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世聯(lián)翻譯公司完成用戶手冊英文翻譯

Document part number: UMVEGLBA Venus Versa_UM_GLB Global,
Rev. 01, November 2015
Venus Versa
User Manual
(International Version)
Venus Versa User Manual (International Version)
Document part number:
UMVEGLBA Venus Versa_UM_GLB Global
Rev. 01, November 2015
Copyright © 2015 Venus Concept Ltd. All rights reserved.
Venus Concept Ltd. reserves the right to make changes to its
products or specifications to improve performance, reliability,
or manufacturability. Information furnished by Venus Concept
Ltd. is believed to be accurate and reliable. However, Venus
Concept Ltd. assumes no responsibility for its use. No license
is granted by its implication or otherwise under any patent or
patent rights of Venus Concept 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 a written permission of Venus Concept Ltd.
Data and Specifications are subject to change without
notification.
Venus Concept 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.
NOTICE: This document may contain Venus Concept
Confidential Information. If you received this document by
mistake, please inform us, so as to enable us to retrieve the
documents. In such cases, copying and distributing this
document are strictly prohibited.
Versa User Manual i
Table of Contents
CHAPTER 1 About this Manual Page
1.1. Use of the Manual ..................................... 1-2
1.2. Scope of the Manual ................................. 1-3
1.3. Document Conventions............................. 1-6
1.4. Symbols .................................................... 1-7
CHAPTER 2 Safety and Regulatory Information Page
2.1. Introduction ............................................... 2-2
2.2. Intended Use ............................................. 2-3
2.3. Intended User and Environment ............... 2-3
2.4. Safety Information .................................... 2-4
2.5. Electrical and Mechanical Safety ............. 2-7
2.6. Fire Safety ................................................. 2-8
2.7. Protective Eyewear ................................... 2-8
2.8. Optical Safety during the IPL Treatment .. 2-9
2.9. RF Treatment Safety Precautions ........... 2-10
2.10. Compliance with International Standards 2-11
2.11. System Safety Features ........................... 2-12
2.12. Electromagnetic Compatibility ............... 2-13
2.13. System Labels ......................................... 2-18
2.14. Contact Information ................................ 2-20
ii Versa User Manual
CHAPTER 3 Installation Page
3.1. Installing the System ................................. 3-2
3.2. Electrical Requirements ............................ 3-2
3.3. Environmental Requirements .................... 3-3
3.4. Equipment List .......................................... 3-4
3.5. Connecting the System to the
Mains Power .............................................. 3-5
3.6. Connecting the Applicators ....................... 3-6
3.6.1. Connecting the IPL Applicator ..... 3-6
3.6.2. Connecting the RF Applicators .... 3-7
3.6.3. Connecting the Viva
Applicator Tip ............................... 3-8
CHAPTER 4 System Description Page
4.1. General Description ................................... 4-2
4.2. System Components .................................. 4-3
4.2.1. System Console ............................. 4-4
4.2.2. Touch Screen ................................ 4-4
4.2.3. Emergency Button ........................ 4-5
4.2.4. IPL Applicator Connection
Receptacle ..................................... 4-6
4.2.5. RF Applicator Connection
Receptacles ................................... 4-7
4.2.6. IPL Applicator Holder .................. 4-8
4.2.7. RF Applicator Holders ................. 4-9
4.2.8. Main Power Switch ..................... 4-10
4.2.9. Power Connection Port .............. 4-11
Versa User Manual iii
CHAPTER 4 System Description (cont.) Page
4.3. IPL Applicators ....................................... 4-12
4.3.1. SR515 Applicator ....................... 4-12
4.3.2. SR580 Applicator ....................... 4-13
4.3.3. HR650 Applicator ...................... 4-14
4.3.4. HR690 Applicator ...................... 4-15
4.3.5. HR650XL Applicator ................. 4-16
4.3.6. HR690XL Applicator ................. 4-17
4.3.7. ACDUAL Applicator .................. 4-18
4.4. RF Applicators ........................................ 4-19
4.4.1. Diamondpolar Applicator .......... 4-19
4.4.2. Octipolar Applicator .................. 4-20
4.4.3. Viva Applicator .......................... 4-21
CHAPTER 5 Operating Instructions Page
5.1. Turning the System On/Off ...................... 5-2
5.2. Logging In ................................................. 5-4
5.3. Selecting the Desired Applicator .............. 5-6
5.4. Treatment Modes and Parameters ............ 5-7
5.4.1. (MP)2 Treatment Mode ................ 5-8
5.4.2. Fractional RF Treatment Mode . 5-12
5.4.3. IPL Treatment Mode .................. 5-17
5.5. Setting the Treatment Parameters ........... 5-21
5.6. Using Preset Parameters in the (MP)2
Treatment Mode...................................... 5-22
iv Versa User Manual
CHAPTER 5 Operating Instructions (cont.) Page
5.6.1. Recalling the Preset Treatment
Parameters ................................. 5-22
5.6.2. Changing the Preset Treatment
Parameters ................................. 5-23
5.7. Emitting the Treatment Energy ............... 5-25
CHAPTER 6 Advanced Features and Settings Page
6.1. Tools screen ............................................... 6-2
6.1.1. Features in the Tools Screen ........ 6-2
6.1.2. Status Bar ..................................... 6-5
6.1.3. Accessing the Tools Screen .......... 6-5
6.2. Setting the Interface language ................... 6-6
6.3. Setting the Volume .................................... 6-7
6.4. Setting the Login Code .............................. 6-8
6.5. Logging Out ............................................. 6-11
6.6. Setting the Auto Logout Time ................. 6-12
6.7. Displaying the System Information ......... 6-13
6.8. Extending the Activation Period ............. 6-14
6.9. Displaying the System Counter
Information .............................................. 6-16
6.10. Activating the Pump ................................ 6-18
6.11. Technician Mode ..................................... 6-18
Versa User Manual v
CHAPTER 7 Care and Maintenance Page
7.1. Cleaning the System ................................. 7-2
7.2. Cleaning the Applicators .......................... 7-2
7.3. Disinfecting the Applicators ..................... 7-3
7.4. Cleaning the Viva Applicator's Tip .......... 7-3
7.5. Adding Water to the Cooling System ....... 7-4
7.6. Circulating the Water ................................ 7-9
7.7. Replacing a Burnt Fuse ........................... 7-14
7.8. Moving the System ................................. 7-15
CHAPTER 8 Troubleshooting Page
8.1. General ...................................................... 8-2
8.2. System Problems ....................................... 8-3
8.3. Errors and Messags ................................... 8-5
vi Versa User Manual
CHAPTER 9 Specifications Page
9.1. System Specifications ................................ 9-2
9.2. SR515 Applicator Specifications .............. 9-3
9.3. SR580 Applicator Specifications .............. 9-4
9.4. HR650 Applicator Specifications .............. 9-5
9.5. HR690 Applicator Specifications .............. 9-6
9.6. HR650XL Applicator Specifications ........ 9-7
9.7. HR690XL Applicator Specifications ........ 9-8
9.8. ACDUAL Applicator Specifications......... 9-9
9.9. Diamondpolar Applicator
Specifications .......................................... 9-10
9.10. Octipolar Applicator Specifications ........ 9-11
9.11. Viva Applicator Specifications ............... 9-12
9.12. Environmental Requirements .................. 9-13
9.13. Output Power Graphs .............................. 9-14
Versa User Manual vii
Appendix A Clinical Guide for (MP)² Treatment
with Diamondpolar Applicator Page
A.1. Introduction .............................................. A-2
A.2. Indications ................................................ A-2
A.3. Contraindications ..................................... A-3
A.4. Exclusion Criteria .................................... A-3
A.5. Pre-Treatment Information ...................... A-4
A.5.1. Recommended Accessories .......... A-4
A.5.2. Clinical Data Management .......... A-4
A.5.3. Expected Clinical Effects ............. A-5
A.5.4. Adverse Effect .............................. A-5
A.5.5. Documentation ............................. A-5
A.5.6. Preparing for the Treatment ........ A-6
A.6. General Treatment Information ............... A-7
viii Versa User Manual
Appendix B Clinical Guide for (MP)² Treatment
with Octipolar Applicator Page
B.1. Introduction .............................................. B-2
B.2. Indications ................................................ B-2
B.3. Exclusion Criteria ..................................... B-3
B.4. Precaution Criteria .................................... B-4
B.5. Pre-Treatment Information ....................... B-5
B.5.1. Recommended Accessories .......... B-5
B.5.2. Clinical Data Management ......... B-5
B.5.3. Expected Clinical Effects ............. B-6
B.5.4. Adverse Effect .............................. B-6
B.5.5. Documentation ............................ B-7
B.5.6. Preparing for the Treatment ........ B-8
B.6. General Treatment Information ................ B-8
Versa User Manual ix
Appendix C Clinical Guide for Fractional RF
Treatment with Viva Applicator Page
C.1. Introduction ............................................... C-2
C.2. Indications ................................................. C-2
C.3. Contraindications ...................................... C-3
C.4. Exclusion Criteria ..................................... C-3
C.5. Possible Side Effects ................................ C-6
C.6. Pre-Treatment Information ....................... C-7
C.7. Preparing the Applicator and Tip ............. C-8
C.8. Test Treatment .......................................... C-9
C.9. Treatment Procedure ............................... C-10
C.10. Treatment Protocol ................................. C-13
C.11. Treatment Parameters ............................. C-13
C.12. Post Treatment Care ............................... C-14
C.13. Follow-Up ............................................... C-15
C.14. Treatment Conclusion ............................. C-15
x Versa User Manual
Appendix D Clinical Guide for SR515 and SR580
Applicators Page
D.1. Introduction .............................................. D-2
D.2. Indications ................................................ D-3
D.3. Contraindications ..................................... D-4
D.4. Precautions ............................................... D-5
D.5. Possible Side Effects ................................ D-5
D.6. Before Starting ......................................... D-6
D.7. Test Spot ................................................... D-7
D.8. Treatment Method .................................... D-7
D.9. Treatment Protocol ................................... D-9
D.9.1. Setting the Treatment
Parameters .................................. D-9
D.9.1.1. Pigmented Lesions .......... D-10
D.9.1.2. Vascular Lesions ............ D-11
D.10. Post-Treatment Care ............................... D-12
Versa User Manual xi
Appendix E Clinical Guide for Hair Removal
Using IPL HR Applicators Page
E.1. Introduction ............................................... E-2
E.2. Indications ................................................. E-3
E.3. Contraindications ...................................... E-4
E.4. Precautions ................................................ E-5
E.5. Possible Side Effects ................................ E-5
E.6. Before Starting .......................................... E-6
E.7. Test Spot ................................................... E-7
E.8. Treatment Method .................................... E-7
E.9. Treatment Protocol ................................... E-9
E.9.1. Setting the Treatment
Parameters ................................. E-10
E.10. Post-Treatment Care ............................... E-11
xii Versa User Manual
Appendix F Clinical Guide for the ACDUAL
IPL Applicator Page
F.1. Introduction .............................................. F-2
F.2. Indications ................................................ F-3
F.3. Contraindications ..................................... F-4
F.4. Precautions ............................................... F-5
F.5. Possible Side Effects ................................ F-5
F.6. Before Starting ......................................... F-6
F.7. Test Spot ................................................... F-7
F.8. Treatment Method .................................... F-7
F.9. Treatment Protocol ................................... F-9
F.9.1. Setting the Treatment Parameters............. F-9
F.10. Post-Treatment Care ............................... F-10
Appendix G Manufacturer Warranty Page
G.1. Manufacturer Warranty ............................ G-2
Versa User Manual xiii
List of Figures
Figure Description Page
2-1. IPL Treatment Room Caution Sign .................................... 2-9
2-2. System Identification Label .............................................. 2-18
2-3. Light Emission Warning Label ........................................ 2-19
3-1. Power Connection Port on the System's Rear Side ........... 3-5
3-2. Connecting the IPL Applicator's Cable Connector ............ 3-6
3-3. Connecting the RF Applicator's Cable Connector ............. 3-7
3-4. Connecting a Tip to the Viva Applicator ........................... 3-8
4-1. System Components ........................................................... 4-3
4-2. Emergency Button .............................................................. 4-5
4-3. IPL Applicator Connection Receptacle .............................. 4-6
4-4. RF Applicator Connection Receptacles ............................. 4-7
4-5. IPL Applicator Holder ........................................................ 4-8
4-6. RF Applicator Holders ....................................................... 4-9
4-7. Main Power Switch .......................................................... 4-10
4-8. Power Connection Port ..................................................... 4-11
4-9. SR515 Applicator ............................................................. 4-12
4-10. SR580 Applicator ............................................................. 4-13
4-11. HR650 Applicator ............................................................ 4-14
4-12. HR690 Applicator ............................................................ 4-15
4-13. HR650XL Applicator ....................................................... 4-16
4-14. HR690XL Applicator ....................................................... 4-17
4-15. ACDUAL Applicator ....................................................... 4-18
4-16. Diamondpolar Applicator ................................................. 4-19
4-17. Octipolar Applicator ......................................................... 4-20
4-18. Viva Applicator ................................................................ 4-21
5-1. Power Connection Port ....................................................... 5-2
5-2. Login Screen ....................................................................... 5-3
xiv Versa User Manual
Figure Description Page
5-3. Entering the Login Code ..................................................... 5-4
5-4. Treatment Screen
(with the Diamondpolar Applicator Selected) .................... 5-5
5-5. Applicator Selector
(with the Diamondpolar Applicator Selected) .................... 5-6
5-6. Elements of the (MP)2 Mode Treatment Screen
(with the Octipolar Applicator Selected) ............................ 5-8
5-7. Elements of the Fractional RF Mode
Treatment Screen .............................................................. 5-12
5-8. Elements of the Fractional RF Mode
Advanced Treatment Screen ............................................. 5-12
5-9. Elements of the IPL Mode Treatment Screen
(with the HR690 IPL Applicator Selected) ....................... 5-17
5-10. Preset Screen ..................................................................... 5-22
5-11. Preset Icon Inward Arrow Changing to Green .................. 5-24
6-1. Tools Screen ........................................................................ 6-2
6-2. Status Bar ............................................................................ 6-5
6-3. Volume Screen .................................................................... 6-7
6-4. Login Screen ....................................................................... 6-8
6-5. Entering the New Login Code ............................................. 6-9
6-6. Re-Entering the New Login Code ..................................... 6-10
6-7. Login Screen ..................................................................... 6-11
6-8. Set Auto Logout Time Screen ........................................... 6-12
6-9. Information Screen ............................................................ 6-13
6-10. Activation Code Screen .................................................... 6-15
6-11. System Counter Information Screen ................................. 6-17
7-1. Water Level Indicator on the System's rear Side ................ 7-4
7-2. Water Filling Kit ................................................................. 7-5
7-3. Disconnecting the IPL Applicator's Cable Connector ........ 7-5
7-4. Connecting Two Parts of the Water Filling Kit' ................. 7-6
7-5. Inserting the Water Filling Kit's Connector ........................ 7-6
7-6. Locking the Water Filling Kit's Connector ......................... 7-7
Versa User Manual xv
Figure Description Page
7-7. Water Filling Kit Locked in Place ...................................... 7-7
7-8. Water Filling Kit Connected to the System ....................... 7-8
7-9. Bypass Tool (Without the Funnel) ..................................... 7-9
7-10. Bypass Tool Connected to the System
(Without the Funnel) ........................................................ 7-10
7-11. Tools Screen ..................................................................... 7-11
7-12. Connecting the Bypass Tool and Starting the
Pump Message .................................................................. 7-11
7-13. Pump Activation Screen ................................................... 7-12
7-14. Water Circulation Completion Message .......................... 7-13
7-15. Power Connection Port and Main Fuses on the
System's Rear Side ........................................................... 7-14
9-1. Graph of Output Power vs. Load ...................................... 9-14
9-2. Graph of Output Power vs. Setting .................................. 9-14
A-1. Diamondpolar Applicator .................................................. A-2
B-1. Octipolar Applicator ........................................................... B-2
C-1. Viva Applicator .................................................................. C-2
D-1. SR515 (Left) and SR580 (Right) IPL Applicators ............ D-2
E-1. HR650 (Upper Left), HR690 (UpperRight),
HR650XL (Lower Left) and HR690XL (Lower Right)
IPL Applicators .................................................................. E-2
F-1. ACDUAL Applicator ......................................................... F-2
xvi Versa User Manual
List of Tables
Table Description Page
1-1. Glossary of Symbols Used in this Manual
or on the Product ................................................................. 1-7
2-1. Manufacturer's declaration –
Electromagnetic Emissions ............................................... 2-13
2-2. Manufacturer's Declaration –
Electromagnetic Immunity ................................................ 2-14
2-3. Manufacturer's Declaration –
Electromagnetic Immunity that is not Life-Supporting .... 2-15
2-4. Recommended Separation Distances between
Portable and Mobile RF Communications Equipment
and the ME Equipment or ME System that is not
Life-Supporting ................................................................. 2-17
6-1. Tools Screen Features ......................................................... 6-3
8-1. Troubleshooting Problems that are
Not Associated with a Message .......................................... 8-3
8-2. Troubleshooting Problems that are
Associated with a Message ................................................. 8-5
D-1. Treatment Parameters for Pigmented Lesions ................. D-10
D-2. Treatment Parameters for Vascular Lesions .................... D-11
E-1. Treatment Parameters for Hair Removal ......................... E-10
F-1. Treatment Parameters for Acne ......................................... F-9
Versa User Manual 1-1
Chapter 1
About this Manual
Chapter Contents:
Section Title Page
1.1. Use of the Manual ....................................................... 1-2
1.2. Scope of the Manual ................................................... 1-3
1.3. Document Conventions .............................................. 1-6
1.4. Symbols ...................................................................... 1-7
About this Manual
1-2 Versa User Manual
1.1. Use of the Manual
Warning
Use of controls or adjustments, or performance of procedures
other than those specified herein, may be hazardous and are not
authorized by Venus Concept.
Personnel operating or maintaining the system are required to
read this manual and to become thoroughly familiar with all its
safety requirements and operating procedures before attempting
to use or operate the system.
This manual has been prepared to aid medical and technical
personnel to understand and operate the system. Do not operate the
system before reading this manual and gaining a clear
understanding of system operation. If any part of this manual is not
clear, contact your Venus Concept representative for clarification.
This manual should always accompany the system, and all
personnel operating the system must know its location.
About this Manual
Versa User Manual 1-3
1.2. Scope of the Manual
This User Manual includes:
• Chapter 1: About this Manual
Provides information on the use and scope of the manual,
document conventions, and a list of the used symbols.
• Chapter 2: Safety and Regulatory Information
Provides general safety and regulatory information on the
system, its intended use, possible hazards, and compliance with
international standards, and shows the system's identification
label.
• Chapter 3: Installation
Provides information regarding the system installation, and its
electrical and environmental requirements, equipment list,
electrical connection and applicators' installation.
• Chapter 4: System Description
Describes the system's main components and their descriptions.
• Chapter 5: Operating Instructions
Provides detailed instructions on how to operate the system and
describes its main interfaces.
• Chapter 6: Advanced Features and Settings
Provides detailed information on the Tools screen and its
features.
About this Manual
1-4 Versa User Manual
• Chapter 7: Care and Maintenance
Provides information on general user care and maintenance,
including cleaning instructions.
• Chapter 8: Troubleshooting
Provides solutions to some problems that may arise while
operating the system.
• Chapter 9: Specifications
Provides a detailed list of the system's technical information and
specifications.
• Appendix A: Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
Provides a clinical guide and detailed information on how to
perform the skin treatment using the Diamond applicators.
• Appendix B: Clinical Guide for (MP)² Treatment with
Octipolar Applicator
Provides a clinical guide and detailed information on how to
perform the skin treatment using the Octipolar applicators.
• Appendix C: Clinical Guide for Fractional RF Treatment
with Viva Applicator
Provides a clinical guide and detailed information on how to
perform the skin treatment using the Viva applicators.
About this Manual
Versa User Manual 1-5
• Appendix D: Clinical Guide for SR515 and SR580
Applicators
Provides a clinical guide and detailed information on how to
perform the skin treatment using the SR applicators.
• Appendix E: Clinical Guide for Hair Removal Using IPL
HR Applicators
Provides a clinical guide and detailed information on how to
perform the hair removal treatment using the HR applicators.
• Appendix F: Clinical Guide for the ACDUAL Applicator
Provides a clinical guide and detailed information on how to
perform the skin treatment using the ACDUAL applicator.
• Appendix G: Manufacturer Warranty
Provides the manufacturer warranty.
About this Manual
1-6 Versa User Manual
1.3. Document Conventions
The following messages in this manual prompt the reader to pay
special attention to specific points:
Warning
Warnings indicate precautions and instructions which, if not
followed, may result in injury.
Caution
Cautions indicate instructions, that if not followed may result in
damage to the equipment or to the quality of treatment.
Note
Notes provide information to aid in obtaining
optimum equipment performance or procedure
results.
About this Manual
Versa User Manual 1-7
1.4. Symbols
Table 1-1 describes the symbols that are used in this manual or on
the product.
Table 1-1. Glossary of Symbols Used in this Manual or on the
Product
Symbol Description
Waste of Electrical and Electronic Equipment
(WEEE) Marking
Type BF Equipment
Manufacturer (accompanied by the name and
address of the manufacturer)
Date of Manufacture
Symbol used with an HF isolated patient circuit
Consult Instruction for Use
System that includes RF transmitters or that
applies RF electromagnetic energy for diagnosis or
treatment
About this Manual
1-8 Versa User Manual
Table 1-1. Glossary of Symbols Used in this Manual or on the
Product
Indication that the device has not been sterilized
Do not re-use, single use, use only once
Warning:
A Warning alerts the user to the possibility of
serious injury, death, or serious adverse reactions
associated with the use or misuse of the system.
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.
Indicates that Federal (USA) law restricts this
device to sale by or on the order of a physician or
licensed practitioner.
Versa User Manual 2-1
Chapter 2
Safety and Regulatory
Information
Chapter Contents:
Section Title Page
2.1. Introduction................................................................. 2-2
2.2. Intended Use ............................................................... 2-3
2.3. Intended User and Environment ................................. 2-3
2.4. Safety Information ...................................................... 2-4
2.5. Electrical and Mechanical Safety ............................... 2-7
2.6. Fire Safety ................................................................... 2-8
2.7. Protective Eyewear ..................................................... 2-8
2.8. Optical Safety during the IPL Treatment.................... 2-9
2.9. RF Treatment Safety Precautions ............................. 2-10
2.10. Compliance with International Standards ................. 2-11
2.11. System Safety Features ............................................. 2-12
2.12. Electromagnetic Compatibility ................................. 2-13
2.13. System Labels ........................................................... 2-18
2.14. Contact Information .................................................. 2-20
Safety and Regulatory Information
2-2 Versa User Manual
2.1. Introduction
Warning
Read this chapter carefully to be familiar with all of safety
requirements and procedures prior to operating the system.
The system is designed for a safe and reliable treatment when used
in accordance with proper operating and maintenance procedures
as outlined in this manual. Only qualified personnel, trained by an
authorized trainer, can use the system and perform the treatments.
The operator and all other personnel operating or maintaining the
system should be familiar with all of the safety information
provided in this manual.
The primary objective should always be in maximizing the safety
of both the client and the treatment operator.
You should carefully read the User Manual instructions before
installing or using the system to become familiar with all safety
requirements and operating procedures, and thereby prevent
accidents, injury and reduce the risk of damaging the machine.
The Venus Versa is designed for professional use only. The
manufacturer cannot be held responsible for damage or injury
caused by improper use or for uses other than those for which this
machine is intended.
Safety and Regulatory Information
Versa User Manual 2-3
2.2. Intended Use
The Venus Versa system is a multi-application device intended to
be used in aesthetic and cosmetic procedures.
For information on the system's intended use, see the Indications
and Contraindications sections in Appendices A, B, C, D, E and F
of this User Manual.
2.3. Intended User and Environment
Warning
The device is intended to be used by professional practitioners
in the aesthetic field, such as physicians, nurses and other
trained practitioners.
• The operator should stand near the client during system
operation.
• The operator is not allowed to leave a client during the entire
treatment.
Safety and Regulatory Information
2-4 Versa User Manual
2.4. Safety Information
Warning
• Use of controls or adjustments, or performance of
procedures other than those specified herein, may result in
hazardous radiation exposure and are not authorized by
Venus Concept.
• Personnel operating or maintaining the system are required
to read this manual and to become thoroughly familiar with
all its safety requirements and operating procedures before
attempting to use or operate the system.
• The system should be protected against unauthorized use.
Make sure that only authorized users have access to the
system's Login code.
• High voltage is present inside the system. Do not attempt to
open its casing.
• Always be aware of the possible dangers of using the system
and take proper precautions as described in this manual.
• The system must be serviced by Venus Concept authorized
service personnel only.
• Failure of the system could result in an unintended increase
of output power.
• Any radiofrequency (RF) device can cause injury if used
improperly.
Safety and Regulatory Information
Versa User Manual 2-5
• All operators must be familiar with the system controls and
know how to shut down the system in case of a problem.
• Do not touch the inner parts of the system. The system services
and repairs must be performed by qualified personnel only.
Failure to do so will void all service agreements.
• Disconnect the system from the mains power supply before
servicing (pull out the plug from the electricity socket).
• Do not use the system unless all enclosure panels are properly
in place.
• Do not tamper with the controls or attempt to open up the
system.
• Do not abuse, sit or lean on the system.
• The system should be kept out of the reach of children.
• A patient history should be completed prior to treatment to
ensure that no complications could arise. It is important to
verify that the client does not fall under the exclusion criteria.
• The product should not be in contact with other equipment.
• For patients with cardiac pacemakers or other active implants, a
possible hazard exists because interference with the action of
the pacemakers may occur, or the pacemaker may be damaged.
In case of doubt, approved qualification advice should be
obtained.
• This equipment/system may cause radio interference or may
disrupt the operation of nearby equipment. It may be necessary
to take mitigation measures, such as reorienting or relocating.
• Portable and mobile RF communications equipment can affect
the system.
Safety and Regulatory Information
2-6 Versa User Manual
• The patient should be fully informed of the treatment protocol
and the expected results, and should sign the informed consent
form prior to beginning of the treatments.
• Only authorized persons are allowed to stand near the system
during the treatment.
• Stop the treatment in case of unexpected changes in the client’s
condition.
• Do not drop the applicators. If an applicator is dropped, turn off
the system immediately. Do not use a broken applicator and call
the local service support.
• There are no user-serviceable parts inside the system. ONLY
Venus-AUTHORIZED PERSONNEL MAY SERVICE THE
SYSTEM, ESPECIALLY INSIDE ITS CABINET.
• Do not allow the applicators to come in contact with hard
materials that could damage their tips.
• The tip of the Viva applicator is for single use only.
Safety and Regulatory Information
Versa User Manual 2-7
2.5. Electrical and Mechanical Safety
• Keep all covers and panels of the system closed. Removing the
covers creates a safety hazard.
• Perform maintenance procedures only when the system is shut
down and disconnected from the mains power.
• Move the system slowly and carefully. The system weighs
approximately 50 kg (110 lbs) and may cause injury if proper
care is not taken when moving it.
• The system is grounded through the grounding conductor in the
power cord. This protective grounding is essential for safe
operation.
Safety and Regulatory Information
2-8 Versa User Manual
2.6. Fire Safety
Warning
There is risk of fire if the system is used in the presence of
flammable materials, solutions or gases, or in an oxygen
enriched environment. Some materials, e.g. darkly colored
clothing or cotton wool, when saturated with oxygen, may be
ignited by the high temperatures produced in normal use of the
equipment.
• Do not use the system in the presence of explosive or
flammable materials.
• Do not use flammable substances when preparing the skin for
treatment.
• If germicide swipes is used for cleaning and disinfecting the
system, it must be allowed to fully dry before the system can be
used again.
2.7. Protective Eyewear
• Exposure to intense pulsed light requires eye protection. Make
sure to wear eye goggles during the IPL treatment.
• The patient has to wear eye cover during the IPL treatment.
Safety and Regulatory Information
Versa User Manual 2-9
2.8. Optical Safety during the IPL
Treatment
• Do not direct the light from the treatment head at anything other
than the targeted area.
• Do not allow reflective objects such as jewelry, watches,
surgical instruments or mirrors to reflect the pulsed light.
• Do not expose any part of the skin, except for the test patch and
the treatment area to the light pulse.
• Do not look directly into the IPL aperture of the treatment head,
even if you are wearing safety glasses.
• The IPL treatment room should be clearly identified with a
caution sign, as shown in Figure 2-1.
CAUTION
INTENSE PULSED LIGHT DEVICE
(VISIBLE TO NEAR INFRARED)
USE PROPER EYE PROTECTION
WHEN OPERATING AND/OR
TREATING PATIENTS
Figure 2-1. IPL Treatment Room Caution Sign
Safety and Regulatory Information
2-10 Versa User Manual
2.9. RF Treatment Safety Precautions
Warning
• RF used in this device can cause injury if used improperly.
• Applicator tip is for single use and has to be cleaned prior to
use.
• Do not allow the applicators to come in contact with metal
elements, as this could damage the (MP)2 electrodes.
• The patient should not come into contact with metal parts which
are earthed or which have an appreciable capacitance to earth
(for example operating table supports, etc.). Use of antistatic
sheeting is recommended for this purpose.
• Applicators' cables should be positioned in such a way that they
do not come in contact with the patient or with other leads.
• Interference produced by the operation of HF surgical
equipment may adversely influence the operation of other
electronic equipment.
• Keep the bodies of the applicators clean. Pay particular
attention to the applicator's RF electrodes. Check the integrity
of all components.
• The applicator tip should be changed for each patient.
• The applicator tip must be cleaned before using it for the first
time. Make sure that the applicator tip is clean before each
treatment.
• Keep your hands away from the applicators during the system
start-up.
Safety and Regulatory Information
Versa User Manual 2-11
2.10. Compliance with International
Standards
Warning
• Federal (USA) law restricts this device to sale by or on the
order of a physician or licensed practitioner.
• Prior the first treatment, the patient has to fill the Health
Declaration Form. If there are one or more positive answers,
treatment is not allowed.
The Venus Versa system complies with the following standards:
• EN 60601-1: Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential Performance
• IEC 60601-1-2: Medical electrical equipment - Part 1-2:
General requirements for safety Collateral Standard:
Electromagnetic compatibility - Requirements and tests
• IEC 60601-2-57 Medical Electrical Equipment - Part 2-57:
Particular requirements for the basic safety and essential
performance of non-laser light source equipment intended for
therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• IEC 60601-2-2 Medical electrical equipment - Part 2-2:
Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and high
frequency surgical accessories
Safety and Regulatory Information
2-12 Versa User Manual
2.11. System Safety Features
• The system is password-protected and does not allow the user to
enter the Treatment screen without entering the correct Login
code.
• Emission of treatment pulses are disabled unless the user
presses the Ready button to place the system in the Ready state.
When the system is in the Ready state, pressing any button on
the screen will set the system back to the Standby state in which
pulse emission is disabled.
• The system is equipped with an Emergency button which shuts
down the system immediately in an emergency situation.
Safety and Regulatory Information
Versa User Manual 2-13
2.12. Electromagnetic Compatibility
Table 2-1. Manufacturer's declaration – Electromagnetic
Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The Venus Versa is intended for use in the electromagnetic environment specified
below. The customer or the user of Venus Versa should assure that it is used in
such an environment.
Emissions Test Compliance Electromagnetic Environment –
Guidance
RF emissions
CISPR 11
Group 2 The Venus Versa must emit electromagnetic
energy in order to perform its
intended function. Nearby electronic
equipment may be affected.
RF emissions
CISPR 11
Class B
Harmonic
emissions IEC
61000-3-2
Class A
Voltage
fluctuations/ flicker
emissions IEC
61000-3-3
Complies The Venus Versa is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.
RF emissions
CISPR 14-1
Complies The Venus Versa is not suitable for
interconnection with other equipment.
RF emissions
CISPR 15
Complies The Venus Versa is not suitable for
interconnection with other equipment.
Safety and Regulatory Information
2-14 Versa User Manual
Table 2-2. Manufacturer's Declaration – Electromagnetic
Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The Venus Versa is intended for use in the electromagnetic environment specified
below. The customer or the user of the Venus Versa should assure that it is used
in such an environment.
Emissions
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment – Guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±6kV contact ±8
kV air
±6kV contact
±8kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power
supply lines;
±1kV for I/O
lines
±2kV for power
supply lines;
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge IEC
61000-4-5
±1kV line(s) to
line(s) ;
±2kV line(s) to
earth
±1kV line to line;
±2kV line(s) to
earth
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<5% UT (>95%
dip in UT) for 0,5
cycle
40% UT (60%
dip in UT) for 5
cycles
70 % UT (30%
dip in UT) for 25
cycles
<5% UT (>95%
dip in UT) for 5s
<5% UT (>95%
dip in UT) for 0,5
cycle
40 % UT (60%
dip in UT) for 5
cycles
70 % UT (30%
dip in UT) for 25
cycles
<5% UT (>95%
dip in UT) for 5s
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the ME equipment or
ME system requires continued
operation during power mains
interruptions, it is
recommended that the ME
equipment or ME system be
powered from an
uninterruptible power supply or
a battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m,
50 Hz @ 230
VAC mains;
60 Hz @ 120
VAC mains
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the AC mains voltage prior to application of the test level.
Safety and Regulatory Information
Versa User Manual 2-15
Table 2-3. Manufacturer's Declaration – Electromagnetic
Immunity that is not Life-Supporting
Guidance and manufacturer’s declaration – electromagnetic immunity
The Venus Versa is intended for use in the electromagnetic environment specified
below. The customer or the user of Venus Versa should assure that it is used in
such an environment.
Emissions
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment –
Guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
V1 = 3 Vrms
150 kHz to
80 MHz
E1 = 3 V/m
80 MHz to
2,5 GHz
Portable and mobile RF
communications equipment should be
used no closer to any part of the ME
equipment or ME system, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Where P is the maximum output
power rating of the transmitter in Watts
(W) according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Safety and Regulatory Information
2-16 Versa User Manual
Table 2-3. Manufacturer's Declaration – Electromagnetic
Immunity that is not Life-Supporting (Cont.)
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Venus Versa is used
exceeds the applicable RF compliance level above, the Venus Versa should be
observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the
Venus Versa.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than [V1] V/m.
Safety and Regulatory Information
Versa User Manual 2-17
Table 2-4. Recommended Separation Distances between
Portable and Mobile RF Communications Equipment and the
ME Equipment or ME System that is not Life-Supporting
Recommended separation distances between portable and mobile RF
communications equipment and the Venus Versa
The Venus Versa is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Venus
Versa can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the Venus Versa as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency
of transmitter (m)
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
Safety and Regulatory Information
2-18 Versa User Manual
2.13. System Labels
Figure 2-2 and Figure 2-3 show the labels that are affixed on the
rear side of the system console.
Figure 2-2. System Identification Label
Safety and Regulatory Information
Versa User Manual 2-19
Figure 2-3. Light Emission Warning Label
Safety and Regulatory Information
2-20 Versa User Manual
2.14. Contact Information
USA: Venus Concept USA Inc.
4556 N. Hiatus Road, Sunrise, FL 33351
United States
Tel.: 1.416.907.0115
Fax: 954.572.5680
Canada: 255 Consumers Rd. Suite 100,
Toronto, Ontario. M2J 1R4, Canada
International:
Hachermesh Street Bld. 62,
Karmiel 21652, Israel
For Latin America and the Caribbean, call 1-888-907-0115.
For all other inquires, contact:
Venus Concept
3 HaBarzel St.
Tel Aviv 69710, Israel
Tel.: +972 3 647 1882
General Inquiries: [email protected]
Service Inquiries: [email protected]
Clinical Inquiries: [email protected]
Website: www.venusconcept.com
Versa User Manual 3-1
Chapter 3
Installation
Chapter Contents:
Section Title Page
3.1. Installing the System ................................................... 3-2
3.2. Electrical Requirements .............................................. 3-2
3.3. Environmental Requirements ..................................... 3-3
3.4. Equipment List............................................................ 3-4
3.5. Connecting the System to the Mains Power ............... 3-5
3.6. Connecting the Applicators ........................................ 3-6
Installation
3-2 Versa User Manual
3.1. Installing the System
The system must be installed only by a qualified Venus Concept
technician.
3.2. Electrical Requirements
The system should be connected to a mains power supply with the
following output:
• Single phase
• 100-240 VAC
• 1.2 kW (Max.)
• 50-60 Hz
As long as the electrical outlet meets the above requirements, the
system automatically adjusts itself to the local mains voltage.
Warning
• For continued protection against fire, only fuses that are
indicated on the system label can be installed in the system.
• Only use a compatible power cord which is approved for the
local mains electricity.
Installation
Versa User Manual 3-3
3.3. Environmental Requirements
• Corrosive materials can damage the electronic parts. Ensure that
the environment is free from corrosive material.
• Metallic dust can damage the electrical equipment. Ensure that
the environment is free from metallic dust.
• For optimal operation, the system should be placed in a room
with an ambient temperature of 15º-30ºC (59º-86ºF), a relative
humidity of less than 80%, and an altitude of up to 3000m.
• For optimal storage, system should be stored (with water
removed) in a room with an ambient temperature of -20°C to
55°C (-4°F to 131°F) and a relative humidity of 0-90% @ 55°C
non-condensing.
• For optimal transportation, the system should be transported
(with water removed) at a temperature range of -20ºC to 55ºC
(-4ºF to 131ºF), at a relative humidity of less than 80%, and an
altitude of up to 15000m.
Installation
3-4 Versa User Manual
3.4. Equipment List
The system includes the following:
• System console
• SR515 Applicator (optional detachable accessory)
• SR580 Applicator (optional detachable accessory)
• HR650 Applicator (optional detachable accessory)
• HR690 Applicator (optional detachable accessory)
• HR650XL Applicator (optional detachable accessory)
• HR690XL Applicator (optional detachable accessory)
• ACDUAL IPL Applicator (optional detachable accessory)
• Diamondpolar Applicator (optional detachable accessory)
• Octipolar Applicator (optional detachable accessory)
• Viva Applicator (optional detachable accessory)
• Goggles
• Patient eye protectors
• Ultrasonic gel
• Power cord
• User Manual
Installation
Versa User Manual 3-5
3.5. Connecting the System to the
Mains Power
To connect the system to electricity:
1. Connect the power cable to the power connection port, as
shown in Figure 3-1.
Power
Connection
Port
Figure 3-1. Power Connection Port
on the System's Rear Side
2. Plug the other end of the power cable to the mains power
supply.
Installation
3-6 Versa User Manual
3.6. Connecting the Applicators
3.6.1. Connecting the IPL Applicator
To connect an IPL applicator:
1. Insert the applicator's cable connector to its receptacle on the
system console, as shown in Figure 3-2.
Figure 3-2. Connecting the IPL Applicator's Cable
Connector
2. Rotate the cable connector clockwise to lock it in place.
3. Place the applicator in its cradle.
To disconnect an IPL applicator:
1. Rotate the applicator's cable connector counter-clockwise to
unlock it.
2. Pull the cable connector out of its receptacle
Installation
Versa User Manual 3-7
3.6.2. Connecting the RF Applicators
To connect an RF applicator:
1. Insert the applicator's RF cable connector to its receptacle on
the system console.
Figure 3-3. Connecting the RF Applicator's Cable
Connector
2. Rotate the cable connector clockwise to lock it in place.
3. Place the applicator in its cradle.
To disconnect an RF applicator:
1. Rotate the applicator's cable connector counter-clockwise to
unlock it.
2. Pull the cable connector out of its receptacle.
Installation
3-8 Versa User Manual
3.6.3. Connecting the Viva Applicator Tip
To connect a tip to the Viva applicator:
1. Hold the tip with its printed lot number facing bottom-right.
2. Align the tip with the applicator, as shown in Figure 3-4.
Figure 3-4. Connecting a Tip to the Viva Applicator
3. Push the tip into the applicator's tip connection port until it
clicks in.
To disconnect the tip from the Viva applicator:
1. From under the applicator's tip connection port press the
release button to disengage the tip.
2. Remove the tip.
Versa User Manual 4-1
Chapter 4
System Description
Chapter Contents:
Section Title Page
4.1. General Description .................................................... 4-2
4.2. System Components ................................................... 4-3
4.3. IPL Applicators ......................................................... 4-12
4.4. RF Applicators .......................................................... 4-19
System Description
4-2 Versa User Manual
4.1. General Description
The Venus Versa system is a non-invasive IPL and RF skin
treatment device intended for use in dermatological procedures
(see Appendices A, B, C, D, E and F).
System Description
Versa User Manual 4-3
4.2. System Components
Figure 4-1 shows the Venus Versa system components.
Touch
Screen
IPL
Applicator
IPL
Applicator
Holder
Top
Handle
Front
Handle
Emergency
Button
System
Console
Cable Holder Pillar
Figure 4-1. System Components
System Description
4-4 Versa User Manual
4.2.1. System Console
The system console is the main enclosure that holds and contains
all external and internal system components.
4.2.2. Touch Screen
The touch screen is the primary means of communication between
the user and the system.
The on-screen graphical user interface keeps the user informed of
the system status and operating parameters at all times.
Via the touch screen, the user controls and monitors the system
operation, using the touch-sensitive buttons and indicators.
System Description
Versa User Manual 4-5
4.2.3. Emergency Button
Figure 4-2 shows the emergency button, which is located on the
front side of the system console.
Emergency
Button
Figure 4-2. Emergency Button
Pressing the emergency button shuts down the system immediately.
To resume the system operation, turn the emergency button
clockwise, to release it (the button pops out), and then restart the
system.
System Description
4-6 Versa User Manual
4.2.4. IPL Applicator Connection
Receptacle
Figure 4-3 shows the IPL applicator connection receptacle, which
is located on top of the system console.
Figure 4-3. IPL Applicator Connection Receptacle
The IPL applicator connection receptacle is the port that connects
the IPL applicator to the system.
System Description
Versa User Manual 4-7
4.2.5. RF Applicator Connection
Receptacles
Figure 4-4 shows the RF applicator connection receptacles, which
is located on top of the system console.
Figure 4-4. RF Applicator Connection Receptacles
The RF applicator connection receptacles are the ports that connect
the RF applicators to the system.
System Description
4-8 Versa User Manual
4.2.6. IPL Applicator Holder
Figure 4-5 shows the IPL applicator holder, which is located on the
right side of the system console.
Figure 4-5. IPL Applicator Holder
The IPL applicator holder is the cradle that holds the IPL
applicator, when the applicator is not in use.
Caution
To prevent damage to an applicator, make to place the
applicator in its designated holder when it is not in use.
System Description
Versa User Manual 4-9
4.2.7. RF Applicator Holders
Figure 4-6 shows the RF applicator holders, which is located on the
left side of the system console.
Figure 4-6. RF Applicator Holders
The RF applicator holders are the cradles that hold the RF
applicators, when the relevant applicator is not in use.
Caution
To prevent damage to an applicator, make to place the
applicator in its designated holder when it is not in use.
System Description
4-10 Versa User Manual
4.2.8. Main Power Switch
Figure 4-7 shows the main power switch, which is located on the
rear side of the system console.
Main
Power
Switch
Figure 4-7. Main Power Switch
The main power switch is used to turn the system on and off.
System Description
Versa User Manual 4-11
4.2.9. Power Connection Port
Figure 4-8 shows the power connection port, which is located on
the rear side of the system console.
Power
Connection
Port
Figure 4-8. Power Connection Port
The power connection port is the electrical receptacle for the
power cord, which connects the system to mains electricity.
System Description
4-12 Versa User Manual
4.3. IPL Applicators
4.3.1. SR515 Applicator
Figure 4-9 shows the SR515 applicator.
Figure 4-9. SR515 Applicator
The SR515 applicator is intended for treatments of pigmented and
vascular lesions.
System Description
Versa User Manual 4-13
4.3.2. SR580 Applicator
Figure 4-10 shows the SR580 applicator.
Figure 4-10. SR580 Applicator
The SR580 applicator is intended for treatments of pigmented and
vascular lesions.
System Description
4-14 Versa User Manual
4.3.3. HR650 Applicator
Figure 4-11 shows the HR650 applicator.
Figure 4-11. HR650 Applicator
The HR650 applicator is intended for hair removal treatments.
System Description
Versa User Manual 4-15
4.3.4. HR690 Applicator
Figure 4-12 shows the HR690 applicator.
Figure 4-12. HR690 Applicator
The HR690 applicator is intended for hair removal treatments.
System Description
4-16 Versa User Manual
4.3.5. HR650XL Applicator
Figure 4-13 shows the HR650XL applicator.
Figure 4-13. HR650XL Applicator
The HR650XL applicator is intended for hair removal treatments.
System Description
Versa User Manual 4-17
4.3.6. HR690XL Applicator
Figure 4-14 shows the HR690XL applicator.
Figure 4-14. HR690XL Applicator
The HR690XL applicator is intended for hair removal treatments.
System Description
4-18 Versa User Manual
4.3.7. ACDUAL Applicator
Figure 4-14 shows the ACDUAL applicator.
Figure 4-15. ACDUAL Applicator
The ACDUAL applicator is intended for the treatment of Acne
Vulgaris.
System Description
Versa User Manual 4-19
4.4. RF Applicators
4.4.1. Diamondpolar Applicator
Figure 4-16 shows the Diamondpolar applicator.
Figure 4-16. Diamondpolar Applicator
The proposed intended use for the Diamondpolar applicator is:
"Use in dermatological procedures requiring treatment of
moderate to severe facial wrinkles and rhytides in Fitzpatrick skin
types I-IV."
System Description
4-20 Versa User Manual
4.4.2. Octipolar Applicator
Figure 4-17 shows the Octipolar applicator.
Figure 4-17. Octipolar Applicator
The proposed intended use for the Octipolar applicator is:
"Use in body contouring via Skin Tightening, Circumferential
Reduction, and Cellulite Reduction."
System Description
Versa User Manual 4-21
4.4.3. Viva Applicator
Figure 4-18 shows the Viva RF applicator.
Figure 4-18. Viva Applicator
The proposed intended use for the Viva applicator is:
"Use in dermatological procedures requiring ablation and
resurfacing of the skin."
System Description
4-22 Versa User Manual
Versa User Manual 5-1
Chapter 5
Operating Instructions
Chapter Contents:
Section Title Page
5.1. Turning the System On/Off ........................................ 5-2
5.2. Logging In ................................................................... 5-4
5.3. Selecting the Desired Applicator ................................ 5-6
5.4. Treatment Modes and Parameters .............................. 5-7
5.5. Setting the Treatment Parameters ............................. 5-21
5.6. Using Preset Parameters in the (MP)2
Treatment Mode ....................................................... 5-22
5.7. Emitting the Treatment Energy ................................ 5-25
Operating Instructions
5-2 Versa User Manual
5.1. Turning the System On/Off
To turn on the system:
1. Verify that the Emergency button is not pressed. If it is, turn it
clockwise to release the button (the button pops out).
2. Verify that the power cord is connected to the power
connection port on the rear side of the system console, as
shown in Figure 5-1.
3. Verify that the power cord is plugged into the mains power
supply.
4. From the rear side of the system console, turn on the main
power switch, as shown in Figure 5-1.
Main
Power
Switch
Power
Cord
Figure 5-1. Power Connection Port
Operating Instructions
Versa User Manual 5-3
5. Verify that the system powers up and the login screen appears,
as shown in Figure 5-2.
Figure 5-2. Login Screen
To turn off the system:
1. From the rear side of the system console, turn off the main
power switch.
2. Verify that the system is turned off.
Note
To turn off the system immediately in an
emergency situation, press the Emergency
button.
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5-4 Versa User Manual
5.2. Logging In
To log in:
1. In the login screen (see Figure 5-2), enter the 8 character code
which is provided with the installation documents, as shown
in Figure 5-3.
Figure 5-3. Entering the Login Code
Operating Instructions
Versa User Manual 5-5
2. Press the Confirm button ; the Treatment screen appears,
as shown in Figure 5-4.
Figure 5-4. Treatment Screen
(with the Diamondpolar Applicator Selected)
Note
It is recommended to change initial Login code,
as described in Chapter 6.
Operating Instructions
5-6 Versa User Manual
5.3. Selecting the Desired Applicator
To select an applicator:
1. Verify that the Treatment screen appears, as shown in Figure
5-4.
2. Use the left/right arrows of the applicator selector, as shown
in Figure 5-5, to select the desired applicator.
Figure 5-5. Applicator Selector (with the Diamondpolar
Applicator Selected)
Note
• Only applicators that are physically
connected to the system can be selected.
• Upon selecting an applicator, the system
displays the treatment screen for that
applicator (showing the relevant parameters
for the selected applicator).
Operating Instructions
Versa User Manual 5-7
5.4. Treatment Modes and Parameters
The system operates in the following treatment modes, according
to the selected applicator:
• (MP)2 treatment mode
Used with the following applicators:
 Diamondpolar applicator
 Octipolar applicator
• Fractional RF treatment mode
 Used with the Viva applicator
• IPL treatment mode
Used with the following applicators:
 SR515 applicator
 SR580 applicator
 HR650 applicator
 HR690 applicator
 HR650XL applicator
 HR690XL applicator
 ACDUAL applicator
For each treatment mode, the system displays the appropriate
parameters in the Treatment screen.
Operating Instructions
5-8 Versa User Manual
5.4.1. (MP)2 Treatment Mode
Figure 5-6 shows the (MP)2 mode Treatment screen.
7
3
9
11
13
12
1
6
8
10
14
5 4
2
Figure 5-6. Elements of the (MP)2 Mode Treatment Screen
(with the Octipolar Applicator Selected)
Elements of the (MP)2 mode Treatment screen, as indicated by
numbers in Figure 5-6, are described below.
1. Applicator selector – Indicates the currently-selected
applicator and enables you to select any applicator that is
connected to the system by pressing the Left/Right arrows.
Indicates that the selected applicator is
Diamondpolar.
Indicates that the selected applicator is
Octipolar.
Operating Instructions
Versa User Manual 5-9
2. Preset button – Displays the Preset screen (see section 5.6,
on page 5-22).
3. Tools button – Displays the Tools screen (see Chapter 6).
4. Energy button – Resets the Energy setting.
5. Numerical temperature indicator – Displays the real-time
numerical value of the patient's skin temperature, as measured
by the applicator's built-in thermometer. Touching the
indicator, toggles the temperature value between Celsius and
Fahrenheit degrees.
6. Graphical temperature indicator – Displays the graph of the
patient's skin temperature versus time. The graph background
is divided into three areas:
• Blue area, indicating that the skin temperature is less than
the optimal value for effective treatment.
• Yellow area, indicating that the skin temperature is optimal
for effective treatment.
• Red area, indicating that the skin temperature is too high.
7. Energy controller – Enables you to set the output energy for
the connected applicator, as a percentage (0 - 100%) of the
maximum (MP)2 energy output (150W for Octipolar, and 75W
For Diamondpolar applicator), by pressing the -/+ buttons.
8. Treatment Time button – Resets the Treatment Time to
zero.
9. Treatment Time controller – Enables you to set the desired
treatment time in minutes (0 - 30 minutes) by pressing the -/+
buttons.
10. Interval Timer button – Resets the countdown timer (to the
user-set Interval Time).
Operating Instructions
5-10 Versa User Manual
11. Interval Timer controller – Enables you to set a timer, to
assist in dividing the treatment time into smaller time
segments, by pressing the -/+ buttons.
This feature can be useful when a large treatment area is
divided into smaller sections which are to be treated
individually.
The Interval Timer starts counting down when the treatment is
initiated and beeps when timer reaches zero. It then starts
another countdown cycle. This sequence is repeated for as
long as the treatment is in progress.
On the Interval Timer controller's display:
• The upper time indicator shows the user-set interval time
(which can be set to 0 - 30 minutes).
• The lower time indicator shows the countdown timer
(which starts from the user-set interval time and beeps
when the timer reaches zero).
12. Stop button – Ends the current treatment session.
Upon pressing the Stop button, the system displays the End of
Treatment message and resets the treatment parameters.
13. Start button – Starts a new treatment session or resumes a
paused one.
Upon pressing the Start button:
• The Start button color changes to green.
• The selected applicator starts emitting (MP)2 energy.
• The treatment timer countdown starts.
Operating Instructions
Versa User Manual 5-11
14. Pause button – Pauses the treatment, without changing the
selected treatment settings.
Upon pressing the Pause button:
• The Pause button color changes to red.
• The (MP)2 energy emission stops.
• The treatment timer countdown stops.
Pressing the Start button resumes the treatment.
Operating Instructions
5-12 Versa User Manual
5.4.2. Fractional RF Treatment Mode
Figure 5-7 and Figure 5-8 show the regular and advanced
Treatment screens of the Fractional RF mode (respectively).
4
2
6
8
10
9
1
3
5
7
11
12
Figure 5-7. Elements of the Fractional RF Mode
Treatment Screen
16
14
13
15
Figure 5-8. Elements of the Fractional RF Mode
Advanced Treatment Screen
Operating Instructions
Versa User Manual 5-13
Elements of the Fractional RF mode Treatment screens, as
indicated by numbers in Figure 5-7 and Figure 5-8, are described
below.
1. Applicator selector – Indicates the currently-selected
applicator and enables you to select any applicator that is
connected to the system by pressing the Left/Right arrows.
Indicates that the selected applicator is Viva.
2. Tools button – Displays the Tools screen (see Chapter 6).
3. Energy button – Resets the Energy setting.
4. Energy controller – Enables you to set the output energy for
the Viva applicator, as a percentage (11 - 100%) of the
maximum energy output, by pressing the -/+ buttons.
5. Pattern Group button – Toggles between pattern groups
I and II.
Indicates that the selected pattern group is I.
Indicates that the selected pattern group is II.
Operating Instructions
5-14 Versa User Manual
6. Pattern selector – Enables you to select the desired pattern in
each pattern group by pressing the Left/Right arrows.
The preset patterns (shown below) determine the footprint of
the applicator pin by setting the tip's active pins during RF
emission.
Operating Instructions
Versa User Manual 5-15
7. Repeat Mode button – Enables you to activate/deactivate the
Repeat mode (repetitive pulsing).
8. Repeat Mode controller – Enables you to set the time
interval between pulses in the Repeat mode, by pressing the
-/+ buttons.
9. Standby button –
• Places the system in the Standby state in which pulse
emission is disabled.
• Illuminates in yellow when the system is in the Standby
state.
• Changes to gray when the system is in the Ready state.
10. Ready button –
• Places the system in the Ready state in which pulse
emission is enabled.
• Illuminates in green when the system is in the Ready state.
• Flashes (for a few seconds) during the transition from
Standby to Ready state.
• Changes to solid gray when the system is in the Standby
state.
Note
• The system's default state is Standby and
changes to Ready only when the Ready
button is pressed.
• When the system is in the Ready state,
pressing any button on the screen will set
the system back to the Standby state.
Operating Instructions
5-16 Versa User Manual
11. Advanced Settings button – Displays the Fractional RF
mode's Advanced Treatment screen, as shown in Figure 5-8,
enabling qualified users to control additional parameters of
the Viva applicator.
12. Pulse Counter – Indicates the remaining number of pulses out
of the total number of pulses of the connected applicator tip.
Once the remaining pulses are consumed, a message appears,
warning that the tip needs to be replaced.
13. Pulse Profile controller – Displays the pulse profile graph
and enables you to control the parameters that determine the
output energy of the Viva applicator, which are the pulse
duration (X axis) and amplitude (Y axis).
The graph displays the resultant RF energy output as a
percentage of the maximum RF energy output.
14. Pulse Amplitude controller – Enables you to select the
desired pulse amplitude (in Volts), by pressing the -/+ buttons.
15. Pulse Duration controller – Enables you to select the desired
pulse duration (in milliseconds), by pressing the -/+ buttons.
16. Save Profile buttons – Enable you to save the set pulse
profile, as determined by pulse duration and pulse amplitude,
for easy access in future treatments. Up to four profiles can be
saved, using buttons 1, 2, 3 and 4.
• To save a profile, press and hold the desired button for
three seconds. Saving a profile to a button overwrites and
deletes any previously saved profile to that button.
• To recall a saved profile, press the button to which the
profile was saved.
Operating Instructions
Versa User Manual 5-17
5.4.3. IPL Treatment Mode
Figure 5-9 shows the IPL mode Treatment screen.
1
7
3
5
9
11
13
14
12
2
4
6
8
10
Figure 5-9. Elements of the IPL Mode Treatment Screen
(with the HR690 IPL Applicator Selected)
Elements of the IPL mode Treatment screen, as indicated by
numbers in Figure 5-9, are described below.
1. Skin Type selector – Enables you to select the skin type that
matches that of the patient, according to Fitzpatrick's Skin
Type category I-VI, by pressing the Left/Right arrows.
2. Contact Cooling controller –
• Enables you to set the cooling level (0% to 100%) for SR515, SR580
and ACDUAL IPL applicators, by pressing the -/+ buttons.
• The cooling level cannot be altered if certain skin types are
selected.
• For HR650, HR690, HR650XL and HR690XL IPL applicators
the cooling level is locked at 100% and cannot be altered.
Operating Instructions
5-18 Versa User Manual
3. Cooling button – Resets the Contact Cooling level.
4. Applicator selector – Indicates the currently-selected
applicator and enables you to select any applicator that is
connected to the system by pressing the Left/Right arrows.
Indicates that the selected applicator is SR515.
Indicates that the selected applicator is SR580.
Indicates that the selected applicator is HR650.
Indicates that the selected applicator is HR690.
Indicates that the connected applicator is
HR650XL.
Indicates that the connected applicator is
HR690XL.
Indicates that the connected applicator is
ACDUAL.
Operating Instructions
Versa User Manual 5-19
5. Tools button – Displays the Tools screen (see Chapter 6).
6. Fluence button – Resets the fluence.
7. Fluence controller – Enables you to set the output fluence
(in J/cm2) for the connected IPL applicator by pressing the -/+
buttons.
8. Pulse Duration button – Resets the pulse duration.
9. Pulse Duration controller – Enables you to set the pulse
duration (in msec) by pressing the -/+ buttons.
10. Repeat Mode button – Enables you to activate/deactivate the
Repeat mode (repetitive pulsing).
11. Repeat Mode controller – Enables you to set the time
interval between pulses in the Repeat mode, by pressing the
-/+ buttons.
12. Standby button –
• Places the system in the Standby state in which pulse
emission is disabled.
• Illuminates in yellow when the system is in the Standby
state.
• Changes to gray when the system is in the Ready state.
13. Ready button –
• Places the system in the Ready state in which pulse
emission is enabled.
• Illuminates in green when the system is in the Ready state.
• Flashes (for a few seconds) during the transition from
Standby to Ready state.
• Changes to solid gray when the system is in the Standby
state.
Operating Instructions
5-20 Versa User Manual
Note
• The system's default state is Standby and
changes to Ready only when the Ready
button is pressed.
• When the system is in the Ready state,
pressing any button on the screen will set
the system back to the Standby state.
14. Pulse Counter – Indicates the number of pulses that have
been fired in the current treatment session. To reset the Pulse
Counter, press it continuously.
Operating Instructions
Versa User Manual 5-21
5.5. Setting the Treatment Parameters
To set the treatment parameters:
1. Verify that the Treatment screen is displayed, as shown in
Figure 5-4.
2. Verify that the Applicator selector indicates the actual
applicator that is to be used.
3. Using the Skin Type selector, select the skin type that matches
that of the patient, according to Fitzpatrick's Skin Type
category I-V.
4. Using the Fluence controller, set the desired fluence.
5. Using the Pulse Duration controller, set the desired pulse
duration.
6. If Repeat mode is to be used, press the Repeat Mode button to
activate it and use the Repeat Mode controller to set the
number of pulses per second.
7. For SR515 and SR580 IPL applicators, use the Contact
Cooling controller to set the desired cooling level.
Note
• The cooling level cannot be altered if
certain skin types are selected.
• For HR650, HR690, HR650XL and
HR690XL IPL applicators the cooling level
is locked at 100% and cannot be altered.
Operating Instructions
5-22 Versa User Manual
5.6. Using Preset Parameters in the
(MP)2 Treatment Mode
The system provides six sets of treatment parameters, which can be
recalled, as desired, in the (MP)2 treatment mode (with
Diamodpolar and Octipolar applicators).
5.6.1. Recalling the Preset Treatment
Parameters
To recall a preset:
1. From the (MP)2 mode Treatment screen (see Figure 5-6),
press the Preset button (as described in section 5.4.1, on page
5-8); the Preset screen appears, as shown in Figure 5-10.
Figure 5-10. Preset Screen
Operating Instructions
Versa User Manual 5-23
2. From the Preset screen, select the desired preset number (1-6);
the system loads the selected preset and the corresponding
parameters (saved with the preset) appear in the (MP)2 mode
Treatment screen (see Figure 5-6).
Note
To quit the Preset screen without making any
changes, press the Return button.
5.6.2. Changing the Preset Treatment
Parameters
Caution
Saving the new treatment parameters to a preset supersedes and
deletes the existing parameters for that preset.
To change the parameters of a preset:
1. Set the desired (MP)2 treatment parameters (as you want them to be
saved in a preset), as described in section 5.5, on page 5-21.
2. Press the Preset button (as described in section 5.4.1, on page
5-8); the Preset screen appears, as shown in Figure 5-10.
3. In the Preset screen, press and hold the button of the preset
number to which you want to save the set treatment
parameters.
Operating Instructions
5-24 Versa User Manual
4. Continue holding the button until the inward arrow of the Preset
screen icon changes to green, as shown in Figure 5-11, indicating
that the new parameters are saved to the selected preset.
Figure 5-11. Preset Icon Inward Arrow Changing to Green
Upon recalling this preset, the system loads and displays the
saved parameters.
Note
To quit the Preset screen without making any
changes, press the Return button.
Operating Instructions
Versa User Manual 5-25
5.7. Emitting the Treatment Energy
To emit the treatment energy:
1. Verify that the Applicator selector indicates the actual
applicator that is to be used.
2. Verify that the treatment parameters are properly set, as
described in section 5.4.
3. Place the system in the Ready state by pressing the Ready
button [not relevant to (MP)2 treatment mode].
4. Verify that the applicator is placed on the treatment area.
5. Emit the treatment energy as follows:
• In the (MP)2 treatment mode, press the Start button.
• In the Fractional RF treatment mode, press the applicator's
trigger.
• In the IPL treatment mode, press the applicator's trigger.
Operating Instructions
5-26 Versa User Manual
Versa User Manual 6-1
Chapter 6
Advanced Features and
Settings
Chapter Contents:
Section Title Page
6.1. Tools screen ................................................................ 6-2
6.2. Setting the Interface language .................................... 6-6
6.3. Setting the Volume ..................................................... 6-7
6.4. Setting the Login Code ............................................... 6-8
6.5. Logging Out .............................................................. 6-11
6.6. Setting the Auto Logout Time .................................. 6-12
6.7. Displaying the System Information .......................... 6-13
6.8. Extending the Activation Period ............................... 6-14
6.9. Displaying the System Counter Information ............ 6-16
6.10. Activating the Pump ................................................. 6-18
6.11. Technician Mode ...................................................... 6-18
Advanced Features and Settings
6-2 Versa User Manual
6.1. Tools screen
Figure 6-1 shows the Tools screen.
Figure 6-1. Tools Screen
6.1.1. Features in the Tools Screen
Features in the Tools screen, as described in Table 6-1, enable the
user to personalize the system, and allow the qualified Venus
Concept technicians to update the system software, calibrate the
screen and control various settings.
Advanced Features and Settings
Versa User Manual 6-3
Table 6-1. Tools Screen Features
Icon Description See Section
Language – Enables you to select
the interface language.
6.2
Volume – Enables you to set the
volume of the system speakers.
6.3
Set Login Code – Enables you to
change the login code.
6.4
Logout – Enables you to log out
of the Treatment screen and lock
the system.
6.5
Set Auto Logout – Enables you
to define the time period, after
which the system automatically
logs out if not in use.
6.6
Information – Displays
information regarding the
system software and hardware.
6.7
Advanced Features and Settings
6-4 Versa User Manual
Table 6-1. Tools Screen Features (cont.)
Icon Description See Section
Activation Code – Enables you
to extend the use of a restricted
device and add new applicators.
6.8
Technician Mode – Allows
qualified Venus Concept
technicians to access the
Technician mode.
6.11
Pump – Enables you to activate
the pump.
6.10
Counter – Displays system
counter information, providing
the usage history of all
applicators that have been used
with the system.
6.9
Exit – Closes the Tools screen
and returns to the Treatment
screen.
Confirm – Confirms and saves
any changes made to the system
settings in the Tools screen.
Changes will not be stored if the
Confirm button is not pressed.
Advanced Features and Settings
Versa User Manual 6-5
6.1.2. Status Bar
Figure 6-2 shows the status bar, which appears at the bottom of the
Tools screen, as shown in Figure 6-1.
Figure 6-2. Status Bar
The status bar displays the applicators that are currently connected
to the system and their usage information:
• If an Octipolar or a Diamondpolar (MP)2 applicator is
connected to the system, the Timer shows the total duration of
RF emission by that applicator.
• If a Viva applicator is connected to the system, the Pulse
Counter shows the total number of pulses emitted by that
applicator.
• If an IPL applicator is connected to the system, the Pulse
Counter shows the total number of pulses emitted by that
applicator.
6.1.3. Accessing the Tools Screen
To access the Tools screen:
• From the Treatment screen, press the Tools button ; the
Tools screen appears, as shown in Figure 6-1.
Advanced Features and Settings
6-6 Versa User Manual
6.2. Setting the Interface language
To set the interface language:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Language icon, as shown in
Table 6-1.
3. Select the desired language.
4. Press the Confirm button.
Advanced Features and Settings
Versa User Manual 6-7
6.3. Setting the Volume
To set the volume:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Volume icon, as shown in
Table 6-1; the Volume screen appears, as shown in Figure 6-3.
Figure 6-3. Volume Screen
3. Use the +/- buttons to set the desired volume (as a percentage
of the maximum volume).
4. Press the Confirm button to close the Volume screen and
return to the Tools screen.
Note
To abort the Volume screen, press the Exit
button .
5. Press the Confirm button in the Tools screen to save the
change.
Advanced Features and Settings
6-8 Versa User Manual
6.4. Setting the Login Code
To set the login code:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Set Login Code icon, as
shown in Table 6-1; the Login screen appears, as shown in
Figure 6-4.
Figure 6-4. Login Screen
3. Enter current login code.
Advanced Features and Settings
Versa User Manual 6-9
4. Press the Confirm button ; the system asks you to enter the
new login code, as shown in Figure 6-5.
Figure 6-5. Entering the New Login Code
5. Enter a new 8-character login code.
Advanced Features and Settings
6-10 Versa User Manual
6. Press the Confirm button ; the system asks you to enter the
new login code again, as shown in Figure 6-6.
Figure 6-6. Re-Entering the New Login Code
7. Re-enter the new login code.
8. Press the Confirm button to close the Login screen and
return to the Tools screen.
Note
To abort the above process at any stage, press
the Exit button .
9. Press the Confirm button in the Tools screen to save the
change.
Advanced Features and Settings
Versa User Manual 6-11
6.5. Logging Out
To log out of the Treatment screen and lock the system:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Logout icon, as shown in
Table 6-1;
• The system logs out.
• The Login screen appears, as shown in Figure 6-7.
Figure 6-7. Login Screen
Note
To return to the Treatment screen, log in.
Advanced Features and Settings
6-12 Versa User Manual
6.6. Setting the Auto Logout Time
To set auto logout time:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Set Auto Logout Time icon,
as shown in Table 6-1; the Set Auto Logout Time screen
appears, as shown in Figure 6-8.
Figure 6-8. Set Auto Logout Time Screen
3. Use the +/- buttons to set the desired auto logout time.
4. Press the Confirm button to close the Set Auto Logout
Time screen and return to the Tools screen.
Note
To abort the Set Auto Logout Time screen,
press the Exit button .
5. Press the Confirm button in the Tools screen to save the
change.
Advanced Features and Settings
Versa User Manual 6-13
6.7. Displaying the System
Information
To display the system information:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Information icon, as shown
in Table 6-1; the Information screen appears, as shown in
Figure 6-9.
Figure 6-9. Information Screen
3. Press the Confirm button to close the Information screen
and return to the Tools screen.
Advanced Features and Settings
6-14 Versa User Manual
6.8. Extending the Activation Period
Use of the system may be restricted to either a specific date
(Expiration Date) or a limited time of operation (Operation Time).
If the system use is restricted, the appropriate information is
displayed at the bottom of the Tools screen. If no such information
is displayed, use of the system is unrestricted.
• If the system use is restricted to a specific date, the effective
Expiration Date is displayed. One week before the Expiration
Date, the following message appears:
Your activation period is about to expire. Please contact
your area CSA to receive your new activation code
(Expiration Date: MMM-DD-YYYY).
• If the Expiration Date has passed without extending it, the
following message appears:
Activation period has expired. Expiration Date: MMM-DDYYYY.
Please enter new Activation Code.
• If the system use is restricted to a limited Operation Time, the
remaining Operation Time (in hours) appears. If the remaining
Operation Time is less than 10 hours, the following message
appears at the bottom of the Treatment screen:
Remaining Operation Time: XX:YY hours
If the remaining Operation Time is less than one hour, the color
of the message text becomes red. If no Operation Time has
remained, the following message appears:
Your activation period has expired. Please enter new
activation code.
• If the system use is restricted to both a specific date and a
limited Operation Time, both the effective Expiration Date and
the remaining Operation Time appear with the above messages.
Advanced Features and Settings
Versa User Manual 6-15
To extend the activation period of a restricted system:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Activation Code icon, as
shown in Table 6-1; Activation Code screen appears, as
shown in Figure 6-10.
Figure 6-10. Activation Code Screen
3. Contact your local Venus Concept representative and mention
the Key Number that is displayed on top the screen. The
representative will provide a new 16-character Activation
Code.
4. Enter the new Activation Code in the Activation Code screen.
5. Press the Confirm button to close the Activation Code
screen and return to the Tools screen.
Advanced Features and Settings
6-16 Versa User Manual
Note
To abort the Activation Code screen, press the
Exit button .
6. Press the Confirm button in the Tools screen to save the
change.
6.9. Displaying the System Counter
Information
The system counter information provides the usage history of all
applicators that have been used with the system.
This feature displays a list of all applicators and their usage
information:
• For Octipolar and Diamondpolar (MP)2 applicators, the Timer
shows the total duration of RF emission by each applicator.
• For Viva and all IPL applicators, the Pulse Counter shows the
total number of pulses emitted by each applicator.
Advanced Features and Settings
Versa User Manual 6-17
To display the system counter information:
1. Access the Tools screen, as described in section 6.1.3.
2. From the Tools screen, press the Counter icon, as shown in
Table 6-1; the System Counter Information screen appears, as
shown in Figure 6-11.
Figure 6-11. System Counter Information Screen
3. Press the Confirm button to close the System Counter
Information screen and return to the Tools screen.
Advanced Features and Settings
6-18 Versa User Manual
6.10. Activating the Pump
For information and instructions on activating the pump, refer to
the section titled "Circulating the Water" in Chapter 7.
6.11. Technician Mode
This feature is password protected and is to be used only by
qualified Venus Concept technicians.
Versa User Manual 7-1
Chapter 7
Care and Maintenance
Chapter Contents:
Section Title Page
7.1. Cleaning the System ................................................... 7-2
7.2. Cleaning the Applicators ............................................ 7-2
7.3. Disinfecting the Applicators ....................................... 7-3
7.4. Cleaning the Viva Applicator's Tip ............................ 7-3
7.5. Adding Water to the Cooling System ......................... 7-4
7.6. Circulating the Water.................................................. 7-9
7.7. Replacing a Burnt Fuse ............................................. 7-14
7.8. Moving the System ................................................... 7-15
Care and Maintenance
7-2 Versa User Manual
7.1. Cleaning the System
Use the following guidelines to clean the system:
• Clean/Wipe the system's external parts at least once a week.
• To ensure safety, turn off the system before wiping any of the
surfaces.
• Avoid using detergents such as ammonia, acetone, hydrochloric
acid, chlorine bleach, and other fluids that can damage or
destroy plastic components.
7.2. Cleaning the Applicators
Caution
Do not immerse the applicator in any liquid.
Use the following guidelines to clean the applicators:
• After each treatment session, wipe the entire applicator with
alcohol/chloride/acetone-free disinfectant.
• Ensure that each applicator is fully dried before performing the
next treatment.
• Use a soft cloth, moistened with enzymatic detergent solution
such as 0.5% ANIOSYME DD1, to clean the applicator until it
is visually clean. Use the enzymatic detergent according to
manufacturer instructions.
• Use a soft cloth, moistened with water to remove any detergent
residuals.
Care and Maintenance
Versa User Manual 7-3
7.3. Disinfecting the Applicators
Use the following guidelines to disinfect the applicators:
• Use germicide swipes to disinfect each applicator for at least
one minute.
• Dry the applicator with a clean cloth.
Caution
• Make sure that the applicator is dried from any inflammable
substance.
• Always perform the cleaning procedure prior to disinfection.
7.4. Cleaning the Viva Applicator's Tip
If the tip requires cleaning, ensure that the system is in the Standby
state before starting the cleaning procedure.
Always make sure that the tip is completely dry before starting the
treatment.
To clean the Viva applicator's tip:
1. Immerse the tip into an ultrasonic cleaner (bath), filled with
Deconex 53 Plus 2% solution, for 15 minutes.
2. Remove the tip from the ultrasonic cleaner and rinse it with
DDW (double distilled water).
3. Air-dry the tip. Make sure the tip is completely dry before
using it for treatment.
Care and Maintenance
7-4 Versa User Manual
7.5. Adding Water to the Cooling
System
Water should be added to the cooling system if the water level
indicator, as shown in Figure 7-1, indicates that the water level is
low.
Water Level Indicator
Figure 7-1. Water Level Indicator on the System's rear Side
Care and Maintenance
Versa User Manual 7-5
A water filling kit is provided for this purpose, as shown in Figure
7-2.
Funnel
Bypass
Quick- Tool
Connector
(Male)
Quick-
Connector
(Female)
Figure 7-2. Water Filling Kit
To add water to the cooling system:
1. Turn off the system and disconnect it from the mains power.
2. Disconnect the IPL applicator's cable connector from its
receptacle on the system console, as shown in Figure 7-3.
Figure 7-3. Disconnecting the IPL Applicator's Cable
Connector
Care and Maintenance
7-6 Versa User Manual
3. Connect the quick-connector of the funnel's tube into that of
the bypass tool, as shown in Figure 7-4.
Figure 7-4. Connecting Two Parts of the Water Filling Kit'
4. Insert the water filling kit's connector into the IPL applicator
connection receptacle, as shown in Figure 7-5.
Figure 7-5. Inserting the Water Filling Kit's Connector
Care and Maintenance
Versa User Manual 7-7
5. Rotate the connector clockwise to lock it in place, as shown in
Figure 7-6 and Figure 7-7.
Figure 7-6. Locking the Water Filling Kit's Connector
Figure 7-7. Water Filling Kit Locked in Place
Care and Maintenance
7-8 Versa User Manual
6. Hold the water filling kit upright and pour water through the
funnel, as shown in, until the water level indicator indicates
that the water level is adequate (see Figure 7-8).
Figure 7-8. Water Filling Kit Connected to the System
Care and Maintenance
Versa User Manual 7-9
7. Disconnect the water filling kit from the system.
8. Re-connect the IPL applicator to the system.
Note
After filling the water for the first time (),
circulate the water, as described in section 7.6.
7.6. Circulating the Water
After filling the cooling system for the first time (or following a
full drainage), water should be circulated through the system. This
procedure is carried out by activating the pump, with the bypass
tool connected to the system.
To circulate the water:
1. Verify that the system is turned on.
2. Verify that the IPL applicator is disconnected from the
system.
3. Verify that the funnel is disconnected from the bypass tool, as
shown in Figure 7-9.
Figure 7-9. Bypass Tool (Without the Funnel)
Care and Maintenance
7-10 Versa User Manual
Caution
Activating the pump with the funnel connected to the
bypass tool causes the water to overflow and pour out of
the funnel
Make sure that the funnel is not connected to the bypass
tool.
4. Connect the bypass tool to the IPL applicator connection
receptacle, as shown in Figure 7-5.
Figure 7-10. Bypass Tool Connected to the System
(Without the Funnel)
Care and Maintenance
Versa User Manual 7-11
5. From the Treatment screen, press the Tools button ; the
Tools screen appears, as shown in Figure 7-11.
Figure 7-11. Tools Screen
6. From the Tools screen, press the Pump button ; a
message appears, prompting you to connect the bypass tool
and start the pump, as shown in Figure 7-12.
Figure 7-12. Connecting the Bypass Tool and Starting the
Pump Message
Care and Maintenance
7-12 Versa User Manual
7. Press the Confirm button ;
• The pump starts working.
• The water starts circulating through the system.
• The Pump Activation screen appears, as shown in Figure
7-13, showing:
 Pump activation time
 Pressure in the cooling system
Figure 7-13. Pump Activation Screen
Note
The only way to stop the pump is to turn off
the system. In case of emergency, press the
Emergency button.
Care and Maintenance
Versa User Manual 7-13
8. Wait (for about one minute) for the system to complete the
water circulation and display the completion message, as
shown in Figure 7-14.
Figure 7-14. Water Circulation Completion Message
9. Turn off the system.
10. Disconnect the bypass tool from the system.
11. Connect the IPL applicator to the system.
12. Turn on the system to commence normal operation.
Care and Maintenance
7-14 Versa User Manual
7.7. Replacing a Burnt Fuse
If the system is properly connected to the mains power and does
not turn on, it is likely that one of its main fuses is burnt.
To replace a burnt fuse:
1. Disconnect the power cable from the power connection port,
as shown in Figure 7-15.
Power
Connection
Port
Main Fuse Compartments
Figure 7-15. Power Connection Port and Main Fuses on the
System's Rear Side
2. Use a screwdriver to open the two main fuse compartments, as
shown in Figure 7-15.
3. Replace the burnt fuse(s).
4. Insert the fuses into their compartments and lock them in
using the screwdriver.
Care and Maintenance
Versa User Manual 7-15
7.8. Moving the System
To move the system:
1. Unplug the power cord from the mains power supply.
2. Release all wheel brakes.
3. Using the handle, carefully move the system to the desired
location.
4. Lock all wheel brakes.
Care and Maintenance
7-16 Versa User Manual
Versa User Manual 8-1
Chapter 8
Troubleshooting
Chapter Contents:
Section Title Page
8.1. General ........................................................................ 8-2
8.2. System Problems......................................................... 8-3
8.3. Errors and Messags ..................................................... 8-5
Troubleshooting
8-2 Versa User Manual
8.1. General
This Chapter provides solutions to some problems that may arise
while operating the system.
• Section 8.2 (Table 8-1) provides solutions to system problems
that are not associated with a message.
• Section 8.3 (Table 8-2) provides solutions to system problems
that are associated with a message.
If you are not able to solve the problem using the provided
solutions, contact your local Venus Concept service representative.
Troubleshooting
Versa User Manual 8-3
8.2. System Problems
Table 8-1. Troubleshooting Problems that are
Not Associated with a Message
Problem Solution
No power • Check the power cable.
Make sure that it is properly
connected to both the
system's power connection
port and the mains power
supply.
• Make sure that main power
switch is on.
If the problem persists, call
Service.
Troubleshooting
8-4 Versa User Manual
Table 8-1. Troubleshooting Problems that are
Not Associated with a Message
Problem Solution
No display • Check the power cable.
Make sure it is properly
connected to both the
system's power connection
port and the mains power
supply.
• Make sure that main power
switch is on.
• Turn off the system, wait for
two minutes, and turn it
back on.
If the problem persists, call
Service.
No response from touch screen Turn off the system, wait for
two minutes, and turn it back
on.
If the problem persists, call
Service.
No energy in applicator Make sure that the applicator is
properly connected.
If the problem persists, call
Service.
Troubleshooting
Versa User Manual 8-5
8.3. Errors and Messags
Table 8-2. Troubleshooting Problems that are
Associated with a Message
Message Solution
Error - Can't Read
Configuration File
Turn off the system, wait for
two minutes, and turn it back
on.
If the problem persists, call
Service.
Error - Can't Read Language
File
Turn off the system, wait for
two minutes, and turn it back
on.
If the problem persists, call
Service.
The Machine is Locked -
Please Contact Your…
Turn off the system, wait for
two minutes, and turn it back
on.
If the problem persists, call
Service.
Set New Login Code Failed -
Please Try Again
Repeat the procedure for
Setting the Login Code (see
Chapter 6).
Troubleshooting
8-6 Versa User Manual
Table 8-2. Troubleshooting Problems that are
Associated with a Message
Message Solution
Invalid Activation Code -
Please Enter New Activation
Code
Enter the Activation Code
again.
If the problem persists, call
Service.
Versa User Manual 9-1
Chapter 9
Specifications
Chapter Contents:
Section Title Page
9.1. System Specifications ................................................. 9-2
9.2. SR515 Applicator Specifications ............................... 9-3
9.3. SR580 Applicator Specifications ............................... 9-4
9.4. HR650 Applicator Specifications ............................... 9-5
9.5. HR690 Applicator Specifications ............................... 9-6
9.6. HR650XL Applicator Specifications ......................... 9-7
9.7. HR690XL Applicator Specifications ......................... 9-8
9.8. ACDUAL Applicator Specifications .......................... 9-9
9.9. Diamondpolar Applicator Specifications ................. 9-10
9.10. Octipolar Applicator Specifications ......................... 9-11
9.11. Viva Applicator Specifications ................................. 9-12
9.12. Environmental Requirements ................................... 9-13
9.13. Output Power Graphs ............................................... 9-14
Specifications
9-2 Versa User Manual
9.1. System Specifications
System console
dimensions:
W × D × H (not packed):
65 × 55 × 110 cm
(25.6 × 21.7 × 43.3 in)
System console
weight:
Approximately 35 kg
(77.2 lbs)
Electrical
requirements:
100 - 240 VAC, 12.5A, 50 - 60 Hz,
single phase
Specifications
Versa User Manual 9-3
9.2. SR515 Applicator Specifications
Output
parameters:
• Optical fluence:
5 - 25 J/cm2
• Wavelength:
515 - 950 nm
• Pulse repetition rate:
Up to 3 Hz
• Treatment area:
10 × 30 mm
Applicator
dimensions:
W × D × H:
23 × 16 × 6 cm
(9 × 6.3 × 2.4 in)
Applicator weight: Approximately 0.6 kg
(1.3 lbs)
Umbilical cable
length:
170 cm
(67 in)
Specifications
9-4 Versa User Manual
9.3. SR580 Applicator Specifications
Output
parameters:
• Optical fluence:
5 - 25 J/cm2
• Wavelength:
580 - 950 nm
• Pulse repetition rate:
Up to 3 Hz
• Treatment area:
10 × 30 mm
Applicator
dimensions:
W × D × H:
23 × 16 × 6 cm
(9 × 6.3 × 2.4 in)
Applicator weight: Approximately 0.6 kg
(1.3 lbs)
Umbilical cable
length:
170 cm
(67 in)
Specifications
Versa User Manual 9-5
9.4. HR650 Applicator Specifications
Output
parameters:
• Optical fluence:
5 - 20 J/cm2
• Wavelength:
650 - 950 nm
• Pulse repetition rate:
Up to 3 Hz
• Treatment area:
10 × 30 mm
Applicator
dimensions:
W × D × H:
23 × 16 × 6 cm
(9 × 6.3 × 2.4 in)
Applicator weight: Approximately 0.6 kg
(1.3 lbs)
Umbilical cable
length:
170 cm
(67 in)
Specifications
9-6 Versa User Manual
9.5. HR690 Applicator Specifications
Output
parameters:
• Optical fluence:
5 - 20 J/cm2
• Wavelength:
690 - 950 nm
• Pulse repetition rate:
Up to 3 Hz
• Treatment area:
10 × 30 mm
Applicator
dimensions:
W × D × H:
23 × 16 × 6 cm
(9 × 6.3 × 2.4 in)
Applicator weight: Approximately 0.6 kg
(1.3 lbs)
Umbilical cable
length:
170 cm
(67 in)
Specifications
Versa User Manual 9-7
9.6. HR650XL Applicator
Specifications
Output
parameters:
• Optical fluence:
5 - 20 J/cm2
• Wavelength:
650 - 950 nm
• Pulse repetition rate:
Up to 3 Hz
• Treatment area:
20 × 30 mm
Applicator
dimensions:
W × D × H:
23 × 16 × 6 cm
(9 × 6.3 × 2.4 in)
Applicator weight: Approximately 0.6 kg
(1.3 lbs)
Umbilical cable
length:
170 cm
(67 in)
Specifications
9-8 Versa User Manual
9.7. HR690XL Applicator
Specifications
Output
parameters:
• Optical fluence:
5 - 20 J/cm2
• Wavelength:
690 - 950 nm
• Pulse repetition rate:
Up to 3 Hz
• Treatment area:
20 × 30 mm
Applicator
dimensions:
W × D × H:
23 × 16 × 6 cm
(9 × 6.3 × 2.4 in)
Applicator weight: Approximately 0.6 kg
(1.3 lbs)
Umbilical cable
length:
170 cm
(67 in)
Specifications
Versa User Manual 9-9
9.8. ACDUAL Applicator
Specifications
Output
parameters:
• Optical fluence:
5 - 25 J/cm2
• Wavelength:
415 - 480 nm
and
630 - 950 nm
• Pulse repetition rate:
Up to 3 Hz
• Treatment area:
10 × 30 mm
Applicator
dimensions:
W × D × H:
23 × 16 × 6 cm
(9 × 6.3 × 2.4 in)
Applicator weight: Approximately 0.6 kg
(1.3 lbs)
Umbilical cable
length:
170 cm
(67 in)
Specifications
9-10 Versa User Manual
9.9. Diamondpolar Applicator
Specifications
Technology: RF + MP2
RF energy: N/A
Maximum RF
output power:
75 W
Output RF
frequency:
1 MHz
Magnetic pulse
frequency:
15 Hz
Magnetic field: Up to 15 Gauss
Specifications
Versa User Manual 9-11
9.10. Octipolar Applicator
Specifications
Technology: RF + MP2
RF energy: N/A
Maximum RF
output power:
150 W
Output RF
frequency:
1 MHz
Magnetic pulse
frequency:
15 Hz
Magnetic field: Up to 15 Gauss
Specifications
9-12 Versa User Manual
9.11. Viva Applicator Specifications
Technology: RF
RF energy: 62 mJ/pin
Maximum RF
output power:
8 W
Output RF
frequency:
0.46 MHz
Magnetic pulse
frequency:
N/A
Magnetic field: N/A
Specifications
Versa User Manual 9-13
9.12. Environmental Requirements
Treatment room: • Temperature:
15° - 30°C
(59° - 86°F)
• Relative humidity:
10% - 80%
Storage/
Transportation:
• Temperature with water in the system:
2° - 55°C
(35.6° - 131°F)
• Temperature without water in the
system:
-20° - 55°C
(-4° - 131°F)
• Relative humidity:
10% - 80%
• Air pressure range:
700 - 1060 hPa
(0.70 - 1.06 Bars)
Specifications
9-14 Versa User Manual
9.13. Output Power Graphs
Figure 9-1. Graph of Output Power vs. Load
Figure 9-2. Graph of Output Power vs. Setting
Versa User Manual A-1
Appendix A
Clinical Guide for (MP)²
Treatment with Diamondpolar
Applicator
Chapter Contents:
Section Title Page
A.1. Introduction.................................................................A-2
A.2. Indications...................................................................A-2
A.3. Contraindications ........................................................A-3
A.4. Exclusion Criteria .......................................................A-3
A.5. Pre-Treatment Information .........................................A-4
A.6. General Treatment Information ..................................A-7
Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
A-2 Versa User Manual
A.1. Introduction
Figure A-1 shows the Diamondpolar applicator.
Figure A-1. Diamondpolar Applicator
A.2. Indications
The Venus Versa system, using the Diamondpolar applicator, is
designed for use in dermatological procedures requiring treatment
of moderate to severe facial wrinkles and rhytides in Fitzpatrick
skin types I- IV.
Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
Versa User Manual A-3
A.3. Contraindications
Treatment with the device is contraindicated for patients with any
of the following conditions:
• Implantable defibrillators, cardiac pacemakers, and other metal
implants
• Subjects with any implantable metal device in the treatment area
A.4. Exclusion Criteria
• Actinic keratozis
• Cancer, melanoma
• Demyelinating diseases
• Defibrillator/Pacemaker
• Disorder of the thyroid gland
• Epilepsy
• Fever
• Infection in the treated area
• Multiple sclerosis
• Mental diseases
• Metal implants near the treated area, excluding dental implants
• Moles at the treated area
• Ongoing use of Isotretinoin (e.g. Roaccutane)
• Pregnancy or IVF procedure
• Specific skin's autoimmune diseases
Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
A-4 Versa User Manual
A.5. Pre-Treatment Information
A.5.1. Recommended Accessories
Prior to the treatment, it is recommended to have the following:
• Glycerin in gel or liquid formulation
• Camera and tripod (tracking tools to follow the client's
progress)
A.5.2. Clinical Data Management
• Establish a detailed patient medical history, including previous
treatment modalities. This would include, and not be limited to,
a questionnaire to ensure that the patient does not fall under any
of the exclusion criteria.
• Review the informed consent form with the patient to ensure
that the patient is well informed of the treatment protocol and
possible side-effects.
• Determine why the patient is seeking this treatment, in order to
understand and manage their expectations to ensure a
satisfactory outcome.
Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
Versa User Manual A-5
A.5.3. Expected Clinical Effects
• Mild discomfort may be associated with the treatment.
• Heat sensation will be felt both during and following the
treatment.
• Erythema may be present in the treated area for up to two hours
post procedure.
A.5.4. Adverse Effect
Caution
Skin burn may occur if the operator does not follow the
instructions, i.e. holding the applicator for too long on the same
spot. If such a burn occurs, it should be treated conventionally.
A.5.5. Documentation
• It is strongly recommended to take photographs of the treatment
area, both before and upon completion of the treatment series,
in order to document the clinical results and verify a positive
outcome. It is imperative to maintain consistency in the
photographic conditions.
• Treatment documents should be kept with the patient chart.
Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
A-6 Versa User Manual
A.5.6. Preparing for the Treatment
• All Jewelry and/or metal items should be removed from the
treatment area.
• The treated area should be clean and free of lotions, creams,
and make-up.
• Ensure that the patient is relaxed, comfortable and lying down
on the treatment bed with the treated area exposed.
• Glycerin should be applied thoroughly to the treatment area.
Caution
Applying an insufficient amount of glycerin to the treatment
area results in bad coupling and may adversely affect the
treatment results.
Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
Versa User Manual A-7
A.6. General Treatment Information
• The recommended treatment duration is between 15 and 30
minutes, depending on the treatment area.
• Acceptable results will likely require a number of treatments,
performed over a period of time, depending on the treatment
area and the performed procedure.
• In the initial treatment it is important to adjust the treatment
time and required energy level to best suit the patient's tolerance
to the treatment. Tolerance will increase as the patient becomes
more familiar with the treatments.
• The aim of the procedure is to heat the surface of the skin on
the treatment area and raise the temperature at least to the
therapeutic temperature (End Point), and maintain it for the
remaining time of the treatment.
• The End Point temperature should be at least 40°C, but should
not exceed 45°C. The treatment should be monitored with an
external IR thermometer.
• For optimal results, it is recommended to maintain the highest
temperature that the patient can tolerate, as long as it does not
exceed 45°C.
• If large areas are treated, it is recommended to divide them into
smaller areas, and divide the total treatment time accordingly.
• During the procedure, ensure that you are gently pressing the
applicator's electrodes against the patient's skin, making sure
that all electrodes are in contact with the skin as much as
possible.
Clinical Guide for (MP)² Treatment with
Diamondpolar Applicator
A-8 Versa User Manual
• The applicator strokes should be long and continuous, and
performed in form of "8" figures, circles, ellipses or waves. The
applicator must always be in motion, while in contact with the
skin surface.
• If the measured skin surface temperature (as measured by the
digital thermometer) at End Point is less than 40˚C, treatment is
not optimal and the desired results will not be accomplished.
• The achieved skin temperature depends on the applicator
movement speed and energy level. The lower the energy, the
slower the movement should be and vice-versa.
• In the event that the patient experiences discomfort or pain
during the treatment, either decrease the energy percentage, or
apply more glycerin, or perform wider and quicker movements,
or stop the treatment.
• Typically, optimal results will be achieved within 6-10 sessions
performed once a week. The actual number of sessions needed
depends on the initial condition of the patient and their
compliance.
Versa User Manual B-1
Appendix B
Clinical Guide for (MP)²
Treatment with Octipolar
Applicator
Chapter Contents:
Section Title Page
B.1. Introduction................................................................. B-2
B.2. Indications................................................................... B-2
B.3. Exclusion Criteria ....................................................... B-3
B.4. Precaution Criteria ...................................................... B-4
B.5. Pre-Treatment Information ......................................... B-5
B.6. General Treatment Information .................................. B-8
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
B-2 Versa User Manual
B.1. Introduction
Figure B-1 shows the Octipolar applicator.
Figure B-1. Octipolar Applicator
B.2. Indications
The Venus Versa system, using the Octipolar applicator, is
designed for use in body contouring via Skin Tightening,
Circumferential Reduction, and Cellulite Reduction.
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
Versa User Manual B-3
B.3. Exclusion Criteria
• Active inflammation and/or infection in the treated area
• Current or history of cancer and premalignant condition
• Degenerative neurologic diseases
• Diseases stimulated by heat (such as recurrent herpes simplex in
the treatment area)
• Internal defibrillator/pacemaker.
• Metal implants in the treated area, excluding dental implants
• Uncontrolled disorder of the thyroid gland
• Varicose veins
• Pregnancy or IVF procedure
• Skin related autoimmune diseases
• Silicone implants and injections in treated area
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
B-4 Versa User Manual
B.4. Precaution Criteria
• Botox injection and implants in the treatment area (wait for one
month after the last injection before starting a treatment)
• Breast feeding
• Epilepsy
• Facial laser resurfacing and deep chemical peeling within the
last month, if face is treated
• Fresh scars, wounds, or scarification of the skin in the treated
area
• Telangiectasia
• Thyroid gland (it is not recommended to perform the treatment
over the thyroid gland)
• Ongoing use of isotretinoin (e.g. Roaccutane)
• Recent injection of fillers
• Recent surgical procedure or special medications
• Rosacea (not recommended if the face is treated; but not a
constraint if treating other body areas)
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
Versa User Manual B-5
B.5. Pre-Treatment Information
B.5.1. Recommended Accessories
Prior to the treatment, it is recommended to have the following:
• Glycerin in gel or liquid formulation
• Weight scale (tracking tool to follow the patient's progress)
• Measuring tape (tracking tool to follow the patient's progress)
• Camera and tripod (tracking tools to follow the client's
progress)
B.5.2. Clinical Data Management
• Establish a detailed patient medical history, including previous
treatment modalities. This would include, and not be limited to,
a questionnaire to ensure that the patient does not fall under any
of the exclusion criteria.
• Review the informed consent form with the patient to ensure
that the patient is well informed of the treatment protocol and
possible side-effects.
• Determine why the patient is seeking this treatment, in order to
understand and manage their expectations to ensure a
satisfactory outcome.
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
B-6 Versa User Manual
B.5.3. Expected Clinical Effects
• Mild discomfort may be associated with the treatment.
• Heat sensation will be felt both during and following the
treatment.
• Erythema may be present in the treated area for up to two hours
post procedure.
B.5.4. Adverse Effect
• Skin burn may occur if the operator does not follow the
instructions, i.e. holding the applicator for too long on the same
spot. If such a burn occurs, it should be treated conventionally.
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
Versa User Manual B-7
B.5.5. Documentation
• It is strongly recommended to take "Before and After"
photographs of the treated area to help document the treatment
progress, manage expectations and maximize the patient
satisfaction. Since many patients are not able to see the progress
of treatment objectively, because it is a slow and gradual
change, these photographs will help in providing objective
evidence of the progress.
"Before and After" photos are also useful tools in promoting the
clinic, and can be presented to other potential clients in order to
show the results they can expect from the treatment.
To ensure consistency in the photographs, use the following
guidelines:
 Make markings on the floor, indicating exactly where the
patient should stand for taking their photos.
 Ensure that the same camera speed, flash and distance are
used the each time.
• Treatment documents, including information such as body
measurements and weight, should be maintained. Body
measurements and weight should be taken before the first
treatment and registered in the treatment documents.
To ensure consistency in the measurements results, guidelines
should be set and followed in order to make sure that all
measurements are carried out exactly in the same manner, each
time.
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
B-8 Versa User Manual
B.5.6. Preparing for the Treatment
• To ensure treatment safety, all Jewelry and/or metal items
(including any belly rings) should be removed from the
treatment area.
• The treated area should be clean and free of lotions, creams,
and make-up.
• Ensure that the patient is relaxed, comfortable and lying down
on the treatment bed with the treated area exposed.
• Glycerin should be applied thoroughly to the treatment area.
B.6. General Treatment Information
• The recommended treatment duration is between 15 and 30
minutes, depending on the treatment area.
• Acceptable results will likely require a number of treatments,
performed over a period of time, depending on the treatment
area and the performed procedure.
• In the initial treatment it is important to adjust the treatment
time and required energy level to best suit the patient's tolerance
to the treatment. Tolerance will increase as the patient becomes
more familiar with the treatments.
• The aim of the procedure is to heat the surface of the skin on
the treatment area and raise the temperature at least to the
therapeutic temperature (End Point), and maintain it for the
remaining time of the treatment (for a minimum duration of 5
minutes on the face, and 10 minutes on other body areas).
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
Versa User Manual B-9
• For easier maintenance of the End Point while treating the body
areas, it is recommended, to divide each treated area into two
smaller sub-areas.
• For optimal clinical results, it is recommended to maintain the
highest temperature that the patient can tolerate.
• During the procedure, ensure that you are gently pressing the
applicator's electrodes against the patient's skin, making sure
that all electrodes are in contact with the skin as much as
possible.
• The applicator movements should be performed in form of "8"
figures, circles, ellipses or lifting movements. The applicator
must always be in motion, while in contact with the skin
surface. In order to avoid overheating and to assist in the
tolerance of the procedure, the applicator should be in constant
motion.
• If the measured skin surface temperature (as measured by the
digital thermometer) at End Point is less than 41˚C on the face
or 41˚C on the body, treatment is not optimal and the desired
results will not be accomplished.
• The achieved skin temperature depends on the applicator
movement speed and energy level. The lower the energy, the
slower the movement should be and vice-versa.
• In the event that the patient experiences discomfort or pain
during the treatment, either decrease the energy percentage, or
apply more glycerin, or perform wider and quicker movements,
or stop the treatment.
• The built-in thermometer is used only to verify that the
recommended temperature (End Point) of the treated area is
achieved and maintained.
Clinical Guide for (MP)² Treatment with
Octipolar Applicator
B-10 Versa User Manual
• In most cases, a full body session will include 8-10 treatments
per treated area. The patient should be treated once a week.
• In the event that the patient suddenly feels bad or is in distress,
the Emergency Button must be pressed, by the patient or the
operator, to shut down the system immediately.
Versa User Manual C-1
Appendix C
Clinical Guide for Fractional
RF Treatment with Viva
Applicator
Chapter Contents:
Section Title Page
C.1. Introduction................................................................. C-2
C.2. Indications................................................................... C-2
C.3. Contraindications ........................................................ C-3
C.4. Exclusion Criteria ....................................................... C-3
C.5. Possible Side Effects .................................................. C-6
C.6. Pre-Treatment Information ......................................... C-7
C.7. Preparing the Applicator and Tip ............................... C-8
C.8. Test Treatment ............................................................ C-9
C.9. Treatment Procedure ................................................. C-10
C.10. Treatment Protocol ................................................... C-13
C.11. Treatment Parameters ............................................... C-13
C.12. Post Treatment Care ................................................. C-14
C.13. Follow-Up ................................................................. C-15
C.14. Treatment Conclusion ............................................... C-15
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-2 Versa User Manual
C.1. Introduction
Figure C-1 shows the Viva applicator.
Figure C-1. Viva Applicator
Through an array of small electrodes organized on a tip,
radiofrequency energy is transmitted into the tissue, producing an
injury in a certain pattern to the skin. The un-affected areas
promote faster healing and the result is an improvement in the tone
and texture of the skin.
C.2. Indications
The Venus Versa system, using the Viva applicator, is designed for
use in dermatological procedures requiring ablation and
resurfacing of the skin.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
Versa User Manual C-3
C.3. Contraindications
Treatment with the device is contraindicated for patients with any
of the following conditions:
• Implantable defibrillators, cardiac pacemakers, and other metal
implants
• Subjects with any implantable metal device in the treatment area
C.4. Exclusion Criteria
Warning
Never treat the eyelids or lips.
• Pacemaker or internal defibrillator, or any other active electrical
implant anywhere in the body (e.g. cochlear implant).
• Permanent implant in the treated area, such as metal plates and
screws, or an injected chemical substance.
• Current or history of any kind of cancer, or pre-malignant
moles.
• Severe concurrent conditions, such as cardiac disorders.
• Pregnancy and nursing.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-4 Versa User Manual
• Impaired immune system due to immunosuppressive diseases,
such as AIDS and HIV, or use of immunosuppressive
medications.*
• Patients with history of diseases stimulated by heat, such as
recurrent herpes simplex in the treatment area, may be treated
only following a prophylactic regime.
• 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, such as keloids, abnormal wound
healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies, or use of anticoagulants.
• Face lift or eyelid surgery (if periorbital treatment is performed)
within a year prior to treatment.
• Facial dermabrasion, facial resurfacing, or deep chemical
peeling within the last three months, if face is treated.
• Neurotoxin/collagen/fat injections or other methods of
augmentation with injected bio-material in the treated area
within six months prior to treatment.
• Use of isotretinoin (Accutane®) within six months prior to
treatment.
* Indicated conditions may be treated at the discretion of – and under the
full responsibility of the medical director/physician, although treatment is
not recommended by Venus Concept. In such cases, a small area should be
treated and assessed a few days later to determine if the patient will
tolerate the treatment without developing short-term adverse effects. Test
spots cannot indicate long-term adverse events.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
Versa User Manual C-5
• Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g.
ibuprofen-containing agents) one week before and after each
treatment session.
• Any surgical procedure in the treatment area within the last six
months or before complete healing.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning
creams within the last two weeks.
• As per the practitioner's discretion, refrain from treating any
condition which might make it unsafe for the patient.
Caution
In case of uncertainty regarding potential side effects, have the
patient consult his/her primary care physician and bring a
written consent for treatment.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-6 Versa User Manual
C.5. Possible Side Effects
Improper use of the system could result in side effects. Although
these effects are rare and expected to be transient, any adverse
reaction should be immediately reported to the physician. Side
effects may appear either at the time of treatment or after.
The side effects may include:
• Discomfort or significant pain post-treatment
• Excessive skin redness (erythema) and/or swelling (edema)
• In-grown hairs
• Damage to natural skin texture (crust, blister, burn)
• Change of pigmentation (hyper- and hypo-pigmentation)
• Scarring
Treatment of male patients in hair-bearing areas may result in some
damage to the follicles and subsequent loss of hair. Avoid the
beard area and other hair- growing zones if the patient does not
wish to experience hair growth reduction.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
Versa User Manual C-7
C.6. Pre-Treatment Information
• Complete or update the patient's medical and physical history.
• Exclude patients presenting any contraindications from
treatment.
• Determine why the patient is seeking treatment and what the
expectations are.
• Inform the patient of the treatment protocol, typical treatment
results and possible adverse effects and discomfort.
• Instruct the patient of the safety aspects he/she should observe.
• Advise the patient to avoid skin irritation or intentional skin
tanning. Sun-screen is advisable when outdoors during daylight
hours.
• The patient should discontinue any topical agents for 2-3 days
prior to treatment.
• The patient should arrive for treatment with clean skin. There
should be no lotion, make-up, perfume, powder, or bath/shower
oil present on the skin in the area to be treated. Shave any hair
in the treatment area.
• No lotion, gel or coupling medium should be used during
treatment.
• Areas of dental crowns, caps, braces, or other metal dental
implants may be more sensitive to treatment and the clinician
may use dental rolls, gauze or a tongue depressor to isolate the
area and make the treatment more comfortable.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-8 Versa User Manual
C.7. Preparing the Applicator and Tip
• Before each treatment clean the entire applicator surface with a
medical disinfectant that does not contain alcohol. Ensure that it
is dry before beginning the treatment.
• Use a different tip for each patient and make sure that the tip is
cleaned, as per the instructions in this manual, prior to the
treatment.
• Connect the tip to the distal port of the applicator and ensure
that the tip is secured in place.
• Check the integrity of the tip's electrode-pins and ensure that
they are all intact. Do not use the tip if any pins are damaged or
missing.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
Versa User Manual C-9
C.8. Test Treatment
Caution
In order to prevent adverse effects, test spots should be
performed before each treatment and upon changing the
treatment parameters.
When beginning a new treatment, perform a small test spot in a
non-conspicuous area of the treatment site, prior to the first
complete session. Test spots are performed to establish the
following requirements:
• Confirm the patient's suitability for treatment: for skin types IIII
wait 24-48 hours before assessing the skin response, and for
skin types IV-VI wait 5-7 days.
• Establish and confirm treatment parameters: If the desired endpoint
of erythema and edema – in a tip-shaped pattern – has not
been achieved within 10-15 minutes, increase the RF energy
level and perform another test spot. If the response is excessive,
decrease the parameters and perform another test spot.
Test spot results will indicate if the patient can tolerate the
treatment without developing adverse effects. According to patient
tolerance to the test spot, you may determine treatment parameters
and whether anesthesia is needed. In addition, it is advisable to
perform a test spot whenever changing parameters.
Caution
For Asian patients, after spot testing, enforce a "waiting period"
for one skin type level higher than the apparent skin type.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-10 Versa User Manual
C.9. Treatment Procedure
• Shave any hair in the treatment area.
• Ensure that the skin is completely dry during the entire
treatment. If the skin moistens during treatment (i.e.
perspiration, etc.) re-wipe the skin with an alcohol pad and
ensure that the skin is completely dry before continuing the
treatment.
• When treating full-face, after completing the first half of the
face, make sure to dry the untreated half before commencing the
treatment.
• Set the treatment parameters. Set the desired energy level
according to the skin type, severity of the treated condition,
treatment area, bone proximity, etc. Set conservative parameters
for a test spot for the first treatment, and then gradually increase
during treatment or in subsequent treatments according to the
desired impact and test spot results.
• Select the desired tip pattern, and enable the Repeat mode, if
desired.
• Treatment consists of a single pass over the treatment area.
Adjust the treatment parameters according to the test spot
response. To perform the treatment, place the tip on the target
zone, perpendicular to the skin surface and with full contact
with the skin.
• Emit a pulse by pressing the applicator's trigger; this will create
a tip-shaped pattern on the patient's skin that will appear 1-2
minutes later. Move the applicator to an adjacent spot on the
skin and emit another pulse. There should be no untreated gaps
between the pulses. Be careful not to overlap the treated zones.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
Versa User Manual C-11
• Examine the treated area. The immediate responses, indicative
of the desired effect, are erythema and edema in the immediate
area of the tip-shaped pattern and possibly also around it. The
edema usually appears 1-2 minutes after pulsing and reaches its
peak (of up to moderate edema) within 30 minutes. It should be
noted that erythema is not easily noticeable – if at all – in darker
skin types. Therefore, the edema will be more prominent in
these patients.
• After completing a full pass on the entire treatment area, if
untreated patches of skin are apparent, re-treat these patches as
per the following procedure:
i. Wipe the untreated patch of skin with a dry gauze pad.
ii. Treat the untreated patches of skin as normally.
• Fine-tuning of the parameters should be done before proceeding
to treatment of the entire facial sub-area with the selected
parameters.
• Treatment consists of a single pass over the designated area.
The applicator tip should be placed on the skin, a pulse emitted,
then lifted and moved to an adjacent spot of the skin. The
emitted pulses should create tip-shaped patterns. Leave no
untreated gaps between the pattern marks, while also being
careful not to overlap the treated zones.
• The parameters can be modified during subsequent visits, as per
the practitioner's discretion.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-12 Versa User Manual
Caution
• The system must be in the Standby state when cleaning the
tip.
• Always check the integrity of the electrode-pins on the tip.
Ensure that no pins are missing. If any pins are missing, do
not use the tip.
• Always perform a test spot, and wait as needed to evaluate
the results, before treatment and before setting or changing
presets.
• Use lower RF energy levels when treating in close proximity
to a bone.
• Non-dry skin may lead to pain. Ensure that the skin is
completely dry during treatment.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
Versa User Manual C-13
C.10. Treatment Protocol
The number of treatment sessions depends on the individual patient
and typically varies between 3-4 sessions, every 4-6 weeks.
One touch-up session may be needed every ~6 months, according
to individual patient response.
C.11. Treatment Parameters
Selecting the appropriate RF Energy level is essential for
successful treatment.
Always start with a low energy level and observe the skin's
reaction before increasing the energy.
When applying energy to tissue, there are different effects
achieved in the tissue:
• With a relatively low increase of temperature there may be
activation of cellular components of the skin.
• Further temperature increase may lead to cellular destruction
(necrosis/coagulation) and an even further temperature increase
leads to ablation.
Caution
When choosing the treatment parameters, take into
consideration the diffusion and depth of the lesion, as well as its
specific anatomical location such as proximity to bone. In
addition, the patient's skin type and tolerance should always be
considered.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-14 Versa User Manual
C.12. Post Treatment Care
• Post-treatment cooling is not necessary. In the event of posttreatment
discomfort, it is recommended to cool the treated area
immediately with air cooling. Cold (not frozen) packs may also
be used. Blistered or ulcerated skin can be treated with a
prescribed cream.
• Tiny scabs of less than 1 mm diameter will usually form 24-72
hours post-treatment and may remain for several days. The
scabs should not be touched or scratched even if they itch, and
should be allowed to shed off naturally.
• Blistered or ulcerated skin can be treated with a prescribed
antibiotic ointment or burn treatment cream as per physician's
discretion.
• During the first two days following treatment, care should be
taken to prevent trauma to the treated site. Hot baths, massage,
etc. should be avoided. The skin should be kept clean to avoid
contamination or infection. Any mechanical or thermal damage
to the area must be avoided.
• Moisturizer may be applied only 24 hours after each treatment,
and then should be applied regularly throughout the course of
the treatment. Make-up may be applied only 24 hours after each
treatment if desired, unless an unwanted reaction occurs in the
area. Generally 24 hours after treatment, patients may use
regular soaps, but not scrub soaps or exfoliants.
• The patient should use a high-factor sunscreen (at least 30 SPF)
and protect the treated area from sunlight for at least one month
after the treatment. Tanning of any sort (sun exposure, tanning
beds, and artificial sunless tanning lotions) is not allowed in the
treated areas during the entire course of the treatment. Tanning
after treatment may cause hyperpigmentation.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
Versa User Manual C-15
C.13. Follow-Up
The following are recommendations for post-treatment follow-up.
The most suitable regimen for each patient should be determined
after reading this section.
• The patient should return 2-3 days after the treatment to ensure
that no adverse events have occurred.
• The patient should return several (4-6) weeks after the last
treatment for evaluation of the treatment area.
• Update the patient's medical history before each session while
being mindful of sun tanning, new medications, etc. If the
patient has not violated the contraindications, treatment may be
performed.
• Prior to treatment, perform a test spot in order to choose the
adequate treatment parameters.
• If no results are observed and adverse events are noticed,
treatment should be discontinued.
C.14. Treatment Conclusion
Treatment should be concluded when the results are satisfactory to
the patient or according to the physician's discretion. Generally 3-4
sessions are needed every 4-6 weeks. Do not perform more than
five consecutive sessions.
Clinical Guide for Fractional RF Treatment
with Viva Applicator
C-16 Versa User Manual
Versa User Manual D-1
Appendix D
Clinical Guide for SR515 and
SR580 Applicators
Chapter Contents:
Section Title Page
D.1. Introduction.................................................................D-2
D.2. Indications...................................................................D-3
D.3. Contraindications ........................................................D-4
D.4. Precautions ..................................................................D-5
D.5. Possible Side Effects ..................................................D-5
D.6. Before Starting ............................................................D-6
D.7. Test Spot .....................................................................D-7
D.8. Treatment Method ......................................................D-7
D.9. Treatment Protocol .....................................................D-9
D.10. Post-Treatment Care .................................................D-12
Clinical Guide for SR515 and SR580
Applicators
D-2 Versa User Manual
D.1. Introduction
Figure D-1 shows the SR515 and SR580 IPL applicators.
Figure D-1. SR515 (Left) and SR580 (Right) IPL Applicators
The effect of Venus Versa is based on well-known principles of
selective photothermolysis, developed both theoretically and
practically during the last two decades. One application that
demonstrates the principle of photothermolysis is IPL-based skin
rejuvenation.
Clinical Guide for SR515 and SR580
Applicators
Versa User Manual D-3
In treating various vascular and pigmented lesions selective
photothermolysis is used to target various chromophores such as
oxyhemoglobin, that serves as a chromophore for the treatment of
vascular lesions, and melanin located in the upper dermis that
serves as the chromophore for various pigmented lesion treatments.
Selective photothermolysis uses the matching of a specific
wavelength of light and pulse duration to obtain optimal heating
effect of the targeted tissue with minimal effect on surrounding
tissues.
D.2. Indications
The SR515 and the SR580 IPL applicators are indicated for the
treatment of benign pigmented epidermal and cutaneous lesions
including: dyschromia, hyperpigmentation, melasma, ephelides
(freckles), lentigines, nevi, and cafe-au-lait macules.
The SR515 and SR580 applicators are also indicated for the
treatment of benign cutaneous vascular lesions including port wine
stains, hemangiomas, facial, truncal and leg telangiectasias,
rosacea, erythema of rosacea, angiomas and spider angiomas,
poikiloderma of civatte, leg veins and venous malformations.
Clinical Guide for SR515 and SR580
Applicators
D-4 Versa User Manual
D.3. Contraindications
• Superficial metal or other implants in the treatment area.
• Current or history of cancer, or current condition of any type of
cancer, or pre-malignant moles.
• Pregnancy and nursing.
• Diseases which may be stimulated by light at the wavelengths
used, such as history of Systemic Lupus Erythematosus,
Porphyria, and Epilepsy.
• Patients with 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 or
Polycystic Ovary Syndrome.
• 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.
• Use of medications, herbs, food supplements, and vitamins known to
induce photosensitivity to light exposure at the wavelengths used,
such as Isotretinoin (Accutane) within the last six months,
Tetracyclines, or St. John's Wort within the last two weeks.
• Any surgical procedure in the treatment area within the last
three months or before complete healing.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning
creams within the last two weeks.
• As per the practitioner's discretion, refrain from treating any
condition which might make it unsafe for the patient.
Clinical Guide for SR515 and SR580
Applicators
Versa User Manual D-5
D.4. Precautions
• When treatment is carried out on the face, avoid treating the
areas that have undergone facial laser resurfacing and deep
chemical peeling within the last month.
• In case of Botox injection, natural fillers and implants in the
treatment area, wait one month after the last injection before
starting a treatment.
• Tanned skin should not be treated. Instruct patients to avoid
tanning throughout the treatment sessions.
D.5. Possible Side Effects
Improper use of the system may result in possible side effects.
Although these effects are rare and expected to be temporary, any
adverse reaction should be reported to the physician immediately.
Side effects may include any of the conditions listed below. Side
effects may appear either at the time of treatment or shortly after.
Some dark-skinned patients may have a delayed response one-totwo
days after treatment and should be evaluated post-test spot
accordingly.
The side effects may include:
• Pain
• Excessive skin redness (erythema) and/or swelling (edema)
• Damage to natural skin texture (crust, blister, burn)
• Change of pigmentation (hyper- and hypo-pigmentation)
• Scarring
Clinical Guide for SR515 and SR580
Applicators
D-6 Versa User Manual
D.6. Before Starting
• Determine why the patient is seeking treatment and what the
expectations are.
• Inform the patient about the treatment protocol, typical
treatment results and possible adverse effects and discomfort.
• Instruct the patient about the safety issues.
• Advise the patient to avoid skin irritation or intentional skin
tanning. Sun-screen is advisable when outdoors during daylight
hours.
• The patient should discontinue any irritant topical agents for 2-
3 days prior to treatment.
• Remove any lotion, make-up, perfume, powder or bath/shower
oil present on the patient's skin in the area to be treated. Wipe
the treatment area with a non-alcoholic preparation.
• Avoid treating over hair.
• Make sure that all jewelry and/or metal items (including any
belly rings) are removed from the treated area, to ensure
treatment safety.
• Before each treatment clean the entire applicator surface with a
medical disinfectant. Wipe the applicator tip with alcohol. Let
the tip dry completely before pulsing. Cleaning of the applicator
should always be done while system is set to Standby state or
turned off.
Clinical Guide for SR515 and SR580
Applicators
Versa User Manual D-7
D.7. Test Spot
Prior to the first complete session, perform a small test spot
treatment on a non-conspicuous site of the treatment area.
Wait for at least 15 minutes for skin types I-IV, or 48 hours for
skin types V-VI and Asian, before assessing the skin response.
This procedure can indicate if the patient can tolerate the treatment
without developing adverse effects.
D.8. Treatment Method
• Ensure that the patient is relaxed, comfortable and lying down
on the treatment bed with the treatment area exposed.
• Ensure that area that is to be treated is free of hair and that the
skin is clean. Ensure that the applicator tip is clean.
• Equip the patient with the appropriate protective eyewear.
• Set parameters for a test spot near the lower energy range for
the first treatment, and then increase gradually during
subsequent treatments as the pigmented/vascular lesions
become less noticeable.
• Set the treatment parameters, taking into consideration the
patient's skin type, the indication for use and the treatment
protocol.
• Apply a layer of ultrasonic gel to the treatment area.
• Place the applicator against the treated area so as to put the
sapphire in full contact with the patient's skin.
• Always start with lower parameters at the first session and
increase gradually during subsequent treatments.
Clinical Guide for SR515 and SR580
Applicators
D-8 Versa User Manual
• Use lower parameters in the following cases: strong and
persistent immediate response (longer than 5 minutes) such as
diffused erythema, prolonged redness in the shape of the light
guide, and excessive patient discomfort.
• If the skin shows no adverse events and there are no visible
changes in the pigmented or vascular lesion, increase the energy
level.
• When treating large areas, it is sometimes easier to divide the
area to smaller sub-areas. Use a white pencil to mark the subareas.
• After adjusting the parameters, emit a pulse at the treatment site
and assess the skin response.
 When treating pigmented lesions, acceptable fluence causes
darkening of the pigmented lesions (sometimes appearing
gray). Continue the treatment with the same parameters.
 When treating vascular lesions, acceptable fluence causes
disappearance or blanching of the treated vessels (some
larger vessels appear bluish or dark). Continue treatment
with the same parameters.
• Treat with up to 20% overlap, to avoid untreated areas.
• In some cases more than one pass may be required. If the skin
shows no adverse effects and there are no visible changes in the
pigmented/vascular lesion, perform an additional pass on the
same area, after completing a full pass on the whole treated
area. Some areas tolerate 1-3 additional passes. Erythema
should subside within a few minutes following each pass.
• If skin response allows, 1-3 passes may be performed until
endpoint is reached.
• Always ensure that the patient is comfortable with the treatment
parameters. In case of patient discomfort, lower the energy
settings.
Clinical Guide for SR515 and SR580
Applicators
Versa User Manual D-9
D.9. Treatment Protocol
• Usually 4-6 treatments are required in order to achieve the
desired results. More sessions may be required for skin with
severe photodamage. Usual intervals for the first three sessions
are 3-4 weeks.
• One touch-up session may be needed every 3-6 months,
according to individual natural physiological processes.
D.9.1. Setting the Treatment Parameters
It is always recommended to start with a low energy level and
observe the skin's reaction before increasing the energy.
Table D-1 and Table D-2 list the recommended energy settings for
various skin types. These are general guidelines. Specific treatment
parameters should be defined for each individual, taking into
consideration the clinical condition, the history of treatments, etc.
Clinical Guide for SR515 and SR580
Applicators
D-10 Versa User Manual
D.9.1.1. Pigmented Lesions
When treating pigmented lesions, acceptable fluence causes
darkening of the pigmented lesions (sometimes appearing gray).
This should be the recommended treatment end-point.
Table D-1. Treatment Parameters for Pigmented Lesions
Applicator Fitzpatrick
Skin Type
Energy
Output
(J/cm2)
Pulse
Duration
(ms)
Frequency
(Hz)
Cooling
SR515 I – II 14-20 10-20 Up to 3
III 10-16 10-20 Up to 3
IV
V
VI
SR580 I – II 14-20 10-20 Up to 3
III 10-16 10-20 Up to 3
IV 8-14 15-20 Up to 3
V 5-10 15-20 Up to 3
VI
Clinical Guide for SR515 and SR580
Applicators
Versa User Manual D-11
D.9.1.2. Vascular Lesions
When treating vascular lesions, acceptable fluence causes
disappearance or blanching of the treated vessels (some larger
vessels appear bluish or dark). This should be the recommended
treatment end-point.
Table D-2. Treatment Parameters for Vascular Lesions
Applicator Fitzpatrick
Skin Type
Energy
Output
(J/cm2)
Pulse
Duration
(ms)*
Frequency
(Hz)
Cooling
SR515 I – II 14-20 10-20 Up to 3
III 10-16 10-20 Up to 3
IV
V
VI
SR580 I – II 16-22 10-20 Up to 3
III 12-18 10-20 Up to 3
IV 8-14 15-20 Up to 3
V 6-12 15-20 Up to 3
VI
* For very small vessels it is recommended to choose shorter
pulse durations.
Clinical Guide for SR515 and SR580
Applicators
D-12 Versa User Manual
D.10. Post-Treatment Care
• Avoid tanning before and after treatments. Sunscreen should be
used to protect the skin from tanning. Treating tanned skin may
cause hyper pigmentation or may lead to adverse events.
• Blistered or ulcerated skin can be treated with a prescribed
antibiotic ointment or burn treatment cream.
• During the first two days following treatment avoid hot baths,
massages, etc.
Versa User Manual E-1
Appendix E
Clinical Guide for Hair Removal
Using IPL HR Applicators
Chapter Contents:
Section Title Page
E.1. Introduction................................................................. E-2
E.2. Indications................................................................... E-3
E.3. Contraindications ........................................................ E-4
E.4. Precautions .................................................................. E-5
E.5. Possible Side Effects .................................................. E-5
E.6. Before Starting ............................................................ E-6
E.7. Test Spot ..................................................................... E-7
E.8. Treatment Method ...................................................... E-7
E.9. Treatment Protocol ..................................................... E-9
E.10. Post-Treatment Care ................................................. E-11
Clinical Guide for Hair Removal Using IPL
HR Applicators
E-2 Versa User Manual
E.1. Introduction
Figure E-1 shows the HR650, HR690, HR 650XL and HR690XL
IPL applicators.
Figure E-1. HR650 (Upper Left), HR690 (UpperRight),
HR650XL (Lower Left) and HR690XL (Lower Right)
IPL Applicators
Clinical Guide for Hair Removal Using IPL
HR Applicators
Versa User Manual E-3
The effect of Venus Versa is based on well-known principles of
selective photothermolysis, developed both theoretically and
practically during the last two decades.
One of the most common applications that demonstrates the
principle of photothermolysis is IPL based hair removal. In hair
removal, an optical energy source focuses on the endogenous
chromophore melanin, which is mainly found in the hair shaft, with
a small amount present in the upper third of the follicular
epithelium. When an appropriate energy source is directed at the
skin, light is primarily absorbed in the hair shaft melanin. Heat is
generated and diffuses to the surrounding follicular epithelium.
In hair removal, selective photothermolysis uses the matching of a
specific wavelength of light and pulse duration to obtain optimal
heating effect of the targeted tissue with minimal effect on
surrounding tissues. The IPL source can cause localized damage by
selectively heating dark target matter, melanin, in the area that
causes hair growth, the follicle, while only minimally heating the
rest of the skin.
Light is absorbed by dark objects. Therefore, the energy can be
absorbed by dark material in the skin at greater speed and higher
intensity than in the lighter surrounding tissue. Melanin is
considered the primary chromophore for all hair removal IPL based
treatments.
E.2. Indications
The HR650, HR690, HR 650XL and HR690XL IPL applicators are
indicated for the removal of unwanted hair and to effect stable
long-term or permanent hair reduction.
Clinical Guide for Hair Removal Using IPL
HR Applicators
E-4 Versa User Manual
E.3. Contraindications
• Superficial metal or other implants in the treatment area.
• Current or history of cancer, or current condition of any type of
cancer, or pre-malignant moles.
• Pregnancy and nursing.
• Diseases which may be stimulated by light at the wavelengths
used, such as history of Systemic Lupus Erythematosus,
Porphyria, and Epilepsy.
• Patients with 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 or
Polycystic Ovary Syndrome.
• 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.
• Use of medications, herbs, food supplements, and vitamins known to
induce photosensitivity to light exposure at the wavelengths used,
such as Isotretinoin (Accutane) within the last six months,
Tetracyclines, or St. John's Wort within the last two weeks.
• Any surgical procedure in the treatment area within the last
three months or before complete healing.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning
creams within the last two weeks.
• As per the practitioner's discretion, refrain from treating any
condition which might make it unsafe for the patient.
Clinical Guide for Hair Removal Using IPL
HR Applicators
Versa User Manual E-5
E.4. Precautions
• When treatment is carried out on the face, avoid treating the
areas that have undergone facial laser resurfacing and deep
chemical peeling within the last month.
• In case of Botox injection, natural fillers and implants in the
treatment area, wait one month after the last injection before
starting a treatment.
• Tanned skin should not be treated. Instruct patients to avoid
tanning throughout the treatment sessions.
E.5. Possible Side Effects
Improper use of the system may result in possible side effects.
Although these effects are rare and expected to be temporary, any
adverse reaction should be reported to the physician immediately.
Side effects may include any of the conditions listed below. Side
effects may appear either at the time of treatment or shortly after.
Some dark-skinned patients may have a delayed response one-totwo
days after treatment and should be evaluated post-test spot
accordingly.
The side effects may include:
• Pain
• Excessive skin redness (erythema) and/or swelling (edema)
• Damage to natural skin texture (crust, blister, burn)
• Change of pigmentation (hyper- and hypo-pigmentation)
• Scarring
Clinical Guide for Hair Removal Using IPL
HR Applicators
E-6 Versa User Manual
E.6. Before Starting
• Determine why the patient is seeking treatment and what the
expectations are.
• Inform the patient about the treatment protocol, typical
treatment results and possible adverse effects and discomfort.
• Instruct the patient about the safety issues.
• Advise the patient to avoid skin irritation or intentional skin
tanning. Sun-screen is advisable when outdoors during daylight
hours.
• The patient should discontinue any irritant topical agents for 2-
3 days prior to treatment.
• Remove any lotion, make-up, perfume, powder or bath/shower
oil present on the patient's skin in the area to be treated. Wipe
the treatment area with a non-alcoholic preparation.
• If necessary, a topical anesthetic may be used according to the
physician's discretion.
• The hair in the area that is to be treated should be clearly visible
to the operator. Mark the area with white or yellow color and
shave it before treatment. Alternatively, ask the patient to shave
at home ~2 days prior to treatment.
• Make sure that all jewelry and/or metal items (including any
belly rings) are removed from the treated area, to ensure
treatment safety.
• Before each treatment clean the entire applicator surface with a
medical disinfectant. Wipe the applicator tip with alcohol. Let
the tip dry completely before pulsing. Cleaning of the applicator
should always be done while system is set to Standby state or
turned off.
Clinical Guide for Hair Removal Using IPL
HR Applicators
Versa User Manual E-7
E.7. Test Spot
Prior to the first complete session, perform a small test spot
treatment on a non-conspicuous site of the treatment area.
Wait for at least 15 minutes for skin types I-IV, or 48 hours for
skin types V-VI and Asian, before assessing the skin response.
This procedure can indicate if the patient can tolerate the treatment
without developing adverse effects.
E.8. Treatment Method
• Ensure that the patient is relaxed, comfortable and lying down
on the treatment bed with the treatment area exposed.
• Ensure that the hair in the treated area is shaved and that the
skin is clean. Ensure that the applicator tip is clean.
• Equip the patient with the appropriate protective eyewear.
• Set parameters for a test spot near the lower energy range for
the first treatment, and then increase gradually during
subsequent treatments as hair density decreases or hair become
lighter/finer.
• Set the treatment parameters, taking into consideration the
patient's skin type, the indication for use and the treatment
protocol.
• Apply a layer of ultrasonic gel to the treatment area.
• Place the applicator against the treated area so as to put the
sapphire in full contact with the patient's skin.
• Always start with lower parameters at the first session and
increase gradually during subsequent treatments.
Clinical Guide for Hair Removal Using IPL
HR Applicators
E-8 Versa User Manual
• Use lower parameters in the following cases: strong and
persistent immediate response (longer than 5 minutes) such as
diffused erythema, prolonged redness in the shape of the light
guide, and excessive patient discomfort.
• If the skin shows no adverse events and there are no visible
changes in the pigmented or vascular lesion, increase the energy
level.
• When treating large areas, it is sometimes easier to divide the
area to smaller sub-areas. Use a white pencil to mark the subareas.
• After adjusting the parameters, emit a pulse at the treatment site
and assess the skin response. Acceptable fluence causes slight
general erythema and perifollicular erythema or edema around
dark/coarse hair follicles. Light and fine hair often does not
show the perifollicular response. Continue the treatment with
the same parameters.
• Treat with up to 20% overlap, to avoid untreated areas.
• When treating light/fine hair, sometimes more than one pass is
required. If the skin shows no adverse effects and there are no
visible changes in hair and follicles, perform an additional pass
on the same area, after completing a full pass on the whole
treated area. Some areas tolerate 1-3 additional passes.
Erythema should subside within a few minutes following each
pass.
• If skin response allows, 1-3 passes may be performed until
endpoint is reached.
• Stubborn dark/coarse hair may also require an additional pass to
show a response.
• Always ensure that the patient is comfortable with the treatment
parameters. In case of patient discomfort, lower the energy
settings.
Clinical Guide for Hair Removal Using IPL
HR Applicators
Versa User Manual E-9
E.9. Treatment Protocol
• Usually 6-10 treatments are required in order to achieve the
desired results. More sessions may be required for light and fine
hair and in hormonally controlled areas. Patients should
schedule another session when hair re-growth is observed.
• Usual intervals for the first three sessions are 4-6 weeks on the
face and 4-8 weeks on the body. Increase the intervals as
treatment progresses and hair becomes lighter and fine. Some
areas like legs and back may require longer intervals.
• One touch-up treatment session may be needed for sporadic
new hair growth due to individual physiological processes.
Clinical Guide for Hair Removal Using IPL
HR Applicators
E-10 Versa User Manual
E.9.1. Setting the Treatment Parameters
It is always recommended to start with a low energy level and
observe the skin's reaction before increasing the energy.
Table E-1 lists the recommended energy settings for various skin
types. These are general guidelines. Specific treatment parameters
should be defined for each individual, taking into consideration the
treatment area, the clinical condition, the history of treatments, etc.
Table E-1. Treatment Parameters for Hair Removal
Applicator Fitzpatrick
Skin Type
Energy
Output
(J/cm2)
Pulse
Duration
(ms)
Frequency
(Hz)
HR650
I – II 14-20 20-50 Up to 3
III 10-16 20-50 Up to 3
IV 6-12 30-50 Up to 3
V Up to 3
VI Up to 3
HR690
I – II 14-20 20-50 Up to 3
III 10-16 20-50 Up to 3
IV 6-14 30-50 Up to 3
V 5-12 30-50 Up to 3
VI 5-10 30-50 Up to 3
HR650XL
I – II 12-18 20-50 Up to 3
III 10-16 20-50 Up to 3
IV 6-12 30-50 Up to 3
V
VI
HR690XL
I – II 12-18 20-50 Up to 3
III 10-16 30-50 Up to 3
IV 6-12 30-50 Up to 3
V 5-10 50 Up to 3
VI 5-10 50 Up to 3
Clinical Guide for Hair Removal Using IPL
HR Applicators
Versa User Manual E-11
E.10. Post-Treatment Care
• Avoid tanning before and after treatments. Sunscreen should be
used to protect the skin from tanning. Treating tanned skin may
cause hyper pigmentation or may lead to adverse events.
• Blistered or ulcerated skin can be treated with a prescribed
antibiotic ointment or burn treatment cream.
• During the first two days following treatment avoid hot baths,
massages, etc.
Clinical Guide for Hair Removal Using IPL
HR Applicators
E-12 Versa User Manual
Versa User Manual F-1
Appendix F
Clinical Guide for the ACDUAL
Applicator
Chapter Contents:
Section Title Page
F.1. Introduction................................................................. F-2
F.2. Indications................................................................... F-3
F.3. Contraindications ........................................................ F-4
F.4. Precautions .................................................................. F-5
F.5. Possible Side Effects .................................................. F-5
F.6. Before Starting ............................................................ F-6
F.7. Test Spot ..................................................................... F-7
F.8. Treatment Method ...................................................... F-7
F.9. Treatment Protocol ..................................................... F-9
F.10. Post-Treatment Care ................................................. F-10
Clinical Guide for the ACDUAL Applicator
F-2 Versa User Manual
F.1. Introduction
Figure F-1 shows the ACDUAL applicator.
Figure F-1. ACDUAL Applicator
The effect of Venus Versa is based on well-known principles of
selective photothermolysis, developed both theoretically and
practically during the last two decades. One application that
demonstrates the principle of photothermolysis is Acne Vulgaris.
Clinical Guide for the ACDUAL Applicator
Versa User Manual F-3
Acne results from the clogging of sebaceous glands with sebum, a
naturally occurring oil, and dead skin cells. In these conditions, the
naturally occurring largely commensal bacterium
Propionibacterium acnes can cause inflammation within and
around the follicle, leading to inflammatory lesions (papules,
infected pustules, or nodules) in the dermis, which results in
redness and may result in scarring or hyperpigmentation.
Selective photothermolysis uses the matching of a specific
wavelength of light and pulse duration to obtain optimal heating
effect of the targeted tissue with minimal effect on surrounding
tissues.
The ACDUAL applicator targets both aspects of Acne Vulgaris. It
uses a blue light (415 nm) to target the porphyrins produced by the
p.Acne bacteria and destroy the bacteria, and also uses a red light
(630 nm) to help reduce inflammation, inhibit sebum production
and improve healing.
F.2. Indications
The ACDUAL IPL applicator is indicated for the treatment of
Acne Vulgaris.
Clinical Guide for the ACDUAL Applicator
F-4 Versa User Manual
F.3. Contraindications
• Superficial metal or other implants in the treatment area.
• Current or history of cancer, or current condition of any type of
cancer, or pre-malignant moles.
• Pregnancy and nursing.
• Diseases which may be stimulated by light at the wavelengths
used, such as history of Systemic Lupus Erythematosus,
Porphyria, and Epilepsy.
• Patients with 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 or
Polycystic Ovary Syndrome.
• 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.
• Use of medications, herbs, food supplements, and vitamins known to
induce photosensitivity to light exposure at the wavelengths used,
such as Isotretinoin (Accutane) within the last six months,
Tetracyclines, or St. John's Wort within the last two weeks.
• Any surgical procedure in the treatment area within the last
three months or before complete healing.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning
creams within the last two weeks.
• As per the practitioner's discretion, refrain from treating any
condition which might make it unsafe for the patient.
Clinical Guide for the ACDUAL Applicator
Versa User Manual F-5
F.4. Precautions
• When treatment is carried out on the face, avoid treating the
areas that have undergone facial laser resurfacing and deep
chemical peeling within the last month.
• In case of Botox injection, natural fillers and implants in the
treatment area, wait one month after the last injection before
starting a treatment.
• Tanned skin should not be treated. Instruct patients to avoid
tanning throughout the treatment sessions.
F.5. Possible Side Effects
Improper use of the system may result in possible side effects.
Although these effects are rare and expected to be temporary, any
adverse reaction should be reported to the physician immediately.
Side effects may include any of the conditions listed below. Side
effects may appear either at the time of treatment or shortly after.
Some dark-skinned patients may have a delayed response one-totwo
days after treatment and should be evaluated post-test spot
accordingly.
The side effects may include:
• Pain
• Excessive skin redness (erythema) and/or swelling (edema)
• Damage to natural skin texture (crust, blister, burn)
• Change of pigmentation (hyper- and hypo-pigmentation)
• Scarring
Clinical Guide for the ACDUAL Applicator
F-6 Versa User Manual
F.6. Before Starting
• Determine why the patient is seeking treatment and what the
expectations are.
• Inform the patient about the treatment protocol, typical
treatment results and possible adverse effects and discomfort.
• Instruct the patient about the safety issues.
• Advise the patient to avoid skin irritation or intentional skin
tanning. Sun-screen is advisable when outdoors during daylight
hours.
• The patient should discontinue any irritant topical agents for 2-
3 days prior to treatment.
• Remove any lotion, make-up, perfume, powder or bath/shower
oil present on the patient's skin in the area to be treated. Wipe
the treatment area with a non-alcoholic preparation.
• Avoid treating over hair. Shave any hair in the treated area prior
to treatment.
• Make sure that all jewelry and/or metal items (including any
belly rings) are removed from the treated area, to ensure
treatment safety.
• Before each treatment clean the entire applicator surface with a
medical disinfectant. Wipe the applicator tip with alcohol. Let
the tip dry completely before pulsing. Cleaning of the applicator
should always be done while system is set to Standby state or
turned off.
Clinical Guide for the ACDUAL Applicator
Versa User Manual F-7
F.7. Test Spot
Prior to the first complete session, perform a small test spot
treatment on a non-conspicuous site of the treatment area.
Wait for at least 15 minutes for skin types I-IV, or 48 hours for
skin types V-VI and Asian, before assessing the skin response.
This procedure can indicate if the patient can tolerate the treatment
without developing adverse effects.
F.8. Treatment Method
• Ensure that the patient is relaxed, comfortable and lying down
on the treatment bed with the treatment area exposed.
• Ensure that area that is to be treated is free of hair and that the
skin is clean. Ensure that the applicator tip is clean.
• Equip the patient with the appropriate protective eyewear.
• Set parameters for a test spot near the lower energy range for
the first treatment, and then increase gradually during
subsequent treatments as the pigmented/vascular lesions
become less noticeable.
• Set the treatment parameters, taking into consideration the
patient's skin type, the indication for use and the treatment
protocol.
• Apply a layer of ultrasonic gel to the treatment area.
• Place the applicator against the treated area so as to put the
sapphire in full contact with the patient's skin.
• Always start with lower parameters at the first session and
increase gradually during subsequent treatments.
Clinical Guide for the ACDUAL Applicator
F-8 Versa User Manual
• Use lower parameters in the following cases: strong and
persistent immediate response (longer than 5 minutes) such as
diffused erythema, prolonged redness in the shape of the light
guide, and excessive patient discomfort.
• Examine the treated area for positive end-points: possible color
change of lesions and slight general skin erythema.
• If the skin shows no adverse events and there are no visible
changes in the pigmented or vascular lesion, increase the energy
level.
• After adjusting the parameters, emit a pulse at the treatment site
and assess the skin response.
• After adjusting the treatment parameters, ensure that there are
no adverse epidermal events and that the lesions show visible
changes. Continue the treatment with these parameters.
• Apply an additional pass to sporadic lesions if the skin response
allows.
• Very inflamed lesions may be more sensitive to a high energy
level. Therefore, decrease the level according to patient's
comfort. Increase the level gradually in subsequent treatments
when the lesions begin to shrink.
• Treat with up to 20% overlap, to avoid untreated areas.
• Always ensure that the patient is comfortable with the treatment
parameters. In case of patient discomfort, lower the energy
settings.
Clinical Guide for the ACDUAL Applicator
Versa User Manual F-9
F.9. Treatment Protocol
• It is recommended to treat the patient twice a week for about
one month (a total of 8-10 treatments).
• Provide prophylactic maintenance treatment twice a month,
then monthly, and then increase the intervals according to
clearance.
F.9.1. Setting the Treatment Parameters
It is always recommended to start with a low energy level and
observe the skin's reaction before increasing the energy.
Table F-1 lists the recommended energy settings for various skin
types. These are general guidelines. Specific treatment parameters
should be defined for each individual, taking into consideration the
clinical condition, the history of treatments, etc.
Table F-1. Treatment Parameters for Acne
Applicator Fitzpatrick
Skin Type
Energy
Output
(J/cm2)
Pulse
Duration
(ms)
Frequency
(Hz)
ACDUAL
I – II 12-16 10 Up to 2
III 10-14 15 Up to 2
IV 8-12 20 Up to 2
V 8 20 Up to 2
VI 8 20 Up to 2
Clinical Guide for the ACDUAL Applicator
F-10 Versa User Manual
F.10. Post-Treatment Care
• Avoid tanning before and after treatments. Sunscreen
(> SPF 30) should be used to protect the skin from tanning.
Treating tanned skin may cause hyper pigmentation or may lead
to adverse events.
• Blistered or ulcerated skin can be treated with a prescribed
antibiotic ointment or burn treatment cream.
• If scabs appear after blistering, they should be kept soft with a
lubricating ointment.
• During the first two days following treatment avoid hot baths,
massages, etc.
• Return to normal acne skin regimen usually 1-2 days after the
treatment if there are potentially harsh or irritant topical agents
in the program. Otherwise, gentle washer and non-irritant
topical agents may be used without interruption.
Versa User Manual G-1
Appendix G
Manufacturer Warranty
Chapter Contents:
Section Title Page
G.1. Manufacturer Warranty ..............................................G-2
Manufacturer Warranty
G-2 Versa User Manual
G.1. Manufacturer Warranty
The Company warrants that the product shall be free from defects in materials and
workmanship for a period of 1 (one) year from the date of shipment by the Distributor
to the purchaser, provided however that in no event shall any warranty extend more
than 15 months from the date it was delivered to the local distributor. The liability of
the Company under this warranty is limited to the repair or replacement (at
Company’s sole decision) of any allegedly defective part or parts under warranty at its
expense.
The warranty contained herein does not extend to any product that is modified or
altered, is not maintained to the Company’s maintenance recommendation, is
operated, handled or stored in a manner other than that specified by the Company,
has its serial number removed or altered, or is treated with abuse, negligence or other
improper treatment (including without limitations, use outside the recommended
working environment).
The Company makes no warranty in respect to accessories and other parts made by
other manufacturers, whether or not warranted by such manufacturers, which have
been attached or connected to the product after installation, unless such accessory
and other parts have been supplied by the Company.
Please fill in your details, scan and e-mail to [email protected]
Business Name:
Contact:
Address:
Telephone Number:
Email Address:
Date Purchased:
S/N:

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  • “我司所需翻譯的資料專業(yè)性強,涉及面廣,翻譯難度大,貴司總能提供優(yōu)質(zhì)的服務(wù)。在一次業(yè)主單位對完工資料質(zhì)量的抽查中,我司因為俄文翻譯質(zhì)量過關(guān)而受到了好評�!�

    中辰匯通科技有限責(zé)任公司

  • “我司在2014年與貴公司建立合作關(guān)系,貴公司的翻譯服務(wù)質(zhì)量高、速度快、態(tài)度好,贏得了我司各部門的一致好評。貴司經(jīng)理工作認(rèn)真踏實,特此致以誠摯的感謝!”

    新華聯(lián)國際置地(馬來西亞)有限公司

  • “我們需要的翻譯人員,不論是筆譯還是口譯,都需要具有很強的專業(yè)性,貴公司的德文翻譯稿件和現(xiàn)場的同聲傳譯都得到了我公司和合作伙伴的充分肯定�!�

    西馬遠(yuǎn)東醫(yī)療投資管理有限公司

  • “在這5年中,世聯(lián)翻譯公司人員對工作的認(rèn)真、負(fù)責(zé)、熱情、周到深深的打動了我。不僅譯件質(zhì)量好,交稿時間及時,還能在我司資金周轉(zhuǎn)緊張時給予體諒�!�

    華潤萬東醫(yī)療裝備股份有限公司

  • “我公司與世聯(lián)翻譯一直保持著長期合作關(guān)系,這家公司報價合理,質(zhì)量可靠,效率又高。他們翻譯的譯文發(fā)到國外公司,對方也很認(rèn)可。”

    北京世博達(dá)科技發(fā)展有限公司

  • “貴公司翻譯的譯文質(zhì)量很高,語言表達(dá)流暢、排版格式規(guī)范、專業(yè)術(shù)語翻譯到位、翻譯的速度非�?臁⒑笃诜⻊�(wù)熱情。我司翻譯了大量的專業(yè)文件,經(jīng)過長久合作,名副其實,值得信賴。”

    北京塞特雷特科技有限公司

  • “針對我們農(nóng)業(yè)科研論文寫作要求,盡量尋找專業(yè)對口的專家為我提供翻譯服務(wù),最后又按照學(xué)術(shù)期刊的要求,提供潤色原稿和相關(guān)的證明文件。非常感謝世聯(lián)翻譯公司!”

    中國農(nóng)科院

  • “世聯(lián)的客服經(jīng)理態(tài)度熱情親切,對我們提出的要求都落實到位,回答我們的問題也非常有耐心。譯員十分專業(yè),工作盡職盡責(zé),獲得與其共事的公司總部同事們的一致高度認(rèn)可。”

    格萊姆公司

  • “我公司與馬來西亞政府有相關(guān)業(yè)務(wù)往來,急需翻譯項目報備材料。在經(jīng)過對各個翻譯公司的服務(wù)水平和質(zhì)量的權(quán)衡下,我們選擇了世聯(lián)翻譯公司。翻譯很成功,公司領(lǐng)導(dǎo)非常滿意�!�

    北京韜盛科技發(fā)展有限公司

  • “客服經(jīng)理能一貫熱情負(fù)責(zé)的完成每一次翻譯工作的組織及溝通。為客戶與譯員之間搭起順暢的溝通橋梁。能協(xié)助我方建立專業(yè)詞庫,并向譯員準(zhǔn)確傳達(dá)落實,準(zhǔn)確及高效的完成統(tǒng)一風(fēng)格�!�

    HEURTEY PETROCHEM法國赫銻石化

  • “貴公司與我社對翻譯項目進行了幾次詳細(xì)的會談,期間公司負(fù)責(zé)人和廖小姐還親自來我社拜訪,對待工作熱情,專業(yè)度高,我們雙方達(dá)成了很好的共識。對貴公司的服務(wù)給予好評!”

    東華大學(xué)出版社

  • “非常感謝世聯(lián)翻譯!我們對此次緬甸語訪談翻譯項目非常滿意,世聯(lián)在充分了解我司項目的翻譯意圖情況下,即高效又保質(zhì)地完成了譯文�!�

    上海奧美廣告有限公司

  • “在合作過程中,世聯(lián)翻譯保質(zhì)、保量、及時的完成我們交給的翻譯工作�?蛻艚�(jīng)理工作積極,服務(wù)熱情、周到,能全面的了解客戶的需求,在此表示特別的感謝�!�

    北京中唐電工程咨詢有限公司

  • “我們通過圖書翻譯項目與你們相識乃至建立友誼,你們報價合理、服務(wù)細(xì)致、翻譯質(zhì)量可靠。請允許我們借此機會向你們表示衷心的感謝!”

    山東教育出版社

  • “很滿意世聯(lián)的翻譯質(zhì)量,交稿準(zhǔn)時,中英互譯都比較好,措辭和句式結(jié)構(gòu)都比較地道,譯文忠實于原文。TNC是一家國際環(huán)保組織,發(fā)給我們美國總部的同事后,他們反應(yīng)也不錯�!�

    TNC大自然保護協(xié)會

  • “原英國首相布萊爾來訪,需要非常專業(yè)的同聲傳譯服務(wù),因是第一次接觸,心中仍有著一定的猶豫,但是貴司專業(yè)的譯員與高水準(zhǔn)的服務(wù),給我們留下了非常深刻的印象�!�

    北京師范大學(xué)壹基金公益研究院

  • “在與世聯(lián)翻譯合作期間,世聯(lián)秉承著“上善若水、厚德載物”的文化理念,以上乘的品質(zhì)和質(zhì)量,信守對客戶的承諾,出色地完成了我公司交予的翻譯工作�!�

    國科創(chuàng)新(北京)信息咨詢中心

  • “由于項目要求時間相當(dāng)緊湊,所以世聯(lián)在保證質(zhì)量的前提下,盡力按照時間完成任務(wù)。使我們在世博會俄羅斯館日活動中準(zhǔn)備充足,并受到一致好評。”

    北京華國之窗咨詢有限公司

  • “貴公司針對客戶需要,挑選優(yōu)秀的譯員承接項目,翻譯過程客戶隨時查看中途稿,并且與客戶溝通術(shù)語方面的知識,能夠更準(zhǔn)確的了解到客戶的需求,確保稿件高質(zhì)量�!�

    日工建機(北京)國際進出口有限公司

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