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IACER Srl 

MNPG71-06 

Classification 

The MIO-SONIC has the following classification: 

 

class  IIa  (Directive  93/42/EEC,  Annex  IX,  rule  9,  10  and  further 
amendments); 

 

class II with BF type applied part (classification EN 60601-1); 

 

unprotected device, IPX0 protection degree based on penetration of 
liquids and dust. Degree of protection IPX7 is for the treatment head. 
DEVICE NOT SUITABLE FOR USE WITH IMMERSION; 

 

equipment and accessories not subject to sterilization; 

 

equipment unsuitable for use in presence of a flammable anesthetic 
mixture containing air, oxygen and nitrous oxide; 

 

equipment suitable for continuous operation; 

 

equipment unsuitable for outdoors use. 

Purpose and scope 

Clinical intended use:  

 

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. 
Very suitable also for applications in the aesthetic field, for the treatment of 
cellulite,  tissue  regeneration,  vascularization  and  lymphatic  drainage.  For 
details, treatable pathologies, specific methods of application and use of the 
programs, see the chapter dedicated to the use of the device. 
The population of patients for electrotherapeutic treatment 
using  the  MIO-SONIC  device  includes  patients  of  both  sexes,  men  and 
women, adults (unless otherwise indicated). For more details, please refer to 

Contraindications

 

Technical features 

Characteristics 

Specifications 

Power supply 

Medical  power  model  GJ24WA-1500120V 
Input: AC 100/240V, 50/60Hz 
Output: DC 15V, 1.2A 

Summary of Contents for Mio-Sonic

Page 1: ...USER MANUAL Ultrasound therapy MIO SONIC...

Page 2: ......

Page 3: ...ESCRIPTION 5 LABELLING 5 Package content 6 HOW TO USE 7 INTRODUCTION TO THE TECHNOLOGY 7 CONTRAINDICATIONS 9 Side effects 9 WARNINGS 9 DEVICE USE 11 Antalgic and de contracting treatments 14 Beauty tr...

Page 4: ...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 modifications integrations The product has been assigned to class IIa accord...

Page 5: ...s 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 treatme...

Page 6: ...lation 100Hz 10 Waveform Pulsed Modulation duty cycle L 5 M 50 H 100 Regolation intensity Adjustable on 3 steps L M H Ultrasound head 5 cm Effective radiant area 4 cm 20 Ultrasonic beam Collimated Hea...

Page 7: ...NPG71 06 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 connect...

Page 8: ...for the disposal of electronic waste Applied part type BF Class II device IPX7 Degree of protection from temporary immersion under water up to 1m of depth and up to 30 minutes only for the ultrasound...

Page 9: ...gy angiology and cardiology these technologies in fact exploit the return echo deriving from an ultrasonic beam which propagates inside the human body and which is slowed down in a different way depen...

Page 10: ...ts into formation of steam zones within the fluid The dissolved gasses within the fluid they aggregate as a result of the lowering of pressure realized by the ultrasound forming bubbles or cavity cont...

Page 11: ...s from epilepsy phlebitis in place thrombophlebitis in feverish state anxiety or serious illnesses vein thrombosis severe osteoporosis inflammation arteriopathies except in case of medical prescriptio...

Page 12: ...n environments with high concentrations of oxygen with aerosol therapy devices or in wet environments use of the device is prohibited in bathroom or shower areas or while showering bathing to use the...

Page 13: ...t immediately and consult the retailer or manufacturer Consult a doctor before using MIO SONIC with metallic osteosynthesis devices IF YOU HAVE ANY DOUBTS REGARDING THE DEVICE USE CONSULT YOUR DOCTOR...

Page 14: ...reated 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 ul...

Page 15: ...M for H intensity is recommended maximum attention in maintaining in continuous moving the ultrasound head The intensity L corresponds approx to 0 08W cm the intensity M approx to 0 80W cm and intens...

Page 16: ...ycle 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 d...

Page 17: ...ion of liquids and it is present in the adipose tissue especially arround the ankles the calves and it affects subjects with a good health and with a tonic musculature Flaccid is manifested in middle...

Page 18: ...will vary from 20 to 30 minutes This job can be performed at intervals of hours or days between an area and the adjacent one or in rapid sequence The use of lotions or gel containing active principles...

Page 19: ...nee gluteus arms abdomen with maximum ultrasound intensity at M Programs Area Intensity N app tot Frequency Thighs drainage M H 20 Daily Thighs compact cellulite M H 30 Daily Thighs flaccid cellulite...

Page 20: ...flaccid cellulite L M 20 Daily Arms edematous cellulite L M 20 Daily Abdomen drainage L M 20 Daily Abdomen compact cellulite L M 25 Daily Abdomen flaccid cellulite L M 30 Daily Abdomen edematous cell...

Page 21: ...e removed using a sponge soaked in solution of water and alcohol Device not subject to sterilization Note Never use solvents for cleaning Cleaning agents cause damage to the device Attention to the ne...

Page 22: ...erly Check the socket operation Network cable not correctly inserted in the registered connector Insert the plug and cable correctly into the device connector Network cable worn out and interrupted Re...

Page 23: ...for recycling of electrical and electronic equipment For further information on the obsolete equipment disposal please contact the dedicated disposal service or the shop in which the device was bough...

Page 24: ...paration or free substitution hand work included 5 Warranty is not applied to damages caused by negligence or use not compliant to the given instructions by intervention on the device from personnel n...

Page 25: ...es and health establishments According to operating principles the device does not generate significant radio frequency energy and is adequately immune to radiated electromagnetic fields under such co...

Page 26: ...o 1 Group 1 Il MIO SONIC utilizza energia RF solo per il suo funzionamento interno Perci le sue emissioni RF sono molto basse e verosimilmente non causano nessuna interferenza negli apparecchi elettro...

Page 27: ...should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Transitori treni elettrici veloci Electrical fast transient burst IEC...

Page 28: ...5 cicli cycles 5 UT 95 buco in dip in UT per for 5s 40 UT 60 buco in dip in UT per for 5 cicli cycles 70 UT 30 buco in dip in UT per for 25 cicli cycles 5 UT 95 buco in dip in UT per for 5s anche dura...

Page 29: ...espected calculated from the equation applicable to the frequency of the transmitter Distanza di separazione raccomandata Recommended separation distance RF condotta Conducted RF IEC 61000 4 6 3Veff d...

Page 30: ...essere previste teoricamente e con precisione Per valutare un ambiente elettromagnetico causato da trasmettitori RF fissi si dovrebbe considerare un indagine elettromagnetica del sito Se l intensit di...

Page 31: ...aximum output power of transmitter W Distanza di separazione alla frequenza del trasmettitore m Separation distance according to the frequency of the transmitter m 1 2 150 80 150 800 0 35 80 800 80 80...

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