From High Energy Inductive Therapy with the Compact II (art nr 3442201-40)
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„Life is an electromagnetic event“

Research on the use of electronic fields for pain management focuses on the multiple mechanisms of pain production. These electromagnetic fields will increase the threshold of pain sensitivity and activates the anticoagulation system. Besides that, strong electromagnetic fields stimulates the production of opioid peptides, activates mast cells and increases the electric capacity of muscular fibers.

It‘s a common observation that the benefits last considerably longer than the time of use. Analgesic effects were still observed at the 7th and even up t14 days after the last treatment.

The COMPACT-II generates a magnetic field of 3 Tesla, which is about 600 times stronger than a normal magnet bar. This strong magnetic field stimulates nerve cells, muscles, and blood vessels consequently as this application of energy results in a physiological change and/or stimulation which is used achieve therapeutic effects. By providing both a static and mobile applicator, the possibility use one of the pre-programmed recommendations, or create and store own program the end-user is assured have maximum results with the COMPACT-II.

The voltage induced in the tissue acts on the cell membranes whose lipid membrane is an insulating dielectric and which form a capacitor with the highly conductive fluid spaces adjacent the membrane. Proteins which cross the entire cell membrane (tunnel proteins) are stored in this phospholipid bilayer, however sometimes only on the outside or inside. Glycolipids and cholesterol are other components of the cell membrane.

The membrane proteins have various tasks. The ion channels are for High Energy Inductive Therapy of greatest interest. While small molecules such as O₂, CO₂ and H₂O can diffuse through the cell membrane along a concentration gradient and since lipophilic substances can across the cell membrane purely passively, the cell membrane is practically impermeable for most ions.

In the extracellular space, the most common ion is Na⁺, and the most common ion of the intracellular space is K⁺. Because of the high concentration gradient, a Na⁺ diffuses int the cell and a K⁺ diffuses out of the cell from time time. In this process, there is also displacement of electrical charges each time.

Since at rest in particular the K⁺ channels are open and the Na⁺ channels are closed, the inside of the cell becomes more negative as compared the outside with each K⁺ ion which diffuses out of the cell at rest. Because the electrical gradient which is changed in this way counteracts the concentration gradient, equilibrium is reached after a certain amount of time. Generally speaking, a membrane potential at rest goes from -80 t-90 mV in this way (resting membrane potential). The resting membrane potential is primarily a K⁺ potential, but naturally dependent on the other ions (if only K⁺ were affected, the resting membrane potential would be 97 mV).

Over time, the concentrations would balance out purely passively, a condition which leads to cell death.

The concentration gradient for Na⁺ and K⁺ must therefore be maintained by an active, ATP-consuming process that the cells can fulfil their tasks – in the nerve, for example, the electrical information transfer and processing. This is the task of the Na⁺ / K⁺ pump which consumes between 50% and 70% of the entire ATP requirement of the cells.

The Na⁺ / K⁺ pump can be influenced by various factors, such as toxins, drugs, or a lack of energy. The resting membrane potential becomes increasingly positive and the cell functions are thus disrupted.

With the change in voltage induced by the High Energy Induction Therapy, the regeneration of a normal resting membrane potential is facilitated. Normally, the passively passing molecules can once again enter and leave through the cell membrane. The energy production in the mitochondria can once again start up and the normal function of the Na⁺/ K⁺ pump is supported. As a result, the preconditions for normalization of the cell functions are restored.

• Magnetic Therapy, www.electrotherapy.org, Prof. tim Watson
• Magnetic Fields for Pain Control; William Pawluk, MD, 2015
• Efficacy of PEMT for chronic lower back pain, PB Lee, ZC Kim, UJ Lim et al, 2006
• Fundamental and practical aspects of therapeutic uses of PEMFs, Basset CA, 1989
• Watson T (2008) electrotherapy: Evidence based practice
• Watson T (2010) Narrative Review: Key concepts with electrophysical agents
• Magnetism in Medicine, Wiley-VCH Verlag
• Electrotherapy, Springer Verlag
• Therapeutic Electrophysical Agents, Wolters Kluwer Health
• Electrotherapy, Evidence Based Practice, Elsevier Health
• Battisti E, Biancardi L, Albanese A, Piazza E, Rigato M, Galassi G, Giordano N (2007) The new magnetic therapy TAMMEF in the treatment of simple shoulder pain, Clin Ter, 2007 Sep-Oct; 158(5):397-401; field (TAMMEF) in patients affected by knee osteoarthritis, Clin Exp Rheumatol 2004, Sep-Oct; 22(5):568-72
• Fischer G, Pelka RB, Barovic J (2005) Adjuvant treatment of knee osteoarthritis with weak pulsating magnetic fields. Results of a placebocontrolled prospective clinical trial, Z Orthop Grenzgeb 2005 Sep-Oct; 143(5):544-50
• McCarthy CJ, Callaghan MJ, Oldham JA (2006) Pulsed electromagnetic energy treatment offers no clinical benefit in reducing the pain of knee osteoarthritis: a systematic review, BMC Musculoskelet Disord 2006 Jun 15;7:51
• Vavken P, Arrich F, Schuhfried O, Dorotka R (2009) Effectiveness of pulsed electromagnetic field therapy in the management of osteoarthritis of the knee: a metaanalysis of randomized controlled trials, J Rehabil Med 2009 May; 41(6):406-11
• Images Cell membrane page 4: Presentation Ludwig-Maximiliansuniersität München / Dr. von Hauner Children’s Hospital

Indications:

Principle
The transducer which is used to magnetic stimulation makes electrical fields by pulse current flowing from a capacitor according to the principle of Faraday's Law. Whenever the capacitor bank is discharged by the action of the control system, a pulse of current flows through the stimulating coil. The magnetic stimulation creates intense, rapidly changing magnetic electrical fields that are able to penetrate soft tissue and bone, to reach deep nervous structures. This magnetic electrical fields is used to the treatment.
This device directly generates (induces) electric current in muscles, nerve tissues, etc. affected by a high induction magnetic field and electrically stimulates it to relieve pain and suppress dysuria such as urinary incontinence.

Intended use
The COMPACT-II is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes non-contacting the affected body area. And, in addition, the electro-magnetic stimulator is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in human.

Device description
The COMPACT-II is intended to help relieve the patient’s muscular pain and suppress urination such as urinary incontinence and has the function of magnetic stimulation. This COMPACT-II consists of the main body and transducer for magnetic stimulation. The function of magnetic stimulation is operated with the parameter such as Mode, Intensity and Time. These parameters can be controlled by users on the LCD touch screen.

Contraindications:

• Do not use the equipment in parallel with other electronic medical equipment.
• Be careful tensure that magnetic stimulation does not penetrate the heart region.

In general, patients in the following categories cannot be treated with this equipment. Prior tany treatment with this equipment, permission of the doctor in charge must be obtained:

• Patients with high fever, pregnant women, the elderly and children.
• Patients with a history or status of epilepsy or seizure disability.
• Patients with suspected status of epilepsy on the basis of electroencephalography.
• Patients with evidence of external wound at brain and neck.
• Patients with cardiac pacemakers, drug injecting pumps or hearing aids.
• Patients with cranial implants.

Instruction for Use Please consult the Instructions for Use for more information on indications and contra-indications and for warnings and recommendations.

These indications and contra-indications originated from the COMPACT-II Instructions for Use 3442204-40