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

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•Check the integrity of the wall mount charger before use. Avoid the
use in case of damage to the case or to the wire;
•Do not use the device in damp environments and/or in presence of
inflammable agents;.
•Do not wear metallic objects during therapy;.
•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).
•Take care to place the “+” side of the applicator on the skin
WARNIG. When using the device plugged in , unplug the charger
from the mains socket at the end of the therapy session . It is
recommended to place the device so that this operation can always
be easily and safely executable . Place the device on a stable surface
( table , nightstand ) , away from other devices that may interfere or
prevent the safe use of the device and its accessories connected .
The manufacturer is considered responsible for the performance ,
reliability and safety of the equipment only if :
•Possible additions, changes and/or reparations are effected from
authorized personnel.
•The electric plant of the environment in which Orthomag is inserted it
is conforming to the national laws.
•The instrument is employed in conformity to the instructions contained
in this manual.
Applied parts. It’s necessary to consider as applied parts the device and
the power supply that can get in contact with the user during the
treatment.
Electromagneticinterference
Use the device at least 3 metres away from televisions, monitors, mobile
phones, WIFI routers or any other electronic device as they may affect its
functioning.
In particular portable communication equipment as WIFI devices, mobile
phones, cordless phones and their base stations, walkie-talkie, can affect
the medical device and it’s recommended a separation distance “d”
calculated from the fabricant in table “R.f. immunity aspects”, column

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800MHz-2,5GHz, paragraph EMC tables. Example: for a mobile phone
with 2W maximum output power the separation distance d is 3,3 m in
order to obtain an immunity level of 3V/m or a separation distance d=0,5m
for an immunity level of 20V/m.
The device must be installed and commissioned in compliance with the
information on electromagnetic compatibility supplied in this manual. Also
see the EMC Charts paragraph.
Using accessories, transducers and cables other than those specified,
except for those transducers and cables sold by the manufacturer as
spare parts for internal components, may result in increased emissions or
decreased immunity of the device.
The device should not be placed next to or on top of other devices.
Should it prove necessary to place it next to or on top of other devices,
supervision is essential at all times to control its normal functioning.
Contraindicationsandsideeffects
•Patient in pregnancy, tuberculosis, juvenile diabetes, viral (in
acute phase) illnesses, mycosis, cardiopathic subjects, tumours,
serious arrhythmias or pacemaker carriers, children, metallic
prosthesis carriers, acute infections, epileptics (different medical
prescriptions excepted). Consult doctor/therapist for any doubt.
•Do not use on irritated skin or on open wound.
•Do not place the applicator near cancerous lesions as it may
have a negative effect on disease .
•o not place the applicator in the cavity , such as the oral . The
device is intended only for external use .
•Avoid quick movements / sudden that might cause malfunction.
•Do not place the applicator on the chest , could increase the risk
of cardiac fibrillation .
•Do not use the device when connected to other medical devices ,
particularly surgical devices at high frequency. Risk of burns in
the treatment area and damage to the device .
•Do not use if you are under medical supervision and did not
consult the same doctor about treatment with the device .
•If you spill interiors following trauma or injury, do not use the
device .
•Do not use the device in the presence of water or other liquids ( in
the bathroom , in the shower , in the pool , etc. ) as this may
increase the risk of electric shock

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WARNING: connect the charger to the power supply when connected to
the device . Do not leave the charger connected to the mains 230V but
disconnect it after each use .
WARNING: during therapy, you may hear a slight hum coming from the
device : it is a normal noise and should not cause concern .
The functionality of some implantable electrical devices , such as
pacemakers , may be affected during treatment with shortwave devices .
Consult your doctor before using the device .
No significant side effects are known of, nor are reported particular
contraindications for excessive time length using the device.
Howtousethedevice
Insert the battery in the rear compartment of Orthomag.
Therapeutic indications (average time of therapy 2 hours per day).
The pre-set program lasts up to 4 hours (then the device switches off).
When using the device with battery, the program duration is guaranteed
up to 3 hours.
How to use the device with the power supply adapter
Connect the applicator to the Orthomag.
Place the applicator onto the part of the body to be treated (see
picture at page 16) and fix it with the elastic strap supplied.
Connect the power supply adapter to Orthomag (the POWER
LED starts blinking green).
Switch on the Orthomag by pressing the middle button.
Choose the program L (50 Hz) or H (75 Hz) by pressing the L
button or the H button, respectively.
When the program L starts, the OUTPUT LED flashes green.
When the program H starts, the OUTPUT LED flashes red.
How to use the device with battery
Before proceeding, ensure that the device was previously
charged at full capacity (at least 4/5 hours).
Connect the applicator to the Orthomag.
Place the applicator onto the part of the body to be treated (see
picture below) and fix it with the elastic strap supplied.
Switch on the Orthomag by pressing the middle button.

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Choose the program L (50 Hz) or H (75 Hz) by pressing the L
button or the H button, respectively.
When the program L starts, the OUTPUT LED flashes green.
When the program H starts, the OUTPUT LED flashes red.
POWER LED behaviour in battery mode
POWER LED green steadily lit: battery fully charged that allows you to
complete the treatment.
POWER LED flashing alternating green/red: battery half charged
(emission of magnetic field is guaranteed but not sufficient to start a
complete new cycle of therapy).
POWER LED red steadily lit: battery is low. The magnetic field is still
emitted until the device is switched off.
Therapeutic indications (average time of therapy 2/4 hours per
day)
To discontinue therapy and switch off the device, press and hold the
power button for 3 seconds.
CAUTION: if the applicator is not connected, the OUTPUT LED
flashes and the device beeps 3 times in a row. Check if the
applicator and the cable are intact and if the device is connected
correctly.
Program L (50 Hz) Program H (75 Hz)
Algodystrophy Scar adherence
Gonarthrosis Arthritis
Cartilage degeneration Arthrosis
Fractures Bursitis
Cartilage injuries Brachialgy
Osteoarthrosis Capsulitis
Osteonecrosis Cervical pain
Osteoporosis Whiplash
Delayed calcification Chondropathy
Pseudo-arthrosis Contusions
Coxarthrosis
Articular pain
Rheumatic disorders
Back pain

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Epicondylitis
Epitrochleitis
Discal Hernia
Plantar fasciitis
Lumbago
Meniscopathy
Metatarsal pain
Periarthritis
Pubalgy
Rheumatisms
Rhizarthrosis
Sciatalgy
Inflammatory diseases
Muscle strains
Placementoftheapplicator
Thanks to its light and flexible structure, Orthomag® universal applicator
allows a perfect contact with the body.
The image below gives some of the possible applications for the most
common diseases treated with magnetic therapy such as cervical
osteoarthritis and / or joints of the elbow / knee arthritis bachelor / joint,
back pain , fractures , sprains .
Place it in the most comfortable on the treatment area , securing it in
place through the use of elastic bands provided.
It is recommended to undertake the processing of magnetic therapy under
the supervision of your physician and / or therapist .

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Maintenance
Batteryrechargeandreplacement
For charge the device follow the instructions bellow:
•Plug the charger to the power socket
•Connect the charger’s plug to the device
The POWER led will flash with a green light till the achievement of the
complete charge of the battery, than the light will switch off (charge
complete, 4-6 hours). During the charge the devise can be used, in
this case the POWER led will light with a green light.
For change battery please follow the instructions bellow:
•Disconnect the device from the charger.
•Remove the belt clip by pushing it down lightly
•Open the battery compartment
•Pull out the battery;
•Insert the new battery (please use only battery provided by the
manufacturer);
•Close the battery compartment;
•Put back the belt.
Before use it please finish a charge clip.
Functioningcontrol
ORTHOMAG equipment offers a magnet in order to control the device
functioning.
Control procedure:
1. Switch on the device in according to user manual safety prescriptions;
2. Start a treatment in according to user manual instructions;
3. Get the magnet and put it near to applicator;
4. Check magnet vibration (it will be proportional to selected treatment
frequency).
Please contact the manufacturer in case of magnet vibration absence.

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Cleaning
ATTENTION: before start any cleaning operations on device always
disconnect the device from mains and extract the battery form battery
compartment (see “Battery recharge and replacement” paragraph”)
Clean the equipment from the dust using a dry soft cloth.
Resistant strains can be removed using a sponge soaked in solution of
water and alcohol (20%).
When not using the device for a long time, clean the device and its
accessories as mentioned before. Place the device and the accessories in
the carriage bag and store them in their box.
When using the same applicator on different patients, we recommend to
clean it carefully using a sponge soaked in solution of water and alcohol
(20%)
We recommend to disconnect the applicator from the device before
cleaning the it.
Pay attention to respect the temperature, humidity and pressure limits
mentioned in this manual also during the cleaning of the device and its
accessories.
Carriageandstorage
Carriage precautions
ORTHOMAG is a portable device, so it does not need any particular
carriage precautions.
However we recommend to put away ORTHOMAG and its accessories
in their own bag after every treatment.
We recommend to not roll up wall mount charger and applicator cable.
Storage precautions
ORTHOMAG is protected till following environmental conditions:
Outside of the packaging
Temperature from +5 to + 40 °C
Rel. humidity from 10 to 93%
Pressure from 700 to 1060 hPa
Inside of the packaging
Temperature from –5 to +40 °C

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Rel. humidity from 10 to 93%
Pressure from 700 to 1060 hPa
Disposal
The equipment is subjected to WEEE regulations (see the symbol
on the label) concerning separate waste collection: when
disposing this product, please use the designed areas for disposing
electronic waste or contact the manufacturer.
Troubleshooting
If it is used in accordance with the instructions of the user manual,
ORTHOMAG does not need a particular regular maintenance.
If you find any malfunctioning using ORTHOMAG, please follow these
instructions:
•Check the mains socket integrity by connecting a working device to
the same socket;
•Check the connection with working wall mount charger and applicator;
•Check the correct connection between ORTHOMAG and the
applicator (or the applicators);
•Check the battery is fully charged (green led on the device must
switch off during recharge);
•Check all the operations have been done properly;
•We suggest a complete check of device every 2 years (contact the
manufacturer or locator dealer).
If you find any problem contact immediately the National Distributor or the
manufacturer at the following address:
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]

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Assistance
Every intervention on device must be performed by manufacturer. For
any assistance intervention contact the National Distributor or the
manufacturer at the following address:
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
You can get any technical documentation on spare parts but only prior
business authorization.
Spareparts
For original spare parts contact the National Distributor or the
manufacturer at following address:
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
To preserve product warranty, functionality and product safety we
recommend to use only original spare parts.