Table of Contents
Advertisement
Quick Links
plus
USER'S MANUAL
SAFETY, GUARANTEE
OncoTherm Kft.
July 2010
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 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
published and without a similar condition including this condition being imposed on the subsequent purchase.
Advertisement
Table of Contents
Related Manuals for OncoTherm EHY-2000 plus
Summary of Contents for OncoTherm EHY-2000 plus
- Page 1 This book is sold subject to the condition that it shall not by 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...
-
Page 2: Table Of Contents
plus Safety, guarantee Contents CONTENTS ............................2 INTRODUCTION ..........................3 THE PRODUCTION IS CONTROLLED ALSO BY THE RIGOROUS PRODUCTION STANDARDS OF EU, CERTIFIED FOR ISO-13485 AND ISO-9001, APPROVED ALSO BY THE GERMAN TÜV PRODUCT SERVICE (MUNICH). THE PRODUCT IS COMPLETELY MANUFACTURED IN THE EUROPEAN UNION.SAFETY AND CAUTIONARY NOTES ........................ -
Page 3: Introduction
Congratulation on your excellent choice! You are an owner of a high-tech medical product, developed and produced by OncoTherm Kft. on the basis of the latest bio-engineering and medical knowledge. EHY-2000 is a German product, approved by the TÜV Product Service (Munich, Germany), tested and approved by the German law according to the European Medical Device Directive (called medical CE). -
Page 4: The Production Is Controlled Also By The Rigorous Production
The device must be installed by a qualified technician/engineer sent or contracted by OncoTherm Kft in compliance with the instructions provided. The manufacturer declines all responsibility for improper installation which may harm people and damage property. -
Page 5: Electrical Connection
7. In the room there has to be a safe place for treatment accessories. 8. On delivery, observe the device carefully and wait for the authorized Service for the installation. 9. If your device looks damaged, do not attempt to use it, when in doubt ask OncoTherm service team for advice. -
Page 6: Installation Notices
7. Electrical safety of the appliance is only guaranteed if the grounding system of the building is in accordance with local electricity board regulations. The OncoTherm service team controls it at the regular services. The proper electric conditions are the liability of the customer. -
Page 7: Safety - Unit
The approval must be on written form from OncoTherm Kft. The relocation and/or using other mains-socket than the originally installed, must be done only by OncoTherm or its authorized service-representative. Only the service personnel, a... -
Page 8: Safety - Waterbed
FOR THIS PROCEDURE ASK THE MANUFACTURER. 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 SERVICE REFER ONLY TO THE ONCOTHERM QUALIFIED PERSONNEL. - Page 9 This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the authorized representative of Oncotherm Ltd. for information concerning the decommissioning of your equipment.
-
Page 10: Important Medical Notices
plus Safety, guarantee Important medical notices Please remember: 1. Intended user of this device is a physician and/or a trained clinical staff under the physician’s control. 2. The treatment has to be permanently monitored by the staff. 3. The treatment needs extra care, when the patient has reduced thermal sensitivity over the treated area. - Page 11 17. Be careful with temperature measurements and the other controlling units. Any metallic part could be an antenna. Using any non- OncoTherm product to control is prohibited. Do not use any system- independent electric device during the treatment. It can cause electric shock due to the broken safety isolation.
- Page 12 plus Safety, guarantee 26. It is optimal if the device is separated from the control-computer. The central computer should be placed outside the treatment room. An observation room has to be arranged from where the personnel can control the patient's treatment. 27.
- Page 13 plus Safety, guarantee The calculation however is based on the so-called “equivalent temperature” idea. This means that electro-hyperthermia heats up the tissue by a dynamic, gradient method. The calculated temperature is such one that has the equivalent distortion ability of the cells as the static overheating. This temperature (due to the dynamical effects) in reality could be smaller than the statically measurable.
-
Page 14: Operator's Table
plus Safety, guarantee Operator’s table: Treated part of the Proposed Electrode-skin Treatment Proposed body electrode**** distance ** time [min] power* [W] [cm] Lungs large 140-150 Kidney standard 100-130 Liver large 120-140 Stomach standard 120-130 Pancreas standard 100-120 Lymph nodes standard 80-110 Superficial small... -
Page 15: Guarantee
plus Safety, guarantee Guarantee The manufacturer guarantees service for the whole instrument (hardware and software). The guarantee is free of charge for one year. After one year service can be guaranteed in the form of a stand-by agreement. The total upgrading of the system, to keep pace with new developments and knowledge in the field, can be included in the stand-by service agreement. -
Page 16: Contacts
Questions in production and management: Oncotherm Dr. Olivér Szász Managing director Belgische Allee 9, D-53842 Troisdorf, Germany Phone: +49-2241-319-920 Fax: +49-2241-319-9211 Email: info@oncotherm.de Ibolya utca 2., H-2071 Páty, Hungary Phone: +36-23-555-510 Fax: +36-23-555-515 E-mail: info@Oncotherm.org Questions in research and development: Prof. Dr. András Szász...
Need help?
Do you have a question about the EHY-2000 plus and is the answer not in the manual?
Questions and answers