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Classification
The I-TECH PHYSIO 4/EMG has the following classification:
•
Class IIa (Directive 93/42/CEE, 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 IP20, against solid bodies greater than
•
12.5mm in diameter and liquids penetration.
•
Equipment unsuitable for use in presence of a flammable
anesthetic mixture with air or oxygen or with nitrous oxide;
Equipment suitable for continuous operation;
•
•
Equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use:
Environmental intended use:
The I-TECH PHYSIO electrotherapy medical device is available in 2 versions:
I-TECH PHYSIO 4 and I-TECH PHYSIO EMG. The two devices differ only for
the presence of the electromyographic module in the EMG version, by
which it is possible to obtain an indication of the pre, during and post
therapy of muscular activity. The EMG module should not be intended as a
medical device with diagnostic evaluations.
Both devices are equipped with medical programs suitable for muscle
rehabilitation in general, pain therapy (analgesic and muscular atrophy
programs) and functional recovery of muscles after trauma or an accident,
specific programs for ionophoresis, incontinence and the treatment of
denervated muscles, as well as non-medical programs for muscle cool-
down, muscle strengthening, beauty treatments (firming and drainage). It
is possible, therefore, to treat a wide range of both chronic and acute
pathologies.
Due to the number of pathologies, these devices are intended for use by a
professional therapist, a fitness coach at a public / private center or clinic,
or professional operators in general.
The patient population intended for electrotherapy treatment using the I-
TECH PHYSIO EMG and / or I-TECH PHYSIO 4 devices includes patients of
both sexes, men and women, of age unless otherwise indicated by medical
doctors. For further details, please refer to the Contraindications section.
IACER Srl
Therapeutic
Ambulatory and hospital
2
MNPG178
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