Kora 353 User manual

USER MANUAL
MNPG396-00 Edition 22/11/21
I.A.C.E.R. Srl
www.koratherapy.com

I.A.C.E.R. Srl
Via E. Ferrari 2 – 30037
Scorzè (VE) ITALY
Tel. [phone] – Fax [phone]
e-mail: [e-mail]
https://www.koratherapy.com

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Summary
Summary 3
Introduction 4
Magnetotherapy 4
Technical specification 5
Manufacturer 5
Declaration of conformity 5
Intended purpose and scope of use 5
Technical characteristics 6
Labelling 7
Device labels in detail 7
Description of the symbols (device and packaging) 8
Contents of the pack 8
How touse the device 9
Warnings 9
Electromagnetic interference 11
Contraindications and side effects 11
Quick use of the device with preset parameters 12
List of stored programs 13
Last 10 15
Settings (language selection) 15
Settings (factory reset) 15
How to look after the device 16
Checking device operation 16
Cleaning the device 16
Transport and storage 17
Disposal 17
Maintenance 18
Support 18
Spare parts 19
EMC Tables 20
Warranty 23

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Introduction
Magnetotherapy
The treatment of certain conditions through low frequency and
high intensity pulsed magnetic fields has garnered great
consensus amongst international scientific circles for many years,
especially as regards chronic and degenerative diseases.
Magnetotherapy uses low frequency and high intensity pulsed
magnetic fields induced by the electric current that runs through a
coil; due to its characteristics it is now universally recognised as
the most suitable technique for the treatment of bone conditions
and in particular for osteoporosis.
The biological modifications induced by the magnetic fields on the
cell membranes guarantee a biostimulation able to restore the
correct functionality of the cell itself.
According to the experiences of several authors, in cases of
osteoporosis, already starting from the sixth treatment session
there is a remarkable regression of pain symptoms and even more
striking is that a significant increase in BMD (Bone Mass Density)
is noted. The high magnetic field flux value (Gauss) generated by
the device allows the treatment of the patient even in the presence
of braces or plaster casts.

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Technical
specification
Manufacturer
I.A.C.E.R. S.r.l.
Via E. Ferrari, 2 • 30037 Scorzè (VE)
Tel. [phone] • Fax [phone]
IACER S.r.l. is an Italian manufacturer of medical devices and veterinary
medical devices.
Declaration of conformity
Kora device assumes the following classifications:
•Device with IP21 degree of protection against the penetration of
solid objects, powders and liquids.
•Device and accessories supplied non-sterile and not subject to
sterilisation;
•Device not suitable for use in the presence of a flammable
anaesthetic mixture with air, with nitrous oxide, with any flammable
agent of any kind and in environments with a high concentration of
oxygen;
•Device intended for continuous operation;
•Device not suitable for external use.
Intended purpose and scope of use
Clinical purpose: Therapeutic
Scope of use: Outpatient Clinic/Hospital and home
Kora is designed and indicated for the treatment, rehabilitation and
functional recovery of conditions concerning:
•Tendons
•Cartilage

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•Ligaments
Kora is particularly indicated for the treatment of delayed union,
osteoporosis, bone oedema, osteonecrosis, as well as ulcers and
neuropathies.
Thanks to the high intensity of the magnetic field it is able to generate,
Kora is particularly indicated in the treatment of bone fractures even in
the presence of rigid bandages or plaster casts.
In accordance with guidelines for medical devices, the manufacturer
suggests a check of the efficiency and safety of the device every 24
months. Useful life of the device and its accessories (period after which
it is suggested to send the device to the manufacturer):3 years
Technical characteristics
Power supply Pow. UES36LCP1-150200SPA, out 15VDC-2A
Max. current consumption 1 A
Insulation class (CEI EN 60601-1) II
Applied part (CEI EN 60601-1) BF
Dimensions (length x width x
height)(mm)
180x110x50
Intensity of the field Adjustable with increasing scale up to 150 Gauss
(per channel).
Frequency of the square wave 1-75 Hz
Therapy time User-settable
The maximum magnetic field intensity is 100 Gauss per channel.
The values of intensity, frequency and time are supplied with an
accuracy of ± 20%.
Ambient operating conditions:
temperature from +5 to + 30°C
relative humidity from 15 to 93%
pressure from 700 to 1060 hPa

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Labelling
Device labels in detail
Label 1
Label 2 Label 3 Label 4
DC 15V/2.0A ON/OFF CH1 CH2
Label 1 (on the back)
Label 4
Label 2
Label 3

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UES36LCP1-150200SPA
Description of the symbols (device and
packaging)
Follow the "instructions for use"
Waste disposal (WEEE Directive)
Class II device
Applied part type BF
CE conformity
Date of manufacture (month/year)
Serial number
Temperatures permitted
Relative humidity
Manufacturer's data
IP21 Degree of protection against the entry of solids, powders
and liquids
Center positive symbol
Contents of the pack
Kora pack contains:
•N°1 Kora device;

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•N°1 medical power supply (approx 1.5mt cable);
•N°1 Use and maintenance manual;
•N°1 Kora-Mat (pillow applicator);
•Magnet for verifying therapy operation
Visit www.koratherapy.com for more information.
How to use
the device
Warnings
It is recommended to read this manual carefully before using the device.
For any further information and details we advise you to visit our website
www.koratherapy.com .
Nevertheless, please follow the following instructions:
•Check the location and meaning of all labels affixed to the device;
•Do not damage the applicator by acting on the connecting wire, also
avoid winding the wire around the applicator or around the device;
•Check the integrity of the power supply each time it is used. Avoid use
in the case of signs of damage to the casing or to the connecting wire;
•People who are not properly trained and who have not read this manual
must not use the device;

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•Avoid using the device while using ointments containing free ions of
magnetisable metals;
•Avoid using the device in humid environments and/or in the presence
of flammable agents;
•During therapy, the user and the patient are advised not to wear metal
objects;
•Position Kora-Mat pillow in such a way that the logo is in contact with
the patient.
•Use only cables and applicators supplied by the Manufacturer.
Inadequate cables and applicators could damage the device and/or
cause harm to the patient;
•The user must periodically check the insulation (integrity) of the
applicators and their cables and check that they are not damaged
(contacting the manufacturer if needed);
•The user must pay attention when using the connecting cables of the
belt and the power supply: strangulation risk.
•The materials used for producing the device exceed the required
standards regarding material toxicity. In case of allergic reactions,
discontinue therapy and consult a doctor.
•Do not connect the device and its accessories to other devices not
indicated in this manual.
•Keep out of the reach of children.
•Avoid exposing the device and its accessories to excessive direct light
and dust. Refer to the indications in the paragraph "How to look after
the device";
•Do not damage the device and its applicators.
CAUTION. Disconnect the power supply from the wall socket at the end of
the therapy session.
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.
•the electrical system of the environment in which Kora is inserted
complies with national laws.
•the devices are used in strict compliance with the instructions reported
in this manual.

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Electromagnetic interference
It is advisable to use the device at a distance of at least 3 meters from
televisions, monitors, mobile phones, WI-FI routers or any other electronic
equipment as these devices could affect the operation of the device.
The device must be installed and operated in accordance with the
electromagnetic compatibility information contained in this manual. See
also the paragraph EMC tables.
The use of accessories, transducers and cables other than those specified,
with the exception of those sold by the manufacturer as replacement parts
for internal components, may result in increased emissions and decreased
immunity.
The device should not be used near or placed on top of other equipment
and, if it is necessary to use it near or placed on top of other equipment, it
should be observed to check normal operation in the configuration in which
it is used.
Contraindications and side effects
Pregnant patients, viral diseases (in the acute phase), 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 veterinarians).
There are no known significant side effects related to therapy, nor have
there been any problems reported related to excessive exposure to the
electromagnetic field generated by the device.

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Quick use of the device with preset parameters
To start using Kora quickly and easily, we recommend that you follow the
steps below:
1. Connect the applicator (or applicators) to the device by connecting
the plug of the applicator cable to one of the two ports (CH1-CH2) on
the panel at the top of the appliance;
2. Connect the mains cable to the power supply and then connect the
power supply outlet to the circular connector on the panel at the top
of the appliance, near the ON/OFF switch:
3. Connect the plug of the mains cable to the mains socket (100-
240VAC, 50-60 Hz);
4. Press the ON/OFF switch on the small panel on the upper part so it is
in the ON position: the display will show the KORA logo and then the
main menu screen; for quick standard use, now select the first item
"Single patient" by pressing the "OK" button.
5. Scroll through the program using the buttons and select
the desired program.
6. Press OK. The display will show the basic setting time of the
therapy (2 hours) and magnetic field intensity. These are the
average values suggested by IACER to immediately start the
treatment effectively.

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7. Press the OK button. The device will start the treatment, displaying
the magnet icon with the magnetic field flux. The green light below the
display notifies the therapy is underway.
8. At the end of the therapy, the device will automatically return to the
program menu screen.
Note: it is possible to temporarily suspend therapy at any time by
pressing the OK button. To resume therapy, press the OK button again.
During the pause phase the green LED goes off, and then comes back
on when the therapy is restarted.
Note: it is possible to exit the treatment at any time by pressing the
/ button once: the device will go back to the screen of the selected
programme (point 6). By pressing the / button again the device
will go back to the initial screen of the program menu (point 5).
Note: the device recognises if the applicators are connected correctly.
During the therapy phase, the connection status is displayed below the
magnet icon. The presence of the symbol next to the channel number
(1 or 2) confirms the applicator is connected correctly and
recognised.The X symbol next to the channel number (1 or 2) tells you
that the applicator is not connected correctly, missing or not working
correctly (see paragraph "Checking device operation").
List of stored programs
PROGRAMMES
1. Analgesic
7. Healing
13. Osteonecrosis
2. Arthritis
8. Ligament lesion
14. Osteoporosis
3. Arthrosis
9. Tendon lesion
15. Treat. 1 Hz
4. Muscular atrophy
10. Sciatic nerve
16. Treat. 18 Hz
5. Discopathy
11. Neuropathy
17. Treat. 50 Hz
6. Fractures
12. Prostheses
18. Treat. 75 Hz

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Analgesic: program to mitigate inflammatory and painful conditions. Also
useful in cases of recovery after surgery.
Arthritis: program designed to reduce pain and slow down the
degenerative process..
Arthrosis: program designed to reduce pain and slow down the
degenerative process.
Muscular Atrophy: program designed to stimulate muscle tissues.
Discopathy: specific program for the treatment of diseases against the
vertebral discs, with regard to bone and cartilage tissues, also useful in
post-surgery.
Fractures: specific program for the stimulation of bone regeneration in a
post-traumatic condition.
Healing: specific program for increasing circulation and reducing the
damaged area.
Ligament lesion: program designed for post-surgery recovery.
Tendon lesion: program designed for post-surgery recovery
Sciatic nerve: specific program to obtain an antalgic effect in favor of the
sciatic nerve.
Neuropathy: specific program to obtain an analgesic and anti-
inflammatory effect on the peripheral nerves.
Prosthesis: specific program to promote osseointegration with the
implanted prosthesis.
Osteonecrosis: specific program for the stimulation of bone tissue in
cases of osteonecrosis, in order to counter the progress of the disease
and alleviate pain.
Osteoporosis: specific program for stimulating bone regeneration.
The therapy duration values are those recommended by IACER S.r.l. and
can be altered by the user. Kora magnetotherapy device incorporates the
indications regarding magnetic field, frequency of therapy and power
delivered that are found in scientific and medical literature.
It is suggested to leave the device on connected to the mattress for very long
periods of time (even 10-12 hours) in case the animal often moves from the
applicator. In this way, adequate effective treatment time can be guaranteed.

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Last 10
This mode allows direct access to the last 10 therapies used by the user.
From the main menu, press until "Last 10" is selected, then press
OK. Choose the therapy from those listed by pressing the and
buttons followed by OK.
Settings (language selection)
Press the ON/OFF switch located on the small panel in the upper part so
it is in the ON position. After Kora logo appears, press and select
the "Settings" menu. At this point select "Language" and use the and
buttons to select the desired language.
N.B.: to turn off the device, press the ON/OFF switch on the back or press
the / button until the screen turns off.
Settings (factory reset)
Press the ON/OFF switch located on the small panel in the upper part so
it is in the ON position. After Kora logo appears, press and select
the "Settings" menu. At this point select the factory reset option and insert
the code “18273”. The values associated with the therapeutic protocols
have been restored to their original condition.

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How to look after
the device
Checking device operation
A magnet (small ring or disc in metal or metal/plastic) is supplied with the
appliance to check device 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 supplied magnet and bring it closer to the applicator;
4. check that the magnet vibrates (proportional to the frequency of the
selected therapy).
Contact the manufacturer if the magnet fails to vibrate.
Cleaning the device
Use a soft dry cloth to remove any dust from the device.
More difficult stains can be removed using a sponge soaked in a water and
alcohol solution (20% alcohol).
For cleaning the pillow case it is recommended to disconnect the applicator
from the device before performing any operation. At this point, once the zip
is opened, it is recommended to remove the internal mattress. Wash the
pillowcase in the washing machine at a maximum of 40 C.

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Respect the temperature, humidity and pressure limits indicated in this
manual even when cleaning the device and its accessories.
Transport and storage
Transport precautions
There is no particular care to be taken during transport as Kora is a portable
device.
It is recommended to store Kora and Kora-Mat pillow in the original box
after each use.
It is recommended not to twist the power supply and applicator cables.
Storage precautions
The storage location should have the following characteristics:
ambient temperature from +5° to +40°C.
relative humidity from 15 to 93%
pressure from 700 to 1060 hPa
Disposal
The product is subject to the WEEE regulation (the symbol is present on
the label ) concerning separate collection: to dispose of the product,
make use of special areas equipped to collect electronic material by

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contacting the competent authorities in your country or the manufacturer
directly.
Maintenance
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 to the power supply and the integrity of all
connection cables;
•check the connection with the applicator (or applicators);
•verify that all operations have been performed correctly;
•every two years check that all functions of the device work correctly
(contact the manufacturer).
If you discover a problem or you require further information, please contact
the manufacturer immediately at:
I.A.C.E.R. S.r.l.
Via E. Ferrari, 2 • 30037 Scorzè (VE)
Tel. [phone] • Fax [phone]
Support
The manufacturer is the only point of contact for technical support
regarding the device. For all technical support matters, please contact:
I.A.C.E.R. S.r.l.
Via E. Ferrari, 2 • 30037 Scorzè (VE)
Tel. [phone] • Fax [phone]
Technical documentation concerning repairable parts may be provided,
but only with prior company authorization and only after giving proper
training to the maintenance personnel.

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Spare parts
Original spare parts for this device can be ordered at any time from the
manufacturer. To order them contact:
I.A.C.E.R. S.r.l.
Via E. Ferrari, 2 • 30037 Scorzè (VE)
Tel. [phone] • Fax [phone]
Use only original spare parts supplied by the manufacturer; if non-original
spare parts are used, the operation and safety of the product might be
affected and the warranty will be null and void.

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EMC Tables
Emission aspects
Emission test
Compliance
Electromagnetic environment -
guidance
RF emissions
Cispr 11
Group 1
Kora product uses RF energy only for its
internal operation.
Therefore, its RF emissions are very low
and not likely to cause
interference in
nearby electronic equipment.
RF emissions
Cispr 11
Class B
Kora is suitable for use in all buildings in
addition to domestic ones and those
directly connected to a low-voltage
power supply network that supplies
buildings for domestic use
The device can be used in all buildings,
including domestic buildings, and those
directly connected to the public low-
voltage power supply network that
supplies buildings for domestic use.
Harmonic emissions
IEC 61000-3-2
Class A
Complies
The device can be used in all buildings,
including domestic buildings, and those
directly connected to the public low-
voltage power supply network that
supplies buildings for domestic use.
Voltage fluctuations
and flicker
IEC 61000-3-3
Complies