Viora Infusion User manual

Electro-Mesotherapy
The New Wave
Needle-Free
in
User Manual

2
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
•Before using the device, please check local regulations. If any local legislation
is violated, use cannot be authorized
Warning
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: [email protected]
Manufacturer's Authorized
Representative
Viora UK Ltd.
450 Bath Road, Longford
Heathrow UB7 0EB, UK
Tel: [phone]
Fax: [phone]

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ENG
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

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1. Introduction
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.
1.1
* 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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ENG
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
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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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
Explanation of the Symbols Used in the System
1.2
1.3
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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ENG
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
EMC - Electromagnetic Compatability
System Labels
1.4
1.5
1.6
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 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.
RF emissions
CISPR 11
Class B
Harmonic emissions IEC
61000-3-2
Class A The Infusion is suitable for use in all establishments
other than domestic and those directly connected
to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Complies
Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all
ME EQUIPMENT and ME SYSTEMS

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ENG
Guidance and manufacturer’s declaration – electromagnetic immunity
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.
IMMUNITY test IEC 60601 test level Compliance level Electromagnetic
environment –
guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
± 6 kV contact ± 8 kV air ± 6 kV contact ± 8
kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
Electrical fast transient/
burst IEC 61000-4-4
± 2 kV for power supply
lines ± 1 kV for input/
output lines
± 2 kV for power
supply lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge IEC 61000-4-5 ± 1 kV line(s) to line(s) ±
2 kV line(s) to earth
± 1 kV line(s) to
line(s) ± 2 kV line(s)
to earth
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines IEC
61000-4-11
<5 % UT
(>95 % dip in UT) for
0,5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in
UT) for 5 s
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT (60 % dip
in UT) for 5 cycles
70 % UT (30 % dip
in UT) for 25 cycles
<5 % UT (>95 % dip
in UT) for 5 s
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the Infusion
requires continued
operation during power
mains interruptions, it is
recommended that the
Infusion be powered from
an uninterruptible power
supply or a battery.
Power frequency (50/60
Hz) magnetic field IEC
61000-4-8
3 A/m 3 A/m Power frequency
magnetic fields should be
at levels characteristic of a
typical location in a typical
commercial or hospital
environment
NOTE: UT is the a.c. mains voltage prior to application of the test level.

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Table 4 – Guidance and Manufacture’s declaration – electromagnetic IMMUNITY – for ME
EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
N/A Table 3 – Guidance and Manufacture’s declaration – electromagnetic IMMUNITY – for
ME EQUIPMENT and ME SYSTEMS that are LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
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.
IMMUNITY test IEC 60601 TEST
LEVEL
Compliance
level
Electromagnetic
environment – guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC 61000-
4-3
3 Vrms 150 kHz to 80
MHz
3 V/m 80 MHz to 2,5
GHz
[3] V
[3] V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Infusion, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as deter-mined
by an electromagnetic site
survey, should be less than
the compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:

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ENG
Table 4 – Guidance and Manufacture’s declaration – electromagnetic IMMUNITY – for ME
EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
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
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
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Infusion is used
exceeds the applicable RF compliance level above, the Infusion should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Infusion. b Over the frequency range 150
kHz to 80 MHz, field strengths should be less than [V1] V/m.

12
Recommended separation distances between portable and mobile
RF communications equipment and the [ME EQUIPMENT or
ME SYSTEM]
The Infusion is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Infusion
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Infusion as recommended below, according to the maximum output power of the
communications equipment
Rated maximum
output power of
transmitter W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in 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.
N/A Table 7 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY
– for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS that are specified for use only in a
shielded location
N/A Table 8 – Guidance and MANUFACTURER’S declaration – electromagnetic 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.

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ENG
2. Safety Instructions
Infusion™ Applications
Be sure to read and understand all instructions before using the Infusion™ Electro-
mesotherapy system. Failure to follow the guidelines in this manual may result in personal
injuries or damage to your equipment.
Danger:
To avoid the risk of electric shock, short-circuiting, fire, burns or possible damage to the
system:
•Never remove the cover of this system unless specifically instructed by the
manufacturer or service provider.
•Never use damaged or worn power cords or plugs.
•Always plug this system directly into a suitable wall outlet. Do not use an
extension cord with this system.
•Not all power cords are the same. Should the power cord supplied with this
system need replacing, contact an authorized service provider immediately to
obtain a replacement.
•Never allow any metal objects, such as screws or paper clips, to fall into the
unit. Should any metal object accidentally fall into the unit, immediately turn
off the power and unplug the power cord. Contact an authorized service
provider for further instructions.
Caution:
To prevent malfunctions or equipment damage:
•Never bend or twist the power cord.
•Never pull on the power cord to remove the plug from the socket, always
2.1
Information regarding potential electromagnetic or other interference comply with the
IEC Standard 60601-1-2: 2004
IEC 60601-1-2: Medical electrical equipment
Part 1-2: Collateral Standard: Electromagnetic compatibility - Requirements and tests"
(2001 + A1:2004)
Other cables and accessories may affect EMC performance
Note
Warning

14
grasp the plug directly when unplugging your power cord.
•Never place heavy objects on the power cord, as this could result in damage
to the cord.
•Never place the equipment on top of or adjacent to a heating device.
•Always unplug the power cord during lightning storms to protect against
power surges that may damage the unit.
•Do not drop the unit or place it near the edge of the table. Should the unit
fall, become damaged or should you detect a strong odor or excessive heat,
immediately:
•Unplug the power cord and shut the unit off.
•Contact an authorized service provider for further instructions.
Patient and operator safety guidelines
To ensure safety and reliability, always use this system in accordance with the proper operating
and maintenance procedures. Viora assumes no liability whatsoever for any damage or injury
that may result from the misuse of this device. Always observe the following safety guidelines
when operating the Infusion™ Electro-mesotherapy system:
•Only a thoroughly trained professional should perform Infusion™ treatments.
•Prior to starting treatment, obtain a detailed patient history to verify that the
patient is eligible and does not have any contraindications to the treatment.
•Fully explain treatment protocols to the patient.
•Always turn the system off using the On/Off switch before connecting or
disconnecting.
•Clean and dry the hand pieces after every use.
Transport and storage conditions
The optimal transport and storage conditions of the system are:
•Ambient temperature: 5°C to 55°C.
•Relative humidity: from 35% to 80%, non condensing
•The packaging protects the Infusion™ system from breakage or damage
according to the company's packaging instruction.
•Atmospheric Pressure Range – 500hPa – 1060hPa
2.2

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ENG
3.1
The Infusion™ system weighs 5 kg (11 lbs). Use back safe lifting techniques.
Caution
3. System Installation
Unpacking the box
After unpacking the system, Viora recommends that you store the shipping box and the
internal Styrofoam covers and braces in the event that the system will have to be relocated
or replaced anytime in the future.
Unpack the system as follows:
•Carefully remove the packed contents from the box.
•Finish removing all the covers and braces from around the main unit.
•Compare the contents of the box to the equipment list (see Box Contents
section below) to ensure that all accessories are present.
•Lift the Infusion™ unit up and out of the bottom Styrofoam brace and
carefully set it on a table or counter.
Box Contents
Inside the box you should find the following components, if any parts are missing or damaged,
contact the manufacturer immediately.
•Infusion™ Electro-mesotherapy main unit
•1 Facial treatment hand piece
•1 Body treatment hand piece
•1 Power cord
•1 User Manual
•25 patient brochures
System Overview
The Infusion™ Electro-mesotherapy system consists of the following components:
•The main unit.
•Two treatment hand pieces: 1 for facial applications, 1 for body applications.
•The power cord
3.2
3.3

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5
8
8
6
7
4
3
2
1
1. Treatment intensity control
2. Body treatment selector
3. Treatment intensity display
4. Body treatment hand piece
5. Facial treatment hand piece
6. Start/Stop push button
7. Facial treatment selector
8. Hand piece connectors
4. Clinical Guide
Indications
The Infusion™ Electro-mesotherapy system, along with Viora’s solutions, is designed to
target a wide range of skin conditions including:
•Temporary reduction in the appearance of cellulite
•Temporary reduction of local fat
•Minimizing fine lines and wrinkles
•Skin rejuvenation
•Skin tightening for body and face
4.1
Equipment Setup
1. Plug in the hand piece connectors; when facing the device, the Face hand piece
should be plugged on the right side of the system and the body hand piece on the
left. Secure both hand pieces in place by turning the metal clasp tight.
2. Before turning the system on, ensure that the power voltage of your unit matches
your country’s voltage requirements.
3. Verify that the power cord is connected to the power connection on the system’s
rear panel and to a suitable wall power outlet.
4. Switch on the power button located at the back of the system.
5. Push the start button on the front.
If you experience difficulties with the system after installation, please refer to section 2
“Troubleshooting.”
3.4

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ENG
4.2 Contraindications
The following conditions are contraindicated with the Infusion™ treatment:
•Patients with pacemaker or internal defibrillator
•Metal or other implants in the treatment area
•Immune system disorders. Consult with a doctor
•Epilepsy
•Pregnancy
•Botox injection or another type of collagen injection treatment within the
last 15 days.
•Surgery of any type on the treatment area within the last 40 days
•Any chronic or active skin diseases such as eczema, psoriasis, sores and rash
•Herpes zoster
5.Treatment Protocol
Pre-Treatment Preparation
Patient History
•Complete or update the patient's medical and physical history.
•Exclude from treatment patients exhibiting any of the listed contraindications
of Section 4.2.
Establish Treatment Expectations and Explain Procedures
•Determine why the patient is seeking treatment and what their expectations
are.
•Set realistic treatment result expectations.
•Inform the patient about the treatment protocol, typical treatment results
and possible adverse effects and discomfort.
•Advise the patient that exfoliating with Pristine's™ microdermabrasion
treatment will maximize treatment results.
Develop Treatment Plan
•Determine the number of treatments and intervals.
•Schedule treatment sessions for 15-45 minutes, depending on the number
and size of areas to be treated.
5.1
5.1.1
5.1.2
5.1.3

18
Treatment Documentation
•Document treatment information and progress throughout the treatment plan.
•Follow the rest procedure guidelines provided with the treatment protocol.
•It is recommended that you take photographs and measure the treatment area:
•Before the first treatment session to establish a baseline
•After the first 2 sessions to document any progress
•Before the last treatment
•Before any maintenance session
Test Procedure
Treatment course should begin only after a test procedure has been performed successfully
and no adverse effects were recorded.
General Treatment Guidelines
Viora strongly recommends the use of sanitary gloves.
Immediately prior to treatment it is recommended to:
•Clean the skin with a hypoallergenic skin cleanser.
•Exfoliate skin with the Pristine™ microdermabrasion system.
•Confirm the desired treatment intensity level in the display panel (see section
5.3 for setting the optimal treatment intensity level).
Understanding Treatment Intensity Levels
Patient sensitivity to Electroporation is affected by a number of physiological attributes like
natural impedance and water content in the skin which vary between patients. Therefore,
comfort zones for each patient are highly individual and treatment intensity levels
must be set accordingly. As higher levels may return better results, it is recommended
that you aim for the highest treatment intensity your patient can comfortably tolerate.
To establish optimum treatment intensity for first time patients:
•Always begin with a treatment intensity level at or below 20%.
•Gradually adjust the treatment intensity level upwards until you establish the
optimal comfort zone for the patient.
5.2
5.3
Treatment may be stopped or paused anytime during the session by pressing
the stop pushbutton located at the front panel.
Note
5.1.4
5.1.5

19
ENG
•Ask for patient feedback during treatment. The patient should feel a tingly
sensation that is not overbearing.
•Treatment intensity settings may be moved up or down anytime during
treatment.
Facial Treatment
1. On the main menu display, select "Face".
2. Select treatment intensity level using the treatment intensity dial.
3. Open one ampoule of treatment solution and pour it into a small bowl. Apply the
solution to the treatment area
4. Press the 'Start' button to begin treatment.
5. Remove the face hand piece from the cradle and gently apply circular motions
working from the center of the face outwards (See illustrations A,B, and C).
6. Slowly increase power intensity according to the patient’s comfort level.
7. When treating the periorbital area, temporarily lower the intensity and continue
gentle circular motions, again gradually increasing the treatment intensity as patient
comfort indicates.
8. Clean and dry the hand piece before returning it to its holder (refer to Section 6.1.
Cleaning the Device).
9. When treating the neck area, use circular motions, working from the front center of
the neck outwards.
5.4
•Be cautious when using treatment intensity higher than 70% when treating
the face.
•Be cautious when using treatment intensity higher than 80% when treating
the body.
Caution
•The treatment intensity should be set according to the patient’s comfort level
and may be adjusted up or down anytime during treatment.
•Reduce the treatment intensity whenever working on the chin, neck or upper
lip areas, as they are generally more sensitive.
Note
This system does not automatically stop treatment and it is the operator's
sole responsibility to stop treatment.
Caution

20
Body Treatment
1. On the main menu display, select "Body".
2. Select treatment intensity level using the treatment intensity dial.
3. Open one ampoule of treatment solution and pour it out into a small bowl. Apply
the solution to the treatment area. Reapply the solution as necessary throughout the
treatment.
4. Press the 'Start' button to begin treatment.
5.5
A
B
C