I-Tech ORTHOMAG User manual

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. [phone] – Fax [phone]
e-mail: [email protected]
www.itechmedicaldivision.com

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

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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
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.

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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 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

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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.

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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

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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)

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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.

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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