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Elamed ALMAG Active User Manual

Pulsed electromagnetic field therapy device
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  • Page 2 Importer: Morulaa HealthTech Pvt Ltd., Plot No.38, First Floor, Rajeswari Street, Santhosh Nagar, Kandanchavadi, Chennai – 600096. Phone: +91 7373122211 Importer License Number: XXXXX...
  • Page 4 Importer: Morulaa HealthTech Pvt Ltd., Plot No.38, First Floor, Rajeswari Street, Santhosh Nagar, Kandanchavadi, Chennai – 600096. Phone: +91 7373122211 Importer License Number: XXXXX...
  • Page 6 Importer: Morulaa HealthTech Pvt Ltd., Plot No.38, First Floor, Rajeswari Street, Santhosh Nagar, Kandanchavadi, Chennai – 600096. Phone: +91 7373122211 Importer License Number: XXXXX...
  • Page 8 ALMAG Active English Pulsed Electromagnetic Field Therapy Device ALMAG Active Deutsch Magnettherapiegerät ALMAG Active Français Appareil de magnétothérapie ALMAG Active Italien Dispositivo per terapia magnetica ALMAG Active Español Aparato magnetoterapéutico ALMAG Active Polish Urządzenie magnetoterapeutyczne ALMAG Active Lithuanian Magnetoterapijos prietaisą...
  • Page 9 DEAR CUSTOMER, Congratula ons! You have just purchased ALMAG Ac ve Pulsed Electromagnet- ic Field Therapy Device (hereina er – Device). The Device is classifi ed as medical equipment product and is listed in the nomenclature of physiotherapeu c devices authorized for use in medical prac ce.
  • Page 10 Symbolic notations on the device Warnings and precautions related to safety and operating efficiency Type BF working part. The working part of the device is protected with reinforced insulation The mark defines the device as complying to Class II in terms of electrical safety according to EN 60601-1 User Manual.
  • Page 11 TABLE OF CONTENTS 1. WARNINGS AND SAFETY INSTRUCTIONS ............6 2. PURPOSE AND OPERATING PRINCIPLE ............... 9 3. SCOPE OF DELIVERY ................... 11 4. INDICATIONS FOR USE ..................11 5. CONTRAINDICATIONS ..................12 6. SIDE EFFECTS ...................... 14 7. PREPARATION FOR USE ..................15 8.
  • Page 12 - facial nerve neurtis ..................38 - radial nerve neuritis ..................39 - ulnar nerve neuritis ..................40 - median nerve neuritis .................. 40 - sciatic nerve (ischias) neuritis ..............40 - peroneal nerve neuritis ................41 - plexitis ......................42 - neuralgia ......................
  • Page 13 1. WARNINGS AND SAFETY INSTRUCTIONS Please, read this User Manual prior to proceeding with medical or prophylac c procedures using the device. To protect the device from damage, keep it out of the reach of children if unsupervised. Visually inspect the device before you start performing treatment. DO NOT use the device in case its housing or cable is damaged! Store and use the device in a dry room.
  • Page 14 Precautions for therapeutic use: Use the device in locations where control unit can be comfortably connected to the socket and cable tension can be avoided during operation. DO NOT: • use the device with mechanically damaged control unit housing and/or control unit cable and/or inductor coils;...
  • Page 15 This device produced by ELAMED complies with the requirements of EN 60601-1-2:2015 concerning the immunity to EM interference and emi ed radia on.
  • Page 16 2. PURPOSE AND OPERATING PRINCIPLE The device is intended to provide physiotherapeu c treatment as well as recov- ery and rehabilita on measures using a low-frequency pulsed magne c fi eld, either in medical facili es or at home, upon the recommenda on of a doctor. The device consists of the control unit (current pulse generator) and an emi er comprising four interconnected inductor coils used to provide exposure to individ- ual parts of the body.
  • Page 17 Matrix layout of the inductor coils Inductor coils are combined into two groups of two coils per group. The groups may be confi gured in the form of 2x2 matrix and/or «spline» composed of four inductor coils. «Spline» emi er confi gura on is achieved using corresponding fas- tener included in delivery.
  • Page 18 3. SCOPE OF DELIVERY • ALMAG Active Pulsed Electromagnetic Field Therapy Device • Spline fastener • Strap • Magnetic field indicator • User Manual • Retail package 4. INDICATIONS FOR USE Musculoskeletal system diseases: - osteochondrosis - humeroscapular periarthrosis - osteoarthritis...
  • Page 19 - radial nerve neuritis - ulnar nerve neuritis - median nerve neuritis - sciatic nerve (ischias) neuritis - peroneal nerve neuritis - plexitis - neuralgia - trigeminal neuralgia - occipital neuralgia - intercostal neuralgia Pancreatic diabetes complications: - diabetic angiopathy - diabetic polyneuropathy Diseases of venous system: - deep vein thrombosis of the lower leg...
  • Page 20 • malignancies*; • condi ons preven ng from procedure performing: alcohol and drug intoxica- on, psychomotor agita on of any genesis; • uncompensated arterial hypertension of Class 3, arterial hypertension crisis of any class; • arterial hypotension (SBP < 90 mm Hg, DBP < 65 mm Hg); •...
  • Page 21 6. SIDE EFFECTS In order to avoid adverse events including increase in arterial blood pressure and comorbid diseases, do not exceed the exposure me as specifi ed in the Direc ons for Use Chapter of this User Manual, defi ned in sec ons «General rules of proce- dure sequence»...
  • Page 22 7. PREPARATION FOR USE In case the device was transported or stored for a long me at temperatures below 10 °С, fi rst keep it at least 2 hours at a temperature in between 10 °С and 35 °С before turning on. Ensure that there is no mechanical damage to the cable and the housing of the device.
  • Page 23 • Should you have ques on(s) and/or concerns during treatment and rehabil- ita on using the device, please, consult with your a ending doctor. You can also seek for advice on the manufacturer’s offi cial website (en.elamed.com).
  • Page 24 • The dura on of the procedure and the treatment modes is determined indi- vidually taking into account the pa ent’s age. The recommended combina ons of the procedure dura on and treatment mode are indicated in sec on «Fea- tures of the methodology of device use in various age categories of pa ents».
  • Page 25 • When using the device for its intend- ATTENTION! ed purpose, pay a en on to the correct When performing procedures, placement of the emi er on the body: locate the emitter with the all the methods s pulate for ac ng by working surface of inductors the north magne c pole of the inductor with the «N»...
  • Page 26 A en on! It is not recommended at the same me (on the same day) to treat two diff erent diseases. A en on! In case the exposure results in the blood pressure increase or de- crease by 10 to 25 mm Hg during the fi rst 6 days of treatment (Mode 3), reduce the treatment dura on by 1/3 during the next ses- sion and apply Mode 2 during the next 3 days of treatment.
  • Page 27 When using the four inductor coils confi gured in the form of «spline», the spline fastener (herea er the fastener) is required. The fastener fi xes the coils together preven ng them from traveling rela ve to each other. Place the inductor coils into the fastener stepwise according to the «spline» ar- rangement as follows: •...
  • Page 28 • Place the rest 1 and 2 inductor coils into the fastener and fi x them with velcros. • Zip up the fastener. USER MANUAL...
  • Page 29 • Four inductor coils are now arranged in the form of «spline». • Use the accessory straps delivered with the device to fi x the «spline» to the extremi es. Locate the straps over the zipper and fi x them with velcros. Where 2х2 matrix inductor coil confi...
  • Page 30 Connect the power cord of the device to the 230 V power network outlet. A en on! Locate the device at the site comfortable for use. Avoid tension of power cord and emi er cable. Only use working (fault-free) power socket.
  • Page 31 8.2. Treatment Modes Set the desired exposure mode using the «Mode Select» bu on switch. The desired mode is selected by pressing the «Mode Select» bu on (Mode 1 – Mode 2 – Mode 3 – Mode 1) in sequence, and a sound signal is heard repeatedly where the number of repe ons corresponds to the mode number.
  • Page 32 The treatment is ini ated and terminated by pressing the «START/ STOP» bu on and is accompanied by sound signal and non-fl ashing glow of the «START/STOP» bu on LED indicator. The exposure (treatment dura on) is set automa cally to 20 minutes for all the treatment modes.
  • Page 33 Once the exposure is completed (or terminated forcedly), the «START/STOP» bu on LED indicator blinks off and the sound signal is heard. A er the comple - on of the treatment, the device waits for 5 minutes and then switches to standby mode.
  • Page 34 8.3. Age-specific dosage prescriptions Applying treatment to pa ents over 15 years old During the treatment, the procedure dura on and the treatment mode are cho- sen in accordance with Table 2. Table 2. Course treatment procedure of patients over 15 years old Treatment day Mode Interruption/Break...
  • Page 35 Table 3. Course treatment procedure for patients at the age of 4 weeks to 1 year old Treatment day Mode Duration (min.) Treatment day Mode Duration (min.) Table 4. Course treatment procedure for patients 1 to 3 years old Treatment day Mode Duration (min.) Treatment day...
  • Page 36 Table 5. Course treatment procedure for patients 3 to 7 years old Treatment day Mode Duration (min.) Treatment day Mode Duration (min.) Table 6. Course treatment procedure for patients 7 to 15 years old Treatment day Mode Duration (min.) 10-12 10-12 10-12 10-12...
  • Page 37 8.4. Inductors application to deliver disease-specific procedures Musculoskeletal system diseases: • ОSTEOCHONDROSIS Locate the inductor coils pairwise in parallel along the spine over the long back muscles in such a way that the vertebrae of concern are between the inductor coils (see Figure 1).
  • Page 38 In case of osteochondrosis complicated by radicular syndrome, the treatment is first applied onto the affected area of the spine, after which the device must be turned off, wait for 10 minutes, a line of emitters is installed along the affected nerve covering the nerve root and treat the second area, as shown in Figure 3.
  • Page 39 • OSTEOARTHRITIS In case of osteoarthritis of one joint, a line of four inductors is spirally wrapped around the joint covering the surrounding tissue as shown in Figure 5. If it is necessary to treat two knee joints, one pair of inductors is applied to one affected joint, the second pair to the second, as shown in Figure 6.
  • Page 40 If the hip joint is damaged, a line of four emitters is placed on the projection of the hip joint from the inguinal region through the large trochanter of the tibia (the most protruding part) to the sacral region, as shown in Figure 8. In case of bilateral lesion of hip joints, the procedures are carried out alternately on one and another joints.
  • Page 41 • ЕPICONDYLITIS The inductor coils are located around the injured joint. In case of shoulder epicondylitis, the inductor coils are applied around the joint, as shown in Figure 10. With epicondylitis of the shoulder joint, in order to increase the treatment effectiveness, the device should act on two areas alternately.
  • Page 42 Injuries and their after-effects: • BONE FRACTURES IMPORTANT! In case of bone fracture, the treatment with the device is started on the 3 or 5 day from the injury occurence. The inductor coils are installed on a plaster cast or directly on a limb during traction, along or around the bone, as shown in Figures 12 and 13.
  • Page 43 • INTERNAL JOINT INJURIES IMPORTANT! In case of hemarthrosis (presence of blood in the joint cavity), the procedures are carried out only after removal of blood from the joint cavity, as directed by the doctor. A line of four inductors are spirally wrapped around the injured joint covering the surrounding tissue, as shown in Figures 14 to 18.
  • Page 44 • POSTTRAUMTIC EDEMA IMPORTANT! The treatment by the device is started no earlier than 12 hours from the moment of the occurence of the injury. The procedures are carried out twice a day during 10 to 15 minutes. The inductor coils are situated along the lesion focus.
  • Page 45 • VERTEBRAL COLUMN AND SPINAL CORD TRAUMAS The patient’s in prone or supine position. A line of four inductors are positioned along the spine. If for any reasons it is prohibited to turn the patient over; he/she can be slightly lifted and the inductors are put under the affected area of the spine so that the first inductor is located closer to the head, and in the injury area it is necessary to apply one of the other three inductors.
  • Page 46 • RADIAL NERVE NEURITIS A line of four inductors is applied (sequentially) onto the internal nude surface of the lower third of the shoulder, forearm and hand according to the following scheme: 1) the patient is in lying position; 2) the affected arm is laid with its palm up; 3) the first inductor lies on the region of the ulnar fossa, then it is necessary to spirally wrap the forearm with inductors so that the fourth inductor lies down on the palm, as shown in Figure 20.
  • Page 47 • ULNAR NERVE NEURITIS A line of four inductors is applied onto the hand of the affected extremity from the palm side, on the area of wrist and on the forearm, as shown in Figure 21. The device’s inductors are located from fingers to forearm. •...
  • Page 48 • PERONEAL NERVE NEURITIS For convenience, the procedure is recommended to be carried out on the patient while he/she is lying on his/her stomach. The first inductor of the line of four inductors is installed on the upper part of the popliteal fossa, the other three ones are placed on the calf outer surface from the affected side, as shown in Figure 22.
  • Page 49 • PLEXITIS Treatment procedure in case of brachial plexitis The procedure is carried out on the patient lying on his/her back, but it is also possible on seated one. The first and the second inductors of the line of four inductors are applied onto the area of the clavicle and shoulder joint (projection of the brachial plexus), the third and the fourth ones are located along the inside of the affected arm, as shown in Figure 23.
  • Page 50 NEURALGIA • TRIGEMINAL NEURALGIA One pair of inductors is superimposed on the projection of the exit point of the trigeminal nerve, depending on which branch of the nerve is affected: - point 1 is on the upper orbital margin and is palpated 1.5 cm off the sides of the middle of the nose bridge (Fig.
  • Page 51 • OCCIPITAL NEURALGIA One pair of inductors is superimposed on the projection of the exit point of the occipital nerve and the posterior surface of the neck, as shown in Figure 25. • INTERCOSTAL NEURALGIA A line of four inductors is placed on the corresponding segment of the spine on both sides and along the affected nerve endings, as shown in Figure 26.
  • Page 52 Pancreatic diabetes complications: • DIABETIC ANGIOPATHY АND POLYNEUROPATHY In the treatment of diabetic polyneuro- and angiopathy, firstly, a line of four inductor coils is located on the front surface of the calf and lower, down to the back of the foot (Fig. 27a). After the end of the exposure, shutdown the device, take a break of 10 minutes, shift the line of four inductor coils to the front inner surface of the thigh, turn on the power and carry out the procedure (Fig.
  • Page 53 Diseases of venous system: • DEEP VEIN THROMBOSIS OF THE LOWER LEG • CHRONIC THROMBOPHLEBITIS • VARICOSE VEINS In case of such diseases, a line of four inductor coils is located along the calf back surface up to the lower third of the thigh. In order to increase the effectiveness of the treatment of varicose veins and its complications, the combined use of magnetotherapy and external drugs prescribed by the attending physician in accordance with the treatment standards, the use of the...
  • Page 54 In case of trophic ulcer in the lower leg, the ulcer is cleaned before the procedure, a clean dressing is applied, and during the procedure, one of the emitters is placed on the projection of the ulcer. Fig. 29. Application of inductor inductors when treating trophic ulcers in calves USER MANUAL...
  • Page 55 9. OPERATING REPAIR General instruc ons Opera ng repair of the device will be carried out by the manufacturer or its representa ve offi ce based on technical examina on by manufacturer’s represent- a ves to determine the nature and extent of the malfunc on. Symptoms of the malfunc on are: - mechanical damage to the power supply unit or coil group casings;...
  • Page 56 10. MAINTENANCE Maintenance of the device does not require special skills, and it will be conduct- ed by representa ves of the healthcare ins tu on where the device is operated, or by the user himself/herself at home. Maintenance scope includes preven ve inspec on and monitoring of the techni- cal condi on of the device including: •...
  • Page 57 Parameters and specifi ca ons of pulsed magne c fi elds Field types: • «traveling» fi eld where series exci ng of all the inductor coils occurs; • «sta onary» fi eld where simultaneous exci ng of all the inductor coils occurs. Opera on modes are summarized in the Table 1.
  • Page 58 The device provides data storage in the internal non-vola le RAM including the last set treatment mode saving and retrieval. The le er «N» on the body of each inductor coil corresponds to the north pole of the magne c fi eld induced by the inductor coils. Class of device –...
  • Page 59 14. ANNEX А Table 1 Manufacturer's manual and declaration – electromagnetic emission These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure its use in the specified electromagnetic environment. Electromagnetic Compliance Electromagnetic environment –...
  • Page 60 Table 2 Manufacturer’s manual and declaration – interference resistance These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure its use in the specified electromagnetic environment. Interference The test level Compliance Electromagnetic environment –...
  • Page 61 Table 3 Manufacturer’s manual and declaration – interference resistance These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure its use in the specified electromagnetic environment. Interference The test level Compliance Electromagnetic environment –...
  • Page 62 15. ENVIRONMENTAL RESPONSIBILITY The external covers of the device are made of high-quality plas cs and can be recycled and re-used as building materials. The electric and elec- tronic components are to be disposed of separately in special facili es used for this purpose under the local law.
  • Page 63 16. MANUFACTURER’S WARRANTY 1. The manufacturer guarantees the conformity of the device’s quality to the requirements of the User Manual, provided that the consumer observes the condi- ons and rules for storage, transporta on and opera on. Warranty opera ng life is 24 months from the date of sale. Warranty period of storage is 60 months from the packing date.
  • Page 64 JSC «Yelatma Instrument Making Enterprise» Tel: +7 (4912) 293-418 WARRANTY CARD for repair (replacement) during the warranty period ALMAG Active Pulsed Electromagnetic Field Therapy Device Manufacturing date ________________________ No. ____________________ Purchased _______________________________________________________ (to be filled in by the trading organization)
  • Page 65 Yelatma Instrument Making Enterprise, JSC 391351, 25 Yanina st., Yelatma, Kasimov District, Ryazan region, Russia tel. +7 (4912) 293-418 e-mail: global@elamed.com elamed.com USER MANUAL BEDIENUNGSANWEISUNG MANUEL D'UTILISATION ISTRUZIONI D'USO MANUAL DE INSTRUCCIONES KLEINGERÄT FÜR MAGNETFELDTHERAPIE APPAREIL DE MAGNÉTOTHÉRAPIE PAR CHAMP MIT WANDERIMPULSMAGNETFELD MAGNÉTIQUE PULSÉ...
  • Page 66 ALMAG-01 English Pulsed Electromagne c Field Therapy Device ALMAG-01 Deutsch Kleingerät für Magnetfeldtherapie mit Wanderimpulsmagnetfeld ALMAG-01 Français Appareil de magnétothérapie par champ magné que pulsé ALMAG-01 Italien Il disposi vo di magnetoterapia a campo pulsato corrente, compa o ALMAG-01 Español El equipo de escala reducida para la terapia magné...
  • Page 67 CONTENTS SAFETY MEASURES ....................PURPOSE AND PRINCIPLE OF OPERATION ............SCOPE OF DELIVERY ..................... INDICATIONS FOR USE ..................CONTRAINDICATIONS ................... SIDE EFFECT ......................THE ORDER OF USE ....................Prepara on for use ..................General rules of procedures ................Procedure administra on order ..............METHODS OF TREATMENT OF VARIOUS DISEASES …………….…………....…..
  • Page 68 Radial nerve neuri s..................Ulnar nerve neuri s ..................Median nerve neuri s ..................Icia c nerve (ischias) neuri s ................Peroneal nerve neuri s ..................Plexi s ......................NEURALGIA ......................Trigeminal neuralgia ..................Occipital neuralgia .................... Intercostal neuralgia ..................TRAUMAS OF CENTRAL NERVOUS SYSTEM ............
  • Page 69 You can also seek advice by phone +7 (4912) 293-418 or on the offi cial website of the manufacturer en.elamed.com. Be sure to keep the User Manual throughout the whole service life of the device.
  • Page 70 Marking Warnings and precau ons related to safety and opera ng effi ciency Type BF working part. The working part of the device is protected with reinforced insula on The mark defines the device as complying to Class II in terms of electrical safety according to EN 60601-1 User Manual.
  • Page 71 SAFETY MEASURES Please study this User Manual carefully before use. Examine the device before use carefully. Make sure that all parts of the device are undamaged. CAUTION! Do not use the device if its case, emit- ters, or cables are damaged. Make sure the cable is not twisted or taut.
  • Page 72 • Use of the components and cables diff erent from the supplied together with the set of the device may result in increased emission or failures in the device opera on. Excep on: components supplied by ELAMED Company as spare parts.
  • Page 73 PURPOSE AND PRINCIPLE OF OPERATION ALMAG has been designed for therapeu c treatment of the human body by means of pulsed electromagne c fi eld, to be performed either by medical staff at physiotherapy departments of healthcare facili es, or by individual pa ents at home. ALMAG consists of: - a control unit (pulse generator) connected to four emi ers;...
  • Page 74 Unplug the device a er the treatment session is over. Flashing green indicators in the center of each of the four emi ers indicate that the magne c fi eld is ac ve, and ALMAG is func oning properly. During opera on the indicators should fl...
  • Page 75 SCOPE OF DELIVERY ALMAG-01 Pulsed Electromagne c Field Therapy Device User Manual Consumer packaging Pulsed electromagne c fi eld (PEMF) indicator INDICATIONS FOR USE Musculoskeletal system diseases: - osteochondrosis - deforming osteoarthri s - humeroscapular periarthrosis - arthri s - epicondyli s - gout - bursi s - myosi s...
  • Page 76 Diseases of peripheral nervous system: - neuri s - facial nerve neuri s - radial nerve neuri s - ulnar nerve neuri s - median nerve neuri s - scia c nerve (ischias) neuri s - peroneal nerve neuri s - plexi s - neuralgia - trigeminal neuralgia...
  • Page 77 CONTRAINDICATIONS - acute infec ous diseases and purulent-infl ammatory processes in the acute phase - pregnancy - diseases and condi ons associated with reduced blood clo ng (including sys- temic blood diseases), con nuing bleeding of any localiza on - malignancies - alcohol intoxica on - cardiovascular diseases accompanied by hemodynamic instability: crisis course of grade 3 arterial hypertension;...
  • Page 78 SIDE EFFECT In order to avoid adverse events associated with impaired adapta on mecha- nisms of pa ents (increased blood pressure, exacerba on of concomitant diseases), do not allow an increase in the exposure me specifi ed in the sec ons «General rules of procedure sequence»...
  • Page 79 THE ORDER OF USE Prepara on for use A er storage or transporta on at temperatures below +10 °C or above +35 °C, keep the device in a room at a temperature from +10 °C to +35 °C for at least 4 hours prior to plugging it in.
  • Page 80 Carry out the treatment sessions (usually 10-20 for the treatment course) at reg- ular intervals, preferably before meal. It is not recommended to have meal for at least 1 hour a er the treatment session. The fi rst few sessions of a treatment course should be carried out daily and should take no longer than 10 minutes.
  • Page 81 Procedure administra on order 1. Remove the device from the consumer container. 2. Before the fi rst use of the device, disinfect it in accordance with the procedure described in the sec on «Prepara on of the device for use». 3.
  • Page 82 METHODS OF TREATMENT OF VARIOUS DISEASES MUSCULOSKELETAL SYSTEM DISEASES Osteochondrosis In case of procedures in the exacerba on period, exposure is applied only to the spine, and maximum dura on of one procedure is 15 minutes. Before the pro- cedure, the device is placed on a couch (bed), a er which the pa ent lies on the device with the aff...
  • Page 83 In case of subacute osteochondrosis, complicated by radicular syndrome, the ex- posure is fi rst applied to the aff ected spine (5 minutes), and then immediately to the aff ected nerve (5 minutes). In the fi rst 6 days, the procedures are carried out for 5 minutes for 2 mes a day, and on the 13th day of treatment, a one-day break is taken.
  • Page 84 Fig. 5 Fig. 6 Fig. 7 Then, for six days, the procedures are carried out 2 mes a day during 5 minutes per joint. On the seventh day, a break should be taken, and the next six days the procedure are carried out 2 mes a day for 8 minutes per joint. On the 13th day of treatment, a one-day break is again made, a er which during the next six days, the procedures are carried out once a day.
  • Page 85 a day during 8 minutes. On the seventh day, a break should be taken, and the next six days the procedure are carried out 2 mes a day for 10 minutes. On the 13th day of treatment, a one-day break is again made, a er which during the next six days, the procedures are carried out once a day for 20 minutes.
  • Page 86 Epicondyli s The procedures are carried out twice a day. The inductor coils are located around the injured joint. In case of shoulder epicondyli s, the coils-inductors of the device are applied around the joint (Fig. 9). The procedures are carried out once or twice a day for 10 minutes. The course of treatment is 20 days with a one-day break a er the 10th day of therapy.
  • Page 87 last inductor is located on the bu ock, the two middle inductors are located on the side surface of thigh, and the fi rst is applied above the inguinal fold (Fig. 7). The procedures are carried out twice a day with an interval of at least 6 hours. The fi...
  • Page 88 again taken. If necessary, the treatment is prolonged for another six days, and the procedures are carried out for 10 minutes 1 or 2 mes a day. Tenosynovi s The treatment is started a er acute symptoms remi ng. The treatment method is similar to the therapy in case of epicondyli s.
  • Page 89 The emi ers are placed around the aff ected joint (for an example of a knee joint treatment, see Fig. 5). Procedures are to be carried out 2 mes a day. Procedures dura on is 10-15 min. The course length is 18 days. In case if the trauma requires joint immobiliza on, the suppor ng treatment course is carried out in 30-40 days.
  • Page 90 bacterial therapy or local an sep cs, in the absence of acute infec ous infl amma on, upon the recommenda on of the a ending physician. The coils-inductors are applied over a wet or dry gauze dressing (a er wound cleaning) along the aff...
  • Page 91 Table 2 The repeated course procedures dura on Treatment day Total dura on for one area (min.) 15-20 15-20 15-20 15-20 15-20 15-20 Interrup on Treatment day Total dura on for one area (min.) 15-20 15-20 15-20 15-20 15-20 15-20 Interrup on Treatment day Total dura on for one area (min.)
  • Page 92 Ulnar nerve neuri s The device is applied in such a way that the first inductor is located closer to the spine. (see Fig. 14). Median nerve neuri s Coils-inductors are applied onto the hand of the affected extremity from the palm side, on the area of wrist and on the forearm (see Fig.
  • Page 93 Fig. 14 Fig. 15 Fig. 16 The treatment of lumbosacral plexi s using the ALMAG device is carried out ac- cording to the same regimen as the treatment of lumbosacral osteochondrosis with radicular syndrome. NEURALGIA In case of trigeminal neuralgia, occipital nerve and intercostal neuralgia, the de- vice is applied so that the fi...
  • Page 94 Fig. 18 Fig. 17 Fig. 19 Occipital neuralgia Two emi ers are placed on the skin projec on of the output point of the occipital nerve and the back surface of the neck (see Fig. 18). Intercostal neuralgia A line of emi ers is applied to the corresponding intercostal space along the af- fected nerve termina ons (see Fig.
  • Page 95 methodology indicated in Table 1. The treatment course is repeat- ed in 1 month. When carrying out repeated courses of treatment, the technique indicated in Table 2 is used. Disorders of the spinal blood circula on The pa ent’s posi on is lying on the stomach or on the back. Emi ers are placed along the vertebral column covering the cer- vical part.
  • Page 96 Diabe c polyneuropathy The coils-inductors are applied in their respec ve turn on the back surface of calf and then on the back of thigh (see Fig. 22, 23): - Field # 1 – the popliteal fossa and the sural muscle; - Field # 2 –...
  • Page 97 The fi rst emi er is placed on the trophic ulcer area (gauze band- age) and the others along the aff ected veins. Procedure me is 10-15 minutes. The course length is 15-20 days, with 1-day breaks a er the 6th and the 12th days of treatment. Since the disease is chronic and requires a long suppor ng treatment in order to avoid relapses, a repeated course is to be taken a er an interval of 40 days.
  • Page 98 SPECIFICATIONS AC power supply ~230V (-32V; +23V), frequency 50Hz Power consump on 51 V • Weight, not more than 0.8 kg Overall dimensions: - Power supply unit 135±10 х 58±5 х 44±5 mm - Emi er (single piece) 90±5 x 15±5 mm Note: max devia on: ±3%.
  • Page 99 LIST OF STANDARDS EN ISO 10993-1 EN 60601-1-11 EN 60601-1 EN 62304 EN 60601-1-2 STORAGE AND TRANSPORTATION STORAGE CONDITIONS TRANSPORT CONDITIONS OPERATING CONDITIONS 100% +40 C +50 C +35 C - 0 C - 0 C +10 C ANNEX А Table 1 Manufacturer's manual and declaration –...
  • Page 100 Table 2 Manufacturer’s manual and declaration – interference resistance These devices are intended for use in the electromagne c environment specifi ed below. The customer or the user of the device should ensure its use in the specifi ed electromagne c environment. Interference The test level according to Compliance...
  • Page 101 Table 3 Manufacturer’s manual and declaration – interference resistance These devices are intended for use in the electromagne c environment specifi ed below. The customer or the user of the device should ensure its use in the specifi ed electromagne c environment. Interference The test level Compliance...
  • Page 102 ENVIRONMENTAL RESPONSIBILITY The external covers of the device are made of high-quality plas cs and can be recycled and re-used as building materials. The electric and elec- tronic components are to be disposed of separately in special facili es used for this purpose under the local law.
  • Page 103 MANUFACTURER’S WARRANTY The manufacturer hereby guarantees that the quality of the device conforms to the requirements of the user manual, provided that the condi ons of proper trans- porta on, usage, and storage are met. Warranty period is 36 months a er date of sale. Within the Warranty period, the manufacturer shall repair or replace the defec- ve device or its parts free of charge upon presenta on of the Warranty sheet.
  • Page 104 Manufacturer’s address: 391351, 25, Yanina st., Yelatma, Kasimov District, Ryazan region, Russia JSC «Yelatma Instrument Making Enterprise» Tel: +7 (4912) 293-418 WARRANTY SHEET for repair (replacement) within warranty period of ALMAG-01 Pulsed Electromagnetic Field (PEMF) Therapy Device (Trademark ALMAG ® Manufacturing date ________________________ No.
  • Page 105 USER MANUAL OM 29.520.03 OM Revision Date – March 21, 2023...
  • Page 106 ALMAG-02 English Pulsed Electromagne c Field Therapy Device ALMAG-02 Deutsch Gerät für Magne eldtherapie ALMAG-02 Français L‘appareil de magnétothérapie ALMAG-02 Italien Il disposi vo di magnetoterapia ALMAG-02 Español El equipo de magnetoterapia...
  • Page 107 CONTENTS SAFETY MEASURES ....................PURPOSE AND PRINCIPLE OF OPERATION ............SCOPE OF DELIVERY ..................... INDICATIONS FOR USE ..................CONTRAINDICATIONS ................... SIDE EFFECT ......................THE ORDER OF USE ....................Prepara on for use ..................General rules of procedures ................Device opera on order ................... TYPES OF MAGNETIC FIELDS ................
  • Page 108 Calcaneal periostosis (plantar fascii s), heel spur Joint contracture (Dupuytren`s contracture) Rheumatoid arthri s (exuda ve stage) Osteoarthri s For severe cases and synovi s Without synovi s Vertebral osteochondrosis Posterior cervical sympathe c syndrome Vertebrobasilar syndrome (refl ex compressive syndrome of the vertebral artery) Vertebrogenic myelopathy syndrome Osteoporosis with and without pathologic fracture TRAUMAS ......................
  • Page 109 Other muscles and tendons’ trauma at the level of ankle joint and foot Nerve traumas at the level of forearm Ulnar nerve trauma at the level of forearm WRIST AND HAND TRAUMAS ................Finger contusion without nail bed injury Finger contusion with nail bed injury TRAUMAS INVOLVING SEVERAL BODY REGIONS ..........
  • Page 110 You can also seek advice by phone +7 (4912) 293-418 or on the offi cial website of the manufacturer en.elamed.com. Please keep the User Manual throughout the whole service life of the device. When handing the device over to another user, please make sure to hand in the Manual as well.
  • Page 111 Marking Warnings on safety and effi cacy of opera on The mark defi nes the device as complying to Class II in terms of electrical safety according to IEC 60601-1 Read the User Manual carefully Emi ers are protected with reinforced insula on Duty cycle: work: 30 min, a pause: 5 min Medical Device Manufacturer...
  • Page 112 Medical devices also should not disturb func oning of other devices. This device manufactured by ELAMED Company meets the require- ments of EN 60601-1-2:2015 (IEC 60601-1-2014) in terms of resistance to electromagne c interference and radia on emi ed.
  • Page 113 PURPOSE AND PRINCIPLE OF OPERATION The device is intended for therapy of a wide range of diseases with low-frequency, low-intensity pulsed electromagne c fi eld. The device is designed for trea ng pa ents with acute and chronic diseases of internal organs, cardiovascular, bronchopulmonary, nervous system and locomotor system diseases, traumas, postopera ve complica ons, dysimmunity.
  • Page 114 Flexible emi ng lines Cable Pulse genera on unit Emi ers Fig. 2 Flexible emi ng line Pulse genera on unit Cable Emi ers Fig. 3 Pulse genera on unit Emi ers Cable Fig. 4 USER MANUAL...
  • Page 115 Func ons of the control and display elements The front panel of the control unit has the following controls and displays (Fig. 5): 1 – « » « » bu ons – program number setup (number downwards/ upwards); 2 – «START/STOP» bu on – switching the PEMF ac on on/off ; 3 –...
  • Page 116 SCOPE OF DELIVERY Product complete set is given in the table below. Table 1 Name Delivery op on 1 Delivery op on 2 Power and control unit Main emi er Flexible emi ng line Magne c fi eld indicator Local emi er Fixing belt Handle Rack...
  • Page 117 INDICATIONS FOR USE Diseases of nervous system: Migraine Disorders of separate nerve roots and plexuses of upper and lower limbs Diabe c polyneuropathy Postherpe c neuropathy Raynaud`s syndrome («dead fi nger» syndrome) Diseases of circulatory system: A er-eff ects of cerebrovascular diseases Atherosclero c vascular disease, endarteri s deformans or oblitera ng endarteri s Atherosclero c (discirculatory) encephalopathy...
  • Page 118 Elbow and forearm traumas: Disloca on, sprain or strain of the capsular ligamentous apparatus of the elbow joint Disloca on of head of radial bone Trauma c rupture of the radial collateral ligament Nerve trauma at the forearm level: Ulnar nerve trauma at the forearm level Wrist and hand traumas: Finger contusion without nail plate injury Finger contusion with nail plate injury...
  • Page 119 CONTRAINDICATIONS - acute infec ous diseases and purulent-infl ammatory processes in the acute phase, febrile state; - pregnancy; - diseases and condi ons associated with reduced blood clo ng (includ- ing systemic blood diseases), con nuing bleeding of any localiza on; - malignancies;...
  • Page 120 SIDE EFFECT In order to avoid adverse events associated with impaired adapta on mechanisms of pa ents (increased blood pressure, exacerba on of the symptoms of concomitant diseases), do not allow an increase in the recom- mended exposure me and follow the rules and procedures recommended by this User Manual.
  • Page 121 THE ORDER OF USE Prepara on for use A er storage in cold premises, the device should be kept at room temper- ature for four hours before use. Examine the device before use carefully. Make sure that all parts of the device are undamaged.
  • Page 122 Press the «POWER» switch to ac vate the de- vice, while the ac ve state indicators will light on the emi ers’ pulse genera on unit, and the control unit display box will be showing the number of the last program used. A dot will light in the right bot- tom corner of the display (Fig.
  • Page 123 For a convenient arrangement of the fl exible lines of the main emi er and the individual fl exible line to form a «solenoid», use the emi ers’ ac- cessories set. The arrangement of these accessories is shown in Fig. 11, 12. Fixing belt Fig.
  • Page 124 Fig. 14 Local emi ers Screw Holder Stand Basis Fig. 15b Handle Fig. 15a For procedure convenience, the local emi ers can be fi xed onto a handle (Fig. 15a) or on a rack (Fig. 15b). The rack consists of a holder with a screw, stand and basis.
  • Page 125 General rules of procedures Before treatment start, carefully read the list of indica ons and contrain- dica ons and be sure to consult your doctor to determine the correct diag- nosis and to exclude your exis ng diseases and condi ons contraindica ng the use of the device.
  • Page 126 TYPES OF MAGNETIC FIELDS The device generates two types of pulsed electromagne c fi elds: «travel- ling» and «sta c». «Traveling» magne c fi eld The main emi er: The main emi er generates «traveling» magne c fi eld of three kinds: 1) «traveling horizontal»...
  • Page 127 2) «traveling ver cal» (Fig. 18, Fig. 19) – simultaneous excita on of the emi ers of the same posi on in all four lines (exposure cluster), followed by one-way excita on of the same neighboring emi ers according to the cyclic law;...
  • Page 128 а) Fig. 20. Traveling diagonal. The emi ers are placed: а) with the North surface facing the pa ent’s body (polarity mark – N), b) with the South surface facing the pa ent’s body (polarity mark – S). The fl exible emi ng line: In case of the separate fl...
  • Page 129 «Sta c» magne c fi eld Simultaneous excita on of all the emi ers in the whole cluster or line. (Fig. 22). Working surface Fig. 22...
  • Page 130 Annex А PARAMETERS AND FEATURES OF THE PRESET EXPOSURE PROGRAMS Emitters used Type of field and scan Field Pulse Total density repeti- expo- ampli- tion fre- sure tude, quency, time, pulses / travelling horizontal travelling travelling horizontal travelling travelling travelling horizontal travelling travelling horizontal travelling...
  • Page 131 static static sta c travelling horizontal travelling vertical travelling travelling vertical travelling ver cal travelling vertical travelling ver cal travelling ver cal travelling horizontal travelling horizontal travelling ver cal sta c travelling ver cal sta c travelling vertical travelling vertical travelling horizontal travelling horizontal travelling horizontal...
  • Page 132 static static static travelling horizontal static travelling horizontal sta c travelling vertical static travelling vertical static travelling vertical static sta c static sta c sta c travelling horizontal sta c travelling horizontal sta c sta c sta c sta c sta c sta c travelling horizontal...
  • Page 133 METHODS OF TREATMENT OF VARIOUS DISEASES NERVOUS SYSTEM DISEASES Мigraine Treatment course length – 10-12 proce- dures, one procedure per day. Program No. 3 is set. The emi ers used: fl exible emi ng line. Emi ers’ arrangement: the fl exible emit- ng line is placed on collar zone with the «N»...
  • Page 134 In case of developing paresis of the corresponding nerve Treatment course – 15 procedures, one procedure per day. The emi ers used: main emi er and fl exible emi ng line. Emi ers’ arrangement: the main emi er is placed over the cervicothorac- ic area of the vertebral column, the fl...
  • Page 135 Fig. 26a Fig. 26b Se ng of Program No.8: • The magne c fi eld direc on in the main emi er: traveling bo om-up, in the fl exible emi ng line – sta c; • Density: main emi er – 20 mT, fl exible emi ng line – 6 mТ; •...
  • Page 136 Fig. 27a Fig. 27b • Frequency: 100 Hz; • Procedure me: 15 min. A er exposure termina on, the device remains plugged in, and the main emi er is moved onto the aff ected intercostal nerves area. See Fig. 27b. Se ng of Program No.10: •...
  • Page 137 DISEASES OF CIRCULATORY SYSTEM A er-eff ects of cerebrovascular diseases The treatment course: 10-12 procedures. One procedure per day. The emi ers used: main emi er, fl exible emi ng line. Emi ers’ arrangement: the main emi er is placed over the cervicothorac- ic area of the spinal column, the head is wrapped with the fl...
  • Page 138 main emi er, while the fl exible emi ng line stays on the waist sympathe c ganglions projec on area, with the emi ers’ «N» polarity surface facing the body. See Fig. 29b. Se ng of Program No.17: • The magne c fi eld direc on in the main emi er: traveling from right to le , in the fl...
  • Page 139 Se ng of Program No.18: • The magne c fi eld direc on in the main emi er: traveling bo om-up; • Density: 20 mT; • Frequency: 100 Hz; • Procedure me: 10 min. Deep vein thrombophlebi s of the lower leg The treatment can be intensifi...
  • Page 140 Se ng of Program No.55: • The magne c fi eld direc on in the main and local emi er: sta c; • Density: 6 mT; • Frequency: 16Hz; • Procedure me: 10 min. A er the procedure me expira on, the device remains plugged in, the main emi er remains on the couch or bed, and the pa ent lies on it with the thigh of his/her diseased limb over the emi er, while the local emi er is placed on the ulcerous area, with the emi ers’...
  • Page 141 MUSCULOSKELETAL SYSTEM AND THE CONNECTING TISSUE DISEASES Gouty arthri s The treatment course length is 15 procedures. One procedure per day. Due to the chronic disease nature, preven ve rou ne courses of pulsed magne c therapy are recommended to be taken 2-3 mes a year. The emi er used: local emi er.
  • Page 142 Gonarthrosis The treatment course: 15 procedures. One procedure per day. Due to the chronic disease nature, pre- ven ve rou ne courses of pulsed mag-net- ic therapy are recommended to be taken 2-3 mes a year. The emi er used: main emi er. The fi...
  • Page 143 Internal and external humeral epicon- dyli s (tennis elbow and golf elbow) The treatment course length – 15-20 procedures. One procedure per day. The emi er used: fl exible emi ng line. Emi er’s arrangement: the fl exible emi ng line is wrapped around the aff ect- ed elbow, with its «N»...
  • Page 144 Se ng of Program No.32: • The magne c fi eld direc on: trave- ling top-down; • Density: 20 mT; • Frequency: 100 Hz; • Procedure me: 7 min. A er that, while the device remains plugged in, the main emi er is wrapped around the forearm and arm, with the «N»...
  • Page 145 Tenosynovi s crepitans of the forearm The treatment course: 15 pro- cedures. One procedure per day. The emi er used: main emit- ter. The aff ected limb is wrapped with the emi er, with its «N» polarity surface facing the body. See Fig.
  • Page 146 The emi er used: main emi er. The main emi er is placed on a couch or bed with its «N» polarity surface upward, and the pa ent lies down on it so that his/her cervicothoracic area of the spinal column is above the emi er. Se ng of Program No.11: •...
  • Page 147 During the procedure, one or two joints at a me can be exposed (e.g. both knee joints). The emi ers used: main emi er and fl exible emi ng line. Emi ers’ arrangement: the main emi er is placed over the adrenal glands projec on area, and the aff...
  • Page 148 Se ng of Program No.38: • The magne c fi eld direc on in the main emi er: traveling clockwise; • Density: 25 mT; • Frequency: 10 Hz; • Procedure me: 15 min. Vertebral osteochondrosis The treatment course: 12-15 procedures. The emi er used: main emi er.
  • Page 149 Se ng of Program No.42: • The magne c fi eld direc on in the main emi er: traveling clockwise; • Density: 20 mT; • Frequency: 100 Hz; • Procedure me: 10 min. Vertebrobasilar syndrome (refl ex compressive syndrome of the vertebral artery) It is a widespread combina on of cerebral and autonomic irritable symp- toms occurring during s mula on of the sympathe c plexus of the vertebral artery, deforma on of its wall or change in its lumen (herniated disc, spondy-...
  • Page 150 • The magne c fi eld direc on in the main emi er: traveling top-down; • Density: 25 mT; • Frequency: 10 Hz; • Procedure me: 20 min. A er the procedure end (without unplugging the device), the head is wrapped with the fl...
  • Page 151 Fig. 47a Fig. 47b Fig. 47c A er the procedure is over (without unplugging the device), the main emi er is wrapped around the thigh bone of the aff ected limb, with its «N» polarity surface facing the body. See Fig. 47b. Se ng of Program No.10: •...
  • Page 152 TRAUMAS Wounds (a er surgical debridement) The treatment course: 15-20 procedures. One procedure per day. The emi er used: local emi er. The emi er is placed onto the wound (over the bandage) with its «N» polarity surface facing the body. Se ng of Program No.68: •...
  • Page 153 Fig. 50 Fig. 51 The injured joint is wrapped with main emi er, with its «N» polarity sur- face facing the body. See Fig. 50. Se ng of Program No.23: • The magne c fi eld direc on in the main emi er: sta c; •...
  • Page 154 Thigh contusion The treatment course: 10-15 proce- dures. One procedure per day. The emi er used: main emi er. The injured thigh is wrapped with the main emi er, with its «N» polarity surface facing the body. See Fig. 52. Se ng of Program No.23: •...
  • Page 155 ANKLE JOINT AND FOOT AREA TRAUMAS Sprain and strain of ankle joint ligaments (72 hours a er trauma) The treatment course: 10 procedures. One procedure per day. The emi er used: main emi er. The injured joint is wrapped with the main emi er, with its «N» polarity side to-wards the body.
  • Page 156 Se ng of Program No.23: • The magne c fi eld direc on in the main emi er: sta c; • Density: 6 mТ; • Frequency: 16 Hz; • Procedure me: 30 min. Ligament rupture at the level of ankle joints and foot Magneto-therapy is to be started a er immobiliza on by means of a plas- ter bandage.
  • Page 157 The emi er used: main emi er. The injured lower leg, ankle joint and foot are wrapped with the main emi er, its «N» polarity surface facing the body. Se ng of Program No.23: • The magne c fi eld direc on: sta c; •...
  • Page 158 Se ng of Program No.79: • The magne c fi eld direc on in the local emi ers: sta c; • Density: 6 mТ; • Frequency: 16 Hz; • Procedure me: 30 min. TRAUMAS INVOLVING SEVERAL BODY REGIONS Mul ple surface traumas of upper limbs Mul ple surface traumas of lower limbs Treatment course length –...
  • Page 159 MAINTENANCE SERVICE Maintenance of the device includes repairs, rou ne inspec on, cleaning from dust and dirt, disinfec on, and periodic control of its operability. The device is provided with the func on of self-diagnos cs: in case of a malfunc on, the exposure stops, and an error code is indicated on the display, accompanied by a sound signal.
  • Page 160 - stop the ac on; - select an exposure program which involves ac on of the local emi er (with the maximal parameters of fi eld density and pulse repe on frequen- cy, e.g. Program No 64); - ac vate the magneto-ac on; - check the presence of magne c fi...
  • Page 161 The surfaces of the device emi ers contain markings of the magne c fi eld polarity: ‘N‘ – north, ‘S’ – south. In case of the device malfunc on, genera on of alarm signaling and auto- ma c termina on of the exposure mode is provided. The device displays the following indica ons: Visual indica ons: - program number;...
  • Page 162 STORAGE AND TRANSPORTATION STORAGE CONDITIONS TRANSPORT CONDITIONS OPERATING CONDITIONS 100% +40 C +50 C +35 C - 0 C - 0 C +10 C Annex В MANUFACTURER’S MANUAL AND DECLARATION ELECTROMAGNETIC EMISSIONS AND IMMUNITY Table 1 Manufacturer's manual and declaration – electromagnetic emission These devices are intended for use in the electromagne c environment specifi...
  • Page 163 Table 2 Manufacturer’s manual and declaration – interference resistance These devices are intended for use in the electromagne c environment specifi ed below. The customer or the user of the device should ensure its use in the specifi ed electromagne c environment.
  • Page 164 Table 3 Manufacturer’s manual and declaration – interference resistance These devices are intended for use in the electromagne c environment specifi ed below. The customer or the user of the device should ensure its use in the specifi ed electromagne c environment.
  • Page 165 MANUFACTURER’S WARRANTY The Manufacturer hereby guarantees that the quality of the device con- forms to the requirements of the User Manual («Specifi ca ons» sec on), provided that the condi ons of proper storage, transporta on, and usage are met by the Customer. Warranty period is 24 months from the date of sale.
  • Page 166 Manufacturer’s address: 391351, 25 Yanina st., Yelatma, Kasimov District, Ryazan region, Russia JSC «Yelatma Instrument Making Enterprise» Tel: +7 (4912) 293-418 WARRANTY CARD for repair (replacement) during the warranty period ALMAG-02 Pulsed Electromagne c Field Therapy Device Manufacturing date __________________ No. ____________________ Purchased ________________________________________________ (to be filled in by the trading organization) Put in operation ____________________________________________...

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