User Manual · 2020. 6. 5. · Syneron Medical (HK) Ltd. ... Wanchai, Hong Kong Tel: +852.2543.4326...

User Manual

PB70

286E

N

PB70286EN 3

Copyright © 2016 Syneron Medical Ltd. All rights reserved.

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

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

Data is subject to change without notification.

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

Specifications are subject to change without notice.

Manual Catalog Part Number: PB70286EN Revision Release Date: September 2016

● Before using the device, please check local regulations. If any local legislation is violated, use cannot be authorized.

● In the United States, federal law restricts prescription medical devices to be sold by or on the order of a physician, or properly licensed practitioner. Syneron-Candela makes no representations regarding federal, state, or local laws or regulations that might apply to the use and operation of this device.

Contact information for equipment manufacturer and technical services:

● Syneron, Inc. 3 Goodyear Irvine, CA 92618 USA Tel: + 1.866.259.6661 (toll free)

● CEpartner4u B.V. Esdoornlaan 13 3951 DB Maarn The Netherlands Tel: + 31.343.442.524 Fax: + 31.343.442.162

● Syneron Medical (HK) Ltd. Rm. 2502-03 HopeWell Centre, 183 Queen’s Road East Wanchai, Hong Kong Tel: +852.2543.4326 Fax: +852.2543.4327

● Syneron Medical Ltd. P.O. Box 550 Industrial Zone, Tavor Building Yokneam Illit 2069200 Israel Tel: + 972.73.244.2200 Fax: + 972.73.244.2202

● Website: www.Syneron-Candela.com ● E-mail: [email protected]

http://www.syneron-candela.com/

mailto:[email protected]

Table of Contents

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TABLE OF CONTENTS 1. Before You Start .................................................................................................................................. 7

Conventions Used in this Manual ................................................................................................... 7 Explanation of the Symbols Used in the System ............................................................................ 8

2. Safety .................................................................................................................................................. 9 Introduction ..................................................................................................................................... 9 System Safety Features ............................................................................................................... 10 Patient and Personnel Safety ....................................................................................................... 10 Installing the System ..................................................................................................................... 11 Operating the System ................................................................................................................... 11 Infrared Energy Safety Issues ...................................................................................................... 11 Radio-Frequency Energy Safety Issues ....................................................................................... 12 Mechanical Rollers Safety Issues ................................................................................................. 12 Electrical and Mechanical Safety .................................................................................................. 12 Maintaining the System ................................................................................................................ 13 Fire Hazards ................................................................................................................................. 13 System Classifications .................................................................................................................. 13 System Nameplate ....................................................................................................................... 14

3. System Description ........................................................................................................................... 15 System Overview .......................................................................................................................... 16

Console .................................................................................................................................... 16 Applicators ................................................................................................................................ 17 Communication Terminal ......................................................................................................... 19

Anatomy of Cellulite ...................................................................................................................... 20 The VelaShape II Procedure ........................................................................................................ 20 Heating of Dermis and Hypodermis with elōs ............................................................................... 22 Mechanical Effects on the Skin..................................................................................................... 22

4. System Installation ............................................................................................................................ 23 Unpacking the System .................................................................................................................. 24 Equipment List .............................................................................................................................. 25 Consumable Supplies ................................................................................................................... 25 Installation Process ....................................................................................................................... 26 Moving the System within the Facility ........................................................................................... 31 Moving the System to another Facility .......................................................................................... 31 Electrical Requirements ................................................................................................................ 32 Environmental Requirements ....................................................................................................... 33

5. Operating Instructions ....................................................................................................................... 34 Activating the System ................................................................................................................... 34 Automatic Vacuum and RF Test ................................................................................................... 35 Defining the Treatment Mode ....................................................................................................... 36 Controlling the Treatment Level ................................................................................................... 37 Communication Terminal Messages ............................................................................................ 37 Initiating Treatment ....................................................................................................................... 38

6. Clinical Guide: Cellulite and Thighs Circumferences Treatment ....................................................... 39 Realistic Expectations ................................................................................................................... 39

User Manual Table of Contents

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Indications .................................................................................................................................... 39 Contraindications .......................................................................................................................... 39 Possible Side Effects .................................................................................................................... 41 Pre-Treatment Preparation ........................................................................................................... 41 Selecting the Appropriate Treatment Type ................................................................................... 42 VelaShape II Circumference Measurement ................................................................................. 43 Treatment Procedure .................................................................................................................... 44 Treatment Protocols ..................................................................................................................... 48 Treatment Parameters .................................................................................................................. 49 Post-Treatment Care .................................................................................................................... 50 Treatment Conclusion .................................................................................................................. 50

7. Maintenance ...................................................................................................................................... 51 Cleaning the Console ................................................................................................................... 51 Cleaning and Maintaining the Vsmooth Applicator ...................................................................... 51

Replacing the Vsmooth Applicator's Filters ............................................................................. 54 Cleaning and Maintaining the Vcontour Applicator ...................................................................... 54

Cleaning/Replacing the Applicator Cover ................................................................................ 54 Cleaning the Vcontour Applicator's Filter ................................................................................. 56

Cleaning the Air Grids .................................................................................................................. 57 Cleaning the System Air Filter ...................................................................................................... 58 Upgrading the System Software ................................................................................................... 59

8. Troubleshooting Guide ...................................................................................................................... 60 9. System Specifications ....................................................................................................................... 62

Parameters ................................................................................................................................... 62 Treatment Area Footprints ............................................................................................................ 62 Electrical Requirements (Factory-Configured per Customer Order) ............................................ 62 Environmental Requirements ....................................................................................................... 62

Treatment Room ...................................................................................................................... 62 Transportation and Storage ..................................................................................................... 62 Degree of Protection Against Ingress of Water ....................................................................... 63

Dimensions ................................................................................................................................... 63 Weight ........................................................................................................................................... 63

10. Electromagnetic Regulation ............................................................................................................ 64 Electromagnetic Emissions .......................................................................................................... 64 Electromagnetic Immunity ............................................................................................................ 65 Recommended Separation Distances .......................................................................................... 67

LIST OF FIGURES Figure 1: System Nameplate Location ....................................................................................................... 14 Figure 2: VelaShape II System .................................................................................................................. 16 Figure 3: Vsmooth Applicator [Left: Operator Panel / Right: Applicator Elements] .................................. 18 Figure 4: Vcontour Applicator [Left: Operator Panel / Right: Applicator Elements] .................................. 18 Figure 5: Communication Terminal ............................................................................................................ 19 Figure 6: Anatomy of Cellulite .................................................................................................................... 20 Figure 7: elōs Heating and Mechanical Manipulation Action ..................................................................... 20

Table of Contents

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Figure 8: Before Treatment ........................................................................................................................ 21 Figure 9: IR Heats the Tissue Up To 2 mm. RF Heats the Tissue Up To 20 mm in Depth ...................... 21 Figure 10: After VelaShape II Treatment Reduction in the Size of the Fat Cells and Fat Chambers ....... 21 Figure 11: Assembled VelaShape II System .............................................................................................. 23 Figure 12: Umbilical Support Mast ............................................................................................................. 26 Figure 13: Inserting the Umbilical Support Mast ........................................................................................ 27 Figure 14: Vcontour Applicator Cradle ....................................................................................................... 27 Figure 15: Dual-Connector Assembly Electronic & Vacuum Sockets ........................................................ 28 Figure 16: Inserting the Dual-Connector Assembly ................................................................................... 28 Figure 17: Installing the Communication Terminal (1) ............................................................................... 29 Figure 18: Installing the Communication Terminal (2) ............................................................................... 29 Figure 19: Communication Terminal Connection ....................................................................................... 30 Figure 20: Connecting the Applicators ....................................................................................................... 30 Figure 21: Operator Panels ........................................................................................................................ 36 Figure 22: Illustration of Circumference Measurements: A) Fixed Distance between the Legs; B) Labeling the circumference; C) Measuring Horizontally; D) Labeling the Arm Against a Wall. ......................................................................................... 43 Figure 23: Removing the Vsmooth Replaceable Cover ............................................................................. 52 Figure 24: Vsmooth Applicator's Internal Components .............................................................................. 53 Figure 25: Replacing the Vsmooth Applicator's Filters .............................................................................. 54 Figure 26: Vcontour Applicator's Internal Components .............................................................................. 55 Figure 27: Replacing the Small Applicator's Filter ..................................................................................... 56 Figure 28: Air Filter and Grids .................................................................................................................... 57 Figure 29: Cleaning the Air Filter ............................................................................................................... 58 Figure 30: Replacing the Software Plug ..................................................................................................... 59

User Manual Before You Start

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1. BEFORE YOU START

Warning

• Read this manual to become familiar with all safety requirements and operating procedures before attempting to operate the system.

• Any intense optical energy or radio frequency (RF) device can cause injury if used improperly.

• High voltage is present inside the system. Always be aware of the possible dangers and take proper safeguards as described in this manual.

• The VelaShape II system must be serviced only by Syneron-Candela qualified personnel.

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

Note The content of this Note offers general information that is important to keep in mind.

Caution A Caution alerts the user to the possibility of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or damage to the equipment.

Warning

A Warning alerts the user to the possibility of injury, death, or serious adverse effects associated with the use or misuse of the system.

Before You Start

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Explanation of the Symbols Used in the System

Symbol Description

Refer to Instruction Manual/Booklet

Caution!

0344 CE Compliance Symbol

CSA Compliance Symbol (212603 CSA master contract number)

Waste of Electrical and Electronic Equipment (WEEE) compliance symbol

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

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

Fuse

Type BF Equipment

Manufacturer

Authorized Representative in the European Union

User Manual Safety

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

Note Protect the VelaShape II system against unqualified use by removal of the key from the keyswitch when the system is unattended.

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

Warning

• Read this chapter to be familiar with all of its safety requirements and operating procedures prior to operating the system.

• Any intense optical energy or RF device can cause injury if used improperly.

• High voltage is present inside the system.

• Always be aware of the possible dangers and take proper safeguards as described in this manual.

• In the event of adverse effects or injury/illness, immediately contact: - In North America: Syneron, Inc. - In Europe: CEpartner4u B.V. - Outside North America and Europe: Syneron Medical Ltd.

• For complete contact information please refer to page 3 of this manual.

Safety

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System Safety Features The VelaShape II system incorporates the following safety features:

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

• The power electronics cannot be activated unless an applicator has been connected to the system.

• Upon system activation, IR, RF, and Vacuum are at Level 0 on the operator panels.

• During activation, the system performs a self-test of the hardware to detect any faults, so that you can shut down the system if necessary.

• IR and RF energies are not delivered unless full contact with the tissue is conducted.

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

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

• Prior to scheduling treatments, obtain a detailed patient history to verify that the patient is eligible and is in fit condition to undergo treatment.

• Fully inform the patient regarding the treatment protocol, the likely results and any risks associated with treatment.

• Before activating the system, make sure any long hair of the treating attendant or the patient is safely pulled back and tied.

• Ascertain that all jewelry is removed.

• Improper treatment technique may cause local burns.

Warning

• Prior to system activation, any personnel operating or maintaining the system should be familiar with the safety information provided in this chapter.

• Opaque eye protection should be used when working within a 30 cm (12") proximity to the patient's eyes.

User Manual Safety

PB70286EN 11

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

Operating the System • Keep all system panels closed. Do not remove the panels and do not touch

any of the system's inner components.

• Keep your hands away from the applicators during system start-up.

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

• Keep the applicators clean and dry.

• Do not allow the replaceable applicator covers to come in contact with hard materials, excessive heat or humidity; these may damage the RF electrodes.

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

• Make sure that all treatment personnel are familiar with the system's controls and know how to shut down the system instantly.

Infrared Energy Safety Issues The VelaShape II emits gentle heating infrared light between 700-2000 nm in a continuous wave mode. Light emission is contained within the applicator chamber and occurs only when the operator presses the trigger button on the applicator, when an adequate vacuum seal is achieved and the RF electrodes are in full contact with the treated surface. Opaque eye protection should be used when working within a 30 cm (12") proximity to the patient's eyes.

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

Safety

PB70286EN 12

Radio-Frequency Energy Safety Issues The RF energy provides gentle heating that is distributed deep into the skin via bi-polar electrode rollers. Full coupling of both electrodes (spiral shaped rollers) to the skin, after applying VelaSpray Ease, is necessary before pressing the trigger button, so that the RF energy is safely conducted to penetrate the skin. If coupling with the skin is broken due to incomplete contact or removing the applicator from the treatment site while the trigger is pressed, IR and RF modes are disabled and blinking lights on the applicator’s operator panel indicate insufficient coupling. The trigger should be released immediately and the applicator should be re-oriented on the skin. In rare cases superficial crusting may be formed on the skin from the RF effect. Because of the heating effect by RF energy, highly conductive objects such as superficial metal or conductive implants, rods, plates or pins should be avoided in the treatment area.

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

Electrical and Mechanical Safety • Keep all covers and panels of the system closed. Removing the covers creates

a safety hazard.

• Keep hands away from the applicators during system start-up.

• Perform maintenance procedures when the system is shut down and disconnected from its electrical power source.

• The system's cables are equipped with isolation coating and the electronic circuitry is also isolated from the mains power supply. In addition, the system’s plastic covers serve as a means of isolation.

• Move the system slowly and carefully. The system weighs approximately 27 kg (59.5 lbs.) and may cause injury if proper care is not used when moving it.

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

• Portable and mobile RF communications equipment can affect medical electrical equipment, Interference may occur in the vicinity of the equipment.

• The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the device. It is forbidden to connect any third-party equipment to the system without written approval from Syneron-Candela.

User Manual Safety

PB70286EN 13

Maintaining the System • Only authorized Syneron-Candela technicians are qualified to service the

system.

• Shut down the system and disconnect the power cable before performing any maintenance procedures (see Chapter 7).

Fire Hazards • The absorption of optical energy or conduction of RF raises the temperature

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

• Keep drapes and towels moist to prevent them from igniting and burning. Use non-flammable prepping solutions.

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

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

System Classifications • Electric shock protection: Class I, Type BF

• Protection against ingress of liquids: Ordinary equipment

• Not suitable for use in presence of flammable substances

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

• The system is classified as a Class IIa device according to Annex IX of the European Medical Device Directive (2007/47/EC).

Warning No modifications to this equipment are allowed!

Safety

PB70286EN 14

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

User Manual System Description

PB70286EN 15

3. SYSTEM DESCRIPTION The VelaShape II is a device that combines elōs technology (electro-optical synergy) with mechanical manipulation of the skin using gentle vacuum suction with or without mechanical massage. It is designed for use in medical and aesthetic practices and is indicated for:

• EU: non-invasive treatment for body contouring via temporary cellulite and circumference reduction.

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

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

• Infrared (IR) optical energy

• Bipolar conductive radio frequency (RF) current

• Mechanical manipulation (vacuum with or without massage rollers)

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

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

System Description

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System Overview The system includes five core modules: the Console, Vsmooth Applicator, Vcontour Applicator, Dual Connector and Communication Terminal (see Figure 2).

Figure 2: VelaShape II System

Console

The VelaShape II console houses the following components:

• Power supply • IR lamp power supply

• Vacuum pump • Main CPU

• RF generator • Other power components


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Applicators

The Vsmooth and Vcontour applicators incorporate the operator panels, and are used for the physical implementation of the RF current, IR energy and mechanical manipulation treatment parameters.

The VSmooth applicator (see Figure 3) utilizes IR, RF and mechanical manipulation by vacuum and massage rollers. It is used for cellulite reduction in large areas such as the thighs, buttocks, or abdomen and for circumference reduction.

The VContour applicator (see Figure 4) utilizes IR, RF and mechanical manipulation by vacuum. It is used for cellulite and circumference reduction of curved areas, for localized fatty deposits, and to reinforce results of Vsmooth applicator, thus leading to contouring of smaller areas such as the lower abdomen, flanks and arms.

The Dual Connector enables the attachment of both applicators at the same time. Please note that working simultaneously with both applicators is not possible.

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

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

• The IR & RF columns of LEDs blink continuously (inadequate coupling).

• The applicator does not move smoothly over the skin.

• Rollers appear damaged, discolored or their movement is impaired.

• Roller axis appears to wear out (color turns from silver to copper).

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


• Electrodes appear damaged.

• The cover's shape appears distorted.

• The vacuum LEDs column of LEDs is cycling continuously from 1 – 3, indicating a clogged filter.

System Description

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The display and selector controls are located on the operator panel of each applicator. The three user-defined treatment modes are: IR, RF, and Vacuum. The levels are indicated by 0, 1, 2, or 3 illuminated LEDs which correspond to no energy, low, medium and high levels, respectively (see Figure 3 and Figure 4).

Figure 3: Vsmooth Applicator [Left: Operator Panel /

Right: Applicator Elements]

Figure 4: Vcontour Applicator [Left: Operator Panel /

Right: Applicator Elements]

Note The images in the figures are for illustration purposes only.

IR Aperture

Applicator Chamber

Level 1 - Low Level 3 - HighLevel 2 - Medium

RF Electrode RollersIR VacuumRF

IR Aperture Vacuum Intake

RF Electrodes

VacuumRF

Trigger

Level 1 - Low

Level 3 - HighLevel 2 - Medium

IR


PB70286EN 19

The applicators are applied to the treatment area so that all four edges of the aperture make a seal with the skin. This allows the vacuum to be effective and ensures that the RF electrodes are fully coupled to the skin. Failure to achieve full contact between the RF electrodes and skin will result in disabled IR and RF energies, indicated by:

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

• An Improve Contact message on the communication terminal's display (see Figure 5).

Communication Terminal

The communication terminal is a digital message board that keeps the user of the VelaShape II system informed of various system conditions and alerts that will occur during the normal course of operation.

It also displays system error messages that require resolution by the user before treatment can be continued.

Figure 5: Communication Terminal

System Description

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Anatomy of Cellulite Cellulite is characterized by Dimpled Skin Surface – mattress-like appearance (see Figure 2-4). The fat cells are located in chambers which are separated by vertical and horizontal Connective Tissue Septa. The Septa are anchored rigid fibers that do not stretch with the skin as the volume within the walls of the chamber increases. When the fat chamber becomes too distended by enlarged fat cells and by retained intercellular fluids, it protrudes beyond the length of the vertical septa, pushing up the skin's surface and resulting in a dimpled skin appearance.

The VelaShape II Procedure The application of elōs (IR and RF energies) to the dermis/hypodermis is intended to deploy heat to the tissues that contribute to cellulite. The vacuum contributes to increased blood circulation (see Figure 7). The blood, which is one of the targets of the hyperthermic effect of the IR and RF, responds in a higher diffusivity of oxygen. This in turn increases the metabolic breakdown of stored fat by the fat cells (lipolysis), thereby reducing the size of the fat cells. Consequently, the bumpiness of the skin, which is largely caused by distended fat cells protruding up from the anchored connective tissue septa, is reduced.

The mechanical action of the vacuum and rollers gently kneads the skin and facilitates deeper penetration of heat, delivering the RF and IR energies to the dermis and hypodermis. This mechanical action helps in draining the excess intercellular fluids from the dermis and the upper part of the hypodermis into the lymphatic system.

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 6: Anatomy of Cellulite

Figure 7: elōs Heating and Mechanical

Manipulation Action

RF electrodes

Lamp

Infrared filter

Parabolicreflector


PB70286EN 21

Figure 8: Before Treatment

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

Up To 20 mm in Depth

Figure 10: After VelaShape II Treatment Reduction in the Size

of the Fat Cells and Fat Chambers

System Description

PB70286EN 22

Heating of Dermis and Hypodermis with elōs Light Energy (see Figure 7):

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

• Maximum electrical power of the IR light is 35 Watts (35 J/sec) for both Vsmooth and Vcontour applicators.

• Depth of heating from light reaches the deep dermis.

RF Energy (see Figure 7):

• Bi-polar conductive RF energy is emitted from the RF electrodes which are embedded in the rollers at a frequency of ~1 MHz.

• Maximum RF energy applied to the patient's skin is 60 Watts for the Vsmooth applicator and 23 Watts for the Vcontour applicator.

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

Mechanical Effects on the Skin Mechanical Rollers (see Figure 9):

• Rollers knead the skin inward so that the IR and RF energies can penetrate deeper in the skin.

• Rolling the skin upward facilitates a better suction effect from the vacuum.

• The repeated kneading of the skin between the rollers improves lymphatic drainage, with overall improvement of the dimpled appearance of cellulite.

Vacuum/Negative Pressure (see Figure 9):

• When all edges of the applicator are in full contact with the skin, a seal is made, allowing the vacuum pump to apply gentle suction.

• Negative pressure dilates the blood vessels, increasing the perfusion in the local area.

• Vacuum levels are:

⇒ Vsmooth applicator – up to 380 mbar of negative pressure

⇒ Vcontour applicator – up to 440 mbar of negative pressure

User Manual System Installation

PB70286EN 23

4. SYSTEM INSTALLATION The system is designed for installation in a clinical environment. The customer shall carry out the installation as described in the following sections.

Figure 11: Assembled VelaShape II System

System Installation

PB70286EN 24

Unpacking the System After unpacking the system, Syneron-Candela recommends that you retain the shipping box and the internal Styrofoam covers and braces in the event that the system will have to be relocated anytime in the future.

Unpack the system as follows:

1. Cut off and remove the three plastic straps that encase the cardboard box.

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

3. You will find a "Vela Product Line Unpacking Instructions" sheet taped to the side of the top Styrofoam cover; follow the instructions on this sheet, and then continue with unpacking and installation from this point.

4. Carefully remove the packed accessories and small Styrofoam boxes from inside the Styrofoam covers.

5. Finish removing all of the Styrofoam covers and braces from around the body of the system.

6. Remove the plastic bag that is wrapped around the system.

Caution The Vsmooth (large) applicator is taped inside the top Styrofoam cover; unpack it carefully.

7. Compare the accessories you unpack to the equipment list (next section) to

ensure that all accessories are present. Report any missing accessories to your Syneron-Candela representative.

8. Lift the system up and out of the bottom Styrofoam brace and carefully set it on the floor.

Warning The system weighs 27 kg (59.5 lbs.) and should only be lifted by two people. Lift correctly and protect your back!

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


PB70286EN 25

Equipment List The VelaShape II system is delivered with the following:

• VelaShape II system console

• Vsmooth applicator (with non-operational protective cover)

⇒ Disposable cover for Vsmooth applicator (x 2)

• Vcontour applicator (with non-operational protective cover)

⇒ Disposable cover for Vcontour applicator (x 2)

• Software plug (installed in system's rear panel)

• Dual-Connector assembly

• Vcontour applicator cradle

• Umbilical support mast (includes five harness loops)

• Accessories kit, including:

⇒ Communications terminal with cable

⇒ User Manual

⇒ Quick-Reference Guide / Quick-Service Guide

⇒ Infrared thermometer (warranted and serviced by manufacturer)

⇒ One pair of protective opaque goggles

⇒ Filter extractor

⇒ Set of two keys

⇒ Cleaning brush

⇒ VelaSpray Ease bottles (x 4)

⇒ System air filters (x 3)

Consumable Supplies The following consumable supplies may be ordered using the following part numbers:

• Replaceable covers for the Vsmooth applicator1

• Replaceable covers for the Vcontour applicator1

• VelaSpray Ease bottles (10-pack)

1 Consult Syneron sales representative

System Installation

PB70286EN 26

Installation Process After unpacking the VelaShape II system, install the applicators in the following manner:

1. Unpack the umbilical support mast with the five installed harness loops (see Figure 12). Ensure that the harness loop's Allen screws are properly seated in their dimples in the mast.

2. Take the mast extension and screw it into the bottom of the support mast as shown in Figure 12.

Figure 12: Umbilical Support Mast


PB70286EN 27

3. Insert the mast as shown in Figure 13, until it is stopped by the pin.

Figure 13: Inserting the Umbilical Support Mast

4. Attach the Vcontour applicator cradle to the mast as shown in Figure 14.

Fasten the knob securely.

Figure 14: Vcontour Applicator Cradle

System Installation

PB70286EN 28

5. Unpack the dual-connector assembly and identify the electronic and vacuum connection sockets, both on the dual-connector and in the system's connection port (see Figure 15).

Figure 15: Dual-Connector Assembly Electronic & Vacuum Sockets

6. Firmly insert the dual-connector assembly into the system's connection port,

making sure that the electronic and vacuum sockets are aligned, as shown in Figure 16. Ensure that the dual-connector's rubber clamps are securely connected to the support mast.

Figure 16: Inserting the Dual-Connector Assembly


PB70286EN 29

7. Unpack the communication terminal and attach it to the mast by pressing its two clamps onto the mast, as shown in Figure 17.

Figure 17: Installing the Communication Terminal (1)

8. Route the terminal's communication cable along the rear side of the terminal and the system, such that it will not interfere with system operation.

Figure 18: Installing the Communication Terminal (2)

System Installation

PB70286EN 30

9. Connect the terminal's communication cable to the connection port on the system's rear panel, as shown in Figure 19.

Figure 19: Communication Terminal Connection

Note The system may be operated without the communication terminal if desired.

10. Unpack the applicators; firmly connect the Vcontour applicator to one of the

dual-connector's connection ports, making sure that the electronic & vacuum sockets are aligned (see Figure 20).

Figure 20: Connecting the Applicators


PB70286EN 31

Refer to Figure 11:

11. Hook the Vcontour applicator's umbilical harness into one side of the harness loops on the umbilical support mast.

12. Place the Vcontour applicator in its cradle.

13. Connect the Vsmooth applicator to the second connection port of the dual-connector, making sure that the electronic and vacuum sockets are aligned.

14. Hook the Vsmooth applicator's umbilical harness into the other side of the harness loops on the umbilical support mast.

15. Place the Vsmooth applicator in its cradle.

Finish the installation:

16. Connect the power cable to the power connection port on the system's rear panel, and plug the cable into the appropriate electrical outlet.

17. Refer to Figure 11 and ensure that all system components are correctly assembled.

18. Insert the key into the keyswitch.

Note If the system has been removed from cold storage, allow it time to warm up to room temperature (15-30°C/59-86°F) before first activation.

Moving the System within the Facility 1. Turn the system off and disconnect the power cable.

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

3. With one hand securing the Vsmooth applicator, slowly push or pull the system using the handle at the back of the system.

Moving the System to another Facility 1. Turn the system off and disconnect the power cable.

2. Disconnect the applicators and pack them in their storage cases.

3. Disconnect and remove the communication terminal.

4. Remove the umbilical support mast.

System Installation

PB70286EN 32

5. Remove the Dual Connector and pack it in its storage box.

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

7. Slowly push or pull the system using the handle at the back of the system and carefully lift it up onto the vehicle. Spread padding on the wall of the transport vehicle to avoid scratching the system's covers and strap the system to the wall.

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

9. Reinstall the umbilical support mast.

10. Reinstall and reconnect the communication terminal.

11. Reinstall the Dual Connector and reconnect the applicators and the power cable.

Caution Do not lay the system on its back or sides! Doing so may damage the vacuum pump.

Electrical Requirements The system is preset at the factory to accommodate the local line voltage according to the customer's order. Accordingly, the system will require a separate line supply of one of the following (appropriate to your country):

• 100 VAC; 6A; 50-60 Hz; single phase

• 110-127 VAC; 5.2A; 50-60 Hz, single phase

• 220-240 VAC; 3.1A; 50 Hz; single phase

Warning

• For continued protection against fire, replace the fuse only with one of the same type and rating.

• Proper grounding is essential for safe operation.

• Do not replace any electric part of the system except fuses!

• Only authorized Syneron-Candela technicians are qualified to service the system.


PB70286EN 33

Environmental Requirements • Corrosive materials can damage electronic parts; therefore the system should

operate in a non-corrosive atmosphere.

• Metallic dust can damage electrical equipment. Dust particles absorb light and heat up. Hot particles located on the aperture guide can damage it; therefore dust particles should be kept to a minimum.

• For optimal operation of the system, maintain room temperature between 15º-30ºC (59º-86ºF) and relative humidity of less than 80%.

• If the system has been stored in an environment cooler than the above mentioned temperatures, allow it time to warm up to room temperature before first activation.

Operating Instructions

PB70286EN 34

5. OPERATING INSTRUCTIONS This chapter will assist you in operating the system for the first time, and will guide you through the initial setup procedures needed to perform in order to start operating the system.

Caution The VelaShape II applicators and disposable covers are not compatible with the older VelaShape systems or VelaSmooth systems!

Activating the System 1. Before turning the system on, verify that the power cable is connected to the

power connection port on the system's rear panel and to the wall power outlet.

2. Verify that the software plug is inserted and secured.

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

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

• Always turn the system off before connecting/disconnecting an applicator or Dual Connector.

3. To activate the system turn the key clockwise; the system initiates a self-test.

During this test, the LEDs on the applicators' operator panels perform a test pattern, and when the first row of lights (Level 0) is illuminated continuously on both applicators, the system is ready for operation. At the same time, the communication terminal will display this message: System Initialization Please Wait…

Note

• Before activation, remove the protective covers from the applicators and install new working covers.

• When the system is not being used, install the protective covers in order to protect the applicators' internal components.

User Manual Operating Instructions

PB70286EN 35

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

The test is performed:

• Immediately after the system powers up

• 90 seconds after each release of the applicator's trigger

During the test the VelaShape II is tested for radiofrequency and vacuum performance, displaying the status of applicator filters. During this test, the triggers of both applicators are disabled.

The test is comprised of three consecutive vacuum pulses for each applicator connected to the system, and can take up to 10 seconds.

It is important to verify that the applicators' chambers are not blocked or positioned against a sealing surface during the test (i.e., verify that the applicator is not applied to the patient during the test).

The test results will be displayed in one of the following manners. If a fault situation is displayed refer to Chapter 8 – Troubleshooting

1. RF failure: – RF LEDs column is blinking. – 100 - RF Failure message on the communication terminal's display.

2. Vacuum sensor fault: – 0 level LED of IR and RF columns are blinking – (Vsmooth applicator only). – 101 - No Vacuum Sensor in LA/SA message on the communication terminal's display.

3. Filters are clogged or applicator chamber is sealed (against the patient's skin or other surface): – Vacuum LEDs are cyclically ascending from 1 to 3. – 03 - Replace Filters message on the communication terminal's display.

4. Filters are missing, punctured or improperly inserted: – Vacuum LEDs are cyclically descending from 3 to 1. – 02 - Insert Filters message on the communication terminal's display.

If one of the above indications appears and you wish to repeat the test, press the trigger on any applicator and wait for 90 seconds; the test will repeat itself.


PB70286EN 36

Defining the Treatment Mode The VelaShape II system has three treatment modes that can be controlled by the operator. They are based on the following integrated technologies:

• Infrared (IR) light energy

• Radio frequency (RF)

• Mechanical manipulation (Vacuum)

Before you begin treatment, you need to define the levels of the three treatment modes.

The operator panel is located on the top of both applicators (see Figure 21). The operator panel consists of three treatment mode buttons and informational display LEDs.

Figure 21: Operator Panels

Each button on the operator panel applies a different treatment mode, as follows:

Table 1: Operator Panel Buttons and Indicators

Button Treatment Mode Description

IR mode Continuous infrared light energy is applied

RF mode Radio frequency current is applied

Vacuum mode Pressing this button activates the vacuum

pump

Applicator cover indicators

• Green LED: cover is operative and installed properly

• Red LED: cover is expired or not installed properly

User Manual Operating Instructions

PB70286EN 37

Controlling the Treatment Level You can adjust the level of each treatment mode, using the corresponding mode buttons:

• IR mode

• RF mode

• Vacuum mode

Use the mode buttons to control the intensity of IR, RF and Vacuum applied to the patient. Each time you press the mode button, you move the intensity up to the next level, as indicated by the lights on the operator panel. e.g., if the current level is 2, and you press the mode button, the level goes to 3. After 3 it goes back to 0 (zero).

Table 2: Treatment Level Intensities

Level Intensity Notes

0 None (mode turned off) Default level; set to avoid accidental activation

1 Low

2 Medium

3 High

Communication Terminal Messages During system operation the terminal's display LCD will always show a split view of the applicators' operating conditions and other relevant information, such as:

• Ready – the applicator is connected, the treatment level configured, but the trigger is not yet pressed.

• Treatment - the applicator is connected, the treatment level configured, and the trigger is pressed.

• Not Available – the applicator is not connected.

Pressing the Info button on the terminal will make the following information available. Press the Scroll button on the left side to view all of the information:

• System Type – VelaShape II.

• VelaShape II - System S/N – the system's factory serial number.

• LA/SA S/N – the Vsmooth applicator or Vcontour applicator type and factory serial number.


PB70286EN 38

• LA/SA Working Hours – the total number of hours already performed by the connected Vsmooth or Vcontour applicator.

• Disposable Status – how much time remains to operate the disposable covers. The number of available operating hours – after which the cover will cease to operate – is printed on the new cover's box label.

• System Freq: 50 or 60 Hz – the system's electrical frequency

Other various Maintenance or Error messages will be discussed in the troubleshooting guide later in this manual (see Chapter 8).

Initiating Treatment Now that you have defined your treatment settings, you are ready to begin treatment. Apply the applicator with moderate pressure to the treatment area and press the trigger on the applicator handle. To stop the treatment, release the trigger.

Warning You may treat patients only after passing appropriate training and have adhered to all local and state regulations regarding the use of this system.

User Manual Cellulite and Thighs Circumferences Treatment

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6. CLINICAL GUIDE: CELLULITE AND THIGHS CIRCUMFERENCES TREATMENT

This chapter provides you with the information required to treat cellulite (generic) and circumferences (thighs) with the VelaShape II system. The entire treatment protocol is related to the cleared indications, and unless otherwise specified, the same procedure applies for both applications.

Realistic Expectations • There will be improvement in cellulite appearance, but not necessarily complete

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

• The degree of response to the VelaShape II treatment, and the number of treatment sessions required will vary among patients and will depend on the clinical and physiological condition at the start of the treatment regimen. Some patients respond better than others.

• The treatment results are temporary and one maintenance treatment session every 2-3 months is essential to sustain them.

• A healthy lifestyle (diet and exercise) may help to obtain better results, but is not essential. However, weight gain may have a negative effect on the results.

Indications The VelaShape II system is indicated for:

• EU: non-invasive treatment for body contouring via temporary cellulite and circumference reduction.

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

Contraindications • Pacemaker or internal defibrillator.

• Superficial metal or other implants in the treatment area.

• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.

Cellulite and Thighs Circumferences Treatment

PB70286EN 40

• History of any kind of cancer.*

• Severe concurrent conditions, such as cardiac disorders.

• Pregnancy and nursing as well as 4-5 months post- natural delivery, or at least 6 months post-cesarean section, or until normal hormonal balance is regained.

• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.*

• Diseases which may be stimulated by light at the wavelengths used.*

• Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.

• Poorly controlled endocrine disorders, such as diabetes.

• Any active condition in the treatment area such as sores, psoriasis, eczema and rash.

• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.

• History of bleeding coagulopathies, or use of anticoagulants.*

• Use of medications, herbs, food supplements & vitamins known to induce photosensitivity to light exposure at the wavelengths used, such as Isotretinoin (Accutane) within the last 6 months, tetracyclines, or St. John's Wort within the last 2 weeks.*

• Any surgical procedure in the treatment area within the last 3 months or before complete healing.

• Treating over tattoo or permanent makeup.

• Area with varicose veins.

• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

(*) Although not recommended, these conditions may be treated at the discretion and under the full responsibility of the medical director/physician. In such cases, a small area should be treated and assessed a few days later to determine if the patient will tolerate the treatment without developing short-term adverse effects. Test spots cannot indicate long-term adverse events.


PB70286EN 41

Note

• In case of uncertainty regarding applicability or potential side effects, have the patient consult his/her physician and bring a written consent for treatment.

• Always test a small area with the selected parameters, and wait several minutes to detect results of the tested area before proceeding with the whole area treatment.

• Additionally for dark skin types (IV-VI), a small area should be treated and assessed a few days later to determine if the patient will tolerate the treatment without developing adverse effects.

• It is not recommended to treat the abdomen sooner than one hour after a meal.

• It is not recommended to treat patients with BMI >30.

Possible Side Effects Certain side effects may be experienced during treatment or shortly afterwards, usually as a result of improper use of the system. Although these side effects are rare and temporary, they should be reported immediately to a physician for proper treatment.

These are the side effects that may appear in the treatment area:

• Pain

• Excessive skin redness (erythema)

• Hair pulling (by mechanical rollers)

• Damage to natural skin texture (scratching, crusting, blister, burn)

• Bruising

Pre-Treatment Preparation • Complete or update the patient's medical and physical history.

• Exclude from treatment patients presenting any of the contraindications for treatment.

• Determine why the patient is seeking treatment and what the expectations are.

• Inform the patient about the treatment protocol, typical treatment results and possible adverse effects or discomfort.

• Instruct the patient about the safety issues.

• Advise the patient to exfoliate the skin with appropriate creams before treatment. The patient should come to the treatment with clean, dry skin (no perfume, no lotion).


PB70286EN 42

• Hair may impair the movement of the applicator, overheat the treatment area or be pulled out during treatment. Removing hair before treatment is advised.

• Advise the patient to avoid anticoagulants, such as aspirin throughout the treatment regimen, if medical condition permits and pertinent to physician approval. Anticoagulants increase the possibility of bruising.

• Before the first treatment session it is important to weigh your patient, photograph and measure the circumference of the treatment area in order to establish a baseline (see VelaShape II Circumference Measurement, page 43). Re-photograph and re-measure before the last treatment and before any maintenance treatment thereafter, and document the results achieved. Additionally you may do so every two sessions to document any progress. Re-weigh your patient before each subsequent session to ascertain no weight gain.

• Mark the treatment areas when the patient is standing (use white or yellow marker), as cellulite or contour may change characteristics when the patient is lying down.

• Make sure that the RF electrodes are clean and intact (not chipped). In addition when using the Vsmooth applicator, verify that the rollers function smoothly. Make sure that all the applicators’ parts are clean and intact.

• Make sure that the Vsmooth filters are clean and correctly inserted (replace them if not).

• Ensure that the replaceable covers of the Vsmooth and Vcontour applicators are firmly inserted and secured in place.

• Fit the patient with opaque eye protectors if the treatment area is within a 30 cm (12") proximity to his/her eyes.

Selecting the Appropriate Treatment Type The system combines two types of energy (IR and RF), and mechanical manipulations (vacuum and/or massage). These combined and synchronized actions optimize the energy delivery.

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

Use the Vsmooth applicator for large areas such as the thighs, buttocks or abdomen.


PB70286EN 43

If the calves and arms are large enough, they may be treated with the Vsmooth applicator.

Use the Vcontour applicator for curved areas or small areas such as the lower abdomen and flanks, and for localized fatty deposits.

The Vcontour applicator may also be applied to reinforce endpoints on small sites of large areas, following treatment with the Vsmooth applicator, such as on the umbilical site in the abdomen area.

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

1. The patient should stand in an upright position adjacent to a wall, barefoot and with both legs attached or at a fixed distance (see Figure 22 [A]).

2. A measuring ruler of hard material (wood or plastic) of at least 1 meter should be placed against the wall. Alternatively, a vertical metal stand with attached marker may be used (see Figure 22 [B]).

3. Measurements should be taken for each anatomical area, usually the "thickest" part of each area:

• Thighs and buttocks – upper third.

• Abdomen – under and above the navel.

• Arms – midway between shoulder and elbow.

Figure 22: Illustration of Circumference Measurements: A) Fixed Distance between

the Legs; B) Labeling the circumference; C) Measuring Horizontally; D) Labeling the Arm Against a Wall.

A B C

D


PB70286EN 44

4. During the entire measurement procedure, the distance between the patient's feet must remain constant.

5. At least 4 marks should be made with a white make-up pencil on each measured area, usually front, back and both sides, while the patient is rotating.

6. A measuring tape should be placed across all marks which were made in each anatomical area, creating a straight and horizontal continuous line between them (see Figure 22 [C]).

7. The measurements and the distance from the floor should be recorded in the patient folder, for identical positioning in subsequent measurements.

8. When measuring the arm circumference, indicate the distance from the wall and always measure at the same distance while the arm is perpendicular to a wall (see Figure 22 [D]).

Treatment Procedure • Always inspect the applicator for cleanliness and integrity. Make sure that

there are no cracks or other damage to any of the applicator's components.

• Select the treatment parameters as suggested in the Treatment Parameters section (see page 49). Always consider the patient's skin response and tolerance.

• Select and mark the treatment area while the patient is standing:

⇒ Vsmooth Applicator: The treatment area is anatomical (i.e. front thigh/back thigh/abdomen/one buttock, etc.). Divide the area into strips; dimensions of each strip: width of the applicator (the distance between the electrodes) and the length of ~30 cm (~12 inches).

⇒ Vcontour Applicator: the area dimensions will be ~10 x 15 cm (~4 x 6 inches), or that of the palm of a large hand.

• It is essential to use VelaSpray Ease lotion, (not gel, and not any other product) for optimal coupling and RF conductivity. Moisten the treatment area with VelaSpray Ease lotion and rub it well into the skin using massage movements with gloved hands. Ensure that a thin layer of lotion (~1 mm) remains on the skin. Replenish the lotion only if it becomes difficult to glide the applicator over the treated area and when the skin appears dry, or when the IR and RF indicators blink continuously.

• Always test a small area with the selected parameters, and wait a few minutes to detect results of the tested area before proceeding with the treatment of the whole area.

• Orient the applicator perpendicular to the treatment area and apply minimal pressure, just enough for complete contact with the skin. When pressing the applicator's trigger the skin will be suctioned into the applicator's chamber by the


PB70286EN 45

vacuum. If you hear air being sucked into the applicator chamber, this indicates that the applicator is not positioned properly on the skin. If adequate coupling between the RF electrodes and the skin is not achieved, the RF and IR will be disabled and their indicator lights on the operator panel will blink.

• You may manually assist the treatment by slightly stretching curved or loose skin with your free hand, and by slightly pushing or pulling the skin to or from the side towards the applicator. You may also improve contact by placing a rolled towel under the treatment area, which will push it up towards the applicator.

• The goal of each treatment session, regardless of which applicator you use, is to heat the deeper skin layers leading to a rise of the patient's skin temperature to the endpoint. Reaching the endpoint twice is the required procedure using the Enhanced Treatment Mode. Endpoint is reached when substantial and persistent radiant heat can be felt on the palm your hand about 5 mm above the skin. The heat is usually accompanied by erythema (at various levels, depending on skin type and anatomical area) and sometimes slight edema. The patient should feel a tolerable heat sensation. This typically occurs at a temperature of 40°-42°C (104°-107°F).

• Endpoint is reached when substantial and persistent radiant heat can be felt by the palm of your hand about 5 mm above the skin. Once this endpoint is reached, this heat must be retained for at least 5-10 minutes for treatment to be effective.

• Treat the desired area in the following manners (see page 46):

1. Gliding slowly in Back & Forth Motions along or across the RF electrodes, without releasing the trigger. This is the preferred treatment manner for the Vsmooth applicator. It may be practiced also with the Vcontour applicator as long as the applicator is in full contact with the skin.

2. Forward Motions only, releasing the trigger at the end of each strip with either applicator. This treatment manner takes longer to reach an endpoint and serves for treating special areas, such as the lower buttocks (or wherever gliding motion is impaired).

3. Circular Motions are typically used to reinforce endpoints, and to retain the heat in the previously treated strips in the same area following motions 1 or 2 above.

4. Zig-Zag Motions are typically used to reinforce endpoints, and to retain the heat in the previously treated strips in the same area in a cross-hatched manner following motions described in 1 or 2 above.

5. Stacking: It is not recommended to stack with the Vsmooth applicator, however when motion is impaired such as in curved areas, stack 2-5 pulses on the same site with full contact of the electrodes with the tissue, and overlapping of ~20% between the sites.


PB70286EN 46

When using the Vcontour applicator, stacking is the preferred treatment manner. Stack up to 10 pulses with ~20% overlapping when moving to an adjacent site. Occasionally more stacked pulses may be applied, especially when reinforcing endpoints on large areas previously treated with the Vsmooth applicator, if the patient's skin response and comfort allow.

Warning • Particular care should be taken when stacking pulses on one

site. Ensure acceptable skin response and patient’s comfort.

• Reduce the IR level when stacking, in particular with the Vcontour applicator.

• When using the Vsmooth applicator: move the applicator over the skin at a

constant rate that will ensure optimal treatment of each point for ~ 3 seconds. Longer times may cause side effects, and shorter times may not be effective.

• It is recommended to treat the front thigh and abdomen from a supine position and the back thigh, buttocks and the back from a prone position. Very large hips and inner thighs may be treated when the patient is lying on the side with a bent knee.

• The treatment area is anatomical (i.e., front thigh, back thigh, abdomen, one buttock, etc.). Divide each area into strips as wide as the applicator cover for repeated passes until the endpoint is reached.

• If the anatomical area is extremely large divide it into two areas, such as half- abdomen, half-thigh or half-buttock. It is easier to reach and maintain the desirable heat on areas that are not too large. However, areas too small may heat up rapidly and result in superficial heating only.

• Treatment Motions with the Vsmooth Applicator (e.g., front thigh): 1. Back and forth motions on a strip of skin, applicator-width and ~30 cm

long, until endpoint of radiant heat (~42°C).

2. Back and forth motions on an adjacent strip until endpoint (overlapping ~20%).


PB70286EN 47

3. Retain the heat by passing over both previous strips in cross-hatched motions (zig-zag or circles).

4. Move to an adjacent strip and treat with back and forth motions until

endpoint.

5. Retain the heat again on all previous strips with cross-hatched motions.

6. Continue the process until you have covered the entire area.

• After the endpoint is achieved the patient may feel an internal heat sensation for 30 minutes or longer.

• Continue treatment with the Enhanced Treatment Mode which consists of two steps:

⇒ Step 1: Reach the endpoint in a certain anatomical area (using the motions described above).

⇒ Step 2: Return to the same anatomical area after ~10 minutes and repeat the procedure reaching the endpoint again.

⇒ While waiting you may treat another area.

⇒ Retaining the heat by covering the treated areas in the interval is recommended.

• When using the Vcontour applicator:

⇒ Divide the treatment area into smaller zones of roughly the size of the palm of a large hand (10 x 15 cm; 4 x 6 inches).

⇒ Go over one zone to complete one pass by stacking with an overlap of ~20%. The number of stacks applied should be according to patient tolerance, but no more than 10 stacks.

⇒ Repeat the same procedure on the same zone, until the desired endpoint is reached (~5 minutes). The number of passes is typically 4-6. Reduce the number of stacks with each successive pass.


PB70286EN 48

⇒ Move to the next zone and treat similarly until reaching the endpoint (~5 minutes).

⇒ Come back to the first zone and treat again until reaching the endpoint (5 minutes or less).

⇒ Treat the second zone again until endpoint (5 minutes or less).

⇒ If an optimal endpoint is not achieved, decrease the treatment area.

Note • Good contact is essential for good results. Always maintain complete

contact between the applicator chamber and the skin.

• For small zones such as the navel area, treat twice, but with less stacks until the endpoint is reached, and ensure a 5-minute interval between treatments.

• When reinforcing results following Vsmooth, treat the small area (such as localized fat deposits) only once.

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

• Blinking of the IR and/or RF LEDs on the operator panel indicates inadequate coupling which results in RF and IR being disabled.

Caution Release the trigger before you lift the applicator from the skin.

Treatment Protocols • Ideally, the treatment should be performed once a week. Spacing the

treatments less than once a week apart may reduce treatment efficacy. Usually 4-6 treatments result in significant circumference reduction and cellulite improvement. Some patients may need a few more sessions. Once per week is an acceptable protocol also when combining the Vsmooth and the Vcontour applicators.

• One maintenance treatment in the month following the initial series of VelaShape II treatments may be necessary to sustain the results, followed by once in 2 – 3 months according to individual results.

Note

• Compliance with the treatment protocol is essential to achieving the desired results.

• VelaShape II treatment performed 3–5 weeks post-liposuction can enhance smooth recovery from the liposuction treatment.


PB70286EN 49

Treatment Parameters Selecting the correct treatment parameters is essential for safe and successful treatment.

• Set the IR mode intensity level according to the vacuum level, so that you do not exceed a total of 5, e.g. with vacuum level 2 you may use IR level 3, but with vacuum level 3 use IR level 1 or 2.

• Do not use high IR levels for very dark or tanned skin, or over hair.

• Reduce IR level when the skin surface is rapidly heated such as in stacking, in particular with the Vcontour applicator.

• Vacuum levels for sensitive areas, such as inner thigh and over loose skin areas, should rarely exceed level 1 and may only be increased according to the patient's tolerance.

• Use high RF levels unless the patient feels an intolerable "stinging" sensation.

• Low IR levels with higher vacuum levels enable prolonged and deeper treatment (e.g. circumference reduction). Higher IR levels with lower vacuum levels facilitate overall smoother appearance of the skin surface (via cellulite reduction).

• When using the Vcontour applicator, stacking is the preferred treatment manner. The typical number of stacked pulses is up to 10.

Table 3: Treatment Parameters for Vsmooth & Vcontour Applicators

Desired Treatment: Cellulite Treatment [Superficial Hypodermis]

Circumference Reduction / Body Contouring [Deep

Hypodermis] IR Level 2 – 3 1 RF Level 3 3

Vacuum Level * 1 – 2 2 – 3 * (*) Vacuum may be lowered in accordance with the patient's tolerance.

Note • The treatment parameters in Table 3 are typical but always

consider individual skin response and patient's comfort.

• Always start with a test spot, treat and increase levels gradually if the patient's skin response and comfort allow.


PB70286EN 50

Post-Treatment Care • If heat sensation is excessive, cool the area with conventional cooling

methods such as cold (not frozen) packs, air cooling with SynerCool, etc.

• In case of side effects such as burns, stop treatment; apply cooling and appropriate creams. Resume treating the area only after the side effects have subsided, and with reduced levels of parameters.

• Prevent post-treatment overheating (e.g., Jacuzzi, sauna, etc.), or risk of physical damage.

Treatment Conclusion • Treatment should be concluded when the results are satisfactory to the patient

or according to the operator's discretion.

• Improvement will take some time to be apparent, and is affected by clinical conditions at the start of treatment regimen. Main impacts may be:

1. Transient skin texture that may show improvement after each session.

2. Thighs circumference reduction may show improvement after 2–3 sessions.

3. Cellulite may show improvement after 4 sessions.

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

User Manual Maintenance

PB70286EN 51

7. MAINTENANCE While the VelaShape II system should not be serviced by anyone other than an authorized Syneron-Candela agent or technician, the system requires regular preventive maintenance and cleaning to ensure optimal system performance. This chapter describes the routine maintenance procedures that users may perform:

• Cleaning the VelaShape II system

• Cleaning the VelaShape II applicators

• Cleaning the air grids

• Replacing the applicators' replaceable covers and filters when required

Warning

The symbol located near the power cable's connection port indicates: WARNING! DISCONNECT POWER SUPPLY CABLE BEFORE MAINTENANCE OR SERVICE PROCEDURES TO AVOID ELECTRIC SHOCK. For continued protection against fire, replace the fuse only with one of the same type and rating.

Cleaning the Console Clean the system at least once a week. Turn the system off and wipe all surfaces with a soft, damp, non-abrasive cloth.

Warning Be careful not to spill any liquids on the system.

Cleaning and Maintaining the Vsmooth Applicator Caring for the Vsmooth applicator involves the following maintenance procedures before and after each treatment:

• Removing, cleaning and replacing the replaceable cover

• Cleaning the interior of the applicator

• Replacing the applicator's filters

Maintenance

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Caution While gently cleaning the interior of the applicator, avoid moisture and dirt from getting into the applicator’s filters.

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


• Rollers appear damaged, discolored or their movement is impaired.

• Roller axis appears to wear out (color turns from silver to copper).

Proceed as follows: 1. Turn the system off and disconnect the replaceable applicator cover by

pressing the two spring-loaded buttons and pull the cover straight off the applicator body, as shown in Figure 23.

Figure 23: Removing the Vsmooth Replaceable Cover

Note The image in the figure is for illustration purposes only.

2. If it becomes necessary to clean the applicator cover during treatment:

• While the system is on, clean the rollers of the Vsmooth applicator while pressing the trigger, with all modes at level 0, while rolling over a mild disinfectant-dampened tissue (that does not contain alcohol).

Press Buttons toRelease Cover


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• Turn the system off and remove the cover. Use hot tap water (no more than 122°F/50°C). The cover should be flushed and washed thoroughly in hot water and mild disinfectant soap or detergent that do not contain alcohol, until all residual VelaSpray Ease is removed. Wipe and dry the cover with a soft cloth. Reconnect the cover only when completely dry.

3. Clean the Vsmooth applicator's interior components at the end of every day as follows (see Figure 24):

• Replace the two filters according to the schedule printed on the cover's box, or when the communication terminal displays a 03 - Replace Filters message (see Figure 25). Never use a pair of filters for more than 10 accumulative hours.

• Clean the RF contacts and ID contacts with a soft cloth.

• Gently clean the IR lamp aperture using a gentle optical lens cleaning solution, such as Fisherbrand® Optical Lens Cleaner or equivalent; be careful not to scratch it.

• Gently dry the IR lamp aperture with lint-free lens cleaning tissue.

• Reconnect the clean and dry applicator's cover.

Figure 24: Vsmooth Applicator's Internal Components

Caution Verify that the vacuum sensor's inlet does not become clogged during cleaning. Avoid inserting spray residue into the inlet.

Maintenance

PB70286EN 54

Replacing the Vsmooth Applicator's Filters

Refer to Figure 25:

1. Use the supplied filter extractor to pull the two filters out of the body of the applicator, as shown in view A. Discard the used filters.

2. Unpack a pair of new filters and firmly insert them into the filter chambers, as shown in view B.

Figure 25: Replacing the Vsmooth Applicator's Filters

Caution Make sure that the interior of the applicator is completely dry before inserting the filters.

Cleaning and Maintaining the Vcontour Applicator Cleaning/Replacing the Applicator Cover

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

• The IR & RF columns of LEDs blink continuously (inadequate coupling) and the communication terminal displays a 01 - Improve Contact message.

• Electrodes appear damaged.

• The cover's shape appears distorted.

BA


PB70286EN 55

Proceed as follows:

1. Remove the applicator cover by pulling it off. Discard the used cover and filter assembly.

2. If it becomes necessary to clean the applicator cover during treatment, use hot tap water (no more than 122°F/50°C). The cover should be flushed and washed thoroughly in hot water and mild disinfectant soap or detergent that do not contain alcohol, until all residual VelaSpray Ease is removed. Wipe and dry the cover with a soft cloth. Reconnect the cover only when completely dry.

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

• Refer to Figure 26: clean the RF applicator contacts (A), the ID microchip contact points (B) and the vacuum inlet (C) with a clean, soft cloth.

• Gently clean the IR lamp's aperture (D) using a gentle optical lens cleaning solution, such as Fisherbrand® Optical Lens Cleaner or equivalent; be careful not to scratch it.

Figure 26: Vcontour Applicator's Internal Components

Caution Make sure that the interior of the applicator is completely dry before connecting a new replaceable cover.

C

B

B

A A

D

Maintenance

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Cleaning the Vcontour Applicator's Filter

Remove the filter from the cover if it becomes necessary to clean, or when the communication terminal displays a 03 - Replace Filters message.

1. Use the supplied filter extractor to pull the filter out of the cover, as shown in Figure 27.

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

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

Figure 27: Replacing the Small Applicator's Filter

Note The image in the figure is for illustration purposes only.


PB70286EN 57

Cleaning the Air Grids Clean the system's two air grids (see Figure 28) at least once every three months as follows:

1. Turn the system off.

2. Remove the grids and brush the outside surfaces of the air grid with soft brush.

3. Be careful not to damage the air grid surface.

Figure 28: Air Filter and Grids

Maintenance

PB70286EN 58

Cleaning the System Air Filter While the system air filter should be cleaned at least once a week, the filter cup needs to be checked daily and cleaned according to the amount of dust and debris that accumulates.

To clean the system air filter (see Figure 29):

1. Turn the system off.

2. Open the filter door by lifting up the lock.

3. Release Screw # 1 on the bottom of the filter cup to open the cup and wipe off the dust and debris.

4. Release Screw # 2 to remove the filter, and wash it with water and soap.

5. When the filter is completely dry, fit it back into place, or put a new filter and secure the filter cup using the screws.

6. The same filter may be re-used after washing, and should be discarded when it can no longer be completely cleaned.

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

Figure 29: Cleaning the Air Filter

Filter

Screw # 2

Filter Cup

Screw # 1


PB70286EN 59

Upgrading the System Software Syneron-Candela periodically releases new software upgrade versions for the VelaShape II system. When such a version is released, it will be sent to the system's registered owner in the form of a software plug. When received, follow these simple steps to update the system's software package (refer to Figure 30):

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

2. Remove the old software plug by loosening the two plug screws and pulling the plug out of its port. You may use a flat screwdriver if necessary.

3. Unpack and install the new software plug; tighten the plug's screws finger-tight – do not use the screwdriver.

4. Plug in the power cable and turn the system on; the system will initialize and install the new software in a completely automatic manner – no action is required of you.

5. The automatic software installation will take approximately 2 minutes, during which the LED lights on the applicators will be flashing in different patterns. Do not disturb the system while this is happening.

6. When the software installation is complete, the system will perform a self-test of three vacuum pulses and the LED lights will stabilize. The system is now ready to resume normal operation.

Figure 30: Replacing the Software Plug

User SW Plug

Plug Screws

Troubleshooting

PB70286EN 60

8. TROUBLESHOOTING GUIDE The VelaShape II system is equipped with a self-testing software routine that continuously monitors system operation. If a system error is detected, the modules are disabled until the problem is solved. The following troubleshooting guides do not attempt to list all possible system failures. Any error not listed should be referred to your Syneron-Candela representative. Table 4 offers a list of possible system errors that will be displayed on the communication terminal's display and operator panels of the applicators, and how to correct them. If the corrective actions listed in the table do not solve the problem, contact your Syneron-Candela representative. Table 5 offers several fault situations that may occur with no operator panel indication or terminal display, and their appropriate corrective actions. If these do not resolve the problem, contact your Syneron-Candela representative. Most times a system error can be cleared by restarting the VelaShape II system. Always try this remedy before contacting your Syneron-Candela representative.

Table 4: System Errors Displayed by Terminal Messages and Operator Panel Indicators

Message Symptom Corrective Action

01 - Improve Contact The applicator's operator panel IR & RF bars blink while the trigger is pressed [except the 0 (zero) row].

The coupling of the applicator to the patient's skin is inadequate. Ensure adequate contact.

02 - Insert Filters Vacuum indicator LEDs are cyclically descending from 3 to 1 – indicating no filters (Vsmooth applicator only).

The system is indicating that you are trying to operate without filter(s) in the applicator. Insert new filter(s) as needed.

03 - Replace Filters Vacuum indicator LEDs are cyclically ascending from 1 to 3 – indicating clogged filters.

The system is sensing that the filters being used are clogged. Clean or replace the filters.

04 - Reconnect Cover

The applicator's cover is not in complete contact with the body of the applicator. Remove the cover and reconnect it securely.

05 - Replace Cover

• The number of allowed operating hours for the disposable cover has expired, replace the cover with a new one.

• Normally the cover should be replaced with a new one according to the schedule printed on the cover's storage box label.

User Manual Troubleshooting

PB70286EN 61

Table 4: System Errors Displayed by Terminal Messages and Operator Panel Indicators (con't)

Message Symptom Corrective Action

06 - Select Mode

Trigger pressed and no IR/RF/Vacuum levels are selected (all at level zero). Select appropriate levels and proceed with treatment.

100 - RF Failure The operator panel's RF bar is blinking while the trigger is not being pressed (after self-test).

Restart the system. If it initializes properly, proceed with normal operation. If the error persists, contact your Syneron-Candela representative.

101 - No Vacuum Sensor in LA/SA

After start-up, all 0 (zero) row LEDs are blinking.

102 - Bad System Type

103 - Applicator Type Not Supported

Trigger will not operate system or LEDs are not responding to user selection.

104 - Vsmooth or Vcontour Initialization Fault

Operator panel LEDs do not form "V" pattern on start-up.

Table 5: Fault Situations with No Indicators or Error Messages

Symptom Corrective Action

No vacuum suction

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 properly installed).

3. Check the applicator connection to the Dual-Connector.

4. Verify that the cover is correctly attached to the applicator. 5. Replace applicator filters or cover.

No IR output 1. Turn the system off. 2. Call your Syneron-Candela representative for further

instructions.

Electrodes are not rotating (Vsmooth applicator).

1. Turn the system off. 2. Check that the applicator chamber is clean and that nothing

is obstructing the electrodes. 3. Connect a new applicator cover.

Applicator ceases to function and the system emits four consecutive "beeps".

Restart the system. If it initializes properly, proceed with normal operation. If the problem persists, contact your Syneron-Candela representative.

Electromagnetic Regulation

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9. SYSTEM SPECIFICATIONS Parameters

RF Power • Up to 60 Watts (Vsmooth applicator)

• Up to 23 Watts (Vcontour applicator)

IR Electrical Power Up to 35 Watts (Vsmooth and Vcontour applicators)

Light Spectrum 700 – 2000 nm

Vacuum Pulsed

Treatment Area Footprints

Vsmooth Applicator 40 mm x 40 mm

Vcontour Applicator 30 mm x 30 mm

Electrical Requirements (Factory-Configured per Customer Order) • 100 VAC; 6A; 50-60 Hz; single phase

• 110-127 VAC; 5.2A; 50-60 Hz, single phase

• 220-240 VAC; 3.1A; 50-60 Hz; single phase

Environmental Requirements Treatment Room

• Operating temperature: 15° – 30°C [59° – 86°F]

• Relative Humidity: Up to 80%

• Atmospheric Pressure: 70 – 106 kPa

Transportation and Storage

• Operating temperature: 00° – 55°C [50° – 131°F]

• Relative Humidity: 10 to 80%

• Atmospheric Pressure: 70 – 106 kPa

User Manual Specifications

PB70286EN 63

Degree of Protection Against Ingress of Water

• IPX0 – Ordinary Equipment

Dimensions • VelaShape II system [W x D x H]: 36 x 55 x 80 cm / 14.2 x 21.6 x 31.5"

• Applicator umbilical harness: 2.8 m / 9.2 feet

Weight • VelaShape II system: 27 kg. / 59.5 lbs.

• Applicators: Less than 2.0 kg. / 4.4 lbs.


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10. ELECTROMAGNETIC REGULATION Electromagnetic Emissions

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

Emissions Test Compliance CISPR 11: RF Emissions Group 2

The VelaShape II system must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

Emissions Test Compliance CISPR 11: RF Emissions Class A

IEC 61000-3-2: Harmonic Emissions N/A

IEC 61000-3-3: Voltage fluctuations/flicker emissions N/A The VelaShape II system is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning statement is heeded:

Warning

This device is intended for use by health care professionals only. This device may cause interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigating measures, such as re-orienting or relocating the device or shielding the location.

User Manual Electromagnetic Regulation

PB70286EN 65

Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance

IEC 61000-4-2: Electrostatic Discharge (ESD) ± 6 kV contact ± 8 kV air

±2, 4, 6 kV Contact ±2, 4, 8 kV Air

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

± 2 kV for power supply lines ±2 kV

± 1 kV for input/output lines N/A

IEC 61000-4-5: Surge ± 1 kV differential Mode 1.0 DM

± 2 kV common mode 2.0 CM

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

3 A/m 3 A/m

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

<5 % UT (>95 % dip in UT) for 0.5 cycle

<5 % UT (>95 % dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles






• Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

• Mains power quality should be that of a typical commercial or hospital environment.

• If the VelaShape II system is required to operate during power interruptions, the system should be powered from an uninterruptible power supply.

• Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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


PB70286EN 66

Electromagnetic Immunity (continued)

Immunity Test IEC 60601 Test Level Compliance Guidelines

61000-4-3: Radiated RF

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

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). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of equipment marked with this symbol:

61000-4-6: Conducted RF

3 VRMS 150 kHz to 80 MHz

3 VRMS 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the VelaShape II 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)

(1) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the VelaShape II system is used exceeds the applicable RF compliance level above, the VelaShape II system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the VelaShape II system. (2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

User Manual Electromagnetic Regulation

PB70286EN 67

Note

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

• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Recommended Separation Distances The following are the recommended separation distances between portable and mobile RF communications equipment and the VelaShape II system.

The VelaShape II system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The owner of the system and/or the user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VelaShape II system as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed below, the recommended separation distance (d) in meters (M) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter's manufacturer.

Rated Maximum Output Power of Transmitter (W)

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)

800 MHz to 2.5 GHz d = 2.33 SQRT(P)

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

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

User Manual · 2020. 6. 5. · Syneron Medical (HK) Ltd. ... Wanchai, Hong Kong Tel: +852.2543.4326...

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Transcript of User Manual · 2020. 6. 5. · Syneron Medical (HK) Ltd. ... Wanchai, Hong Kong Tel: +852.2543.4326...