Classification; Purpose And Scope - I-Tech T-ONE REHAB Notice D'utilisation

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Classification

The T-ONE REHAB has the following classification:
class IIa (Directive 93/42/CEE, Annex IX, rule 9 and further
amendments/additions);
class II with BF type applied part (classif. 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:
T-ONE REHAB è studiato ed indicato per:
TENS therapy: pain relief treatments for the skeletal and muscular
system and for the articular system.
REHA: therapy: pain relief treatments for the skeletal and muscular
system and for the articular system.
DENERVATED-TRIANGULAR:
denervated muscles.
IONOPHORESIS: programs for localised administration of active
ingredients
WAVE: wave rehabilitation treatment used in physiotherapy
(interferential, Kotz, modulated Tens)
IPP (Induratio Penis Plastica) or Peyronie's disease treated with
iontophoresis
URO: pelvic floor rehabilitation treatment
NEMS: programs for professional and amateur sportive use
BEAUTY: body care and beauty programs
MEM: free memory in which you can set the TENS and NEMS
programs
The patient population intended for electrotherapy treatment using the T-
ONE REHAB device 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 home
treatment
and
86
rehabilitation
of
MNPG236-02

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