IACER I-TECH MAG2000 PLUS User manual

USER MANUAL
Magnetotherapy model
MAG2000 PLUS


III
INDEX
INDEX III
TECHNICAL SPECIFICATIONS 4
MANUFACTURER 4
DECLARATION OF CONFORMITY 4
CLASSIFICATIONS 5
PURPOSE AND SCOPE 5
TECHNICAL FEATURES 6
DEVICE AND COMMANDS DESCRIPTION 7
LABELLING 8
Package content 10
HOW TO USE 11
INTRODUCTION TO TECHNOLOGY 11
CONTRAINDICATIONS AND SIDE EFFECTS 11
WARNINGS 11
PATIENT PREPARATION:POSITIONING OF THE THERAPEUTIC BELT AND SOLENOIDS,MAIN
APPLICATIONS AND SUGGESTIONS 14
SETUP AND PROGRAMS INSTRUCTIONS 16
Connections and power on 16
Main menu 16
Program selection 18
Free program selection 21
Language selection 24
CARE OF THE DEVICE 25
MAINTANCE 25
DISPOSAL 27
WARRANTY 27
Assistance 29
Spare parts 29
INTERFERENCE AND ELECTROMAGNETIC COMPATIBILITY TABLES 29

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Technical specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. 041.5401356 • Fax 041.5402684
IACER Srl is an Italian medical devices manufacturer (CE certificate n°
0068/QCO-DM/230-2020 issued by MTIC InterCert S.r.l. notified body
n°0068).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italia
herewith declares under its own responsibility, that the family product
MAG2000
which includes the following models
MAG700, MAG2000, MAG2000 Premium and MAG2000 PLUS
UMDNS Code: 12415
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as
modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations.
The products have been assigned to class IIa, according to Annex IX, rule 9
of the Directive 93/42/EEC (and further modifications/integrations) and
bear the mark
Compliance of the concerned products with the Directive 93/42/EEC has
been assessed and certified by the notified body:
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123, Italia
Certified number: 0068/QCO-DM/230-2020
following the certification procedure according to Annex II (excluding point
4) of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Martellago, 19/06/2020

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Classifications
MAG2000 PLUS has the following specifications:
•class IIa equipment (Directive 93/42/CEE, Annexed IX, rule 9 and
following modifications);
•class II applied part type BF (Classif. EN 60601-1);
•IP21 protection equipment against solids, dust and liquids penetration;
•equipment and accessories not subjected to sterilization;
•use of the equipment is prohibited close to flammable substances when
mixed with air, with nitrous oxide or when mixed with any flammable
agents and in environments with high concentrations of oxygen;
•continuous operating mode equipment;
•equipment not suited to be used in external.
Purpose and scope
Clinical Purpose: Therapeutic
Scope of Use: Ambulatory/Hospital and domestic
MAG2000 PLUS is indicated for the treatment, rehabilitation and functional
recovery of the following pathologies:
•wrist, hand, shoulder, foot, ankle and knee articulation
•skeletal motor apparatus
•arthrosis
•atrophies and muscular dystrophy
•bursitis
•bruises
•degeneration of locomotor apparatus
•sprains
•periarthritis
•benign lesions and muscular tears
•tendinitis
MAG2000 PLUS is particularly recommended for the treatment and care of
osteoporosis and all pathologies borne by bone tissues. Thanks to the high
intensity of the magnetic field that can generate, MAG2000 PLUS is
particularly indicated in the treatment of bone fractures even in the
presence of rigid bandages or plaster.

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MAG2000 PLUS is a device intended for both the professional user
(physician, therapist, etc.) and the patient at home. In case of home
therapy, the use of the device is recommended only on indication of the
physician/therapist.
The patient population intended for magnetotherapy treatment using the
MAG2000 PLUS device includes patients of both sexes, men and women, of
age (unless otherwise indicated by medical doctors). For further details,
please refer to the Contraindications section.
Technical features
Characteristics Specification
Power supply UE24WCP-150120SPA,15V DC, 1.2A
Max. absorbed current 0,6A
Insolation class (EN 60601-
1)
II
Applied part (EN 60601-1) BF
Dimensions (length x width
x height)
179x107x50 mm
Field intensity
Adjustable on increasing level up to
100gauss (per channel) in P1-P20
programs.
Adjustable on increasing level up to
150gauss (per channel) in P21-P35
programs.
Adjustable on increasing level up to 200
Gauss (per channel) in USER programs
Squared wave frequency Adjustable 1-120Hz
Therapy time Adjustable (max 12 consecutive hours)
Environmental conditions of
operation
Temperature
From +5 to + 28 °C
Relative humidity
From 15 to 93%
Pressure
From 700 to
1060hPa

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ATTENTION! The device delivers current above 10mA..
In free programs (User01-User10) maximum magnetic field intensity
is 200 Gauss for each channel with professional solenoids couple.
Intensity, frequency and time values are given ±20% of accuracy.
Expected life of the device and its accessories: 2 years.
Device and commands description
Power button and return to the program choice menu.
OK
OK key, confirmation button.
Selection/increment key.
Selection/decrement key.
During the therapy a green light will turn on.
Label
(retro)

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1. ON/OFF button
2. Power supply entrance DC
15V/1.2A
3. CH2 connector 2
4. CH1 connector 1
Labelling
The label on the side is
placed on the back of
the device
1
2
3
4

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Symbol
Description
Manufacturer logo
Certification of the product issued by the notified
body N° 0068.
Manufacturer
Manufacturing date (YYYY-MM)
Attention, consult operating instructions.
Product subject to WEEE regulations concerning
separate waste collection of electronic equipment.
Class II equipment.
Applied part type BF.
Admission temperature (storage, packaging).
Relative humidity (storage, packaging).
IP20
IP01
Protection level against solids, dusts and liquids
entrance (device protected against solid foreign
objects ≥ 12,5 mm and greater and vertically falling
water drops). The case of the device guarantees the
The label is placed on
the protective
envelope.

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Symbol
Description
IP20 level protection. The envelope guarantees the
IP01 level protection.
The IP21 protection is
guaranteed only when using the device inside the
envelope.
Only domestic usage.
Not protected against liquid entrance, keep dry.
Power supply symbol.
Package content
The MAG2000 PLUS package contains:
•N°1 MAG2000 PLUS device;
•N°1 power supply (cable approx. 1.5m);
•N°1 operating and belt position manual;
•N°1 elastic therapeutic belt with 3 solenoids (cable 1.5m);
•N°1professional solenoids couple (cable 1.5m);
•N°1 magnet tester;
•N°1 carrying bag;
•N°1 protective envelope.
Solenoids couple, magnetotherapy carpet and OSTEOMAT mattress are
available as accessories on demand. Visit website
www.itechmedicaldivision.com to obtain more information.

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How to use
Introduction to technology
It’s a long time that low frequency and high intensity pulsed electromagnetic
fields have met maximum scientific consent in chronic and degenerative
diseases treatment.
Magnetotherapy uses low frequency and high intensity pulsed
electromagnetic fields induced by electric current on a bobbin; due to its
characteristics, the electromagnetotherapy is universally recognized as the
most suitable technique for the treatment of bony pathologies, in particular
for the osteoporosis.
Pulsed electromagnetic fields induces biological modifications on biological
membrane assures a biostimulation in order to re-establish correct cellular
functions.
According to different authors experiences in osteoporosys a considerable
disease regression is evident from the sixth treatment and moreover it’s
evident an important increase of BMD (Bone Mass Density). The magnetic
field high value (Gauss) generated by the device allows treatments in
presence of braces or plaster bandage.
MAG 2000 PLUS is a high performance and easy to use device with also free
memories (10 user programs in which you can adjust therapy time, magnetic
field intensity and working frequency). MAG 2000 PLUS and its professional
applicators allow treatment of big area with high magnetic field intensity.
Contraindications and side effects
Patient in pregnancy, tuberculosis, juvenile diabetes, viral (in acute phase)
illnesses, mycosis, cardiopathic subjects, tumours, serious arrhythmias or
pacemaker carriers, children, metallic prosthesis carriers, acute infections,
epileptics (different medical prescriptions excepted).
No significant side effects are known of, nor are reported contraindications for
excessive time length using the device.
Warnings
It is recommended that you read this manual carefully before using the
device. For any further information and in-depth we suggest you visiting our

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website www.itechmedicaldivision.com in the section dedicated to
magnetotherapy.
It is recommended to:
•Check the position and the meaning of all the labels on the
equipment;
•Do not damage the applicator by acting on the connecting wire, and
do not wrap the wire around the applicator or the appliance;
•Avoid the use of the system to persons not adequately educated by
reading the manual. Keep out of the reach of children, animals and
pests;
•During therapy it is advisable to the patient and user not to wear
metallic objects;
•Check the integrity of the power supply before each use. Avoid use in
case of signs of damage to the casing or to the connecting wire;
•ONLY use cables and applicators supplied by the manufacturer.
Inadequate cables and applicators may damage the appliance and/or
damage the patient;
•Do not hold the device in hand while using it. It Is recommended to
place it on a table or similar support: position the device in such a
way that this operation is always easy and can be safely executed.
Place the device on a stable shelf (table, nightstand), away from
other devices that may interfere or prevent safe use of the device
and related accessories.
Is prohibited:
•The use of the device by persons incapable of understanding and
wanting, suffering from sensitiveness to sensitivity, temporarily
incapacitated if not assisted by qualified personnel;
•The use of the device near inflammable substances, gases, explosives,
in environments with high concentrations of oxygen, in the presence
of aerosols or in very humid environments (do not use in the
bathroom or during the shower/bath);
•The use of the appliance in the presence of signs of deterioration
and/or damage to the same or to the accessories (electrodes,
chargers, etc.) and/or cables; contact the dealer or the manufacturer
in accordance with the Assistance section. Check the integrity before
each use;
•The use of the appliance contemporary to liniments containing free
ions of magnetic metals;

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•Use of the device on open wounds and/or irritated skin;
•To connect the device and its accessories to other devices not listed
in this manual.
Warning:
•Position the applicator in such a way that the green side is in contact
with the patient;
•The user must periodically check the insulation (integrity) of the
applicators and their cables and check that they are not damaged (if
necessary, contacting the manufacturer);
•The use of the connection cables of the belt and the feeder: danger
of strangulation. Be extremely careful if it is necessary to pass the
cables near the neck and the patient's head: In this case it is necessary
to maintain a safe position and to avoid abrupt movements that can
cause the cables to twist.
•To avoid exposing the device and its accessories to excessive direct
light and dust. See the paragraph Care of the device.
The manufacturer shall be deemed to be responsible for the performance,
reliability and safety of the appliance only if:
•any additions, modifications and/or repairs are carried out by
authorized personnel directly by the manufacturer. Any
modification, addition and/or repair performed by unauthorized
personnel may result in the loss of safety of the device or its
malfunction;
•the electrical system of the environment in which MAG2000 is
inserted complies with national laws;
•the appliance is used in strict accordance with the operating
instructions contained in this manual.
Should any foreign materials penetrate the device contact the retailer or
manufacturer immediately. If dropped down, check that the housing is not
cracked or damaged in any way; if so, contact the retailer or manufacturer.
Should you notice any changes in the device’s performance during
treatment, interrupt the treatment immediately and consult the retailer or
manufacturer.
ATTENTION!Disconnect the power supply from the main socket
at the end of each therapy session.
The materials used to produce the device have exceeded the
prescribed standards for the toxicity of the materials themselves. In
case of allergic reactions, discontinue therapy and consult a physician.

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In case you need to use the extended treatment device (even up to 8
hours) it is advisable to use an intensity not exceeding 50G for all
programs. In this case the efficacy of the treatment is given by the
prolonged time of therapy rather than the maximum field intensity
settable. High field intensities (above 80/100G) are indicated for short
treatments (up to 2 hours) or in the presence of rigid
bandages/braces.
Applied parts. It’s necessary to consider as applied parts not only all
accessories (belt with 2/3 solenoids, professional solenoids couple, etc.) but
also the device and the power supply that can get in contact with the user
during the treatment.
Patient preparation: positioning of the therapeutic belt and
solenoids, main applications and suggestions
Here below a list of main positions for the therapeutic belt and for the
solenoids couple.
Wrap the belt around the area to be treated (or position the belt on the
area, for example in vertebral column treatment). During this phase take
care to place the green side of the therapeutic belt on the skin.
The professional solenoids couple must be placed on the area to be treated
(in opposite position or position on the area, for example in vertebral
column treatment). Also, in this case take care to place the green side of
the therapeutic belt on the skin.
Ankle
Hip
Back (lumbar)
Knee
Shoulder
Wrist
Elbow
Cervical

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Knee
Tibia/fibula
Ankle
Shoulder
Femoral head
Femur
Vertebral column
Lumbar
Suggestions for proper use:
•In P1-P20 programs a longed treatment with an intensity higher
than 60 can heat the 3 solenoids belt and this aspect makes therapy
less comfortable: we recommend spacing out treatments and to
not go over 2 consecutive hours of therapy;
•In P21-P35 programs we recommend using the professional
solenoids couple if you want to adjust an intensity higher than
100G and a treatment time longer than 2 hours;
•Do not adjust intensity higher than 50G if you use magnetotherapy
carpet (optional accessory) for prolonged treatments.
Applicator choice depends on operator discretion (solenoids couple or
solenoids belt).

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We recommend to use professional solenoids couple (which guarantee
high performance and greater field strength and tissue penetration.) if you
need an higher field intensity or in case of tissue treatment in depth or still
in presence of rigid bandages or braces.
Setup and programs instructions
Connections and power on
For proper installation of the device, we recommend to carefully read and
follow the below steps:
1. connect the applicator (or the applicators) to the device by
connecting applicator cable to one of the two plugs (CH1-CH2)
placed on the device upper side;
2. connect the power supply cable to the main, then connect the
power supply plug to the circular connector placed on the device
upper side, near to the ON/OFF switch;
3. connect the power supply plug to the main socket (110-230VAC,
50-60 Hz);
4. Move the ON/OFF switch, placed on device upper side, to the ON
position: I-TECH logo and programs menu will be displayed on
screen.
ATTENTION!To keep the device protected from penetration of solid
objects, powders and liquids, it is recommended to use it ALWAYS
INSERTED inside the envelope of protection!
Main menu
The MAG2000 PLUS device is equipped with 35 programs with preset and
user-modifiable values according to your needs. The first 20 programs are
associated with the treatment of specific pathologies with preset
parameters recommended by IACER, while the following 15 have only the
preset working frequency, leaving the user the freedom to choose the
duration and the cycles of sessions.The device has also the possibility to
store 10 user memories (USER01-USER10) to fully customizable
parameters.
Therapy duration values are recommended by I.A.C.E.R. S.r.l. however the
user can adjust the time as he prefers. Also, for each seating cycle (column
Treatment cycles of the table List of programs above) the manufacturer

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IACER recommends at least one treatment / session per day of the ongoing
seating cycle.
MAG2000 PLUS uses therapy time values, working frequency values and
field intensity values coming from scientific and medical literature, as result
of well-known experimentations and clinical evaluations (Barker - Lunt 1983,
Bassett – Pawluk – Pilla 1974, Bassett - Valdes – Hernandez 1982).
LIST OF PROGRAMS
Pre-adjusted values
Recommended values
N° Pathology Hz Time (hours)
Treatment
cycles
1
Osteoporosis
50
2 - 6
30
2
Arthrosis
15
2 - 6
20
3
Arthritis
30
2 - 6
20
4
Cerv. Arthrosis
5
2 - 6
15
5
Articular Pain
25
2 - 6
15
6
Cervicalgias
10
2 - 6
15
7
Sprains
50
2 - 6
15
8
Fractures
50
2 - 6
30
9
Epicondylitis
45
2 - 6
20
10
Epitrocleitis
40
2 - 6
20
11
Intercost. Con.
15
2 - 6
20
12
Lumbalgy
60
2 - 6
15
13
Lumbar Pain
60
2 - 6
15
14
Shoulder Art.
30
2 - 6
15
15
Knee Arthrosis
45
2 - 6
20
16
Periarthritis
50
2 - 6
20
17
Coxarthrosis
50
2 - 6
20
18
Musc. Atrophy
35
2 - 6
20
19
Musc. Contract.
20
2 - 6
15
20
Osteonecrosis
50
2 - 6
20
21
1Hz
1
free
free
22
3Hz
3
free
free
23
5Hz
5
free
free
24
10Hz
10
free
free

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*Autoscan program allows to adjust the desired therapy time
then it will start automatically a frequency cycle from 5 Hz to 120
Hz with a time therapy of 5 minutes for each frequency. It’s an
ideal program for the regeneration of both hard tissues (bones)
and soft tissues (tendons, ligaments) in the same treatment.
Program selection
Here are the instructions to follow for choosing the appropriate program
according to the pathology:
1. Within the menu, scroll through the list of programs by using the
keys and , then select the desired program and press OK.
Pre-adjusted values
Recommended values
N° Pathology Hz Time (hours)
Treatment
cycles
25
15Hz
15
free
free
26
20Hz
20
free
free
27
30Hz
30
free
free
28
40Hz
40
free
free
29
50Hz
50
free
free
30
60Hz
60
free
free
31
70Hz
70
free
free
32
80Hz
80
free
free
33
90Hz
90
free
free
34
100Hz
100
free
free
35
Autoscan*
*
2 - 6
20
36
User01
free
free
free
37
User02
free
free
free
38
User03
free
free
free
39
User04
free
free
free
40
User05
free
free
free
41
User06
free
free
free
42
User07
free
free
free
43
User08
free
free
free
44
User09
free
free
free
45
User10
free
free
free

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01
Osteoporosis
02
Arthrosis
03
Arthritis
04
Cerv. Arthrosis
05
Articular Pain
06
Cervicalgias
07
Sprains
08
Fractures
2. The display will show the basic therapy time setting (from the
figure, 2 hours) and the magnetic field intensity (50G) of the
selected program. These are average values suggested by IACER to
start the treatment immediately and effectively.
3. Press the button by highlighting the magnet icon in the lower
left then press OK.
4. The device will begin the treatment, displaying the magnet icon
with the magnetic field flow on the display. The green light below
the display alerts you to the current therapy.

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5. At the end of the therapy the device will automatically return to
the Program menu screen.
ATTENTION:The device recognizes the correct connection of the
applicators. During the treatment, below the magnet icon, the
connection status is displayed. The presence of the symbol next
to the channel number (Ch1 or Ch2) confirms the correct
connection and recognition of the applicator. The symbol X next to
the number of the channel (Ch1 or Ch2) warns of the incorrect
connection of the applicator, its absence or its incorrect functioning
(see Functioning control paragraph).
ATTENTION: it’s possible to temporary stop the therapy at any time
by pressing OK key at least for 2 seconds. Press again OK key to
continue the treatment. During the pause time green led turns off
until the treatment restarts.
ATTENTION:it’s possible to get out from the treatment at any time
by pressing once key, the screen will display the basic settings
(step 2). By pressing again key the screen will display programs
menu (step 1).
SETTABLE PROGRAMS INSTRUCTIONS
MAG2000 PLUS allows the user to modify the preset parameters in the
programs associated with the pathologies. After choosing the desired
program, follow these steps to change the parameters related to the
therapy time and the intensity of the magnetic field:
1. In the program detail press OK button to select the moving
wrench icon on the left side.
2. Press and buttons to adjust the desired therapy hours
(from 0 to 24) and confirm by pressing OK. Screen will highlight the
therapy minutes.
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