I-Tech LaMagneto User manual

USER MANUAL
MNPG262-02Edition27/01/2020
Magnetotherapy model
LaMagneto
I.A.C.E.R. Srl
www.itechmedicaldivision.com

I.A.C.E.R. Srl
Via S. Pertini 24/A –30030
Martellago (VE) ITALY
Tel. [phone] –Fax [phone]
e-mail: [email protected]
https://www.itechmedicaldivision.com

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Summary
Summary 3
Introduction 4
Magnetotherapy 4
Technical specification 5
Manufacturer 5
Declarationofconformity 5
Classifications 6
Intendedpurposeandscopeofuse 7
Technicalcharacteristics 8
Labelling 9
Devicelabelsindetail 9
Descriptionofthesymbols(deviceandpackaging) 10
Contentsofthepack 10
Howtouse thedevice 11
Warnings 11
Electromagneticinterference 12
Contraindicationsandsideeffects 13
Quickuseofthedevicewithpresetparameters 13
Useofthetherapeuticbeltsandsolenoids,mainapplicationsandsuggestions 15
Instructionsforusingthepresetprograms 17
InstructionsforusingprogrammesinDoublePatientmode 20
Listofstoredprograms 23
Last10 28
Settings(languageselection) 29
Howtolookafterthedevice 30
Checkingdeviceoperation 30
Cleaningthedevice 30
Transportandstorage 31
Disposal 31
Maintenance 31
Support 32
Spareparts 32
EMCTables 33
Warranty 37

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Introduction
Magnetotherapy
The treatment of certain conditions through low frequency and
high intensity pulsed magnetic fields has garnered great
consensus amongst international scientific circles for many
years, especially as regards chronic and degenerative diseases.
Magnetotherapy uses low frequency and high intensity pulsed
magnetic fields induced by the electric current that runs through
a coil; due to its characteristics it is now universally recognised
as the most suitable technique for the treatment of bone
conditions and in particular for osteoporosis.
The biological modifications induced by the magnetic fields on
the cell membranes guarantee a biostimulation able to restore
the correct functionality of the cell itself.
According to the experiences of several authors, in cases of
osteoporosis, already starting from the sixth treatment session
there is a remarkable regression of pain symptoms and even
more striking is that a significant increase in BMD (Bone Mass
Density) is noted. The high magnetic field flux value (Gauss)
generated by the device allows the treatment of the patient even
in the presence of braces or plaster casts.

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Technical
specification
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
IACER S.r.l. is an Italian manufacturer of medical devices (CE
certificate No. issued by the Notified Body No. 1936 TÜV Rheinland
Italia srl).
Declarationofconformity
IACER S.r.l., with registered office in via S. Pertini 24/A 30030
Martellago (VE), declares that the LAMAGNETO device complies with
the essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices (Leg. Decree46/97 of 24 February
1997 "Implementation of Directive 93/42/EEC concerning medical
devices"), Annex II as amended by Directive 2007/47/EC of 5
September 2007 (Leg. Decree37/2010 of 25 January 2010).
Notified body:TÜV Rheinland Italia srl, Via Mattei 3 - 20010 Pogliano
Milanese (MI) Italy.
Certification path:Annex II, excluding item 4.
The LaMagneto X device is a class IIa equipment according to Annex
IX, rule 9 of Directive 93/42/EEC (and subsequent amendments).
Martellago, 13/03/18 The legal representative
Massimo Marcon

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Classifications
In accordance with point 1.1 of Annex IX of DIRECTIVE 93/42/EEC
(and subsequent amendments), the LaMagneto is a type of device
designed for continuous use for less than 24 hours. According to point
1.4 of the same annex, the device relies on an electrical energy source,
therefore it is considered as an active medical device. With reference to
point 1.5 of the mentioned annex, the LaMagneto is an active
therapeutic device, as it is intended for the treatment of various types of
conditions. In accordance with Rule 9, paragraph 3 of Annex IX of
Directive 93/42/EEC, all active therapeutic devices intended for the
administration or exchange of energy are in Class IIa unless their
characteristics are such as to enable them to release energy to the
human body or exchange energy with the human body in a potentially
dangerous form, taking into account the nature, density and part where
the energy is applied, in which case they fall into class IIb. Considering
the fact that pulsed magnetic fields do not fall into the category of
ionising radiation, and that do not involve direct application of electric
current on the patient, it can be said that the energy exchanged by the
device with the human body is not at all dangerous.
Therefore, the devices of the LaMagneto line are active medical
devices belonging to class IIa. With regard to the second sentence of
Annex IX, "If several rules apply to the same device, based on the
performance specified for the device by the manufacturer, the strictest
rules resulting in the higher classification shall apply to the device of the
LaMagneto line. Therefore the classification is IIa.
The LaMagneto device assumes the following classifications:
•Class II with type BF applied part (Classif. IEC EN 60601-1);
•Device with IP21 degree of protection against the penetration of
solid objects, powders and liquids.
•Device and accessories supplied non-sterile and not subject to
sterilisation;
•Device not suitable for use in the presence of a flammable
anaesthetic mixture with air, with nitrous oxide, with any flammable
agent of any kind and in environments with a high concentration of
oxygen;
•Device intended for continuous operation;
•Device not suitable for external use.

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Intendedpurposeandscopeofuse
Clinical purpose: Therapeutic
Scope of use: Outpatient Clinic/Hospital and home
LaMagneto is designed and indicated for the treatment, rehabilitation
and functional recovery of conditions concerning:
•joints of the wrist, hand, shoulder, foot, ankle and knee
•the musculoskeletal system
•arthrosis
•muscular atrophies and dystrophies
•bursitis
•bruises
•degenerative disease of the locomotor system
•sprains
•periarthritis
•benign lesions and pulled muscles
•tendinitis and tendinosis
LaMagneto is particularly indicated for the treatment of delayed union,
osteoporosis, bone oedema, osteonecrosis, as well as ulcers and
neuropathies.
Thanks to the high intensity of the magnetic field it is able to generate,
LaMagneto is particularly indicated in the treatment of bone fractures
even in the presence of rigid bandages or plaster casts.
The distinctive feature of the LaMagneto device is the possibility of
managing two treatments at the same time, by setting different times
and programs.
LaMagneto is a device intended for both professional users (doctor,
therapist etc.) and for in-home therapy. With regard in-home therapy,
it is recommended that the device only be used following advice
from your doctor/therapist.
In accordance with guidelines for medical devices, the manufacturer
suggests a check of the efficiency and safety of the device every 24
months. Useful life of the device and its accessories (period after which
it is suggested to send the device to the manufacturer):3 years

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Technicalcharacteristics
Power supply
Pow. UES36LCP-150200SPA, out 15VDC-2A
Max. current consumption
1 A
Insulation class (CEI EN 60601-1)
II
Applied part (CEI EN 60601-1)
BF
Dimensions (length x width x
height)(mm)
180x110x50
Intensity of the field
Adjustable with increasing scale up to 150 Gauss
(per channel).
Frequency of the square wave
1-100 Hz
Therapy time
User-settable
The maximum magnetic field intensity is 150 Gauss per channel
with a professional applicator with a pair of solenoids (optional
accessory).
The values of intensity, frequency and time are supplied with an
accuracy of ± 20%.
Ambient operating conditions:
temperature from +5 to + 30°C
relative humidity from 15 to 93%
pressure from 700 to 1060 hPa

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Label 1 (on
the back)
Labelling
Devicelabelsindetail
Label 1
Label 2 Label 3 Label 4
DC 15V/2.0A ON/OFF CH1 CH2
UES36LCP-150200SPA
Label 2
Label 3
Label 4

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Descriptionofthesymbols(deviceand
packaging)
Follow the "instructions for use"
Waste disposal (WEEE Directive)
Class II device
Applied part type BF
This product complies with European Community Directive
93/42/EEC and subsequent amendments
Date of manufacture (month/year)
Serial number
Temperatures permitted
Relative humidity
Manufacturer's data
IP21
Degree of protection against the entry of solids, powders and
liquids
Center positive symbol
Contentsofthepack
The LaMagneto pack contains:
•N°1 LaMagneto device;
•N°1 medical power supply (approx 1.5mt cable);
•N°1 Use and maintenance manual;

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•N°2 belt applicator with 3 solenoids (approximately 1.5mt
cable);
•N°1 device carry bag;
•Magnet for verifying therapy operation
•Non-woven fabric strip 15x150 cm (see page 15 for further
details)
The professional applicator with a pair of solenoids is available as an
optional accessory. Visit www.itechmedicaldivision.com for more
information.
Howtouse
thedevice
Warnings
It is recommended to read this manual carefully before using the device.
For any further information and details we advise you to visit our website
www.itechmedicaldivision.com and refer to the section dedicated to
magnetotherapy.
Nevertheless, please follow the following instructions:
•Check the location and meaning of all labels affixed to the device;
•Do not damage the applicator by acting on the connecting wire, also
avoid winding the wire around the applicator or around the device;
•Check the integrity of the power supply each time it is used. Avoid
use in the case of signs of damage to the casing or to the connecting
wire;
•People who are not properly trained and who have not read this
manual must not use the device;
•Avoid using the device while using ointments containing free ions of
magnetisable metals;
•Avoid using the device in humid environments and/or in the presence
of flammable agents;
•During therapy, the user and the patient are advised not to wear
metal objects;
•Position the applicator in such a way that the green side is in contact
with the patient's skin;

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•Use only cables and applicators supplied by the Manufacturer.
Inadequate cables and applicators could damage the device and/or
cause harm to the patient;
•The user must periodically check the insulation (integrity) of the
applicators and their cables and check that they are not damaged
(contacting the manufacturer if needed);
•The user must pay attention when using the connecting cables of the
belt and the power supply: strangulation risk.
•The materials used for producing the device exceed the required
standards regarding material toxicity. In case of allergic reactions,
discontinue therapy and consult a doctor.
•Do not connect the device and its accessories to other devices not
indicated in this manual.
•Keep out of the reach of children and animals.
•Avoid exposing the device and its accessories to excessive direct
light and dust. Refer to the indications in the paragraph "How to look
after the device";
CAUTION. Disconnect the power supply from the wall socket at the end of
the therapy session.
The manufacturer is to be considered responsible for the safety, reliability
and performance of the device provided that:
•any additions, modifications and/or repairs are carried out by
personnel authorised directly by the manufacturer.
•the electrical system of the environment in which LaMagneto is
inserted complies with national laws.
•the devices are used in strict compliance with the instructions
reported in this manual.
Electromagneticinterference
It is advisable to use the device at a distance of at least 3 meters from
televisions, monitors, mobile phones, WI-FI routers or any other electronic
equipment as these devices could affect the operation of the device.
The device must be installed and operated in accordance with the
electromagnetic compatibility information contained in this manual. See
also the paragraph EMC tables.
The use of accessories, transducers and cables other than those
specified, with the exception of those sold by the manufacturer as
replacement parts for internal components, may result in increased
emissions and decreased immunity.

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The device should not be used near or placed on top of other equipment
and, if it is necessary to use it near or placed on top of other equipment, it
should be observed to check normal operation in the configuration in
which it is used.
Contraindicationsandsideeffects
Pregnant women, patients with tuberculosis, juvenile diabetes, viral
diseases (in the acute phase), mycosis, subjects with heart disease, those
suffering from tumours, severe arrhythmias or pacemaker wearers,
children, those with magnetisable prostheses, acute infections, epileptics
(unless otherwise prescribed by doctors).
There are no known significant side effects related to therapy, nor have
there been any problems reported related to excessive exposure to the
electromagnetic field generated by the device.
Quickuseofthedevicewithpresetparameters
To start using LaMagneto quickly and easily, we recommend that you
follow the steps below:
1. Connect the applicator (or applicators) to the device by connecting
the plug of the applicator cable to one of the two ports (CH1-CH2)
on the panel at the top of the appliance;
2. Connect the mains cable to the power supply and then connect the
power supply outlet to the circular connector on the panel at the top
of the appliance, near the ON/OFF switch:
3. Connect the plug of the mains cable to the mains socket (110-
230VAC, 50-60 Hz);
4. Press the ON/OFF switch on the small panel on the upper part so it
is in the ON position: the display will show the I-TECH MEDICAL
DIVISION logo and then the main menu screen; for quick standard
use, now select the first item "Single patient" by pressing the "OK"
button.
5. Scroll through the program using the buttons and select
the desired program;

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6. Press OK. The display will show the basic setting time of the
therapy (2 hours) and magnetic field intensity. These are the
average values suggested by IACER to immediately start the
treatment effectively.
7. Press the OK button. The device will start the treatment, displaying
the magnet icon with the magnetic field flux. The green light below
the display notifies the therapy is underway.
8. At the end of the therapy, the device will automatically return to the
program menu screen.
Note: it is possible to temporarily suspend therapy at any time by
pressing the OK button. To resume therapy, press the OK button again.
During the pause phase the green LED goes off, and then comes back
on when the therapy is restarted.
Note: it is possible to exit the treatment at any time by pressing the
/ button once: the device will go back to the screen of the
selected programme (point 6). By pressing the / button again

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the device will go back to the initial screen of the program menu (point
5).
Note: the device recognises if the applicators are connected correctly.
During the therapy phase, the connection status is displayed below the
magnet icon. The presence of the symbol next to the channel
number (1 or 2) confirms the applicator is connected correctly and
recognised.The X symbol next to the channel number (1 or 2) tells you
that the applicator is not connected correctly, missing or not working
correctly (see paragraph "Checking device operation").
Useofthetherapeuticbeltsandsolenoids,mainapplicationsand
suggestions
Some of the main positions for applying the therapeutic belt and the
solenoids are given below.
N.B: it is recommended to interpose the non-woven fabric strip
between the skin and the applicator.
Wrap the 3-solenoid belt (applicator) around the area to be treated (or
place it over the area, such as in the treatment of the vertebral column)
taking care that the green side of the belt is placed in contact with the
skin. Two photos are given below by way of example.
The professional solenoids (accessory to be purchased separately)
must be placed on the area to be treated, opposite each other, taking
care that the green side is placed on the same side of the skin.
The photos below are for illustration purposes only concerning
applicator placement. Remember that between the applicator and the
skin it is necessary to interpose the non-woven fabric strip contained in
the pack.

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Ankle
Hip
Back (lumbar)
Knee
Shoulder
Wrist
Elbow
Cervical vertebrae
Knee
Tibia / fibula
Ankle
Shoulder
Femoral head
Femur

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Vertebral column
Lumbar
Suggestions for correct use:
•The device and the applicators are designed to operate in the
temperature ranges indicated with treatments of up to 12
consecutive hours;
•In the P1-P41 programs, if you set an intensity higher than 100,
with extended therapy times, the 3-solenoid belt could heat up
thereby making the therapy uncomfortable: it is advisable to
split up the treatment sessions and do not exceed 2/3
consecutive hours of therapy;
•In P42-P45 programs, if you want to set an intensity higher than
100 with treatments over 2 hours, we recommend using the
professional applicator with a pair of solenoids available as an
optional accessory for LaMagneto.
Instructionsforusingthepresetprograms
Per utilizzare LaMagneto impostando liberamente i parametri relativi a
tempo di terapia e intensità del campo magnetico, seguire i seguenti
semplici passi:
1. Connect the applicator (or applicators) to the device by connecting
the plug of the applicator cable to one of the two ports (CH1-CH2)
on the panel at the top of the appliance;
2. Connect the mains cable to the power supply and then connect the
power supply outlet to the circular connector on the panel at the top
of the device, near the ON/OFF switch;
3. Connect the plug of the mains cable to the mains socket (110-
230VAC, 50-60 Hz);
4. Press the ON/OFF switch on the small panel in the upper part so it
is in the ON position: the display will show the I-TECH MEDICAL
DIVISION logo and then the main menu screen;

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5. Select "Single Patient" and scroll through the programs using the
and buttons and select the desired program
6. Press OK. The display will show the basic setting of therapy time (2
hours) and intensity of magnetic field that we will modify;
a) Press the button so that the spanner is highlighted. At this
point press OK: the display shows a moving spanner icon on
the left-hand side;

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b) Use the and buttons to set the desired therapy hours
(from 0 to 24) and confirm by pressing the OK button. The
display will highlight the minutes of therapy;
c) Use the and buttons to set the desired therapy
minutes (from 0 to 59) and confirm by pressing the OK button.
The display will highlight the intensity of the treatment;

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d) Use the and buttons to set the treatment intensity and
confirm by pressing the OK buttons.
7. The device will return to the screen in point 6. Press OK: the device
will start the treatment, displaying the magnet icon with the magnetic
field flux. The green light tells you the therapy is underway.
8. At the end of the therapy, the device will automatically return to the
program menu screen.
InstructionsforusingprogrammesinDoublePatientmode
To use the "Double Patient" mode of the LaMagneto device, follow
these simple steps:
1. Connect the applicator (or applicators) to the device by connecting
the plug of the applicator cable to one of the two ports (CH1-CH2)
on the panel at the top of the appliance;
2. Connect the mains cable to the power supply and then connect the
power supply outlet to the circular connector on the panel at the top
of the device, near the ON/OFF switch;
3. Connect the plug of the mains cable to the mains socket (110-
230VAC, 50-60 Hz);
4. Press the ON/OFF switch on the small panel in the upper part so it
is in the ON position: the display will show the I-TECH MEDICAL
DIVISION logo and then the main menu screen;
5. Select "Double Patient" by pressing the button and press OK;