Electrotherapy/biofeedback unit - TOTEM UG for perineal rehabilitation

Electrotherapy/biofeedback unit -TOTEM UG for perineal rehabilitation.

TOTEM-UG is a patient-wearable unit for the re-education of incontinence by means of electrostimulation and/or perineal biofeedback, through wireless connection with a personal computer.
The therapeutic objectives are the attenuation or remission of incontinence manifestations, exploiting the effectiveness of perineal stimulation and the great contribution of biofeedback techniques in functional re-learning.
TOTEM-UG, equipped with the special software, must be used in combination with a personal computer (desktop or laptop, not supplied with the device) equipped with the Windows operating system (W-XP or W-Vista or W-7).

The connection with the PC is "wireless" (bluetooth) without any physical connection between the patient unit and the PC. The TOTEM-UG unit is applied to the patient's waist using the belt supplied.
In addition to the probes supplied with the standard equipment, or as optional accessories, any type of probe for perineal electrostimulation and EMG biofeedback available on the market can be used, both with ring electrodes and side electrodes, as long as they are equipped with 2mm socket terminations. Any balloon probe equipped with a female luer-lock pneumatic connection can also be used for manometric biofeedback.
The use of TOTEM Combicon special vaginal probes allows you to:
1 - perform asymmetrical electrostimulation of the two branches of the pubococcygeus, with independent parameters and intensity and, simultaneously, acquire a pressure value proportional to the contraction obtained globally by the perineum.
2 - Simultaneously acquire the EMG signals of the two branches (Right-Sn) of the pubococcygeus and again simultaneously acquire a pressure value proportional to the contraction obtained globally from the perineum.     

Features:
✓ Compact and lightweight wearable unit
✓ Two stimulation channels
✓ Two EMG biofeedback channels
✓ Two pressure gauge channels
✓ "wireless" connection with the computer
✓ Two waveforms selectable according to probe type
✓ Status display via LCD
✓Detachable Li-Po battery


EFFECTS OF PERINEAL STIMULATION
In addition to manual re-education and pelvis/perineal kinesis-therapy, perineal stimulation is the most common method in the recovery of continence, particularly in female patients.
Perineal stimulation is normally practiced with the aid of intra-vaginal electrodes, characterized by at least one pair of contacts, usually ring-shaped, spaced about 2 cm apart.
The real goal is the stimulation of the muscle group of the levators of the anus and, in particular, of the pubococcygeus muscle. There are many effects, observed by several experimenters, of perineal stimulation:
Strengthening effect on the pelvic floor. Electrostimulation causes a significant increase in muscle activity. When the manual muscle function test (PC-Test) leads to a value of 1 or 2 (1 = barely perceptible contraction, 2 = weak contraction) endo-vaginal electrostimulation proved to be particularly effective, allowing a rapid recovery of at least 2 points.
The effectiveness of electrostimulation makes use of the excito-motor action, which causes an increase in muscle tone, and the vascular action on the local circulation. The two actions are obviously linked, but distinct.

Effect on urethral closure pressure - Significant increases in urethral closure pressure have been observed by some experimenters (Dr. PIGNE' - BOURCIER).

Effect on bladder tone - A net improvement in bladder compliance was observed accompanied by a considerable reduction in uninhibited detrusor contractions and an improvement in cystomanometric capacity.

Specifications:
Power supply: Internal with Li-Po 3.7 Volt 1130 mAh battery (autonomy of about 8 hours), removable and rechargeable using a special external charger supplied as standard.
Output voltage: Symmetrical or alternating biphasic biphasic pulses max. 100 Vpp (14 Vrms); Energy per pulse torque: 2.5 mJ max.
Output current: max. 100 mApp (14mA rms) with load normalized to 1000 Ohms.
DC component output: max. 4 mVrms
Communication: wireless bluetooth.
Input Signals: EMG (Envelope): 0 to 300.0 μV resolution 0.1 μV -
Pressure: from 0 to 300 cmH2O resolution 1 cmH2ODimens: - 190x160x60 mm.
Weight: - Kg. 0.2 (only patient unit with battery inserted).
Working environment and storage: Working 5°C to 35°C (20% to 80% RH)
Storage 5°C to 45°C - (8% to 95% RH)
Therapeutic parameters that can be set by software:· Intensity – 0 to 100 mApp on 1000 Ohm normalized load.
Frequency - 1 to 200 Hz. (±5%)
pulse width - 30 to 500 μs. (±5%)
pulse type - SYMMETRICAL BI-PHASIC or ALTERNATING BI-PHASIC.
Stimulation cycle rise time - 0 to 59 s. (±1s.)· Stimulation cycle plateau - 0 to 59 s. (±1s.)· Stimulation cycle descent time - 0 to 59 s. (±1s.)· Stimulation cycle rest time - 0 to 59 s. (±1s.)· sitting time – 1 to 99 min' (±1min.')

TOTEM-UG is a class IIa medical device according to Directive 93/42/EEC e.s.m

Equipment:
STANDARD ACCESSORIES SUPPLIED WITH TOTEM-UG.

• Patient unit TOTEM-UG
• Removable rechargeable Li-Po battery for TOTEM-UG
• External charger for LiPo battery TOTEM-UG
• Power cable for TOTEM-UG charger
• Connection cable to the special TOTEM Combicon probes.
• Special vaginal probe TOTEM Combicon. Electrode surface: 2 cm2/electrode.
• Envelope of 4 mm electrodes that can be used as a reference electrode in EMG biofeedback.
• 5-pole cable with protected 2mm banana termination, suitable for connecting perineal probes for electrostimulation and EMG biofeedback.
• Special nylon belt for fastening the TOTEM-UG patient unit at the waist.
• TOTEM-UG Software CD including the user manual.
• USB key to be applied to the computer for "wireless" bluetooth connection with the TOTEM-UG patient unit.

OPTIONAL ACCESSORIES FOR TOTEM-UG.

• XELRU-TOTEM-CVS - 3-pole cable (2mm protected termination) suitable for perineal electrostimulation and biofeedback with PERIPROBE probes (with two electrodes).
• XELV2STW - Personal vaginal probe PERIPROBE -2STW, 2-wire connection with 2mm female termination.
• XELA2STW - Personal anal probe PERIPROBE ANA-2STW, 2-wire connection with 2mm termination femmina.Elettrodi large surface ring.
• XELRU-VMIN - Personal PERIPROBE Minima vaginal probe, semi-spherical electrodes, 2-wire connection with 2mm female termination.
• XELANA-2STW - Personal anal probe PERIPROBE ANA-2STW, 2-wire connection with 2mm female termination. Side electrodes.
• XELRU-TOTEM-LIPO37 - Additional rechargeable Li-Po battery for TOTEM-UG.

Delivery: Minimum 25 working days.