IBRAMED SONOPEEL, Operation Manual

Page 1: ...1st edition 10 2009 Ultrasonic Peeling SONOPEEL Operation Manual ...

Page 2: ...TION 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 ...

Page 3: ...L 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 Environm...

Page 4: ...t 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...

Page 5: ...ns 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...

Page 6: ... 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 Of...

Page 7: ...nsported 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 un...

Page 8: ...on 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 f...

Page 9: ... 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 s...

Page 10: ...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 Bef...

Page 11: ... 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 ...

Page 12: ...is 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 proce...

Page 13: ...t 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 ...

Page 14: ...ltrasound 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 int...

Page 15: ...l 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 ...

Page 16: ...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 spat...

Page 17: ...ich 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 t...

Page 18: ... 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 relea...

Page 19: ...se 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 all...

Page 20: ...n 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 ...

Page 21: ...ions to the use of the currents The precautions and contraindications to the MENS or GMES currents are not different from any other forms of electrostimulation current Some precautions must be taken Do not apply on undiagnosed pains it can motivate a more vigorous physical activity before a lesion is recovered or disguises a serious illness Implanted Electronic Device a patient with an implanted e...

Page 22: ...and remove the electrodes Do not place the electrodes on the mouth or neck muscle spasms can occur and cause airway blockage Aversion to the use of electrical stimulation Some people do not tolerate electrical stimulation These patients should probably be excluded from the treatment which uses this equipment Attention The electrical stimulation over the cardiac area may increase the risk of fibril...

Page 23: ...t has sometimes blackheads or acne Excessive sweating It may have redness and be irritable when subjected to aggressive treatments The inflammation of the tissues is the result of the excessive oxidation of fatty material 4 Mixed skin This is not a skin type but an alteration of the dry and oily areas The middle part forehead nose and chin is generally more oily due to the abundance of the active ...

Page 24: ...ous sliding on both pens or with a fixed pen in the muscular insertion with the approximation by a slow dragging of the movable pen The movement is from the center to the periphery and against the gravity 8th Remove all the gel and apply nourishing mask according to the skin type and to the manufacturer or apply green clay uniformly When it is dried remove with water or physiological solution 9th ...

Page 25: ...t according to the manufacturer and select the same polarity of the product P or P f With a pipette or dropper distribute the product on the area being treated g Press START and slide the back of the spatula slowly and gently across all the area if necessary sprinkle some physiological solution to facilitate the sliding and improve the permeation h Increase the current intensity close to 990µA sub...

Page 26: ...g for stretch marks optional accessory bought separately Select on the device a Combined therapy ON b Time from 20 to 30 min c Current type GMES place the dispersive electrode a single wire cable with alligator clip adapter and aluminum plate electrode with vegetal cloth moistened with water which is close to the treatment area d Polarity P e Intensity from 100 to 150 µA f Press START g With the n...

Page 27: ...o the skin conditions divide the time and work on hemi face c Press START and select the average intensity d Drag the tip of the spatula 45o slowly and with low pressure e 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...

Page 28: ...gh frequency 5 min Neurodyn Esthetic Ibramed 7th 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 Avoid sun exposure during the treatment The results can be potentialized with the application of LASERPULSE therapeutic laser 600 nm 4 a 6 J cm2 all over the treated area immediate...

Page 29: ...ion are linked to altered epidermal calcium levels The journal of investigative dermatology 2 5 1138 1144 2003 CLARKE G STENNER L The Therapeutic Use of Ultrasound Physiotherapy 62 6 185 190 1976 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 Iontophor...

Page 30: ...Manual de Operação SONOPEEL 1 a edição 10 2009 30 CONTROLS INDICATORS AND CONNECTIONS Figure 8 Upper view of SONOPEEL Figure 9 Front view of SONOPEEL ...

Page 31: ...Manual de Operação SONOPEEL 1 a edição 10 2009 31 Figure 10 Rear view of SONOPEEL Figure 11 Side view of SONOPEEL Figure 12 Lower view of SONOPEEL ...

Page 32: ...t or of GMES current microgalvanic 8 Luminous indicator yellow of the current channel MENS or GMES of the presence of an output current intensity for the patient Whenever the equipment is with intensity current this indicator will remain alight 9 UP and DOWN PEELING INTENSITY control keys emission intensity of ultrasound peeling There are three Steps of intensity Low Medium and High 10 Patient s c...

Page 33: ...dicated on a liquid crystal display Figure 14 The description and the necessary steps to operate the equipment are shown below Figure 14 Liquid crystal display of SONOPEEL Field destined to the selection of PEELING MODE by continuous or pulsed ultrasound 50 Field destined to enable the COMBINED THERAPY which allows the selection of the combined therapy ON turned on or OFF turned off Field destined...

Page 34: ...ent intensity in µA micro ampères for the current MENS and GMES Ranging from 0 to 990 µA steps of 10 µA 1st step Remove the equipment from the transport box and from the plastic bag protection Connect the detachable power supply cable 12 and connect the equipment into the local electrical network socket 2nd step To perform the ULTRASONIC PEELING or SONOPHORESIS or COMBINED THERAPY or ISOLATED THER...

Page 35: ...connected to the alligator clip adapter and fixed to the aluminum plate vegetal cloth electrode moistened with water which will be fixed to the patient or next to the treatment area The ACTIVE electrode will always be the spatula and the DISPERSIVE electrode will always be the alligator clip electrode To apply the isolated therapy follow the same procedure just select the ultrasound intensity to z...

Page 36: ...o functions START starting the treatment STOP stopping the treatment always press the center of this key Once the parameters and their values are respectively chosen as described in the previous paragraphs press the START key Note that the parameter selection cursor stops flashing now The programming will be in execution at this moment Now choose the ultrasound peeling intensity necessary for the ...

Page 37: ...uppose that in clinical practice or literature pulsed ULTRASONIC PEELING with application time of 15 minutes is suggested Turn on the equipment The default programming described in the preceding page will be executed Note the cursor flashing in the field CONT figure 17 Figure 17 Liquid crystal display ready for the selection of the desired parameters 1 Choosing the Pulsed mode for ultrasound peeli...

Page 38: ...es to prepare the patient and to place the electrodes are made before turning on and programming the device 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 The size area in cm of the el...

Page 39: ...ion of contact There is not any risk of harmful effects to the cells nor allergic or sensibility reactions Durability of silicone rubber electrodes Wear of the silicone electrodes due to utilization time is normal A worn electrode will lose the homogeneity of electrical current conduction giving the impression that the device is weak It can also have formation of electrical conduction points where...

Page 40: ... safety of the equipment only when the unit was used according to the usage instructions contained in the owner s manual where maintenance repairs and modifications have been made by the manufacturer or expressly authorized service centers and where the components which can cause safety and operation risks to the equipment have been replaced by original spare parts in case of damage If required IB...

Page 41: ...iod starts from the date of purchase to the first consumer purchaser even if the product is transferred to third parties The warranty will cover the replacement of component parts and labor to repair the defects whenever it is possible to determine the presence of a manufacturing defect 3 The customer service during the warranty period will be made exclusively at IBRAMED sale point by IBRAMED itse...

Page 42: ...e local to the installation of the device such as electric net masonry hydraulic network grounding system as well as well as their adaptations 6 The warranty does not cover pieces subjected to natural wear like control buttons control keys handles and moving parts panel adhesives ultrasound transducer ultrasonic spatula transducer pen for electrolifting spherical tip pen for microcurrent conductiv...

Page 43: ...s designed can significantly damage the performance of emissions and immunity Thus DO NOT USE accessories spatula transducer electrodes and cables of 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 an...

Page 44: ...PP Power Cable IEC 2 X 0 75 X 1500 MM 2 K 798 1 Kit Cable 114 For Sonopeel Black 1 via 1 5 mt 3 K 726 1 Kit peeling ultrasonic transducer Spatula 1 3 mt 4 P 060 1 Aluminum plate 5 E 115 1 Rubber conductive electrode 5cm x 3cm 6 G 066 1 Black alligator clip Cód GJ0705 7 B 013 1 Gel tube Cap 100 grames 8 B 064 1 Sapphire Line Bag 9 M 135 1 Ibramed Digital Operation Manual 10 C 053 1 Protection fuse ...

Page 45: ...ter time and use the metallic blade of the spatula may become rough If it happens the equipment should be sent to maintenance for the technical characteristics of the spatula may be changed Also avoid shocks and mechanical forces on the spatula If it happens the equipment should be sent to maintenance for the technical characteristics of the spatula may be changed OPTIONAL ACCESSORIES WHICH ADAPT ...

Page 46: ... Continuous Pulsed Pulse repetition frequency of 10 Hz Duty Factor 50 ULTRASONIC PEELING intensity Low Medium or High Pulse repetition frequency range FREQ at 50 of the MICROCURRENT maximum amplitude variable from 1 Hz to 500 Hz steps of 10 Hz MICROCURRENT wave form square wave with inversion of positive and negative polarity every 3 seconds MICROGALVANIC wave form continuous current MICROCURRENT ...

Page 47: ...EL 1 a edição 10 2009 47 Temperature for transportation and storage 5 to 50o C Work environment temperature 5 to 45o C uA microamperes Hz Hertz VA volt amperes Note The device and its features may change without previous notice ...

Page 48: ...lity and should be installed according to the instructions described in this instruction manual The short distance operation 1 meter for example of a therapy device for short waves or microwaves can produce instability in the output of the device Communication equipment for radio frequency mobile or portable can cause interference and affect the functioning of SONOPEEL We recommend you not to touc...

Page 49: ...Manual de Operação SONOPEEL 1 a edição 10 2009 49 ...

Page 50: ...IEC CISPR 11 IEC CISPR 11 Group 1 SONOPEEL uses RF energy only for its internal functions However its RF emissions are very low and it is unlikely to cause any interference in nearby electronic equipments RF Emissions NBR IEC CISPR 11 IEC CISPR 11 Class A SONOPEEL is suitable to be used in all kinds of places other than residential and which are not directly connected to the public distribution of...

Page 51: ...r 6 kV by contact 8 kV by air Floors should be wooden concrete or ceramic If floors are covered with synthetic material the relative humidity should be at least 30 Fast electric transitories pulse train Burst IEC 61000 4 4 2 kV in the feeding lines 1 kV in the input output lines 2 kV in the feeding lines 1 kV in the input output lines The quality of power supply should be that of a typical hospita...

Page 52: ...0 UT 60 of voltage drops in UT by 5 cycles 70 UT 30 of voltage drops in UT by 25 cycles 5 UT 95 of voltage drops in UT by 5 seconds The quality of power supply should be that of a typical commercial or hospital environment If the user s equipment requires continued operation during power failure it is recommended the equipment be powered by an uninterruptible power supply or a battery Magnetic fie...

Page 53: ...uipment of RF portable or mobile should not be used near any part of SONOPEEL including cables with separation distance smaller than the recommended calculated from the equation applicable to the transmitter frequency Recommended separation distance d 1 2 P d 0 35 P 80 MHz to 800 MHz d 0 7 P 800 MHz to 2 5 GHz Where P is the maximum nominal output of the transmitter in watts W according to the tra...

Page 54: ... used above the unit must be observed in order to check whether the operation is normal If an abnormal performance is observed additional procedures such as reorientation or replacement of the equipment may be necessary b Over the frequency range from 150 KHz to 80 MHz the field strength must be less than 10 V m Recommended separation distances between the communication equipment of RF portable an...

Page 55: ...ters m can be determined through the applicable equation to the frequency of the transmitter where P is the maximum nominal output power in watts W according to the transmitter manufacturer 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 a...