Manual Utilizare Engleza

User Manual

DC53112, Revision A 2

DC20298 3

Copyright © 2007 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: DC20298 Revision Release Date: May 2007

• 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 sale by or on the order of a physician, or properly licensed practitioner. Syneron makes no representations regarding federal, state, or local laws or regulations that might apply to the use and operation of this device.

Contact information for equipment manufacturer and technical services:

• Syneron, Inc. 111 Granton Drive, Unit 110 Richmond Hill, Ontario L4B 1L5 Canada Tel: + 1.905.886.9235 Fax: + 1.905.886.7046

• Syneron GmbH (authorized representative in the European Union) 7 Ludwig Ganghofer Str. D-82031 Grünwald Germany Tel: + 49.89.642.4810 Fax: + 49.89.642.48170

• Syneron Medical Ltd. (Manufacturer) P.O. Box 550 Yokneam Illit Industrial Park Israel 20692 Tel: + 972.4.909.6200 Fax: + 972.4.909.6202

• Website: www.syneron.com

• E-mail: [email protected]

P

M

http://www.syneron.com/

mailto:[email protected]

Table of Contents

DC20298 4

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

Conventions Used in this Manual ............................................................................................... 1-1 Explanation of the Symbols Used in the System........................................................................ 1-2

2. Introduction...................................................................................................................................... 2-1 System Overview........................................................................................................................ 2-1

Platform .................................................................................................................................. 2-1 Applicators.............................................................................................................................. 2-1

Anatomy of Cellulite.................................................................................................................... 2-4 The VelaSmooth Procedure ....................................................................................................... 2-5 Heating of Dermis and Hypodermis with elōs............................................................................. 2-6 Mechanical Effects the Skin........................................................................................................ 2-7

3. Safety .............................................................................................................................................. 3-1 Introduction ................................................................................................................................. 3-1 System Safety Features ............................................................................................................. 3-2 Patient and Personnel Safety ..................................................................................................... 3-2 Installing the System................................................................................................................... 3-2 Operating the System................................................................................................................. 3-3 Infrared Energy Safety Issues .................................................................................................... 3-3 Radio-Frequency Energy Safety Issues ..................................................................................... 3-3 Mechanical Rollers Safety Issues............................................................................................... 3-4 Maintaining the System .............................................................................................................. 3-4 Fire Hazards ............................................................................................................................... 3-4 System Classifications................................................................................................................ 3-4 Device Labels ............................................................................................................................. 3-5

4. System Installation .......................................................................................................................... 4-1 Installation Process..................................................................................................................... 4-1 Moving the System within the Facility......................................................................................... 4-4 Moving the System to another Facility........................................................................................ 4-4 Equipment List ............................................................................................................................ 4-4 Electrical Requirements.............................................................................................................. 4-5 Environmental Requirements ..................................................................................................... 4-5

5. Operating Instructions ..................................................................................................................... 5-1 Activating the System ................................................................................................................. 5-1 Defining the Treatment Mode ..................................................................................................... 5-1 Controlling the Treatment Level ................................................................................................. 5-3 Initiating Treatment ..................................................................................................................... 5-3

6. Clinical Guide: Cellulite Treatment.................................................................................................. 6-1 Realistic Expectations................................................................................................................. 6-1 Indications................................................................................................................................... 6-1 Contraindications ........................................................................................................................ 6-1 Possible Side Effects .................................................................................................................. 6-2 Pre-Treatment Preparation ......................................................................................................... 6-3 Selecting the Appropriate Treatment Type................................................................................. 6-3 Treatment Procedure.................................................................................................................. 6-4

VelaSmooth User Manual Table of Contents

DC20298 5

Illustrations of Recommended Treatment Motions......................................................................6-7 Treating the Front Thighs in the Supine Position....................................................................6-7 Treating the Abdomen in the Supine Position ........................................................................6-9 Treating the Calves, Back Thighs, and buttocks in the Prone Position ................................6-11 Treating the Back in the Prone Position................................................................................6-13

Treatment Protocols ..................................................................................................................6-15 Body Applicator .....................................................................................................................6-15 Contour Applicator ................................................................................................................6-15

Treatment Parameters...............................................................................................................6-15 Post-Treatment Care .................................................................................................................6-16 Treatment Conclusion ...............................................................................................................6-17

7. Maintenance.....................................................................................................................................7-1 Cleaning the Platform..................................................................................................................7-1 Cleaning the Applicators..............................................................................................................7-2 Cleaning the Air Grids .................................................................................................................7-4 Cleaning the Air Filter ..................................................................................................................7-5

8. Troubleshooting ...............................................................................................................................8-1 9. System Specifications ......................................................................................................................9-1

Parameters ..................................................................................................................................9-1 Treatment Area Footprints...........................................................................................................9-1 Electrical Requirements (Factory-Configured per Customer Order) ...........................................9-1 Environmental Requirements ......................................................................................................9-1 Dimensions..................................................................................................................................9-1 Weight..........................................................................................................................................9-1

LIST OF FIGURES

Figure 2-1: VelaSmooth System ...............................................................................................................2-3 Figure 2-2: Body Applicator [Left: Operator Panel / Right: Applicator Elements] .....................................2-3 Figure 2-3: Contour Applicator [Left: Operator Panel / Right: Applicator Elements] ................................2-4 Figure 2-4: Anatomy of Cellulite................................................................................................................2-4 Figure 2-5: elōs Heating and Mechanical Manipulation Action.................................................................2-5 Figure 2-6: Heating from IR and RF Energies ..........................................................................................2-6 Figure 2-7: Scheme of Rollers and Suction Direction of Impact ...............................................................2-7 Figure 3-1: Labels Affixed to the System and Applicators ........................................................................3-5 Figure 3-2: System Label Locations .........................................................................................................3-6 Figure 4-1: Umbilical Support Mast...........................................................................................................4-1 Figure 4-2: Inserting the Umbilical Support Mast......................................................................................4-2 Figure 4-3: Contour Applicator Cradle ......................................................................................................4-2 Figure 4-4: Connecting the Applicator ......................................................................................................4-3 Figure 4-5: Line Voltage Label Location ...................................................................................................4-5 Figure 5-1: Operator Panels......................................................................................................................5-2 Figure 6-1: Recommended Treatment Motions ........................................................................................6-5

Table of Contents

DC20298 6

Figure 6-2: Treatment Areas of the Front Thigh........................................................................................6-7 Figure 6-3: Front Thighs Treatment Step 1...............................................................................................6-8 Figure 6-4: Front Thighs Treatment Step 2...............................................................................................6-8 Figure 6-5: Front Thighs Treatment Step 3...............................................................................................6-8 Figure 6-6: Front Thighs Treatment Step 4...............................................................................................6-9 Figure 6-7: Abdomen Treatment Step 1....................................................................................................6-9 Figure 6-8: Abdomen Treatment Step 2....................................................................................................6-9 Figure 6-9: Abdomen Treatment Step 3..................................................................................................6-10 Figure 6-10: Abdomen Treatment Step 4................................................................................................6-10 Figure 6-11: Abdomen Treatment Step 5................................................................................................6-10 Figure 6-12: Abdomen Treatment Step 6................................................................................................6-11 Figure 6-13: Calves, Back Thighs, and Buttocks Treatment Step 1 .......................................................6-11 Figure 6-14: Calves, Back Thighs, and Buttocks Treatment Step 2 .......................................................6-11 Figure 6-15: Calves, Back Thighs, and Buttocks Treatment Step 3 .......................................................6-12 Figure 6-16: Calves, Back Thighs, and Buttocks Treatment Step 4 .......................................................6-12 Figure 6-17: Calves, Back Thighs, and Buttocks Treatment Step 5 .......................................................6-12 Figure 6-18: Calves, Back Thighs, and Buttocks Treatment Step 6 .......................................................6-13 Figure 6-19: Back Treatment Step 1 .......................................................................................................6-13 Figure 6-20: Back Treatment Step 2 .......................................................................................................6-13 Figure 6-21: Back Treatment Step 3 .......................................................................................................6-14 Figure 6-22: Back Treatment Step 4 .......................................................................................................6-14 Figure 6-23: Back Treatment Step 5 .......................................................................................................6-14 Figure 7-1: Body Applicator RF Contacts & Vacuum Inlet ........................................................................7-2 Figure 7-2: Contour Applicator Cover Remover........................................................................................7-3 Figure 7-3: Contour Applicator RF Contacts & Vacuum Inlet ...................................................................7-3 Figure 7-4: Air Filter and Grids..................................................................................................................7-4 Figure 7-5: Cleaning the Air Filter .............................................................................................................7-5

LIST OF TABLES

Table 5-1: Operator Panel Buttons ...........................................................................................................5-2 Table 5-2: Treatment Level Intensities......................................................................................................5-3 Table 6-1: Treatment Parameters Using the Body Applicator ................................................................6-16 Table 6-2: Treatment Parameters Using the Contour Applicator............................................................6-16 Table 8-1: System Errors Troubleshooting Guide.....................................................................................8-1

VelaSmooth User Manual Before You Start

DC20298 1-1

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 VelaSmooth system must be serviced only by Syneron Medical Ltd. qualified personnel.

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

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

Caution A Caution alerts the user to the possibility of a problem with the device associated with its use or misuse. Such problems include system malfunction, failure, and damage to the system or other property. The caution statement includes a precautionary action that should be taken to avoid the hazard.

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

Before You Start

DC20298 1-2

Explanation of the Symbols Used in the System

Symbol Description

Attention: Consult Accompanying Document

0344 CE Compliance Symbol

212603

CSA Compliance Symbol (212603 CSA master contract number)

Waste of Electrical and Electronic Equipment (WEEE) compliance symbol

Fuse

Type BF Equipment

M Manufacturer

P Authorized Representative in the European Union

VelaSmooth User Manual Introduction

DC20298 2-1

2. INTRODUCTION The VelaSmooth is a device that combines elōs technology (electro optical synergy) with mechanical manipulation of the skin using gentle vacuum suction with (Body Applicator), or without (Contour Applicator) massage rollers. It is designed for use in medical and aesthetic practices and indicated for a temporary reduction in the appearance of cellulite. It is also indicated for the relief of minor aches and muscle spasms, as well as for the improvement of local blood circulation. In addition, body contouring, skin texture benefit and reduction in circumferential measurement may also be achieved in most patients.

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 manipulations (vacuum with or without massage rollers)

These three technologies work together to provide dermal and sub-dermal heating, mechanical modifications and improved blood circulation, 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 Overview The system includes two core modules: the Platform and the Applicators (see Figure 2-1).

Platform

The VelaSmooth platform houses the power components:

• Power supply • IR lamp power supply

• Vacuum pump • Other power components

• RF generator

Applicators

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

Introduction

DC20298 2-2

The large Body Applicator (see Figure 2-2) utilizes IR, RF and mechanical manipulation by vacuum and massage rollers. It is designed for the treatment of large body areas such as thighs, buttocks, and abdomen. Calves and arms that are large enough may be also treated by the Body Applicator.

The small Contour Applicator (see Figure 2-3) utilizes IR, RF, and mechanical manipulation by vacuum only. It is designed for the treatment of small body areas such as calves, arms, bra-line, under-chin, and face, as well as for reinforcement of results achieved by the Body Applicator.

The VelaSmooth applicators are composed of a permanent handpiece and a replaceable cover. The replaceable covers of the VelaSmooth applicators are reusable for limited periods of time.

• The replaceable cover of the Body Applicator is designed for use of up to 30 working hours.

• The replaceable cover of the Contour Applicator is designed for use of up to 60 working hours.

Note Do not use replaceable covers for more than the recommended durations.


DC20298 2-3

UmbilicalHarness

ReplaceableCover

Contour (small)Applicator

Contour ApplicatorCradle

Body (large)Applicator

ReplaceableCover

Body ApplicatorCradle

Keyswitch

Figure 2-1: VelaSmooth System

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 LED's which correspond to no energy, low, medium and high levels, respectively (see Figure 2-2 and Figure 2-3).

IR VacuumRF

Trigger

IR ApertureRF Electrode Rollers

Applicator Chamber

Level 1 - Low Level 3 - High

Level 2 - Medium

Figure 2-2: Body Applicator [Left: Operator Panel / Right: Applicator Elements]

Introduction

DC20298 2-4

IR Aperture Applicator Chamber

RF Electrodes

VacuumRF

Trigger

Level 1 - Low

Level 3 - HighLevel 2 - Medium

IR

Figure 2-3: Contour Applicator [Left: Operator Panel / Right: Applicator Elements]

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 the RF electrodes contact with the skin will result in disabled IR and RF energies, indicated by blinking of the LED's on the applicators' operator panels.

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

Fat Cells Dimpled Skin Surface

Connective Tissue or Septa Figure 2-4: Anatomy of Cellulite


DC20298 2-5

The VelaSmooth Procedure The application of elōs (IR and RF energies) to the dermis/hypodermis is intended to deploy heat to these tissues that contribute to cellulite. The vacuum contributes to the increased blood circulation (see Figure 2-5). The blood, which is one of the targets of the hyperthermic effect of the IR and RF, responds in a higher diffusivity of oxygen. This in turn increases the metabolic breakdown of stored fat by the fat cells (lipolysis), thereby reducing the size of the fat cells. Consequently, the bumpiness of the skin, which is largely caused by distended fat cells protruding up from the anchored connective tissue septae, is reduced.

The mechanical action of the vacuum and rollers gently kneads the skin and facilitates deeper penetration of heat, producing energies to the dermis and hypodermis. The 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 fat cells size and draining excess fluids to the lymphatic system, are accompanied by shrinkage of the connective tissue septae and facilitate the overall shrinkage of the fat chambers size.

Figure 2-5: elōs Heating and Mechanical Manipulation Action

Introduction

DC20298 2-6

Heating of Dermis and Hypodermis with elōs Light Energy (see Figure 2-6):

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

• Maximum electrical power of the IR light is 20 Watts (20 J/sec) for the Contour Applicator; and 50 Watts (50 J/sec) for the Body Applicator.

• Depth of heating from light reaches the deep dermis.

RF Energy (see Figure 2-6):

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

• Maximum electrical power of the RF energy is 20 Watts or 20 J/sec.

• Depth of heating from RF energy reaches the hypodermis.

Lamp

RF Electrode RF Electrode

InfraredFilter

Figure 2-6: Heating from IR and RF Energies


DC20298 2-7

Mechanical Effects the Skin Mechanical Rollers (see Figure 2-7):

• 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.

Vacuum/Negative Pressure (see Figure 2-7):

• 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 circulation in the local area.

• Vacuum levels are 200 (Level 1), 250 (Level 2), and 300 (Level 3) mbar of negative pressure.

Figure 2-7: Scheme of Rollers and Suction Direction of Impact

VelaSmooth User Manual Safety

DC20298 3-1

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

Note Protect the VelaSmooth 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 Medical Ltd. assumes no liability whatsoever for any damage or injury as a result of an application of a product which is not in strict accordance with the instructions provided with the product. The primary consideration should be to maximize safety for both treating attendant and the patient.

Warning

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

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

• High voltage is present inside the system.

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

• In the event of a death or serious injury/illness, immediately contact: - In North America: Syneron, Inc. - In Europe: Syneron GmbH. - Outside North America and Europe: Syneron Medical Ltd.

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

Safety

DC20298 3-2

System Safety Features The VelaSmooth 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 panel.

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

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

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

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

• Ascertain that all jewelry is removed.

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

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

Warning

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

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.


DC20298 3-3

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

any of the system's inner components.

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

• Always turn the system off before changing the applicator.

• Keep the applicator dry and clean.

• Do not allow the replaceable applicator cap to come in contact with hard materials that could 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 VelaSmooth emits gentle heating infrared light between 700-2000 nm in a continuous wave mode. Light emission occurs only when the operator presses the trigger button on the applicator, and only when the RF electrodes are in contact with the skin. The light is contained within the applicator chamber, which is sealed completely to the skin before the trigger is pressed. Specific filtered eyewear is not necessary as there is no directional scattering of light, posing any ocular hazard to the operator or the patient.

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 form on the skin from the IR effect.

Radio-Frequency Energy Safety Issues The RF energy provides gentle heating that is distributed deep into the skin via bi-polar electrode rollers. Full coupling of both electrodes (spiral shaped rollers) to the skin, after applying VelaSpray Ease or other recommended product, is necessary before pressing the trigger button, so that the RF energy is safely conducted to penetrate the skin. If coupling is broken with the skin by applying or removing the applicator from the treatment site while the trigger is pressed, IR and RF 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 form on the skin from the RF effect.

Safety

DC20298 3-4

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.

Maintaining the System • Only authorized Syneron technicians are qualified to service the system.

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

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

of 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 • Medical device Class: IIa

• Electric shock protection: Class I, Type BF

• Protection against ingress of liquids: Ordinary equipment

• Not suitable for use in presence of flammable substance

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


DC20298 3-5

• The system is classified as an IIa device, in accordance with the standards set by the European Medical Device Directive (93/42/EEC) for CE marking.

Device Labels The following labels (see Figure 3-1) are affixed to the system's rear panel and to the applicators. The system label numbers refer to their locations in the diagram presented in Figure 3-2.

7. Attention: Consult Accompanying Document

C US212603

8. CSA Compliance 9. WEEE Compliance

4. Fuse Label - 100 Volts 5. Fuse Label - 115 Volts 6. Fuse Label - 230 Volts

2. Identification Label -115 Volts System



Medical Ltd.

Industrial ZoneYokneam Illit20692, Israel

: 230V~; 3.5A 50-60 Hz

: Vela: AS2033(X)

Smooth

MADE IN ISRAEL

POWER

MODELPART No.

MANUFACTUREDSERIAL No.

: Nov 2006: L00123456

0344

Medical Ltd.


: 115V~; 6.5A 50-60 Hz

: Vela: AS2034(X)

Smooth

MADE IN ISRAEL

POWER

MODELPART No.


: Nov 2006: L00123456

0344

Medical Ltd.


: 100V~; 7A 50-60 Hz

: Vela: AS2402(X)

Smooth

MADE IN ISRAEL

POWER

MODELPART No.


: Nov 2006: L00123456

0344

10. Applicator Label - Body 11. Applicator Label - Contour

Medical Ltd.


:Vela Applicator:AS2035(X)

MADE IN ISRAEL

ModelPART No.


:Nov 2006:L00123456

Medical Ltd.


:Vela SA Applicator:AS3887(X)

MADE IN ISRAEL

ModelPART No.


:Nov 2006:L00123456

Figure 3-1: Labels Affixed to the System and Applicators

Safety

DC20298 3-6

Labels # 1,2,3

Label # 8Label # 7

Label # 9

Labels # 4,5,6

C US212603

Medical Ltd.


: 100V~; 7A 50-60 Hz

: Vela: AS2402(X)

Smooth

MADE IN ISRAEL

POWER

MODELPART No.


: Nov 2006: L00123456

0344

Figure 3-2: System Label Locations

VelaSmooth User Manual System Installation

DC20298 4-1

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

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

1. Unpack the umbilical support mast with the four installed harness loops (see Figure 4-1). Ensure that the harness loop Allen screws are properly seated in their dimples in the mast.

UmbilicalSupport Mast

Pin

Harness Loops

Dimple

Figure 4-1: Umbilical Support Mast

System Installation

DC20298 4-2

2. Insert the mast as shown in Figure 4-2, until it is stopped by the pin.

Support Mast

Connection Port Electronic Socket

Pin

Vacuum Socket

Figure 4-2: Inserting the Umbilical Support Mast

3. Attach the Contour Applicator cradle to the mast as shown in Figure 4-3. Fasten the knob securely.

Figure 4-3: Contour Applicator Cradle


DC20298 4-3

4. Unpack the applicators; and connect one of them to the connection port (shown in Figure 4-2), making sure that the electronic & vacuum sockets are aligned (see Figure 4-4).

Figure 4-4: Connecting the Applicator

5. Hook the applicators' umbilical harnesses into both sides of the harness loops on the umbilical support mast (see Figure 4-1). The connector of the applicator which is not in use will hang loose and be ready to be connected to the port when required.

6. Place the Body Applicator in its cradle (see Figure 2-1).

7. Place the Contour Applicator in its cradle (see Figure 2-1).

Finish the installation:

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

9. Insert the key into the keyswitch, turn the key to start the system and wait for the lights on the operator panels of the applicators to appear and stabilize, indicating that the system is ready for use.

System Installation

DC20298 4-4

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 large 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. Remove the umbilical support mast.

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

5. Slowly push or pull the system using the handle at the back of the system, lift it up onto the vehicle and lay it carefully on its rear panel. Spread padding on the bed of the transport vehicle to avoid scratching the system's covers.

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

7. Reinstall the umbilical support mast.

8. Reconnect and reinstall the applicators, and the power cable.

Equipment List The VelaSmooth system includes the following:

• System platform

• Software module

• Body Applicator (large), and three additional replaceable applicator covers

• Contour Applicator (small), and two additional replaceable applicator covers

• Contour Applicator cover remover

• Umbilical support mast (includes harness loops)

• Contour Applicator cradle

• Cleaning brushes kit

• Air filter box (10 pieces)

• Set of two keys

• VelaSpray Ease (four bottles)

• User manual


DC20298 4-5

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; 7A; 50-60Hz; single phase

• 115 VAC; 6.5A; 50-60Hz, single phase

• 230 VAC; 3.5A; 50-60Hz; 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.

C US212603

Figure 4-5: Line Voltage Label Location

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 optical light 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 then 80%.

VelaSmooth User Manual Operating Instructions

DC20298 5-1

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

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

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

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 changing an applicator.

2. To activate the system on, turn the key clockwise; the system initiates a self-

test of controller memory. During this test, the lights on the applicators' operator panels blink, and when the first row of lights (Level 0) is on, the system is ready for operation.

Defining the Treatment Mode The VelaSmooth 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.

Operating Instructions

DC20298 5-2

The operator panel is located on the top of both Applicators (see Figure 5-1). The operator panel consists of three treatment mode buttons and an information screen.

Body Applicator Contour Applicator

Figure 5-1: Operator Panels

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

Table 5-1: Operator Panel Buttons

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

VelaSmooth User Manual Operating Instructions

DC20298 5-3

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. I.e., 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 5-2: Treatment Level Intensities

Level Intensity Notes

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

1 Low

2 Medium

3 High

Initiating Treatment Now that you have defined your treatment settings, you are ready to begin treatment. Place the applicator lightly on 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.

VelaSmooth User Manual Cellulite Treatment

DC20298 6-1

6. CLINICAL GUIDE: CELLULITE TREATMENT This chapter provides you with the information required to treat cellulite with the VelaSmooth system.

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

elimination. However, the response is individual.

• The degree of response to the VelaSmooth 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 more than others.

• The treatment results are temporary and one maintenance treatment session every 1-3 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 VelaSmooth system is indicated for temporary reduction in the appearance of cellulite, for temporary improvement in the local blood circulation and for the relief of minor muscle spasms, aches and pain.

Contraindications • Pacemaker or internal defibrillator.

• Superficial metal or other implants in the treatment area.

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

• Severe concurrent conditions, such as cardiac disorders. Avoid treating the thyroid area in case of any thyroid pathology.

• Pregnancy and nursing as well 3-6 months post-childbirth or the normal hormonal balance 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.

Cellulite Treatment

DC20298 6-2

• 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 medication and herbs 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.

• Facial laser resurfacing and deep chemical peeling within the last 3 months, if face is treated.

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

• Excessively tanned skin from sun, tanning-beds or tanning creams within the last 2 weeks.

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

Note • In case of uncertainty regarding potential side effects, have the

patient consult his/her physician and bring a written consent for treatment.

• Additionally, 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.

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)


DC20298 6-3

• Hair tweezing

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

• Bruising

Pre-Treatment Preparation • Advise the patient to exfoliate the skin with appropriate creams before

treatment. The patient should come to the treatment with clean, dry skin (no perfume, no lotion).

• Hair may hinder smooth movement of the applicator and overheat the treatment area. Shaving (not waxing) 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.

• Schedule treatment durations of 45-60 minutes, depending on the area of treatment.

• It is suggested to take a photo, weigh the patient and measure the circumference of the treated area before the first session, at every fourth session, before the last session, and at every maintenance session thereafter to assess clinical response and to ascertain that there was 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 Body Applicator, verify that the rollers function smoothly. Make sure that all the applicators’ parts are clean.

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 Body Applicator for treating cellulite in large body areas such as buttocks, abdomen and thighs.

Use the Contour Applicator for contouring and firming of small areas, such as under-chin, neck, cheeks, bra-line, and inner side of knee, calves and arms.

Cellulite Treatment

DC20298 6-4

If the calves and arms are large enough, they may be treated with the Body Applicator.

The Contour Applicator may be also applied to reinforce endpoints on small sites of large areas, following treatment with the Body Applicator, such as the naval site in the abdomen area.

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

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

• Always use the combination of all three modes (IR, RF and Vacuum) in any level, according to the patient’s skin response and comfort.

• Select the treatment parameters as suggested in the Treatment Parameters section (see page 6-15).

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

• 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 overall contact with the skin. When pressing the applicator's trigger the skin will be lifted by the suction (and rotating rollers in the Body Applicator), and drawn into the applicator chamber. If you hear air being sucked into the applicator chamber, this indicates that the applicator is not positioned properly on the skin. If a good 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 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 treated area, which will push it towards the applicator.

• Treat the desired area in one of the following manners (refer to Figure 6-1):

1. Sliding slowly in Backward & Forward Motions along or across the RF electrodes, without releasing the trigger. This is the preferred treatment


DC20298 6-5

manner for the Body Applicator. It may be practiced also with the Contour Applicator if movement with complete contact is possible.

2. Forward Motions only, releasing the trigger at the end of each pass by any of the applicators. This treatment manner takes longer to reach an endpoint and serves special purposes.

3. Circular Motions are typically used to reinforce results in the same area following the motions described above.

4. Zig-Zag Motions are typically used to reinforce results in the same area in a cross-hatched manner following motions described above.

5. Stack 2-6 pulses (~5 seconds) on the same site when movement is impaired, or when it is difficult to achieve good contact with curved areas, such as hips.

When using the Contour Applicator, stacking is the preferred treatment manner. More pulses may be applied occasionally with the Contour Applicator, especially when reinforcing endpoints on large areas previously treated with the Body Applicator, if the patient's skin response and comfort allow.

Warning Particular care should be taken when stacking over the treatment area to ensure acceptable skin response and patient’s comfort.

Forward Motions

Backward &Forward Motions Zig-Zag Motions

StacksCircular Motions

Figure 6-1: Recommended Treatment Motions

• Work upwards or sidewards, along or across the RF electrodes to achieve best contact and suction.

• Slow movement of the applicator over the skin will ensure optimal treatment of each point for about 5 seconds. Longer times may cause side effects, and shorter times may not be effective.

• Using the Body Applicator, treat one area at a time: front thigh, abdomen or back thigh alone, or together with one buttock, as well as the back while the patient is lying in a supine or prone position, respectively. Very large hips and inner thighs may be treated when the patient is lying on the side with a bent knee.

Cellulite Treatment

DC20298 6-6

• Using the Contour Applicator, treat the following areas:

1. Under-Chin & Neck: treat the submentum and neck from ear to ear, and up from the clavicle to the chin. Ask the patient to tip his/her head back over a rolled towel to stretch out the area. If "multiple chins" are present, ensure that the tip has full contact. Using your hand to manipulate the area may be necessary. Avoid bony areas and the Adam’s apple, if present. Do not treat the neck of patients with thyroid diseases.

2. Arms: treat along the triceps from axilla to elbow, while the patient is lying on their back with bent arms (see photo). Treat along the outer part of the arm when the arm is placed alongside the body or when patient is laying in a prone position with bent arms. If the arms are large enough you may use the Body Applicator.

3. Face: treat only the cheeks (soft tissue only). Avoid the cheekbones, forehead and orbital area if vacuum is used. You may treat the whole face without vacuum for textural improvement. Avoid the upper and lower eyelids!

• Perform one pass after the other with the Body or the Contour Applicator on a strip of skin that matches the applicator's width. Stop passing only when you achieve an endpoint of persistent radiant warmth, which may be accompanied by erythema and some edema. Some skin types and anatomical areas show more erythema than others, but radiant warmth is essential.

• Move to an adjacent strip of skin and treat it in the same manner. If the endpoints on the previous strip do not persist for 5-10 minutes, re-treat it.

• Retain the heat by passing over both strips in a cross-hatched manner (circles followed by zigzags) for a few minutes.

• Do the cross-hatched passes on all the previous strips, following each new strip of an area.

• For an illustrated guide to the recommended treatment maneuvers, refer to the section titled Illustrations of Recommended Treatment Motions, starting on page 6-7.

• When using the Contour Applicator, stack 2-5 pulses on each site before moving to the next site. Cover the whole area (arms, calves, etc.) repeatedly along and across to maintain the heat as described below.

• In subsequent treatment sessions it may be necessary to increase the intensity level and the number of passes to achieve the desirable skin warmth. The endpoint, and not the time or number of passes, is the indication to stop treatment.


DC20298 6-7

• Combination therapy is possible by adding Mesotherapy every second session following the VelaSmooth treatment, or according to other protocols. Post-Liposuction VelaSmooth treatment, following complete recovery (2-3 months) enhances smooth recovery.

Note

• Always maintain a seal between the applicator chamber and the skin!

• Good contact is essential for good results!

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

Warning

• Blinking of the IR and/or RF LED's on the operator panel indicates bad coupling which results in RF and IR being disabled.

• Release the trigger whenever you lift the applicator from the skin!

Illustrations of Recommended Treatment Motions The illustrations on the following pages offer examples of the recommended treatment motion maneuvers of the VelaSmooth applicators over the various parts of the body.

Treating the Front Thighs in the Supine Position

Each front thigh is divided into three longitudinal parts: external, central and inner thigh (see Figure 6-2). Treat the front thighs with the Body Applicator.

Central ThighInner Thigh

External Thigh

Figure 6-2: Treatment Areas of the Front Thigh

Cellulite Treatment

DC20298 6-8

1. Backward & forward motions along the length of the central and external thigh from knee to groin and back (see Figure 6-3). Repeat the motions until the endpoint is reached. Continue with backward & forward motions on the Inner thigh. If the skin is very loose, use low vacuum level and hold the skin to improve the applicator movement.

Figure 6-3: Front Thighs Treatment Step 1

2. Circular motions over the entire previously treated zone, emphasizing areas of higher fat accumulation or cellulite and small circular motions around the knee area for 2-3 minutes to sustain the endpoint (see Figure 6-4):


3. Zig-zag motions cross-hatched over the entire front thighs, repeating this maneuver whenever fat accumulation or cellulite is detected and make sure that the endpoint is sustained (Figure 6-5):



DC20298 6-9

4. You may complete with three forward motions in the inner thigh towards the groin area to assist the drainage of fluids to the lymph nodes (see Figure 6-6):


5. Reinforcing results, mainly on loose skin or on cellulite-rich areas, may be done by Stacking with the Contour Applicator.

Treating the Abdomen in the Supine Position

Treat the Abdomen with the Body Applicator:

1. Backward & forward motions across half the abdominal zone – one strip below and one besides the umbilical zone. After reaching endpoint, repeat this stage on the other abdominal half (see Figure 6-7):

Figure 6-7: Abdomen Treatment Step 1

2. Backward & forward motions across half of the lower ribs area. After reaching the endpoint, repeat on the other half of the ribs area. This motion may not be suitable for very thin patients (see Figure 6-8):


Cellulite Treatment

DC20298 6-10

3. Circular motions around the umbilical zone to sustain the endpoint (see Figure 6-9):


4. Backward & forward motions across the umbilical zone in a shape of sun rays to sustain the endpoint (see Figure 6-10):


5. Forward motions from the pubic area to the umbilical area, while stretching the loose skin of the pubic zone with one hand (see Figure 6-11):



DC20298 6-11

6. Moving the applicator in large circular clockwise motions on the entire abdomen may assist in activating constipated bowels.

7. Stacking in the entire umbilical zone; no more than 5 seconds in the same site. Use the Body or the Contour Applicator (see Figure 6-12):


8. Low fat areas near bones (hips or ribs), where contact with the skin is difficult may be treated with the Contour Applicator.

Treating the Calves, Back Thighs, and buttocks in the Prone Position

Treat the Calves, Back Thighs, and Buttocks with the Body Applicator. Small calves may be treated with the Contour Applicator.

1. Backward & forward motions along the calf; never touch the area behind the knee joint. Stop when reaching the endpoint (see Figure 6-13):

Figure 6-13: Calves, Back Thighs, and Buttocks Treatment Step 1

2. Circular motions along the same calf for 2-3 minutes to sustain the endpoint, particularly where there is fat accumulation or fluid retention (see Figure 6-14):


Cellulite Treatment

DC20298 6-12

3. Lengthwise backward & forward motions along the back thigh and buttocks from above the knee to the buttocks and back (see Figure 6-15). Work in 2-3 strips and move from one strip to the other after reaching the endpoint in each strip. Heating of the buttocks may be more difficult because of poor circulation.


4. Circular motions along the back thigh and buttocks with more emphasis on areas with greater fat accumulation or cellulite. Repeat for 2-3 minutes to sustain the endpoint (see Figure 6-16):


5. Zig-zag motions cross-hatched along the back thigh from above the knee to the buttocks over the entire pretreated zone, giving special attention to areas with greater fat accumulation or cellulite, and make sure that the endpoint is sustained (see Figure 6-17 and Figure 6-15):



DC20298 6-13

6. Forward motions up the buttocks to model them. It may help to stretch the area with one hand (see Figure 6-18):


7. Reinforcing results, mainly on loose skin or on cellulite-rich areas, may be done by Stacking with the Contour Applicator.

Treating the Back in the Prone Position

Treat the Back with the Body Applicator. Do not treat the backs of very thin patients.

1. Descending long forward motions on the central back from the shoulder area to the lumbar zone until the endpoint is reached (see Figure 6-19):

Figure 6-19: Back Treatment Step 1

2. Backward & forward motions along the back sides and the lumbar areas

until the endpoint is reached (see Figure 6-20):


Cellulite Treatment

DC20298 6-14

3. Circular motions over the hips and lumbar area to sustain the endpoint (see Figure 6-21):


4. Zig-zag motions along the sides of the back to sustain the endpoint (see

Figure 6-22):


5. Backward & forward motions along the sides of the back (see Figure 6-23):


6. Circular motions in zones of fat accumulation.

7. You may use the Contour Applicator on low fat areas where contact with the skin is difficult.


DC20298 6-15

Treatment Protocols Body Applicator

• Ideally, the treatment should be performed twice a week for at least one month. Three treatments a week is an acceptable protocol, but not more often than that. Spacing the treatments less than twice a week apart will reduce treatment efficacy. Usually, up to 12 treatments result in significant cellulite improvement that affects also the local contour. Some patients may need a few more sessions.

• One maintenance treatment session a month may be necessary to sustain the results, followed by once in 6 weeks up to once in 3 months, according to individual results.

Contour Applicator

• The treatment protocol is usually 8 sessions once or twice a week, creating a substantial improvement in the treated areas. Once or twice a week is an acceptable protocol also when combining the Body and the Contour Applicators.

• Maintenance treatments to sustain the results may be necessary once every 4-6 weeks, with increasing intervals as needed.

Note Compliance with the treatment protocol is essential to achieving expected results.

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

• Set the IR mode at intensity level 1-3, according to the vacuum level, so that you do not exceed a total of 4, e.g. with vacuum level 1 you may use IR level 3, but with vacuum level 3 use IR level 1. Do not use high IR levels for very dark or tanned skin, or over hair or dark tattoos.

• Set the RF mode at intensity level 2; you may increase the intensity level to 3 as treatment progresses or in subsequent sessions, if the patient feels comfortable and skin response allows.

Cellulite Treatment

DC20298 6-16

• Set the Vacuum mode at intensity level 1 for 1-2 sessions and increase to intensity levels 2 or 3 during subsequent sessions, and according to the patient’s skin response and comfort. Vacuum levels for sensitive areas, such as abdomen, inner thigh, and over loose skin areas, should only be increased according to the patient's tolerance.

Table 6-1: Treatment Parameters Using the Body Applicator

Session IR Level RF Level Vacuum Level

First & Second Sessions 2 – 3 2 1

Subsequent Sessions 1 – 2 2 – 3 2 – 3

Table 6-2: Treatment Parameters Using the Contour Applicator

Treatment Area IR Level RF Level Vacuum Level Typical # Stacked Pulses

Under-Chin 2 – 3 3 1 – 2 3 – 4

Neck & Cheeks 2 – 3 3 1 (no more) 2 – 3

Arm, Calf, Bra-Line 2 – 3 3 2 4 – 5

Note • The treatment parameters in Table 6-1 and Table 6-2 are typical but

need to be adjusted to 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.

• When vacuum levels are increased, keep the IR levels lower.

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

methods.

• 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.


DC20298 6-17

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

• 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. Cellulite that may show improvement after 6-12 bi-weekly sessions (occasionally more).

3. Several users report circumference reduction and skin tightening in the very early sessions.

VelaSmooth User Manual Maintenance

DC20298 7-1

7. MAINTENANCE While the VelaSmooth system should not be serviced by anyone other than an authorized Syneron 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 VelaSmooth system

• Cleaning the VelaSmooth applicators and their covers

• Cleaning the air grids

• Cleaning the air filters

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 Platform 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.

Maintenance

DC20298 7-2

Cleaning the Applicators Clean the applicators after each treatment, as follows:

1. At the end of the session, clean the rollers of the Body Applicator while pressing the trigger, with all the modes at level 0, while rolling over a mild disinfectant-dampened tissue (that does not contain alcohol).

2. Turn the system off.

3. Disconnect the replaceable applicator cover of both applicators and clean them; using hot tap water (no more than131°F/55°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. Re-use the cover only when dry. Fast drying may be achieved by using a hair dryer with lowest temperature and at a moderate speed.

Caution

• Do not use alcohol, acetone or other harsh chemicals to clean the replaceable applicator covers.

• Do not sterilize the replaceable applicator covers.

4. Clean the Body Applicator RF contacts and the vacuum inlet at the end of

every day as follows (see Figure 7-1):

• Turn the system off.

• Remove the Body Applicator's replaceable cover by pressing the two buttons (A).

• Clean the RF applicator contacts (B) and the vacuum inlet (C) with a soft tissue.

D

C

B B

A A

Figure 7-1: Body Applicator RF Contacts & Vacuum Inlet


DC20298 7-3

• Gently clean the IR lamp (D); be careful not to scratch it.

• Reconnect the clean and dry Body Applicator's replaceable cover.

5. Clean the Contour Applicator RF contacts and the vacuum inlet at the end of every day as follows:

• Refer to Figure 7-2: remove the Contour Applicator's replaceable cover by holding the Contour Applicator Cover's Removal Tool with the hook facing upwards. Insert the hook into one of the two vacuum holes which are located in the cover chamber, and gently press upwards until the cover is released. Support the cover with your other hand and take care not to drop the cover.

ReplaceableCover

Removal Tool

Figure 7-2: Contour Applicator Cover Remover

• Clean the Contour Applicator Cover with disinfectant soap/detergent and hot water as described for the Body Applicator.

• Refer to Figure 7-3: clean the RF applicator contacts (A) and the vacuum inlet (B) with a soft tissue.

• Gently clean the IR lamp (C); be careful not to scratch it.

• Reconnect the clean and dry Contour Applicator's replaceable cover.

B

A A

C

Figure 7-3: Contour Applicator RF Contacts & Vacuum Inlet

Maintenance

DC20298 7-4

Cleaning the Air Grids Clean the system's two air grids (see Figure 7-4) at least once every three months as follows:


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.

Air Filter

Air Grids

Figure 7-4: Air Filter and Grids


DC20298 7-5

Cleaning the Air Filter While the 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 filter (see Figure 7-5):


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

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

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

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

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

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

Filter

Screw # 2

Filter Cup

Screw # 1

Figure 7-5: Cleaning the Air Filter

VelaSmooth User Manual Troubleshooting

DC20298 8-1

8. TROUBLESHOOTING The VelaSmooth 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 guide does not attempt to list all possible system failures. Any error not listed should be referred to Syneron's Service Center.

Table 8-1 offers a list of possible system errors, and how to correct them. If the corrective actions listed in the table do not solve the problem, contact Syneron's Service Center.

Most times a system error can be cleared by restarting the VelaSmooth system. Always try this remedy before contacting the service center.

Table 8-1: System Errors Troubleshooting Guide

Symptom Corrective Action

Operator panel bars blink and system does not operate

1. The system has malfunctioned, and the lights will blink until the error has been cleared by repositioning the applicator or by replenishing the VelaSpray Ease.

2. If problem persists, switch the system off, call the Syneron Service Center immediately and notify them of the error.

No display on the operator panel


2. Check the power cable. Make sure the cable is connected to both the wall socket and the system inlet.

3. Check the applicator connection.

No vacuum suction


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.

No IR output 1. Turn the system off.

2. Call the Syneron Service Center.

Electrodes are not rotating on Body Applicator


2. Check that the applicator chamber is clean and that nothing is obstructing the electrodes.

3. Install a new applicator cover.

O-Ring

VelaSmooth User Manual Specifications

DC20298 9-1

9. SYSTEM SPECIFICATIONS Parameters

RF Electrical Power Up to 20 Watts

IR Electrical Power Up to 50 Watts (Body Applicator)

Up to 20 Watts (Contour Applicator)

Light Spectrum 700 – 2000 nm

Treatment Area Footprints

Contour Applicator 25 mm x 25 mm

Body Applicator 40 mm x 40 mm

Electrical Requirements (Factory-Configured per Customer Order) • 94 – 106 VAC; 7A; 50/60Hz; Single Phase

• 100 – 130 VAC; 10A; 50/60Hz, single phase

• 207 – 254 VAC; 6A; 50/60Hz; single phase

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

Relative Humidity up to 80%

Dimensions • VelaSmooth system [W x D x H]: 36 x 55 x 80 cm / 14.2 x 21.6 x 31.5 inches

• Applicator umbilical harness: 3 m / 10 feet

Weight • VelaSmooth system: 30 kg. / 66 lbs.

• Applicators (small/large): Less than 2.0 kg. / 4.4 lbs.

Date post:	22-Oct-2014
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