miniSTIM
miniSTIM is intended for the electrostimulation of the perineal muscles (especially the pubococcygeal and puborectal muscles) for the prevention and treatment of stress incontinence, urge incontinence, overactive bladder, mild prolapse and treatment of perineal pain, for domestic use directly by patient.
miniSTIM allows the preventive or therapeutic treatment of urinary incontinence, using a perineal probe or transcutaneous electrodes.
Prevention and treatment of stress incontinence, urge incontinence, overactive bladder, mild prolapse and treatment of perineal pain, for home use directly by the patient.
5 pre-set programs
– P1 | for Stress incontinence (with perineal probe);
– P2 | for Urge incontinence (with perineal probe);
– P3 | for Mixed incontinence (with perineal probe);
– P4 | for Pelvic pain (with perineal probe);
– P5 | for Overactive Bladder (OAB) andf Nocturia (with transcutaneous electrodes on n. tibialis posterior).
The ergonomics of miniSTIM make use of an OLED display and only 2 buttons. Given the particular brightness, the display is clearly visible in any environmental situation.
2 different types of impulses
Pre-set according to the selected program. The pulses can be Biphasic Symmetrical for stimulation using
surface electrodes or Alternating Biphasic for stimulation using the vaginal probe enclosed in the standard package.
| Power supply | Internal 4.5 V. with 3 Alkaline 1.5V AAA batteries (LR03) |
|---|---|
| Battery life | 20 hours / 40 sessions with standard alkaline batteries (variable depending on the program and stimulation level) |
| Electrical safety class | Internal power supply according to IEC 60601-1 |
| Operation type | continuous |
| Usage time | Depending on the selected program; the equipment has no limitations on usage time and can be used continuously (until the primary batteries are completely discharged) |
| Stimulation intensity output | 1 to 99 mApp in 1mA steps on 1KΩ load (with 200 μs pulses) |
| Programs | 5 pre-set quick use |
| Output waveform | fixed P1 – P4 alternating symmetric biphasic pulses, P5 symmetric biphasic pulses |
| Energy | for each pair of pulses, approximately 2mJ |
| Output DC component | max. 4 mVrms |
| Action time | Pre-set according to the selected program: 3 to 60 seconds (±0.5 seconds) or Continuous |
| Reset time | Pre-set according to the selected program: from 1 to 7 seconds (± 0.5 seconds) |
| Session time | 15 to 50 minutes (± 0.5 minutes) depending on the program |
| Output connection to the patient | 1 channel via micro-coaxial connector to which to connect the supplied cable with plug terminations protected by 2 mm |
| Applied part | Perineal probe or surface electrodes |
| Open Circuit Detection | resets the stimulation intensity if the connection of the electrodes is interrupted or the adhesion of the electrodes to the skin is insufficient |
| Frequency | Pre-set according to the selected program: 1 to 100 Hz (± 5%) |
| Frequency during Rest | Pre-set according to the selected program: from 3 to 10 Hz (± 5%) |
| Pulse width | pre-set according to the selected program: 50 to 300 us (± 5%) |
| Electromagnetic susceptibility | Class A compliant according to CISPR 11 |
| Dimensions and Weight | 90x50x30 mm – approximately 90 g. (including batteries) |
| Environment | Work +5°C/+40°C (15% / 90% U.R. – 700hPa / 1060hPa) Storage -25°C / +70°C – (90% U.R.) |
| Protection against the penetration of solids and liquids | IP22 |
| CE marking | Class IIa medical device according to rule 9 Annex VIII 2017/745 MDR – CE0051 marking, issued by IMQ, according to Annex IX of Regulation 2017/745 |
| Production quality control | In ISO9001 – ISO13485 certified system |
| CND – EMDN | Z12062701 |
| Included in packaging | – 1 miniSTIM electronic stimulator; – 1 vaginal probe; – 1 pack of 4 reusable 50×50 mm electrodes,; – 1 wires for connecting miniSTIM to the supplied vaginal probe; – 1 wires for connecting miniSTIM to surface electrodes; – 3 LR03 (AAA) alkaline batteries; – 1 storage bag; – 1 MiniSTIM User Guide; – 1 MiniSTIM Quick Start Guide. |
CERTIFICATIONS
Certified Quality Management System
UNI EN ISO 9001:2015
UNI CEI EN ISO 13485:2016
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