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Scope of this Manual

This manual contains information for safe and effective operation of the AGFA

CR Detectors, Plates and Cassettes: the CR HD5.x General/FLFS/AEC

detector, the CR HM5.x Mammo detector, the CR MD4.xR General/FLFS plate

and cassette and the CR MM3.xR Mammo plate and cassette.

| AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |

Introduction to this Manual

2322D EN 20180409 1008

Содержание CR HD5 AEC Series

Страница 1: ...AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR User Manual 2322D EN 20180409 1008 ...

Страница 2: ...on of the AGFA CR Detectors Plates and Cassettes 26 Description of the CR HD5 x General Detector and CR HD5 x FLFS Detector 27 Description of CR MD4 xR Plate and Cassette 29 Specific Application Description of CR Full Leg Full Spine FLFS cassette 31 Specific Application Description of the CR HD5 x AEC Detector 33 Description of CR HM5 x Mammo Detector 35 Description of CR MM3 xR Plate and Cassette...

Страница 3: ...ttes 54 Cleaning the Interior of the Mammo Cassette 55 Disinfecting the Cassettes 58 Approved disinfectants 59 Use of protective plastic envelope 59 Safety directions for disinfection 60 Technical Specifications 61 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Contents iii 2322D EN 20180409 1008 ...

Страница 4: ...ot be available for your local area Please contact your local sales representative for availability information Agfa NV diligently strives to provide as accurate information as possible but shall not be responsible for any typographical error Agfa NV shall under no circumstances be liable for any damage arising from the use or inability to use any information apparatus method or process disclosed ...

Страница 5: ...is Manual Topics Scope of this Manual About the safety notices in this document Disclaimer AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to this Manual 5 2322D EN 20180409 1008 ...

Страница 6: ...ors Plates and Cassettes the CR HD5 x General FLFS AEC detector the CR HM5 x Mammo detector the CR MD4 xR General FLFS plate and cassette and the CR MM3 xR Mammo plate and cassette 6 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to this Manual 2322D EN 20180409 1008 ...

Страница 7: ...otice indicates a hazardous situation which can lead to a potential minor injury to a user engineer patient or any other person An instruction is a direction which if it is not followed can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution A prohibition is a direction which if it is not followed can cause damage to the equi...

Страница 8: ...cument To improve reliability function or design Agfa reserves the right to change the product without further notice This manual is provided without warranty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Note In the United States Federal law restricts this device to sale by or on the order of a physicia...

Страница 9: ...User Configuration System Documentation Product Complaints Compatibility Installation Environmental Protection Safety Directions AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to the AGFA CR Detectors Plates and Cassettes 9 2322D EN 20180409 1008 ...

Страница 10: ...e workstation It is intended that these devices are only operated in a radiological environment by qualified staff The CR HD5 x General detector and the CR MD4 xR plate and cassette are specifically designed for general radiography applications Topics Specific Application Full Leg Full Spine Specific Application CR Mammography Specific Application AEC cassettes without backscatter protection 10 AG...

Страница 11: ... but can also be used for general radiography applications CR HD5 x FLFS detectors and CR MD4 xR FLFS cassettes are to be used as described in the CR Full Leg Full Spine User Manual document 4408 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to the AGFA CR Detectors Plates and Cassettes 11 2322D EN 20180409 1008 ...

Страница 12: ...gulations For more information refer to the CR Mammography System User Manual document 2344 CR HM5 x Mammo detectors can be delivered with an IP Gain Calibration CD The contents of this CD the IP gain calibration file have to be uploaded to the NX workstation prior to use The IP gain calibration file can only be used with the plate or detector it has been delivered with 12 AGFA CR Detectors Plates...

Страница 13: ...only in combination with X ray modalities with an AEC system Automatic Exposure Control positioned behind the cassette as this is the case for e g specific trauma or pediatric X ray modalities AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to the AGFA CR Detectors Plates and Cassettes 13 2322D EN 20180409 1008 ...

Страница 14: ...lly handle the equipment and those who have authority over the equipment Before attempting to work with this equipment the user must read understand note and strictly observe all warnings cautions and safety markings on the equipment 14 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 15: ...tector CR HM5 x Mammo detector CR HD5 x AEC detector CR MD4 xR General plate and cassette CR MD4 xR FLFS cassette CR MM3 xR Mammo plate and cassette AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to the AGFA CR Detectors Plates and Cassettes 15 2322D EN 20180409 1008 ...

Страница 16: ...4 CR Full Leg Full Spine User Manual 4408 NX User Manual 4420 CR HM5 x User Documentation IP Gain Calibration CD The documentation shall be kept with the system for easy reference Technical documentation is available in the product service documentation which is available from your local support organization 16 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introducti...

Страница 17: ...ons and may have caused or contributed to a serious injury Agfa must be notified immediately by telephone fax or written correspondence to the following address Agfa Service Support local support addresses and phone numbers are listed on www agfa com Agfa Septestraat 27 2640 Mortsel Belgium Agfa Fax 32 3 444 7094 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduc...

Страница 18: ... software Version NX 2 0 8500 3 0 8500 or older CR HM5 x Mammo detector Without IP gain calibration file Configuration 2 NX software Version NX 2 0 8500 3 0 8500 SU1 or newer For plates or detectors that are delivered with an IP gain calibration file the IP gain calibration files must be loaded on the NX workstation CR HM5 x Mammo detector With or without IP gain calibration file How to retrieve t...

Страница 19: ...roblem Solving Table 2 Uploading the gain calibration file Problem A plate or detector is replaced or a new plate or detector is intro duced to the system without a certified Agfa service engineer being present Solution The IP gain calibration file has to be uploaded by the end user Procedure Follow the instructions on the IP Gain Calibration CD sleeve The IP gain calibration file is automatically...

Страница 20: ...a gain calibration file The cassette is not initialized properly The plate or detector can only be used after upgrade of the NX software Table 4 Finding the right gain calibration file Problem It is not clear which IP gain calibration CD belongs to which plate or detector Solution Match the identification values Procedure 1 Read the RF tag on the plate or detector The field Identifi cation contain...

Страница 21: ...cassettes combine the CR plate and CR Cassette recommendations Topics CR Plate CR Cassette AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to the AGFA CR Detectors Plates and Cassettes 21 2322D EN 20180409 1008 ...

Страница 22: ...rbon dioxide carbon monoxide and small concentrations of organic and inorganic degradation products Disposal Waste codes applicable for European Union Plates containing storage phosphor Product 09 01 99 Waste not otherwise specified Packaging 15 01 06 Mixed packaging Information applicable for USA Plates containing barium Product These plates when discarded are a hazardous waste EPA waste code D00...

Страница 23: ...onents other than those mentioned in 16 02 09 to 16 02 12 16 02 14 Discarded equipment other than those mentioned in 16 02 09 to 16 02 13 Packaging 15 01 06 Mixed packaging 15 01 06 Mixed packaging Information applicable for USA Cassettes containing lead Product These cassettes when discarded are a hazardous waste EPA waste code D008 under the Resource Conservation and Re covery Act RCRA due to th...

Страница 24: ...re that the measurement cells of the AEC are placed between cassette and X ray source For modalities with an AEC system positioned underneath the cassette use the HD5 x AEC detector Wrong response WARNING The Automatic Exposure Control device may give wrong response The CR detector or CR plates and cassettes causes X ray scattering during exposure which is also detected by the measurement cells of...

Страница 25: ...in accordance with the local regulations If no specific regulations are valid a regular quality control of the complete plates and cassettes inventory applied at least quarterly with the Agfa Auto QC tools Auto QC2 Auto QC Mammo or with an equivalent tool is required AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Introduction to the AGFA CR Detectors Plates and Casset...

Страница 26: ...lates Topics Description of the CR HD5 x General Detector and CR HD5 x FLFS Detector Description of CR MD4 xR Plate and Cassette Specific Application Description of CR Full Leg Full Spine FLFS cassette Specific Application Description of the CR HD5 x AEC Detector Description of CR HM5 x Mammo Detector Description of CR MM3 xR Plate and Cassette Special Application Description of CR Mammo Cassette ...

Страница 27: ...ine FLFS cassette The labeling and layout of the CR HD5 x detectors are illustrated below The tube side is black 1 2 3 6 5 4 1 Clip 2 Detector format 3 Lock to open the cassette 4 Shutter opening mechanism 5 Rubber corner protections 6 Label Figure 1 General view on CR HD5 x General Detector Figure 2 Detail view on CR HD5 x General FLFS Detector label AGFA CR Detectors Plates and Cassettes CR HD5 ...

Страница 28: ...ce 6 Lead foil 7 Cassette body grey 8 IP Label 9 RF Tag Figure 3 View on protruding image plate within CR HD5 x General Detector 28 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 29: ...n Specific Application Description of CR Full Leg Full Spine FLFS cassette 1 2 3 5 4 1 Clip 2 Detector format 3 Lock to open and close the cassette 4 Shutter opening mechanism 5 Label Figure 4 General view on the CR MD4 xR General Plate and Cassette Figure 5 Detail view on CR MD4 xR General FLFS Plate and Cassette label AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR D...

Страница 30: ...all labels of the cassettes 1 Cassette orientation marker 2 Black tube side 3 Fleece 4 Powder phosphor plate 5 Fleece 6 Lead foil 7 Cassette body red 8 IP Label 9 RF Tag Figure 6 Cross section CR MD4 xR General Cassette 30 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 31: ...nd yellow dots The NX workstation is capable of stitching images made with detectors or cassettes of the same type and scan resolution only E g it is not possible to stitch images made with HD5 x FLFS detectors and MD4 xR FLFS cassettes or images made with MD4 xR FLFS and MD4 xR SR FLFS cassettes Limitations CR FLFS detectors cassettes can be used for other than Full Leg or Full Spine imaging howe...

Страница 32: ...er areas Stitching area The stitching area of FLFS images contains certain artifacts such as cassette border stitching line and as a consequence the image quality is not perfect 32 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 33: ... 8 General view on the CR HD5 x AEC Detector It is intended to use the CR HD5 x AEC Detectors for general radiography applications only in combination with X ray modalities with an AEC system positioned behind the cassette as this is the case for e g specific trauma or pediatric X ray modalities Figure 9 Detail view on CR HD5 x AEC Detector label AGFA CR Detectors Plates and Cassettes CR HD5 x CR ...

Страница 34: ...el 8 RF Tag Figure 10 View on protruding image plate within CR HD5 x AEC Detector CR HD5 x AEC detectors are not equipped with a lead foil backscatter protection which will cause a significant reduction of image quality if used in other applications than in the cassette support or bucky tray of X ray modalities specified for general radiography applications 34 AGFA CR Detectors Plates and Cassette...

Страница 35: ...ammo Cassette 1 2 4 6 3 5 1 Clip 2 Detector format 3 Opening mechanism with status indicator 4 Lock to open and close the cassette 5 Shutter opening mechanism 6 Label Figure 11 General view on the CR HM5 x Mammo Detector Figure 12 Detail view on CR HM5 x Mammo Detector label AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and...

Страница 36: ...R HM5 x Mammo is subject to change 1 Chest wall side marker 2 Black tube side 3 Fleece 4 Needle phosphor plate 5 Fleece 6 Cassette body grey 7 IP Label 8 RF Tag Figure 13 Cross section CR HM5 x Mammo Detector 36 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 37: ...de 2 Label indicating tube side of the cassette Figure 14 Orientation markers on the CR HM5 x Mammo Detector AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and Cassettes 37 2322D EN 20180409 1008 ...

Страница 38: ...o Cassette 1 3 4 6 2 5 1 Clip 2 Detector format 3 Opening mechanism with status indicator 4 Lock to open and close the cassette 5 Shutter opening mechanism 6 Label Figure 15 General view on the CR MM3 xR Plate and Cassette Figure 16 Detail view on CR MM3 xR Mammo plate and cassette label 38 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Dete...

Страница 39: ...xR Mammo is subject to change 1 Chest wall side marker 2 Black tube side 3 Fleece 4 Needle phosphor plate 5 Fleece 6 Cassette body red 7 IP Label 8 RF Tag Figure 17 Cross section CR MM3 xR Mammo plate and cassette AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and Cassettes 39 2322D EN 20180409 1008 ...

Страница 40: ...Label indicating tube side of the cassette Figure 18 Orientation markers on the CR MM3 xR Mammo plate and cassette 40 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Description of the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 41: ...te 3 Shutter opening mechanism 4 Label Figure 19 General view on the CR Mammo cassette CR Mammo cassettes are specifically designed for the mammography application and are easily distinguishable from CR General cassettes by their label CR HM5 x Mammo detectors and CR MM3 xR cassettes are not equipped with a lead foil back scatter protection which will cause a significant reduction of image quality...

Страница 42: ...rst Use and Normal Operation Storage and Transport Operation Conditions Cleaning Disinfecting the Cassettes 42 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 43: ...s this might damage the cassette and plate It is good practice to check the integrity of the cassette and plate after a cassette drop Observe great care when handling the detectors The needle detector is shock sensitive and drops should be avoided When the detector has been dropped put it aside and contact your local service to check for func tionality CAUTION Do not use the detector again a corru...

Страница 44: ...k tube side of the cassette 2 Red cassette orientation marker Figure 20 Skull AP Portrait 1 Black tube side of the cassette 2 Red cassette orientation marker Figure 21 Chest PA Landscape 44 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 45: ...2 Red cassette orientation marker pointing towards the chest wall side Figure 22 Mammography AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates and Cassettes 45 2322D EN 20180409 1008 ...

Страница 46: ...he cassette surface The cassette must be lying on a flat and stable floor For foot exams the patient should always stand in the center of the cassette 46 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates and Cassettes 2322D EN 20180409 1008 ...

Страница 47: ...ke the precautions necessary to ensure that the CR detectors and CR plates and cassettes remain protected from impact The gain calibration CD and the CD sleeve are an integral part of the corresponding CR Mammography cassette and plate or detector It is necessary to store the gain calibration CD accordingly In case of loss of the gain calibration CD contact Agfa service personnel AGFA CR Detectors...

Страница 48: ... CR detectors and CR plates and cassettes Avoid UV radiation or direct sunlight on the CR detectors and CR plates and cassettes The storage of CR detectors and CR plates and cassettes shall be protected against radiation in such a way that the annual dose rate at the place of installation will not exceed 1m Sv a Use plastic envelops to protect the CR detectors and CR cassettes against contact with...

Страница 49: ...assettes Cleaning the Cassettes of the CR Detectors Plates and Cassettes Cleaning the Interior of the Mammo Cassette AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates and Cassettes 49 2322D EN 20180409 1008 ...

Страница 50: ...other solution on the image plate The inner lining of the CR detectors is made of fleece This ensures a high degree of protection against electrostatic charging and dust collection on the image plates Nonetheless it is recommended to clean the image plates of the CR HD5 x detectors and CR MD 4 xR plates and cassettes quarterly using the following procedure The CR MM3 xR image plate and the image p...

Страница 51: ...w By putting the plate on the cassette so that the hooks are hanging over the border of the cassette a bending of the image plate is avoided 6 For CR MD4 xR and CR HD5 x only use AGFA CR Phosphor Plate Cleaner and a soft lint free cellulose cloth or Polynit wipes to clean the plate For CR MM3 xR and CR HM5 x only use AGFA CR Phosphor Plate Cleaner and Polynit wipes to clean the plate AGFA CR Detec...

Страница 52: ...ers purchased from Agfa or an Agfa certified dealer to clean the plates WARNING If CR Phosphor Plate Cleaner is used do not pour it directly onto the image plate 7 Wait approximately 10 minutes until the surface is dry before putting the plate back in the cassette 8 Put the image plate back into the cassette Verify that the white phosphor side is oriented to the black tube side of the cassette and...

Страница 53: ...tte The label on the image plate must correspond to the label on the cassette 9 When the image plate is completely inside proceed as follows First insert the key into the cassette Then close the shutter 10 Remove the key Note After cleaning it is necessary to erase the detector before use AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Pl...

Страница 54: ...the surface of the cassette as liquids could enter and damage the cassette CAUTION Be sure that all surfaces are thoroughly dry before returning the cassettes to use CAUTION Never use alcohol based cleaners or disinfectants ethanol isopropanol n propanol as these chemicals will cause damage to the cassette and the digitizer CAUTION Do not use AGFA CR Phosphor Plate Cleaner PROSAT wipes AGFA CURIX ...

Страница 55: ... 3 Turn the cassette around so that the black tube side faces upwards 4 Fix the shutter with both thumbs and let the image plate slide out carefully onto the table Make sure that the surface of the plate is not scratched 5 Open the locks on the right and left side of the cassette AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates and ...

Страница 56: ...eat out loose particles 8 Put the top and the tube side part together Make sure that the tube side part slides correctly in the top part 9 Slide the top part and the tube side part together 10 Close the locks on the right and left side of the cassette 56 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates and Cassettes 2322D EN 2018040...

Страница 57: ... Note Make certain you put the correct image plate into the correct cassette The label on the image plate must correspond to the label on the cassette 12 When the image plate is completely inside proceed as follows First insert the key into the cassette Then close the shutter Lock the shutter with the key 13 Remove the key AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 x...

Страница 58: ...age the cassette UV disinfection is also not allowed For detailed information on how to apply disinfection refer to the instructions for use that are delivered with the disinfectant Topics Approved disinfectants Use of protective plastic envelope Safety directions for disinfection 58 AGFA CR Detectors Plates and Cassettes CR HD5 x CR MD4 xR CR HM5 x CR MM3 xR Handling the AGFA CR Detectors Plates ...

Страница 59: ...overview jsp ID 45445721 Use of protective plastic envelope If the cassette is used in an environment where disinfection is required or where it may get into contact with blood or other body fluids use plastic envelopes to protect the cassette from direct patient contact Make sure that the plastic envelope is not wrinkled to avoid the creases showing in the image AGFA CR Detectors Plates and Casse...

Страница 60: ...age plate and assure that the cassette is clean CAUTION Be sure that all surfaces are thoroughly dry before returning the equipment to use Disinfecting solution may cause skin irritation to the patient CAUTION Disinfecting solution or wipes may cause eye and skin irritation Wear gloves and wash hands with soap and water following use Consult the manufacturer s Material Safety Data Sheets MSDS and ...

Страница 61: ... is available as HR 1 and SR 2 35x43 24x30 18x24 Note Size 35x43 is available as HR 1 35x43 Weight cassette image plate 35x43 cm approximately 1900 g Cassette material Body ABS3 Tube side Carbon fiber Corners Estane Shutter PP4 Inner lining Fleece Backscatter pro tection 150 µ lead 150 µ lead Image plate mate rial CsBr Eu Compatible AGFA digitizer DX S DX G DX M Gain calibration AGFA CR Detectors ...

Страница 62: ...18x24 cm 540 g Cassette ma terial Body ABS ABS Tube side ABS ABS Corners Estane Estane Shutter PP PP Inner lining Fleece Fleece Backscatter protection 150 µ lead Image plate material BaSrFBrl Eu CSBr Eu BaSrFBrI Eu Compatible AGFA digitiz er DX G DX M DX M Gain calibra tion Can be required Scanned area and pixel matrix Refer to the digitizer specifications Environmental storage and trans port cond...

Страница 63: ...stored upon expo sure is still available The image re tention is better than 50 up to 24 hours after irradiation Identification Memory chip RF tag embedded in the image plate Compliance to ISO 40902001 Outer cassette dimensions are com pliant with ISO 4090 2001 HR1 High Resolution SR2 Standard Resolution ABS3 Acrylonitryl Butadiene Styrene PP4 Polypropylene AGFA CR Detectors Plates and Cassettes C...

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