Syneron Candela VelaShape III User manual

Science. Results. Trust.
Service Manual

Copyright © 2014 Syneron, Inc. All rights reserved.
Syneron, Inc. reserves the right to make changes to its products or specifications to improve performance, reliability, or
manufacturability. Information furnished by Syneron, Inc. is believed to be accurate and reliable. However, Syneron,
Inc. assumes no responsibility for its use. No license is granted by its implication or otherwise under any patent or
patent rights of Syneron, Inc.
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 prior written permission of Syneron, Inc.
Data is subject to change without notification.
Syneron, Inc. 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, Inc.
Specifications are subject to change without notice.
Manual Catalog Part Number: PB81501LW
Revision Release Date: July 2014
•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, st
ate, or local laws or regulations that might apply to the use and operation of this
device.
Contact Information for Syneron Call Centers:
•
Syneron, Inc.
3 Goodyear, Suite A
Irvine, CA 92618
USA
Tel: + 1.866.259.6661 (toll free)
•
CEpartner4u B.V.
Esdoornlaan 13
3951 DB Maarn
The Netherlands
Tel: + 31.343.442.524
Fax: + 31.343.442.162
•
Syneron Medical (HK) Ltd.
Room 3103, 31/F, Hopewell Centre,
183 Queen's Road East, Wan Chai, Hong Kong
Tel: [phone]
[phone]
Fax: [phone]

VelaShape III Service Manual Table of Contents
PB81501LW
TOC-1
Table of Contents
CHAPTER 1 Introduction Page
1.1. Scope of This Manual...............................................................................................................1-3
1.2. Conventions Used in this Manual.............................................................................................1-3
1.3. Contents of This Manual...........................................................................................................1-4
1.4. Applicable Documents..............................................................................................................1-4
1.5. Important Information................................................................................................................1-5
1.5.1. Physician Responsibility..................................................................................................1-5
1.5.2. Maintenance....................................................................................................................1-5
1.5.3. Modification of Device .....................................................................................................1-5
1.5.4. Resale Inspection............................................................................................................1-5
1.5.5. Communicating with Syneron..........................................................................................1-6
1.6. Explanation of Symbols Used in the System and Accessories................................................1-7
1.7. Service Reports........................................................................................................................1-7
CHAPTER 2 Safety and Regulatory Page
2.1. Introduction...............................................................................................................................2-3
2.2. Safety Precautions....................................................................................................................2-3
2.2.1. General Precautions........................................................................................................2-3
2.2.2. Infrared Energy................................................................................................................2-4
2.2.3. Radiofrequency Energy...................................................................................................2-5
2.2.4. Working within the System Cabinet.................................................................................2-5
2.3. System Safety Features ...........................................................................................................2-6
2.3.1. Main On/Off Power Switch ..............................................................................................2-6
2.3.2. System Self-Testing ........................................................................................................2-6
2.3.3. Footswitch & Applicator Triggers.....................................................................................2-6
2.3.4. Software Safety Features................................................................................................2-6
2.3.5. Safety Fuses....................................................................................................................2-6
2.4. Specifications............................................................................................................................2-7
2.4.1. Output Parameters ..........................................................................................................2-7
2.4.2. Treatment Area Footprints...............................................................................................2-7
2.4.3. Control Panel...................................................................................................................2-7
2.4.4. Electrical Requirements...................................................................................................2-7
2.4.5. Environmental Requirements..........................................................................................2-8
2.4.5.1. Treatment Room.....................................................................................2-8
2.4.5.2. Storage/Transportation...........................................................................2-8
2.4.5.3. Degree of Protection Against Ingress of Water......................................2-8
2.4.6. System Console Dimensions [W x D x H].......................................................................2-8
2.4.7. Weight..............................................................................................................................2-8
2.5. Regulatory.................................................................................................................................2-9
2.5.1. System Classifications.....................................................................................................2-9
2.5.2. Standard Compliances....................................................................................................2-9
2.5.3. Electromagnetic Emissions ...........................................................................................2-10
2.5.4. Electromagnetic Immunity.............................................................................................2-11
2.5.5. Electromagnetic Immunity (continued)..........................................................................2-12
2.5.6. Recommended Separation Distances...........................................................................2-13
CHAPTER 3 System Installation Page
3.1. Introduction...............................................................................................................................3-3
3.2. Unpacking the System..............................................................................................................3-3
3.3. Equipment List..........................................................................................................................3-4
3.3.1. Consumable Supplies......................................................................................................3-4

Table of Contents VelaShape III Service Manual
PB81501LW
TOC-2
3.4. System Dimensions..................................................................................................................3-5
3.5. Installation Process...................................................................................................................3-6
3.6. Moving the System within the Facility.......................................................................................3-8
3.7. Moving the System to another Facility......................................................................................3-8
3.8. Electrical Requirements............................................................................................................3-8
3.9. Environmental Requirements....................................................................................................3-9
CHAPTER 4 Modules Replacement Page
4.1. Removing the Handle Bar.........................................................................................................4-3
4.2. Removing the VelaShape III Covers.........................................................................................4-4
4.2.1. Removing the Utility Panel Service Door.........................................................................4-4
4.2.2. Removing Lower Rear Cover ..........................................................................................4-5
4.2.3. Removing the Front Display Panel..................................................................................4-6
4.2.4. Removing Front Bottom Panel.........................................................................................4-7
4.2.5. Removing the Rear Top Panel ........................................................................................4-8
4.3. Replacing the Internal Components .........................................................................................4-9
4.3.1. Removing the System Components Cover .....................................................................4-9
4.3.2. Removing the System Air Filter Cup..............................................................................4-11
4.3.3. Replacing the Control Panel..........................................................................................4-12
4.3.4. Replacing the RF Generator..........................................................................................4-13
4.3.4.1. Replacing the RF Generator Card........................................................4-15
4.3.4.2. Replacing the RF Card Fuses ..............................................................4-17
4.3.4.3. Replacing the RF Generator Fans........................................................4-18
4.3.5. Replacing the CPU ........................................................................................................4-19
4.3.6. Replacing the Power Supply..........................................................................................4-21
4.3.7. Replacing the Solid-State Relay....................................................................................4-23
4.4. Replacing the Vacuum Pump .................................................................................................4-24
4.4.1. Accessing the Vacuum Pump Screws...........................................................................4-26
4.4.2. Removing the Vacuum Pumps Omega Frame..............................................................4-27
4.4.3. Completing Vacuum Pump Removal.............................................................................4-28
4.5. Replacing the Valve Assembly...............................................................................................4-30
4.6. Replacing the Canister............................................................................................................4-31
4.7. Replacing the Wheels.............................................................................................................4-32
4.8. Replacing Pump Fans.............................................................................................................4-33
4.9. Replacing the Service Panel...................................................................................................4-34
4.9.1. Replacing the Power Breaker & Inlet Unit .....................................................................4-35
4.9.2. Replacing the Footswitch Port.......................................................................................4-36
4.9.3. Replacing the Umbilical Port..........................................................................................4-37
4.10. Replacing the Air Filter Assembly...........................................................................................4-38
CHAPTER 5 Maintenance and Calibrations Page
5.1. Calibration Tools.......................................................................................................................5-3
5.2. Overall Functional Tests...........................................................................................................5-6
5.2.1. Prepare the System.........................................................................................................5-6
5.2.2. System Cooling Fan Test ................................................................................................5-6
5.2.3. System and Applicator Functional Tests.........................................................................5-7
5.3. Vacuum Level and Leakage Tests ...........................................................................................5-9
5.3.1. Prepare the System.......................................................................................................5-10
5.3.2. Absolute Vacuum Level Test: System, Umbilical and Applicator..................................5-11
5.3.3. Vacuum Leakage Test: System, Umbilical and Applicator............................................5-12
5.3.4. Absolute Vacuum Level Test: System and Umbilical....................................................5-13
5.3.5. Vacuum Leakage Test: System and Umbilical..............................................................5-13
5.3.6. Absolute Vacuum Level and Leakage Tests: System Only...........................................5-14
5.3.7. Absolute Vacuum Level Test: Applicator with Cover.....................................................5-15
5.4. RF Energy Verification Test....................................................................................................5-16

VelaShape III Service Manual Table of Contents
PB81501LW
TOC-3
5.5. IR Thermometer Accuracy Verification Test...........................................................................5-18
5.6. Electrical Frequency Setup.....................................................................................................5-19
5.7. Programming the System's Serial Number.............................................................................5-21
5.8. System Software Upgrade......................................................................................................5-25
5.8.1. Prepare the System and Applicator...............................................................................5-25
5.8.2. Upgrade the Host Software...........................................................................................5-27
5.8.3. Upgrade the GUI Software............................................................................................5-28
CHAPTER 6 Troubleshooting Page
6.1. Introduction...............................................................................................................................6-3
6.1.1. Troubleshooting Guides ..................................................................................................6-3
CHAPTER 7 Spare Parts and Special Tools Page
7.1. Introduction...............................................................................................................................7-3
7.2. Spare Parts Catalog .................................................................................................................7-3
7.3. Special Tools List......................................................................................................................7-4
7.4. Spare Parts Illustrations............................................................................................................7-4
List of Figures
Figure # Description Page
Figure 1-1: System Nameplate..............................................................................................................1-6
Figure 3-1: System Dimensions ............................................................................................................3-5
Figure 3-2: Applicator on Handle...........................................................................................................3-6
Figure 3-3: Applicator's Connection Port...............................................................................................3-6
Figure 3-4: Service Panel......................................................................................................................3-7
Figure 4-1: Handle Screws Cover.........................................................................................................4-3
Figure 4-2: Handle Bar Screws.............................................................................................................4-3
Figure 4-3: Removing the Utility Panel Service Door............................................................................4-4
Figure 4-4: Panel Screws......................................................................................................................4-5
Figure 4-5: Front Bezels........................................................................................................................4-6
Figure 4-6: Rear Control Panel Screws.................................................................................................4-6
Figure 4-7: Front Bottom Panel Screws................................................................................................4-7
Figure 4-8: Rear Head Screws..............................................................................................................4-8
Figure 4-9: Removing the System Components Cover (1)...................................................................4-9
Figure 4-10: Removing the System Components Cover (2)...............................................................4-10
Figure 4-11: Removing the System Air Filter Cup...............................................................................4-11
Figure 4-12: Control Panel Screws .....................................................................................................4-12
Figure 4-13: RF Generator Cables......................................................................................................4-13
Figure 4-14: RF Generator Screws (1)................................................................................................4-14
Figure 4-15: RF Generator Screws (2)................................................................................................4-14
Figure 4-16: Replacing the RF Generator Card..................................................................................4-15
Figure 4-17: RF Card Screws..............................................................................................................4-16
Figure 4-18: RF Card Orientation........................................................................................................4-16
Figure 4-19: RF Card Fuses................................................................................................................4-17
Figure 4-20: RF Generator Fans.........................................................................................................4-18
Figure 4-21: CPU Housing Screws .....................................................................................................4-19
Figure 4-22: CPU Cables (1)...............................................................................................................4-19
Figure 4-23: CPU Air Tube..................................................................................................................4-20
Figure 4-24: CPU Standoff Screws .....................................................................................................4-20
Figure 4-25: Power Supply Housing Screws.......................................................................................4-21

Table of Contents VelaShape III Service Manual
PB81501LW
TOC-4
Figure 4-26: Power Supply Cables......................................................................................................4-21
Figure 4-27: Power Supply Tray Screws.............................................................................................4-22
Figure 4-28: Power Supply Cage Screws............................................................................................4-22
Figure 4-29: Solid-State Relay Cables................................................................................................4-23
Figure 4-30: Solid State Relay Screws................................................................................................4-23
Figure 4-31: Vacuum Pump Panel Screws..........................................................................................4-24
Figure 4-32: Vacuum Pump.................................................................................................................4-24
Figure 4-33: Vacuum Pump Grounding Cable ....................................................................................4-25
Figure 4-34: Bottom Panel Screws......................................................................................................4-26
Figure 4-35: Omega Frame Screws....................................................................................................4-27
Figure 4-36: Omega Frame Support Stud...........................................................................................4-27
Figure 4-37: Omega Frame Removal..................................................................................................4-28
Figure 4-38: Air Pump Tube Quick Connector....................................................................................4-28
Figure 4-39: Vacuum Pump Bolts & Screws .......................................................................................4-29
Figure 4-40: Vacuum Pump Power Cables.........................................................................................4-29
Figure 4-41: Valve Assembly Cables ..................................................................................................4-30
Figure 4-42: Valve Assembly Screws..................................................................................................4-30
Figure 4-43: Canister quick connector & bracket screws....................................................................4-31
Figure 4-44: Canister Rear Connection...............................................................................................4-32
Figure 4-45: Pump Fans......................................................................................................................4-33
Figure 4-46: Pump Fan Harnesses on the CPU..................................................................................4-33
Figure 4-47: Service Panel Screws .....................................................................................................4-34
Figure 4-48: Power Inlet Clip Holders..................................................................................................4-35
Figure 4-53: Main Fuses......................................................................................................................4-35
Figure 4-50: Footswitch Port................................................................................................................4-36
Figure 4-51: Footswitch CPU Connection...........................................................................................4-36
Figure 4-52: Umbilical Port Screws.....................................................................................................4-37
Figure 4-53: Umbilical Vacuum Tube..................................................................................................4-37
Figure 4-54: Umbilical CPU Cables.....................................................................................................4-38
Figure 4-55: Air Filter Panel Screws....................................................................................................4-38
Figure 4-56: Disconnecting the Air Pump Tubes.................................................................................4-39
Figure 4-57: Air Filter Screws..............................................................................................................4-39
Figure 5-1: Vela Vacuum & IR Lamp Toolkit – P/N # KT7039(x)..........................................................5-3
Figure 5-2: Universal Power Meter Kit P/N # AS4597(x) ......................................................................5-5
Figure 5-3: Service Mode Screen..........................................................................................................5-6
Figure 5-4: Functional Tests..................................................................................................................5-8
Figure 5-5: VelaShape III Vacuum Leakage Test Phases ....................................................................5-9
Figure 5-6: VelaShape III Test and Calibration Screen.......................................................................5-10
Figure 5-7: Calibrating the Digital Display...........................................................................................5-10
Figure 5-8: VelaShape III Absolute Vacuum Level Test: Applicator (1)..............................................5-11
Figure 5-9: VelaShape III Absolute Vacuum Level Test: Applicator (2)..............................................5-11
Figure 5-10: VelaShape III Absolute Vacuum Level Test: Applicator (3)............................................5-12
Figure 5-11: VelaShape III Absolute Vacuum Level Test: Umbilical...................................................5-13
Figure 5-12: VelaShape III Absolute Vacuum Level and Leakage Tests: System..............................5-14
Figure 5-13: VelaShape III Absolute Vacuum Level Test: VContour or VSmooth
Applicator with Cover (1).................................................................................................5-15
Figure 5-14: VelaShape III RF Energy Verification (1)........................................................................5-16
Figure 5-15: VelaShape III Test and Calibration Screen.....................................................................5-17
Figure 5-16: VelaShape III RF Energy Verification (2)........................................................................5-17
Figure 5-17: IR Thermometer Accuracy Verification Test...................................................................5-18
Figure 5-18: VelaShape III Treatment Screen.....................................................................................5-19
Figure 5-19: Electrical Frequency Setup.............................................................................................5-20
Figure 5-20: Programming the System's Serial Number (1)................................................................5-21
Figure 5-21: Programming the System's Serial Number (2)................................................................5-22
Figure 5-22: Programming the System's Serial Number (3)................................................................5-22
Figure 5-23: Programming the System's Serial Number (4)................................................................5-23
Figure 5-24: Programming the System's Serial Number (5)................................................................5-23
Figure 5-25: Programming the System's Serial Number (6)................................................................5-24

VelaShape III Service Manual Table of Contents
PB81501LW
TOC-5
Figure 5-26: Connect the New Applicator ...........................................................................................5-25
Figure 5-27: System Software Upgrade (1).........................................................................................5-26
Figure 5-28: System Software Upgrade (2).........................................................................................5-26
Figure 5-29: System Software Upgrade (3).........................................................................................5-27
Figure 5-30: System Software Upgrade (4).........................................................................................5-28
Figure 5-31: System Software Upgrade (5).........................................................................................5-29
Figure 5-32: System Software Upgrade (6).........................................................................................5-30
Figure 5-33: System Software Upgrade (7).........................................................................................5-30
Figure 7-1: Spare Parts Illustration # 1..................................................................................................7-5
Figure 7-2: Spare Parts Illustration # 2..................................................................................................7-6
Figure 7-3: Spare Parts Illustration # 3..................................................................................................7-7
Figure 7-4: Spare Parts Illustration # 4..................................................................................................7-8
Figure 7-5: Spare Parts Illustration # 5..................................................................................................7-9
Figure 7-6: Spare Parts Illustration # 6................................................................................................7-10
Figure 7-7: Spare Parts Illustration # 7................................................................................................7-11
Figure 7-8: Vela Vacuum & IR Lamp Toolkit ......................................................................................7-12
Figure 7-9: Universal Power Meter Kit ...............................................................................................7-13

Table of Contents VelaShape III Service Manual
PB81501LW
TOC-6

Service Manual
CHAPTER 1
Introduction

Introduction VelaShape III Service Manual
PB81501LW
1-2
Table of Contents
Section Page
1.1. Scope of This Manual.................................................................................................1-3
1.2. Conventions Used in this Manual...............................................................................1-3
1.3. Contents of This Manual.............................................................................................1-4
1.4. Applicable Documents................................................................................................1-4
1.5. Important Information..................................................................................................1-5
1.5.1. Physician Responsibility.....................................................................................1-5
1.5.2. Maintenance.......................................................................................................1-5
1.5.3. Modification of Device ........................................................................................1-5
1.5.4. Resale Inspection...............................................................................................1-5
1.5.5. Communicating with Syneron.............................................................................1-6
1.6. Explanation of Symbols Used in the System and Accessories...................................1-7
1.7. Service Reports..........................................................................................................1-7

VelaShape III Service Manual Introduction
PB81501LW
1-3
1.1. Scope of This Manual
Caution
Service personnel operating or maintaining the VelaShape III system
should read this manual thoroughly before attempting to operate or
service the device.
This manual provides installation, maintenance and service instructions of the VelaShape III
system, as well as safety & regulatory information and a comprehensive description of the
system.
Note
While the manual is intended to aid service personnel in the care and
service of the equipment, it cannot serve as a substitute for service
engineer training, provided by Syneron or its agents.
1.2. 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/service engineer to the possibility of injury,
death, or serious adverse reactions associated with the use or misuse of
the system.

Introduction VelaShape III Service Manual
PB81501LW
1-4
1.3. Contents of This Manual
This service manual includes the following chapters:
•Chapter 1: Introduction
Provides the scope of the manual and a list of applicable documents.
•Chapter 2: Safety and Regulatory
Describes safety issues regarding the use, service and maintenance of the VelaShape III
system.
•Chapter 3: Installation and Operation
Contains a synopsis of the system's installation and operating instructions; this frees the
field service engineer from having to carry a user manual.
•Chapter 4: Modules Replacement
Provides instructions for replacement of the unit's modules and assemblies.
•Chapter 5: Maintenance and Calibrations
Details the routine maintenance tasks required by the field service engineer on periodic
visits.
•Chapter 6: Troubleshooting
Lists the system's error displays and various problems, probable causes, symptoms/
diagnostic checks, and the appropriate corrective actions.
•Chapter 7: Spare Parts Catalog and Special Tools
Provides an easy-to-use catalog, including illustrations of the system's modules and parts.
1.4. Applicable Documents
•VelaShape III User Manual [PB8149(x)]
•VelaShape III Quick-Reference Guide [PB7151(x)]

VelaShape III Service Manual Introduction
PB81501LW
1-5
1.5. Important Information
1.5.1. Physician Responsibility
Federal (USA) law restricts prescription medical devices to sale by or on the order of a
physician, or properly licensed practitioner. That physician will be responsible for the use and
operation of the device and for all user qualifications. Syneron makes no representations
regarding federal, state or local laws or regulations that might apply to the use and operation
of any medical device. The physician is responsible for contacting his or her local licensing
agencies to determine any credentials required by law for clinical use and operation of the
device.
1.5.2. Maintenance
The VelaShape III system is a precision, technical medical device that requires routine
service as well as consumable parts. All service must be performed by an authorized service
engineer and all parts must be purchased from Syneron. Failure to obtain service and parts
through Syneron voids all warranties, express and implied. Please call Syneron or your local
representative for details.
1.5.3. Modification of Device
Unauthorized modification of the hardware, software or specifications of the system or its
accessories voids all warranties, express and implied. Syneron takes no responsibility for the
use or operation of such a device.
1.5.4. Resale Inspection
The VelaShape III system is a precision, technical medical device. If the device is resold by
anyone other than an authorized sales representative, Syneron offers a resale inspection by an
authorized technician to assure that the device is working in accordance with the
manufacturer's specifications. Using the device after it has been resold and before it has been
inspected is a misuse of the device, which may result in injuries and voids all warranties,
express and implied.

Introduction VelaShape III Service Manual
PB81501LW
1-6
1.5.5. Communicating with Syneron
During any communication with the service department at Syneron, or with any of the service
depots, it is necessary to mention the serial number of the VelaShape III system being
discussed.
The serial number may be found on the system's nameplate, adhered to the system's rear
panel (see Figure 1-1).
Figure 1-1: System Nameplate

VelaShape III Service Manual Introduction
PB81501LW
1-7
1.6. Explanation of Symbols Used in the System
and Accessories
Symbol Description
Refer to Instruction Manual/Booklet
Caution!
0433 CE Compliance Symbol
Discard Product After Expiration Date
Single Use Only
Product was Sterilized by Ethylene Oxide Process
RF Interference may occur in the vicinity of equipment with the
following symbol
Waste of Electrical and Electronic Equipment (WEEE) compliance
symbol
Fuse
Type BF Equipment
Manufacturer
Authorized Representative in the European Union
1.7. Service Reports
At the end of every service call, fill out a copy of the VelaShape III System Final Test
Form (next page) and send it to the Syneron Call Center.

VelaShape III Service Manual Final Test Form
System S/N: __________________Service Rev. ___________ New Customer Loaner Resale Marketing
Final Test / Upon Arrival Test Date Originated: ____________
System Damage Upon arrival Yes / No
If Yes, Add Damage Description & Cause: _______________________________________________________________
Applicator Display
Ensure the OLED screen on applicators panel is illuminated.
Fans
Ensure all fans operate when system is turned on.
Vacuum Levels
Check that default vacuum level is 1. Press the trigger; the vacuum pump will start to operate
and the pressure valve will operate intermittently. Release the trigger. Repeat the test with the
vacuum set to level 2, and then to level 3, ensuring the pressure valve operation changes
accordingly. Verify that all three levels on applicator mirror the levels on the GUI when
changed. Repeat this entire test using the applicator keypad.
IR Lamp
Press the IR icon on system display to set IR to level 1 and press the trigger. Verify IR lamp
turns on by pressing the trigger. Repeat test with IR set to level 2, and then to level 3. Verify
that all three levels on applicator mirror the levels on the GUI when changed. Repeat this
entire test using the applicator keypad.
RF Display
Press the RF icon on system display and ensure that the RF is set to level 1. Press the
trigger. Repeat the test with the RF set to level 2, and then to level 3. Verify that all 3 levels on
applicator mirror the levels on the GUI when changed. Repeat this entire test using the
applicator keypad.
Footswitch
With an applicator connected, press and hold the footswitch; ensure vacuum is pulsed.
Initialization Test
With an applicator and disposable cover are connected, turn on the system; ensure no error
messages appear upon start-up. Confirm that the disposable cover is recognized by
applicator.
IR Sensor Verification [User Mode, System and hotplate must be turned ON for 20 minutes at least]
Place the applicator without the cover over the hotplate (tool P/N TL74260)
and check that the IR sensor temperature displays on the screen: 43º C ±2ºC
VS:________ ºC / VC:________ ºC
RF Testing [Press the RF test button and the footswitch - Service Mode]
RF out w/Load
VS:________ Vpp / VC:________ Vpp
Measured value should be : 145V<Vpp<176V
Vacuum Testing [Service Mode]
System
Above (–0.50) [Bar]
Above (-6.8) [PSI]
Pass / Fail
Umbilical
(–0.45) to (–0.85) [Bar]
(-6.53) to (-12.35) [PSI]
Pass / Fail
Applicator
(–0.45) to (–0.85) [Bar]
(-6.53) to (-12.35) [PSI]
Pass / Fail
Vacuum Leakage Test [Service Mode]
(Vacuum level drop within 60 second < 60 [mBar])
Fans Test
[Service Mode]
HC SW Ver. _____________
HC PLD Ver. ____________
GUI Ver. _______________
System
Pass / Fail
Pump Fans
RF Fans
PS Fan
Umbilical
Pass / Fail
SA S/N: _______________
LA S/N: _______________
Notes
1. _________________________________________________________________________________________________
2. _________________________________________________________________________________________________
3. _________________________________________________________________________________________________
4. _________________________________________________________________________________________________
Date:_________________________ Call ID:_____________________ Checked By:__________________

Service Manual
CHAPTER 2
Safety and
Regulatory

Safety & Regulatory VelaShape III Service Manual
PB81501LW
2-2
Table of Contents
Section Page
2.1. Introduction.................................................................................................................2-3
2.2. Safety Precautions......................................................................................................2-3
2.2.1. General Precautions...........................................................................................2-3
2.2.2. Infrared Energy...................................................................................................2-4
2.2.3. Radiofrequency Energy......................................................................................2-5
2.2.4. Working within the System Cabinet....................................................................2-5
2.3. System Safety Features .............................................................................................2-6
2.3.1. Main On/Off Power Switch .................................................................................2-6
2.3.2. System Self-Testing ...........................................................................................2-6
2.3.3. Footswitch & Applicator Triggers........................................................................2-6
2.3.4. Software Safety Features...................................................................................2-6
2.3.5. Safety Fuses.......................................................................................................2-6
2.4. Specifications..............................................................................................................2-7
2.4.1. Output Parameters.............................................................................................2-7
2.4.2. Treatment Area Footprints..................................................................................2-7
2.4.3. Control Panel......................................................................................................2-7
2.4.4. Electrical Requirements......................................................................................2-7
2.4.5. Environmental Requirements.............................................................................2-8
2.4.5.1. Treatment Room.........................................................................2-8
2.4.5.2. Storage/Transportation...............................................................2-8
2.4.5.3. Degree of Protection Against Ingress of Water...........................2-8
2.4.6. System Console Dimensions [W x D x H] ..........................................................2-8
2.4.7. Weight ................................................................................................................2-8
2.5. Regulatory ..................................................................................................................2-9
2.5.1. System Classifications........................................................................................2-9
2.5.2. Standard Compliances.......................................................................................2-9
2.5.3. Electromagnetic Emissions ..............................................................................2-10
2.5.4. Electromagnetic Immunity................................................................................2-11
2.5.5. Electromagnetic Immunity (continued).............................................................2-12
2.5.6. Recommended Separation Distances..............................................................2-13

VelaShape III Service Manual Safety & Regulatory
PB81501LW
2-3
2.1. Introduction
This chapter describes the safety issues regarding the use and maintenance of the VelaShape
III system, with special emphasis on optical and electrical safety.
The system is designed for safe and reliable treatment, when handled in accordance with
proper operation and service procedures. The field service engineer servicing the system
should be familiar with the safety information provided in this chapter. Syneron 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.
Read this chapter to be familiar with all of its safety requirements and operating procedures
prior to operating or servicing the system. Always be aware of the possible dangers and take
proper safeguards as described in this manual.
For complete contact information please refer to page 3 of this manual.
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.
2.2. Safety Precautions
2.2.1. General Precautions
•Only Syneron-authorized technical personnel may service the system, especially inside its
protective covers. Dangerous voltages are present inside the system.
•Power Cable: use only the power cable supplied with the VelaShape III system.
•Maintenance and service should be performed only when the system is shut down and
disconnected from power. Performing maintenance procedures with the system powered
up may be hazardous to the operator and destructive to the system.
•Portable and mobile RF communications equipment can affect medical electrical
equipment, Interference may occur in the vicinity of the equipment.

Safety & Regulatory VelaShape III Service Manual
PB81501LW
2-4
•Any person with a cardiac pacemaker or other active implants should not be allowed in the
vicinity of the system while energized and/or during operation; a possible hazard exists
because of interference with the action of the pacemaker.
•Never operate the system in the presence of explosive or flammable gasses, such as
flammable anesthetics, oxidizing gasses, etc. If alcohol is used for cleaning and
disinfecting, it must be allowed to dry thoroughly before the system is set to operational
mode.
•Do not allow the applicator to come in contact with hard materials that could damage the
RF electrodes.
•Do not turn the system on if you detect water leakage from the system or from the
applicator. If the system is on when you detect leakage, turn it off immediately.
•Never leave the system turned on, open or unattended during system service.
Caution
•Only common workshop tools and specific specialized Syneron tools are
allowed for servicing the system.
•Always check that all parts removed from the system (including fastening
hardware) have been reinstalled. Never allow any "leftover" items after
servicing the system.
•Always ensure that no fastening hardware (screws, washers, nuts, etc.) have
fallen into the system during servicing. Recover all fallen items!
•Always check that all tools used on the system are accounted for after
completion of the service call.
2.2.2. Infrared Energy
The VelaShape III emits infrared light at 850nm 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.