INTRABEAM®
Contents
1. Payload max 95 kg 209 43 lbs Dimensions 900 x 1690 x 600 mm 35 43 x 66 53 x 23 62 INTRABEAM Floor Stand Weight 275 kg 606 Ibs Transport Position 740 x 1940 x 1500 mm 29 13 x 76 38 x 59 06 Consumables INTRABEAM Radiation Shield Flat 20 cm x 20 cm 10 per box Material Tungsten INTRABEAM Drapes 5 per box ca 1000 mm ca 39 37 ACC NI f CA Ea qi Floor stand Dimensional drawings 1 Working position example 2 Transport position 4 X ray Source and Beam Characteristics The mobile radiation source of INTRABEAM accelerates electrons through the 100 mm drift tube with a maximum voltage of 50 kV onto a gold target where the low energy x ray radiation is generated and then emitted isotropically 4 1 Beam energies 40 kV 10 20 or 40 pA 50 kV 5 10 20 or 40 pA INTRABEAM Radiation source 30 1 Gy min gma 2 Gy min ee 3 Gy min 20 A Gy min 5 Gy min aa a Spherical dose distribution y min 10 of the x rays The steep drop in the dosage ensures that most of the radiation remains 0 in the targeted tissue 10 20 Source Settings 50 kV 40 pA 4 2 Beam characteristics Diameter of the Approx Radiation intensity Approx Treatment time target area mm in the periphery Gy Minute 15 Gy Minute 10 re j 20 2 3 6 5 30 0 9 16 7 40 0 4 Bb 50 025 60 All displayed values are valid for the operat2. The user is requested via the user interface to press the start button at least twice to con firm that he really wants to perform the test The unintended execution of a verification test is not possible The optical interlock enables the system to detect if the x ray source has been correctly mounted on the stereotactic frame adapter or the INTRABEAM Floor Stand The system also detects whether the applicator has been correctly attached to the INTRABEAM Floor Stand The x ray source will only be enabled for radiation emission if it has been correctly mounted on the carrier system intended for it Once the x ray source has been successfully connected to the carrier system the user must follow the menu prompts on the user interface to actively set the system status to ready for radiation emission Radiation will only be emitted if the user presses the Start button again As soon as the system Is ready for radiation emission this ready status is indicated by an acoustic signal This warns the user that radiation will be emitted when the Start button is pressed again Radiation emission can only be started by trained and authorized staff after the necessary verification steps have been completed the dose has been confirmed by a second person verified by a password and the system has been set to the treatment mode 6 2 Interlock to prevent unintended access to the controlled area Protection against unintended access to the controlled area
3. e Radiation emission is acoustically and visually indicated on the x ray source and the user interface Persons entering the controlled area are able to obtain information on the radiation status of the system In addition further safety systems such as an external warning lamp or a door contact switch can be connected with the INTRABEAM via an external interlock switch If for example the external interlock is activated by opening of the door during a treatment session radiation emission is instantly interrupted automatically and can only be resumed after the interlock has been closed and continued radiation emission has been confirmed 6 3 Interlock to prevent incorrect radiation data transmission Protection against incorrect radiation data transmission e Every signal transmitted by the control console to the x ray source is returned by the X ray source and checked for completeness and correctness by the control console If the signal is not correctly returned by the x ray source radiation emission is stopped or not started The count rate is constantly monitored during treatment by the internal radiation monitor If the count rate deviates from the planned rate by more than 10 radiation emission is stopped e The ratio between the planned treatment time and the count rate is constantly monitored In the event of any deviations radiation emission is stopped 6 4 Interlock to prevent incorrect dose entry e The dose to be administ
4. exactly above or beside the ion chambers inside the water Accurate posi tioning and stepping of the source ensures the remeasurement of the depth dose curve Even the measurement of a depth dose curve is possible 5 2 QA Check QA Tools Inside the so called PDA five diodes in each direction measure the radiation of the XRS4 The objective of this test is to ensure the sphericity of the beam With the PAICH the output in the z axis can be checked An ion chamber is mounted in the probe adjuster in a way that the ion chamber window is right above the tip of the XRS4 In this test the internal radiation monitor and the output are checked 5 3 Online control IRM Prior to each treatment session the x ray source must be subjected to a verification process comprising at least two levels before it is enabled by the software for radiation emission e Verification of the isotropy of the radiation field A photodiode array PDA is used to test the radiation field in all 5 axes Only if all diodes measure identical radiation i e if the field is soherical within specified tolerances will the system be released for the next verification step e Verification of the radiation output using an external ionization chamber is only possible after successful completion of the PDA test The counts measured by the internal radiation monitor are compared with the reading of the ionization chamber The x ray source is not enabled for treatment planning un
5. INTRABEAM Product Specifications Content o CON On Un BP WN non eley O EE Page 4 Mobility of the System amp Interaction of the System Components Page 5 Dimensions of the System Components aan nanasa Page 6 X ray Source and Beam Charactertstcs k Page 8 o DOSIMEUY NET E Page 10 Safety Concept n ee E Page 12 ge POT OM eher E Page 15 rte IT E Page 17 Processing Cleaning Disinfection Sterilization u anna aan Page 18 1 System Description INTRABEAM is a mobile radiation instrument which received both FDA and CE approval for the irradiation of all solid tumors in 1999 Treatment can be performed in operating rooms special radiation protection measures are normally not required The mobile ra diation source of INTRABEAM produces low energy x ray radiation which is emitted isotropically equally distributed The INTRABEAM carrier system with six degrees of freedom weight compensation and magnetic brakes ensures easy flexible and precise positioning of the source into the targeted area Ideally integrated in the INTRABEAM Cart the control unit ensures exact setting and monitoring of the desired dose INTRABEAM is a mobile system which can be used parallel in multiple operating rooms am d 2 Mobility of the System amp Interaction of the System Components All INTRABEAM components are completely flexible and movable Most component
6. M Needle Applicator is CE approved 8 Technical Requirements 8 1 Electrical requirements Two outlets are necessary to use the INTRABEAM during treatment one for the floor stand and one for all components on the cart which are connected together with a medical insulating transformer INTRABEAM Floor Stand Rated voltage 100V 115V 230V Power consumption max 400 VA Rated frequency 50 60 Hz Electrical standard Complies with IEC 60601 1 EN 60601 1 UL 60601 1 Approval CAN CSA C22 2 No 601 1 M90 Protection class Degree of protection IPXO Type B equipment Product classification in acc with 93 42 EEC Annex IX INTRABEAM Cart Medical Insulating Transformer Rated voltage 100V 240 V Rated frequency 50 60 Hz Power input 600 VA Power output 230V Case protection IP 20 Protection Class 8 2 Ambient requirements Operation Temperature 15 C 40 C 59 F 1049F Relative humdity 30 75 Air pressure 700 hPa 1060 hPa Transportation and Storage Temperature 20 C 70 C 4 F 158 F Relative humidity 10 90 without condensation Air pressure 500 hPa 1060 hPa Requirements could differ for accessories Please see separate user manuals 17 9 Processing Cleaning Disinfaction Sterilization All non sterile components of the INTRABEAM can be easily cleaned and disinfected Large casters and nearly no tight cleavings ensure simple and quick cl
7. conserving surgery 7 1 INTRABEAM Spherical Applicator Spherical applicators are available with diameters of 1 5 to 5 cm in half cm increments The applicator fills out the entire wound cavity after tumor removal The tumor bed tissue is adapted smoothly around the applicator surface The x ray probe is located then in the center of the applicator and therefore also of the tumor cavity The material of the applicator is medical grade acrylic and can be steam sterilized 15 16 7 2 INTRABEAWM Balloon Applicator Balloon applicators are restricted to breast cancer therapy and are available with diameters of 3 to 5 cm in half cm increments They can be inserted through a small channel into the tumor bed During the time the balloon is inflated the solid spherical shape does not change After treatment the balloon can be deflated and removed through the channel without the need for another operation The balloon applicator comes in a sterile set with accessories to place and remove the applicator 7 3 INTRABEAM Needle Applicator To perform tumor bed treatment in lesions which can be reached only through very small incisions the needle applicator can be used ep _ a N00871 a A pa A Pe The INTRABEAM Balloon Applicator is FDA approved The INTRABEAM Balloon Applicator is pending CE clearance The INTRABEAM Needle Applicator is pending FDA clearance The INTRABEA
8. eaning of the cart The floor stand can also be cleaned in a very short time C b Floor Stand gt INTRABEAM Cart C b Control Console PRS 500 C a User Terminal C b Keyboard C a S X ray Source 4 G a ETO Quality Tools PDA PAICH C a Cables XRS QA C a V X Block C a ES INTRABEAM Water Phantom d Transportation Trays XRS4 QA C a INTRABEAM Spherical Applicator wa X sterilizable steam INTRABEAM Balloon Applicator single use sterile INTRABEAM Needle Applicator single use sterile INTRABEAM Flat Shields single use sterile INTRABEAM Drapes gt E single use sterile a 4 7 Yo Hypochlorid b Meliseltol c wipe moist d ethyl alcohol distilled water 1 1 plus a dash of household dish washing liquid also mentioned in the detailled user manuals The processing method of the INTRABEAM Spherical Applicators was validated by Carl Zeiss The INTRABEAM Spherical Applicators can be processed with the following method If possible you should use a machine for clea ning and disinfection The manual procedure should only be used when a machine is not available as it is clearly less effective and reproducible e Never clean the applicators and sterilization containers with metal brushes or steel wool e Never clean the applicators and sterilization containers using ultrasoundprocedures e The applicators and sterilization containers must not be exposed to temperatures high
9. er than 141 C 286 F Prepare cleaning and disinfecting agents that meet the following requirements Aldehyde free disinfecting agent otherwise blood contamination remains The disin fecting agent must be certified in accor dance with VAH DGHM or FDA approval or CE label stipulations The disinfecting agent is compatible with the cleaning agent used The disinfecting agent is generally suitable for cleaning and disinfecting devices made of metal and plastic The disinfecting agent must not contain the following organic mineral and oxidizing acids minimum permissible pH value 5 5 strong bases maximum permissible pH value 8 5 recommended neutral enzy matic cleaning agent organic solvents e g alcohol ether ketone benzine oxidants e g hydrogen peroxide halogens chlorine iodine bromine aromatic halogenated hydrocarbons Rinsing with sterile or low germ maximum 10 microbes ml and lowendotoxin maxi mum 0 25 endotoxin units ml water e g purified water highly purified water e Only use the steam sterilization method fractioned vacuum method described in this manual for sterilization of the cleaned and disinfected applicators Other pro cedures are not approved Do not use gravitation methods hot air sterilization radiation sterilization formaldehyde sterilization ethylene oxide sterilization or plasma sterilization For steam steri
10. ered must only be prescribed by an appropriately trained authorized doctor this is a legal requirement in most countries information during system training and note in the user manual e The dose is entered by one person usually a physicist and a second person who must be a doctor this is checked via the profile of the user name must verify the dose planning and confirm it by entering a password 13 14 6 5 Interlock to prevent interference with the application software The INTRABEAM is a closed system Only data conforming to the specific data format of the application software can be loaded via CD DVD 6 6 Electrical safety e The system has been successfully subjected to the conformity assessment procedure and complies with the essential requirements stipulated in Council Directive 93 42 EEC and with IEC 60601 1 EN 60601 1 UL 60601 1 CAN CSA C22 2 No 601 1 IEC 60601 1 2 and IEC 60601 2 8 7 Application Options The physical and radiobiological effect of the low energy x rays produced from the XRS4 INTRABEAM is used in nearly the whole body side except heart and central circulation system Various types of different applicators suitable for the different cavities are used to fill out the tumor bed after removal of the tumor Carl Zeiss continuously works on the development of new applicator types for additional treatment applicators Radiotherapy after tumor removal with a spherical applicator after breast
11. ion of the XRS4 at 50 kV and 40 pA 4 3 Beam allocation Point source type emission Dose isotropic around XRS 4 isocenter Sharp dose fall off approx 1 r3 in soft tissue or equivalent Positional uncertainty of delivered dose less 1 mm at 40 mm treatment diameter 4 4 On site dose monitoring An internal radiation monitor IRM detects the back bouncing counts and assures on site monitoring The IRM result is displayed on the treatment screen of the control terminal so that the operator knows which dose is being delivered at any time during treatment Internal Cathode Accelerator Beam Electron Gold Radiation Gun Section Deflector Beam Target Monitor 10 5 Dosimetry System A full set of quality assurance and dosimetry tools are pro vided with the INTRABEAM The factory calibrated system is delivered with the specific depth dose curves and a refe rence measurement with the ion chamber belonging to the system Every day a two step quality control check ensures that all parameters such as isotropy internal radiation monitor and output work do not exceed the tolerances defined during calibration For commissioning a completely shielded manual adjustable water phantom can be used to remeasure the depth dose curve 5 1 Consignment Sale System calibration by Carl Zeiss and with the water phantom A water phantom with a highly precise movement technique enables the physicist to position the tip of the XRS4
12. lization please take the following factors into account The steam sterilization method is validated according to DIN EN ISO 17665 previously DIN EN 554 ANSI AAMI ISO 11134 valid IQ OQ commissioning and product specific performance assessment PQ The maximum sterilization temperature Is 138 C 280 F plus tolerance according to DIN EN ISO 17665 previously DIN EN 554 ANSI AAMI ISO 11134 With the fractioned vacuum method the sterilization time exposure time at steriliza tion temperature is at least 5 min1 at 132 C 270 F 134 C 273 F 1or 18 min prion inactivation Please see the user manual for detailed infor mation on cleaning disinfection and steriliza tion of the INTRABEAM Spherical Applicators 19 zeg UE JO YIEWApPEI pala sibal e SI oNYIJYYLNI DeMJ9SeJ S U IJAdo Y DY IPN SS Z LI 010Z Jaded paydea q 99JJ 9UIJ0 U gt UO pajulid TUdWdO Bnap ed 1UYyda Hulobuo JO yns 1 e se pue Maan JO adods pue ubisap ul abugpun o palqns UOIJEUOJU BOW JO 9 1 8 U9S9JdeJ PU 0IDoJ INOA Peju0 asea d juno JNOA UI pnpoid y JO jeAoIdde JO Sn P S uand y WO J9JJI Kew 9J0U20JQ aY JO S JUaJUOD aY Auewad u pajulid I8SL 0L0 Of NA CE 0297 www meditec zeiss com radiotherapy Carl Zeiss Surgical GmbH E mail intrabeam meditec zeiss com A Carl Zeiss Meditec Company Carl Zeiss Stralse 22 73447 Oberkochen Germany
13. s such as the 1 6 kg light x ray source are stored in a storage container inside the INTRABEAM Cart The cart and floor stand can be easily stowed away with all components when not in use With its open space on top of the cart the system quality check can be done easily on the cart The touch pad terminal control console dosimeter and everything else needed for system quality assurance and the treatment are mounted ergonomically on the cart Large casters and guiding rollers ensure easy transportation inside and outside the operating room The set up of the cart also ensures quick and easy cleaning in the OR The cart and floor stand can be moved through normal doors and through elevators If necessary When in use the x ray source is inserted in the arm of the INTRABEAM carrier With 12 casters in the base the carrier can be moved smoothly to any position in the OR Weight compensation and six axes provide enough freedom to bring the x ray source in every position needed for treatment Electromagnetic brakes hold the source into the exact position during treatment The operator can control the system at any time from the control panel at the INTRABEAM Cart during the process 3 Dimensions of the System Components INTRABEAM X Ray Source 4 Weight 1 6 kg 3 57 Ibs Dimensions 70 x 175 x 110 mm width x height x length INTRABEAM Cart Weight of cart unloaded incl permanently mounted user terminal approx 105 kg 231 Ibs
14. til a coefficient has been computed 5 4 Radiation protection during dosimetry Every tool provided with the INTRABEAM is completely self shielded and does not require any additional radiation protection 11 12 6 Safety Concept Interlocks A closed meshed interlock system controls the INTRABEAM during treatment and quality assurance It prevents the user against e g unintended radiation emissions unintended access to the controlled area and incorrect radiation data transmission see 6 1 6 3 This safety concept is also responsible for ensuring the proper work during treatment and will adjust and sound an alert if anything else occurs To obtain the license for operation of the INTRABEAM it may be necessary to create a safety strategy and or failure analysis a hospital radiation protection manual and an emergency plan Suggestions on how to establish this are provided by Carl Zeiss 6 1 Interlock to prevent unintended radiation emission Unintended radiation emissions are prevented by an optical interlock system and a multilayered inquiry in the software The optical interlock detects whether the appropriate verification device has been correctly attached to the x ray source Only then and only when the device protects the environment from radiation will the x ray source be enabled for radiation emission If the device is removed during the test radiation emission is immediately deactivated by the interlock
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