Syneron Candela VelaShape III System User Manual

System User Manual

PB81499EN

the order of a physician, or properly licensed practitioner. Syneron makes no representations regarding federal, state, or local laws or regulations that might apply to the

Syneron Medical Ltd. reserves the right to make changes to its products or specifications to improve performance, reliability, or manufacturability. Information furnished by Syneron Medical Ltd. is believed to be accurate and reliable. However, Syneron Medical Ltd. assumes no responsibility for its use. No license is granted by its implication or otherwise under any patent or patent rights of Syneron Medical Ltd.

No part of this document may be produced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Syneron Medical Ltd.

Data is subject to change without notification. Syneron Medical Ltd. has patents and pending patent applications, trademarks, copyrights, or other intellectual

property rights covering subject matter in this document. The furnishing of this document does not give you any license to these patents, trademarks, copyrights, or other intellectual property rights except as expressly provided in any written agreement from Syneron Medical Ltd.

Specifications are subject to change without notice. Manual Catalog Part Number: PB81499EN

Revision Release Date: January 2015

● Before using the device, please ch eck 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

use and operation of this device.

Contact information for equipment manufacturer and technical services:

● Syneron, Inc.

3 Goodyear, Suite A Irvine, CA 92618 USA Tel: + 1.866.259.6661 (toll free)

● CEpartner4u B.V.

Esdoornlaan 13 3951 DB Maarn The Netherlands Tel: + 31.343.442.524 Fax: + 31.343.442.162

● Syneron Medical (HK) Ltd.

Room 3103, 31/F, Hopewell Centre, 183 Queen's Road East, Wan Chai, Hong Kong Tel: +852-2543-4326 +852-9406-3090 Fax: +852-2543-4327

● Syneron Medical Ltd.

P.O. Box 550 Industrial Zone, Tavor Building Yokneam Illit 20692 Israel Tel: + 972.73.244.2200 Fax: + 972.73.244.2202

● Website: www.Syneron-Candela.com

● E-mail: info@syneron.com

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Table of Contents

TABLE OF CONTENTS

1. Before You Start ....................................................................................................................................... 8

Conventions Used in this Manual ........................................................................................................ 8

Explanation of the Symbols Used in the System ................................................................................. 9

2. Safety ..................................................................................................................................................... 10

Introduction ........................................................................................................................................ 10

System Safety Features .................................................................................................................... 11

Patient and Personnel Safety ............................................................................................................ 11

Grounding the System ....................................................................................................................... 12

Operating the System ........................................................................................................................ 12

Infrared Energy Safety Issues ........................................................................................................... 12

Radio Frequency Energy Safety Issues ............................................................................................ 12

Mechanical Rollers Safety Issues (Vsmooth Appli cat or) ................................................................... 13

Electrical and Mechanical Safety ....................................................................................................... 13

Maintaining the System ..................................................................................................................... 13

Fire Hazards ...................................................................................................................................... 14

System Classifications ....................................................................................................................... 14

System Nameplate ............................................................................................................................ 15

3. System Description ................................................................................................................................ 16

System Overview ............................................................................................................................... 17

Console ......................................................................................................................................... 17

Applicators ..................................................................................................................................... 18

Anatomy of Cellulite ........................................................................................................................... 20

The VelaShape III Procedure ............................................................................................................ 20

Heating of Dermis and Hypodermis with elōs .................................................................................... 22

Mechanical Effects of Vacuum on the Skin ....................................................................................... 22

4. System Installation ................................................................................................................................. 23

Unpacking the System ....................................................................................................................... 23

Equipment List ................................................................................................................................... 25

Cover Packs ...................................................................................................................................... 25

System Dimensions ........................................................................................................................... 26

Installation Process ............................................................................................................................ 27

Moving the System within the Facility ................................................................................................ 30

Moving the System to another Facility ............................................................................................... 30

Electrical Requirements ..................................................................................................................... 30

Environmental Requirements ............................................................................................................ 31

5. Operating Instructions ............................................................................................................................ 32

Activating the System ........................................................................................................................ 32

Automatic Vacuum and RF Test ................................................................................................... 32

Setting Treatment Parameters – Tablet Contr ol P anel ..................................................................... 33

Default Settings ............................................................................................................................. 35

Setting Treatment Parameters – Applicat or Control Panel ............................................................... 35

Utilities Mode ..................................................................................................................................... 37

System Information Screen ........................................................................................................... 37

Maintenance Screen ..................................................................................................................... 38

Settings Screen ............................................................................................................................. 39

User Diagnostics Screen ............................................................................................................... 40

Service Mode Screen .................................................................................................................... 41

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VelaShape III User Manual Table of Contents

Video List Screen .......................................................................................................................... 42

Initiating Treatment ............................................................................................................................ 43

6. Clinical Guide: Cellulite and Circumference Treatment ......................................................................... 44

Realistic Expectations ....................................................................................................................... 44

Indications ......................................................................................................................................... 44

Contraindications ............................................................................................................................... 44

Possible Side Effects ......................................................................................................................... 46

Pre-Treatment Preparation ................................................................................................................ 46

Selecting the Appropriate Treatment Type ........................................................................................ 47

VelaShape III Measurement .............................................................................................................. 48

Circumference ............................................................................................................................... 49

Cellulite ......................................................................................................................................... 50

Treatment Procedure ......................................................................................................................... 51

Applicator Positioning .................................................................................................................... 52

Test Spot ....................................................................................................................................... 52

Treatment Technique: Identifying the Applicator and Cover ............................................................. 52

Treatment Using the VContour Applicator .................................................................................... 52

Treatment Protocol Using the Circumference Mode ......................................................................... 53

Treatment Protocol of Large Areas Using Circumf erence Mode (Medium Cover) ....................... 53

Treatment Protocol of Small Areas Using Cir cumference Mode (Small Cover) ........................... 56

Treatment Protocol Using Deep Mode .............................................................................................. 57

Treatment Protocol of Focal Fat Deposits Using Deep Mode (Large and Medium Covers) ........ 57

Cellulite Mode Treatment Protocol Using the V Smooth Applicator ................................................... 63

Treatment Protocol Using Cellulite Mode ..................................................................................... 63

Treatment Options with Cellulite Mode ......................................................................................... 68

Endpoints (When to Stop Treating an Area) ..................................................................................... 69

Post-Treatment Care ......................................................................................................................... 70

Treatment Conclusion ....................................................................................................................... 70

7. Maintenance ........................................................................................................................................... 71

Cleaning the Console ........................................................................................................................ 71

Cleaning and Maintaining the VSmooth Applicato r ........................................................................... 72

Replacing the VSmooth Applicator's Filters .................................................................................. 74

Cleaning and Maintaining the VContour Applicator .......................................................................... 75

Cleaning the VContour Applicator's Filter ..................................................................................... 76

Cleaning the System Air Filter ........................................................................................................... 77

8. Troubleshooting Guide ........................................................................................................................... 78

9. System Specifications ............................................................................................................................ 81

Output Parameters ............................................................................................................................ 81

Treatment Area Footprints ................................................................................................................. 81

Control Panel ..................................................................................................................................... 81

Electrical Requirements ..................................................................................................................... 81

Environmental Requirements ............................................................................................................ 82

Treatment Room ........................................................................................................................... 82

Storage/Transportation ................................................................................................................. 82

Degree of Protection Against Ingress of Water ............................................................................ 82

System Console Dimensions [W x D x H] ......................................................................................... 82

Weight ................................................................................................................................................ 82

10. Electromagnetic Compliance ............................................................................................................... 83

Electromagnetic Emissions ............................................................................................................... 83

Electromagnetic Immunity ................................................................................................................. 84

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Table of Contents

Recommended Separation Distances ............................................................................................... 86

LIST OF FIGURES

Figure 1: System Nameplate Location ....................................................................................................... 15

Figure 2: VelaShape III System ................................................................................................................. 17

Figure 3: VContour Applicator [Left: Operator Panel / Right : Applicator Elements].................................. 18

Figure 4: VSmooth Applicator Elements .................................................................................................... 19

Figure 5: Anatomy of Cellulite .................................................................................................................... 20

Figure 6: elōs Heating and Mechanical Manipulation Action .................................................................... 20

Figure 7: Before Treatment ........................................................................................................................ 21

Figure 8: After VelaShape III Treatment Reduction in the Size of the Fat Cells and Fat Chambers ........ 21

Figure 9: Unpacking the System ................................................................................................................ 23

Figure 10: System Dimensions .................................................................................................................. 26

Figure 11: Umbilical Support Mast ............................................................................................................. 27

Figure 12: Mast and Umbilical Cable Installation ....................................................................................... 27

Figure 13: Umbilical Connection Port ......................................................................................................... 28

Figure 14: Applicator on Handle ................................................................................................................. 28

Figure 15: Service Panel ............................................................................................................................ 29

Figure 16: Main Menu Screen .................................................................................................................... 33

Figure 17: Treatment Settings Ribbon ....................................................................................................... 34

Figure 18: Default Settings ......................................................................................................................... 35

Figure 19: Applicator Control Panels ......................................................................................................... 35

Figure 20: Applicator Control Panel Display .............................................................................................. 36

Figure 21: Control Panel Buttons ............................................................................................................... 36

Figure 22: Parameter Icons and Level Displays ........................................................................................ 36

Figure 23: System Information Screen; About VelaS hape III Tab ............................................................. 37

Figure 24: System Information Screen; Counters Tab ............................................................................... 37

Figure 25: Maintenance Screen ................................................................................................................. 38

Figure 26: Settings Screen; Date & Time Tab ........................................................................................... 39

Figure 27: Settings Screen; Display Settings Tab ..................................................................................... 39

Figure 28: Settings Screen; Audio Settings Tab ........................................................................................ 40

Figure 29: User Diagnostics Screen .......................................................................................................... 40

Figure 30: Service Mode Screen ................................................................................................................ 41

Figure 31: Video List Selection Tab ........................................................................................................... 42

Figure 32: Maintenance Videos (example) ................................................................................................ 42

Figure 33: Practice Enhancement Videos (exam ple) ................................................................................. 43

Figure 34: Illustration of Circumference Measur em ents: A) Fixed Distance between the Legs; B) Labeling the circumference; C) Measuring Horizontally;

D) Labeling the Arm Against a Wall. ......................................................................................... 49

Figure 35: Illustration of cellulite stages (A- S tage Zero; B- Stage One; C- Stage Two; D- Stage Three) 50

Figure 36: Sub-Area Divided into Segments .............................................................................................. 53

Figure 37: Identifying Sub-Areas and Segments fo r Anterior and Posterior Abdomen

Circumference Reduction .......................................................................................................... 53

Figure 38: Cycle 1 “Horizontal Snake-Like” ............................................................................................... 54

Figure 39: Cycle 2 “Vertical Snake-Like” .................................................................................................... 55

Figure 40: Sub-Area Divided into Segments .............................................................................................. 56

Figure 41: Cycle 1 and Cycle 2 in Small Sub-Areas .................................................................................. 57

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VelaShape III User Manual Table of Contents

Figure 42: Deep Mode protocol Segmentation .......................................................................................... 57

Figure 43: Flanks (A) and Middle Back (B) Segmentation for the Treatment of Focal Fat Deposit .......... 58

Figure 44: Cycle 1-Step #1 “Horizontal Snake-Like” ................................................................................. 60

Figure 45: Cycle 1 – Step #2 “Vertical Snake-Like” ................................................................................... 61

Figure 46: Cellulite Mode Protocol Sub-Area Segm entation ..................................................................... 63

Figure 47: Segment A Treatment Illustration ............................................................................................. 65

Figure 48: Segment B Treatment Illustration ............................................................................................. 65

Figure 49: Segment C Treatment Illustration ............................................................................................. 66

Figure 50: Segment D Treatment Illustration ............................................................................................. 66

Figure 51: Horizontal Snake-Like ............................................................................................................... 67

Figure 52: Vertical Snake-Like ................................................................................................................... 67

Figure 53: Removing the VSmooth Replaceable Cov er ............................................................................ 72

Figure 54: VSmooth Applicator's Internal Compo nents ............................................................................. 73

Figure 55: Replacing the VSmooth Applicator's Filters .............................................................................. 74

Figure 56: Applicator's Internal Components ............................................................................................. 75

Figure 57: Replacing the VelaShape III Applicator' s Filter ........................................................................ 76

Figure 58: Cleaning the Air Filter ............................................................................................................... 77

PB81499EN

Before You Start

● Read this manual to become familiar with all safety requirements

The content of this Note offers general information that is important to

A Caution alerts the user to the possibility of a potentially hazardous A Warning alerts the user to the possibility of injury, death, or serious

1. BEFORE YOU START

Warning

and operating procedures before attempting to operate the system.

● Any intense optical energy or radio frequency (RF) device can

cause injury if used improperly.

● High voltage is present inside the system. Always be aware of the

possible dangers and take proper safeguards as described in this manual.

● The VelaShape III system must be serviced only by Syneron

Medical Ltd. qualified personnel.

Conventions Used in this Manual

The following conventions in the form of notes, cautions and warnings are used in this manual:

Note

keep in mind.

Caution

situation which, if not avoided, may result in minor or moderate injury to the user or damage to the equipment.

Warning

adverse reactions associated with the use or misuse of the system.

PB81499EN

VelaShape III User Manual Before You Start

Explanation of the Symbols Used in the System

Symbol Description

Refer to instruction manual/booklet

Caution!

0344

CE Compliance Symbol

Waste of Electrical and Electronic Equipment (WEEE) compliance symbol

RF Interference may occur in the vicinity of equipment with the following symbol

Product Shelf-Life: product may not be stored for longer than this period after being opened for the first time

Fuse

Type BF Equipment

Manufacturer

Authorized Representative in the European Union

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Safety

● Read this chapter to be familiar with all of its safety requirements

2. SAFETY

This chapter describes the safety issues regarding the use and maintenance of the VelaShape III system, with special emphasis on optical and electrical safety.

Introduction

The system is designed for safe and reliable treatment, when used in accordance with proper operation and maintenance procedures. Only trained practitioners are qualified to operate the system. The user and all other personnel operating or maintaining the system should be familiar with the safety information provided in this chapter. Syneron Medical Ltd. assumes no liability whatsoever for any damage or injury as a result of an application of a product which is not in strict accordance with the instructions provided with the product. The primary consideration should be to maximize safety for both treating attendant and the patient.

Warning

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.

PB81499EN

VelaShape III User Manual Safety

Prior to system activation, any personnel operating or maintaining the

System Safety Features

The VelaShape III system incorporates the following safety features:

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

connected to the system.

● Upon system activation, IR, RF, and Vacuum are at Level 0 on the control

panel.

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

any faults, so that you can shut down the system if necessary.

● IR and RF energies are not delivered unless full contact with the tissue is

conducted and the applicator's trigger or footswitch is pressed.

Patient and Personnel Safety

When handling the VelaShape III system, the primary safety concern should be the safety of both the treating attendant and the patient. Follow these personal safety guidelines to maintain a high level of personnel safety:

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

● Before activating the system, make sure any long hair of the treating attendant

or the patient is safely pulled back and tied.

● Ascertain that all jewelry is removed.

● Prior to scheduling treatments, obtain a detailed patient history to verify that

the patient is eligible and is in fit condition to undergo treatment.

● Fully inform the patient regarding the treatment protocol, the likely results

and any risks associated with treatment.

● Improper treatment may cause local burns.

● Opaque eye protection should be used when working within a 30 cm (12")

proximity to the patient's eyes.

Warning

system should be familiar with the safety information provided in this chapter.

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Safety

Grounding the System

When installing the system, ensure that the system is grounded through the grounding conductor in the power cable. This protective grounding is essential for safe operation.

Operating the System

● Keep all system panels closed. Do not remove the panels and do not touch

any of the system's inner components.

● Keep your hands away from the applicator during system start-up.

● Keep the applicator dry and clean.

● Do not allow the replaceable applicator covers to come in contact with hard

materials, excessive heat or humidity; these may damage the RF electrodes.

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

● Make sure that all treatment personnel are familiar with the system's controls

and know how to shut down the system in the event of an emergency.

Infrared Energy Safety Issues

The VelaShape III emits gentle heating infrared light in a continuous wave mode. Light emission is contained within the applicator chamber and occurs only when the operator presses the trigger button on the applicator or footswitch, when an adequate vacuum seal is achieved and the RF electrodes are in full contact with the treated surface. Opaque eye protection should be used when working within a 30 cm (12") proximity to the patient's eyes.

Do not aim the applicator at anything but the intended target area; it should always be oriented toward the treatment area, and the trigger button or footswitch pressed only when full contact is made with the skin. In rare cases superficial crusting may be formed on the skin from the IR effect.

Radio Frequency Energy Safety Issues

The RF energy provides gentle heating that is distributed deep into the skin via bi-polar electrodes. Full coupling of both electrodes to the skin, after applying VelaSpray Ease or any other recommended product, is necessary before pressing the trigger button or footswitch, so that the RF energy is safely conducted to penetrate the skin. If coupling with the skin is broken due to incomplete contact or removing the applicator from the treatment site while the trigger or footswitch is pressed, IR and RF modes are disabled and an error message on the control panel indicates insufficient coupling. The trigger or footswitch should be released immediately and the applicator should be re-oriented on the skin. In rare cases superficial crusting may be formed on the skin from the RF effect.

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VelaShape III User Manual Safety

Because of the heating effect by RF energy, highly conductive objects such as superficial metal or conductive implants, rods, plates or pins should be avoided in the treatment area.

Mechanical Rollers Safety Issues (Vsmooth Applicator)

Beware of any loose material in or near the immediate treatment area that may get caught in the rollers. There should be no loose cords, clothing, hair, etc. in the treatment area. Ensure integrity of rollers' coating before and during treatment.

Electrical and Mechanical Safety

● Keep all system panels closed. Removing the panels creates a safety hazard.

● Keep hands away from the applicator during system start-up.

● Perform maintenance procedures when the system is shut down and

disconnected from its electrical power source.

● The system's cables are equipped with isolation coating and the electronic

circuitry is also isolated from the mains power supply. In addition, the system’s plastic covers serve as a means of isolation.

● Move the system slowly and carefully. The system weighs approximately

20 kg (44 lbs.) and may cause injury if proper care is not used when moving it.

● The system is grounded through the grounding conductor in the power cable.

This protective grounding is essential for safe operation. The RF electrodes are the only non-grounded component of the system, due to the nature of the treatment.

● Portable and mobile RF communications equipment can affect medical

electrical equipment, Interference may occur in the vicinity of the equipment.

● The use of accessories and cables other than those specified may result in

increased emissions or decreased immunity of the device. It is forbidden to connect any third-party equipment to the system without written approval from Syneron Medical.

Maintaining the System

● Only authorized Syneron technicians are qualified to service the system.

● Shut down the system and disconnect the power cable before performing any

maintenance procedures (see Chapter 7).

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Safety

Fire Hazards

● The absorption of optical energy or conduction of RF raises the temperature

of the absorbing material. Do not use the system in the presence of explosive or flammable materials.

● Do not use flammable substances when preparing the skin for treatment.

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

the system is used.

System Classifications

● Electric shock protection: Class A, Group I

● Protection against ingress of liquids: Ordinary equipment

● Not suitable for use in presence of flammable substances.

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VelaShape III User Manual 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

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System Description

3. SYSTEM DESCRIPTION

The VelaShape III is a device that combines elōs technology (electro optical synergy) with mechanical manipulation of the skin using gentle vacuum suction.

The system is designed for use in medical and aesthetic practices, to be userfriendly, safe and reliable. It integrates the following technologies:

● Infrared (IR) optical energy.

● Bipolar conductive radio frequency (RF) current.

● Mechanical manipulation (vacuum with or without massage rollers).

These three technologies work together to provide dermal and sub-dermal heating, and mechanical modifications resulting in improved blood circulation, enhanced lymphatic drainage, as well as an increased metabolic rate of the adipose tissue.

While this system is considered safe for both the operator and the patient, it should be operated only by trained, qualified treating attendants.

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VelaShape III User Manual System Description

● Power supply

● IR LEDs power supply

● Vacuum pump

● Main CPU

● RF generator

● Tablet

● Other power components

System Overview

The system includes three core modules: the Console, Applicator and TouchScreen Control Panel (see Figure 2).

Console

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Figure 2: VelaShape III System

The VelaShape III console houses the following components:

System Description

Applicators

The VSmooth and VContour applicators are used for the physical implementation of the RF current, IR energy and mechanical manipulation treatment parameters.

The VContour applicator (see Figure 3) utilizes RF and mechanical manipulation by vacuum. It is used for circumference reduction and focal fat deposit treatment in different body areas such as: abdomen, flanks, thigh, arms, middle-back, submental, etc.

The VSmooth applicator (see Figure 4) utilizes IR, RF and mechanical manipulation by vacuum and massage rollers. It is used for cellulite and skin treatment in different zones such as: abdomen, thigh, buttocks, arms, etc.

The VelaShape III applicators are composed of a permanent handpiece and a replaceable cover. The replaceable covers of the VelaShape III applicators are usable for limited periods of time.

The replaceable cover of the VelaShape III applicator should be replaced according to the schedule printed on the cover's storage box, or sooner if one of the following is observed:

● After cleaning the replaceable cover and applicator spring connectors, an

Improve Vacuum Seal message appears on the screen.

● Electrodes appear damaged.

The filter should be cleaned or replaced according to the schedule printed on the cover's storage box, or sooner if a reduction in vacuum effectiveness is observed.

Figure 3 shows the display and selector controls that are located on the operator panel of the applicator as well as on the touch-screen control panel (see Figure 3).

Figure 3: VContour Applicator [Left: Operator Panel /

Right: Applicator Elements]

Figure 4 shows the VSmooth applicator and its operating elements:

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VelaShape III User Manual System Description

The images in the figures are for illustration purposes only.

Figure 4: VSmooth Applicator Elements

Note

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

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System Description

Mechanical Manipulation Action

Anatomy of Cellulite

Cellulite is characterized by

Dimpled Skin Surface

like appearance (see Figure 5). The fat cells are located in chambers which are separated by vertical and horizontal Connective Tissue

Septae.

The Septae are anchored rigid fibers that do not stretch with the skin as the volume within the walls of the chamber increases. When the fat chamber becomes too distended by enlarged fat cells and by retained intercellular fluids, it protrudes beyond the length of the vertical septae, pushing up the skin's surface and resulting in a dimpled skin appearance.

– mattress-

Figure 5: Anatomy of Cellulite

The VelaShape III Procedure

The application of elōs (IR and RF energies) to the dermis/hypodermis is intended to deploy heat to the tissues that contribute to cellulite. The vacuum contributes to increased blood circulation (see Figure 6). The blood, which is one of the targets of the hyperthermic effect of the IR and RF, responds in a higher diffusivity of oxygen. This in turn increases the metabolic breakdown of stored fat by the fat cells (lipolysis), thereby reducing the size of the fat cells. Consequently, the bumpiness of the skin, which is largely caused by distended fat cells protruding up from the anchored connective tissue septae, is reduced.

Figure 6: elōs Heating and

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VelaShape III User Manual System Description

Both actions, reducing the size of the fat cells and draining excess fluids to the lymphatic system, are accompanied by 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: Before Treatment

Figure 8: After VelaShape III Treatment Reduction in the Size

of the Fat Cells and Fat Chambers

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System Description

Heating of Dermis and Hypodermis with elōs

Light Energy (see Figure 6):

● IR light at wavelength of 850 nm and maximum power of 3.3 Watts.

● Maximum electrical power of the IR light is 9 Watts (9 J/sec).

● Depth of heating from light reaches the deep dermis.

RF Energy (see Figure 6):

● Bi-polar conductive RF energy is emitted from the RF electrodes at a

frequency of ~1 MHz.

● Maximum electrical power of the RF energy is 150 Watts.

● The heat generated by the RF energy reaches the depth of the hypodermis.

Mechanical Effects of Vacuum on the Skin

● 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 (vacuum) dilates the blood vessels, increasing the perfusion

in the local area.

● Vacuum levels are up to 390 mbar of negative pressure.

PB81499EN

VelaShape III User Manual System Installation

4. SYSTEM INSTALLATION

The system is designed for installation in a clinical environment. The customer will carry out the installation as described in the following sections.

Unpacking the System

After unpacking the system, Syneron 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 plastic straps that encase the cardboard box.

2. Lift the cardboard box up and off the packaged components and set it aside.

Refer to Figure 9:

3. Carefully remove the packed accessories box from inside the Styrofoam

brace.

4. Finish removing all of the Styrofoam braces from around the system console.

5. Remove the plastic bag that is wrapped around the system console.

Figure 9: Unpacking the System

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System Installation

The system weighs 20 kg (44 lbs.) and should only be lifted by two

6. 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 representative.

7. Lift the system up and out of the bottom Styrofoam brace and carefully set it

on the floor.

Warning

people. Lift correctly and protect your back!

8. Finish unpacking the accessories and continue with the installation process.

PB81499EN

VelaShape III User Manual System Installation

Always ensure that the applicator filters are clean, dry and have not

Equipment List

The VelaShape III system is delivered with the following:

● VelaShape III system console.

● Umbilical cable mast.

● Accessories kit, including:

 VSmooth Applicator (includes one replace able c over).  VContour Applicator (includes one medium-size replaceable cover).  Footswitch  Applicator umbilical cable.  System air filters (x 3).  VelaSpray Ease lotion (2 bottles of 300 ml).  VContour small replaceable cover.  VContour large replaceable cover.  One pair of protective opaque goggles.  User Manual.  Quick-Reference Guide.  Filter extractor.

Cover Packs

Four types of cover packs are available:

● VContour Large Cover Pack – contains five large covers and appropriate

filters.

● VContour Medium Cover Pack – contains five medium covers and

appropriate filters.

● VContour Small Cover Pack – contains five small covers and appropriate

filters.

● VSmooth Cover Pack – contains five covers for the VSmooth applicator and

appropriate filters.

Caution

passed their maximal number of operating hours before starting a treatment.

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System Installation

System Dimensions

Space should be allocated with adequate ventilation and free airflow. The working area for the system should be prepared according to the system dimensions presented in Figure 10. In order to guarantee proper ventilation, always keep the sides of the system at least 0.5m (20") from the wall or from other obstructions to air flow. After positioning the system, lock the brakes on the rear wheels by pressing the pedals on top of each wheel.

Figure 10: System Dimensions

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VelaShape III User Manual System Installation

Installation Process

After unpacking the VelaShape III system, install the applicator in the following manner:

1. Unpack the umbilical support mast with the five installed harness loops (see

Figure 11). Ensure that the harness loop's Allen screws are properly seated in their dimples in the mast.

Figure 11: Umbilical Support Mast

2. Refer to Figure 11 & Figure 12: insert the mast into the hole in the rear

handle until it stops.

Figure 12: Mast and Umbilical Cable Installation

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System Installation

3. Refer Figure 13: insert the applicator's umbilical connector into the

applicator's connection port, and press it in until it 'clicks' into place. The connector and connection port are polarized to prevent improper connection.

Figure 13: Umbilical Connection Port

4. Refer to Figure 12: hook the umbilical cable into the harness loops leaving

enough clearance to open the rear compartment door, as shown.

5. Unpack an applicator and connect it to the umbilical cable. It has the same

kind of connection port as the one in the console's service panel (see Figure 13.

6. Hang the applicator in the cradle, as shown in Figure 14.

Figure 14: Applicator on Handle

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VelaShape III User Manual System Installation

If the system has been removed from cold storage, allow it time to warm

Refer to Figure 15:

7. Unpack the power cable, ensure that it has a proper wall connector (for your

country) and connect it to the power connection port on the system's service panel (6), and plug the other end into the appropriate electrical outlet.

8. Unpack the footswitch and connect it to the footswitch

connection port on the system's service panel (2). The connector and connection port are polarized to prevent improper connection.

Note

up to room temperature (15-30°C/59-86°F) before first activation.

Figure 15: Service Panel

Service Panel Connections:

1. USB communications port (used only by Syneron service engineers).

2. Footswitch connection port.

3. Umbilical connection port.

4. Main On/Off switch.

5. Fuse housing (see Chapter 7 – Maintenance).

6. Power cable inlet.

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System Installation

Do not lay the system on its back or sides! Doing so may damage the

Moving the System within the Facility

1. Turn the system off and disconnect the power cable.

2. Disconnect the applicator and place it in a safe location.

3. Release the wheel brakes at the base of the system.

4. Slowly push or pull the system using the system's handle.

Moving the System to another Facility

1. Turn the system off and disconnect the power cable.

2. Disconnect the applicator and pack it in its storage case.

3. Release the wheel brakes at the base of the system.

4. Slowly push or pull the system using the system's handle and carefully lift it up

onto the vehicle. Spread padding on the wall of the transport vehicle to avoid scratching the system's panels and strap the system to the wall.

5. Upon arrival at the new facility, position the system in its new location, using

the system handle.

6. Reconnect the applicator, footswitch and the power cable.

Caution

vacuum pump.

Electrical Requirements

The system incorporates a universal power supply module that allows it to be connected to standard electrical outlets anywhere. The system's electrical requirements are:

● 100-230 VAC; up to 4A; 50-60 Hz; single phase The electrical requirements are printed on the system's nameplate, located on the

system's rear panel. Input power lines should be free of transients, voltage and current spikes, sags

and surges. Consequently, the system power line should not be shared with other heavy variable loads such as elevators, air conditioning systems, large motors, etc.

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VelaShape III User Manual System Installation

● For continued protection against fire, replace the fuses only with

It is recommended that the system be connected to a separate power line with separate circuit breakers. Syneron cannot guarantee performance unless the system is connected to a dedicated circuit.

Warning

those 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 technicians are qualified to service the

system.

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 up to 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.

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Operating Instructions

High voltage is present inside the system. Always be aware of the

5. OPERATING INSTRUCTIONS

This chapter will assist you to operate 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.

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, connect the umbilical cable to its connection port and ensure that the applicator is connected to the umbilical cable.

Warning

possible dangers and take proper safeguards as described in this manual.

2. Toggle the main power switch (on the service panel) to the On position; the

system initiates an automatic vacuum and RF test. When this test is completed the system is ready for operation.

Automatic Vacuum and RF Test

The VelaShape III is equipped with an automatic vacuum and RF self-test routine.

The test is performed after the applicator is connected. During the test the VelaShape III system is tested for radiofrequency and vacuum

performance. During this test, the trigger or footswitch of the applicator is disabled.

The test is comprised of three consecutive vacuum pulses, and can take up to 3 seconds.

It is important to verify that the applicator's chamber is 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).

If a fault situation is detected, it will be displayed as an error message on the control panel (refer to Chapter 8 – Troubleshooting).

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VelaShape III User Manual Operating Instructions

Setting Treatment Parameters – Tablet Control Panel

After activation (main On/Off switch), the system starts the automatic vacuum and RF self-test routine while displaying a startup animation. When complete, the

Main Menu screen will be displayed (see Figure 16).

Figure 16: Main Menu Screen

The numbered tags in Figure 16 correlate to the following numbered explanations and definitions of the screens elements.

1. Actual Skin Temperature – this is a reading of the patient skin's current

temperature as measured by the applicator's temperature sensor, in degrees Celsius.

2. Target Skin Temperature – this is the target temperature of the skin in

degrees Celsius, set by the operator using the slide control.

3. Slide Control – this control sets the target temperature of the skin. Use your

finger to 'slide' the control up or down to achieve the desired target temperature (40-45°C).

4. RF On/Off Indicator – RF is On when the ring is green and blinking; RF is

Off when the ring is black.

5. Session Timer – this clock keeps track of the duration of the patient's

treatment session.

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6. Cover Type Indicator – this tag indicates which type of cover is connected

to the applicator.

7. Options – use your finger to 'pull' this tab up; this will display the Treatment

Settings

ribbon (see Figure 17).

Operating Instructions

When you 'pull up' the Options tab the Treatment Settings ribbon appears. The numbered tags in Figure 17 correlate to the following numbered explanations and definitions of the screen’s elements.

Figure 17: Treatment Settings Ribbon

1. IR Level – using your finger to 'tap' on the IR (Infra-Red) button in order to

toggle between these intensity levels: 0, 1, 2 or 3.

2. RF Level – using your finger to 'tap' on the RF (Radio-Frequency) button in

order to toggle between these intensity levels: 0, 1, 2 or 3.

3. VAC Level – using your finger to 'tap' on the VAC (Vacuum) button in order

to toggle between these intensity levels: 0, 1, 2 or 3. The large electrode cover has four vacuum intensity levels.

4. End Treatment – press this button to end the patient's session, reset the

clocks and be ready for the next patient.

5. Utilities – for use only by Syneron-trained system engineers, or under direct

instructions from the Syneron Service Center.

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VelaShape III User Manual Operating Instructions

Default Settings

The intensity level of each parameter setting is displayed in the following illustrations:

Figure 18: Default Settings

Setting Treatment Parameters – Applicator Control Panel

After activation (main On/Off switch), the system starts the automatic vacuum and RF self-test routine. When complete, the display on the connected applicator initializes while displaying an icon of the connected type of cover for several seconds.

Press the central OK button (see Figure 21) to toggle between views of the current temperature sensor (see Figure 19), the parameter setting icons (see Figure 22) and information display screen (see Figure 20).

Figure 19: Applicator Control Panels

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Operating Instructions

Both control panels – tablet and applicator – operate in parallel and

The applicator display will automatically enter into a screen saver (idle)

Control Panel Display

Panel Buttons

Note

display the same information.

Press the central OK button until the display changes to the information display screen from which you may adjust the system's operating parameters.

Refer to Figure 20: the following information is displayed:

● IR level currently set

● RF level currently set

● Vacuum level currently set

● mBar: current vacuum reading

● T (reading on left side): current temperature reading

(reading on right side is only for use of Syneron technical personnel).

Figure 20: Applicator

Refer to Figure 21: press the ► or ◄ buttons to toggle between the parameter icons (IR, RF or VAC).

Press the ▲ or ▼ button to select the desired intensity level for that parameter.

You may now proceed with the treatment procedure.

Figure 22: Parameter Icons and Level Displays

Figure 21: Control

Note

mode after a one-minute period of inactivity. To reactivate the display, press any button or pull the trigger.

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VelaShape III User Manual Operating Instructions

Utilities Mode

Utilities mode is accessible by pressing the Utilities button on the Treatment Settings

System Information Screen

● Pressing the Utilities button displays the System Information screen in the

ribbon (see arrow # 5 in Figure 17).

About VelaShape III tab (see Figure 23). In this screen you will see basic

console information including hardware serial numbers and version numbers of the various software packages. Press the Back button to return to the Main

Treatment

screen.

Figure 23: System Information Screen; About V elaShape III Tab

● Counters Tab: press this tab to display a screen that displays information

concerning the disposable cover connected to the applicator (see Figure 24): allowable time limit, time already used and time remaining until expiration. Press the Back button to return to the Main Treatment screen.

Figure 24: System Information Screen; Counters Tab

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Operating Instructions

Maintenance Screen

Refer to Figure 25: the two tabs on this screen, Update Software and GUI

Update From Network

, deal with upgrading the software packages on the system. Consult with your Syneron service representative before doing anything in this screen.

Press the Back button to return to the Main Treatment screen.

Figure 25: Maintenance Screen

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VelaShape III User Manual Operating Instructions

Settings Screen

● Date & Time Tab (see Figure 26): use the touch-control tools in this screen to

set the current date and time into the VelaShape III system. Press the Back button to return to the Main Treatment screen.

Figure 26: Settings Screen; Date & Time Tab

● Display Settings Tab (see Figure 27): use the touch-control tools in this

screen to adjust the LCD display brightness. Press the Back button to return to the Main Treatment screen.

Figure 27: Settings Screen; Display Settings Tab

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Operating Instructions

● Audio Settings Tab (see Figure 28): use the touch-control tools in this

screen to adjust the audio volume of the system's feedback signals. Press the

Back button to return to the Main Treatment screen.

User Diagnostics Screen

This screen (see Figure 29) is used to assist your Syneron service representative with system troubleshooting. Consult with the service representative before doing anything in this screen.

Press the Back button to return to the Main Treatment screen

Figure 28: Settings Screen; Audio Settings Tab

Figure 29: User Diagnostics Screen

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VelaShape III User Manual Operating Instructions

Operating controls and changing parameters inside this area of the

Service Mode Screen

This screen is designed for use ONLY by Syneron-qualified service personnel. It is password protected and is accessible only to Syneron-qualified service personnel.

Press the Back button to return to the Main Treatment screen.

Warning

software by people who are not trained for this purpose can cause the VelaShape III system to operate outside of its therapeutic envelope, can possibly cause injury to patients and damage the system.

Figure 30: Service Mode Screen

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Operating Instructions

Video List Screen

Two categories of video clips are available in the system's software for viewing by clinic staff and/or patients. Select any one for viewing as follows:

● Press the Video List tab; two selection buttons appear (see Figure 31):

Figure 31: Video List Selection Tab

● Maintenance Videos: pressing this button will display a list of videos that

will assist you in performing various maintenance procedures on the VelaShape III system (i.e., Upgrade VelaShape III Software, see Figure 32).

Figure 32: Maintenance Videos (example)

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VelaShape III User Manual Operating Instructions

You may treat patients only after passing appropriate training and have

● Practice Enhancement Videos (see Figure 33): pressing this button will

display a list of videos that will assist you in performing selected sections of the clinical procedure, or explanatory videos presenting the system and its capabilities.

Initiating Treatment

Now that you have prepared the system and defined your treatment settings, you are ready to begin treatment. Apply the applicator with moderate pressure to the first treatment section and press the trigger on the applicator handle or the footswitch. To stop the treatment, release the trigger or the footswitch.

If desired you may pull up the Options tab to keep the parameter setting icons in view while you are performing the treatment.

Warning

adhered to all local and state regulations regarding the use of this system.

Figure 33: Practice Enhancement Videos (example)

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Cellulite and Circumference Treatment

6. CLINICAL GUIDE: CELLULITE AND CIRCUMFERENCE TREATMENT

This chapter provides you with the information required to treat cellulite and circumferences with the VelaShape III system. The entire treatment protocol is to the cleared indication, and unless otherwise specified, for each application specific procedure should be applied.

Realistic Expectations

● There will be improvement in cellulite appearance, but not necessarily

complete elimination. There will be improvement in circumferences. However the improvement of both cellulite and circumference reduction is based on individual being treated.

● The degree of response to the VelaShape III 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

USA: The VelaShape III system is indicated for temporary reduction in circumferences of the abdomen and thighs, as well as temporary reduction in the appearance of cellulite. It is also indicated for the relief of minor aches and muscle spasms, as well as for the improvement of blood circulation.

EU/Canada/Singapore: The VelaShape III system is indicated for non-invasive treatment for body contouring via temporary cellulite and circumference reduction.

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.

● History of any kind of cancer.*

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VelaShape III User Manual Cellulite and Circumference Treatment

● 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 treatmen t withou t de v elop ing s ho r tterm adverse effects. Test spots cannot indicate long-term adverse events.

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Cellulite and Circumference Treatment

● In case of uncertainty regarding applicability or potential side

Note

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.

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VelaShape III User Manual Cellulite and Circumference Treatment

● 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).

● Hair may impair the movement of the applicator and/or overheat the

treatment area. 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 you r patient,

photograph and measure the circumference of the treatment area in order to establish a baseline (see VelaShape III Measurement, page 48).

● 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 all the applicators’ parts are clean and intact. Make sure that

the RF electrodes are clean and intact (not chipped). When using the VSmooth applicator, verify that the rollers function smoothly.

● Make sure that the cover filters are clean and correctly inserted (replace them

if not).

● Ensure that the replaceable cover is 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 VelaShape III combines two types of energy, IR and RF, and mechanical manipulations of vacuum and/or rollers (massage) in two different applicators: VContour applicator and VSmooth applicator. Each applicator combined and synchronized different actions to optimize the energy delivery. The VContour applicator combines the RF energy and mechanical manipulation of vacuum, while the VSmooth applicator combines the IR and RF energy and mechanical manipulation via vacuum and rollers (massage).

You should examine the patient’s skin before treatment to determine the suitable type of treatment to apply, to ensure effective treatment with minimal risk of skin damage. Selecting the correct treatment type is essential for successful treatment.

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Cellulite and Circumference Treatment

● The VContour applicator is used for circumference reduction and focal fat

deposit treatment in different body areas such as: abdomen, flanks, thigh, arms, middle-back, submental, etc. The applicator has three types of covers: Large, Medium and Small.

● The VSmooth applicator is used for cellulite and skin treatment in

different zones such as: abdomen, thigh, buttocks, arms, etc. The applicator has one type of cover.

Table 1: Selecting the Appropriate Treatment Type

Treatment

Type

Circumferential Reduction

Circumferential

Reduction – Small Areas

Localized Fatty

Deposits

4 Cellulite

Localized Fatty

Deposits plus Cellulite

Treatment Area Applicator Cover Treatment Protocol

Option 1: three bi-weekly

sessions.

Abdomen

VContour Medium

Option 2: one long treatment (repeating twice in the same session).

Very Small

Area

Abdomen

VContour Small Three bi-weekly sessions

Large

VContour

followed by

Three bi-weekly sessions

Medium

Abdomen,

Thighs, Buttocks

Abdomen,

Thighs, Buttocks

VSmooth VSmooth Three bi-weekly sessions VContour

followed by

VSmooth

Large

followed by

VSmooth

Three bi-weekly sessions

VelaShape III Measurement

In order to establish a baseline for the VelaShape III treatment and follow up on the results, it is advised to weigh the patient, photograph, assess the cellulite degree and measure the circumference of the treatment area. Circumference and cellulite measurements should be performed 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 transient edema.

Circumference Reduction treatment may be performed on similarly size areas such as: thighs,

arms, etc.

Circumference Reduction treatment may be performed on areas such as Submental.

Localized Fatty Deposits treatment may be performed on similarly size areas such as: flanks,

thighs, middle back, etc.

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VelaShape III User Manual Cellulite and Circumference Treatment

Circumference

The suggested circumference 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 34 [A]).

2. A measuring ruler of hard material (wood or plastic) of at least one meter

should be placed against the wall. Alternatively, a vertical metal stand with an attached marker may be used (see Figure 34 [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.

Figure 34: Illustration of Circumference Mea surements: A) Fixed Distance between

the Legs; B) Labeling the circumference; C) Measuring Horizontally;

D) Labeling the Arm Against a Wall.

4. During the entire measurement procedure, the distance between the patient's

feet must remain constant.

5. At least four 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 34 [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 34 [D]).

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Cellulite and Circumference Treatment

Cellulite

The suggested cellulite classification method is according to the NurnbergerMuller Scale that classifies cellulite into four categories using the pinch test.

By gently pinching a few inches of skin between your thumb and forefinger, in the area intended for treatment, we can distinguish four (4) stages of cellulite appearance (Hexsel et al.):

1. Stage Zero – there is no alteration to the skin surface (no dimpling is seen on

the skin when the patient is standing naked in front of the mirror). When the skin is pinched no orange peel effect is seen (see Figure 35-A).

2. Stage One – the skin of the affected area is smooth while the patient is

standing or lying down (no dimpling is seen on the skin when the patient is standing), but undulations (bumps and lumps) on the skin surface can be seen on pinching the skin or during muscle contraction (see Figure 35-B).

3. Stage Two – the "orange peel" or "mattress" (dimpling) appearance is evident

when standing, without the use of any manipulation (skin pinching or glutens muscle contraction, see Figure 35-C)

4. Stage Three – presence of alteration described in stage two, plus presence of

raised and depressed areas and nodules (dimpling that can be seen both when the patient is standing and lying down, see Figure 35-D).

Table 2: Cellulite stages summary according to Nurnberger-Muller Scale

Stage Zero

Stage One Stage Two

Stage Three

Standing Supine Pinch Test

− − −

− − Cellulite / Dimpling

Cellulite / Dimpling − Cellulite / Dimpling Cellulite / Dimpling Cellulite / Dimpling Cellulite / Dimpling

Figure 35: Illustration of cellulite stages (A- Stage Zero; B- Stage One; C- Stage Two;

D- Stage Three)

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VelaShape III User Manual Cellulite and Circumference Treatment

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 parameters as suggested in the Treatment Parameters section of

each treatment procedure. Always consider the patient's skin response and tolerance.

● Select and mark the treatment area while the patient is standing. The area

dimensions will correlate to the cover aperture.

● 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. You may need to re-apply the lotion during treatment procedure.

● 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 or footswitch the skin will be suctioned into the applicator's chamber by the vacuum (excluding treatment where the vacuum is turned off) and energy will be delivered into the skin. If you hear air being suctioned 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 an

Improve Vacuum Seal message will appear on the screen.

● 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 is to heat the deeper skin layers leading to

a rise of the patient's skin temperature to the endpoint. The heat is usually accompanied by erythema (at various levels, depending on skin type and anatomical area) and sometimes slight edema starting already after four to five (4-5) minutes of treatment. The patient should feel a tolerable heat sensation. This typically occurs at a temperature of 43-45°C (110-113°F).

● The endpoint is reached when substantial and persistent radiant heat can be

distinguished and the skin surface temperature measured by the IR thermometer is between 43-45°C (110-113°F). Once this endpoint is reached, this heat must be retained for at least 10 minutes for treatment to be effective. Therefore the minimal treatment duration of a single sub-area is 15 minutes.

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Cellulite and Circumference Treatment

The most accurate skin temperature is read directly

Note

underneath the IR thermometer aperture.

Applicator Positioning

Position the applicator perpendicular to the skin and apply light but sufficient pressure to ensure good contact.

Test Spot

Before starting treatment, test a small area with the selected parameters and wait several minutes to observe the results.

Treatment Technique: Identifying the Applicator a nd Cov er

Treatment Using the VContour Applicator

Treatment can performed with two different protocol modes:

● Circumference Mode

● Deep Mode

The Circumference Mode treatment protocol for circumference reduction supports two types of covers:

● When treating larger treated areas (such as abdomen, arms, thighs) use the

Medium Cover as a standalone.

● When treating smaller treated areas (such as submental) use the Small

Cover as a standalone.

The Deep Mode treatment protocol for focal fat deposits supports a combination of two covers. Treatment is performed using the Large Cover followed by the Medium Cover and it is used for different body areas (such as: flanks, , middleback, etc.).

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VelaShape III User Manual Cellulite and Circumference Treatment

Treatment Protocol Using the Circumference Mode

Treatment Protocol of Large Areas Using Circumference Mode (Medium Cover)

Zone Segmentation

Select the appropriate zone for treatment of circumference reduction using the Medium Cover; define the size of the targeted sub-area, large, medium or small, and divide it into segments:

● Large size sub-area (25 x 20 cm) will be divided into 20 segments.

● Medium size sub-area (15 x 20cm) will be divided into 12 segments.

● Small size sub-area (10 x 20 cm) will be divided into 8 segments.

Each segment of the sub-area is the size of the Medium Cover (5 x 5cm).

Figure 36: Sub-Area Divided into Segments

Figure 37: Identifying Sub-Areas and Segments for Anterior and Posterior Abdomen

Circumference Reduction

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Cellulite and Circumference Treatment

If the patient has a high BMI, additional sub-areas will be added and

Note

treated according to the same treatment protocol. Each sub-area will be treated individually in the same session.

Treatment Parameters

Applicator Cover Parameter Level Notes

VContour

Applicator

Cycle # 1:

May increase if needed for increased depth. Do not increase >1 for loose skin areas.

Maintain RF Level at 3 whenever possible to achieve an optimized result.

Medium

Cover

Vacuum

RF 3

Start at level #1

1-3

Treat each segment from A1 to A20 in the “Horizontal Snake-Like” treatment technique (see Figure 38) with five consecutive stacking pulses, then four consecutive pulses, then three consecutive pulses and then two consecutive pulses. Continue treating each sub-area from A1 to A20 with two consecutive stacking pulses until the surface temperature reaches 43-45°C or the patient cannot tolerate further heat.

Figure 38: Cycle 1 “Horizontal Snake-Like”

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VelaShape III User Manual Cellulite and Circumference Treatment

When coupler agent is added over the treatment area, continue

Cycle # 2:

In this cycle, the same sub-area set (A1-A20) will be started and treated with two consecutive stacked pulses using the “Vertical Snake-Like” treatment technique (see Figure 39) until the surface temperature reaches 43-45°C or the patient cannot tolerate further heat.

Figure 39: Cycle 2 “Vertical Snake-Like”

Cycle # 3:

In this cycle, the same sub-area set (start from sub-area A1 to A20) will be started and continued with two consecutive stacking pulses (same as in Cycle # 2) using the “Horizontal Snake-Like” treatment technique until the surface temperature reaches 43-45°C or the patient cannot tolerate further heat.

Cycle # 4 (Optional):

If the total time duration of Cycles # 1, 2 and 3 is less than 15 minutes, continue with the “Vertical Snake-Like” treatment technique (see Figure 39) and apply one pulse per sub-area until the 15-minute treatment duration for all four cycles is reached.

Note

treatment when an additional stacking pulse is added to the current number of consecutive pulses used prior to adding the coupler; for example, if coupler agent is added at the stage when two consecutive pulses are being applied at each sub-area, the treatment should be continued with three consecutive pulses. When the whole area is completed with the three consecutive pulses, the treatment will continue with two consecutive pulses.

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Cellulite and Circumference Treatment

For the medium and small size sub-areas set (including segments A1-A12 and A1-A8 respectively) treatment protocol is similar, and will be performed with the same three consecutive cycles.

Treatment Time

The large size sub-area (25 x 20 cm) set includes 20 segments (A1-A20), the medium size sub-area (15 x 20 cm) set includes 12 segments (A1-A12) and the small size sub-area (10 x 20 cm) set includes 8 segments (A1-A8). The 3-4 consecutive cycles should take at least 15 minutes.

Treatment Protocol of Small Areas Using Circumference Mode (Small Cover)

Zone Segmentation

Select the appropriate zone for treatment of circumference reduction using the Small Cover, and divide it into segments.

The appropriate size of the targeted sub-area (2 x 24 cm) contains two (2) sets of eight (8) segments (1 x 3 cm).

Treatment Parametersd

Applicator Cover Parameter Level

VContour Applicator

(*) Start at level 1, if enabled; increase the RF to level 2 during the subsequent treatments.

Cycle #1:

Start with a sub-area set in the higher line (A1-A8) followed by the lower line of the sub-area (B1-B8). Treat each sub-area from A1 to A8 and B1 to B8 with 5 consecutive stacking pulses, then 4 consecutive pulses, then 3 consecutive pulses and then with 2 consecutive pulses. Continue treating each sub-area from A1 to A8 and B1 to B8 with 2 stacking pulse until the surface temperature reaches 43-45°C or the patient cannot tolerate further heat.

Figure 40: Sub-Area Divided into Segments

Vacuum 1

Small Cover

RF 1 – 2*

Start at level 1; if possible, increase the RF level to 2 at subsequent treatments.

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VelaShape III User Manual Cellulite and Circumference Treatment

Cycle #2:

A second cycle of same sets of sub-areas should be re-treated in the same manner (sub-area set A1 to A8, then sub-area set B1 to B8) with 2 stacking pulse until the surface temperature reaches 43-45°C, or the patient cannot tolerate further heat.

Figure 41: Cycle 1 and Cycle 2 in Small Sub-Areas

Treatment Time and Number of Treatment Sessions

The size sub-area (2 x 24cm) set includes 16 segments that should be treated in two cycles. Each subject will be treated with three bi-week ly tre a tments.

Treatment Protocol Using Deep Mode

Treatment Protocol of Focal Fat Deposits Using Deep Mode (Large and Medium Covers)

Zone Segmentation

Select the appropriate zone for treatment of focal fat deposits using the Deep mode protocol, combining the Large Cover followed by the Medium Cover. Define the size of the targeted sub-area as 15cm x 15cm, and divide it into nine (9) segments.

Each segment of the sub-area is at the size of the Large and Medium Cover (5x5 cm).

Figure 42: Deep Mode protocol Segmentation

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Cellulite and Circumference Treatment

(A)

(B)

In some cases, large areas can contain the 15cm x 15cm sub-area more than once. In this case each sub-area will be treated according to the treatment protocol.

Figure 43: Flanks (A) and Middle Back (B) Segmentation for the Treatment of Focal Fat Deposit

The Deep Mode treatment protocol includes two cycles, performed with the VContour applicator and the Large Cover without vacuum manipulation in cycle #1, while in cycle #2 the applicator is used with the Medium Cover and vacuum manipulation.

In order to achieve good clinical results, it is recommended to reach 43-45°C on the skin surface, maintaining it for at least 5 minutes in each step of the treatment (at least 15 minutes of treatment for the cycle).

PB81499EN

VelaShape III User Manual Cellulite and Circumference Treatment

Vacuum

Off

(e)

Vacuum

Off

3 / 2

(2)

Vacuum

Off

3 / 2

(2)

1 – 3

(f)

3 / 2

(2)

Vacuum

1 – 3

(3)

3 / 2

(2)

1 – 3

(3)

3 / 2

(2)

Treatment Parameters

Applicator Cover Cycle Step Parameter Level

Step #1

VContour

Large Cycle #1

Step #2

Step #3

Vacuum

Step #1

Medium Cycle #2

Step #2

Vacuum

Step #3

If the patient feels uncomfortable you may:

1. Re-apply VelaSpray Ease lotion at minimum intervals of one minute, in

each step of each cycle.

2. Use the "Quick Technique" mannerg when stacking one pulse.

3. Only after trying both options 1 & 2 above and the patient still feels

uncomfortable, reduce the RF level to 2.

Maintain RF Level at 3 whenever possible to achieve an optimized result.

Option to increase vacuum from 1 -> 2 -> 3 based on patient tolerance (in areas where there is

minimal laxity).

"Quick Technique" manner: stacking one pulse in each segment, while moving the applicator

faster in the “Horizontal snake-like” or “Vertical snake-like” manner according to the step.

PB81499EN

Cellulite and Circumference Treatment

Cycle #1 – Step #1:

● Attach the Large Cover to the VContour applicator.

● Set the RF level to 3.

● Apply a thin layer of VelaSpray Ease lotion on the sub-area.

● Treat each segment from 1 to 9 in the “Horizontal Snake-Like” manner (see

Figure 44) with four consecutive stacking pulses, then three consecutive stacking pulses and then two consecutive stacking pulses. Continue treating each segment of the sub-area (from 1 to 9) with two stacking pulses in the “Horizontal Snake-Like” manner until the treated area reaches two full minutes of treatment.

● After two full minutes of treatments, continue treating each segment of the

sub-area (from 1 to 9) with one pulse in the “Horizontal Snake-Like” manner until the treated area reaches five full minutes of treatment.

Figure 44: Cycle 1-Step #1 “Horizontal Snake-Like”

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VelaShape III User Manual Cellulite and Circumference Treatment

Cycle #1 – Step #2

● RF level should be maintained at level 3.

● Apply a thin layer of VelaSpray Ease lotion on the sub-area.

● Treat each segment of the sub-area (from 1 to 9) stacking two (2) pulses in

the “Vertical Snake-Like” manner (see Figure 45). Continue treat each segment of the sub-area (from 1 to 9) stacking one pulse in the “Vertical

Snake-Like” manner until the treated area reaches five full minutes of

treatment.

Cycle #1 – Step #3

● RF level should be maintained at level 3.

● Apply a thin layer of VelaSpray Ease lotion on the sub-area.

● Treat each segment of the sub-area (from 1 to 9) stacking two (2) pulses in

the “Horizontal Snake-Like” manner. Continue treat each segment of the sub-area (from 1 to 9) stacking one pulse in the “Horizontal Snake-Like” manner until the treated area reaches five full minutes of treatment.

Cycle #2 – Step #1

● Remove the Large Cover and attach the Medium Cover to the VContour

applicator.

● Set the RF level to 3.

Figure 45: Cycle 1 – Step #2 “Vertical Snake-Like”

● Set the Vacuum level to 1.

● Apply a thin layer of VelaSpray Ease lotion on the sub-area.

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Cellulite and Circumference Treatment

● Treat each segment from 1 to 9 in the “Horizontal Snake-Like” manner

with four consecutive stacking pulses, then three consecutive stacking pulses and then two consecutive stacking pulses. Continue treating each segment of the sub-area (from 1 to 9) stacking two pulses in the “Horizontal Snake-Like” manner until the treated area reaches two full minutes of treatment.

● After two full minutes of treatments, continue treating each segment of

the sub-area (from 1 to 9) stacking one pulse in the “Horizontal Snake-

” manner until the treated area reaches five full minutes of treatment.

Cycle #2 – Step #2

● RF level should be maintained at level 3.

● Apply a thin layer of VelaSpray Ease lotion on the sub-area.

● Treat each segment of the sub-area (from 1 to 9) stacking two (2) pulses

in the “Vertical Snake-Like” manner. Continue treat each segment of the sub-area (from 1 to 9) stacking one pulse in the “Vertical Snake-Like” manner until the treated area reaches five full minutes of treatment.

Cycle #2 – Step #3

● RF level should be maintained at level 3.

● Apply a thin layer of VelaSpray Ease lotion on the sub-area.

● Treat each segment of the sub-area (from 1 to 9) stacking two (2) pulses

Treatment Time

The size of the sub-area (15 x 15cm) set includes 9 segments that should be treated in two cycles of at least 15 minutes each.

in the “Horizontal Snake-Like” manner. Continue treat each segment of the sub-area (from 1 to 9) stacking one pulse in the “Horizontal Snake-

Like” manner until the treated area reaches five full minutes of treatment.

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VelaShape III User Manual Cellulite and Circumference Treatment

If the patient has a high BMI or the treated area is large, more than

Cellulite Mode Treatment Protocol Using the VSmooth Applicator

Cellulite mode is the treatment protocol of choice for cellulite and skin laxity. It

is supported by the elōs technology, combining RF and IR energy with

mechanical manipulation via vacuum and massage. The Treatment is performed using the Large Electrode Cover attached to the VSmooth applicator, and it can be performed on different body areas, such as: thighs, abdomen, buttocks, etc.

Treatment Protocol Using Cellulite Mode

Zone Segmentation

Select the appropriate zone and target the sub-area for treatment of cellulite and skin laxity; first define the area to be treated in Cycle # 1 according to Deep Mode - Zone Segmentation. For Cycle #2 define the size of the targeted subarea as approximately 20 x 25cm, each sub-area will be divided into four elliptical, overlapping segments as shown in Figure 46.

Figure 46: Cellulite Mode Protocol Sub-Area Segmentation

Figure 46 above demonstrates single sub-areas segmentation:

● Segment A – superior segment

● Segment B – inferior segment

● Segment C – left segment

● Segment D – right segment

The Cellulite Mode treatment protocol includes six steps performed using the VSmooth applicator and the attached cover.

Note

one sub-area will be treated according to the same treatment protocol. Each sub-area will be treated individually in the same session.

PB81499EN

Cellulite and Circumference Treatment

● Example # 1: Thighs area can be divided up into three sub-areas:

 Anterior la te ra l  Anterior inner  Posterior

● Example # 2: Anterior abdomen area can be divided up into two sub-areas:

 Right  Left

Treatment Parameters

Applicator Cover Step Parameter Level Note

Maintain RF Level at 3

RF 3

whenever possible to achieve optimized results.

VSmooth

Large

Electrode

All Steps

(Step # 1 to

Step # 6)

Vacuum

Massage On

1-3

Start at 1

1-3

Start at 1

Start with IR level 1and increase according to patient's tolerance from 1 -> 2 -> 3.

May increase if needed for increased depth. Do not increase >1 for loose skin areas.

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VelaShape III User Manual Cellulite and Circumference Treatment

Illustration

Step #1:

● Attach the Large electrode cover to the

VSmooth applicator.

● Set the RF level on 3; IR level on 1; and

Vacuum level on 1 on the touch screen or on the applicator.

● Apply a thin layer of VelaSpray Ease

lotion on the sub-area.

● Treat segment A in a circular horizontal

Clock-Wise manner (see Figure 47) in a

gliding technique, until the skin surface at the treated segment reaches 43-45°C or the patient cannot tolerate the heat.

Figure 47: Segment A Treatment

Step #2:

● Maintain the RF at level 3; IR level at 1;

and Vacuum level at 1 on the touch screen or on the applicator.

● Apply a thin layer of VelaSpray Ease

lotion on the sub-area.

● Treat segment B in a circular horizontal

Clock-Wise manner (see Figure 48) in a

gliding technique, until the skin surface at the treated segment reaches 43-45°C or the patient cannot tolerate the heat.

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Figure 48: Segment B Treatment

Cellulite and Circumference Treatment

Illustration

Step #3:

● Maintain the RF at level 3; IR level

at 1; and Vacuum level at 1 on the touch screen or on the applicator.

● Apply a thin layer of VelaSpray

Ease lotion on the sub-area.

● Treat segment C in a circular

horizontal Clock-Wise manner (see Figure 49) in a gliding technique, until the skin surface at the treated segment reaches 43-45°C or the patient cannot tolerate the heat.

Figure 49: Segment C Treatment

Step #4:

● Maintain the RF at level 3; IR level

at 1; and Vacuum level at 1 on the touch screen or on the applicator.

● Apply a thin layer of VelaSpray

Ease lotion on the sub-area.

● Treat segment D in a circular

horizontal Clock-Wise manner (see Figure 50) in a gliding technique, until the skin surface at the treated segment reaches 43-45°C or the patient cannot tolerate the heat.

Figure 50: Segment D Treatment

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VelaShape III User Manual Cellulite and Circumference Treatment

Figure 51: Horizontal Snake-Like

Figure 52: Vertical Snake-Like

Step #5:

● Maintain the RF at level 3; IR

level at 1; and Vacuum level at 1 on the touch screen or on the applicator.

● Apply a thin layer of VelaSpray

Ease lotion on the sub-area.

● Treat all treated sub-area in the

Horizontal Snake-Like manner

(see Figure 51) in a gliding technique, until the skin surface at the treated segment reaches 43-45°C or the patient cannot tolerate the heat.

Step #6:

● Maintain the RF at level 3; IR

● Apply a thin layer of VelaSpray

● Treat all treated sub-area in the

Treatment Time

level at 1; and Vacuum level at 1 on the touch screen or on the applicator.

Ease lotion on the sub-area.

Vertical Snake-Like manner (see

Figure 52) in a gliding technique, until the skin surface at the treated segment reaches 43-45°C or the patient cannot tolerate the heat.

PB81499EN

In order to achieve good clinical results, it is recommended that the total treatment duration for each sub-area should be:

● For the thighs - each sub-area should be treated for at least 10 minutes.

● For the abdomen and buttocks - each sub-area should be treated for at

least 15minutes.

Cellulite and Circumference Treatment

Treatment Options with Cellulite Mode

The Cellulite Mode treatment protocol can be used as:

● Standalone for the treatment of cellulite and skin laxity.

● Combined treatment with Circumference Mode for circumference reduc tio n

in addition to the treatment of cellulite and skin laxity.

● Combined treatment with Deep Mode for localized fatty deposits in addition

to the treatment of cellulite and skin laxity.

Treatment should perform as follows (see Table 3):

Table 3: Treatment Options with Cellulite Mode

Treatment

Protocol

Cellulite Mode

Circumference Mode plus Cellulite Mode

Treated

Area

Thighs

Abdomen

Thighs

Abdomen

# of Sub-Areas

Three (3) sub-areas:

● Anterior lateral

● Anterior inner

● Posterior

Normal Size - one (1) subarea

Large Size - divide abdomen into half, two (2) sub-areas

Three (3) sub-areas:

● Anterior lateral

● Anterior inner

● Posterior

Normal Size - one (1) subarea

Large Size - divide abdomen into half, two (2) sub-areas

Treatment Duration

(Recommended)

10 minutes per sub-area.

15 minutes per sub-area, wait 5 minutes and repeat.

15 minutes per sub-area with Circumference Mode.

10 minutes per sub-area with Cellulite Mode.

15 minutes with Circumference Mode. 15 minutes with Cellulite Mode.

15 minutes per sub-area with Circumference Mode.

15 minutes per sub-area with Cellulite Mode.

Deep Mode plus Cellulite Mode

(*) Perform Deep Mode Cycle #1 only in the zones that require treatment. (**) When choosing to treat Localized Fatty Deposits and Cellulite with Deep Mode followed by Cellulite Mode on the thigh area: the sub-area, anterior inner thigh, should be treated with 15 minutes of Cellulite Mode only (Deep Mode - Cycle #1 will be skipped).

Thighs

Abdomen

Three (3) sub-areas:

● Anterior lateral

● Anterior inner

● Posterior

Normal Size - one (1) subarea

Large Size - divide abdomen into half, two (2) sub-areas

15 minutes per sub-area with Deep Mode (Cycle #1) **.

10 minutes per sub-area with Cellulite Mode.

15 minutes with Deep Mode (Cycle #1). 15 minutes with Cellulite Mode.

15 minutes per sub-area with Deep Mode (Cycle #1).

15 minutes per sub-area with Cellulite Mode.

PB81499EN

VelaShape III User Manual Cellulite and Circumference Treatment

In the event of excessive heat sensation or any side effects (i.e. burn),

Release the trigger or footswitch before you lift the applicator from the

● Compliance with the treatment protocol is essential to achieving the

Endpoints (When to Stop Treating an Area)

● Use the radiant thermometer to measure the temperature on the skin surface,

skin temperature should be 43-45°C.

● If the patient feels an intolerable heat sensation before reaching 43-45°C, try

to re-apply some VelaSpray Ease lotion, if patient still cannot tolerate the heat, lower the RF and continue treatment. If the patient tolerates this well, complete the indicated pulses and phases.

● Mild erythema is normal.

● Heat should be persistent.

Warning

stop treatment and apply cooling.

Caution

skin.

Note

desired 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, treat the small area (such as localized fat deposits) only once.

● After treatment, the treated area may show temporary signs of erythema and slight edema.

● A Bad Coupling message on the control panel indicates inadequate coupling, which results in RF being disabled.

● VelaShape III treatment performed 3–5 weeks post-lipolysis can enhance smooth recovery from the lipolysis treatment.

PB81499EN

Cellulite and Circumference Treatment

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 parameter levels.

● Avoid 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 the treatment regimen. Main impacts may be:

 Transient skin texture that may show improvement after each session.  Circumference reduction may show improvement after 2–3 sessions.  Cellulite may show improvement after 4 sessions.

● Take photos and measurements of the treatment areas after the last session.

PB81499EN

VelaShape III User Manual Maintenance

Each patient should be assigned with his/her own set of covers in Be careful not to spill any liquids on the system.

7. MAINTENANCE

While the VelaShape III system should not be serviced by anyone other than an authorized Syneron representative, the system requires regular preventive maintenance and cleaning to ensure optimal system performance. This chapter describes the routine maintenance procedures that operators may perform:

● Cleaning the VelaShape III system.

● Cleaning the VelaShape III applicator and its replaceable covers.

● Cleaning the air filter.

● Replacing the applicator's replaceable covers and filters when required

Note

order to provide safe and hygienic treatments. This also allows the patient to keep track of the number of treatment hours administered.

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 fuses only with ones 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.

Clean the umbilical cable with pre-moistened wipes.

Warning

PB81499EN

Maintenance

While gently cleaning the interior of the applicator, avoid moisture and dirt

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.

Caution

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, then pull the cover straight off the applicator body, as shown in Figure 53.

Figure 53: Removing the VSmooth Replaceable Cover

PB81499EN

VelaShape III User Manual Maintenance

The image in the figure is for illustration purposes only.

Note

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).

● 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 54):

● Replace the two filters (see Figure 55) according to the schedule printed

on the cover's box. 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 (or new) applicator's cover.

Figure 54: VSmooth Applicator's Internal Components

PB81499EN

Maintenance

Verify that the vacuum's aperture does not become clogged during

Make sure that the interior of the applicator is completely dry before

Caution

cleaning. Avoid inserting spray residue into the aperture.

Replacing the VSmooth Applicator's Filters

Refer to Figure 55:

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.

Figure 55: Replacing the VSmooth Applicator's Filters

Caution

inserting the filters.

PB81499EN

VelaShape III User Manual Maintenance

Cleaning and Maintaining the VContour Applicator

The replaceable cover of the applicator should be replaced according to the schedule printed on the cover's box label, or sooner if one of the following is observed:

● After cleaning the replaceable cover and the applicator's pin connectors, an

Improve Vacuum Seal message appears on the control panel (inadequate

coupling).

● Electrodes appear damaged.

● The cover's shape appears distorted.

Proceed as follows:

1. After each treatment turn the system off and remove the applicator cover by

pulling it off.

2. Remove the filter from the cover and wash or discard it.

3. Wash the cover thoroughly using hot tap water (no more than 50°C/122°F)

and a mild disinfectant, alcohol-free soap until all residual VelaSpray Ease is removed. Wipe and dry the cover with a soft cloth and store it in the patient's kit. Re-use the cover only when completely dry.

4. Allow the cover to dry overnight with the RF electrodes facing up.

5. There are two filters per cover, one inserted and one spare; after each

treatment the filter should be removed, the spare filter should be inserted and the used one washed, wiped with a soft cloth and allowed to dry in the patient box until next the treatment.

6. Clean the applicator's components at the end of every day as follows:

● Refer to Figure 56: remove the applicator cover.

● Clean the RF contacts (A), the ID microchip contact points (B) and the

vacuum inlet (C) with a clean, soft cloth.

● Gently clean the IR LED’s aperture (D) using a gentle, alcohol-free optical

lens cleaning solution; be careful not to scratch it.

Figure 56: Applicator's Internal Components

PB81499EN

Maintenance

Make sure that the interior of the applicator and the cover are The image in the figure is for illustration purposes only.

Caution

completely dry before inserting the filter and reconnecting the cover.

Cleaning the VContour Applicator's Filter

Remove the filter from the cover if it becomes necessary to clean or replace it.

1. Use the supplied filter extractor to pull the filter out of the cover, as shown in

Figure 57.

2. Wash the filter and allow it to dry completely before reusing it.

3. Firmly insert the clean filter into the filter chamber.

Figure 57: Replacing the VelaShape III Applicator's Filter

Note

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VelaShape III User Manual Maintenance

Be sure that the filter is completely dry before re-assembling.

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 58):

1. Turn the system off.

2. Open the cover of the system's rear utility cabinet to access the filter

assembly.

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, wash it with water and soap and set it

aside to dry.

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. It should be discarded when it

is no longer white after cleaning.

Caution

Figure 58: Cleaning the Air Filter

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Troubleshooting

8. TROUBLESHOOTING GUIDE

The VelaShape III 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 representative.

Table 4 offers a list of possible system errors that will be displayed on the control panel's display, and how to correct them. If the corrective actions listed in the table do not solve the problem, contact your Syneron representative.

Table 5 offers several fault situations that may occur with no operator panel indication or control panel display, and their appropriate corrective actions. If these do not resolve the problem, contact your Syneron representative.

Most times a system error can be cleared by restarting the VelaShape III system. Always try this remedy before contacting your Syneron representative.

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VelaShape III User Manual Troubleshooting

Table 4: System Errors Messages Displayed On Screen and/or Applicator Panel

Message Symptom Corrective Action

● Remove and clean the applicator cover.

Improve Vacuum Seal

Vacuum is not implemented correctly upon the skin.

● Replace the cover filter.

● Put on a new cover.

● Make sure the patient skin is

cleaned and shaved.

● Make sure there is a good vacuum seal between the applicator cover and patient skin,

RF Out of Range

The system cannot apply RF correctly.

● Make sure there is an adequate amount of gel.

● Make sure the applicator is placed on the skin appropriately.

No applicator, No Tip

System freezes, no RF or IR pulses emitted to the patient's skin even if footswitch/trigger is pressed.

● Let go of footswitch/trigger and make sure that the applicator and tip are well connected and sealed.

● Let go of footswitch/trigger and wait 10 minutes for the system to recognize the applicator and tip.

● If after 10 minutes the system does not recognize the applicator and tip restart the system.

● If after restart the system does not recognize the applicator and tip unplug other medical devices in the room and restart the system again.

PB81499EN

Troubleshooting

Table 5: Other Fault Situations with No Error Messages

Symptom Corrective Action

1. Turn the system off.

2. Check that air filter is clean and the filter cover is properly fastened (the cover's sealing O-ring should be

No vacuum suction

properly installed).

3. Check the applicator connection to the umbilical cable, and the umbilical cable's connection to the system.

4. Verify that the cover is correctly attached to the applicator.

5. Replace applicator filters or cover.

No IR output

1. Turn the system off.

2. Call your Syneron representative for further instructions.

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VelaShape III User Manual Specifications

9. SYSTEM SPECIFICATIONS

Output Parameters

Console

Peak RF Power RF Frequency RF Mode Light Wavelength Vacuum

IR Power RF Power – Small Cover RF Power – Medium Cover RF Power – Large Cover

IR Electrical Power RF Power

150 Watts 1 MHz Bi-Polar 850 nm (-200) to (-390) Millibars Pulsed

VContour Applicator

Up to 1.7 W Up to 10 W (average per duty cycle) Up to 50 W (average per duty cycle) Up to 75 W (average per duty cycle)

VSmooth Applicator

Up to 3.2 W Up to 75 W (average per duty cycle)

Treatment Area Footprints

Large Cover Medium Cover Small Cover

Cover with Rollers

Control Panel

● Tablet computer with 10.1 inch, high-definition GUI display

● Android operating system

Electrical Requirements

● 100-230 VAC; up to 4A; 50-60 Hz; single phase

VContour Applicator

25 mm x 50 mm 25 mm x 30 mm 10 mm x 13 mm

VSmooth Applicator

40 mm x 40 mm

PB81499EN

Specifications

Environmental Requirements

Treatment Room

● Temperature: 15 – 30°C [59 – 86°F]

● Relative humidity: Up to 80%

● Air pressure range: 70 – 106 kPa

Storage/Transportation

● Temperature: 10 – 55°C [50 – 131°F]

● Relative humidity: 10% – 80%

● Air pressure range: 70 – 106 kPa

Degree of Protection Against Ingress of Water

● IPX0 – Ordinary Equipment

System Console Dimensions [W x D x H]

● 38 x 49 x 132 cm / 15 x 19 x 51.8 inches

Weight

● VelaShape III system: 20 kg. / 44.1 lbs.

● VContour Applicator: 0.4 kg. / 0.9 lbs.

● VSmooth Applicator: 1.0 kg. / 2.2 lbs.

PB81499EN

VelaShape III User Manual Electromagnetic Compliance

This device is intended for use by health care professionals only. This

10. ELECTROMAGNETIC COMPLIANCE

Electromagnetic Emissions

The VelaShape III 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 1

The VelaShape III 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 em issions N/A

The VelaShape III 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

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.

PB81499EN

Electromagnetic Compliance

UT is the AC mains voltage prior to application of the test level.

Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance

IEC 61000-4-2: Electrostatic Discharge (ESD)

IEC 61000-4-4: Electrical Fast Transient/Burst

IEC 61000-4-5: Surge

IEC 61000-4-8: Power Frequency (50/60 Hz) Magnetic Field

IEC 61000-4-11: Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines

● Floors should be wood, concrete or ceramic tile. If floors are covered with

synthetic material, the relative humidity should be at least 30%.

± 6 kV contact ± 8 kV air

± 2 kV for power supply lines ±2 kV ± 1 kV for input/output lines N/A ± 1 kV differential Mode 1.0 DM ± 2 kV common mode 2.0 CM

3 A/m 3 A/m

<5 % U

0.5 cycle 40% UT (60% dip in UT) for

5 cycles 70% UT (30% dip in UT) for

25 cycles 5% UT (95% dip in UT) for

5 cycles

(>95 % dip in UT) for

±2, 4, 6 kV Contact ±2, 4, 6, 8 kV Air

<5 % UT (>95 % dip in UT) for

0.5 cycle 40% UT (60% dip in UT) for

5 cycles 70% UT (30% dip in UT) for

25 cycles 5% UT (95% dip in UT) for

5 cycles

● Mains power quality should be that of a typical commercial or hospital

environment.

● If the VelaShape III 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

PB81499EN

VelaShape III User Manual Electromagnetic Compliance

● At 80 and 800 MHz, the higher frequency range applies.

Electromagnetic Immunity (continued)

Immunity Test

61000-4-3: Radiated RF

61000-4-6: Conducted RF

(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 III system is used exceeds the applicable RF compliance level above, the VelaShape III 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 III system.

IEC 60601

Test Level

3 V/m 80 MHz to 2.5 GHz

3 V

150 kHz

RMS

to 80 MHz

Compliance Guidelines

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).

3 V/m 80 MHz to

2.5 GHz

3 V

150 kHz

RMS

to 80 MHz

Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey less than the compliance level in each frequency range

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 III system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d =1.17 * SQRT(P)

, should be

(2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less

than 3 V/m.

Note

● These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reflection from structures, objects and people.

PB81499EN

Electromagnetic Compliance

At 80 and 800 MHz, the higher frequency range applies.

Recommended Separation Distances

The following are the recommended separation distances between portable and mobile RF communications equipment and the VelaShape III system.

The VelaShape III 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 III 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 Output Power of

Transmitter (W)

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 23.33 150 14.32 14.32 28.53

Separation Distance According to Frequency of Transmitter (M)

150 KHz to 80 MHz

d = 1.17 SQRT(P)

80 MHz to 800 MHz

d = 1.17 SQRT(P)

Note

800 MHz to 2.5 GHz

d = 2.33 SQRT(P)

PB81499EN

Syneron Candela VelaShape III System User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1. BEFORE YOU START

Conventions Used in this Manual

Explanation of the Symbols Used in the System

2. SAFETY

Introduction

System Safety Features

Patient and Personnel Safety

Grounding the System

Operating the System

Infrared Energy Safety Issues

Radio Frequency Energy Safety Issues

Mechanical Rollers Safety Issues (Vsmooth Applicator)

Electrical and Mechanical Safety

Maintaining the System

Fire Hazards

System Classifications

System Nameplate

3. SYSTEM DESCRIPTION

System Overview

Console

Applicators

Anatomy of Cellulite

The VelaShape III Procedure

Heating of Dermis and Hypodermis with elōs

Mechanical Effects of Vacuum on the Skin

4. SYSTEM INSTALLATION

Unpacking the System

Equipment List

Cover Packs

System Dimensions

Installation Process

Moving the System within the Facility

Moving the System to another Facility

Electrical Requirements

Environmental Requirements

5. OPERATING INSTRUCTIONS

Activating the System

Automatic Vacuum and RF Test

Setting Treatment Parameters – Tablet Control Panel

Default Settings

Setting Treatment Parameters – Applicator Control Panel

Utilities Mode

System Information Screen

Maintenance Screen

Settings Screen

User Diagnostics Screen

Service Mode Screen

Video List Screen

Initiating Treatment

6. CLINICAL GUIDE: CELLULITE AND CIRCUMFERENCE TREATMENT

Realistic Expectations

Indications

Contraindications

Possible Side Effects

Pre-Treatment Preparation

Selecting the Appropriate Treatment Type

VelaShape III Measurement

Circumference

Cellulite

Treatment Procedure

Applicator Positioning

Test Spot

Treatment Technique: Identifying the Applicator a nd Cov er

Treatment Using the VContour Applicator

Treatment Protocol Using the Circumference Mode

Treatment Protocol of Large Areas Using Circumference Mode (Medium Cover)

Treatment Protocol of Small Areas Using Circumference Mode (Small Cover)

Treatment Protocol Using Deep Mode

Treatment Protocol of Focal Fat Deposits Using Deep Mode (Large and Medium Covers)

Cellulite Mode Treatment Protocol Using the VSmooth Applicator

Treatment Protocol Using Cellulite Mode

Treatment Options with Cellulite Mode

Endpoints (When to Stop Treating an Area)

Post-Treatment Care

Treatment Conclusion

7. MAINTENANCE