VENUS CONCEPT Venus Viva User manual

Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01
User Manual
International

Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01
Copyright 2009 Venus Concept. All rights reserved.
Print date: July 2013
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 the express written permission of
Venus Concept Ltd.
Data is 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 except as expressly provided in any written
agreement from Venus Concept Ltd.
For Latin America and the Caribbean please call 1-888-907-0115.
All other inquires, please contact:
Venus Concepts is a subsidiary
Of Venus Technologies
#38 HaBarzel St., Tel Aviv, Israel 69710
Ph. [phone]
International (M)
Hachermesh Street Bld. 62, Karmiel 21652, Israel.
Canada
255 Consumers Rd. Suite 100, Toronto, Ontario. M2J 1R4.
Europe (P)
Obelis S.A. - Av.de Tervuren, 34 bte 44, B-1040 Brussels, Belgium.
General Inquiries
[email protected]m
Service Inquiries
[e-mail]
Website
www.venus-concept.com

Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01
Table of Contents
Chapter 1 -Before You Start…………………………………………….........................…1-1
Glossary of Symbols Used in this Manual........................................................................1-1
S/N Label .........................................................................................................................1-2
WARNING........................................................................................................................1-3
Chapter 2 - Introduction..................................................................................................2-1
View of Venus Viva System .............................................................................................2-1
System Description ..........................................................................................................2-2
Chapter 3 - Safety ..........................................................................................................3-1
Introduction ......................................................................................................................3-1
The Operator....................................................................................................................3-1
Fire Hazards ....................................................................................................................3-3
Chapter 4 - System Installation ......................................................................................4-1
Equipment List .................................................................................................................4-1
Electrical Requirements ...................................................................................................4-2
Environmental Requirements...........................................................................................4-2
Connect the Applicators...................................................................................................4-3
Connect/Disconnectiong a Tip to Scan FX Applicator.....................................................4-4
Chapter 5 -Operating the System..................................................................................5-1
Turning the System On/Off ..............................................................................................5-1
Login Screen....................................................................................................................5-1
Treatment Screen ............................................................................................................5-2
Selecting Desired Applicator............................................................................................5-3
Fractional RF Treatment Mode ........................................................................................5-3
Operating the Scan FX Applicator....................................................................................5-7
(MP)2 Treatment Mode....................................................................................................5-8
Tools Screen..................................................................................................................5-10
Chapter 6 - Treatment Procedures.................................................................................6-1
Fractional RF Treatment Mode Using Scan FX Applicator ..............................................6-1
Exclusion Criteria .............................................................................................................6-1
Possible Side Effects .......................................................................................................6-3
Pre-treatment...................................................................................................................6-3
Test Treatment.................................................................................................................6-4
Treatment Procedure .......................................................................................................6-5
Treatment Protocol...........................................................................................................6-6
Treatment Parameters .....................................................................................................6-7
Post Treatment Care........................................................................................................6-7
Follow-Up.........................................................................................................................6-8

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Treatment Conclusion......................................................................................................6-8
(MP)2 Treatment Modality Using Firm FX and Firm BX Applicators .................................6-9
Exclusion Criteria .............................................................................................................6-9
Precaution Criteria ...........................................................................................................6-9
Pre-Treatment................................................................................................................6-10
General Treatment Information......................................................................................6-11
Chapter 7 - Maintenance................................................................................................7-1
Cleaning the System........................................................................................................7-1
Cleaning the applicators...................................................................................................7-1
Disinfection the applicators ..............................................................................................7-2
Cleaning the tip ................................................................................................................7-2
Chapter 8 - Troubleshooting............................................................................................8-1
Chapter 9 - Technical Specifications ..............................................................................9-1
Chapter 10 - Manufacturer Warranty.............................................................................10-1

Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01
Before You Start
Glossary of Symbols Used in this Manual
The following are symbols that you will find throughout this operating manual and their
meanings:
WARNING sign: The information stated where you will see this
symbol is extremely important and must be noted!
Provides general information that is important to keep in mind.
Waste of Electrical and Electronic Equipment (WEEE) Marking.
Fuse.
Type BF Equipment.
Manufacturer.
Obelis S.A.
Authorized Representative in the European Community.
Manufacturer (accompanied by the name and address of the
manufacturer).
Date of Manufacture.
Symbol used with a HF isolated patient circuit.
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S/N Label
Consult Instruction for Use.
System that includes RF transmitters or that applies RF
electromagnetic energy for diagnosis or treatment.
Figure 1-1, Venus Viva
Serial Number Label
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WARNING
Read the User Manual instructions carefully before installing or using the System to
become familiar with all safety requirements and operating procedures thereby
prevent accidents, injury and reduce the risk of damaging the machine.
The Venus VIVA 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.
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2. Introduction
View of Venus Viva System
c
d
J
g
k
f
i
a
b
e
h
J
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a. Firm FX Applicator. (detachable accessory)
b. Firm BX Applicator. (detachable accessory)
c. Scan FX Applicator. (detachable accessory)
d. Firm FX Holder.
e. Scan FX Holder.
f. Firm FX/BX Applicator Socket.
g. Scan FX Applicator Socket.
h. Touch Screen.
i. Serial Number Label.
j. On/Off Button.
k. Power Socket.
System Description
The Venus VIVA is a non invasive medical aesthetic device for dermatological procedures
requiring ablation and resurfacing of the skin.
Sublative Rejuvenation with Venus Viva is a unique procedure which uses radio
frequency energy to deliver an effective but controlled ablative treatment. The procedure
is intended to provide a noticeable
Wrinkle Reduction
Increase of Skin Tightening.
Temporary Circumferential Reduction.
Cellulite Reduction
The energies supplement each other to provide optimal treatment results with minimal
risk of side effects.
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The system offers 3 main applicators for small and large areas:
Firm FX Applicator. (detachable accessory)
Firm BX Applicator. (detachable accessory)
Scan FX Applicator. (detachable accessory)
Intended user and environment:
The device is intended to be used by professional practitioners in the medical
aesthetic field.
The operator should stand near the client.
The operator is not allowed to leave a client during the entire treatment.
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3. Safety
This chapter describes safety issues regarding the use and maintenance of the
System, with special emphasis on electrical safety.
Introduction
The System is designed for a safe and reliable treatment when used in accordance to
proper operating and maintenance procedures as outlined in this operating manual.
Only trained and qualified personnel, 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.
The Operator

All operators MUST be familiar with the system controls and know how
to shut down the system in case of trouble.

Always be aware of the possible dangers of using the System and take
proper precautions as described in this manual.

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.

RF used in this (MP)² technology can cause injury if used improperly.

High voltage is present inside the System, do not attempt to open the
casing.

Disconnect the System from the power supply before servicing (pull out
Please carefully read this chapter and be familiar with all of its safety
requirements and operating procedures prior to operating the System.
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the plug).

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.

Venus Viva System should be kept out of the reach of Children.

Do not allow the Applicators to come in contact with metal elements this
could damage the (MP)2electrodes.

A patient history should be completed prior to treatment to ensure no
complications could arise. It is important to verify client does not full
under the exclusion criteria.

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). The use of antistatic sheeting is
recommended for this purpose.

The cables to the Applicators should be positioned in such a way that
contact with the PATIENT or other leads is avoided.

The product should not be in contact with other equipment.

Failure of the System could result in an unintended increase of output
power.

Interference produced by the operation of HF SURGICAL
EQUIPEMENT may adversely influence the operation of other electronic
EQUIPEMENT.

For PATIENT 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.

The patient should then be fully informed of the treatment protocol,
expected results and should sign informed consent form prior to
beginning treatments.

Only authorized person is allowed to stand near the system during the
treatment.

Stop the treatment in case of unexpected changes in client’s condition.
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
Do not drop the Applicators. In case the Applicators were dropped, turn
off the system immediately. Don’t use the broken applicator and call to
local service support.

There are no user-serviceable parts inside the system. ONLY Venus-
AUTHORIZED PERSONNEL MAY SERVICE THE SYSTEM,
ESPECIALLY INSIDE ITS CABINET.

Keep the bodies of the applicators clean; pay particular attention to the
RF electrodes of the Scan FX applicator. Check the integrity of all
components.

Do not allow the applicators to come in contact with hard materials that
could damage the tips
Fire Hazards

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.
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4. System Installation
The system is designed for operation in a clinical environment and it may be easily
transported inside a protective carrying case. The Venus VIVA system is set up by doing
the following:
1. Unpack the system.
2. Check the integrity of the system and all components.
3. Connect the Scan FX applicator to the system platform
4. Connect the Firm BX applicator or Firm FX applicator to the system platform.
5. Connect the power cable to the system cable connection port.
6. Plug the system's power cable into an appropriate electrical outlet.
7. Turn the system on.
Equipment List
The System includes the following:
System platform (Console Venus VIVA).
Firm FX Applicator. (detachable accessory)
Firm BX Applicator. (detachable accessory)
Scan FX Applicator. (detachable accessory)
Power cord.
User Manual.
Quick reference guide (only for non-English speakers’ countries).
Ultrasonic Bath
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Electrical Requirements
The System can automatically accommodate the most of the local mains voltage.
Specifically, the System can be energized of the mains voltage as follow:
Single phase 100/120/240V ~, 350W(MAX), 50/60Hz
Environmental Requirements
Corrosive materials can damage electronic parts, ensure that the environment is
free from corrosive material.
Metallic dust can damage electrical equipment.
For optimal operation, the System should be placed in a room with temperature
between 10º- 35ºC (50º-95ºF) with a relative humidity of less than 80% and
altitude up to 3000m.
For optimal storage, system should be stored in a place with temperature between
-20 to 55°C (-13 to 131°F) with a relative humidity of 0-90 % @ 55°C non-
condensing. For Optimal transportation system should be transport under the
temperature range between -10º- 60ºC (14º-140ºF) with a relative humidity of less
than 80% and altitude up to 15000m.
For continued protection against fire, only fuses that are defined on the System
label can be insulted in the System. Only power cord which is suitable to be
connected to the System and approved for the local mains, must be used.
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Connect the Applicators
1. Connect the applicator's cable connector (A) to the system's connection port
2. To disconnect the applicator, turn the black ring (B) counter-clockwise (in the
direction of the arrow) until it releases and then pull the connector out.
3. Seat the applicator in its cradle (see Figure 4-3).
Figure 4-1,
Scan FX Applicator Socket
Figure 4-2,
Firm FX Applicator Socket /
Firm BX Applicator Socket
Figure 4-3
Applicators in its cradle
4-3
A
B
B
A

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Connect/Disconnecting a Tip to Scan FX
Applicator
Refer to Figure 4-4: to connect a tip to the applicator, hold it in the correct orientation –
with the embossed "T" facing the top of the applicator and aligned with the top of the
applicator –and push it onto the applicator's connection port (A) until you feel it click.
To remove the tip from the applicator, press the release button under the tip's connection
port (B); the tip will pop off.
Figure 4-4
Connected tip to applicator
4-4
B
A

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5. Operating the System
Turning the System On/Off
Before turning the System “ON”, verify that the power cord is connected to the inlet
located on the rear panel of the system and to the main power outlet.
Switch on the system by turning the main power switch located in the rear panel of the
system to its “ON” position, and by turning on the “ON/OFF” button located underneath the
screen. The ON/OFF button will be illuminated in green and within 50 seconds the Login
Screen (See Figure 5-1) will be displayed on the system's touch screen.
Login Screen
Once Login screen is displayed, enter the 8 character code provided with the installation
documents and press the Confirm button (see Figure 5-1, marked A).
It is recommended to change initial Login code, using Set Login Code option in Tools
Menu. Once the correct code has been entered, the default Treatment screen will be
displayed.
Figure 5-1: Login screen
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Treatment Screen
The Treatment Screen is the system main screen (see Figure 5-2). Operator can
control treatment parameters, start and stop a treatment, and access Tools screen
from this screen.
In order to perform a treatment, operator should follow these steps:
1. Select the desired Applicator according to required treatment mode and area
2. Adjust treatment parameters
3. Initiate treatment
Figure 5-2: Default Treatment screen
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Selecting Desired Applicator
Before initiating the treatment, operator should select the desired applicator, according
to the required treatment modality and the size of the treatment area.
Scan FX Applicator is intended for fractional RF treatment
Firm FX applicator is intended for (MP)2treatments for small treatment areas
Firm BX applicator is intended for (MP)2treatments for large areas
Selecting the desired applicator is done by pressing on the left and right arrows on the
Applicator Selection button (see Figure 5-2, marked A). Each applicator is associated
with certain treatment parameters which will be displayed on the screen upon selection
of applicator. The system default applicator is the Firm FX applicator.
Fractional RF Treatment Mode
Figure 5-3 presents the treatment parameters associated with Scan FX applicator. The
numbered tags correspond to the following numbered elements of the screen:
Figure 5-3: Scan FX Treatment screen
5-3