mnpg71-00 _mio-sonic eng - I
Contents
1. ATTENTION the device is equipped with a right combination detector between the ultrasound head and patient skin in order to guarantee patient safety In case of wrong combination the treatment time led starts flashing ATTENTION it s important to keep in continuous movement ultrasound head on the treated area during the therapy with slow and circular or vertical at least of 7 8 cm movements It s forbidden to keep ultrasound head fixed in a point during the treatment Analgesic and decontracting treatments In the imagines pain zones are illustrated by the red color and trigger points by the blue color Make reference to the figures in the attached table PAIN ZONES AND TRIGGER POINTS in order to get details and suggestions about treatable pathologies Pain zones could be different from trigger points as it s illustrated in the figures First we recommend a daily treatment of 10 minutes for a period of 21 days If the pain persists we suggest a therapy interruption IACER Srl 11 di 24 MNPG71 Rev 00 del 20 06 11 MEDICAL DIVISION of 7 days and eventually you can start a new therapy cycle of 21 days Patholgy Ultras Frequency Intensity Headache L daily Face pain L daily Mononeuropathy L M daily Muscle pain M H daily Cervical Rizopathy L M daily Neuralgia M H daily Sciatalgy M H daily Knee pain M H daily Trapezius pain M H daily Lumbalgy M H d2. 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 determined 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 Ko IACER Srl 22 di 24 MNPG71 Rev 00 del 20 06 11 I A C E R S r l SU Sede operativa 30030 Martellago VE Via S Pertini 24 A Tel 39 041 5401356 Fax 39 041 5402684 Sede legale S Marco 2757 30124 Venezia Cod Fisc P IVA IT 00185480274 R E A VE N 120250 M VE001767 Cap Soc 110 000 00 i v www iacer ve it iacer iacer it
3. to put away MIO SONIC and its accessories in their own bag after every treatment Storage precautions Mio Sonic is protected till following environmental conditions Outside of the packaging temperature from 5 to 40 C humidity from 30 to 85 pressure from 800 to 1060 hPa Inside of the packaging temperature from 10 to 50 C humidity from 20 to 93 pressure from 700 to 1060 hPa IACER Srl 17 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION Disposal The equipment is subjected to WEEE regulations see the symbol on the label concerning separate waste collection when disposing this product please use the designed areas for disposing electronic waste or contact the manufacturer Electromagnetic interferences and device safety The device doesn t produce and doesn t receive interferences from other equipments However it s opportune to use the instrument keeping it at least at 3 meters from televisions monitors cellular telephones or any other electronic equipment The device is manufactured in compliance with EC 60601 1 2 2001 DIN VDE 0750 Part 1 2 The device is also in compliance with IEC EN 60601 1 IEC EN 60601 2 5 and IEC EN 60601 2 10 Assistance Every intervention on device must be performed by manufacturer or national distributor For any assistance intervention contact 1 A C E R S r l Via S Pertini 24 a 30030 Martellago VE Italy Tel 39 041 5401356 Fax 39 041 540268
4. 4 You can get any technical documentation on spare parts but only prior business authorization IACER Srl 18 di 24 MNPG71 Rev 00 del 20 06 11 I TEGU MEDICAL DIVISION Spare parts Contact the manufacturer or the national distributor for original spare parts at following address 1 A C E R S r l Via S Pertini 24 a 30030 Martellago VE Italy Tel 39 041 5401356 Fax 39 041 5402684 To preserve product warranty functionality and product safety we recommend to use only original spare parts Warranty Make reference to the national laws for any warranty conditions by contacting the national distributor or directly the manufacturer IACER I TECH logo is owned by I A C E R Srl and is registered IACER Srl 19 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION EMC Compliance Electromagnetic emission Emission Test Compliance Electromagnetic environment guidance Mio Sonic device uses RF Energy only for its internal function Therefore its RF RF Emissions Group 1 emission are very low and are Cispr 11 not likely to cause any interference in nearby electronic equipment RF Emissions Class B Mio Sonic device is suitable Cispr 11 for use in all establishments Harmonic Emissions Class A including domestic IEC 61000 3 2 Complies establishments and those directly connected to the public Voltage Fluctuations low voltage power supply Flicker emissions Compl
5. 9 6 W 20 peak value 4 8 W 20 medium Effective absorption 2 4 W cm 20 peak value 1 2 W cm 20 medium Ultrasound frequency 1MHz 10 Modulation waveform 100Hz 10 Waveform Pulsed Ultrasound intensity levels Adjustable on 3 levels L M H 20 30 50 duty cycle Ultrasound head dimensions 5 cm Radiant area 4 cm 10 Type of ultrasound beam Collimated Ultrasound head material Aluminum Labeling Model Mio Sonic Power supply DC 15V 1 2A om bos Rai a Power area ratio Acoustic frequency 1 0 MHz se gne N type Collimated Mm Type of beam Modulation shape 100 Hz IPK7 only for treatment head Waveform pulsed 4 Waveform IA C E R Srl Via S Pertini 24 a 30030 Martellago VE ITALY c m TEGO le2W e 4 Maximum Intensity pasew Maximum absorption Arg 4 0cm AE Radiant area Modulation Frequency 1MHz LOT MED1032WHJ09 1 4 0cm SN 11020001 IACER Srl 8 di 24 MNPG71 Rev 00 del 20 06 11 I TEGU MEDICAL DIVISION Symbols description A Attention Please read annex documents E Product subject to WEEE regulations concerning noi separate waste collection of electronic equipment Class Il equipment Applied part type BF C o476 Product in compliance with Directive 93 42 E
6. CAL DIVISION local sanguine circulation stimulation e skin trophism improvement e cell oxygenation Treatments Ultrasound treatments for drainage cellulite problems concern the following body areas Thigh Calfs Hips pads Ankles Knees Gluteus Arms Abdomen with M level as maximum ultrasound intensity Cellulite and drainage each treatment has to be done on a maximum area 20x20 cm size for 10 minutes Consequently a thigh complete treatment will depend on thigh dimension and it will last from 20 to 30 minutes PROGRAMS ZONE Intensity N Frequency appl Thighs drainage M H 20 daily Thighs compact cellulite M H 30 daily Thighs flaccid cellulite M H 40 daily Thighs edematous cellulite d E gally Calfs drainage M H 20 daily Calfs compact cellulite M H 25 daily Calfs flaccid cellulite M H 30 daily Calfs edematous cellulite H 30 daily Pads drainage M 20 daily Pads compact cellulite M 25 daily Pads flaccid cellulite M 30 daily Pads edematous cellulite M H 30 daily IACER Srl 15 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION Ankles and knees L H 15 daily drainage Ankles and knees compact cellulite zal 20 daily Ankles and knees flaccid L H 25 daily cellulite Ankles and knees edematous cellulite d i Sal Gluteus drainage M H 20 daily Gluteus compact cellulite M H 25 daily G
7. EC MDD and following modifications Dir 2007 47 EC ol Manufacturing date month year S N xxxxxx Serial number Specifications Mio Sonic has the following specifications e Class lla equipment Directive 93 42 CEE Annexed IX rule 9 and following modifications e Class Il applied part type BF Classif EN 60601 1 e Equipment not protected against liquid penetration IPX7 only for ultrasound head NOT INDICATED FOR IMMERSION TREATMENTS e Equipment and accessories not subjected to sterilization e Use of the equipment is prohibited close to flammable substances or in environments with high concentrations of oxygen or nitrogen protoxide e Continuous operating mode equipment e Equipment not suited to be used in external Purpose Clinical purpose Therapeutic and aesthetic Use Clinic and domestic use IACER Srl 9 di 24 MNPG71 Rev 00 del 20 06 11 O I TECH Mio Sonic is indicated for the treatment of muscular and nervous pathologies for traumas recovery and also for chronic and acute pathologies Ultrasound therapy is particularly indicated for analgesic treatment and for contracted muscle relaxation and in neuritis sciatalgy articular calcification tendinitis hematomas and contractures treatments Ultrasound therapy is also indicated for treatments in aesthetic field like for example in cellulite treatment tissues regeneration vascularization and lymphatic drainage Please r
8. I TECH MEDICAL DIVISION USER MANUAL MNPG71 Rev 00 del 20 06 11 Ultrasound Mio Sonic IACER Srl 1 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION I A C E R Srl SU Via S Pertini 24 A 30030 Martellago VE ITALY Tel 39 041 5401356 Fax 39 041 5402684 e mail iacer iacer it http www itechmedicaldivision com IACER Srl 2 di 24 MNPG71 Rev 00 del 20 06 11 I TEGU MEDICAL DIVISION Summary SUD aaa ran 3 INIFORUCHON p 4 Waninpeo aaa 6 Contraindications arnie 6 DIME ee E 7 Accessories and device description eese 7 Technical feat reS giacenti 7 Labicano 8 Symbols description rara 9 Specifications rana 9 PUL POSE oen e aen ao EXER RURAL TE aiar 9 Kit CONTERIS e 10 How to use MIO Sonic 10 Analgesic and decontracting treatMents iii 11 beautiful aaa 12 Ie atilitg ancien eco ori vo C v ER We REY D TTT 17 Carriage and storage siriana 17 Disposal odis cR eE ane R EERTE DIVER DUE NE 18 Electromagnetic interferences and device safety 18 ASSIST CE laine 18 Spare parten ei DH ORBI I MEI EXER PNE UAM 19 Eiche 19 IACER Srl 3 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION Introduction Mio Sonic is an innovative and advanced medical device for ultrasound treatment Thanks to its practicity it s ideal for home use The sound is given by a body vibration that expands in the air with a specific frequenc
9. aily Thigh pain M H daily Neck pain L M daily Shoulder pain L M daily Elbow pain L M daily Rheumatic pains L M daily Intercostal pains L M daily Menstrual pains L daily Phantom limb pain L M daily Hip pain M H daily Knee osteoarthritis pain M daily Beauty treatments Cavitation Cavitation is a physical fenomena that consists in the formation of vapor zones within a fluid The fluid dissolved gas forms vapor bubbles or cavities due to ultrasound pressure decrease Then vapor bubbles collapses because of movement in high pressure zones The delivered energy produces different reactions on the surrounding areas Cavitation applications IACER Srl 12 di 24 MNPG71 Rev 00 del 20 06 11 O I TECH Acoustic waves with frequency from 1 to 16 Mhz are used in medical field both for diagnosis and dermatoligic purposes In fact these waves produces a thermal and analgesic effect and also a cavitation effect than can be used for kidney stones removal litotrissia Microbubbles collapse destroys kidney stones and it pulverizes solid substances within the kidney Moreover cavitation effect is used in aesthetic medecine in order to decrease or eliminate adiposities This technique is called non surgical liposuction Cellulite is a deasese affecting the hypoderma that is a tissue under the dermal tissue and with an adipose nature The consequence is an increase of adipose cells volume like so hydric retention and liquids stasis in the inter cell s
10. chemical and cavitation effects Ultrasounds therapy is particularly indicated for locomotor apparatus a pathologies in order to obtain an Aeey analgesic effect in sciatic pain and pete neuritis in periarticular calcifications in Duplays disease in Dupuytren s Tah disease in hematomas and in heal se tissues in tendinitis in muscle contractures The ultrasounds can be used also in cellulite treatment by activating local circulation and by decreasing orange peel effect They promotes active substances penetration like essential oils liposolubil vitamins for example vitamin A and E and water soluble agents through skin by relaxing the tissues with great results in wrinkles treatment Ultrasounds result very efficacious in anti inflammatory process that re generate tissues in case of acne in fats movement for tissue metabolism promotion with positive effects also on vascularization and lymphatic drainage IACER Srl 5 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION Warnings eThe device doesn t produce or receive electromagnetic interferences from other devices However it s recommended to keep a distance of at least 3 meters from televisions monitor mobile phones or other electronic devices e The device must not be used in the presence of patient monitoring equipment eDo not use the device with electrosurgical or shortwave or microwave therapy equipment Use of the device
11. ead chapter How to use Mio Sonic to get all information about treatments applications details and programs Read and follow carefully user manual instructions for a secure and safe use of the device Kit contents Mio Sonic Medical Power Supply Ultrasound gel User manual Carriage bag How to use Mio Sonic Before and after using Mio Sonic clean and disinfect ultrasound head with a disinfectant solution Instructions 1 Connect the power supply plug to the device 2 Put a good quantity of ultrasound gel on the area to be treated The gel is an important factor in order to guarantee a right combination between the treated zone and the ultrasound head so finally the therapy efficacy IACER Srl 10 di 24 MNPG71 Rev 00 del 20 06 11 TECH 3 Move the on ON OFF switch on ON position PWR led and L low intensity led will be switched on 4 Putthe ultrasound head on the area to be treated 5 Select the intensity using the button MODE middle intensity led M and high intensity led H will light up sequentially 6 Select the treatment time using the button TIME 5 10 15 leds will light up sequentially and the device will start to work ATTENTION in ultrasound treatment we recommend an adjusted intensity equal to M If you use intensities equal to H pay attention to keep ultrasound head in continuous movement Intensity equal to L corresponds to 0 7 W cm M corresponds to 0 95 W cm and H corresponds to 1 2 W cm
12. etration Application Ultrasound head has to work in a uniform way on the area to be treated in order to avoid adipose anti aesthetic and solid masses on non treated areas Ultrasound head has to be in continuous movement in order to avoid treated zone overheating Ultrasound head has to be in continuous contact with the treated zone through a conductive gel better if its a gel with active ingredient We always recommend to treat a maximum area of 20cmX20cm size for 10 minutes afterwards treat an adjacent area in order to treat finally all interested area This kind of treatment can be done with hours or days intervals or consecutively between the different areas Cream or gel use with active ingredients promotes ultrasound action In fact ultrasound action promotes substances and active principles penetration into the tissues Phonophoresis As a consequence ultrasound effect will be amplified if you use a specific active principle Cavitation purpose is to transform adipose cells fat in a form which can be easily eliminated by lymphatic system After a cavitation treatment we heartily recommend to do optionally e awalk at a fast pace for 30 40 minutes e a pressotherapy treatment for 20 30 minutes e swimming for 20 30 minutes in order to promote liquid fat elimination Thanks to their effects thermal chimical mechanical cavitation ultrasounds are indicated for IACER Srl 14 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDI
13. ies network that supplies buildings IEC 61000 3 3 used for domestic purposes Electromagnetic immunity Mio Sonic is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Immunity Test EN 60601 1 2 Compliance Electromagnetic Test level Level environment guidance Floors should be wood Electrostatic concrete or ceramic tile Discharge ESD 6kV contact 6kV contact If floor are covered with EN 61000 4 2 8kV air 8kV air synthetic material the relative humidity should be at least 30 Mains power quality er aA Ai 2kV for power should be that l of a EN 61000 4 4 lines supply lines typical commercial or hospital environment Mains power quality Surge duds a See pE ihat oE ce EN 61000 4 5 made ade typical commercial or hospital environment IACER Srl 20 di 24 MNPG71 Rev 00 del 20 06 11 I TEGU MEDICAL DIVISION Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 596 Ur gt 95 dip in Ur For 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ut gt 95 dip in Ur for 5 seconds lt 5 Us gt 95 dip in Ur For 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec
14. is prohibited to persons known to be of unsound mind eUse of the device is prohibited in hyposensitive zones and on carotid sinus Avoid neck and mouth treatment eUse of the device is prohibited to persons temporarily disabled unless assisted by qualified personnel e g a doctor or therapist eUse of the device is prohibited in the presence of signs of deterioration of the device itself e Should any foreign matters penetrate the device contact the retailer or manufacturer immediately elf dropped check that the housing is not cracked or damaged in any way if so contact the retailer or manufacturer e Should you notice any changes in the device s performance during treatment interrupt the treatment immediately and consult the retailer or manufacturer patients being treated in a centre must also be informed of the event Use of the device is prohibited in combination with other medical devices Use of the device is prohibited close to flammable substances or in environments with high concentrations of oxygen eConsult a doctor before using Mio Sonic with metallic osteosynthesis devices Contraindications Use of the device is prohibited to persons with a pace maker cardiopathic subjects epileptics pregnant women anxious people or people suffering from heart disease phlebitis thrombophlebitis or serious illnesses IACER Srl 6 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION Use of the device is prohibi
15. luteus flaccid cellulite M H 30 daily Gluteus edematous cellulite m gally Arms drainage L M 15 daily Arms compact cellulite L M 20 daily Arms flaccid cellulite L M 20 daily Arms edematous cellulite L M 20 daily Abdomen drainage L M 20 daily Abdomen compact L M 25 daily cellulite Abdomen flaccid cellulite L M 30 daily Abdomen edematous cellulite Mi 20 caly Acne Pimples L 10 20 daily ATTENTION e Keep always in movement ultrasound head e Use a good dose of gel in order to guarantee the contact e Treat a maximum area 20x20cm size during a therapy session e If the area is bigger than 20x20 cm size do more treatments in succession on smaller zones e Treat in a uniforme way the interested area CONTRAINDICATIONS e Phlogosis e Neoplasia e Pregnancy IACER Srl 16 di 24 MNPG71 Rev 00 del 20 06 11 O I TECH e Metal materials near the treated area Heart area directly on the chest Persons with a pace maker Arteriopathies Serious osteoporosis Thrombophlebitis Near genital and eyes area Tumors Growing bones younger than 12 years old Vertebral column it s forbidden to treat area on spinal cord Cleaning Clean the equipment from the dust using a dry soft cloth Resistant stains can be removed using a sponge soaked in solution of water and alcohol Carriage and storage Carriage precautions MIO SONIC is a portable device so it does not need any particular carriage precautions However we recommend
16. onds Mains power quality should be that of a typical commercial or hospital environment If the user requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Mains frequency magnetic field EN 61000 4 8 3 A m 3 A m Mains frequency magnetic field should be that of a typical commercial or hospital environment r f Electromagnetic immunity Mio Sonic is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Immunity EN 60601 Compliance Electromagnetic environment Test 1 2 Level guidance Test level Conducted 3 Veff from 3 Veff from Portable and mobile RF RF 150kHz to 150kHz to communications equipment EN 61000 4 80MHz 80MHz should be used no closer to any 6 part oft he device including IACER Srl 21 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION RF Radiata EN 61000 4 3 3 Veff da 80MHz a 2 5GHz 3 Veff da 80MHz a 2 5GHz cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 AP from 150kHz to 80MHz d 1 2 VP from 80 MHz to 800 MHz d 2 3 VP from 800 MHz to 2 5 GHz where P is the maximum output power rating
17. paces There are three kinds of cellulite desease e Compact this type of cellulite causes an oedema that is a liquids concentration it appears in adipose tissue in particular near the ankles calfs thighs and it s present also in persons with good health conditions and with tonic muscles e Flaccid is found in middle age persons with hypo tonic muscles e Edematous is the progression of compact cellulite and it appears in presence of circulatory pathologies Cavitation and aesthetic Aesthetic cavitation consists in low frequency 0 03 3 MHz ultrasound waves application that generates vapor bubbles in adipose tissue These bubbles rapidly implode delivering energy that breaks up adipose cell and transform localised fat in a form which can be easily eliminated by lymphatic system and urinary way and with the help of a right drainage In aesthetic field 3 MHz ultrasounds has been used for years Recently new studies induce ultrasound devices manufacturers to decrease working frequencies since ultrasounds ability to penetrate in depth in tissues is in inverse proportion to the ultrasound beam frequency Nowadays the marketing offers 3MHz 1MHz till 0 03MHz ultrasound devices IACER Srl 13 di 24 MNPG71 Rev 00 del 20 06 11 I TEGR MEDICAL DIVISION M H 3MHz beam 3 Z characteristically more collimated but with lower tissue _ penetration rn 1MHz beam i characteristically less collimated but with higher tissue pen
18. particular between tissues with different acoustic impedance for example bone soft tissues and increases microcirculation The bloodstream helps to dissipate the increased heat There are also Not Thermal Effects in ultrasound waves propagation IACER Srl 4 di 24 MNPG71 Rev 00 del 20 06 11 Q I TECH The first are the Mechanical Effects caused by the ultrasound waves force on the cells that move toward low pressure zones As a consequence cells torsions and rotations with small vortexes happen in interstitial fluids streaming These pressure variations can provoke permeability alterations of cells membranes biochemical and biological effects In case of adipose cells pressure variations promotes complex molecules liberation as fats that are released in circulatory system and subsequently they are eliminated through lymphatic system and micro circulation Another aspect related to biochemical effect is the Phonophoresis a technique that introduces drugs in tissues through the ultrasounds A non thermal effect is the Cavitation In therapeutic field the ultrasounds are obtained in an artificial way In fact some mineral crystals are able to dilate and condense when they are subjected to electric field action Ultrasound irradiation creates some vibrations and a consequent intensive micro massage on tissues in depth and as a consequence heat is generated ultrasounds interaction with biological tissues has mechanical thermal
19. ted to persons persons suffering from serious cardiovascular problems tuberculosis vertebral column diseases malignant tumour neoplasia or with metallic prosthesis carriers different medical prescriptions excepted acute infections vein thrombosis serious osteoporosis arteriopathies inflammations and to persons younger than 12 years old In the event of injury muscle stress or any other health problem use the device only under medical supervision Avoid to position the device in a way that ultrasound beam hits the eye area or in presence of glands near uterus and abdomen or in thrombophlebitis and inflammation area Side effects With ultrasound therapy inflammation temporary increases can happen in treatment area and so pain temporary increase traumas due to more dosage nervous system reactions sanguine coagulation If this occurs suspend the treatment and consult a doctor Accessories and device description Treatment time led Treatment time selector Switching on led 4 Intensity indicator led Intensity selector ON OFF Ultrasound head Power supply connector Technical features Power supply 100 240VAC 50 60 Hz with MM1510 series power supply output 15VDC 1 Amp max IACER Srl 7 di 24 MNPG71 Rev 00 del 20 06 11 I TECH MEDICAL DIVISION Insulation class CEI EN II 60601 1 Applied part CEI EN 60601 1 BF Dimensions mm 200x50x70 Maximum absorption
20. y and finally it reaches the ear Sound frequency is measured in Hertz Hz and it is the number of oscillations pressure variations per second The human ear can nominally hear sounds in a range from 20 Hz to 20000 Hz Wavelength is the spatial period of the wave in a complete oscillation Ultrasounds are mechanical sound waves with frequencies higher than frequencies audible by the human ear Ultrasounds mechanical waves generated by piezoelectric elements are used in different industrial fields for years Thanks to the study of ultrasound waves in human application new diagnostic medical instrumentation has been built and they are widely used in gynecology gastroenterology hagiology and cardiology These instrumentations uses back echo resulting from ultrasound beam that spreads in the human body and it is decelerated in different ways by anatomic structures Each tissue has a specific acoustic impedance so ultrasound wave crossing through anatomic structures provokes different biological effects Thermal Effect is the first effect that has a pain killer function in orthopedics sport medicine and in aesthetic fields for cellulite and adipose tissue treatment How do ultrasound waves generate heat Ultrasound waves loss energy when they 7 cross through the tissues The delivered nc energy is given to the crossed anatomic sese structure Then energy to heat conversion musceto increases significantly local temperature naz
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