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User Manual
User Manual
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OID.0.9.2342.19200300.100.1.1
TY TNHH =MST:0312927632, CN=CÔNG

TY TNHH THIẾT BỊ Y TẾ
INAMED, O=CÔNG TY TNHH
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MK-161-EN N
User Manual
Copyright © 2021 Viora. All rights reserved.

Viora reserves the right to make changes to its products or specifications to improve
performance, reliability or manufacturability. Information furnished by Viora is believed to be
accurate and reliable. However, Viora assumes no responsibility for its use. No license is
granted by its implication or otherwise under any patent or patent rights of Viora.
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 Viora.
Viora 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 Viora.
Specifications are subject to change without notice.
P/N: MK-161-EN N
Release Date: March 2021
Warning
 Before using the system, check local regulations. If any local legislation is
violated, use cannot be authorized.
 In the United States, federal law restricts prescription medical devices to
sale by or on the order of a physician, or properly licensed practitioner.
Viora makes no representations regarding federal, state, or local laws or
regulations that might apply to the use and operation of this system.
Manufacturer's Address
Viora Ltd
Sagi 2000, Industrial Park
Migdal HaEmek, Israel 1812003
Tel: +972 9955 1344
Fax: +972 9955 1345
Website: www.vioramed.com
E-mail: info@vioramed.com
EU Authorized Representative
OBELIS S.A.
Bd Général Wahis, 53
B-1030 Brussels, Belgium
Tel: +32.2.732.59.54
Fax: +32.2.732.60.03
0344
This device complies with the European Medical Device Directive 93/42/EEC
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User Manual
Table of Contents
1 Before You Start .................................................................................................................................................. 7
1.1 Conventions Used in the Manual ...................................................................................................... 7
1.2 Explanation of the Symbols Used in the System ......................................................................... 8
2 Introduction .......................................................................................................................................................... 9
2.1 System Overview ...................................................................................................................................... 9
2.1.1 System Console .................................................................................................................................11
2.1.2 Handpieces ..........................................................................................................................................11
2.1.3 Disposable Sterilized Tip and Cover – V-FR Handpiece .................................................... 11
2.1.4 Display Unit .........................................................................................................................................11
2.2 System Specifications ........................................................................................................................... 11
2.3 Handpiece Specifications.................................................................................................................... 12
2.3.1 V-ST Specifications ........................................................................................................................... 12
2.3.2 V-FR Specifications........................................................................................................................... 12
2.3.3 V-FORM - BC Large Applicator Specifications ...................................................................... 12
2.3.4 V-FORM - BC Medium Applicator Specifications ................................................................ 13
2.3.5 V-FORM – BC Small Applicator Specifications ...................................................................... 13
2.3.6 V-FC Specifications .......................................................................................................................... 13
2.3.7 V-VR Specifications .......................................................................................................................... 13
3 Safety .....................................................................................................................................................................14
3.1 System Classifications .......................................................................................................................... 14
3.2 Electrical Requirements ....................................................................................................................... 14
3.3 Environmental Requirements ............................................................................................................ 15
3.4 Space Requirements ............................................................................................................................. 15
3.5 Safety when Operating the System ................................................................................................ 15
3.6 System Safety Features ........................................................................................................................ 16
3.7 Potential Fire Hazards .......................................................................................................................... 16
3.8 Patient and Personnel Safety ............................................................................................................ 16
3.9 Foot Pedal .................................................................................................................................................17
3.10 Safety in Maintaining the System ................................................................................................ 17
3.11 Transport and Storage Conditions .............................................................................................. 17
3.12 RF-Based Technology Safety ............................................................................................................. 17
3.12.1 V-ST and V-VR Handpieces Safety ....................................................................................... 18
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3.12.2 V-FORM and V-FC Handpieces Safety ................................................................................ 18

3.12.3 V-FR Handpiece Safety .............................................................................................................. 18
4 System Installation ...........................................................................................................................................19
4.1 Equipment List ........................................................................................................................................19
4.2 Unpacking .................................................................................................................................................20
4.3 Assembling the Back Cradle .............................................................................................................. 20
4.4 Connecting the Foot Pedal ................................................................................................................ 21
4.5 Connecting the Power Cable............................................................................................................. 21
4.6 Connecting the Handpieces .............................................................................................................. 22
4.6.1 Connecting the V-ST Single-Use tip ......................................................................................... 22
4.6.2 Connecting the V-FR Tip................................................................................................................ 24
4.6.3 Connecting the V-FR Tip Cover................................................................................................... 24
4.6.4 Connecting BC Applicators On V-FORM ................................................................................. 25
4.6.5 Connecting V-FC Tip on V-FC Handpiece ............................................................................. 25
4.6.6 Connecting V-VR tip on V-VR Handpiece .............................................................................. 26
4.7 Wheel Brakes ...........................................................................................................................................27
4.8 Moving the System within the Facility .......................................................................................... 27
4.9 Moving the System to another Facility ......................................................................................... 27
5 Operating Instructions ....................................................................................................................................28
5.1 System ON/OFF ......................................................................................................................................28
5.2 Login/Logout ...........................................................................................................................................28
5.3 Set time and Date ..................................................................................................................................29
5.4 Add Configuration .................................................................................................................................29
5.5 Adding a New License ......................................................................................................................... 30
5.6 Main Menu ...............................................................................................................................................31
5.7 Set Up Menu ............................................................................................................................................31
5.8 Treatment Tips Screen ......................................................................................................................... 33
5.9 V-ST Treatment Screens ...................................................................................................................... 34
5.9.1 V-ST Treatment Menu..................................................................................................................... 34
5.9.2 V-ST Treatment Screen ................................................................................................................... 34
5.9.3 V-ST Output Power .......................................................................................................................... 36
5.10 V-FR Treatment Screens ...................................................................................................................... 37
5.10.1 V-FR Treatment Menu ............................................................................................................... 37
5.10.2 V-FR Treatment Screen ............................................................................................................. 37
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5.10.3 V-FR Output Power ..................................................................................................................... 39

5.11 V-FORM Treatment Screen ................................................................................................................ 40
5.11.1 V-FORM Treatment Screen..................................................................................................... 40
5.11.2 V-FORM Output Power ............................................................................................................. 42
5.12 V-FC Treatment Screens...................................................................................................................... 43
5.13 V-VR Treatment Screen ....................................................................................................................... 45
5.14 System Messages ...................................................................................................................................47
6 Clinical Guidelines for RF-Based Technology ........................................................................................ 48
6.1 Contraindications ...................................................................................................................................48
6.2 Possible Side Effects ............................................................................................................................. 49
6.3 Realistic Expectations ........................................................................................................................... 50
6.4 Consult Meeting .....................................................................................................................................51
6.5 Treatment Follow-Up ........................................................................................................................... 51
6.6 V-ST Clinical Guide ................................................................................................................................51
6.6.1 Indications of Use ............................................................................................................................. 51
6.6.2 Test Procedure ...................................................................................................................................52
6.6.3 Pre-Treatment Preparation ........................................................................................................... 52
6.6.4 Treatment Guidelines ...................................................................................................................... 52
6.6.5 Treatment Schedule ......................................................................................................................... 52
6.6.6 Post-Treatment Care ....................................................................................................................... 53
6.7 V-FR Clinical Guide ................................................................................................................................53
6.7.1 Indications of use..............................................................................................................................53
6.7.3 Test Procedure ...................................................................................................................................54
6.8 V-FORM and V-FC Clinical Guide .................................................................................................... 57
6.8.1 Indications of use..............................................................................................................................57
6.8.3 Test Procedure ...................................................................................................................................58
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6.9 V-VR Clinical Guide ...............................................................................................................................61

6.9.1 Indications of Use ............................................................................................................................. 61
6.9.2 Test Procedure ...................................................................................................................................61
7 System Maintenance .......................................................................................................................................63
7.1 Cleaning the System ............................................................................................................................. 63
7.2 Cleaning the Handpieces .................................................................................................................... 63
7.3 Replacing the filters in the V-FORM Handpiece ....................................................................... 64
7.3.1 Replacing the external filter in the BC Large Applicator ................................................... 64
7.3.2 Replacing the internal filter in the V-FORM BC Applicators ............................................ 65
7.3.3 Replacing the side filter in the V-FORM Handpiece ........................................................... 66
8 Troubleshooting ................................................................................................................................................68
8.1 Fault Messages .......................................................................................................................................68
8.2 Failure Messages ....................................................................................................................................70
8.3 Operation troubleshooting ................................................................................................................ 71
9 About Viora .........................................................................................................................................................72
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User Manual
1 Before You Start

Warning
• Read this manual to become familiar with all safety requirements and
operating procedures before attempting to operate the system.
• Any intense radio frequency (RF) device can cause injury if used
improperly.
• High voltage is present inside the system. Always be aware of the
possible dangers and take proper safeguards as described in this manual.
• The system and its components must be serviced only by qualified
personnel.
• Only a trained person can upgrade the software version.
• To avoid risk of electric shock, this equipment must only be connected to
a supply main with protective earth.
• No modification of this equipment is allowed.
1.1 Conventions Used in the Manual

The following conventions in the form of notes, cautions and warning are used in this manual:
Warning
A Warning alerts the operator to the possibility of injury, death, or serious
adverse reactions associated with the use or misuse of the system.
Caution
A Caution alerts the operator to the possibility of a problem with the device
associated with its use or misuse. Such problems include system malfunction,
failure, and damage to the system or other property. The caution statement
includes a precautionary action that should be taken to avoid the hazard.
Note
The content of this Note offers general information that is important to keep in
mind.
Note
In many places throughout this manual you will see words or phrases in the text
which are bolded in a sans-serif typeface, such as this. These are words and
phrases that you will always see on the LCD display of the control panel.
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1.2 Explanation of the Symbols Used in the System

Symbol Description
CE Compliance Symbol
0344
Dispose of according to WEEE regulations
Fuse
Type BF Equipment
High frequency isolated patient circuit
Manufacturer
Non-ionizing electromagnetic radiation
CAUTION: Federal law restricts this device to sale by or on the

order of a physician
Refer to instruction manual
Authorized Representative in the European Union
Discard Product After Expiration Date
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2 Introduction
V10 is a Radiofrequency (RF) Non-Surgical Viora system.
The V10 system developed by Viora utilizes radiofrequency (RF) for aesthetic and
dermatological procedures, with applications for the face, neck, chest and hands. The system
is based on well-established technology of bipolar radiofrequency, which is extensively used
for the coagulation and ablation of soft tissues. Over the past decade, RF technology has
become widely used in the aesthetics and dermatology field for skin tightening and
resurfacing.
The V10 is classified in Class IIb, Per Rule 9, Annex IX of the Medical Council Directive
93/42/EEC of 14 June 1993, amended by Council Directive 2007/47/EC of 5 September 2007.
Note
• Only personnel who have undergone and completed a thorough
training course are permitted to operate the system.
• The intended users are aesthetic physicians or dermatologists. Eligibility
of users shall be in accordance with local market regulations.
2.1 System Overview
Figure 2.1.1: System Console
Figure 2.1.2: V-ST Handpiece Figure 2.1.3: V-ST Single-Use tip
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Figure 2.1.4: V-FR Handpiece Figure 2.1.5: V-FR Tip Figure 2.1.6: V-FR Tip Cover
Figure 2.1.7: V-FORM Handpiece Figure 2.1.8: BC Large Applicator
Figure 2.1.9: BC Small Applicator Figure 2.1.10: BC Medium Applicator
Figure 2.1.11: V-FC Handpiece Figure 2.1.12: V-FC Tip
Figure 2.1.13: V-VR Handpiece connected to

Single-use tip Figure 2.1.14: V-VR Single-use tip
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2.1.1 System Console

The system console houses the following components:
• 2 Rear connectors
• RF Generator
• Display Unit
• Service panel
2.1.2 Handpieces
The system can accommodate five handpieces as follows:
• V-ST
• V-FR
• V-FORM
• V-FC
• V-VR
The handpieces are attached with a cable to the connector on the rear panel of the main
console.
2.1.3 Disposable Sterilized Tip and Cover – V-FR Handpiece

A disposable tip (Figure 2.1.5), containing a matrix of bi-polar electrode pins attaches to the
end of the handpiece and placed on the skin during treatment. The distance between the pins'
center is 0.03 mm and tip form is 13 rows and 8 columns of pins.
A thermoelectrically cooled bracket surrounding the grid area is designed to cool surrounding
skin and reduce pain during treatment.
V-FR tip cover (Figure 2.1.6) should beused when the V-FR handpiece is not in use to protect
it.
2.1.4 Display Unit

The display unit - touch screen mainly presents the following information:
1. Treatment types
2. Treatment settings
3. Pulse / Time counter
4. Treatment time
2.2 System Specifications
V-ST
Handpiece Supported
V-FR
V-FORM
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V-VR
V-FC
Maximum Power 250 watts
Electrical requirements 100-240V, 50-60 Hz
Operating temperature 10º-30ºC (50º-86ºF)
Environmental Requirements and relative humidity from 10% to 80%,
non-condensing
User interface 8.1-inch touch screen
Weight 24 kg
Dimensions 100H x 54W x 46D Cm
2.3 Handpiece Specifications

2.3.1 V-ST Specifications
Treatment area Frequency mode Frequency (Hz) Energy (J/cm3)
Mode 1 0.8MHz
Mode 2 1.7MHz
8mmX8mm 0 - 130 J/cm3
Mode 3 2.45MHz
Mode 4 0.8MHz, 1.7MHz, 2.45MHz
2.3.2 V-FR Specifications

Pulse Duration
Treatment area Frequency (nm) Energy (Joule)
(ms)
7.3mm x 21.8mm 1 MHz 0-10 J 10-100 ms
2.3.3 V-FORM - BC Large Applicator Specifications
Treatment area Frequency mode Frequency (Hz) Power (W)
Mode 1 0.8MHz
Mode 2 1.7MHz
97mm X 83mm Up to 50 W
Mode 3 2.45MHz
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2.3.4 V-FORM - BC Medium Applicator Specifications
Mode 1 0.8MHz
63 mm X 57 mm Mode 2 1.7MHz
Up to 50 W
Mode 3 2.45MHz
2.3.5 V-FORM – BC Small Applicator Specifications
Mode 1 0.8MHz
Mode 2 1.7MHz
Up to 25 W
Ø 24mm Mode 3 2.45MHz
2.3.6 V-FC Specifications
Mode 1 0.8MHz
Mode 2 1.7MHz
Up to 35 W
2.3.7 V-VR Specifications
Mode 1 0.8MHz
Mode 2 1.7MHz
Up to 80 W
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3 Safety
To ensure dependable, consistent and safe treatments, the following safety measures must be
taken into consideration when operating and maintaining the system. The person operating
the system must be familiar with the safety regulations provided in this chapter. The user
must read the user manual completely before operating the V10. It is important that you read
the safety chapter carefully read before you attempt to install or operate the system.
If any sections of the safety chapter are unclear, or if any questions arise prior to, or during
installation and/or operation of the handpiece, contact your local distributor.
Viora assumes no liability whatsoever for any damage or injury caused as a result of actions
taken which are not in strict accordance with the instructions provided in this manual.
Improper use may result in injury and the primary consideration when operating the system
must be to maximize safety for both patient and operator.
Isolation means is performed by manual removal of the power cord from the AC supply.
Warning
• It is important that the operators of this system familiarize themselves with all
safety requirements and operating procedures prior to operating the system.
• Any intense RF device may cause injury if used improperly.
• Failure of HF equipment could result in an unintended increase of output power.
• Always be aware of the possible dangers and take proper safeguards as described
in Section 3.5 of this user manual.
• For complete contact information please refer to page 2 of this user manual.
• To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth
3.1 System Classifications

• Electric shock protection: Class I, Type BF
• Not suitable for use in presence of flammable substances
• Protection against ingress of liquids: Ordinary equipment
• Mode of operation –pulses
3.2 Electrical Requirements

The V10 system is preset to accommodate the local line voltage according to the customer's
order. Accordingly, the system will require a separate line supply of one of the following
(appropriate to customer’s country):
Power: 100-240 Vac, 4 A, 50/60 Hz
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User Manual
Warning
To protect against risk of fire, replace the fuse with the same type and rating
only.
3.3 Environmental Requirements

• Electronic parts can be damaged by corrosive materials. System must operate in a
non-corrosive environment.
• For optimal operation of the system, maintain room temperature between
10º-30ºC (50º-86ºF) and relative humidity from 10% to 80%, non-condensing.
• Atmospheric Pressure Range: 5kPa – 106kPa.
• If the system has been stored in an environment cooler than the above mentioned
temperatures, allow it time to warm up to room temperature before the first activation.
• Metallic dust is potentially harmful to electrical equipment.
• Do not place the system near the wall.
3.4 Space Requirements

The V10 system is designed for installation in a clinic. The base dimensions of the system are
100 cm (H) x 54cm (W) x 46cm (D). A sufficient space of 30 cm must be cleared in all
directions to permit appropriate ventilation.
3.5 Safety when Operating the System

• Keep all system covers closed at all times and do not touch any of the system's inner
components. Only authorized service technicians are permitted to remove the panels.
• Always make sure that the V-FR tip is replaced before a new treatment session begins.
In no case should the same V-FR tip be used for more than one patient.
• Avoid operating the system in the presence of potentially explosive or flammable
materials.
• Always make sure that all operating personnel have been properly trained and are
familiar with the system's controls and know the proper steps on how to shut down
the system instantly when required.
• Only aesthetic physicians and dermatologists are allowed to operate the system.
• No part of the system should be immersed in liquid.
• Medical electrical equipment can be affected and experience interference, by portable
and mobile RF communications equipment.
• Only original and specified accessories and cables should be used. Using any other
equipment may result in increased emissions or decreased durability of the system.
Warning
It is forbidden to connect any third-party equipment to the system without
written approval from Viora.
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User Manual
3.6 System Safety Features

The V10 system incorporates the following safety features:
• Default treatment parameters are automatically recommended when operator makes a

treatment selection.
• The handpiece is equipped with a trigger. If the trigger is not pressed, no energy will
be emitted.
• The system automatically tests for proper coupling prior to any pulse by releasing a
short sub pulse at low voltage. If coupling between electrodes and skin is insufficient
the RF energy will be disabled.
• The handpiece and treatment tip must be properly connected to the system in order
for the treatment mode to be activated. When handpiece, applicator or tip are not well
connected, system will alert.
• The system can be switched to a 'Standby' mode, disabling the release of energy.
• The system will automatically move to 'Standby' mode if a pulse is not emitted for at
least 5 minutes.
Warning
• Objects such as superficial metal or conductive implants, rods, plates or pins
in the treatment areas are contraindicated to the treatment.
• In case of improper coupling in RF handpiece, indicated on screen and by
audio signal the trigger should be released immediately and the handpiece
should be re-oriented on the skin. In rare cases superficial burns may occur
from the heat generated by the RF electrodes.
3.7 Potential 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 alcohol is used for disinfecting the handpiece, it must be completely dry before the
system is used.
3.8 Patient and Personnel Safety

When handling the V10 system, the primary concern should be the safety of both operator
and patient. Carefully read the following safety guidelines:
• Before beginning any treatment course, the operator should complete a detailed
patient history to verify that the patient is eligible for the treatment and is in a healthy
condition.
• The operator should provide the patient with information about the treatment, the
treatment protocol, expected results and any risks or side effects associates with the
treatment.
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User Manual
• Only trained operators are allowed to perform treatments.

• A test procedure must be performed before any treatment course and at any new
anatomical area, in order to evaluate the treatment parameters.
Warning
• Improper treatment may cause local burns.
• Untrained operators should not operate the system
3.9 Foot Pedal

V10 is supplied with a foot pedal to emit pulses on V-FR, V-ST, V-FC, V-VR and V-FORM
handpieces.
Warning
• Move to ‘standby’ mode before connecting or disconnecting the foot
pedal.
• When foot pedal or trigger is stuck, operator should release the pedal
or trigger.
3.10 Safety in Maintaining the System

• Only authorized service technicians are qualified to open the system’s panels to service
the system.
• Shut down the system and disconnect the power cable before you perform any of the
maintenance procedures in chapter.
3.11 Transport and Storage Conditions

The optimal transport and storage conditions of the system are:
• Ambient temperature: -5°C to 65°C.
• Relative humidity: from 10% to 80%, non-condensing.
• The packaging protects the V10 system from breakage or damage according to the
company’s packaging instructions.
• Atmospheric Pressure Range: 50kPa – 106kPa.
3.12 RF-Based Technology Safety

Any intense RF device may cause injury if used improperly.
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User Manual
RF energy is emitted into the skin via bi-polar electrodes. After applying ultrasound gel (when
using V-VR or V-ST) or glycerin (when using V-FORM and V-FC handpieces), full coupling of
all electrodes to the skin is necessary before pressing the trigger button, to ensure the RF
energy is safely conducted. If coupling with the skin is broken due to incomplete contact or
removal of the handpiece from the treatment area while the trigger is pressed, a beeping
sound will indicate improper coupling.
Warnings
If there is improper coupling, release the trigger immediately and then re-
orient the electrodes on the skin. In rare cases, superficial burns can occur
from the heat generated by the RF electrodes.
3.12.1 V-ST and V-VR Handpieces Safety

When operating the handpiece apply ultrasound gel to the treatment area to ensure
proper contact.
3.12.2 V-FORM and V-FC Handpieces Safety

When operating the handpieces apply glycerin to the treatment area to ensure proper
contact.
3.12.3 V-FR Handpiece Safety

The V-FR handpiece will not operate until a V-FR tip is connected and recognized by V10.
Warnings
• V-FR tip replacements should only be purchased through Viora’s

authorized local distributor.
• V-FR Tips are sterile. Individual tips should be discarded if they come in
contact with an unsterile surface after removed from package (floor,
hands).
• Treatment tips should only be used for a single treatment application
on a single patient to avoid cross contamination.
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User Manual
4 System Installation
4.1 Equipment List
Component Description Quantity Part No.
System Console 1 VRF2000

Back Cradle Kit 1 VTL20100
General
Foot Pedal 1 AS40030-P
Power Cable 1 VRT3001-UK
Handpiece 1 V-ST2001
V-ST
V-ST Single-Use tips 1 box (10 tips) AS47000-KIT
Handpiece 1 V-FR2002
V-FR V-FR tips 1 box (10 tips) FRTIP1000-3

V-FR Tip cover 1 VTO-1001-8
Cleaning Brush 1 VMD9101-2
Handpiece 1 VTL45900
BC Small applicator 1 VTL45910
BC Medium applicator 1 VTL45930
BC Large applicator 1 VTL45920
BC Large Applicator
V-FORM 100 VMD9102
External Filters
Applicators Internal Filters 10 AS70005
3mm Ball-End Allen Key 1 MS45015
Handpiece Side Filters 100 AS70006

1.5mm Ball-End Allen Key 1 MS50030
V-FC Handpiece 1 VTL48005
V-FC V-FC Tip 2 VTL48007
V-FC Maintenance Kit 1 VTL48009
V-VR Handpiece 1 VTL48010
V-VR
V-VR tip 12 VTL48012
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4.2 Unpacking
The V10 system was carefully packed to ensure safe delivery and arrival of the system and its
components.
Make sure that you have all of the contents. Refer to 4.1 Equipment List.
Make sure that there are no visible signs of damage to the system or to the package contents.
If you are missing some of the contents or there are visible signs of damage, contact your
local distributor.
4.3 Assembling the Back Cradle

• Unscrew the 4 bolts in the rear side of the system and dispose them.
Figure 4.3.1: Unscrew 4 bolts
• Place the back cradle in front of the 4 holes.
Figure 4.3.2: Assembling the Cradle
• Use the supplied key to screw the 4 bolts and secure it. Make sure the cradle is firmly
attached to the system before placing the handpieces in the cradle.
Figure 4.3.3: Assembled cradle
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User Manual
4.4 Connecting the Foot Pedal

• Connect the foot pedal cable to the connector on the rear panel
Figure 4.4.1: Connecting the Foot Pedal
• Fasten the screws to secure it into place.
Note
• In order to avoid a potential accident, please store the foot pedal in safe
place when not in use
• Foot pedal must not get wet. Do not keep any liquids in the vicinity of
the foot pedal.
4.5 Connecting the Power Cable

• Connect the power cable to the power connection port on the system's rear
panel.
Figure 4.5.1: Connecting the Power Cable
• Plug the electrical cable into an appropriate electrical outlet. Refer to 3.2
Electrical Requirements on Safety chapter.
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4.6 Connecting the Handpieces
Warning
Make sure that V10 power is turned off whenever you connect or disconnect any
of the handpieces.
• Remove the handpiece from the package.
• Place the handpiece on the cradle
• Connect the handpiece connector at the end of the cable to the connector on
the rear panel by rotating the handpiece connector until it is securely locked
0B Figure 4.6.1: Connecting the RF handpieces 1B Figure 4.6.2: Rotate to lock
Note
There are 2 handpiece connectors on the back of the system. Both connectors
are identical and can serve V-FR, V-ST V-FC, V-VR and V-FORM handpieces.
4.6.1 Connecting the V-ST Single-Use tip
• Take the V-ST single use tip out of its package
• Pull small amount of ultrasound gel to cover the inner part of its electrodes
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User Manual
Figure 4.6.3: V-ST Single-Use tip preparation

• Attach the V-ST Single-Use tip to the V-ST handpiece with its orientation marking in
alignment with the handpiece's central line with an "arch" movement before securing
into place
Tips’ orientation
marking Central line
Figure 4.6.4: Attachment of V-ST Single-Use tip
• Ensure the V-ST Single-Use tip is secure before use by pulling it out
Figure 4.6.5: Ensuring proper connection of V-ST Single-Use tip
• In the end of the treatment, disconnect the V-ST Single-Use tip by sliding it off in a
downward “arch” motion:
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User Manual
Figure 4.6.6: Disconnection of V-ST Single-Use tip
4.6.2 Connecting the V-FR Tip
Note
To allow smooth attachment of the V-FR tip, use a lubricant around the O-ring
(Vaseline or any other mild lubricant) on first operation and every 6 months
To connect a V-FR tip to the V-FR handpiece, peel the seal off of the tip container
only while wearing a glove to maintain sterility and attach the tip to the V-FR handpiece.
Figure 4.6.7: Connecting the V-FR Tip
4.6.3 Connecting the V-FR Tip Cover

The system is supplied with a black V-FR tip cover. When the V-FR handpiece is not in use, use
the cover to protect it.
Figure 4.6.8: Connecting the V-FR Tip cover
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4.6.4 Connecting BC Applicators On V-FORM

• To connect the BC Large, Medium or Small applicator to the handpiece, align the
applicator's guide with the handpiece groove and push the applicator into the
handpiece until clicking sound is heard.
• To release the applicator from the handpiece, simply press the release button on
the applicator and remove the applicator away from the handpiece.
Figure 4.6.9: Connecting the BC Small Applicator Figure 4.6.10: Releasing the BC Small Applicator
4.6.5 Connecting V-FC Tip on V-FC Handpiece

• To connect the tip to the handpiece, align the applicator's guide with the
handpiece groove and push the applicator into the handpiece until clicking
sound is heard.
Figure 4.6.11: Connecting the V-FC Tip
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Figure 4.6.12: Releasing the V-FC Tip
4.6.6 Connecting V-VR tip on V-VR Handpiece

• To connect the applicator to the handpiece, align the applicator's guide with the
handpiece groove and push the applicator into the handpiece until clicking
sound is heard.
Figure 4.613: Connecting the V-VR tips
Figure 4.6.14: Releasing the V-VR tip
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4.7 Wheel Brakes

The system is equipped with wheel brakes. To complete installation – please make sure that
the wheel brakes are secured and locked.
4.8 Moving the System within the Facility

• Make sure the system is turned off and the power cable is disconnected.
• The system is equipped with wheel brakes. Make sure they are released to allow
movement.
• Use the handle located at the back of the system to carefully move it around.
4.9 Moving the System to another Facility

• Make sure system should be without any Handpieces on it
• Make sure the system is turned off and the power cable is disconnected.
• The system is equipped with wheel brakes. Make sure they are released to allow
movement.
• Use the handle located at the back of the system to carefully move it around.
• Slowly load the system onto the vehicle. Make sure the system is secured in place
and proper padding is used to protect the system while traveling.
• To unload the system in the new facility, carefully remove it from the vehicle and
use the handle on the back of the system to place it in its new location.
• Reinstall the system.
Note
It is recommended that the system only be moved when it is packaged in its
original case and coverings.
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5 Operating Instructions
Warning
Operator should not use the handpiece if dropped on the floor
5.1 System ON/OFF

To turn the system on:
• Press the ON/OFF button located at the rear panel of the system.
• Following start up, the system will display the login screen.
To turn the system off:
• Press the Login/Logout button on the Main menu screen.
• Press the ON/OFF button located at the back of the system.
5.2 Login/Logout
The login screen protects against use of V10 by unauthorized personnel. When treatment is
completed, press the logout button to prevent unauthorized users from activating the system.
Note
It is forbidden to reveal the V10 password to any unauthorized person.
Figure 5.2.1: Login Screen
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• Enter the login code supplied by your local distributor. The default code is 1234.
Press the ‘backspace’ button if you enter a wrong digit.

• Press Login. The system will verify the code and display the main menu screen.
5.3 Set time and Date
Figure 5.3.1 Set Time and Date screen

C
A. Press the day button
B. Press the minus/plus button until you reach the desired number.
C. Repeat the same action with month/Year/Hour/Minutes buttons. Once date and hour
are set, press OK button to confirm.
5.4 Add Configuration

The configuration codes are generated by Viora and provided to the local distributor
upon the purchase of each system.
A configuration code determines the configuration of the actual device which then
reflects the licensing codes to be provided to the user.
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Figure 5.4.1: Add Configuration screen

B
A. Type the 30 digits configuration code as provided to you by the local distributor.
B. Press the OK button to confirm.
5.5 Adding a New License

The Licensing code determines the allowance of usage per application. Each license
allows use for a specific application, for a pre-determined period of time and/or
application usage.
B
Figure 5.5.1: Add License screen
A. Type the 30 digits license code provided to you by the local distributor.
B. Press the OK button to confirm.
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5.6 Main Menu

The main menu identifies which handpieces are connected to V10.
Press the treatment selection key for the desired type of treatment.
Figure 5.6.1: Main Menu Screen
Note
Please make sure that the handpiece in use correspondence with the displayed
treatment screen.
5.7 Set Up Menu

• Treatment preferences - Allows the operator to set a default trigger settings for V-
FORM treatment:
o Enable all triggers
o Disable side triggers
o Disable handle trigger
o Enable foot pedal (HP triggers disabled)
Operator may always switch between basic options through resetting the default
preferences.
• System information - Shows indications for:
o Serial numbers of the system and connected handpieces
o Software versions
o Usage data for connected handpieces and tips
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• Events and Logs

o Events History - Shows history of system events such as self-test failures.
o Treatments History - Shows details about past treatments:
 Treatment date
 Treatment time
 Duration
 Handpiece used
 Usage
 Last energy used
• Touch Screen Calibration – Allow the operator to calibrate touch screen
• License - Shows details about:
o Active licenses - Allows the operator to view all active licenses on the
system.
o Licenses History - Shows details (indication) about all the licenses that
were on the systems (including expired codes).
o Add License- allows operator to add a new license.
o Configuration History - Shows details of previous configuration.
o Add Configuration- add a new configuration code
Figure 5.7.1: Software licensing configuration, through Set-up Menu
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5.8 Treatment Tips Screen

Step 1. From the treatment menu, press the key to access treatment tips. Treatment
tips are divided into three categories:
a. General
b. V-ST
c. V-FR
Step 2. Press the key for the desired category.
Step 3. Press Close to return to the treatment menu.
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5.9 V-ST Treatment Screens

5.9.1 V-ST Treatment Menu
The V-ST treatment menu offers four different treatment programs. One program is for body
treatment and three are for facial treatments (forehead, cheeks, neck and décolleté). Choose
the desired treatment area by pressing the touch screen.
Figure 5.8.1: V-ST Treatment Menu
5.9.2 V-ST Treatment Screen
E F G
Figure 5.8.2: V-ST Treatment Screen
C D
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A. Mode - The system has four different RF treatment modes that can be controlled by
the operator. The modes are based on the following integrated technologies:
Mode I – Low RF frequency of 0.8MHz (suitable for deep treatments).
Mode II – Medium RF frequency of 1.7 MHz (suitable for mid-layer treatments).
Mode III – High RF frequency of 2.45 MHz (suitable for superficial treatments).
Mode IV – Combines all three frequencies for multi layer treatments.
To choose the desired treatment mode, press the mode number
Note
Changing modes will move the system to Standby. Press the Ready / Standby
key to resume work.
B. Energy - To control the energy level, press the energy (+) or (-) keys. The smaller (+) /
(-) keys will change energy by 2J. The large (+) / (-) keys will change energy by 10J.
C. Minute counter - Counts time usage for current treatment. Press the key to
zero the counter. When a pulse is not released 5 minutes or longer, counter will
automatically pause and system will move to ‘Standby’ mode.
D. Cooling - The RF electrodes are cooled during treatment. The cooling icon
indicates that cooling is activated. If a pulse is not released within 60 seconds, cooling
will stop and the system will move to Standby mode. In order to resume treatment,
press the key.
E. Home - Pressing the key, operator opens the main menu.
F. Menu - Pressing the key, operator opens the treatment menu.
G. Standby / Ready - indicates that the system is ready for work and
pulses can be emitted by pressing the trigger on the handpiece or the foot pedal.
System will move to mode if:

o Pulse is not emitted for 5 minutes or longer
To resume work, press the Standby key. Wait for the cooling to restart (indicated by
the progress bar).
To release an RF pulse, press the trigger located on the handpiece or the foot pedal.
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Note
• Pressing the trigger or foot pedal continuously, will emit consequent RF
pulses.
• Pressing the trigger or foot pedal accidentally with no contact on the
skin, will cause bad coupling alert sound.
• Follow the treatment movements as per the arrow indications on the
image.
5.9.3 V-ST Output Power
V-ST power stability

150
mode 1
100
power [W]
mode 1
node 2
50
mode 2
mode 3 0
mode 3 0 100 200 300 400 500
Resistance [Ω]
Figure 5.8.3: V-ST power stability
Figure 5.8.4: V-ST output power
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5.10 V-FR Treatment Screens

5.10.1 V-FR Treatment Menu
The V-FR Treatment menu offers three different treatment programs (Shallow, Medium and
Deep). Upon choosing the treatment program, the relevant treatment screen appears.
Figure 5.9.1: V-FR Menu Screen
5.10.2 V-FR Treatment Screen

G H
F
A
B
C E
D Figure 5.9.2: V-FR Treatment Screen
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A. Program – indicates the selected program. Program may be changed through the
treatment screen as well as through the treatment menu screen.
B. Energy - Control the desired RF energy using the energy (+) / (-) keys.
C. Tip pulse counter - Displays total pulses count with inserted tip.
D. Pulse counter - Counts and displays emitted pulses for current treatment. Press the
key to zero the counter. The operator does not need to move to Standby mode
to zero the counter.
E. Cooling - Indicates whether the cooling feature is enabled. The operator may switch
the cooling feature on and off as desired by pressing the cooling key.
Note
Cooling reduces pain and makes the treatment more comfortable to the patient
hence recommended to be used at all times and as per treatment protocol.
F. Home - Pressing the key opens the main menu.
G. Menu - Pressing the key opens the treatment menu.
H. Standby / Ready - indicates that the system is ready for work and
pulses can be emitted by pressing the trigger on the handpiece or foot pedal. System
will move to mode if:

o Pulse is not emitted for 5 minutes or longer.
I. Pulse Duration - Determines the length of the pulse during which
energy is released (“On” time).
J. Vacuum - Indicates whether vacuum feature is enabled. Operator may switch

the vacuum feature on and off as desired by pressing the vacuum key.
Note
Vacuum ensures optimal coupling between skin and electrodes and is
recommended to use at all times.
K. Smart Heat - Provides volumetric heating by releasing a low energy pulse for a
more efficient fractional RF delivery due to lower skin impedance. Operator may
switch the smart heat feature on and off as desired by pressing the Smart Heat key.
To resume work, press the Standby key.
To release an RF pulse, press the trigger located on the handpiece or the foot pedal.
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5.10.3 V-FR Output Power
Figure 5.9.3: V-FR output power
Figure 5.9.4: V-FR power stability
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5.11 V-FORM Treatment Screen

5.11.1 V-FORM Treatment Screen
G F B H
E
Figure 5.11.1: V-FORM Treatment Screen
D
Note
key to resume work.
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B. RF Energy level - Press the desire number 1-4 while 1 is the lowest energy level and 4
is the highest level
C. Vacuum level - Press the desire number 1-4 while 1 is the lowest vacuum level, 4 is
the highest level and off is no vacuum.
D. Countdown clock – Press the clock button to insert the desire treatment time (
Figure 5.11.1 and 5.11.2) after setting the time the system will show the countdown
left until the end of treatment
E. Temperature indicator - displays the real time measured temperature
F. Handpiece indicator
G. Home - Pressing the key, operator opens the main menu.
System will move to mode if:

o Pulse is not emitted for 5 minutes or longer
To resume work, press the Standby key.
To release an RF pulse, press the trigger located on the handpiece OR the foot pedal.
Figure 5.11.2: V-FORM set Countdown clock screen

L
K
I. Delete button
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J. Set clock minutes - 0-9 button to set the treatment duration

K. Confirmation button – pressing on the OK button will set the time and back to
treatment screen
L. Cancel button - back to treatment screen
Note
• Pressing the trigger or foot pedal continuously, will emit continuous RF
pulses.
5.11.2 V-FORM Output Power
Out. Power
50.00
45.00
Out Power
40.00
35.00
30.00
25.00
20.00
15.00
10.00
0 1 2 3 4 5
UI Power
Mode 1 Mode 2 Mode 3
Figure 5.10.3: V-FORM output power
BC Large - Power Stability

55.00
52.50
50.00
47.50
Out Power
45.00
42.50
40.00
37.50
35.00
32.50
30.00
27.50
25.00
22.50
20.00
17.50
15.00
0 100 200 300 400 500 600
R Load
Mode1 RF Level - 1 Mode1 RF Level - 2 Mode1 RF Level - 3
Mode1 RF Level - 4 Mode2 RF Level - 1 mode2 RF Level - 2
Figure 5.10.4: V-FORM power stability
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5.12 V-FC Treatment Screens
H G B C I
Figure 5.12.1: V-FC Treatment Screen

F E D
Note
key to resume work.
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B. RF Energy level - Press the desire number 1-4 while 1 is the lowest energy level and 4
is the highest level
C. Vacuum level - Press the desire number 1-4 while 1 is the lowest vacuum level, 4 is
the highest level and off is no vacuum.
D. Countdown clock – Press the clock button to insert the desire treatment time (
Figure 5.12.1 and 5.12.2) after setting the time the system will show the countdown
left until the end of treatment
M L
Figure 5.12.2: V-FC set Countdown clock screen
E. Temperature indicator - displays the real time measured temperature

F. Applicator Time counter
G. Handpiece indicator
H. Home - Pressing the key, operator opens the main menu.
I. Standby / Ready - indicates that the system is ready for work and
System will move to mode if pulse is not emitted for 5 minutes or

longer. To resume work, press the Standby key. To release an RF pulse, press the
trigger located on the handpiece OR the foot pedal.
J. Delete button
K. Set clock minutes - 0-9 button to set the treatment duration
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L. Confirmation button – pressing on the OK button will set the time and back to
treatment screen
M. Cancel button - back to treatment screen
Note
• Pressing the trigger or foot pedal continuously, will emit continuous RF
pulses.
5.13 V-VR Treatment Screen
G F H
Figure 5.12.1: V-V-VR Treatment Screen

E D C
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Note
key to resume work.
B. RF Power level - Press the desire number 1-10

C. Countdown clock – Press the clock button to insert the desire treatment time (Figure
5.12.1 and 5.12.2) after setting the time the system will show the countdown left until
the end of treatment
Figure 5.12.2: V-VR set Countdown clock screen

L K
D. Temperature indicator - displays the real time measured temperature

E. Tip Time counter
F. Handpiece indicator
G. Home - Pressing the key, operator opens the main menu.
System will move to mode if pulse is not emitted for 5 minutes or
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longer. To resume work, press the Standby key. To release an RF pulse, press the
foot pedal.
I. Delete button
J. Set clock minutes - 0-9 button to set the treatment duration
K. Confirmation button – pressing on the OK button will set the time and back to
treatment screen
L. Cancel button - back to treatment screen
Note
• Pressing foot pedal continuously, will emit continuous RF pulses.
• Pressing the foot pedal accidentally with no contact on the skin, will
cause bad coupling alert sound.
5.14 System Messages

The system continuously performs self-test procedures relating to the handpieces attached
and the internal operation. Status or error messages will appear on the screen and display the
relevant information when required. To continue, operator must press the ‘OK’ key or wait for
the progress bar to disappear.
The following screen categories may appear:
• Cooling bar: System will alert once electrodes should be cooled down during the ST
treatment. A progress bar will indicate when cooling process is completed.
• V-FR / V-VR tip warnings

o Treatment tips should only be used for a single treatment application on
a single patient to avoid cross contamination.
o System will alert the operator if an empty tip is inserted.
o For V-FR treatment. every 20 pulses, the operator should stop treatment
and clean the V-FR tip of any debris that may affect the treatment.
System will go into ‘Standby’ mode and trigger/ foot pedal will be
disabled until “OK” key is pressed. To clean the tip, use a brush dipped
with alcohol. Make sure the tip is completely dry before resuming
treatment.
Warning
Any tip replacements should only be purchased through Viora’s authorized
local distributor.
• V-FORM, V-VR and V-FC Applicator / tip warning - System will alert the operator if
no applicator / tip is connected.
In the event of a high impedance warning (bad coupling), during RF Treatment, a
notification sound will be heard. In such case, operator should make sure there is good
contact between the skin and the electrodes.
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6 Clinical Guidelines for RF-Based Technology
Note
Before starting any treatment with V10 system, please review the relevant treatment
protocol
6.1 Contraindications
The following conditions are contraindicated to the treatment:
• Pregnancy and breast feeding.
• Treatment over tattoo or permanent makeup.
• Any Permanent implant in the designated treatment area (including but not limited
to: silicon or injected chemical material, metal plates or other metal material).
• Any implanted electronic device anywhere in the body (such as cardiac pacemaker,
defibrillator and cochlear implant).
• Severe concurrent conditions (such as cardiac disorders).
• Blood coagulopathy or excessive bleeding or bruising or use of blood thinning
medications (anticoagulants), whether prescribed or over-the-counter.
• Active skin disease in the treatment area (such as psoriasis, sores, eczema and any
type of rash).
• Tendency to skin disorders (such as keloids and impaired wound healing process) and
extremely dry and fragile skin.
• Skin cancer (active or in the past), pre-malignant moles, malignancy (active or recent)
or history of any kind of cancer.
• Immunosuppressive diseases (such as HIV Positive) or the use of immunosuppressive
medications.
• Endocrine disorder (such as diabetes and thyroid disease).
• History of disease which may be stimulated by heat, such as recurrent Herpes in the
treatment area.
• History of hip replacement, hip or femur surgery, or other metallic implants (such as
gold threads).
• History of deep vein thrombosis - Thrombosis is the formation of a blood clot
("thrombus") in a deep vein
• Plastic surgery such as face lifting or eyelid surgery within the past 12 months.
• Use of Accutane within the past 6 months.
• Facial controlled abrasion (such as dermabrasion, facial resurfacing, or medium/deep
chemical peeling) within the past 3 months.
• Botox injections in the past 5-7 days
• Chemical peel or natural fillers (such as hyaluronic acid) in the past 2-4 weeks
Additional Contraindications when treating with V-FR handpiece
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• Augmentation techniques with injected bio-materials (such as injections of

Botulinum toxin, collagen protein or fat) within the past 6 months.
• Natural filler (such as hyaluronic acid) in the treatment area within the past 6 months.
• Extremely tanned skin (including tanning beds or tanning creams) within the past 2
weeks.
• Any use of NonSteroidal Anti-Inflammatory Drugs (NSAIDs, such as Nurofen, Advil,
and Motrin) 7 days before and 7 days after every treatment.
Additional Contraindications when treating with V-VR handpiece

• Active Sexually Transmitted Diseases
• Any prior aesthetic or medical surgery affecting the treating area (vulvovaginal area), 3
months prior to the treatment or before complete healing.
• Current urinary tract infection
• Greater than a stage 2 pelvic organ prolapse
• Patients in the middle of menstrual cycle (on the day of the treatment)
• Absence of normal physical examination and pap smear
Caution
Though the treatment is not advised for any of the above conditions, patients
may be treated in some cases after consulting with their primary physician and
providing a written consent for the treatment at their physician’s discretion
6.2 Possible Side Effects

Improper use of the system may result in side effects. Although these effects are highly rare
and expected to pass, any adverse reaction should be immediately reported to the patient's
physician and to Viora’s clinical team.
Appearance of side effects may occur during the treatment or shortly after. These side effects
may include the following:
• Discomfort
• Appearance of any pigmentation (hyper- pigmentation or hypo-pigmentation)
• Changes in skin texture, such as burn, blister and crust
• Excessive skin edema and /or erythema.
• Urticaria (hives)
• Hematoma
• Scarring
• Allergic contact dermatitis to the acoustic contact gel or glycerin
The following adverse effects relate only to V-RF treatment:

• Post treatment mild or strong pain
• In-grown hair
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• Skin infection
The following adverse effects relate only to V-VR treatment:

• Transient sensitivity during intercourse
• Bleeding due to atrophy
• Vaginal laceration in case of stenotic vagina
Caution
In the event side effects persist or are severe than the above, the patient should
consult a physician and notify Viora immediately.
Note
• Some dark-skinned patients (including Asian skin) may have a delayed
response of one-to-two days after treatment and should be evaluated
post-test procedure accordingly.
• Proper use of the system by following the treatment protocol and
operation instructions will prevent or minimize adverse effects.
6.3 Realistic Expectations

It is extremely important for the treatment’s success and patient’s satisfaction to set realistic
expectations and advise the client of the following:
• Shortly after the treatment erythema and edema are likely to appear in the treated
zone. The edema is likely to clear up within a few hours while erythema may persist up
to 12-24 hours from treatment time.
• The degree of response to the treatment, and the number of treatment sessions
required will vary among patients and will depend on the clinical and physiological
condition at the start of the treatment regimen.
• The outcomes of the treatment will appear progressively, while temporary
improvement in the skin will be observed immediate after each treatment; the
maximum long-term result can be observed 2-4 months after the last treatment.
• Maintenance sessions may be required.
Additionally, the following should be explained to the patient prior to FR
treatment:
• Light ablation may be detected with gradual improvement in skin
texture/laxity.
• After the treatment and throughout the healing stage, small pin-point
crusts may appear in the area of each ablated spot, at the contact
area of the electrode pins with the skin. These crusts will undergo
natural exfoliation.
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6.4 Consult Meeting

The first visit of any patient should be dedicated to reviewing treatment possibilities,
contraindications and performing a test procedure in order to establish the patient is an
appropriate candidate for the treatment, and test for the optimal treatment parameters.
Upon the patient's initial visit, practitioners should follow the below steps during a consult
meeting:
• Establish patient's needs and review symptoms.
• Set patient's expectations and desired end point for the treatment.
• Complete patient's medical history and review contraindications.
• Review with the patient the application method and operation, expected treatment
results and possible side/adverse effects during or post treatment.
• Prior to commencing treatment sessions advise the patient to:
o Avoid skin irritation or exposure to sun and using sunscreen during
daylight hours.
o Stop using any irritant topical agents for at least 2-3 days before to
treatment session.
• Sign the patient on an informed consent form including the above.
• Establish a schedule of treatments.
• Take photos, measurements, etc.
• Perform a test procedure.
6.5 Treatment Follow-Up

Post-treatment follow-ups are very important to determine the most suitable regimen for
each patient.
• The patient must be evaluated 2-3 days post treatment to make sure no side/adverse
effects appear.
• Always inquire and update the patient history portfolio (including medical history and
contraindications).
• Following completion of treatment course, patient should return after 4-6 weeks for
evaluation.
• Prior to any maintenance treatment, perform a new test procedure in order to choose
and verify the treatment parameters.
6.6 V-ST Clinical Guide

6.6.1 Indications of Use
The V-ST handpiece is indicated for skin tightening.
The V-ST handpiece utilizes proprietary CORE™ technology, bi-polar RF energy in three RF
frequencies: 0.8, 1.7 and 2.45 MHz, as well as a combination of all three frequencies within a
single pulse.
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6.6.2 Test Procedure

The first clinical visit of any patient should be dedicated to reviewing treatment possibilities,
contraindications and performing a test procedure in order to establish whether the patient is
an appropriate candidate for the treatment, as well as testing for the optimal treatment
parameters. In addition, performing a test procedure minimizes the possibilities for side
effects and adverse response to the treatment. At the start of the treatment course and at
every subsequent session, it is important to inquire and update the patient history portfolio,
being mindful of new prescriptions, aesthetic or medical procedure, etc.
6.6.3 Pre-Treatment Preparation

The following steps should be taken before any treatment or test is performed.
• Ensure that the V-ST handpiece is properly inserted into the system.
Make sure the electrodes are completely clean and dry. Left over residues on the
handpiece may damage the system and cause superficial burns on the skin
• Use a mild cleansing solution (not alcohol-based solution) to clean the treatment area.
• Make sure the treatment area is dry and free of any moisture, liquids or lint.
• If there is excessive thick hair on the treatment area, it is recommended to shave it as it
may interfere with the passage of the energy (men only).
Note
Areas of metal dental implants (such as dental braces, caps and crowns) may be
more sensitive to RF energy. In this case, the practitioner may isolate the area
using gauze, dental rolls or a tongue depressor.
6.6.4 Treatment Guidelines

• Apply a layer of ultrasound gel in an amount covering half the height of the
electrodes.
• Set the RF mode according to the treatment area and as indicated in the treatment
protocol.
• Set RF according to Test Procedure results. Selecting the appropriate RF energy level is
crucial for safe and effective operation.
• Place the handpiece on the treatment area in a perpendicular orientation and apply
slight pressure, making sure both electrodes are in good contact with the skin surface.
• Examine the skin response to the chosen parameters before increasing the RF energy
level.
• According to the practitioner's discretion and specific patient’s reaction, the treatment
parameters can be modified during subsequent sessions.
6.6.5 Treatment Schedule

Note that treatment sessions may be considerably longer and depend on the treatment area,
physiological attributes and patient's response.
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• Number of Treatments: 3-6

• Treatment Intervals: 2-4 weeks
• Maintenance: 1 treatment every 3-6 months, or as required.
6.6.6 Post-Treatment Care

• If patient notes excessive heat sensation or strong erythema, the area may be cooled
with the following; chilled Aloe Vera Gel, cold (not frozen) packs or cold compresses.
• In any other case of rare blistering, refer the patient to a doctor.
• If adverse effects appear, promptly stop the treatment and apply cooling gel.
Immediately refer to a doctor.
• Treatment should be resumed only after the patient has been thoroughly evaluated by
a doctor and the side effects have subsided. Reduce the treatment parameters in
subsequent treatments.
• Following the skin tightening treatment, patients should take special care of the
treated area, making sure to avoid the use of hot water and discontinue use of
abrasive or harsh products for two days.
6.7 V-FR Clinical Guide

6.7.1 Indications of use
The V-FR Handpiece is indicated for ablation and resurfacing of the skin.
The V-FR handpiece uses Viora’s innovative SVC™ technology to give physicians greater
control by delivering unprecedented penetration depth control, to determine the desired
biological response. By delivering bi-polar RF energy in a pixilated fashion to the skin, isolated
spots of skin are heated, leaving healthy surrounding tissue. This allows a faster healing
process and extra cellular matrix remodeling mainly driven by fibroblast activity.
Warning
Dermatologists and aesthetic physicians may treat patients only after passing
appropriate training and adhere to all local and state regulations regarding the
use of this system.

• Hair in the treatment area should be shaved. Hair may disrupt electrodes’ full coupling
with the skin and as result may cause burns.
• Use a mild cleansing solution to clean the treatment area. Make sure the treatment
area is dry and free of any moisture, liquids or lint.
• If need, apply a topical anesthetic material (water-based only, containing at least 15%
active ingredients) on the entire treatment area. Follow manufacturer guidelines when
applying material.
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• At the end of anesthetic activity (according to manufacturer guidelines) wipe off the
excess material from the skin with a tissue.
• Wash the skin with soap and lukewarm water and make sure the skin is completely
clean of any residues.
• Once the skin is clean, sterilize the treatment area using an alcohol pad (at least 70%
ethanol).
• Make sure the skin is completely dry before initiating the treatment.
• There is no need for the use of any medium solutions during the treatment (such as
ultrasound gel or coupling gel).
• Before beginning the treatment make sure the handpiece is clean, dry and intact.
• Open the sealed pack of the treatment tip and check the integrity of the pins making
sure they are all intact and that the tip’s frame is undamaged.
• Connect the treatment tip to the handpiece and ensure the tip is secured in place.
Note
Areas of metal dental implants (such as dental braces, caps and crowns) may be
more sensitive to RF energy. In this case, the practitioner may isolate the area
using gauze, dental rolls or a tongue depressor.

Before receiving a patient for a V-FR treatment session, a test procedure must be performed
during the initial consult meeting. The test procedure should be performed at non-exposed
site of the treatment area. If more than one area is to be treated, a test should be performed
on all treatment sites.
The test procedure serves several purposes:

• Establishing the client is an appropriate candidate for the treatment:
o For skin types I–III wait 1-2 days before assessing the skin response.
o For skin types IV-VI wait 5-7 days before assessing the skin response.
• Providing the client with an opportunity to experience the V-FR treatment.
• Finding the correct parameters according to skin’s reaction and patient’s tolerance to
the test procedure
• Minimizing possibilities for adverse effects.
Warning
• Patients with skin types V-VI may be more sensitive to treatment. Lower
energy levels should be applied.
• When treating Asian skin classify it as one grade higher on the Fitzpatrick
scale.
The test procedure should be conducted as follows:

a) For facial treatments perform the test on concealed areas such as the back of the
neck. For body treatments perform the test on the target area.
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User Manual
b) Chose the relevant treatment program (Shallow, Medium or Deep).
c) Set the energy to 0.25 J.
d) Apply one pulse. If no heat sensation was reported by the patient, increase the energy
level by 0.25 J and apply additional pulse in an adjacent spot.
e) Continue in the same manner until the patient reports a noticeable heat sensation.
Note the energy level you have reached (XJ)
f) Release additional 2-3 pulses at the same energy (x J)

g) Increase the energy level by 0.25J (X+0.25J) and release 2-3 pulses
h) Increase the energy level again by 0.25J (X+0.50J) and release additional 2-3 pulses
i) Never release pulses in the same spot
j) Wait 10 minutes to allow a pattern to appear. The desired end point is local erythema
and edema.
k) If the skin does not show signs of erythema and edema after 10 minutes, increase the
RF energy by an additional 0.25J (X+0.75J) and release an additional pulse adjacent to
the location of the previous pulse.
l) Wait additional 10 minutes to allow the end point to appear.
m) Treatment area must be examined 24 hours post test procedure and a grid like
pattern matching the electrode pins should be visible on the treated area.
Note
• Test procedure is to be executed and evaluated prior to beginning
treatment schedule
• For complete treatment protocol please refer to the treatment protocol
attached to this user manual.
At the start of the treatment course, and at every subsequent session, it is important to inquire
and update the patient history portfolio, being mindful of new prescriptions, aesthetic or
medical procedure, etc.

• After completing the pre-treatment guidelines, set the treatment parameters
according to the test results.
• Place the tip in full contact with the skin at a 90 degree angle to the surface of the
target region.
• Apply one pulse by pressing down the trigger on the handpiece or the foot pedal at
the same time.
Note
Only one pulse at a time is possible when treating with the V-FR handpiece.
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User Manual
• The LED located at the back of the handpiece will light up as an indication of the
released pulse. The light has no bearing on the actual treatment and is only a visual
indication that a pulse has been released.
• On Standby mode, the LED light will be OFF
• On Ready mode, the LED light will blink.
• Once the pulse is completed a beeping sound is heard to indicate the pulse is
completed. The handpiece can then be safely moved to an adjacent spot in the
treatment area.
• For every pulse released, the number of pulses indicated on the display screen will
increase by one.
• Do not leave untreated spaces between the pulses and do not overlap between the
pulses.
• Pass over the treatment area once.
• In case the system recognizes insufficient coupling, the RF energy will be disabled and
the system will not emit a pulse. This will be accompanied by a message on screen and
an audio indication. The system will not count this as a pulse.
• Throughout the treatment, make sure that the electrode-pins are:
o Clean and have no cellular remains (appearing as black material).
o Make sure that the tips are cleaned every 20 pulses while the system is on
Standby mode. A note will appear on the screen every 20 pulses.
o Unharmed – ensure that no pins are missing or damaged.
• Examine the treated area for the desired end point; erythema and edema on the
treatment area.
• Edema will normally appear within several minutes after the treatment.
• At the end of the treatment, examine the area to make sure there are no untreated
patches of skin. If such patches exist follow the below instructions:
o Set the system to Standby Mode.
o Clean the untreated patches and the tip with a dry lint-free gauze pad.
o Pass over the untreated patches and avoid treated areas.
• At the end of every treatment session remove the treatment tip and clean the
handpiece according to the cleaning guidelines. Insert the V-FR tip cover when the
system is not in use in order to protect the handpiece.
Warning
• Do not treat over the eyelids or the lips.
• Do not treat different patients with the same tip, in order to prevent
cross-contamination.
• Do not treat with an expired tip.
• Do not use the V-FR Tip in case the sterile package is damaged
• Note that in darker skin types erythema is not easily noticeable;
therefore, the end point of edema will be more outstanding in these
patients.
• Before cleaning the tip make sure to set the system to Standby mode
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• Treatment Intervals: 4-6 weeks

• Emollient cream should be applied to the treatment area.
• If patient notes excessive heat sensation or strong erythema or any discomfort, the
area may be cooled with the following; chilled Aloe vera gel, cold (not frozen) packs or
cold compresses.
• If rare blistering or ulcerated skin occurs, mild hydrocortisone ointment may be
applied or a prescribed antibiotic ointment.
• Usually 1-3 days after the treatment small scabs (less than 1 mm in diameter) will
appear and will possibly remain for several days. Do not scratch or touch the scabs and
allow them to shed off naturally from the skin.
• Advise the patient of the following precautions during the first 2 days after the V-FR
treatment:
o Avoid using hot water massages.
o Avoid using of abrasive or harsh products.
o Avoid any mechanical or thermal damage to the treated area.
o Avoid any type of skin tanning (by sun exposure, tanning beds or artificial
sunless tanning lotions) during the entire course of the treatment.
o Keep the skin clean in order to avoid contamination or infection.
• Use a high-factor sunscreen (at least 30 SPF) to protect the treated area for at least 1
month after every treatment.
• Moisturizing cream may be applied several hours (~½ a day) after treatment.
• Make-up may be applied 24 hours after treatment.
• Avoid using any kind of soap on the treatment area up to 24 hours after the treatment.
6.8 V-FORM and V-FC Clinical Guide

6.8.1 Indications of use
The V-FORM and V-FC handpieces, are intended for temporarily reduction of cellulite and
Body contouring via temporary circumferences reduction.

• Use a mild cleansing solution (not alcohol based solution) to clean the treatment area.
• Make sure the treatment area is dry and free of any moisture, liquids or lint.
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• Apply a very thin layer (<1 mm) of glycerin onto the treatment area to assure good
coupling and conductivity.
• Place the applicator perpendicular to the treatment area.

The first visit of any patient to a salon, spa or clinic should be dedicated to reviewing
treatment possibilities, contraindications and performing a test spot in order to establish that
the patient is an appropriate candidate for the treatment and test for the optimal treatment
parameters. In addition, performing a test spot procedure minimizes the possibilities for side
effects and adverse response to the treatment.
At the start of the treatment course and at every subsequent session, it is important to
inquire and update the patient history portfolio, being mindful of new prescriptions, aesthetic
or medical procedure, etc. Selecting the correct treatment parameters is essential for safe,
accurate and efficient treatment.
The test procedure is divided into 2 steps:
A. Step 1 – Finding the patient comfort level
1. For V-FORM, insert the BC Large, Medium or Small applicator (depending on the
treatment area size).
2. Set the treatment parameters as follows:
• RF Mode - MODE IV
• RF Intensity – OFF
• Vacuum Intensity – Level 1
3. Identify a zone enough for footprint of the chosen applicator, in the less visible site of
the desired treatment area.
4. Perform 3 stacked pulses on the same spot.
5. If no adverse effects appear and patient comfort allows, increase the vacuum intensity
by 1 level and repeat the same procedure o the same spot.
6. Continue in the same manner with vacuum level 3 and 4.
7. Ask the patient to assess the discomfort during the test procedure using the scale
below and record it on the patient sheet:
Discomfort Scale:
0 – No Discomfort 1 – Mild 2 – Moderate 3 – Significant 4 - Unbearable
8. The highest vacuum level applied that generated moderate discomfort will be the
selected vacuum level for the next phase.
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B. Step 2 – Validating the parameters
1. Select another zone in the same treatment area (wide enough for four footprints
of the applicator with about 40% overlapping).
2. Set the treatment parameters as follows:
a. RF Mode - MODE IV
b. RF Intensity – Level 3
c. Vacuum Intensity – chosen level from Step 1
3. Perform Pre-heating phase of the zone, until the skin temperature reaches an
endpoint of 39-420C (review detected body temperature on the treatment screen
or on the V-FORM handpiece screen, Figure 6.8.1).
4. Figure 6.8.1: V-FORM IR Thermometer screen
5. Once endpoint is reached, continue in the same manner and maintain the
temperature for 7 minutes performing a ‘mini’ treatment.
Note
In the parameter validation step, it is recommended to work on more sensitive areas within
the treatment area; if such exist (this includes areas such as the flanks in the abdomen area).
Ask for patient feedback during treatment.
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6. Treatment area should be assessed 48-hours post test procedure for any local
side effects.
7. If the patient developed side effects, the chosen vacuum level should be 1 below
the initial patient’s indication.
8. Make a record of the patient’s subjective response as well as the skin’s response
on the patient’s treatment sheet.
Note
• The operator may increase the parameters in subsequent treatments according to

patient’s comfort level and skin’s response.
• Make sure to follow clean up procedures for consumables and systems’ at the end of
the treatment session.

1. Make sure there is full contact between the electrodes and the skin without putting
unnecessary pressure on the applicator.
2. Pulses are released when the trigger on the applicator is pressed down.
3. If the trigger is held down, the system will continue to release consecutive pulses until
the press button is released.
4. Once the pulse and vacuum stop slide the applicator to the next spot on the
treatment area.
5. Overlap about 30-40% of the pervious pulse.
Note
Sliding the applicator before the vacuum pulse ends may cause bruising.
6. Clean the applicator thoroughly at the end of every treatment session using an
alcohol based solvent.
7. Let the handpiece and applicators dry completely before using them again.
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• Treatment Intervals: 1 week
• Maintenance: 1 treatment every 3-4 months, or as required

If patient notes excessive heat sensation or strong erythema, the area may be cooled with the
following; chilled Aloe Vera gel, cold (not frozen) packs or cold compresses.
• If rare blistering occurs, mild hydrocortisone ointment may be applied or a prescribed
antibiotic ointment.
• If adverse effects appear, promptly stop the treatment and apply cooling gel.
• Treatment should be resumed only after the patient has been thoroughly evaluated and the
side effects have subsided. Reduce the treatment parameters in subsequent treatments.
6.9 V-VR Clinical Guide

6.9.1 Indications of Use
The V-VR handpiece is indicated for electrocoagulation of soft tissues for the treatment of
vulvovaginal laxity. The vulva area is referred to the labia majora.

The first clinical visit of any patient should be dedicated to reviewing treatment possibilities,
contraindications and performing a test procedure in order to establish whether the patient is
an appropriate candidate for the treatment, as well as testing for the optimal treatment
parameters. In addition, performing a test procedure minimizes the possibilities for side
effects and adverse response to the treatment. At the start of the treatment course and at
every subsequent session, it is important to inquire and update the patient history portfolio,
being mindful of new prescriptions, aesthetic or medical procedure, etc.

• Ensure that the V-VR tip is properly inserted into the handpiece.
• Make sure the electrodes are completely clean, dry and intact. Any damaged tip
should be replaced immediately.
• Empty bladder immediately before procedure.
• Use a mild cleansing solution (not alcohol-based solution) to clean the surrounding
treatment area.
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• Apply a thin layer of ultrasound gel (~2 mm) over the tip.
• Set the RF mode according to the treatment protocol.
• Set RF energy according to Test Procedure results. Selecting the appropriate RF energy
is crucial for safe and effective operation.
• For labia majora treatment:
o Place the handpiece with the active electrode over the labia skin and
apply slight pressure, making sure the tip is in good contact with the skin
surface.
o Press the foot-pedal and treat the area unilaterally (dividing the left and
right side) while monitoring skin temperature on the treatment screen.
Move over the area with circle or line motions, to cover the entire
treatment area.
• For vaginal treatment:
o Gently place the handpiece inside and measure the vaginal canal by
inserting the HP until resistance. Measure depth of the vaginal canal and
back out 2-3cm. Make sure the tip is in good contact with the vaginal
surface.
Press the foot-pedal and treat the entire area while monitoring skin temperature on the
treatment screen. Work from inside-out (line movements) with “half-moon motions”.
• Number of Treatments: 3
• Treatment Intervals: 4 weeks
• Post treatment the following may apply:
o A mild cramping, which should resolve within 24 hours
o Light spotting immediately post procedure
o Increased vaginal discharge due to ultrasound gel used during the
treatment that remained
o You may resume normal physical and sexual activity, unless otherwise
directed by your practitioner
o No restrictions on showering, bathing, swimming or hot tubs. In a case of
spotting or mild bleeding, wait for one day
• Contact your practitioner if:
o Bleeding lasting longer than 24 hours
o Pain unresolved by over the counter medication
o Cramping lasting longer than 24 hours
o Fever > 38֩ C (101֩ F ).
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7 System Maintenance
The V10 system requires standard maintenance and cleaning procedures to ensure optimal
system performance. However, please note that the system should be technically serviced only
by authorized service technicians.
This section details the general routine maintenance procedures that may be performed by
trained and approved operators.
Warning
DISCONNECT THE POWER SUPPLY CABLE BEFORE PERFORMING ANY
MAINTENANCE OR SERVICE PROCEDURES TO AVOID ELECTRIC SHOCK!
• For continued protection against fire, replace the fuse only with one of
the same type and rating
7.1 Cleaning the System

It is recommended to clean the system at least once a week.
• Turn the system OFF.
• Wipe all external surfaces with a soft, damp, non-abrasive cloth.
• To clean the LCD screen, use a suitable solution for computer screens.
7.2 Cleaning the Handpieces

All the Handpieces and/or electrodes must be thoroughly cleaned after every treatment.
• Turn the system OFF.
• Wipe the V-ST Electrodes with a dry cloth to remove excess ultrasound gel.
• Wipe the V-FORM BC Applicators including the IR sensor with wet wipes (alcohol
based) to remove residual glycerin.
• The external filter in V-FORM BC Large Applicator should be replaced before every
treatment (see instructions in 7.3.1).
• The internal filter in the V-FORM BC Applicators should be replaced once every 3
months (see instructions in 7.3.2).
• The side filter in the V-FORM Handpiece should be replaced once every 3 months (see
instructions in 7.3.3).
• Wipe the V-FC Tip including the IR sensor with wet wipes (alcohol based) to remove
residual glycerin.
• The side filter in the V-FC Handpiece should be replaced once every 6 months.
• Using a cotton pad and an Isopropyl-based alcohol solvent (70%), carefully wipe the
electrodes and handpieces, making sure all corners are thoroughly cleaned.
Warning
Damaged or broken applicators and/or tips should be replaced.
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Note
Gel accumulation on V-ST electrodes may cause a spark and potentially a
superficial burn in the next treatment performed.
7.3 Replacing the filters in the V-FORM Handpiece

7.3.1 Replacing the external filter in the BC Large Applicator
External Filter should be replaced before every treatment.
1. Disconnect the applicator from the handpiece.
Figure 7.3.1: The filter house is in the middle

2. Pull the filter house
Figure 7.3.2: Pulling the filter house

3. Replace the used filter with a new one, using tweezers. Make sure to place the filter
with the rough part facing to you.
Figure 7.3.3: Replacing the filter

4. Place the filter house back in the applicator
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Figure 7.3.4: Placing the filter house back in the applicator
7.3.2 Replacing the internal filter in the V-FORM BC Applicators

Internal Filter should be replaced once every 3 months
1. Disconnect the applicator from the handpiece.
Figure 7.3.5: Inside BC applicators
2. By using the supplied Hex key, Unscrew the filter plug
Figure 7.3.6: Unscrewing the filter plug
3. Disconnect the filter from the filter plug.
Figure 7.3.7: Disconnecting the filter from the filter plug
4. Insert the new filter into the filter house.
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Figure 7.3.8: Filter house
5. Place the filter plug back in the applicator.
Figure 7.3.9: Replacing the filter plug
6. By using the Hex key, screw in the filter plug.
7.3.3 Replacing the side filter in the V-FORM Handpiece

Side Filter should be replaced once every 3 months. Follow the next steps to replace
the filters:
1. Take the supplied “Allen Key” and unscrew the “filter house” cover
Figure 7.3.10: The supplied “Allen Key” Figure 7.3.11: Unscrewing the “filter house” cover
2. Take out the 2 filters and insert 2 new filters (one on top of the other)
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Figure 7.3.12: Replacing the old filters Figure 7.3.13: Inserting the new filters
3. Make sure the filters are placed on the left side and screw back the “filter house” cover
Figure 7.3.14: Placing filters on the left Figure 7.3.15: Screwing back the “filter house” cover
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8 Troubleshooting
The V10 system is equipped with a self-testing software routine that continuously monitors
system operation. The following troubleshooting guide does not attempt to list all possible
system failures.
8.1 Fault Messages

The following table offers a list of the most probable system failures and instructions on how
to solve them. If the corrective actions listed in the table do not solve the problem, Please
contact your local distributor for further assistance.
Message on screen Probable Cause Corrective Action Problem Continued action

solved
Bad coupling (sound Bad coupling Make sure that all Yes Allowing to generate a
notification only) between the electrodes are in full pulse
electrodes and the contact No Contact the local
skin. with the skin distributor
Overheating System is over heated Wait for few minutes Yes Resume work
until system is cooled
down and the message
disappears from the No Contact the local
screen. distributor
No Handpiece Improper connection Disconnect and Yes Resume work

Connected of the handpiece reconnect the
handpiece
No Contact the local
distributor
No V-FORM Connect the applicator / Yes

Applicator / V-FC tip tip to the handpiece Resume work
Only V-FORM / V-FC
connected. Please
handpiece is
connect V-FORM No
connected to the
Applicator / V-FC tip Contact the local
system and no
to resume distributor
applicator is
connected to the
handpiece
No Tip Connected When V-FR / V-VR 1. Connect the V-FR / Yes Resume after new tip
Treatment is selected V-VR Tip connected
and there is no 2. If there is already a
treatment tip tip connected,
connected please replace it
distributor
with a new one
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V-FR / V-VR Tip The V-FR / V-VR Replace the Tip Yes Resume after new tip
Failure handpiece can't connected
recognized the Tip No Contact the local
distributor
No Foot Pedal is Connect the foot pedal Yes Resume work
Foot Pedal is
Disconnected connected to the No Contact the local
system distributor
Release the Foot Pedal Yes Resume work
Foot Pedal Pressed
If the pedal is pressed No 1. Reconnect the

and user want to
Pedal (Confirm
proceed to Ready
that system is off)
Mode.
2. Contact the local
distributor
If the trigger is Release the Trigger Yes Resume work
Handpiece trigger is
Pressed pressed and user
want to go Ready No Contact the local
Mode distributor
User tried to insert 1. Verify the code Yes Resume work
Configuration or
license code is Incorrect code is entered
incorrect correctly No Contact the local
2. Verify the code distributor
has a match
with the S/N of
the device
User tried to insert Enter a new code Yes Resume work
Configuration or
License code has Used code
already been No Contact the local
entered into this distributor
system
General failure Reboot the system. Yes Resume work
General Main Board
Failure –
Failure code 106
distributor
Table 8.1.1: Fault Messages
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8.2 Failure Messages

The following table offers a list of Technical failure message that will appear under various,
faulty conditions. The message will be accompanied by Error Number. Upon receiving one of
the following warning messages, please contact your local distributor for more information
and repair:
o System failure
o V-ST failure
o V-FORM failure
o V-FC failure
o V-FR failure
o V-VR failure
o V-ST HP cooling failure
o V-FR HP cooling failure
o Communication failure
Message on screen Error Number
General Main Board Failure 101 – 108
General RF Board Failure 201 - 204
General Handpiece Failure 501 - 513
Table 8.2.1: Failure Messages
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8.3 Operation troubleshooting

The following table displays a list of operation failures without warning that may occur
under various faulty conditions and instructions on how to solve them. If the corrective
actions listed in the table do not solve the problem. Please contact your local
distributor for further assistance.
Problem Corrective Action Problem Continued action

solved
System is not turned ON Ensure proper connection to Yes Resume work
mains outlet No Contact the local distributor
The system is turned ON, Reset the system Yes Resume work
but the screen is No Contact the local distributor
black/white
No sound Make sure the volume setting Yes Resume work
on the setup screen is not set No Contact the local distributor
to minimum.
Noisy system Reboot the system. Yes Resume work
No Contact the local distributor
Weak vacuum in V-FORM Replace the filter in the Yes Resume work
applicators / V-FC tip - handpiece and / or applicator
Vacuum is not working No Contact the local distributor
properly
Table 8.3.1: Troubleshooting
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9 About Viora
Viora, a leading provider of medical aesthetic solutions, is passionate about helping customers
deliver the most effective results to their patients. Since 2005, Viora has sought to improve
upon treatment experiences by enhancing existing technology to give customers the best
non-invasive solutions available.
Viora’s non-invasive and minimally invasive products treat a wide range of symptoms and are
the perfect solutions to address today’s most commonly requested treatments, such as skin
tightening, body & facial contouring, cellulite reduction, skin rejuvenation, acne clearance,
skin resurfacing, stretch mark reduction, hair removal, skin lightening and more.
Viora’s skilled and knowledgeable clinical and technical teams, working with clinicians around
the world have produced innovative, proprietary technologies such as CORE™, SVC™, Co-
Polar RF™ and PCR™. These technologies have revolutionized non-invasive treatments to
improve control and increase opportunity for practitioners, while enhancing patient
experience. In addition, this in-house expertise has been at the forefront of implementing new
developments in response to market demand, improving upon treatments using existing
technologies such as laser and IPL. By formulating exclusive combination protocols and
combining different proprietary technologies, Viora achieves enhanced clinical results and
greater customer and patient satisfaction.
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APPENDIX A – EMC Tables

Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS –
for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
The V10 is intended for use in the electromagnetic environment specified below. The
customer or the user of the V10 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment –

guidance
Group 2
RF emissions The V10 uses RF energy only for its
CISPR 11 internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
Class A The V10 is suitable for use in all
RF emissions
establishments other than domestic,
CISPR 11
and may be used in domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic
purposes, provided the following
warning is heeded:
Warning: This
equipment/system is intended for
use by healthcare professionals only.
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 re-orienting or
relocating the V10 or shielding the
location.
Harmonic emissions AC mains
Compliance
IEC 61000-3-2
Class A
Voltage Compliance
AC mains
fluctuations/flicker
emissions
IEC 61000-3-3
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Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY –

for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
customer or the user of the V10 should assure that it is used in such an environment.
Immunity test Compliance

IEC 60601 Electromagnetic
level
test level environment –
guidance
Electrostatic 8 kV contact 8 kV contact Floors should be

discharge (ESD) IEC wood, concrete or
61000-4-2 2, 4, 8, 15kV air 2, 4, 8, 15kV air ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least 30
%.
Electrical fast 2 kV for power 2 kV for power Mains power quality

transient/burst IEC supply lines supply lines should be that of a
61000-4-4 typical commercial
1 kV for N/A or hospital
input/output lines environment.
Surge IEC 61000-4- 1 kV line(s) to 1 kV line(s) to Mains power quality

5 line(s) line(s) should be that of a
typical commercial
2 kV line(s) to 2 kV line(s) to or hospital
earth earth environment.
2 kV Signal N/A
input/output) to
earth
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Voltage dips, short 0% UT; 0.5cycle at 0% UT; 0.5cycle at

interruptions and 0°, 45°, 90°, 0°, 45°, 90°,
voltage variations 135°,180°, 225°, 135°,180°, 225°, Mains power quality
on power supply 270° and 315° 270° and 315° should be that of a
input lines IEC typical commercial
61000-4-11 0% UT; 1cycle and 0% UT; 1cycle and or hospital
70% UT; 25/30 70% UT; 25/30 environment. If the
cycles cycles user of the V10
requires continued
Single phase at 0° Single phase at 0° operation during
0% UT; 250/300 0% UT; 250/300 power mains
cycle cycle interruptions, it is
recommended that
the V10 be powered
from an
uninterruptible
power supply or a
battery.
Power frequency 30 (A/m) 30 (A/m) Power frequency

(50/60 Hz) magnetic fields
magnetic field IEC should be at levels
61000-4-8 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.
N/A Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic

IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are LIFE-SUPPORTING
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Table 4 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY –

for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Declaration – electromagnetic immunity
customer or the user of the V10 should assure that it is used in such an environment
IMMUNITY IEC 60601 TEST Compliance Electromagnetic environment –
test LEVEL level guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of V10,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
Conducted RF 3V, 6V 3Vrms, 6V transmitter.
IEC 61000-4-6 Recommended separation distance
Radiated RF 3V/m 3V/m

IEC 61000-4-3
where
P is the maximum output power
3V/m from 0.15 3V/m from rating of the transmitter in watts (W)
to 0.15 to according to the transmitter
manufacturer and d is the
80MHz; 80MHz;
recommended separation
6V/m from 0.15 6V/m from
distance in metres (m).
to 0.15 to
Field strengths from fixed RF
80MHz and 80% 80MHz and
transmitters, as determined by an
AM 80% AM
electromagnetic site survey,
at 1kHz at 1kHz
should be less than the compliance
level in each frequency range.
10V/m from D Interference may occur in the
80MHz vicinity of equipment marked with
10V/m from
80MHz to 2.7GHz the following symbol:
to 2.7GHz
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N/A Table 5 – Recommended separation distances between portable and mobile

RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for LIFE-
SUPPORTING ME EQUIPMENT and ME SYSTEMS
Table 6 – Recommended separation distances between portable and mobile

RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME
EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between

portable and mobile RF communications equipment and the V10
The V10 is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the V10 can help prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and V10 as recommended
below, according to the maximum output power of the communications equipment
Rated maximum Separation distance according to frequency of transmitter

output
m
power of
150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2,5
transmitter
MHz GHz
outside ISM in ISM bands
W
bands
0.01 0.12 0.2 0.4 1

0.1 0.37 0.64 1.3 2.6
1 1.17 2 4 8
10 3.7 6.4 13 26
100 11.7 20 40 80
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (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
77
User Manual

IMMUNITY – for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS that are specified
for use only in a shielded location.
IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING and
are specified for use only in a shielded location N/A because the device is not specified
for use only in a shielded location.
Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test Band a) Service a) Modulationb) Maximu Distance IMMUNITY Compliance

m level
frequency (MHz) (m) TEST LEVEL
power (V/m)
(MHz) (V/m)
(W)
385 380 – TETRA 400 Pulse 1.8 0.3 27 27
390 modulationb)
18 Hz
450 430 – GMRS 460, FM c) 2 0.3 28 28
470
FRS 460 ± 5 kHz
deviation
1 kHz sine
710 704 – LTE Band 13, Pulse 0.2 0.3 9 9
787 modulationb)
745 17
217 Hz
780
810 800 – GSM 800/900, Pulse 2 0.3 28 28
960 modulationb)
870 TETRA 800,
18 Hz
iDEN 820,
930
CDMA 850,
LTE Band 5
1720 1 700 GSM 1800; Pulse 2 0.3 28 28
– modulationb)
CDMA 1900;
1845
1 990 217 Hz
GSM 1900;
1970
DECT;
LTE Band 1, 3,
4, 25; UMTS
78
User Manual
2450 2 400 Bluetooth, Pulse 2 0.3 28 28

– modulationb)
WLAN,
2 570 217 Hz
802.11 b/g/n,
RFID 2450,
LTE Band 7
5240 5 100 WLAN 802.11 Pulse 0.2 0.3 9 9
– modulationb)
5500 a/n
5 800 217 Hz
5785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and
the V10 may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a)
For some services, only the uplink frequencies are included.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case.
Note
• Information regarding potential electromagnetic or other interference comply with the IEC
Standard 60601-1-2: Fourth edition (2014) Medical electrical equipment Part 1-2:
Collateral Standard: Electromagnetic compatibility - Requirements and tests
• The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not offer adequate protection
to radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment
Warning
• Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
• Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation
• Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the V10, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result
• Power output accuracy is considered essential performance and that severe
EM disturbances can cause loss of accuracy
79

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User Manual

Digitally signed by CÔNG TY

TY TNHH =MST:0312927632, CN=CÔNG

Y TẾ Thành Phố Hồ Chí Minh, Việt

Copyright © 2021 Viora. All rights reserved.

3.12.2 V-FORM and V-FC Handpieces Safety ................................................................................ 18

5.10.3 V-FR Output Power ..................................................................................................................... 39

6.9 V-VR Clinical Guide ...............................................................................................................................61

1 Before You Start

1.1 Conventions Used in the Manual

1.2 Explanation of the Symbols Used in the System

Dispose of according to WEEE regulations

High frequency isolated patient circuit

Non-ionizing electromagnetic radiation

CAUTION: Federal law restricts this device to sale by or on the

Refer to instruction manual

Authorized Representative in the European Union

Discard Product After Expiration Date

2.1 System Overview

Figure 2.1.1: System Console

Figure 2.1.2: V-ST Handpiece Figure 2.1.3: V-ST Single-Use tip

Figure 2.1.7: V-FORM Handpiece Figure 2.1.8: BC Large Applicator

Figure 2.1.9: BC Small Applicator Figure 2.1.10: BC Medium Applicator

Figure 2.1.11: V-FC Handpiece Figure 2.1.12: V-FC Tip

Figure 2.1.13: V-VR Handpiece connected to

2.1.1 System Console

2.1.3 Disposable Sterilized Tip and Cover – V-FR Handpiece

2.1.4 Display Unit

2.2 System Specifications

2.3 Handpiece Specifications

Treatment area Frequency mode Frequency (Hz) Energy (J/cm3)

2.3.2 V-FR Specifications

7.3mm x 21.8mm 1 MHz 0-10 J 10-100 ms

2.3.3 V-FORM - BC Large Applicator Specifications

Treatment area Frequency mode Frequency (Hz) Power (W)

2.3.4 V-FORM - BC Medium Applicator Specifications

Treatment area Frequency mode Frequency (Hz) Power (W)

Mode 4 0.8MHz, 1.7MHz, 2.45MHz

2.3.5 V-FORM – BC Small Applicator Specifications

Treatment area Frequency mode Frequency (Hz) Power (W)

2.3.6 V-FC Specifications

Treatment area Frequency mode Frequency (Hz) Power (W)

2.3.7 V-VR Specifications

Treatment area Frequency mode Frequency (Hz) Power (W)

3.1 System Classifications

3.2 Electrical Requirements

3.3 Environmental Requirements

3.4 Space Requirements

3.5 Safety when Operating the System

3.6 System Safety Features

• Default treatment parameters are automatically recommended when operator makes a

3.7 Potential Fire Hazards

3.8 Patient and Personnel Safety

• Only trained operators are allowed to perform treatments.

3.9 Foot Pedal

3.10 Safety in Maintaining the System

3.11 Transport and Storage Conditions

3.12 RF-Based Technology Safety

3.12.1 V-ST and V-VR Handpieces Safety