Chairman of Nervous System and Neurosurgical Diseases BSMU

CONTRIBUTORS:

Chairman of Physiotherapy and Balneology Department, the Belarusian Academy of Postgraduate Education, Corresponding Member of NASB, Professor V.S.Ulashchik

Chairman of Nervous System and Neurosurgical Diseases BSMU,

Academician NASB,Professor F.V.Oleshkevich

Leading researcher SRI of Neurology, Neurosurgery and Physiotherapy

Candidate of Medical Science, E.N.Ponomareva

Chief of physiotherapeutic branch of the MainMilitaryClinical Hospital named after academician N.N.Burdenko, Doctor of Medical Sciences A.A.Ushakov

Associate Professor of Physiotherapy and Balneology Department, the BelarusianAcademy of Postgraduate Education, ,

Candidate of Medical Science, L.E.Kozlovskaja

Leading scientific employee of Institute of Solid-State and Semi-Conductors Physics NAS RB;

Doctor of physical and mathematical sciences, Professor G.A.Govor

General Director of SPF “Dipol”, Candidate of Physical and Mathematical Sciences V.V.Mihnevich

It is AUTHORIZED to application in medical practice on territory of the Republic of Belarus.

THE REGISTRATION CERTIFICATE № ИМ - 7.5895/0612

Date of registration is 19.12.2006.

*

NASB – the NationalAcademy of Science of Belarus

BSMU – the BelarusianStateMedicalUniversity

SRI – Scientific Research Institute

NAS RB – the NationalAcademy of Science of the Republic of Belarus

1. PURPOSE OF THE DEVICE

1.1. Device «SETA-D" 1 is intended both for local, and for transcranial contactless influence by low and mid-frequency pulse magnetic field of intensity up to 1.2 Tesla when there are diseases and/or traumatic injuries of peripheral and central nervous, cardiovascular, musculoskeletal, digestive and urinogenital systems.

1.2. Device «SETA-D" can be applied in conditions of hospitals, polyclinics, at home and at working premises.

2. SPECIFICATIONS

2.1. Device «SETA-D-1"– with two Inductors, Inductor I-40, Inductor I-100);

Device «SETA-D-2"– with one Inductor I-40;

Device «SETA-D-3"– with one Inductor I-100;

Device «SETA-D-4"– with two Inductors I-40;

Device «SETA-D-5"– with two Inductors I-100;

Inductor I-40 — diameter of 40 mm with depth of influence up to 30 mm.

Inductor I-100 — diameter of 100 mm with depth of influence up to 70 mm.

The inductors work by turns.

2.2. Power supply is from AC network, voltage of 220V, frequency of 50 Hz.

2.3. Power consumption is no more than 150 W.

2.4. Overall dimensions, mm, no more than:

Device 250 х 300 х 95;

Inductor I-40 270 х 92 х 40;

Inductor I-100 320 х 135 х 40.

2.5. The weight of the device is no more than 10 kg.

2.6. The grade of electrical safety is II type В.

2.7. The form of pulses of a magnetic induction is unipolar, triangular.

The device provides the choice of amplitude of magnetic induction pulses and performance of the programmed modes according to table 1.

Table 1

Amplitude of magnetic induction pulses, Tl / Number of a mode / Number of pulses in a series / Number of pulses in one minute / Frequency of series, series/min / Duration of work
min
Inductor I-40, I-100
0.2 / 0.4 / 0.6 / 0.8 / 1.0 / 1.2
+ / + / + / + / + / + / 1 / 8 / 96 / 12 / 10
+ / + / + / + / + / + / 2 / 12 / 240 / 20 / 5
+ / + / + / + / + / 3 / 15 / 300 / 20 / 5
+ / + / + / + / + / 4 / 10 / 300 / 30 / 5
+ / + / + / 5 / 15 / 300 / 20 / 10
+ / + / + / 6 / 10 / 300 / 30 / 10
+ / + / + / 7 / 30 / 600 / 20 / 5
+ / + / + / 8 / 20 / 600 / 30 / 5
+ / + / 9 / 30 / 600 / 20 / 10
+ / + / 10 / 20 / 600 / 30 / 10
+ / + / + / 11 / 60 / 1200 / 20 / 5
+ / + / + / 12 / 40 / 1200 / 30 / 5
+ / + / 13 / 60 / 1200 / 20 / 10
+ / + / 14 / 40 / 1200 / 30 / 10
+ / + / + / 15 / 90 / 1800 / 20 / 5
+ / + / + / 16 / 60 / 1800 / 30 / 5

3. PREAPARATIONFORWORKANDOPERATINGPROCEDURE

3.1. Operation of the device can be carried out by the people who have studied all sections of the user guide and procedures of treatment.

3.2. Take the device out from the transport packing. After transportation at negative temperatures, the device should be sustained for drying at room temperature 25±10 °С for not less than 2 hours.

3.3. Connect the plug of the network cord of the device to the network socket of alternating voltage of 220 W, 50 Hz.

3.4. Switch the key switch of the network located on the back panel, in position ‘I’. After switching the unit indicator of the network will light up.

NOTE: When switching the number of mode [Р01] - [Р16] of the last program is established.

3.5. Press button " MODE ", switch the device to choose the number of the programmed mode. Digital indicator [Р01] - [Р16] should flash.

3.6. Establish the necessary number of mode [Р01] - [Р16] with buttons ◄ ►

3.7. Press button " MODE ", switch the device to choose the amplitude of magnetic inductionpulses. The digital indicator [0.2t] - [1.2t] should flash.

3.8. Establish necessary amplitude of magnetic induction pulses [0.2t] - [1.2t] withbuttons ◄ ►

3.9. Press button " MODE ", switch the device to choose an inductor. Indicators of inductors "I", "II" should flash.

3.10. Establish inductor "I" or inductor "II" with buttons ◄ ►.

3.11. Press button «MODE», switch the device in a condition of readiness for application. The digital indicator of number of mode [Р01]–[Р16] and unit indicators индукторов "I", "II" should light in a continuous mode.

3.12.Put the inductor of the device on a point of the body as it is required by a procedure of treatment.

3.13. Press button " START - STOP ", switch the device in an operating mode. On the digital indicator return readout of time of influence should be displayed.

3.14. For a forced stop of an operating mode, press button " START - STOP ".

3.15. To restart the mode, press button " START - STOP ".

3.16. The full stop of a mode is carried out:

Automatically, after end of the influence;

By the operator, after pressing button " START - STOP", during an operating mode.

3.17. After completingthe work of the device, switch the switch of the network located on the back panel, in position “0” and disconnect the plug of the network cord of the device from the network socket.

4. THE MAJOR INFORMATIONABOUT PHYSIOLOGICAL AND MEDICAL INFLUENCE OF THE PULSE MAGNETIC FIELD

The influence of a pulse magnetic field with an induction from 0.2 up to 1.2 Tesla, in contrast tovariable magnetic fields with a low induction, can be characterized by the following:

— Formation of a magnetic fieldin tissues of the induced (induction) electric current which size depends on speed of change and intensity As the living tissue practically does not interfere the magnetic field to passage through itthenplacing of an electric field occurs in regular intervals on any depth and in any tissues (bone, muscular, nervous and internal organs) where the magnetic field is distributed. The formed electric current operates on all excitable structures of the organism;

- Creation of infrasonic mechanical oscillatory movements in mediums of the organism in a zone of influence that for its turn change the excitability of cells and speed of current of many biochemical processes in bodies and tissues;

- More active influence on water systems of an organism that is accompanied by various positive shifts in reactions and the processes proceeding in a water phase.

As a result of application of the magnetic induction therapy method the excitability of a nerve muscular fibre, regeneration of injured tissues, development of collateral circulation, functioning of endocrine and exocrine glandsare stimulated, the speed of biochemical reactions and exchange processes increases .

Immediately after the procedure the anesthetizing effect is observed. It is determined by the peripheral and spinal mechanism of blocking, and then during the later period - by improvement of microcirculation and reduction of edema and inflammation. The anti-inflammatory/ antiphlogistic effect is connected with improvement of microcirculation and resorptionof decay productsin the center of inflammation, and the change of a charge and permeability of membranes determines well-defined anti-edematous effect. Due to nerve - reflex and humoral mechanisms of the magnetic induction therapy method there is a normalization of work of various organs and systems of the organism.

The basic advantages of magnetic induction therapy:

- Acceleration of cell regenerationprocess;

- Acceleration of new cells growth;

- Removal of a pain syndrome (analgetic effect)

- Antiphlogistic/Anti-inflammatory effect;

- Vasodilatation;

- Improvement oftissuemobility;

- Removal of muscle spasms;

- Strengthening of the immune system;

- Normalization of functioning of vegetative nervous system;

- Stimulation and stabilization of bone tissues;

-Stabilization of blood pressure;

- Recovery of the injured muscles and ligaments ;

- Essential increase of efficiency of medicines and taken nutrients, vitamins and minerals;

- Absence of an injurious action when influencing on normal structures of the organism;

- Simplicity in use.

1. INDICATIONS TO APPLICATION

5.1. DISEASESOFCENTRALNERVOUSSYSTEM

5.1.1.Ischemic stroke, transient disorder of cerebral circulation.

5.1.2.Consequences of craniocerebral injury andclosedinjuryof spinal cord with disordered motor function.

5.1.3.Cerebral spastic infantile paralysis

5.1.4.Hysterical paralysis

5.2.Diseases of peripheral nervous system.

5.2.1.Neuritis (neuropathy), polyneuritis (polyneuropathy).

5.2.2.Neuralgia, causalgia.

5.2.3.Hypotrophy, atrophy of muscles in result of hypodynamia.

5.2.4.Primary infectious-allergic neuritis, plexitis, polyradiculoneuritis.

5.2.5.Toxic polyneuropathy.

5.3.Diseasesofbronchopulmonary system.

5.3.1. Bronchial asthma.

5.3.2.Chronic bronchitis..

5.3.3.Pulmonary sarcoidosis

5.4.Diseasesofcardiovascular system.

5.4.1.Essential hypertension of I-IIAstages.

5.4.2.Occlusal deases of peripheral arteries atherosclerotic genesis.

5.5.Diseasesand traumatic injuries of musculoskeletal system.

5.5.1.Osteochondrosis, deforming spondylitisofspinewith effect of secondary radicular syndrome (acute pain, trophic disturbances ) in the form of cervical, thoracal, lumbosacralradiculitis.

5.5.2.Deforming osteoarthritis, gouty, psoriatic, reactive arthritis, rheumatic diseases of paraarticular soft tissues (tendonitis, tendovaginitis, ligamentitis, bursitis, periarthritis).

5.5.3.Traumatic injuries of musculoskeletal system (bruises,sprain of ligaments, fracture of bones, extensive wounds of soft tissues, sluggish wounds, trophic ulcers).

5.6.Surgical diseases.

5.6.1.Furuncule, carbuncle, hydradenitis.

5.6.2. Mastitis.

5.6.3. Prostatitis.

5.6.4. Hemorrhoids.

5.7. Diseases of digestive apparatus

5.7.1. Hyperkinetic diskinesia of a stomach, a duodenum, a large intestineand a gall-bladder.

5.7.2. Hyperkineticevacuated disfunction of a stomach after resection and vagotomy.

5.7.3. Chronic cholecystitis (uncalculous).

5.7.4. Chronic pancreatitis.

5.8 Diseases of urinary organs

5.8.1. Urolithiasis, ureteral calculus, state after lithotripsy.

5.8.2. Аtonyof urinary bladder, asthenia of sphincter.

5.9. Diseases of genitals.

5.9.1. Chronic inflammatory diseases of the uterus and appendages.

5.9.2. Inflammatory diseases caused by hypofunction of ovaries.

5.9.3. Malesexualdisorders, impotence.

5.10. Dental diseases.

5.10.1. Parodontosis.

5.10.2. Filling pains.

5.10.3. Neuralgias of II-III branch of trigeminus.

Note: With the purpose of reduction of the instruction size, some treatment procedures of separate diseases are not given. For their specification it is necessary to address directly to the manufacturer

6. CONTRA-INDICATIONS TO APPLICATION *

6.1. Malignant neoplasms.

6.2. System diseases of blood.

6.3. Sharp festering diseases of skin and hypodermic cellular tissue, purulent complications of open traumatic injuries musculoskeletal of system.

6.4. Fractures of bones beforeimmobilization and fixings, myorrhexis, rupture of vessels and sinews which demand operative intervention (before putting in stitches).

6.5. Susceptibility to bleeding.

6.6. Blood hypo coagulation.

6.7. Recurrent thromboembolism.

6.8. Thrombophlebitis.

6.9. Thyrotoxicosis.

6.10. Decompensatedstate on the part of cardiovascular system.

6.11. Implanted electric cardiostimulator.

6.12. Myocardial infarction

6.13. Cardiac rate abnormalities (fibrillation,extra systole).

6.14. High grade hypotonia, bradycardia.

6.15. Essential hypertension ofII B and III stages.

6.16. Septic endocarditis, sepsis, urosepsis.

6.17. Bronchial asthma of II stage, hormone-dependent forms.

6.18. Ureteral calculus in diameter of more than 1 cm, kidney block.

6.19. Pregnancy.

6.20. Epilepsy.

7. POSSIBLE COMPLICATIONS

7.1. Short-term aggravation of a pain symptom. In this case the size of the magnetic induction and duration of influence are reduced.

7.2. Lowering of blood pressure, collapse when influencing on the area of the neck and vegetative ganglia

.

8. THE ORDER OF CARRYING OUT OF PROCEDURES

8.1. Before the beginning of procedure give a convenient positionto the patient. The procedure can be carried out both with contact when the inductor adjoins to a skin surface, and distantly through gauze and other bandages, including splint and plaster. Thus the humidity of bandages has no value. Metal splints, alien metal bodies in soft and bone tissues do not prevent carrying out of induction therapy.

8.2. Application of induction therapy on the area of heart, eyes, and testicles is not recommended.

8.3. It is forbidden to apply the device at the presence of pregnant women.

8.4. Two procedures of influence - stable and scanning are applied. The stable one is justified at influence on a small area of the body or the pathological center. The scanning procedure of influence is used on the big surfaces and areas of the body such as a backbone, extremities, etc. To influence on a trunk of the nerve, an impellent point of a muscle/motor plate, area of face, neck, fine joints apply inductorI-40 with diameter of40 mm, and in all other cases - inductor II-100 with diameter of100 mm.

8.5. When choosing the optimum modes of influence it is possible to be guided by the following main principles:

- At subacute and chronic inflammatory processes, at injuries of the neuromuscular apparatus, for stimulation of processes of regeneration of the injured tissues, table 2;

Table 2

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.6; 0.8; 1.0 / 3 / 15 / 20 / 5
0.6 / 5 / 15 / 20 / 10
0.6 / 7 / 30 / 20 / 5
0.4 / 9 / 30 / 20 / 10

—at acute inflammatory process and acute form of painsyndrome, table 3;

Table 3

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.4; 0.6 / 11 / 50 / 20 / 5
0.4; 0.6 / 15 / 90 / 20 / 5

—atacuteinflammatoryprocesses, acuteformofpainsyndrome, by effecting on the face, cervical spine, intercostal nerves, table 4;

Table 4

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.6; 0.8; 1.0 / 3 / 15 / 20 / 5
0.4; 0.6 / 7 / 30 / 20 / 5

- At chronic inflammatory processes, for stimulation of processes of tissueregeneration, stimulation of the neuromuscular apparatusandextremities, table 5;

Table 5

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.4; 0.6 / 5 / 15 / 20 / 10
0.4 / 9 / 30 / 20 / 10

—muscular stimulationatacuteprocesses, table 6;

Table 6

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency серий, серий/min / Action time,
min
1.0; 1.2 / 2 / 12 / 20 / 5

—muscular stimulationatchronicprocesses, table 7;

Table 7

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency серий, серий/min / Action time,
min
1.0; 1.2 / 1 / 8 / 12 / 10

9. PROCEDURES OF TREATMENT AND DOSAGE

The procedures described below can be applied for device SETA-D-1 with two inductors I-40 and I-100. In other cases, apply procedures according to the doctor’s prescription.

10. DISEASESOFCENTRALNERVOUSSYSTEM

10.1.1. Ischemic stroke, transientdisorder of cerebral circulation

The methodof magnetic induction therapy of neuromuscular system on the side of a paralysis is meant for theafferent pulsation from periphery into the central nervous system and the transcranial stimulation of temporarily inactivated nervous elements close to ischemic center of brain.

The first course of magnetic induction therapy is prescribed in 10- 15 days from the moment of an ischemic insultoccurrence. During that period both paretic muscles of flexural and extension groups are stimulated. On application of further courses if hypertone in paralyzed muscles occurs, these muscles are not stimulated, and the muscles antagonists (extensors of extremities)are effected.

Operation factors: table 8

—treatment course of 10 — 15 times.

Table 8

Amplitude of magnetic induction pulses, Tl / Number of modeа / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.8; 1.0 / 3 / 15 / 20 / 5
0.6 / 7 / 30 / 20 / 5

When carrying out of the further courses of treatment as spasticity and contraction in muscles occur, stimulation is made on only overdistended muscles. The operating mode is according to table 9.

Table 9

Amplitude of magnetic induction pulses, Tl / Number of modeа / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.6 / 5 / 15 / 20 / 10
0.4 / 9 / 30 / 20 / 10

Procedure.

The neuromuscular apparatus/systemon the side of hemiparesis is stimulatedby a stable procedure.

In consistently contact way inductor I-40 is established on an internal surface of the shoulder (the projection of the median and ulnarnerves).

Inductor I-100 is placed on an internal surface of the forearm (flexor muscles of hands and fingers). Further inductor I-40 is transferred to an external surface of the shoulder (the projection of aradialnerve), and inductor I-100 is transferred to an external surface of the forearm (flexor muscles of hands and fingers). Then inductor I-40 is transferred to the lower extremity and is placed on the external surface of thethird of the shin (the projection of afibular nerve), and inductor I-100 is placed on

anteroexternal surface of the shin (musclesinnervated by afibular nerve). Then inductor I-40 is placed ona popliteal space (the projection of a tibial nerve), and inductor I-100 is placed on a gastrocnemius muscle. Theinfluence is carried outendfor 5 minutes in each of the zones/areas.

10.1.2. Consequences of a craniocereberal trauma and th e closed trauma of a spinal cord with impellent infringements

Application of magnetic induction therapy is recommended for the patients who haveparesis, paralyses (spastic and languid), sensitive infringements, trophic disorders and dysfunctions of pelvicorgans. Application of influence is justified within first two years after the trauma.

Operation factors: table 10

—at flabby paresis, at spastic;

—treatment course of 10 — 15 times. The course of treatment is repeated in 2— 3 months

Table 10

Amplitude of magnetic induction pulses, Tl / Number of modeа / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.6 / 5 / 15 / 20 / 10
0.4 / 9 / 30 / 20 / 10

Procedure.

Incaseofflaccid/flabbyparalysis Inductor I-40 isplacedonthe motor plate of the stimulated nerve,Inductor I-100 is placed with contact tothe muscles innervated by this nerve.

Incaseof central paralysis asimilarprocedure (10.1.1.) for stimulation of muscles, which are in the condition of hypotonus and stretched, hypotrophicallychanged, but the muscles in the condition of hypertonus and changed contracturedly, are not stimulated.

Atdysfunctionof pelvic organs, Inductor I-100 is placed firmly in contact way above symphysis pubis, andInductor I-40 is moved slowly along the perineumпо.

10.1.3. Cerebral spastic infantile paralysis

Themagneticinductiontherapyisappliedduringtheearlyperiodofdisease, whencontractionsarenotdefinedyet. attheageof 3-5. In comparison with electrostimulation the method of magnetic induction therapy doesn’t have an irritating effect on skin coverings and tolerable

by children well.

Operation factors: table 11

—treatment course of 10 — 15 times. Treatment course is repeated in each 2 — 3 months.

Table 11

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.6; 0.8 / 3 / 15 / 20 / 5
0.4; 0.6 / 5 / 15 / 20 / 10

Procedure.

InductorI-40 is used. The procedure is contactless through the linen, scanning.

Witheachpulsetheinductor ismoved paravertebrallyalong the long muscles of the back, gluteuses and along theantagonists of the spastic muscles of the lower extremities such as abductor of the thigh and anterior tibial muscle of the shin. At stiffness in knee and ankle joints the magneticinductiontherapy is applied on these joints too. At epileptic seizure the magneticinductiontherapy is not conducted

10.1.4. Hysterical paralysis

Magneticinductiontherapykeepshighelectrical muscular irritability and has a positive effect on mental state of the ill.

Operation factors: table 12

—treatment course of — 5 — 10 times.

Table 12

Amplitude of magnetic induction pulses, Tl / Number of mode / Quantity of impulses in a series / Frequency of series, series/min / Duration of work,
min
0.6 / 3 / 15 / 20 / 5
0.6 / 5 / 15 / 20 / 10
0.6 / 7 / 30 / 20 / 5
0.4 / 9 / 30 / 20 / 10

Procedure.

Inductor I-40 is used. The procedure is contact, stable.

The inductor is placed on the motor plate of the nerve –radial, ulnar, median, fibular ortibial. InductorI-100 is placedfirmly on the muscles innervated by this nerve.

Themostefficientplacementoftheinductor is found and simultaneously the ill person is treated by suggestion.

10.2. Diseasesofperipheralnervoussystem.

10.2.1. Neuritis (neuripathy), polyneuriis (polyneuropathy).

The magnetic induction therapy is the most effective method of physiotherapy at different diseases of peripheral nerves. Inthiscasethestimulationaccelerates regeneration of neural [nerve] tissue up to the recovery of muscular innervation, maintains electrical irritability and contractile function in them, improvesmicrocirculation and trophic processes, removes an irritating sign - pain efficiently.

Thismethodhasitsspecialsignificancewhen there occurtraumatic injuries of nerve trunks after reconstructive operations on the nerve.Applyingofthemagneticinductivetherapythroughbandage on the area of the stitches which stimulates the regeneration of the nerve during the earlier period before formation of the healing tissue and prevents from complication such as formation of neuroma.

Withdevelopmentofthepartial degenerationresponsethe muscle is able torespond to the dirge pulse with clonus. Atfurtherprocesseswithcompletedegenerationresponse, though the muscles stop responding to the dirge pulse by intensity of up to 1.2 Tl, the influence is conducted in this case too.

Operation factors: table 13

—treatment course of 10 – 15 times. Thetreatmentcoursesarerepeated until recovery of muscular innervation and appearanceof active clonus. The interval between the courses is 1—2 months.