I-Tech MAG2000 Manual de usuario
USER MANUAL
MNPG52-04 Edition27/06/2013
Magnetotherapy model
MAG2000
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. +39 041 5401356 – Fax +39 041 5402684
http://www.itechmedicaldivision.com
I.A.C.E.R. Srl 3 MNPG52-04
Summary
Summary 3
Introduction 4
Magnetotherapy 4
Technical Specifications 5
Declaration of conformity 5
Specifications 6
Purpose 6
Technical features 7
Labelling 8
Label details 9
Symbols description 9
Kit contents 10
How to use 10
Warnings 10
Electromagnetic interference 12
Contraindications and side effects 12
Quick use of the device with presetted parameters
12
Adjustable programs instructions 17
Stored programs list 21
Set up ( language selection) 22
Maintenance 23
Functioning control 23
Cleaning 23
Carriage and storage 24
Disposal 24
Troubleshooting 24
Assistance 25
Spare parts 25
EMC tables 27
Warranty 30
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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 the bony pathologies, in particular for the
osteoporosys.
Pulsed electromagnetic fields induce biological modifications on
biological membrane 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 is a device able to satisfy home user needs thanks to
its high magnetic intensity and its use facility.
I.A.C.E.R. Srl 5 MNPG52-04
Technical
Specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. +39 0415401356 • Fax +39 0415402684
www.itechmedicaldivision.com • iacer@iacer.it
IACER S.r.l. is an Italian medical devices manufacturer (CE medical
certificate n° MED24021 issued by Cermet notified body 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 dispositivi 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
I.A.C.E.R. Srl 6 MNPG52-04
Specifications
MAG 2000 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);
•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
Clinical purpose: Therapeutic
Use: Clinic/Hospital and domestic use
MAG2000 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
I.A.C.E.R. Srl 7 MNPG52-04
•degeneration of locomotor apparatus
•sprains
•periarthritis
•benign lesions and muscular tears
•tendinitis
MAG2000 is particularly suitable for the treatment and the care of the
osteoporosis and all the pathologies on bony tissues.
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 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 UE24WCP-150120SPA, 15VDC 1.2A
Max. absorbed current 0,6 A
Insulation class (CEI EN 60601-1) II
Applied part (CEI EN 60601-1) BF
Dimensions (mm) 180x110x50
Field intensity Adjustable on increasing level up to 100
Gauss (each channel) in P1-P20 programs.
Adjustable on increasing level up to 150
Gauss (each channel) in P21-P35 programs.
Squared wave frequency 1-100 Hz
Therapy time Adjustable by user
In frequency programs (from 21 to 35) maximum magnetic field
intensity is 150 Gauss for each channel with solenoids couple
applicator.
I.A.C.E.R. Srl 8 MNPG52-04
Intensity, frequency and time values are given with ±20% of
accuracy.
Environmental conditions of operation
Temperature from +5 to + 40 °C
Relative humidity from 10 to 93%
Pressure from 500 to 1060 hPa
Labelling
Label 1 (back)
Label 4
Label 3
Label 2
I.A.C.E.R. Srl 9 MNPG52-04
Labeldetails
Label 1
Label 2 Label 3 Label 4
DC 15V/1.2 A ON/OFF CH1 CH2
UE24WCP-150120SPA
Symbolsdescription
Attention, consult operating instructions
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)
I.A.C.E.R. Srl 10 MNPG52-04
Serial number
Admission temperatures
Relative humidity
Fabricant information
IP21
Protection level against solids, dusts and liquids entrance
Kitcontents
MAG2000 contains:
•N°1 MAG2000 device;
•N°1 power supply;
•N°1 user and maintenance manual;
•N°1 elastic therapeutic belt with 3 solenoids;
•N°1 carriage bag
Moreover solenoids couple and magnetotherapy carpet are available as
accessories.
Visit website www.iacer.it to obtain more information.
Howtouse
Warnings
Please read carefully the user manual before using MAG2000.
We recommend to visit magnetotherapy section on website
www.itechmedicaldivision.com in order to obtain other information.
Take care of what follows:
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