User Manual. Advanced Markus Chamber Ionization Chamber Type 34045

Transcription

1 User Manual Advanced Markus Chamber Contents Operating Manual Technical Manual Service Manual D /05 en ext/hn

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). Product standards The product fully complies with the requirements of the following standards: IEC 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 D /05 en

3 General Information PTW-Freiburg works in strict accordance with a quality management system that is continuously updated according to the national and international standards. PTW-FREIBURG Physikalisch-Technische Werkstätten Dr. Pychlau GmbH Lörracher Str FREIBURG Germany Tel.: Fax: info@ptw.de D /05 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... 7 Operating Manual Application Measuring Ranges Technical Manual Technical Specifications Electromagnetic Compatibility according to IEC Accessories and Spare Parts Service Manual Cleaning Preventive Maintenance Disposal of the Product Literature...35 Index D /05 en

5 List of Figures List of Figures Figure 1: Advanced Markus chamber type with protection cap... 6 Figure 2: Definition of the patient environment...12 Figure 3: Drawing of the Advanced Markus chamber type (dimensions in mm) D /05 en 5

6 Intended Use Intended Use The Advanced Markus chamber type is a plane-parallel chamber for connection to therapy dosemeters according to IEC for electron measurement. It can be used for absolute dosimetry and for the measurement of beam profiles in radiotherapy. Figure 1: Advanced Markus chamber type with protection cap The Advanced Markus chambers type will be referred to as detectors in the following chapters. 6 D /05 en

7 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. D /05 en 7

8 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. 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! 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. Thoroughly inspect and test the product before using it again. 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. Before putting the product into operation, inspect all connection cables, connectors, housing, and covers for signs of damage. Replace damaged cables and connectors immediately. 8 D /05 en

9 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 2). 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. Exclusion of operation as a controlling instrument: Use the product as a measuring device only. Do not use measuring results to control radiodiagnostic equipment or radiotherapy units. 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 /05 en 9

10 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 Hazards originating from other system components. Hazards to Persons! Equipment Damage! Observe the safety information provided in the user manuals of the system components. 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 interference 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. Make sure that the product is used in an electromagnetic environment as described in IEC D /05 en

11 Safety Information 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". NOTICE To avoid equipment damage, always use the product in compliance with the user manual: Use the product within the rated range of use as indicted in the section "Technical Specifications". Handle the product with care. 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. D /05 en 11

12 Safety Information HINT Please observe the user manuals of all connected devices! Symbols on the Product and Nameplate Symbol Description Please 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") Figure 2: Definition of the patient environment 12 D /05 en

13 Operating Manual - Application Operating Manual 1 Application 1.1 Quick Start (Workflow) Connect the dosemeter and switch it on. Perform all necessary adjustments at the dosemeter. Verify that the high voltage is correctly adjusted. Connect the detector. Allow for a stabilization time of 15 minutes before starting the measurement. For absolute dosimetry: Determine the correction factor for the air density correction. If possible, set the correction factor at the dosemeter or note it down for the correction of the measured value. Pre-irradiate the detector. Check the leakage current. Perform a zero adjustment. Perform the measurement. NOTICE To avoid equipment damage, observe the information about dosemeter connection and setup and about measurements provided in the user manual of the dosemeters used. 1.2 General Application Information The detectors are intended to be used with PTW therapy dosemeters according to IEC The detectors are used for dose and dose rate measurement for the measuring quantity 'absorbed dose to water'. With the protection cap properly screwed on, the detectors are waterproof and can be used in a water phantom. NOTICE To avoid damage to the detector, observe the following points. Avoid sharp bends of the detector cable at its entry into the detector housing not and avoid excessive force to the detector cable. Otherwise breaks may occur, allowing water to enter the cable. Before use, set up the detector with the entrance window pointing towards the radiation source. D /05 en 13

14 Operating Manual - Application Operate the detectors only in the rated ranges of use indicated in section 3 "Technical Specifications". Other operating conditions may lead to incorrect results. HINT Using the detectors with other dosemeters or within other rated ranges of use is the sole responsibility of the user. WARNING High voltage is a source of risk. Bodily Injury! The combination of different connection systems to connect the detectors requires special precaution. Connect high voltage only via an active current limitation (I max < 0.5 ma). When the detectors are properly connected, high voltage is not applied to any of the exposed components. Before a measurement is performed, high voltage must have been applied for at least 15 minutes. Pre-irradiate the detectors as described in section 3 "Technical Specifications". Connection cables with an overall length of up to 100 m can be used between the detectors and the measuring device. NOTICE The detector membrane is very sensitive and can easily be damaged. Do not touch the membrane with your hands or with tools. Air Density Correction The detectors are vented and require air density correction. The correction factor k TP for air density correction is calculated according to the following formula: T temperature in sensitive volume [ C] P atmospheric pressure at measuring site [hpa] T 0 calibration temperature 20 C or 22 C P 0 atmospheric pressure for calibration hpa Check the aeration for proper functioning by comparison with other chambers or by using a radioactive check device. Application in Water The detectors are not waterproof. NOTICE To avoid damage to the detector, observe the following points: Always attach the protection cap provided for this purpose when using the detectors in water. Using the detectors in water without the protection cap may cause damage to the detectors and to the dosemeter and may lead to dangerous short-circuits. The detectors are allowed to remain immersed in water without interruption for a maximum of 12 hours. After use, remove the detectors from the water and do not remove the protection cap until you have thoroughly dried them! 14 D /05 en

15 Operating Manual - Application Guard Ring The detector guard ring encloses the sensitive volume. The potential of the guard ring is equivalent to the potential of the central electrode. When the detector is properly connected, high voltage is not applied to any of the exposed components. Polarity Effect Depending on the radiation quality, on the measuring depth and on the field size, polarity effects greater than ±1% may occur. In these situations, the measured value needs to be corrected. The correction factor k P for the polarity effect is calculated according to the following formula: M 1 M 2 Q Co absolute measured value for the commonly used polarity absolute measured value for the opposite polarity M 1 and M 2 need to be generated with the same dose. The index Q refers to the individual radiation conditions. The index Co refers to the measurement with 60 Co gamma radiation. HINT If 60 Co gamma radiation is not available, DIN permits using photon radiation with the minimum available peak energy (in the range from 4 MV to 6 MV if possible) to be used to determine the denominator in the formula for the correction factor k P by approximation instead of the measurement with 60 Co gamma radiation. Pay attention to the change in air density during the measurement and perform an air density correction if required. D /05 en 15

16 Operating Manual - Application 1.3 Special Application Considerations NOTICE Use only accessories, such as positioner, adapter, chamber plate, or check device, approved by PTW for the different applications; refer to section 5 "Accessories and Spare Parts". Application with Protection Cap in Water Proceed as follows: For measurements in a water phantom, always screw the protection caps onto the detectors. Screw the protection cap tight so the red lines on the cap and the detector housing are lined up. After prolonged use, the protection cap may have to be screwed on beyond the red mark to make the connection waterproof. If this is the case, the sealing ring is worn or deformed and needs to be replaced. Please contact PTW Technical Support for replacement of the sealing ring. Application with the Radioactive Check Device Proceed as follows: Unscrew the protection cap from the detector. Screw the compensating ring onto the detector until the red lines on the ring and on the detector housing are lined up. Attach the holding device T23343/11 to the detector. Application in the Slab Phantom Special chamber plates are available for measurements with the detector. Mount the detector as follows: Unscrew the protection cap from the detector. Screw the compensating ring onto the detector until the red lines on the ring and on the detector housing are lined up. Insert the detector into the chamber plate. Dry the detectors thoroughly before removing the protection cap. When the detectors are not in use: Screw the protection cap onto the detector housing loosely to avoid permanent pressure on the sealing ring. 16 D /05 en

17 Operating Manual - Measuring Ranges 2 Measuring Ranges When used in combination with the PTW dosemeters, the typical measuring ranges of the detectors are as given below. The resolution of the digital display is at least 0.5% of the indicated measuring ranges. Measuring ranges for use with the PTW therapy dosemeter type UNIDOS Measuring ranges Dose LOW HIGH Dose rate LOW MEDIUM HIGH 3.0 mgy mgy mgy Gy 17.9 mgy/min Gy/min mgy/min Gy/min 89.6 Gy/min kgy/min 1 1 The upper measuring range limit in consideration of the recombination losses is given in the Technical Specifications. D /05 en 17

18 Operating Manual - Measuring Ranges 18 D /05 en

19 Technical Manual - Technical Specifications Technical Manual 3 Technical Specifications Only values with specified tolerances or limits are guaranteed. Values without tolerances are for informational purposes only. Device designation Manufacturer Advanced Markus chamber Ionization chamber type PTW-Freiburg Application absolute dosimetry measurement of beam profiles in radiotherapy Particular design characteristics Measuring quantities Sensitive volume Effective point of measurement (reference point) Reference direction of incidence plane-parallel chamber vented waterproof only with the protection cap guard ring absorbed dose to water and absorbed dose rate to water 0.02 cm³ (radius 2.5 mm; depth 1 mm) inside of entrance window (at the center of the chamber); 1.06 mm with protection cap perpendicular to the entrance window Dimensions refer to Figure 3 Response Chamber voltage Leakage current Cable leakage Cable length 0.67 nc/gy ±( ) V nominal: +300 V maximal: ±400 V ±4 fa 1 pc/(gy cm) 1.05 m (with connector) D /05 en 19

20 Technical Manual - Technical Specifications Device designation Maximum dose rate during continuous radiation at nominal voltage Maximum dose per radiation pulse at nominal voltage Ion collection time at nominal voltage Polarity effect Advanced Markus chamber Ionization chamber type % saturation 375 Gy/s 99.0 % saturation 5.56 mgy 22 µs 1 % for electrons 9 MeV 99.5% saturation 187 Gy/s 99.5% saturation 2.78 mgy Directional response ±0.1 % for tilting of the detector axis ±10 Transient periods for temperature equilibrium pressure equilibrium Pre-irradiation (2... 3) min/k 10 s 1 Gy Stabilization time The response after 15 minutes and 2 hours differs by less than ±0.5 % from the value after 1 hour. Post irradiation leakage Stability Wall material Entrance window Area density Entrance window Electrode material signal drops to < 1 % within < 5 s long-term stability: 1 % per year dose stability: ±1 % per 10 kgy Co-60 entrance foil: PE (CH 2 ) 0.03 mm protection cap: PMMA 0.87 mm air: 0.4 mm total: 1.3 mm entrance foil: 2.76 mg/cm² protection cap: mg/cm² air: 0 mg/cm² total: 106 mg/cm² acrylic (PMMA), graphite-coated, diameter 5 mm 20 D /05 en

21 Technical Manual - Technical Specifications Device designation Rated range of use Energy Field size / beam width Temperature Relative humidity Atmospheric pressure Maximum operating altitude Environmental conditions for transport and storage Temperature Relative humidity Atmospheric pressure Max. dwell in water Connecting systems Advanced Markus chamber Ionization chamber type electrons ( ) MeV protons ( ) MeV 3 cm x 3 cm 40 cm x 40 cm ( ) C / (50 104) F ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa 3000 m above sea level ( ) C / (4 140) F ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa 12 h with protection cap only PTW-M, BNT, TNC D /05 en 21

22 Technical Manual - Technical Specifications Figure 3: Drawing of the Advanced Markus chamber type (dimensions in mm) 22 D /05 en

23 Technical Manual 4 Electromagnetic Compatibility according to IEC The following statements apply to the Advanced Markus chamber type The Advanced Markus chamber will be referred to as product in these statements. WARNING Magnetic and electrical fields are capable of interfering with the proper performance of the product. Product Failure! Do not use cables longer than specified. This might impair the electromagnetic compatibility characteristics of the product. WARNING Magnetic and electrical fields are capable of interfering with the proper performance of the product. Product Failure! 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. Guidance and Manufacturer s Declaration Electromagnetic Emissions The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions IEC/CISPR 11 RF emissions IEC/CISPR 11 Harmonic emissions IEC Voltage fluctuations/flicker emissions IEC Group 1 Class B not applicable not applicable The product uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The product is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 1) 1) The product fulfils the requirements of IEC/CISPR 11 Class B. However, it is not intended for use in domestic establishments. D /05 en 23

24 Technical Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product should assure that it is used in such an environment. Immunity tests IEC test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC ± 6 kv contact ± 8 kv air not applicable Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst IEC ± 2 kv for power supply lines not applicable Mains power quality should be that of a typical commercial or hospital environment. ± 1 kv for input/output lines ± 1 kv for input/output lines Surges IEC ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth not applicable Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC < 5 % U T (> 95 % dip in U T ) for ½ cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles not applicable Mains power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains interruptions, it is recommended that the product be powered from an uninterruptible power supply or a battery. < 5 % U T (> 95 % dip in U T ) for 5 s 24 D /05 en

25 Technical Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity Immunity tests IEC test level Compliance level Electromagnetic environment guidance Power frequency (50/60 Hz) magnetic field IEC A/m not applicable Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: U T is the a.c. mains voltage prior to application of the test level. D /05 en 25

26 Technical Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product should assure that it is used in such an environment. Immunity tests IEC test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC V rms 150 khz to 80 MHz U 1 = 3 V d = (3.5 / U 1 ) P = 1.2 P Radiated RF IEC V/m 80 MHz to 2.5 GHz E 1 = 3 V/m d = (3.5 / E 1 ) P = 1.2 P 80 MHz to 800 MHz d = (7 / E 1 ) P = 2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a), should be less than the compliance level in each frequency range. b) Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 26 D /05 en

27 Technical Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the product is used exceeds the applicable RF compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the product. b) Over the frequency range 150 khz to 80 MHz, field strengths should be less than [U 1 ] V/m = 3 V/m. D /05 en 27

28 Technical Manual Recommended separation distances between portable and mobile RF communications equipment and the product The product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the product as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m W 150 khz to 80 MHz d = (3.5 / U 1 ) P = 1.2 P 80 MHz to 800 MHz d = (3.5 / E 1 ) P = 1.2 P 800 MHz to 2.5 GHz d = (7 / E 1 ) P = 2.3 P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 28 D /05 en

29 Technical Manual - Accessories and Spare Parts 5 Accessories and Spare Parts Radioactive check device 90 Sr T48010 Holder for radioactive check device T23343/11 TRUFIX precision mounting system for positioning of detectors in TBA systems L PMMA chamber plate 30 cm x 30 cm T23343/12 PMMA chamber plate 40 cm x 40 cm RW3 chamber plate 30 cm x 30 cm RW3 chamber plate 40 cm x 40 cm T T29672/U10 T D /05 en 29

30 Technical Manual - Accessories and Spare Parts 30 D /05 en

31 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 specially trained staff. In addition, ensure that all other service tasks are only performed by PTW-Freiburg or by an organization authorized by PTW-Freiburg. 6 Cleaning Detectors and Connection Cables NOTICE To avoid surface damage, do not use disinfectants on a phenol base or peroxide compounds to disinfect the surface. NOTICE The detector membrane is very sensitive and can easily be damaged. Do not touch the membrane with your hands or with tools. The outer shell of the detectors is made of plastic. To avoid impairing the equipment functions, the detectors must not be treated with or come in contact with grease, oil, alcohol, or substances containing solvents. Cleaning agents and solvents contained in disinfectants (alcohols) have proved to be particularly harmful. Clean the parts with water and 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 /05 en 31

32 Service Manual - Preventive Maintenance Disconnect the detectors from the measuring device (always pull on the connector, not on the cable!). Wipe the detectors and connection cables down with a dry or slightly moist cloth. Do not allow liquids to enter the detectors or cables. Do not spray liquids onto the detectors and connectors. All contacts must remain clean and dry. Clean the detectors and connection cables with soap water and disinfect them with a disinfectant. HINT Due to its surface geometry, the product cannot be thoroughly disinfected. The detectors cannot be sterilized. Detector Connectors NOTICE To avoid equipment damage, do not immerse the connectors in liquids. The connectors must always be clean. Use a soft brush to remove dust (do not blow onto the connector!). Non-use When not in use, the detectors should be stored in their case for protection. The connector of the detector should be protected against humidity and dust with the supplied cap. 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. Conduct a functional control. For this, you can use a radioactive check device of PTW (refer to section 5 "Accessories and Spare Parts"). For further information on the functional control please refer to the user manual of the radioactive check device. If damage or malfunctions are identified, the product must be repaired before it is used again. Check the leakage current after having connected the detector. The detectors are designed for operation in a limited temperature and humidity range (refer to section 3 "Technical Specifications"). If a detector has been subjected to higher humidity this can result in increased leakage current. Such a detector can normally be restored to normal functionality by heating to 40 C for at least 8 hours at low humidity. Repair Repairs may only be carried out by PTW Freiburg or by persons/companies authorized by PTW Freiburg. The chamber volume must be protected against mechanical damage by means of the protective cap. 32 D /05 en

33 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. 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. Calibration The exact calibration factor and supplementary data are included in the calibration certificate. For use at high energies (above 1.3 MeV correction factors according to the relevant national or international dosimetry protocols must be observed (e.g., IAEA TRS 277 or TRS 398). The product should be recalibrated at a dose rate typical for the application. Calibrations should be done at 60 Co. It is recommended to have the product calibrated every 2 years at PTW-Freiburg or by specially trained staff on site (when using a radioactive check device and performing regular check measurements: 6 years). Inspections must also be performed after repairs or after each influence that may have changed the behavior of the product. D /05 en 33

34 Service Manual - Disposal of the Product 8 Disposal of the Product The typical lifetime of the product is approx. 10 years, if used normally. The cost for a potential return at the end of the product lifetime is to be borne by the customer. 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. 34 D /05 en

35 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 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy [4] IEC Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirement [5] IEC Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests D /05 en 35

36 Index Index A Accessories Air density correction Application Application considerations Application considerations, special Application information, general Application in water... 14, 16 C Calibration Cleaning D Detector alignment Disposal E Electromagnetic compatibility R Radioactive check device Repair S Safety information... 7 Safety inspections Slab phantom Spare parts Symbols T Technical inspections of the measuring system Technical specifications W Workflow G General information... 2 Guard Guard ring H High voltage I Intended use... 6 L List of figures... 5 Literature M Maintenance Measuring ranges... 17, 17 Membrane... 14, 31 P Polarity effect Protection cap Q Quick start D /05 en