DENAS ALMAG Active User manual
2
English
58
Deutsch
114
Français
170
Italien
ALMAG Active
Pulsed Electromagnetic Field Therapy Device
ALMAG Active
Magnettherapiegerät
ALMAG Active
Appareil de magnétothérapie
ALMAG Active
Dispositivo per terapia magnetica
226
Español
ALMAG Active
Aparato magnetoterapéutico
282
Polish
ALMAG Active
Urządzenie magnetoterapeutyczne
338
Lithuanian
ALMAG Active
Magnetoterapijos prietaisą
2
DEAR CUSTOMER,
Congratulaons! You have just purchased ALMAG Acve Pulsed Electromagnet-
ic Field Therapy Device (hereinaer – Device). The Device is classified as medical
equipment product and is listed in the nomenclature of physiotherapeuc devices
authorized for use in medical pracce.
Please, read this Operang Manual carefully that is the document cerfying the
main parameters guaranteed by the manufacturer as well as specificaons, indica-
ons for use, intended use procedures and safety precauons. This knowledge will
allow you to make the best use of the unique product capabilies on the treatment
and prevenon of a wide range of diseases, either under medical facility environ-
ment where the physiotherapy department is present or by paents themselves at
home, on their doctor’s advice.
Aenon!
Please, retain the Operang Manual all of the way through a product’s lifecycle.
Whenever the device is transferred to third pares, the Operang Manual shall be
transferred with the product.
Carrying out the treatment sessions by the paent at home does
not require any special training and/or skills. To be more effecve
in using the device, please, read the Operang Manual and follow
treatment procedures.
!
OPERATING MANUAL
ENG
3
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 IEC 60601-1.
Operating Manual. Please read the Operating Manual carefully.
Working cycle: work: 20 min, a pause: 10 min
Control Unit of the product provides the ingress protection against items
over 1 mm in diameter as well as vertically dripping water.
Compliant with MDD/93/42 EEC.
Manufacturer’s Trade Mark;
Device/product Name;
Factory number;
Power consumption;
Rated voltage and frequency;
Date of manufacture;
«Made in Russia» text.
Symbolic notations on the device
!
IP41
4
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. OPERATION PROCEDURES ..................................................................................16
8.1. General rules of procedure sequence ........................................................ 16
8.2. Treatment modes ....................................................................................... 24
8.3. Age-specific dosage prescriptions .............................................................. 27
8.4. Inductors application to deliver disease-specific procedures .................... 30
Musculoskeletal system diseases:
- osteochondrosis ...........................................................................................30
- humeroscapular periarthrosis ..................................................................... 31
- osteoarthritis ............................................................................................... 32
- epicondylitis .................................................................................................34
Injuries and their after-effects:
- bone fractures ............................................................................................. 35
- internal joint injuries ................................................................................... 36
- posttraumtic edema ................................................................................... 37
- dislocations, damage to the ligamentous apparatus – sprains, tears;
damage to skeletal muscles, soft tissue injuries .......................................... 37
- vertebral column and spinal cord traumas .................................................. 38
Diseases of peripheral nervous system:
- neuritis .........................................................................................................38
OPERATING MANUAL
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5
- 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 ......................................................................................................43
- trigeminal neuralgia .....................................................................................43
- occipital neuralgia ........................................................................................44
- intercostal neuralgia .................................................................................... 44
Pancreatic diabetes complications:
- diabetic angiopathy & polyneuropathy ....................................................... 45
Diseases of venous system:
- deep vein thrombosis of the lower leg ........................................................ 46
- chronic thrombophlebitis ............................................................................ 46
- varicose veins ...............................................................................................46
9. OPERATING REPAIR ............................................................................................ 48
10. MAINTENANCE ................................................................................................ 49
11. SPECIFICATIONS ............................................................................................... 49
12. LIST OF STANDARDS USED ............................................................................... 51
13. STORAGE AND TRANSPORTATION ....................................................................51
14. ANNEX А.......................................................................................................... 52
15. ENVIRONMENTAL RESPONSIBILITY .............................................................. 55
16. MANUFACTURER’S WARRANTY ....................................................................... 56
17. ACCEPTANCE CERTIFICATE ............................................................................. 394
6
1. WARNINGS AND SAFETY INSTRUCTIONS
Please, read this Operang Manual prior to proceeding with medical or prophy-
lacc 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.
Keep control unit and emier away from humidity when treang sur-
faces with disinfectant soluon(s). Keep the device in dry place avoiding its
exposure to shocks and vibraons.
Do not expose the device to direct sunlight or high temperatures.
In case the device was transported or stored at low temperatures, first
keep it at least 2 hours at room temperature before use.
Do not twist or bend the cables. Aer using, keep the device in the retail
packaging.
OPERATING MANUAL
ENG
7
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;
• use the device with disassembled control unit housing and/or inductor
coil housing;
• lift and carry the device using cable, do not plug it out of the socket by
the mains cable.
IP42
!
!
Direcons for environmental protecon: Dispose of the device at the
end of its lifecycle as electronic waste at dedicated disposal locaons.
Disclaimer of liability: The manufacturer will not be liable for damages
resulng from non-compliance with the direcons given above.
The emier provides the ingress protecon against items over 1 mm in
diameter as well as vercally dripping water with the housing inclined by 15°.
Aenon! The device needs special measures to ensure ELECTROMAG-
NETIC COMPATIBILITY and is subject to commissioning in accordance with
the EMC-related informaon given in this Operang Manual.
Aenon! The use of mobile RF communicaon devices may interfere
with MEDICAL ELECTRICAL EQUIPMENT.
8
Important electromagnetic compatibility (EMC) information
Since electronic devices like PCs and mobile (cell) phones become increasingly
popular, medical equipment in use may be sensitive i.e. it interferes with
electromagnetic noise generated by other devices. Electromagnetic interference
may impair the operation of the medical device and create a potentially unsafe
situation.
Medical devices, in turn, should not impair the operation of other devices.
EN 60601-1-2:2015 (IEC 60601-1-2014) standard was implemented to intro-
duce EMC requirements and further prevent the emergence of unsafe situaons
associated with the use of products. The standard specifies the levels of immu-
nity to electromagnec interference as well as the maximum levels of electro-
magnec emission as applicable to medical equipment. This device produced by
ELAMED complies with the requirements of EN 60601-1-2:2015 concerning the
immunity to EM interference and emied radiaon.
Nevertheless, some precautions should be observed, namely:
• The use of components and cables other than those supplied with the
device may result in increased emissions or malfunctions. The exception may be
parts supplied by ELAMED as spare parts.
• Make sure that the equipment operates correctly if the operating
environment differs from what specified in the tables of Annex А.
Special requirements to ensure electromagnetic compatibility are given in
Annex А.
!
OPERATING MANUAL
ENG
9
The device is intended to provide physiotherapeuc treatment as well as recov-
ery and rehabilitaon measures using a low-frequency pulsed magnec field, either
in medical facilies or at home, upon the recommendaon of a doctor.
The device consists of the control unit (current pulse generator) and an emier
comprising four interconnected inductor coils used to provide exposure to individ-
ual parts of the body.
The device is designed to be used under regular climac condions.
2. PURPOSE AND OPERATING PRINCIPLE
Device overview
А. Control Unit
B. Emitter
C. Inductor Coils
D. Magnetic field
indicator
A
B
C
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2
3
4
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10
Matrix layout of the inductor coils
«Spline» emitter configuration composed of four inductor coils
(fastener is omitted for clarity)
Inductor coils are combined into two groups of two coils per group. The groups
may be configured in the form of 2x2 matrix and/or «spline» composed of four
inductor coils. «Spline» emier configuraon is achieved using corresponding fas-
tener included in delivery.
12
34
4321
OPERATING MANUAL
ENG
11
Musculoskeletal system diseases:
- osteochondrosis
- humeroscapular periarthrosis
- osteoarthritis
- epicondylitis
Injuries and their after-effects:
- internal joint injuries
- posttraumtic edema
- skeletal injuries (bone fractures, dislocations, damage to the ligamentous
apparatus – sprains, tears; damage to skeletal muscles, soft tissue injuries)
- vertebral column and spinal cord traumas
Diseases of peripheral nervous system:
- neuritis
- facial nerve neurtis
4. INDICATIONS FOR USE
• ALMAG Active Pulsed Electromagnetic Field Therapy Device 1
• Accessories:
Spline fastener 1
Strap 2
Magnetic field indicator 1
• Operating Manual 1
• Retail package 1
3. SCOPE OF DELIVERY
12
- 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
- chronic thrombophlebitis
- varicose veins
• acute infecous diseases and purulent-inflammatory processes of any locaon;
• pregnancy;
• diseases and condions accompanied by impaired hemostasis of the hypo-
coagulaon type (decreased blood coagulaon), risk of bleeding and hemorrhagic
syndrome, including systemic blood diseases (hemophilia, thromboc thrombocy-
topenic purpura, etc.), as well as bleeding of any genesis and locaon;
5. CONTRAINDICATIONS
OPERATING MANUAL
ENG
13
• malignancies*;
• condions prevenng from procedure performing: alcohol and drug intoxica-
on, psychomotor agitaon 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);
• aneurysms of aorta and large vessels;
• hemodynamically significant cardiac arrhythmias and/or intracardiac conduc-
on disturbances (atrial fibrillaon and fluer, paroxysmal supraventricular and
ventricular tachycardia, ventricular extrasystole of degree four or five according to
Lown-Wolf-Ryan scale, atrioventricular block degree two or three, sinus bradyar-
rhythmia);
• any condions and diseases of the thyroid gland, accompanied by hyperpro-
ducon of thyroid hormones;
• acve tuberculosis process of any locaon;
• acute and subacute stage of myocardial infarcon;
• implanted cardiostimulator present in the exposure area.
Metal inclusions, if present in bone ssue, is not a contraindicaon to administra-
on of the device in therapeuc doses.
Metal dental crowns, if present in mouth cavity, is not a contraindicaon to ad-
ministraon of the device in therapeuc doses.
* Treatment using the ALMAG Acve device may be carried out for paents with the di-
agnosis of a malignant neoplasm only as directed and under the supervision of the aend-
ing physician, aer a comprehensive antumor therapy (surgical treatment, chemotherapy
course, radiaon therapy) and in the absence of metastasis and progression of the tumor
process.
14
In order to avoid adverse events including increase in arterial blood pressure and
comorbid diseases, do not exceed the exposure me as specified in the Direcons
for Use Chapter of this Operaon Manual, defined in secons «General rules of pro-
cedure sequence» and «Features of methods of device use in different age groups
of paents» of this operaon manual. Before treatment start, be sure to consult
your doctor to exclude your exisng diseases and condions contraindicang the
use of the device.
Aenon!
Aenon!
6. SIDE EFFECTS
!In case the exposure results in the blood pressure increase or de-
crease by 10 to 25 mm Hg during the first 6 days of treatment
(Mode 3), reduce the treatment duraon by 1/3 during the next ses-
sion and apply Mode 2 during the next 3 days of treatment. From
that me onwards, resume Mode 1 treatment.
!In case the exposure results in the blood pressure increase or de-
crease by more than 25 mm Hg consult with your aending doctor
prior to the next session to adjust the treatment procedure. Keep a
log by entering the measurement data required to trace the me
course of blood pressure.
OPERATING MANUAL
ENG
15
In case the device was transported or stored for a long me at temperatures
below 10 °С, first keep it at least 2 hours at a temperature in between 10 °Сand
35 °Сbefore turning on.
Ensure that there is no mechanical damage to the cable and the housing of the
device.
Aenon!
Disinfection methods
Disinfect the external surfaces of the device before its first use and as required
from then on by double wiping with a coarse calico or gauze cloth moistened with
disinfectant solution approved for use in medical practice to protect the plastic
and metal items from dermatomycosis infection. Keep interval between wipings
according to the directions for use of disinfectant solution. Keep control unit and
emitter internals away from contacting with disinfectant solution. Next wipe the
surfaces with cloth moistened with water and then wrung-out, and dry at ambient
temperatures below +50 °С.
A 3% hydrogen peroxide solution and a 5% chloramine solution can be used
as a disinfectant solution.
7. PREPARATION FOR USE
!DO NOT use the device if any of the above damage occurs!
16
8. OPERATION PROCEDURES
8.1. General rules of procedure sequence
Aenon!
• Carrying out the treatment sessions by the paent at home does not require
any special training and/or skills.
• Please, read the instrucon carefully before proceeding to get maximum ef-
fect. Proceed according to the above procedures.
The effecveness of magnetotherapy procedures depends on:
- exact conformity with the recommendaons relang to the procedure for de-
vice use;
- individual magnec sensivity of the paent;
- the stage and features of the course of the disease, for which the treatment is
being carried out.
• Should you have queson(s) and/or concerns during treatment and rehabil-
itaon using the device, please, consult with your aending doctor. You can also
seek for advice on the manufacturer’s official website (en.elamed.com).
Before treatment start, carefully read the list of indicaons and con-
traindicaons and be sure to consult your doctor to determine the
correct diagnosis and to exclude your exisng diseases and condi-
ons contraindicang the use of the device.
!
OPERATING MANUAL
ENG
17
• The duraon of the procedure and the treatment modes is determined indi-
vidually taking into account the paent’s age. The recommended combinaons
of the procedure duraon and treatment mode are indicated in secon «Fea-
tures of the methodology of device use in various age categories of paents».
The use of the device in pediatric pracce for children from 1 month of age and
older should be carried out strictly in accordance with the age dosages specified
in this manual.
Aenon!
Aenon!
• The procedures are carried out once a day, at the same me (at regular me
intervals). Provided that it is well tolerated, in order to increase the effecveness of
treatment, it is recommended to increase the mulplicity of the procedure repeats
be up to 2 mes a day. At the same me, the break between the procedures should
be at least 8 hours, and the total duraon of the procedures should not exceed 40
minutes per day. When treang two joints, the interval between procedures for
alternate joints should be at least 10 minutes.
• The procedure administraon methods (the frequency and duraon of the pro-
cedures, the impacted area, the locaon of the inductor coils, the duraon of the
treatment course) can be adjusted by the aending physician, taking into account
the individual characteriscs of the paent and the parcular course of the dis-
ease for which the treatment is being carried out.
The exposure (treatment duration) is set automatically to 20 minutes
for all the treatment modes.
The device generates the sound signal
each 5 minutes when in treatment mode.
To set the recommended
treatment duration (less than 20 minutes), terminate the treatment
forcedly by pressing the «START/STOP» button again.
!
The mode set function is only active when there is no exposure.
!
18
• When using the device for its intend-
ed purpose, pay aenon to the correct
placement of the emier on the body:
all the methods spulate for acng by
the north magnec pole of the inductor
coils (marked with the «N» sign on the
coil housings). During the procedure, the
device is applied directly to the affected
organ and surrounding ssue, to its pro-
jecon area or reflecng zones with the
north side («N») facing the body.
• The treatment is carried out by acng on the lesion itself, the surrounding
ssues and reflectory zones by applying the inductor coils of the device directly to
skin. Due to high penetrang ability of the magnec field induced by the device, the
treatment can also be carried out through clothing, dry or wet gauze bandage, or a
plaster bandage up to 1 cm thick.
• The opmal posion of the paent during the procedure – supine. Aer the
procedure, in order to achieve the maximum effect, it is necessary to remain in a
horizontal posion for 30 minutes.
• If the device is required to treat several diseases or condions, proceed as
follows: Bring the 1st disease treatment course to compleon, then make a break
for 10 to 15 days and finally proceed to the 2nd disease treatment course. If the
device is required to treat the single disease or condion, keep the pause of 1,5 to
2 months between treatment courses. Shorter pauses between treatment courses
are only allowed upon your aending doctor’s advice.
ATTENTION!
When performing procedures,
locate the emitter with the
working surface of inductors
with the «N» letter facing
the treated area
OPERATING MANUAL
ENG
19
Aenon!
Aenon!
Aenon!
Before starng the procedure, define the configuraons of inductor coils in the
form of a «flexible spline» or «matrix» (depending on the requirements of the
methodology for treang a specific disease).
The traveling pulsed magnec field is to be directed from the 1st inductor coil to
the 4th inductor coil when «spline» emier configuraon is used, namely:
The coil directly connected to the control unit is referred to as the 1st coil. Where
the matrix emier configuraon is used, the inductor coils queuing and the direc-
on of the traveling pulsed magnec field are similar.
In case the exposure results in the blood pressure increase or de-
crease by 10 to 25 mm Hg during the first 6 days of treatment
(Mode 3), reduce the treatment duraon by 1/3 during the next ses-
sion and apply Mode 2 during the next 3 days of treatment. From
that me onwards, resume Mode 1 treatment.
In case the exposure results in the blood pressure increase or de-
crease by more than 25 mm Hg consult with your aending doctor
prior to the next session to adjust the treatment procedure. Keep a
log by entering the measurement data required to trace the me
course of blood pressure.
!
!
It is not recommended at the same me (on the same day) to treat
two different diseases.
!
20
12 3 4
When using the four inductor coils configured in the form of «spline», the spline
fastener (hereaer the fastener) is required. The fastener fixes the coils together
prevenng them from traveling relave to each other.
Place the inductor coils into the fastener stepwise according to the «spline» ar-
rangement as follows:
• Unzip the fastener and open the velcros located inside the fastener.
• Take the 3rd and 4th inductor coils of the device and fix them with velcros in the
fastener at the 3rd and 4th coils connecon point.
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