STIWELL® Electrotherapy Easy-To-Use Electrotherapy

STIWELL® Electrotherapy Easy-to-Use Electrotherapy

Muscle weakness Stroke Incontinence

Smart Innovations STIWELL med4

Innovative Solutions for Neurorehabilitation

MED-EL is renowned worldwide for their innovative products in the area of medical technology. With more than 30 years of experience in the research and development of neurostimulation devices, MED-EL is a pioneer in this extremely interesting area of medicine. With state-of-the- art technology and competent partners MED-EL strives to translate innovative solutions into user-friendly products.

The Business Unit Neurorehabilitation STIWELL develops and supplies trendsetting neurorehabilitation products. For more than 20 years STIWELL has leased and sold electrical stimulation devices to provide comprehensive therapy after stroke, treat incontinence, build-up muscles after surgery and treat pain conditions.

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STIWELL med4 Scope of Application 2 Application Examples 4 STIWELL Biofeedback PC Games and EMG-triggered Stimulation 6 Guidelines Functional Electrical Stimulation (FES) 7 Neurological Disorders – Testimonials 8 The Comprehensive Therapy Concept 10 Convincing Programme Quality 12 STIWELL Academy 14 Scope of Delivery and Accessories 15 Technical Data 16 1 STIWELL med4

STIWELL med4 Scope of Application

Neurological disorders

The STIWELL med4 can be used after stroke and other neurological disorders (traumatic brain injury, cerebral palsy in infantile brain damage, multiple sclerosis, etc.) as follows: – (Re)learning of movements and everyday activities – Muscle strengthening in cases of nerve damage, pareses, peroneal nerve paralysis (foot drop) and in arm/hand rehabilitation after hand surgery – Muscle relaxation in cases of increased muscle tone (spasticity)

With EMG-triggered multi-channel electrical stimulation the STIWELL med4 can be used to practice voluntary movements and to strengthen the muscles. Interaction with the nervous system allows successful treatment of many neurological disorders.

EMG-triggered multi-channel electrical stimulation

In central neural weaknesses or deficits, electrical pulses can support muscle function. Functional electrical stimulation uses these electrical pulses to partly restore or compensate motor deficits due to injury or illness.

Simultaneous or sequential activation of up to four muscle groups allows developing even complex physiological movement patterns with the STIWELL med4. Muscle activity is measured and the patient triggers the impulse. Individual muscles are electrically stimulated thus leading to a complete motion sequence.

The STIWELL med4 ideally supplements physiotherapeutic and ergotherapeutic applications aiming at practicing challenging motor tasks (e.g. grasping and releasing objects or pinpoint hand-to- mouth coordination) and relearn motion sequences.

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STIWELL med4 Scope of Application

Feedback programmes Medium frequency

Symptom-oriented biofeedback training with cognitive Medium frequency currents are used to strengthen re-learning effect is an efficient therapy method muscles and are suitable for the following indications: supplementing therapeutic treatment of neurological Muscle atrophy, disorders or injuries of the central lesions. Depending on the neurological symptoms, nervous system (CNS), regenerable peripheral neural maximum power, muscle endurance, intermuscular lesions, neuro-orthopaedic functional disorders. coordination and muscle relaxation can be trained. Visual and acoustic feedback helps the patient to consciously realise and modulate muscle tension. Pain therapy

Transcutaneous electrical nerve stimulation (TENS) is a Muscle strengthening symptomatic and conservative pain therapy. It is based on the application of electrical pulses through the Muscles atrophy when they are inactive, e.g. in cases skin (transcutaneous). Variable settings of stimulation of illness, after accidents or immobility. This process parameters allow treating acute and chronic pain. can be delayed, stopped and muscles strengthened Treatment can be conveniently included in a daily routine with electrically induced pulses. Endurance, blood and – in the best case – help reduce pain medication. flow and mobility are also improved. Electrical signals help strengthen the muscles by causing them to contract. The electrical signals triggering muscle Incontinence - pelvic floor exercises contraction are transmitted to the muscle from the device via electrodes attached to the skin. The STIWELL med4 can be used to treat urinary and faecal incontinence (e.g. after pregnancy, surgery or Using the STIWELL med4 in cases of muscle weakness: illness). Biofeedback and electrical stimulation and – Muscle strengthening, muscle coordination after combinations thereof help learning how to exercise accident, surgery and illness, e.g. shoulder, arm, and strengthen the pelvic floor in a controlled manner. hip, knee and for arm/hand rehabilitation after Intracorporeal and surface electrodes register even hand surgery smallest muscle activities which are typically not – Strengthening of weak, denervated muscles due to consciously perceived. The patient can read out the peripheral nerve damage and incomplete tetraplegia intensity of muscle contraction on the display of the – Strengthening of back, abdominal and pelvic floor device or receives an acoustic feedback. muscles in various spinal cord diseases (nerve root compression after herniated disk, back pain, etc.) All programme parameters can be adjusted individually and saved under a separate programme name for Prophylaxis and therapy of muscular atrophies with repeated use. electromyostimulation can help avoid orthopaedic secondary injuries and shorten the period of inpatient treatment.

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Application Examples EMG-triggered Multi-Channel Electrical Stimulation

The STIWELL med4 electrotherapy device is used for Precision and lateral pinch rehabilitation after stroke and other neurological disorders (traumatic brain injury, cerebral palsy in infantile brain damage, multiple sclerosis, etc.).

It can be used to practice motion sequences with targeted activities. Everyday movements such as grasp/release, open/close hand, hand to mouth, arm extension and stand up from sitting position, can be repeated and practiced on a regular basis. Targeted training of finger and hand movements, e.g. precision/lateral pinch, is also possible.

Functional electrical stimulation is intended to restore those complex movements. This is achieved with well timed, subsequent stimulation of muscles and muscle groups which need to be activated for a functional movement. The patient controls the motion impulse independently while the STIWELL med4 provides correctly timed stimulation sequences. Combined biofeedback and functional electrical stimulation allow various treatment approaches.

The STIWELL med4 offers different EMG-triggered multi-channel electrical stimulation programmes whose parameters can be individually adjusted. In addition, the device supports targeted muscle strengthening after neural lesions (e.g. facial, peroneal, plexus or femoral nerve pareses). It can also be used to treat excessive muscle tone (spasticity).

The effectiveness of functional electrotherapy has been proven in several studies. The international guidelines are based on these studies and recommend suitable therapy (see page 7).

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Application Examples EMG-triggered Multi-Channel Electrical Stimulation

Arm extension Stand up from sitting position

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STIWELL Biofeedback PC Games and EMG-triggered Stimulation

Feedback and EMG-triggered training at the PC offers Symptom-oriented biofeedback training the therapist a choice of new therapy methods and motivates the patient. The STIWELL med4 stimulator The STIWELL med4 has different biofeedback is set to the patient’s individual muscle tone at the programmes. Depending on the clinical symptoms beginning of each session. The control keys allow fast (spasm, muscle degeneration, coordination problems), and easy adjustment of the training intensity and the suitable programme can be selected. display setup (vertical/horizontal) to the patient’s abilities and needs.

Indications – Disorders or injuries of the central nervous system (CNS) – e.g. spasticity or pareses after stroke, condition after traumatic brain injury (tbi) – Diseases or injuries of the spinal cord – e.g. incomplete tetraplegia – Regenerative peripheral neural lesions – Neuro-orthopaedic functional disorders – Incontinence

Spasticity control Visual feedback shows symptomatic increase of muscle tension (indicated by 2 balloons).

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Guidelines Functional Electrical Stimulation (FES)

The following overview includes a selection of international clinical guidelines recommending functional electrical stimulation in the application scope of the STIWELL med4 based on high evidence.

Neuromuscular electrical stimulation (NMES) - Functional electrical stimulation (FES) upper extremity, spasticity, shoulder pain Department of Veterans Affairs, Winstein C. et al. Department of Defense And The American Heart Association/American Stroke Association. AHA/ASA Guideline 2016. A Guideline for Healthcare Professionals. From the American Heart Association/American Clinical Practice Guideline for the Management of Stroke Stroke Association. Stroke, 2016 rehabilitation. VA/DoD Version 2.0; 2010 ...... Management of the upper extremity following stroke Neuromuscular, EMG-triggered and functional Herbert D. et al. electrical stimulation (NMES, EMG-ES & FES) Platz T. et al. Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015. S2e-Leitlinien der DGNR zur motorischen Rehabilitation der International Journal of Stroke 0(0) 1–26. oberen Extremität nach Schlaganfall. (S2e-guidelines of DGNR of World Stroke Organization; 2016 motor rehabilitation for upper extremity after stroke.) ...... Neurologie & Rehabilitation 2 2009. (to be updated) Electrical stimulation of the paretic arm ...... using surface electrodes S1 Leitlinie Querschnittlähmung. Neurotraumatologie Veerbeek J. et al. und Erkrankungen der Wirbelsäule und Nervenwurzel. (S1 Guideline Paraplegia. Neurotraumatology and Guideline Stroke Disorders of the Spinal Cord and Nerve Root.) Royal Dutch Society for Physical Therapy (Koninklijk Nederlands Genootschap voor Fysiotherapie, KNGF); 2014 Curt. A. et al...... Hans-Christoph Diener, Christian Weimar (Hrsg.). Leitlinien für Electrical stimulation & Diagnostik und Therapie in der Neurologie herausgegeben von FES treatment of the upper extremity der Kommission „Leitlinien“ der Deutschen Gesellschaft für EBRSR Evidence-Based Review of Stroke Rehabilitation. Neurologie Thieme Verlag, Stuttgart, September 2012. Canadian Partnership for Stroke Recovery.

Upper Extremity Interventions chapter 10. Foley N. et al., www.ebrsr.com; London Ontario Canada; Oct 2013 ...... Electrical stimulation of the shoulder EBRSR Evidence-Based Review of Stroke Rehabilitation. Canadian Partnership for Stroke Recovery.

Painful Hemiplegic Shoulder chapter 11. Mehta S. et al., www.ebrsr.com; London Ontario Canada; Sept 2013 ...... Electrical stimulation Stroke Foundation of New Zealand and New Zealand Guidelines Group.

Clinical Guidelines for Stroke Management 2010. Wellington: Stroke Foundation of New Zealand; 2010 ......

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Neurological Disorders Testimonials

Khloe

Little Khloe was born with hemiparesis. Electrotherapy was recommended to her mother as a treatment option. On the Internet she discovered the STIWELL med4, which is also an ideal therapy device for children. The family travelled all the way from South Africa to Innsbruck to buy a STIWELL med4.

Khloe practices twice per day and her muscles have become significantly stronger within six months. She now can, e.g., actively participate in swimming class.

Julia Friederike

“The STIWELL therapy was a great support after An 84-year-old woman talks about her positive I had a stroke. In the beginning I could not experience and changes in rehabilitation with move my arm and hand, and I was very happy the STIWELL med4 after stroke. when I regained some mobility in my hand after treatment with electrical current. It was a good “The therapy helped me reach my goal to feeling and I became very ambitious to keep confidently and independently cope with day-to- fighting until my body would function all on day activities. The current had positive effects on its own again. Mobility slowly improved during my sensation in my arm and hand. Grasping and therapy. Therapy was very helpful and felt good moving objects were clearly more confident and in my arm and hand, and a bit of normality was easier after electrical treatment.” restored after such an experience. Job-related training also worked out great and I had fun Before therapy the patient reported that she doing it. felt severely impaired because she dropped objects. A relevant improvement of the grasping I was so happy to have had this therapy. It function was observed in therapy. Everyday helped me a lot. I want to thank my great activities like emptying the dishwasher were therapists who worked wonders with the regularly practiced with the support of electrical STIWELL therapy.” stimulation.

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Daniel Josef

Daniel suffers from tetraspasticity due to “My name is Josef and I have suffered from the infantile brain damage. All four extremities are consequences of stroke. Due to pronounced affected, the muscles of his left hand are already hemiplegia, I neglected my left side (visually, severely shortened. Due to a growth spurt at the acoustically, …). Immediately after leaving the beginning of puberty, muscle shortening caused a clinic I started with regular physiotherapy and loss of many acquired skills. occupational therapy twice a week and noticed minor improvements. My physiotherapist told me Daniel’s mother says: “To be successful we about the STIWELL med4 electrical stimulation supported this treatment with an active device which he used repeatedly during therapy physioprogramme, increased stretching and and it did me good every time. the STIWELL myofeedback device. We placed the electrodes on the back and thigh for I asked my doctor to prescribe it for home use. strengthening. We used myofeedback to innervate My insurance agreed to pay for it and now I can various leg and arm functions. We saw the first use it whenever I like. This is a great benefit progress within the first six weeks. Daniel broke because I can use the various programmes through certain leg movement patterns, i.e. he (my physiotherapist gave me a thorough training) does not tuck up his legs when he exerts himself. for muscle relaxation, muscle development, He became stronger which was particularly stimulation increase etc. in my own home! obvious in (supported) standing up. He can help more and support his weight for a short time. Without this additional help and support I would His newly gained strength is most obvious when certainly not have come as far as I have - to be he is trotting on horseback. His back is much able to take my first steps without my walker! straighter, his head stays up and under control, and he can push himself up with his legs. We used I would like to thank the entire STIWELL team for the myofeedback particularly for the abductors their friendly support even when I inadvertently (abduct leg laterally), the front thigh muscles miss the date to extend the lease or need (stretching the knee) and buttock muscle (prone anything else. I wish every patient strength and position, raise bent leg); approximately three endurance! Let yourself be surprised by the times a week. Improved control of the treated effectiveness of the device!“

This patient usedThis previousSTIWELL the med4 for model of therapy. muscles was seen after 2-3 weeks.”

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All in One The Comprehensive Therapy Concept

The “STIWELL med4” is the ideal therapeutic device strength endurance, muscle relaxation and intermuscular for all pathologies requiring treatment with coordination. EMG-triggered stimulation combines conventional electrotherapy, EMG-triggered stimulation biofeedback training and stimulation. and biofeedback – with all features included in a pocket-size device. Functional electrical stimulation is easy to use in hospitals and at home. Users The comprehensive therapy concept is complemented by the device’s user-friendly features. Physicians, physiotherapists, ergotherapists, speech and language therapists, sports scientists and patients use the STIWELL med4 in the areas of neurology, Rehabilitation at home physical medicine and rehabilitation, accident surgery, orthopaedics, urology, pain therapy, dermatology, The STIWELL med4 is intended for use in hospitals general medicine, sports medicine and sports therapy. but also for home use by the patient. The responsible physician/therapist will adjust the programmes and follow up on therapy progress. Statistical data 4-channel stimulation and 2-channel regarding the performed treatments can be recalled EMG measurement allow: from the STIWELL med4 when linked to a personal computer. – Synchronous/asynchronous extremity movements (coordination training) – Control of complex movement patterns in one Symptom-oriented biofeedback training extremity or simple movements in several extremities simultaneously Depending on the neurological symptoms, symptom- oriented biofeedback training allows playful training of central innervation ability, maximum strength,

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Operation – Easy to operate – Programme selection for home therapy – Storing intensity – Creating and saving of individual programmes – Recording of treatment data

Programmes – Conventional electrotherapy programmes – Training programmes for functional movements – Biofeedback games – EMG-triggered stimulation – Programmes to treat peripheral lesions and pareses

Technology – 4 stimulation channels – 2 EMG-triggered measuring channels – Rechargeable battery supply – Medium frequency – Low frequency – Exponential current

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Convincing Programme Quality

Muscle Strengthening Atrophy – power endurance Muscle strength training in case of atrophy Agonist / antagonist Muscle strength training for agonist / antagonist Maximum power training Muscle strength training (maximum strength training) Circulation improvement Blood circulation improvement

Denervated Muscles Mild atrophy Mild atrophy Severe atrophy Severe atrophy / degeneration

Feedback Programmes EMG-triggered (1 EMG) Muscle atrophy, diseases / lesions of the CNS, neuro-orthopaedic functional disorders, EMG-triggered (2 EMG) regenerable peripheral nerve injury Muscle tension Muscle atrophy, diseases / lesions of the CNS, regenerable peripheral nerve injury Relaxation training Increased muscle tone (spastic pareses), neuro-orthopaedic tension syndromes (e.g. tension headache, vertebragenic pain syndromes) Coordination training Muscle tone control exercises, neuro-orthopaedic coordination deficits, Myosymmetry muscle atrophy, diseases / lesions of the CNS, regenerable peripheral nerve injury

Feedback Games On Display Power training Muscle atrophy, diseases / lesions of the CNS, regenerable peripheral nerve injury

Feedback Games On PC EMG-triggered (1 EMG) Muscle atrophy, diseases / lesions of the CNS, neuro-orthopaedic functional disorders, EMG-triggered (2 EMG) regenerable peripheral nerve injury Power training Muscle atrophy, diseases / lesions of the CNS, regenerable peripheral nerve injury Endurance training Relaxation training Increased muscle tone (spastic pareses), neuro-orthopaedic tension syndromes (e.g. tension headache, vertebragenic pain syndromes) Myosymmetry Muscle tone control exercises, neuro-orthopaedic coordination deficits, muscle atrophy, Coordination training diseases / lesions of the CNS, regenerable peripheral nerve injury

Pain Therapy TENS conventional Phantom pain, scar pain, postoperative pain, lumbar back pain, acute pain TENS frequency modulated TENS burst Deeper pain zones, myopathic pain, chronic pain

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Urology Urge incontinence Urge incontinence Stress incontinence Stress incontinence Mixed incontinence, Mixed incontinence continence anal EMG-triggered (1 EMG) Stress incontinence, mixed incontinence EMG-triggered (2 EMG) EMG-triggered anal Peak speed (feedback) Stress incontinence, urge incontinence

Functional Programmes Grasp / release / (EMG) Training of motion sequences, strength training Open / close / (EMG) Training of motion sequences, strength training Hand to mouth / (EMG) Training of motion sequences, strength training Arm extension / (EMG) Training of motion sequences, strength training

Sports Overall endurance Stamina training Power endurance Power endurance training Peak speed Snapping power training Bodybuilding beginners Bodybuilding for beginners Bodybuilding advanced Bodybuilding advanced Agonist / antagonist power Agonist / antagonist strength training Agonist / antagonist time Agonist / antagonist stamina training Regeneration Regeneration Circulation improvement Blood circulation improvement Stimulation programme Warm-up and regeneration training

Medium Frequency MF 3kHz + MF 3 kHz (EMG) Muscle atrophy, diseases / lesions of the CNS, regenerable peripheral nerve injury, neuro-orthopaedic functional disorders

Individual Programmes Single phase programme For individual programming – all parameters are individually programmable Single phase programme (EMG) Three phase programme

Saved Programmes Programme name To save individual settings

13 STIWELL Academy - Certify now!

The STIWELL Academy has the goal to train health practitioners and therapists on modern therapy methods of EMG-triggered multi-channel electrical stimulation (EMG-MES). EMG-MES is one specification in the area of functional electrical stimulation. International guidelines state a high recommendation degree for functional electrical stimulation in stroke treatment. Case examples of patients, concepts of motor learning and Our seminars and workshops focus on the use of evidence-based knowledge complete this combination of EMG-triggered multi-channel electrical stimulation in theoretical and practical training. Increase your knowledge neurorehabilitation and practical applications. by attending our certification workshops!

In addition, we offer online training (webinars) to increase and enhance your knowledge of EMG-triggered multi-channel electrical stimulation.

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Scope of Delivery and Accessories

Scope of Delivery

Stimulator STIWELL med4 Charger and line cord Main cable 4 electrode cables Reference cable USB cable Instructions for use Software CD Transport case

STIWELL med4 Accessories

Self-adhesive electrodes Special electrodes 4 self-adhesive electrodes round 2.5 cm Vaginal electrode 4 self-adhesive electrodes round 3 cm Anal electrode 4 self-adhesive electrodes 5 x 5 cm 4 self-adhesive electrodes 5 x 9 cm 2 self-adhesive electrodes 8 x 13 cm Other 4 self-adhesive electrodes oval 4 x 6.4 cm Fixation band 30 cm Fixation band 70 cm Electrode gel Spectra 360 Rubber electrodes 2 rubber electrodes 4 x 6 cm 2 rubber electrodes 6 x 8 cm 4 sponge bags for rubber electrode 4 x 6 cm 4 sponge bags for rubber electrode 6 x 8 cm

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Technical Data

The STIWELL med4 is a medical device with internal power supply (rechargeable Li-ion battery). It is intended for indoor (at room temperature) use only.

Stimulator Charger

Stimulation channels: programme-dependent, max. 4 Input voltage: 90–264 VAC EMG measuring 2 Mains frequency: 47–63 Hz channels: Power consumption: 15.1 W Current forms: low-frequency, biphasic and Output: 12.6 V=/ 1.2 A direct current-free rectangular, Electrical safety: EN 60950 triangular and trapezoid pulses EN 60601-1 Power supply: Li-ion battery, 1950 mAh, 11.1 V EN 60335-2-29 Charging time: max. 170 min. UL 60601-1 PC interface: USB 1.1 and USB 2.0 compatible EN 60601-1-2 Dimensions: H x W x D: 175 x 95 x 30 mm Weight: 440 g EMG measuring range: 1 μV–2000 μV

Programmes Environmental conditions

Programmes for output voltage: 80 V at 1000 Ohm Operating conditions: operating temperature/humidity: denervated muscle: output current: max. 80 mA 10°C to 40°C/10%–90% pulse width: 2*1 ms –2*250 ms Storage and transport storage temperature/humidity: pulse frequency: 0.1 Hz –50 Hz conditions: -20°C to 70°C /10% –90% Programmes for output current: innervated muscle: 100 mA at 1000 Ohm pulse width: 2*50 μs –2*500 μs pulse frequency: 1 Hz–140 Hz MF programmes: output current: 80 mA at 1000 Ohm fundamental frequency: 3 kHz amplitude modulation frequency: 5 –70 Hz

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The products are subject to approval by the national competent authorities and may be currently unavailable or not offered for sale by MED-EL in your region. Please contact [email protected] for further information.

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MED-EL Medical Electronics STIWELL Neurorehabilitation Fürstenweg 70, 6020 Innsbruck Tel: +43 5 77 88 56 52 Fax: +43 5 77 88 56 95 [email protected]

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