Infrared Energy Safety Issues

The VelaShape II emits gentle heating infrared light between 700-2000 nm 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, 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 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.
PB70286EN 11
Safety
Radio-Frequency Energy Safety Issues

The RF energy provides gentle heating that is distributed deep into the skin via
bi-polar electrode rollers. Full coupling of both electrodes (spiral shaped rollers)
to the skin, after applying VelaSpray Ease, is necessary before pressing the
trigger button, 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 is pressed, IR and RF modes
are disabled and blinking lights on the applicator’s operator panel indicate
insufficient coupling. The trigger 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.
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

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 covers and panels of the system closed. Removing the covers creates
a safety hazard.
• Keep hands away from the applicators 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
27 kg (59.5 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-Candela.
12 PB70286EN
User Manual Safety
Maintaining the System

• Only authorized Syneron-Candela technicians are qualified to service the
system.
• Shut down the system and disconnect the power cable before performing any
maintenance procedures (see Chapter 7).
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.
• Keep drapes and towels moist to prevent them from igniting and burning. Use
non-flammable prepping solutions.
• 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 I, Type BF
• Protection against ingress of liquids: Ordinary equipment
• Not suitable for use in presence of flammable substances
• The VelaShape II system and applicators comply with U.S. Federal

Regulations.
• The system is classified as a Class IIa device according to Annex IX of the

European Medical Device Directive (2007/47/EC).
Warning
No modifications to this equipment are allowed!
PB70286EN 13
Safety
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
14 PB70286EN
User Manual System Description
3. SYSTEM DESCRIPTION
The VelaShape II is a device that combines elōs technology (electro-optical
synergy) with mechanical manipulation of the skin using gentle vacuum suction
with or without mechanical massage. It is designed for use in medical and
aesthetic practices and is indicated for:
• EU: non-invasive treatment for body contouring via temporary cellulite and
circumference reduction.
• USA: temporary reduction in the appearance of cellulite and temporary

reduction of thighs circumferences. It is also indicated for the relief of
minor muscle aches and spasms, as well as for the temporary improvement
of local blood circulation.
The system is designed 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.
PB70286EN 15
System Description
System Overview
The system includes five core modules: the Console, Vsmooth Applicator,
Vcontour Applicator, Dual Connector and Communication Terminal (see
Figure 2).
Figure 2: VelaShape II System
Console
The VelaShape II console houses the following components:

• Power supply • IR lamp power supply
• Vacuum pump • Main CPU
• RF generator • Other power components
16 PB70286EN
Applicators
The Vsmooth and Vcontour applicators incorporate the operator panels, and
are used for the physical implementation of the RF current, IR energy and
mechanical manipulation treatment parameters.
The VSmooth applicator (see Figure 3) utilizes IR, RF and mechanical

manipulation by vacuum and massage rollers. It is used for cellulite reduction in
large areas such as the thighs, buttocks, or abdomen and for circumference
reduction.
The VContour applicator (see Figure 4) utilizes IR, RF and mechanical

manipulation by vacuum. It is used for cellulite and circumference reduction of
curved areas, for localized fatty deposits, and to reinforce results of Vsmooth
applicator, thus leading to contouring of smaller areas such as the lower
abdomen, flanks and arms.
The Dual Connector enables the attachment of both applicators at the same time.
Please note that working simultaneously with both applicators is not possible.
The VelaShape II applicators are composed of a permanent handpiece and a

replaceable cover. The replaceable covers of the VelaShape II applicators are
usable for limited periods of time.
The replaceable cover of the Vsmooth applicator should be replaced according to

the schedule printed on the cover's storage box, or sooner if one of the following
is observed:
• The IR & RF columns of LEDs blink continuously (inadequate coupling).
• The applicator does not move smoothly over the skin.
• Rollers appear damaged, discolored or their movement is impaired.
• Roller axis appears to wear out (color turns from silver to copper).
The replaceable cover of the Vcontour applicator should be replaced according

to the schedule printed on the cover's storage box, or sooner if one of the
following is observed:
• Electrodes appear damaged.
• The cover's shape appears distorted.
• The vacuum LEDs column of LEDs is cycling continuously from 1 – 3,
indicating a clogged filter.
PB70286EN 17
System Description
The display and selector controls are located on the operator panel of each
applicator. The three user-defined treatment modes are: IR, RF, and Vacuum. The
levels are indicated by 0, 1, 2, or 3 illuminated LEDs which correspond to no
energy, low, medium and high levels, respectively (see Figure 3 and Figure 4).
IR RF Vacuum RF Electrode Rollers IR Aperture
Applicator Chamber
Level 1 - Low Level 2 - Medium Level 3 - High
Figure 3: Vsmooth Applicator [Left: Operator Panel /

Right: Applicator Elements]
RF Electrodes
Trigger
Vacuum
RF
IR
Level 3 - High
Level 2 - Medium
Level 1 - Low
IR Aperture Vacuum Intake
Figure 4: Vcontour Applicator [Left: Operator Panel /

Right: Applicator Elements]
Note
The images in the figures are for illustration purposes only.
18 PB70286EN
The applicators are 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 will result in disabled IR and RF
energies, indicated by:
• Blinking of the LEDs on the applicator's operator panel.
• An Improve Contact message on the communication terminal's display (see

Figure 5).
Communication Terminal
The communication terminal is a digital message board that keeps the user of the
VelaShape II system informed of various system conditions and alerts that will
occur during the normal course of operation.
It also displays system error messages that require resolution by the user before
treatment can be continued.
Figure 5: Communication Terminal
PB70286EN 19
System Description
Anatomy of Cellulite
Cellulite is characterized by Dimpled
Skin Surface – mattress-like
appearance (see Figure 2-4). The fat
cells are located in chambers which
are separated by vertical and
horizontal Connective Tissue
Septa. The Septa 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 Figure 6: Anatomy of Cellulite
enlarged fat cells and by retained
intercellular fluids, it protrudes beyond the length of the vertical septa, pushing
up the skin's surface and resulting in a dimpled skin appearance.
The VelaShape II 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 7). 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 septa, is reduced.
The mechanical action of the vacuum and rollers gently kneads the skin and
facilitates deeper penetration of heat, delivering the RF and IR energies to the
dermis and hypodermis. This mechanical action helps in draining the excess
intercellular fluids from the dermis and
Parabolic
the upper part of the hypodermis into the reﬂector
lymphatic system.
Lamp
Both actions, reducing the size of the fat Infrared filter

cells and draining excess fluids to the
lymphatic system, are accompanied by RF electrodes
shrinkage of the connective tissue septa

and facilitate the overall shrinkage of the
size of the fat chambers, thus leading to
a reduction in the appearance of cellulite
and a reduction in the circumference of
the treated area.
Figure 7: elōs Heating and Mechanical

Manipulation Action
20 PB70286EN
Figure 8: Before Treatment
Figure 9: IR Heats the Tissue Up To 2 mm. RF Heats the Tissue

Up To 20 mm in Depth
Figure 10: After VelaShape II Treatment Reduction in the Size

of the Fat Cells and Fat Chambers
PB70286EN 21
System Description
Heating of Dermis and Hypodermis with elōs

Light Energy (see Figure 7):
• Broad spectrum IR light at wavelengths of 700-2000 nm.
• Maximum electrical power of the IR light is 35 Watts (35 J/sec) for both
Vsmooth and Vcontour applicators.
• Depth of heating from light reaches the deep dermis.
RF Energy (see Figure 7):
• Bi-polar conductive RF energy is emitted from the RF electrodes which

are embedded in the rollers at a frequency of ~1 MHz.
• Maximum RF energy applied to the patient's skin is 60 Watts for the

Vsmooth applicator and 23 Watts for the Vcontour applicator.
• The heat generated by the RF energy reaches the depth of the hypodermis.
Mechanical Effects on the Skin

Mechanical Rollers (see Figure 9):
• Rollers knead the skin inward so that the IR and RF energies can
penetrate deeper in the skin.
• Rolling the skin upward facilitates a better suction effect from the vacuum.
• The repeated kneading of the skin between the rollers improves lymphatic
drainage, with overall improvement of the dimpled appearance of
cellulite.
Vacuum/Negative Pressure (see Figure 9):
• When all edges of the applicator are in full contact with the skin, a seal is
made, allowing the vacuum pump to apply gentle suction.
• Negative pressure dilates the blood vessels, increasing the perfusion in the
local area.
• Vacuum levels are:

⇒ Vsmooth applicator – up to 380 mbar of negative pressure
⇒ Vcontour applicator – up to 440 mbar of negative pressure
22 PB70286EN
User Manual System Installation
4. SYSTEM INSTALLATION
The system is designed for installation in a clinical environment. The customer
shall carry out the installation as described in the following sections.
Figure 11: Assembled VelaShape II System
PB70286EN 23
System Installation
Unpacking the System

After unpacking the system, Syneron-Candela recommends that you retain the
shipping box and the internal Styrofoam covers and braces in the event that the
system will have to be relocated anytime in the future.
Unpack the system as follows:
1. Cut off and remove the three plastic straps that encase the cardboard box.
2. Lift the cardboard box up and off the packaged components and set it aside.
3. You will find a "Vela Product Line Unpacking Instructions" sheet taped to
the side of the top Styrofoam cover; follow the instructions on this sheet, and
then continue with unpacking and installation from this point.
4. Carefully remove the packed accessories and small Styrofoam boxes from
inside the Styrofoam covers.
5. Finish removing all of the Styrofoam covers and braces from around the body
of the system.
6. Remove the plastic bag that is wrapped around the system.
Caution
The Vsmooth (large) applicator is taped inside the top Styrofoam
cover; unpack it carefully.
7. Compare the accessories you unpack to the equipment list (next section) to
ensure that all accessories are present. Report any missing accessories to your
Syneron-Candela representative.
8. Lift the system up and out of the bottom Styrofoam brace and carefully set it
on the floor.
Warning
The system weighs 27 kg (59.5 lbs.) and should only be lifted by two
people. Lift correctly and protect your back!
9. Finish unpacking the accessories and continue with the installation process.
24 PB70286EN
Equipment List
The VelaShape II system is delivered with the following:
• VelaShape II system console
• Vsmooth applicator (with non-operational protective cover)
⇒ Disposable cover for Vsmooth applicator (x 2)
• Vcontour applicator (with non-operational protective cover)
⇒ Disposable cover for Vcontour applicator (x 2)
• Software plug (installed in system's rear panel)
• Dual-Connector assembly
• Vcontour applicator cradle
• Umbilical support mast (includes five harness loops)
• Accessories kit, including:
⇒ Communications terminal with cable
⇒ User Manual
⇒ Quick-Reference Guide / Quick-Service Guide
⇒ Infrared thermometer (warranted and serviced by manufacturer)
⇒ One pair of protective opaque goggles
⇒ Filter extractor
⇒ Set of two keys
⇒ Cleaning brush
⇒ VelaSpray Ease bottles (x 4)
⇒ System air filters (x 3)
Consumable Supplies
The following consumable supplies may be ordered using the following part
numbers:
• Replaceable covers for the Vsmooth applicator 1
• Replaceable covers for the Vcontour applicator1
• VelaSpray Ease bottles (10-pack)
1
Consult Syneron sales representative
PB70286EN 25
System Installation
Installation Process
After unpacking the VelaShape II system, install the applicators in the following
manner:
1. Unpack the umbilical support mast with the five installed harness loops (see
Figure 12). Ensure that the harness loop's Allen screws are properly seated in
their dimples in the mast.
2. Take the mast extension and screw it into the bottom of the support mast as
shown in Figure 12.
Figure 12: Umbilical Support Mast
26 PB70286EN
3. Insert the mast as shown in Figure 13, until it is stopped by the pin.
Figure 13: Inserting the Umbilical Support Mast
4. Attach the Vcontour applicator cradle to the mast as shown in Figure 14.
Fasten the knob securely.
Figure 14: Vcontour Applicator Cradle
PB70286EN 27
System Installation
5. Unpack the dual-connector assembly and identify the electronic and vacuum
connection sockets, both on the dual-connector and in the system's connection
port (see Figure 15).
Figure 15: Dual-Connector Assembly Electronic & Vacuum Sockets
6. Firmly insert the dual-connector assembly into the system's connection port,
making sure that the electronic and vacuum sockets are aligned, as shown in
Figure 16. Ensure that the dual-connector's rubber clamps are securely
connected to the support mast.
Figure 16: Inserting the Dual-Connector Assembly
28 PB70286EN
7. Unpack the communication terminal and attach it to the mast by pressing its
two clamps onto the mast, as shown in Figure 17.
Figure 17: Installing the Communication Terminal (1)
8. Route the terminal's communication cable along the rear side of the terminal
and the system, such that it will not interfere with system operation.
Figure 18: Installing the Communication Terminal (2)
PB70286EN 29
System Installation
9. Connect the terminal's communication cable to the connection port on the

system's rear panel, as shown in Figure 19.
Figure 19: Communication Terminal Connection
Note
The system may be operated without the communication terminal if
desired.
10. Unpack the applicators; firmly connect the Vcontour applicator to one of the
dual-connector's connection ports, making sure that the electronic & vacuum
sockets are aligned (see Figure 20).
Figure 20: Connecting the Applicators
30 PB70286EN
Refer to Figure 11:
11. Hook the Vcontour applicator's umbilical harness into one side of the
harness loops on the umbilical support mast.
12. Place the Vcontour applicator in its cradle.
13. Connect the Vsmooth applicator to the second connection port of the dual-
connector, making sure that the electronic and vacuum sockets are aligned.
14. Hook the Vsmooth applicator's umbilical harness into the other side of the
harness loops on the umbilical support mast.
15. Place the Vsmooth applicator in its cradle.
Finish the installation:
16. Connect the power cable to the power connection port on the system's rear
panel, and plug the cable into the appropriate electrical outlet.
17. Refer to Figure 11 and ensure that all system components are correctly
assembled.
18. Insert the key into the keyswitch.
Note
If the system has been removed from cold storage, allow it time to warm
up to room temperature (15-30°C/59-86°F) before first activation.
Moving the System within the Facility

1. Turn the system off and disconnect the power cable.
2. Release the wheel brakes at the base of the system.
3. With one hand securing the Vsmooth applicator, slowly push or pull the
system using the handle at the back of the system.
Moving the System to another Facility

1. Turn the system off and disconnect the power cable.
2. Disconnect the applicators and pack them in their storage cases.
3. Disconnect and remove the communication terminal.
4. Remove the umbilical support mast.
PB70286EN 31
System Installation
5. Remove the Dual Connector and pack it in its storage box.
6. Release the wheel brakes at the base of the system.
7. Slowly push or pull the system using the handle at the back of the system and
carefully lift it up onto the vehicle. Spread padding on the wall of the
transport vehicle to avoid scratching the system's covers and strap the system
to the wall.
8. Upon arrival at the new facility, position the system in its new location, using
the system handle.
9. Reinstall the umbilical support mast.
10. Reinstall and reconnect the communication terminal.
11. Reinstall the Dual Connector and reconnect the applicators and the power
cable.
Caution
Do not lay the system on its back or sides! Doing so may damage the
vacuum pump.
Electrical Requirements
The system is preset at the factory to accommodate the local line voltage
according to the customer's order. Accordingly, the system will require a separate
line supply of one of the following (appropriate to your country):
• 100 VAC; 6A; 50-60 Hz; single phase
• 110-127 VAC; 5.2A; 50-60 Hz, single phase
• 220-240 VAC; 3.1A; 50 Hz; single phase
Warning
• For continued protection against fire, replace the fuse only with
one of the same type and rating.
• Proper grounding is essential for safe operation.
• Do not replace any electric part of the system except fuses!
• Only authorized Syneron-Candela technicians are qualified to
service the system.
32 PB70286EN
Environmental Requirements
• Corrosive materials can damage electronic parts; therefore the system should
operate in a non-corrosive atmosphere.
• Metallic dust can damage electrical equipment. Dust particles absorb light and
heat up. Hot particles located on the aperture guide can damage it; therefore
dust particles should be kept to a minimum.
• For optimal operation of the system, maintain room temperature between

15º-30ºC (59º-86ºF) and relative humidity of less than 80%.
• If the system has been stored in an environment cooler than the above
mentioned temperatures, allow it time to warm up to room temperature before
first activation.
PB70286EN 33
Operating Instructions
5. OPERATING INSTRUCTIONS
This chapter will assist you in operating the system for the first time, and will
guide you through the initial setup procedures needed to perform in order to start
operating the system.
Caution
The VelaShape II applicators and disposable covers are not
compatible with the older VelaShape systems or VelaSmooth
systems!
Activating the System

1. Before turning the system on, verify that the power cable is connected to the
power connection port on the system's rear panel and to the wall power outlet.
2. Verify that the software plug is inserted and secured.
Warning
• High voltage is present inside the system. Always be aware of
the possible dangers and take proper safeguards as described in
this manual.
• Always turn the system off before connecting/disconnecting an
applicator or Dual Connector.
3. To activate the system turn the key clockwise; the system initiates a self-test.
During this test, the LEDs on the applicators' operator panels perform a test
pattern, and when the first row of lights (Level 0) is illuminated continuously
on both applicators, the system is ready for operation.
At the same time, the communication terminal will display this message:
System Initialization Please Wait…
Note
• Before activation, remove the protective covers from the applicators
and install new working covers.
• When the system is not being used, install the protective covers in
order to protect the applicators' internal components.
34 PB70286EN
User Manual Operating Instructions
Automatic Vacuum and RF Test

The VelaShape II is equipped with an automatic Vacuum and RF self-test
routine.
The test is performed:

• Immediately after the system powers up
• 90 seconds after each release of the applicator's trigger
During the test the VelaShape II is tested for radiofrequency and vacuum
performance, displaying the status of applicator filters. During this test, the
triggers of both applicators are disabled.
The test is comprised of three consecutive vacuum pulses for each applicator
connected to the system, and can take up to 10 seconds.
It is important to verify that the applicators' chambers are not blocked or

positioned against a sealing surface during the test (i.e., verify that the applicator
is not applied to the patient during the test).
The test results will be displayed in one of the following manners. If a fault
situation is displayed refer to Chapter 8 – Troubleshooting
1. RF failure:
– RF LEDs column is blinking.
– 100 - RF Failure message on the communication terminal's display.
2. Vacuum sensor fault:

– 0 level LED of IR and RF columns are blinking – (Vsmooth applicator only).
– 101 - No Vacuum Sensor in LA/SA message on the communication
terminal's display.
3. Filters are clogged or applicator chamber is sealed (against the patient's

skin or other surface):
– Vacuum LEDs are cyclically ascending from 1 to 3.
– 03 - Replace Filters message on the communication terminal's display.
4. Filters are missing, punctured or improperly inserted:

– Vacuum LEDs are cyclically descending from 3 to 1.
– 02 - Insert Filters message on the communication terminal's display.
If one of the above indications appears and you wish to repeat the test, press the
trigger on any applicator and wait for 90 seconds; the test will repeat itself.
PB70286EN 35
Defining the Treatment Mode

The VelaShape II system has three treatment modes that can be controlled by the
operator. They are based on the following integrated technologies:
• Infrared (IR) light energy
• Radio frequency (RF)
• Mechanical manipulation (Vacuum)
Before you begin treatment, you need to define the levels of the three treatment
modes.
The operator panel is located on the top of both applicators (see Figure 21). The
operator panel consists of three treatment mode buttons and informational display
LEDs.
Figure 21: Operator Panels
Each button on the operator panel applies a different treatment mode, as follows:
Table 1: Operator Panel Buttons and Indicators
Button Treatment Mode Description
IR mode Continuous infrared light energy is applied
RF mode Radio frequency current is applied
Pressing this button activates the vacuum

Vacuum mode
pump
• Green LED: cover is operative and installed

Applicator cover properly
indicators • Red LED: cover is expired or not installed
properly
36 PB70286EN
User Manual Operating Instructions
Controlling the Treatment Level

You can adjust the level of each treatment mode, using the corresponding mode
buttons:
• IR mode
• RF mode
• Vacuum mode
Use the mode buttons to control the intensity of IR, RF and Vacuum applied to
the patient. Each time you press the mode button, you move the intensity up to
the next level, as indicated by the lights on the operator panel. e.g., if the current
level is 2, and you press the mode button, the level goes to 3. After 3 it goes back
to 0 (zero).
Table 2: Treatment Level Intensities
Level Intensity Notes
None
0 Default level; set to avoid accidental activation
(mode turned off)
1 Low
2 Medium
3 High
Communication Terminal Messages

During system operation the terminal's display LCD will
always show a split view of the applicators' operating
conditions and other relevant information, such as:
• Ready – the applicator is connected, the treatment level
configured, but the trigger is not yet pressed.
• Treatment - the applicator is connected, the treatment
level configured, and the trigger is pressed.
• Not Available – the applicator is not connected.
Pressing the Info button on the terminal will make the following information
available. Press the Scroll button on the left side to view all of the information:
• System Type – VelaShape II.
• VelaShape II - System S/N – the system's factory serial number.
• LA/SA S/N – the Vsmooth applicator or Vcontour applicator type and factory
serial number.
PB70286EN 37
• LA/SA Working Hours – the total number of hours already performed by the
connected Vsmooth or Vcontour applicator.
• Disposable Status – how much time remains to operate the disposable
covers. The number of available operating hours – after which the cover will
cease to operate – is printed on the new cover's box label.
• System Freq: 50 or 60 Hz – the system's electrical frequency
Other various Maintenance or Error messages will be discussed in the

troubleshooting guide later in this manual (see Chapter 8).
Initiating Treatment
Now that you have defined your treatment settings, you are ready to begin
treatment. Apply the applicator with moderate pressure to the treatment area and
press the trigger on the applicator handle. To stop the treatment, release the
trigger.
Warning
You may treat patients only after passing appropriate training and
have adhered to all local and state regulations regarding the use of
this system.
38 PB70286EN
User Manual Cellulite and Thighs Circumferences Treatment
6. CLINICAL GUIDE: CELLULITE AND THIGHS

CIRCUMFERENCES TREATMENT
This chapter provides you with the information required to treat cellulite
(generic) and circumferences (thighs) with the VelaShape II system. The entire
treatment protocol is related to the cleared indications, and unless otherwise
specified, the same procedure applies for both applications.
Realistic Expectations
• There will be improvement in cellulite appearance, but not necessarily complete
elimination. There will be improvement in thighs circumferences. However, the
improvement of both cellulite and circumference reduction is based on the
individual being treated.
• The degree of response to the VelaShape II treatment, and the number of

treatment sessions required will vary among patients and will depend on the
clinical and physiological condition at the start of the treatment regimen.
Some patients respond better than others.
• The treatment results are temporary and one maintenance treatment session
every 2-3 months is essential to sustain them.
• A healthy lifestyle (diet and exercise) may help to obtain better results, but is
not essential. However, weight gain may have a negative effect on the results.
Indications
The VelaShape II system is indicated for:
• EU: non-invasive treatment for body contouring via temporary cellulite and
circumference reduction.
• USA: temporary reduction in the appearance of cellulite and temporary

reduction of thighs circumferences. It is also indicated for the relief of
minor muscle aches and spasms, as well as for the temporary improvement
of local blood circulation.
Contraindications
• Pacemaker or internal defibrillator.
• Superficial metal or other implants in the treatment area.
• Current or history of skin cancer, or current condition of any other type of

cancer, or pre-malignant moles.
PB70286EN 39
Cellulite and Thighs Circumferences Treatment
• History of any kind of cancer.*
• Severe concurrent conditions, such as cardiac disorders.
• Pregnancy and nursing as well as 4-5 months post- natural delivery, or at least
6 months post-cesarean section, or until normal hormonal balance is regained.
• Impaired immune system due to immunosuppressive diseases such as AIDS

and HIV, or use of immunosuppressive medications.*
• Diseases which may be stimulated by light at the wavelengths used.*
• Patients with a history of diseases stimulated by heat, such as recurrent Herpes

Simplex in the treatment area, may be treated only following a prophylactic
regimen.
• Poorly controlled endocrine disorders, such as diabetes.
• Any active condition in the treatment area such as sores, psoriasis, eczema and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very

dry and fragile skin.
• History of bleeding coagulopathies, or use of anticoagulants.*
• Use of medications, herbs, food supplements & vitamins known to induce

photosensitivity to light exposure at the wavelengths used, such as Isotretinoin
(Accutane) within the last 6 months, tetracyclines, or St. John's Wort within
the last 2 weeks.*
• Any surgical procedure in the treatment area within the last 3 months or before
complete healing.
• Treating over tattoo or permanent makeup.
• Area with varicose veins.
• As per the practitioner's discretion, refrain from treating any condition which
might make it unsafe for the patient.
(*) Although not recommended, these conditions may be treated at the discretion
and under the full responsibility of the medical director/physician.
In such cases, a small area should be treated and assessed a few days later to
determine if the patient will tolerate the treatment without developing short-
term adverse effects. Test spots cannot indicate long-term adverse events.
40 PB70286EN
Note
• In case of uncertainty regarding applicability or potential side
effects, have the patient consult his/her physician and bring a
written consent for treatment.
• Always test a small area with the selected parameters, and wait
several minutes to detect results of the tested area before
proceeding with the whole area treatment.
• Additionally for dark skin types (IV-VI), a small area should be
treated and assessed a few days later to determine if the patient
will tolerate the treatment without developing adverse effects.
• It is not recommended to treat the abdomen sooner than one hour
after a meal.
• It is not recommended to treat patients with BMI >30.
Possible Side Effects

Certain side effects may be experienced during treatment or shortly afterwards,
usually as a result of improper use of the system. Although these side effects are
rare and temporary, they should be reported immediately to a physician for
proper treatment.
These are the side effects that may appear in the treatment area:
• Pain
• Excessive skin redness (erythema)
• Hair pulling (by mechanical rollers)
• Damage to natural skin texture (scratching, crusting, blister, burn)
• Bruising
Pre-Treatment Preparation
• Complete or update the patient's medical and physical history.
• Exclude from treatment patients presenting any of the contraindications for
treatment.
• Determine why the patient is seeking treatment and what the expectations are.
• Inform the patient about the treatment protocol, typical treatment results and
possible adverse effects or discomfort.
• Instruct the patient about the safety issues.
• Advise the patient to exfoliate the skin with appropriate creams before
treatment. The patient should come to the treatment with clean, dry skin (no
perfume, no lotion).
PB70286EN 41
• Hair may impair the movement of the applicator, overheat the treatment area
or be pulled out during treatment. Removing hair before treatment is advised.
• Advise the patient to avoid anticoagulants, such as aspirin throughout the
treatment regimen, if medical condition permits and pertinent to physician
approval. Anticoagulants increase the possibility of bruising.
• Before the first treatment session it is important to weigh your patient,
photograph and measure the circumference of the treatment area in order to
establish a baseline (see VelaShape II Circumference Measurement, page 43).
Re-photograph and re-measure before the last treatment and before any
maintenance treatment thereafter, and document the results achieved.
Additionally you may do so every two sessions to document any progress. Re-
weigh your patient before each subsequent session to ascertain no weight gain.
• Mark the treatment areas when the patient is standing (use white or yellow
marker), as cellulite or contour may change characteristics when the patient is
lying down.
• Make sure that the RF electrodes are clean and intact (not chipped). In
addition when using the Vsmooth applicator, verify that the rollers function
smoothly. Make sure that all the applicators’ parts are clean and intact.
• Make sure that the Vsmooth filters are clean and correctly inserted (replace
them if not).
• Ensure that the replaceable covers of the Vsmooth and Vcontour applicators
are firmly inserted and secured in place.
• Fit the patient with opaque eye protectors if the treatment area is within a
30 cm (12") proximity to his/her eyes.
Selecting the Appropriate Treatment Type

The system combines two types of energy (IR and RF), and mechanical
manipulations (vacuum and/or massage). These combined and synchronized
actions optimize the energy delivery.
You should examine the patient’s skin before treatment to determine the suitable
type of treatment to apply, to ensure effective treatment with a minimal risk of
skin damage. Selecting the correct treatment type is essential for successful
treatment.
Use the Vsmooth applicator for large areas such as the thighs, buttocks or
abdomen.
42 PB70286EN
If the calves and arms are large enough, they may be treated with the Vsmooth
applicator.
Use the Vcontour applicator for curved areas or small areas such as the lower
abdomen and flanks, and for localized fatty deposits.
The Vcontour applicator may also be applied to reinforce endpoints on small

sites of large areas, following treatment with the Vsmooth applicator, such as on
the umbilical site in the abdomen area.
VelaShape II Circumference Measurement

In order to establish a baseline for the VelaShape II treatment and follow up on the
results, it is advised to weigh the patient, photograph and measure the circumference
of the treatment area. Circumference measurements should be done before the first
treatment session and at least once more before the last treatment, and before any
maintenance treatment thereafter, in order to document the results achieved.
Additionally you may do so after the first two sessions (before starting the third
treatment) to document any progress. Measurements after the treatment session may
be inaccurate due to a transient edema. The suggested measurement method is:
1. The patient should stand in an upright position adjacent to a wall, barefoot

and with both legs attached or at a fixed distance (see Figure 22 [A]).
2. A measuring ruler of hard material (wood or plastic) of at least 1 meter

should be placed against the wall. Alternatively, a vertical metal stand with
attached marker may be used (see Figure 22 [B]).
3. Measurements should be taken for each anatomical area, usually the

"thickest" part of each area:
• Thighs and buttocks – upper third.
• Abdomen – under and above the navel.
• Arms – midway between shoulder and elbow.
A B C
Figure 22: Illustration of Circumference Measurements: A) Fixed Distance between

the Legs; B) Labeling the circumference; C) Measuring Horizontally;
D) Labeling the Arm Against a Wall.
PB70286EN 43
4. During the entire measurement procedure, the distance between the patient's
feet must remain constant.
5. At least 4 marks should be made with a white make-up pencil on each

measured area, usually front, back and both sides, while the patient is rotating.
6. A measuring tape should be placed across all marks which were made in each
anatomical area, creating a straight and horizontal continuous line between
them (see Figure 22 [C]).
7. The measurements and the distance from the floor should be recorded in the
patient folder, for identical positioning in subsequent measurements.
8. When measuring the arm circumference, indicate the distance from the wall
and always measure at the same distance while the arm is perpendicular to a
wall (see Figure 22 [D]).
Treatment Procedure
• Always inspect the applicator for cleanliness and integrity. Make sure that
there are no cracks or other damage to any of the applicator's components.
• Select the treatment parameters as suggested in the Treatment Parameters

section (see page 49). Always consider the patient's skin response and tolerance.
• Select and mark the treatment area while the patient is standing:
⇒ Vsmooth Applicator: The treatment area is anatomical (i.e. front
thigh/back thigh/abdomen/one buttock, etc.). Divide the area into strips;
dimensions of each strip: width of the applicator (the distance between the
electrodes) and the length of ~30 cm (~12 inches).
⇒ Vcontour Applicator: the area dimensions will be ~10 x 15 cm
(~4 x 6 inches), or that of the palm of a large hand.
• It is essential to use VelaSpray Ease lotion, (not gel, and not any other
product) for optimal coupling and RF conductivity. Moisten the treatment
area with VelaSpray Ease lotion and rub it well into the skin using massage
movements with gloved hands. Ensure that a thin layer of lotion (~1 mm)
remains on the skin. Replenish the lotion only if it becomes difficult to glide
the applicator over the treated area and when the skin appears dry, or when
the IR and RF indicators blink continuously.
• Always test a small area with the selected parameters, and wait a few minutes
to detect results of the tested area before proceeding with the treatment of the
whole area.
• Orient the applicator perpendicular to the treatment area and apply minimal
pressure, just enough for complete contact with the skin. When pressing the
applicator's trigger the skin will be suctioned into the applicator's chamber by the
44 PB70286EN
vacuum. If you hear air being sucked into the applicator chamber, this indicates
that the applicator is not positioned properly on the skin. If adequate coupling
between the RF electrodes and the skin is not achieved, the RF and IR will be
disabled and their indicator lights on the operator panel will blink.
• You may manually assist the treatment by slightly stretching curved or loose
skin with your free hand, and by slightly pushing or pulling the skin to or
from the side towards the applicator. You may also improve contact by
placing a rolled towel under the treatment area, which will push it up towards
the applicator.
• The goal of each treatment session, regardless of which applicator you use, is
to heat the deeper skin layers leading to a rise of the patient's skin temperature
to the endpoint. Reaching the endpoint twice is the required procedure using
the Enhanced Treatment Mode. Endpoint is reached when substantial and
persistent radiant heat can be felt on the palm your hand about 5 mm above
the skin. The heat is usually accompanied by erythema (at various levels,
depending on skin type and anatomical area) and sometimes slight edema.
The patient should feel a tolerable heat sensation. This typically occurs at a
temperature of 40°-42°C (104°-107°F).
• Endpoint is reached when substantial and persistent radiant heat can be felt by
the palm of your hand about 5 mm above the skin. Once this endpoint is
reached, this heat must be retained for at least 5-10 minutes for treatment to be
effective.
• Treat the desired area in the following manners (see page 46):
1. Gliding slowly in Back & Forth Motions along or across the RF
electrodes, without releasing the trigger. This is the preferred treatment
manner for the Vsmooth applicator. It may be practiced also with the
Vcontour applicator as long as the applicator is in full contact with the
skin.
2. Forward Motions only, releasing the trigger at the end of each strip with
either applicator. This treatment manner takes longer to reach an endpoint
and serves for treating special areas, such as the lower buttocks (or
wherever gliding motion is impaired).
3. Circular Motions are typically used to reinforce endpoints, and to retain
the heat in the previously treated strips in the same area following
motions 1 or 2 above.
4. Zig-Zag Motions are typically used to reinforce endpoints, and to retain
the heat in the previously treated strips in the same area in a cross-hatched
manner following motions described in 1 or 2 above.
5. Stacking: It is not recommended to stack with the Vsmooth applicator,
however when motion is impaired such as in curved areas, stack 2-5
pulses on the same site with full contact of the electrodes with the tissue,
and overlapping of ~20% between the sites.
PB70286EN 45
When using the Vcontour applicator, stacking is the preferred treatment

manner. Stack up to 10 pulses with ~20% overlapping when moving to an
adjacent site. Occasionally more stacked pulses may be applied, especially
when reinforcing endpoints on large areas previously treated with the
Vsmooth applicator, if the patient's skin response and comfort allow.
Warning
• Particular care should be taken when stacking pulses on one
site. Ensure acceptable skin response and patient’s comfort.
• Reduce the IR level when stacking, in particular with the
Vcontour applicator.
• When using the Vsmooth applicator: move the applicator over the skin at a
constant rate that will ensure optimal treatment of each point for ~ 3 seconds.
Longer times may cause side effects, and shorter times may not be effective.
• It is recommended to treat the front thigh and abdomen from a supine position
and the back thigh, buttocks and the back from a prone position. Very large
hips and inner thighs may be treated when the patient is lying on the side with
a bent knee.
• The treatment area is anatomical (i.e., front thigh, back thigh, abdomen, one
buttock, etc.). Divide each area into strips as wide as the applicator cover for
repeated passes until the endpoint is reached.
• If the anatomical area is extremely large divide it into two areas, such as half-
abdomen, half-thigh or half-buttock. It is easier to reach and maintain the
desirable heat on areas that are not too large. However, areas too small may
heat up rapidly and result in superficial heating only.
• Treatment Motions with the Vsmooth Applicator (e.g., front thigh):

1. Back and forth motions on a strip of skin, applicator-width and ~30 cm
long, until endpoint of radiant heat (~42°C).
2. Back and forth motions on an adjacent strip until endpoint

(overlapping ~20%).
46 PB70286EN
3. Retain the heat by passing over both previous strips in cross-hatched

motions (zig-zag or circles).
4. Move to an adjacent strip and treat with back and forth motions until
endpoint.
5. Retain the heat again on all previous strips with cross-hatched motions.
6. Continue the process until you have covered the entire area.
• After the endpoint is achieved the patient may feel an internal heat sensation
for 30 minutes or longer.
• Continue treatment with the Enhanced Treatment Mode which consists of
two steps:
⇒ Step 1: Reach the endpoint in a certain anatomical area (using the
motions described above).
⇒ Step 2: Return to the same anatomical area after ~10 minutes and repeat
the procedure reaching the endpoint again.
⇒ While waiting you may treat another area.
⇒ Retaining the heat by covering the treated areas in the interval is
recommended.
• When using the Vcontour applicator:
⇒ Divide the treatment area into smaller zones of roughly the size of the
palm of a large hand (10 x 15 cm; 4 x 6 inches).
⇒ Go over one zone to complete one pass by stacking with an overlap of
~20%. The number of stacks applied should be according to patient
tolerance, but no more than 10 stacks.
⇒ Repeat the same procedure on the same zone, until the desired endpoint is
reached (~5 minutes). The number of passes is typically 4-6. Reduce the
number of stacks with each successive pass.
PB70286EN 47
⇒ Move to the next zone and treat similarly until reaching the endpoint
(~5 minutes).
⇒ Come back to the first zone and treat again until reaching the endpoint
(5 minutes or less).
⇒ Treat the second zone again until endpoint (5 minutes or less).
⇒ If an optimal endpoint is not achieved, decrease the treatment area.
Note
• Good contact is essential for good results. Always maintain complete
contact between the applicator chamber and the skin.
• For small zones such as the navel area, treat twice, but with less
stacks until the endpoint is reached, and ensure a 5-minute interval
between treatments.
• When reinforcing results following Vsmooth, treat the small area
(such as localized fat deposits) only once.
• After the treatment, the treated area may show temporary signs of
erythema and slight edema.
• Blinking of the IR and/or RF LEDs on the operator panel indicates
inadequate coupling which results in RF and IR being disabled.
Caution
Release the trigger before you lift the applicator from the skin.
Treatment Protocols
• Ideally, the treatment should be performed once a week. Spacing the
treatments less than once a week apart may reduce treatment efficacy.
Usually 4-6 treatments result in significant circumference reduction and
cellulite improvement. Some patients may need a few more sessions. Once
per week is an acceptable protocol also when combining the Vsmooth and
the Vcontour applicators.
• One maintenance treatment in the month following the initial series of

VelaShape II treatments may be necessary to sustain the results, followed by
once in 2 – 3 months according to individual results.
Note
• Compliance with the treatment protocol is essential to achieving
the desired results.
• VelaShape II treatment performed 3–5 weeks post-liposuction can
enhance smooth recovery from the liposuction treatment.
48 PB70286EN
Treatment Parameters
Selecting the correct treatment parameters is essential for safe and successful
treatment.
• Set the IR mode intensity level according to the vacuum level, so that you do
not exceed a total of 5, e.g. with vacuum level 2 you may use IR level 3, but
with vacuum level 3 use IR level 1 or 2.
• Do not use high IR levels for very dark or tanned skin, or over hair.
• Reduce IR level when the skin surface is rapidly heated such as in stacking, in
particular with the Vcontour applicator.
• Vacuum levels for sensitive areas, such as inner thigh and over loose skin
areas, should rarely exceed level 1 and may only be increased according to
the patient's tolerance.
• Use high RF levels unless the patient feels an intolerable "stinging" sensation.
• Low IR levels with higher vacuum levels enable prolonged and deeper
treatment (e.g. circumference reduction). Higher IR levels with lower vacuum
levels facilitate overall smoother appearance of the skin surface (via cellulite
reduction).
• When using the Vcontour applicator, stacking is the preferred treatment

manner. The typical number of stacked pulses is up to 10.
Table 3: Treatment Parameters for Vsmooth & Vcontour Applicators

Circumference Reduction /
Cellulite Treatment
Desired Treatment: Body Contouring [Deep
[Superficial Hypodermis]
Hypodermis]
IR Level 2–3 1
RF Level 3 3
Vacuum Level * 1–2 2–3*
(*) Vacuum may be lowered in accordance with the patient's tolerance.
Note
• The treatment parameters in Table 3 are typical but always
consider individual skin response and patient's comfort.
• Always start with a test spot, treat and increase levels gradually if
the patient's skin response and comfort allow.
PB70286EN 49
Post-Treatment Care
• If heat sensation is excessive, cool the area with conventional cooling
methods such as cold (not frozen) packs, air cooling with SynerCool, etc.
• In case of side effects such as burns, stop treatment; apply cooling and
appropriate creams. Resume treating the area only after the side effects have
subsided, and with reduced levels of parameters.
• Prevent post-treatment overheating (e.g., Jacuzzi, sauna, etc.), or risk of

physical damage.
Treatment Conclusion
• Treatment should be concluded when the results are satisfactory to the patient
or according to the operator's discretion.
• Improvement will take some time to be apparent, and is affected by clinical

conditions at the start of treatment regimen. Main impacts may be:
1. Transient skin texture that may show improvement after each session.
2. Thighs circumference reduction may show improvement after

2–3 sessions.
3. Cellulite may show improvement after 4 sessions.
• Take photos and measurements of the treatment areas after the last session.
50 PB70286EN
User Manual Maintenance
7. MAINTENANCE
While the VelaShape II system should not be serviced by anyone other than an
authorized Syneron-Candela agent or technician, the system requires regular
preventive maintenance and cleaning to ensure optimal system performance. This
chapter describes the routine maintenance procedures that users may perform:
• Cleaning the VelaShape II system
• Cleaning the VelaShape II applicators
• Cleaning the air grids
• Replacing the applicators' replaceable covers and filters when required
Warning
The symbol located near the power cable's connection port

indicates:
WARNING! DISCONNECT POWER SUPPLY CABLE BEFORE
MAINTENANCE OR SERVICE PROCEDURES TO AVOID
ELECTRIC SHOCK.
For continued protection against fire, replace the fuse only with one
of the same type and rating.
Cleaning the Console

Clean the system at least once a week. Turn the system off and wipe all surfaces
with a soft, damp, non-abrasive cloth.
Warning
Be careful not to spill any liquids on the system.
Cleaning and Maintaining the Vsmooth Applicator

Caring for the Vsmooth applicator involves the following maintenance
procedures before and after each treatment:
• Removing, cleaning and replacing the replaceable cover
• Cleaning the interior of the applicator
• Replacing the applicator's filters
PB70286EN 51
Maintenance
Caution
While gently cleaning the interior of the applicator, avoid moisture and
dirt from getting into the applicator’s filters.
The replaceable cover of the Vsmooth applicator should be replaced according to

the schedule printed on the new cover's box label, or sooner if one of the
following is observed:
• Rollers appear damaged, discolored or their movement is impaired.
• Roller axis appears to wear out (color turns from silver to copper).
Proceed as follows:
1. Turn the system off and disconnect the replaceable applicator cover by
pressing the two spring-loaded buttons and pull the cover straight off the
applicator body, as shown in Figure 23.
Press Buttons to
Release Cover
Figure 23: Removing the Vsmooth Replaceable Cover
Note
The image in the figure is for illustration purposes only.
2. If it becomes necessary to clean the applicator cover during treatment:

• While the system is on, clean the rollers of the Vsmooth applicator while
pressing the trigger, with all modes at level 0, while rolling over a mild
disinfectant-dampened tissue (that does not contain alcohol).
52 PB70286EN
• Turn the system off and remove the cover. Use hot tap water (no more
than 122°F/50°C). The cover should be flushed and washed thoroughly in
hot water and mild disinfectant soap or detergent that do not contain
alcohol, until all residual VelaSpray Ease is removed. Wipe and dry the
cover with a soft cloth. Reconnect the cover only when completely dry.
3. Clean the Vsmooth applicator's interior components at the end of every day
as follows (see Figure 24):
• Replace the two filters according to the schedule printed on the cover's
box, or when the communication terminal displays a 03 - Replace Filters
message (see Figure 25). Never use a pair of filters for more than
10 accumulative hours.
• Clean the RF contacts and ID contacts with a soft cloth.
• Gently clean the IR lamp aperture using a gentle optical lens cleaning
solution, such as Fisherbrand® Optical Lens Cleaner or equivalent; be
careful not to scratch it.
• Gently dry the IR lamp aperture with lint-free lens cleaning tissue.
• Reconnect the clean and dry applicator's cover.
Figure 24: Vsmooth Applicator's Internal Components
Caution
Verify that the vacuum sensor's inlet does not become clogged
during cleaning. Avoid inserting spray residue into the inlet.
PB70286EN 53
Maintenance
Replacing the Vsmooth Applicator's Filters
Refer to Figure 25:
1. Use the supplied filter extractor to pull the two filters out of the body of the
applicator, as shown in view A. Discard the used filters.
2. Unpack a pair of new filters and firmly insert them into the filter chambers, as
shown in view B.
A B
Figure 25: Replacing the Vsmooth Applicator's Filters
Caution
Make sure that the interior of the applicator is completely dry before
inserting the filters.
Cleaning and Maintaining the Vcontour Applicator

Cleaning/Replacing the Applicator Cover
The replaceable cover of the Vcontour applicator should be replaced according

to the schedule printed on the cover's box label, or sooner if one of the following
is observed:
• The IR & RF columns of LEDs blink continuously (inadequate coupling)
and the communication terminal displays a 01 - Improve Contact message.
• Electrodes appear damaged.
• The cover's shape appears distorted.
54 PB70286EN
Proceed as follows:
1. Remove the applicator cover by pulling it off. Discard the used cover and
filter assembly.
2. If it becomes necessary to clean the applicator cover during treatment, use hot
tap water (no more than 122°F/50°C). The cover should be flushed and
washed thoroughly in hot water and mild disinfectant soap or detergent that
do not contain alcohol, until all residual VelaSpray Ease is removed. Wipe
and dry the cover with a soft cloth. Reconnect the cover only when
completely dry.
3. Clean the Vcontour applicator's components at the end of every day as

follows:
• Refer to Figure 26: clean the RF applicator contacts (A), the ID microchip
contact points (B) and the vacuum inlet (C) with a clean, soft cloth.
• Gently clean the IR lamp's aperture (D) using a gentle optical lens cleaning
solution, such as Fisherbrand® Optical Lens Cleaner or equivalent; be
careful not to scratch it.
B
D
A
A
Figure 26: Vcontour Applicator's Internal Components
Caution
Make sure that the interior of the applicator is completely dry before
connecting a new replaceable cover.
PB70286EN 55
Maintenance
Cleaning the Vcontour Applicator's Filter
Remove the filter from the cover if it becomes necessary to clean, or when the
communication terminal displays a 03 - Replace Filters message.
1. Use the supplied filter extractor to pull the filter out of the cover, as shown in
Figure 27.
2. Wash the filter and allow it to dry completely before reusing it.
3. Firmly insert the clean filter into the filter chamber.
Figure 27: Replacing the Small Applicator's Filter
Note
The image in the figure is for illustration purposes only.
56 PB70286EN
Cleaning the Air Grids

Clean the system's two air grids (see Figure 28) at least once every three months
as follows:
1. Turn the system off.
2. Remove the grids and brush the outside surfaces of the air grid with soft
brush.
3. Be careful not to damage the air grid surface.
Figure 28: Air Filter and Grids
PB70286EN 57
Maintenance
Cleaning the System Air Filter

While the system air filter should be cleaned at least once a week, the filter cup
needs to be checked daily and cleaned according to the amount of dust and debris
that accumulates.
To clean the system air filter (see Figure 29):
2. Open the filter door by lifting up the lock.
3. Release Screw # 1 on the bottom of the filter cup to open the cup and wipe off
the dust and debris.
4. Release Screw # 2 to remove the filter, and wash it with water and soap.
5. When the filter is completely dry, fit it back into place, or put a new filter and
secure the filter cup using the screws.
6. The same filter may be re-used after washing, and should be discarded when
it can no longer be completely cleaned.
Caution
Be sure that the filter is completely dry before re-assembling.
Filter
Screw # 2
Filter Cup
Screw # 1
Figure 29: Cleaning the Air Filter
58 PB70286EN
Upgrading the System Software

Syneron-Candela periodically releases new software upgrade versions for the
VelaShape II system. When such a version is released, it will be sent to the
system's registered owner in the form of a software plug. When received, follow
these simple steps to update the system's software package (refer to Figure 30):
1. Turn the system off and unplug the power cable.
2. Remove the old software plug by loosening the two plug screws and pulling
the plug out of its port. You may use a flat screwdriver if necessary.
3. Unpack and install the new software plug; tighten the plug's screws finger-
tight – do not use the screwdriver.
4. Plug in the power cable and turn the system on; the system will initialize and
install the new software in a completely automatic manner – no action is
required of you.
5. The automatic software installation will take approximately 2 minutes,

during which the LED lights on the applicators will be flashing in different
patterns. Do not disturb the system while this is happening.
6. When the software installation is complete, the system will perform a self-test
of three vacuum pulses and the LED lights will stabilize. The system is now
ready to resume normal operation.
Plug Screws
User SW Plug
Figure 30: Replacing the Software Plug
PB70286EN 59
Troubleshooting
8. TROUBLESHOOTING GUIDE
The VelaShape II system is equipped with a self-testing software routine that
continuously monitors system operation. If a system error is detected, the
modules are disabled until the problem is solved.
The following troubleshooting guides do not attempt to list all possible system
failures. Any error not listed should be referred to your Syneron-Candela
representative.
Table 4 offers a list of possible system errors that will be displayed on the
communication terminal's display and operator panels of the applicators, and how
to correct them. If the corrective actions listed in the table do not solve the
problem, contact your Syneron-Candela representative.
Table 5 offers several fault situations that may occur with no operator panel
indication or terminal display, and their appropriate corrective actions. If these do
not resolve the problem, contact your Syneron-Candela representative.
Most times a system error can be cleared by restarting the VelaShape II system.
Always try this remedy before contacting your Syneron-Candela representative.
Table 4: System Errors Displayed by Terminal Messages and Operator Panel Indicators
Message Symptom Corrective Action
The applicator's operator panel The coupling of the applicator
IR & RF bars blink while the to the patient's skin is
01 - Improve Contact
trigger is pressed [except the 0 inadequate. Ensure adequate
(zero) row]. contact.
The system is indicating that
Vacuum indicator LEDs are
you are trying to operate
cyclically descending from 3 to
02 - Insert Filters without filter(s) in the
1 – indicating no filters
applicator. Insert new filter(s)
(Vsmooth applicator only).
as needed.
Vacuum indicator LEDs are The system is sensing that the
03 - Replace Filters cyclically ascending from 1 to 3 filters being used are clogged.
– indicating clogged filters. Clean or replace the filters.
The applicator's cover is not in
complete contact with the
04 - Reconnect Cover body of the applicator.
Remove the cover and
reconnect it securely.
• The number of allowed
operating hours for the
disposable cover has
expired, replace the cover
with a new one.
05 - Replace Cover
• Normally the cover should
be replaced with a new one
according to the schedule
printed on the cover's
storage box label.
60 PB70286EN
User Manual Troubleshooting
Table 4: System Errors Displayed by Terminal Messages and Operator Panel Indicators (con't)
Message Symptom Corrective Action

Trigger pressed and no
IR/RF/Vacuum levels are
06 - Select Mode selected (all at level zero).
Select appropriate levels and
proceed with treatment.
The operator panel's RF bar is
100 - RF Failure blinking while the trigger is not
being pressed (after self-test).
101 - No Vacuum After start-up, all 0 (zero) row
Restart the system. If it
Sensor in LA/SA LEDs are blinking.
initializes properly, proceed
102 - Bad System Type with normal operation.
Trigger will not operate system If the error persists, contact
103 - Applicator Type your Syneron-Candela
or LEDs are not responding to
Not Supported representative.
user selection.
104 - Vsmooth or Operator panel LEDs do not
Vcontour Initialization
form "V" pattern on start-up.
Fault
Table 5: Fault Situations with No Indicators or Error Messages
Symptom Corrective Action

2. Check that air filter is clean and the filter
cover is properly fastened (the cover's
sealing O-ring should be properly installed).
No vacuum suction
3. Check the applicator connection to the
Dual-Connector.
4. Verify that the cover is correctly attached to the applicator.
5. Replace applicator filters or cover.
No IR output 2. Call your Syneron-Candela representative for further
instructions.
Electrodes are not rotating 2. Check that the applicator chamber is clean and that nothing
(Vsmooth applicator). is obstructing the electrodes.
3. Connect a new applicator cover.
Applicator ceases to Restart the system. If it initializes properly, proceed with normal
function and the system operation.
emits four consecutive If the problem persists, contact your Syneron-Candela
"beeps". representative.
PB70286EN 61
Electromagnetic Regulation
9. SYSTEM SPECIFICATIONS
Parameters
• Up to 60 Watts (Vsmooth applicator)

RF Power
• Up to 23 Watts (Vcontour applicator)
IR Electrical Power Up to 35 Watts (Vsmooth and Vcontour applicators)
Light Spectrum 700 – 2000 nm
Vacuum Pulsed
Treatment Area Footprints
Vsmooth Applicator 40 mm x 40 mm
Vcontour Applicator 30 mm x 30 mm
Electrical Requirements (Factory-Configured per Customer Order)

• 100 VAC; 6A; 50-60 Hz; single phase
• 110-127 VAC; 5.2A; 50-60 Hz, single phase
• 220-240 VAC; 3.1A; 50-60 Hz; single phase
Environmental Requirements
Treatment Room
• Operating temperature: 15° – 30°C [59° – 86°F]

• Relative Humidity: Up to 80%
• Atmospheric Pressure: 70 – 106 kPa
Transportation and Storage
• Operating temperature: 00° – 55°C [50° – 131°F]

• Relative Humidity: 10 to 80%
• Atmospheric Pressure: 70 – 106 kPa
62 PB70286EN
User Manual Specifications
Degree of Protection Against Ingress of Water
• IPX0 – Ordinary Equipment
Dimensions
• VelaShape II system [W x D x H]: 36 x 55 x 80 cm / 14.2 x 21.6 x 31.5"
• Applicator umbilical harness: 2.8 m / 9.2 feet
Weight
• VelaShape II system: 27 kg. / 59.5 lbs.
• Applicators: Less than 2.0 kg. / 4.4 lbs.
PB70286EN 63
10. ELECTROMAGNETIC REGULATION

Electromagnetic Emissions
The VelaShape II system is intended for use in the following electromagnetic
environment. The owner of the system and/or the user must ensure that it is
operated the correct environment.
Emissions Test Compliance

CISPR 11: RF Emissions Group 2
The VelaShape II system must emit electromagnetic energy in order to perform

its intended function. Nearby electronic equipment may be affected.
Emissions Test Compliance

CISPR 11: RF Emissions Class A
IEC 61000-3-2: Harmonic Emissions N/A
IEC 61000-3-3: Voltage fluctuations/flicker emissions N/A
The VelaShape II system is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings
used for domestic purposes, provided the following warning statement is heeded:
Warning
This device is intended for use by health care professionals only.
This device may cause interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigating measures,
such as re-orienting or relocating the device or shielding the location.
64 PB70286EN
User Manual Electromagnetic Regulation
Electromagnetic Immunity
Immunity Test IEC 60601 Test Level Compliance
IEC 61000-4-2: Electrostatic ±2, 4, 6 kV Contact
± 6 kV contact ± 8 kV air
Discharge (ESD) ±2, 4, 8 kV Air
IEC 61000-4-4: Electrical Fast ± 2 kV for power supply lines ±2 kV

Transient/Burst ± 1 kV for input/output lines N/A
± 1 kV differential Mode 1.0 DM
IEC 61000-4-5: Surge
± 2 kV common mode 2.0 CM
IEC 61000-4-8: Power
Frequency (50/60 Hz) Magnetic 3 A/m 3 A/m
Field
<5 % UT (>95 % dip in UT) for <5 % UT (>95 % dip in UT) for
0.5 cycle 0.5 cycle
IEC 61000-4-11: Voltage Dips, 40% UT (60% dip in UT) for 40% UT (60% dip in UT) for
Short Interruptions and Voltage 5 cycles 5 cycles
Variations on Power Supply 70% UT (30% dip in UT) for 70% UT (30% dip in UT) for
Input Lines 25 cycles 25 cycles
5% UT (95% dip in UT) for 5% UT (95% dip in UT) for
5 cycles 5 cycles
• Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30%.
• Mains power quality should be that of a typical commercial or hospital

environment.
• If the VelaShape II system is required to operate during power interruptions,

the system should be powered from an uninterruptible power supply.
• Power frequency magnetic fields should be at levels characteristic of a typical

location in a typical commercial or hospital environment.
Note
UT is the AC mains voltage prior to application of the test level.
PB70286EN 65
Electromagnetic Immunity (continued)
IEC 60601
Immunity Test Compliance Guidelines
Test Level
d =1.17 * SQRT(P) 80 MHz to 800 MHz
d =2.33 * SQRT(P) 800 MHz to 2.5
GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
61000-4-3: 3 V/m 80 MHz 3 V/m 80 MHz to
Radiated RF to 2.5 GHz 2.5 GHz Field strengths from fixed RF
transmitters, as deter-mined by an
electromagnetic site survey1, should be
less than the compliance level in each
frequency range2.
Interference may occur in the vicinity of
equipment marked with this symbol:
Portable and mobile RF

communications equipment should be
used no closer to any part of the
VelaShape II system, including cables,
61000-4-6: 3 VRMS 150 kHz 3 VRMS 150 kHz than the recommended separation
Conducted RF to 80 MHz to 80 MHz distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
d =1.17 * SQRT(P)
(1) Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the VelaShape II system is used exceeds
the applicable RF compliance level above, the VelaShape II system should be
observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the
VelaShape II system.
(2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
66 PB70286EN
User Manual Electromagnetic Regulation
Note
• At 80 and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
Recommended Separation Distances

The following are the recommended separation distances between portable and
mobile RF communications equipment and the VelaShape II system.
The VelaShape II system is intended for use in an electromagnetic environment

in which radiated RF disturbances are controlled. The owner of the system and/or
the user can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the VelaShape II system as recommended below, according to
the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed below, the
recommended separation distance (d) in meters (M) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter's
manufacturer.
Rated Maximum Separation Distance According to Frequency of Transmitter (M)

Output Power of 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Transmitter (W) d = 1.17 SQRT(P) d = 1.17 SQRT(P) d = 2.33 SQRT(P)
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
Note
At 80 and 800 MHz, the higher frequency range applies.
PB70286EN 67

VelaShape II

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User Manual

Contact information for equipment manufacturer and technical services:

Figure 8: Before Treatment ........................................................................................................................ 21

1. BEFORE YOU START

Conventions Used in this Manual

A Warning alerts the user to the possibility of injury, death, or

Explanation of the Symbols Used in the System

Refer to Instruction Manual/Booklet

CSA Compliance Symbol (212603 CSA master

Waste of Electrical and Electronic Equipment (WEEE)

RF Interference may occur in the vicinity of equipment

Product Shelf-Life: product may not be stored for

Authorized Representative in the European Union

System Safety Features

• The system is activated by a key that should be available only to trained

• The power electronics cannot be activated unless an applicator has been

• During activation, the system performs a self-test of the hardware to

Patient and Personnel Safety

• Make sure that only well-trained attendants perform treatment.

• Prior to scheduling treatments, obtain a detailed patient history to verify

• Ascertain that all jewelry is removed.

• Improper treatment technique may cause local burns.

Installing the System

Operating the System

• Always turn the system off before connecting/disconnecting an applicator, or

• Keep the applicators clean and dry.

• Never use the system in the presence of explosive or flammable materials.

Infrared Energy Safety Issues

Radio-Frequency Energy Safety Issues

Mechanical Rollers Safety Issues

Electrical and Mechanical Safety

Maintaining the System

• If alcohol is used for disinfecting, it must be allowed to dry thoroughly before

• Protection against ingress of liquids: Ordinary equipment

• Not suitable for use in presence of flammable substances

• The VelaShape II system and applicators comply with U.S. Federal

• The system is classified as a Class IIa device according to Annex IX of the

Figure 1: System Nameplate Location

• USA: temporary reduction in the appearance of cellulite and temporary

The system is designed to be user-friendly, safe and reliable. It integrates the

These three technologies work together to provide dermal and sub-dermal

Figure 2: VelaShape II System

The VelaShape II console houses the following components:

The VSmooth applicator (see Figure 3) utilizes IR, RF and mechanical

The VContour applicator (see Figure 4) utilizes IR, RF and mechanical

The VelaShape II applicators are composed of a permanent handpiece and a

The replaceable cover of the Vsmooth applicator should be replaced according to

The replaceable cover of the Vcontour applicator should be replaced according

IR RF Vacuum RF Electrode Rollers IR Aperture

Level 1 - Low Level 2 - Medium Level 3 - High

Figure 3: Vsmooth Applicator [Left: Operator Panel /

Figure 4: Vcontour Applicator [Left: Operator Panel /

• Blinking of the LEDs on the applicator's operator panel.

• An Improve Contact message on the communication terminal's display (see

Figure 5: Communication Terminal

The VelaShape II Procedure

Both actions, reducing the size of the fat Infrared filter

shrinkage of the connective tissue septa

Figure 7: elōs Heating and Mechanical

Figure 8: Before Treatment

Figure 9: IR Heats the Tissue Up To 2 mm. RF Heats the Tissue

Figure 10: After VelaShape II Treatment Reduction in the Size

Heating of Dermis and Hypodermis with elōs

• Broad spectrum IR light at wavelengths of 700-2000 nm.