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DX-D 300

8207/050

User Manual

-D

300

-D

300

-D

300

0172E EN 20181116 1653

Summary of Contents for 8207/050

Page 1: ...DX D 300 8207 050 User Manual DX D 300 DX D 300 DX D 300 0172E EN 20181116 1653 ...

Page 2: ...1 DR Detector handle control buttons 22 U arm remote control 23 Portable DR Detector 24 Emergency stop button 25 Emergency shutdown power switch 26 System Documentation 27 The DX D 300 User Documentation 28 The Getting Started material 28 Options and Accessories 29 Anti scatter grids 29 Product Complaints 30 Compliance 31 General 32 Safety 32 Electromagnetic Compatibility 32 X Ray Safety 32 Classi...

Page 3: ... Step 3 Prepare the exposure 62 Step 4 Check the exposure settings 63 Step 5 Execute the exposure 64 Step 6 repeat steps 2 to 5 for the next subexposures 65 Step 7 digitize the image 66 Step 8 perform a quality control 67 Stopping the System 68 Problem solving 69 DR Detector is Exceeding the Maximum Working Temperature 70 DR Detector must be Recalibrated 70 DR Detector Problem 70 Technical Data 71...

Page 4: ...purpose Products and services may not 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 app...

Page 5: ...Introduction to this Manual Topics Scope About the safety notices in this document Disclaimer DX D 300 Introduction to this Manual 5 0172E EN 20181116 1653 ...

Page 6: ...n integrated Digital Radiography X Ray System to be used as medical diagnostic aid in General Radiography and emergency departments It explains how the different components of the DX D 300 System work together 6 DX D 300 Introduction to this Manual 0172E EN 20181116 1653 ...

Page 7: ... person CAUTION A caution safety notice 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 fol...

Page 8: ...issions that may appear in this document 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 sal...

Page 9: ...ontrols System Documentation Options and Accessories Product Complaints Compliance Connectivity Labels Messages Installation Cleaning and Disinfecting Patient data security Maintenance Environmental protection Safety Directions DX D 300 Introduction 9 0172E EN 20181116 1653 ...

Page 10: ...cess and view static X ray radiographic images of the skeleton including skull spinal column and extremities chest abdomen and other body parts on adult pediatric or neonatal patients Applications can be performed with the patient in the sitting standing or lying position This device is not intended for mammography applications 10 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 11: ...eceived proper training Users are those persons who actually 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 DX D 300 Introduction 11 0172E EN 20181116 1653 ...

Page 12: ...of the DR Detector bucky is restricted to DR Detectors with a size equivalent to 14x17 inch 43x35 cm and 43x35 CR Cassettes DR Detectors with a size equivalent to 17x17 inch 43x43 cm The DX D 300 configuration with integrated DR Detector automatically detects the grid status The DX D 300 configuration with DR Detector Bucky does not detect the grid status DX D 300 can be used in combination with C...

Page 13: ...3 X Ray Generator Control 4 Mobile table 5 DR Detector 6 U arm 7 Vertical column 8 X Ray tube Figure 1 DX D 300 configuration with integrated DR Detector DX D 300 Introduction 13 0172E EN 20181116 1653 ...

Page 14: ...D 300 operation controls Topics NX Application on the NX Workstation Software Console on the NX Workstation DR Detector Switch on the NX Workstation X Ray generator control in the operator room U arm control panel Control panel of the collimator DR Detector handle control buttons U arm remote control Portable DR Detector Emergency stop button Emergency shutdown power switch 14 DX D 300 Introductio...

Page 15: ...X application is used to define patient information select exposures and process images Figure 3 NX application The operation of the NX application is described in the NX User Manual document 4420 DX D 300 Introduction 15 0172E EN 20181116 1653 ...

Page 16: ...e Console is used to control X Ray generator settings and X Ray system position The software console has two screens Figure 4 X Ray generator controls Figure 5 X Ray system automatic po sitioning controls 16 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 17: ...n be used to activate another DR Detector It is positioned in the title bar of the NX application Battery status icon empty Meaning Full Medium Low Empty Wired DR Detector Wireless DR Detector is off or disconnected Connec tion status icon wi fi wired empty Meaning Good Low Bad Wired DR Detector DR Detec tor is off or disconnec ted DR Detec tor status icon blinking empty DX D 300 Introduction 17 0...

Page 18: ...tec tor is ready for expo sure DR Detector is initializing for exposure DR Detector is off or discon nected or in error DR Detector is inactive no thumbnail se lected 18 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 19: ...dswitch to make exposures Figure 6 the X Ray generator control box Following warning is printed on the X ray generator control box in English WARNING This x ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are observed DX D 300 Introduction 19 0172E EN 20181116 1653 ...

Page 20: ... the U arm the control panel with touch screen console and control buttons to control X Ray generator settings and U arm position MOVE SID DX D 300 Figure 7 U arm control panel 20 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 21: ...panel of the automatic collimator The display shows the dimensions of the collimated area and of the source image distance SID in centimeters or in inches Values in centimeter have no decimal point Values in inches have one digit after the decimal point DX D 300 Introduction 21 0172E EN 20181116 1653 ...

Page 22: ...DR Detector handle control buttons The DR Detector handle control buttons to control the U arm position SID Figure 9 DR Detector handle control buttons 22 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 23: ...U arm remote control The remote control to control U arm position SID TUBE ROTATION DETECTOR ROTATION MOVE F1 F2 Figure 10 U arm remote control DX D 300 Introduction 23 0172E EN 20181116 1653 ...

Page 24: ...arker For an overview of the operation controls of the DR Detector refer to the user manual of the DR Detector The DR Detector may come in contact with the patient Note DR Detectors that operate wireless contain an RF transmitter For detailed information refer to the DR Detector User Manual 24 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 25: ...on involving the patient operating personnel or any system component activate the emergency stop All motor driven system movements will be stopped For detailed information about the emergency button switch refer to the DX D 300 U arm User Manual document 0171 DX D 300 Introduction 25 0172E EN 20181116 1653 ...

Page 26: ...rs third parties or one of the units The entire system will be shut down and the power supply will be disconnected The emergency shutdown power switch for the room is typically located on the wall and easy to access often close to the power off switch of the X ray system It is installed and labeled by customer WARNING It must be ensured that the emergency switches are always freely accessible 26 D...

Page 27: ...ent Technical documentation is available in the product service documentation which is available from your local support organization The user documentation consists of DX D 300 User Documentation CD digital media NX User Documentation CD digital media User documentation for the supported DR Detectors Digitizer User Documentation CD digital media DX D 300 Owner s Manual paper binder Getting Starte...

Page 28: ...171 DX D Software Console User Manual document 0189 DX D Full Leg Full Spine User Manual document 0179 DX D DR Detector Calibration Key User Manual document 0134 The Getting Started material Getting Started with NX document 4417 Getting started with DX D 300 document 0170 28 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 29: ... U arm User Manual document 0171 Anti scatter grids Anti scatter grids are used to reduce scattered radiation and improve image quality Grids are available as an option Refer to the Agfa website for specifications on the anti scatter grids that have been found compatible with the system and the DR Detectors http www agfahealthcare com global en library overview jsp ID 54332498 DX D 300 Introductio...

Page 30: ... of this product must notify Agfa If the device malfunctions 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 30 DX D 300 Introduction 017...

Page 31: ...Compliance Topics General Safety Electromagnetic Compatibility X Ray Safety Classification DX D 300 Introduction 31 0172E EN 20181116 1653 ...

Page 32: ...rocedures required by 93 42 EEC Medical Device Directive European Council Directive 93 42 EEC on Medical Devices Safety IEC 60601 1 Electromagnetic Compatibility IEC 60601 1 2 X Ray Safety IEC 60601 1 3 IEC 60601 2 54 IEC 60601 2 7 For USA The system conforms to DHHS radiation Standards of 21CFR subchapter J as of the date of manufacture 32 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 33: ... with air or with oxygen or with nitrous oxide Equipment for use in environments where no flammable gases or vapors are present Mode of operation Suitable for continuous operation Labelling CE label 93 42 EEC Medical Devices Europe EN 60601 1 CUL label CSA 22 2 No 601 1 Canada Remarks for HF emission and immun ity This equipment generates uses and can radiate radio frequency RF en ergy and if not ...

Page 34: ... should not be disconnected or modified X ray Exposure Parameters The X Ray Exposure Parameters and DAP value can be configured to be displayed in the NX Image Detail pane printed in the film text box transmitted to the Archive transmitted to the RIS via MPPS Modality Performed Procedure Step The NX Image Detail pane displays the X Ray Exposure Parameters and DAP value for the individual sub expos...

Page 35: ...ate of manufacture Dangerous voltage Ionizing radiation The INMETRO label is positioned close to the type label Type label Mark Meaning Sample of subtype 8207 050 The type label is located near to the top of the vertical column The type label information for each combi nation of X ray tube and X ray generator is available in the technical data DX D 300 Introduction 35 0172E EN 20181116 1653 ...

Page 36: ...Mark Meaning The 21 CFR Subchapter J label is positioned close to the type label 36 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 37: ...ll that either a problem has occurred or that a requested action cannot be performed The user must read these messages carefully They will provide information on what to do from then on This will be either performing an action to resolve the problem or to contact the Agfa service organization Details on the contents of messages can be found in the service documentation which is available to Agfa s...

Page 38: ...ents of the DX D 300 are suitable for use within the patient environment Labeling the DR Detectors CAUTION Selecting the wrong DR detector can cause the need to retake the image On a configuration with multiple wireless DR Detectors of the same type it is required to apply labeling to the DR Detector containing a unique nickname for each DR Detector The nicknames must be configured on the NX works...

Page 39: ...s and equipment All existing universal precautions should be extended to avoid potential contaminations and to avoid patients coming into close contact with the device The user is responsible for selecting a disinfection procedure Topics Cleaning Disinfecting Approved disinfectants DX D 300 Introduction 39 0172E EN 20181116 1653 ...

Page 40: ...nt if required Do not use any corrosive dissolving or abrasive cleaning or polishing agents Make sure no liquid gets in the device CAUTION Clean the equipment with only a little moisture Note Do not open the equipment for cleaning No components inside the device require cleaning by the user Using unsuitable cleaning agents or methods can damage the property when surface becomes dull and brittle e ...

Page 41: ...sion protection If you plan to use other disinfectants approval of Agfa is needed before use as most disinfectants can damage the device UV disinfection is also not allowed Perform the procedure following the instructions for use the disposal instructions and the safety instructions of the selected disinfectants and tools and of the hospital DX D 300 Introduction 41 0172E EN 20181116 1653 ...

Page 42: ...ions on the disinfectants that have been found compatible with the cover material of the device and can be used on the outer surface of the device http www agfahealthcare com global en library overview jsp ID 41651138 42 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 43: ...ents are met and that the security of the patient data is guarded The user must define who can access patient data in which situations The user must have a strategy available on what to do with patient data in case of a disaster DX D 300 Introduction 43 0172E EN 20181116 1653 ...

Page 44: ...Maintenance Maintenance procedures are described in the DX D 300 Owner s Manual 44 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 45: ...ervice organization and or dealer By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product The recycling of materials will help to conserve natural resources Battery notice The battery symbol on the products and or accompanying document...

Page 46: ...fa certified field service engineer A non certified engineer performing a modification or service intervention on a medical device acts on his own responsibility and makes the warranty void WARNING Do not connect the equipment with anything other than specified Doing so may result in fire or electric shock WARNING Do not connect additional extensions cords or multiple power socket outlets to the s...

Page 47: ...ation of operating elements by patients WARNING System unavailability due to hardware or software failure If the product is used in critical clinical workflows a backup system has to be foreseen CAUTION Before moving the U arm out of horizontal position check that no objects are lying on the bucky that can fall off CAUTION Damaged grid Reduced image quality Please handle the grids with special car...

Page 48: ... be void if it is obvious that operating conditions are not met CAUTION Power failure can cause an image being lost Connect the workstation and the digitizer to an uninterrupted power supply UPS or an institutional standby generator 48 DX D 300 Introduction 0172E EN 20181116 1653 ...

Page 49: ...on Topics Starting DX D 300 Basic workflow using the DR Detector Workflow for Full Leg Full Spine examination Basic workflow using a CR cassette Stopping the System DX D 300 Operation 49 0172E EN 20181116 1653 ...

Page 50: ... the button on the U arm control box in the examination room The U arm unit and the touch screen console are powered on 3 Start NX The NX application and the software console are available on the NX workstation For detailed information about starting up NX refer to the NX User Manual document 4420 4 In a configuration with a wireless DR Detector power on the DR Detector attach a fully charged batt...

Page 51: ...r Topics Step 1 retrieve the patient info Step 2 Select the exposure Step 3 Prepare the exposure Step 4 Check the exposure settings Step 5 execute the exposure Step 6 perform a quality control DX D 300 Operation 51 0172E EN 20181116 1653 ...

Page 52: ...Step 1 retrieve the patient info At the NX workstation 1 When a new patient comes in define the patient info for the exam 2 Start the exam 52 DX D 300 Operation 0172E EN 20181116 1653 ...

Page 53: ...table DR Detector The selected DR Detector is activated The DR Detector Switch shows which DR Detector is active and shows its status The default X Ray exposure parameters for the selected exposure are sent to the modality and displayed on the software console The default U arm position for the selected exposure is sent to the modality and displayed on the software console for automatic positionin...

Page 54: ...ed WARNING Monitor the patient position hands feet fingers etc with special care to avoid injury to the patient caused by unit movements Patient hands must be kept away from mobile components of the unit Intravenous tubing catheters and other patient connected lines should be routed away from moving equipment WARNING Liquids ingressing the DR Detector may cause malfunction and contamination If the...

Page 55: ...the DR Detector is ready for exposure On a DR Detector that has a status indicator Check if the status of the DR Detector is ready for exposure If the status is not ready for exposure the DR Detector cannot be used for making an exposure In the operator room at the X ray generator console 1 Check if the exposure settings displayed on the console are suitable for the exposure 2 If other exposure va...

Page 56: ...NING Do not select another thumbnail until the preview image is visible in the active thumbnail In the operator room at the NX workstation The image is acquired from the DR detector and displayed in the thumbnail The actual X Ray exposure parameters are sent back from the generator to the NX workstation and are shown in the Image Detail pane If collimation is applied the image is automatically cro...

Page 57: ...on which quality control is to be performed 2 Prepare the image for diagnosis by using e g L R markers or annotations 3 If the image is OK send the image to a hardcopy printer and or PACS Picture Archiving and Communication System DX D 300 Operation 57 0172E EN 20181116 1653 ...

Page 58: ...Leg Full Spine User Manual document 0179 The availability of DR Full Leg Full Spine depends on the configuration of the system Refer to the CR Full Leg Full Spine User Manual document 4408 part of the NX User Documentation 58 DX D 300 Operation 0172E EN 20181116 1653 ...

Page 59: ...nsole It is advised to identify cassettes after the exposure as described in this workflow Topics Step 1 retrieve the patient info Step 2 select the exposure Step 3 Prepare the exposure Step 4 Check the exposure settings Step 5 Execute the exposure Step 6 repeat steps 2 to 5 for the next subexposures Step 7 digitize the image Step 8 perform a quality control DX D 300 Operation 59 0172E EN 20181116...

Page 60: ...Step 1 retrieve the patient info At the NX workstation 1 When a new patient comes in define the patient info for the exam 2 Start the exam 60 DX D 300 Operation 0172E EN 20181116 1653 ...

Page 61: ...ware console for automatic positioning of the U arm 2 Select the subexposure if more than one image is required for the same cassette If an image thumbnail is configured for multiple exposures on a single cassette another set of thumbnails is shown in the image detail pane Now you have to select one of these thumbnails to send the proper default X Ray exposure parameters to the modality for each e...

Page 62: ...sette and X Ray tube f Switch on the light localizer on the collimator Adapt collimation if required g Apply radiation protective measures for the patient if needed WARNING Monitor the patient position hands feet fingers etc with special care to avoid injury to the patient caused by unit movements Patient hands must be kept away from mobile components of the unit Intravenous tubing catheters and o...

Page 63: ...oom at the touch screen console 1 Check if the exposure settings displayed on the console are suitable for the exposure 2 If other exposure values are required than those defined in the NX exam use the console to overwrite the default defined exposure settings DX D 300 Operation 63 0172E EN 20181116 1653 ...

Page 64: ...rs are sent back from the console to the NX workstation and are shown in the Image Detail pane The actual X Ray exposure parameters and the Exposure Index EI value on the NX workstation can be used to monitor the performance of the Automatic Exposure Control of the X Ray system A green OK mark appears on all thumbnails for which the exposures are made and for which exposure settings are sent back ...

Page 65: ...Step 6 repeat steps 2 to 5 for the next subexposures DX D 300 Operation 65 0172E EN 20181116 1653 ...

Page 66: ... 1 Insert the cassette in the digitizer 2 Click ID in the examination window of NX Note You can also use an ID Tablet to identify the cassette and digitize it using any digitizer The image will appear in the image overview pane of the examination window 66 DX D 300 Operation 0172E EN 20181116 1653 ...

Page 67: ... the image on which quality control is to be performed 2 Prepare the image for diagnosis by using e g L R markers or annotations 3 If the image is OK send the image to a hardcopy printer and or PACS Picture Archiving and Communication System DX D 300 Operation 67 0172E EN 20181116 1653 ...

Page 68: ...ector If the power of the DR Detector remains on no warming up time will be needed after starting the NX workstation 2 Press the Power OFF button on the X ray generator control box to switch off the generator 3 In a configuration with a wireless DR Detector power off the DR Detector turn off the DR Detector remove the battery pack 4 Switch off the DR Generator Sync Note If the DR Detector is power...

Page 69: ...Problem solving Topics DR Detector is Exceeding the Maximum Working Temperature DR Detector must be Recalibrated DR Detector Problem DX D 300 Problem solving 69 0172E EN 20181116 1653 ...

Page 70: ... Start the NX workstation DR Detector must be Recalibrated Details A message is displayed on NX indicating that the DR De tector must be recalibrated Cause A DR Detector must be recalibrated at regular interval Brief Solution Follow the instructions in the DR System Key User Man ual to calibrate the DR Detector DX D DR Detector Calibration Key User Manual document 0134 DR Detector Problem Details ...

Page 71: ...l Data Topics DX D 300 Technical Data Fixed DR Detector Technical Data Fixed DR Detector Technical Data U Arm Technical Data Portable DR Detector Technical Data DX D 300 Technical Data 71 0172E EN 20181116 1653 ...

Page 72: ... Temperature ambient between 10 and 35 degrees Celsius Humidity non condensing between 30 and 75 relative humidity Atmospheric pressure between 70 and 106 kPa For overall system environmental conditions the environmental conditions of the DR Detector or image plate should be taken into account Refer to the related User Manual for environmental conditions for the DR Detector or image plate When usi...

Page 73: ...ction Operating voltage 90 240 V AC Mains fuse protection 6A Mains frequency 47 63 Hz Power consumption Maximum power consumption 45 W Warming up time 1 hour Throughput Maximum number of image acquisitions 150 acquisitions per hour Pixel Matrix Pixel size 139 µm H V Pixel matrix 3072 H x 3072 V Active pixel matrix 3056 H x 3056 V Fill factor 100 Detector type Amorphous Silicon Active area size 42 ...

Page 74: ...Reliability Estimated product life if regularly serviced and maintained according to Agfa instruc tions 100 000 RAD 74 DX D 300 Technical Data 0172E EN 20181116 1653 ...

Page 75: ...g voltage 24V 3 5A DC Warming up time 5 minutes Throughput Maximum number of image acquisitions 150 acquisitions per hour Reliability Estimated product life if regularly serviced and maintained according to Agfa instruc tions 100 Gy Pixel Matrix Pixel size 148 µm H V Pixel matrix 2880 H x 2880 V Active pixel matrix 2860 H x 2874 V Fill factor 100 Detector type Amorphous Silicon Active area size 42...

Page 76: ... Distance to calibration temperature 10 C 10 C Distance to calibration pressure 100 mbar 100 mbar Pixium RAD 4343 G E Environmental Conditions during normal operation Temperature ambient between 15 and 40 Celsius Humidity Atmospheric pressure Maximum altitude Refer to environmental conditions of the X ray sys tem minimum maximum Distance to calibration temperature 10 C 10 C Distance to calibration...

Page 77: ...urer Manufacturer U Arm Sedecal S A Polígono Ind Rio de Janeiro 9 13 28110 Algete Madrid Spain Refer to the DX D 300 U arm User Manual document 0171 for technical data of the U arm DX D 300 Technical Data 77 0172E EN 20181116 1653 ...

Page 78: ...Portable DR Detector Technical Data Refer to the DR Detector User Manual 78 DX D 300 Technical Data 0172E EN 20181116 1653 ...

Page 79: ...ent and the affected device power the equipment from a source different from that of the affected device consult the service engineers for further suggestions To comply with the regulations applicable to an electromagnetic interference for a Group 1 Class A Medical Device all interconnect cables to peripheral devices must be shielded and properly grounded Use of cables not properly shielded and gr...

Page 80: ...ic equipment RF emissions CISPR 11 Class A The device is suitable for use in all establishments other than domestic and those directly con nected to the public low voltage power supply network that sup plies buildings used for domes tic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flick er emissions IEC 61000 3 3 Complies Note In accordance with Standard IEC 61601 1 2 the...

Page 81: ...Surge IEC 61000 4 5 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth The quality of the voltage supplied should correspond to that of a typical com mercial or clinical en vironment Voltage dips short inter ruptions and voltage varia tions on pow er supply in put lines IEC 61000 4 11 0 UT for 0 5 cy cle at 0 45 90 135 180 22...

Page 82: ...t 1 kHz Portable RF communications equipment including peripher als such as antenna cables and external antennas should be used no closer than 30 cm to any part of the equipment in cluding cables specified by manufacturer Otherwise deg radation of the performance of this equipment could result Proximity fields from RF wireless com munications equipment IEC 61000 4 3 Refer to the section Im munity ...

Page 83: ...14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89 MHz to 24 99 MHz 28 0 MHz to 29 7 MHz and 50 0 MHz to 54 0 MHz Immunity to RF wireless communication equipment ISM Band MHz Modulation Distance m Immunity test level V m 300 390 Pulse modulation 18 Hz 0 3 27 430 470 FM 5 kHz deviation 1 kHz sine 0 3 28 704 787 Pulse modulation 217 Hz 0 3 9 800 960 Pulse modulation 18 Hz 0 3 28 1700 1990 Pu...

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