I-Tech MIO-CARE Beauty, User Manual

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IACER Srl 62 MNPG95
Compliance of the concerned product with the Directive 93/42/EEC has
been assessed and certified by the Notified Body
0476 - Kiwa Cermet Italia S.p.a.
Via di Cadriano 23 – 40057 Cadriano di Granarolo (BO), Italia
Certificate no.: MED24021
following the certification procedure according to Annex II (excluding point
4) of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
Classification
The MIO-CARE 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);
•
equipment protection level IP22 against liquid and dust penetration;
•
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
Environmental intended use: Ambulatory and home
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 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.
MIO-CARE is used to apply electrical micro impulses which create energy; this
energy, modulated with different parameters specific for different impulses, can
give the patient many benefits from pain relief to muscles relaxation, from muscles
MASSIMO MARCON Martellago, 14/09/2018