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

e-mail: [email protected] -

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

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

I.A.C.E.R. Srl 4 MNPG52-04

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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