INTRABEAM Technical Specifications
Contents
1. 17 9 Safety Concept Interlock 18 A monitoring system checks the INTRABEAM during the treatment and quality assurance It prevents the user against unintended radiation emissions and optional unintended access to the controlled area and incorrect radiation data transmission see 9 1 9 3 This safety concept is also responsible for ensuring the proper control during treatment and In case of an interference a sound alert is triggered To obtain the license for the utilization of the INTRABEAM it may require creation of a safety plan and or failure analysis a hospital radiation protection manual and an emergency plan Suggestions on how to establish this can be provided by Carl Zeiss 9 1 Interlock to prevent unintended radiation emission Unintended radiation emissions are prevented by an optical interlock system and a multilayered inquiry in the software m The optical interlock detects whether the ap propriate verification device has been correctly attached to the miniaturized accelerator Only then and only when the device protects the environment from radiation will the miniaturized accelerator be enabled for radiation emission If the device is removed during the test radia tion emission is immediately deactivated by the interlock m The user is requested via the user interface to press the start button at least twice to confirm that he really wants to perform the test The unintended execution of a verific2. INTRABEAM Technical Specifications Content System Description Applications Mobility of the System amp Components System Dimensions Miniaturized Accelerator Beam Characteristics Radiation Safety Quality Assurance and Dosimetry Safety Concept Interlock Technical Requirements Processing Cleaning Disinfection Sterilization 20 21 rz gt aA Em 1 System Description INTRABEAM received FDA approval in the USA in 1997 and was Miniaturized Accelerator awarded the CE certification in Europe in 1999 for the irradiation of targeted lesions using intersitial intraoperative intracavity or surface irradiation techniques Treatment can be performed in operating rooms structural alterations for radiation protection are normally not required The miniaturized accelerator of INTRABEAM produces low energy x ray photons which are 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 miniaturized accelerator 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 is therefore suitable for use in multiple operating rooms The miniaturized accelerator emits low energy X ray photons max 50 kV in an isotropic distribution for
3. 5 cm The applicators are reusable and sterilizable Please refer to the instruc tion manual 2 2 INTRABEAM Needle Applicator The INTRABEAM Needle Applicator can be used for the interstitial irradiation of tumors e g in the treatment of vertebral metastases Spinal metas tases are often accompanied by severe pain and the danger of a compression fracture In Kypho IORT with INTRABEAM vertebral metastases can be irradiated intraoperatively in a targeted localized and minimally invasive technique using the needle applicator After the intraoperative radiotherapy the affected vertebra is stabilized by the insertion of bone cement in a procedure known as kyphoplasty The single use INTRABEAM Needle Applicator has a diameter of 4 4 mm 2 3 INTRABEAM Flat Applicator The INTRABEAM Flat Applicator is used for the treatment of tumors on surgically exposed surfaces e g tumors of the gastrointestinal tract The INTRABEAM Flat Applicator has an optimized flat radiation field by means of a flattening filter at 5 mm from the applicator surface Using the Posi tion Marker a sterilizable metal ring which may be placed on the surgically exposed surface the area to be irradiated can be isolated The INTRABEAM Flat Applicators are available in the diameters 1 2 3 4 5 and 6 cm The applicators are reusable and sterilizable Please refer to the instruction manual This INTRABEAM applicator has CE certification and is awaiting FD
4. doctor this is checked via the profile of the user name must verify the dose planning and confirm it by entering a password 9 5 Interlock to prevent interference with the application software m The INTRABEAM is a closed system Only data conforming to the specific data format of the application software can be loaded via CD DVD 19 10 Technical Requirements 11 Processing Cleaning Disinfection Sterilization 10 1 Electrical requirements All non sterile components of the INTRABEAM can cleaning of the cart The Floor Stand can also be be easily cleaned and disinfected Large casters and cleaned in a very short time Two electrical outlets are necessary in order to operate the INTRABEAM nearly no tight cleavings ensure simple and quick during treatment one for the Floor Stand and one for all components on the cart which are connected together with a medical insulating transformer Component Cleaning Disinfection Single Use Sterilizable Floor Stand C D INTRABEAM Floor Stand INTRABEAM Cart Medical Insulating Transformer ull c D Rated voltage 100 V 115 V 230V 115 V 230V e A Rated frequenzy 50 60 Hz 50 60 Hz AO Power consumption max 400 VA 600 VA peels Electrical standard IEC 60601 1 IEC 60601 1 UL 60601 1 a i CAN CSA C22 2 No 601 1 M90 CAN CSA C22 2 No 601 1 M90 Quality Tools PDA PAICH C a Product cla
5. 3 cm 30 mm 1 18 4 cm 40 mm 1 57 4cm 40 mm 1 57 5cm 50 mm 1 97 6 cm 60 mm 2 36 Outer diameter 1 5 cm 15 mm 0 59 4 4mm 1cm 14 mm 0 55 1cm 14mm 0 55 2 0 cm 20 mm 0 79 2 0 cm 20 mm 0 79 2cm 24 mm 0 94 2cm 24 mm 0 94 2 5 cm 25 mm 0 98 2 5 cm 25 mm 0 98 3cm 34 mm 1 34 3cm 34 mm 1 34 3 0 cm 30 mm 1 18 3 0 cm 30 mm 1 18 4cm 44 mm 1 73 4cm 44 mm 1 73 3 5 cm 35 mm 1 38 2 13 2 52 4 0 cm 40 mm 1 57 4 5 cm 45 mm 1 77 5 0 cm 50 mm 1 97 3 5 cm 35 mm 1 38 6cm 64 mm 2 52 Materials used for applicators and components m Stainless steel m ULTEM Polyetherimide m Stainless steel m ULTEM Polyetherimide m Polycarbonate m Stainless steel m ULTEM Polyetherimide m EPDM m Stainless steel m ULTEM Polyetherimide m EPDM m Stainless steel m ULTEM Polyetherimide m EPDM 3 Mobility of the System amp Components 4 10 The INTRABEAM system is highly mobile and all components are easily transportable Most com ponents such as the 1 6 kg miniaturized accelera tor are stored in containers upon the INTRABEAM Cart The cart and floor stand can be easily stowed away with components when not in use The cart s spacious table top allows the system quality assur ance check to be carried out in situ The touch key terminal co
6. Accelerator INTRABEAM X ray Source XRS 4 Weight 4 5 kg 9 92 Ibs Dimensions 381 x 305 x 89 mm W Mange ea WS 100 x 12 01 x350 Dimensions 70 x 175x 110 mm Width x height x length 2 75 X6 89 x 4 32 Width x height x length Rated voltage 100 240 V AC Power consumption max 60 VA Rated frequency 50 60 Hz Beam current at 40 kV 40 uA Beam current at 50 kV 5 10 20 or 40 pA 1 Working position 2 Transport position aar op F 1940 mm 76 38 s go 1 Eil 1850 1800 mm N 72 83 70 87 j 1000 mm 39 37 11 5 Miniaturized Accelerator 6 Beam Characteristics The miniaturized accelerator 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 photons are generated and then emitted isotropically m Point source type x ray emission m Spherical dose distribution around the isocentre of Internal Radiation the miniaturized accelerator XRS 4 Monitor m Steep dose gradient approx 1 r in water soft tissue equivalent m Positional accuracy of delivered dose 1 mm at 40 mm treatment diameter from isocentre Online dose monitoring An internal radiation monitor IRM detects the part of the x ray photons emitted in the direction of the cathode Beam characteristics of the miniaturized Beam characteristics of the accelerator XRS 4 INTRABEAM Needle Applicator Spherical dose distribution of t
7. uniform dose delivery i ie Maneuverability SS gt pret Six axes allow the miniaturized accelerator ani mimigiat to be placed anywhere in three dimensional space required for therapy int mei Applicators Multiple applicator types see page 6 ff which can be attached to the miniaturized accelerator adapt the radiation field for a variety of applications Floor Stand The Floor Stand combines performance with reliability flexibility and ease of use electromagnetic brakes lock the miniaturized accelerator in the treatment position with millimeter accuracy Suitable for mobile use in any OR 2 Applications The physical and radiobiological char acteristics of the miniaturized accelera tor s low energy photons allow for use in a range of applications This allows use within many body sites A range of different applicators is available to meet the various clinical requirements 2 1 INTRABEAM Spherical Applicator The INTRABEAM Spherical Applicators are used for the intracavitary or intraoperative delivery of radia tion to the tumor bed e g at the time of breast conserving surgery The applicator fills the tumor cavity created by the tumor excision The tumor bed tissue adheres to the applicator via surface ten sion The probe tip is centered within the applicator and therefore the tumor cavity The INTRABEAM Spherical Applicators are available in the diameters 1 5 2 2 5 3 3 5 4 4 5
8. 0 387 8037 micro zeiss com China Carl Zeiss Shanghai Co Ltd 1 f Ke Yuan Building 11 Ri Yin Nan Road Waigaoqiao Free Trade Zone 2005 Yang Gao Bei Road Shanghai 200131 China Phone 86 21 5048 17 17 sro zeiss com cn Czech Republic Carl Zeiss spol s r o Radlicka 14 3201 150 00 Prague 5 Czech Republic Phone 420 233 101 221 Zeiss zeiss cz France Carl Zeiss Meditec France SAS 60 route de Sartrouville 78230 Le Pecq France Phone 33 1 34 80 21 00 med zeiss fr Germany Carl Zeiss Meditec VG mbH Carl Zeiss Strasse 22 73447 Oberkochen Germany Phone 49 7364 20 6000 vertrieb meditec zeiss com Surgical Ophthalmology Phone 49 800 470 50 30 iol order meditec zeiss com Hong Kong Carl Zeiss Far East Co Ltd Units 11 12 25 F Tower 2 Ever Gain Plaza No 88 Container Port Road Kwai Chung Hong Kong Phone 852 2332 0402 czfe zeiss com hk India Carl Zeiss India Pvt Ltd 22 Kensington Road Ulsoor Bangalore 560 008 India Phone 91 80 2557 88 88 info zeiss co in Italy Carl Zeiss S p A Viale delle Industrie 20 20020 Arese Milan Italy Phone 39 02 93773 1 infomed zeiss it Japan Carl Zeiss Meditec Japan Co Ltd Shinjuku Ku Tokyo 160 0003 22 Honchio Cho Japan Ophthalmic instruments Phone 81 3 33 55 0331 medsales zeiss co jp Surgical instruments Phone 81 3 33 55 0341 cmskoho zeiss co jp Malaysia Carl Zeiss Sdn Bhd Lot2 Jalan 243 51 A 46100 Petali
9. 30 20 10 20 30 30 20 10 0 10 20 30 Width mm Radiation field from 0 5 mm depth 0 5 30 20 10 0 10 20 30 Width mm 350 300 250 200 150 100 50 0 350 300 250 200 150 100 50 0 350 300 250 200 150 100 50 0 Beam characteristics of the INTRABEAM Surface Applicator 4 cm diameter The INTRABEAM Surface Applicator creates an optimized flat radiation field by means of a flattening filter upon the target surface 50 kV 5 10 20 or 40 pA Radiation field in 0 mm depth 30 103 100 20 90 80 10 70 60 og 50 fant o 40 D 10 I 30 vA 20 10 30 l 0 30 20 10 0 10 20 30 Width mm Radiation field in 5 mm depth 30 103 100 20 90 80 10 70 60 o 50 o S 40 40 T 30 20 20 10 30 l l l l 0 30 20 10 0 10 20 30 Width mm Radiation field from 0 5 mm depth 12 103 100 10 90 80 8 70 60 6 50 40 4 30 20 10 0 5 is 20 10 O 10 20 30 30 Depth mm Width mm 7 Radiation Safety Radiation measurement during treatment delivery To measure the radiation exposure a realistic an thropomorphic phantom with a silicone breast was created in which a 3 5 cm spherical applicator was inserted The irradiation area was covered with the INTRABEAM Radiation Shield Flat as in a sta
10. A approval As of April 2012 2 4 INTRABEAM Surface Applicator The INTRABEAM Surface Applicator is used in the treatment of tumors on the surface of the body for example irradiation of non melanoma skin cancers It is particularly useful for patients with high surgical risk or for the purposes of cosmesis The applicator creates an optimized flat radiation field by means of a flattening filter on the target surface Using the Position Marker a sterilizable metal ring which may be placed on the surface of the body the area to be irradiated can be isolated The INTRABEAM Surface Applicator is available in diameters of 1 2 3 and 4 cm The applicators are reusable and sterilizable Please refer to the instruc tion manual 2 5 INTRABEAM Cylinder V Applicator The INTRABEAM Cylinder V Applicator is used for the irradiation of vaginal wall tumours and consists of a cylindrical applicator and a probe guard which may be inserted in the applicator The Dwell Step per allows the probe guard which encases the tip of the miniaturized accelerator to be precisely positioned in the INTRABEAM Cylinder V Applica tor This enables manual stepping of the probe tip and establishment of a homogeneous cylindrical dose distribution of a user defined length The INTRABEAM Cylinder V Applicator is available in diameters of 2 2 5 3 and 3 5 cm The applicators are reusable and sterilizable Please refer to the instruction manual This IN
11. TRABEAM applicator has CE certification and is awaiting FDA approval As of April 2012 Component Available sizes INTRABEAM Spherical Applicator 1 5 cm 2 0 cm 2 5 cm 3 0 cm 3 5 cm 4 0 cm 4 5 cm 5 0 cm diameter INTRABEAM Needle Applicator 4 4 mm diameter INTRABEAM Flat Applicator 1 0 cm 2 0 cm 3 0 cm 4 0 cm 5 0 cm 6 0 cm diameter INTRABEAM Surface Applicator 1 0 cm 2 0 cm 3 0 cm 4 0 cm diameter INTRABEAM Cylinder V Applicator 2 0 cm 2 5 cm 3 0 cm 3 5 cm diameter Components of a set m NTRABEAM Sperical m INTRABEAM Needle m NTRABEAM Flat Applicator m INTRABEAM Surface m INTRABEAM Cylinder V Applicator Applicator m INTRABEAM Position Marker Applicator Applicator m Sterilization container m Guide shaft 2x m NTRABEAM Lumen Plug m INTRABEAM Positionsmarker m INTRABEAM Cylinder V m NTRABEAM Lumen Plug Probe Guard m NTRABEAM Lumen Plug m NTRABEAM Cylinder V Dwell Stepper m NTRABEAM Cylinder V Base Plate Usage reusable single use reusable reusable reusable Anatomical Sites Any part of the human body Any part of the human body Any part of the human body Skin Vagina and surrounding tissue not intended for use on the heart or in the central circulatory system not intended for use on the heart or in the central circulatory system not intended for use on the heart or in the central circulatory system Geometry of dose distribution spherical dose distr
12. 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 emis sion is instantly interrupted automatically and can only be resumed after the interlock has been closed and continued radiation emission has been confirmed 9 3 Interlock to prevent incorrect radiation data transmission m 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 miniaturized accelerator radiation emission is stopped or not started m 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 m The ratio between the planned treatment time and the count rate is constantly monitored In the event of any deviations radiation emission is stopped 9 4 Interlock to prevent incorrect dose entry m The dose to be administered must only be pre scribed by an appropriately trained authorized doctor this is a legal requirement in most coun tries information during system training and note in the user manual m The dose is entered by one person usually a physicist and a second person who must be a
13. and sterile containers only to temperatures no higher than 141 C 286 F Use the following materials for cleaning disinfection m Filtered air for the drying process m Soft brush m Soft cloth For the Cylinder V Applicator Brush the inside of the Cylinder V Applicators and if necessary of the probe guard m Disposable syringe min 10 ml with attached long canulae For Flat Surface Cylinder V Applicator m Use the provided Lumen Plug Cleaning disinfecting agent m The disinfecting agent must be compatible with the cleaning agent used m The disinfecting agent must be suitable for the cleaning and disinfection of instruments made of metal and plastics m Rinsing with sterile or low germ maximum 10 microbes ml and lowendotoxin maximum 0 25 endotoxin units ml water e g purified water highly purified water The disinfecting agent must not contain the following m Organic mineral and oxidizing acids minimum permissible pH value 5 5 m Strong bases maximum permissible pH value 8 5 recommended neutral enzymatic cleaning agent m Organic solvents e g alcohol ether ketone benzine m Oxidants e g hydrogen peroxide m Halogens chlorine iodine bromine m Aromatic halogenated hydrocarbons Cleaning Disinfection and Sterilization of Applicators Only use the steam sterilization method fractioned vacuum method described in this manual for ster lization of the cleaned and disinfected appli
14. ation test is not possible The optical interlock enables the system to detect if the miniaturized accelerator has been correctly mounted on the INTRABEAM Floor Stand The system also detects whether the applicator has been attached correctly The miniaturized accel erator will only be enabled for radiation emission if it has been correctly mounted on the carrier system intended for it Once the miniaturized accelerator has been suc cessfully connected to the carrier system the user must follow the menu prompts on the user inter face 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 emis sion 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 verifica tion steps have been completed the dose has been verified by a password and the system has been set to the treatment mode 9 2 Interlock to prevent unintended access to the controlled area m Radiation emission is acoustically and visually indicated on the miniaturized accelerator and the user interface Persons entering the controlled area are able to obtain information on the radia tion status of the system m n addition further safety systems such as
15. cators Other procedures are not approved For steam sterilization please take the following factors into account m The steam sterilization method is validated according to DIN EN ISO 17665 1 m The maximum sterilization temperature is 138 C 280 F plus tolerance according to DIN EN ISO 17665 1 m With the fractioned vacuum method the steriliza tion time exposure time at sterilization tempera ture is at least 5 min at 132 C 270 F 134 C 273 F or for the INTRABEAM Spherical Applica tor 18 min prion inactivation Please see the user manual for detailed information on cleaning disinfection and sterilization of the applicators Th Your local contact Argentina Carl Zeiss Argentina S A Calle Nahuel Huapi 4015 25 C1430 BCO Buenos Aires Argentina Phone 54 11 45 45 66 61 bruzzi zeiss com ar Australia Carl Zeiss Pty Ltd Tenancy Office 4 Level 1 40 52 Talavera Road North Ryde NSW 2113 Australia Phone 61 2 9020 1333 med zeiss com Austria Carl Zeiss GmbH Laxenburger Str 2 1100 Vienna Austria Phone 43 1 79 51 80 austria zeiss org Belgium Carl Zeiss NV SA Ikaroslaan 49 1930 Zaventem Belgium Phone 32 2 719 39 11 info zeiss be Brazil Carl Zeiss do Brasil Ltda Av Nacoes Unidas 21711 CEP04795 100 Sao Paulo Brazil Phone 55 11 5693 5521 medbrasil zeiss org Canada Carl Zeiss Canada Ltd 45 Valleybrook Drive Toronto ON M3B 2S6 Canada Phone 1 80
16. he emitted x rays and records dose output in real time The IRM result is displayed on the treatment screen of the control terminal so that the operator knows what dose is being delivered The steep dose gradient due to rapid low kV x ray at any time throughout treatment attenuation ensures a localized dose distribution 40 kV 40 pA 50 kV 5 10 20 or 40 pA Subject to appropriate calibration Cathode Gun 30 149 E 1 Gy min W 3 Gy min W 5 Gy min E 2 Gy min 4 Gy min amp 6 Gy min o 20 E 7 Gy min 123 100 47 Accelerator Section z A 29 o E 100 z 18 80 z S 11 105 Ci 7 4 20 Source Settings 3 50 kV 40 pA 2 30 l l l l l 30 1 Beam Deflector 30 20 10 0 10 20 30 30 20 10 0 10 20 30 mm Width mm Percentage Depth Dose Curve Normalized at 10 mm 1000 Electron Beam Q Y 100 5 U lt 9 Wn oO m Gold Target 10 o m 0 5 10 15 20 25 30 35 40 45 Distance to XRS Isocentre mm 12 14 Beam characteristics of the INTRABEAM Flat Applicator 5 cm diameter The INTRABEAM Flat Applicator has an optimized flat radiation field by means of a flattening filter at 5 mm from the applicator surface 50 kV 5 10 20 or 40 uA Height mm Height mm Depth mm Ra Ee Radiation field in 0 mm depth 30 30 30 l 20 300 200 l l l l 10 0 10 20 30 Width mm Radiation field in 5 mm depth
17. ibution spherical dose distribution Flat dose distribution opti mized for tissue radiation in 5 mm distance from the applicator surface Flat dose distribution optimized for tissue radiation directly in contact with the surface Cylinder shaped dose distribution Fixation to the region of interest Guide shafts can be used for deep approach routes Fixation via INTRABEAM Position marker can be sewed or glued to the region of interest possible Fixation via INTRABEAM Position marker can be sewed or glued to the region of interest possible Fixation by use of INTRABEAM Cylinder V Base Plate 5cm 54 mm 2 13 Length mm 1 5 cm 167 5 mm 6 59 94 mm Probe length 1 0 cm 169 05 mm 6 67 1 0 cm 169 05 mm 6 67 2 0 cm 120 5 mm 47 4 2 0 cm 170 0 mm 6 69 2 0 cm 174 05 mm 6 85 2 0 cm 174 05 mm 6 85 2 5 cm 120 5 mm 47 4 2 5 cm 172 5 mm 6 79 3 0 cm 178 05 mm 7 01 3 0cm 178 05 mm 7 01 3 0 cm 120 5 mm 47 4 3 0 cm 175 0 mm 6 89 4 0 cm 181 55 mm 7 15 4 0 cm 181 55 mm 7 15 3 5 cm 120 5 mm 47 4 3 5 cm 177 5 mm 6 99 5 0 cm 184 35 mm 7 26 4 0 cm 180 0 mm 7 09 6 0 cm 185 55 mm 7 31 4 5 cm 182 5 mm 7 19 5 0 cm 185 0 mm 7 28 Inner diameter N A N A 1cm 10 mm 0 39 1 cm 10 mm 0 39 N A absorption body 2 cm 20 mm 0 79 2 cm 20 mm 0 79 3 cm 30 mm 1 18
18. l Zeiss Thailand Floor 8 Thosapol Land Building 2 230 Ratchadapisek Road Huaykwang Bangkok 10310 Thailand Phone 66 2 2 74 06 43 thailand zeiss com sg United Kingdom Carl Zeiss Ltd 15 20 Woodfield Road Welwyn Garden City Hertfordshire AL7 1JQ United Kingdom Phone 44 1707 871200 info zeiss co uk United States of America Carl Zeiss Meditec Inc 5160 Hacienda Drive Dublin CA 94568 USA Phone 1 925 557 4100 info meditec zeiss com EN_30_010_0158II Printed in Germany AW CZ V 2012 Koo The contents of the brochure may differ from the current status of approval of the product in your country Please contact our regional representative for more information Subject to change in design and scope of delivery and as a result of ongoing technical development Printed on elemental chlorine free bleached paper 2012 by Carl Zeiss Meditec AG All copyrights reserved INTRABEAM is a registered trademark of Carl Zeiss CE 0297 i pl Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany www meditec zeiss com radiotherapy L Email intrabeam meditec zeiss com
19. ndard Examples to illustrate the exposure level with INTRABEAM Example 1 Without the use of any means of external radiation protection other than covering the irradiation area appropriately with the flat INTRABEAM radiation shield 10 patients can be treated a year until an exposure dose of 1 mSv is reached at a distance of 2 m from the x ray source at a height of 1 meter Calculated based on values taken from US National Council on Radiation Protection and Measurements NCRP Structual Shielding Design for Medical X Ray Imaging Facilities Rep 147 Bethesda MD 2004 clinical procedure Measurements were taken at eight different angles relative to the isocenter of the source at a radial distance of 1 and 2 m The measurements were then repeated at 1 and 2 m above floor level Experimental set up for radiation exposure measurements with the phantom m distance 1 and 2 m height 2 m distance 1 and 2 m height Example 2 If 100 procedures per year are to be performed a distance of 2 m would need to be maintained from the public area e g the corridor to ensure that the corresponding wall and or window shields the ra diation by a factor of at least 10 This corresponds to a material with a lead equivalent of 0 05 mm at a peak energy of 50 kV such as 10 mm of concrete or 26 mm of gypsum Detailed information are available in our brochure Information on Radiation Safety 15 8 Quality Assurance and D
20. ng Jaya Selangor Darul Ehsan Malaysia Phone 60 3 7877 50 58 malaysia zeiss com sg Mexico Carl Zeiss de M xico S A de CV Avenida Miguel Angel de Quevedo 496 04010 Mexico City Mexico Phone 52 55 59 99 0200 Cz mexico zeiss org Netherlands Carl Zeiss B V Trapezium 300 Postbus 310 3364 DL Sliedrecht Netherlands Phone 31 184 43 34 00 info zeiss nl New Zealand Carl Zeiss N Z Ltd 15B Paramount Drive P O Box 121 1001 Henderson Auckland 0650 New Zealand Phone 64 9 838 5626 med zeiss com Poland Carl Zeiss sp Z 0 0 ul Lopuszanska 32 02 220 Warsaw Poland Phone 48 22 858 2343 medycyna zeiss pl Singapore Carl Zeiss Ptd Ltd 50 Kaki Bukit Place Singapore 415926 Singapore Phone 65 6741 9600 info zeiss com sg South Africa Carl Zeiss Pty Ltd 363 Oak Avenue Ferndale Randburg 2194 South Africa Phone 27 11 886 9510 info zeiss co za South Korea Carl Zeiss Co Ltd Seoul 121 828 Mapo gu 141 1 Sangsu dong 2F BR Elitel Bldg South Korea Phone 82 2 3140 2600 korea zeiss co kr Spain Carl Zeiss Meditec Iberia S A U Ronda de Poniente 15 Tres Cantos 28760 Madrid Spain Phone 34 91 203 37 00 info zeiss es Sweden Carl Zeiss AB Tegeluddsvaegen 76 10254 Stockholm Sweden Phone 46 84 59 25 00 info zeiss se Switzerland Carl Zeiss AG Feldbachstrasse 81 8714 Feldbach Switzerland Phone 41 55 254 7534 med zeiss ch Thailand Car
21. ntrol console dosimeter and all other components required 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 operat ing room The set up of the cart also ensures quick and easy cleaning before entering the OR The cart and Floor Stand can be moved through standard width doors and within elevators When in use the miniaturized accelerator is inserted in the arm of the INTRABEAM carrier The carrier can be moved smoothly to any position in the OR due to its intergral casters located in the base Weight com pensation and six axes provide enough freedom to position the miniaturized accelerator within any posi tion in three dimensional space needed for access to the treatment area Electromagnetic brakes hold the miniaturized accelerator in the exact position during treatment The operator can monitor and controls the system at any time during the treatment from the control panel on the INTRABEAM Cart System Dimensions INTRABEAM Floor Stand INTRABEAM Cart Weight 275 kg 606 Ibs Unloaden weight of cart 105 kg 231 Ibs 740 x 1940 x 1500 mm incl permanently mounted 2913 76 38 X59060 Width x height x length Transport position user terminal Payload max 95 kg 209 43 Ibs 900 x 1690 x 600 mm 3543 X 66 53 X 23 62 Width x height x length Dimensions INTRABEAM Control Unit Miniaturized
22. osimetry A full set of quality assurance and dosimetry tools is provided with the INTRABEAM The factory calibrated system is delivered with the specific depth dose curves and a reference measurement with the ion chamber integral to the system Prior to every treatment a two step quality control check ensures that all parameters such as isotropy internal radiation monitor and out put work do not exceed the tolerances defined during calibration For commissioning a completely shielded manually adjustable water phantom can be used to verity the depth dose curve Verification of the Isotropie and OE the Dose output and the Dose output 8 1 QA Check QA Tools Inside the so called PDA Photo Diode Array five diodes positioned orthogonally to each other measure the radiation of the miniaturized accelerator The objective of this test is to assure the isotropy i e spherical pattern of the emitted beam With the PAICH Probe Adjuster lon Chamber Holder the output can be checked An ion chamber is mounted onto the probe adjuster in such a way that the ion chamber window sits right above the tip of the miniaturized accelerator In this test the internal radiation monitor is verified as well The counts measured by the internal radiation monitor are compared with the reading of the ionization chamber The miniaturized accelerator is not enabled for treatment planning until a coefficient has been computed Temperature and pre
23. ssification Type B Type B Cables XRS QA C a Case protection IP20 IP20 V X Block C a Protection class Protection class Protection class INTRABEAM Water Phantom d Transportation Trays XRS 4 QA C a INTRABEAM Spherical Applicator See user manual X Sterilizable with steam INTRABEAM Needle Applicator single use sterile INTRABEAM Flat Applicator See user manual X Sterilizable with steam INTRABEAM Surface Applicator See user manual X Sterilizable with steam 10 2 Ambient requirements INTRABEAM Cylinder V Applicator See user manual X Sterilizable with steam INTRABEAM Flat Shields single use sterile Operation INTRABEAM Drapes 7 single use sterile Temperature 15 C 40 C 59 F 104 F T a 4 7 Hypochlorid b Meliseltol c wipe moist d ethyl alcohol distilled water 1 1 plus a dash of household dish washing Relative humd ity 30 75 liquid also mentioned in the detailled user manuals Air pressure 800hPa 1060 hPa Transportation and Storage Temperature 20 in TO OCT A OP se LOG Relative humdity 10 90 without condensation Air pressure 500 hPa 1060 hPa Requirements could differ for accessories Please see separate user manuals 20 The processing of the applicators was validated by Carl Zeiss using the following procedure and can therefore be processed in a sterile manner If possible clean and disinfect the applicators by machine Expose the applicators
24. ssure sensors are located within the control unit and the PAICH Pressure and temperature can be calibrated to ensure exact dose calculation 16 On site dose monitoring The three elements of quality assurance with INTRABEAM PN Independant verification of the Depth Dose Curve and the Dose Distribution Online dose monitoring 8 2 Online control through IRM An internal radiation monitor IRM detects the part of the x ray photons emitted in the direction of the cathode and records dose output in real time The IRM result is displayed on the treatment screen of the control terminal so that the operator knows what dose is being delivered at any time through out treatment Subject to appropriate calibration Independant verification of the Depth Dose Curve and the Dose distribution 8 3 Radiation protection during dosimetry Every tool provided with the INTRABEAM for quality assurance is completely self shielded and does not require any additional radiation protection 8 4 Commisioning System calibration by Carl Zeiss and with the water phantom A water phantom with a high precision movement technique enables the physicist to position the tip of the miniaturized accelerator exactly above or beside the ion chambers inside the water Accurate positioning and stepping of the source ensures the verification of the depth dose curve Even the measurement of a depth dose curve is possible
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