I-Tech MAG 1000 User manual

USER MANUAL
Magnetotherapy model
MAG1000

III
INDEX
INDEX III
TECHNICAL SPECIFICATIONS 4
MANUFACTURER 4
DECLARATION OF CONFORMITY 4
CLASSIFICATIONS 5
PURPOSE AND SCOPE 5
TECHINICAL FEATURES 6
DEVICE AND COMMANDS DESCRIPTION 7
LABELLING 8
Package content 9
HOW TO USE 10
INTRODUCTION TO TECHNOLOGY 10
CONTROINDICATIONS 11
Side effects 11
WARNINGS 11
PATIENT PREPARATION:POSITIONING OF THE THERAPEUTIC BELT 13
INSTRUCTIONS FOR USE 13
DEVICE CARE 16
MAINTENANCE 16
TROUBLESHOOTING 17
Battery charging 17
Replacing the battery 18
DISPOSAL 18
WARRANTY 19
Assistance 20
Spare parts 21
INTERFERENCE AND ELCTROMAGNETIC COMPATIBILITY TABLES 21

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Technical specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
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), Italy
herewith declares under its own responsibility, that the product
MAG1000
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
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
MAG1000 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).
•Equipment not protected against liquids penetration.
•Equipment and accessories not subjected to sterilization;
•Use of the equipment is prohibited close to flammable substances
or 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 and domestic
MAG1000 is projected and indicated for healing, rehabilitation and
functional recovery treatments for pathologies of:
•wrist articulation
•hand articulation
•shoulder articulation
•foot articulation
•ankle articulation
•knee articulation
•skeletal motor apparatus
•arthrosis
•atrophies and muscular distrofie
•bursitis
•bruises
•degeneration of locomotor apparatus
•sprains
•periarthritis
•benign lesions and muscular tears
•tendonitis
MAG1000 is particularly suitable for the treatment and the care of the
osteoporosis and all the pathologies on bony tissue.

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MAG1000 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
MAG1000 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.
Techinical features
Characteristics
Specification
Power supply Rechargeable batteries, Ni-MH
AA2300mAh 4,8V
Battery charger Input AC 110-240V, 50/60Hz, 200mA;
Output DC 6.8V, 300mA
Max current absorbed
≤150mA (therapy mode)
Isolation class (EN 60601-1)
II
Applied part (EN 60601-1)
BF
Field intensity
40mW for channel
Adjustable on 3 levels:
low, medium, high
Carrier frequency
27MHz
Squared wave frequency
From 8 to 640Hz
Number of programmes
20
Dimensions
(length x width x height))
153x91x38mm
Environmental conditions of
operation
Temperature
From +5° to +40°C
Relative humidity
From 30% to 80%
Pressure
From 500 to
1060hPa
Transport and storage
conditions
Temperature
From -10° to +55°C
Relative humidity
From 10% to 90%
Pressure
From 500 to
1060hPa
Expected lifetime: 3 years.

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Device and commands description
ON/OFF Key
Start/pause key
TM.
Time set key
PR.
Programs selection key
IN.
Field intensity key
Label
(retro)

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Battery status indication
PROGRAM P-01
Selected program for therapy
PULSE RATE 8Hz
Selected pulse rate
INTENSITY
Magnetic field intensity level selected:
1- low, 2- medium, 3 - high
TIMER 45’00’’
Therapy time (minutes and seconds)
A/B
Working channel: A- channel1, B- channel2
Labelling
Symbol
Description
Manufacturer logo
Certification of the product issued by the notified body N°
0068.
Manufacturer
Manufacturing date (YYYY-MM)
Attention, consult operating instructions.
The label on the side is
placed on the back of
the device

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Symbol
Description
Product subject to WEEE regulations concerning separate
waste collection of electronic equipment.
Class II equipment.
Applied part type BF.
Permitted storage temperatures (on the box)
Relative humidity of storage (on the box)
IP22
Medical device protected against the penetration of solids
(with a diameter d≥12,5mm) and against the vertical drops
when the device is kept at 15° from its normal functioning
position.
Power supply (DC 6.8V / 0.3A).
A
BA / B (CH1 / CH2) channel 1/2.
Non ionizing
Package content
The Mag1000 package contains:
•n°1 MAG1000 device;
•n°1 elastic therapeutic belt;
•n°1 battery pack (inside the device);
•n°1 battery charger;
•n°1 user manual;
•n°1 carrying bag.

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How to use
Introduction to technology
Electromagnetotherapy distinguishes itself from the “traditional”
magnetotherapy since it uses high frequency electromagnets instead of
permanent magnets: particularly, we refer to electromagnetotherapy when
using devices emitting high frequency and low intensity pulsed
electromagnetic fields (PEMF, carrying frequency from 20 to 30 MHz, with
frequencies up to 5.000 Hz).
The MAG1000 has been designed to exploit these fields, in fact it generates
an electric signal with a carrier frequency of 27mhz, which is modulated with
specific frequencies and therefore is able to soothe the anatomical site
affected by pain. For this purpose, electromagnetic fields are generated by
a radiant circuit (antennas) contained inside a special ergonomic container
and therefore exploited mainly in the treatments for pain, that is to restore
the biomagnetic cell field that with the disease had weakened. In fact,
PEMFs are able to return to the altered biological system the ability to react
with more energy against the damaging process, giving back to the cells the
optimal energy lost.
The use of high frequency and to low intensity PEMFs, allows to get ample
therapeutic results without collateral effects. This also allows the use in
acute pathological trials. The electromagnetotherapy is particularly suitable
for the care of the soft tissues pathologies, with extraordinary results in the
regeneration of the tissues themselves.
Due to its characteristics, the electromagnetotherapy is universally
recognized as the most suitable technique for the treatment of the bony
pathologies, in particular for the osteoporosis.
There are lots of effects that can be brought back to
electromagnetotherapy: the piezoelectric effect, the effect of orientation of
the collagen, the stimulation of the calcic deposition (Barker - Lunt 1983,
Bassett – Pawluk – Pilla 1974, Bassett - Valdes – Hernandez 1982).
Since the present day, all the equipments of electromagnetotherapy were
built particularly to satisfy or the medical sector (with high prices) or the
economic demands of patients, but with products of low quality.
MAG1000 is born really to reconcile the demand to have an equivalent
device, for performances and effectiveness, to those devoted to medical
sector, also maintaining a simplicity of use and an extremely favorable price.

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Controindications
Patient in pregnancy, tuberculosis, juvenile diabetes, viral (in acute phase)
illnesses, mycosis, cardiopathic subjects, serious arrhythmias or pacemaker
carriers, children, metallic prosthesis carriers, acute infections, epileptics
(different medical prescriptions excepted).
The functioning of some electric implantable devices, such as pacemakers,
could be compromised during a treatment with a short-wave therapy
device. Consult a physician before starting the treatment.
Side effects
No significant side effects are known of, nor are reported particular
contraindications for excessive time length using the device.
Warnings
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;
•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;
•avoid the use of the system to persons not adequately educated by
reading the manual;
•ONLY use cables and applicators supplied by the manufacturer.
Inadequate cables and applicators may damage the appliance and/or
damage the patient;
•during therapy it is advisable to the patient and user not to wear
metallic objects.
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,

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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;
•to connect the device and its accessories to other devices not listed in
this manual.
Warning:
•to connect the device and its accessories to other devices not listed in
this manual;
•to connect the device and its accessories to other devices not listed in
this manual;
•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.
WARNING! Connect the battery charger plug to 230V main only when
connected to MAG1000 device for batteries recharging. Disconnect
the battery charger from main after each use.
WARNING! During therapy it is possible to hear a light hiss coming
from MAG1000: such operation is normal and must not arouse worry.
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 MAG1000 is
inserted complies with national laws;
•the appliance is used in strict accordance with the operating
instructions contained in this manual.

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Patient preparation: positioning of the therapeutic belt
Here below a list of main positions for the therapeutic belt. 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.
Ankle
Hip
Back (lumbar)
Knee
Shoulder
Wrist
Elbow
Cervical
Instructions for use
Follow the instructions for the correct operation of the MAG1000:
1) Switch on MAG1000 pressing ON/OFF key .
2) Check battery status: if the icon , on the upper side of the display
is flashing, proceed to recharge the unit following the instructions (see
chapter Battery charging.
3) Connect the therapeutic belt (or belts) to the plug A (CH1) / B (CH2) on
device upper side.
4) Chose therapy program running through programs menu, using PR. Key
5) Set therapy time using TM. key: each program has its own set therapy
time, which can be modified pressing TM. with 5 minutes steps. Therapy
time can be increased up to 23 hours and 55 minutes. It’s possible to
quickly scroll time list pressing TM. key

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6) MAG1000 is now ready for use: the display shows information about
the program in use, the working frequency (not adjustable), the
adjusted therapy time and field intensity (adjustable during the
treatment).
7) Press key: the display will show the remaining therapy time, while
it will be possible to modify field intensity during the whole treatment,
pressing more times IN. key. The relative icon is positioned on the lower
right side of the display, with the indication of the three intensities (1-
low intensity,2- medium intensity-two bars and 3- high intensity).
8) The therapy can be suspended pressing the key : in basso a destra
sul display verrà visualizzato l’indicatore lampeggiante . Per
riprendere la terapia premere nuovamente .
9) To end the therapy, press key : MAG1000 will show again the
selected program and adjusted therapy time. To switch off MAG1000,
press again key .
10) A sound signal informs of the end of the program, and the display will
show the flashing icons 0’00’’; to start again a new therapy, press key
and then follow again the indications from step 4).
WARNING: In case no operation is performed for more than 2
minutes, MAG1000 automatically shuts down in order to preserve
the battery.
LIST OF STORED PROGRAMS
Pr.
Carrier
frequency
(MHz)
Squared
wave
frequency
(Hz)
Time
(h/min) Name Area
P-01 27 8 45min
Arthritis-
Arthrosis
Body, arms, legs
P-02
27
8
2h
Rheumatisms
Body, arms, legs
P-03 27 8 4h
Pain-
Articular
prosthesis
Body, arms, legs

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Pr.
Carrier
frequency
(MHz)
Squared
wave
frequency
(Hz)
Time
(h/min) Name Area
P-04 27 16 45min
Herniated
disc
Body
P-05
27
16
2h
Muscular pain
Body, legs
P-06
27
16
4h
Osteoporosis
Legs
P-07
27
32
2h
Fractures
Body, arms, legs
P-08
27
32
4h
Sprains
Arms, legs
P-09
27
48
2h
Dislocations
Arms, legs
P-10
27
48
4h
Traumas
Arms, legs
P-11 27 64 2h
Bruises
Arms, legs
P-12 27 64 4h
Myalgia
Arms, legs
P-13 27 80 2h
Tendonitis
Body, arms, legs
P-14
27
80
4h
Hematoma
Body, arms, legs
P-15
27
160
2h
Epicondylitis
Arms, legs
P-16
27
160
4h
Epytrocleitis
Arms, legs
P-17
27
320
2h
Lumbago
Body, arms, legs
P-18 27 320 4h
Muscular
contractures
Body, arms, legs
P-19 27 640 2h
2h Medium
application
Body, arms, legs
P-20 27 640 4h
4h Long
application
Body, arms, legs
IACER S.r.l. suggest the therapy time as shown on the table and pre-setted
on MAG1000. However, the user can adjust the time as he prefers.
MAG1000 uses therapy time values, working frequency values and field
intensity values coming from scientific and medical literature, as result of
well-known sperimentations and clinical evaluations (Barker - Lunt 1983,
Bassett – Pawluk – Pilla 1974, Bassett - Valdes – Hernandez 1982).

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Device care
Maintenance
If used following the instructions given in this user guide, the equipment
does not require any particular kind of maintenance.
It is recommended that the manufacturer carries out a functional test every
24 months. The manufacturer does not consider the MAG1000 device
repairable by any personnel outside the company. Each operation of the
kind perpetuated by personnel not authorized by the manufacturer will be
considered as tampering the device, freeing the manufacturer from granting
warranty and from any danger that the user or the operator may be exposed
to.
WARNING: after a long period of inactivity, it may happen that the
instrument does not turn on due to battery discharge, not due to
actual malfunction; it is appropriate to charge the battery as
indicated in the appropriate paragraph before assuming non-
existent malfunctions.
CLEANLINESS
To clean the equipment from the dust, use a soft dry cloth. More resistant
stains can be removed using a sponge soaked in water and alcohol solution
(20% solution). In case of non-prolonged use, clean the device and its
accessories as indicated above and store them in the transport bag and store
them in the packaging box.
Device not subject to sterilisation.
TRANSPORTATION AND STORAGE
Precaution for the transportation
There is no particular precaution to be taken during transportation of the
device, since MAG1000 is a portable device. In any case it is recommended
to store MAG1000 and its accessories in the supplied carrying bag after each
treatment.
Precaution for the storage
Store the device in a cool, well-ventilated place. Do not store heavy objects
on the device.
It is recommended to switch off MAG1000 at the end of each treatment and
to remove the cables from the connectors. MAG1000 should be kept in the
supplied carrying bag, together with the rest of the equipment supplied and

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carefully stored on a secure surface. The performances of the equipment
are granted if it is stored according to the following conditions:
Outside the carrying bag:
temperature from +5 to + 40 °C
relative humidity from 30 to 80%
atmospheric pressure from 500 to 1060 hPa
Inside the supplied carrying bag:
temperature: from -10°C to +55°C
maximum relative humidity: from 10% to 90%
atmospheric pressure: from 500 to 1060hPa
Troubleshooting
Any type of work on MAG1000 must be carried out exclusively by the
manufacturer or by an authorized dealer. In any event, any presumed
malfunction of MAG1000 must be verified before sending the device to the
manufacturer.
Here below are some typical situations:
•check battery status;
•check the correct connection between MAG1000 and the
therapeutic belt;
•check all the operations have been done properly.
If the problem persists contact the manufacturer.
Battery charging
If the battery status is insufficient to complete the working program, the
display will show the icon on the upper right side, near wording
PROGRAM.
To proceed with the charging, switch off MAG1000 pressing and
connect the battery charger to the plug on the upper side of MAG1000 MAG
1000 is equipped with a software protection that switch off the equipment
when the battery charger is connected. Carry out two 5-hour charging cycles
(maximum time set for charging) to obtain a full charge of the batteries, as
it takes at least 8/10 hours. When the batteries are fully charged, the display
displays the full battery charge icon.
WARNING: at the end of the charge wait at least 30 minutes before
switching on the device; in order to allow the cooling of the battery

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pack, overheated during charging and the closure of the integrated
safety system that prevents the device from turning on.
Replacing the battery
If, after normal recharging, the battery cannot sustain a full treatment
session, recharge again, as it is probably approaching the end of its useful
life. If even after a second recharge the battery still cannot complete a
treatment session, follow the steps here below:
•Contact the manufacture or authorized dealer for original
spare part;
•Open the battery compartment on the back side of MAG1000,
disconnect the red/black wire from connector and remove the
exhausted battery;
•Insert new battery and connect the red/black wire to the plug;
•Close battery compartment.
WARNING: for disposal exhausted battery follow the instructions on
chapter Disposal.
Do not open or burn battery. Do not short circuit poles. Keep battery away
from sparks or naked flames. In the event of internal electrolyte coming into
contact with skin or garments, wash immediately with water. In the event
of electrolyte coming into contact with eyes, rinse thoroughly and seek
medical attention.
WARNING: It is suggested to recharge the device once a month in
case of prolonged inactivity. This is for a correct battery
maintenance.
Disposal
The MAG1000 magnetotherapy apparatus, compatibly with the operating
and safety requirements, has been designed and built to have a minimum
negative impact on the environment, following the provisions of the
European Directive 2012/19/EU on the disposal of waste electrical and
electronic equipment.
The criteria followed are those of minimizing the amount of waste, toxic
materials, noise, unwanted radiation and energy consumption.

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Careful research on optimizing the efficiency of the machines guarantees a
significant reduction in consumption, in harmony with the concepts of
energy saving.
This symbol indicates that the product must not be disposed of
with another household waste.
The correct disposal of obsolete equipment, accessories and especially
batteries, helps to prevent possible negative consequences on human
health and the environment.
The user must dispose of the equipment to be scrapped by taking them to
the collection center indicated for the subsequent recycling of electrical and
electronic equipment.
For more detailed information on disposing of obsolete equipment, please
contact the City Council, the waste disposal service or the shop where you
purchased the product.
Warranty
IACER Srl guarantees a warranty period from the purchasing date for
MAG1000 device, unless information contained in this manual regarding
installation, use and maintenance is strictly adhered. The wearing parts
(batteries) are not included in the warranty, unless of visible manufacturing
defects. The warranty is void in case of tampering of the device and in case
of intervention on the same by personnel not authorized by the
manufacturer or by the authorized dealer.
As established by the Medical Device Directive 93/42/EEC, the manufacturer
is obliged to trace at any time the equipment supplied to intervene promptly,
if necessary, as a result of manufacturing defects.
The warranty conditions are those described in the following paragraph
Warranty conditions. The warranty is provided by IACER.
WARNING! In the event of non-shipment, the manufacturer declines all
responsibility, if corrective action on the equipment is necessary.
Should you need to return the goods then please pack the device and all the
accessories so that it won’t be damaged during transportation. In order to
be entitled to the warranty assistance, the purchaser must enclose to the
device a copy of the purchasing receipt, proving origin and purchasing date.
For more information on the warranty please contact the distributor or
vendor, in order to check the norm and standard in force in your Country,
or ultimately the manufacturer IACER Srl.

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Warranty conditions
1) Should assistance be needed, enclose the purchasing receipt when
sending the device to the manufacturer.
2) The warranty period is valid only on the electronic parts. The
warranty will be granted by the shop or directly by the
manufacturer.
3) The warranty covers only the product damages, which causes its
malfunctioning.
4) Warranty means that only the manufacturing defect components
or material are covered by reparation or free substitution, hand
work included.
5) Warranty is not applied to damages caused by negligence or use
not compliant to the given instructions, by intervention on the
device from personnel not authorized, accidental causes or
negligence form the purchaser.
6) Warranty is not applied in case of damages caused by unsuitable
power supplies.
7) Warranty does not apply to wearing parts.
8) Warranty does not include transportation costs which have to be
covered by the purchaser.
9) After the warranty period, the warranty is no more applicable. In
this case all the assistance interventions will be performed by
debiting the costs of the substitution of the parts, the hand work
and the transportations costs.
10) The court of Venice has exclusive jurisdiction over any dispute.
Assistance
The manufacturer is the sole agent for technical assistance on the
equipment. For any technical assistance, please contact:
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
Any technical documentation concerning repairable parts may be provided,
but only after company authorization and only after having given adequate
instruction to the intervention personnel.