I-Tech ORTHOMAG User manual

USER MANUAL
Magnetotherapy model
ORTHOMAG

ii
Summary
SUMMARY ...................................................................................... II
TECHNICAL SPECIFICATIONS........................................................... 4
MANUFACTURER .................................................................................. 4
DECLARATION OF CONFORMITY................................................................ 4
CLASSIFICATIONS .................................................................................. 5
PURPOSE AND SCOPE ............................................................................. 5
TECHNICAL SPECIFICATIONS..................................................................... 6
DEVICE DESCRIPTION AND CONTROLS ........................................................ 7
LABELLING ........................................................................................... 8
Package content ........................................................................... 9
HOW TO USE................................................................................. 10
INTRODUCTION TO TECHNOLOGY............................................................ 10
CONTRAINDICATIONS........................................................................... 10
Side effects.................................................................................. 11
WARNINGS........................................................................................ 11
PREPARING THE PATIENT:MAIN POSITIONS OF THE APPLICATOR.................... 14
HOW TO USE THE DEVICE...................................................................... 16
CARE OF THE DEVICE..................................................................... 19
MAINTANCE ...................................................................................... 19
TROUBLESHOOTING............................................................................. 20
Battery recharge ......................................................................... 20
Battery replacement ................................................................... 21
DISPOSAL .......................................................................................... 21
WARRANTY ....................................................................................... 22
Assistance ................................................................................... 23
Spare parts.................................................................................. 23
INTERFERENCE AND ELECTROMAGNETIC COMPATIBILITY TABLES.................... 23

iii

IACER Srl 4 MNPG207-03
Technical specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
IACER Srl is an Italian medical devices manufacturer (CE certificate
n°0068/QCO-DM/230-2020 issued by MTIC InterCert S.r.l. notified body
n°0068).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italia
herewith declares under its own responsibility, that the product
ORTHOMAG
UMDNS Code: 12415
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as
modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations.
The products have been assigned to class IIa, according to Annex IX, rule 9 of
the Directive 93/42/EEC (and further modifications/integrations) and bear the
mark
Compliance of the concerned products with the Directive 93/42/EEC has been
assessed and certified by the notified body:
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123
Certified number: 0068/QCO-DM/230-2020
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Martellago, 19/06/2020

IACER Srl 5 MNPG207-03
Classifications
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 and scope
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.
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.

IACER Srl 6 MNPG207-03
Technical specifications
Feature
Specification
Power supply Lithium polymer batteries, 3.7V 900mAh
Battery charger model AK12G-1200100V
input 100-240V, 50/60Hz, 0.5A; output 12V, 1A
Max. current consumption
≤300mA (in therapy)
Insulation (EN 60601-1)
II
Applied parts (EN 60601-1)
BF
Field strength
20 Gauss ± 30%
Square wave frequency
50Hz (L program)
75Hz (H program)
Pulse width
16ms (L program),
10.66ms (H program)
Duty cycle
80%
Therapy duration
Preset to 4 hours
Dimensions
(Length x Width x Height)
97.9x71.8x30mm
Weight
88g
Usage conditions
Ambient
temperature
From +5° to +40°C
Relative humidity
From 30% to 85%
Atmospheric
pressure
From 700 to 1060hPa
Transport and storage
conditions
Ambient
temperature
From -5° to +40°C
Relative humidity
From 10% to 93%
Atmospheric
pressure
From 700 to 1060hPa
Useful life of the device: 3 years.

IACER Srl 7 MNPG207-03
Device description and controls
Power on/off key
L
L Program key (50Hz)
H
H Program key (75Hz)
Label (back)

IACER Srl 8 MNPG207-03
Labelling
Symbol
Description
Manufacturer's logo.
Product certification issued by notified body No. 0068.
Manufacturer's Data.
Date of manufacture (YYYY-MM).
Follow the instructions for use.
WEEE directive for the disposal of electronic and
electrical waste.
Type BF applied part
Allowed temperatures (storage and use temperatures,
on the packaging and on the device body).
Relative humidity (relative humidity for storage and use,
on the packaging and on the device body).
IP22
Protection rating against ingress of solids, dusts and
liquids (device protected against solid foreign objects of
diameter ≥ 12.5 mm and against vertical drops of water
when the device is kept at 15° from normal operating
The label
on the side
is placed on
the back of
the device.

IACER Srl 9 MNPG207-03
Symbol
Description
position).
Power supply (DC12V/1A)
Package content
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.

IACER Srl 10 MNPG207-03
How to use
Introduction to technology
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.
Contraindications
•Pregnant women, patients with tuberculosis, juvenile diabetes, viral
diseases (in the acute phase), mycosis, subjects with heart disease, those
suffering from tumours, severe arrhythmias or pacemaker wearers,
children, those with magnetisable prostheses, acute infections, epileptics
(unless otherwise prescribed by doctors).Check with your
doctor/therapist if you have any doubts/questions.
•Do not place the applicator on damaged, dirty or wounded skin. Irritated
skin, lesions or ulcers can cause infection in the applicator placement
area.
•Do not place the applicator near cancerous lesions as it may worsen the
disease.
•Do not place the applicator in cavities, such as the oral cavity. The device
is indicated for external use only.

IACER Srl 11 MNPG207-03
•Avoid rapid/sudden movements that could cause the device to
malfunction.
•Do not place the applicator on the chest, it could increase the risk of
cardiac fibrillation.
•Do not use the device when connected to other medical devices,
especially high frequency surgical devices. Danger of burns in the
treatment area and damage to the device.
•Do not use if you are under medical supervision and have not consulted
your doctor about treatment with the device.
•In case of internal effusions as a result of trauma or accident, do not use
the device.
•Do not use the device in the presence of water or other liquids (in the
bathroom, while showering, in the swimming pool, etc.) as this can
increase the risk of electric shock.
WARNING: connect the battery charger to the mains only when
connected to the device. Do not leave the battery charger connected to
the 230V mains, make sure you disconnect it after each use.
WARNING: a slight hum from the device may be heard during therapy -
this is normal and nothing to worry about.
The functionality of some implantable electrical devices, such as pacemakers, may
be impaired during treatment with shortwave devices. Consult your doctor before
using the device.
Side effects
There are no known significant side effects connected to this therapy, nor
have there been any problems reported related to excessive exposure to the
electromagnetic field generated by the device.
Warnings
Please read this manual carefully before using the device. For any further
information and details we advise you to visit our website
www.itechmedicaldivision.com and refer to the section on magnetotherapy.
You should:
•read the user manual carefully and follow the instructions;
•check the location and meaning of all labels affixed to the device;
•only use the device in accordance with the instructions for use
contained in this manual;

IACER Srl 12 MNPG207-03
•use and store the device in a clean and dry place;
•not expose the device to dust, dirt, direct sunlight and water;
•avoid electric shocks to the device;
•not drop or allow the device to fall;
•not open the device, in case of problems contact the manufacturer;
•not use the device in case of faults or malfunctions;
•not modify the device or the applicator without the manufacturer's
authorisation as malfunctions may occur;
•check the condition of the battery charger before use: do not use if
the plastic casing or cable are damaged or have deteriorated;
•not wear metal objects during therapy;
•only use cables and applicators supplied by the manufacturer.
YOU MUST NOT :
•allow the device to be used by people (including children) with
reduced physical, sensory and motor skills or by people not
instructed to use it without the supervision of someone who has
been trained how to use the device.Such people may not use the
device correctly or in accordance with the information provided in
this manual, and may be harmed as a result;
•use the device near flammable substances, gases, explosives, in
environments with high oxygen concentrations, in the presence of
aerosols or in very humid environments (do not use in the bathroom
or while showering/bathing);
•use the device in the presence of signs of deterioration and/or
damage to it or to the accessories (applicator, battery charger, etc.)
and/or cables: contact the dealer or the manufacturer as indicated in
the Support paragraph. Check the condition of the device before
each use;
•use the device while using ointments containing free ions of
magnetisable metals;
•use the device on open wounds and/or irritated skin;
•connect the device and its accessories to other devices not indicated
in this manual.
Warning:
•The device can be used for personal home use;
•Medical device. Keep out of the reach of children in order to avoid
inhalation or ingestion of small parts;

IACER Srl 13 MNPG207-03
•Electronic medical devices require special precautions regarding
electromagnetic compatibility;
•The device must be put into operation in accordance with the
provisions of the EMC tables;
•The device should not be used in environments with strong
electromagnetic interference: near televisions, microwave ovens or
mobile phones, etc .;
•The device is suitable for use on a single person;
•Unsuitable cables and accessories could damage the device and
could endanger the patient;
•The user must periodically check the condition and insulation of the
cables and applicators;
•Position the applicator so that the side with the “+” symbol is in
contact with the patient.
WARNING: If you are using the device connected to the mains,
disconnect the battery charger from the mains socket at the end of
the therapy session.It is recommended to position the device so that
this operation is always easy and safe to perform. Place the device
on a stable shelf/support (table, bedside table), away from other
devices that may interfere or prevent safe use of the device and its
connected accessories.
The manufacturer is to be considered responsible for the safety, reliability
and performance of the device provided that:
•Any additions, modifications and/or repairs are carried out by
personnel authorised directly by the manufacturer. Any
modification, addition and/or repair carried out by unauthorised
personnel is prohibited as it could result in the loss of safety of the
device or its malfunction.
•The electrical system of the environment in which ORTHOMAG is
inserted complies with national laws.
•The device is used in strict compliance with the instructions given in
this manual.
Applied PartsIn addition to the applicator, parts applied to the patient are
also considered to be the device itself and the battery charger that may come
into contact with the user during treatment.

IACER Srl 14 MNPG207-03
Preparing the patient: main positions of the applicator
The flexible applicator guarantees a comfortable fit and wearability, adapting
effectively to different parts of the body. It is also very light and compact.
The following image provides some of the possible applications for the most
common conditions treatable with magnetotherapy such as cervical and/or
elbow/knee joint arthritis, scapula/humeral arthritis, lumbar pain, fractures,
sprains.
Position it in the most comfortable way on the area to be treated, fixing it in
position using the elastic straps provided.
It is recommended that you undergo magnetotherapy treatment under the
supervision of your doctor and/or therapist.

IACER Srl 15 MNPG207-03

IACER Srl 16 MNPG207-03
How to use the device
Insert the battery in the rear compartment of Orthomag.
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.
•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.

IACER Srl 17 MNPG207-03
LIST OF PROGRAMS
Therapeutic indications (average time of therapy 2/4 hours per day)
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
Epicondylitis
Epitrochleitis
Discal Hernia
Plantar fasciitis
Lumbago
Meniscopathy
Metatarsal pain
Periarthritis
Pubalgy
Rheumatisms
Rhizarthrosis
Sciatalgy
Inflammatory diseases
Muscle strains
To stop therapy and turn off the device, press and hold the on/off key for 3
seconds.
WARNING: if the applicator is disconnected, the output LED flashes
and the device emits 3 consecutive beeps. Check the condition of the
applicator, the cable and the correct connection to the device.

IACER Srl 18 MNPG207-03
WARNING: in the case of equipment supplied for hire, ORTHOMAG
can be locked in the L or H program in order not to allow the
program to be changed by the end user (this is in order to strictly
follow the instructions given by medical personnel).This function can
only be enabled via software/PC by authorised personnel.
In this case, the device only allows switching on/off and starting therapy via
the ON/OFF key. The OUTPUT LED indicates the active program (green LED =
program L, red LED = program H).If you try to choose a different program, you
will hear a beep (3 consecutive beeps).Therapy can be suspended (paused) by
pressing the L or H key once (depending on the active therapy).Press the
button again to restart the treatment.

IACER Srl 19 MNPG207-03
Care of the device
Maintance
If used in accordance with the information reported herein, this device
requires no particular routine maintenance operations.
In the event of malfunction, first follow these simple steps:
•make sure that the power outlet to which the device is connected is
working properly by connecting another working device;
•check the connection with the battery charger and the condition of
all connection cables;
•check the connection with the applicator;
•recharge the battery until the charging LED goes off;
•verify that all operations have been performed correctly;
•every two years check that all the functions of the device work
correctly (contact the manufacturer).
If you discover a problem or you require further information, please contact
the manufacturer immediately.
CHECKING DEVICE OPERATION
A magnet (small ring or disc in metal or metal/plastic) is supplied with the
device to check its operation.
Procedure for checking:
1. switch on the device following all the safety instructions provided in
this manual;
2. start any therapy, following the instructions for use of this manual;
3. hold the magnet supplied and bring it close to the applicator;
4. check that the magnet vibrates (proportional to the frequency of the
selected therapy).
Contact the manufacturer if the magnet does not vibrate.
CLEANLINESS
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%).