Page 1 DR 400 5520/100 5520/200 User Manual 3231E EN 20210708 1530...
Page 2: Table Of Contents
| DR 400 | Contents Contents Legal Notice ................7 Introduction to this Manual ........... 8 Scope of this Manual ..........9 About the safety notices in this document ....10 Disclaimer ..............11 Introduction to DR 400 ............12 Intended Use ............
Page 3 DR 400 | Contents | iii Cleaning and Disinfecting ........54 Cleaning ............55 Disinfecting ..........57 Disinfecting safety directions ....... 58 Approved disinfectants ........ 59 Maintenance ............60 Maintenance of the radiographic table, radiographic wall stand and X-Ray Tube Stand Safety Directions ..............64...
Page 4 | DR 400 | Contents Collimator Parameters ....... 106 X-ray modality status frame ........107 Ready For Exposure Status ......108 Modality Position ........109 DR Detector Switch ........110 Filter Status ..........111 Grid Status ..........112 Radiation status ......... 113 Unknown status .........
Page 5 DR 400 | Contents | v Rotating the bucky ..........167 Loading of the bucky in the Radiographic Table ..168 Loading of the bucky in the Radiographic Wall Stand Unloading of the bucky in the Radiographic Table ..170 Unloading of the bucky in the Radiographic Wall Stand ..................171...
Page 6 | DR 400 | Contents Compatibility ............217 Connectivity ............218 Compliance ............219 General ............220 Safety ............220 Electromagnetic Compatibility ....220 X-Ray Safety ..........220 X-Ray Accuracy .......... 221 Environmental Compliance ......221 Biocompatibility .........221 Usability ............ 221 Equipment Classification ........222 Patient data security ..........
Page 7: Legal Notice
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. DR 400 is a trademark of Agfa NV, Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement.
Page 8: Introduction To This Manual
8 | DR 400 | Introduction to this Manual Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • Disclaimer 3231E EN 20210708 1530...
Page 9: Scope Of This Manual
DR 400 | Introduction to this Manual | 9 Scope of this Manual This User Manual describes the features of the DR 400 System, an integrated X-Ray imaging system. It explains how the different components of the DR 400 System work together.
Page 10: About The Safety Notices In This Document
10 | DR 400 | Introduction to this Manual About the safety notices in this document The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use. DANGER: A danger safety notice indicates a hazardous situation of direct, immediate danger for a potential serious injury to a user, engineer, patient or any other person.
Page 11: Disclaimer
DR 400 | Introduction to this Manual | 11 Disclaimer Agfa assumes no liability for use of this document if any unauthorized changes to the content or format have been made. Every care has been taken to ensure the accuracy of the information in this document.
Page 12: Introduction To Dr 400
12 | DR 400 | Introduction to DR 400 Introduction to DR 400 Topics: • Intended Use • Intended User • Configuration • Options and Accessories • Operation Controls • Installation • Radiation Protection • Labels • Cleaning and Disinfecting •...
Page 13: Intended Use
DR 400 | Introduction to DR 400 | 13 Intended Use • The DR 400 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult or pediatric patients.
Page 14: Intended User
14 | DR 400 | Introduction to DR 400 Intended User This manual has been written for trained users of Agfa products and trained diagnostic X–Ray clinical personnel who have received proper training. Users are those persons who actually handle the equipment and those who have authority over the equipment.
Page 15: Configuration
DR 400 | Introduction to DR 400 | 15 Configuration DR 400 is a configurable DR (Direct Radiography X-ray system) or CR (Computed Radiography) X-ray system. The complete DR 400 consists of the following components: • Radiographic table with an integrated Fixed DR Detector or with a bucky.
Page 16: Applied Parts
16 | DR 400 | Introduction to DR 400 The Software Console is available on the NX workstation, to synchronize the X-ray exposure parameters between the NX application and the generator. Other configurable features include: • Tube head display with controls for X-ray exposure parameters •...
Page 17 DR 400 | Introduction to DR 400 | 17 • DR Detector Radiographic table • Table top of the radiographic table • Patient hand grips (optional) • Lateral cassette holder (optional) • Mattress (optional) • Compression belt (optional) Radiographic wall stand •...
Page 18: Options And Accessories
18 | DR 400 | Introduction to DR 400 Options and Accessories The system is delivered with a set of labels. When using multiple DR Detectors, on the labels a nickname is written to identify the DR Detector. An identical label is attached to the bucky of the X-ray system to identify the dedicated workspace of each DR Detector.
Page 19: Operation Controls
DR 400 | Introduction to DR 400 | 19 Operation Controls Topics: • Radiographic table • Radiographic wall stand • Control Panel of the X-Ray Tube Stand • Tube head display • NX Application on the NX Workstation • Software Console •...
Page 20: Radiographic Table
20 | DR 400 | Introduction to DR 400 Radiographic table The radiographic table is used for positioning of the patient lying or sitting over the detector or the cassette in the bucky for exposure. The radiographic table supports the patient and the detector or the cassette for free exposure.
Page 21: Radiographic Wall Stand
DR 400 | Introduction to DR 400 | 21 Radiographic wall stand The radiographic wall stand is used for positioning of patients standing upright or sitting towards the bucky for exposure. Figure 3: Radiographic wall stand with vertical bucky Related Links...
Page 22: Control Panel Of The X-Ray Tube Stand
22 | DR 400 | Introduction to DR 400 Control Panel of the X-Ray Tube Stand Figure 4: Control Panel of the X-Ray Tube Stand with tube head display (controls for X-ray tube position and for X-ray exposure parameters) Figure 5: Control Panel of the X-Ray Tube Stand with X-ray tube angle...
Page 23: Tube Head Display
DR 400 | Introduction to DR 400 | 23 Tube head display The tube head display can be used to control X-ray exposure parameters. It displays the system status. Figure 6: Example of the tube head display Related Links Software Console and Tube Head Display...
Page 24: Nx Application On The Nx Workstation
24 | DR 400 | Introduction to DR 400 NX Application on the NX Workstation The NX application is used to define patient information, select exposures and process images. Figure 7: NX application The operation of the NX application is described in the NX User Manual, document 4420..
Page 25: Software Console
DR 400 | Introduction to DR 400 | 25 Software Console The Software Console is available to support X-ray exposure and position parameter control on the NX workstation. It is displayed on the NX workstation next to the NX application.
Page 26: Dr Detector Switch
26 | DR 400 | Introduction to DR 400 DR Detector Switch The DR Detector Switch shows which DR Detector is active and shows its status. The DR Detector Switch can be used to activate another DR Detector. The DR Detector Switch can be switched to CR, depending on the configuration.
Page 27: X-Ray Generator Mini Console
DR 400 | Introduction to DR 400 | 27 X-ray generator mini console The X-ray generator mini console is available in the operator room. Power ON button Power ON indicator Power OFF button Press and hold to prepare for exposure...
Page 28 28 | DR 400 | Introduction to DR 400 Starting the exposure Before starting the exposure: 1. Check if the exposure settings displayed on the console are suitable for the exposure. 2. Check the Ready for Exposure status. Press the exposure button down fully and keep it pressed until the exposure has ended.
Page 29: Manual Collimator
DR 400 | Introduction to DR 400 | 29 Manual collimator The collimator sets the exposure field and displays it by means of a light field. The collimator provides X-ray filtering using the integrated filters or by inserting a filter in the rails.
Page 30: Automatic Collimator
30 | DR 400 | Introduction to DR 400 Automatic collimator The collimator sets the exposure field and displays it by means of a light field. The collimator provides X-ray filtering using the integrated filters or by inserting a filter in the rails.
Page 31: Portable Dr Detector
DR 400 | Introduction to DR 400 | 31 Portable DR Detector When performing an exposure, keep in mind the following detector orientation aids: 1. Tube side 2. Patient orientation marker For an overview of the operation controls of the DR Detector, refer to the user manual of the DR Detector.
Page 32: Emergency Stop Button
32 | DR 400 | Introduction to DR 400 Emergency stop button Figure 13: Emergency stop button If a system malfunction causes an emergency situation involving the patient, operating personnel or any system component, activate the emergency stop on the radiographic table. All motor driven movements will be stopped.
Page 33: Emergency Shutdown Power Switch
DR 400 | Introduction to DR 400 | 33 Emergency shutdown power switch Use the emergency shutdown power switch, if a dangerous situation cannot be eliminated by pressing the emergency stop button. WARNING: Use the emergency shutdown power switch in case of danger to patients, operators, third parties, or one of the units.
Page 34: Installation
34 | DR 400 | Introduction to DR 400 Installation Installation and configuration is performed by an Agfa trained and authorized service engineer. Contact your local support organization for more information. On a configuration with multiple DR Detectors of the same type, it is required to apply labeling to the DR Detector containing a unique nickname for each DR Detector.
Page 35: Radiation Protection
DR 400 | Introduction to DR 400 | 35 Radiation Protection X-ray radiation can cause serious damage to the health, therefore observe great care and ensure that protection against X-ray exposure is always applied. Some of the effects of X-ray radiation are cumulative and may extend over a period of time.
Page 36: Monitoring Of Personnel
36 | DR 400 | Introduction to DR 400 Monitoring of Personnel The monitoring checks the amount of X-ray radiation the personnel has been exposed to. It determines safety of the operators and it helps checking if safety measures of the X-ray environment are adequate. Inadequate or improper protection can lead to serious damage to the health.
Page 37: Protected Area And Significant Zones Of Occupancy
DR 400 | Introduction to DR 400 | 37 Protected area and significant zones of occupancy If the operator or staff does not need to be close to the patient during the exposure, the operator and staff use the protected area to control the following functions: •...
Page 38 38 | DR 400 | Introduction to DR 400 WARNING: The radiation protection has to be applied to the patient and to the operator. Related Links Radiation Protection on page 35 Topics: • Significant zones of occupancy at the radiographic table •...
Page 39 DR 400 | Introduction to DR 400 | 39 X-ray tube Focal spot label [—] Significant zone of occupancy. Minimum area 60x60 cm. Minimum height above the floor 200 cm. Dose meter DR Detector or cassette Significant zone of occupancy at the left side of the radiographic table...
Page 40 40 | DR 400 | Introduction to DR 400 X-ray tube Focal spot label [—] Significant zone of occupancy. Minimum area 60x60 cm. Minimum height above the floor 200 cm. Dose meter Protective device Wall DR Detector or cassette Significant zone of occupancy at the right side of the radiographic wall...
Page 41 DR 400 | Introduction to DR 400 | 41 Scattered radiation (general radiography) S1,S2 S4,S5 Kerma [uGy] • S1,S2 (wall stand): 100 kV; SID 110 cm; tube/detector centre height 140cm over floor • S3: 100 kV; SID 100 cm; table height of 70 cm (standard working height) •...
Page 42: Labels
42 | DR 400 | Introduction to DR 400 Labels Mark Meaning This mark shows compliance of the equipment with Directive 93/42/EEC (for European Union). This mark indicates that the equipment has a Type B applied part Serial number Manufacturer...
Page 43 DR 400 | Introduction to DR 400 | 43 • DR Detector identification label • Additional Labeling of the radiographic table • Additional Labeling of the radiographic wall stand • Labeling of the bucky • Labeling of the Automatic Exposure Control (AEC) •...
Page 44: Warning Labels On The Radiographic Table
44 | DR 400 | Introduction to DR 400 Warning labels on the radiographic table Figure 18: Warning labels on the radiographic table Warning labels on the radiographic wall stand Figure 19: Warning labels on the radiographic wall stand 3231E EN 20210708 1530...
Page 45: Type Label
DR 400 | Introduction to DR 400 | 45 Type label Mark Meaning Type label positioned on the low- er left or right hand side of the X- ray tube stand. The type label information for each combination of X-ray tube and X-ray generator is available in the technical data.
Page 46: Dr Detector Identification Label
46 | DR 400 | Introduction to DR 400 DR Detector identification label Label Meaning Writable label to identify and dedicate a DR Detector to an X- ray system bucky. 3231E EN 20210708 1530...
Page 47: Additional Labeling Of The Radiographic Table
DR 400 | Introduction to DR 400 | 47 Additional Labeling of the radiographic table Type label on the lower left or right hand side of the X-ray tube stand. (example of subtypes 5521/100, 5521/110) (example of subtypes 5521/200, 5521/210)
Page 48 48 | DR 400 | Introduction to DR 400 (example of subtypes 5521/400, 5521/410) This mark indicates that the equipment has a Type B applied part Top side according to patient ori- entation to indicate the orienta- tion of the AEC sensors (optional)
Page 49: Additional Labeling Of The Radiographic Wall Stand
DR 400 | Introduction to DR 400 | 49 Additional Labeling of the radiographic wall stand Type label on the lower right hand side of the radiographic wall stand. (Sample of subtype 5522/100) This mark indicates that the equipment has...
Page 50: Labeling Of The Bucky
50 | DR 400 | Introduction to DR 400 Labeling of the bucky The type label is located on the rear cov- er of the bucky or on the bucky drawer below the rotating platform. The type label information for each bucky model is available in the technical data.
Page 51 DR 400 | Introduction to DR 400 | 51 ous substances do not leak or mutate under normal use. The label is located on the rear cover of the bucky or on the bucky drawer below the rotating platform. Related Links...
Page 52: Labeling Of The Automatic Exposure Control (Aec)
52 | DR 400 | Introduction to DR 400 Labeling of the Automatic Exposure Control (AEC) The type label is located on the AEC ioni- zation chamber. The label is not visible without disassembling the component. Figure 22: Example of type label...
Page 53: Labeling Of The Dr Generator Sync Box
DR 400 | Introduction to DR 400 | 53 Labeling of the DR Generator Sync Box The type label is located on the DR Gener- ator Sync Box Figure 23: Example of type label Functional earth Medical equipotential 3231E EN 20210708 1530...
Page 54: Cleaning And Disinfecting
54 | DR 400 | Introduction to DR 400 Cleaning and Disinfecting All appropriate policies and procedures should be followed to avoid contamination of the staff, patients and equipment. All existing universal precautions should be extended to avoid potential contaminations and to avoid patients coming into (close) contact with the device.
Page 55: Cleaning
DR 400 | Introduction to DR 400 | 55 Cleaning To clean the exterior of the equipment: 1. Stop the system WARNING: When the equipment is going to be cleaned, be sure to turn off the main power of the system. Never use anhydrous or high solvency alcohols, benzine, thinner or any other flammable cleaning agent.
Page 56 56 | DR 400 | Introduction to DR 400 Figure 24: Cleaning button A black screen hides the screen and shows a number counting down. 2. Clean the display. The operation is not affected. 3. The display can be used again after the countdown has finished.
Page 57: Disinfecting
Disinfecting To disinfect the device, use only disinfectants and disinfection methods that are approved by Agfa and that correspond to the national regulation and guidelines as well as explosion protection. If you plan to use other disinfectants, approval of Agfa is needed before use, as most disinfectants can damage the device.
Page 58: Disinfecting Safety Directions
58 | DR 400 | Introduction to DR 400 Disinfecting safety directions WARNING: Using a disinfectant that can form an explosive or flammable gas mixtures is hazard to life and health because of explosion risk. Switch the equipment off before disinfecting. Allow the gas mixture to evaporate before switching the x-ray system back on.
Page 59: Approved Disinfectants
DR 400 | Introduction to DR 400 | 59 Approved disinfectants Refer to the Agfa website for specifications 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.
Page 60: Maintenance
60 | DR 400 | Introduction to DR 400 Maintenance Always consult the Agfa Service documentation and an Agfa trained and authorized Service engineer for complete maintenance schedules. Maintenance of the DR Detector The DR Detector requires regular calibration. Calibration instructions are described in the DR Detector Calibration Key User Manual (doc 0134).
Page 61 DR 400 | Introduction to DR 400 | 61 Table 1: Lifetime and maintenance Lifetime Expected lifetime for the X-ray unit 10 years Periodic maintenance The equipment shall have a technical mainte- Every 12 months or after nance to maintain fault-free operation and en- 60.000 cycles, whatever...
Page 62 62 | DR 400 | Introduction to DR 400 and the service to be informed. The equipment must only be put back into operation when the fault has been repaired. Topics: • Warming-up of X-ray tube • Conditioning procedure for the X-ray tube...
Page 63 DR 400 | Introduction to DR 400 | 63 5. Take a sequence of exposures with the following kV values. Take one exposure per 30 seconds. Table 2: Sequence of exposures Time (minutes) kV Time (minutes) Time (minutes) 50 4.0 50 4.5...
Page 64: Safety Directions
64 | DR 400 | Safety Directions Safety Directions Topics: • General Safety Directions • Safety Directions for the X-Ray System • Safety Directions for the radiographic table 3231E EN 20210708 1530...
Page 65: General Safety Directions
DR 400 | Safety Directions | 65 General Safety Directions WARNING: Safety is only guaranteed when an Agfa certified field service engineer has installed the product. WARNING: The product must only be installed using released components and in released configurations.
Page 66 66 | DR 400 | Safety Directions CAUTION: All Agfa medical products must be used by trained and qualified personnel. 3231E EN 20210708 1530...
Page 67: Safety Directions For The X-Ray System
DR 400 | Safety Directions | 67 Safety Directions for the X-Ray System WARNING: Avoid unnecessary dose by checking the workstation selection on the X-ray generator console before exposing. In a configuration with a DR Detector configured on a virtual port,...
Page 68 68 | DR 400 | Safety Directions CAUTION: Excessive ambient temperature may impact performance of DR Detectors and cause permanent damage to the equipment. Refer to the related user manual for environmental conditions for the DR detector. If ambient temperature and humidity is outside the specified range, do not operate the system or use air conditioning.
Page 69: Safety Directions For The Radiographic Table
DR 400 | Safety Directions | 69 Safety Directions for the radiographic table WARNING: The system is not intended for operation in explosion-prone areas. Such an operation is hazardous to life and health because of explosion risk. Please note the applicable regulations on formation of explosive gas mixtures when cleaning and using in combination with patients.
Page 70: Basic Workflow
70 | DR 400 | Basic Workflow Basic Workflow Topics: • Starting the System • Performing an exposure using the DR Detector • Performing an exposure using a CR cassette • X-Ray System Positioning • Stopping the System • Guidelines for pediatric applications...
Page 71: Starting The System
DR 400 | Basic Workflow | 71 Starting the System Allow the DR Detector to warm up before the system is used for clinical purposes. The warming-up time starts as soon as the DR Detector has been powered on and the NX workstation is running. To check if a warming-up time is required, refer to the DR Detector technical data.
Page 72 72 | DR 400 | Basic Workflow 1. Close the collimator blades fully. Make sure that the collimator blades are fully closed and that no patient is present in the room. To avoid radiation on a panel, remove the panel, turn the tube away from the panel, or cover the panel with a lead apron.
Page 73: Performing An Exposure Using The Dr Detector
DR 400 | Basic Workflow | 73 Performing an exposure using the DR Detector Topics: • Step 1: retrieve the patient info • Step 2: select the exposure • Step 3: prepare the exposure • Step 4: check the exposure settings •...
Page 74: Step 1: Retrieve The Patient Info
74 | DR 400 | Basic Workflow 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. 3231E EN 20210708 1530...
Page 75: Step 2: Select The Exposure
DR 400 | Basic Workflow | 75 Step 2: select the exposure In the operator room: At the NX workstation, select the thumbnail for the exposure in the Image Overview pane of the Examination window. The default X-Ray exposure parameters for the selected exposure are sent to the modality and displayed on the software console.
Page 76: Step 3: Prepare The Exposure
76 | DR 400 | Basic Workflow Step 3: prepare the exposure In the examination room: 1. Position the DR Detector. When using the bucky, check that the identification labels on the DR Detector and on the bucky match. Do not use a DR Detector that is dedicated to another bucky.
Page 77: Step 4: Check The Exposure Settings
DR 400 | Basic Workflow | 77 Step 4: check the exposure settings Related Links DR Detector Switch on page 26 On the NX application: 1. Check if the DR Detector Switch displays the name of the DR Detector that's being used 2.
Page 78: Step 5: Execute The Exposure
78 | DR 400 | Basic Workflow Step 5: execute the exposure In the operator room: Press the exposure button to execute the exposure. Make sure the generator is ready for exposure before you press the exposure button. WARNING: During exposure ionizing radiation is emitted by the X-ray system.
Page 79: Step 6: Perform A Quality Control
DR 400 | Basic Workflow | 79 Step 6: perform a quality control At the NX workstation: 1. Select 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.
Page 80: Performing An Exposure Using A Cr Cassette
80 | DR 400 | Basic Workflow Performing an exposure using a CR cassette Note: Using an ID Tablet to identify cassettes before the exposure will break the communication of X-ray parameters between the NX workstation and the X-ray generator console. It is advised to identify cassettes after the exposure, as described in this workflow.
Page 81: Step 1: Retrieve The Patient Info
DR 400 | Basic Workflow | 81 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. 3231E EN 20210708 1530...
Page 82: Step 2: Select The Exposure
82 | DR 400 | Basic Workflow Step 2: select the exposure In the operator room at the NX workstation: 1. Select the thumbnail for the exposure in the Image Overview pane of the Examination window. 2. Select CR in the Detector Switch.
Page 83: Step 3: Prepare The Exposure
DR 400 | Basic Workflow | 83 Step 3: prepare the exposure In the examination room: 1. Position the cassette. Note: For a free exposure, partial lead covering of the cassette may be required if multiple images are taken on one cassette.
Page 84: Step 4: Check The Exposure Settings
84 | DR 400 | Basic Workflow Step 4: check the exposure settings In the operator room on the Software Console: 1. Check if the exposure settings displayed on the console are suitable for the exposure. 2. Check the Ready for Exposure status.
Page 85: Step 5: Execute The Exposure
DR 400 | Basic Workflow | 85 Step 5: execute the exposure In the operator room: Press the exposure button to execute the exposure. WARNING: During exposure ionizing radiation is emitted by the X-ray system. To indicate the presence of ionizing radiation, the radiation indicator on the control console lights up.
Page 86: Step 6: Repeat Steps 2 To 5 For The Next Subexposures
86 | DR 400 | Basic Workflow Step 6: repeat steps 2 to 5 for the next subexposures 3231E EN 20210708 1530...
Page 87: Step 7: Digitize The Image
DR 400 | Basic Workflow | 87 Step 7: digitize the image In the examination room: Take the exposed cassette. In the operator room: 1. Insert the cassette in the digitizer. 2. Click ID in the examination window of NX.
Page 88: Step 8: Perform A Quality Control
88 | DR 400 | Basic Workflow Step 8: perform a quality control In the operator room at the NX workstation: 1. Select 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.
Page 89: X-Ray System Positioning
DR 400 | Basic Workflow | 89 X-Ray System Positioning Topics: • Radiographic table exposures • Oblique Exposures • Lateral Exposures • Radiographic wall stand exposures 3231E EN 20210708 1530...
Page 90: Radiographic Table Exposures
90 | DR 400 | Basic Workflow Radiographic table exposures 1. Position the patient on the radiographic table. 2. Position the X-ray tube stand with the X-ray tube over the patient. The bucky is automatically aligned to the X-ray tube by mechanical coupling.
Page 91: Oblique Exposures
DR 400 | Basic Workflow | 91 Oblique Exposures 1. Position the patient on the radiographic table. 2. Move the X-ray tube stand out of the coupling range of the bucky. 3. Position the bucky under the patient. 4. Set the required angle of the X-ray tube.
Page 92: Lateral Exposures
92 | DR 400 | Basic Workflow Lateral Exposures 1. Unlock the X-ray tube arm and rotate 90° around. 2. Rotate the X-Ray tube 90° around. Check the angle on the angle display. 3. Mount the lateral cassette holder on the side rail of the tabletop. Fix it using the two lower screws.
Page 93: Radiographic Wall Stand Exposures
DR 400 | Basic Workflow | 93 Radiographic wall stand exposures 1. Adjust the height of the bucky on the radiographic wall stand. 2. Position the patient in front of the radiographic wall stand. 3. Move the table top away from the radiographic wall stand.
Page 94: Stopping The System
94 | DR 400 | Basic Workflow Stopping the System To stop the system: 1. Stop the NX workstation. NX can be stopped in two ways, either by logging out of Windows or without logging out of Windows. For detailed information on stopping NX, refer to the NX User Manual, document 4420.
Page 95: Guidelines For Pediatric Applications
The user documentation of this product contains a set of guidelines for pediatric applications, applicable in the U.S.A. Refer to document "Exposure Techniques for pediatric and adult use with DR 400". Guidelines for Pediatric Applications CAUTION: Children are more radiosensitive than adults.
Page 96 96 | DR 400 | Basic Workflow For example if your adult abdomen settings are: 70--85 kVp, 200--400 mA, 15--80 mAs, consider starting at 65--75 kVp, 100--160 mA, 2.5--10 mAs for a pediatric patient. Whenever possible use high kVp techniques and large SID (Source Image Distance).
Page 97: Software Console And Tube Head Display
DR 400 | Software Console and Tube Head Display | 97 Software Console and Tube Head Display The software console is displayed on the NX workstation. On a configuration with tube head display, the software console is displayed on the tube head display as well. The arrangement and availability of the controls may be different.
Page 98: Action Buttons
98 | DR 400 | Software Console and Tube Head Display Action buttons Table 4: Action buttons Icon Description Button to clean the tube head display during operation. Press and hold the cleaning button for 2 seconds. 3231E EN 20210708 1530...
Page 99: Planned Exposures
DR 400 | Software Console and Tube Head Display | 99 Planned exposures By clicking the status bar, an overview is displayed of the exposures that still have to be taken for the examination. Select an exposure to load the default X-ray exposure parameters and to activate the selected DR Detector.
Page 100: Image Preview Window
100 | DR 400 | Software Console and Tube Head Display Image Preview Window After an exposure, the acquired image is displayed on the tube head display. To return to the controls, push the display anywhere. To disable image preview, toggle the Image preview button.
Page 101: Main Screen Of The Tube Head Display
DR 400 | Software Console and Tube Head Display | 101 Main screen of the Tube head display Patient information Status bar with exam type Modality position DR Detector Switch Filter status Grid status Collimator status Radiographic parameters Position parameters...
Page 102: Position Parameters
102 | DR 400 | Software Console and Tube Head Display Position parameters Table 5: Position parameters Source image distance (SID) No value is displayed for free exposures or if the X-ray tube is not pointing to the selected DR detector.
Page 103: X-Ray Tube Stand Tracks Table Height
DR 400 | Software Console and Tube Head Display | 103 X-ray tube stand tracks table height To keep constant SID while adjusting table height: 1. Set the required SID by adjusting the position of the X-ray tube stand. The distance between the X-ray tube head and the table top must not be less than 50 cm.
Page 104: X-Ray Tube Stand Tracks Wall Stand Height
104 | DR 400 | Software Console and Tube Head Display X-ray tube stand tracks wall stand height To keep constant position of the tube head unit relative to wall stand bucky while adjusting wall stand height: 1. Set the required position of the X-ray tube stand.
Page 105 DR 400 | Software Console and Tube Head Display | 105 Position tracking is kept active for the next exposure. Related Links Collision indicator on page 135 Emergency stop button on page 32 3231E EN 20210708 1530...
Page 106: Collimator Parameters
106 | DR 400 | Software Console and Tube Head Display Collimator Parameters On systems with an automatic collimator, the collimation is automatically set, based on the selected exposure. To use the same collimation setting on subsequent exposures, push the restore button to restore the collimation setting of the previous exposure.
Page 107: X-Ray Modality Status Frame
DR 400 | Software Console and Tube Head Display | 107 X-ray modality status frame 4 5 6 7 Ready for exposure status Modality position DR detector switch Filter status Grid status Heat units Radiation status Figure 36: X-ray modality status frame Topics: •...
Page 108: Ready For Exposure Status
108 | DR 400 | Software Console and Tube Head Display Ready For Exposure Status Table 9: Exposure ready Color Description Green Exposure ready. Indicates that the selected technique is properly set and there are no interlock failures or system faults.
Page 109: Modality Position
DR 400 | Software Console and Tube Head Display | 109 Modality Position The modality position is automatically selected, based on the selected exposure. To modify the position on the modality where the exposure will be made, click the drop-down arrow and select the modality position from the list.
Page 110: Dr Detector Switch
110 | DR 400 | Software Console and Tube Head Display DR Detector Switch The DR Detector Switch shows which DR Detector is active and shows its status. The DR Detector Switch can be used to activate another DR Detector.
Page 111: Filter Status
DR 400 | Software Console and Tube Head Display | 111 Filter Status On systems with automatic filtering, the filter is automatically set, based on the selected exposure. The filter setting can be modified on the software console or on the collimator.
Page 112: Grid Status
112 | DR 400 | Software Console and Tube Head Display Grid Status Table 13: Grid status - automatically detected (no icon) No grid is required. The correct grid type is inserted. The correct grid type is not inserted. A grid is inserted, but no grid is required.
Page 113: Radiation Status
DR 400 | Software Console and Tube Head Display | 113 Radiation status Table 15: Radiation status Icon Description The X-ray tube is prepared. After pressing the exposure button completely, the X-ray ex- posure is made. The indicator on the console will light up.
Page 114: Unknown Status
114 | DR 400 | Software Console and Tube Head Display Unknown status If a status is unknown, a question mark icon is displayed: Figure 38: Unknown status Depending on the component for which the unknown status is displayed, an action is required on the component or on the software to provide the system with the missing information.
Page 115: Generator Controls
DR 400 | Software Console and Tube Head Display | 115 Generator controls Heat units and DAP value Radiographic working mode Radiographic parameters Automatic exposure control X-ray tube load Figure 39: Operation controls To change a value, use the + and - buttons. The values increase or decrease step by step each time the corresponding button is pushed.
Page 116: Radiographic Working Modes
116 | DR 400 | Software Console and Tube Head Display Radiographic working modes You can select following radiographic working modes according to the parameters to be controlled and the degree of automation: Table 16: Radiographic working modes One point mode, by selecting kV. The mA,ms exposure is controlled by AEC.
Page 117 DR 400 | Software Console and Tube Head Display | 117 The value of mA and ms are adjusted automatically to keep the mAs value constant, within the boundaries of generator or X-ray tube limitations. The setting of density, dose and patient size is not available.
Page 118: Radiographic Parameters
118 | DR 400 | Software Console and Tube Head Display Radiographic Parameters You can set up following radiographic parameters: • kV: shows the radiographic kV value (X-ray tube voltage) selected for the exposure. • mAs can show: • The radiographic mAs value selected for the exposure.
Page 119: Focal Spot Indicator
DR 400 | Software Console and Tube Head Display | 119 Focal Spot Indicator A focal spot indicator shows the selected focal spot of the X-ray tube: “Small” or “Large”. Table 17: Focal Spot Indicator Small Large You can change the focal spot by touching this indicator. It keeps kV and constant mAs, whenever it is possible.
Page 120: Automatic Exposure Control (Aec)
120 | DR 400 | Software Console and Tube Head Display Automatic Exposure Control (AEC) Automatic Exposure Control (AEC) produces consistent detector dose regardless of the radiographic technique selected and of the patient size. The AEC module comprises the controls for the selection of the exposure detector fields (ionization chamber), S-value and density compensation.
Page 121 DR 400 | Software Console and Tube Head Display | 121 Table 19: Automatic filter low dose middle dose high dose Density These buttons are used to adjust the AEC cut-off dose (and patient entrance dose accordingly). Density can be increased and decreased in a range of -4 to +4. Each step is a change of one exposure step.
Page 122 122 | DR 400 | Software Console and Tube Head Display Table 21: kV variation over patient size Patient size Extra Small normal kV * 0.9 Small normal kV * 0.95 Medium normal kV Large normal kV * 1.05 Extra Large normal kV * 1.1...
Page 123: X-Ray Tube Load
DR 400 | Software Console and Tube Head Display | 123 X-Ray Tube Load As a way to increase the tube life cycle, the power percentage of the tube is reduced to a 80% by default. 100% If a specific technique requires 100% of the X-ray tube power, touch the 100% button.
Page 124: Dap Value
124 | DR 400 | Software Console and Tube Head Display DAP Value The DAP value shows the radiation value of the last exposure. The radiation measure is read as DAP value (Dose Area Product) in cGy*cm (for example: DAP 12.22).
Page 125: Heat Units
DR 400 | Software Console and Tube Head Display | 125 Heat Units The status of the heat units is displayed below the X-ray icon. During exposures, the heat units are calculated and totalled. The heat units display shows the percentage of the thermal capacity of the X-ray tube that is used.
Page 126: X-Ray Modality Controls
126 | DR 400 | Software Console and Tube Head Display X-ray modality controls Select the modality position. Select the DR detector or switch to CR. All configured detectors are displayed. Only the detectors that can be used with the selected modality position, can be selected.
Page 127: System Messages
DR 400 | Software Console and Tube Head Display | 127 System messages System messages are displayed at the bottom of the software console. The color of the message indicates the importance: Blue Information Yellow Warning Orange Error Messages that require feedback from the user contain a button that can be pressed.
Page 128 128 | DR 400 | Software Console and Tube Head Display The system messages screen lists all messages since the last startup of the software. Figure 43: Messages history Related Links X-ray generator messages and warning signals on page 194...
Page 129: Radiographic Table And X-Ray Tube Stand
DR 400 | Radiographic Table and X-Ray Tube Stand | 129 Radiographic Table and X-Ray Tube Stand The radiographic table with integrated X-ray tube stand allows X-ray examinations from head to foot of lying or sitting patients. The tube stand has two variants, depending on the side where the tube stand rail is protruding: •...
Page 130 130 | DR 400 | Radiographic Table and X-Ray Tube Stand X-ray tube arm X-ray tube Control panel of the X-ray tube stand Figure 44: Radiographic table with integrated X-ray tube stand, example of left hand version Movement control buttons Tube head display Handle with integrated release button for omni direction movement.
Page 131 DR 400 | Radiographic Table and X-Ray Tube Stand | 131 • Effect of SID on patient dose 3231E EN 20210708 1530...
Page 132: Positioning The X-Ray Tube Stand
132 | DR 400 | Radiographic Table and X-Ray Tube Stand Positioning the X-Ray Tube Stand The operation controls of the X-ray tube stand are located at the control panel. The X-ray tube stand must be positioned by the operator manually.
Page 133 DR 400 | Radiographic Table and X-Ray Tube Stand | 133 Rotation of the collimator around the axis of the X-ray beam The standard position of the X-ray tube arm is indicated by markers. When the tube arm is in standard position it is centered in transversal direction on the bucky.
Page 134: Stop Positions
134 | DR 400 | Radiographic Table and X-Ray Tube Stand Stop positions The system includes stop positions. • On the longitudinal axis movement, to position the X-ray tube in regularly used exposure distances to the radiographic wall stand, e.g. 150 cm and 180 cm.
Page 135: Collision Indicator
DR 400 | Radiographic Table and X-Ray Tube Stand | 135 Collision indicator Systems with motorized movement have a collision indicator. The collision indicator avoids collision of the X-ray tube head with the table. The collision indicator will give a signal in following situations: •...
Page 136: Positioning The Radiographic Table
136 | DR 400 | Radiographic Table and X-Ray Tube Stand Positioning the radiographic table There are two versions of the radiographic table: • Fixed height radiographic table with a height of 70 cm • Elevating radiographic table with adjustable height from 55 cm to 90 cm The movements of the radiographic table are controlled by foot pedals mounted at front side of the table.
Page 137: Positioning The Floating Tabletop
DR 400 | Radiographic Table and X-Ray Tube Stand | 137 Positioning the floating tabletop To release the brake for moving the floating tabletop, double click and hold the foot pedal. The tabletop can be moved in longitudinal and transversal direction manually.
Page 138: Adjusting Height
138 | DR 400 | Radiographic Table and X-Ray Tube Stand Adjusting height To adjust the height, double click and hold the foot pedal. Table 24: Movement controls Foot pedal to lower table height (minimum 55 cm). Foot pedal to raise table height (maximum 90 cm).
Page 139: Positioning The Bucky
DR 400 | Radiographic Table and X-Ray Tube Stand | 139 Positioning the Bucky The bucky center position is automatically aligned to the position of the X-ray tube stand. The mechanical coupling between the bucky and the X-ray tube stand is active within the travel range of the bucky.
Page 140: Radiographic Table Accessories
140 | DR 400 | Radiographic Table and X-Ray Tube Stand Radiographic Table Accessories WARNING: Using wrong accessories that cannot be properly attached to the system can lead to hazardous situations and injury. Use only original accessories provided by the manufacturer.
Page 141: Mounting The Patient Hand Grips
DR 400 | Radiographic Table and X-Ray Tube Stand | 141 Mounting the patient hand grips The pair of patient hand grips are used to stabilize the patient and give a feeling of security. Using the hand grips will avoid the patient grasping the table edges which could cause a risk to pinch fingers.
Page 142: Mounting The Tabletop Hand Grips
142 | DR 400 | Radiographic Table and X-Ray Tube Stand Mounting the tabletop hand grips The pair of tabletop hand grips are used by the operator for moving the floating tabletop. Using the hand grips will avoid the operator grasping the table edges which could cause a risk to pinch fingers.
Page 143: Collision Protection
DR 400 | Radiographic Table and X-Ray Tube Stand | 143 Collision protection Collision protection is only available on the elevating radiographic table. The collision protection accessories are mounted on the frame of the radiographic table. They protect the tabletop from damage when colliding with objects below.
Page 144: Mattress
144 | DR 400 | Radiographic Table and X-Ray Tube Stand Mattress The mattress fits the tabletop (220 cm x 80 cm) and is X-ray translucent. 3231E EN 20210708 1530...
Page 145: Lateral Cassette Holder
DR 400 | Radiographic Table and X-Ray Tube Stand | 145 Lateral cassette holder The lateral cassette holder supports a cassette or detector in lateral position and is attached to the tabletop. Figure 53: Lateral cassette holder 3231E EN 20210708 1530...
Page 146: Compression Belt
146 | DR 400 | Radiographic Table and X-Ray Tube Stand Compression belt The compression belt provides additional fixation for the patient on the table. It can be adjusted to patient thickness. Figure 54: Compression belt 3231E EN 20210708 1530...
Page 147: Manual Collimator
DR 400 | Radiographic Table and X-Ray Tube Stand | 147 Manual Collimator The Collimator can rotate ± 90° on its vertical axis while the X-ray tube remains in the same position. This movement is performed by manually turning the collimator and has detents every 90°.
Page 148 148 | DR 400 | Radiographic Table and X-Ray Tube Stand 1. Disconnect the cable of the radiation meter. cable connecting the radiation meter to the generator 2. Unscrew the screw on the left hand side of the rail system.
Page 149: Automatic Collimator
DR 400 | Radiographic Table and X-Ray Tube Stand | 149 Automatic Collimator The collimator can limit the collimated area to the size of the cassette or DR Detector inserted in the bucky. Display • Size of the collimated area •...
Page 150 150 | DR 400 | Radiographic Table and X-Ray Tube Stand • Semi-automatic collimation mode • Manual collimation mode • Dose Area Product Meter (DAP) 3231E EN 20210708 1530...
Page 151: Semi-Automatic Collimation Mode
DR 400 | Radiographic Table and X-Ray Tube Stand | 151 Semi-automatic collimation mode The semi-automatic collimation mode is activated if any of following conditions applies: • the tube head unit is rotated by more than +/-3° from the center position •...
Page 152: Manual Collimation Mode
152 | DR 400 | Radiographic Table and X-Ray Tube Stand Manual collimation mode The manual collimation mode is activated when the user turns the key at the backside of the collimator. The yellow indicator at front of collimator is lit and an open key lock is displayed in the lower left corner of the collimator display.
Page 153: Dose Area Product Meter (Dap)
DR 400 | Radiographic Table and X-Ray Tube Stand | 153 Dose Area Product Meter (DAP) An integrated DAP meter (Dose Area Product Meter) in the automatic collimator is availabe as an option. The DAP meter reads the radiation as Dose Area Product in [cGy x cm The measured radiation value is transferred to the Software Console automatically and displayed after each exposure.
Page 154: Effect Of Sid On Patient Dose
154 | DR 400 | Radiographic Table and X-Ray Tube Stand Effect of SID on patient dose Changing the distance of the X-ray tube to the patient affects the dose applied to the patient. For example doubling the distance reduces the dose by a factor of 4. The new dose can be calculated by a formula: new mAs = known mAs ×...
Page 155: Radiographic Wall Stand
DR 400 | Radiographic wall stand | 155 Radiographic wall stand The radiographic wall stand allows vertical X-ray exposures of patients standing or sitting in front of the radiographic wall stand. The wall stand has two variants: • wall stand with vertical bucky, supporting vertical movement (up and down) •...
Page 156 156 | DR 400 | Radiographic wall stand Button to switch on the collimator light Front panel Vertical movement handle (both sides) Tilting extension Tilting handle Figure 59: Radiographic wall stand, vertical version and vertical tilting version CAUTION: The format indications on the front panel show the format of the cassette or detector.
Page 157: Positioning The Radiographic Wall Stand
DR 400 | Radiographic wall stand | 157 Positioning the Radiographic Wall Stand Vertical movement handle with brake switch Tilting angle scale Tilting handle Figure 60: Positioning controls DANGER: Make sure that no persons or objects are within the movement area of the system where they can collide with moving parts of the system.
Page 158 158 | DR 400 | Radiographic wall stand To stop movement and lock the bucky into position, release the switch. CAUTION: The maximum load for the bucky movement in vertical direction is 20 kg. The bucky may slip downward when applying excessive load.
Page 159: Radiographic Wall Stand Accessories
DR 400 | Radiographic wall stand | 159 Radiographic Wall Stand Accessories WARNING: Using wrong accessories that cannot be properly attached to the system can lead to hazardous situations and injury. Use only original accessories provided by the manufacturer. Topics: •...
Page 160: Patient Hand Grips
160 | DR 400 | Radiographic wall stand Patient hand grips The patient hand grips for wall stand are mounted fixed at the backside of the bucky. The patient uses these grips for stabilization and support of correct correct positioning, e.g. for chest exams.
Page 161: Mounting The Overhead Handle
DR 400 | Radiographic wall stand | 161 Mounting the overhead handle CAUTION: The overhead handle can bear up to 20 kg. It is not intended to hold the whole weight of a patient. Take care that the overhead handle does not collide with the ceiling when moving the bucky upward manually.
Page 162: Spacer
162 | DR 400 | Radiographic wall stand Spacer The spacer allows examination of sitting patients by offering additional space to position legs and feed under the bucky. Figure 63: Spacer 3231E EN 20210708 1530...
Page 163: Wall Stand Fixation Kit
DR 400 | Radiographic wall stand | 163 Wall stand fixation kit For additional stability of the radiographic wall stand an additional fixation of the radiographic wall stand is provided. The kit is installed at backside of the radiographic wall stand under the head cover and then fixed to a wall. It has to be installed by service.
Page 164: Bucky
164 | DR 400 | Bucky Bucky The bucky is installed in the radiographic table and in the radiographic wall stand. The bucky clamps the cassette or detector during exposure and centers them relative to the Automatic Exposure Control (AEC) and the grid.
Page 165 DR 400 | Bucky | 165 Topics: • Bucky configuration • Rotating the bucky • Loading of the bucky in the Radiographic Table • Loading of the bucky in the Radiographic Wall Stand • Unloading of the bucky in the Radiographic Table •...
Page 166: Bucky Configuration
166 | DR 400 | Bucky Bucky configuration Cassette only configuration The workflow with cassettes requires removing the cassette from the bucky after each exposure. The cassette has to be scanned using a digitizer to get the final image. The correct orientation of the cassette is applied by the way it is inserted in the bucky and there is no need to use the rotation mechanism.
Page 167: Rotating The Bucky
DR 400 | Bucky | 167 Rotating the bucky The cassette or detector in the bucky can be rotated without removing it from the clamping. To change the orientation of the cassette or detector in the bucky: 1. Open the bucky drawer halfway by pulling the front handle.
Page 168: Loading Of The Bucky In The Radiographic Table
168 | DR 400 | Bucky Loading of the bucky in the Radiographic Table To load the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the front handle. 2. Push the cassette or detector towards the rear slider to open the clamping mechanism wide enough to contain the cassette or detector.
Page 169: Loading Of The Bucky In The Radiographic Wall Stand
DR 400 | Bucky | 169 Loading of the bucky in the Radiographic Wall Stand To load the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the front handle. 2. Rotate the drawer to portrait orientation.
Page 170: Unloading Of The Bucky In The Radiographic Table
170 | DR 400 | Bucky Unloading of the bucky in the Radiographic Table To unload the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the front handle. 2. Push firmly with both hands the cassette or detector towards the rear clamp to open the clamping mechanism.
Page 171: Unloading Of The Bucky In The Radiographic Wall Stand
DR 400 | Bucky | 171 Unloading of the bucky in the Radiographic Wall Stand To unload the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the handle. 2. Rotate the carrier back to portrait position.
Page 172: Automatic Cassette Size Sensing
172 | DR 400 | Bucky Automatic Cassette Size Sensing The ACSS functionality of the bucky detects the size and orientation of the CR cassette or the DR detector and allows the collimator to limit the collimated area accordingly. The collimation setting received from the NX workstation or the collimation area set by the user is automatically adjusted.
Page 173: Centering And Collimating
DR 400 | Bucky | 173 Centering and collimating Depending on the format of the cassette or detector inside the bucky and the body part to expose, collimation and centering of the X-ray field have to be applied before exposure.
Page 174 174 | DR 400 | Bucky Any of the above conditions is not true. Collimating To set the X-ray collimation area, pull out the bucky drawer until the cassette or detector edge is visible. Align the X-ray collimation field to the size of the cassette or detector.
Page 175: Bucky Types
DR 400 | Bucky | 175 Bucky types The type of bucky installed in the system defines which functionality is available. Table 27: Modality positions Radiographic table 5523/100 5523/110 5523/115 5523/120 5523/125 5523/300 Radiographic wall stand, left loading 5523/200 5523/210...
Page 176 176 | DR 400 | Bucky Automatic cassette size sensing (ACSS) 5523/125 5523/220 5523/225 5523/270 5523/275 Integraded charger for DR 14s DR Detector 5523/115 5523/125 5523/215 5523/225 5523/265 5523/275 Table 29: Bucky for fixed DR detector Radiographic table 5523/300 Radiographic wall stand, left loading...
Page 177: Cassette And Detector Formats
DR 400 | Bucky | 177 Cassette and detector formats To adjust the side clamps to the format of the cassette or detector, indications are available in cm (and inch, depending on the bucky type). Corresponding indications are printed on the wall stand cover to align the collimation area.
Page 178: Standard Cassette Formats
178 | DR 400 | Bucky Standard cassette formats 35 cm x 43 cm 35 cm x 35 cm 24 cm x 30 cm 18 cm x 24 cm 15 cm x 30 cm 3231E EN 20210708 1530...
Page 179: Dr Detector Formats And Orientation
DR 400 | Bucky | 179 DR Detector formats and orientation For information on how to use the DR Detector in the bucky, refer to following sections and to the user manual of the DR Detector. Topics: • Orientation of DR 10s in the bucky •...
Page 180: Orientation Of Dr 10S In The Bucky
180 | DR 400 | Bucky Orientation of DR 10s in the bucky The clamps of the bucky may trigger the DR 10s power switch. To avoid switching off the detector when inserting it in the bucky, apply the orientation as described below.
Page 181: Orientation Of Dr 14S In The Bucky
DR 400 | Bucky | 181 Figure 71: Portrait orientation in the radiographic wall stand left loading Orientation in the radiographic wall stand right loading • To use the detector landscape orientation, insert the detector in landscape orientation. • To use the detector in portrait orientation: 1.
Page 182 182 | DR 400 | Bucky 2. Rotate the detector in the bucky. Figure 73: Landscape orientation in the radiographic table Orientation in the radiographic wall stand left loading • To use the detector in landscape orientation, insert the detector in landscape orientation.
Page 183: Orientation Of Dx-D 10C, Dx-D 10G In The Bucky
DR 400 | Bucky | 183 Figure 75: Portrait orientation in the radiographic wall stand right loading Orientation of DX-D 10C, DX-D 10G in the bucky To avoid damage to the cable of the detector, there are restrictions on the orientation of the detector when loading the bucky.
Page 184: Using Dx-D 45C, Dx-D 45G, Xd 10, Xd⁺10 Only Outside The Bucky
184 | DR 400 | Bucky Orientation in the radiographic wall stand left loading • To use the detector in portrait orientation, insert the detector in portrait mode with the cable at upper left hand side. • To use the detector in landscape orientation: 1.
Page 185: Grids
DR 400 | Bucky | 185 Grids Anti-scatter grids are used to reduce scattered radiation and improve image quality. Grids are available as an option. For DR Detectors focused grids are used. Focused grids require centering of the X-ray source to the detector and a specific distance range between X-ray source and detector.
Page 186: 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.
Page 187: Grid Focal Distance Color Indication
DR 400 | Bucky | 187 Grid focal distance color indication The handle of the grid is visible when the grid is inserted and its color indicates the focal distance of the grid. Focal Distance Color 100 cm 150 cm...
Page 188: Grid Detection
188 | DR 400 | Bucky Grid detection The grid detection functionality of the bucky detects the type and position of the inserted grid. The grid status is shown on the tube head display and on the Software Console. Related Links...
Page 189: Storage Box For Dr Detector And Grids
DR 400 | Bucky | 189 Storage box for DR Detector and grids The storage box provides vertical storage space for a DR Detector and up to three grids. It can be mounted to the wall or stand on a stable surface.
Page 190: Automatic Exposure Control (Aec)
190 | DR 400 | Bucky Automatic Exposure Control (AEC) The use of an AEC ensures optimal and reproducible image quality independent of the radiation, the object exposed or other factors. The AEC has three sensor elements (ionization chambers). The AEC is mounted in the bucky of the radiographic table and the radiographic wall stand between the grid and the detector or cassette.
Page 191: X-Ray Generator Mini Console
DR 400 | X-Ray Generator Mini Console | 191 X-Ray Generator Mini Console The X-ray generator mini console is limited in functionality to power on and power off the generator and to connect the DR Generator Sync with the exposure hand switch to trigger the exposure.
Page 192: Starting And Stopping The Generator
192 | DR 400 | X-Ray Generator Mini Console Starting and stopping the generator The generator is switched on and off by the power buttons on the X-ray generator mini console. Press the Power ON button on the X-ray generator control box to switch on the generator.
Page 193: X-Ray Tube Start-Up Modes
DR 400 | X-Ray Generator Mini Console | 193 X-ray tube start-up modes The system can make exposures using two start-up modes, when pressing the exposure button in preparation stage: • Low speed start-up that boosts the tube anode to ca. 3000 rpm.
Page 194: X-Ray Generator Messages And Warning Signals
194 | DR 400 | X-Ray Generator Mini Console X-ray generator messages and warning signals Acoustic signals The generator indicates particular states with acoustic signals: • Exposure is terminated: 500 ms tone • Errors: rapid series of tones Visual signals The generator indicates particular states with visual signals: •...
Page 195 DR 400 | X-Ray Generator Mini Console | 195 • X-ray generator errors • Error numbers 3231E EN 20210708 1530...
Page 196: X-Ray Generator Errors
196 | DR 400 | X-Ray Generator Mini Console X-ray generator errors Follow the instructions for each specific error. Never open the machine. The table contains an action for each error. Notify service Notify service on frequent occurrence Can be eliminated by operator...
Page 197: Error Numbers
DR 400 | X-Ray Generator Mini Console | 197 Error numbers Display Explanation Error Action tube kV max Tube voltage too high (>166 kV/132 kV) control A max Load current too high (> 250 A) tube mA max Tube current too high (> 900 A)
Page 198 198 | DR 400 | X-Ray Generator Mini Console Display Explanation Error Action watchdog Watchdog error receive timeout Serial interface receipt timeout E²Prom wait timeout E2PROM access timeout fillament system Heater fault DAP system Area dose measuring system self test error...
Page 199 DR 400 | X-Ray Generator Mini Console | 199 Display Explanation Error Action no Tube mA Tube current < 50% after 30 ms tube > 70°C Hood temperature > 70°C to save data push 'M' 'NOT' signal 'EMERGENCY' safety signal active...
Page 200 200 | DR 400 | X-Ray Generator Mini Console Display Explanation Error Action grid is on Grid active in idle state RTC checksum, Batt. RTC (real time clock) error, RTC battery discharged starter system Normal speed starter fault current no main current Load current <...
Page 201 DR 400 | X-Ray Generator Mini Console | 201 Display Explanation Error Action Transfer system Serial interface controller error CAN system CAN bus transfer error BUS system CAN bus transfer is highly interfered or in- terrupted SCB transfer timeout Storz bus system timeout...
Page 202: Exposure Parameters
202 | DR 400 | X-Ray Generator Mini Console Exposure parameters Tube Voltage The tube voltage can be selected in steps of 1 kV in the range of 40 to 150 kV. mAs Product Step Step Step Step 0.63 Tube current [mA]...
Page 203 DR 400 | X-Ray Generator Mini Console | 203 Step Step (only for generator with 50 kW power or higher) (only for generator with 65 kW power or higher) Exposure time [ms] Step Step Step Step 1250 1600 2000 2500...
Page 204 204 | DR 400 | X-Ray Generator Mini Console HFe 401 HFe 501 HFe 601 HFe 801 (40 kW) (50 kW) (65 kW) (80 kW) HSS: 400 mA HSS: 500 mA E7869XX HSS: 650 mA HSS: 800 mA • LSS: Low Speed Start option •...
Page 205: Problem Solving
DR 400 | Problem solving | 205 Problem solving Topics: • Restoring connection between generator and NX after generator failure • Automatic collimation always too wide or too narrow • Empty Bucky Failure, Double Exposure Failure • NX does not connect to the generator due to ID tablet •...
Page 206: Restoring Connection Between Generator And Nx After Generator Failure
206 | DR 400 | Problem solving Restoring connection between generator and NX after generator failure Details An error on the generator occurred. NX lost connection to the generator. An error message that no connection with the genera- tor can be established is displayed on the Software Console.
Page 207: Automatic Collimation Always Too Wide Or Too Narrow
DR 400 | Problem solving | 207 Automatic collimation always too wide or too narrow Details The collimated area is not adapted correctly to the size of the cassette or DR Detected inserted in the bucky. Cause The sensors in the bucky that detect the size of the cas- sette or DR Detector are dirty or have become weak.
Page 208: Empty Bucky Failure, Double Exposure Failure
208 | DR 400 | Problem solving Empty Bucky Failure, Double Exposure Failure Details The exposure button was pressed but no exposure was performed. No radiation icon is displayed. The prepara- tion icon is displayed. • CR: Error message 40 is displayed on the Software Con- sole.
Page 209 DR 400 | Problem solving | 209 NX does not connect to the generator due to ID tablet Details This occurs on a DR installation in combination with a digitizer using an ID Tablet. The NX application and the Software Console cannot connect to the generator.
Page 210: No Table Movement
210 | DR 400 | Problem solving No table movement Details The table is not moving up or down when pressing the foot pedals with double click. No error is shown. Cause One of the foot pedals was pressed longer than 90 sec- onds.
Page 211: Dr Detector Is Exceeding The Maximum Working Temperature
DR 400 | Problem solving | 211 DR Detector is Exceeding the Maximum Working Temperature Details A message is displayed on NX indicating that the DR De- tector is exceeding the maximum working temperature. Cause Due to ambient temperature conditions and the number of acquired images, the DR Detector’s internal tempera-...
Page 212: Dr Detector Must Be Recalibrated
212 | DR 400 | Problem solving 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...
Page 213: System Does Not Start Completely If Collimator Is In Manual Mode
DR 400 | Problem solving | 213 System does not start completely if collimator is in manual mode Details System does not start completely if collimator is in manual mode. An error message is displayed indicating a problem with the collimator during start up.
Page 214: Tube Head Display Shows Screen To Check Network Connection
214 | DR 400 | Problem solving Tube head display shows screen to check network connection Details The tube head display shows only the following screen. Cause The tube head display does not detect a network con- nection. Brief Solution Check on the NX workstation if all network cables are plugged in.
Page 215: Radiographic Parameter Limits
DR 400 | Problem solving | 215 Radiographic Parameter Limits Switching between small focus and large focus may have a delay of a few seconds to enable the filament to warm up before switching. The settings of kV and mAs or of mA and ms are defined by an algorithm. The...
Page 216: Product Information
216 | DR 400 | Product Information Product Information Topics: • Compatibility • Connectivity • Compliance • Equipment Classification • Patient data security • Product Complaints • Environmental protection • System Documentation • Training • Technical Data • Remarks for HF-emission and immunity...
Page 217: Compatibility
Compatibility The system must only be used in combination with other equipment or components if these are expressly recognized by Agfa as compatible. A list of such equipment and components is available from Agfa service on request. Changes or additions to the equipment must only be carried out by persons authorized to do so by Agfa.
Page 218: Connectivity
218 | DR 400 | Product Information Connectivity The NX workstation is connected to the X-ray system to exchange X-ray exposure parameters. The NX workstation requires a 100 Mbit ethernet network to exchange information with a number of other devices.
Page 219: Compliance
DR 400 | Product Information | 219 Compliance The system is compliant with specific directives and standards. Topics: • General • Safety • Electromagnetic Compatibility • X-Ray Safety • X-Ray Accuracy • Environmental Compliance • Biocompatibility • Usability 3231E EN 20210708 1530...
Page 220: General
220 | DR 400 | Product Information General • The product has been designed in accordance with the MEDDEV Guidelines relating to the application of Medical Devices and have been tested as part of the conformity assessment procedures required by 93/42/EEC Medical Device Directive (European Council Directive 93/42/EEC on Medical Devices).
Page 221: X-Ray Accuracy
DR 400 | Product Information | 221 • IEC 60601-2-28 For USA The system conforms to DHHS radiation Standards of 21CFR subchapter J as of the date of manufacture. X-Ray Accuracy The system fulfills the X-ray radiation accuracy according EN IEC 60601-2-54 with a variation of max.
Page 222: Equipment Classification
222 | DR 400 | Product Information Equipment Classification Per EN/IEC 60601-1, EN/IEC 60601-2-54, this device is classified as following: Table 30: Equipment classification Class I equipment Equipment in which protection against electric shock does not rely on basic insulation only, but in- cludes a fixed connection to mains power with pro- tective earth conductor.
Page 223: Patient Data Security
DR 400 | Product Information | 223 Patient data security The user must ensure that the patients’ legal requirements are met and that the security of the patient data is guarded. The user must define who can access patient data in which situations.
Page 224: Product Complaints
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...
Page 225: Environmental Protection
DR 400 | Product Information | 225 Environmental protection Figure 81: WEEE symbol Figure 82: Battery symbol WEEE end user notice The directive on Waste Electrical and Electronic Equipment (WEEE) aims to prevent the generation of electric and electronic waste and to promote the reuse, recycling and other forms of recovery.
Page 226: System Documentation
The DR 400 User Documentation CD contains: • DR 400 User Manual (this document) • DX-D DR Detector Calibration Key User manual, document 0134 Other documentation available on the DR 400 User Documentation CD: • DAP Datasheet • X-ray Tube Documentation •...
Page 227: Training
The user must make sure that training is received in accordance with local laws or regulations that have the force of law. Your local Agfa or dealer representative can provide further information on training. The user must note the following information in the system documentation: •...
Page 228: Technical Data
228 | DR 400 | Product Information Technical Data Topics: • DR 400 Technical Data • Generator Technical Data • Radiographic Table and X-Ray Tube Stand Technical Data • Radiographic Wall Stand Technical Data • X-Ray Tube Technical Data •...
Page 229: Dr 400 Technical Data
DR 400 | Product Information | 229 DR 400 Technical Data Manufacturer Agfa NV Septestraat 27 2640 Mortsel, Belgium Type 5520/XXX Power line 400 V Y- 400V 3N~ PE (Y) 50/60 Hz source Power line 400/480 400/480V 3~PE (delta without N) 50/60Hz...
Page 230 230 | DR 400 | Product Information Environmental conditions Table 31: Environmental conditions for the X-ray system Environmental Conditions (during storage and transport) Temperature (ambient) between -15° and 50° Celsius Humidity (non condensing) between 15 and 90 % relative humidity...
Page 231: Generator Technical Data
DR 400 | Product Information | 231 Generator Technical Data Manufac- Spellman High Voltage Electronics GmbH turer Josef-Baumann-Strasse 23 D-44805 Bochum, Germany Supported EDITOR HFe EDITOR HFe EDITOR HFe EDITOR HFe Models Max. Pow- 40 kW 50 kW 65 kW...
Page 232 232 | DR 400 | Product Information The values for Power Output represent the maximum power output of the X- ray generator. These values do not represent the available exposure parameter settings on the Software Console. Related Links Exposure parameters...
Page 233: Radiographic Table And X-Ray Tube Stand Technical Data
DR 400 | Product Information | 233 Radiographic Table and X-Ray Tube Stand Technical Data Manufacturer Agfa NV Septestraat 27 2640 Mortsel, Belgium Type TS-Fix-L-001 5521/100 TS-Fix-R-001 5521/110 TS-Elev-L-001 5521/200 TS-Elev-R-001 5521/210 TS-Fix-L-002 5521/300 TS-Fix-R-002 5521/310 TS-Elev-L-002 5521/400 TS-Elev-R-002 5521/410...
Page 234 234 | DR 400 | Product Information Minimum room height 245 cm Tabletop attenuation equivalent mm ≤ 0.7 Aluminum According to DIN EN 60601-1-3 with 100kV and HVL 3.6 mm Al FDA 21 CFR § 1020.30 (n) with 100kV and HVL 3.6 mm Al...
Page 235 DR 400 | Product Information | 235 Rotation of the collimator around ±90° the axis of the X-ray beam CAUTION: Rotation may be limited by cables. Avoid strain on the cables during rota- tion. 3231E EN 20210708 1530...
Page 236: Radiographic Wall Stand Technical Data
236 | DR 400 | Product Information Radiographic Wall Stand Technical Data Manufacturer Agfa NV Septestraat 27 2640 Mortsel, Belgium Type WS-Manual-001 5522/100 WS-Manual-T-001 5522/200 WS-Manual-002 5522/300 WS-Manual-T-002 5522/400 Dimensions Height 2245 mm Width 610 mm (only front panel) 715 mm (with tilting handles)
Page 237 DR 400 | Product Information | 237 DIN EN 60601-1-3 with 100kV and HVL 3.6 mm Al FDA 21 CFR § 1020.30 (n) with 100kV and HVL 3.6 mm Al Weight Weight 157 kg (vertical wall stand) 196 kg (tilting wall stand)
Page 238: X-Ray Tube Technical Data
238 | DR 400 | Product Information X-Ray Tube Technical Data Manufacturer Canon Electron Tubes & Devices Co., Ltd. 1385 Shimoishigami Otawara-Shi, Tochigi-Ken 324-8550 Ja- E7884X X-ray Tube 12º 150 kVp dual focal spots 0.6 and 1.2 mm 300 KHU...
Page 239 DR 400 | Product Information | 239 150 kVp dual focal spots 0.6 and 1.2 mm 600 KHU LS 21/53 kW (50Hz) 23/58 kW (60Hz) HS 40/100 kW (180Hz) 14,49x10 mAh@150kVp maximum load 3231E EN 20210708 1530...
Page 240: Bucky Unit Technical Data
240 | DR 400 | Product Information Bucky Unit Technical Data Manufacturer Agfa NV Septestraat 27 2640 Mortsel, Belgium Type BT-Cassette-T-001 5523/100 BT-Cassette-T-GSS-001 5523/110 CASS BUCKY TABLE W/O ACSS INCL DET CHARG 5523/115 BT-Cassette-T-ACSS-001 5523/120 CASS BUCKY TABLE ACSS INCL DET CHARG...
Page 241 DR 400 | Product Information | 241 65.5 cm x 60.0 cm x 8.0 cm Dimensions in radiographic table (WxLxH) Dimensions in radiographic wall stand 62.5 cm x 61.5 cm x 12.5 cm (WxLxH) Weight (without detector) Bucky for DR Detector or CR cassette in 23.5 kg...
Page 242 242 | DR 400 | Product Information Expected lifetime for the bucky 10 years 3231E EN 20210708 1530...
Page 243: Automatic Exposure Control (Aec) Technical Data
DR 400 | Product Information | 243 Automatic Exposure Control (AEC) Technical Data Table 32: Varex AEC ionization chamber Manufacturer Varex Imaging Americas Corp. 3835 Carnation Street Franklin Park, IL 60131 U.S.A. Supported Type ICX1945B Description 3-field ionization chamber with electronics Maximum dose rate 1.250 uGy/s...
Page 244: Manual Collimator Technical Data
244 | DR 400 | Product Information Manual Collimator Technical Data Manufacturer Ralco Via dei Tigli 13/G 20853 Biassono (MB), Italy Supported type R 221 Maximum radiation leakage 150 kVp – 4 mA Inherent filtration 2 mm Aluminum equivalent Added filtration...
Page 245: Automatic Collimator Technical Data
DR 400 | Product Information | 245 Automatic Collimator Technical Data Manufacturer Ralco Via dei Tigli 13/G 20853 Biassono (MB), Italy Supported type R 225 ACS Maximum radiation leakage 150 kVp – 4 mA Inherent filtration 2 mm Aluminum equivalent...
Page 246: Dose Area Product Meter (Iba Dap) Technical Data
246 | DR 400 | Product Information Dose Area Product Meter (IBA DAP) Technical Data Manufacturer IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck Supported Type 120-131 HS/RS485 Dose area product range (0.1...99999999.99) cGy x cm Minimum readout value 0.01 cGy x cm 14.0 cm x 14.0 cm...
Page 247: Dose Area Product Meter (Vacutec Dap) Technical Data
DR 400 | Product Information | 247 Dose Area Product Meter (VacuTec DAP) Technical Data Manufacturer VacuTec Messtechnik GmbH Dornblüthstrasse 13 D-01277 Dresden, Germany Supported Type VacuDAP 2004 Dose area product range (1.0...9999999.9) cGy x cm Minimum readout value 0.1 cGy x cm 14.7 cm x 14.7 cm...
Page 248: Fixed Dr Detector
248 | DR 400 | Product Information Fixed DR Detector Two types of fixed DR Detectors are supported. Topics: • Fixed DR Detector Technical Data • Fixed DR Detector Technical Data Fixed DR Detector Technical Data Manufacturer Manufacturer DR Detector Varex Imaging Corporation, 1678 So.
Page 249 DR 400 | Product Information | 249 Active pixel matrix 3056(H) x 3056(V) Fill factor 100 % Detector type Amorphous Silicon Active area size 42,7 cm (H) x 42,7 cm (V) Reliability Estimated product life (if regularly serviced 100 000 RAD...
Page 250 250 | DR 400 | Product Information Pixel Matrix Pixium RAD Pixium RAD Pixium RAD Pixium RAD 4343 C 4343 G 4343 C-E 4343 G-E Pixel size 148 µm (H,V) Pixel matrix 2880(H) x 2880(V) Active pixel 2869(H) x 2874(V)
Page 251 DR 400 | Product Information | 251 minimum maximum Distance to calibration temperature -10 °C +10 °C Distance to calibration pressure -100 mbar +100 mbar Pixium RAD 4343 G, Pixium RAD 4343 G-E Environmental Conditions (during normal operation) Temperature (ambient) between 15° and 40° Celsius...
Page 252: Portable Dr Detector Technical Data
252 | DR 400 | Product Information Portable DR Detector Technical Data Refer to the DR Detector User Manual. 3231E EN 20210708 1530...
Page 253: Nx Workstation Technical Data
DR 400 | Product Information | 253 NX Workstation Technical Data Electrical connection Operating voltage 90 – 263VAC Mains fuse protection 5.5A Mains frequency 47 – 63 Hz Power consumption Maximum power consumption 320W 3231E EN 20210708 1530...
Page 254: Dr Generator Sync Box Technical Data
254 | DR 400 | Product Information DR Generator Sync Box Technical Data Model name DR Generator Sync Box Type number 5400/516 Labeling Dimensions Depth 21.5 cm Width 33.5 cm Height 6.5 cm Weight 3.2 kg Electrical connection 100-240 V AC, 50/60 Hz Power consumption 40 W (max.
Page 255: Remarks For Hf-Emission And Immunity
DR 400 | Product Information | 255 Remarks for HF-emission and immunity It is hereby certified that the device has interference suppression according to the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A.
Page 256 IEC 61000-3-3 DR 400 is used in a professional healthcare facility / radiological environment. Environmental conditions are stated in the user manual. This device was tested for a professional healthcare environment as described above. Nevertheless the HF-emission and immunity can be influenced by connected data cables depending on length and the manner of installation.
Page 257 DR 400 | Product Information | 257 ded to use an energy supply • 0% U for 250 pe- free of interruptions or a riods battery. Magnetic field at the 30 A/m Magnetic field at the net- supply frequency work frequency should cor-...
Page 258 258 | DR 400 | Product Information investigation of the location is recommended, to ascertain the electromagnetic environment as a result of stationary high frequency transmitters. If the field strength of the device exceeds the test level given above, the device must be observed with regard to its normal operation at each place of use.
Page 259 DR 400 | Product Information | 259 • Immunity to RF wireless communication equipment • Precautions on EMC • Cables, transducers and accessories • Maintenance on EMC relevant parts 3231E EN 20210708 1530...
Page 260: Immunity To Rf Wireless Communication Equipment
260 | DR 400 | Product Information Immunity to RF wireless communication equipment Service ISM Band Distance Immunity test level (MHz) (V/m) 300-390 TETRA 400 430-470 GMRS 460; FRS 460 704-787 LTE Band 13, 17 800-960 GSM 800/900; TETRA 800, IDEN 820;...
Page 261: Precautions On Emc
DR 400 | Product Information | 261 Precautions on EMC WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Page 262: Cables, Transducers And Accessories
262 | DR 400 | Product Information Cables, transducers and accessories Cables, transducers and accessories which were tested and found to comply with the collateral standard IEC60601-1-2 (EMC): CAUTION: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment...
Page 263 DR 400 | Product Information | 263 remark from; type; maximum length mandatory Table output terminal (x8 24V, 10 x AWG21 (0.5 mm light push button, double expo- 20 m sure protection); wall stand input terminal mandatory table output terminal (230 V);...
Page 264 264 | DR 400 | Product Information remark from; type; maximum length wired hand control 1.8 m For type 5520/200 only remark from; type; maximum length shielded table output terminal; 9 pin sub D; wall stand input terminal (CAN) 20 m...
Page 265: Maintenance On Emc Relevant Parts
DR 400 | Product Information | 265 Maintenance on EMC relevant parts Concerning the EMC safety of the DR 400 device, no relevant parts could be inspected by the operator. EMC relevant parts will be inspected from AFGA service engineer within the regular service interval until the end of lifetime.

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