I-Tech ORTHOMAG Bedienungsanleitung

USER MANUAL

MNPG207-02 Edition 02/12/2016

Magnetotherapy model

ORTHOMAG

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. +39 041 5401356 – Fax +39 041 5402684

e-mail: [email protected]

www.itechmedicaldivision.com

I.A.C.E.R. Srl 3 MNPG207-02

Summary

Summary 3

Introduction 4

Magnetotherapy 4

Technical Specifications 5

Manufacturer 5

Declaration of conformity 5

Specifications 6

Technical features 7

Labelling 8

Label details 8

Symbols description 8

Kit contents 9

How to use 10

Warnings 10

Contraindications and side effects 12

How to use the device 13

Maintenance 17

Functioning control 17

Troubleshooting 19

Assistance 20

Spare parts 20

EMC tables 21

I.A.C.E.R. Srl 4 MNPG207-02

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

osteoporosis.

Pulsed electromagnetic fields induce biological modifications on

biological membrane in order to re-establish correct cellular

functions.

According to different authors experiences in osteoporosis 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.

Thanks to its innovative universal applicator, light and flexible,

and to the portability guarantee by a lithium rechargeable battery,

ORTHOMAG represents an extremely powerful, easy-to-use

device to be used everywhere.

I.A.C.E.R. Srl 5 MNPG207-02

Technical

Specifications

Manufacturer

I.A.C.E.R. S.r.l.

Via S. Pertini, 24/a • 30030 Martellago (VE)

Tel. 041.5401356 • Fax 041.5402684

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 ORTHOMAG 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 (excluded point 4).

ORTHOMAG is a Class IIa equipment, with reference to Directive

93/42/EEC (MDD), annex IX rule 9 (and following modifications).

Martellago, 01/10/15 Legal Rappresentative

Mario Caprara

I.A.C.E.R. Srl 6 MNPG207-02

Specifications

ORTHOMAG 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);

•IP22 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

ORTHOMAG 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

•degeneration of locomotor apparatus

•sprains

•periarthritis

•muscular tears

•tendinitis

ORTHOMAG is particularly suitable for the treatment and the care of

the osteoporosis and all the pathologies on bony tissues.

I.A.C.E.R. Srl 7 MNPG207-02

ORTHOMAG 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.

According to medical devices directives, the fabricant suggests a

device control to check its efficiency and safety every 2 years.

Expected lifetime of the device and its accessories: 3 years.

Technicalfeatures

Power supply

Battery charger

DC 3.7V Lithium battery

12V/1A

Max. absorbed current ≤300 mA (therapy mode)

Insulation class (CEI EN 60601-1) II

Applied part (CEI EN 60601-1) BF

Dimensions and Weight 97,9x71,8x30mm, 88gr

Peak of Intensity 20 Gauss ±30%

Frequency 50 Hz (at “High” mode), 75 Hz (at “Low” mode)

Pulse width 16ms (at “High” mode), 10,66ms (at “Low” mode)

Duty cycle

Treatment time

80%

Pre-set at 4 hours

Environmental conditions of operation:

Temperature from +5 to + 40 °C

Relative humidity from 30 to85%

Pressure from 700 to1060 hPa

I.A.C.E.R. Srl 8 MNPG207-02

Labelling

Labeldetails

Label 1

Label 2

DC INPUT 12V 1A

Symbolsdescription

Attention, consult operating instructions

Product subject to WEEE regulations concerning separate

waste collection of electronic equipment

Class II equipment

Label 2

Label 1 (on the back)

I.A.C.E.R. Srl 9 MNPG207-02

Applied part type BF

Compliance with Directive 93/42/EEC and following

modifications

Manufacturing date (month/year)

Admission temperatures

Relative humidity

Fabricant information

IP22 Degree of protection against ingress of solids , powders and

liquids (device protected against solid foreign diameter

≥12,5mm and against dripping water vertical when the device

is kept at 15 ° from the normal operating position ) .

Only domestic use

Kitcontents

ORTHOMAG kit:

•N°1 ORTHOMAG device;

•N°1 wall mount charger (cable 1.5 m);

•N°1 user and maintenance manual;

•N°1 universal flexible applicator (cable 1.5 m);

•N°1 carriage bag;

•N°1 test emissions magnet;

•N°2 elastic bands (S and L size);

•N°1 car charger (optional).

Visit website www.orthomag.eu to obtain more information.

I.A.C.E.R. Srl 10 MNPG207-02

Howtouse

Warnings

Please read carefully the user manual before using Orthomag.

We recommend to visit magnetotherapy section on website

www.itechmedicaldivision.com in order to obtain other information.

Take care of what follows:

•Read carefully the user manual and follow the instructions given

•This device can be used for a domestic personal use

•The device have to be used in an environment with a temperature

range from 5 to 40°C.

•Do not expose to temperatures above 55 ° C or below -10 ° C

•Do not use the device in an environment with humidity upper than

90%.

•Storage the device in a clean and dry environment

•Avoid the device and accessories exposition to excessive direct

sunlight, dust and water.

•Avoid electrical shock to the device

•Avoid accidental fall of the device

•Do not open the device, in case of problems , contact the

manufacturer .

•Orthomag is a medical device. Keep it out of children and animal’s

reach.

•Do not use the device in case of anomalies or malfunctions

•Medical electronic require special precautions with regard to

electromagnetic compatibility

•The device must be operated in accordance with the requirements of

the EMC tables .

•The device should not be used in environments where there ia

presence of strong electromagnetic interference : close to televisions,

microwave ovens or mobile phones etc.

•Use of the device is not intended for persons (including children ) with

reduced physical , sensory and motor or uneducated people to use

without the supervision of skilled / educated person on the use of the

device. These people could not use the device properly in accordance

with this manual.

•Do not modify the device or the accessories without the authorization

of the manufacturer. It can cause malfunctions

•This device is designed to treat one person only

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