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Summary of Contents for I-Tech UT1032
- Page 1 USER MANUAL Ultrasound therapy model UT1032 MIO-SONIC...
- Page 2 Index INDEX XXXI 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 3 Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang 518108 Nanshan District, Shenzhen P.R. China herewith declares under its own responsibility, that the product Model: UT1032 Name: MIO-SONIC has been designed and manufactured according to the European Medical Device Directive 93/42/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 4 Annex II (excluding point 4) of the Directive 93/42/EEC. Classification From now on, for the sake of simplicity, in this user manual, reference will be made to the device MIO-SONIC meaning the device model UT1032, name MIO-SONIC. The MIO-SONIC has the following classification: •...
- Page 5 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 temperature Relative humidity From 30% to 75% Atmospheric From 800 to 1060hPa pressure Environmental From -10° to +50°C temperature Storage and transportation Relative humidity From 20% to 93% conditions Atmospheric From 700 to 1060hPa pressure Service life of the device: 2 years. Device and commands description (1) Time indicator light (2) Time button...
- Page 7 Labelling Symbols Description Importer’s logo Product CE certification released by Notified Body n°0197. Manufacturer Authorised representative. Importer. Manufacturing date Read instructions for use WEEE Directive for the disposal of electronic waste Applied part type BF MNPG549-00...
- Page 8 Symbols Description Class II device Degree of protection from temporary immersion under IPX7 water, up to 1m of depth and up to 30 minutes (only for the ultrasound head). Serial number Batch number Package content The MIO-SONIC package contains: n° 1 MIO-SONIC device; n°...
- 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 feverish state, anxiety or serious illnesses, vein thrombosis, severe osteoporosis, inflammation, arteriopathies (except in case of medical prescription).
- Page 12 • to use the device in presence of signs of deterioration of the device itself, cables and/or ultrasound head: please contact the dealer or IACER Srl following the instructions given in the paragraph Support. Control carefully the integrity of the device before each use; •...
- Page 13 Consult doctor before using MIO-SONIC with metallic osteosynthesis devices. IF YOU HAVE ANY DOUBTS REGARDING THE DEVICE USE CONSULT YOUR DOCTOR. Device use Clean and disinfect the ultrasound head with a disinfectant solution before and after the use. To utilize MIO-SONIC: Connect the power supply to the device.
- Page 14 Wash the area to be treated so that it is free of oil and dirt. Apply a generous layer of ultrasound transmission gel on the treatment area. The gel is fundamental to ensure a correct fit between the treated area and the ultrasound head and so the efficiency of the therapy.
- Page 15 Clean the ultrasound head from the gel before storing the device and its accessories in the bag. DO NOT IMMERSE THE DEVICE IN WATER! N.B. before storing the device and its accessories in the bag, disconnect the cables. If this does not do, the cables may take excessive folds near the connectors, that can cause a damage of the cables.
- Page 16 It is recommended to execute a daily cycle of therapy, with an average duration of 10 minutes each, for a maximum period of 21 days. In case the pain persists, stop for 7 days the treatment and eventually restart another therapy cycle of 21 days.
- Page 17 Device care Maintance If used following the instructions given in this user guide, the equipment does not require any particular kind of maintenance. It is recommended that IACER Srl carries out a functional test every 24 months. The manufacturer does not consider the MIO-SONIC device repairable by any not authorized personnel.
- Page 18 In operation temperature from +5 to + 40 °C relative humidity from 30 to 75% pressure from 800 to 1060hPa Inside the supplied carrying bag temperature from –10 to +50 °C relative humidity from 20 to 93% pressure from 700 to 1060hPa Troubleshooting Any type of work on MIO-SONIC must be carried out exclusively by the IACER Srl or by an authorized dealer.
- Page 19 PROBLEM POSSIBLE CAUSE SOLUTION a noticeable drop in Possible failure of the the effectiveness of device current generator the treatment. circuit. 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.
- Page 20 In the event of subsequent warranty intervention, the equipment must be packaged so as to avoid damage during transport and sent to IACER Srl together with all accessories. To be eligible for warranty work, the purchase must send the appliance with the receipt or invoice proving the correct origin of the product and the date of purchase.
- Page 21 Technical documentation related to repairable parts could be attached, but only after company authorization and only after having given adequate instruction to the intervention personnel. Spare part IACER Srl shall make available at any time the original spare parts for the equipment.
- Page 22 MIO-SONIC. All rights reserved MIO-SONIC and the logo property exclusively of I.A.C.E.R. Srl and registered. Edition: MNPG549-00 of the 30/04/2024 MNPG549-00...
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