Viora Infusion User Manual

User Manual

The

New Wave

Needle-Free

in

Electro-Mesotherapy

Copyright © 2013 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.

Manual Catalog Part Number: MK-021 E

Release Date: October 2013

Warning

• Before using the device, please check local regulations. If any local legislation

is violated, use cannot be authorized

Corporate Headquarters

Viora Inc.
392 Summit Ave.
Jersey City, NJ 07306
USA
T: +201.332.4100
F: +201.332.4200
Toll Free: +1.877.384.8032
Web: www.vioramed.com
Email: [e-mail]

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Manufacturer's Authorized
Representative

Viora UK Ltd.
450 Bath Road, Longford
Heathrow UB7 0EB, UK
Tel: [phone]
Fax: [phone]

Table of Contents

1. INTRODUCTION ------------------------------------------------------------------------------------4

1.1 Electro-mesotherapy Technology - Overview ------------------------------------------------- 4

1.2 Infusion™ Applications ----------------------------------------------------------------------------- 6

2. SAFETY INSTRUCTIONS ---------------------------------------------------------------------------7

2.1 Important Safeguards ------------------------------------------------------------------------------- 7

3. SYSTEM INSTALLATION ---------------------------------------------------------------------------- 8

3.1 Unpacking the box ---------------------------------------------------------------------------------- 8

3.2 Box Contents----------------------------------------------------------------------------------------- 9

3.3 System Overview ----------------------------------------------------------------------------------- 9

3.4 Equipment Setup ------------------------------------------------------------------------------------ 9

4. CLINICAL GUIDE ------------------------------------------------------------------------------------ 10

4.1 Indications --------------------------------------------------------------------------------------------- 10

4.2 Contraindications ------------------------------------------------------------------------------------ 10

5. TREATMENT PROTOCOL -------------------------------------------------------------------------- 11

5.1 Pre-Treatment Preparation ------------------------------------------------------------------------ 11

5.2 General Treatment Guidelines ---------------------------------------------------------------------------- 12

5.3 Understanding Treatment Intensity Levels ------------------------------------------------------ 12

5.4 Facial Treatment ------------------------------------------------------------------------------------- 13

5.5 Body Treatment ------------------------------------------------------------------------------------- 14

5.6 Post-Treatment Care ------------------------------------------------------------------------------- 16

5.7 Treatment Schedule --------------------------------------------------------------------------------- 16

6. MAINTENANCE -------------------------------------------------------------------------------------- 17

6.1 Cleaning the Device --------------------------------------------------------------------------------- 17

6.2 Troubleshooting ------------------------------------------------------------------------------------- 17

7. TECHNICAL SPECIFICATIONS -------------------------------------------------------------------18

8. INFUSION WARRANTY ---------------------------------------------------------------------------- 18

ENG

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1. Introduction

1.1

Electro-mesotherapy Technology - Overview

Viora’s Electro-mesotherapy technology was developed to effectively and safely deliver
therapeutic solutions through the skin’s outer layers to the dermis below. Based on the
Nobel Prize* winning principles of electroporation Elelctro-Mesotherapy creates temporary
passageways through the stratum corneum without puncturing the skin.

The Electro-mesotherapy Ionwave™ is Viora’s proprietary adjustable wave pulse specifically
developed for the Infusion™ device. Ionwave™ electrically enhances skin permeability and
cell absorption of healing solutions through a predetermined manipulation of parameters
including: current, pulse length, frequency and treatment duration.

Infusion™ Solutions
All natural, Infusion™ solutions are created from the purest, high quality clinically proven
ingredients. Each solution is a blend of special serums, proteins and healing agents and
is precisely formulated for a specific application. Using only the most sterile ingredients,
Infusion™ Ionic Solutions are hypoallergenic and non-irritating. Rich in vitamins and nutrients,
Viora’s Ionic Solutions nourish the skin and promote repairs from the inside out.

Infusion™ Electro-mesotherapy procedure

Electro-mesotherapy’s Ionwave™ breaks through the challenging stratum corneum
by creating micro channels in the cell membrane. Micro channels are opened when
the amount of current being applied exceeds the membranes ability to absorb it.
Through this mechanism, the Ionwave™ stimulates the structural rearrangement of the lipid
bilayer, consequently increasing the cell permeability and absorption of materials. These
channels are short-lived and reseal soon after the compounds are delivered.

* Awarded by The Royal Swedish Academy of Sciences, October 2003, winners Peter Agre and Roderick

MacKinnon. For further reading, visit: http://nobelprize.org/nobel_prizes/chemistry/laureates/2003/chemadv03.pdf

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Viora’s Ionic Solutions, together with Ionwave’s™ electro chemical manipulation of cell
channels, affect skin at the cellular level. Scientifically engineered to achieve the desired
effect, the interplay between these two modalities determines the penetrations depth and
ensures sufficient permeability.

To achieve optimal results, Infusion™ Electro-mesotherapy employs the combination of:

• Electroporation Ionwave™

• Infusion™ Ionic Solutions

ENG

1. When the Ionwave™ properties
come into contact with the cell, they
begin the structural rearrangement of
the lipid bilayer to form micro pores in
the cell membrane.

2. As the gatekeepers to the cell, micro
channels enable or restrict the passage
of soluble compounds. Micro channels
are short-lived and reseal soon after
compounds are delivered.

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1.2

Infusion™ Applications

You should expect visible improvements immediately following an Infusion™ treatment.
Most patients report that their skin feels firmer, more supple and looks radiant. Be aware,
however, that the degree of response is highly individual and the number of treatment
sessions required will vary from patient to patient. Results also depend on the clinical and
physiological condition of the skin at the start of the treatment course. Some patients will
respond better than others. Infusion™ can be used either alone or in combination with
other aesthetic treatments in a variety of clinical applications.

Infusion™ Face Care

• CollagenBoost for skin firming and tightening

• Anti-Wrinkle and Lifting for skin lifting and the reduction of wrinkles, fine lines

and crow’s feet

• Intensive Hydration for dry and mature skin

Infusion™ Body Care

• Body Lipoelim for body sculpting

• Skin Firm to replenish dry and sagging skin

• Anti-Stretch mark for damaged skin

1.3

Explanation of the Symbols Used in the System

Symbol Description

Attention: Consult Accompanying Document

Dispose of according to WEEE regulations

Fuse

Type BF Equipment

Manufacturer

Non-ionizing electromagnetic radiation

CE Compliance Symbol

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1.4

System Labels

1.5

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

• Operation mode – continuous

ENG

1.6

EMC - Electromagnetic Compatability

Table 1– Guidance and Manufacture’s declaration – ELECTROMAGNETIC EMISSIONS –
for all ME EQUIPMENT and ME SYSTEMS

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Guidance and manufacturer’s declaration – electromagnetic emissions

The Infusion is intended for use in the electromagnetic environment specified below.
The customer or the user of the Infusion should assure that it is used in such an
environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 1

RF emissions

CISPR 11

Harmonic emissions IEC

61000-3-2

Voltage fluctuations/ flicker
emissions IEC 61000-3-3

Class B

Class A The Infusion is suitable for use in all establishments

Complies

The Infusion uses RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in nearby

electronic equipment.

other than domestic and those directly connected
to the public low-voltage power supply network that
supplies buildings used for domestic purposes.

Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all
ME EQUIPMENT and ME SYSTEMS

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