Classification; Purpose And Scope - I-Tech MIO-CARE PRO Notice D'utilisation

Classification

The MIO-CARE PRO has the following classification:
class IIa (Directive 93/42/CEE, Annex IX, rule 9 and further
•
amendments);
• class II with BF type applied part (classif. EN 60601-1);
equipment protection level IP22 against liquid and dust penetration;
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equipment and accessories not subject to sterilization;
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• equipment unsuitable for use in presence of a flammable anesthetic
mixture containing air, oxygen and nitrous oxide;
equipment suitable for continuous operation;
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• equipment unsuitable for outdoors use.

Purpose and scope

Clinical intended use:
Environmental intended use:
MIO-CARE PRO is indicated for the treatment and the functional
rehabilitation of the following pathologies and anatomical zones:
wrist articulation;
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• hand articulation;
shoulder articulation;
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foot articulation;
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• ankle articulation;
• knee articulation;
skeletal motor apparatus;
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arthrosis;
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atrophies and muscular dystrophy;
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• bruises;
• sprains;
neuralgias;
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benign lesions and muscular tears;
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tendinitis.
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The MIO-CARE PRO 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 present manual. It is also
intended to be used by therapist, by personal trainer in a center or private
clinic and by health professional in aesthetic center.
IACER Srl
Therapeutic
Ambulatory and home
65 MNPG148-05