Almagia ALMAG+ Operation Manual

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DEAR CUSTOMER,

Congratula ons! You have just purchased ALMAG+ Magnetotherapy Device incl.

accessories (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.

Please, read this Opera on Manual carefully that is the document cer fying the

main parameters guaranteed by the manufacturer as well as speciﬁ ca ons, indica-

ons for use, intended use procedures and safety precau ons. This knowledge will

allow you to make the best use of the unique product capabili es on the treatment

and preven on of a wide range of diseases, either under medical facility environ-

ment where the physiotherapy department is present or by pa ents themselves at

home, on their doctor's advice.

A en on!

Carrying out the treatment sessions by the pa ent at home does not

require any special training and/or skills. To be more eﬀ ec ve in us-

ing the device, please, read the Opera on Manual and follow treat-

ment procedures.

A en on!

Should you have ques on(s) and/or concerns on the use of the de-

vice, please, consult with your local physiotherapist.

Please, retain the Opera on Manual all of the way through a product's lifecycle.

Whenever the device is transferred to third par es, the Opera on Manual shall be

transferred with the product.

OPERATION MANUAL

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Андрей

March 14, 2025

Какой режим более подойдёт после перелома малой берцовой через 3,5 месяца?

Summary of Contents for Almagia ALMAG+

Page 1 DEAR CUSTOMER, Congratula ons! You have just purchased ALMAG+ Magnetotherapy Device incl. accessories (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. Please, read this Opera on Manual carefully that is the document cer fying the main parameters guaranteed by the manufacturer as well as speciﬁ...
Page 2 Symbolic nota ons on the device 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. Compliant with na onal regulatory documents. Class II product.
Page 3: Table Of Contents
TABLE OF CONTENTS WARNINGS AND SAFETY INSTRUCTIONS ............... 4 PURPOSE AND OPERATING PRINCIPLE ..............6 SCOPE OF DELIVERY ....................8 STORAGE AND TRANSPORTATION ................8 INDICATIONS FOR USE ................... 9 CONTRAINDICATIONS .................... 10 SIDE EFFECTS ......................10 PREPARATION FOR USE ..................11 OPERATION PROCEDURES ..................
Page 4: Warnings And Safety Instructions
WARNINGS AND SAFETY INSTRUCTIONS Please, read this Opera on Manual prior to proceeding with medical or prophy- lac 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 5 Precau ons for therapeu c use: Use the device in loca ons where control unit can be comfortably connect- ed to the socket and cable tension can be avoided during opera on. DO NOT: • use the device with mechanically damaged control unit housing and/or control unit cable and/or inductor coils;...
Page 6: Purpose And Operating Principle
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 7 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 8: Scope Of Delivery
SCOPE OF DELIVERY • ALMAG+ Magnetotherapy Device • Accessories: Spline fastener Strap Magne c ﬁ eld indicator • Opera on manual • Retail package STORAGE AND TRANSPORTATION The device can be stored indoors at temperatures of -50 °С to +40 °С and rela ve humidity up to 98% at a temperature of +25 °С.
Page 9: Indications For Use
INDICATIONS FOR USE • Arthri des, arthroses, osteochondropathy, or bone spur; • Dorsopathy including osteochondrosis vertebralis, herniated nucleus pulposus, or scoliosis; • Osteoporosis; • Hypertensive disease of the I and II degree; • Dystonia (vegetovascular dystonia); • Complica ons of diabetes mellitus Type I and II; •...
Page 10: Contraindications
CONTRAINDICATIONS • Acute pyoinﬂ ammatory condi ons; • Aor c aneurysm; • Pregnancy; • Systemic blood diseases; • Malignancies; • Thyrotoxicosis; • Alcoholic intoxica on; • Atrial ﬁ brilla on; • Implanted cardios mulator present in the exposure area. Metal inclusions, if present in bone ssue, is not a contraindica on to adminis- tra on of the device in therapeu c doses.
Page 11: Preparation For Use
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 12: Operation Procedures
OPERATION PROCEDURES Please, consult with your a ending doctor. Take a close look at the list of indica- ons and contraindica ons. 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. There are device controls on the upper casing of the control unit.
Page 13: Treatment Modes
Treatment Modes The desired treatment mode is set with «Mode Select» bu on as indicated in Table 1. Table 1 Opera ng Field Inductor coil Peak (amplitude) Mode mode type excita on value of the mag- descrip on frequency ne c ﬁ eld density on the inductor coil working surface (mT)
Page 14 The exposure (treatment dura on) is set automa cally to 20 minutes for all the treatment modes. The treatment is ini ated and terminated by pressing the «START/STOP» but- ton and is accompanied by sound signal and non-ﬂ ashing glow of the «START/ STOP»...
Page 15: Detailed Procedures
The device generates the sound signal each 5 minutes when in treatment mode. To set the recommended treatment dura on (less than 20 minutes), terminate the treatment forcedly by pressing the «START/STOP» bu on again. Once the exposure is completed (or terminated forcedly), the «START/STOP» bu on LED indicator blinks oﬀ...
Page 16 When using the device as intended, pay a en on to the correct deployment of the emi er according to recommenda ons of the treatment procedure (i.e. the direc on of the traveling pulsed magne c ﬁ eld and the exposure to the northern magne c pole).
Page 17 • Unzip the fastener and open the velcros located inside the fastener. • Take the 3rd and 4th inductor coils of the device and ﬁ x them with velcros in the fastener at the 3rd and 4th coils connec on point. OPERATION MANUAL...
Page 18 • Place the rest 1st and 2nd inductor coils into the fastener and ﬁ x them with velcros. • Zip up the fastener. • Four inductor coils are now arranged in the form of «spline».
Page 19 • 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. OPERATION MANUAL...
Page 20 Where 2х2 matrix inductor coil conﬁ gura on is recommended, the following emi er arrangement op on should be used (no spline fastener is required): the emi ers are placed pairwise directly to the exposure areas according to the treat- ment procedures.
Page 21: Device User Manual
DEVICE USER MANUAL A en on! 1. Prior to ini a ng the course of treatment, the exact diagnosis should be estab- lished and any contraindica ons should be excluded. 2. Carrying out the treatment sessions by the pa ent at home does not require any special training and/or skills.
Page 22: Age-Speciﬁ C Dosage Prescrip Ons
AGE SPECIFIC DOSAGE PRESCRIPTIONS Applying treatment to pa ents over 15 years old In case of using the device in a healthcare ins tu on, proceed with Mode 3 ﬁ rst for 3 to 5 days, and then proceed with Mode 1. The treatment session will last for 10 to 20 minutes, and the treatment course will last for 7 to 12 days based on the doctor’s prescrip on.
Page 23 Repeat the treatment once or twice a day in compliance with dosages. Keep me interval between sessions at least 8 hours. Among persons with arterial hypertension, blood pressure should be monitored in the ﬁ rst 6 days of treatment just before session and 20 to 30 minutes a er treat- ment.
Page 24 Applying treatment to pa ents under 15 years old Pediatric use of the device shall comply with the age-speciﬁ c dosage prescrip- ons as follows: 4 weeks to 1 year old Table 3. Course treatment procedure for pa ents at the age of 4 weeks to 1 year old Treatment day Mode Dura on (min.)
Page 25 3 to 7 years old Table 5. Course treatment procedure for pa ents 3 to 7 years old Treatment day Mode Dura on (min.) Treatment day Mode Dura on (min.) 7 to 15 years old Table 6. Course treatment procedure for pa ents 7 to 15 years old Treatment day Mode Dura on (min.)
Page 26: Inductors Applica On To Deliver Disease-Speciﬁ C Procedures
INDUCTORS APPLICATION TO DELIVER DISEASE SPECIFIC EXPOSURES Musculoskeletal system disorders: • ARTHRITIDES AND/OR ARTHROSES For pa ents with the single joint ar- thri s, apply the «spline» of four inductor coils helically around the joint engaging the surrounding ssues. For pa ents with two joints aﬀ...
Page 27 • OSTEOCHONDROPATHY AND/OR BONE SPUR For pa ents with osteochondropathy or bone spur, use transversal applica on technique; locate the inductor coils pair- wise on both sides of the abnormal focus. See Figure 3 for the exemplary bone spur treatment. Fig.
Page 28 For pa ents with osteochondrosis (her- niated nucleus pulposus), treat the spine area of concern ﬁ rst, and then apply the inductor coil «spline» down the aﬀ ected nerve, and expose the second area. See Figure 5 for the exemplary treat- ment of a pa ent with lumbar osteochon- drosis and nerve root syndrome.
Page 29 Cardiovascular diseases: • HYPERTENSIVE DISEASE of the I and II degrees (essen al hypertension) For pa ents with hypertensive disease of the I and II degrees, apply the «spline» of four inductor coils to the collar zone. The exposure me shall comply with the age-speciﬁ...
Page 30 See Figure 8 for the exemplary diabetes treatment. Blood vessel diseases: • LEG ATHEROSCLEROSIS (OBLITERATING ENDARTERITIS) For pa ents with lower extremity arterial atherosclerot- ic occlusive disease apply the «spline» of four inductor coils along the anterior leg surface, down the vessels (top-down) and nerves, star ng from the occlusion zone and below.
Page 31 For pa ents with both the extremi es aﬀ ected, expose both the legs once a day. If one leg is aﬀ ected, expose twice a day at least 6 hours apart when trea ng at home. See Figure 10 for the exemplary vari- cose vein disease treatment.
Page 32 • BRONCHITIS Locate the inductor coils pairwise on two areas, in parallel with the spline over interscapular region. See Figure 12 for the exemplary bronchi s treatment. Neurological condi ons: • INDIVIDUAL NERVE ROOT AND PLEXUS DIS- ORDERS IN UPPER AND LOWER EXTREMITIES INCLUDING POST-INJURY AND POST-STROKE For pa ents with individual nerve root and plexus disorders in upper and lower extremi es...
Page 33 See Figure 14 for the exemplary post- stroke disorders treatment. Injuries (fractures): Place the inductor coils along the pro- jec on of the aﬀ ected area. The treatment through the gauze or plaster bandage is al- lowed. The number of inductor coils will depend on the surface area of the injured region.
Page 34: Specifications
SPECIFICATIONS Power supply AC mains frequency 50 Hz 60 Hz voltage ~230 ~120 Nominal power 110 VA max 55 VA max Emi er to Control Unit cable length 1.2 m ±0.1 m Cable length between two pairs 0.4 m ±0.05 m of inductor coils Power cord length 2.0 m ±0.1 m...
Page 35 The average service life is 5 years. The easily touched parts of the device are made of biosafety materials. Outer surfaces of the device’s components are resistant to chemical disinfec on using any disinfectant solu on approved for use in medical prac ce to protect the plas c and metal items.
Page 36 Important electromagne c compa bility (EMC) informa on Since electronic devices like PCs and mobile (cell) phones become increas- ingly popular, medical equipment in use may be sensi ve i.e. it interferes with electromagne c noise generated by other devices. Electromagne c interference may impair the opera on of the medical device and create a poten ally unsafe situa on.
Page 37: List Of Standards Used
LIST OF STANDARDS USED IEC 60601-1;2005 «Medical electrical equipment. Part 1. General requirements for basic safety and essen al performance». IEC 60601-1-2:2007 «Medical electrical equipment. Part 1-2. General require- ments for basic safety and essen al performance. Collateral standard. Electromag- ne c compa bility.
Page 38: Operating Repair
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 39: Appendix А
APPENDIX А Manufacturer's manual and declaration – electromagnetic emission The device is 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. Electromagnetic Compliance Electromagnetic environment –...
Page 40 Manufacturer’s manual and declaration – interference resistance The device is 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 Compliance...
Page 41 Manufacturer’s manual and declaration – interference resistance The device is 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 42 The ﬁ eld density in the propaga on of radio waves from sta onary radio transmit-ters, such as base sta ons of radio telephone networks (cellular / wireless), and surface-mobile radios, amateur radio sta ons, AM and FM broadcast transmi ers, television transmi ers can not be determined by calcula on with suﬃ cient accuracy.
Page 43 Recommended values for separation distance between portable and mobile radio frequency communication means and the device The device is intended for use in an electromagne c environment in which the levels of radiated interference are monitored. The purchaser or the user of the device can avoid the eﬀ ects of electromagne c interference providing a minimum separa on distance between portable and mobile radio frequency communica on devices (transmi ers) and the device, as recommended below, taking into account the maximum output power of transmission equipment Nominal maximum...
Page 44: Acceptance Certificate
ACCEPTANCE CERTIFICATE ALMAG+ Magnetotherapy Device incl. accessories, S/N _______________ com- plies with GIKS.941519.114 TU speciﬁ ca ons and is classiﬁ ed as ﬁ t for opera on. So ware version: GIKS.21-0101. Date of manufacture: ___________________ Stamp here _____________________________________ (Full name and signature of the person responsible for acceptance) ALMAG+ Magnetotherapy Device incl.
Page 45: Caring For The Environment
CARING FOR THE ENVIRONMENT The body parts of the device, made of high-quality plas cs, are recyclable in the form of structural materials for reuse. Electrical and electronic components shall be disposed of separately in dedicated centers in accordance with local legisla on. Do not dispose of these components with household waste.
Page 46: Manufacturer's Warranty
MANUFACTURER’S WARRANTY 1. The manufacturer guarantees the conformity of the device’s quality to the requirements of the Opera on Manual, provided that the consumer observes the condi ons and rules for storage, transporta on and opera on. Warranty opera ng life is 12 months from the date of sale. Warranty period of storage is 60 months from the packing date.
Page 47 Manufacturer’s address: 25, Yanina st., Yelatma, 391351, Ryazan region, Russia JSC «Yelatma Instrument Making Enterprise» Tel/fax: +7 (4912) 503-023, +7 (49131) 2-04-57 WARRANTY CARD for repair (replacement) during the warranty period ALMAG+ Magnetotherapy Device as per GIKS.941519.114 TU speciﬁ ca on incl.