User Manual NORMI 13 (T42023)

Transcription

1 User Manual Contents Operating Manual Technical Manual Service Manual ext/bru

2 General Information General Information The product bears the CE-mark "CE" 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 I device without a measuring function (MDD). Product standards The product fully complies with the requirements of the following standards: DIN 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. 2 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.

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

4 Table of Contents Table of Contents General Information...2 Table of Contents... 4 List of Figures...6 Intended Use... 7 Accessories... 7 Safety Information... 8 Operating Manual Description of the Test Object Preparing the Constancy Test Required Test Equipment Test Conditions Test Setup Constancy Test Purpose of the Constancy Test...19 Performing the Constancy Test...19 Verifying the Performance Characteristics...20 Assessing the Results...22 Constancy Test Report Accessories Use of the Bucky Mounting Device T20005 with a Test Object Use of the Wall Stand Holder T20018 with Bucky Mounting Device T20005 and Test Object Technical Manual Technical Specifications NORMI Accessories Rated Range of Use and Ambient Conditions Accessories and Spare Parts

5 Table of Contents Service Manual Cleaning Preventive Maintenance Disposal of the Product Literature...42 Index

6 List of Figures List of Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: 6 Definition of the patient environment...10 NORMI 13 test object Schematic test setup with PMMA absorber (near image receptor)...17 Schematic test setup with Al absorber (near tube) Bucky mounting device T Bucky mounting device T20005 with test object Wall stand holder T Wall stand holder T20018 with bucky mounting device T20005 and test object...31 Drawing bucky mounting device T20005 (dimensions in mm)...34 Drawing wall stand holder T20018 (dimensions in mm)... 35

7 Intended Use - Accessories Intended Use is a test object for constancy tests of digital projection radiography systems according to DIN The standard DIN applies to equipment working with imaging plates or semiconductor image receptors and where the diagnosis is carried out using a film at the viewing box or image display device (diagnosis on a clinical review monitor). It describes a method that helps to test the constancy of decisive performance characteristics of X-ray equipment. NORMI 13 fulfills all requirements of the standard DIN for constancy tests. This user manual describes the design of the test object, the test setup, and the test procedure. The evaluation of the results is the sole responsibility of the user. HINT This user manual only describes the use of the NORMI 13 test object. For detailed information about constancy tests, please refer to the standard DIN WARNING Hazards originating from other system components. Hazards to Persons! Equipment Damage! Observe the safety information provided in the user manuals of the medical X-ray equipment and of the measuring devices. will be referred to as test object in the following chapters. Note: In the United States, federal law restricts this device to sale by or on the order of a physician. Accessories The following accessories are available for the test object: Bucky mounting device for diagnostic test object T20005: for the convenient fixation of NORMI 13 and a PMMA absorber to the wall bucky Wall stand holder T20018: for the convenient fixation of NORMI 13 to the wall bucky, with or without an additional, optional copper plate. The wall stand holder must always be used in combination with the bucky mounting device T For more information about using the accessories, refer to section 4 "Accessories". 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

9 Safety Information Safety Information Strictly observe the following safety information concerning the signal word WARNING. Failure to do so may endanger the lives of the patient, the user, and other persons involved. 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 Application for uses other than those stated in the user manual. Bodily Injury! Equipment Damage! WARNING Use of the product when it is not in perfect operating condition. Bodily Injury! Equipment Damage! Before using the product, verify that it is in correct working order and operating condition. 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. WARNING Hazards originating from other system components. Hazards to Persons! Equipment Damage! Observe the safety information provided in the user manuals of the medical X-ray equipment and of the measuring devices. 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. Exclusion of operation in the patient environment: Do not operate the product in the patient environment (refer to Figure 1). 9

10 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 prevent equipment damage, always employ the product as instructed in the user manual: Operate the product within the rated ranges of use indicated in the "Technical Specifications". Handle the product with care. 10 Figure 1: Definition of the patient environment

11 Safety Information Symbols on the Nameplate Symbol Description Refer to the user manual! The product bears the CE-mark. Manufacturer and date of manufacture Reference number Serial number For a description of additional symbols, if applicable, please refer to the equipment description. 11

12 Safety Information 12

13 Operating Manual - Description of the Test Object Operating Manual 1 Description of the Test Object The overall dimensions of the structure plate are 300 mm x 300 mm x 10 mm, and the plate is composed of the following components: PMMA plate, 8 mm thick grid plate, 0.5 mm thick copper plate, 1 mm thick front foil, 0.5 mm thick Absorber The structure plate is used in combination with an absorber: aluminum absorber, thickness of 25 mm or PMMA absorber, thickness of 30 mm HINT The standard DIN specifies a requirement for a 1-mm copper plate for the PMMA absorber. The PTW structure plate already includes this copper plate. additional, optional copper plate with a thickness of 1.3 mm for measurements at 100 kv 13

14 Operating Manual - Description of the Test Object Figure 2: NORMI 13 test object 1 Dose measurement area, marking not radiopaque 5 Free area for signal normalization 2 Crosshairs for central alignment, not radiopaque 7 Radiation-absorbing line marks for light field adjustment 3 X-ray tube axis 8 Low contrast objects for contrast resolution 6 X-ray test pattern for spatial resolution 4 Dynamic steps 14

15 Operating Manual - Preparing the Constancy Test 2 Preparing the Constancy Test 2.1 Required Test Equipment The following test equipment is needed for performing the constancy test: NORMI 13 test object PMMA or aluminum absorber CONNY II diagnostic dosemeter (T11007) or NOMEX Dosemeter (L981816) or NOMEX Multimeter (L981815) additional equipment for documentation on film: densitometer ruler magnifying lens with a magnification of 4 times or more for diagnosis on a clinical review monitor: luminance meter 2.2 Test Conditions To allow the constancy of the X-ray system to be assessed by comparison with the reference values, it is mandatory to perform all tests under the same conditions, which are specified below: use of the same test equipment identical radiographic or fluoroscopic, image processing, documentation, and viewing conditions test object positioned in the same place with the same spatial orientation and the same beam geometry; the maximum permitted deviation of the distance between focus and image receptor compared with the initial state is 1% max. for imaging plate systems: use of the same plate for units with removable anti-scatter grid: use of the same grid with the same orientation and the same distance for X-ray equipment with light field indicator: test object positioned such that the edges of the light field (center of the penumbra region) coincide with the four line marks of the test object These conditions must be defined and recorded during the acceptance test. 15

16 Operating Manual - Preparing the Constancy Test 2.3 Test Setup The NORMI 13 test object is intended for tests in compliance with the standard, employing a PMMA and copper absorber or an aluminum absorber. The test setup with a PMMA absorber is shown in Figure 3. The test setup with an aluminum absorber is shown in Figure 4. Position the test object as close to the image receptor of the application device as possible. The center of the test object should be located in the middle of the radiation beam. Over-couch tubes: Place the test object on the patient couch with the measuring plate facing up. The FOCUS label points upward. Center the test object relative to the X-ray tube and adjust the light field indicator to the edge marks of the test object. During this procedure, line up the edge of the light field and the four line marks of the test object. HINT If there is no light field indicator, the test object can be centered relative to the radiation field on the image display device by means of fluoroscopy control. Using the supplied reclosable fastener, attach the dose detector to the dose measurement area (1, Figure 2). Make sure that neither the dose detector nor the detector cable cover any of the test elements. Under-couch tubes: Screw the four standoffs to the measuring plate and place the test object on the patient couch with the measuring plate facing down. The FOCUS label points downward. Wall bucky: Use the bucky mounting device (T20005) to fasten the test object and the PMMA absorber (refer to 4.1 "Use of the Bucky Mounting Device T20005 with a Test Object"). If the test object is used in combination with the aluminum absorber, the wall stand holder is needed in addition to the bucky mounting device (refer to 4.2 "Use of the Wall Stand Holder T20018 with Bucky Mounting Device T20005 and Test Object"). 16

17 Operating Manual - Preparing the Constancy Test Figure 3: Schematic test setup with PMMA absorber (near image receptor) 1 Additional, optional copper plate, 1.3 mm thick, for measurements at 100 kv 5 Collimator 2 Supporting plate (patient couch) 6 NORMI 13 test object (consisting of structure plate and 1 mm copper plate) 3 Entrance plane of the image receptor 7 PMMA absorber, 30 mm 4 X-ray tube 8 Anti-scatter grid 17

18 Operating Manual - Preparing the Constancy Test Figure 4: Schematic test setup with Al absorber (near tube) 1 X-ray tube 5 Supporting plate (patient couch) 2 Collimator 6 Anti-scatter grid 3 Aluminum absorber, 25 mm 7 Entrance plane of the image receptor 4 NORMI 13 test object (consisting of structure plate and 1 mm copper plate) 18

19 Operating Manual - Constancy Test Constancy Test Purpose of the Constancy Test The constancy test is intended to ensure consistent image quality and achieving the required image quality with the same radiation exposure. The first constancy test is performed immediately after the acceptance test of an X-ray system. During this test, the initial state is documented and the reference values are defined. 3.2 In order to take the effects of the X-ray generator, X-ray tube, application device, and image receptor into account, images with manual exposure setting and with automatic exposure control and simultaneous dose measurement are required. Proceed as follows to obtain the test image: In subsequent constancy tests, the measured values of the various performance characteristics are compared with these reference values. Adjust the same parameters, voltages, and analysis programs as well as documentation and display conditions as in the acceptance test. HINT The following performance characteristics are to be verified: dose exposure index optical density / luminance or pixel value spatial resolution contrast resolution coincidence of light field and radiation field artifacts For constancy tests with voltages of 100 kv, an additional 1.3 mm copper plate can be attached to obtain adequate switching times. Ensure the correct orientation of the plate. The cut-out must be positioned over the dose measurement area. On test images with the copper plate, two spots are visible next to the X-ray test pattern towards the center of the image. Performing the Constancy Test Position the test object section 2.3 "Test Setup". according to 19

20 Operating Manual - Constancy Test Set the X-ray tube voltage as follows: Manual setting: 70 kv (100 kv for X-ray tubes that are only used in the voltage range of about 100 kv) Application device with automatic exposure control: 100 kv (70 kv for X-ray tubes that are only used in the voltage range of about 70 kv) Generate a test image with each X-ray tube and each application device with an automatic exposure control function. Read the measured value indicated on the detector. Document and analyze the results according to the standard DIN Verifying the Performance Characteristics The following performance characteristics shall be verified in the constancy test: The permitted limit deviations of the individual performance characteristics are detailed in section 3.4 "Assessing the Results" Dose Measure the dose always in the same area (1, Figure 2). Mount the detector with the same orientation on the radiation entrance side of the test object. Be sure not to exceed the intended range. It is important to keep the radiation detector of the dosemeter clear, also when using the additional copper plate for 100 kv Exposure Index The exposure index is given in data relating to the test image. Create a test image that is shown on the image display device or on film. The image can be taken without a structure plate and with only the absorber Optical Density or Luminance or Pixel Value Determine either the optical density or the luminance. As an alternative to determining the luminance, you can analyze the pixel values of the digital test image. 20

21 Operating Manual - Constancy Test Optical density Using a densitometer, measure the optical density always in the same place on the test image that is shown on a film. Choose the step in the middle of the dynamic steps for the measurement (4, Figure 2). Determine the spatial resolution by means of the X-ray test pattern. Use the same image processing parameters for the test image as for the determination of the reference values. Visually evaluate the X-ray test pattern using a magnifying lens with a 4 to 8 x magnification. The parameter is the number of line pairs per millimeter (Lp/mm) in the line group which can be distinguished at the resolution. Compare the parameter with the reference value and the limit value. Luminance Using a luminance meter, measure the luminance always in the same place on the test image that is shown on the image display device. Choose the step in the middle of the dynamic steps for the measurement (4, Figure 2). Pixel value The pixel value P indicates the intensity of the exposure incident on the detector system (e. g., imaging plate) at a given pixel Spatial Resolution Contrast Resolution Determine the number of low contrast elements that are discernible on the test image. Prerequisite: all steps of the dynamic range must be discernible on the same test image. Use the same image processing parameters for the test image as for the determination of the reference values. The pixel value is determined at the output of the imaging system or on the images stored in the PACS (Picture Archiving and Communication System). The preferred spot for determining the pixel value is the step in the middle of the dynamic steps (4, Figure 2). The measuring field should comprise no less than 1000 pixels. It has proven useful to utilize the area of the steps minus a border. The measured pixel value P depends on the dose value that might be measured behind the step. The mean of all pixel values of this measurement area is calculated as the characteristic pixel value and is defined as the reference value for the constancy test. 21

22 Operating Manual - Constancy Test Coincidence of the light field and the radiation field Using a test image, determine the deviation between the light field and the radiation field. Compare the irradiated field with the field outlined by the line marks of the test object (to which the light field indicator has been adjusted). Add the marks missing on the test image. Determine the deviations in both horizontal and vertical direction. Use the measurement tools of the program installed at the workplace. Only in exceptional situations should rulers be used for measurements. HINT This test cannot be performed on facilities without a light field indicator Artifacts Check the test image for artifacts that may affect the quality of the diagnosis. 3.4 Assessing the Results The evaluation of the results is based on the following maximum deviations from the reference values determined in the initial state. If the deviations exceed the permitted ranges, measures must be taken to eliminate the causes, i. e., to restore the initial state Dose Measurements with PMMA absorber: With automatic exposure control, the dose values shall not deviate by more than ±30% at 70 kv (±25% at 100 kv), and with manual exposure setting, by not more than ±30% at 70 kv and 100 kv from the reference value. Measurements with aluminum absorber: With automatic exposure control, the dose values shall not deviate by more than ±25% at 70 kv (±20% at 100 kv), and with manual exposure setting, by not more than ±30% at 70 kv and 100 kv from the reference value Exposure Index The exposure index and the maximum permitted deviations are manufacturer-specific parameters and usually indicated in the test image data. The maximum permitted deviation of the exposure index from the image receptor dose is ±50%. 22

23 Operating Manual - Constancy Test Optical Density For both, automatic exposure control and manual exposure setting, the measured optical density shall not deviate more than ±30% from the reference value Pixel Value Perform three ROI measurements for determining the permitted deviations from the reference value: at the reference step (field in the middle, measured behind 1 mm of copper) Preference at the adjoining step (measured behind 0.65 mm of copper) Pdose+step Luminance For both, automatic exposure control and manual exposure setting, the maximum deviation ΔL of the measured luminance shall not exceed +100% / -50%. at the adjoining step (measured behind 1.4 mm of copper) Pdose+step Calculate the maximum (P+1) and the minimum (P-1) deviation from the reference value according to the following formula: P+1 = Preference + factor (Pdose+step-Preference) P-1 = Preference + factor (Pdose+step-Preference) The factor used in the calculation depends on the voltage, it is 0.45 for 70 kv and 0.7 for 100 kv (see Table 1). 70 kv 100 kv Limit of the pixel value towards a P (P1.4 - P1) lower dose: P-1 P (P1.4 - P1) Limit of the pixel value towards a P (P P1) higher dose: P+1 P (P P1) P1 = pixel value behind the 1-mm Cu step (reference value) P0.65 = pixel value behind the 0.65-mm Cu step P1.4 = pixel value behind the 1.4-mm Cu step Table 1: Formulas for calculation of the permitted deviations 23

24 Operating Manual - Constancy Test Model calculation The following pixel values were determined by the ROI measurement of the reference step P1 and the adjoining steps P0.65 and P1.4 for 70 kv: The image of the X-ray test pattern should not be of poorer quality compared with the initial state. The measured values, in particular, should not drop below the reference values determined in the acceptance test. The limit value for spatial resolution valid in the last acceptance test must not be exceeded by any of the X-ray images obtained with the test object. P1 or Preference: Pdose+step (P0.65): Pdose+step (P1.4): For the calculation of the limit values P-1 and P+1, these pixel values are entered in the appropriate formula. Minimum deviation P-1: ( ) = Maximum deviation P ( ) = Spatial Resolution Contrast Resolution The number of discernible low contrast elements in the test object shall not deviate from the reference value determined in the acceptance test. The limit value for contrast resolution valid in the last acceptance test shall not be exceeded.

25 Operating Manual - Constancy Test Coincidence of the light field and the radiation field The deviations referred to the image receptor plane shall not exceed 2% of the distance (r) between focus and image receptor in each case. 3.5 Constancy Test Report The test report shall include the following minimum information: Indication that the test was performed according to DIN Operator of the X-ray installation Tested installation and and V Magnitude of the horizontal deviations between light field and radiation field Magnitude of the vertical deviations between light field and radiation field Imaging scale according to DIN that was defined and documented during the acceptance test as a criterion for the constancy test Artifacts The X-ray image must be free from structures whose size, shape, edge sharpness, and difference in optical density or luminance relative to the surrounding area could affect the diagnosis. Imaging system (image receptor type, analysis software) Test equipment Exposure parameters (e. g., distance between focus and image receptor, distance between focus and test object, tube voltage) Reference values, maximum deviations and current parameter readings Date and name of the person performing the test We recommend using a standardized protocol where the test results can be entered in tabular form. This makes it easier to compare them to the initial values. The standard DIN provides a model form sheet. 25

26 Operating Manual - Accessories 4 Accessories 4.1 Use of the Bucky Mounting Device T20005 with a Test Object Disassembly Holding the assembled bucky mounting device with both hands, lift it off the wall bucky. To further disassemble the bucky mounting device, place it on a suitable table. Unscrew the star knob bolts (4, Figure 5) and remove the test object. Assembly Place the test object with the PMMA absorber (30 mm) and the bucky mounting device T20005 on a suitable table. Place the NORMI 13 test object on the PMMA absorber. Join both components by means of four knurled screws. Undo the screws of the bucky mounting device. Then use the two star knob bolts (4, Figure 5) to fix the PMMA absorber (threaded bores on the sides) on the bucky mounting device T Using a ruler or the edge of the table, align the height of the test object in the bucky mounting device. Set the angle bracket for fitting the bucky mounting device to the thickness of the wall bucky. Tighten the star knob bolts on the bucky mounting device. Holding the assembled bucky mounting device with both hands, suspend it in the wall bucky. It may prove necessary to adjust the position of the bucky mounting device. 26

27 Operating Manual - Accessories Figure 5: Bucky mounting device T Star knob bolt for adjusting the angle bracket to the thickness of the wall bucky 2 Adjustment range for thickness of the wall bucky 3 Adjustment range for position of the test object 4 Star knob bolt for fixing the PMMA absorber or the wall stand holder T

28 Operating Manual - Accessories 1 2 Figure 6: Bucky mounting device T20005 with test object 1 Bucky mounting device 2 PMMA absorber (with test object) 28

29 Operating Manual - Accessories 4.2 Use of the Wall Stand Holder T20018 with Bucky Mounting Device T20005 and Test Object Assembly Disassembly Place the wall stand holder T20018, the test object, and the bucky mounting device T20005 on a suitable table. Holding the assembled holder with both hands, lift it off the wall bucky. To further disassemble the holder, place it on a suitable table. Fasten the rails of the wall stand holder T20018 to the bucky mounting device T20005 (refer to Figure 8). Undo the set screws (3, Figure 7) and remove the test object. Set the angle bracket for fitting the bucky mounting device to the thickness of the wall bucky. Insert the test object in the wall stand holder. Using the set screws (3, Figure 7), press the test object against the rails. HINT For further use, please remember that the test object and the holder are not firmly joined. Using a ruler or the edge of the table, align the height of the test object in the mounted holder. Holding the assembled holder with both hands, suspend it in the wall bucky. It may prove necessary to adjust the position of the bucky mounting device. 29

30 Operating Manual - Accessories Figure 7: Wall stand holder T Rail 2 Attachment point 3 Set screw 4 Nameplate 30

31 Operating Manual - Accessories Figure 8: Wall stand holder T20018 with bucky mounting device T20005 and test object 1 Bucky mounting device 2 Wall stand holder 3 Test object 31

32 Operating Manual - Accessories 32

33 Technical Manual - Technical Specifications Technical Manual 5 Technical Specifications Only values with specified tolerances or limits are guaranteed. Values without tolerances are for informational purposes only. 5.1 NORMI 13 Device designation Manufacturer PTW-Freiburg Application test object for constancy tests of digital projection radiography systems according to DIN Structures dynamic steps: 7 steps with heigths of 0 mm; 0.30 mm; 0.65 mm; 1.00 mm; 1.40 mm; 1.85 mm, 2.30 mm radiation-absorbing line marks for light field adjustment X-ray test pattern for spatial resolution low contrast objects for contrast resolution free area for signal normalization area for dose measurement, marks not radiopaque crosshairs for central alignment, marks not radiopaque Material Dimensions test object: PMMA absorber: aluminum absorber: Weight (test object only) approx. 2.0 kg PMMA plate, 8 mm thick grid plate, 0.5 mm thick copper plate, 1 mm thick front foil, 0.5 mm thick 300 mm x 300 mm x 10 mm 300 mm x 300 mm x 30 mm 163 mm x 163 mm x 25 mm 33

34 Technical Manual - Technical Specifications 5.2 Accessories Bucky Mounting Device T20005 Device designation Bucky mounting device for diagnostic test object, T20005 Manufacturer PTW-Freiburg Intended use mechanical accessory for test objects (e.g., NORMI 13 with PMMA absorber for fixing the test objects to the wall bucky) Dimensions refer to Figure 9 / clamping range for wall ( ) mm Material angle bracket: aluminum star knob bolts: steel, plastic handle Weight approx. 0.8 kg , , Figure 9: 34 Drawing bucky mounting device T20005 (dimensions in mm)

35 Technical Manual - Technical Specifications Wall Stand Holder T20018 Wall stand holder, T20018 Manufacturer PTW-Freiburg Intended use mechanical accessory for bucky mounting device T20005 for fixing the test objects (e.g., NORMI RAD/FLU or NORMI 13) to the wall bucky Dimensions refer to Figure 10 clamping range for test object 25 mm Material rails: PVC (polyvinyl chloride) screws: POM (polyoxymethylene) Weight approx. 0.6 kg Device designation Figure 10: Drawing wall stand holder T20018 (dimensions in mm) 35

36 Technical Manual - Technical Specifications 5.3 Rated Range of Use and Ambient Conditions Rated range of use Temperature Relative humidity Atmospheric pressure Maximum operating altitude Transport and storage conditions Temperature Relative humidity Atmospheric pressure 36 ( ) C, ( ) F ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa 3000 m above sea level ( ) C, ( ) F ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa

37 Technical Manual - Accessories and Spare Parts 6 Accessories and Spare Parts NORMI 13 Set PMMA set for quality control of digital X-ray installations acc. to DIN 6868 part 13. Includes structure plate, PMMA absorber, bucky mounting device, Velcro tape and carrying case L NORMI 13 Set Al set for quality control of X-ray installations acc. to DIN 6868 part 13. Includes structure plate, Al absorber (to be fixed directly to the collimator), bucky mounting device, Velcro tape and carrying case L % Cu Absorber, (300 x 300 x 1.3) mm for measurements at tube voltage of 100 kv T NORMI holder for bucky wall stand for fixation of the test object NORMI 13 or NORMI RAD/FLU on a bucky wall stand. Includes bucky mounting device T20005 and accessory T20018 L Bucky mounting device T20005 for mounting the diagnostic test objects X-Check FLU, NORMI 13 and the REX phantom to a bucky wall stand Wall stand holder accessory for T20005 for mounting the NORMI RAD/FLU or NORMI 13 test object at a bucky wall stand T20018 CONNY II diagnostic dosemeter battery operated, with semi-conductor detector for constancy tests of conventional and mammography X-ray installations T11007 NOMEX Set incl. NOMEX Dosemeter and Multimeter, software, BT adapter, 2 x 2 m and 5 m USB cable, power supply, transport case, box. Measures dose, dose rate, dose/pulse, pulses, time, kv, TF, HVL. Semiconductor detectors or ICs can be connected. L NOMEX Dosemeter incl. software, USB cable, BT adapter, power supply and a transport case. Measures (depending on the detector) dose, dose rate, dose/pulse, pulses, time, kv, TF and HVL. NOMEX Multimeter, external semiconductor detectors or ion chambers can be connected. L NOMEX Multimeter incl. NOMEX Multimeter, NOMEX Software, 2 m USB cable, 5 m active ext. cable and a transport case/box. Measures dose, dose rate, dose/pulse, pulses, time, kv, TF and HVL. Requires connection to a PC or NOMEX Dosemeter L

38 Technical Manual - Accessories and Spare Parts 38

39 Service Manual - Cleaning Service Manual WARNING 7 Cleaning Improper execution of service tasks. Hazards to Persons! Equipment Damage! General Information on Cleaning Ensure that the service tasks described below are only performed by specialized staff. NOTICE In addition, ensure that all other service tasks are only performed by PTW-Freiburg or by a person authorized by PTW-Freiburg. 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. The product must not be treated or come in contact with fat, oil, alcohol, or substances containing solvents. Cleaning agents and solvents contained in disinfectants (alcohols) have proved to be particularly harmful. 39

40 Service Manual - Preventive Maintenance 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. Surfaces Clean the surfaces as follows: 40 Only wipe the product down. Liquids must not be allowed to enter the product. Do not immerse the product in water or other liquids. Do not apply spray to the product. 8 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 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 PTWFreiburg.

41 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 product contains components made of lead which must be disposed of in compliance with the legal provisions. 41

42 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] DIN Image quality assurance in diagnostic X-ray departments Part 13: RöV constancy test of projection radiography systems with digital image receptors 42

43 Index Index A P Accessories... 26, 34 Artifacts... 22, 25 Performance characteristics, verification Pixel value... 20, 23 B R Bucky mounting device T , 29 Rated range of use Repair C Cleaning Coincidence of light field and radiation field... 22, 25 Constancy test performance preparation purpose test conditions test report Contrast resolution... 21, 24 D Description Disposal Dose... 20, 22 E S Safety information... 8 Spatial resolution... 21, 24 Symbols T Technical specifications... T T Test equipment... Test setup W Wall stand holder T Exposure index... 20, 22 G General information... 2 I Intended use... 7 L List of figures... 6 Literature Luminance... 20, 23 M Maintenance Maximum deviations O Optical density... 20, 23 43