Stimulette den2x Leaflet

Qualit y By C ompetence

stimulette den2x Device characteristics -

Reliable and safe Modern microcontroller technology Innovative design User-friendly operation Clear arrangement of all function keys All operational parameters on LCD Individual settings easy to program and safe

Technical data Supply voltage ~110/230 V, ±10 % / 60/50 Hz Power input 160VA Max. output current intensity (peak value) up to 300 mA Regulated constant current output Dimensions (WxHxD) 330 x 123 x 300 mm Weight 4 kg Protection class I Unit type BF

0408 Literature 1: Kern H, Carraro U, Adami N, Biral D, Hofer C, Forstner C, Mödlin M, Vogelauer M, Pond A, Boncompagni S, Paolini C, Mayr W, Protasi F, Zampieri S. Home-Based Functional Electrical Stimulation Rescues Permanently Denervated Muscles in Paraplegic Patients With Complete Lower Motor Neuron Lesion. Neurorehabilitation and Neural Repair. 2010 Oct; 24(8): 709-721 2: Kern H, Carraro U, Adami N, Hofer C, Loefler S, Vogelauer M, Mayr W, Rupp R, Zampieri S. One year of home-based daily FES in complete lower motor neuron paraplegia: recovery of tetanic contractility drives the structural improvements of denervaed muscle. Neurol Res. 2010 Feb; 32(1):5-12. PubMed PMID: 20092590.

3: Meyerspeer M, Mandl T, Reichel M, Mayr W, Hofer C, Kern H, Moser E. Effect of functional electrical stimulation in denervated thigh muscles of paraplegic patients mapped with T2 imaging. MAGMA. 2008 May;21(3):219-26. Epub 2008 Apr 19.

4: Boncompagni S, Kern H, Rossini K, Hofer C, Mayr W, Carraro U, Protasi F. Structural differentiation of skeletal muscle fibers in the absence of innervation in humans. Proc Natl Acad Sci USA. 2007 Dec 4;104(49):19339-44. Epub 2007 Nov 27. PubMed PMID: 18042706; PubMed Central PMCID: PMC2148291.

5: Hofer C, Forstner C, Mödlin M, Jäger H, Mayr W, Kern H. In vivo assessment of conduction velocity and refractory period of denervated muscle fibers. Artif Organs.

2005 Jun;29(6):436-9. PubMed PMID: 15926977.

6: KernH, Rossini K, Carraro U, Mayr W, Vogelauer M, Hoellwarth U, Hofer C. Muscle biopsies show that FES of denervated muscles reverses human muscle degeneration from permanent spinal motoneuron lesion. J Rehabil Res Dev. 2005 May-Jun;32(3 Suppl 1):42-52. PubMed PMID: 16195962.

7: Gallasch E, Rafolt D, Kinz G, Fend M, Kern H, Mayr W. Evaluation of FES-induced knee joint moments in paraplegics with denervated muscles. Artif Organs. 2005 Mar;29(3):207-11. PubMed PMID: 15725218.

8: Mödlin M, Forstner C, Hofer C, Mayr W, Richter W, Carraro U, Protasi F, Kern H. Electrical stimulation of denervated muscles: first results of a clinical study. Artif Organs. 2005 Mar;29(3):203-6. PubMed PMID:15725217.

9: Kern H, Salmons S, Mayr W, Rossini K, Carraro U. Recovery of long-term denervated human muscles induced by electrical stimulation. Muscle Nerve. 2005 Jan; 31(1):98-101. PubMed PMID: 15389722.

10: Mayr W, Hofer C, Bijak M, Rafolt D, Unger E, Sauermann S, Lanmueller H, Kern H. „Functional electrical stimulation (FES) of denervated muscles: existing and prospective technological solutions.“ Basic Appl Myol 2002; (12): 287.

stimulette den2x High performance 2-channel electrical stimulator specialized to be used for activating denervated muscles

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stimulette den2x

The stimulette den2x is a compact, high performance two-channel electrotherapy device that was developed to be used exclusively for stimulating denervated muscles.

It features the latest microcontroller technology, a graphic LCD display and simple operation by touch sensors.

Until now, adequate electrotherapy devices for the rehabilitation of paraplegic patients with flaccid paralyses have not been available.

The EU Project RISE - a team of scientists and physicians from Austria, Germany, Italy, United Kingdom, Slovenia and Iceland - was initiated in 2001 in order to acquire essential insights in functional electrical stimulation (FES) of denervated muscles.

The EU Project RISE demonstrates that home-based FES of denervated muscle is an effective home therapy that results in rescue of muscle mass and tetanic contractility.

For paraplegic patients with complete lower motor neuron denervation FES is the only option in the treatment of denervated muscles. This procedure allows to counteract muscle atrophy and muscle degeneration.

Direct and indirect benefits of stimulating denervated muscles: Recovery of muscle mass and fiber size Recovery of tetanic contractility Restoration of muscle fiber structure Enhanced cushioning effect for seating Better skin condition Reduced risk of pressure sores Improved cosmetic appearance of lower extremities Increased self-esteem If standing upright is accomplished: Improved cardiovascular fitness Unloading of seating surface

stimulette den2x

Biphasic rectangular or ramp shaped long-duration impulses of very high intensity are required to stimulate denervated muscles.

This stimulator is capable of delivering impulses with current intensities of up to ±300mA, with strict avoidance of DC components.

Twelve individual therapy sequences may be programmed and allocated to function keys. Due to the user friendly, self-explaining menu design, the individual programming of these therapy sequences is easy to accomplish and does not require extensive schooling.

Ramp and rectangular current waveforms with and without train envelope may be chosen.

Sequence of impulse delivery over time is adjusted by various time parameters (rise time, decay time, impulse duration, interpulse pause, surge duration, surge interval).

The following parameters are programmable: • Impulse amplitude: max. ±300mA • Impulse waveform: rectangular / ramp shaped (3 different waveforms) • Impulse duration ID: 10ms 200ms • Impulse pause IP: 10ms 2s • Surge duration: 100ms 11s • Surge interval: 100ms 11s • Treatment duration: 1 - 59min Treatment period, maximal current intensity and the number of activated current waveforms may be selected in a password-protected manner.

Only the original safety electrodes may be used for therapy, for safety reasons.

These newly developed electrodes are licensed to Schuhfried (Patent W. Mayr AT503420; WO2007/131248).

This invention is a surface electrode for transcutaneous electrical-stimulation which, as long as it is applied correctly, prevents excessive local current density and ensuing potential skin burns.

Original Schuhfried safety electrodes