ChemoBooster
Contents
1. AR 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 EQUIPMENT having a durable and substantially continuous ENCLOSURE of conductive grounded material Not grounded parts of the enclosure are isolated from LIVE parts by insulation at least equivalent to REINFORCED INSULATION User s Manual v7 6 oncoGherm ChemoBooster zii rail Installation General 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 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 for which it was expressly designed 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 only to grounded 230 V A C socket Ensure that the socket is properly installed 2 Notice that a minimum 1 Ampere fuse shall protect the socket 3 Make sure that the device uses a single phase independent from other app2. Correct tuning is very important for the correct and effective operation of the machine Correct tuning must be checked after the process There are some possibilities of checking the result When the treatment has been started let the treatment run until the required time limit There is no continuous supervision is needed during the use of the device intervention is necessary only in special situations such as e The electrode s position has been changed because of the patient s movements In some of this cases the machine must be stopped and the tuning procedure must be repeated e The set power is too high or too small and treatment values must be changed In this case the machine does not need to be stopped only values must be changed e The patient feels heat on his her skin In this case the electrode is not laid onto the body of the patient properly As much portion of the electrode surface needs to be in direct contact with the patient as possible to ensure power distribution e Also the tuning parameters can be changed during the treatment User s Manual v7 19 oncoGherm ChemoBooster zii rail To finish the treatment before removing the electrode the device RF supply must be stopped Do not remove the applicator when the RF power is on Tuning The ChemoBooster has a special radio frequency generator which must be carefully tuned to the patient If it is not done the energy which the device releases i
3. electrode Disposal If it is requested the manufacturer carries out disposal of the device In case of disposal the manufacturer is responsible for organizing the transportation of the unit with accessories Price of transportation and packaging is subject to discussion User s Manual v7 18 oncoGherm ChemoBooster zii rail Device control The Oncotherm ChemoBooster is devoted to the high level requirements of modern medical practice The equipment for safety purposes is isolated from the common power network and supported by a specially developed software General instructions It s strongly recommended to disinfect the electrodes with antiseptic solution or alcohol Use only damp textile If the textile is too wet liquid can penetrate into any part of the equipment All metal objects parts necklaces rings jewels watches pipes coins phones must be far away from the electrode while the treatment is run The best placement of the electrode when it is placed directly on the skin without any isolation material You could place special paper on the treated area of the patient in case the patient is sensible to silver and the electrode can be placed on this paper The electrode must always be on the patient so they have to be fixed Note that the too strongly fixing f the electrodes can be uncomfortable for the patient Take care of the cables do not break them Check proper connection of the electrode
4. 23 555 515 E mail ProfSzasz Oncotherm org User s Manual v7 5 onco herm ChemoBooster ae Germ 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 to the new owner The manufacturer cannot accept liability if these instructions are not adhered to A special training is required to operate the equipment For this procedure 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 service refer only to the Oncotherm qualified personnel Symbols and their definitions Please refer to the below symbols 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 operating and maintenance instructions in the literature accompanying this product A RA Reads it before a usage the User s manual te This symbol informs the user the device is intended to emit non ionizing radiation
5. EE o dog 19 GENERAL INSTRUCTIONS esee eene eene eese essen senes ene ee eee eset esee renean 19 TURING A R 20 PREPARATION FOR USE eeeeeeeeeeeneen eene nennen nenne sessi nae tese essa nen 20 APPENDIX 1 DECLARATION OF CONFORMITY eee 26 APPENDIX 2 GUARANTEE eere eee eere roe eee e rosse e atn e setate eese e eese eoa 27 APPENDIX 3 PATIENT CONSENT sccccsssssscsssssccccsscccccssssscccesscceeees 28 User s Manual v7 2 onco rherm ChemoBooster 000 0 UU MEER re n Introduction The ChemoBooster Congratulations 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 ChemoBooster is a German product approved by the T V Product Service Munich Germany tested and approved by the German law according to the European Medical Device Directive called medical CE 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 Union How to use this manual The user s manual of ChemoBooster 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
6. cesse tet ex eee coteel oca Queue ene cest e eee soe gue ooo dong ee oue Cota de Qe EE rueda 9 GENERAL DESCRIPTION eere ee eee ene eee eene nete e tnos eee tn aset tetas esee euo 10 INTENDED USE eeeeeeeeeeeeee eene enne nene ses se n enini etes s esae e testis nennen 10 EPEC IS S vunsescueae eb MEI NIE 10 SIDE BBEECTS c7 tertie pe esie eV Ereec tiber iei eene eei eess etai ess 10 MAIN INDIGATIONS iiseo essen ase sese oir NERA eE RENTE canatectsesevsbaveontaccaagoasss canstacecons 10 AVAILABLE APPLICATORS eee e e eee e nnne nnne nn nn nn nnns sna snas sens nass nale 11 CONTRA INDICATION 5 rri IRE eee Ic a raaa 11 IMPORTANT MEDICAL NOTICES cccccccsseeececccecceceeseescecsceceeueeseeccesseseueueeses 11 WRITTEN CONSENT TO TREATMENT cccccccccessseeceecececeeeeseeecscseeseueueneeesees 13 TECHNICAL DESCRIPTION u cccccssssccccssscccccsssscccscssscccsccssccssscsececees 15 TECHNICAL DETA Seoirse tonn eere anisini a Yr do ROSE eed Ee eL REA Fn 15 M TAPIAUAE 16 ACCOSSOTIOS ennnen e e eE E T T DET 17 Transportation and storage esses eene enne 17 Before C 18 CLEANING I sien 18 Disinfecting the accessories esee sees 18 Disposal eee rM err RIR E ERI aad aes oe Bhd es 18 DEVICE CONTR ODL 5 5 rera ordre eaa a roa are aaa Se rron aa ee eb ep eaae prn a er
7. eus 6 10 Y XI xeuuv aqivo qr sse Cge uonoes J xeuuy 2dd cr 6 sayanda OF jo suoisi o1d y Zumo 8007 1006 OSI 00C S8P 1 OSI NH Sjuoumoop oAreuuou 19470 Jo sprepuejs SuIMo 0j eui YIM Ajrunoguoo Ul SI s r uongje oop siy yorym o 1ejsoog ow yo jonpoud y 3y Apypiqisuodsai epos Ino Japun ore oop yy uueugoouo IM KieSung Ad ILOT z g m eA oqq Ss91ppy fJ WY pooug 1491njogjnue i 49 s00g Oouiaq IPPON edAr oor op de1oq 04 29 g 2120 02u uoneu sisop jonpoaq ETIURITUTRE JO UOLIA 26 s Manual v7 User oncoGherm ChemoBooster OON Appendix 2 Guarantee The manufacturer guarantees service for the whole instrument hardware and software The guarantee is free of charge for two years After two years service can be guaranteed in the form of a stand by agreement Upgrading the system to keep up with new developments and state of the art know how 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 showing the date of claim is within guarantee period Guarantee is valid only in case the problem has been shown or the failure has been documented e g print out from the failure Guarantee is not valid if the defect is due to accidental damage misuse or negligence and in case of alterations or repairs carrie
8. not able to communicate with the physician Inclination to epilepsy needs extra attention Special care is necessary if the patient has hairs at the treatment location e g pubic hair or at head hair or hair on breast for men because the burning and the mistreating is very likely Please do a saving before treatment if necessary or at least please make very tight control of the treatment use small power longer time If you are not able to save please ultrasound ECG gel on the hair for better contact or at least please make the hair wet by infusion solution Please ask the patient about his her cavities bladder stomach pleural cavity etc sensing Stop the treatment User s Manual v7 11 onco therm ChemoBooster aoe Germ immediately if any unusual happen near the cavities and continue it only when the hair is removed The tissue electrode must be smoothly cover the patient s skin Any humps or irregular cover could cause burn on the patient s skin Check the position of the electrode to keep it as smooth on the skin as possible The applicator electrode is flexible to have the best contact with the skin Staff in pregnancy is not recommended to operate the ChemoBooster device Do not use the electrodes in the vicinity of the patient s metallic prothesis implant bone replacement pacemaker joint support surgery clips etc The distance has to be laterally the same from the outside circumflex of the elec
9. safe operation of the ChemoBooster you can continue with the technical and theoretical background On the base of this knowledge you can learn the treatment process with ChemoBooster Device control part should be used as a guideline to treatments User s Manual v7 3 oncoGherm ChemoBooster BOSSE Intended use 1 The ChemoBooster device is devoted to support the chemotherapy treatments by intensifying the effects of the chemotherapy by several ways The first is that the Booster increases the blood volume which is proportional with the drug concentracion in the selected part of the body Another effect is that the use of the Booster increases the pO2 oxygen concentration in the given volume which helps the drug metabolism The third useful effect of the Booster is that extra drug concentration in the desired volume decreases the drug in the non targeted volumes User s Manual v7 4 oncoGherm ChemoBooster Resins Em Contacts In case of any question we are happy to serve you Questions in production and management Oncotherm Dr Oliv r Sz sz e Managing director Belgische Allee 9 D 53842 Troisdorf Germany Phone 49 2241 319 920 Fax 49 2241 319 921 1 Email info oncotherm de and Ibolya utca 2 H 2071 P ty Hungary Phone 36 23 555 510 Fax 436 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 436
10. the opening screen you can set the parameters of the action by the Power set and Time set buttons After that the action can be started by pushing the Start button At the beginning of the action the device checks if the last saved tuning position is optimal for the actual action actual patient If not the device starts the tuning method and saves the optimal tuning position automatically During the action the following information can be found on the display e Actual output power Set power e Elapsed time User s Manual v7 21 Onc okem ChemoBooster 0000 0 aA TES Both the time and power values can be changed during the operation by the Power set and Time set buttons The operation of the device can be paused by pushing the Pause button On the display the similar text appears The operation can be continued by pushing the Start or the Continue button and can be aborted by pushing the Pause button After the abort another treatment can be set and started User s Manual v7 22 onco rherm ChemoBooster 0000 00 UU MER herm Saving tuning positions To reach the optimal power transmission into the patient the device must be tuned The device tunes itself at the beginning of action but sometimes you need to start the tuning manually First the electrodes must be placed onto the patient then all the four Power set and Time set buttons have to be pushed on the same time The display will change to th
11. 2 Electrical safety of the appliance is only guaranteed if the grounding system of the building is in accordance with local electricity board regulations Avoid the mains and grounding discrepancies as they increase the risk of potential electric shock 13 Devices which are to be discarded shall be made unusable Pull out the plug from the mains socket and remove the cable Safety 1 The device is only suitable for normal treatment use and for the purposes and intended use stated in these operating instructions 2 Do not use any extension and radio frequency cables only those which are provided by the authorized service and or by Oncotherm 3 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 itself 4 The mains lead of the unit should be unplugged when the unit is not in use for an extended period of time 5 Do not plug in or unplug the mains lead with wet hands 6 Do not use the device barefoot 7 Take care that objects do not fall and liquids are not spilled into the interior of the device If liquid is spilt into the equipment disconnect it from the mains and consult a qualified service technician 8 Do not allow untrained inexperienced personnel to operate and or control the equipment 9 Never leave the device exposed to environmental effects rain sun etc 10 The patient s surface must not be damp Af
12. condition values apply Temperature 150 gt 430 Relative humidity 20 gt 60 non condensing Air pressure 700hPa gt 1060hPa Storage only in closed room User s Manual v7 17 oncoGherm ChemoBooster zii rail Before use Check the electrode before each use of the device for broken insulation or damage of the surface of the electrode Electrodes with damaged surface are dangerous for the patient so do not use this electrode but call the service During the treatment check continuously that the patient is not able to touch any connection cables associated with the electrode Cleaning Maintenance of external surfaces 1 Turn the power off before cleaning the unit 2 To clean use a soft dry cloth 3 If the surfaces are extremely dirty use a soft cloth dipped into a soap and water solution or a weak detergent solution 4 Wring the cloth well before wiping the unit 5 Wipe once again with a soft dry cloth 6 Never use alcohol paint thinner benzene or a chemically treated cloth to clean this unit Such chemicals may damage the surface of your unit Disinfecting the accessories Electrode It is very important to disinfect the electrode before each treatment Suggested solution is Isopropanol 70 V V or ethanol according to user instructions on the bottle Use only damp textile If the textile is too wet liquid can penetrate into any part of the equipment Use disposable paper bandage to fix the
13. cted benefits and risks and the likelihood or probability that the benefits and risks will occur e Patient must comprehend the relevant information e Patient must voluntarily grant consent without coercion or duress User s Manual v7 13 oncoGherm ChemoBooster zii rail Doctors must give information to the patient about a particular treatment or test in order for the patient to decide whether or not you wish to undergo such treatment or test This process of understanding the risks and benefits of treatment is known as informed consent It is based on the moral and legal premise of patient autonomy Patient have the right to make decisions about your own health and medical conditions e Patient must give your voluntary informed consent for treatment and for most medical tests and procedures The legal term for failing to obtain informed consent before performing a test or procedure on a patient is called battery a form of assault e For many types of interactions for example a physical exam with your doctor implied consent is assumed e For more invasive tests or for those tests or treatments with significant risks or alternatives you will be asked to give explicit written consent e Under certain circumstances there are exceptions to the informed consent rule The most common exceptions are these e An emergency in which medical care is needed immediately to prevent serious or irreversible harm e Incompe
14. d out by unauthorized staff Guarantee becomes void if the equipment is not stored handled operated or managed in any way according to the User s Manual Any changes in the hardware and or software without written permission of the manufacturer are strictly prohibited and voids guarantee 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 User s Manual v7 27 onco herm ChemoBooster eae Germ Appendix 3 Patient Consent ONCOTHERMIA SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND WRITTEN INFORMED CONSENT HAS BEEN OBTAINED IMPORTANT INFORMATION AND WARNING PATIENT s CONSENT My treatment with ONCOTHERMIA has been personally described to me by Dr The following points of information among others have been specifically discussed and made clear and I have had the opportunity to ask any questions concerning this information 1 I patient s name understand that ONCOTHERMIA is used to treat certain types of tumors malignant and benign and my physician has told me that I am this type of patient Initials 2 I understand that there is a risk of surface or adipose erythematic reaction sometimes burn injury by
15. dso eArsnjoxo exysonu ofeq soumue o Yy uueuoouo pouedsq SA peprunrojuo ap uoiovure ooq 6 IMY XI xouuv qquo q TI SSe Ce uonoss xouuv OAF TH C6 9 u onq 23 9p suonisodsrp xne juourguriojuoo 8007 1006 OSI 00C S8F 1 OSI NA Sjeuuou sjuounaop samme no souuou xne ej v 2uuojuoo 192 uonere oop 2195 ayy os nbre soog oway impoid a anb oi rqesuodsor amas ANOU snos suore osp YY uuougoout snoN sieSug1 4 YA 31101105002 ap uontav osq 6 3o3 X1 xouuv Cao q 1I ssejo Cg ONES TI xouuy ormpuory Og 1p uoSuntmumsag up ger 8007 1006 OSI 00Z 68PET OSI NA umumnsurioqn uojuoumxo q usAneuuou Jopo USULION uopuag oj uap jur 4uorzoq Sunrepprg osorp uors sep jne 1ojs00g OWI ppipoiq sep gep Sunuow1ueJoA Zmapp ur wep yy uuogoouo mw qosjmq qp Sunagpq sjgjunrojuow 6 1BOY XI xouuv qq QII sser CE uomypes II xouuv DAA TH ES ANYON 23 ua1oxrra 182 8007 1006 OSI 00C 68v 1 OSI Na 3uoumwop puea ejpue jo 2 12prepur s opue oj pour os ourumissuaAQ I 1 amp UPIXesIQ euuap AP seyezjwo wos lojsoog owayg uopmpojd ye masue 333 Jopun PSIO YY WPM A exsusAS AS 9spourumjssua49AQ WO UEJXESIO T 13 Aled LLOC H Bip ELEGIA KULLO Jopanq Surgeuejq ZS Z J9A1 O 3G OIOC PEN ZI 3A eotA1es 19npoid ANS ANL Aq penss 670 68L 0 0I TO ON o1eognao ET xouuy 3uouissossy jruuojuo SurMo 0 eui uo peseq sr uongie oop stu T oroz eunf c ereq Md LLOC H 92e d Qzc uomnere oeq Jo qumu uomneasidow uequinw
16. e tuning mode To start the tuning push the Start button During the tuning you will see the next on the display User s Manual v7 23 onco rherm ChemoBooster ears Ghee n When the optimal tuning position has been found the position will be showed on the display and the device automatically saves it The saving is confirmed by the display BOOSTER After the tuning you can step back to the opening screen by pushing the Pause button Emergency stop In emergency situations for example if the patient feels burn the patient can stop the device by a separated emergency button The push of the button stops the action and restarts the device So an emergency stop will lead back to the action screen where a new action can be started Take care about that the patient could reach the emergency button in every situation Switching off the device The turn off of the device can be made by the main switch placed on the back plate of the device User s Manual v7 24 onco rherm ChemoBooster ES e n Error and warning messages If the electrode is not connected you can see the next message on the display If the electrode is not correctly placed onto the patient or it s seriously damaged a tuning error can occur BOOSTER In this case you must be check the electrode itself and the position of the electrodes on the patient User s Manual v7 25 onco therm ChemoBooster f con
17. form ion o Declarati Appendix 1 TII PUTNO 103 6 eruees x xouuv Ci T q 1I ssep ersyKeregur e nya I xeuuy oaar utwmpenp Oy usenvpnou 00C 1006 OSI 00CSSPtI OSI NH woureynur WajsnurneeA uofo imyerse uasa menou uaprmu re uarprepueis uotAeenas uo AXjr sminmxyeA pup uogof 15 500g OWY oj0nj BABES ENS aurnuve hnisgA Eewo UPPUIOUISX oumuennnxeA yy unogoou apy muons JA snjnnyxea snnsrexnurua snurmge A 6 92o3 X xouuv Qq q 1I SSe c onoes TI xouuy 533 zt e6 ufinqou 53 9p uea uasuredag op su 3 o 8007 1006 OSI 00C S8P T OSI NA uoioumoop aAoneuuou apur jo uounou apuoSjo op iow st Surururyjsuo012AO ur Y Surpponoq Fuera ezop dowem soog Ouroq pmposd jou wp projjifipoppioowjueloA uero Japuo pasya UPA YN WOWO fiM spuepr9poN JN Suniepq124 sprog3rsuroqu22424 6 BULON XT XOUUY CICIN q 1I sser ore jp xouuv DAA TH ES vamanp 23 Pep oistAo1d oquenb v oseq ut 8007 1006 OSI EOOT S8HEL OSI NA IAneuuou 1uoumoop mye pe o ewou ojuongos epe ounopuoo 2 o0sHojgH IS ouorzerquorp vjsonb openb e 121500 owy onopoid qt oq virpiqesuodso1 earsnjoso esou ej opos oumnmrgorp Yy uuegioouo ION ouere LI vjrunr0juoo Ip ouorzvaepuorq 6 PIS2Y XT xouuv cq q 1I ssej e uorosag TI xeuuy 2gS cr c6 BANDEN Og ep seuororsodsrp sej uoo opino op 8007 1006 OSI 00CS8PE I OSI NF soAneuuou sojuoumoop sono n seunou sep uoo uoroere oop s aaya 2s onb e 12 s00g owy ojonpoud op pepruuruoo ej pepriiqesuo
18. ile the RF radiation is on Do not use wet textile tissue that could release water to penetrate into any parts of the equipment The selected part of the body where the drug is wanted to be concentrated must be between the two electrodes Any metallic object or infusion needle can not be between the electrodes 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 Do not install the machine in the vicinity of RF sensitive User s Manual v7 12 onco herm ChemoBooster ae Germ 20 21 22 23 24 equipments ECG EEG intensive care control monitor ultra sound video rectoscopy and or other sensitive imaging systems without shielding It should be noted that microwave sources could influence the Oncotherm device in the treatment room and vice versa Make sure that those devices are well shielded The personnel responsible for the treatment equipment should check the cables before each treatment At any doubt about the intact isolation stop the use of the device and call for an immediate service check up If itis possible use the electrodes personally for the given patient Another cases thin paper tissue like a simple paper towel or medical hygienic paper can be used between the bare skin and the electrode for hygienic reasons The ChemoBooste
19. liances e g air conditioning diagnostics systems computers sterilization equipment Pre installation notices 1 The room shall have normal climate conditions e g temperature humidity pollution etc throughout its lifetime Temperature range 15 30 C humidity range 20 60 non condensing 2 No aggressive pollution e g chemicals fibres 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 In the room there has to be a safe place for treatment accessories 8 Avoid using your equipment immediately after sudden changes of the ambient temperature due to the moisture damage in the electronic components User s Manual v7 7 oncoGherm ChemoBooster zii iral 9 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 10 Good air circulation around the device is essential to prevent internal overheat of the electronic parts 11 Take care of not braking the power cables 1
20. n the form of radio frequency will not heat the patient but is lost in the air cables and the internal electronic parts The tuning is the most important way of the personalization of the device and guarantees best available effect in the patient A good tuning means that the outgoing power from the device is mostly absorbed by the patient and not reflected In case of proper tuning the patient becomes part of the resonant electronic circuit Preparation for use The electrodes have to be positioned on the tumor area with best overlapping Please control before using the device e Electrode cables shall not be broken e Electrode material shall not be torn or damaged e Electrode needs to be cleaned and disinfected to prevent infection e Electrodes can be used until significant damage on the electrode surfaces can t be observed User s Manual v7 20 onco rherm ChemoBooster RHET te n Turning on the device The switch on of the device can be made by the main switch placed on the back plate of the device After the turn on you can see the name of the manufacturer and the type of the device for a short time then the opening screen appears on the display of the device BOOSTER Here the parameters of action can be set by the Power set and the Time set buttons After that the action can be started by pushing the Start button In this case the device will use the last saved tuning position see next point Action On
21. onco rherm ChemoBooster Bs Ghee onco amp rherm hightech m e dictne User s manual ChemoBooster Version v7 Oct 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 oncoGherm ChemoBooster gneaqenm Content CONTENT eceeeceoeo epe peas EEE S 2 INTRODUCTION mt 3 THE CHEMOBOOSTER eeeeeeeeeee e een nnn nennen hern nn nn nn nn nnne nan 3 HOW TO USE THIS MANUAL eeceeeeennee e n nennen nnn nnn nnn nn aree n nn n nena aenaa 3 INTENDED USE 55 o EPFL EE REY YE Re Eva EE CREER ERE ERE FE YR ER LU Xa ERE eye EE PER LEY Rd 4 SAFETY WARNING csissscciessscesesssisssecssscscccessssseosoasccssesddnovoessssdbnccassonoaeasosoes 6 SYMBOLS AND THEIR DEFINITIONS e eee eere eese etna etna nue 6 INSTALLATION RT 7 EINI SSN D 7 ELECTRICALCONNECTION eiie a a liie aseescded Seecuetsanweccedase 7 PRE INSTALLATION NOTICES eere e nennen nnn nnn nnn nnn nnn nna n nna 7 SAFETY ME 8 Resident TiS kS ioe uo
22. r 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 Take care that the cables to the electrode as far as possible placed from the patient while they can burn the patient Resident risk Due to the intensive heat delivery to the body effect of the heat on the heart function could happen like in general hyperthermia cases e g hot car effect on children or hot bath effect on some sensitive person etc The general sign of the problem is the heart arrhythmia which you must check when the heat delivery is too intensive large area is treated or huge power is applied The heart arrhythmia could happen for patients having rare electrosmog sensitivity or psychological indisposition against electric field radiation Note the field is delivered in low frequency about 1 10 of the regular radiobroadcasts frequencies Do remember the patient s sensing is the best safety alarm for any unwanted not expected events Do not ignore it react immediately Written consent to treatment A written signed consent to treatment is mandatory before start of the first treatment for the given patient This consent has to contain e Clear capacity or ability to make the decision e The medical provider must disclose information on the treatment test or procedure in question including the expe
23. s Applicable for most of the pharmaceutical products taken by e orally intravenous infusion i v muscular injection rectal suppository skin addicted heath bathes inhalations User s Manual v7 10 oncoGherm ChemoBooster OON Available applicators e electrode Contra indication e Treatment is strictly prohibited when the patient is unconscious e Can not be used for treating patients who have pacemaker or other type of electrical implants e Can not be used for treating patients with any metallic lead or implanted system e g implanted deep brain stimulator DBS e Especial care is requested with continuous patient feedback at treating patients who have joint support who have surgery clips who have bone replacement or have insensitive surface area at the treatment region due to the surgery of other e Can not be used under the age of 6 e Use is prohibited under pregnancy Important medical notices 1 Intended user of this device is a trained physician and or a trained Clinical staff In the case of reduced thermal sensitivity the use of the device needs extra care Treatment is strictly prohibited when the patient is unconscious It is prohibited to treat patient with permanent electric stimulators e g pace maker deep brain stimulator etc Treatment is prohibited when the patient is under deep sedation or anesthesia Treatment is strictly prohibited in case of children who are
24. tence in which someone is unable to give permission or to refuse permission for testing or treatment User s Manual v7 14 onco herm ChemoBooster BAS Cherm Technical description Technical details Electrode Start button plug Pause button Power set Time set buttons buttons Emergency Display Continue button plug button User s Manual v7 15 ChemoBooster ancoGherm The device Device height mm Device width mm Device depth mm Device weight kg Electrical input V Electrical max load A Electrical avg load A RF output forwarded W RF output useful W RF frequency MHz Medical device class II B 110 mm 380 mm 330 mm 7 6 kg 230 1 phase 1 0 8 80 1 80 13 56 User s Manual v7 16 onco herm ChemoBooster BE Cherm Accessories Order Accessories Description Photo numbe This user s manual in User s manual printed form Electrode 28x22 cm WARNING The use of ACCESSORIES and CABLES other than those specified may result in increased EMISSION or decreased IMMUNITY of the ChemoBoosier device therefore it is forbidden Transportation and storage Oncotherm service is responsible for transportation and storage The following transportation and storage conditions apply Temperature 50 gt 550 Relative humidity 10 gt 75 non condensing Air pressure 500hPa gt 1060hPa The following operating
25. ter cleaning the surface the user have to wait until it is dry 11 Do not use other surgical or endocardial devices while patient is being treated 12 Dangerous voltage inside Do not open the cabinet There are no user serviceable parts inside Only qualified service personnel should carry out repairs User s Manual v7 8 onco herm ChemoBooster eae Germ Resident risks User has to follow the instructions mentioned above otherwise burning or overheating of the tissue can occur User s Manual v7 9 oncoGherm ChemoBooster Acorn General description Intended use The Booster device is devoted to support the chemotherapy and or radiotherapy treatments by localizing personalizing and intensifying the effects of the applied therapy by several ways The Booster is not intended and not capable to be used for any separate treatments Its intended use is only for complementary application helping extending boosting of treatment of arts Effects e Increases the oxygenation and decreases acidity of the tissues e The drug metabolism is promoted drastically e Increases the venous drainage with greater re absorption of catabolites and decreases of the oedema in areas with inflammatory processes e Speeds healing of wounds e Stimulates the immune system and decreases of free radicals Side effects e skin can become red slight burn e overdose in the local area where ChemoBooster is used Main indication
26. trode tissue as the diameter of the electrode itself Before rearranging and or repositioning the applicator please pause stop the treatment Also in case of any necessary medical aid injection infusion etc please pause stop the treatment Do not touch the electrode during the treatment process Be careful with temperature measurements and the other controlling units Any metallic part could be an antenna Using to control any non Oncotherm product 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 have to be removed from the patient and kept away from the treatment bed Do not treat patients who have earphones hearing aid music devices walkman mp3 player etc and or any wire connected instruments Also please keep away any sharp objects knives scissors needles pens pencils glasses etc Also credit cards and or any other magnetically sensitive products diskettes tapes etc should be kept away from the treatment There is no guarantee of losing data from these media 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 wh
27. using ONCOTHERMIA Initials 3 I understand that there are no laboratory tests that will predict the success of the treatment Initials 4 I understand that I must immediately report any unusual symptoms to Dr and be especially aware of persistent nausea fatigue lethargy decreased appetite itchiness pain etc Initials I now authorize Dr to begin my treatment with ONCOTHERMIA OR if my treatment has already begun with ONCOTHERMIA to continue such treatment Patient s Name Address Telephone PHYSICIAN STATEMENT I have fully explained to the patient the nature and purpose of the treatment with ONCOTHERMIA and the potential risks associated with that treatment I have asked the patient if he she has any questions regarding this treatment or the risks and have answered those questions to the best of my ability I also acknowledge that I have read and understand the prescribing information listed above Physician Date NOTE TO PHYSICIAN It is strongly recommended that you retain a signed copy of the informed consent with the patient s medical records SUPPLY OF patient CONSENT FORMS A supply of Patient s Consent forms as printed above is available free of charge from Oncotherm GmbH Belgishe Allee 9 D 53842 Troisdorf Germany info oncotherm de Phone 49 2241 319 920 User s Manual v7 28
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