Almagia ALMAG+ User manual

1
OPERATION MANUAL
DEAR CUSTOMER,
Congratulaons! You have just purchased ALMAG+ Magnetotherapy Device incl.
accessories (hereinaer – Device). The Device is classified 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 specifica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.
AƩenƟon!
AƩenƟon!
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.
Carrying out the treatment sessions by the paent at home does not
require any special training and/or skills. To be more effecve in us-
ing the device, please, read the Operaon Manual and follow treat-
ment procedures.
Should you have queson(s) and/or concerns on the use of the de-
vice, please, consult with your local physiotherapist.
!
!

2
ALMAG+
Warnings and precauons related to safety and operang efficiency.
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. The housing is protected with reinforced insulaon,
no protecve earthing is required.
Operaon Manual. Please read the Operaon Manual carefully.
Control Unit of the product provides the ingress protecon against
items over 1 mm in diameter as well as vercally dripping water.
Manufacturer’s Trade Mark;
Device/product Name;
Factory number;
Power consumpon;
Rated voltage and frequency;
Date of manufacture;
Specificaon symbol;
«Made in Russia» text.
Symbolic notaons on the device
!
IP41

3
OPERATION MANUAL
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 ..................................................................................... 12
Visual Display .................................................................................................... 12
Treatment Modes .............................................................................................. 13
Detailed Procedures .......................................................................................... 15
DEVICE USER MANUAL .......................................................................................... 21
Age-specific dosage prescripons ..................................................................... 22
Inductors applicaon to deliver disease-specific procedures ........................... 26
SPECIFICATIONS ..................................................................................................... 34
LIST OF STANDARDS USED ..................................................................................... 37
MAINTENANCE ...................................................................................................... 37
OPERATING REPAIR ................................................................................................ 38
APPENDIX А........................................................................................................... 39
ACCEPTANCE CERTIFICATE ..................................................................................... 44
CARING FOR THE ENVIRONMENT .......................................................................... 45
MANUFACTURER’S WARRANTY ............................................................................. 46

4
ALMAG+
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.
Keep control unit and emier away from humidity when treang sur-
faces with disinfectant soluon(s). Keep the device in dry place avoiding its
exposure to shocks and vibraons.
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. Aer using, keep the device in the retail
packaging.
!

5
OPERATION MANUAL
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;
• use the device with disassembled control unit housing and/or inductor
coil housing;
• liand carry the device using cable, do not plug it out of the socket by
the mains cable.
IP42
Direcons for environmental protecon: Dispose of the device at the
end of its lifecycle as electronic waste at dedicated disposal locaons.
Disclaimer of liability: The manufacturer will not be liable for damages
resulng from non-compliance with the direcons given above.
The emier provides the ingress protecon against items over 1 mm in di-
ameter as well as vercally dripping water with the housing inclined by 15°.
AƩenƟon! The device needs special measures to ensure ELECTROMAG-
NETIC COMPATIBILITY and is subject to commissioning in accordance with
the EMC-related informaon given in this Operaon Manual.
AƩenƟon! The use of mobile RF communicaon devices may interfere
with MEDICAL ELECTRICAL EQUIPMENT.
!
!

6
ALMAG+
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 field, 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.
The device is designed to be used under regular climac condions: Ambient
temperature +10 °Сto +35 °С, atmospheric pressure 86.6 kPa to 106.7 kPa (600 to
800 mm Hg).
PURPOSE AND OPERATING PRINCIPLE
DEVICE OVERVIEW
A. Control Unit
B. Emier
C. Inductor Coils
A
B
C
C

7
OPERATION MANUAL
Matrix layout of the inductor coils
«Spline» emier configuraon composed of four inductor coils
(fastener is omied 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» emier configuraon is achieved using corresponding fas-
tener included in delivery.

8
ALMAG+
• ALMAG+ Magnetotherapy Device 1
• Accessories: 1
Spline fastener 1
Strap 2
Magnec field indicator 1
• Operaon manual 1
• Retail package 1
SCOPE OF DELIVERY
The device can be stored indoors at temperatures of -50 °Сto +40 °Сand relave
humidity up to 98% at a temperature of +25 °С.
The device is transportable using any mode of transport within temperate and
cold macroclimac areas at ambient temperatures of -50 °Сto +50 °С.
During operaon, aer being used for the intended purpose, the device should
be stored in a retail package at an ambient temperature of +1 °C to +40 °C.
In case of return for exchange or repair, the device must be fully packed.
STORAGE AND TRANSPORTATION

9
OPERATION MANUAL
• 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;
• Atherosclerosis;
• Vein and lymph vascular disease including varicosity and its complicaons
as well as lymphostasis;
• Asthma;
• Bronchis;
• Nerve root and plexus disorders in extremies including post-traumac
as well as poststroke disorders;
• Injuries (fractures).
INDICATIONS FOR USE

10
ALMAG+
• Acute pyoinflammatory condions;
• Aorc aneurysm;
• Pregnancy;
• Systemic blood diseases;
• Malignancies;
• Thyrotoxicosis;
• Alcoholic intoxicaon;
• Atrial fibrilla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.
Metal dental crowns, if present in mouth cavity, is not a contraindicaon to ad-
ministraon of the device in therapeuc doses.
CONTRAINDICATIONS
Do not exceed the exposure me as specified in the Direcons for Use Chapter of
this Operaon Manual, to avoid adverse events including increase in arterial blood
pressure and aggravated morbidies.
SIDE EFFECTS

11
OPERATION MANUAL
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. DO NOT use the device if any of the above damage occurs!
Disinfecon 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 soluon approved for use in medical pracce to protect the plasc and
metal items from dermatomycosis infecon. Keep interval between wipings accord-
ing to the direcons for use of disinfectant soluon. Keep control unit and emier
internals away from contacng with disinfectant soluon. Next wipe the surfaces
with cloth moistened with water and then wrung-out, and dry at ambient temper-
atures below +50 °С.
When using at home, it is recommended to disinfect externals with 0,5% to 1%
aqueous chlorhexidine/CHX/Gibitan soluon. The product is odour-free and is clas-
sified as low-hazardous substance. Use any appropriate vessel or dishware to pre-
pare the treatment soluon by mixing with water.
AƩenƟon! Please, wear rubber gloves when preparing the soluon.
PREPARATION FOR USE
!
!

12
ALMAG+
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.
Visual Display
When the device is powered on, the Start/Stop buon (« / ») LED starts blink-
ing to indicate that the device is on and in waing mode.
The device changes the mode into normal operaon mode upon brief pressing
any buon. The «START/STOP» buon LED stops flashing, and 1-2-3 mode indica-
tor LEDs light on and offsequenally, and then the LED corresponding to the last
previously set mode number (1, 2, or 3) lights up and a sound signal is heard corre-
sponding to the mode. The device is now ready for operaon.
OPERATION PROCEDURES
Mode indicaon
«Mode Select» buon
«START/STOP» buon

13
OPERATION MANUAL
Treatment Modes
The desired treatment mode is set with «Mode Select» buon as indicated in
Table 1.
Table 1
Operang
mode
Field
type
Inductor coil
excitaon
frequency
Peak (amplitude)
value of the mag-
nec field density
on the inductor coil
working surface
(mT)
Mode
descripon
1 traveling 6.25
(1/8 of the
mains
frequency)
20±6 Basic mode
of operaon
2 traveling 6.25
(1/8 of the
mains
frequency)
8±2 Pediatric mode
with reduced
magnec field
density
3staonary 100
(doubled mains
frequency)
6±2 Therapeuc mode
with pronounced
analgesic and an-
inflammatory effects
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. Mode indica-
on is provided by corresponding LED indicator.

14
ALMAG+
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-flashing glow of the «START/
STOP» buon LED indicator.
The operability of the device with the treatment mode switched on can be fur-
ther checked with magnec field indicator applying it alternavely to the inductor
coils on the side where «N» leer is located. The pulsed magnec field if present is
evidenced by the LED lamp glowing in the middle of indicator display.
Magnec field indicator

15
OPERATION MANUAL
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 offand 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. The mode number LED indicator blinks offand the «START/STOP» buon
starts blinking.
The device provides work for 8 hours in the recursive short-me mode: The ex-
posure me is 20 minutes for all the modes followed by 10 minutes idle period.
Notes:
Detailed Procedures
The treatment is carried out by acng on the lesion itself, the surrounding ssues
and reflectory zones by applying the inductor coils of the device directly to skin.
Due to high penetrang ability of the magnec 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 mode set funcon is only
acve when there is no exposure.
• Disconnect the device from the
mains aer use.

16
ALMAG+
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 field and the exposure to the northern
magnec pole). All the procedures include the exposure to the northern magnec
pole from the inductor coils indicated with «Ν»leer on the coil bodies i.e. the coil
is to be applied to the body with the end where «Ν»is located.
The traveling pulsed magnec field is to be directed from the 1st inductor coil to
the 4th inductor coil when «spline» emier configuraon is used, namely:
The coil directly connected to the control unit is referred to as the 1st coil. Where
the matrix emier configuraon is used, the inductor coils queuing and the direc-
on of the traveling pulsed magnec field are similar.
When using the four inductor coils configured in the form of «spline», the spline
fastener (hereaer the fastener) is required. The fastener fixes 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:
12 3 4

17
OPERATION MANUAL
• 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 connecon point.

18
ALMAG+
• Place the rest 1st and 2nd inductor coils into the fastener and fix them with
velcros.
• Zip up the fastener.
• Four inductor coils are now arranged in the form of «spline».

19
OPERATION MANUAL
• Use the accessory straps delivered with the device to fix the «spline» to the
extremies. Locate the straps over the zipper and fix them with velcros.

20
ALMAG+
Where 2х2 matrix inductor coil configura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.