IACER I-TECH MAG2000 PLUS User manual

USER MANUAL
MNPG53-02Edition10/05/2011
Magnetotherapy model
MAG2000
PLUS
I.A.C.E.R. Srl
www.iacer.it 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] -
http://www.itechmedicaldivision.com

I.A.C.E.R. Srl 3 MNPG53-02
Summary
Summary 3
Introduction 4
Magnetotherapy 4
Technical specifications 5
Manufacturer 5
Declaration of Conformity 5
Specifications 6
Purpose 6
Technical features 7
Labeling 8
Label details 8
Symbols description 9
Kit contents 9
How to use 10
Warnings 10
Electromagnetic interference 11
Contraindications and side effects 11
Quick use of the device with presetted parameters 11
Therapeutic belt and solenoids couple positioning 13
Adjustable programs instructions 15
MAG2000 PLUS free memories use 18
Stored programs list 22
Set up (language selection) 23
Maintenance 24
Functioning control 24
Cleaning 24
Carriage and storage 25
Disposal 25
Troubleshooting 25
Assistance 26
Spare parts 27
Warranty 27

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Introduction
Magnetotherapy
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, cells and blood vessels with different
therapeutic effects: antiflogistic, antiedemigen and tissue repair.
In general magnetotherapy 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 performances 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.

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Technical
specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE) -ITALY
Tel. [phone] • Fax [phone]
www.iacer.it • [email protected]
IACER S.r.l. is an Italian medical devices manufacturer (CE medical
certificate n°MED24021 issued by Cermet notified b ody n°0476).
DeclarationofConformity
IACER S.r.l., headquartered in Italy, via S. Pertini 24/A 30030
Martellago (VE), declares on its own responsibility that MAG2000 is
manufactured in conformity with Directive 93/42/EEC (MDD), dated 14
June 1993 (D. Lgs. 46/97 dated 24 February 1997 “Attuazione della
Direttiva 93/42/CEE concernente i dispositive medici), Annex II as
modified by Directive 2007/47/CE dated 5 September 2007 (D. Lgs.
37/2010 dated 25 January 2010).
Notified body: Cermet, Via di Cadriano 23 – 40057 Cadriano di
Granarolo (BO) Italy.
Certification Path: Annex II.
MAG2000 is a Class IIa equipment, with reference to Directive
93/42/EEC (MDD), annex IX rule 9 (and following modifications).
Martellago, 03/06/10 Legal Representative
Mario Caprara

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Specifications
MAG 2000 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. CEI EN 60601-1);
•Equipment not protected against liquid 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
Clinic purpose: Therapeutic
Use: Clinic and domestic use
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
•neuralgias
•periarthritis
•benign lesions and muscular tears
•tendinitis

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MAG2000 PLUS is particularly suitable for the treatment and the care of
the osteoporosis and all the pathologies on bony tissue, for
dermatologic applications (varicose ulcers, phlebitis ulcers, arteropatic
ulcers, acne, burn sore, not healed wounds, cellulite, skin illnesses: in
these cases we recommend a low treatment intensity, lower than 40).
Moreover the device is indicated for tissue reconstruction.
Cellulite treatment is not inserted in the CE0476 marking of the device
device. Cellulite treatment can be used only for beauty purposes.
Thanks to its high magnetic field intensity MAG2000 PLUS is
particularly suitable for the treatment of bone fractures also with rigid
bandages or braces.
MAG2000 device is indicated both for professional (physiotherapists,
medics etc.) and for domestic user. In case of home therapy we
recommend using the device exclusively on medical/therapist
suggestion.
Expected lifetime: 5 years.
Technicalfeatures
Power supply Power Supply MM1510 Series, 15VDC 1A
Max. absorbed current 0,5 A
Insulation class (CEI EN 60601-1) II
Applied part (CEI EN 60601-1) BF
Dimensions (mm) 180x110x50
Field intensity Adjustable on increasing levels up to 100 Gauss
(each channel) in P1-P20 programs
Adjustable on increasing levels up to 150 Gauss
(each channel) in P21-P35 programs
Adjustable on increasing levels up to 200 Gauss
(each channel) in USER programs
Squared wave frequency Adjustable 1-120 Hz
Therapy time Adjustable by user
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 with ±20% of
accuracy.

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Environmental conditions of operation
temperature from+5 to + 40 °C
rel. humidity from 30 to 80%
pressure from 500 to 1060 hPa
Labeling
Labeldetails
Label 1
Label 1 (back)
Label 4
Label
3
Label 2

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Label 2 Label 3 Label 4
DC 15V/1A ON/OFF CH1 CH2
Symbolsdescription
Attention, consult attached documentation
Product subject to WEEE regulations concerning separate waste
collection of electronic equipment
Class II equipment
Applied part type BF
Compliance with Directive 93/42/EEC and following modifications
Manufacturing date (month/year)
Kitcontents
MAG2000 PLUS contains:
•N°1 MAG2000 PLUS device;
•N°1 power supply;
•N°1 user and maintenance manual;
•N°1 elastic therapeutic belt with 3 solenoids;
•N°1 professional solenoids couple;
•N°1 carriage bag
Magnetotherapy carpet is available as accessory on demand. Visit
website www.iacer.it to obtain more information.

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Howtouse
Warnings
Please read carefully the user manual before using MAG2000 PLUS. We
recommend to visit magnetotherapy section on website www.iacer.it in
order to obtain other information.
Take care of what follows:
•Take care of position and meaning of the labels on MAG2000 PLUS;
•Do not damage the therapeutic belt acting on connection cable and
avoid to roll up the cable around the belt or the device;
•Check the integrity of the power supply before use. Avoid the use in
case of damage to the case or to the wire;
•Avoid the use of MAG2000 PLUS to people not educated through the
reading of the manual;
•Avoid the use of MAG2000 PLUS contemporary with ointments
containing free ions of magnetic metals;
•Do not use the device in damp environments;
•Do not use in presence of inflammable agents;
•Do not wear metallic objects during therapy;
•Take care to place the green side of the therapeutic belt on the skin;
•Use only cables and applicators supplied by the Manufacturer.
Inadequate cables and applicators could damage the device and/or
could be hazardous for the patient;
•The user must periodically verify cables and applicators insulation and
control their integrity (eventually by contacting the manufacturer).
•In case of prolonged treatments (even up to 8 hours) we suggest to
use intensity lower than 50. In this case the efficacy is given by the
prolonged treatment time rather than maximum adjustable intensity;
•High magnetic field intensity (higher than 80/100 Gauss) are
recommended for short treatments (up to 2 hours) or in presence of
rigid bandages/braces.
WARNING. Disconnect the power supply from the main after each
treatment.
The manufacturer is considered responsible of the performances,
reliability and safety of the instrument only if:
•Possible additions, changes and/or reparations are effected from
authorized personnel.