Therapeutic unit for Electrostimulation, Biofeedback (EMG),Evoked stimulation
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The therapeutic unit evoStim® E is an electromedical equipment for perineal re-education by electrostimulation and EMG biofeedback. It allows passive perineal treatments (with 1 electrostimulation channel), active perineal recovery (with 1 biofeedback channel) and perineal muscular relearning (by EMG-triggered 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).
Biofeedback is of EMG type, and can be applied either on perineal muscles (with vaginal / anal probe) or on external muscles (with transcutaneous self-adhering electrodes).
Since the acquired EMG signal is in the order of a few μV, EMG biofeedback also requires the use of a transcutaneous reference electrode, essential for the suppression of electrical interference.
Visual feedback on the display consists in switching-on a number of concentric circles proportional to the pressure exerted on the balloon of the probe by perineal muscles, during a voluntary contraction. With the range selfcalibration, administering biofeedback programs is quite easy with the evoStim® E unit.
Evoked stimulation (programme EVO)
Evoked stimulation, also called muscular cognitive relearning, Evoked stimulation exploits both, the activere-education (biofeedback) and passive re-education
(electrostimulation). The EVO program provides action/rest cycles of electrical stimulation, but any cycle must be triggered by the voluntary contraction of the patient when a certain threshold is attained. The acquired EMG signal is measured in μV and it is directly proportional to the contraction of perineal muscles, which may be measured in the vagina. The pre-defined trigger threshold is 8 μV and may be modified 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.
• 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 lead wires terminating with 2 mm plug protected (RED / BLACK) + 1 lead wire (BLUE) for the reference electrode, required for the suppression of electrical interference during the EMG signal acquisition.
• Biofeedback EMG range: from 2 to 199 μV 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 insufficient.
• 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: ISO9001 - ISO13485 certified system.
• Registration at the Medical Devices Repertoire of the Ministry of Health: Progressive number assigned ________, CND: Z12062701 + Z12062499
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