OncoTherm EHY-2000plus User manual

USER‘S MANUAL
EHY-2000plus
OncoTherm Kft.
Both the hardware and software are
specially developed for the OncoTherm
systems.
Copyrights belong to OncoTherm Kft.
All rights reserved.
This book is sold subject to the condition that it
shall not by any way of trade or otherwise, be
lent, re-sold, hired out or otherwise circulated
without the OncoTherm prior consent in any
form of binding or cover other than that in
which it is purchased and without a similar
condition including this condition being
imposed on the subsequent purchase.

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User’s Manual
EHY-2000plus
Oncotherm Kft.
Date: 2018.07.27.
Version: 24

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Contents
CONTENTS .....................................................................................................................................................................2
INTRODUCTION ............................................................................................................................................................4
HOW TO USE THIS MANUAL............................................................................................................................................4
CONTACTS ....................................................................................................................................................................5
SAFETY WARNING........................................................................................................................................................6
SYMBOLS AND THEIR DEFINITIONS...........................................................................................................................7
INSTALLATION...........................................................................................................................................................8
GENERAL .....................................................................................................................................................................8
ELECTRICAL CONNECTION............................................................................................................................................8
INSTALLATION NOTICES ...............................................................................................................................................10
SAFETY........................................................................................................................................................................11
RESIDENT RISKS:...........................................................................................................................................................12
GENERAL DESCRIPTION ............................................................................................................................................13
INTENDED USE .............................................................................................................................................................13
TARGET GROUP ..........................................................................................................................................................13
SIDE EFFECTS...............................................................................................................................................................14
AVAILABLE APPLICATORS............................................................................................................................................14
CONTRA INDICATION .................................................................................................................................................15
IMPORTANT MEDICAL NOTICES..............................................................................................................................16
DEVICE CONTROL......................................................................................................................................................21
Display-EHY-2000plus......................................................................................................................................21
Control panel of waterbed ..........................................................................................................................27
Tuning .................................................................................................................................................................28
Starting the device .........................................................................................................................................30
Doing a treatment ..........................................................................................................................................32
Switch off the device .....................................................................................................................................34
Time-meters.......................................................................................................................................................35
Warning and error messages.......................................................................................................................35
THE USAGE OF THE WEB-BOX..................................................................................................................................38
PURPOSE ....................................................................................................................................................................38
SYSTEM STRUCTURE......................................................................................................................................................38
USAGE .......................................................................................................................................................................39
STARTING THE WEB .....................................................................................................................................................39
LOGGING IN AND THE MAIN MENU.............................................................................................................................39
TREATMENT MENU .......................................................................................................................................................42
TREATMENT VIEW ........................................................................................................................................................46
PATIENT MANAGEMENT MENU.....................................................................................................................................46
IMPORTANT NOTICES...................................................................................................................................................52
IMPORTANT NOTES FOR THE USE OF THE SOFTWARE ......................................................................................................52
SUPPORTED BROWSERS ...............................................................................................................................................52
REQUESTED TECHNICAL BACKGROUND.......................................................................................................................53
Client browser ..................................................................................................................................................53
Network..............................................................................................................................................................53

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Alternative configuration..............................................................................................................................53
TECHNICAL DESCRIPTION ........................................................................................................................................54
THE MAIN RF-UNIT.......................................................................................................................................................54
TECHNICAL DATA .......................................................................................................................................................54
TECHNICAL DATA OF THE WATERBED ...........................................................................................................................55
CLEANING .................................................................................................................................................................56
SERVICING/MAINTENANCE ........................................................................................................................................57
DISPOSAL ...................................................................................................................................................................57
ACCESSORIES.............................................................................................................................................................58
APPENDIX 1 –GUARANTEE......................................................................................................................................60
APPENDIX 2 –DECLARATION OF CONFORMITY SAMPLE.................................................................................61
APPENDIX 3 –TABLE OF PROPOSED ELECTRODES..............................................................................................62
APPENDIX 4 –REFILLING OF THE BOLUS ELECTRODE .........................................................................................63
APPENDIX 5 - ELECTROMAGNETIC COMPATIBILITY INFORMATION ..............................................................69
APPENDIX 6 - TREATMENT IN 9 STEPS ....................................................................................................................77
APPENDIX 7 - PATIENT CONSENT ...........................................................................................................................78
APPENDIX 8 - BRAIN TREATMENT ...........................................................................................................................79
APPENDIX 9 - ROLLICEL DATASHEET......................................................................................................................81
APPENDIX 10 - MEMORY FOAM PILLOW..............................................................................................................82

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Introduction
Congratulation on your excellent choice!
You are the owner of a high-tech medical product, developed and produced by
Oncotherm Kft.
on the basis of the latest bio-engineering and medical knowledge.
The design and production of EHY-2000plus is controlled by the rigorous EU standards, certified for
ISO 13485 certified also by the German TÜV SÜD Product Service GmbH (Munich). The product is
completely manufactured in the European Union.
How to use this manual
The user’s manual of EHY-2000plus explains the proper use and maintenance of
the device. We recommend you to follow the content order first time you study
the manual. After you are familiar with the safe operation of the EHY-2000plus,
you can continue with the technical and theoretical background. On the base
of this knowledge, you can learn the treatment process with EHY-2000plus. The
device control part should be used as a guideline for treatments. We
recommend to keep this manual close at hand since you may need to refer to it
in the future.
You can find the latest valid version of the User’s Manual on our website
(www.oncotherm.org/for Specialists (please login)/User’s Manuals).

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Contacts
Please do not hesitate to contact us if you have any questions:
Questions in connection with production and management:
Oncotherm Group
Dr. Olivér Szász
CEO Hungary/Germany
Belgische Allee 9, D-53842 Troisdorf, Germany
Phone: [phone]
Fax: [phone]
Email: [email protected]
and
Gyár utca 2., H-2040 Budaörs, Hungary
Phone: [phone]
Fax: [phone]
E-mail: i[email protected]
Questions about research and development:
Prof. Dr. András Szász
Chief Scientific Officer
E-mail: [e-mail]
Your local distributor:

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Safety Warning
Please read these installation- and operating-instructions carefully before using your
device. These instructions contain important notes regarding safe installation, use
and maintenance of your appliance.
Please keep these instructions in a safe place you can always access and, if you sell
the appliance, hand them over to the new owner.
The manufacturer cannot accept liability if these instructions are not adhered to.
A technical training is required to operate the equipment! For this procedure,
please ask the manufacturer or the distributor.
To reduce the risk of fire or electric shock, do not expose this appliance to rain or
moisture. Due to dangerous high voltage, do not open the cabinet. For technical
support please contact the qualified personnel of Oncotherm.

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Symbols and their definitions
Please note the symbols below for correct usage of the equipment:
This symbol is intended to inform the user about the ground independent (body
floating) construction. Do not rearrange the professional installation.
This symbol is intended to alert the user to the presence of important operation
and maintenance instructions in the literature accompanying this product.
This symbol warns the user to read the relevant part in the User’s manual.
This symbol informs the user that the device is intended to emit non-ionizing
radiation.
This symbol indicates that the waste of electrical and electronic equipment
must not be disposed as unsorted municipal waste but has to be collected
separately. Please contact the authorized representative of Oncotherm Group
for information concerning the decommissioning of your equipment.
CLASS I
Conductive-enclosed CLASS I EQUIPMENT:
EQUIPMENT having a durable and substantially continuous ENCLOSURE of
conductive material which envelops all conductive parts with the exception of
small parts, such as nameplates, screws and rivets, which are isolated from LIVE
parts by insulation at least equivalent to REINFORCED INSULATION. The
ENCLOSURE of insulation-enclosed CLASS II EQUIPMENT may form a part or the
whole of the SUPPLEMENTARY INSULATION.

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Installation
General
The device must be installed by a qualified technician/engineer on behalf of the
Oncotherm Group in compliance with the instructions provided. The
manufacturer declines all responsibility for improper installation which may harm
people and damage property.
When the packing is removed, check that the appliance is not damaged. If you
have any doubts, do not use the appliance, but call for a qualified technician.
The packaging items (plastic bags, foamed polystyrene, nails, etc.) are potential
sources of danger. Never leave them within the reach of children.
This device shall be used for the purpose it was expressly designed for. Any other
use is considered improper and consequently dangerous. The manufacturer
declines all responsibility for damage resulting from improper and irresponsible
use.
Electrical connection
1. Connect the equipment to 230/110V A/C socket with ground only.
Ensure that the socket is properly installed.
2. Observe that a min. 16 Ampere fuse protects the socket.
3. Make sure that the device uses the single-phase independently from
other appliances. Use an independent phase for the device and others
for the other applied electric appliances (for example: air-conditioning,
diagnostics systems, computers, sterilization equipment, etc.) in the
room.
(Our service team controls these conditions, and we will be taken into
consideration during installation to satisfy these requests.)

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Pre-installation notices
1. Put the device into a quiet, independent room, devoted only to the
Oncotherm device and treatment procedure.
2. The room must have normal conditions (e.g. temperature humidity,
pollution, etc.) at all times.
•temperature range: 15 –23 °C
•humidity range: 20 –60 %
•No aggressive pollution (e.g. chemicals, fibers, dust, smoke,
etc.) is allowed in the room where the device is installed
3. Let the room have enough natural and/or artificial light for the proper
handling of the treatment.
4. Do not install the device on textile carpet. Avoid using the equipment
on soft surfaces.
5. Do not use the equipment where it may be exposed to vibrations.
6. Avoid using the equipment near appliances generating strong electro-
magnetic fields (e.g. motors, transformers, etc.).
7. There has to be a safe place for treatment accessories in the room.
8. On delivery, observe the device carefully and wait for the authorized
Service for the installation.
9. If your device looks damaged, do not use it. In case of any questions
ask the Oncotherm service team for advice.
10.To move the device into another room and/or into any other place
from the place where it was installed originally please ask for the
assistance of the Oncotherm service. The unauthorized relocation is
strictly prohibited in order to avoid the mains and grounding
discrepancies and the possible electric shock.
11.Avoid using your equipment immediately after sudden changes of the
outside temperature, due to the moisture damage in the electronics.
12.Ensure that no objects fall or no fluid passes through the ventilation
openings. If liquid is spilt into the equipment, disconnect it from the
mains and consult a qualified service technician.
13. Dangerous voltage inside. Do not open the cabinet. There are no user
serviceable parts inside. Only qualified service personnel should carry
out repairs.