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NORMI 13 (T42023)

Literature

D703.131.00/03 en

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 6868-13

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

Summary of Contents for NORMI 13

Page 1: ...D703 131 00 03 en 2015 09 ext Bru User Manual NORMI 13 T42023 Contents Operating Manual Technical Manual Service Manual...

Page 2: ...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 F...

Page 3: ...2023 General Information D703 131 00 03 en 3 PTW Freiburg Physikalisch Technische Werkst tten Dr Pychlau GmbH L rracher Str 7 79115 FREIBURG Germany Tel 49 761 49055 0 Fax 49 761 49055 70 info ptw de...

Page 4: ...3 Constancy Test 19 3 1 Purpose of the Constancy Test 19 3 2 Performing the Constancy Test 19 3 3 Verifying the Performance Characteristics 20 3 4 Assessing the Results 22 3 5 Constancy Test Report 25...

Page 5: ...NORMI 13 T42023 Table of Contents D703 131 00 03 en 5 Service Manual 39 7 Cleaning 39 8 Preventive Maintenance 40 9 Disposal of the Product 41 Literature 42 Index 43...

Page 6: ...or 17 Figure 4 Schematic test setup with Al absorber near tube 18 Figure 5 Bucky mounting device T20005 27 Figure 6 Bucky mounting device T20005 with test object 28 Figure 7 Wall stand holder T20018 3...

Page 7: ...the use of the NORMI 13 test object For detailed information about constancy tests please refer to the stan dard DIN 6868 13 WARNING Hazards originating from other system compo nents Hazards to Person...

Page 8: ...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 I...

Page 9: ...s 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 envi ronment Do not operate the produc...

Page 10: ...tec tion may be impaired Use the product only in conjunction with the products approved by PTW for this pur pose and or the products listed in the section Intended Use NOTICE To prevent equipment dama...

Page 11: ...ols on the Nameplate Symbol Description Refer to the user manual The product bears the CE mark Manufacturer and date of manu facture Reference number Serial number For a description of additional symb...

Page 12: ...NORMI 13 T42023 Safety Information 12 D703 131 00 03 en...

Page 13: ...e 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 a...

Page 14: ...object 1 Dose measurement area marking not radiopaque 2 Crosshairs for central alignment not radiopaque 3 X ray tube axis 4 Dynamic steps 5 Free area for signal normalization 6 X ray test pattern for...

Page 15: ...s 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 co...

Page 16: ...abel points down ward 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 tes...

Page 17: ...with PMMA absorber near image receptor 1 Additional optional copper plate 1 3 mm thick for measurements at 100 kV 2 Supporting plate patient couch 3 Entrance plane of the image receptor 4 X ray tube 5...

Page 18: ...7 3 6 5 4 Figure 4 Schematic test setup with Al absorber near tube 1 X ray tube 2 Collimator 3 Aluminum absorber 25 mm 4 NORMI 13 test object consisting of structure plate and 1 mm copper plate 5 Sup...

Page 19: ...olution coincidence of light field and radiation field artifacts 3 2 Performing the Constancy Test In order to take the effects of the X ray generator X ray tube application device and image recep tor...

Page 20: ...st The per mitted limit deviations of the individual perfor mance characteristics are detailed in section 3 4 Assessing the Results 3 3 1 Dose Measure the dose always in the same area 1 Figure 2 Mount...

Page 21: ...han 1000 pixels It has proven use ful 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...

Page 22: ...e Results The evaluation of the results is based on the fol lowing maximum deviations from the reference values determined in the initial state If the deviations exceed the permitted ranges measures m...

Page 23: ...step measured behind 0 65 mm of copper Pdose step 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 ac...

Page 24: ...83 0 45 16603 13483 14887 3 4 6 Spatial Resolution 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...

Page 25: ...ape edge sharpness and differ ence in optical density or luminance relative to the surrounding area could affect the diagnosis 3 5 Constancy Test Report The test report shall include the following min...

Page 26: ...des on the bucky mounting device T20005 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 dev...

Page 27: ...mounting device T20005 1 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 te...

Page 28: ...NORMI 13 T42023 Operating Manual Accessories 28 D703 131 00 03 en 1 2 Figure 6 Bucky mounting device T20005 with test object 1 Bucky mounting device 2 PMMA absorber with test object...

Page 29: ...y 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 n...

Page 30: ...NORMI 13 T42023 Operating Manual Accessories 30 D703 131 00 03 en 1 4 3 2 Figure 7 Wall stand holder T20018 1 Rail 2 Attachment point 3 Set screw 4 Nameplate...

Page 31: ...3 T42023 Operating Manual Accessories D703 131 00 03 en 31 1 3 2 Figure 8 Wall stand holder T20018 with bucky mounting device T20005 and test object 1 Bucky mounting device 2 Wall stand holder 3 Test...

Page 32: ...NORMI 13 T42023 Operating Manual Accessories 32 D703 131 00 03 en...

Page 33: ...es 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 co...

Page 34: ...5 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...

Page 35: ...rg 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...

Page 36: ...emperature Relative humidity Atmospheric pressure Maximum operating altitude 10 40 C 50 104 F 10 80 no condensation max 20 g m absolute humidity 700 1060 hPa 3000 m above sea level Transport and stora...

Page 37: ...k FLU NORMI 13 and the REX phantom to a bucky wall stand T20005 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 diag...

Page 38: ...NORMI 13 T42023 Technical Manual Accessories and Spare Parts 38 D703 131 00 03 en...

Page 39: ...rformed by PTW Freiburg or by a person authorized by PTW Freiburg 7 Cleaning General Information on Cleaning NOTICE To avoid surface damage do not use disinfec tants on a phenol base or peroxide compo...

Page 40: ...a solution with a quaternary ammonium compound Surfaces Clean the surfaces as follows Only wipe the product down Liquids must not be allowed to enter the product Do not immerse the product in water or...

Page 41: ...pprox 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 separate...

Page 42: ...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 6868 13 Image quality assuran...

Page 43: ...tion 21 24 D Description 13 Disposal 41 Dose 20 22 E Exposure index 20 22 G General information 2 I Intended use 7 L List of figures 6 Literature 42 Luminance 20 23 M Maintenance 40 Maximum deviations...

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