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IBRAMED SONOPEEL Operation Manual

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

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Summary of Contents for IBRAMED SONOPEEL

  • Page 1 SONOPEEL Operation Manual Ultrasonic Peeling edition (10/2009)
  • Page 2 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. Manual de Operação - SONOPEEL edição (10/2009)

  • Page 3: Table Of Contents

    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 Manual de Operação - SONOPEEL edição (10/2009)
  • Page 4 Unplug the cable when the equipment will not be used for a long time. Manual de Operação - SONOPEEL edição (10/2009)

  • Page 5: General Care With The Equipment

    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.

  • Page 6: Explanation Of The Used Symbols

    - 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) Manual de Operação - SONOPEEL edição (10/2009)
  • Page 7 -. 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. Manual de Operação - SONOPEEL edição (10/2009)

  • Page 8: Preliminary Observations

    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.

  • Page 9: Description Of Sonopeel

    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).

  • Page 10: Sonopeel - Power Supply

    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.

  • Page 11: Ultrasonic Spatula

    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...

  • Page 12: Advantages Of The Ultrasonic Peeling

     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. Manual de Operação - SONOPEEL edição (10/2009)

  • Page 13: Contraindications

     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. Manual de Operação - SONOPEEL edição (10/2009)

  • Page 14: Ultrasonic Peeling

     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 Manual de Operação - SONOPEEL edição (10/2009)

  • Page 15: Combined Therapy

    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.
  • Page 16  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 Manual de Operação - SONOPEEL edição (10/2009)
  • Page 17 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.
  • Page 18 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 Manual de Operação - SONOPEEL edição (10/2009)
  • Page 19 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...
  • Page 20 In this case , the ultrasound intensity should be zero. The current intensity should be adjusted according to the therapeutic purposes. Manual de Operação - SONOPEEL edição (10/2009)
  • Page 21  Hearing devices: hearing devices should be removed during the session. If submitted to electrical stimulation, the devices can suffer damages or present irregularities of operation. Manual de Operação - SONOPEEL edição (10/2009)
  • Page 22 SONOPEEL SUGGESTED PROTOCOLS BASIC GUIDELINES  The results of the treatment with SONOPEEL are visible in the first session.  The ideal sequence of treatment is from 6 to 12 sessions, once a week.  The spatula should be cleaned with 2% chlorhexidine after each session.
  • Page 23 -The middle part (forehead, nose and chin) is generally more oily due to the abundance of the active sebaceous glands. -The drier areas are located around the eyes and on the face. SONOPEEL ULTRASONIC PEELING FOR DEVITALIZED SKIN HYDRATION/NUTRITION Sanitize the skin with cleanser SONOPEEL ultrasonic peeling a) Pulsed mode –...
  • Page 24 PROTOCOL FOR SKIN DEEP CLEANSING WITH SONOPEEL ULTRASONIC PEELING 1st Sanitize the skin with cleanser 2nd Emollience = emolient + ozone vapor from 5 to 10 min ( Dermosteam - Ibramed) 3rd SONOPEEL ultrasonic pelling a) Pulsed mode – PULS...
  • Page 25  The dermocosmetic serum should be water soluble and ionizable. The choice of the active principles must meet the necessities of the skin.  The treatment can extended to the neck avoiding the combined therapy or the currents on the thyroid gland. Manual de Operação - SONOPEEL edição (10/2009)
  • Page 26 SONOPEEL ULTRASONIC PEELING ASSOCIATED WITH PMES or GMES FOR THE STRETCH MARK TREATMENT Sanitize the skin with alcoholic chorexidina 0,5% 2nd SONOPEEL ultrasonic peeling Select the device a) Pulsed mode – PULS b) Combined therapy OFF c) Select the treatment time from 5 to 15 min (the time varies according to the...
  • Page 27 Moisten the skin with water constantly and clean the spatula whenever it is necessary 3rd Disinfection with high frequency (5 min) (Neurodyn Esthetic – Ibramed) Select on the device a) Combined therapy OFF b) Select the treatment time (5 a 10 min).

  • Page 28: References

    Movements from the center to the periphery against the gravity. Remove the gel and apply normalysing soothing lotion. Disinfection with high frequency (5 min) (Neurodyn Esthetic – Ibramed) Apply sunscreen according to the skin type  The treatment can be extended to the neck and décolleté avoiding the combined therapies or the currents over the thyroid glands.
  • Page 29 FRICK, A. Microcurrent Electrical Therapy Journal of Equine Veterinary Science 25(10), 418-422, 2005. HIKIMA, T.; OHSUMI, S.; SHIROUZU, K.; TOJO, K. Mechanisms of Synergistic Skin Penetration by Sonophoresis and Iontophoresis. Biological & Pharmaceutical Bulletin, 32 (5), 905-909, 2009. Manual de Operação - SONOPEEL edição (10/2009)
  • Page 30 CONTROLS, INDICATORS AND CONNECTIONS Figure 8. Upper view of SONOPEEL. Figure 9. Front view of SONOPEEL. Manual de Operação - SONOPEEL edição (10/2009)
  • Page 31 Figure 10. Rear view of SONOPEEL. Figure 11. Side view of SONOPEEL. Figure 12. Lower view of SONOPEEL. Manual de Operação - SONOPEEL edição (10/2009)
  • Page 32 11- Spatula transducer connection of ultrasound peeling. 12- Power cable connection to be connected to the local power supply line. 13- Fuse rack – (See chapter SONOPEEL – Electrical feed). 14- Characteristic board of line tension. Manual de Operação - SONOPEEL...

  • Page 33: Operating Instructions

    15- Tag with the characteristics of SONOPEEL. 16- General characteristics tag 17- Attention tag: Don’t open. Risk of electric shock. 18 – Spatula transducer accessory. OPERATING INSTRUCTIONS All the parameters are programmed by touch keyboard and indicated on a liquid crystal display (Figure 14).
  • Page 34 2nd step: To perform the ULTRASONIC PEELING or SONOPHORESIS or COMBINED THERAPY or ISOLATED THERAPY, connect the spatula transducer into the connection (11) located in the front part of SONOPEEL. The blue channel is for the connection of the ultrasound peeling spatula transducer and the fixation connector of the spatula handle has screws which must be fixed into the output connector.
  • Page 35 (5) will show the following messages for a couple of seconds (Figure 15). Figure 15. Liquid crystal display with the presentation messages. After this presentation, the display (5) will start its operation indicating the page “default” of the equipment programming (Figure 16). Manual de Operação - SONOPEEL edição (10/2009)
  • Page 36 START key is pressed, the equipment starts executing the parameters chosen by the operator. At this moment these UP/DOWN keys (orange colored) start the operation to increase or reduce the current intensity (MENS or GMES). Manual de Operação - SONOPEEL edição (10/2009)
  • Page 37 (Three “steps” – Low, Medium and High). As seen up to now, the panel of SONOPEEL is self-explanatory, just take a couple of minutes handling it to be familiar to the way of programming it.

  • Page 38: Electrodes - Recommendations

    ELECTRODES - RECOMMENDATIONS SONOPEEL makes the electric stimulation by microcurrent (MENS) and microgalvanic (GMES) possible. For this purpose we use special conductive rubber electrodes and aluminum/vegetal cloth plate electrodes which are provided with the equipment.

  • Page 39: Equipment And Its Applicators Cleansing

     After using the electrodes, clean them with running water. Always clean the electrodes before you keep them. APPLICATORS – BIOCOMPATIBILITY (ISO 10993-1): IBRAMED declares that the material used in the applicators (spatula transducer and electrodes) provided with the equipment do not cause allergic reactions and do not cause potential irritation on the skin.

  • Page 40: Maintenance

    SONOPEEL is an electronic equipment and contains heavy metal like lead. So, there are contamination risks to the environment associated with the elimination of this equipment and accessories at the end of their useful lives. SONOPEEL, its parts and accessories cannot be eliminated as city waste. Contact the local distributor to have information about rules and laws related to the elimination of electrical wastes, electronic equipments and their accessories.

  • Page 41: Warranty Term

    3) The customer service during the warranty period will be made exclusively at IBRAMED sale point, by IBRAMED itself or another one explicitly designated by the manufacturer through written authorization.
  • Page 42 The selling points are neither authorized to alter the conditions mentioned in this document nor take any commitment on behalf of IBRAMED Equipment: Serial number: ANVISA registration (M.S.): Manufacturing date:...

  • Page 43: Accessories Accompanying Sonopeel

    SONOPEEL equipment in other equipments or electro medical systems. The accessories described in these instructions for use are designed and manufactured by IBRAMED to be used only with SONOPEEL equipment. Remember: He use of cables, spatula transducer and other accessories different from the ones specified on this instruction manual can result in the increase of the emissions or reduction of the immunity of SONOPEEL equipment.
  • Page 44 List of accessories: spatula transducer, electrodes, cables and their lengths, designed with the SONOPEEL equipment to meet the requirements of electromagnetic compatibility (accessories 1 to 3) and list of the other accessories which do not affect the electromagnetic compatibility requirements (accessories 4 to 12).
  • Page 45 OPTIONAL ACCESSORIES WHICH ADAPT TO SONOPEEL SONOPEEL allows adaptation of optional accessories which can be purchased separately. Figure 20. Optional accessory: spherical tips pen for microcurrent (tonifying and renewing) Figure 21.
  • Page 46 SONOPEEL – Technical characteristics SONOPEEL is a CLASS II monophasic equipment with applied part type BF of security and protection, designed for continuous mode operation. Power: 100 - 240 volts 50/60 Hz. Input power - Consume (max.): 50 VA Duty frequency of the ultrasound spatula: 26,5 KHz (+/- 10%)
  • Page 47 Temperature for transportation and storage: 5 to 50 Work environment temperature: 5 to 45 uA = microamperes Hz = Hertz VA = volt amperes Note: The device and its features may change without previous notice. Manual de Operação - SONOPEEL edição (10/2009)

  • Page 48: Electromagnetic Compatibility

    Electromagnetic Compatibility: SONOPEEL was developed to meet the requirements of the IEC 60601-1-2 standard of electromagnetic compatibility. The purpose of this standard is:  To ensure that the level of spurious signals generated by the equipment and radiated to the environment are below the limits specified in the IEC CISPR 11, group 1, class A (Radiated emission).
  • Page 49 Manual de Operação - SONOPEEL edição (10/2009)
  • Page 50 Manufacturer’s guidelines and declaration – Electromagnetic emissions SONOPEEL is destined to be used in the electromagnetic environment specified below. The user of the equipment should ensure that it will be used in such an environment. Electromagnetic environment - Emission test...
  • Page 51 Manufacturer’s guidelines and declaration – electromagnetic immunity SONOPEEL is destined to be used in the electromagnetic environment specified below. The user of the equipment should ensure that it will be used in such an environment. Test level Electromagnetic Immunity test...
  • Page 52 (50/60 Hz) 3 A/m 3 A/m a typical location in a typical commercial IEC 61000-4-8 hospital environment. NOTA: U is the c.a. voltage before applying the test level. Manual de Operação - SONOPEEL edição (10/2009)
  • Page 53 Manufacturer’s guidelines and declaration – Electromagnetic immunity SONOPEEL is destined to be used in the electromagnetic environment specified below. The user of the equipment should ensure that it will be used in such an environment. Test level Electromagnetic Immunity test...
  • Page 54 Recommended separation distances between the communication equipment of RF portable and mobile and SONOPEEL SONOPEEL is destined to be used in electromagnetic environment in which RF disturbances are controlled. The user of the equipment can help to prevent the electromagnetic interference by maintaining the minimum distance between the...
  • Page 55 NOTE 1: From 80 MHz to 800 MHz, applies to the separation for the higher frequency range. NOTA 2: These guidelines may not be applicable in all situations. The electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Manual de Operação - SONOPEEL edição (10/2009)

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