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

following the certification procedure according to Annex II (excluding point 4) of
the Directive 93/42/EEC.
Martellago, 03/08/2020
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Place, date

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);
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• equipment protection level IP22 against liquid and dust penetration;
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;
equipment unsuitable for outdoors use.
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Purpose and scope

Clinical intended use:
Environmental intended use:
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 strengthening to drainage, from isotonic exercises to hematomas'
treatment, to the treatment of the imperfections using the beauty programs.
The patient population intended for electrotherapy treatment using the MIO-
CARE device includes patients of both genders, men and women, of age (unless
otherwise indicated by medical doctors). For further details, please refer to the
Contraindications section.
The CE0068 mark is only for the medical programs (see the following paragraphs
related to the detailed description of the programs).
IACER Srl
MASSIMO MARCON
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Legal Representative
Therapeutic
Ambulatory and home
65 MNPG95-05