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.