Vaginal probe with two electrodes and balloon: ideal for perineal reeducation by electrostimulation or EMG or manometric biofeedback

The vaginal probe with two circular electrodes and a central balloon is perfect for the treatment of incontinence through electrostimulation or EMG / Manometric biofeedback . It can be used both by the professional who deals with the rehabilitation of incontinence, and by the patient for home therapy.

How to use:

- For perineal electrostimulation: it must be used with a certified electromedical device, capable of generating symmetrical biphasic impulses (with zero mean value). The anatomical shape and the two circular electrodes, distal and proximal, spaced 40 mm apart, allow undifferentiated stimulation of all perineal muscles. An extended plastic ring defines the limit of insertion of the probe and separates the invasive part with a 2 mm banana termination. The electrical connection to the stimulation unit is obtained by means of 2 cables of about 20 m with a 2 mm banana-shaped termination.

- For EMG / Pressure biofeedback: as an alternative to electrostimulation, the probe can be used for intra-cavitary EMG biofeedback, detecting, through two electrodes, the muscle action potential generated by the perineal muscles during contraction. Electromyographic surface detection also generally requires a reference electrode. Therefore, it is necessary to place an adhesive electrode on the external skin surface, preferably at the level of a bony protrusion (example: iliac crest). The same probe can be used for pressure-related feedback (also at the same time as EMG detection) by detecting. Across the globe, the global pressure signal from the pelvic area, directly proportional to the force produced by the perineal muscles. In some cases, the use of manometric biofeedback through the VAG-2STFW probe, turns out to be simpler with respect to the
EMG biofeedback, as it is less influenced by factors of a hormonal nature in the vaginal mucosa.
Furthermore, manometric biofeedback does not provide another external ground electrode. The balloon is made of medical silicone. For pressure biofeedback, the
The probe must be used with devices prepared for manometric detections, using a standard Luer-lock pneumatic connection (ISO 594). The tube does not require any pre-inflation phase; the only precaution is to connect the probe to the device before inserting it into the genital cavity.

Wear position:

Suitable for bed therapy, its special constructive shape allows easy insertion and comfortable retention by the patient.

Technical characteristics:

- Code: RU / V2STFW

- Materials in contact with the patient: ABS + gold + silicone. The metallization is carried out using a nickel-free galvanized technique. Latex free.

- Invasiveness: vaginal hole for a maximum of 1 hour.

- Dimensions: ∅ min / max. 15/25 mm, Length 110 mm.

- Weight: 35g.

- Electrode surfaces: Upper 5.71 cm2 - Lower 13.59 cm2

- Available colors: Pink and Neutral

- Packaging: Delivered in individualized packaging (non-sterile) with warranty label and instructions for use.

- Cleaning and disinfection: with water and, if necessary, neutral soap. If necessary, disinfect with alcohol or rinse with water before use. DO NOT sterilize.

- Personal use: Can be used for 60 sessions for a single patient (cannot be used by more patients)

- Combined use: It must be used with an electromedical device (provided with CE marking) capable of distributing biphasic pulses with zero mean value and / or capable of
detect surface EMG signals from 0 to 300.0 µV and / or capable of detecting pressures from 0 to 300 cmH2O with pressure input in Luer-lock (ISO 594).

- Production quality control: In certified ISO9001-ISO13485 system.

- Environment of use and conservation: from +5 ° C to + 35 ° C with RH between 20% and 80%.

- CE marking: Class IIa device according to standard 5 An, IX 93/42 / CE - Marking, issued by IMQ (CE0051), according to An. II of Directive 93/42 / CEE.

- Registration in the Medical Devices Directory of the Ministry of Health: Progressive number assigned 1377112, CND: U070399

Contraindications:

- Bladder or vaginal infections

- Colorectal or genitourinary tumors

- Pregnancy

- Pacemaker carriers (consult with the
doctor who has prescribed the pacemaker)

- Reflux vesicoureteral

- Hypotonic bladder