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IACER Srl 

28 

MNPG71-06 

Guida e dichiarazione del costruttore 

 IMMUNITÀ ELETTROMAGNETICA 

 PER GLI 

APPARECCHI ED I SISTEMI CHE NON SONO DI SOSTENTAMENTO DI FUNZIONI VITALI 

Guidance and manufacturer’s declaration –

 ELECTROMAGNETIC IMMUNITY 

 FOR 

EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING

 

Il  MIO-

SONIC  è  previsto  per  funzionare  nell’ambiente  elettromagnetico  sott

o  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 
or the user of the device should assure that it is used in such an environment

.

 

(2)

 

Queste  linee  guida  potrebbero  non  applicarsi  in  tutte  le  situazioni.  La  propagazione 
elettromagnetica  è  influenzata 

dall’assorbimento  e  dalla  riflessione  di  strutture, 

oggetti e persone. 

Electromagnetic propagation is affected by absorption and reflection from structures, 
objects and people.

 

a)

 

Le intensità di campo per trasmettitori fissi come le stazioni base per radiotelefoni (cellulari 
e cordless) e radiomobili terrestri, apparecchi di radioamatori, trasmettitori radio in AM e 
FM  e  trasmettitori  TV  non  possono  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’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. 

 

Field strengths from fixed RF transmitters, such as base stations for radio (cellular/cordless) 
telephones  and  land  mobile  radios,  amateur  radio,  AM  and  FM  radio  broadcast  and  TV 
broadcast  cannot  be  predicted  theoretically  with  accuracy.  To  assess  the  electromagnetic 
environment  due  to  fixed  RF  transmitters,  an  electromagnetic  site  survey  should  be 
considered.  If  the  measured  field  strength  in  the  location  in  which  MIO-SONIC  is  used 
exceeds the applicable RF compliance level above, MIO-SONIC should be observed to verify 
normal  operation.  If  abnormal  performance  is  observed,  additional  measures  may  be 
necessary, such as re-orienting or relocating MIO-SONIC. 

b)

 

L’intensità  di  campo  nell’intervallo  di  frequenza  da  150kHz  a  80MHz  dovrebbe  essere 

minore di 3V/m.

 

 

Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. 

 

 

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...

Page 32: ......

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