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Inmanuuin184 User Manual Ep100 V.2019.04.01 Ing

This user manual provides instructions for the safe operation of the EP electroporation system. It describes the components, installation, operation, maintenance and cleaning of the device. The manual also outlines intended uses including facial and body applications, as well as safety warnings, contraindications and technical specifications. Proper reading of the manual is necessary for safe use of the EP system.

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Paulo Oliveira
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© © All Rights Reserved
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0% found this document useful (0 votes)
70 views13 pages

Inmanuuin184 User Manual Ep100 V.2019.04.01 Ing

This user manual provides instructions for the safe operation of the EP electroporation system. It describes the components, installation, operation, maintenance and cleaning of the device. The manual also outlines intended uses including facial and body applications, as well as safety warnings, contraindications and technical specifications. Proper reading of the manual is necessary for safe use of the EP system.

Uploaded by

Paulo Oliveira
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 13

USER MANUAL

EP
ELECTROPORATION

ABOUT THIS MANUAL


Version: 2019.04.01 Year: 2019 Language: English
All the rights to this manual are reserved, especially reproduction, publication and translation rights. No portion of this manual may be
reproduced by no means (photocopy, microfilm or other methods) without previous written authorization from ECLERIS. Neither can it
be reproduced, multiplied or published through any electronic data processing form.

The information contained in this manual may be modified or broaden without previous notification, without it representing any
responsibility to ECLERIS.

ECLERIS S.R.L.
FRANCISCO N. LAPRIDA 4955. VILLA
MARTELLI
(B1603ABK) BUENOS AIRES.
ARGENTINA
Tel/Fax: +54 11 48383200
Web: www.ecleris.com
E-Mail: [email protected]

Directora Técnica: Farm. Doris Inés Rasi


Sanchez, MN: 12.856
Autorizado por la ANMAT PM-1120-46
Condición de venta: “Venta exclusiva a
profesionales e instituciones sanitarias”.
USER MANUAL – EP

CONTENT
1. SYMBOLS................................................................................................................................ 3
2. SAFETY INFORMATION ......................................................................................................... 3
2.1 WARNINGS .......................................................................................................................... 3
2.2 CONTRAINDICATIONS ....................................................................................................... 4
3. DESCRIPTION......................................................................................................................... 4
3.1 INTRODUCTION .................................................................................................................. 4
3.1.1 ADVANTAGES .............................................................................................................. 6
3.2 INTENDED USE ................................................................................................................... 6
3.2.1 RECOMMENDED USES – FACIAL APPLICATION ...................................................... 6
3.2.2 RECOMMENDED USES – BODY APPLICATION ......................................................... 7
3.3 INTENDED USER ................................................................................................................ 7
3.4 COMPONENTS .................................................................................................................... 7
4. INSTALLATION........................................................................................................................ 8
4.1 REVISION ............................................................................................................................ 8
5. OPERATION ............................................................................................................................ 9
6. PROCEDURES ........................................................................................................................ 9
6.1 SUGGESTED PROCEDURE TO PERFORM WITH THE EP ELECTROPORATION
SYSTEM ....................................................................................................................................... 10
6.1.1 FACIAL APPLICATION ............................................................................................... 10
6.1.2 BODY APPLICATIONS ............................................................................................... 10
6.1.3 SUGGESTIONS .......................................................................................................... 10
7. MAINTENANCE ..................................................................................................................... 10
7.1 CLEANING ......................................................................................................................... 10
7.2 ELECTRICAL CONNECTIONS .......................................................................................... 11
7.3 FUSE CHANGE.................................................................................................................. 11
8. TECHNICAL SPECIFICATIONS ............................................................................................ 11
9. TROUBLESHOOTING ........................................................................................................... 12
10. TECHNICAL SERVICE....................................................................................................... 13
11. WARRANTY ....................................................................................................................... 13

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USER MANUAL – EP

1. SYMBOLS
Attention! Read the related
This side up
documentation
Manufacturer Identification
Alternate current (Name, Address)

Protect against water Applicable part B type

Date of manufacture
Fragile
(MM/AAAA)

Do not discard with the


Product code
household waste
Serial Number

2. SAFETY INFORMATION
This manual contains all the necessary information for the appropriate care and handling of the
equipment and accessories during their use.

Please, read this manual thoroughly before using the EP.

This symbol will be used in this manual to indicate information that includes warnings or
important precautions.

Should you have any doubt regarding the contents of this manual, the operation or equipment
safety, please contact your local distributor or the nearest ECLERIS office.

2.1 WARNINGS
It is important to read this manual thoroughly before using EP.

ECLERIS shall not be liable for the damages that may occur if the EP is not used accord-ing to
these instructions and following these criteria:

 Do not install the EP near heating sources such as stoves.


 Install the device on a firm and leveled surface, in a perfectly ventilated room.
 Avoid exposing the device and fittings to direct sunlight, dust, humidity, vibrations or
excessive impacts.
 Do not use volatile substances (benzine, alcohol, thinner or solvents in general) to clean
the EP, since they may damage it.
 Do not introduce objects in the holes or rest any containers with liquid over the
equipment.
 Prevent AC power cord from being walked over or placed under any piece of furniture.
 Do not use the device in case of electrical storms.
 Unplug the AC interlock cable when the EP is not being used.
 The EP is grounded through a conductor of the power supply cable. This essential
grounding is provided for a safe operation of the device.
 In case of interference with other electro medical or electrical equipment, widen the
distance between the EP and the other device in order to minimize these effects

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USER MANUAL – EP

 Do not open the EP. Maintenance and repairs shall be made by ECLERIS or authorized
companies. ECLERIS shall not be liable for the consequences of maintenance or repairs
made by unauthorized people.
 This instructions manual must be kept together with the equipment for future
consultations. Should the equipment be sold or donated, the manual shall go with it..

If as a consequence of:

 Inadequate use of the device


 No use of this manual
 Poor care and maintenance of the equipment
 Repair and manipulation by unauthorized personnel

…personal or material damage is produced to a third party, ECLERIS, the manufacturer and
sales agent of this equipment, will not assume responsibility for said damage.

2.2 CONTRAINDICATIONS
 Pacemaker.
 Defibrillator.
 Epilepsy.
 Pregnancy.
 Botulinum toxin: do not treat until 30 days have passed and never in the application area.
 Surgical intervention, not until 40 days have passed.
 Herpes zoster.
 Skins that were recently treated with other types of exfoliation.
 Highly sensitive skins.
 Extremely fine skins.
 Active acne.
 Uncontrolled diabetes.
 Eczemas.
 Dermatitis.
 Skin cancer.
 Viral injuries.
 Vascular injuries.
 Tattoos.

Small red marks or light erythema may appear during the procedure. They will disappear in a few
minutes. It is recommended not to exert pressure on the applicator in order to prevent their
appearance, especially on the face.

3. DESCRIPTION

3.1 INTRODUCTION
The EP was designed to perform esthetic procedures. It is a new solution for the transdermal
administration of macromolecules, revolutionizing iontophoresis. It constitutes an alternative to
the traditional way of administrating cosmetics.

Electroporation is a technique widely used to open channels in cell membranes that was recently
generalized to perform the same function on the skin. Electrical stimulation alters cell polarization
and causes the opening of bridges in the cellular membranes that favor substance penetration.

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USER MANUAL – EP

These electrical stimuli invert their polarity thus avoiding electrolysis and causing inter cellular
channel pulse-opening through which the applied substances may pass. This method was
defined as electroporation and it is considered a non-invasive alternative to mesotherapy.

The skin acts as a semi-permeable barrier avoiding direct substance penetration from the
exterior. The stratum corneum is the most resistant epidermic layer and the one that presents the
greatest impediment for external elements to penetrate the skin.

This particular layer has dielectric qualities (electric current insulation or barrier). When applying
electrical potentials to a dielectric, the capacitor effect generates accumulation of charges on both
sides of the dielectric element generating an electrical field through this insulation. If enough
charge is built up thus increasing the potential energy, the dielectric rupture point is reached. In
the case of the skin, this point causes cell realignment producing small channels and pores that
increase skin permeability.

When applying an alternating current the external cell layers are realigned, generating the
opening and modification of spaces through which the product-flow through the skin is enabled.

For example, if you have a brick wall and you wish to pass liquid through it, if all the bricks are
well fixed together there may be a little permeability but not much. If you find a way to move the
bricks, for example by rotating them, there will be spaces among these bricks that will increase
the possibility to pass substances through them. A similar phenomenon occurs at skin level, living
aside the difference in rigidity, etc.

By passing the dielectric barrier, electroporation causes a physical readjustment of skin cells. As
electroporation uses an alternating current (it permanently changes direction) a continuous
readjustment is achieved and new pores and channels are created while the current is active.

The electrical stimuli also alters the lipid inter cellular spaces causing molecular changes that
generate the appearance of ultra micro pores that as a whole increase cutaneous permeability.
Lipid molecules recover their structure when the stimulus stops.

Thanks to the combination of microdermabrasion and electroporation, there is a significant


increase of the non-specific permeability of the skin, favoring concentration gradients that allow
the passage of macromolecules as collagen, elastine, heparin, aminoacids, hyaluronic acid,
vitamins, etc. Substances penetrate without causing any pain, damage or unpleasant sensations.
It is not possible to administer these substances by other methods like iontophoresis or
ultrasound methods.

The type of stimulus used avoids the electrolysis of the substances to be transferred and does not
produce pH variations.

The EP has a body and a facial applicator that allow performing both types of procedures. It does
not require a return electrode or the application of conductive gel.

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3.1.1 ADVANTAGES
 Transdermal application of products.
 Introduction of ionic, non-ionic and lipid substances, including macromolecules, while
iontophoresis cannot introduce neutral substances and is limited to use the pores of oil and
sudoriferous glands and hair.
 Non-invasive, needle free.
 Painless.
 Non-ionizing and non-thermal waves.
 No electrical contact with the patient.
 No risk of chemical burns, muscle fasciculation, pain or swelling.
 No return electrode.
 No molecular ionization of the transferred substance.
 Reduces the necessary dose of the product applied.
 No alteration of skin pH.
 No systemic effects.
 No muscle stimulation.
 No contraindications for prosthesis.
 No conductive gel.
 Permanence of the achieved effect.

3.2 INTENDED USE


The EP ECLERIS was desgined to be used in aesthetic treatments in which macromolecules are
administered transdermally.

3.2.1 RECOMMENDED USES – FACIAL APPLICATION


 Face lifting – skin rejuvenation.
 Fatty neck and double chin.
 Photo aging prevention and treatment.
 Hyper-pigmentation.
 Acne and its scars.
 Moisturizing.
 Skin rejuvenation.
 Fine lines and wrinkles.
 Open pores.

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USER MANUAL – EP

 Oily skins.

3.2.2 RECOMMENDED USES – BODY APPLICATION


 Cellulite.
 Stretch marks.
 Localized adiposity.
 Body toning.
 Breast toning.
 Moisturizing.
 Liquid retention.
 Tired legs.
 Mesotherapy without needles.
 Pre-laser treatments for epilation/rejuvenation.
 Body shaping.
 Pre/Post surgical treatment of plastic surgeries.
 Collagen synthesis stimulation.

3.3 INTENDED USER


The EP ECLERIS was desgined to be used by health professionals with knowledge in the
technique of electroporation.

3.4 COMPONENTS
The EP includes the following necessary components. Please identify and check them before you
proceed with the installation.

 Main Unit
 Facial electroporation applicator
 Body electroporation applicator
 Acrylic applicators support
 AC Power cord
 User’s Manual
 EP Scalp applicator (OPTIONAL)

1. Display
2. Start / Stop EP
3. EP- Regulator
4. EP+ Regulator
5. Face Handpiece
Connector
6. Body Handpiece
Connector
7. Face Selector
8. Body Selector
9. Acrylic support

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USER MANUAL – EP

10. AC interlock power cord


connector with fuse holder
11. On/Off Switch

ELECTROPORATION APPLICATORS

1. Facial Electroporation Applicator


2. Body Electroporation Applicator

EP Scalp applicator

4. INSTALLATION
Experienced personnel are not required for the installation of the EP.

Thoroughly follow the instructions included in this section.

Open the acrylic support and place the EP on a flat surface.

Connect the facial applicator to the Face connector and the body one to the Body connector. If
the procedure only requires the use of one applicator, there is no need to connect the other one
for the correct functioning of the EP.

4.1 REVISION
Once installation is over and before starting-up the EP, please go through the following check list:

 Verify that the electrical network has its grounding connection in perfect conditions, and
that it makes perfect contact with the device.
 Check that the fuse holder has a fuse and that it is of the correct rating (T1AL250V for 110
and 220 V).
 Check applicators condition.

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USER MANUAL – EP

If before starting the EP you detect any abnormality, please contact the technical
department of your local distributor or the closest ECLERIS office, prior to its use.

5. OPERATION
This device is not intended to be operated by physically and mentally handicapped
people, child included.

Connect the AC interlock cable to the device and to the electrical network.

Turn on the device activating the ON/OFF switch.

The following messages will appear on the display when the equipment starts working:

1) If you wish to perform a body application, select the power level to be used with the + and
- commands.
2) If you wish to perform a facial application, select Face and the display will show the
following message:

3) Select the power level to be used with the + and - commands.


4) For starting a procedure apply the substance to transfer on the application area and press
EP Start/Stop. At this moment, the EP-Therapy message will blink indicating that the
device is delivering energy though the selected output (BODY or FACE)
5) Then perform circular movements on the applied product with the selected applicator until
its complete absorption.
6) Once the session is over, press EP Start/Stop. The message EP-Theraphy will stop
blinking and the EP will stop delivering energy.

6. PROCEDURES
The procedure depends on the experience and knowledge of the professional as well as the
objective to be reached.

If any abnormality is detected when using the equipment, please contact the technical
department of your local distributor or the closest ECLERIS office.

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USER MANUAL – EP

6.1 SUGGESTED PROCEDURE TO PERFORM WITH THE EP


ELECTROPORATION SYSTEM
6.1.1 FACIAL APPLICATION
1) Apply the substance to transfer.
2) Select EP Start/Stop.
3) Select Face.
4) With the + and – buttons adjust the power desired for the application. Start with 50%.
5) Perform circular movements on the applied product with the facial applicator until its
complete absorption. Increase the power while you advance with the procedure until you
reach 100%.

6.1.2 BODY APPLICATIONS


1) Apply the substance to transfer.
2) Select EP Start/Stop.
3) Select Body.
4) With the + and – buttons regulate the power desired for the application. Start with 50%.
5) Make sure all applicator electrodes are in contact with the treated area in order to avoid
discomfort sensations. Perform circular movements on the applied product with the body
applicator until its complete absorption. Increase the power while you advance with the
procedure until you reach 100%.

6.1.3 SUGGESTIONS
 Use low powers when you start the procedure and growlingly increase them.
 Total time of the procedure depends on the area to be treated, product penetration rate
and the desired quantity to be absorbed.
 After the procedure apply the moisturizing cream (preferably a hypoallergenic one) and
solar protection (SPF 15-30).
 Make-up can be immediately applied after the procedure although it not is recommended
for the first 24 hours.

7. MAINTENANCE
In order to keep your EP in optimum functioning conditions, perform the following procedures:

 Periodic cleaning of all exterior components.


 Cleaning of the applicators.
 Connections inspection.
 Annual technical inspection.

To perform any revision or maintenance work, contact your local distributor or the nearest
ECLERIS office.

7.1 CLEANING
Before cleaning the EP, disconnect the power supply cable from the electrical network.

EXTERNAL SURFACES:

Clean all external surfaces using a piece of cotton or clean cloth slightly moistened with mild
detergent or soap. Use only adequate products for the external cleaning of electrical equipments,
prepared in accordance with the manufacturer’s indications.

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USER MANUAL – EP

Perform all cleaning with special care, preventing water or humidity access to the
device.

Do not use detergents, solvents or any other abrasive agent.

Clean the external surfaces every 15 days.

ELECTROPORATION APPLICATOR:

Clean both applicators after each session.

Disconnect them from the EP before proceeding with their cleaning.

Cleaning shall be performed using a wet cloth or a piece of clean cotton slightly moistened with
alcohol in order to remove any possible remains of the applied products.

Do not use detergents, solvents or any other abrasive agent

7.2 ELECTRICAL CONNECTIONS


Constantly check the condition of all components and their aging process.

Verify that the following does not exist:

 Faulty condition, broken or cut cables.


 Faulty connections between cable and plug.
 Oxide corrosion in connectors.

7.3 FUSE CHANGE


To avoid loss of time and an inoperative EP, it is recommended to have a spare fuse.

1) Disconnect the power cord from the electrical network and equipment
2) Under the AC interlock cable connector there is a small rectangular plastic holder where
the fuses are located. With the help of a screwdriver and with slight pressure, remove the
lid.
3) Remove the burnt fuse, and replace it with the extra fuse that is located inside the same
plastic holder. Use T1AL250V for 110 V 220 V supply.
4) Place the fuse lid back, pushing it until a “click” is heard.
5) Connect the AC interlock cable.

8. TECHNICAL SPECIFICATIONS
POWER SUPPLY 100-240 VAC
Nº OF PHASES 1 (single-phased)
FREQUENCY 50 – 60 Hz
CLASS I
TYPE B
PRTECTION LEVEL AGAINST WATER
IPX0
ENTRANCE
CONSUMPTION 12 W
FUSES T1AL250V
APPLICATORS Body and Facial

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USER MANUAL – EP

DIMENSIONS 285 x 190 x 75 mm


WEIGHT 1.56 Kg
10 – 40 ºC
OPERATING CONDITIONS 35 – 75 % relative humidity
700 – 1060 HPa
-30 – 50 ºC
STORAGE AND TRANSPORTATION
10 – 95 % relative humidity
CONDITIONS
500 – 1060 HPa

9. TROUBLESHOOTING
The following table indicates the most common problems and their quick solutions. Please consult
this table for any difficulty you may find.

PROBLEM PROBABLE CAUSE ACTION


It is not connected to the local Connect the power cord to the
electrical network electrical network

The AC power cord is broken or cut Change the power cord


The EP does not
start
Power cord is not in good condition Change the power cord

The fuse is broken or burnt out Change fuse

On/Off switch green Contact the technical department


light turns on but the Internal fuse burnt or defective board of your local distributor or the
display doesn’t nearest ECLERIS office

FACE output is selected or Select the BODY output Check


programmed level is low BODY Level
Connect BODY applicator to the
BODY output is not
FACE output. If you have energy
working
replace the applicator. If not,
Defective BODY applicator
Contact the technical department
of your local distributor or the
nearest ECLERIS office
BODY output is selected or Select the BODY output Check
programmed level is low BODY Level.
Connect FACE applicator to the
FACE output is not
BODY output. If you have energy
working
replace the applicator. If not,
Defective FACE applicator
Contact the technical department
of your local distributor or the
nearest ECLERIS office

If you are unable to fix the problem, please contact your local distributor or the closest ECLERIS
office and request technical service.

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USER MANUAL – EP

10. TECHNICAL SERVICE


The EP must be repaired and/or maintained exclusively by authorized ECLERIS technical services.
ECLERIS recommends using the following procedures for a quicker repair service and
replacement of guaranteed products.

1) Contact the technical department of your local distributor or the nearest ECLERIS office.
2) Give detailed information of the problem.
3) If the problem cannot be solved by troubleshooting, the product must be sent for its repair
or replacement.

The following product information must be attached:

 Owner’s name.
 Owner’s address.
 Contact name and phone number.
 Product’s serial number
 Problem’s description

Send the EP for repair or replacement. The EP must be sent in its original packing so that it is not
damaged during transportation. ECLERIS is not responsible for damages, which may occur during
transportation, caused by deficient packaging.

11. WARRANTY
ECLERIS states that EP has complied with the required quality control verification and has no
manufacturing defects. This guarantees the appropriate functioning under adequate use in
agreement with the indications of this manual. The warranty period is for one (1) year as from the
date of purchase.

ECLERIS shall not be liable for any damage caused to/by EP due to incorrect use, negligence,
cleaning or incorrect storage. Any repairs made by personnel not authorized by ECLERIS will void
the warranty. The described warranty is exclusively valid for the original buyer.

The following parts are excluded from the warranty:

 Parts and components manufactured by third parties.


 Cables and plugs.
 Damages resulting from connections to inadequate power supplies.

Disregarding the warranty situation, all shipment from and to the technical service facilities
authorized by ECLERIS is the sole responsibility of the client.

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