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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

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.

Operating Instructions

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.

5 4

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).

Figure 5-7. Elements of the Fractional RF Mode

Treatment Screen

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.

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

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

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

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

* 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

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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