Classification; Purpose And Scope - I-Tech MIO-CARE TENS Manual De Usuario

Compliance of the concerned product with the Directive 93/42/EEC has
been assessed and certified by the Notified Body
Via di Cadriano 23 – 40057 Cadriano di Granarolo (BO), Italia
following the certification procedure according to Annex II (excluding point
4) of the Directive 93/42/EEC.
Martellago, 14/09/2018
________________
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);
•
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:
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
IACER Srl
0476 - Kiwa Cermet Italia S.p.a.
Certificate no.: MED24021
62
MASSIMO MARCON
_____________________
Legal Representative
Therapeutic
Ambulatory and home
MNPG95