Classification; Purpose And Scope; Caratteristiche Tecniche - I-Tech MIO-PERISTIM Notice D'utilisation

Classification

The MIO-PERISTIM has the following classification:
class IIa (Directive 93/42/CEE, Annex IX, rule 9 and further
•
amendments);
• 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:
MIO-PERISTIM is a stimulator designed and engineered for the treatment of
pathologies affecting urogenital system, like urinary or faecal incontinence.
The treatment of incontinence is possible using protocols with specific
waveforms, frequency and impulse width of the stimulation. A probe (vaginal
probe for urinary incontinence in women, anal probe for faecal incontinence
both for men and women) transmits the impulses to pelvic floor muscles or to
sphincter, causing the contractions and strength recovery.
Thanks to its TENS protocols, MIO-PERISTIM is particularly suitable for pain
therapy. TENS impulses can reduce and, in many patients, eliminate the pain
generated from pathologies affecting muscles and tendons.
The patient population intended for electrotherapy treatment using the MIO-
PERISTIM 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.
The CE0068 mark is only for the medical programs (see the following
paragraphs related to the detailed description of the programs).

Caratteristiche tecniche

Characteristics
Power supply
IACER Srl
Therapeutic
Ambulatory and home
Specifications
Rechargeable batteries AAA Ni-MH 4.8V
800mAh
43 MNPG152-07