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I-Tech MIO-SONIC User Manual

Ultrasound therapy
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USER MANUAL
Ultrasound therapy
MIO-SONIC

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Summary of Contents for I-Tech MIO-SONIC

  • Page 1 USER MANUAL Ultrasound therapy MIO-SONIC...
  • Page 3 Index INDEX TECHNICAL INFORMATION ANUFACTURER ECLARATION OF CONFORMITY LASSIFICATION URPOSE AND SCOPE ECHNICAL FEATURES EVICE AND COMMANDS DESCRIPTION ABELLING Package content HOW TO USE NTRODUCTION TO THE TECHNOLOGY ONTRAINDICATIONS Side effects ARNINGS EVICE USE Antalgic and de-contracting treatments Beauty treatments DEVICE CARE AINTANCE ROUBLESHOOTING...

  • Page 4: Declaration Of Conformity

    I.A.C.E.R. S.r.l Via Enzo Ferrari, 2 – 30037 Scorzè (Ve), Italia herewith declares under its own responsibility, that the product MIO-SONIC UMDNS Code: 11248 has been designed and manufactured according to the European Medical Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further...

  • Page 5: Purpose And Scope

    Therapeutic and aesthetic Environmental intended use: Ambulatory The MIO-SONIC device for ultrasound therapy is ideal for the treatment of muscular and nervous pathologies and for the recovery of traumas, in case of both chronic and acute pathologies. In fact, ultrasound therapy is indicated for antalgic treatments and relaxation of contracted muscles, in the treatment of neuritis and sciatalgia, joint calcifications, tendinitis, hematomas and contractures.
  • Page 6 Characteristics Specifications Isolation (EN 60601-1) Applied part (EN 60601-1) Dimensions 202x490x700mm (length x height x depth) Weight 193g (power adapter not included) Functioning Continuous Maximum power 6.4W ± 20% (modulation duty cycle at 100%) Effective power 1.6W/cm² ± 20% (modulation duty cycle at 100%) Frequency range 1MHz ±...
  • Page 7 Device and commands description (1) Time indicator light (2) Time button (3) Power indicator light (4) Intensity indicator light (5) Mode button (6) Power switch (7) Ultrasound head (8) AC/DC adapter connector Labelling IACER Srl MNPG71-06...
  • Page 8 1m of depth and up to 30 minutes (only for the ultrasound head). Pay attention, Sign of danger Package content The MIO-SONIC package contains: n° 1 MIO-SONIC device; n° 1 medical power supply; n° 1 ultrasound gel;...
  • Page 9 How to use Introduction to the technology The sound is given by a body vibration whose oscillation propagates in the air with a certain frequency and reaches the human ear. The number of oscillations (or pressure variations) per second is called sound frequency, measurable in cycles per second, Hertz (Hz).
  • Page 10 circulation, which allows the dissipation of one part of the heat produced. After that there are also non thermal effects related to the propagation of ultrasonic waves: the mechanical effects are due to the strength applied by the sound waves on the cells that thus undergo micro-displacements towards areas with less pressure, getting into torsion and rotation phenomes, with consequent formation of small vortices in the interstitial fluids (streaming).
  • Page 11 Contraindications It is absolutely prohibited the use of MIO-SONIC in patients with severe arrythmia or has a pacemaker, with heart disease or severe cardiovascular problems, suffers from epilepsy, phlebitis in place, thrombophlebitis, in...
  • Page 12 • to use the device in the presence of patient monitoring equipment, of electrosurgical or shortwave or microwave therapy equipment or other equipment that sends electrical impulses into the body and in general in combination to other medical devices, since it could cause problems to the device;...

  • Page 13: Device Use

    • the environmental electrical installation to which MIO-SONIC is connected is compliant to the national laws; • the instructions for use contained in this manual are strictly followed. Should any foreign materials penetrate the device contact the retailer or manufacturer immediately. If dropped down, check that the housing is not cracked or damaged in any way;...
  • Page 14 device will enter in standby mode. If the warming feature is not needed, press both the MODE button and the TIME button simultaneously, in this way the device will go back to standby mode. When the device is in standby mode, the modulation duty cycle is defaulted at 5% and the (L) indicator light will be illuminated.
  • Page 15 ULTRASOUND HEAD STATIONARY IN ONE POINT DURING THE THERAPY. At the end of the therapy all the time lights indicator will shut off. Move the switch on the OFF button and unplug the device from its power supply. Clean the ultrasound head from the gel before storing the device and its accessories in the bag.
  • Page 16 Antalgic and de-contracting treatments For the details and suggestions about the treatable pathologies with ultrasound please refer to 1-2-3 pages of the PAIN ZONE AND TREATMENTS POINT card included in the manual. In the figures of the table are indicated in red color the pain areas, with blue color the treatment points (trigger points).
  • Page 17 Beauty treatments Cavitation and aesthetics In medical field, for dermatological diagnosis and applications, is used sound waves frequencies between 1 and 16MHz for both thermal antalgic effect who can produce, for both controlled cavitation to use to remove the kidney stone (shock wave lithotripsy), which are crushed right through the formation of micro-bubbles which imploding erode solid formations inside the kidneys.
  • Page 18 3MHz beam, typically more collimated but with less tissue penetration. Application The ultrasound head must evenly act on the treated zone, so as to evitate that in the untreated area remain substantial and unsightly adipose formations. IT MUST ALSO BE MAINTAINED IN A CONTINUOUS MOVEMENT TO PREVENT THE OVERHEATING OF THE TREATED AREA.
  • Page 19 • swimming for 20/30 minutes, in order to favorite the disposal of fat “became liquid”. Thanks to the effects that the product (thermal, chemical, mechanical, cavitation), ultrasounds are useful for their ability to: • stimolation of the local circulation system, •...
  • Page 20 N° app. Area Intensity Frequency Ankles and knees edematous Daily cellulite Gluteus drainage Daily Gluteus compact cellulite Daily Gluteus flaccid cellulite Daily Gluteus edematous cellulite Daily Arms drainage Daily Arms compact cellulite Daily Arms flaccid cellulite Daily Arms edematous cellulite Daily Abdomen drainage Daily...

  • Page 21: Transportation And Storage

    CLEANLINESS Switch off MIO-SONIC after each therapy session, as well as remove the cable by the specific connector. Clean the device from dust using a dry soft cloth. Resistant strains can be removed using a sponge soaked in solution of water and alcohol.

  • Page 22: Troubleshooting

    700 to 1060hPa Troubleshooting Any type of work on MIO-SONIC must be carried out exclusively by the manufacturer or by an authorized dealer. In any event, any presumed malfunction of MIO-SONIC must be verified before sending the device to the manufacturer.

  • Page 23: Warranty

    Disposal The MIO-SONIC device was designed and engineered to have minimal negative environmental impact, in consideration of its performance and safety requirements, following the disposition given by the European Directive 2012/19/EU, regarding the waste of electrical and electronic equipment. Rigorous standards were followed in order to minimize the amount of waste, use of toxic materials, noise, non-required radiation and energy consumption.
  • Page 24 entitled to the warranty assistance, the purchaser must enclose to the device a copy of the purchasing receipt, proving origin and purchasing date. For more information on the warranty please contact the distributor or vendor, in order to check the norm and standard in force in your Country, or ultimately the manufacturer IACER Srl.
  • Page 25 Electromagnetic interferences electromagnetic compatibility tables The MIO-SONIC equipment has been designed and manufactured according to the TECHNICAL STANDARD on ELECTROMAGNETIC COMPATIBILITY legislation EN 60601-1-2:2015 with the aim of providing adequate protection from harmful interference when installed in homes and health establishments.

  • Page 26: Compatibility Tables

    Il cliente o l’utilizzatore di MIO-SONIC deve garantire che esso venga usato in tale ambiente. The MIO-SONIC is intended for use in the electromagnetic environment specified below. The customer or the user of the MIO-SONIC should assure that it is used in such an environment. Ambiente elettromagnetico – Guida Prova di emissione Conformità...
  • Page 27 ALL EQUIPMENT AND SYSTEMS Il MIO-SONIC è previsto per funzionare nell’ambiente elettromagnetico sotto specificato. Il cliente o l’utilizzatore di MIO-SONIC deve garantire che esso venga usato in tale ambiente. The MIO-SONIC is intended for use in the electromagnetic environment specified below. The...
  • Page 28 ALL EQUIPMENT AND SYSTEMS Il MIO-SONIC è previsto per funzionare nell’ambiente elettromagnetico sotto specificato. Il cliente o l’utilizzatore di MIO-SONIC deve garantire che esso venga usato in tale ambiente. The MIO-SONIC is intended for use in the electromagnetic environment specified below. The...
  • Page 29 EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING Il MIO-SONIC è previsto per funzionare nell’ambiente elettromagnetico sotto specificato. Il cliente o l’utilizzatore del MIO-SONIC deve garantire che esso venga usato in tale ambiente. The device is intended for use in the electromagnetic environment specified below. The customer...
  • Page 30 Se l’intensità di campo misurata nel luogo in cui si usa un MIO-SONIC, supera il livello di conformità applicabile di cui sopra, si dovrebbe porre sotto osservazione il funzionamento normale del MIO-SONIC. Se si notano prestazioni anormali, possono essere necessarie misure aggiuntive come un diverso orientamento o posizione del MIO-SONIC.
  • Page 31 Recommended separation distances between portable and mobile RF communications equipment for MIO-SONIC that are not life-supporting Il MIO-SONIC è previsto per funzionare in un ambiente elettromagnetico in cui sono sotto controllo i disturbi irradiati RF. Il cliente o l’operatore del MIO-SONIC possono contribuire a...

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