IBRAMED SONOPEEL User manual

1st edition
(10/2009)
Ultrasonic Peeling
SONOPEEL
Operation Manual

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ATTENTION:
THIS INSTRUCTION MANUAL IS PART OF THE
SONOPEEL EQUIPMENT MANUFACTURED BY
IBRAMED.
WE ASK YOU TO READ THIS INSTRUCTION MANUAL
CAREFULLY BEFORE USING THE EQUIPMENT AND
ALWAYS MAKE REFERENCES TO IT WHENEVER
DIFFICULTIES ARISE. ALWAYS KEEP IT CLOSE TO
YOU.

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CONTENT
General care with the Equipment--------------------------------------------------------------5
Explanation of the used symbols---------------------------------------------------------------6
Preliminary observations------------------------------------------------------------------------8
Description of SONOPEEL-------------------------------------------------------------------9
SONOPEEL –Essential Performance--------------------------------------------------------9
SONOPEEL –Power Supply-----------------------------------------------------------------10
Ultrasonic Spatula ------------------------------------------------------------------------------11
Advantages of the Ultrasonic Peeling -------------------------------------------------------12
Expected effects---------------------------------------------------------------------------------12
Contraindications--------------------------------------------------------------------------------13
Ultrasonic Peeling-------------------------------------------------------------------------------14
Low Frequency Ultrasound--------------------------------------------------------------------14
Combined Therapy------------------------------------------------------------------------------15
Care and contraindications with the current use---------------------------------------------20
Suggested SONOPEEL protocols------------------------------------------------------------22
References----------------------------------------------------------------------------------------28
SONOPEEL –Controls, indicators and connections--------------------------------------30
Operating instructions--------------------------------------------------------------------------33
Electrodes –Recommendations---------------------------------------------------------------39
Environmental Protection----------------------------------------------------------------------40

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Equipment and its applicators cleansing-----------------------------------------------------40
Maintenance-------------------------------------------------------------------------------------40
Technical Support and Troubleshooting-----------------------------------------------------41
Warranty Term ---------------------------------------------------------------------------------42
Accessories accompanying SONOPEEL---------------------------------------------------44
Technical Features –SONOPEEL------------------------------------------------------------47
Electromagnetic Compatibility----------------------------------------------------------------49
The lightening symbol inside a triangle is a warning to the user of the
presence of "dangerous voltages" without insulation in the internal part
of the appliance which can be strong enough to pose the risk of electric
shock.
An exclamation mark inside a triangle alerts the user of important
operation instructions and maintenance (technical service) in the
instruction manual which follows the equipment.
ATENÇÃO: To prevent against electric shock, do not use the plug of
the appliance with an extension, or any other kind of socket unless the
terminal are fully inserted into it. Unplug the cable when the equipment
will not be used for a long time.
ATTENTION
RISK OF ELECTRIC SHOCK
DO NOT OPEN

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General Care with the Equipment:
SONOPEEL does not need special care to be installed. We suggest you some general
care:
Avoid places subjected to vibrations.
Install the equipment on a steady horizontal surface in a place with perfect
ventilation.
In case of built-in closet, make sure there is free circulation of air in the rear of the
equipment.
Do not put the equipment on carpets, cushions and other fluffy surfaces that may
obstruct ventilation.
Avoid humid, hot and dusty places.
Place the network cable so that it is free, away from places where people can step
on it and do not put any piece of furniture on it.
Do not insert objects into the holes and do not put containers with liquid on it.
Do not use volatile substances (benzene, alcohol, solvents in general) to clean the
cabinet as they may damage the finishing. Only use soft, dry and clean fabric.
For the disinfection of accessories that come in contact with the patient, use only
cotton moistened with chlorhexidine gluconate 0.2 (aqueous solution) then dry them
with paper

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Explanation of symbols used:
-ATTENTION! Check and observe exactly the instructions for use contained
in the operation manual.
- CLASS II Equipment. Equipment in which the protection against electric
shock is not based only on basic insulation, but also incorporates additional
safety precautions such as double or reinforced insulation and neither it has
resources for grounding protection, nor it depends on installation conditions.
-Equipment with applied BF type.
- Dangerous voltage (risk of electric shock).
IPX1 - Protected against dripping water.
- It indicates sensitivity to electrical discharge
-It indicates the starting of the action (START)
- It indicates: Off (no electric current)
- It indicates: Off (no electric current)
- It indicates: On (with electric current)

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08
V~ - Volts in alternating current
~ line - Electric network in alternating current
In the Shipping Box:
- FRAGILE: The content in this package is fragile and must be transported
carefully
- THIS SIDE UP: It indicates the correct position to transport the package.
-LIMITS OF TEMPERATURE: It indicates the temperature limits for
transportation and storage of the package.
-. KEEP AWAY FROM THE RAIN: The packaging must not be transported
under the rain.
- MAXIMUM STACKING: Maximum number of identical packing which can
be stacked one over the other. In this equipment, the limit is 5 units.
5ºC
50ºC

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Preliminary Observations:
SONOPEEL is an equipment to clean the skin, to remove the impurities and
the dead cells through the ultrasound peeling of celular stimulation and permeation of
actives by the combined therapy (ultrasound associated to therapeutic electric
currents). It utilizes the microcomputer technology, that is, it is controlled by
computers. It is a non invasive technique, with no systemic effects, it is not addicted
and it does not have any collateral effects. It consists of ultrasonic microvibration
applications on the skin in a pleasant, fast and effective way. It can be associated or
not with therapeutic electric currents.
Concerning the type and the degree of protection against electric shock,
SONOPEEL is a CLASS II device with BF applied part of safety and protection. It
must be operated only by qualified professionals belonging to the authorized medical,
physiotherapeutic and esthetic departments. The professional who has the license will
be responsible for the use and operation of the equipment. IBRAMED does not make
any representation referring to the federal, state or local laws and regulations which
can be applied to the use and operation of any electro medical equipment. It is not
foreseen the use of these units in locations where there is danger of explosion, such as
the departments of anesthesia, or in the presence of a flammable anesthetic mixture
with air, oxygen or nitrous oxide.
POTENCIAL ELECTROMAGNETIC INTERFERENCE: As far as the limits to
electromagnetic disturbance are considered, SONOPEEL is a medical electrical
equipment belonging to Group 1 Class A. The simultaneous connection of the patient
to SONOPEEL and to a high frequency surgical equipment may result in burning
either on the application place of application and possible damages to the equipment.
The short distance operation (1 meter, for example) of short wave or microwave
equipment can produce instability in the output of the device. To prevent
electromagnetic interference, we suggest a group of electric network for SONOPEEL
and another separate group for the shortwave or microwave equipment. We also
suggest that the patient, SONOPEEL and the connecting cables remain at least 3
meters away from the shortwave or microwave therapy devices.
Mobile or portable radiofrequency communication equipment, can cause interference
and affect the functioning of Sonopeel.

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Description of SONOPEEL:
SONOPEEL is a device that allows treatment in the medical, cosmetic and
esthetic fields; it has no systemic side effects and is not addictive. SONOPEEL is
controlled by computers and it was designed according to the current technical
standards for construction of medical equipment (NBR IEC 60601-1 and NBR IEC
60601-1-2).
ESSENCIAL PERFORMANCE: SONOPEEL is an equipment to clean the
skin, to remove the impurities and the dead cells through the ultrasound peeling which
also permits the simultaneous application of the combined therapy, that is, ultrasound
emission together with the electrical stimulation which can be microcurrent or micro
galvanic to favor the skin renewal and rebalancing or to permeate ionized actives.
It is an ultrasonic generator of 26,5 KHz frequency and of electrical currents
for the electrostimulation. The adequate intensity to the treatment depends on the
patient’s sensitivity and it must be according to the clinical purposes. SONOPEEL is
an equipment which stimulates the skin through ultrasonic peeling and should be
applied to the skin in a gentle, safe and enjoyable way. It promotes a deep and fast face
renewal.
The selection of functions and parameters is made through touch screen
keyboard and the all the information are presented on the liquid crystal display.
SONOPEEL has independent controls for the ultrasonic intensity and the
electrostimulation.
SONOPEEL provides the following modes of operation:
1. Peeling mode by ultrasound with continuous or pulsed emission 50% (tip of
the spatula).
2. Ultrasound mode with continuous or pulsed emission 50% (sonophoresis)
(back of the spatula):
Ultrasound + microcurrent (MENS);
Ultrasound + microgalvanic (GMES - positive or negative polarity).
4. Isolated therapy (only electrostimulation) (back of the spatula):
Electrostimulation only by microcurrent (MENS);
Electrostimulation only by microgalvanic (GMES –positive or negative
polarity).

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SONOPEEL –POWER SUPPLY
SONOPEEL single phase equipment which can be operated on voltages
ranging from 100-240 volts 50/60 Hz. The selection of the tension is
automatic , so there is no need to be worried with the local tension. The cable
to the power network is detachable. The equipment uses the plug network as a
resource to separate its circuits electrically in relation to the electrical network in all
poles. To change it, unplug the power outlet and with the help of a small
screwdriver, remove the protection cover, disconnect the fuse, substitute it
and put the cover back again.
Always use the fuses indicated by IBRAMED:
Use the 5.0A fuse for nominal current, operating voltage 250V~
and fast action model 20AG (breaking current of 50A).
SECURITY RISKS MAY OCCUR IF THE EQUIPMENT IS NOT PROPERLY
INSTALLED.
Notes:
1- There are dangerous voltages within the equipment. Never open the
equipment.
2- SONOPEEL does not need any kind of stabilizer. Never use power stabilizer.
Before connecting SONOEEL, be sure that:
The voltage and the frequency of the electrical network in the place where
the equipment will be installed are the same as described on the label of the
voltage and power network in the back of the equipment.
To prevent electrical shock, do not use the plug of the device with an
extension cable, or any other outlets, unless the terminals are fully inserted
into the receptacle.

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Cleaning and disinfection should always be made with the extension
cable unplugged.
The maintenance and the technical assistance of SONOPEEL should
always be made in an authorized service and only by qualified
technicians.
Ultrasonic espatula
The transducer, in a very simple language, is a device that transforms one type
of energy into another. The spatula transducer transforms electrical energy into
mechanical energy (acoustic). These devices use piezoelectric crystals, which, when
receive appropriate alternating current, generate ultrasound waves in the frequency
determined by the crystal.
The metallic part of Sonopeel ultrasonic spatula also acts as an electrode, i.e.,
it allows the passage of the currents produced by the equipment generator
(microcurrent MENS and microgalvanic GMES) and it can act as COMBINED
THERAPY with simultaneous emission of low frequency ultrasound + MENS or
simultaneous emission of low frequency ultrasound + GMES (negative or positive
polarity) or even it can act as COMBINED THERAPY emitting MENS or just GMES,
in this case, it is not necessary to increase the ultrasound intensity.
Figure 1. Spatula Transducer for ultrasonic peeling, ultrasound mode
(sonophoresis), combined therapy –ultrasound with microcurrent (MENS) or
ultrasound with microgalvanic (GMES) or isolated therapy with microcurrent (MENS)
or with microgalvanic (GMES).

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Figure 2. Spatula transducer for ultrasonic peeling in the exfoliation position for
exfoliation, sliding with the tip of the spatula at 45oangle.
Figure 3. Spatula transducer in the position for sonophoresis, combined therapy or
isolated therapy (slow and uniform sliding).
Advantages of the ultrasonic peeling
It is painless and it quickly cleans the skin.
It can be safely performed on sensitive or plentiful vascularized skin.
It emulsifies and removes sebum from the skin; it is effective for the treatment
of acne.
It helps in the treatment of hyper pigmentation spots.
It prepares the skin for esthetic procedures.
It increases the absorption capacity of the skin.

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It refreshes, renews and regenerates the skin remarkably.
It oxygenates and deeply hydrates the skin.
Excellent results are obtained when it is followed by ultrasound combined
therapy + MENS or ultrasound + GMES
Low operational cost.
It can be applied in all kinds of skin even the most delicate.
Expected results
It removes the impurities and the dead cells
It increases the permeability of the cellular membranes, allowing the
absorption of the therapeutic substances.
It activates the microcirculation.
It promotes drainage and tissue detoxification.
It improves the skin tonus.
It visibly enhances the efficacy of the cosmetic procedures.
It strengthens blood vessels, it stimulates tissue regeneration and it accelerates
the process of scar normalization.
It eliminates fine wrinkles and prevents its formation.
It lightens dark circles under eyes by improving the blood supply and the
lymphatic circulation.
It softens and hydrates the skin.
It gradually lightens the spots on the skin.
It helps in anti-cellulite procedures, if applied before these procedures it favors
the penetration of actives.
It has anti-inflammatory and anti-edemas effect.
Analgesia ano muscle relaxation.
Contraindications
Gravidic abdomen.
Eyeball.
Thrombophlebitis areas.
Cardiac areas.

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Implanted electronic device –it is recommended that a patient with an
implanted electronic device (pacemaker) is not subjected to ultrasound therapy
or combined therapy, unless a medical opinion has been previously given.
Reproductive organs.
Inflammations and/or acute infections.
Areas treated by radiotherapy.
Tumors.
Epilepsy.
Active acne.
1. ULTRASONIC PEELING
Peeling mode by ultrasound with continuous or pulsed emission 50%
Purpose of the treatment: deep cleaning.
Accessories used
a) Ultrasonic spatula (position of the spatula, vide figure 2).
(tip of the spatula).
General guidelines
The skin should previously be cleaned with cleansing solution.
Protect the eyes with gauze moisturized with physiological solution.
Constantly spray the skin with water.
Clean the spatula at regular intervals or whenever it is necessary.
2. LOW FREQUENCY ULTRASOUND (SONOPHORESIS)
Ultrasound mode with continuous or pulsed emission 50%
Purpose of the treatment: permeation of actives with low frequency ultrasound.
Accessories used

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a) Ultrasonic spatula (position of the spatula, vide figure 3).
General guidelines
This resource is usually applied after the ultrasonic peeling to favor the
permeation of the actives.
It can be used in the continuous mode where the mechanical effects are
associated with the thermal effects (heat production and vasodilation)
It can be used in the pulsed mode where there is a predominance of the
mechanical effects.
The sliding of the spatula should be slow and the skin should be kept moist.
3. COMBINED THERAPY
a) Low frequency ultrasound associated with the microcurrent (MENS)
For this kind of treatment the metallic part of SONOPEEL ultrasonic spatula, which
also acts as an electrode, is used together with the connecting cable for the closing of
the electric field, and the selection of the current in the liquid crystal display must be
MENS. This allows SONOPEEL to perform the Combined Therapy: ultrasound +
microcurrent (MENS).
Recent studies show that the ultrasound application increases the skin
permeability, i.e. it allows the delivery of drugs through the skin, a phenomenon
known as sonophoresis. Significant advances have been made in the sonophoresis
research in recent years, especially under low frequency conditions (20-100kHz),
being the cavitation considered the main effect which favors the active penetration into
the skin. SONOPEEL allows the use of ultrasound combined with the microcurrent in
order to favor the penetration of actives into the skin; it also promotes the increment of
tissue nutrition together with the physiological benefits offered by the microcurrent.
The microcurrent - MENS (Microcurrent Electrical Neuromuscular
Stimulation) is a modality of non-invasive therapy which uses low amperage current,
in microamperes (µA) with positive and negative polarity alternation every 3 seconds.
Its therapeutic effects are related to the increase of the cellular metabolism, the

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stimulus in the repair process and tissue regeneration, the local pH
normalization and the increase in the protein synthesis (collagen and elastin). It
promotes the revitalization and renewal of the skin. It is a sub-sensorial current, that is,
not active; it does not excite the peripheral innervations.
Expected effects of electric stimulation by microcurrent (MENS):
It increases the production of ATP up to 500%.
It stimulates the protein synthesis.
It increases in the capture of O2 in the treated areas.
It increases in the amino acid transport .
It promotes the membrane transport.
It restores the tissue bioelectricity.
Accessories used
a) Ultrasonic spatula
b) Cable for the closing of the electric field.
c) Conductive rubber electrodes
d) Neutral gel

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Figure 4. Ultrasound combined therapy + MENS. Ultrasonic spatula (back of the
spatula), connecting cable with banana pin end to connect the electrode, conductive
rubber electrode 5 x 3 cm to close the electric field and conductive neutral gel.
b) Ultrasound combined with the microgalvanic (GMES –positive or negative
polarity)
Therapeutic ultrasound is used to transfer the actives through the skin and the
cavitation seems to be the main effect which promotes the increase of permeability of
the cutaneous barrier.
In this modality of treatment the metallic part of SONOPEEL ultrasonic spatula
also acts as an electrode; it is used together with the connecting cable to the closing of
the electric field, and the option of current in the liquid crystal display should be
GMES. That allows SONOPEEL to perform Combined Therapy: ultrasound +
electrostimulation with the micropolarized current which can be (P+) or negative (P-)
according to the active to be ionized which should be informed by the manufacturer.
For that, it is necessary to close the electric field with the specific cable with
banana pin end coupled to the alligator pin adaptor, connected to an aluminum
plate/vegetal cloth electrode moisturized with water (dispersive). The dispersive
electrode should be placed next to the area of the treatment, and the polarity of the
active electrode (spatula) should be equal to the active which is intended to be ionized.
The microgalvanic current - GMES (Galvanic Microcurrent Electrical
Stimulation) of low intensity in microamperes (µA) can be indicated for ionizing the
polarized actives. After the ultrasound peeling and consequently the deep cleansing
and the dead cells removal of the corneal layers, the skin is able to the prevention and
the treatment of wrinkles and photoaging.
Iontophoresis or ionization, also called ionic transfer is the penetration of the
substances via transdermal (skin) in a conservative way, by means of polarized current
which drives the ionized substance by the unidirectional electric flow. Iontophoresis

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uses the principle of repulsion of equal charges, called “electro-repulsion of charges” ,
to transport the substance of the skin surface to deeper layers. The active incorporated
to the solution or gel (melange) should be polarized, i.e., should have a definite
charge, and be deposited under the active electrode, and both –the active electrode and
the melange –should have the same polarity.
Studies have been showing that both modalities of energy, low frequency
ultrasound (sonophoresis) and polarized current (iontophoresis) can have synergic
effects when applied simultaneously, maximizing the permeation of the actives in the
skin associated, of course, to the development of adequate formulations, to the
increase of the efficiency of the current, consequently, to the amplification of the
quantity of active released both in the skin and through it.
Accessories used
a) Ultrasonic spatula
b) Cables with banana pin end for alligator clip connection
c) Alligator clip adapter to fix the aluninum plate electrodes with vegetal cloth
d) Aluminum plate
e) Vegetal cloth

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Figure 5. Ultrasound combined therapy + GMES. Ultrasonic spatula (back of the
spatula), connecting cable with banana pin end for the alligator clip adapter, aluminum
plate electrode and vegetal cloth moistened with water to close the electric field
(dispersive). In this case, the intensity of the ultrasound must be increased according to
the therapeutic purposes.
4. ISOLATED THERAPY
It follows the same technical principles of SONOPEEL combined therapy
where the metal part of the ultrasonic spatula operates like an electrode and a
connecting cable fixed to an electrode to close the electric field. However, with
ISOLATED THERAPY, the ultrasound intensity should be zero, allowing the isolated
emission only with electrostimulation with MENS or with GMES, according to the
clinical purposes.

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Electrostimulation only through microcurrent (MENS)
Figure 6. Electrostimulation isolated by MENS. Ultrasonic spatula (back of the
spatula), connecting cable with banana pin end for the electrode, conductive rubber
electrode to close the electric field and conductive neutral gel. In this case , the
ultrasound intensity should be zero. The current intensity should be adjusted according
to the therapeutic purposes.