User Manual X-Check FLU L981319

Transcription

1 User Manual X-Check FLU Contents Operating Manual Technical Manual Service Manual D /01 en Hn/Fr

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 measuring function (MDD). 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. 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 service, support or warranty please contact your supplier. 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. No part of the technical documentation may be reproduced without written permission from PTW-Freiburg. PTW-Freiburg is registered manufacturer according to the ElektroG (Elektro- und Elektronikgeräte-Gesetz). Elektro-Altgeräte-Register (EAR) Registration number DE 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, PTW-Freiburg works in strict accordance with a quality management system which is continuously updated according to national and international standards. PTW-FREIBURG Physikalisch-Technische Werkstätten Dr. Pychlau GmbH Lörracher Str FREIBURG GERMANY Phone: Fax: info@ptw.de 2 D /01 en

3 Contents Contents General Information 2 Contents 3 Illustrations 4 Intended Use 5 Safety Information 5 Operating Manual 9 1 Description of the X-Check FLU Test Object General X-Check FLU base package X-Check FLU structure plate Mechanical accessories Attenuation plates Alternative absorber Mounting sequence 12 2 Performance Tests Radiation output from the X-ray source assembly Test equipment Test execution Evaluation and interpretation of results Test of Grey-scale Image, Automatic Intensity Control, Threshold Contrast and Optical Density Test equipment Test execution Evaluation and interpretation of results Resolution of high-contrast detail Test equipment Test execution Evaluation and interpretation of results Frequency of constancy tests 18 Technical Manual 19 3 Technical Specifications 19 D /01 en 3

4 Illustrations Service Manual 21 4 Cleaning 21 5 Preventive Maintenance 21 6 Disposal of the Product 21 Literature 22 Appendix: Low Contrast Test at differing kvp`s and levels of filtration 23 Index 25 Illustrations Figure 1: Definition of patient environment 8 Figure 2: X-Check FLU, construction with 30 PMMA attenuation phantom 10 Figure 3: X-Check FLU, structure plate 11 Figure 4: Measurement of radiation output from the X-ray source assembly under automatic exposure control. 13 Figure 5: Test equipment for Grey-scale image and Threshold contrast test D /01 en

5 Intended Use Intended Use Safety Information The Phantom X-Check FLU is a test object for constancy tests. It is an universal test tool, including test objects for testing of geometrical characteristics, high resolution, grey scale, low contrast and optical densities. All of the characteristics correspond to the specifications required for the constancy checks in IEC Introduction Quality assurance (QA) helps to ensure high quality of diagnostic X-ray equipment. A comprehensive survey of all components and steps, which must be included into a QA program, like preconditions, organization, training requirements etc. is given by a guide of the WHO. Following aims of QA are mentioned: a) Decrease of costs b) Reduction of patients' exposure c) Insurance of an optimal image quality Especially the QA part Technical components of image production - X-ray equipment and films including development is of high importance. The international quality standard IEC demands the performance of constancy tests at X-ray equipment in regular intervals. Required test tools and test procedures are described in the mentioned standard. The instruction manual describes the use of the test object X-Check FLU in constancy tests of equipment for indirect radioscopy and indirect radiography based on IEC 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 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 hazard Signal Words DANGER Indicates an iinent 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 could result in minor injury or product / property damage. NOTE Provides useful information to assure that you get the most from your equipment. D /01 en 5

6 Safety Information Safety Information DANGER Operation in areas where an explosion hazard may occur or in oxygen-enriched atmospheres Explosion Hazard! The product is not suitable for operation in areas of risk where an explosion hazard may occur. Explosion hazards may be caused by the use of combustible anaesthetics, skin-cleansing agents and disinfectants. Furthermore the product is not suitable for application in oxygen-enriched atmospheres. The atmosphere is considered to be oxygen-enriched when more than 25 % of oxygen or nitrous oxide is added to the ambient air. WARNING Improper handling. 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. Exclusion of operation in the patient environment: Neither the product nor any peripheral devices may be operated in the patient environment (refer to Figure 1). WARNING Packaging material is a source of risk. Suffocation Hazard! Dispose of the packaging material, observing the applicable waste-control regulations. Keep the packaging material out of children's reach. WARNING Confusion of chemicals. Risk of Poisoning! Chemicals required for application or maintenance of the device, for instance, must under all circumstances be stored, prepared, and kept at hand in their specific containers. Failure to observe this instruction may result in severe consequences. WARNING Hazards originating from other system components. Patient Hazard! Equipment Damage! Observe the safety information provided in the user manuals of the system components. Exclusion of operation as device with patient contact: The device is not intended for use in direct contact with the patient. Neither the device nor any peripheral device may have contact to the patient. Never touch the patient and open connectors of the device at the same time. 6 D /01 en

7 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 intended protection can be reduced. CAUTION Operation under inadequate ambient conditions. Equipment Damage! Always observe the ambient conditions as indicated in the `Technical Specifications`. 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. D /01 en 7

8 Safety Information Figure 1: Definition of patient environment 8 D /01 en

9 Operating Manual Description of the X-Check FLU Test Object Operating Manual 1 Description of the X-Check FLU Test Object 1.1 General The X-Check FLU test object is a universal test tool, including objects for testing of geometrical characteristics, high resolution, grey scale, low contrast and optical densities. All of the characteristics correspond to the specifications required for the constancy checks in IEC It is constructed in a compatible way to the X-Check RAD (IEC ) and thus one set of attenuation plates may be used for both applications. Different tissue simulating and attenuating plates are available for particular applications. Using the 30 PMMA attenuation layer the X- Check FLU is physically constructed in a compatible way to the phantom NORMI 4 with its 30 PMMA layer. This phantom has been established as a phantom for the German Standard DIN since more than 15 years. With its outer dimensions of 300 x 300 it has been established as a practical tool for carrying out the constancy tests. Further it is possible to use the structure plate in conjunction with an aluminum attenuation plate of 25 thickness and longer distance supports. This combination also allows measurements according to IEC (acceptance tests), as well. The phantom can be attached to the collimator by adaptation rails. This solution allows fast arrangements for overcouch tubes. The other aluminum plate can be mounted to the structure plate by means of supports of 28 cm to be used for undercouch tubes. D /01 en 9

10 1.2 X-Check FLU base package X-Check FLU Operating Manual Description of the X-Check FLU Test Object Figure 2: X-Check FLU, construction with 30 PMMA attenuation plate 1 Adapter for structure plate and attenuation plates (4 brackets). 2 Copper layer Milled screw 4 Milled based screw 5 Distance supports 6 PMMA attenuation plate 30 7 X-Check FLU; structure plate with thickness X-Check FLU structure plate Grey-scale field test contains 3 circles with different attenuation properties. 2 Circles are placed within squares of 2 x 2 cm. Hardened by the attenuation phantom these two objects produce two contrast steps of about 10 % each. The X-ray images of the two squares appear on the image display device as a dark spot surrounded by a less dark background. The area in the middle of the two squares can be used as a reference for the low contrast test. The two circles within the squares can be used as a reference point for optical density measurement. white spot surrounded by an even whiter background and 10 D /01 en

11 Operating Manual Description of the X-Check FLU Test Object Low-contrast test contains 19 circles of different depths, drilled into an aluminum block; hardened by the attenuation phantom (30 PMMA Cu or 25 Al), they produce contrasts for X- radiation varying from 0.5 % to 20 % at 70 kv and 2.5 inherent filtration. Grey scale and low contrast tests are drilled out on one aluminum plate, so that absolute precision of the contrast steps can be guaranteed. The steps are similar to following (at 70 kv): 0.5 %, 1.0 %, 1.4 %, 1.8 %, 2.3 %, 2,7 %, 3.3 %, 3.9 %, 4.5 %, 5.5 %, 6.6 %, 7.6 %, 8.6 %, 10.8 %, 12.3 %, 14.5 %, 16.0 %, 18.0 %, 20.0 %. Matrix with intervals of 1 cm made of radiation absorbing material for test of image geometry. High resolution test pattern comprises a lead-foil raster of 21 orthogonal groups with 5 lines each; provides spatial frequencies from 0.5 LP / to 5.0 LP / according to IEC Following line pairs per are built-in: 0.5 LP / 0.56 LP / 0.63 LP / 0.71 LP / 0.8 LP / 0.9 LP / 1.0 LP / 1.12 LP / 1.25 LP / 1.4 LP / 1.6 LP / 1.8 LP / 2.0 LP / 2.24 LP / 2.5 LP / 2.8 LP / 3.15 LP / 3.55 LP / 4.0 LP / 4.5 LP / 5.0 LP / If required, the 1.3 copper-plate can be used as a correction filter and can be mounted at a distance of 175 in front of the high resolution test pattern, close to the X-ray source assembly Figure 3: X-Check FLU, structure plate 1 High resolution test pattern 2 Grey scale field test 3 Low contrast test D /01 en 11

12 Operating Manual Description of the X-Check FLU Test Object Mechanical accessories These accessories can be used with the standard attenuation phantom Distance supports 184 long (4 pieces) Adapter for structure plate and attenuation plates (4 brackets) Milled screw (8 pieces) Milled base screw (8 pieces) Milled screw for mounting chains (2 pieces) Chains for mounting at a bucky unit (not visible in the picture) Attenuation plates 30 PMMA attenuation plate size 300 x 300 ; It can be positioned close to the patient support or at a distance of 173 or 203 above. The construction also allows the application with X-ray equipment with X-ray source assemblies under the patient support. 1.3 copper layer It is used to reduce the thickness and mass of the attenuation phantom; it can be attached to the 30 attenuation phantom to provide a hardening (at 70 kv) close to the combination mentioned in the specifications of IEC The 30 PMMA-plate and if necessary the additional 1.3 copper layer shall be used as a substitute for the patient to provide appropriate hardening for carrying out the grey-scale and low contrast test and to provide appropriate attenuation and hardening of the X-ray beam interacting with the automatic exposure control system. 1.3 Alternative absorber Absorber for overcouch tubes, L accessory for measurements in attenuated diagnostic X-ray beams. Absorber made of Al 99.5, mounted at the collimator. Dimensions 163 x 163 x 25. For rail distance 177. Absorber for overcouch tubes, L accessory for measurements in attenuated diagnostic X-ray beams. Absorber made of Al 99.5, mounted at the collimator. Dimensions 163 x 163 x 25. For rail distance 170. Absorber for undercouch tubes, L98191x can also be used for overcouch tubes and Bucky units. For use with X-Check test objects. Al absorber 250 x 250 x 25. Includes 4 supports 25 cm in length. 1.4 Mounting sequence For an easy mounting of the components please follow the subsequent points. First assemble the brackets to the structure plate as well as to the attenuation plates using the milled base screws. Then fix the 4 distance supports at the brackets on the structure plate using the milled screws. Finally put the attenuation plates with brackets onto the 4 distance supports and fix it using the milled screws. 12 D /01 en

13 Operating Manual Performance Tests 2 Performance Tests Test execution 2.1 Radiation output from the X- ray source assembly Test equipment For performing the measurements use a PTW diagnostic dosemeter CONNY II, DIADOS E or DIADOS with detector, since these dosemeters have an overall reproducibility better than 5 % (including long-term stability, instrument noise and read-out ability) according to IEC Use the 30 PMMA-phantom and if necessary the additional 1.3 copper layer as a substitute for the patient, to provide appropriate attenuation and hardening of the X-ray beam interacting with the automatic exposure control system. Place the detector in the radiation beam emerging from the X-ray source assembly. Measurement geometry shall ensure that the distance of the detector from the focal spot and the position of the detector within the radiation field are reproducible to ± 1 % of the focal spot to detector distance used in the initial constancy test. The same radiation field size shall be used. Whenever possible, carry out this test under both manual and automatic exposure control. alternative: Absorber, 25 Al detector (1.3 Cu) 30 PMMA or 25 Al phantom X-ray image intensifier Figure 4: Measurement of radiation output from the X-ray source assembly under automatic exposure control. D /01 en 13

14 Operating Manual Performance Tests Testing under manual control For testing under manual control, use the loading factors which are identical to those used in the initial constancy test. Record the reading of the dosemeter Testing under automatic exposure control For testing under automatic exposure control, arrange the X-ray source assembly and the X- ray image receptor as in normal clinical praxis. Place the attenuation plate between the detector of the dosemeter and the detectors of the automatic control system (see Figure 2), so as not to affect the operation of the automatic control system. For each X-ray system a specific area for positioning the detector has to be chosen to minimize that effect. NOTE The area for positioning the detector on the phantom can be marked by a waterproof pen or by a sticker. Fix the detector at a special place where the measurement will not be affected by an unforeseen detector moving. For fixing the detector we recoend to use a tape which is adhesive on both sides or a velcro fastening from which one side can be fixed to the detector and the other side to the phantom or to an auxiliary thin plate which can be positioned itself onto the patient couch (if no phantom is used) Evaluation and interpretation of results Compare the measured values of radiation output with the established baseline values. Under manual control the radiation output should be within ± 20 % of the baseline values. Under automatic exposure control the criteria to be applied depend on the material used in the attenuation plate. If only the 30 PMMA attenuation plate or the aluminum plate is used the radiation output should be within the range + 25 % to 20 % of the baseline values. If an additional copper plate is used, the action levels for the radiation output should be within ± 25 % of the baseline values. If the system fails to meet the criteria, please follow the guidance given in IEC NOTE A gradual decrease in the radiation output is to be expected as a result of aging of the X-ray tube. In order to allow for this, it will be necessary from time to time to determine new baseline values. This holds especially for testing under manual control, whereas for automatic exposure control a decrease in the radiation output is compensated and cannot be detected. Record the reading of the dosemeter. NOTE The sensitivity of DIADOS, DIADOS E and CONNY II allows to measure behind a phantom as well. For example measurements are possible behind the absorber T42011, a 25 Al plate which can be attached to the collimator of the X- ray source assembly (see ordering information, options). It can be used alternatively to the attenuation phantom, see Figure D /01 en

15 Operating Manual Performance Tests 2.2 Test of Grey-scale Image, Automatic Intensity Control, Threshold Contrast and Optical Density Test equipment For the X-Check FLU measuring arrangement see Figure 1 and Figure 4: structure plate, 30 PMMA attenuation plate copper layer or 25 Al plate (without copper layer), 4 distance supports and mounting brackets Test execution Place the X-Check FLU test object as shown in Figure 4 onto the patient support. If necessary, turn around the test object and turn the X-ray image intensifier or the serial changer to the top to be able to position the structure plate as close as possible to the image intensifier. Ensure that the test device is in the center of the field of the X-ray image intensifier and has the same orientation with respect to the X-ray image intensifier as the one used in the initial constancy test. Set the distance between the focal spot and the input surface of the X-ray image intensifier to that specified for the most recent initial constancy test. Select the largest field size available of the X-ray image intensifier and collimate the X-ray beam to the main dimensions of the test device. Operate the radioscopic unit using the manual settings of X-ray tube voltage and X-ray tube current specified for the initial constancy test; with window levels and image handling parameters (edge enhancement etc.) as specified in the initial constancy test; under automatic intensity control NOTE Usually settings are chosen which are similar to those used in clinical practice. 30 PMMA + 25 Al or 1.3 Cu structure plate X-Check FLU X-ray image intensifier Figure 5: Test equipment for Grey-scale image and Threshold contrast test. D /01 en 15

16 Operating Manual Performance Tests Stand directly in front of the image display device and observe the image details visible on the image display device under the room lighting conditions used during the initial constancy test. For threshold contrast test, where applicable, repeat the test procedure using the image storage system operating at the same settings as used in the initial constancy test Evaluation and interpretation of results Grey-scale image and automatic intensity control Check the visibility of both the white and black spots of the grey-scale field test on the image display device. Record the indicated values of X-ray tube voltage and X-ray tube current during radioscopy under automatic intensity control. Both the black and white spots shall be equally visible on the image display device. The indicated value of X-ray tube voltage, if provided by the equipment, shall be within ± 5 kv of the baseline value. The indicated value of X-ray tube current, if provided by the equipment, shall be within ± 20 % of the baseline value Threshold contrast for detail of large size Count the number of circles which are just perceptible at the low-contrast test: on the image display device during radioscopy on the image display device when using the storage facility The number of disks visible shall not differ more than one from the number recorded at the initial constancy test. If the system fails to meet the criterion, please follow the guidance given in IEC Measurement of optical density at the radiogram If a radiogram is made the two circles within the squares identify the specific points were measurements of optical density are carried out. Therefore use the DensiX densitometer. The optical density differences should be within ± 0.10 of the baseline values. If the system fails to meet the criterion, please follow the guidance given in IEC If both the black and white spots are not equally visible, the desired degree of visibility may be restored by minor adjustments to the brightness and contrast controls of the image display device. If this action fails, or if the system fails to meet any of the other criteria, please follow the guidance given in IEC D /01 en

17 Operating Manual Performance Tests 2.3 Resolution of high-contrast detail This test checks the constancy of resolution of the X-ray equipment by producing a radiographic image of a high-contrast test device Test equipment The X-Check structure plate which provides a high resolution test pattern containing periodic patterns of radio-opaque materials; If a correction filter is required, the 1.3 copper plate can be used in conjunction with the high resolution test pattern Test execution If possible without making use of tools, remove the anti-scatter grid. The measuring geometry used in 2.2 (Figure 4) can be taken over, but the attenuation plates have to be removed. Assure that the main direction of the bars in the image forms an angle of approximately 45 with the lines on the image display device. Stand directly in front of the image display device and observe the image detail visible on the image display device under room lighting conditions as used in the initial constancy test. If available, repeat the procedures above while using the image storage system operating at the settings used in the initial constancy test Evaluation and interpretation of results Count the number of line pair groups which are adequately resolved on the image display device during radioscopy; on the image display device while the image storage facility is being used; on the radiogram. The number of groups of the resolution pattern that are visible should not be more than two and shall not be more than three less than in the initial constancy test. If the system fails to meet the criteria, please follow the guidance in IEC Select the same field sizes of the X-ray image intensifier as were used in the initial constancy test and collimate the X-ray beam to the main dimensions of the test pattern. Set the X-ray tube voltage to the same settings as specified in the initial constancy test. If the system cannot be operated under manual control, perform the test under automatic intensity control. The X-ray tube voltage should be set to about 70 kv, with the X-ray tube current at the highest possible setting that does not cause the image on the image display device to become too bright, for example to "whiteout". If "white-out" occurs, place a correction filter, e.g. the 1.3 copper layer in the X- ray beam close to the X-ray source assembly by means of the distance supports. D /01 en 17

18 Operating Manual Performance Tests 2.4 Frequency of constancy tests With reference to chapter 2.1 Radiation output from the X-ray source assembly Initially, a series of constancy tests should be carried out daily for at least one week in order to establish the baseline values by calculating the mean value of the output measurements. With reference to chapter 2.2 Test of Grey-scale Image, Automatic Intensity Control, Threshold Contrast and Optical Density and 2.3 Resolution of high-contrast detail Carry out the constancy tests according to the instructions for use as provided by the manufacturer. If no such information is provided, the constancy tests shall be performed at least quarterly under conditions specified in IEC Subsequently, the constancy tests should be repeated in a two-week cycle up to six months in order to obtain data regarding the reliability of the X- ray source assembly, high-voltage generator and automatic control system. Thereafter, the constancy tests shall be repeated according to the instructions for use as provided by the manufacturer. If no such information is provided, the constancy test shall be performed at least annually. 18 D /01 en

19 Technical Manual Technical Manual 3 Technical Specifications Only values with specified tolerances or limits are guaranteed. Values without tolerances are for information only. Device designation X-Check FLU Manufacturer Intended Use Components of X-Check FLU base package Weight Environmental conditions for operation Temperature Rel. humidity Atmospheric pressure Environmental conditions for transport and storage Temperature Rel. humidity Atmospheric pressure PTW-Freiburg Test object for constancy tests of fluoroscopic and indirect radio-graphic X-ray equipment according to IEC Structure plate X-Check FLU Adapter (bracket) for structure plates and attenuation plates (4 pieces required) PMMA attenuation plate, 300 x 300 x 30 Copper attenuation plate, 300 x 300 x 1.3 Distance supports 184 long (4 pieces required) Milled base screw (8 pieces required) Carrying case for X-Check FLU Structure plate approx. 1 kg complete base package approx. 6.6 kg ( ) C ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa ( ) C ( ) %, no condensation (max. 20 g/m³ absolute humidity) ( ) hpa D /01 en 19

20 Technical Manual Technical Specifications Figure 6: Components of X-Check FLU base package 20 D /01 en

21 Service Manual Cleaning Service Manual WARNING Improper execution of service tasks. Hazards to Persons! Equipment Damage! The following service tasks must only be performed by specially trained staff. Further service tasks may only be carried out by PTW-Freiburg or by persons authorized by PTW-Freiburg. 4 Cleaning WARNING Liquids have entered the device. Shock Hazard, Erroneous Measurement! The device must be thoroughly inspected by service personnel before being used again. CAUTION Disinfection of the surface with disinfectants on a phenol base or peroxide compounds. Equipment Damage! Do not use disinfectants on a phenol base or peroxide compounds to disinfect the surface. Wipe the product clean with a moist cloth. Liquids may, under no circumstances, penetrate the device. Do not spray the device. Due to its surface geometry, the product cannot be thoroughly disinfected. Furthermore, the product cannot be sterilized. 5 Preventive Maintenance Check before each use Before each use, visually inspect the device for signs of mechanical damage. If damages or malfunctions are identified, the device must be repaired before it is used again. The device does not require any other, regular maintenance measures. 6 Disposal of the Product The typical lifetime of device is about 10 years. At the end of the product life the device components must be disposed of in compliance with the applicable waste control regulations. The different materials must be separated and recycled as appropriate. Device contains components of lead. These components must be recycled according to local regulations. The cost for a potential return at the end of the product life time is to be borne by the customer. D /01 en 21

22 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 Radiation protection instrumentation Ambient and/or directional dose equivalent (rate) meters and/or monitors for beta, X and gaa radiation [4] IEC Evaluation and routine testing in medical imaging departments - Part 2-9 Constancy tests - Equipment for indirect radioscopy and indirect radiography [5] DIN 6868: Sicherung der Bildqualität in röntgendiagnostischen Betrieben, Part 1: Allgemeines [6] DIN 6868: Sicherung der Bildqualität in röntgendiagnostischen Betrieben, Part 58: Abnahmeprüfung an medizinischen Röntgen-Einrichtungen der Projektionsradiographie mit digitalen Bildempfängersystemen [7] Röntgenverordnung: Verordnung über den Schutz vor Schäden durch Röntgenstrahlen 22 D /01 en

23 Appendix: Low Contrast Test at differing kvp`s and levels of filtration Appendix: Low Contrast Test at differing kvp`s and levels of filtration The X-Check FLU low contrast test contains 19 circles of different depths. Hardened by the attenuation phantom (30 PMMA Cu), they produce contrasts varying from 0.5 % to 20 % at 70 kv and 2.5 inherent filtration. In detail, the steps are similar to following (at 70 kv and 2.5 inherent filtration): 0.5 %, 1.0 %, 1.4 %, 1.8 %, 2.3 %, 2,7 %, 3.3 %, 3.9 %, 4.5 %, 5.5 %, 6.6 %, 7.6 %, 8.6 %, 10.8 %, 12.3 %, 14.5 %, 16.0 %, 18.0 %, 20.0 %: Filter X-Check structure plate + 30 PMMA X-Check structure plate + 30 PMMA + 1 Cu X-Check structure plate + 30 PMMA + 1,3 Cu kvp ,68 % 0,64 % 0,61 % 0,57 % 0,58 % 0,52 % 0,48 % 0,45 % 0,58 % 0,47 % 0,46 % 0,44 % 2 1,40 % 1,30 % 1,23 % 1,15 % 1,13 % 1,05 % 0,97 % 0,98 % 1,04 % 1,01 % 0,93 % 0,89 % 3 1,95 % 1,83 % 1,72 % 1,62 % 1,59 % 1,46 % 1,35 % 1,28 % 1,48 % 1,40 % 1,31 % 1,25 % 4 2,55 % 2,38 % 2,21 % 2,08 % 2,05 % 1,87 % 1,74 % 1,66 % 1,92 % 1,80 % 1,70 % 1,61 % 5 3,27 % 3,04 % 2,84 % 2,67 % 2,59 % 2,40 % 2,23 % 2,11 % 2,44 % 2,30 % 2,17 % 2,05 % 6 3,87 % 3,56 % 3,33 % 3,13 % 3,05 % 2,81 % 2,62 % 2,49 % 2,89 % 2,69 % 2,53 % 2,40 % 7 4,72 % 4,38 % 4,09 % 3,84 % 3,72 % 3,44 % 3,21 % 3,10 % 3,55 % 3,30 % 3,11 % 2,95 % 8 5,61 % 5,19 % 4,82 % 4,54 % 4,43 % 4,07 % 3,79 % 3,63 % 4,22 % 3,91 % 3,68 % 3,48 % 9 6,46 % 6,00 % 5,58 % 5,24 % 5,09 % 4,71 % 4,38 % 4,15 % 4,89 % 4,52 % 4,25 % 4,02 % 10 7,94 % 7,36 % 6,86 % 6,44 % 6,26 % 5,77 % 5,37 % 5,14 % 6,00 % 5,57 % 5,20 % 4,93 % 11 9,60 % 8,90 % 8,27 % 7,76 % 7,52 % 6,95 % 6,46 % 6,12 % 7,25 % 6,68 % 6,27 % 5,93 % 12 11,13 % 10,29 % 9,56 % 8,98 % 8,68 % 8,02 % 7,45 % 7,10 % 8,36 % 7,72 % 7,22 % 6,84 % 13 12,66 % 11,68 % 10,87 % 10,19 % 9,85 % 9,08 % 8,46 % 8,01 % 9,47 % 8,76 % 8,19 % 7,75 % 14 16,06 % 14,81 % 13,75 % 12,90 % 12,44 % 11,46 % 10,67 % 10,12 % 11,99 % 11,06 % 10,33 % 9,76 % 15 18,44 % 16,98 % 15,77 % 14,77 % 14,24 % 13,09 % 12,19 % 11,56 % 13,69 % 12,64 % 11,79 % 11,15 % 16 21,96 % 20,23 % 18,75 % 17,56 % 16,87 % 15,53 % 14,43 % 13,67 % 16,28 % 14,97 % 13,97 % 13,18 % 17 24,38 % 22,46 % 20,82 % 19,48 % 18,71 % 17,19 % 15,97 % 15,11 % 17,99 % 16,59 % 15,45 % 14,64 % 18 27,70 % 25,50 % 23,60 % 22,06 % 21,13 % 19,43 % 18,03 % 17,07 % 20,36 % 18,74 % 17,44 % 16,44 % 19 35,30 % 32,40 % 29,93 % 27,93 % 26,64 % 24,86 % 22,72 % 21,37 % 25,68 % 23,55 % 21,91 % 20,71 % D /01 en 23

24 Appendix: Low Contrast Test at differing kvp`s and levels of filtration Filter X-Check structure plate + 30 PMMA + 1,5 Cu X-Check structure plate + 30 PMMA + 2 Cu X-Check structure plate + 30 PMMA + 2,5 Cu kvp ,53 % 0,49 % 0,45 % 0,43 % 0,51 % 0,48 % 0,44 % 0,42 % 0,53 % 0,48 % 0,46 % 0,42 % 2 1,07 % 0,99 % 0,93 % 0,87 % 1,05 % 0,96 % 0,89 % 0,84 % 1,00 % 0,93 % 0,83 % 0,83 % 3 1,50 % 1,38 % 1,29 % 1,21 % 1,46 % 1,34 % 1,23 % 1,19 % 1,42 % 1,30 % 1,20 % 1,16 % 4 1,92 % 1,78 % 1,67 % 1,58 % 1,87 % 1,72 % 1,58 % 1,53 % 1,83 % 1,69 % 1,57 % 1,48 % 5 2,47 % 2,27 % 2,15 % 2,01 % 2,39 % 2,21 % 2,07 % 1,95 % 2,36 % 2,17 % 2,04 % 1,90 % 6 2,90 % 2,67 % 2,50 % 2,37 % 2,82 % 2,59 % 2,41 % 2,29 % 2,78 % 2,54 % 2,31 % 2,23 % 7 3,55 % 3,26 % 3,05 % 2,89 % 3,44 % 3,17 % 2,95 % 2,79 % 3,37 % 3,10 % 2,87 % 2,74 % 8 4,19 % 3,85 % 3,61 % 3,43 % 4,06 % 3,75 % 3,50 % 3,32 % 3,96 % 3,67 % 3,43 % 3,25 % 9 4,84 % 4,50 % 4,19 % 3,95 % 4,70 % 4,32 % 4,04 % 3,82 % 4,61 % 4,23 % 3,98 % 3,71 % 10 5,94 % 5,48 % 5,12 % 4,84 % 5,75 % 5,30 % 4,92 % 4,69% 5,61 % 5,18 % 4,81 % 4,54 % 11 7,17 % 6,62 % 6,16 % 5,83 % 6,91 % 6,37 % 5,96 % 5,64 % 6,73 % 6,22 % 5,83 % 5,47 % 12 8,24 % 7,61 % 7,12 % 6,72 % 7,98 % 7,32 % 6,84 % 6,51 % 7,80 % 7,18 % 6,67 % 6,35 % 13 9,31 % 8,65 % 8,05 % 7,62 % 9,04 % 8,38 % 7,78 % 7,35 % 8,80 % 8,13 % 7,59 % 7,19 % 14 11,76 % 10,87 % 10,15 % 9,60 % 11,42 % 10,49 % 9,80 % 9,27 % 11,10 % 10,24 % 9,54 % 9,04 % 15 13,47 % 12,45 % 11,59 % 10,96 % 13,04 % 11,97 % 11,18 % 10,59 % 12,70 % 11,69 % 10,93 % 10,29 % 16 16,04 % 14,72 % 13,73 % 12,95 % 15,46 % 14,19 % 13,24 % 12,51 % 15,06 % 13,84 % 12,87 % 12,19 % 17 17,75 % 16,30 % 15,17 % 14,32 % 17,10 % 15,66 % 14,62 % 13,83 % 16,66 % 15,31 % 14,26 % 13,49 % 18 19,99 % 18,43 % 17,14 % 16,16 % 19,33 % 17,78 % 16,49 % 15,62 % 18,84 % 17,28 % 16,11 % 15,35 % 19 25,23 % 23,12 % 21,50 % 20,28 % 24,31 % 22,32 % 20,73 % 19,57 % 23,69 % 21,69 % 20,19 % 19,05 % 24 D /01 en

25 Index Index C Calibration Cleaning D Disposal E Electromagnetic compatibility F Fuses G General information... 2 I Illustrations... 6 Intended use... 7 L Literature M Maintenance S Safety information... 7 Safety inspections Safety, electrical T Technical Inspection of the Measuring System Technical specifications W Warnings D /01 en 25