Therapeutic unit for perineal Electrostimulation,
Biofeedback (Pressure), Evoked stimulation
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• Supply: - Internal 4,5 V by 3 Alkaline batteries 1,5V type AAA (LR03) . Battery life of about 20 hours (depends on use).
• Class of electrical safety – Internal supply according to CEI 62-5 (IEC 60601-1 3a edition).
• Output current: - Biphasic symmetrical pulses or biphasic alternating pulses. Max. 99 mApp on a normalised load of 1000 ohm;
• Energy per twin pulse: 2,5 mJ max.
• DC component at the output: max. 4 mVrms
• Connection to the applied part: 1 bipolar cable with terminals (RED / BLACK) with 2 mm plug protected + 1 Luer-lock termination tube.
• Biofeedback pressure range: from 2 to 199 cmH2O in 20 steps.
• Adjustable parameters:
- Intensity – 0 to 99 mA, in steps of 1 mA.
- frequency - 1 to 150 Hz. (±5%)
- pulse-width - 50 to 400 μs. (±5%) in steps of 10 μs
- pulse type - BI-PHASIC SYMMETRICAL or BI-PHASIC ALTERNATED
- ramp time of the stimulation cycle - 0,3-1s. automatically adjusted.
- plateau of the stimulation cycle - 1 to 60 s. (±1s.) in steps of 1 s.
- rest time of the stimulation cycle - 0 a 60 s. (±1s.) in steps of 1 s.
- frequency during rest - 3 to 5 Hz. automatically adjusted.
- session time - selectable among 15, 30, 45, 60, 90 min'. (±1min'.) or C.
• Open circuit detection: resets the stimulation intensity if the probe
connection is interrupted or if the contact with the vaginal wall is poor.
• Dimensions - 73x147x25 mm.
• Weight: - Kg. 0,2 (including batteries).
• Working and storage environment limits: Working +5°C/+40°C (15% / 93% R.H.) - Storage -25°C / 70°C - (8% al 93% R.H.)
• Electromagnetic Susceptibility: Complies with class B according to CISPR 11.
• CE marking: Medical device class IIa according to rule 9 Annex IX 93/42/CE - CE marking, released by IMQ (CE0051), according to Annex II of Directive 93/42/CEE.
• Manufacturing quality: in ISO9001 - ISO13485 certified system.
• Registration at the Medical Devices Repertoire of the Ministry of Health: Progressive number assigned ________, CND: Z12062701+ Z12062499
• 1 Unit evoStim P (Code EVO-P)
• 3 Alkaline batteries 1,5 V AAA (LR03)
• 1 Plastic key for battery compartment opening.
• 1 lead wires for connecting the applied part
• 1 user guide
• 1 Vaginal balloon probe VAG-2STFW. (Code RU-V2STFW)
• 1 padded bag or rigid plastic handbag.
• 1 interlocking stand for vertical support of the unit on a horizontal surfacetended use :
The therapeutic unit evoStim® P is an electromedical equipment for perineal re-education by intra-vaginal electrostimulation and pressure biofeedback. It allows passive perineal treatments (with 1 electrostimulation channel), active perineal recovery (with 1 biofeedback channel) and perineal muscular re-learning (by pressuretriggered electrostimulation).
It is intended for both professional use and personal use by the patient.
In personal use, the rapid selection of a perineal electrostimulation program, among the 4 available, is intuitive for the patient and, when the unit is switched-ON, the last program previously used is loaded.
The pulse generator can deliver symmetrical biphasic pulses (for ring electrode probes) or alternating biphasic pulses (for side-electrode probes). In addition to the probe included in the standard package, any type of perineal probe available
on the market may be used provided it has 2 mm female connectors.
The perineal biofeedback is of manometric type, it can be carried out with the special balloon probe supplied in the package or with any type of probe equipped with Luer-lock female pneumatic link.
Visual feedback on the display is obtained by switching-on a number of concentric circles proportional to the pressure exerted on the probe balloon by perineal muscles during a voluntary contraction.
Evoked Stimulation (programme EVO) Evoked stimulation exploits both, the active ree d u c a t i o n (biofeedback) and passive re-education (electrostimulation).
The EVO programme provides action/rest cycles of electrical stimulation, but any c y c l e m u s t b e t r i g g e r e d b y t h e voluntary contraction of the patient when a certain threshold is attained.
The ballon pressure is measured in CmH2O and it is directly proportional to the contraction of perineal muscles measured within the vaginal walls. The pre-defined trigger threshold is 8 cmH2O and can be changed by the user. The threshold also changes automatically, increasing every 3 valid voluntary contractions. The last reached threshold value is automatically stored at the end of the session and will be the start threshold of the next session. Patient's ability, his/her willing and perseverance to reach ever greater thresholds makes this program involving and effective for functional recovery of the pelvic floor.
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