USERMANUAL 8
Classification
TheMIO-CAREhas thefollowingclassification:
• classIIa(Directive93/42/EEC,Annex IX, rule 9,10and furtheramendments);
• classIIwithBFtypeappliedpart(classification EN 60601-1);
• equipmentprotection levelIP22against liquid and dustpenetration;
• equipmentandaccessoriesnotsubject tosterilization;
• equipment unsuitable for use in presence of a flammable anesthetic mixture containing air,
oxygen and nitrousoxide;
• equipmentsuitableforcontinuous operation;
• equipmentunsuitableforoutdoors use.
Purpose and scope
Clinicalintendeduse:Therapeutic
Environmentalintendeduse:Ambulatory andhome
The MIO-CARE electronic stimulator is a medical device specifically intended for domestic use
and is targeted to adults, who acquired the specific knowledge to use the device by reading the
presentmanual.Itisalsointendedtobeusedbytherapist,bypersonaltrainerinacenterorpriva-
teclinicandby healthprofessionalinaestheticcenter.
MIO-CAREisusedtoapplyelectricalmicroimpulseswhichcreateenergy;thisenergy, modulated
withdifferentparametersspecificfordifferentimpulses,cangivethepatientmanybenefitsfrom
pain relief to muscles relaxation, from muscles strengthening to drainage, from isotonic exerci-
sestohematomas’ treatment, tothe treatmentof the imperfectionsusingthe beautyprograms.
The patient population intended for electrotherapy treatment using the MIO-CARE device inclu-
des patients of both genders, men and women, of age (unless otherwise indicated by medical
doctors). For furtherdetails, please refertothe Contraindications section.
The CE0068 mark is only for the medical programs (see the following paragraphs related to the
detaileddescriptionofthe programs).
