SAFETY, GUARANTEE
Contents
1. and PC Good air circulation around the device is essential to prevent internal overheat of the electronic parts Choose a dust free well ventilated position do the everyday cleaning by washing up the floor as it is usual in medical institutions Take care of the intactness of cables and water pipes Do not break them or obstruct the free flow of the cooling water 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 EHY 2000 hightech m 10 11 aren oe plus Safety guarantee Only an authorized service personnel should carry out repairs and any other work on the device 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 qualified and authorised OncoTherm personnel should service the unit when it does not operate normally or shows marked change in its performance Devices which are to be discarded must be made unusable Pull out the plug remove the cable and make the door lock and door catch unusable Safety Unit The device is only suitable for normal treatment use and for the purposes and intended use sta2. away from the treatment bed Do not treat patients who have earphones hearing aid music devices Walkman walk watch etc and or any wire connected instruments Credit cards and or any other magnetically sensitive products diskettes tapes etc are recommended not to be kept near the treatment No guarantee of not loosing the information from the data carriers Do not treat near the eyes of the patient The direct RF radiation can cause temporary or permanent blindness The treatment of the head requires special training at one of the OncoTherm reference clinics Do not clean the electrodes while the equipment is on Do not use such wet textile tissue that could release water to penetrate into any parts of the equipment The optimal placement of the applicators is to position them parallel to each other Such an arrangement gives the most effective heating power Note that in many cases only a small power is required for the treatment for example when treating a brain tumour which can be regulated by the output power control or by placing the electrodes in a non parallel arrangement Patient must be between the electrode and counter electrode placed into the waterbed Do not wrap the electrode into any textile material for the treatment Reduce the thickness of textile material to a minimum between the electrode and patient s skin Textile quality has an effect on tuning frequency which can lead to system error in tuning under the gi
3. EHY 2000 tech m i in 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 EHY 200 ist plus Safety guarantee Contents CONTENTS A E E E E S INTRODUCTION THE PRODUCTION IS CONTROLLED ALSO BY THE RIGOROUS PRODUCTION STANDARDS OF EU CERTIFIED FOR ISO 13485 AND ISO 9001 APPROVED ALSO BY THE GERMAN T V PRODUCT SERVICE MUNICH THE PRODUCT IS COMPLETELY MANUFACTURED IN THE EUROPEAN UNION SAFETY AND CAUTIONARY NOTES E 4 A HAOL S R L I 4 ELECTRICAL CONNECTION a e A e reto veut aso E a a AETAT 5 INSTALLATION E E A E a iis 5 Pre installation NOtICES ccccccccccccccccceecsecccsesuscecesscceecccesseecccueueeesssessssecsseesseseceessessceeeeeseecessaeeeeeseses 5 Insiallation ais iis riri be Duae RP 6 EHY 2000 Safety guarantee Introduction Congratulation on your excellent choice You are an owner of a high tech medical pr
4. de and Ibolya utca 2 H 2071 Paty Hungary Phone 36 23 555 510 Fax 36 23 555 515 E mail info Oncotherm org Questions in research and development Prof Dr Andr s Sz sz Research director Telefon 36 23 555 510 Fax 36 23 555 515 E mail ProfSzasz Oncotherm org Your local distributor 16
5. ges in the hardware and or software without written permission of the manufacturer is strictly prohibited Service during and after guarantee period is available in all countries where the product is officially distributed For further information please contact your local distributor Any suggestions and or requests for further development of the system are highly appreciated and very welcome Quality references EHY2000plus and WEY 2000 are C marked Product Service Munich has given the EC Certificate The device is constructed and produced to satisfy the IEC 601 1 standard and the 93 42 EEC MDD Medical Device Directive The equipment has passed an EMC Electro Magnetic Compatibility check MIKES Product Service Strasskirchen EHY2000plus has a Technical Report concerning conformity according to MSZ 16260 86 Safety levels of high frequency electromagnetic fields Rep No 2000 19 112 2 issued by ORKI The rights to this system are the sole property of the manufacturers Patent is pending Not permitted change in installed hardware and or software makes certificates invalid 15 EHY 2000 Saint een mate en me p us Safety guarantee Contacts In case of any question we are happy to serve you Questions in production and management Oncotherm om Dr Oliv r Szasz Managing director Belgische Allee 9 D 53842 Troisdorf Germany Phone 49 2241 319 920 Fax 49 2241 319 9211 Email info oncotherm
6. ial small 0 60 80 90 Cole rectal region standard 0 90 100 130 Breast standard 0 60 80 100 Prostate standard 0 60 60 80 Oesophagus large 0 90 100 120 Head neck small 0 60 80 100 Please carefully monitor the patient and do not exceed Her His personal tolerance Patient must not feel any burning or too much hot Always be sure the electrode bolus tightly touches the skin of the patient in a largest available surface take extra care on the testes could be variable depending on the area of the actual tumor Electrode dimensions Small 10cm Standard 20cm Large 30cm 14 EHY 2000 Wn een mated ey Me p us 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 Guarantee covers both spare parts and labour Service under guarantee is only provided upon presentation of reasonable evidence e g completed guarantee card or purchase receipt that the date of claim is within guarantee period Guarantee is not valid if the defect is due to accidental damage misuse or neglect and in case of alterations or repairs carried out by unauthorised persons Any chan
7. ian Since the packing plastic bags foamed polystyrene nails etc are potential sources of danger never leave them within the reach of children 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 The user must not replace the supply cable of this appliance Always call an after sale service centre authorised by the manufacturer in case of cable damage or replacement This device must be used for the purpose for which it was expressly designed Any other use is considered to be improper and consequently dangerous The manufacturer declines all responsibility for damage resulting from improper and irresponsible use EHY 2000 Wn een mated ey Me plus Safety guarantee Electrical connection 1 Connect the equipment to 220 240 V 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 Let 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 preinstallation discussions
8. lack border with the skin on a small part of the body can cause burning Do not use the equipment improperly it can be dangerous Always check the user s manual Operating the EHY device is not suggested for a staff during pregnancy Do not use the electrodes in the vicinity of the patient s metallic prothesis implantat bone replacement pacemaker joint support surgery clips etc Please consult the supervisor immediately before treating such a person Check the patient ask about her his feelings frequently Check the good water cooling of the electrode before positioning it After setting up treatment parameters the door made of glass has to be locked to avoid the unauthorized use or misuse At rearranging and or positioning the applicator please pause stop the treatment In case of any necessary medical aid injection infusion etc please pause stop the treatment 10 EHY 200 17 18 19 20 21 22 23 24 29 rate plus Safety guarantee 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 Before the treatment any metallic pieces necklaces rings jeweller watches pipes coins phones hairpins pens etc has to be left far
9. ndocardial devices while patient is on the waterbed Warning A SPECIAL TRAINING IS REQUIRED TO OPERATE THE EQUIPMENT 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 8 hightech EHY 2000 plus Safety guarantee 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 operating and maintenance instructions in the literature accompanying this product Reads it before a usage the User s manual This symbol informs the user 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 and must be collected separately Please contact the authorized representative of Oncotherm Ltd for information concerning the decommissioning of your equipment CLASS I EQUIPMENT having a durable and substantially continuous ENCLOSURE of insulating 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 equivalen
10. nt Follow the procedure written in the maintenance part see above Alcohol or its substitute has to be used for disinfecting 29 Before the treatment any sharp objects knives scissors needles pens pencils glasses etc have to be left far away from the treatment bed in case of using waterbed 30 Using waterbed mattress without checking of its sufficient amount of water can be dangerous the patient can suffer a burn 31 The EHY treatment can have a side effect about 3 of the cases In cases when the treatment area is covered by a considerable adipose tissue subcutane fat burn could create Also red skin slight burn could happen 32 The water in the mattress must be heated up before the treatment See in detail the Treatment information Preparation section 33 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Everybody who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of the system standard IEC 60601 1 1 If in doubt consult the technical service department or your local representative Resident risks User has to follow the instructions men
11. oduct developed and produced by OncoTherm Kft on the basis of the latest bio engineering and medical knowledge C EHY 2000 is German product approved by the TUV Product Service Munich Germany tested and approved by the German law according to the European Medical Device Directive called medical CE EHY 2000 Wn een mated ey Me p us Safety guarantee The production is controlled also by the rigorous production standards of EU certified for ISO 13485 and ISO 9001 approved also by the German TUV Product Service Munich The product is completely manufactured in the European rin Safety and cautionary notes Please read these installation and operating instructions carefully before using your device These instructions contain important notes regarding installation use and maintenance of your appliance Please keep these instructions in a safe place and if you sell the appliance hand them to the new owner The manufacturer cannot accept liability if these instructions are not adhered to Instructions Read the instructions in this user s manual carefully since you will find all the instructions you require to ensure safe installation use and maintenance Always keep this manual close at hand since you may need to refer to it in the future When the packing is removed check that the appliance is not damaged If you have any doubts do not use the appliance call for a qualified technic
12. t to REINFORCED INSULATION The ENCLOSURE of insulation enclosed CLASS II EQUIPMENT may form a part or the whole of the SUPPLEMENTARY INSULATION EHY 2000 hightech m Parente plus Safety guarantee Important medical notices Please remember 1 10 11 12 13 14 15 16 Intended user of this device is a physician and or a trained clinical staff under the physician s control The treatment has to be permanently monitored by the staff The treatment needs extra care when the patient has reduced thermal sensitivity over the treated area Treatment is strictly prohibited when the patient is unconscious Treatment is prohibited when the patient is under deep sedation or anesthesia Treatment is strictly prohibited in case of children who aren t able to communicate with physician If the patient has inclination to epilepsy the physician has to take extra attention Check the position of the electrode to keep it as smooth on the skin as possible The applicator electrode has water bolus a flexible surface to have the best contact with the skin Note that the direct contact placement of electrodes on the skin has to be controlled carefully because some temperature increase on the skin can occur It will not be a sudden effect and can be indicated by the patient Be careful because of the touching of electrode black border to the skin Because of the special feature of RF field the contact the b
13. ted in the operating instructions Do not use any extension and radio frequency cables only those which are provided by the authorized service and or by OncoTherm Before starting any cleaning work on the device it must be disconnected from the electric supply by removing the plug from the socket Do not pull the cable The mains lead of the unit should be unplugged when the unit is not in use Do not plug in or unplug the mains lead with wet hands Do not use the device barefoot Take care that objects do not fall and liquids are not spilled into the interior of the device through openings Do not allow children to operate and or control the equipment Do not allow people who are not experienced nor trained in operating the equipment to use it without supervision Never leave the device exposed to environmental effects rain sun etc Every six months the service team has to check the device according to the Periodical safety testing instruction see User s manual Technical part Appendix 1 EHY 2000 Wn een mated ey Me p us Safety guarantee Safety Waterbed 1 Never use waterbed without the mattress Touching pure copper heating surface can cause burn 2 Never use the mattress without water Only distilled water can be used as the patient can compress it and can touch copper heating surface almost directly Check of filling up Push the middle of one half of the mattress with one hand till reaching bot
14. thorized relocation is strictly prohibited avoid the mains and grounding discrepancies and the possible electric shock Avoid using your equipment immediately after sudden changes of the outside temperature due to the moisture damage in the electronics Ensure that no objects or fluids pass through the ventilation openings If liquid is spilt into the equipment disconnect it from the mains and consult a qualified service technician Dangerous voltage inside Do not open the cabinet There are no user serviceable parts inside Only qualified service personnel should carry out repairs Installation notices This unit should be situated away from heat registers radiators stoves or other appliances that produce heat Also windy places or the near vicinity of the windows should be avoided For best performance and safety please place this unit in the middle of the room make it possible for the operator to access the device from any direction Any walls and or grounded surfaces have to be minimum 1 5 meter away from the treatment bed on the way that the patient could not reach any surfaces independent from the device which could cause an electric shock for him her The EHY unit must be located on a suitable place where the emergency switch of the device can be accessible for anybody in case of a dangerous situation This emergency switch cut off the mains voltage of EHY device itself but this button does not affect on the waterbed
15. tioned above otherwise burning or overheating of the tissue can occur The temperature calculation displayed temperature is only a calculation Take in consideration that the temperature of some points of the heated local area can be considerably higher than the average This effect in the Literature is called hot spots This inaccuracy can cause overheating of the tissue 12 Safety guarantee hightech medicine EHY 2000 fus 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 Tolerated accuracy of forwarded and reflected power 3090 is checked at start up but will not be checked continuously under the treatment This can cause overheating of the tissue 13 EHY 2000 Wn een mated ey Me p us Safety guarantee Operator s table Treated part of the Proposed Electrode skin Treatment Proposed body electrode distance time min power W cm Lungs large 0 90 140 150 Kidney standard 0 60 100 130 Liver large 0 60 120 140 Stomach standard 0 60 120 130 Pancreas standard 0 90 100 120 Lymph nodes standard 0 60 80 110 Superfic
16. tom Then push with other hand the middle of the other half minimum 2 meter from the first point It must not reach the bottom 3 Water leakage is shown on display sensed electronically in wastewater tank In case of waterloss failure treatment can be finished but call for service soon If water flows quickly treatment must be stopped switch off the bed and pull out mains plug 4 In case of noticing water in the plastic tray or on the surface of the mattress please check water level in mattress and presence of possible mechanical damage Do not use damaged mattress avoid electric shock 5 The patient s surface must not be damp After cleaning the surface the user have to wait until it is dry 6 Using EHY2000plus with not heated waterbed may decrease the temperature of the body of a patient In case of everyday use keep the bed switched on permanently Heating up the water from room temperature to treating temperature level requires about 12 16 hours 7 Check the temperature settings before each treatment Recommended temperature setting is 32 C because the treatment itself is heats also so patient will have sweaty skin which is not suitable for correct EHY2000plus treatment 8 Check the alarm system daily during continuous use Switch off for a short time Switching on the waterbed a self test is implemented and a warning is going on till user sets the desired temperature again 9 Do not use other surgical or e
17. ven circumstances During treatment relaxing so called alpha music is suggested for psychological reasons faster recovery is possible This kind of radio frequency treatment has an effect on the surroundings This is why some attention should be taken on how to set up the treatment system and how to furnish the room in which treatments will take place Note do not install the machine in the vicinity of sensitive equipments ECG EEG intensive care control monitor ultra sound video rectoscopy and or other sensitive imaging systems etc without shielding Shielding is also required to defend the EHY 2000plus in the vicinity of large electro magnetic sources and or high power machines power transformer X ray units NMR CT etc It should be noted that microwaves could influence the OncoTherm device in the treatment room and vice versa Make sure that these machines are well shielded 11 EHY 2000 Rd n een mated ey Me 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 The personnel responsible for treatment equipment should check the cables before each treatment At any doubt about the intact isolation stop the treatment and call for an immediate service check up 28 Clean the electrodes before each treatme
18. will be also taken into consideration to satisfy these requests Installation Pre installation notices 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 throughout its lifetime e temperature range 15 23 C e humidity range 20 60 e 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 subject to vibration 6 Avoid using the equipment near appliances generating strong electro magnetic fields e g motors transformers etc 7 Inthe room there has to be a safe place for treatment accessories 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 EHY 2000 hightech m 10 11 12 13 plus Safety guarantee To move the device into another room and or into any other place from the place where it originally was installed please ask for the assistance of the OncoTherm service The unau
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