User Manual. OCTAVIUS Detector 729 (T10040) and Detector Interface 4000 (T16039)

Transcription

1 User Manual OCTAVIUS Detector 729 (T10040) and Contents Operating Manual Technical Manual Service Manual D /04 en Sa

2 General Information General Information The product bears the CE-mark "CE 0124" in accordance with the Council Directive 93/42/EEC about Medical Devices and fulfills the essential requirements of Annex I of this directive. The product is a class IIb device (MDD). Electrical Safety The product fully complies with the requirements of the following standards: IEC Electromagnetic compatibility The product fully complies with the requirements of the following standards: IEC The user manual is an integral part of the product. It should always be kept near the product. Observance of the manual is a prerequisite for proper product performance and correct operation. Operator safety, specified measuring accuracy, and interference-free operation can only be guaranteed if original products and parts are used. Furthermore, only the accessories listed in this manual are approved by PTW-Freiburg and only they or other accessories whose use has been expressly permitted by PTW-Freiburg may be used in conjunction with the product. Safe operation and proper product performance are not guaranteed if accessories or consumables from other manufacturers are used. PTW-Freiburg cannot be held liable for damage resulting from the use of accessories or consumables from other manufacturers or when the user ignores the instructions and information given in this manual. The warranty period is 1 (one) year and begins on the day of delivery. It is unaffected by repairs covered by the warranty regulations. PTW-Freiburg only considers itself responsible for the safety, reliability, and performance of the product if the assembly, extension, readjustment, modification, or repair is carried out by PTW-Freiburg or by persons authorized by PTW-Freiburg, and if the product is used in compliance with the technical documentation. In case of any questions concerning the service, support, or warranty, please contact your supplier. This manual is in conformity with the product specifications and all applicable safety standards that are valid as at the printing date. All rights are reserved for devices, circuits, techniques, software, and names as referred to in the manual. PTW-Freiburg reserves the right to make modifications. Please contact PTW or your local representative for the most current information concerning the products of interest. No part of the technical documentation may be reproduced without written permission from PTW-Freiburg. PTW-Freiburg is a registered manufacturer according to the ElektroG (Elektro- und Elektronikgeräte-Gesetz). Elektro-Altgeräte-Register (EAR). Registration number DE PTW-Freiburg works in strict accordance with a quality management system that is continuously updated according to the national and international standards. 2 D /04 en

3 General Information PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH Lörracher Str FREIBURG Germany Tel.: Fax: info@ptw.de D /04 en 3

4 Table of Contents Table of Contents General Information...2 Table of Contents... 4 List of Figures...5 Intended Use... 6 Safety Information... 8 Operating Manual Equipment Description OCTAVIUS Detector Detector Interface Installation and Start-up Calibration System Installation Measurement Setup Trigger Measurement Accessories BQ-CHECK Energy Test Phantom T Technical Manual Technical Specifications OCTAVIUS Detector 729 T BQ-CHECK Energy Test Phantom T Accessories and Spare Parts D /04 en

5 List of Figures Service Manual Cleaning Preventive Maintenance Fuses Disposal of the Product Literature...44 Appendix: China Electronic Industry Standard Compliance 附录 : 中华人民共和国电子产业标准...45 Index...47 List of Figures Figure 1: OCTAVIUS Detector Figure 2: Detector Interface Figure 3: BQ-CHECK energy test phantom T Figure 4: Definition of the patient environment...13 Figure 5: OCTAVIUS Detector Figure 6: Front view of the Detector Interface Figure 7: Rear view of the Detector Interface Figure 8: Components and installation of the measuring system Figure 9: Design of BQ-CHECK...27 Figure 10: Block diagram of external trigger input Figure 11: Block diagram of the internal trigger generation Figure 12: Unlocking the fuse holder...42 D /04 en 5

6 Intended Use - Components of the System Intended Use The OCTAVIUS Detector 729 (T10040) and the are designed for the following uses: Constancy check of medical linear accelerators: Measure symmetry, flatness, central axis dose, check the beam quality Online beam data analysis: Measure a radiation field online for beam data analysis IMRT patient plan verification: Measure field data for IMRT patient plan verification Components of the System The measuring system consists of the following components: OCTAVIUS Detector 729 T10040 Detector Interface 4000 T16039 Network cable with a length of 25 m L RS232 cable with a length of 20 m T22373/K67-20 BeamAdjust software S The product is designed for use with medical linear accelerators (LINAC), but it can also be used with other medical treatment machines designed for similar applications. These treatment machines employ a different technical principle (e.g., Co-60 source or circular accelerators). We will refer to the OCTAVIUS Detector 729 as detector array and to the Detector Interface 4000 as detector interface in this document. Note: In the United States, federal law restricts this device to sale by or on the order of a physician. Figure 1: OCTAVIUS Detector 729 Figure 2: Detector Interface D /04 en

7 Intended Use - Accessories Accessories BQ-CHECK Energy Test Phantom T42030: Phantom for constancy checks of the photon and electron energy of medical linear accelerators In the text below, the BQ-CHECK energy test phantom will be referred to as BQ-CHECK. Figure 3: BQ-CHECK energy test phantom T42030 For more information about using the accessories, refer to section 3 "Accessories". D /04 en 7

8 Safety Information Safety Information This is the safety alert symbol. It is used to alert the user to potential hazards. Obey all safety messages that follow this symbol to avoid any possible bodily injury or equipment damage. All safety messages consist of the following components: Safety alert symbol and signal word Type of danger Source of danger Consequence Measures to prevent hazards. Signal Words DANGER Indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury. WARNING Indicates a hazard. If not avoided, the hazard can result in death or serious injury. CAUTION Indicates a potential hazard. If not avoided, the hazard can result in minor or moderate injury. NOTICE Indicates a potential hazard. If not avoided, the hazard can result in product damage. HINT Provides application tips or other useful information to ensure that you get the most from your equipment. 8 D /04 en

9 Safety Information Safety Information Strictly observe the following safety information concerning the signal words DANGER and WARNING. Failure to do so endangers the lives of the patient, user, and other persons involved. DANGER Operation in areas where an explosion may occur or in oxygen-enriched atmospheres. Explosion Hazard! Do not operate the product in areas of risk where an explosion may occur. Explosion hazards may be caused, for example, by the use of combustible anesthetics, skin-cleansing agents, and disinfectants. Do not operate the product in oxygenenriched atmospheres. The atmosphere is considered to be oxygen-enriched when more than 25 % of oxygen or nitrous oxide is added to the ambient air. DANGER Electricity is a source of risk, particularly when the product is not in perfect operating condition or when it is operated inappropriately. Shock Hazard! Before using the product, verify that it is in correct working order and operating condition. DANGER Electricity is a source of risk, particularly when the product is not in perfect operating condition or when it is operated inappropriately. Shock Hazard! To disconnect the product from the power line, first remove the plug from the wall outlet. After that, disconnect the cable from the product. Switch on products on which moisture condensation has developed as a result of temperature changes only after they are completely dry. Liquids must not enter the product. If liquids have entered the product, dry the product or wait for it to dry completely. The product must be thoroughly inspected by service personnel before being used again. The product is a device of IEC protection class I. Connect the product only to a properly installed power outlet with earthing contact. Do not use extension cords. Connect all devices of a system to the same electric circuit. Devices that are not connected to the same circuit must be electrically isolated (use RS232 interface with galvanic insulation). Before putting the product into operation, inspect all connection cables, connectors, housing, and covers for signs of damage. Replace damaged cables and connectors immediately. D /04 en 9

10 Safety Information DANGER Electricity is a source of risk, particularly when the product is operated inappropriately. Shock Hazard! Exclusion of operation in the patient environment: Do not operate the product nor any peripheral devices in the patient environment (see Figure 4). Exclusion of operation with patient contact: The product is not intended for use in direct contact with the patient. Ensure that neither the product nor any peripheral devices come into contact with the patient. DANGER Electricity is a source of risk, particularly when the product is operated inappropriately. Shock Hazard! Use of peripheral devices: Connect only peripheral devices (PC, printer) that meet the requirements of the standard IEC (UL ) or the standard IEC Connect devices to other devices or to parts of systems only if it has been ascertained that this connection does not impair the safety of the patient, the operator, or the environment. If the device specifications do not contain information regarding the connection of the device to other equipment, consult, for example, the manufacturers of the other equipment or other informed experts to verify that the connection does not impair the safety of the patient, operator, or environment. Always observe the standard IEC D /04 en

11 Safety Information WARNING Improper handling. Hazards to Persons! The product is a medical device and must only be handled by persons who are trained in the use of such equipment and are capable of applying it properly. The operator must be trained in the use and operation of the product. WARNING Magnetic and electrical fields are capable of interfering with the proper performance of the product. Product Failure! When operating the product, make sure that all external devices operated in its vicinity comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems, cell phones, etc. are possible sources of disturbance as they may emit higher levels of electromagnetic radiation. Keep the product away from these devices and verify its performance before use. Do not use cables longer than specified. This might impair the electromagnetic compatibility characteristics of the product. Do not use the product in the immediate vicinity or placed on top of or below other equipment. However, if the application requires an arrangement of devices as described above, the product should be monitored in order to ensure its proper functioning in the specific arrangement. WARNING Radiation is a source of risk, particularly when the product is operated inappropriately. Risks to Persons! Exclusion of operation as a controlling instrument: Use the product as a measuring device only. Do not use measuring results to control an equipment that produces radiation, e.g., a radiodiagnostic equipment or a radiotherapy unit. WARNING The product may adversely affect the data transmission of other clients in the network. Network Problem! When operated via the Ethernet interface, connect the product to data networks only if these networks do not determine the safety of the patient, the operator, or other persons present, i.e., only to class A networks as defined in Annex H of IEC : Ensure that only system administrators who are capable of understanding, assessing, and controlling the risk arising from the connection of the product to the data network establish the connection. Furthermore, ensure that any future risk resulting from changes to the data network (e.g., connection of devices affecting the system safety or changes to the network configuration, etc.) will be understood, assessed, and controlled. Make sure that the product is used in an electromagnetic environment as described in IEC D /04 en 11

12 Safety Information WARNING Application for uses other than those stated in the user manual. Bodily Injury! Equipment Damage! Always apply the product in compliance with its intended use. Failure to do so may lead to severe or even fatal injuries and/or equipment damage and may void the warranty. WARNING Hazards originating from other system components. Hazards to Persons! Equipment Damage! Observe the safety information provided in the user manuals of the system components. CAUTION Use of the product without observing the user manual. Bodily Injury! Equipment Damage! Always use the product in compliance with the user manual. Otherwise, the provided protection may be impaired. Use the product only in conjunction with the products approved by PTW for this purpose and/or the products listed in the section "Intended Use". Use the product within the rated range of use as indicted in the section "Technical Specifications". Before connecting the product to the power line, make sure that line voltage and frequency are equivalent to the ratings indicated on the nameplate of the product. Handle the product with care. 12 D /04 en

13 Safety Information NOTICE To avoid damage to the cables and connectors, observe the following points: Do not kink the cables. Observe the stated minimum bend radius of the cables. Never exert pressure on the cables. Do not step on the cables. Do not roll trolleys over the cables. Do not pull or twist the cables. Disconnect the cables from the devices during transport and when the devices are not in use. Do not let the cables hang down unrestrained. The connectors must always be clean. Do not allow connectors to lie on the floor. Always protect connectors when pulling them through cable conduits. HINT Observe the user manuals of all connected devices! HINT Set up the device so that the operator has a clear, unobstructed view of the indicators and controls and can operate the controls easily. HINT Set up the product so that the disconnecting device is easily accessible. Figure 4: Definition of the patient environment D /04 en 13

14 Safety Information Symbols on the Nameplate Symbol Description Refer to the user manual! Refer to the user manual! The product bears the CE-mark. Manufacturer and date of manufacture Reference number Serial number Separate collection for electrical and electronic equipment! (refer also to the section "Disposal of the Product") Labeling according to "Administration on the Control of the Pollution caused by Electronic Information Products (ACPEIP)" (China RoHS) (refer also to the "Appendix") For a description of additional symbols, if applicable, please refer to the equipment description. 14 D /04 en

15 Operating Manual - Equipment Description Operating Manual 1 Equipment Description Together, the detector array and the detector interface form a multi-channel dosemeter for measuring dose and dose rate in radiotherapy. These devices were designed following the standard IEC The detector interface is the interface between the detector array and the appropriate measuring or analysis software on a PC. The associated BeamAdjust software is used for measuring data acquisition and measuring data analysis (refer to the BeamAdjust user manual). The BeamAdjust software is included in the delivery. For the constancy check and IMRT patient plan verification applications, optional analysis software (such as MultiCheck or VeriSoft) is required. 1.1 OCTAVIUS Detector 729 The OCTAVIUS Detector 729 is a two-dimensional detector array with 729 (27 x 27) vented ionization chambers. The arrangement of the ionization chambers allows performing the following tasks: measuring dose distributions measuring profiles in the Gun-Target and Left- Right directions measuring diagonal profiles checking the congruence of light and radiation fields for any field size checking the leaf positions for any field sizes D /04 en 15

16 OCTAVIUS Detector 729 (T10040) and Operating Manual - Equipment Description Figure 5: OCTAVIUS Detector 729 Elements Symbol 1 Area of ionization chambers (27 cm x 27 cm) 2 Electronics area 3 Position of ionization chambers 4 Mark for use in the rotation unit of the OCTAVIUS 4D system The nameplate is located on the back of the detector array. 16 D /04 en

17 Operating Manual - Equipment Description 1.2 Detector Interface 4000 Figure 6: Front view of the Detector Interface 4000 Indicators and operating controls 1 Power LED (LED illuminated = device is switched on) Symbol I D /04 en 17

18 Operating Manual - Equipment Description Figure 7: Rear view of the Detector Interface 4000 Indicators and operating controls 1 Connector for one of the following detector arrays: OCTAVIUS Detector 1000 SRS OCTAVIUS Detector 1500 Symbol DETECTOR ARRAY Do not use this connector when a detector array is connected at connector 7. 2 Trigger input (connecting system BNC) TRIGGER IN 3 Trigger input (connecting system BNT) TRIGGER IN 4 Main switch O 5 Power line fuses 2 x T 315 mal, 250V 6 Power supply required mains voltage 7 Connector for one of the following detector arrays: OCTAVIUS Detector 729 OCTAVIUS Detector 729 XDR STARCHECK STARCHECK maxi ( ) V~ DETECTOR ARRAY Do not use this connector when a detector array is connected at connector D /04 en

19 Operating Manual - Equipment Description 8 Ethernet port; using the Ethernet port is possible with BeamAdjust software version 1.5 or higher 9 Cover for the protection of the trigger input 3 (connecting system BNT) 10 Serial port; using the serial port is possible with all BeamAdjust software versions I O I O I The nameplate is located on the side of the detector interface. WARNING The product may adversely affect the data transmission of other clients in the network. Network Problem! Via the Ethernet interface, the product may be connected to data networks only if these networks do not determine the safety of the patient, the operator, or other persons present, i.e., only to class A networks as defined in Annex H of IEC : Only system administrators who are capable of understanding, assessing, and controlling the risk arising from the connection of the product to the data network are authorized to establish the connection. It must also be ensured that any future risk resulting from changes to the data network (e.g., connection of devices affecting the system safety or changes to the network configuration, etc.) will be understood, assessed, and controlled. D /04 en 19

20 Operating Manual - Installation and Start-up 2 Installation and Start-up 2.1 Calibration The chambers and amplifiers of the detector array are manufactured with very high precision. A change of the response of the chambers is not to be expected. If required, the calibration can be verified by means of the PTW software ArrayCal. If problems occur nevertheless, the detector array has to be sent to PTW for relative calibration. During installation of the respective software (e.g., BeamAdjust) the calibration file of the detector array (*.cal) delivered on the installation CD is copied into the appropriate directory. After the first start of the software, make sure that this file is selected in the options for the measurement (refer to the software user manual). In the PTW lab, the detector array undergoes a relative calibration at 60 Co. With this calibration, the response of each chamber is adjusted to the response of the center chamber of the detector array. The calibration data are saved in a calibration file. The chamber to chamber variation of the response is less than ± 1 % when using the supplied calibration file. Absolute dose measurements are only possible after a cross-calibration against an absolute dosemeter. The user is responsible for this cross-calibration. The cross-calibration is used to determine a correction factor for the center chamber. This correction factor is valid for all channels of the detector array, however, only in combination with the calibration file. PTW recommends performing the cross-calibration with a field size matching the field size of the application. 20 D /04 en

21 Operating Manual - Installation and Start-up 2.2 System Installation NOTICE To avoid damage to the cables and connectors, observe the following points: Do not kink the cables. Observe the stated minimum bend radius of the cables. Never exert pressure on the cables. Do not step on the cables. Do not roll trolleys over the cables. Do not pull or twist the cables. Disconnect the cables from the devices during transport and when the devices are not in use. Do not let the cables hang down unrestrained. Connect all cables according to Figure 8. PTW recommends the connection via the network. Connect the detector interface to the power supply. Turn on the detector interface with the main switch on the back of the device. In the measuring or analysis software, select the desired connection for data transfer. For this, please refer to the software user manual. The connectors must always be clean. Do not allow connectors to lie on the floor. Always protect connectors when pulling them through cable conduits. NOTICE To avoid equipment damage due to unsuitable positioning of the connection cable, pay attention to the cable connection between the detector array and the detector interface while rotating the gantry, especially if you use an SC Holding Device. D /04 en 21

22 Operating Manual - Installation and Start-up Control room Radiation protection wall Treatment room PC Power supply RS232 cable or Ethernet cable PTW Detector interface PTW Detector array Figure 8: Components and installation of the measuring system 22 D /04 en

23 Operating Manual - Installation and Start-up 2.3 Measurement Setup CAUTION Insufficient temperature equalization. Measuring Error! The stabilization time of 15 min is only valid for devices and build-up material whose temperature is similar to the ambient temperature. If devices and build-up material have a different temperature (e.g., after storage in a cool room), wait until the temperature in the devices and the build-up material has adapted to the ambient temperature. In case of a high difference in temperature and large mass (e.g., OCTAVIUS phantom) this can take several hours. Insufficient temperature equalization leads to a zero drift (offset), i.e. to erroneous measuring results. Furthermore, the air density correction of the measuring results is faulty. NOTICE To avoid equipment damage from direct radiation, irradiate only the area marked on the detector array, which identifies the location of the ionization chambers. Do not irradiate any other part of the detector array because the electronic equipment underneath may be damaged. The detector array is suitable for use with field sizes up to 27 cm x 27 cm. To extend the service life of the detector array and reduce the risk of damage to electronic components from radiation, PTW recommends observing the following guidelines: Perform LINAC QA at field sizes not larger than 20 cm x 20 cm or 25 cm x 25 cm. This applies to radiation qualities greater than 6 MV in particular. Pre-irradiate the detector array at the minimum energy, exposing it to a dose not greater than the recommended dose. Preirradiate only the area of the detector array's ionization chambers that is needed for the measurement. D /04 en 23

24 Operating Manual - Installation and Start-up NOTICE To avoid equipment damage from scattered radiation, avoid measurements involving large fields and much build-up material. The ratio of scattered radiation outside the irradiated area increases with the field size and the thickness of build-up material on the detector array. As a result the electronic components of the detector array will be exposed to increased scattered radiation. If this happens over a longer period, the lifetime of the detector array can be reduced. NOTICE To avoid equipment damage, do not use the detector array for measurements in water. This would destroy the detector array. HINT A zero measurement is recommended after each power up of the detector interface (refer to the user manual of the measuring software, e.g., BeamAdjust). Observe the stabilization time of 15 min. Place the detector array on at least 3 cm of backscatter material. Position the detector array on the treatment table. Observe the gun/target orientation indicated on the detector array. Using the position lasers and the light field indicator, adjust the detector array to the desired SSD (source surface distance, usually cm). If you intend to check the leaf positions, make sure the projection of the leaves in the isocenter matches the chamber rows of the detector array. For MLC QA with MultiCheck, it is recommended to use the SC Holding Device T41021 together with the holder for a detector array T to minimize setup inaccuracy. With the SC Holding Device T41021, the detector array can be moved with the gantry. 24 D /04 en

25 Operating Manual - Installation and Start-up HINT Measurements have to be performed with a PTW measuring software (e.g., BeamAdjust). For further information, please refer to the appropriate user manual. HINT In case of communication problems: PTW recommends the connection with a network cable. In case of communication via an RS 232 connection, some of the interval times may not be available due to the amount of data. In this situation, the PTW measuring software will display an appropriate error message. When long RS232 cables (> 20 m) are used, communication problems can occur with some PCs at a high baud rate (115200). The use of an USB-RS232 converter (for example LINDY USB-RS232 converter) may improve the communication in this case. If the software shows a communication disturbance, it may not be possible to reactive the connection. In order to remedy the disturbance, a shorter cable link must be chosen temporarily. In some cases, a different RS232 interface helps, if available, or the use of an USB-RS232 converter Application Patient Plan Verification The VeriSoft software is needed for patient plan verification. For this, you can use the detector array in one of the following ways: Use the detector array in a 30 cm x 30 cm slab phantom on the treatment table. The typical assembly consists of 3 cm of back scattering material and 5 cm of build-up material. Irradiate the detector array with a gantry angle of 0. Use the detector array in an OCTAVIUS phantom T40054 on the treatment table. Use the detector array with the SC Holding Device. In this case, the detector array can be rotated together with the LINAC gantry. Through this, the irradiation is always carried out perpendicular to the chamber plane in spite of the rotating gantry. For 4D patient plan verification, insert the detector array in the OCTAVIUS Rotation Unit. The rotation unit will be rotated according to the gantry angle, ensuring perpendicular incidence of the radiation beam on the detector array at all times. The software VeriSoft 5.0 or higher is required for this purpose. For detailed information on patient plan verification, please refer to the VeriSoft user manual. D /04 en 25

26 Operating Manual - Installation and Start-up Application LINAC QA The MultiCheck software is needed for LINAC QA applications. For LINAC QA, you can use the detector array in one of the following ways: Use the detector array in a 30 cm x 30 cm slab phantom on the treatment table. For constancy checks, the thickness of the back scattering and build-up material used is irrelevant. Be sure to always use the same scattering conditions. Use the detector array with the SC Holding Device. In this case the detector array can be rotated together with the LINAC gantry. This allows the verification of test parameters at different gantry angles. For detailed information on LINAC QA, please refer to the MultiCheck user manual. 2.4 Trigger Measurement In case of low pulse repetition rates, an interference (beat) can occur between the measuring intervals and the pulses of the linear accelerator. In the dose distribution, these will be represented as cycling waves or break-ins. In this case you can trigger the measurement by single pulses of the linear accelerator. The triggering ensures that the same number of pulses is considered in each measuring interval. Triggering can be done in one of the following ways: 1. Triggering via an external signal of the linear accelerator: For this, connect the trigger signal cable of the linear accelerator to the BNC connector of the detector interface (refer to Figure 7, item 2 and Figure 10). 2. Generation of a trigger signal via a semiconductor detector: For this, connect a semiconductor detector (e.g., a Dosimetry Diode P TN60016) to the BNT connector of the detector interface (refer to Figure 7, item 3 and Figure 11). Position the semiconductor detector in the radiation field. In the detector interface, the detector signal will be used to generate an internal trigger signal. 26 D /04 en

27 Operating Manual - Accessories 3 Accessories 3.1 BQ-CHECK Energy Test Phantom T Description of BQ-CHECK Figure 9: Design of BQ-CHECK 1 Frame 2 Aluminum wedge (2 pieces) 3 Copper wedge D /04 en 27

28 Operating Manual - Accessories Usage of BQ-CHECK Attach BQ-CHECK to the detector array: The GUN and TARGET marks on BQ-CHECK have to match the marks on the detector array. BQ-CHECK must be aligned on the detector array as accurately as possible. The exact positioning can be checked by means of the outer edges of the phantom. If BQ-CHECK is aligned correctly, three sides are congruent and you cannot feel any edge between BQ-CHECK and the detector array. Position both devices together on the treatment table. Observe the gun/target orientation indicated on the detector array or on BQ-CHECK. Place the detector array at the isocenter of the linear accelerator. For this, use the room lasers and the crosshairs on the sides of detector array. At the linear accelerator, adjust the radiation quality to check. Deliver the field. The measurement and the analysis is done by means of the PTW software MultiCheck. HINT Please observe the user manual of MultiCheck. 28 D /04 en

29 Technical Manual - Technical Specifications Technical Manual 4 Technical Specifications Only values with specified tolerances or limits are guaranteed. Values without tolerances are for informational purposes only. 4.1 OCTAVIUS Detector 729 T10040 Device designation OCTAVIUS Detector 729 T10040 detector array for dose measurement with Detector Interface 4000 T16039 Manufacturer PTW-Freiburg Intended use constancy check of medical linear accelerators online beam data analysis IMRT patient plan verification Mode of operation continuous operation Electrical safety IEC Protection class Overvoltage category Electromagnetic compatibility Measured quantities Measuring modes Chamber voltage I II suitable for operation in a basic electromagnetic environment according to IEC absorbed dose to water [Gy], absorbed dose rate to water [Gy/min] dose, dose rate V D /04 en 29

30 Technical Manual - Technical Specifications Device designation OCTAVIUS Detector 729 T10040 detector array for dose measurement with Detector Interface 4000 T16039 Measuring range Dose rate Measuring range Low Measuring range High Dose Measuring range Low Measuring range High Resolution with BeamAdjust Dose rate Dose Characteristics of the ionization chambers (irrespective of the measuring circuit) Maximum dose rate for continuous irradiation Maximum dose per irradiation pulse Ion collection time Polarity effect Energy response (refrred to 60 Co) 800 ms intervals ( ) Gy/min 400 ms intervals ( ) Gy/min 200 ms intervals ( ) Gy/min Fast mode (100 ms intervals) ( ) Gy/min 800 ms intervals ( ) Gy/min 400 ms intervals ( ) Gy/min 200 ms intervals ( ) Gy/min Fast mode (100 ms intervals) ( ) Gy/min 100 mgy up to max. display 200 mgy up to max. display 0.1 mgy/min 0.1 mgy > 1 Gy/s (for 99.0 % saturation) approx mgy (for 99.0 % saturation) 156 μs polarity reversal not possible 6 MV: 2 % 18 MV: 5 % Humidity dependence variation of response ± 0.5 % Repeatability ± 0.5 % acc. to IEC Zero drift (offset current) (measuring range Low, interval 400 ms) Zero adjustment center chamber: 1 mgy/min maximum of all chambers: 2 mgy/min software controlled Non-linearity of dose and dose rate ± 0.5 % acc. to IEC Deviation by changing the range ± 0.5 % (after electrical calibration) 30 D /04 en

31 Technical Manual - Technical Specifications Device designation OCTAVIUS Detector 729 T10040 detector array for dose measurement with Detector Interface 4000 T16039 Pre-irradiation (recommended) (area of ionization chambers) Stabilization time To be able to perform highly accurate measurements, the ionization chambers should be irradiated with 3 Gy. Then the variation of response will be 1 % (referred to the steady-state condition). The electrical response after 15 min, 2 h, and 6 h differs by less than ± 0.5 % from the value after 1 h. Post irradiation leakage After 10 min of irradiation with 60 Co, the signal drops to 1 % within < 5 s. Long-term stability Effect of electromagnetic disturbances Dead time Dimensions Detector array Detector interface Weight Detector array with cable Detector interface without cable Fuse ± 1 % per year ± 1 % of the lower limit of the measuring range according to IEC none 22 mm 300 mm 420 mm 80 mm 250 mm 310 mm 5.4 kg 2.4 kg 2 x T 315 mal, 250 V Power supply ( ) VAC -15 % / +10 % (70-40) ma (50 / 60) Hz Power consumption Recalibration Ionization chamber array Detector type Number of ionization chambers Arrangement Chamber size Chamber volume Effective measuring point Area density above the chamber volume approx. 15 W 2 year intervals recommended vented ionization chamber 729 matrix of 27 x 27 chambers (10 mm center to center) 5 mm x 5 mm x 5 mm cm³ 7.5 mm below surface of detector array marked by crosshairs on the sides of the detector array 0.6 g/cm² D /04 en 31

32 Technical Manual - Technical Specifications Device designation Rated range of use Dose rate (for dose measurement) Energy Field size Temperature Relative humidity Atmospheric pressure Maximum operating altitude Reference conditions for Temperature Relative humidity Scattered radiation Environmental conditions for transport and storage Temperature Relative humidity Atmospheric pressure Connecting systems OCTAVIUS Detector 729 T10040 detector array for dose measurement with Detector Interface 4000 T16039 refer to measuring ranges dose rate 60 Co 25 MV 2 cm x 2 cm 27 cm x 27 cm ( ) C ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa 3000 m above sea level +20 C 50 % 0 μsv/h ( ) C ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa Sub-D connector, 25-pole 32 D /04 en

33 Technical Manual - Technical Specifications Trigger Inputs External Trigger Connecting system BNC connector Polarity of the trigger voltage positive or negative referred to outer shield (housing) Galvanic insulation no Minimum trigger voltage ± 2.5 V Maximum trigger voltage ± 25.0 V Minimum pulse duration 2.5 µs Figure 10: Block diagram of external trigger input D /04 en 33

34 Technical Manual - Technical Specifications Internal Trigger Generation via Semiconductor Detector Connecting systems BNT connector Compatible detectors semiconductor detectors, e.g., dosimetry diode P TN60016 Polarity of the trigger current positive referred to inner shield Galvanic insulation no Minimum charge / pulse 300 fc Minimum pulse duration 1 µs Maximum pulse duration 30 µs Figure 11: Block diagram of the internal trigger generation 34 D /04 en

35 Technical Manual - Technical Specifications 4.2 BQ-CHECK Energy Test Phantom T42030 Device designation Manufacturer Intended use Material Frame Absorber Dimensions Weight Rated range of use of the radiation qualities for OCTAVIUS Detector 729 Photons Electrons Environmental conditions for transport and storage Temperature Relative humidity Atmospheric pressure BQ-CHECK energy test phantom, Type T42030 PTW-Freiburg constancy check of the photon and electron energy of medical linear accelerators aluminum copper wedge (1 piece) and aluminum wedge (2 pieces) on the diagonals 300 mm x 300 mm x 45 mm approx. 2.8 kg ( ) MV ( ) MeV ( ) C ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa D /04 en 35

36 Technical Manual - Accessories and Spare Parts 5 Accessories and Spare Parts OCTAVIUS Detector 729 The set consists of: OCTAVIUS Detector 729 Detector interface 4000 Network cable, 25 m RS232 cable, 20 m Carrying case for measuring system BeamAdjust software L T10040 T16039 L T22373/K67-20 T S Accessories OCTAVIUS Rotation unit for 4D dosimetry with an OCTAVIUS detector OCTAVIUS phantom octagonal phantom for use of the OCTAVIUS detector 729 for IMAT and Tomotherapy Positioning device for precise adjustment of detector arrays SC Holding Device for isocentric fixation of measuring devices on a collimator SC Mounting Plate for detector arrays BQ-CHECK energy test phantom for constancy check of the photon and electron energy of medical linear accelerators Converter USB-RS232 to connect PTW devices to a USB port of the PC via the RS232 interface Software MultiCheck for constancy checks on LINACs Software VeriSoft for patient plan verification L T40054 T40049 T41021 T T42030 L S S D /04 en

37 Technical Manual - Accessories and Spare Parts Spare parts Fuse T 315 mal, 250 V L D /04 en 37

38 Technical Manual - Accessories and Spare Parts 38 D /04 en

39 Service Manual - Cleaning Service Manual WARNING Improper execution of service tasks. Hazards to Persons! Equipment Damage! Ensure that the service tasks described below are only performed by specialized staff. In addition, ensure that all other service tasks are only performed by PTW-Freiburg or by a person authorized by PTW-Freiburg. 6 Cleaning General Information on Cleaning DANGER Liquids have entered the product. Shock Hazard! Erroneous Measurements! Have the product inspected by service personnel before putting it into service again. NOTICE To avoid surface damage, do not use disinfectants on a phenol base or peroxide compounds to disinfect the surface. The product cannot be sterilized or completely disinfected. Clean the product simply by wiping it down with a dry or slightly moistened cloth. Use water or a mild soap solution. Alternatively, you can use a common disinfection agent for medical instruments which is specified in the list of disinfectants of your national hygiene institute (e.g., VAH in Germany). If your country does not provide such a list, we recommend either a solution on an aldehyde base or a solution with a quaternary ammonium compound. D /04 en 39

40 Service Manual - Preventive Maintenance Surfaces Turn the detector interface off and disconnect it from the power line before you start cleaning the device surface. Wipe the product down. Liquids must not be allowed to enter the product. Do not spray liquids onto the product and connectors. The connector contacts must be kept clean and dry. Connection Cables Clean the cables as described below: Disconnect the cables from the devices (always pull on the connectors, not on the cables!). Wipe the cables down. 7 Preventive Maintenance Below, you will find a list of the maintenance measures and inspections necessary for the product. Check before each use Before each use, visually inspect the product and cables for signs of mechanical damage. If damage or malfunctions are identified, the product must be repaired before it is used again. Repair Repairs may only be carried out by PTW-Freiburg or by persons/companies authorized by PTW- Freiburg. Do not immerse the cables in liquids! Connectors NOTICE To avoid equipment damage, do not immerse the connectors in liquids. Liquids must not be allowed to enter the connectors. The connectors must always be clean. Use a soft brush to remove dust (do not blow onto the connector!). 40 D /04 en

41 Service Manual - Preventive Maintenance Safety Inspections Only regularly inspected products are fail-safe. To preserve the functional security and operational safety, a safety inspection is to be executed at regular intervals according to the national regulations. These inspections must only be performed by independent persons with adequate training and experience. Calibration The exact calibration factor and supplementary data are included in the calibration certificate. The product should be recalibrated at a dose rate typical for the application. It is recommended to have the product calibrated every 2 years at PTW-Freiburg or by specially trained staff on site. It is recommended to execute the safety inspections every 2 years. Technical Inspection of the Measuring System The product must be inspected at regular intervals according to the national regulations. It is recommended to perform technical inspections of the measuring system every 2 years at PTW-Freiburg or a qualified calibration laboratory. Inspections must also be performed after repairs or after each influence that may have changed the behavior of the product. D /04 en 41

42 Service Manual - Fuses 8 Fuses The detector interface uses 2 microfuses that are accessible from the back of the device. To replace the fuses proceed as follows: Switch the detector interface off and disconnect the power cord from the power line. Disconnect the power cord from the detector interface. Lift the locking clip on the fuse holder, using a small screwdriver, and remove the fuse holder. Replace the fuses. Reinsert the fuse holder and reconnect the power cord. Figure 12: Unlocking the fuse holder 42 D /04 en

43 Service Manual - Disposal of the Product 9 Disposal of the Product The typical lifetime of the product is approx. 10 years. At the end of the product lifetime, the components of the product must be disposed of in compliance with the applicable waste control regulations. The different materials must be separated and recycled as appropriate. The electronic components must be recycled according to the local regulations. The product does not contain hazardous materials. D /04 en 43

44 Literature Literature [1] Council Directive 93/42/EEC concerning medical devices (Medical Device Directive - MDD) [2] Council Directive 97/43/EURATOM on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure [3] IEC Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirement [4] IEC Medical electrical equipment - Part 1: General requirements for basic safety and essential performance [5] IEC Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements [6] IEC Protection against electric shock - Common aspects for installation and equipment [7] IEC Information technology equipment - Safety - Part 1: General requirements 44 D /04 en

45 Appendix: China Electronic Industry Standard Compliance 附录 : 中华人民共和国电子产业标准 Appendix: China Electronic Industry Standard Compliance 附录 : 中华人民共和国电子产业标准 This Supplement concerns China Electronic Industry Standard Compliance 此附录涉及中华人民共和国电子产业标准的相关规定 The following product pollution control information is provided according to SJ/T Marking for Control of Pollution caused by Electronic Information Products. 根据 SJ/T 标准规定的 电子信息产品污染控制标识要求 特提供以下有关产品污染控制方面的信息 1. Explanation of Pollution Control Label 污染控制标识说明 This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ/T Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products. The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is "Year". In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual, and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly. Consumables or certain parts may have their own label with an EFUP value less than the product. Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures. This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning. 该标识表明本产品含有的有毒有害物质超出 SJ/T 标准规定的 电子信息产品中有毒有害物质的限量要求 标识中的数字为本产品的环保使用期限 (EFUP), 表明在正常使用的条件下, 电子信息产品内含的有毒有害物质或元素不会发生外泄或突变, 用户使用该电子信息产品不会对环境造成任何严重污染或对人身 财产造成任何严重损害的期限 单位为年 为保证所声明的环保使用期限, 应按产品手册中所规定的指示和环境条件进行正常使用, 并严格遵守产品维护程序中规定的定期维护和保养日程 产品中的耗件或某些零部件可能具有单独的标识, 其环保使用期限有可能短于产品本身的环保使用期限 应按产品维护程序定期更换这些耗件或零部件, 以保证所声明的整个产品的环保使用期限 本产品在使用寿命结束后不可作为普通生活垃圾处理, 必须另行收集并作妥善处理 D /04 en 45

46 Appendix: China Electronic Industry Standard Compliance 附录 : 中华人民共和国电子产业标准 2. Name and Concentration of Hazardous Substances 有毒有害物质的名称及含量 Table 1 - Hazardous substances name and concentration. 表 1 - 有毒有害物质的名称及含量 Component Name 部件名称 Hazardous substances name 有毒有害物质的名称 (Pb) ( 铅 ) (Hg) ( 汞 ) (Cd) ( 镉 ) (Cr(VI)) ( 六价铬 ) PBB) ( 多溴联苯 ) (PBDE) ( 多溴二苯醚 ) T10040, T16039 X O X X X X O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in SJ/T X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in SJ/T Data listed in the table represents best information available at the time of publication. This table shows where these substances may be found in the supply chain of PTW electronic information products, as of the date of sale of the enclosed product. Note that some of the component types listed above may or may not be a part of the enclosed product. O: 表示该有毒有害物质在该部件所有均质材料中的含量均在 SJ/T 标准规定的限量要求以下 X: 表示该有毒有害物质至少在该部件的某一均质材料中的含量超出 SJ/T 标准规定的限量要求 此表所列数据为直至发布时所能获得的最全面信息 此表表明自本产品销售之日起在 PTW 电子信息产品的供应链上何处可能找到以上所述有毒有害物质 请注意, 以上所列的部件类型中的一些可能不属于本产品 46 D /04 en

47 Index Index A Accessories... 7, 27, 36 ArrayCal B BeamAdjust... 15, 20 BQ-CHECK... 27, 35, 36 C Calibration... 20, 41 Calibration file Cleaning Components... 6 Cross-calibration D Detector array Detector Interface... 15, 17 Disposal E Energy test phantom... 27, 35, 36 F Fuses... 37, 42 G Gantry mount... 24, 25, 26 General information... 2 I Intended use... 6 P Plan verification R Rated range of use Measurement transport and storage Repair Response S Safety information... 8 Safety inspections Slab phantom... 25, 26 Spare parts Standards Symbols System installation System setup System start T Technical inspections of the measuring system Technical specifications Trigger inputs Trigger measurement U USB V VeriSoft... 15, 25, 36 L Leafs LINAC QA List of figures... 5 Literature M Maintenance Measurement, leaf positions Measurement setup Measuring range Measuring tasks MultiCheck... 15, 26, 36 D /04 en 47