I-Tech Mio-Sonic User Manual

I-Tech Mio-Sonic User Manual

Ultrasound
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USER MANUAL
MNPG71 Rev. 03 del 12/09/16
Ultrasound
Mio-Sonic
IACER Srl
1 di 24
MNPG71 Rev. 03 del 12/09/16

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Summary of Contents for I-Tech Mio-Sonic

  • Page 1 USER MANUAL MNPG71 Rev. 03 del 12/09/16 Ultrasound Mio-Sonic IACER Srl 1 di 24 MNPG71 Rev. 03 del 12/09/16...
  • Page 2 I.A.C.E.R. Srl 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. 03 del 12/09/16...
  • Page 3: Table Of Contents

    Summary Summary..................3 Introduction ................4 Warnings ................... 6 Contraindications ..............6 Side effects ................. 7 Accessories and device description .......... 7 Technical features ..............7 Labeling ..................8 Symbols description ..............9 Specifications ................9 Purpose ..................9 Kit contents ................10 How to use Mio Sonic ..............
  • Page 4: Introduction

    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 frequency and finally it reaches the ear. Sound frequency is measured in Hertz (Hz) and it is the number of oscillations (pressure variations) per second.
  • Page 5 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).
  • Page 6: Warnings

     Use of the device is prohibited close to flammable substances or in environments with high concentrations of oxygen.  Consult doctor before using Mio-Sonic with metallic osteosynthesis devices. Contrai ndications Use of the device is prohibited to persons with a pace-maker,...
  • Page 7: Side Effects

    Use of the device is prohibited 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.
  • Page 8: Labeling

    Radiant area 4 cm² ± 10% Type of ultrasound beam Collimated Ultrasound head (material) Aluminum Labeling Power/area ration Model: Mio-Sonic Type of Power supply: DC 15V/1.2A max RBN (Max): 5.0 Work frequency beam Acoustic frequency: 1.0 MHz Beam type: Collimated Maximum Waveform: pulsed Ie:1.6W/cm²...
  • Page 9: Symbols Description

    Symbols description Attention. Please read annex documents Product subject to WEEE regulations concerning separate waste collection of electronic equipment Class II equipment Applied part type BF Product in compliance with Directive 93/42/EEC 0476 (MDD) (and following modifications Dir. 2007/47/EC) Manufacturing date (month/year) S/N xxxxxx Serial number Specifications...
  • Page 10: Kit Contents

    Ultrasound therapy is also indicated for treatments in aesthetic field like for example in cellulite treatment, tissues regeneration, vascularization and lymphatic drainage. Please read chapter “How to use Mio-Sonic” to get all information about treatments, applications details programs.
  • Page 11: Analgesic And Decontracting Treatments

    right combination between the treated zone and the ultrasound head so finally the therapy efficacy. 3. Move the on ON/OFF switch on ON position: PWR led and L (low intensity) led will be switched on. 4. Put the ultrasound head on the area to be treated. 5.
  • Page 12: Beauty Treatments

    First we recommend a daily treatment of 10 minutes for a period of 21 days. If the pain persists we suggest a therapy interruption of 7 days and eventually you can start a new therapy cycle of 21 days. Patholgy Ultras.
  • Page 13 Cavitation applications 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.
  • Page 14 3MHz beam, characteristically more collimated but with lower tissue penetration. 1MHz beam, characteristically less collimated but with higher tissue penetration 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.
  • Page 15  local sanguine circulation stimulation  skin trophism improvement  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.
  • Page 16 Ankles and knees daily drainage Ankles and knees daily compact cellulite Ankles and knees flaccid daily cellulite Ankles and knees daily edematous cellulite Gluteus drainage daily Gluteus compact cellulite daily Gluteus flaccid cellulite daily Gluteus edematous daily cellulite Arms drainage daily Arms compact cellulite daily...
  • Page 17: Cleaning

    Carriage and storage Carriage precautions MIO-SONIC is a portable device, so it does not need any particular carriage precautions. However we recommend to put away MIO-SONIC and its accessories in their own bag after every treatment.
  • Page 18: Disposal

    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 int erferences and devi ce safet y The device doesn't produce and doesn't receive interferences from other equipments.
  • Page 19: Spare Parts

    Spare parts Contact the manufacturer or the national distributor for original spare parts at following address: I.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.
  • Page 20 Flicker emissions Complies used for domestic purposes. IEC 61000-3-3 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...
  • Page 21 3 A/m commercial or hospital EN 61000-4-8 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-...
  • Page 22 cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2 P from 150kHz to 80MHz d = 1,2 P from 80 MHz to 800 RF Radiata 3 Veff da 3 Veff da EN 61000-4- 80MHz a...

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