INCONTINENCE
The following programs are medical.
Mixed incontinence
TOTAL
Because of the presence of clinical programs, this product is a medical device. Therefore it is
certified by the CERMET Body n°. 0476 according to 93/42/CEE directive for medical devices.
The certification covers clinical applications.
Type
The urology programs require the use of specific endovaginal and endorectal electrode
probes, certified according to the Directive for Medical Devices 93/42/EEC. These are bipolar
probes with a 2-mm female adapter which attaches to 2-mm male cables.
Warnings
Urological electrostimulation is a medical application, which must be carried out under
medical supervision.
Use
To correctly use the probe electrode, follow the instructions provided by the manufacturer
and given by the physician.
Maintenance
For cleaning, sterilization and disinfection, refer to the manufacturer's instructions.
Suggestions
In case of deterioration of the probe electrode, replace it immediately.
THE DENERVATED PROGRAMS
The following programs are medical
Triangular (low denervation level)
Trapezoidal (intermediate denervation level)
Rectangular (high denervation level)
Total
The home user can use the denervated treatments only after consulting the specialist who will
prescribe the medications to use and give the indications for the type of currents to use.
The denervation level and the program to use are identified by the doctor using an electromyograph.
In absence of this sophisticated tool the doctor can use the empirical method, that is the treatment
starts with a triangular form (supposing that the denervation is partial) and in case of no muscular
response it changes to the trapezoidal form and then to the rectangular one.
Because of the presence of clinical programs, this product is a medical device. Therefore it is
certified by the CERMET Body n°. 0476 according to 93/42/CEE directive for medical devices. The
certification covers clinical applications.
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