Kora 353 User Manual

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USER MANUAL

MNPG396-00 Edition 22/11/21

I.A.C.E.R. Srl

www.koratherapy.com

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Summary of Contents for Kora 353

Page 1 USER MANUAL MNPG396-00 Edition 22/11/21 I.A.C.E.R. Srl www.koratherapy.com...
Page 2 I.A.C.E.R. Srl Via E. Ferrari 2 – 30037 Scorzè (VE) ITALY Tel. +39 041 5401356 – Fax +39 041 5402684 e-mail: info@koratherapy.it https://www.koratherapy.com...
Page 3: Table Of Contents
Summary Summary Introduction Magnetotherapy Technical specification Manufacturer Declaration of conformity Intended purpose and scope of use Technical characteristics Labelling Device labels in detail Description of the symbols (device and packaging) Contents of the pack How to use the device Warnings Electromagnetic interference Contraindications and side effects Quick use of the device with preset parameters...
Page 4: Introduction
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;...
Page 5: Technical Specification
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 I.A.C.E.R.
Page 6: Technical Characteristics
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.
Page 7: Labelling
Labelling Label 3 Label 2 Label 4 Label 1 (on the back) Device labels in detail Label 1 Label 2 Label 3 Label 4 DC 15V/2.0A ON/OFF CH1 CH2 I.A.C.E.R. Srl MNPG396-00...
Page 8: Description Of The Symbols (Device And Packaging)
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; I.A.C.E.R. Srl MNPG396-00...
Page 9: How To Use The Device
• 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 www.koratherapy.com Visit for more information. How to use the device Warnings It is recommended to read this manual carefully before using the device.
Page 10 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.
Page 11: Electromagnetic Interference
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.
Page 12: Quick Use Of The Device With Preset Parameters
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"...
Page 13: List Of Stored Programs
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.
Page 14 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.
Page 15: Last 10
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 buttons to select the desired language.
Page 16: How To Look After The Device
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;...
Page 17: Transport And Storage
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.
Page 18: Maintenance
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;...
Page 19: Spare Parts
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. +39 0415401356 • Fax +39 0415402684 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.
Page 20: Emc Tables
RF emissions Class B Kora is suitable for use in all buildings in Cispr 11 addition to domestic ones and those directly connected to a low-voltage power supply network that supplies...
Page 21 Immunity aspects Kora is intended to work in the electromagnetic environment specified below.The customer or user should make sure that it is used in such environment Immunity test Test level Compliance Electromagnetic 60601-1-2 level environment - guidance Electrostatic Floors should wood, ±...
Page 22 RF immunity aspects Kora is intended to work in the electromagnetic environment specified below. The customer or user should make sure that it is used in such environment Immunity test Test level EN Compliance Electromagnetic environment 60601-1-2 level guidance Immunity to 3 Veff.
Page 23: Warranty
Warranty Kora is covered by a 2 year warranty starting from the date of purchase on the electrical and electronic parts. The parts subject to normal wear and tear are not covered by the warranty (fabric case of applicators as...