User Manual MP3-S Therapy Beam Analyzer

User Manual MP3-S Therapy Beam Analyzer D176.131.0/2 2006-02 Hn/zi

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 1 of this directive. The product is a class IIb device (MDD). This manual is in conformity with the product specifications and all applicable safety standards valid at printing date. All rights are reserved for devices, circuits, techniques, software and names referred to in the manual. 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 be guaranteed only if original products and parts are used. Furthermore only the accessories listed in this manual are approved by PTW-Freiburg and may be used in conjunction with the product, or else accessories whose use has been expressly permitted by PTW-Freiburg. Safe operation and proper product performance are not guaranteed if accessories or consumables from other manufacturers are used. Electromagnetic immunity: The product fully complies with the electromagnetic immunity requirements of standard EN 60601-1-2 `Electromagnetic Compatibility - Medical Electrical Equipment`. The device is in conformity with the Low Voltage Directive 73/23/EEC. No part of the technical documentation may be reproduced without written permission from PTW-Freiburg. PTW-Freiburg works in strict accordance with a quality management system which is continuously updated according to national and international standards. PTW-Freiburg cannot be held liable for damages resulting from the use of accessories, 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 considers itself responsible for safety, reliability and performance of the product only, if 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. PTW-FREIBURG Physikalisch-Technische Werkstätten Dr. Pychlau GmbH Lörracher Straße 7 79115 FREIBURG GERMANY Tel. +49 761 49055-0 Fax +49 761 49055-70 info@ptw.de www.ptw.de 2 D176.131.0/2

Contents Contents 1 Intended Use 4 2 Safety Information 4 3 The Components of the MP3-S System 7 3.1 Perspex Tank 8 3.2 Moving Mechanism 9 3.3 Positioning Device 9 3.4 Lifting Carriage/Water Reservoir 10 3.5 TBA Control Unit and Control Pendant 12 3.6 System Enhancements 12 4 Assembly and Installation of the System 13 4.1 Positioning Device, Lifting Carriage/Water Reservoir, Perspex Tank 13 4.2 Connection and Use of the Lifting Carriage/Water Reservoir 16 4.3 Connecting the TBA Control Unit and Control Pendant 18 4.4 Connecting the MP3-S System to a PC 19 4.5 Mounting Detectors to the Moving Mechanism 19 4.6 Connecting the Detectors 22 4.7 Mounting the Reference Chamber 22 4.8 Setup for TPR Measurements 23 5 Installation Check 24 6 Error Messages and Troubleshooting 25 7 Cleaning, Maintenance, Disposal 27 7.1 Cleaning and Disinfection 27 7.2 Maintenance 28 7.3 Disposal of the System 28 8 Technical Specifications 29 9 Basic System Components 30 9.1 MP3-S Basic Equipment 30 9.2 Standard Configuration 30 Literature 31 List of Figures 31 Index 32 D176.131.0/2 3

MP3 Therapy Beam Analyzer Intended Use / Safety Information 1 Intended Use 2 Safety Information The MP3-S Therapy Beam Analyzer is a computercontrolled measuring system for dose distribution and radiation analysis in radiotherapy. The basic system consists of the following components: The following safety statements are divided into DANGER, WARNING, CAUTION and NOTE. Definitions DANGER Perspex tank moving mechanism TBA control unit Indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury. control pendant dual-channel electrometer TANDEM semiflex ion chamber, 0.125 cm 3 WARNING Indicates a hazard. If not avoided, the hazard can result death or serious injury. MEPHYSTO software The standard system configuration includes the basic system as well as a positioning device for alignment of the Perspex tank, a combined lifting carriage/water reservoir, a reference chamber and a computer. The system can be expanded with additional accessories (see section 3.6 System Enhancement ). The system is designed for use as a measuring device only. Do not use the system to control X-ray systems or radiotherapy systems. The system components must not come in contact with the patient. CAUTION Indicates a potential hazard. If not avoided, the hazard could result in minor injury or product / property damage. NOTE Provides useful information to assure that you get the most from your equipment. NOTE Please observe the information given in the user manuals supplied with the dual-channel electrometer TANDEM, the TBA control unit, the MEPHYSTO software program, the PC and the semiflex chamber. 4 D176.131.0/2

Safety Information Safety Information DANGER Explosion Hazard The system is not designed for use in areas of medical locations where an explosion hazard may occur. An explosion hazard may result from the use of flammable anesthetics, skin cleansing agents and disinfectants. Furthermore, the product s suitability for use in an oxygen-enriched atmosphere is restricted. The atmosphere is oxygen-enriched when the room air contains more than 25 % oxygen or nitrous oxide. WARNING Shock Hazard Strictly observe the following warnings. Failure to do so may endanger the lives of the patient, the users and other persons involved. Before using the system, the operator must ascertain that it is in correct working order and operating condition. All connectors, electrodes as well as sensors and probes must be checked for signs of damage. Damaged parts must be replaced immediately, before use. To disconnect the device from the power line, first remove the plug from the wall outlet, then disconnect the cable from the device. Devices on which moisture condensation has developed as a result of temperature changes must not be switched on unless completely dry. The devices are protection class I equipment. They must be connected to properly installed wall outlets with a non-fused earthed wire. Do not use multiple portable socket outlets (MPSO) to connect the device to the power line. All devices of the system must be connected to the same electric circuit. Devices which are not connected to the same circuit must be electrically isolated (isolated RS232 interface!). Do not use in the patient environment: Neither the product nor the peripheral devices may be used in the patient environment (patient environment = area with a radius of 6 ft (1.83 m around the patient). Do not let the device come in contact with the patient: The device is not designed for patient contact. Do not let the device or a connected printer come in contact with the patient. Avoid simultaneous contact with the patient and open device connectors. Do not use as control device: The device is only designed for use as a measuring instrument. Do not use the device to control X-ray systems or radiotherapy systems. Use of Peripheral Devices: Peripheral devices (PC, printer) may be connected to the product only if they meet the requirements of the standard IEC 60950 (EN 60950). These devices may not be operated in the patient environment, if it is not guaranteed that they meet the requirements of IEC 60601-1 (EN 60601-1). Devices may be connected to other devices or to parts of systems only when it has been made certain that there is no danger to the patient, the operator, or the environment as a result: In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned or other informed experts as to whether there is any possible danger to the patient, the operator, or the environment as a result of the proposed combination of devices. Standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-1 (EN 60601-1-1) must be complied with in any case. D176.131.0/2 5

Safety Information WARNING CAUTION Equipment Failure Magnetic and electrical fields are capable of interfering with the proper performance of the devices. For this reason make sure that all external devices operated in the vicinity of the system comply with the relevant EMC requirements. X-ray equipment, MRI devices and radio systems are a possible source of interference as they may emit higher levels of electromagnetic radiation. Keep the system away from these devices and verify its performance before use. Suffocation Hazard Dispose of the packaging material, observing the applicable wastecontrol regulations. Keep the packaging material out of children's reach. Patient Hazard The product is a medical electrical 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 of the device. Risk of Poisoning Chemicals required, for instance, for the application and maintenance of the device must under all circumstances be stored, prepared, and kept at hand in their specific containers. Failure to observe this instruction may have severe consequences for the patient. Equipment Damage Before connecting the devices to the power line, verify that the ratings of your local power line are those indicated on the device nameplate. Equipment Damage Set up the devices in a location that affords sufficient ventilation. The ventilation openings of the devices must not be obstructed. The ambient conditions specified in the "Technical Specifications" chapter must be ensured at all times. NOTE This symbol means: Refer to user manual. This symbol means: Separate collection for electrical and electronic equipment! (refer also to section Disposal of the Product) This symbol means: The product bears the CE-mark. 6 D176.131.0/2

The Components of the MP3-S System 3 The Components of the MP3-S System Trigger Signal from Accelerator Dual Channel Electrometer Measuring- and Control Signals Control Unit RS232 Computer Printer Meas. Signals Control Signals RS232 Reference detector Moving Mechanism TPR- Sensor Cable Box Control Signal Control Pendant Therapy Planning System Field detector MP3-S Perspex Tank manual levelling and adjustment MP3-S Positioning Device Waterhose TPR- Signal MP3-S Lifting Carriage and Water Reservoir Figure 3-1. MP3-S System Configuration D176.131.0/2 7

The Components of the MP3-S System 3.1 Perspex Tank The moving mechanism as well as several ancillary devices are attached to the Perspex tank. The tank (Figure 3-2) is filled with water. The water level should remain approx. 20 mm below the top edge of the tank. Horizontal lines on the tank allow it to be easily leveled. As an alternative, you can use the boxed-air level that comes as part of the MP3-S accessories. Additional marks at the bottom and on the walls of the tank allow it to be aligned, using the accelerator light beam diaphragm and laser system. The Perspex plates are glued together. On the inside of the tank, a special sealing agent protects the glue from penetrating water. Figure 3-2. MP3 Perspex tank with junction box (moving mechanism not yet installed) MP3/MP3-S motor cable Control pendant Figure 3-3. Connections at the junction box MP3/MP3-S control 8 D176.131.0/2

The Components of the MP3-S System 3.2 Moving Mechanism The moving mechanism is made of stainless steel and is permanently installed on the tank. It consists of three arms with the following designations: A = horizontal arm, fixed, B = vertical arm and C = moving horizontal arm with slider. The moving mechanism is suitable for both horizontal and vertical radiation. Holding devices for detectors to move in the field are screwed to the slider of the C- arm. The slider and the arms are moved by stepper motors that permit a minimum step width of 0.1 mm. The reproducibility of the geometric positioning is also ± 0.1 mm. The travel range limits can be adjusted for each axis and stored in the TBA control unit to ensure that the detector does not hit the Perspex walls. 3.3 Positioning Device The positioning device allows the Perspex tank to be aligned, using the light beam diaphragm, the laser system and the lines on the walls of the tank. The positioning device has three leg levelers that allow the height to be adjusted by ± 10 mm. Additionally, the three set screws allow the tank to be adjusted horizontally by ± 10 mm, or by approx. 1 on a vertical axis (micro-adjustment). A locking mechanism allows the tank to be rotated by 45 or 90. Horizontal alignment of the tank is easy when it is filled to the horizontal lines and the water surface is used as a level. The positioning device is screwed to the Perspex tank and to the triangular carrier of the lifting carriage/water reservoir (see section 4.1). The components of the moving mechanism, particularly the guides and moving parts, are not adversely affected by water. Bending or contortion due to water absorption or corrosion are thus excluded. Figure 3-4. MP3-S positioning device for tank alignment D176.131.0/2 9

The Components of the MP3-S System 3.4 Lifting Carriage/Water Reservoir Part of the MP3-S system is a combined lifting carriage/water reservoir on top of which the Perspex tank plus the position device are placed (Figure 3-5). The combined lifting carriage/water reservoir consists of an elevating system with a triangular carrier, water tank, pump and control panel. The triangular carrier of the carriage can be lifted by means of a motor-driven, mechanical elevating system. The movement is controlled via the push buttons on the control panel of the lifting carriage/water reservoir. The platform is lifted exactly parallel. The pump is made of stainless steel. Solenoid valves allow the pumping direction to be reversed to fill and empty the tank, as required. When the MP3-S system is not in use, the Perspex tank must be emptied. For this purpose, the water is pumped into the water reservoir (see section 4.2). Two versions of the lifting carriage/water reservoir are available: with and without the TPR option. In conjunction with additional accessories, the version with TPR option allows the automatic measurement of tissue-air ratios. For measurement details, please refer to the MEPHYSTO user manual. Figure 3-5. MP3-S lifting carriage/water reservoir (without TPR option) 10 D176.131.0/2

The Components of the MP3-S System Figure 3-6. MP3-S lifting carriage/water reservoir (with TPR option) D176.131.0/2 11

The Components of the MP3-S System 3.5 TBA Control Unit and Control Pendant The MP3-S system is operated via the TBA control unit and a control pendant. The TBA control unit is an interface that connects the MP3-S water phantom to the computer. It supplies the power for the stepper motors and controls the detector movement. The control pendant can be connected either to the TBA control unit or to the junction box (at the Perspex tank). The control pendant indicates the detector coordinates A, B and C and allows the detector to be moved at two different speeds (10 mm/s and 50 mm/s). Additionally, the limits for the detector movement, the null point in the central beam and the reference points can be determined via the control pendant. Please note that some of the control pendant functions are available only when it is directly connected to the water tank (see TBA Control Unit user manual). 3.6 System Enhancements LA 48,SLA48, Air Scanner, PLEXITOM, FIPS Plus The following equipment can be added to the MP3-S system: The corresponding measuring programs are already implemented in the MEPHYSTO software (not for FIPS Plus). The Linear Array LA48 is used for the measurement of profiles, predominantly profiles of dynamic fields. The LA48 has 47 ion chambers. The measurement is performed in the water-filled MP3-S Perspex tank. For the measurement, you also need a multi-channel therapy dosemeter MULTIDOS with ME48. The SLA48 is a 2D moving mechanism for the measurement of profiles with the LA48 in an acrylic build-up material. The Air Scanners are a series of moving mechanisms using a single detector for in-air measurement of profiles. The PLEXITOM is a motor-driven solid acrylic phantom (PMMA) for small fields (100 mm x 100 mm). A single detector allows the measurement of depthdose curves and profiles. The FIPS Plus System is used for the densitometric evaluation of radiographic films. For the measurement, a laser scanner is connected to the PC via a special interface. The FIPS Plus software is required for control of the laser scanner and evaluation of the measurement results. 12 D176.131.0/2

Assembly and Installation of the System 4 Assembly and Installation of the System 4.1 Positioning Device, Lifting Carriage/Water Reservoir, Perspex Tank NOTE You can use the supplied tools to assemble the system. Use only the supplied stainless steel screws to attach the different components (e.g., the arms of the moving mechanism). All components must be of the same connection system (M, TNC, or BNT). * Place the positioning device on the lifting carriage/water reservoir or on another suitable support (table, carriage). Check that the leg levelers are located in the recesses provided in the triangular carrier. * Screw the positioning device to the triangular carrier. * Place the Perspex tank on the positioning device as shown in Figure 4-1 and secure the tank on the positioning device, using four M6x16 screws and the four 6.4 washers. * Mount the junction box (T41013.1.100) to the Perspex tank as shown in Figure 3-2, using M4x12 screws and washers. * Place the A-axis on the supports to the right and left of the angle pieces on the Perspex tank and secure the axis with a swivel washer and an M6x16 screw at each end, as shown in Figure 4-2. * Hook the B-axis onto the conical bolt of the A-slide, at the same time guiding the supporting rolls over the support profile at the bottom of the Perspex tank, as shown in Figure 4-3. * Mount the B-axis to the A-slider, using two M5x16 screws. Do not yet tighten the screws. * Align the B-axis vertically. To do so, use one edge of guide rail B and the vertical crosshair line of the Perspex tank. Now tighten the two M5x16 screws. * Remove the M3x12 screws to loosen the cable holder at the top and back of the A-slider. Secure the two motor cables B/C with the cable holders and tighten the two M3x12 screws (Figure 4-3). Figure 4-1. MP3-S Perspex tank and positioning device on lifting carriage with detail view D176.131.0/2 13

Assembly and Installation of the System Figure 4-2. Mounting the A-axis Figure 4-3. Mounting the B-axis 14 D176.131.0/2

Assembly and Installation of the System * Place the C-axis on the B-slider, the centering shoulder engaging in the centering bore and the catch pin in the groove (Figure 4-4). * Check that the two bevel gear wheels engage properly in the centering shoulder and adjust, if necessary, be turning the threaded control shaft of the C-axis. * Mount the C-axis to the B-slider, using four M4x10 screws. * Plug the three connectors of the motor cables A, B and C into the corresponding sockets at the junction box. Figure 4-4. Mounting the C-axis D176.131.0/2 15

Assembly and Installation of the System 4.2 Connection and Use of the Lifting Carriage/Water Reservoir Model without TPR Option * Slip one tube clamp each over the inlet and outlet tube of the lifting carriage/water reservoir. * Connect the inlet and outlet tubes to the appropriate fitting on the Perspex tank and secure the tubes with one clamp each (Figures 4-1, 4-5). Model with TPR Option * Slip one tube clamp over the water hose of the lifting carriage/water reservoir. * Connect the tube to the appropriate fitting on the Perspex tank and secure it with a tube clamp (Figure 4-6). Both Models * Use the power cord, to connect the water reservoir to the power line. * Before filling the Perspex tank, ensure that the water and the tank both have room temperature. After use, the Perspex tank should be emptied to prevent deformation of the walls and undue stress on the seams. * Fill the reservoir with distilled water (see Note for water quality): It is recommended first to fill the Perspex tank to the maximum level and then to pump the water into the water reservoir. This way, the tank will never overflow, because the water reservoir has a greater capacity. It may prove useful to fill some more water into the water reservoir to prevent bubbles and strong movements of the water, when the water reservoir is almost empty and the pump continues to operate for a few seconds. If the tank carriage was filled with more water, the user must be ready to turn off the pump when the Perspex tank is full. The pump can be turned off with the OFF button. The automatic switch-off prevents the pump from running dry, should it be turned on while the water reservoir is empty. Figure 4-5. Complete MP3-S system without TPR 16 D176.131.0/2

Assembly and Installation of the System Figure 4-6. Water hose connection with TPR Figure 4-7. Complete MP3-S system with TPR D176.131.0/2 17

Assembly and Installation of the System NOTE Use only distilled water to fill the water reservoir. Add 0.5 liters of Cillit-HS-Combi to one filling of the water reservoir. Cillit-Combi is produced by Cillit Wassertechnik GmbH & Co (Heilbronn/Germany) and helps to prevent corrosion of the metal parts of the MP3 moving mechanism. *) Cillit-HS-Combi is commonly used in the water circuit of heating systems. Cillit-HS-Combi is by no means a dangerous substance; still you should not drink it or store it in the vicinity of food. Furthermore, Cillit-HS- Combi has no effect on the absorption and scatter characteristics of high-energy radiation. **) The Perspex tank is drained by pumping the water into the MP3-S water reservoir. The inclination of the tank that is necessary to complete empty it can be achieved by adjusting one of the screw feet. Do not tilt the tank manually. If the water reservoir needs to be emptied, the water can be pumped out via the drain plug (see chapter 6 Error Messages and Troubleshooting ). 4.3 Connecting the TBA Control Unit and Control Pendant Follow these steps to connect the TBA control unit: Front Panel * Control Pendant: connection for control pendant NOTE It is also possible to connect the control pendant at the junction box of the Perspex tank (socket on the underside of the junction box). Rear Panel * Dosemeter: connection for signal cable of dualchannel electrometer TANDEM * Power supply: connection for power cord. * RS232: connects TBA control unit and PC via interface cable (L178012 or T22373/K67-30). * Moving mechanism: connection of control cable (T43164/K1) and motor cable (T43164/K2) to junction box (T41013.1.100) of Perspex tank. NOTE The TBA control unit and the dual-channel electrometer TANDEM may be installed in the treatment room as well as in the control room. Installation in control room: RS232 connection of TBA control unit to PC via interface cable L178012. Installation in treatment room: RS232 connection of TBA control unit to PC via interface cable T22373/K67. For permanent cabling of the MP3-S, the PTW-C- Box can be used. Installing one C-Box each in the treatment room and in the control room is an easy and quick way of creating cablings for different measuring systems. Please refer to the PTW-C-Box user manual. * To reorder from PTW-Freiburg, use Cat. No. L999010. ** P. Pychlau, PTW-Freiburg, November 1989 18 D176.131.0/2

Assembly and Installation of the System CAUTION Equipment Damage Do not expose the TANDEM to direct or scattered radiation. The device should be installed in the treatment room only for the duration of the measurement. Do not leave it in the treatment room for prolonged periods of time to prevent damage due to radiation. 4.4 Connecting the MP3-S System to a PC Via the RS232 interface of the TBA control unit, the MP3-S system is connected to a PC (see section 3.3 and your PC manual). 4.5 Mounting Detectors to the Moving Mechanism Mounting the Chamber 31010 or the Light Probe 9311 * Secure holder T4316/U141 on the C-slider, using two M4x10 screws. * Introduce the chamber or the light probe into the holder such that the end of the stem is flush with the rear edge of the holder, and secure chamber or light probe with the clamping screw (see figure 4-8). because the reference point of these chambers is 9.5 mm behind the chamber tip. When using the adjusting cube in conjunction with the PinPoint chamber type 31014, please note that this chamber s reference point is 3.4 mm behind the chamber tip. Compared with the chamber type 31010, the reference point is thus moved 1.1 mm toward the chamber tip. The reference point of the chamber is thus located almost exactly under the front line of the two lines on the adjusting cube. CAUTION Erroneous Measurement Please ensure that the adjusting cube is removed before any measurement. Mounting the Electron Chamber 23343 * Secure holder T4316/U151 on the C-slider, using two M4x10 screws. * Introduce the chamber as shown in Figure 4-9 as far as it will go, then secure it with the two clamping screws. CAUTION Equipment Damage The light probe is not watertight. Therefore, do not use it under water. For convenient adjustment of the reference point of the chamber 31010 in the central beam and on the water surface, you can use adjusting cube T4316/U241. After mounting the chamber, the adjusting cube is carefully slipped over the chamber cap and secured with the two plastic screws. The black lines engraved in pairs and with a distance of 2 mm each allow the exact adjustment at the water surface and on the central beam. The adjusting cube is intended for use with the 0.125 cm 3 chamber type 31010. With these chambers, the reference point is located 4.5 mm behind the chamber tip. If the adjusting cube is to be used for one of the 0.3 cm 3 chambers of the type 31013, both chamber and cube must be moved 5 mm toward the chamber tip, D176.131.0/2 19

Assembly and Installation of the System Figure 4-8. Adjusting cube (top), Mounting the chamber 31010 and the light probe 9311 Figure 4-9. Mounting the chamber 23343 20 D176.131.0/2

Assembly and Installation of the System Mounting the Electron Chamber 34001 * Secure holder T4316/U271 on the C-slider, using two M4x10 screws. * Introduce the chamber as shown in Figure 4-10 as far as it will go, then secure it with the two clamping screws. Mounting the Diamond Detector T60003 * Secure holder T4316/U251 on the C-slider, using two M4x10 screws. * Introduce the diamond detector into the holder such that the thin part of the metal stem (area between detector housing and cable exit) rests on both edges of the bore hole in the holder. * Push the detector toward the front so that the thicker part of the metal stem at the cable exit rests against the rear edge of the holder. * Secure the detector with the clamping screw (Figure 4-11). Figure 4-10. Mounting the Electron chamber 34001 D176.131.0/2 21

Assembly and Installation of the System Figure 4-11. Mounting the Diamond Detector 60003 4.6 Connecting the Detectors * Attach the plug holder T4316/U161 to the Perspex tank. * Connect the chamber to the extension cable T2954/K2-20. * Clamp the connectors in the holder. * Connect the extension cable to the detector input labeled FIELD on the rear side of the TANDEM. 4.7 Mounting the Reference Chamber Use chambers 31010 or 31013 as reference chambers. Secure the guide tube at the holder. Ensure that the complete ionization volume of the reference chamber is positioned within the radiation field and does not collide with the moving mechanism. Slide the chamber into the guide tube such that the chamber protrudes at the front of the tube. Lock the chamber with the clamping bolt. Secure the chamber connector with the second clamping screw. Connect extension cable T2954/K2-20 to the chamber and to the detector input REF on the rear of the TANDEM. Mount the reference chamber holder T4316/U171 to the upper edge of the Perspex wall. 22 D176.131.0/2

Assembly and Installation of the System 4.8 Setup for TPR Measurements Check whether your MP3-S system is suitable for TPR measurements (lifting carriage/water reservoir with TPR option). Using cable T4316/K300, connect the lifting carriage/water reservoir to the junction box. Attach holder T4316/U371 for the liquid level switch L409005 to the moving mechanism (see figure 3-12). Mount the liquid level switch in the holder (may be preinstalled). Connect the liquid level switch to the Probe socket in the junction box. liquid level switch type L409005 screw M4x10 DIN 912 holder type 4316/U371 C-slider C-axis Figure 4-12. Installing the liquid level switch D176.131.0/2 23

Installation Check 5 Installation Check Before starting the MP3-S system, please check the following points: * Are the connectors of the control cable (T43164/K1) and of the motor cable (T43164/K2) between TBA control unit and junction box (T41013.1.100) at the Perspex tank properly connected on both sides? * Are the motor cables of the moving mechanism connected to the correct sockets at the junction box? * Is the interface cable (L178012 or T22373/K67) between TBA control unit and computer connected on both sides? * Is the TANDEM connected to the TBA control unit (T10006.1.002)? * Is the control pendant connected to the junction box (or to the TBA control unit)? * Are the detector and the reference chamber connected to the TANDEM? * Is the Perspex tank connected to the water reservoir? * Are the water reservoir, the lifting carriage and the TBA control unit connected to mains with their power cords? * For TPR measurements: Are the liquid level switch and the water reservoir connected to the junction box? 24 D176.131.0/2

Error Messages and Troubleshooting 6 Error Messages and Troubleshooting If problems occur, please check the installation as outlined in chapter 5. The following list of possible problems may be a useful guideline for troubleshooting. For detailed information on the individual components, please refer to the corresponding user manuals. For control pendant operating instructions and troubleshooting tips, please refer to the Control Unit user manual. NOTE When contacting our Service team, please give the full serial number of your device. 1. The Power LED at the TBA control unit is not illuminated. 2. The TANDEM Power LED is not illuminated. * Check whether the power cord is connected. * Is the TBA control unit turned on? * Check the fuses in the cold appliance socket on the back of the device. * Check whether the connection cable T10006.1.002 to the TBA control unit is connected. * Is the Power LED at the TBA control unit illuminated? Refer to 1. * Check the TANDEM fuses. Refer to the TANDEM User Manual. 3. No information on the control pendant display. * Is the control pendant connected? * When the control pendant is connected to the moving mechanism: Is the control cable T43164/K1 properly connected between TBA control unit and junction box at the moving mechanism? * Is the Power LED at the TBA control unit illuminated? Refer to 1. 4. No meaningful characters on the control pendant display. * Is the control cable T43164/K1 between TBA control unit and junction box connected and screwed tight? * Is the Reset button on the back of the TBA control unit stuck or is an object pushing against the button? * Verify the function of the serial interface, using a PC software program (e.g. MEPHYSTO). If the program displays the message "No proper Connection", a TBA control unit defect is very likely. If the communication is functioning, either the control pendant of the connection cable is defective. 5. An axis does not respond when you push one of the direction buttons, and the message c02 is displayed. 6. The control pendant display shows the message c08. 7. The control pendant display shows the message c09. Start or end point is out of range. The error code is displayed while one of the buttons ( -A...+ C, GOTO REF etc.) is pressed. For troubleshooting tips, please refer to the Control Unit user manual. The data in the TBA control unit memory are faulty (coordinates and limits of the moving mechanism). The TBA control unit must be reinitialized. Refer to the Control Unit user manual. The reference point is lost. Refer to the Control Unit user manual. D176.131.0/2 25

Error Messages and Troubleshooting 8. When you press the direction buttons, the message c10 is displayed. 9. When you press the direction buttons, the message c11 is displayed. 10. One of the axes does not respond upon activation of the direction button. The TBA control unit reports that no motor is detected at one of the axes. * Is the motor cable T43164/K2 connected? * Are the motor connectors (in the correct order) connected to the junction box? * Check whether the correct moving mechanism has been selected in MEPHYSTO or via the control pendant. * Replace the motor cable T43164/K2 (if available) to find out whether the cable is defective. The TBA control unit indicates that a short-circuit exists in one motor or in the motor cable T43164/K2. Please note that the error status remains active until the Reset button is pressed. * Remove the connector of the motor concerned. Push the Reset button. If the message c10 appears when you push the direction keys, the motor may be defective. This can be verified by reversing the connection of the two motors at the junction box. * Disconnect the connector of the motor cable T43164/K2 directly at the junction box. Push the Reset button. If the message c10 then appears upon activation of the direction buttons, please check the cable or replace it. * If the axis reports the message c02, refer to troubleshooting tip 5. * Check the axis limits. If upper and lower limit are identical, the axis cannot be moved. For configuration of the limits, refer to the Control Unit user manual. PC Software Error Messages 11. All Points are out of Limits See troubleshooting tip 5. 12. No proper Connection to the MP2/MP3 Controller! TPR 13. Water is not added or drained 14. TPR does not stop pumping -> sensor connected? * Verify whether the serial PC connection cable is correctly connected. * Verify whether the correct COM port is configured in the PC software. * Check whether the connection cable to the water reservoir (T43164/K300) is connected. * Check whether the liquid level switch is correctly connected. * Check whether the reservoir is connected to mains and the water pump can be operated via the control buttons at the water reservoir. * Is the control cable T43164/K1 properly connected between TBA control unit and junction box at the moving mechanism? * Check whether the liquid level switch is connected. * Is the liquid level switch correctly mounted at the holder? 26 D176.131.0/2

Cleaning, Maintenance, Disposal 7 Cleaning, Maintenance, Disposal 7.1 Cleaning and Disinfection Device Surface * Before cleaning the device surface, be sure to disconnect the MP3-S power cord from the mains. * Wipe the devices clean with a moist cloth. Do not let liquid enter the devices. Use one of the disinfectants listed below. Due to the device geometry, a thorough disinfection is not possible. Do not apply spray to the devices. The devices cannot be sterilized. WARNING Shock Hazard, Erroneous Measurements Devices into which liquids have penetrated must be immediately cleaned and checked by a service technician, before they can be reused. CAUTION Equipment Damage Do not disinfect the device surface with phenol-based disinfectants or peroxide compounds. The device surface is resistant to the following disinfectants: 2 % solution of Kohrsolin 1 % aqueous solution of Sokrena 5 % solution of Sagrotan 5 % solution of Gigasept Cables Clean and disinfect the cables as described below: Cleaning the Water Reservoir Usually the water reservoir does not need to be cleaned for a long time. To facilitate cleaning of the water reservoir, you can unscrew the two inspection fittings at the top of the lifting carriage/water reservoir. A drain plug can be pulled out underneath the lifting carriage/water reservoir. Then you can rinse the tank thoroughly with a jet of water or by using a highpressure cleaner. For cleaning, you can use a mild cleaning agent suitable for plastic material or soap water. A drain plug (SW32) is located at the bottom of the water reservoir. Open this plug to drain the dirty water. After cleaning, the tank must be thoroughly rinsed to remove all remains of the cleaning agent. Eventually, reinstall the drain plug. Close the two caps at the top of the tank and tighten the screws evenly, but not fully. Cleaning the Perspex Tank The Perspex tank is drained by pumping the water into the MP3-S water reservoir. The inclination of the tank that is necessary to complete empty it can be achieved by adjusting one of the screw feet. Do not tilt the tank manually. The supporting profile and the angle are adjusted by PTW-Freiburg. Do not remove them. For cleaning, use a mild cleaning agent suitable for plastic material or soap water. After cleaning, thoroughly remove all remains of the cleaning agent. Disconnect the cables from the devices (always pull on the connectors, not on the cables!). Clean the cable by rubbing it down with a cloth moistened with soap water. Use a disinfectant for disinfection. Do not immerse the cable in liquids! Moving Mechanism The shafts and toothed wheels of the moving mechanism should be lubricated with the supplied grease at intervals of 1 to 2 years or when necessary (use small amount of grease only!). D176.131.0/2 27

Cleaning, Maintenance, Disposal 7.2 Maintenance Checks before each use * Before each use, visually inspect the devices and cables for signs of mechanical damage. If you detect signs of damage or functional problems, have the system repaired before putting it into service again. Technical Inspections For safety, the devices require regular maintenance. To ensure the functional and operational safety of the system, the technical inspections should be carried out on an annual basis. 7.3 Disposal of the System At the end of the product life, the components of the system must be disposed of in compliance with the applicable waste control regulations. The different materials must be separated and recycled as appropriate. The MP3-S Therapy Beam Analyzer does not contain any hazardous material. The electronic components must be recycled according to local regulations. The cost for an eventual return at the end of the product life time is to be borne by the customer. These checks should be performed by independent persons with adequate training and experience. Technical Inspection of the Measuring System PTW-Freiburg or another qualified test lab should perform the technical inspection of the measuring system at intervals of 2 years maximum. These inspections must also be carried out after repairs or any incidents that may affect the device behavior. The device does not require any other maintenance. 28 D176.131.0/2

Technical Specifications 8 Technical Specifications Environmental Conditions for Operation ambient temperature: rel. humidity: atmospheric pressure: (+10... +40) C (10... 80) % rel. humidity, max. 20 g/m³ (600... 1200) hpa Environmental Conditions for Storage and Transport ambient temperature: (-20... +60) C rel. humidity: atmospheric pressure: Moving Mechanism reproducibility Max. Cable Length (between TBA control unit and water phantom): Perspex Tank MP3-S material: outside dimensions: inside dimensions: wall thickness: max. water quantity: (10... 85) % rel. humidity, max. 20 g/m³ (600... 1200) hpa 0.1 mm 40 m PMMA 634 mm x 536 mm x 522.5 mm 594 mm x 496 mm x 502.5 mm 20 mm 142 l Positioning Device, rotatable, T41002.1.016 adjustments vertical, travel of: ± 10 mm horizontally in the plane: ± 10 mm pivoting around vertical axis: approx. ± 1 swiveling to positions: 0, ± 45 and ± 90 When using an LA48, the swiveling axis is at the cross hairs of the LA48. MP3-S Positioning Device, basic model, T41002.1.020 adjustments vertical, travel of: horizontally in the plane: pivoting around vertical axis: Design outside dimensions: overall height in middle position: outside dimensions of the support plate: support plate material: weight: ± 10 mm ± 10 mm approx. ± 1 591 mm x 689 mm 153 mm 591 mm x 689 mm 22 mm chip board, plastic-coated approx. 13 kg MP3-S Lifting Carriage and Water Reservoir T41003-230A / T41003-115A outside dimensions: elevation range, upper platform edge: elevation range, water surface: time for full lift: carrying capacity: weight: tank capacity: pump type: pumping capacity: pump time for entire water quantity: material of water reservoir: power supply: 720mm x 1000 mm 750 mm x 1035 mm (with positioning device) approx. 1252 mm x 1538 mm (with positioning device) approx. 58 seconds 200 kg approx. 95 kg approx. 156 l centrifugal pump approx. 24 l/min approx. 6 min polypropylene 230 V / 50-60 Hz / 2 A 115 V / 50-60 Hz / 4 A Design outside dimensions: overall height in middle position: outside dimensions of the support plate: support plate material: weight: 571 mm x 669 mm 117.5 mm 536 mm x 634 mm 5 mm aluminum, anodized ca. 22 kg D176.131.0/2 29

MP3 Therapy Beam Analyzer Basic System Components 9 Basic System Components 9.1 MP3-S Basic Equipment MP3-S Perspex tank, complete MP3-S moving arm A MP3-S moving arm B MP3-S moving arm C MP3/MP3-S junction box MP3-S accessories Cover, adjusting cube, ball-shaped screwer SW 3, hexagon head screwer (SW 2,5, 3, 4, 5), level, Cillit Combi HS, Fat Staburags NBU 12K, accessory mounting TBA control unit TANDEM, connection system M Signal cable MP3/MP3S control cable, 4 m MP3/MP3S control cable, 4 m TBA control pendant Interface cable RS232, 30 m Semiflex chamber, 0.125 cm 3 MP3/MP3-S probe holder TBA holder for chamber plug Extension cable M6m MEPHYSTO software 9.2 Standard Configuration We recommend using the basic system (see chapter 8) with the following accessories: MP3-S positioning device, rotatable MP3-S positioning device MP3-S lifting carriage/water reservoir, 230 / 50 60 Hz MP3-S lifting carriage/water reservoir, 115 / 50 60 Hz Semiflex chamber, 0.125 cm 3 Semiflex chamber, 0.3 cm 3 MP3/MP3-S reference chamber holder MP3 connection cable for TPR option A PC system is required. 30 D176.131.0/2

Literature Literature [1] Medical Device Directive (MDD) of 02.08.1994 [2] IEC 60601-1-2 Medical electrical equipment, Part 1: General requirements for safety 2 nd Collateral Standard: Electromagnetic compatibility Requirements and tests [3] EN 55011 Industrial, scientific and medical (ISM) radio-frequency equipment Radio disturbance characteristics Limits and methods of measurement [4] IEC 60950 Safety of information technology equipment including electrical business equipment [5] IEC 60601-1 Medical electrical equipment Part 1: General requirements for safety [6] IEC 60601-1-1 Medical electrical equipment 1 st Collateral Standard: Requirements for the safety of medical electrical systems. List of Figures Figure 3-1. MP3-S System Configuration 7 Figure 3-2. MP3 Perspex tank with junction box (moving mechanism not yet installed) 8 Figure 3-3. Connections at the junction box 8 Figure 3-4. MP3-S positioning device for tank alignment 9 Figure 3-5. MP3-S lifting carriage/water reservoir (without TPR option) 10 Figure 3-6. MP3-S lifting carriage/water reservoir (with TPR option) 11 Figure 4-1. MP3-S Perspex tank and positioning device on lifting carriage with detail view 13 Figure 4-2. Mounting the A-axis 14 Figure 4-3. Mounting the B-axis 14 Figure 4-4. Mounting the C-axis 15 Figure 4-5. Complete MP3-S system without TPR 16 Figure 4-6. Water hose connection with TPR 17 Figure 4-7. Complete MP3-S system with TPR 17 Figure 4-8. Adjusting cube (top), Mounting the chamber 31010 and the light probe 9311 20 Figure 4-9. Mounting the chamber 23343 20 Figure 4-10. Mounting the Electron chamber 34001 21 Figure 4-11. Mounting the Diamond Detector 60003 22 Figure 4-12. Installing the liquid level switch 23 D176.131.0/2 31

Index Index A A-axis, installation... 13 Accessories... 30 Address... 2 Air Scanner... 12 Align the tank... 8 Alignment of tank... 9 B Basic equipment... 30 Basic system... 4 B-axis, mounting... 13 C C-axis, mounting... 15 Chamber, mounting of... 19 Cillit-HS-Combi... 18 Cleaning... 27 Control pendant... 12 D Detectors, connection of... 22 Detectors, mounting of... 19 Diamond detector, mounting of... 21 E Electron chamber, mounting of... 21 EMC requirements... 6 Explosion hazard... 5 F Fips Plus System... 12 G General information... 2 I Installation check... 24 Intended use... 4 J Junction box... 8 Junction box, mounting of... 13 L LA48... 12 Level... 8 Lifting carriage/water reservoir... 10 Lifting carriage/water reservoir, connection of... 16 Light probe, mounting of... 19 List of Figures... 31 Literature... 31 M Maintenance... 28 Manufacturer s address... 2 Moving mechanism... 9 Multiple portable socket outlets... 5 O Order information... 30 P PC, connection to... 19 Perspex tank... 8 Perspex tank, mounting of... 13 PLEXITOM... 12 Positioning device... 9 Positioning device, assembly... 13 Protection class... 5 R Reference chamber, mounting of... 22 Reproducibility... 9 S Safety information... 4 SLA48... 12 Stepper motor... 9 System Components... 30 System enhancements... 12 T TANDEM... 18 Tank, align... 8, 9 TBA control unit... 12 TBA control unit, connection of... 18 Technical inspections... 28 Technical Specifications... 29 TPR measurements... 23 TPR option... 10 Travel range limits... 9 W Water... 18 Water level... 8 32 D176.131.0/2