2 | DR 400 | Contents Contents Legal Notice ................5 Introduction ................6 Introduction to this Manual ........7 Scope of this Manual ........8 Warnings, Cautions, Instructions and Notes ..Disclaimer ........... 10 Introduction to DR 400 ..........10 Intended Use ..........
Page 3
DR 400 | Contents | 3 Step 7: digitize the image ......74 Step 8: perform a quality control ....75 X-Ray System Positioning ........76 RAD Table Exposures ........77 Oblique Exposures ........78 Lateral Exposures ........79 RAD Wall Stand Exposures ......
Page 4
4 | DR 400 | Contents System messages ........... 143 Restoring connection between generator and NX after generator failure ............145 Automatic collimation always too wide or too narrow Empty Bucky Failure, Double Exposure Failure ..147 NX does not connect to the generator due to ID tablet No table movement ..........149...
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. DR 400 is a trademark of Agfa HealthCare N.V., 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.
DR 400 | Introduction | 7 Introduction to this Manual Topics: • Scope of this Manual • Warnings, Cautions, Instructions and Notes • Disclaimer 3231A EN 20150710 1114...
8 | DR 400 | Introduction 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. 3231A EN 20150710 1114...
DR 400 | Introduction | 9 Warnings, Cautions, Instructions and Notes The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use. Warning: Warnings are directions which, if they are not...
10 | DR 400 | Introduction 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.
DR 400 | Introduction | 11 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.
12 | DR 400 | Introduction 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.
DR 400 | Introduction | 13 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: • RAD Table with an integrated DX-D Fixed DR Detector or with a bucky. In the bucky a DR Detector or a CR cassette can be inserted.
Page 14
X-ray tube stand mounted on RAD Table X-ray tube with collimator and tube head display Portable DR Detector RAD Table with integrated generator RAD Wall Stand Figure 1: DR 400 configuration for DR Topics: • Applied Parts Applied Parts Applied Parts refer to parts of the medical electrical equipment that in normal use necessarily comes into physical contact with the patient for the equipment to perform its function.
Page 15
DR 400 | Introduction | 15 • Mattress (optional) • Compression belt (optional) RAD Wall Stand • Front panel of the RAD Wall Stand • Overhead arm support (optional) • Patient hand grips (optional) DR Detector • DR Detector 3231A EN 20150710 1114...
16 | DR 400 | Introduction Equipment Classification Per EN/IEC 60601-1:2005, EN/IEC 60601-2-54:2009, this device is classified as following: Table 1: Equipment classification Class I equipment Equipment in which protection against electric shock does not rely on basic insulation only, but includes a fixed connection to mains power with protective earth conductor.
DR 400 | Introduction | 17 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.
18 | DR 400 | Introduction Operation Controls Topics: • RAD Table • RAD Wall Stand • Control Panel of the X-Ray Tube Stand • NX Application on the NX Workstation • Software Console • DR Detector Switch • X-ray generator mini console •...
Page 19
DR 400 | Introduction | 19 Figure 3: RAD Wall Stand with vertical bucky Related Links RAD Wall Stand on page 96 Control Panel of the X-Ray Tube Stand Figure 4: Control Panel of the X-Ray Tube Stand with tube head display...
Page 20
20 | DR 400 | Introduction Tube head display The tube head display can be used to control X-ray exposure parameters. It displays the system status. Last name, first name *June 10, 1960, 08154711032, Chest PA 0.1 mm Cu Detector table 1 mm Al 35°...
Page 21
DR 400 | Introduction | 21 Figure 8: Software Console DR Detector Switch The DR Detector Switch is available in the device status frame of the Software Console. The DR Detector Switch shows which DR Detector is active and shows its status.
Page 22
22 | DR 400 | Introduction Meaning Good Low Bad Wired DR Detector DR detector status icon (blinking) Meaning Ready Initializing Error Sleep One DR detector exposure must be selected X-ray generator mini console The X-ray generator mini console is available in the operator room.
Page 23
DR 400 | Introduction | 23 The X-ray tube is prepared for performing an exposure. 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.
Page 24
24 | DR 400 | Introduction The collimator provides X-ray filtering using the integrated filters or by inserting a filter in the rails. An integrated DAP meter (Dose Area Product Meter) in the collimator is available as an option. Figure 12: Collimator...
Page 25
DR 400 | Introduction | 25 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 RAD Table. All motor driven movements will be stopped.
Page 26
26 | DR 400 | Introduction Warning: It must be ensured that the emergency switches are always freely accessible. 3231A EN 20150710 1114...
• DX-D Software Console, DR Tube Head Display User Manual, document 0389 • User manuals for the supported DR Detectors • 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 • Collimator Datasheet •...
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: •...
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...
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.
DR 400 | Introduction | 31 Compliance The system is compliant with specific directives and standards. Topics: • General • Safety • Electromagnetic Compatibility • X-Ray Safety • X-Ray Accuracy • Environmental Compliance • Biocompatibility General • The product has been designed in accordance with the MEDDEV...
Page 32
32 | DR 400 | Introduction interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. If required, contact your local service organization.
DR 400 | Introduction | 33 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. The NX workstation communicates with other devices in the hospital network using one of the following protocols: •...
34 | DR 400 | Introduction 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.
DR 400 | Introduction | 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
36 | DR 400 | Introduction X-ray room Patient environment Workstation Operator room: protected area Figure 14: Protected area and significant zones of occupancy Warning: The radiation protection has to be applied to the patient. If operator or staff needs to be close to the patient during normal use (e.g.
Page 37
DR 400 | Introduction | 37 Significant zones of occupancy at the RAD Table 50 cm 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...
Page 38
38 | DR 400 | Introduction Radiation Protection on page 35 Stray Radiation on page 186 Significant zones of occupancy at the RAD Wall Stand 50 cm Phantom X-ray tube Focal spot label [—] Significant zone of occupancy. Minimum area 60x60 cm.
Page 39
DR 400 | Introduction | 39 Significant zone of occupancy at the left side of the RAD Table Figure 16: Significant zones of occupancy at the RAD Wall Stand Warning: The radiation protection has to be applied for the patient and for the operator.
40 | DR 400 | Introduction Labels Mark Meaning This mark shows compliance of the equipment with Directive 93/42/EEC (for European Union). This mark indicates that this is a Type B Equipment Serial number Manufacturer Date of manufacture Label Meaning...
Page 41
DR 400 | Introduction | 41 • Warning labels on the RAD Wall Stand • Type label • DR Detector identification label • Additional Labeling of the RAD Table • Additional Labeling of the RAD Wall Stand • Labeling of the bucky •...
Page 42
42 | DR 400 | Introduction Type label Mark Meaning Type label positioned on the lower left 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 43
DR 400 | Introduction | 43 Additional Labeling of the RAD Table Type label on the lower left hand side of the X-ray tube stand. The type label information for each combination of X-ray tube and X-ray 5521/210 generator is available in the technical data.
Page 44
44 | DR 400 | Introduction (Sample of subtype 5522/100) This mark indicates that this is a Type B Equipment Functional earth The bucky can be tilted to horizontal position. Do not use the bucky as a seat. A pinch point label is located on top of the tilting extension.
Page 45
DR 400 | Introduction | 45 Compliance with China RoHS SJ/ T11364-2006. Indication of the Environment Friendly Use Period (EFUP) as the period (years) during which the hazardous 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.
46 | DR 400 | Introduction 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. The user is responsible for selecting a disinfection procedure.
Page 47
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 48
• Using unsuitable disinfectants can cause discoloration and damage of the surface of the equipment. 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.
DR 400 | Introduction | 49 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.
50 | DR 400 | Introduction Maintenance Always consult the Agfa Service documentation and an AGFA trained and authorized Service engineer for complete maintenance schedules. Topics: • Maintenance • Maintenance of the RAD Table, RAD Wall Stand and X-Ray Tube Stand...
Page 51
DR 400 | Introduction | 51 additions, maintenance or repairs are carried out by an Agfa certified field service engineer. Table 2: Lifetime and maintenance Lifetime Expected lifetime for the X-ray unit 10 years Periodic maintenance The equipment shall have a technical maintenance to...
Page 52
52 | DR 400 | Introduction Warming-up of X-ray tube The X-ray tube needs to be warmed-up before making X-ray exposures at the start of each day and when the X-ray tube has not been in use for more than an hour.
DR 400 | Introduction | 53 Environmental protection Figure 21: WEEE symbol Figure 22: 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.
Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Warning: All Agfa medical products must be used by trained and qualified personnel. Warning: Ionizing radiation can lead to radiation injuries if handled incorrectly.
Page 55
DR 400 | Introduction | 55 Warning: Operating the equipment when it is faulty includes the risk of radiological exposure and injury to the patient and to the operator. Operate the equipment only in safe and fault-free conditions. Safety Directions for the X-Ray System...
Page 56
56 | DR 400 | Introduction Caution: Excessive ambient temperature may impact performance of DR Detectors and cause permanent damage to the equipment. If ambient temperature and humidity is outside the range specified in the technical data, do not operate the system or use air conditioning.
Page 57
DR 400 | Introduction | 57 Caution: Make sure that the patient hand grips are securely mounted. 3231A EN 20150710 1114...
58 | DR 400 | Getting started Getting started Topics: • Starting the System • Basic workflow using the DR Detector • Basic workflow using a CR cassette • X-Ray System Positioning • Guidelines for Pediatric Applications • Stopping the System...
DR 400 | Getting started | 59 Starting the System To start the system: Note: 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.
60 | DR 400 | Getting started Basic workflow 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 •...
DR 400 | Getting started | 61 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. 3231A EN 20150710 1114...
62 | DR 400 | Getting started 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.
DR 400 | Getting started | 63 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.
64 | DR 400 | Getting started Step 4: check the exposure settings Related Links DR Detector Switch on page 21 On the NX application: 1. Check if the DR Detector Switch displays the name of the DR Detector that's being used 2.
DR 400 | Getting started | 65 Step 5: execute the exposure In the operator room: Press the exposure button to execute the exposure. Instruction: 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.
66 | DR 400 | Getting started 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.
DR 400 | Getting started | 67 Basic workflow 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.
68 | DR 400 | Getting started 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. 3231A EN 20150710 1114...
DR 400 | Getting started | 69 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.
70 | DR 400 | Getting started 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.
DR 400 | Getting started | 71 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.
72 | DR 400 | Getting started 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.
74 | DR 400 | Getting started 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.
DR 400 | Getting started | 75 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.
76 | DR 400 | Getting started X-Ray System Positioning Topics: • RAD Table Exposures • Oblique Exposures • Lateral Exposures • RAD Wall Stand Exposures 3231A EN 20150710 1114...
DR 400 | Getting started | 77 RAD Table Exposures 1. Position the patient on the RAD 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.
78 | DR 400 | Getting started Oblique Exposures 1. Position the patient on the RAD 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.
DR 400 | Getting started | 79 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.
80 | DR 400 | Getting started RAD Wall Stand Exposures 1. Adjust the height of the bucky on the RAD Wall Stand. 2. Position the patient in front of the RAD Wall Stand. 3. Move the table top away from the RAD Wall Stand.
DR 400 | Getting started | 81 Guidelines for Pediatric Applications Caution: Children are more radiosensitive than adults. Adopting the Image Gently campaign guidelines and reducing dose for radiographic procedures while maintaining acceptable clinical image quality will benefit patients. Please review the following link and reduce pediatric technique factors accordingly: http://www.pedrad.org/associations/5364/ig/...
Page 82
82 | DR 400 | Getting started • Avoid multiple scans and use alternative diagnostic studies (such as ultrasound or MRI) when possible. 3231A EN 20150710 1114...
DR 400 | Getting started | 83 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.
84 | DR 400 | Operation Operation Topics: • Tube head display • RAD Table and X-Ray Tube Stand • RAD Wall Stand • Bucky • Grids • Storage box for DR Detector and grids • Automatic Exposure Control (AEC) •...
DR 400 | Operation | 85 Tube head display Last name, first name *June 10, 1960, 08154711032, Chest PA Detector table 0.1 mm Cu 1 mm Al 35° Patient information Status bar with exam type Modality position DR Detector Switch...
86 | DR 400 | Operation RAD Table and X-Ray Tube Stand The RAD 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 87
DR 400 | Operation | 87 Control panel of the X-ray tube stand Figure 28: RAD 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.
88 | DR 400 | Operation 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. To release the brake for the selected movement direction or rotation, press and hold the button and move the X-ray tube stand.
Page 89
DR 400 | Operation | 89 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 90
90 | DR 400 | Operation The vertical stop on the tube stand is always active. The two transversal stops are active when the X-ray tube is rotated towards the wall stand (90°+/- 10°). To enter a stop position, move the X-ray tube stand or the X-ray tube arm in longitudinal or vertical direction.
DR 400 | Operation | 91 Positioning the RAD Table There are two versions of the RAD table: • Fixed height RAD Table with a height of 70 cm • Elevating RAD Table with adjustable height from 55 cm to 90 cm The movements of the RAD table are controlled by foot pedals mounted at front side of the table.
Page 92
92 | DR 400 | Operation Foot pedal to raise table height (maximum 90 cm). When minimum or maximum position of the table is reached, the movement is stopped automatically. When the standard exposure height (70 cm) is reached, the movement is stopped automatically.
DR 400 | Operation | 93 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.
94 | DR 400 | Operation RAD Table Accessories Caution: 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: • Mounting the patient hand grips •...
Page 95
DR 400 | Operation | 95 Note: The collision protection is influenced by the patient weight. Take special care when moving the RAD Table with a patient lying on. Figure 35: Location of the collision protection accessories Other RAD Table accessories On request further accessories for the RAD table are available: •...
96 | DR 400 | Operation RAD Wall Stand The RAD Wall Stand allows vertical X-ray exposures of patients standing or sitting in front of the RAD Wall Stand. The wall stand has two variants: • wall stand with vertical bucky, supporting vertical movement (up and down) •...
Page 97
DR 400 | Operation | 97 Vertical movement handle (both sides) Tilting extension Tilting handle Figure 38: RAD Wall Stand, vertical version and vertical tilting version Caution: The format indications on the front panel show the format of the cassette or detector. Take into account that the actual area for imaging is smaller than indicated.
98 | DR 400 | Operation Positioning the RAD Wall Stand Vertical movement handle with brake switch Tilting angle scale Tilting handle Figure 39: Positioning controls Warning: Maintain visual contact with the patient while moving the equipment close to the patient in order to detect hazardous situations (e.g.
Page 99
DR 400 | Operation | 99 Caution: The maximum load for the bucky movement in vertical direction is 20 kg. The bucky may slip downward when applying excessive load. Note: Do not move the bucky with excessive force to the end stop positions.
Page 100
100 | DR 400 | Operation The X-ray tube stand is moving up or down accordingly. Note: The movement of the X-ray tube is automatically stopped if the distance between the X-ray tube head and the table top would become too small (less than 10 cm).
DR 400 | Operation | 101 RAD Wall Stand Accessories Caution: 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: • Patient hand grips •...
Page 102
102 | DR 400 | Operation Caution: Do not insert the handle oriented parallel to the bucky. The handle may collide with the Wall Stand column. Caution: Take care of the overhead handle position when tilting the bucky. To mount and position the overhead handle: 1.
Page 103
DR 400 | Operation | 103 Stand under the head cover and then fixed to a wall. It has to be installed by service. Other RAD Wall Stand accessories On request further accessories for the RAD Wall Stand is available: •...
104 | DR 400 | Operation Bucky The bucky is installed in RAD table and RAD 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 105
DR 400 | Operation | 105 • Bucky configuration • Rotating the bucky • Loading of the bucky in the RAD Table • Loading of the bucky in the RAD Wall Stand • Unloading of the bucky in the RAD Table •...
106 | DR 400 | Operation 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 107
DR 400 | Operation | 107 Function Bucky with Bucky with Bucky for fixed tray for tray for DR detector multiple multiple cassette or cassette or detector detector formats formats RAD Table 5523/100 5523/120 5523/300 RAD Wall Stand, 5523/200 5523/220...
Page 108
108 | DR 400 | Operation Indicators for large format cassette or detector position to the top of the bucky Large format detector positioned to the top of the bucky Figure 46: Wall stand bucky with large format detector positioned to the top...
DR 400 | Operation | 109 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.
110 | DR 400 | Operation Loading of the bucky in the RAD 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.
DR 400 | Operation | 111 Loading of the bucky in the RAD 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.
112 | DR 400 | Operation Unloading of the bucky in the RAD 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.
DR 400 | Operation | 113 Unloading of the bucky in the RAD 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.
114 | DR 400 | Operation 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 115
DR 400 | Operation | 115 The ACSS functionality of the bucky is only available in combination with the automatic collimator Ralco 225 ACS. The ACCS functionality is not available when the collimator is in manual mode. Related Links Automatic collimator...
116 | DR 400 | Operation 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. Caution: Inserting DX-D 10C, DX-D 10G using other orientations than described will damage the cable when closing the bucky or when rotating the carrier.
Page 117
DR 400 | Operation | 117 Orientation in the RAD Wall Stand right loading • To use the detector landscape orientation, insert the detector in landscape mode with the cable at upper right hand side. • To use the detector in portrait orientation: 1.
118 | DR 400 | Operation 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.
DR 400 | Operation | 119 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...
120 | DR 400 | Operation 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. 3231A EN 20150710 1114...
DR 400 | Operation | 121 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.
122 | DR 400 | Operation 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 RAD Table and RAD Wall Stand between the grid and the detector or cassette.
DR 400 | Operation | 123 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 124
124 | DR 400 | Operation cable connecting the radiation meter to the generator 2. Unscrew the screw on the left hand side of the rail system. 3. Pull out the radiation meter. The DAP meter is calibrated during production to be used up to 2000 m altitude.
DR 400 | Operation | 125 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 • Active filter Operation mode indicators •...
Page 126
126 | DR 400 | Operation • Dose Area Product Meter (DAP) 3231A EN 20150710 1114...
DR 400 | Operation | 127 Semi-automatic collimation mode The semi-automatic collimation mode is activated if any of following conditions applies: • the collimator is rotated by more than +/-3° • the tube head unit is rotated by more than +/-3° from the center position •...
128 | DR 400 | Operation 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.
DR 400 | Operation | 129 Dose Area Product Meter (DAP) An integrated DAP meter (Dose Area Product Meter) in the collimator is availabe as an option. The DAP meter reads the radiation as Dose Area Product in [µGy x m The measured radiation value is transferred to the Software Console automatically and displayed after each exposure.
130 | DR 400 | Operation 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 ×...
DR 400 | Operation | 131 X-Ray Generator Console The X-ray generator 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.
132 | DR 400 | Operation 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.
DR 400 | Operation | 133 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.
134 | DR 400 | Operation 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 135
DR 400 | Operation | 135 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 136
136 | DR 400 | Operation Error Display Explanation Action number receive timeout Serial interface receipt timeout 2 E²Prom wait timeout E2PROM access timeout fillament system Heater fault DAP system Area dose measuring system self test error filament parameter Deviating heating parameters...
Page 137
DR 400 | Operation | 137 Error Display Explanation Action number dose too low after Dose too small after 50 ms 50ms (automatic exposure control) pulse delay too long Exposure pause between 2 pulses > 2 sec (automatic exposure control) exp.
Page 138
138 | DR 400 | Operation Error Display Explanation Action number CAN system CAN bus transfer error BUS system CAN bus transfer is highly interfered or interrupted SCB transfer Storz bus system timeout timeout SCB false version Storz bus version error...
DR 400 | Operation | 139 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] Step...
Page 140
140 | DR 400 | Operation Step mA 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 3200 4000...
Page 141
DR 400 | Operation | 141 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 •...
142 | DR 400 | Problem solving Problem solving Topics: • System messages • Restoring connection between generator and NX after generator failure • Automatic collimation always too wide or too narrow • Empty Bucky Failure, Double Exposure Failure •...
DR 400 | Problem solving | 143 System messages The system can display messages to the user on the screen. • Software Console • Message frame Click the message frame to view older messages. • Dialog box The software console displays a dialog box in the middle of the screen.
Page 144
Messages that require no user response disappear automatically. Warning or error messages may instruct to contact the Agfa service organization if the problem repeats, but by following the instructions in the message, the user can restore the operation of the system.
DR 400 | Problem solving | 145 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 generator can be established is displayed on the Software Console.
146 | DR 400 | Problem solving 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 cassette or DR Detector are dirty or have become weak.
DR 400 | Problem solving | 147 Empty Bucky Failure, Double Exposure Failure Details The exposure button was pressed but no exposure was performed. No radiation icon is displayed. The preparation icon is displayed. • CR: Error message 40 is displayed on the Software Console.
Page 148
148 | DR 400 | Problem solving 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.
DR 400 | Problem solving | 149 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 seconds.
150 | DR 400 | Problem solving DR Detector is Exceeding the Maximum Working Temperature Details A message is displayed on NX indicating that the DR Detector is exceeding the maximum working temperature. Cause Due to ambient temperature conditions and the number of acquired images, the DR Detector’s internal...
DR 400 | Problem solving | 151 DR Detector must be Recalibrated Details A message is displayed on NX indicating that the DR Detector must be recalibrated. Cause A DR Detector must be recalibrated at regular interval. Brief Solution Follow the instructions in the DR System Key User Manual to calibrate the DR Detector: •...
152 | DR 400 | Technical Data Technical Data Topics: • DR 400 Technical Data • Generator Technical Data • RAD Table and X-Ray Tube Stand Technical Data • RAD Wall Stand Technical Data • X-Ray Tube Technical Data •...
DR 400 | Technical Data | 153 DR 400 Technical Data Manufacturer Agfa HealthCare N.V. 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 V 400/480V 3~PE (delta without N) 50/60Hz...
154 | DR 400 | Technical Data (+ 0.2 mm Al with DAP meter integrated in the collimator) Environmental conditions Environmental Conditions (during storage and transport) Temperature (ambient) between -15° and 50° Celsius Humidity (non condensing) between 15 and 90 % relative humidity...
DR 400 | Technical Data | 155 Generator Technical Data Manufacturer Spellman High Voltage Electronics GmbH Josef-Baumann-Strasse 23 D-44805 Bochum, Germany Supported EDITOR HFe EDITOR HFe EDITOR HFe EDITOR HFe Models Max. Power 40 kW 50 kW 65 kW 80 kW...
Page 156
156 | DR 400 | Technical Data 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...
158 | DR 400 | Technical Data Minimum room height 245 cm Tabletop attenuation equivalent ≤ 0.7 mm 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 159
DR 400 | Technical Data | 159 Rotation of the collimator ±90° around the axis of the X-ray Caution: Rotation may be beam limited by cables. Avoid strain on the cables during rotation. 3231A EN 20150710 1114...
160 | DR 400 | Technical Data RAD Wall Stand Technical Data Manufacturer Agfa HealthCare N.V. 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 Vertical RAD Wall Stand 65.1 cm x 36.7 cm x 224.5 cm...
Page 161
DR 400 | Technical Data | 161 Vertical RAD Wall Stand 157 kg Vertical and tilting RAD Wall 196 kg Stand Maximum load on the bucky 32 kg Maximum load on the brakes for 250 N the vertical movement (*) specific values do not apply as technical data of the system in China...
162 | DR 400 | Technical Data X-Ray Tube Technical Data Manufacturer Toshiba Electron Tubes & Devices Co., Ltd. 1385 Shimoishigami Otawara-Shi, Tochigi-Ken 324-8550 Japan E7884X X-ray Tube 12º 150 kVp dual focal spots 0.6 and 1.2 mm 300 KHU...
Page 163
DR 400 | Technical Data | 163 150 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 3231A EN 20150710 1114...
164 | DR 400 | Technical Data Bucky Unit Technical Data Manufacturer Agfa HealthCare N.V. Septestraat 27 2640 Mortsel, Belgium Type BT-Cassette-T-001 5523/100 BT-Cassette-T-ACSS-001 5523/120 BT-Cassette-WS-L-001 5523/200 BT-Cassette-WS-ACSS-L-001 5523/220 BT-Cassette-WS-R-001 5523/250 BT-Cassette-WS-ACSS-R-001 5523/270 BT-Fixed-T-001 5523/300 BT-Fixed-WS-L-001 5523/310 BT-Fixed-WS-R-001 5523/320 Dimensions Dimensions in RAD Table 65.5 cm x 60.0 cm x 8.0 cm...
Page 165
DR 400 | Technical Data | 165 (type 5523/100, 5523/200, 5523/250, 5523/300, 5523/310, 5523/320) Operating voltage 24 VDC Operating current 80 mA Electrical connection (type 5523/120, 5523/220, 5523/270) Operating voltage 24 VDC Operating current 375 mA Supported sizes Supported sizes...
166 | DR 400 | Technical Data Automatic Exposure Control (AEC) Technical Data Manufacturer VacuTec Messtechnik GmbH Dornblüthstrasse 13 D-01277 Dresden, Germany Supported Type No. 145 00 44 Description 3-field chamber with electronics Exposure dose range 1 to 100 uGy...
DR 400 | Technical Data | 167 Ralco R221 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...
168 | DR 400 | Technical Data Ralco R225 ACS 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...
DR 400 | Technical Data | 169 Dose Area Product Meter (DAP) Technical Data Manufacturer VacuTec Messtechnik GmbH Dornblüthstrasse 13 D-01277 Dresden, Germany Supported Type VacuDAP 2004 Dose area product range (0.1 to 3x10 ) µGy x cm Attenuation 0.44 mm Al equivalent (70 kV) Quality filtration 0.24 mm Al equivalent (70 kV)
170 | DR 400 | Technical Data DX-D Fixed DR Detector Technical Data Manufacturer Manufacturer DR Detector Varian X-Ray Products, 1678 So. Pioneer Rd, Salt Lake City, UT 84104, USA Supported models 4343R (part number 7965) CsI conversion screen 4343R (part number 7964)
Page 171
DR 400 | Technical Data | 171 Reliability Estimated product life (if regularly 100 000 RAD serviced and maintained according to Agfa instructions) 3231A EN 20150710 1114...
DR 400 | Technical Data | 173 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 3231A EN 20150710 1114...
174 | DR 400 | Technical Data 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.
DR 400 | Remarks for HF-emission and immunity | 175 Remarks for HF-emission and immunity Topics: • Remarks for HF-emission and immunity • Essential performance • Cables, transducers and accessories 3231A EN 20150710 1114...
Table 6: Guidance and manufacturer’s declaration – electromagnetic emissions The DR 400 system is intended for use in the electromagnetic environment specified below. The customer or the user of the DR 400 system should assure that it is used in such an environment. Emission test...
Page 177
IEC 61000-3-3 This DR 400 system is intended for operation in the electromagnetic environment given below. The user of the DR 400 system should ensure that it is used in such an environment. Table 7: Guidance and manufacturer’s declaration – electromagnetic...
Page 178
Table 8: Guidance and manufacturer’s declaration – electromagnetic immunity The DR 400 system is intended for use in the electromagnetic environment specified below. The customer or the user of the DR 400 system should assure that it is used in such an environment. Immunity test...
Page 179
DR 400 | Remarks for HF-emission and immunity | 179 Use portable and mobile radio sets at a safe distance from the device (including the leads) not closer than the recommended protective distance, which is calculated according to the equation suitable for the transmission frequency.
Page 180
Table 9: Recommended separation distances between portable and mobile RF communications equipment and the DR 400 system The DR 400 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of...
Page 181
DR 400 | Remarks for HF-emission and immunity | 181 power of transmitter 150 kHz to 80 80 MHz to 800 800 MHz to 2.5 d = 1.2 d = 1.2 d = 2.3 0.01 0.12 0.12 0.23 0.38 0.38 0.73...
182 | DR 400 | Remarks for HF-emission and immunity Essential performance EUT-specific compliance criteria considering Essential Performance of Equipment under Test: • No error messages on panel and on display of EUT • No unintended move of table, wall stand and tube-head during mode X- Ray and Standby / no interruption during “Move”...
DR 400 | Remarks for HF-emission and immunity | 183 Cables, transducers and accessories Cables, transducers and accessories which were tested and found to comply with the collateral standard IEC60601-1-2 (EMC): Caution: Using cables and accessories not mentioned in this...
Page 184
184 | DR 400 | Remarks for HF-emission and immunity from type maximum remark length 24V, light push button, duple exposure protection) table output wall stand 3 x AWG18 20 m mandatory terminal (230 input terminal (1.0 mm table output...
DR 400 | Remarks for HF-emission and immunity | 185 For type 5520/200 only from type maximum remark length table output wall stand input 9 pin sub D 20 m shielded terminal terminal (CAN) Optional from type maximum remark length...
Need help?
Do you have a question about the DR 400 and is the answer not in the manual?
Questions and answers